Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care, 51732-51834 [2019-20736]
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Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 403, 416, 418, 441, 460,
482, 483, 484, 485, 486, 488, 491, and
494
[CMS–3346–F; CMS–3334–F; CMS–3295–F]
RIN 0938–AT23
Medicare and Medicaid Programs;
Regulatory Provisions To Promote
Program Efficiency, Transparency, and
Burden Reduction; Fire Safety
Requirements for Certain Dialysis
Facilities; Hospital and Critical Access
Hospital (CAH) Changes To Promote
Innovation, Flexibility, and
Improvement in Patient Care
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
This final rule reforms
Medicare regulations that are identified
as unnecessary, obsolete, or excessively
burdensome on health care providers
and suppliers. This final rule also
increases the ability of health care
professionals to devote resources to
improving patient care by eliminating or
reducing requirements that impede
quality patient care or that divert
resources away from furnishing high
quality patient care. Additionally, this
rule updates fire safety standards for
Medicare and Medicaid participating
End-Stage Renal Disease (ESRD)
facilities by adopting the 2012 edition of
the Life Safety Code and the 2012
edition of the Health Care Facilities
Code. Finally, this final rule updates the
requirements that hospitals and Critical
Access Hospitals (CAHs) must meet to
participate in the Medicare and
Medicaid programs. These requirements
are intended to conform to current
standards of practice and support
improvements in quality of care, reduce
barriers to care, and reduce some issues
that may exacerbate workforce shortage
concerns.
DATES:
Effective date: These regulations are
effective on November 29, 2019. The
incorporation by reference of certain
publications listed in the rule is
approved by the Director of the Federal
Register as of November 29, 2019.
Implementation dates: The
regulations at § 485.641 regarding
Quality Assessment and Performance
Improvement Programs (QAPI) in
critical access hospitals (CAHs) must be
implemented by March 30, 2021.
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SUMMARY:
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The regulations at § 482.42(b) and
§ 485.640(b) regarding hospital and
critical access hospital (CAH) antibiotic
stewardship programs must be
implemented by March 30, 2020.
FOR FURTHER INFORMATION CONTACT:
For issues related to Regulatory
Provisions to Promote Program
Efficiency, Transparency, and Burden
Reduction, contact Kristin Shifflett,
(410) 786–4133.
For issues related to Fire Safety
Requirements for Certain Dialysis
Facilities, contact Kristin Shifflett, (410)
786–4133.
For issues related to the Hospital and
Critical Access Hospital (CAH) Changes
to Promote Innovation, Flexibility, and
Improvement in Patient Care, contact
CAPT Scott Cooper, USPHS, (410) 786–
9465, Mary Collins, (410) 786–3189,
Alpha-Banu Wilson, (410) 786–8687, or
Kianna Banks, (410) 786–3498.
SUPPLEMENTARY INFORMATION: We note
that this rule finalizes provisions that
were proposed in three separate
proposed rules that were published in
the Federal Register on separate dates.
Specifically, we are finalizing the
provisions of the following proposed
rules, discussed as follows:
• ‘‘Regulatory Provisions to Promote
Program Efficiency, Transparency, and
Burden Reduction,’’ published
September 20, 2018 (83 FR 47686);
• ‘‘Hospital and Critical Access
Hospital (CAH) Changes to Promote
Innovation, Flexibility, and
Improvement in Patient Care,’’
published June 16, 2016 (81 FR 39448);
and
• ‘‘Fire Safety Requirements for
Certain Dialysis Facilities,’’ published
November, 4, 2016 (81 FR 76899)
To assist readers in referencing
sections contained in this preamble, we
are providing a table of contents.
Table of Contents
I. Final Rule: Regulatory Provisions To
Promote Program Efficiency,
Transparency, and Burden Reduction
A. Executive Summary and Background
1. Purpose
2. Summary of Major Provisions
3. Summary of Costs and Benefits for
Regulatory Provisions To Promote
Program Efficiency, Transparency, and
Burden Reduction
B. Provisions of the Proposed Rule and
Analysis and Response to Public
Comments
1. Religious Nonmedical Health Care
Institutions (RNHCIs)—Discharge
Planning
2. Ambulatory Surgical Centers
3. Hospice
4. Hospitals
5. Transplant Centers
6. Home Health Agencies
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7. Comprehensive Outpatient
Rehabilitation Facility (CORF)—
Utilization Review Plan
8. Critical Access Hospitals
9. Community Mental Health Center
10. Portable X-Ray Services
11. Rural Health Clinics (RHCs) and
Federally Qualified Health Centers
(FQHCs)
12. Emergency Preparedness for Providers
and Suppliers
13. Technical Corrections
14. Waiver of Proposed Rulemaking
C. Collection of Information Requirements
II. Final Rule: Fire Safety Requirements for
Certain Dialysis Facilities
A. Background
B. Provisions of the Proposed Rule and
Analysis and Response to Public
Comments
1. 2012 Edition of the Life Safety Code
2. Incorporation by Reference
3. Ambulatory Health Care Occupancies
4. 2012 Edition of the Health Care
Facilities Code
5. Technical Corrections
C. Collection of Information Requirements
III. Final Rule: Hospital and Critical Access
Hospital (CAH) Changes To Promote
Innovation, Flexibility, and
Improvement in Patient Care
A. Background
B. Provisions of the Proposed Rule and
Analysis and Response to Public
Comments for Hospitals
1. General Comments
2. Implementation Timeframe
3. Non-Discrimination
4. Licensed Independent Practitioner
5. Quality Assessment and Performance
Improvement (QAPI) Program
6. Nursing Services
7. Medical Record Services
8. Infection Prevention and Control and
Antibiotic Stewardship Programs
9. Technical Corrections
C. Provisions of the Proposed Regulations
and Responses to Public Comments for
Critical Access Hospitals
1. Organization Structure
2. Periodic Review of Clinical Privileges
and Performance
3. Provision of Services
(§ 485.635(a)(3)(vii))
4. Provision of Services (§ 485.635(g))
5. Infection Prevention and Control and
Antibiotic Stewardship Programs
(§ 485.640)
6. Quality Assessment and Performance
Improvement (QAPI) Program (§ 485.641)
7. Technical Corrections
D. Requirements for Issuance of
Regulations
E. Collection of Information Requirements
for Hospital and Critical Access Hospital
(CAH) Changes To Promote Innovation,
Flexibility, and Improvement in Patient
Care
IV. Economic Analyses
A. Regulatory Impact Analysis for
Regulatory Provisions To Promote
Program Efficiency, Transparency, and
Burden Reduction
1. Statement of Need
2. Overall Impact
3. Anticipated Effects
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4. Alternatives Considered
5. Uncertainty
6. Conclusion
B. Regulatory Impact Statement for Fire
Safety Requirements for Certain Dialysis
Facilities
C. Regulatory Impact Analysis for Hospital
and Critical Access Hospital (CAH)
Changes to Promote Innovation,
Flexibility, and Improvement in Patient
Care
1. Statement of Need
2. Overall Impact
3. Anticipated Effects
4. Effects on Small Entities
5. Alternatives Considered
6. Conclusion
D. Accounting Statement and Table
E. Regulatory Reform Analysis Under E.O.
13771
I. Final Rule: Regulatory Provisions To
Promote Program Efficiency,
Transparency, and Burden Reduction
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A. Executive Summary and Background
1. Purpose
Over the past several years, we have
revised our requirements, Conditions of
Participation (CoPs) and Conditions for
Coverage/Conditions for Certification
(CfCs) to reduce the regulatory burden
on providers and suppliers while
emphasizing health and safety. We
identified obsolete and burdensome
regulations that could be eliminated or
reformed to improve effectiveness or
reduce unnecessary reporting
requirements and other costs, with a
particular focus on freeing up resources
that health care providers, health plans,
and States could use to improve or
enhance patient health and safety. We
also examined policies and practices not
codified in rules that could be changed
or streamlined to achieve better
outcomes for patients while reducing
burden on providers and suppliers of
care, and we identified non-regulatory
changes to increase transparency and to
become a better business partner. In
addition, the Centers for Medicare &
Medicaid Services (CMS) and the
Department of Health and Human
Services (HHS) have reaffirmed their
commitment to the vision of creating an
environment where agencies
incorporate and integrate the ongoing
retrospective review of regulations into
Department operations to achieve a
more streamlined and effective
regulatory framework. The objectives
were to improve the quality of existing
regulations consistent with statutory
requirements; streamline procedural
solutions for businesses to enter and
operate in the marketplace; maximize
net benefits (including benefits that are
difficult to quantify); and reduce costs
and other burdens on businesses to
comply with regulations.
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In accordance with these goals, we
published three final rules that
identified unnecessary, obsolete, or
excessively burdensome regulations on
health care providers, suppliers, and
beneficiaries. These rules further
increased the ability of health care
professionals to devote resources to
improving health care by eliminating or
reducing requirements that impede
quality patient care or that divert
providing high quality patient care:
• ‘‘Reform of Hospital and Critical
Access Hospital Conditions of
Participation’’, published May 16, 2012
(77 FR 29034);
• ‘‘Regulatory Provisions to Promote
Program Efficiency, Transparency, and
Burden Reduction’’, published May 16,
2012 (77 FR 29002) and;
• ‘‘Regulatory Provisions to Promote
Program Efficiency, Transparency, and
Burden Reduction; Part II’’, published
May 12, 2014 (79 FR 27105).
This final rule is a continuation of our
efforts to reduce regulatory burden and
is in accordance with the January 30,
2017 Executive Order ‘‘Reducing
Regulation and Controlling Regulatory
Costs’’ (Executive Order 13771). We are
finalizing changes to the current
requirements, CoPs, and CfCs that will
simplify and streamline the current
regulations and thereby increase
provider flexibility and reduce
excessively burdensome regulations,
while also allowing providers to focus
on providing high-quality healthcare to
their patients. This final rule will also
reduce the frequency of certain required
activities and, where appropriate, revise
timelines for certain requirements for
providers and suppliers and remove
obsolete, duplicative, or unnecessary
requirements. We believe these policies
balance patient safety and quality, while
also providing broad regulatory relief for
providers and suppliers.
In the proposed rule, we stated that
we seek to reduce burdens for health
care providers and patients, improve the
quality of care, decrease costs, and
ensure that patients and their providers
and physicians are making the best
health care choices possible. Therefore,
we solicited public comments on
additional regulatory reforms for burden
reduction in future rulemaking.
Specifically, we sought public comment
on additional proposals or
modifications to the proposals set forth
in the proposed rule, ‘‘Regulatory
Provisions to Promote Program
Efficiency, Transparency, and Burden
Reduction,’’ published September 20,
2018 (83 FR 47686) that would further
reduce burden on Medicare and
Medicaid participating providers and
suppliers and create cost savings, while
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51733
also preserving quality of care and
patient health and safety. We also noted
in the proposed rule (83 FR 47686),
consistent with our ‘‘Patients Over
Paperwork’’ Initiative, that we are
particularly interested in improving
existing requirements, within our
statutory authority, where the
requirements as currently written make
providing quality care difficult or less
effective. We also noted that such
suggestions could include or expand
upon comments submitted in response
to Requests for Information (RFIs) that
were included in the 2017 prospective
payment regulations for most provider
types.
2. Summary of Major Provisions
We are reducing regulatory burden on
providers and suppliers by modifying,
removing, or streamlining current
regulations that we now believe are
unnecessary, obsolete or excessively
burdensome. Specifically, we are
finalizing the following revisions:
a. Discharge Planning in Religious
Nonmedical Health Care Institutions
(RNHCIs)
We have revised the requirements at
42 CFR 403.736(a) and (b) pertaining to
a discharge plan. This revision
simplifies the discharge process for
RNHCIs by requiring them to assess the
need for a discharge plan and provide
discharge instructions to the patient and
the patient’s caregiver as necessary
when the patient is discharged home.
b. Ambulatory Surgical Center (ASC):
Transfer Agreements With Hospitals
We are replacing the requirement at
§ 416.41(b)(3), that ASCs have written
transfer agreements or privileges with
the local hospital with a requirement
that ASCs must periodically provide the
local hospital with written notice of its
operation and patient population
served.
c. ASC Requirements for
Comprehensive Medical History and
Physical Assessment
We are removing the current
requirements at § 416.52(a) for a History
and Physical within 30 days of the
procedure and replacing them with
requirements that defer, to a certain
extent, to the ASC policy and operating
physician’s clinical judgment to ensure
that patients receive the appropriate
pre-surgical assessments tailored to the
patient and the type of surgery being
performed. We still require the
operating physician to document any
pre-existing medical conditions and
appropriate test results, in the medical
record, before, during and after surgery.
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In addition, we have retained the
requirement that all pre-surgical
assessments include documentation
regarding any allergies to drugs and
biologicals, and that the medical history
and physical examination (H&P), if
completed, be placed in the patient’s
medical record prior to the surgical
procedure.
d. Hospice Requirements for Medication
Management
We are removing the procedural
requirements at § 418.106(a)(1), related
to having on the hospice staff, an
individual with specialty knowledge of
hospice medications.
e. Hospice Requirements: Orientation of
Skilled Nursing Facility (SNF) and
Intermediate Care Facilities for
Individuals With Intellectual
Disabilities (ICF/IID) Staff
We are revising the requirements at
§ 418.112(f) to explicitly require
hospices to coordinate with SNFs/NFs
and ICFs/IID for assuring orientation of
facility staff.
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f. Hospital Quality Assessment and
Performance Improvement Program
(QAPI Program)
We are finalizing a new standard at 42
CFR 482.21(f), ‘‘Unified and integrated
QAPI program for multi-hospital
systems.’’ For a hospital that is part of
a hospital system, consisting of multiple
separately certified hospitals using a
system governing body that is legally
responsible for the conduct of two or
more hospitals, the system governing
body can elect to have a unified and
integrated QAPI program for all of its
member hospitals if the arrangement is
in accordance with all applicable State
and local laws. The system governing
body is responsible and accountable for
ensuring that each of its separately
certified hospitals meets all of the
requirements of this section.
g. Hospital Requirements for
Comprehensive Medical History and
Physical Examinations (§§ 482.22,
482.24, and 482.51)
We are allowing hospitals the
flexibility to establish a medical staff
policy describing the circumstances
under which such hospitals can utilize
a pre-surgery/pre-procedure assessment
for an outpatient, instead of a
comprehensive medical history and
physical examination (H&P). We believe
that allowing this option will greatly
reduce the burden on the hospital, the
practitioner, and the patient. In order to
exercise this option, a hospital must
document the assessment in a patient’s
medical record. The hospital’s policy
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must consider patient age, diagnoses,
the type and number of surgeries and
procedures scheduled to be performed,
comorbidities, and the level of
anesthesia required for the surgery or
procedure; nationally recognized
guidelines and standards of practice for
assessment of specific types of patients
prior to specific outpatient surgeries and
procedures; and applicable state and
local health and safety laws.
h. Hospital Infection Control Program
We are broadly revising § 482.42, and
issuing a new standard at § 482.42(d),
‘‘Unified and integrated infection
prevention and control and antibiotic
stewardship programs for multi-hospital
systems.’’ Like the requirement for a
unified and integrated QAPI program,
the standard for infection control
permits a hospital that is part of a
hospital system consisting of multiple
separately certified hospitals using a
single governing body, such body can
elect to have a unified and integrated
infection prevention and control
program for all of its member hospitals
in accordance with all applicable State
and local laws. The system governing
body is responsible and accountable for
ensuring that each of its separately
certified hospitals meets all of the
requirements of this section. Each
separately certified hospital within the
system must demonstrate that—the
unified and integrated infection control
program is established in a manner that
takes into account each member
hospital’s unique circumstances and
any significant differences in patient
populations and services offered in each
hospital; the unified and integrated
infection control program establishes
and implements policies and
procedures to ensure that the needs and
concerns of each of its separately
certified hospitals, regardless of practice
or location, are given due consideration,
and that the unified and integrated
infection control program has
mechanisms in place to ensure that
issues localized to particular hospitals
are duly considered and addressed; and
a qualified individual (or individuals)
has been designated at the hospital as
responsible for communicating with the
unified infection control program and
for implementing and maintaining the
policies and procedures governing
infection control as directed by the
unified infection control program.
i. Special Requirements for Psychiatric
Hospitals
At § 482.61(d), we are clarifying the
scope of authority for non-physician
practitioners or Doctors of Medicine and
Doctors of Osteopathic Medicine (MD/
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DOs) to document progress notes of
patients receiving services in
psychiatric hospitals.
j. Special Requirement for Transplant
Centers and Definitions
We are making a nomenclature
change at 42 CFR part 482 and the
transplant center regulations at
§§ 482.68, 482.70, 482.72 through
482.104, and at § 488.61. This change
updates the terminology used in the
regulations to conform to the
terminology that is widely used and
understood within the transplant
community, thereby reducing provider
confusion.
k. Data Submission, Clinical Experience,
and Outcome Requirements for ReApproval of Transplant Centers
We are removing the requirements at
§ 482.82 that state that transplant
centers must meet all data submission,
clinical experience, and outcome
requirements in order to obtain
Medicare re-approval. Transplant
centers will still be required to comply
with the CoPs at §§ 482.72 through
482.104 and the data submission,
clinical experience, and outcome
requirements for initial Medicare
approval under § 482.80.
l. Special Procedures for Approval and
Re-Approval of Organ Transplant
Centers
We are revising § 488.61(f) through (h)
to remove the requirements with respect
to the re-approval process for transplant
centers. This change corresponds to the
proposed removal of the provisions at
§ 482.82. We are retaining the
requirements in § 488.61(f) through (h)
that pertain to the initial approval
process for transplant centers.
m. Home Health Agency (HHA)
Requirements for Verbal Notification of
Patient Rights and Responsibilities
We are removing the requirements for
verbal (meaning spoken) notification of
all patient rights at § 484.50(a)(3), and
replacing it with a requirement that
verbal notice must be provided for those
rights related to payments made by
Medicare, Medicaid, and other federally
funded programs, and potential patient
financial liabilities as specified in the
Social Security Act (the Act).
n. Personnel Requirements for Portable
X-Ray Technologists
We are revising § 486.104(a),
‘‘Condition for coverage: Qualifications,
orientation and health of technical
personnel’’, to focus on the
qualifications of the individual
performing services.
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o. Portable X-Ray Requirements for
Orders
We are revising the requirements for
portable x-ray orders at § 486.106(a)(2)
by removing the requirement that
physician or non-physician
practitioner’s orders for portable x-ray
services must be written and signed and
replacing the specific requirements
related to the content of each portable
x-ray order with a cross-reference to the
requirements at 42 CFR 410.32, which
also apply to portable x-ray services.
p. Emergency Preparedness
Requirements: Requirements for
Emergency Plans
We are removing the requirements
from our emergency preparedness rules
for Medicare and Medicaid providers
and suppliers that facilities document
efforts to contact local, tribal, regional,
State, and Federal emergency
preparedness officials, and that facilities
document their participation in
collaborative and cooperative planning
efforts.
q. Emergency Preparedness
Requirements: Requirements for Annual
Review of Emergency Program
We are revising this requirement so
that applicable providers and suppliers
review their Emergency program
biennially, except for Long Term Care
facilities, which will still be required to
review their emergency program
annually.
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r. Emergency Preparedness
Requirements: Requirements for
Training
We are revising the requirement that
facilities develop and maintain a
training program based on the facility’s
emergency plan annually by requiring
facilities to provide training biennially
(every 2 years) after facilities conduct
initial training for their emergency
program, except for long term care
facilities which will still be required to
provide training annually. In addition,
we are requiring additional training
when the emergency plan is
significantly updated.
s. Emergency Preparedness
Requirements: Requirements for Testing
For inpatient providers, we are
expanding the types of acceptable
testing exercises that may be conducted.
For outpatient providers, we are
revising the requirement such that only
one testing exercise is required
annually, which may be either one
community-based full-scale exercise, if
available, or an individual facility-based
functional exercise, every other year and
in the opposite years, these providers
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may choose the testing exercise of their
choice.
2. Proposals That Reduce the Frequency
of Activities and Revise Timelines
a. Comprehensive Outpatient
Rehabilitation Facility (CORF)
Utilization Review Plans
We are amending the utilization
review plan requirements at § 485.66 to
reduce the frequency of utilization
reviews from quarterly to annually. This
would allow an entire year to collect
and analyze data to inform changes to
the facility and the services provided.
b. CAH Annual Review of Policies and
Procedures
We are changing the requirement at
§ 485.635(a)(4) to require a CAH’s
professional personnel to, at a
minimum, conduct a biennial review of
its policies and procedures instead of an
annual review.
c. Community Mental Health Center
(CMHC) Requirements for Updating the
Client Assessment
At § 485.914, we are removing the
requirement that all CMHC clients
receive an updated assessment every 30
days. Instead, we would require updates
of the patient assessment in accordance
with client needs and standards of
practice. For clients receiving partial
hospitalization services, we are
retaining the 30-day assessment update
time frame to be consistent with existing
Medicare payment requirements for
recertification of partial hospitalization
services.
d. Rural Health Clinic (RHC) and
Federally Qualified Health Center
(FQHC) Review of Patient Care Policies
We are revising the requirement at
§ 491.9(b)(4) that RHC and FQHC
patient care policies be reviewed at least
annually by a group of professional
personnel, to review every other year in
order to reduce the frequency of policy
reviews.
e. RHC and FQHC Program Evaluation
We are revising the requirement at
§ 491.11(a) by changing the frequency of
the required RHC or FQHC evaluation
from annually to every other year.
3. Proposals That Are Obsolete,
Duplicative, or That Contain
Unnecessary Requirements
a. Hospice Aide Training and
Competency Requirements
We are revising § 418.76(a)(1)(iv) to
remove the requirement that a State
licensure program meet the specific
training and competency requirements
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51735
set forth in § 418.76(b) and (c) in order
for such licensure to qualify a hospice
aide to work at a Medicare-participating
hospice, deferring to State licensure
requirements.
b. Medical Staff: Autopsies
We are finalizing our proposal to
remove the requirement for hospitals at
§ 482.22(d), which states that a
hospital’s medical staff should attempt
to secure autopsies in all cases of
unusual deaths and of medical-legal and
educational interest. We are deferring to
State law regarding such medical-legal
requirements.
c. Hospital and CAH Swing-Bed
Requirements
We are removing the cross reference
to § 483.10(f)(9) at § 482.58(b)(1) (for
hospital swing-bed providers) and
§ 485.645(d)(1) (for CAH swing-bed
providers); the repealed provisions gave
a resident the right to choose to, or
refuse to, perform services for the
facility if they so choose.
We are removing the cross-reference
to § 483.24(c) at § 482.58(b)(4) (for
hospital swing-bed providers) and
§ 485.645(d)(4) (for CAH swing-bed
providers) requiring that the facility
provide an ongoing activity program
based on the resident’s comprehensive
assessment and care plan directed by a
type of qualified professional specified
in the regulation.
We are removing the cross-reference
to § 483.70(p) at § 482.58(b)(5) (for
hospital swing-bed providers) and
§ 485.645(d)(5) (for CAH swing-bed
providers requiring facilities with more
than 120 beds to employ a social worker
on full-time basis).
We are removing the cross-reference
to § 483.55(a)(1) at § 482.58(b)(8) (for
hospital swing-bed providers) and
§ 485.645(d)(8) (for CAH swing-bed
providers) requiring that the facility
assist residents in obtaining routine and
24-hour emergency dental care.
d. Home Health Agency Home Health
Aide Requirements
We are revising § 484.80(c)(1) to
clarify that skill competencies may be
assessed by observing an aide
performing the skill with either a
patient or a pseudo-patient as part of a
simulation. We are defining the terms
‘‘pseudo-patient’’ and ‘‘simulation’’ in
§ 484.2.
We are revising the requirement at
§ 484.80(h) related to completing a full
competency evaluation when an aide is
found to be deficient in one or more
skills. Instead of completing a full
competency evaluation, an aide would
only be required to complete retraining
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and a competency evaluation directly
related to the deficient skills.
e. CAH Disclosure Requirements
We are removing § 485.627(b)(1), the
requirement for CAHs to disclose the
names of people with a financial
interest in the CAH. This is currently a
requirement under the program integrity
requirements at 42 CFR 420.206, which
are referenced in the provider agreement
rules in 42 CFR 489.53(a)(8), making
this CAH CoP requirement duplicative
of those regulations.
3. Summary of Costs and Benefits for
Regulatory Provisions To Promote
Efficiency, Transparency, and Burden
Reduction
1. Overall Impact
This final rule will create savings and
reduce burden in many areas. Several of
the changes will create measurable
monetary savings for providers and
suppliers, while others will create less
quantifiable savings of time and
administrative burden. We anticipate a
total first year net savings of
approximately $843 million, and
slightly more in future years.
2. Section-by-Section Economic Impact
Estimates
Table 1 summarizes the provisions for
which we are able to provide specific
estimates for savings or burden
reductions (these estimates are
uncertain and could be substantially
higher or lower, as explained in the
regulatory impact analysis section of
this final rule):
TABLE 1—SUMMARY OF NET SAVINGS BY PROVISION
Provider and supplier type and description of proposed provisions
Religious Nonmedical Health Care Institutions:
• Discharge Planning .......................................
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Ambulatory Surgical Centers:
• Governing Body and Management ...............
• Patient Admission, Assessment and Discharge (History and Physical).
• Medical Records ...........................................
Hospices:
• Drugs and Biologicals, Medical Supplies,
and Durable Medical Equipment ***.
• Hospices That Provide Hospice Care to
residents of a SNF/NF or ICF/IID.
• Hospice Aide and Homemaker Services ......
Hospitals:
• Quality Assessment and Performance Improvement Program.
• Medical staff: Autopsies ................................
• Infection Control ............................................
• Special requirements for hospital providers
of long-term care services (‘‘swing-beds’’).
• Special Requirements for Psychiatric Hospitals.
• Patient Admission, Assessment and Discharge (History and Physical).
Transplant programs:
• Various provisions related to performance **
Home Health Agencies:
• Patient rights .................................................
• Home health aide services ...........................
• Clinical records .............................................
Critical Access Hospitals:
• Provision of Services ....................................
• Organizational structure ................................
• Special requirements for CAH providers of
long-term care services (‘‘swing-beds’’).
Comprehensive Outpatient Rehabilitation Facilities:
• Utilization Review Plan .................................
Community Mental Health Centers:
• Assessment Update ......................................
Portable X-Ray Services:
• Qualifications of X-ray technicians *** ...........
• Removing written orders ...............................
RHC (4,160 clinics) & FQHC (7,874 center locations):
• Patient Care Policies Review .......................
• Program Evaluation ......................................
Emergency Preparedness for Providers and Suppliers:
• Review of Emergency Preparedness Program.
• Emergency Plan ............................................
• Training and Testing—Training Program .....
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Number of
affected
entities
Frequency
Estimated savings
(annualized,
$millions)
As patients are discharged (Estimated 619 annual
discharges).
18
Upon failed hospital transfer agreement attempts ..
Every patient registration at an ASC or at a hospital outpatient/.
ambulatory surgery department ..............................
Recurring annually ..................................................
5,557
5,557
(*)
77.
5,557
0.
Recurring annually ..................................................
4,602
94.
Recurring annually ..................................................
4,602
1.
Recurring annually ..................................................
4,602
2.
Recurring annually ..................................................
4,823
31.
Recurring annually ..................................................
Recurring annually ..................................................
Recurring annually ..................................................
4,823
4,823
478
0.
115.
30.
Recurring annually ..................................................
620
154.
Every patient registration at an ASC or at a hospital outpatient/ambulatory surgery department.
4,823
Recurring annually ..................................................
750
Not Quantified.
Recurring annually ..................................................
Recurring annually ..................................................
Recurring annually ..................................................
12,624
12,624
12,624
57.
Not Quantified.
Not Quantified.
Recurring biennially .................................................
Recurring annually ..................................................
Recurring annually ..................................................
1,353
1,353
1,246
Recurring annually ..................................................
188
(*)
Recurring annually ..................................................
52
(*)
Recurring annually ..................................................
Recurring annually ..................................................
500
500
31.
28.
Recurring biennially .................................................
Recurring biennially .................................................
12,034
12,034
4.
5.
Recurring biennially .................................................
56,983
70.
Recurring annually ..................................................
Recurring biennially .................................................
68,275
53,543
7.
26.
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(*)
77.
1.
(*)
77.
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51737
TABLE 1—SUMMARY OF NET SAVINGS BY PROVISION—Continued
Provider and supplier type and description of proposed provisions
• Training and Testing—Testing ......................
Number of
affected
entities
Frequency
Recurring annually ..................................................
36,971
Estimated savings
(annualized,
$millions)
21.
* Amount is less than half a million dollars and rounds to zero.
** These include changes to the following requirements: Special Requirements for Transplant Programs; Data submission, Clinical Experience,
and Outcome Requirement for Re-approval of Transplant Programs; and Special Procedures for Approval and Re-Approval of Organ Transplant
Programs.
*** This estimate is for first full year savings only and will increase in future years.
B. Provisions of the Proposed Rule and
Analysis and Response to Public
Comments on ‘‘Medicare and Medicaid
Programs; Regulatory Provisions To
Promote Program Efficiency,
Transparency, and Burden Reduction’’
In response to our September 20, 2018
proposed rule (83 FR 47686), we
received 620 public comments.
Commenters included individuals,
healthcare professionals and
corporations, national associations,
health departments and emergency
management professionals, and
individual facilities that would be
impacted by the regulation. Generally,
the comments received were supportive.
Most comments were centered around
the proposed revisions to the emergency
preparedness regulations for Medicare
and Medicaid providers and suppliers.
We have organized our responses to the
comments as follows: (1) Comments
specific to individual types of providers
and suppliers (2); general comments;
and (3) comments regarding our savings
estimates.
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1. Religious Nonmedical Health Care
Institutions (RNHCIs)—Discharge
Planning (§ 403.736(a) and (b))
Section 1861(ss)(1) of the Act defines
the term ‘‘Religious Nonmedical Health
Care Institution’’ (RNHCI) and lists the
requirements that a RNHCI must meet to
be eligible for Medicare participation.
Section 403.736(a) and (b) of the
RNHCI’s CoPs, as amended in the
November 28, 2003 Federal Register (68
FR 66710), requires RNHCIs to have a
discharge planning process for patients.
Since the RNHCI’s religious tenets
prohibit conventional or
unconventional medical treatment of a
beneficiary, and medical postinstitution services are not utilized by
RNHCI patients, we believe that
extensive discharge requirements are
unnecessarily burdensome. Therefore,
we proposed a more condensed and
flexible process for discharge planning
and instructions for RNHCIs. We
proposed to remove the requirements at
§ 403.736(a) and (b), and proposed
instead to require RNHCIs to provide
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discharge instructions to the patient or
the patient’s caregiver when the patient
is discharged home.
The majority of commenters
expressed strong support for the
proposed changes to the RNHCIs
discharge planning process. We did not
receive any comments in opposition to
the proposed requirement; therefore, we
are incorporating the changes as
proposed in this final rule.
Comment: One commenter stated that
they agreed with allowing flexibility
and giving the institution the freedom to
determine which patients should be
provided a discharge plan. However,
they commented that there should be a
way to monitor this process to make
institutions accountable and not omit
providing a discharge plan if a patient
needs one.
Response: As for all providers and
suppliers, Medicare surveys RNHCIs for
compliance with the CoPs. We believe
this enforcement process adequately
ensures that RNHCIs are correctly
interpreting and following our
requirements.
Comment: The majority of the
commenters stated that they agree with
the changes proposed to the discharge
planning process at § 403.736(a) and (b).
They stated that this change would
reduce burden and allow greater
flexibility to the RNHCIs.
Response: We appreciate the
comments received on the proposed
changes for RNHCIs and will finalize
the changes as proposed.
Final Rule Action: We are finalizing
the proposed changes without changes.
Contact: Mary Collins, (410) 786–
3189.
2. Ambulatory Surgical Centers
Section 416.2 of our rules defines an
ambulatory surgical center (ASC) as any
distinct entity that operates exclusively
for the purpose of providing surgical
services to patients not requiring
hospitalization, in which the expected
duration of services would not exceed
24 hours following an admission. The
surgical services performed at ASCs are
scheduled, primarily elective, non-lifethreatening procedures that can be
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safely performed in an ambulatory
setting. We received 99 timely public
comments on our proposed changes to
the ASC CfC requirements. Commenters
included ASC industry associations,
healthcare systems, national
accreditation organizations, clinician
associations, individual ASCs, and
clinicians. Overall, the majority of the
commenters were supportive of the
goals of the proposed changes.
Summaries of the major issues and our
responses are set forth below.
a. Governing Body and Management;
Hospitalization Requirements
(§ 416.41(b)(3)(i) and (ii))
We proposed to remove the
requirement for a written hospital
transfer agreement or hospital physician
admitting privileges at § 416.41(b)(3).
The requirements in § 416.41(b)(1) and
(2) continue to require the ASC to have
an effective procedure for the immediate
transfer, to a hospital, of patients
requiring emergency medical care
beyond the capabilities of the ASC and
that the hospital must be a local hospital
that meets the requirements for payment
for emergency services under § 482.2.
As part of this revision, ASCs are not
precluded from obtaining hospital
transfer agreements or hospital
physician admitting privileges when
possible.
Comment: The comments submitted
regarding the removal of the transfer
agreement were almost evenly split
between supporters and opponents.
Specifically, the ASCs supported the
removal of the transfer agreement and
hospitals were opposed to the removal
of the transfer agreement. Comments in
support of removal of the written
hospital transfer agreement stated that
the current requirement is unnecessary,
obsolete and extremely burdensome
because of the small number of patient
transfers, the creation of The Emergency
Medical Treatment and Labor Act
(EMTALA), and the exhaustive
administrative paperwork and
negotiation burden that is required
when the local hospital system refuses
to sign the written hospital transfer
agreement. Comments in support of the
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removal also stated that ASCs should
not be forced to close their businesses
because regulations cannot be met due
to competition issues with the local
hospital and their outpatient surgery
center. Comments opposing removal of
the written hospital transfer agreement
stated that transfer agreements have the
potential to ensure that there is a plan
for emergencies, that appropriate
continued care will be delivered, and
that both the ASC and hospital
communicate with one another. In
addition, we received several comments
that suggested the regulation should
instead specify that the ASC would be
deemed to have met the hospital
transfer agreement provision if a ‘‘good
faith effort’’ was documented. One
commenter suggested that instead of an
all or nothing provision, ASCs should
periodically provide local hospitals
with a written notice. The commenter
contended that this requirement would
notify the hospital of ASC services in
the community and the types of patients
that are receiving care that may need
additional care beyond the capability of
the ASC.
Response: We continue to believe
that, because of the existing EMTALA
regulations, the small number of
transfers, and the burden ASCs incur
when faced with local hospital
competition issues, removing this
requirement is necessary and
appropriate. We agree that
communication between ASCs and
hospitals is important; however, we do
not agree that a mandated transfer
agreement is a necessary or effective
method to assure this communication.
In response to the commenter’s
suggestions described above, and to
assure that hospitals are aware of the
potential for receiving patient transfers
from an ASC, we are revising our
proposal at § 416.41(b)(3) to require the
ASC to periodically provide the local
hospital with written notice of its
operation and patient population
served. For example, the notice would
include details such as hours of
operation and the procedures that are
performed in the ASC. Providing
written notice, rather than securing a
transfer agreement, will alleviate the
administrative burden of negotiating or
being denied negotiating opportunities
associated with the requirement of a
written transfer agreement between the
ASC and hospital. We are requiring that
the notice be provided ‘‘periodically’’ to
the local hospital to ensure the ASC
keeps the local hospital informed and
up-to-date on ASC information and any
patient population changes. The
‘‘periodically’’ phrasing is similar to the
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reappraisal requirement for the medical
staff privileges in ASCs located at
§ 416.45(b), ‘‘Medical staff- Standard:
Reappraisals’’, and is meant to have the
same meaning. This change does not
preclude those ASCs and hospitals with
functional working relationships to
continue to have written transfer
agreements, which we encourage, and
prior preparations in place for patient
transfers in the event of an emergency.
b. Patient Admission, Assessment and
Discharge (§ 416.52(a)(1), (2), (3) and (4))
The current regulations at § 416.52
require ASCs to ensure that a physician
or other qualified practitioner provide a
comprehensive medical history and
physical assessment (H&P) completed
not more than 30 days before the date
of the scheduled surgery.
We proposed to remove the current
requirements at § 416.52(a) and replace
them with requirements under the
facility’s established policies for presurgical medical histories and physical
examinations (H&P), including any
associated testing, and the operating
physician’s clinical judgment, to ensure
patients receive the appropriate presurgical assessments that are tailored for
the patient and the type of surgery being
performed. We proposed to require each
ASC to establish and implement a
policy that identifies patients who
require an H&P prior to surgery. We
proposed that the policy would include
the time frame for the H&P to be
completed prior to surgery. We
proposed that the policy would be
required to consider the age of patients,
their diagnoses, the type and number of
surgeries that are scheduled to be
performed at one time, all known
comorbidities, and the planned level of
anesthesia for the surgery to be
performed. ASCs would not be limited
to these factors, and would be permitted
to include others to meet the needs of
their patient populations. Furthermore,
we proposed that each ASC’s policy
would be required to follow nationally
recognized standards of practice and
guidelines, as well as applicable state
and local health and safety laws. To
conform to the proposed changes to the
medical history and physical
examination requirements at § 416.52(a),
we proposed to revise the requirement
at § 416.47(b)(2), that states ‘‘Significant
medical history and results of physical
examination,’’ by adding ‘‘as
applicable.’’
Comment: A majority of commenters
supported the proposed change to
remove the medical H&P examination
requirement no more than 30 days
before the date of the scheduled surgery,
and defer to the ASCs established
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policies for pre-surgical H&Ps and the
operating physician’s clinical judgment.
The comments agreed that allowing
ASCs flexibility to establish patient
policies, and encouraging the use of
clinician judgment, are appropriate to
assure patient health and safety while
also reducing the burden on patients
and providers, and reducing
expenditures on potentially unnecessary
pre-operative testing that is performed
because it is required by policy.
However, a small number of comments
supported only part of this change,
suggesting instead that CMS should
retain the H&P requirement while
allowing the ASC the discretion to
determine the timeframe for the H&P
relative to the date of surgery. Another
commenter opposed any changes and
recommended retaining the H&P
requirement and 30-day time frame. One
commenter stated that they believe the
burden of assessing patients prior to
surgery would be shifted from one
provider (the primary care physician) to
another (the anesthesiologist), and that
allowing ASCs the flexibility to
establish their own policies based on
their clinical judgment and patient
population needs would burden ASCs
and healthcare workers, create
inefficiencies, and lead to variations in
standards of care from facility to facility.
Response: We appreciate the support
of the vast majority of commenters, and
continue to believe that the change is
appropriate to support patient health
and safety while eliminating the
burdens of potentially unnecessary
examinations and tests. The content of
ASC-wide policies surrounding the
appropriate use of medical histories and
physicals, as well as pre-operative
testing, could be informed by specialty
societies, medical literature, past
experience, or other factors. We disagree
that variations between facilities would
be an inherently undesirable effect of
the change; variations to take into
account unique patient needs and
facility characteristics are preferable to
a ‘‘one size fits all’’ approach of
mandatory 30 day H&Ps. Allowing ASCs
and physicians to work together to
implement their own policies, based on
their clinical judgment and patient
population served, will provide the
most optimal balance between burden
and necessary examinations and testing,
by identifying when a medical H&P
examination should be completed, if
appropriate. We are finalizing the
proposal to require ASCs to address
certain patient characteristics, such as
age, diagnosis, the type and number of
procedures, comorbidities and the
planned anesthesia level, when
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developing their policies and
procedures for pre-surgical
examinations and testing. We believe
this change will ensure those patients
who would actually be protected by a
medical H&P examination will receive
one based on ASC policy, and in a time
frame established by that policy, thereby
reducing burden on physicians,
facilities, and patients. We reiterate that
ASCs are still required to perform a
patient assessment upon admission
before surgery, that the ASC is not
precluded from retaining the H&P
requirement in facility policies, and that
we are not discouraging pre-surgical
H&Ps where clinically indicated.
Comment: One commenter expressed
concern over the wording of the
proposed regulation text in
§ 416.52(a)(1)(iii), stating that the ASC
policy must follow nationally
recognized standards of practice and
guidelines. The commenter believed the
term ‘‘follow’’ could be problematic for
ASCs, and be interpreted as being
required to ‘‘adhere’’ to national
guidelines that are not delineated, thus
depriving the ASC of the ability to
determine what clinical practices make
the best sense for its patients.
Response: We agree and have revised
the regulation text to be consistent with
the regulation text that is being finalized
for hospital outpatient H&P
requirements. We are finalizing the
regulation text to state that the ASC
policy must be based on any applicable
nationally recognized standards of
practice and guidelines, and any
applicable State and local health and
safety laws.
Comment: One commenter asked
CMS to coordinate any changes to the
regulations with updates to the
accreditation organizations (AOs)
standards.
Response: National accreditation
organizations must meet or exceed CMS
standards, and their standards must be
updated, as appropriate, to reflect
changes in the CMS regulations. As AOs
may choose to exceed CMS
requirements, so they may choose to
retain any or all of the requirements that
we are removing in this final rule to the
extent that they do not conflict with any
of our revisions.
We did not receive any public
comments on the proposed technical
change to the medical records proposed
at § 416.47(b)(2) and are finalizing the
technical change to the medical records
section as proposed.
Final Rule Action:
1. Rather than deleting, we are
finalizing revisions to § 416.41(b)(3) to
require ASCs to periodically provide the
local hospital with written notice of its
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51739
operation and patient population
served.
2. We are finalizing the proposal to
revise the requirement at § 416.47(b)(2),
to state ‘‘Significant medical history and
results of physical examination, as
applicable.’’
3. We are finalizing the proposal to
eliminate the requirement at § 416.52(a)
for each patient to have a medical
history and physical assessment
completed by a physician not more than
30 days before the scheduled surgery,
and replace it with the requirement for
ASCs to develop and maintain a policy
that identifies those patients who
require a medical history and physical
examination prior to surgery. In
addition, require the policy to include
the timeframe for the medical history
and physical examination to be
completed prior to surgery. The policy
must also address, but not be limited to,
the following factors: Patient age,
diagnosis, the type and number of
procedures scheduled to be performed
on the same surgery date, known
comorbidities, and the planned
anesthesia level. Upon admission, each
patient must have a pre-surgical
assessment completed by a physician or
other qualified practitioner in
accordance with applicable State health
and safety laws, who will be performing
the surgery.
4. We are revising § 416.52(a)(1)(iii) to
clarify that the ASC policy must be
based on nationally recognized
standards of practice and guidelines,
and applicable State and local health
and safety laws.
Contact: CAPT Jacqueline Leach,
USPHS, 410–786–4282.
Response: Deference to stateestablished standards regarding the
training and competency of health care
professionals is standard practice. States
already establish such standards for
health care professions such as nursing,
laboratory technicians, phlebotomists,
and therapists, to name a few. Seventysix percent of states have already
established their own qualification
standards for aides, aides furnishing
services in those states are already
permitted to provide services to
individuals through private pay
agencies without meeting the Medicare
standards, and there is no indication
that these already applicable standards
are insufficient to assure patient health
and safety. As deference to state
standards is the norm across the health
care spectrum, and as current state
standards are already demonstrated to
be sufficient to assure patient health and
safety, we see no reason to impose a
separate Federal standard. Therefore, we
are finalizing this proposed change. In
the absence of state requirements,
hospices will continue to be required to
assure that an aide meets the Federal
training standards. Furthermore, all
hospices in all states will continue to be
required to comply with the existing
requirements that hospice aides may
only perform those skills that are
consistent with the training that the aide
has received (§ 418.76(g)(2)(iv)), and
that, if an area of concern is verified by
the hospice during an on-site aide
supervision visit, then the hospice must
conduct, and the hospice aide must
complete, a competency evaluation in
accordance with § 418.76(c) and
(h)(1)(iii).
3. Hospice
b. Drugs and Biologicals, Medical
Supplies, and Durable Medical
Equipment (§ 418.106(a)(1) and (e)(2)(i))
We proposed to delete the
requirements at § 418.106(a)(1), which
required hospices to ensure that the
interdisciplinary group confers with an
individual with education and training
in drug management as defined in
hospice policies and procedures and
State law, who is an employee of or
under contract with the hospice, to
ensure that drugs and biologicals meet
each patient’s needs. Meeting each
patient’s needs would continue to be the
responsibility of all Medicareparticipating hospices in accordance
with the requirements of all other
hospice CoPs.
Comment: We received numerous
comments that both supported and
opposed the proposal to eliminate the
process requirement that a hospice must
confer with an individual with expertise
in medication management regarding
a. Hospice Aide and Homemaker
Services (§ 418.76)
We proposed to revise
§ 418.76(a)(1)(iv) to remove the
requirement that a hospice aide training
State licensure program must meet the
specific training and competency
requirements set forth in § 418.76(b) and
(c) in order to be deemed an appropriate
qualification for employment. This
change would defer to State licensure
requirements, except in states where no
requirements exist.
Comment: Many comments supported
the proposed revision to defer to
existing state requirements for hospice
aide training, and only impose Federal
requirements in the absence of state
standards. However, other comments
did not support this proposed change,
arguing that state education and training
standards for hospice aides should not
be accepted as being sufficient to assure
patient health and safety.
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the plan of care for each patient. Many
commenters agreed that this process
requirement is no longer necessary
because this is standard practice in
hospices. However, other commenters,
while agreeing that it is standard
practice, still believe that there is value
in having a distinct regulatory
requirement to this effect, due to the
important role that medications play in
hospice care and the potential for safety
lapses.
Response: Hospices would continue
to be required to comprehensively
assess patients on a regular schedule
and on an as needed basis in accordance
with the requirements of § 418.54(a), (b)
and (d), and to assure that each patient’s
plan of care is developed and
continually updated to meet each
patient’s needs as identified in the
assessment process in accordance with
the requirements of§ 418.56(b) through
(d). These existing regulations, which
we are not revising, focus on assuring
the outcomes of safe, effective, patientcentered care. Furthermore, hospices
will still be required to comply with the
quality assessment and performance
improvement (QAPI) CoP at § 418.58,
which requires hospices to monitor
patient outcomes and implement
improvement projects to address
identified areas of concern. To the
extent that patient outcomes are not
being achieved due to problems with
medication management, both the
hospice’s internal QAPI program and
the external hospice survey process will
be capable of identifying and addressing
those problems, regardless of the
removal of this process requirement. In
light of these existing requirements, and
in response to the support for the
proposed change expressed by a variety
of commenters, we are finalizing the
proposed change to remove the process
requirement at § 418.106(a)(1) without
revisions.
We proposed to replace the
requirement at § 418.106(e)(2) that
hospices provide a physical paper copy
of policies and procedures, which are
written to guide the actions of hospice
staff, with a requirement that hospices
provide information regarding the use,
storage, and disposal of controlled drugs
to the patient or patient representative,
and family, which can be developed in
a manner that speaks to the perspectives
and information needs of patients,
families, and caregivers. This
information would be provided in a
more user-friendly manner, as decided
by each hospice. Hospices would be free
to choose the content and format(s) that
best suits their needs and the needs of
their patient population. We proposed
to require that, regardless of the format
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chosen, this information would have to
be provided to patients, families and
caregivers in a manner that allowed for
access to the information on a continual,
as-needed basis.
We would continue to require that
hospices discuss the information
regarding the safe use, storage and
disposal of controlled drugs with the
patient or representative, and the
family/caregiver(s), in a language and
manner that they understand to ensure
that these parties are effectively
educated. This requirement is included
in the current hospice CoPs and is
consistent with Department of Health
and Human Services guidance regarding
Title VI of the Civil Rights Act
(‘‘Guidance to Federal Assistance
Recipients Regarding Title VI
Prohibition Against National Origin
Discrimination Affecting Limited
English Proficient Persons,’’ 68 FR
47311, August 8, 2003, https://
www.hhs.gov/civil-rights/forindividuals/special-topics/limitedenglish-proficiency/guidance-Federalfinancial-assistance-recipients-title-VI/).
We continue to expect hospices to
utilize technology, such as telephonic
interpreting services and any other
available resources for oral
communication in the individual’s
primary or preferred language. We
would also continue to require that
hospices document in the patient’s
clinical record that the information was
provided and discussed.
Comment: We received many
comments regarding the proposed
change to allow hospices to determine
the content and form of the controlled
drug storage, use, and disposal notice
for patients and families. Commenters
universally supported the goal of
improving patient and family education
on this subject and supported the shift
away from providing policies and
procedures. However, a few commenters
raised concern about the intersection of
this change with section 3222 of the
recently adopted Substance UseDisorder Prevention that Promotes
Opioid Recovery and Treatment for
Patients and Communities Act
(‘‘SUPPORT Act’’) (Pub. L. 115–271),
that requires hospices, which permit
their employees to dispose of
medications in the patient’s home, to
provide their written policies and
procedures to patients, families and
caregivers. This provision, which
amends section 302 of the Controlled
Substances Act (21 U.S.C. 822), is under
the jurisdiction of the Department of
Justice.
While most commenters expressed
appreciation for the proposal to allow
hospices to determine the form and
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content of the notice, other commenters
suggested that CMS should develop
education materials that hospices must
provide to patients and families.
Whether hospice or CMS-generated,
commenters suggested that using
alternative formats such as pictorial
infographics and videos may be
valuable tools in communicating this
important information. Commenters
also suggested that the information
should be accessible to all individuals,
regardless of impairments or language
spoken.
Response: In light of the changes
included in section 3222 of the
SUPPORT Act, it is not appropriate to
finalize this proposed change. However,
we encourage hospices to develop easily
understood materials that explain safe
storage, use, and disposal of controlled
drugs to patients, their families, and
caregivers in addition to meeting the
regulatory requirement to provide a
copy of the hospice’s clinical policies
and procedures. We continue to believe
that providing such materials is a
positive practice for improving
comprehension of this crucial
information and improving compliance
with safe handling, use, and disposal
practices.
c. Hospices That Provide Hospice Care
to Residents of a SNF/NF or ICF/IID
(§ 418.112(c)(10) and (f))
Section 418.112(f) of the hospice
CoPs, as finalized in the 2008 Hospice
CoP final rule (73 FR 32088), requires
hospices to assure orientation of Skilled
Nursing Facility/Nursing Facility (SNF/
NF) or ICF/IID staff furnishing care to
hospice patients. We proposed to
remove § 418.112(f) and add a new
requirement at § 418.112(c)(10),
‘‘Written agreement,’’ to permit both
entities to negotiate the mechanism and
schedule for assuring orientation of
facility staff.
Comment: While comments
supported the intent behind the
proposed change to permit hospices and
long term care facilities to negotiate the
roles and responsibilities for orienting
long term care facility staff to the
hospice philosophy of care and hospice
procedures, some comments did not
support moving the topic into the
content of the written agreement.
Comments stated that requiring this
subject to be addressed in the written
agreement would create a onetime
burden for hospices of renegotiating the
written agreement with each long term
care facility, and that this burden was
not acceptable even in light of the
potential long-term regulatory relief of
the proposed change. Some comments
suggested that the current regulations at
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§ 418.112(f) instead be revised to allow
for hospices and facilities to negotiate
their respective roles and
responsibilities outside of the written
agreement.
Response: We agree with commenters
that the goal of regulatory flexibility is
worthwhile, and we appreciate the
feedback regarding the scope of the
regulatory burden that would be
incurred when renegotiating existing
contracts with long term care facilities.
In light of the burden concerns raised in
the comments, we agree that a different
approach to achieving the same goal is
warranted. We are not finalizing the
proposal to move the requirements
related to facility staff orientation and
training from a standalone requirement
to a provision in the written agreement.
In order to achieve the original
regulatory goal of adding flexibility and
reducing hospice costs for this activity,
we are revising existing § 418.112(f),
Orientation and training of staff, to
clarify that a hospice must consult with
and thus share responsibility with the
facility to assure facility staff orientation
and training. We received 26 timely
public comments pertaining to all
proposed changes to the hospice
requirements. Commenters included
hospice industry associations,
individual hospice providers, national
accrediting organizations, clinician
associations, and consumer advocacy
groups. Overall, the majority of
commenters were supportive of the goal
of the proposed changes. Comments not
directly related to our proposals are
summarized below.
Comment: A few comments
specifically related to the hospice CoPs
were submitted in response to the
solicitation for ideas for further burden
reduction efforts. Comments included
removing the core services requirement
for dietary counseling and providing
waivers for social worker supervision.
Response: We appreciate the
suggestions, and will consider revising
the social work supervision
requirements in future rulemaking. The
hospice interpretive guidelines related
to § 418.114(b)(3) (State Operations
Manual, Pub. 100–07, Appendix M,
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/
downloads/som107ap_m_hospice.pdf,
accessed on January 16, 2019) state,
‘‘Each hospice must employ or contract
with at least one MSW to serve in the
supervisor role. . . .’’ We believe that
this existing flexibility regarding
contracting for this service, when
coupled with the fact that the
supervision role can be performed
remotely, is adequate to address
concerns regarding the provision of
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social work supervision at this time
while we consider this waiver
suggestion. Dietary counseling as a core
service is a statutory requirement (see
section 1861(dd)(2)(A)(ii)(I) of the Act))
and cannot be repealed through
regulatory mechanisms.
Comment: We received numerous
comments with suggestions related to
Medicare payment requirements for
hospice services (for example, notice of
election requirements and the coverage
requirements for continuous home care
level of care), use of the CMS Common
Working File, hospice quality measures,
Medicaid payment issues, and Medicare
audits.
Response: These comments are not
within the scope of this regulation,
which is related to the health and safety
standards for Medicare providers. We
publish an annual proposed hospice
payment rule, and comments related to
payment policies and rates may also be
submitted to that rule for consideration.
All out of scope comments have been
shared with the appropriate components
within CMS.
Final Rule Action:
1. We are finalizing the proposed
changes to §§ 418.76(a)(1)(iv) and
418.106(a)(1) without change. We are
not finalizing our proposed change to
418.106(e)(2)(i).
2. Revise § 418.112(f) to require
hospice and facilities to share
responsibility for facility staff
orientation and training.
Contact: Danielle Shearer, 410–786–
6617.
4. Hospitals
a. Quality Assessment and Performance
Improvement Program (§ 482.21)
We proposed a new standard at
§ 482.21(f), ‘‘Unified and integrated
QAPI program for multi-hospital
systems.’’ We would allow that for a
hospital that is part of a hospital system
consisting of two or more separately
certified hospitals subject to a system
governing body legally responsible for
the conduct of each hospital, the system
governing body could elect to have a
unified and integrated QAPI program for
all of its member hospitals after
determining that such a decision is in
accordance with all applicable State and
local laws. The system governing body
would be responsible and accountable
for ensuring that each of its separately
certified hospitals meets all of the
requirements of this section. Each
separately certified hospital subject to
the system governing body would have
to demonstrate that: The unified and
integrated QAPI program was
established in a manner that took into
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account each member hospital’s unique
circumstances and any significant
differences in patient populations and
services offered in each hospital; and
the unified and integrated QAPI
program establishes and implements
policies and procedures to ensure that
the needs and concerns of each of its
separately certified hospitals, regardless
of practice or location, are given due
consideration, and that the unified and
integrated QAPI program has
mechanisms in place to ensure that
issues localized to particular hospitals
are duly considered and addressed.
Comment: Most commenters
supported the proposal to allow
hospitals that are part of a multihospital system to have a unified and
integrated QAPI program. A few
commenters expressed appreciation for
the expanded flexibility that this
proposal would afford hospitals by
reducing burden, increasing efficiencies,
and eliminating the duplication of
efforts.
A few commenters generally
supported this proposal, but
recommended that individual, hospitalspecific data be recorded and made
available to the system’s governing body
and the public. These data, the
commenters stated, would help to
identify best practices and processes
from facilities that are excelling in
certain areas and will account for and
address performance outliers across the
broader hospital system. Finally,
another commenter expressed concern
that the proposed requirement might
group QAPI scores together and hide
poor performance, which they stated
may mislead consumers about the sitespecific care they are receiving.
Response: We thank the commenters
for their support. We believe that a
hospital’s governing body should be
afforded the option of unifying and
integrating the various member
hospitals within their multi-hospital
system into a unified QAPI program.
Such a model would incorporate each
individual hospital’s QAPI program,
which would enable increased
efficiencies, innovations, provider
flexibility, and allow for the
dissemination of best practices for
patient care while also potentially
improving patient safety and outcomes.
We also believe that a unified QAPI
model is a natural progression for a
multi-hospital system that utilizes a
system governing body (as allowed at
§ 482.12) and a unified medical staff (as
allowed at § 482.22).
In response to the commenter’s
concerns regarding individual hospital
data, we agree that hospital specific data
should be used to address specific
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individual hospital issues and to
identify and disseminate best practices.
As we have proposed, ‘‘the system
governing body is responsible and
accountable for ensuring that each of its
separately certified hospitals meets all
of the requirements of this section.’’ We
do not see this requirement as
prohibiting an individual hospital from
reporting its own data to the governing
body and most especially to the unified
and integrated QAPI program, since we
are requiring that each separately
certified hospital in the system
demonstrate that the unified and
integrated QAPI program takes into
account each member hospital’s unique
circumstances as well as any significant
differences in patient populations and
services offered in each hospital. Each
hospital must also demonstrate that the
unified and integrated program has
mechanisms in place to ensure that
issues localized to particular hospitals
are duly considered and addressed.
We are unclear as to what the
commenter means by ‘‘QAPI scores’’
and to what the commenter is referring
regarding the grouping of ‘‘QAPI scores
together’’ in order to ‘‘hide poor
performance.’’ The current QAPI CoP
does not require anything related to
‘‘QAPI scores’’ and we are not finalizing
any such requirements in this rule. We
believe that the commenter might have
been confusing QAPI with the various
data that are collected for the Inpatient
Quality Reporting Program. These
programs are unrelated and the quality
reporting program remains unchanged
by this rule.
Comment: One commenter
recommended that CMS include the
following language in proposed
§ 482.21(f)(2) regarding a hospital’s
medical staff: ‘‘. . . Including
consulting with each of its separately
certified hospital’s medical staff.’’ The
commenter stated that a hospital’s
medical staff brings a unique clinical
perspective to the activities of the
governing body with regard to quality
and safety issues. The commenter also
urged CMS to clarify that the proposed
requirement will not include an
Ongoing Professional Practice
Evaluation and Focused Professional
Practice Evaluation, which they state, is
the responsibility of the hospital’s
medical staff.
Response: While we agree with the
commenter that a hospital’s organized
medical staff brings a unique clinical
perspective to the activities of the
governing body with regard to quality
and safety issues, we believe that a
number of the hospital CoPs already
effectively ensure that this clinical
perspective is heard by the governing
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body while also holding the medical
staff responsible and accountable for
these patient safety and quality of care
issues. For example, the provision at
§ 482.12(a)(1), under the hospital
Governing body CoP, requires that the
hospital’s governing body must,
‘‘consult directly with the individual
assigned the responsibility for the
organization and conduct of the
hospital’s medical staff, or his or her
designee. At a minimum, this direct
consultation must occur periodically
throughout the fiscal or calendar year
and include discussion of matters
related to the quality of medical care
provided to patients of the hospital.’’
This requirement applies to all
hospitals, governing bodies, and
medical staffs, regardless of
organizational structure.
Additionally, the QAPI CoP itself, at
§ 482.21(e), contains a standard that
requires the hospital medical staff
(among other hospital leaders) to be
responsible and accountable for
ensuring that the QAPI program is
focused on improved quality of care and
patient safety. Similarly, the Medical
staff CoP requirement at § 482.22(b)
requires that the hospital’s medical staff
‘‘must be well organized and
accountable to the governing body for
the quality of the medical care provided
to patients.’’ And finally, at
§ 482.22(b)(4)(iii) and (iv), the CoPs
require that a separately certified
hospital, which uses a unified and
integrated medical staff accountable to a
system governing body, must
demonstrate that its unified and
integrated medical staff: (1) Is
established in a manner that takes into
account each member hospital’s unique
circumstances and any significant
differences in patient populations and
services offered in each hospital and (2)
establishes and implements policies and
procedures to ensure that the needs and
concerns expressed by members of the
medical staff, at each of its separately
certified hospitals, regardless of practice
or location, are given due consideration,
and that the unified and integrated
medical staff has mechanisms in place
to ensure that issues localized to
particular hospitals are duly considered
and addressed. Therefore, we do not
believe that any additional language is
needed here.
Comment: One commenter requested
that CMS include ‘‘affiliates’’ and CAHs
in the unified and integrated QAPI and
infection control requirements. The
commenter defines ‘‘affiliates’’ as
hospitals and providers within a
healthcare system that may bill under
separate Tax Identification Numbers
(TINs). The commenter noted that this
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option would afford hospitals additional
flexibility and ease administrative
burden.
Response: We are not clear on
whether the commenter is confusing
TINs and CMS Certification Numbers
(CCNs), which CMS uses to distinguish
separately certified hospitals, CAHs,
and other Medicare-participating
providers and suppliers for survey and
certification purposes in determining
compliance with the CoPs and CfCs
specific to each provider and supplier
type. We do not use TINs in our
determination of when a facility
requires separate certification.
A CAH must be separately evaluated
for its compliance with the CAH CoPs
(found at 42 CFR part 485, subpart F),
which would not include the
requirements included in this section of
the rule since these are hospital CoPs.
It would not be possible to evaluate the
CAH’s compliance as part of an
evaluation of a hospital’s compliance.
However, this does not preclude a
multi-hospital system’s single governing
body from also serving as the CAH’s
governing body, so long as the
governing body clearly identifies the
policies and decisions that are
applicable to the CAH.
Final Rule Action: We are finalizing
the requirements in § 482.21(f), without
modification.
Contact: Alpha-Banu Wilson, 410–
786–8687.
b. Medical Staff, Medical Records
Services, and Surgical Services
(§§ 482.22, 482.24, and 482.51)
Hospital Medical History and Physical
Examination Requirements
We proposed to revise the current
requirements at § 482.22(c)(5)(i) and (ii)
with respect to medical staff bylaws,
and to allow for an exception under the
proposed paragraph (c)(5)(iii). We are
retaining the current language in
paragraphs (c)(5)(i) and (ii) that the
H&P, and any update to it, must be
completed and documented by a
physician (as defined in section 1861(r)
of the Act), an oral and maxillofacial
surgeon, or other qualified licensed
individual in accordance with State law
and hospital policy. We proposed to
include this same language regarding
who can complete and document the
assessment in the proposed provision at
§ 482.22(c)(5)(iii). This provision would
require the medical staff bylaws to state
that an assessment of the patient (in lieu
of the requirements of paragraphs
(c)(5)(i) and (ii)) be completed and
documented after registration, but prior
to surgery or a procedure requiring
anesthesia services, when the patient is
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receiving specific outpatient surgical or
procedural services and when the
medical staff has chosen to develop and
maintain a policy that identifies, in
accordance with the requirements at
paragraph (c)(5)(v), specific patients as
not requiring a comprehensive medical
history and physical examination, or
any update to it, prior to specific
outpatient surgical or procedural
services. The proposed paragraphs
(c)(5)(iii) and (iv) would require the
medical staff to develop and maintain a
policy that identifies those patients for
whom the assessment requirements of
paragraph (c)(5)(iii) would apply. We
also proposed a new requirement at
paragraph (c)(5)(v) for a medical staff
that chooses to develop and maintain a
policy for the identification of specific
patients to whom the assessment
requirements in paragraph (c)(5)(iii)
would apply. Under this proposed
paragraph, if the medical staff exercised
the option to perform a simplified
assessment in some cases, the written
policy would have to indicate the
specific outpatient surgical or
procedural services to which it applied.
The policy for each procedure would
need to indicate the hospital’s
consideration of patient age, diagnoses,
the type and number of surgeries and
procedures scheduled to be performed,
comorbidities, and the level of
anesthesia required for the surgery or
procedure; nationally recognized
guidelines and standards of practice for
assessment of specific types of patients
prior to specific outpatient surgeries and
procedures; and applicable State and
local health and safety laws.
In order to make clear that this
proposed requirement would be an
option that a hospital and its medical
staff could elect to use at their
discretion, we proposed language that
states ‘‘the provisions of paragraphs
(c)(5)(iii), (iv), and (v) do not apply to
a medical staff that chooses to maintain
a policy that adheres to the
requirements of paragraphs (c)(5)(i) and
(ii) for all patients.’’ In other words, a
hospital and its medical staff would be
free to exercise their clinical judgment
in determining whether a policy for
identifying specific patients as not
requiring a comprehensive H&P (or any
update to it) prior to specific outpatient
surgical or procedural services, and
instead requiring only a pre-surgical
assessment for these patients, would be
their best course. Or, if a hospital and
its medical staff decided against such a
policy, then only the current H&P and
update requirements (at §§ 482.22,
482.24, and 482.51) would continue to
apply and the proposed requirements
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for this CoP, as well as those proposed
for §§ 482.24 and 482.51, would not
apply.
For the current CoP at § 482.24,
‘‘Medical Record Services,’’ we
specified that we would revise the
provisions at § 482.24(c)(4)(i)(A) and (B)
regarding an H&P and its update to
allow for an exception under proposed
paragraph (c)(4)(i)(C) where we
proposed to add a new requirement that,
if applicable, the medical record would
have to document assessment of the
patient (in lieu of the requirements of
paragraphs (c)(4)(i)(A) and (B)) after
registration, but prior to surgery or a
procedure requiring anesthesia services,
for specific outpatient surgical or
procedural services.
We also proposed to revise the current
CoP, § 482.51, ‘‘Surgical Services,’’ to
allow for an exception to the
requirements at § 482.51(b)(1)(i) and (ii).
Under proposed paragraph (b)(1)(iii), we
proposed a new requirement that, prior
to surgery or a procedure requiring
anesthesia services and except in the
case of emergencies, an assessment of
the patient must be completed and
documented after registration (and in
lieu of the requirements of paragraphs
(b)(1)(i) and (ii)). This proposed
requirement would only apply in those
instances when the patient is receiving
specific outpatient surgical or
procedural services and when the
medical staff has chosen to develop and
maintain a policy that identifies, in
accordance with the requirements at
§ 482.22(c)(5)(v), specific patients as not
requiring a comprehensive medical
history and physical examination, or
any update to it, prior to specific
outpatient surgical or procedural
services.
Comment: As reflected in the public
comments for similar proposed changes
for ASCs that we have previously
discussed, the majority of comments
submitted were supportive of the
proposed changes that would give a
hospital and its medical staff the
flexibility to establish a policy for a presurgical or pre-procedural assessment of
the patient (in lieu of the requirements
of paragraphs (c)(5)(i) and (ii) for a
comprehensive pre-surgical or preprocedural H&P and its update),
provided that the patient assessment is
completed and documented after
registration, but prior to surgery or a
procedure requiring anesthesia services,
and the patient is receiving specific
outpatient surgical or procedural
services as outlined in the policy.
Several commenters stated that they
appreciated the regulatory flexibility to
establish specific patient policies such
as these as long as they are based on
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recognized guidelines and best practices
as well as on the clinical judgment of
the medical staff. They stated that they
believe such parameters are necessary to
ensure patient health and safety while
still allowing for reasonable methods to
reduce the burden on both patients and
providers, including the additional
expense of pre-operative testing that is
often performed unnecessarily on many
patients undergoing only minor
outpatient procedures and may be an
unintended consequence of the
requirement for a comprehensive H&P
within 30 days of admission or
registration for all hospital patients
regardless of the surgery or procedure
that they are undergoing.
Response: We thank the commenters
for their support and agree that the
flexibility provided by these revisions
will reduce unnecessary regulatory
burden affecting both patients and
providers. We believe that it also has the
potential to greatly reduce unnecessary
costs associated with the current
requirements for a comprehensive H&P
for a specific class of patients
undergoing low-risk outpatient surgeries
and procedures for which there exist
clear guidelines regarding the extent of
pre-operative patient assessment and
testing needed.
Comment: Some commenters either
did not support these changes or had
certain reservations about them, even
though they supported the overall intent
of the changes. One commenter stated
that the change will not serve those
beneficiaries with advanced illness
well, recommended that the rule be
revised to require that the assessment
must be consistent with the patient’s
situation, medical complexity, and the
proposed procedure, and believes that
the requirements must err on the side of
more, rather than less,
comprehensiveness. Another
commenter stated that while they
appreciated CMS’ recognition that the
timing of H&Ps may, in some instances,
be duplicative and cause unnecessary
burden, they were aware of cases where
the current H&P requirements prevented
an adverse event. They also stated that
the proposed revisions will be just as,
and possibly more, burdensome than
the current requirements; that CMS
should consider comments before
proceeding; and that, while they agree
that there seems to be no evidence
supporting a strict 30-day requirement,
additional flexibility would be
appreciated. One commenter stated that
they believe the burden of assessing
patients prior to surgery would be
shifted from one provider (the primary
care physician or the surgeon) to
another (the anesthesiologist), and
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expressed concerns over the increased
responsibility and liability that might be
then imposed on an anesthesiologist
(beyond his or her primary
responsibility for anesthesia services
and care provided to a patient) for a
surgery or procedure in which he or she
was not the operating practitioner. A
few commenters also expressed
concerns over whether reimbursement
requirements and rates would now
change for outpatient surgeries and
procedures that would only require an
assessment and not a comprehensive
H&P, including concerns over which
practitioner would now be reimbursed
for the assessment (for example, the
patient’s primary care practitioner
versus the operating practitioner).
Response: We appreciate the concerns
raised by commenters and have
thoroughly considered them. However,
we must again note and emphasize to
readers that this revision will be a
regulatory option available to hospitals
and one that a hospital and its medical
staff must make the policy decision to
exercise. We expect that this decision
will be based on the clinical judgment
and recommendations of the medical
staff, which must be supported by
nationally recognized evidence and
guidelines for best practices in this area,
in order for the hospital to determine if
the best course would be to establish a
policy for identifying specific patients
as not requiring a comprehensive H&P
(or any update to it) prior to specific
outpatient surgical or procedural
services, and instead require a more
limited pre-surgical assessment for these
patients. We expect that most hospitals
and their medical staffs will perform
risk/benefit analyses to inform their
decisions. We also expect that a number
of these hospitals, based on their
analyses, will decide to maintain a
policy that continues to follow the
current H&P and update requirements
(at §§ 482.22, 482.24, and 482.51) and
will not choose to exercise this option
in any way. Conversely, we also expect
that some will choose to exercise this
option fully and to the broadest extent
possible while still remaining in
compliance with the requirements
finalized. We further expect that another
significant subset of hospitals will fall
somewhere in the middle in their policy
decisions and will most likely elect to
exercise this option within an even
more narrow and stringent set of
parameters than CMS is requiring here.
The regulatory flexibility and
framework of these final requirements
will allow each hospital to establish and
tailor its own policy parameters
according to its specific patient
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populations, individual institutional
needs and resources, and own medical
staff recommendations as long as the
policies and procedures established and
implemented meet or exceed the
requirements finalized in this rule. As
finalized here, these requirements,
while providing a hospital with an
alternative and less burdensome
approach to pre-surgical patient
assessment, will also at the same time
ensure that a hospital takes into
consideration all patient safety factors
and quality of care issues, such as the
degree of complexity of the patient’s
medical condition as well as that of the
planned procedure itself, when it
establishes a process to identify those
patients to whom such a policy would
apply.
In response to the commenter who
stated that, under this new option, the
assessment of patients prior to surgery
will be ‘‘shifted from one provider (the
primary care physician or the surgeon)
to another (the anesthesiologist),’’ we
note that the Anesthesia services CoP
contains a separate provision (separate
and distinct from the H&P, update, and
pre-surgical assessment requirements in
the Surgical services CoP) that requires
that a ‘‘. . . preanesthesia evaluation
[be] completed and documented by an
individual qualified to administer
anesthesia . . .’’ and that it must be
‘‘. . . performed within 48 hours prior
to surgery or a procedure requiring
anesthesia services.’’ The
anesthesiologist is responsible for this
evaluation, but not for the H&P, update,
and pre-surgical assessment
requirements that we are finalizing here.
While an anesthiologist could certainly
qualify to perform any of these presurgical assessments, we expect the
operating practitioner, who is also
responsible for the pre-, intra-, and postoperative care of the patient and must
be a physician (as defined in section
1861(r) of the Act), an oral and
maxillofacial surgeon, or, in accordance
with State law and hospital policy,
another qualified licensed individual
(who would most likely be a member of
the operating practitioner’s team, such
as an NP or PA, and who, by extension,
would also be responsible for the care
of the patient) to perform the presurgical assessment as required in this
final rule. If a hospital and its medical
staff choose to establish policies and
procedures that delineate the duties and
responsibilities of any individual
anesthiologist (or any individual
qualified to administer anesthesia) to
include performance of the pre-surgical
assessments included under this rule,
then the hospital would need to
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demonstrate that these pre-surgical
assessments are separate and distinct
from the pre-anesthesia evaluations of
patients required at § 482.52.
Furthermore, a hospital must also
ensure that any such policies and
procedures, which assign these presurgical assessment duties and
responsibilities to an individual
anesthiologist (or an individual
qualified to administer anesthesia) as
discussed here, are not only in
accordance with State law, but are also
consistent in this regard with the
current standards of both anesthesia
care and surgical care.
The comments regarding
reimbursement requirements and rates
for outpatient surgeries and procedures
are outside the scope of the CoPs and
this rule.
Comment: A few commenters were
concerned about compliance with the
revised requirements if no clear and
recognized guidelines or
recommendations exist for pre-surgical
patient assessment for specific classes of
patients undergoing certain outpatient
surgeries and procedures.
Response: The revised requirements,
which allow for the option of
establishing a policy for identification of
specific patients to whom the
assessment requirements in
§ 482.22(c)(5)(iii) would apply, are
conditioned upon a hospital and its
medical staff demonstrating evidence
that the specific parameters required in
this final rule are met. A hospital and
its medical staff should not include
those classes of patients and those
outpatient surgeries and procedures in
its pre-surgical patient assessment
policy if the hospital finds that it cannot
meet the requirements we are finalizing
at §§ 482.22(c)(5)(v), including the
requirement that the medical staff must
demonstrate evidence that its policy is
based on nationally recognized
guidelines and standards of practice for
the assessment of specific types of
patients prior to specific outpatient
surgeries and procedures.
Final Rule Action: We are finalizing
the requirements in §§ 482.22, 482.24,
and 482.51, with only minor
modifications. Specifically, we are
changing the term ‘‘oromaxillofacial
surgeon’’ to the correct term of ‘‘oral and
maxillofacial surgeon’’ where indicated.
Contact: CAPT Scott Cooper, USPHS,
410–786–9465.
c. Medical Staff: Autopsies (§ 482.22(d))
We proposed to remove the
requirement at § 482.22(d), which states
that a hospital’s medical staff should
attempt to secure autopsies in all cases
of unusual deaths and of medical-legal
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and educational interest. The
mechanism for documenting permission
to perform an autopsy must be defined
and there must be a system for notifying
the medical staff, and specifically the
attending practitioner, when an autopsy
is being performed.
Comment: Several commenters agreed
with the proposal, which they stated
would remove duplicative
administrative work and allow hospitals
to defer to State requirements when an
autopsy is necessary. Many
commenters, including national
associations representing medical
examiners and pathologists, disagreed
with the removal of the requirement that
a hospital’s medical staff attempt to
secure autopsies for unusual deaths or
educational purposes. The commenters
stated that hospitals should attempt to
obtain family permission for autopsies
related to deaths resulting from
questions about efficacy of treatment,
for educational purposes, or for issues of
unintended outcomes of treatment or
medical uncertainty and these
commenters also expressed concern that
the removal of this proposal would lead
to a further reduction in an already low
national autopsy rate.
However, many of these commenters
stated that hospitals should not be
required to attempt to obtain family
permission, or perform autopsies, in
cases of medical-legal interest. In those
circumstances, the commenters stated,
hospitals should report the death to, and
consult with, the authority of their local
medical examiner, coroner, or
medicolegal death investigative
authority.
Finally, one commenter requested
that CMS specifically state that
hospitals are not prohibited from
performing autopsies.
Response: We agree that hospitals
should not attempt to secure autopsies
in medical-legal cases without first
contacting their State’s medical
examiner or medical authority, in
accordance with their State’s laws. We
will defer to state law on this issue,
since each State has their own standards
and laws regarding the performance of
autopsies for medical-legal purposes,
and we therefore are removing this as a
requirement in the CoPs for hospitals.
Furthermore, we believe that it is
appropriate to remove the duplicative
and burdensome requirement that
hospitals attempt to secure autopsies for
other cases of unusual deaths or for
educational interest. We clarify that
removing this requirement would not
prohibit hospitals from performing
autopsies and we believe that hospitals
will implement their own policies
regarding autopsies. While we
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understand the commenter’s concerns
regarding the decline in the national
autopsy rate, we disagree that the
removal of this specific requirement
will cause a measurable decrease in the
autopsy rate, impact quality of care, or
dissuade hospitals from performing
autopsies. As commenters themselves
have noted, there are various causes that
may have contributed to the reduction
in the autopsy rate including risk
adversion due to litigation concerns and
concerns about reimbursement rates,
and we have no additional evidence that
would lead us to the conclusion that the
removal of this requirement would
exacerbate these numbers. We therefore
are finalizing our proposal to remove
the requirements at § 482.22(d).
Although we are finalizing our proposal,
we note that the removal of this
requirement should not be construed as
a diminution of our support for
hospitals continuing to perform
autopsies for various purposes, and we
encourage hospitals to establish policies
regarding autopsies, where appropriate.
Comment: A few commenters
suggested that all hospital admissions
require the patient (or his or her
representative) to affirmatively allow or
prohibit an autopsy in the event of
death. One commenter also stated that
autopsies should be required for any
hospital death, unless explicitly rejected
by next of kin.
Response: Mandating that hospitals
perform autopsies, or that hospitals ask
permission to perform an autopsy upon
a patient’s admission, would be unduly
burdensome to hospitals and contrary to
the purpose of the CoPs, which establish
baseline health and safety requirements.
However, hospitals may choose to
establish their own policy that would
require patients or their representatives
to permit or decline autopsies upon
admission, if they believe such a
requirement is appropriate. As we
previously stated, there is no
prohibition against autopsies and
hospitals are free to enact policies
regarding autopsies if they choose to do
so.
Additionally, requiring hospitals to
perform autopsies could potentially
conflict with State and local laws
regarding autopsies for medical-legal
cases. For instance, certain State laws
require that hospitals report deaths
arising from medical-legal
circumstances to their local medical
examiner or other authoritative body, so
that a determination can be made as to
whether an autopsy must be performed.
Final Rule Action: We are finalizing
the proposal to remove § 482.22(d),
without modification.
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Contact: Alpha-Banu Wilson, 410–
786–8687.
d. Infection Control (§ 482.42)
We proposed a new standard at
§ 482.42(c), ‘‘Unified and integrated
infection control program for multihospital systems.’’ Like the proposed
requirements for a unified and
integrated QAPI program, the proposed
standard for infection control would
allow that for a hospital that is part of
a hospital system consisting of multiple
separately certified hospitals subject to
a system governing body legally
responsible for the conduct of each
hospital, such system governing body
could elect to have a unified and
integrated infection control program for
all of its member hospitals after
determining that such a decision was in
accordance with all applicable State and
local laws. The system governing body
would be responsible and accountable
for ensuring that each of its separately
certified hospitals met all of the
requirements of this section. Each
separately certified hospital subject to
the system governing body would have
to demonstrate that the unified and
integrated infection control program: (1)
Was established in a manner that took
into account each member hospital’s
unique circumstances and any
significant differences in patient
populations and services offered in each
hospital; (2) established and
implemented policies and procedures to
ensure that the needs and concerns of
each of its separately certified hospitals,
regardless of practice or location, are
given due consideration; (3) had
mechanisms in place to ensure that
issues localized to particular hospitals
are duly considered and addressed; and
(4) designated a qualified individual(s)
at the hospital with expertise in
infection prevention and control to be
responsible for communicating with the
unified infection control program, for
implementing and maintaining the
policies and procedures governing
infection control, and for providing
infection prevention education and
training to hospital staff.
Comment: Most commenters
supported the proposal to allow
hospitals that are part of a multihospital system to have a unified and
integrated infection control program.
The proposed rule included a specific
request for public comment on whether
there are any other programs currently
required under the CoPs for each
separately certified hospital, beyond the
QAPI and Infection control programs
proposed here, that stakeholders believe
would likewise be better managed under
a system governing body legally
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responsible for the conduct of each
separately certified hospital. In
response, we received comments asking
CMS for further revisions to the CoPs,
like those proposed for QAPI and
infection control programs here (and
with specific mention of revising the
Nursing services CoP in this way), to
allow for similar departmental and
operational integration among hospitals
within a multi-hosptial system with a
single governing body. The commenters
stated that expansion of this flexibility
for other hospital services, departments,
units, and programs would reduce
operational burden for individual
hospitals, ensure the proper level of
staff expertise for member hospitals, and
improve the quality and continuity of
care for all patients served within the
system. A few commenters also
expressed appreciation for the expanded
flexibility that this proposal would
afford hospitals by reducing burden,
increasing efficiencies, and eliminating
the duplication of efforts.
One commenter encouraged CMS to
apply this approach to situations when
a multi-hospital system’s providers have
to fulfill additional requirements
stemming from Medicaid or Medicare
managed care plans or other external
regulatory entities. The commenter
suggested the mandated training related
to the special needs plan models of care
(42 CFR 422.101(f)(2)(ii)) as an example
of how this could be applied. The
commenter stated that a multihospital
system with a unified infection control
program as allowed under the
requirements finalized in this rule, and
that is also potentially participating in
an ACO, would most certainly meet the
Model of Care training requirement.
This commenter also suggested an
alternative approach where ACO
participants would be deemed as
meeting the Model of Care requirement
for all other external regulatory entities
by meeting the unified infection control
program requirements finalized here.
Response: We thank the commenters
for their support. We believe that a
hospital’s governing body should be
afforded the option of unifying and
integrating the various member
hospitals within their multi-hospital
system into a unified infection control
program. As we discussed for unified
and integrated QAPI programs, such a
model would incorporate each
individual hospital’s infection control
program, which would enable increased
efficiencies, innovations, provider
flexibility, and allow for the
dissemination of best practices for
patient care while also potentially
improving patient safety and outcomes.
We also believe that a unified infection
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control model is a natural progression
for a multi-hospital system that utilizes
a system governing body (as allowed at
§ 482.12), a unified medical staff (as
allowed at § 482.22), and a unified QAPI
program (as finalized in this rule at
§ 482.12).
The comments and recommendations
regarding the application of the unified
infection control model and its CoP
requirements to any additional
requirements mandated by Medicare
and Medicaid managed care plans or
other external regulatory entities are
outside the scope of the CoPs and this
rule.
Final Rule Action: We are finalizing
the proposed requirements in § 482.42.
Moreover, in addition to revisions
proposed and finalized for the Hospital/
CAH Innovation Rule regarding
Antibiotic Stewardship Programs (ASPs)
(now part of the Infection Prevention
and Control CoP discussed in Section
III.B.6. of this final rule and finalized
here at § 482.42), we are finalizing
changes to § 482.42 that will now
address the designated and qualified
individual(s) at the hospital responsible
for communicating with the unified
infection control program, for
implementing and maintaining the
policies and procedures governing
infection control, and for providing
infection prevention education and
training to hospital staff with regard to
the ASP as well. We are also making
other minor modifications to this
section to finalize changes proposed in
the Hospital/CAH Innovation Proposed
Rule. All of these changes are discussed
later in Section III.B.6. of this final rule.
Contact: CAPT Scott Cooper, USPHS,
410–786–9465.
e. Special Requirements for Hospital
Providers of Long-Term Care Services
(‘‘Swing-Beds’’) (§ 482.58(b)(1), (4), (5),
and (8), and Identical CAH
Requirements: § 485.645(d)(1), (4), (5),
(6), and (7))
Hospitals providing swing-bed
services must meet all of the
requirements at 42 CFR part 482, which
includes the swing-bed requirements at
§ 482.58 for patients receiving swingbed services, and CAHs providing
swing-bed services must meet all of the
requirements at 42 CFR part 485,
subpart F, which includes the swingbed requirements at § 485.645 for
patients receiving swing-bed services.
The swing-bed requirements within the
hospital and CAH CoPs include a subset
of cross-referenced long-term care
requirements contained in 42 CFR part
483, subpart B, for which hospital and
CAH swing-bed providers are surveyed
as they are for all of the CoPs in their
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respective programs. We have
determined that some of the crossreferenced long-term care requirements
for hospitals and CAH swing-bed
providers are unnecessary and unduly
burdensome, given their focus on
‘‘residents’’ and longer length of stays,
which we believe are not relevant to
swing-bed patients. Thus, we proposed
to remove the following requirements:
§§ 482.58(b)(1) and (c) and 485.645(d)(1)
(incorporating long-term care facility
requirements at § 483.10(f)(9)). Under
our current regulations at § 483.10(f)(9),
the resident has a right to choose to, or
refuse to, perform services for the
facility, and the facility must not require
a resident to perform services for the
facility. Regulations at §§ 482.58(b)(1)
and 485.645(d)(1) incorporate this
resident right by reference.
We expect hospital and CAH swingbed providers who do offer patients the
option of providing services for the
facility to have current policies and
procedures that reflect this policy that
includes protocol for establishing an
agreement between the two parties.
Comment: Commenters universally
supported the proposal to remove the
provision requiring hospitals and CAH
swing-bed providers to provide
residents with the right to choose to, or
refuse to, perform services for the
facility, and not requiring a resident to
perform services for the facility. As with
the majority of the hospital and CAH
swing-bed proposals, commenters noted
that this requirement is unnecessary, the
source of confusion, or is unduly
burdensome.
Response: We appreciate the
comments received and continue to
believe that this change is appropriate.
Final Rule Action: We are finalizing
this proposed change without revisions.
§§ 482.58(b)(4) and 485.645(d)(4)
(incorporating long-term care facility
requirements at § 483.24(c)): The facility
must provide, based on the
comprehensive assessment and care
plan and the preferences of each
resident, an ongoing program to support
residents in their choice of activities
and the activities program must be
directed by a qualified professional who
is a qualified therapeutic recreation
specialist or an activities professional.
Patients receiving swing-bed services in
a hospital or CAH are not long term
residents of the facility and generally
only receive swing-bed services for a
brief period of time for transition after
the provision of acute care services. We
expect that for those patients who
receive swing-bed services for an
extended period of time, their nursing
care plan—as required under
§ 482.23(b)(4) for hospitals and
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§ 485.635(d)(4) for CAHs—is based on
assessing the patient’s nursing care
needs and will support care that
holistically meets the needs of the
patient, taking into consideration
physiological and psychosocial factors.
Comment: The majority of
commenters were supportive of the
proposed removal of the requirement for
hospital and CAH swing-bed providers
to provide an ongoing program to
support residents in their choice of
activities and have an activities program
that is directed by a qualified
professional. As with the majority of the
hospital and CAH swing-bed proposals,
commenters noted that this requirement
is unnecessary, the source of confusion,
or is unduly burdensome due to the
limited length of stay for most patients
receiving swing-bed services.
Commenters generally agreed that the
activity needs of those patients who
receive swing-bed services for an
extended period of time would be met
via the hospital and CAH nursing care
plan requirements.
However, one commenter noted that
in the event a swing-bed patient
receives care for an extended period of
time, the nursing care plan will not
include interest-based group and
individual activities that support the
patient’s physical, mental and
psychosocial well-being. The
commenter noted that therapeutic or
recreational activities differ significantly
from the goals that normally would be
identified in a nursing care plan.
Response: We appreciate the
comments received and continue to
believe that this change is appropriate.
It is expected that hospitals and CAHs,
using an interdisciplinary approach, are
providing services that meet the needs
of all of their patients, including those
receiving swing-bed services, regardless
of their length of stay. In addition,
nursing care plans are intended to
provide direction on the type of nursing
care the needed by the patient,
stemming from the patient’s diagnoses,
that is organized based on the specific
needs of the patient. The care plan is
dynamic and should change as the
needs of the patient change. As a result,
if the needs of the patient include
interest-based group and individual
activities that support the patient’s
physical, mental and psychosocial wellbeing, we expect that the hospital or
CAH will provide these services to the
patient.
Final Rule Action: We are finalizing
this proposed change without revision.
§§ 482.58(b)(5) and 485.645(d)(5)
(incorporating long-term care facility
requirements at § 483.70(p)): Any
facility with more than 120 beds must
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employ a qualified social worker on a
full-time basis.
In accordance with the hospital and
CAH swing-bed requirements, hospital
swing-bed providers are not permitted
to have more than 100 beds while CAH
swing-bed providers are not permitted
to have more than 25 beds for the
provision of inpatient or swing-bed
services. Based on feedback from
stakeholders, removing this requirement
would eliminate confusion for providers
and accreditation organizations.
Comment: Commenters universally
supported the proposal to remove the
provision requiring hospitals and CAH
swing-bed providers with more than 120
beds to employ a full-time social
worker. As with the majority of the
hospital and CAH swing-bed proposals,
commenters noted that this requirement
is unnecessary, the source of confusion,
or is unduly burdensome.
Response: We appreciate the
comments received and continue to
believe that this change is appropriate.
Final Rule Action: We are finalizing
this proposed change as proposed.
§§ 482.58(b)(7) and 485.645(d)(7)
(incorporating the long-term care facility
requirement at § 483.55(a)(1)): Under
our long-term care facility requirements,
the facility, must provide routine and
emergency dental services to meet the
needs of each resident, or obtain them
from an outside resource, in accordance
with § 483.70(g).
Hospitals and CAHs are required to
provide care in accordance with the
needs of the patient that have been
identified in such patients’ plans of
care; this could include non-emergency
dental care. We expect that hospital
swing-bed providers are currently
addressing the emergent dental care
needs of their patients under the
existing hospital CoP at § 482.12(f)(2),
which requires that hospitals have
written policies and procedures for
appraisal of emergencies, initial
treatment, and referral when
appropriate. Similarly, we expect that
CAH swing-bed providers are currently
addressing the emergent dental care
needs of their patients under the
existing emergency services CoP at
§ 485.618, which requires CAHs to
provide emergency care necessary to
meet the needs of its inpatients and
outpatients. As a result, we believe that
this portion of the requirement is
duplicative, given the current CoP
requirements.
Comment: Commenters universally
supported the proposal to remove the
provision requiring hospitals and CAH
swing-bed providers provide or obtain
from an outside resource routine and
emergency dental services to meet the
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needs of each resident. As with the
majority of the hospital and CAH swingbed proposals, commenters noted that
this requirement is unnecessary, the
source of confusion, or is unduly
burdensome.
In addition, the most recent
guidelines from the American Dental
Association note that patients should
have regular dental visits, with the
frequency determined by their dentist to
accommodate for the patients’ current
oral health status and health history
(American Dental Association, https://
www.ada.org/en/press-room/newsreleases/2013-archive/june/americandental-association-statement-onregular-dental-visits).
Response: We appreciate the
comments received and continue to
believe that this change is appropriate.
Final Rule Action: We are finalizing
this proposed change as proposed.
Contact: Kianna Banks, 410–786–
3498.
f. Special Requirements for Psychiatric
Hospitals (§ 482.61(d))
We believe that as currently written
and implemented, this requirement
requires clarification regarding the
language that progress notes ‘‘must be
recorded by the doctor of medicine or
osteopathy responsible for the care of
the patient as specified in § 482.12(c),
nurse, social worker and, when
appropriate, others significantly
involved in active treatment
modalities.’’ We believe that nonphysician practitioners, including
physician assistants, nurse practitioners,
psychologists, and clinical nurse
specialists, when acting in accordance
with State law, their scope of practice,
and hospital policy, should have the
authority to record progress notes of
psychiatric patients for whom they are
responsible. Therefore, we proposed to
allow the use of non-physician
practitioners or MD/DOs to document
progress notes of patients receiving
services in psychiatric hospitals.
Comment: Commenters were mostly
supportive of the proposal to clarify the
documentation requirements for
recording progress notes in the patient’s
medical records for patients receiving
services in psychiatric hospitals.
Commenters noted that the proposed
change would reduce barriers for care
providers and will give non-physician
practitioners expanded access to
document the provision of the health
care to patients, resulting in improved
continuity of care.
Response: We appreciate the
comments received and continue to
believe that this change is appropriate.
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Comment: One commenter opposed
the proposed change, noting that the
existing regulatory language already
permits non-physician practitioners to
document progress notes in the patient’s
medical records for patients receiving
services in psychiatric hospitals;
therefore, the change would be unlikely
to produce costs savings from
incorporating psychologists or other
licensed practitioners in this
requirement. Another commenter
opposed the inclusion in the proposed
rule of psychologists in the list of nonphysician practitioners allowed to
document the patient’s progress notes.
The commenter notes that the current
regulations permit psychologists to
document the services they provide
(psychotherapy, psychological/
neuropsychological testing notes), but
they should not be granted the authority
to write medical progress notes due to
the current Medicare regulations under
§ 482.12(c)(1)(vi).
Response: While we agree with the
commenter regarding the intent of the
current regulatory language, we believe
that there is a need to clarify the intent
of the language and ensure that the
healthcare providers with the authority
to document the progress reports are
clearly identified. The majority of
commenters supported the need for
clarification due to the failure of the
regulatory text to specify the nonphysician practitioners who could
document progress reports.
Additionally, we believe
psychologists are appropriately
included in the list of non-physician
practitioners who have the authority to
document in progress notes for patients
receiving services in psychiatric
hospitals. The regulation at
§ 482.12(c)(1)(vi), referenced by the
commenter, states that a clinical
psychologist, as defined in § 410.71, has
the authority to admit patients and
oversee the care of Medicare patients
(but only with respect to clinical
psychologist services as defined in
§ 410.71 of this chapter and only to the
extent permitted by State law).
Furthermore, non-physician
practitioners currently document in the
progress notes of patients in acute care
hospitals to the extent of their scope of
practice and hospital policy.
We believe that the revised language
in this final rule will clarify our original
intent in the proposed rule (as
understood by readers as evidenced by
the comments discussed here that
request and support such clarification
on this issue) that non-physician
practitioners, including physician
assistants, nurse practitioners,
psychologists, and clinical nurse
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specialists, when acting in accordance
with applicable State scope of practice
laws, and hospital policies, should have
the authority to record progress notes
for all psychiatric and medical
problems, which are present upon
patient admission or which develop
during hospitalization, for any
psychiatric patient for whom these
licensed practitioners are responsible as
long as such patient problems fall
within the bounds of a licensed
practitioner’s specific State scope of
practice laws and hospital policies.
Comment: One commenter requested
that clarification be provided regarding
the use of the phrase ‘‘hospital policy’’
as it relates to the requirement that nonphysician practitioners act in
accordance with hospital policy.
Response: Psychiatric hospitals must
comply with the hospital CoPs under 42
CFR part 482, which includes the
requirements for psychiatric hospitals.
The hospital CoPs require that the
hospital’s governing body approve all
hospital policies, and in accordance
with § 482.12(a)(4), the governing body
must determine (in accordance with
State law) which categories of
practitioners are eligible candidates for
appointment to the medical staff. The
governing body is required to appoint
members of the medical staff after
considering the recommendations of the
existing members of the medical staff
and approve medical staff bylaws and
other medical staff rules and
regulations. Non-physician
practitioners, whether employees or
contractors, would be subject to all
rules, regulations, and policy manuals
utilized by the hospital.
Final Rule Action: We are finalizing
the changes as proposed.
• Contact: Kianna Banks, 410–786–
3498.
5. Transplant Centers
a. Special Requirement for Transplant
Centers (§§ 482.68 and 482.70)
We proposed to update the
terminology within the hospital
regulation at part 482 and the transplant
regulations at §§ 482.68, 482.70, 482.72
through 482.104, and at § 488.61, for
clarification and consistency.
Specifically, we proposed a
nomenclature change which would:
• Replace the term transplant
‘‘center’’ in the regulation language with
transplant ‘‘program’’ (each organ type
would be a transplant program). A
transplant program is located within a
transplant hospital that provides
transplantation services for a particular
type of organ. Since individual
transplant programs are surveyed for
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compliance with the CoPs, using the
term transplant program throughout the
regulation better aligns with current
surveyor practice and will reduce
provider confusion. In order to provide
further clarity, we also proposed to
update the definitions at § 482.70.
• Consistently use Independent
Living Donor Advocate (ILDA)
throughout the regulation.
• Change ‘‘beneficiaries’’ to
‘‘recipients’’.
Comment: All comments we received
expressed support for the proposed
nomenclature change, which would
make the terminology used in the
regulations consistent with the
terminology used by the Organ
Procurement and Transplantation
Network (OPTN) and the transplant
community.
Response: We thank the commenters
for their support. We are finalizing this
proposal without modification.
b. Data Submission, Clinical Experience,
and Outcome Requirements for ReApproval of Transplant Centers
(§ 482.82)
We proposed to remove the
requirements at § 482.82 that require
transplant centers to submit data
(including, but not limited to,
submission of the appropriate OPTN
forms for transplant candidate
registration, transplant beneficiary
registration and follow-up, and living
donor registration and follow-up),
clinical experience, and outcome
requirements for Medicare re-approval,
and make conforming changes to
§ 482.102(a)(5) ‘‘Condition of
participation, Patient and living donor
rights’’ and § 488.61 ‘‘Special
Procedures for Approval and ReApproval of Organ Transplant Centers.’’
Comment: Most commenters,
including several major organizations
which represent the interests of
transplant surgeons and other
professionals, transplant patients,
individual transplant programs,
members of the transplant community,
and the OPTN, strongly supported the
proposal to remove the provision that
requires transplant centers that are
applying for Medicare re-approval to
meet all data submission, clinical
experience, and outcome requirements
in order to be re-approved. These
commenters agreed with our analysis of
the unintended consequences that have
occurred because of the Medicare reapproval requirements and many agreed
that eliminating this requirement would
improve transplantation in the United
States. Many of these commenters also
stated their belief that the proposal
would reduce administrative burdens. A
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few commenters also supported
maintaining the requirements for initial
Medicare approval for transplant
centers.
Several commenters, including
members of the transplant community
and interested individuals, objected to
the removal of this proposal. These
commenters as a whole were concerned
that removing this proposal would affect
quality of care and patient outcomes.
Specifically, commenters were
concerned as to whether information on
transplant centers outcomes would
continue to be available to the public,
and whether CMS would still be able to
identify underperforming transplant
programs, in order to ensure patient
safety and continued positive outcomes.
Other commenters stated that, absent
these requirements, CMS would rely
upon transplant programs notifying
CMS of changes rather than having a
process in place that would monitor
such changes. A few commenters
expressed concerns regarding how CMS
would identify underperforming
transplant programs and requested
guidance as to how CMS plans to ensure
patient safety and positive outcomes by
using the QAPI program instead of the
current re-approval process. Others
requested clarification as to how CMS
would continue to monitor outcomes
absent this requirement.
Response: We appreciate the
commenters’ support. CMS is
committed to ensuring that our
regulations support a patient’s access to
lifesaving organs. We also strive to
protect the quality of care that the
transplant recipient and donor receives
while in the transplant facility and we
agree with commenters that the removal
of this requirement will work towards
achieving these goals. We appreciate the
numerous studies and professional
opinions that were submitted by the
public that further bolstered our
understanding of the unintended
consequences that have occurred as a
result of the Medicare re-approval
requirements for transplant centers and
we therefore are finalizing our proposal
to remove these requirements at
§ 482.82. We believe that the removal of
these requirements will lead to
improved patient outcomes, increased
transplantation opportunities for
patients on the waitlist, improved organ
procurement for transplantation, greater
organ utilization, and reduced burden
on transplant programs. We note that
the removal of these requirements
directly aligns with our goal to increase
access to kidney transplants by
increasing the utilization of available
organs from deceased donors and
reducing the organ discard rate, which
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we outline in the Advancing American
Kidney Health Paper, which can be
found on the Office of the Assistant
Secretary for Planning and Evaluation
website at https://aspe.hhs.gov/pdfreport/advancing-american-kidneyhealth.
We understand the concerns that
commenters raised regarding the
availability of transplant program
outcome data and we remind
commenters that transplant outcomes
will still be available to the public every
six months on the Scientific Registry for
Transplant Recipients (SRTR) website at
https://www.srtr.org/. In addition, CMS
will continue to survey the program’s
QAPI program to make sure the program
is tracking adverse events, performing
thorough analysis of each adverse event,
and that performance improvement
projects ensure adverse events do not
recur. CMS will also do complaint
investigations based on public or
confidential reports about outcomes or
adverse events.
It is our expectation that transplant
programs will use their QAPI programs
to continue to monitor quality of care,
evaluate transplantation activities and
outcomes, and conduct performance
improvements when necessary. We
believe that these efforts and the survey
of the CoPs provides sufficient oversight
to ensure that transplant programs will
continue to achieve and maintain high
standards of care.
Comment: A few commenters, who
were generally supportive of the
proposals, had additional clarifying
questions for CMS about the survey
process. One commenter asked whether
additional reporting on the part of the
hospital and transplant based QAPI
programs would be required. A few
commenters asked whether CMS would
monitor hospital and QAPI based
programs through a different
mechanism, while one comment asked
whether CMS will be providing
published information regarding these
reviews. One commenter also expressed
their opposition to a change to the
transplant QAPI regulations, and they
expressed concern that changing these
regulations will have unintended
negative consequences on transplant
survival outcomes, safety issues, and an
increased focused on transplant volume
by programs. Another commenter asked
the following questions:
• Whether the monitoring schedule
for CMS surveys of transplant programs
will remain the same;
• What circumstances will trigger a
review from CMS outside of routine
recertification surveys; and
• What options will be available to a
transplant program with condition level
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deficiencies on recertification surveys
once the mitigating factors and SIAs are
removed.
Response: We did not propose
changes to the transplant program QAPI
requirements and, consistent with other
provider types, there is no public
reporting for the hospital and transplant
QAPI programs. Transplant programs
must continue to abide by the hospital
and transplant program QAPI CoPs at
§§ 482.21 and 482.96, respectively. On
survey, documentation of
communication between these QAPI
entities is expected and the hospital
QAPI program should report to the
Governing Body any issues with
transplant outcomes.
In response to the questions about the
survey process, we note that the survey
interval will not change, and that public
or confidential reports may trigger a
complaint survey. Mitigating factors and
systems improvement agreements were
for outcomes non-compliance only and
are therefore unnecessary with the
removal of the outcomes re-approval
requirement at § 482.82.
Comment: A few commenters were
generally supportive of CMS’s goals to
improve organ transplantation by
removing provider disincentives, but
the commenters suggested that this
could be achieved through
improvements to the quality and
outcomes measures. Specifically, the
commenters suggested that reported
outcomes focus on long term outcomes
instead of short term outcomes, data on
waitlist survival, donor utilization, total
volume of organs transplanted,
transplant rate utilization, costeffectiveness, and other quality of care
measures.
Response: We believe that the wide
variety of data and studies presented in
the proposed rule regarding the
unintended consequences of the reapproval requirements sufficiently
demonstrates that it is no longer
appropriate to include specific outcome
measures as a requirement for Medicare
re-approval. Transplant programs,
however, will still need to abide by
these outcome measures for initial
Medicare approval.
Comment: One commenter opposed
the transplant center proposals and
suggested that CMS look at Organ
Procurement Organization (OPO)
performance in producing quality
organs.
Response: We thank the commenters
for their feedback regarding OPO
performance measures. However, we
note that comments regarding OPOs are
outside the scope of this final rule.
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c. Special Procedures for Approval and
Re-Approval of Organ Transplant
Centers (§ 488.61(f) Through (h))
We proposed to remove the
requirements at § 488.61(f) through (h)
for mitigating factors and transplant
systems improvement agreements for
the re-approval process for transplant
centers. This change is complementary
to the proposed removal of § 482.82,
described previously.
Comment: The majority of
commenters were supportive of the
proposal to remove the mitigating
factors and systems improvement
agreements requirement for the reapproval process for transplant centers.
These commenters stated that the
removal of this requirement will relieve
undue burden on transplant programs.
However, a few commenters opposed
the removal of this provision. The
commenters were concerned that the
removal of this provision would
negatively impact programs and they
noted that programs that failed to meet
the re-approval requirements would be
terminated, which would limit patient
access. The commenter suggested that, if
this proposal is finalized, CMS should
monitor the number of programs that
have been decertified or that will face
decertification based on conditions.
Response: The proposed change to
remove the mitigating factors and
systems improvement agreements
afforded to transplant centers for
Medicare re-approval is a
complementary change to the removal
of the Medicare re-approval
requirements in § 482.82. We are
finalizing the removal of § 482.82,
making the existence of the mitigating
factors and systems improvement
agreement requirements obsolete.
However, we note that transplant
programs are still afforded the
opportunity to submit mitigating factors
or enter into systems improvement
agreements for the initial Medicare
approval, and that we are not making
additional changes to the current
processes other than the provisions
regarding mitigating factors and systems
improvement agreements.
Final Rule Action:
1. We are finalizing the proposal to
make nomenclature changes throughout
the transplant center regulations at
§§ 482.68, 482.70, 482.72 through
482.104, and at § 488.61, without
modification.
2. We are finalizing the proposal to
remove § 482.82, without modification.
3. We are finalizing the proposal to
remove the mitigating factor and
systems improvement agreement
requirements for Medicare re-approval
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at § 488.61(f) through (h), without
modification.
Contact: Alpha-Banu Wilson, 410–
786–8687.
6. Home Health Agencies
We received 27 timely public
comments on our proposed changes to
the HHA requirements. Commenters
included industry associations,
healthcare systems, individual HHAs,
consumer advocacy organizations, and
clinicians. Overall, the majority of
commenters were supportive of the goal
of the proposed changes. Those
comments are discussed below.
a. Patient Rights (§ 484.50(a)(3) and
(c)(7))
We proposed to delete the
requirement at § 484.50(a)(3) that HHAs
must provide verbal notification of all
patient rights. We proposed to limit the
verbal notification requirements to those
requirements set out in section
1891(a)(1)(E) of the Act for which verbal
notification is mandatory. We proposed
to revise § 484.50(c)(7) to implement
this more limited verbal notification
requirement. Revised § 484.50(c)(7)
would require HHAs to verbally discuss
HHA payment and patient financial
liability information with each HHA
patient as described above.
Comment: The majority of comments
submitted regarding this topic expressed
support for the proposed change to
require written notice of patient rights
for all enumerated rights, and oral
notice only for those rights specifically
set forth in the Act as requiring such
oral notice. However, a small number of
comments did not support this change,
stating that oral notice of all rights,
rather than only those set forth in the
Act, has value to patients and
caregivers. One commenter stated that
oral notice is particularly important for
individuals with lower literacy levels
due to disabilities.
Response: Consistent with the notice
of patient rights requirements for other
outpatient provider types, such as
hospices, ambulatory surgery centers,
and community mental health centers,
for which written notice of patient
rights is the only requirement, and in
light of the support for this proposed
change expressed by the majority of
commenters, we are finalizing this
change. We are sensitive to concerns
related to those individuals with lower
literacy levels due to disabilities that
may impact understanding of the notice
of patient rights. We remind all HHAs
that, as part of their Medicare provider
agreements, and in accordance with the
other requirements of § 484.50, they are
responsible for complying with the
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provisions of the Americans with
Disabilities Act and Section 504 of the
Rehabilitation Act when communicating
with all patients regarding all subjects,
including the notice of patient rights.
HHAs must provide equal access to
individuals with disabilities, including
the provision of auxiliary aids and
alternate formats, including, but not
limited to, the provision of qualified
interpreters, large print documents,
Braille, digital versions of documents,
and audio recordings.
b. Home Health Aide Services
(§ 484.80(h)(3))
We proposed to eliminate the
requirement at § 484.80(h)(3) that HHAs
conduct a full competency evaluation of
home health aides, and replace it with
a requirement to retrain the aide
regarding the identified deficient skill(s)
and require the aide to complete a
competency evaluation related only to
those skills.
Comment: Comments overwhelmingly
supported the proposed change to
remove the requirement that a home
health aide must complete a full
competency evaluation whenever a skill
deficiency is noted during the aide
supervision process.
Response: We continue to believe that
this change is appropriate, and are
finalizing it as proposed.
c. Clinical Records (§ 484.110(e))
We proposed to remove the
requirement at § 484.110(e) that the
requested clinical record copy must be
provided at the next home visit, while
retaining the requirement that the
information must be provided within 4
business days.
Comments: Comments universally
supported the proposal to remove the
requirement that HHAs must provide to
patients a copy of information contained
in the clinical record by the time of the
next HHA visit. A few comments
explicitly supported maintaining the
requirement to provide the requested
information to patients within 4 days.
However, other comments stated that
the proposed change did not provide
enough burden relief, and suggested that
the requirement to provide a copy of
such information within 4 days should
also be revised to allow HHAs up to 30
calendar days to provide such
information. Commenters stated that 4
business days was insufficient time to
access records, which may be archived
offsite, make copies, and send those
copies in the mail to arrive within 4
business days at the patient’s home. One
comment stated that the regulations
should not include any requirements for
HHAs to provide patients with
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information from their own clinical
records. Other commenters suggested
that a shorter timeframe for providing
information could be limited to only the
information from the current 60 day
episode of care, rather than to all
certification periods from the episode of
care or the patient’s entire record of care
that may cross several different episodes
of care. Additionally, some commenters
stated that HHAs should be permitted to
charge patients a fee for providing
information from the patient’s own
clinical record. However, other
commenters specifically supported the
prohibition on charging patients a fee to
receive information from their own
records.
Response: We appreciate the
commenters’ support for our proposed
revisions, and for their suggestions for
further changes regarding the HHA
clinical records provisions. Addressing
the evolving need for the electronic
exchange of health information amongst
health care providers and also between
patients and their health care providers
is an Administration priority. As such,
we will consider the issues raised by
commenters in the broader context of
interoperability and health information
exchange, and will use these comments
to inform future rulemaking. We are not
finalizing the changes to § 484.110(e) at
this time.
d. Additional Comments
Summaries of the additional
suggestions that we received that are not
directly related to our proposals and our
responses are set forth below.
Comment: Several commenters
suggested that the requirement for
HHAs to provide certain specified
information, such as the upcoming HHA
visit schedule and information about the
treatments being furnished by HHA
clinicians (§ 484.60(e)) in writing to
patients, should be completely removed
or significantly revised to remove most
of the specified information from the
list. Commenters specifically cited the
requirement to provide patients with a
visit schedule, contact information for a
hospice clinical manager, and
information about the treatments being
provided as being overly burdensome
requirements.
Response: While we understand the
concerns expressed by commenters, we
continue to believe that providing
patient-centered, patient-directed care
necessitates the provision of this crucial
information to all patients. Patients
cannot be active participants in their
own care and advocates for their own
interests without having essential
information about when care will be
provided to them, what treatments are
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being (or are supposed to be)
administered during their care, and
information for how to contact a clinical
member of the HHA care team to
discuss their questions and concerns.
While it may be challenging for HHAs
to keep patients abreast of their own
care, such efforts form the basis of
patient-centered care and cannot be
ignored.
Comment: A commenter suggested
that the CoP for the comprehensive
assessment should be revised to permit
a registered nurse or a therapist to
perform the comprehensive assessment
in all cases where both services are
ordered. A few commenters suggested
that HHAs should not be required to
provide any clinical services by their
own employees, per the requirements of
§ 484.105(f), and should instead be
allowed to provide all clinical services
under arrangement.
Response: Changes of this magnitude
would mark a significant departure from
longstanding CMS policy. As such, we
believe that it would be most
appropriate to use the traditional notice
and comment rulemaking process to
allow all interested parties the
opportunity to comment on the
concepts. We will take these suggestions
under consideration for future
rulemaking efforts.
Comment: Several commenters stated
that nurse practitioners, in addition to
physicians, should be allowed to write
orders for the home health plan of care
and provide care plan oversight.
Response: Section 1861(m) of the Act
requires the HHA plan of care to be
under the direction of a physician.
Section 1861(r) of the Act defines
‘‘physician’’ in a manner that does not
include other licensed practitioners,
such as nurse practitioners and
physician assistants. Therefore,
pursuant to statute, other licensed
practitioners may not establish and
maintain the home health plan of care,
including reviewing, signing, and
ordering services on the home health
plan of care.
Comment: A few commenters
submitted comments related to
physician signatures and
communication with physicians
regarding orders and the plan of care.
Some comments stated that a physician
signature should not be required for
therapy orders. The commenters stated
that requiring a physician signature on
such orders delays the initiation of
therapy services. Another comment
stated that HHAs should not be required
to communicate with all physicians
who write orders for the plan of care
when there is a change in the plan of
care.
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Response: In order to maintain
appropriate oversight of the HHA plan
of care, all HHA services, including
therapy services, must be ordered by a
physician (§ 484.60(b)(1)). The CoPs
allow for verbal orders in order to
facilitate a timely initiation of care,
requiring that verbal orders be
authenticated and dated by the
physician in accordance with applicable
state laws and regulations, and
consistent with the HHA’s own internal
policies. Typically, a physician writes
orders for a therapist to evaluate and
treat the patient. The requirement for
the physician order and subsequent
signature in accordance with State law
and HHA policy would not delay
therapy services after the therapist’s
evaluation and recommended treatment
plan has been communicated to the
physician for approval. It is not
necessary to withhold therapy services
while waiting for the physician
confirmation of the therapy plan.
We agree with the commenter that
communicating with all involved
physician(s) is not necessary for every
single change in the plan of care.
Section 484.60(c)(3) requires such
communication only when the change
to the plan of care is due to a change
in the patient’s health status (for
example, initiating a new medication) or
a change in the plan for the patient’s
discharge from the HHA. The
communication of other changes that do
not fall into one of these categories (for
example, adjusting the dose of a current
medication) is left to the discretion of
HHA clinical staff and the clinical
manager(s) responsible for the patient’s
care.
Comment: Numerous commenters
submitted suggestions for changes to
HHA payment policies, such as the face
to face requirement and the homebound
requirement, which they believe should
be addressed as part of CMS burden
reduction efforts. A single commenter
suggested a revision to the Home Health
Consumer Assessment of Healthcare
Providers and Systems (HHCAHPS). A
small number of commenters submitted
comments regarding information in the
HHA interpretive guidelines.
Response: Comments not related to
the HHA CoPs are outside of the scope
of this rule. Individuals wishing to
submit comments regarding CMS
payment policies may submit those
comments as part of the annual HHA
payment policy proposed rule. We have
shared these unrelated comments with
the appropriate components within
CMS.
Final Rule Action:
1. We are finalizing the proposal to
delete the requirement at § 484.50(a)(3)
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that HHAs must provide verbal
notification of all patient rights.
2. We are finalizing the proposal to
revise § 484.50(c)(7), requiring HHAs to
verbally discuss HHA payment and
patient financial liability information
with each HHA patient.
3. We are finalizing the proposal to
eliminate the requirement at
§ 484.80(h)(3) to conduct a full
competency evaluation, and replace it
with a requirement to retrain the aide
regarding the identified deficient
skill(s), and require the aide to complete
a competency evaluation related only to
those skills.
4. We are not finalizing the proposal
to remove the requirement at
§ 484.110(e) that the requested clinical
record copy must be provided at the
next home visit.
Contact: Danielle Shearer, 410–786–
6617.
7. Comprehensive Outpatient
Rehabilitation Facilities (CORFs)—
Utilization Review Plan (§ 485.66)
We proposed to amend the utilization
review plan requirements at § 485.66 to
reduce the frequency of utilization
reviews from a quarterly basis to an
annual requirement.
We received two timely public
comments on our proposed changes to
the CORF requirements. Both comments
expressed strong support for the
proposed changes; therefore we are
finalizing those changes as proposed in
this final rule.
1. Final Rule Action: We are finalizing
the proposal to revise § 485.66,
requiring the facility to have a written
utilization review plan that is
implemented annually, without
modification.
Contact: CAPT Jacqueline Leach,
USPHS, 410–786–4282.
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8. Critical Access Hospitals
a. Organizational Structure
(§ 485.627(b)(1))
We proposed to remove the
requirement for CAHs to disclose the
names and addresses of their owners,
those with a controlling interest in the
CAH or in any subcontractor in which
the CAH directly or indirectly has a 5
percent or more ownership interest, in
accordance with 42 CFR part 420,
subpart C. This requirement is
duplicative, as it is also a requirement
for the provider agreement for Medicare
participation. This proposal was also
included in the Medicare and Medicaid
Programs; Hospital and Critical Access
Hospital (CAH) Changes To Promote
Innovation, Flexibility, and
Improvement in Patient Care; Proposed
Rule (81 FR 39447) for the same reason.
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Comment: Commenters universally
supported the proposal to remove the
CAH disclosure requirement, noting that
the requirement duplicates a provision
found elsewhere in our regulations.
Comments received regarding this
provision in the Medicare and Medicaid
Programs; Hospital and Critical Access
Hospital (CAH) Changes To Promote
Innovation, Flexibility, and
Improvement in Patient Care; Proposed
Rule (81 FR 39447, 39460, June 16,
2016) were consistent with those
received for this proposed rule, with
commenters also universally supporting
the proposal.
Response: We appreciate the
comments received and continue to
believe that this change is appropriate.
Final Rule Action: We are finalizing
the proposed changes without
modification.
Contact: Kianna Banks, 410–786–
3498.
b. Provision of Services (§ 485.635(a)(4))
Current regulations at § 485.635
require a CAH’s professional healthcare
staff to review policies and procedures
annually; the review group must
include one or more doctors of medicine
or osteopathy and one or more
physician assistants, nurse practitioners,
or clinical nurse specialists. Based on
our experience with other providers, we
proposed a flexible approach that would
allow CAHs to maintain their health and
safety policies in such a manner as to
achieve the intended outcomes for all
patients. Thus, we proposed to change
the requirement at § 485.635(a)(4) from
‘‘annual’’ to ‘‘biennial’’.
We received 20 public comments on
our proposed changes to this CAH
requirement. Commenters included
hospital industry associations,
individual providers, and national
accrediting organizations. Overall the
commenters were supportive of the
proposed changes.
Summaries of the comments and our
responses are set forth below.
Comment: All of the commenters
agreed with the effort to reduce burden.
However, a few of commenters
suggested moving to a 3-year timeframe
for reviews and several other
commenters suggested aligning with
hospital requirements and removing the
timeframe and allow CAHs to determine
when reviews are done.
Response: CAHs are rural providers
with separate Conditions of
Participation from hospitals and they do
not have the range or number of
personnel, among other requirements
we require for hospitals.
We believe that the approach of
requiring a biennial review reduces
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burden while maintaining the
appropriate safeguards for healthy
outcomes for CAH patients. Therefore,
we are finalizing this requirement
without modification.
Final Rule Action: We are finalizing
the proposed changes to § 485.635(a)(4).
Contact: Mary Collins, 410–786–3189.
c. Special Requirements for CAH
Providers of Long-Term Care Services
(‘‘Swing-Beds’’) (§ 485.645(d)(1), (4), (5)
and (8))
The special requirements for CAH
swing-bed providers are nearly identical
to the requirements for hospital
providers of swing-bed services. As a
result, please refer to the discussion on
the special requirements for hospital
providers of swing-bed services under
section II.D.3 for the details of the
proposed changes for these
requirements for both hospitals and
CAHs. We proposed the following
revisions to the CAH swing-bed
requirements:
• Revision of § 485.645(d)(1) to
remove the cross-referenced long-term
care requirement in § 483.10(f)(9),
which requires that CAH swing-bed
providers to offer residents the right to
choose to or refuse to perform services
for the facility and prohibits a facility
from requiring a resident to perform
services for the facility;
• Removal of § 485.645(d)(4), which
requires CAH swing-bed providers to
provide an ongoing activity program
that is directed by a qualified
therapeutic recreation specialist or an
activities professional who meets
certain requirements (cross-referenced
long-term care requirement § 483.24(c));
• Revision of § 485.645(d)(4) (as
redesignated) to remove the crossreferenced long-term care requirement
§ 483.70(p), which requires that CAH
swing-bed providers with more than 120
beds to employ a qualified social worker
on a full-time basis; and
• Revision of § 485.645(d)(7) (as
redesignated) to remove the crossreferenced long-term care requirement
§ 483.55(a)(1), which requires CAH
swing-bed providers to assist in
obtaining routine and 24-hour
emergency dental care to its residents.
Contact: Kianna Banks, 410–786–
3498.
9. Community Mental Health Centers
(§ 485.914(d))
We require CMHCs, at § 485.914(d)(1),
to update clients’ comprehensive
assessments every 30 days. We
proposed to revise § 485.914(d)(1) to
require that the CMHC update each
client’s comprehensive assessment via
the CMHC interdisciplinary treatment
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team, in consultation with the client’s
primary health care provider (if any),
when changes in the client’s status,
responses to treatment, or goal
achievement have occurred, and in
accordance with current standards of
practice. Additionally, at
§ 485.914(d)(2), we proposed to retain
the minimum 30-day assessment update
time frame for those clients who receive
PHP services. We believe this proposed
change will allow for the provider and
client to choose a visit schedule that is
appropriate for the client’s condition
and not cause extra work or time for
documentation that is unnecessary.
Ultimately, this proposed change may
allow for greater flexibility for the
provider and client, saving time for
both.
We received 4 timely public
comments on our proposed changes to
the requirements at § 485.914(d).
Commenters included physicians,
associations and health networks.
Overall, the majority of commenters
were supportive of the goal of the
proposed changes. Summaries of the
major issues and our responses are set
forth below.
All of the comments expressed strong
support for the proposed changes to
§ 485.914(d); therefore, we are
incorporating those changes as proposed
in this final rule.
Comment: We received several
comments in support of the proposed
change to the CMHC update to the
comprehensive assessment requirement.
Most commenters agreed that, for
patients admitted for non-PHP services,
it made sense to allow patients care
needs, responses to treatment and care
goals to drive decisions about when a
patient needs to have an updated
assessment. Commenters also agreed
that it was appropriate to keep the
requirement to update to the
comprehensive assessment every 30
days for PHP patients. One commenter
raised a concern regarding the proposed
update to the comprehensive
assessment requirement changes as it
relates to patients needing to transfer to
the hospital emergency department. The
commenter stated that some emergency
departments receive patients directly
from CMHCs for emergency mental
health treatment, and that it is
important for the treating physician in
the ED to know what medications the
patient is taking. A commenter agreed
with the proposed change to the
comprehensive assessment update
requirement, and asked for CMS to
consider making similar burden
reducing changes to all the requirements
for the ’’Persons centered active
treatment plan’’ under § 485.916.
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Response: We appreciate all of the
positive feedback on the proposed
changes to remove the 30-day updated
assessment timeframe for non-PHP
patients, and are finalizing this proposal
without change. We understand the
concerns raised related to how this
assessment change would impact CMHC
patients who must be transferred to a
hospital emergency room. In the CMHC
CoPs under § 485.914(e)(5)(v)(A)–(E), we
state that when a client becomes an
immediate threat to the physical safety
of themselves, staff or other individuals,
the CMHC must document a description
of the client’s behavior and the
intervention(s) used (including
medications), alternatives or other less
restrictive interventions attempted, the
client’s condition or symptom(s) that
warranted the use of the restraint or
seclusion, and the client’s response to
the intervention(s) used. Typically,
patient transfers from a CMHC to an
emergency room include a transfer note
summarizing the above information,
including all current medications and
any PRN medications that were given
prior to the transfer to the emergency
room. Furthermore, we agree with the
suggestion that conforming changes
should be made to § 485.916, because
the requirements of § 485.914 and
485.916 constitute a cycle of care, with
assessment and care planning feeding
into one another. However, because we
did not propose any changes to the
client centered active treatment plan
CoP (§ 485.916), we are legally not
permitted to make any changes in a final
rule without proposing the change to
the public in a proposed rule. Therefore
we will not be amending the regulatory
language in § 485.916 but will consider
proposing a change to the requirements
at a future date.
Final Rule Action: We are finalizing
the proposal to revise § 485.914(d) that
the CMHC must update each client’s
comprehensive assessment via the
CMHC interdisciplinary treatment team,
in consultation with the client’s primary
health care provider (if any), when
changes in the client’s status, responses
to treatment, or goal achievement have
occurred and in accordance with
current standards of practice. For clients
that receive PHP services, the
assessment must be updated no less
frequently than every 30 days.
Contact: CAPT Mary Rossi-Coajou,
USPHS, 410–786–6051.
10. Portable X-Ray Services
(§§ 486.104(a) and 486.106(a))
We proposed to revise the personnel
qualification requirements at
§ 486.104(a)(1), (2), (3), or (4) by
removing school accreditation
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requirements and simplifying the
structure of the requirements. We
proposed that all operators of portable
X-ray equipment would meet one of the
following:
(1) Successful completion of a
program of formal training in X-ray
technology at which the operator
received appropriate training and
demonstrated competence in the use of
equipment and administration of
portable x-ray procedures; or
(2) Successful completion of 24 full
months of training and experience
under the direct supervision of a
physician who is certified in radiology
or who possesses qualifications which
are equivalent to those required for such
certification.
We proposed to update § 486.106(a)(2)
(specific to portable x-ray services) to
cross reference the requirements at
§ 410.32 instead of setting forth specific
order requirements. We proposed to
retain the requirement that the portable
x-ray order must include a statement on
why it is necessary to perform a portable
x-ray as opposed to performing the
study in a facility where x-rays are more
typically performed.
We received 9 timely public
comments on our proposed changes to
the portable x-ray requirements.
Commenters included long-term care
facility associations, portable x-ray
associations, portable x-ray suppliers,
and health care systems. Overall, the
majority of commenters were supportive
of the goal of the proposed changes.
Summaries of the major issues and our
responses are set forth below.
Comment: All of the comments
received regarding our proposal to
revise the personnel requirements for
individuals who perform portable x-ray
services supported the proposed
revision. A single commenter suggested
that option 2, related to 24 full months
of training and experience under the
direct supervision of a physician, and
should not be included because these
training programs are no longer offered.
Response: We agree with the
comments that it is appropriate to revise
the personnel requirements for
individuals who perform portable x-ray
services in a manner that focuses on the
skills of the individual rather than the
accreditation of the institution that
provided the training, and we are
finalizing this change. We do not agree
that it is appropriate to eliminate the
qualification option related to 24 full
months of training and experience
under the direct supervision of a
physician. The fact that such programs
are no longer offered does not mean that
those individuals who completed such
programs are no longer qualified to
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perform portable x-ray services, and
thus excluded from performing their job
duties. Excluding those individuals
would not benefit patient health and
safety or patient access to portable x-ray
services; and may, in fact, reduce the
number of qualified portable x-ray
technicians and negatively impact
access to care.
Comment: All of the comments
received regarding our proposal to
revise the requirements for portable xray orders supported the proposed
revision. One commenter specifically
supported, while another specifically
disagreed with, the proposal to retain
the requirement that each order must
specify the reason that portable x-ray
services are necessary.
Response: We agree with the
comments that it is necessary and
appropriate to revise the requirements
for portable x-ray orders to align with
the separate payment requirements for
diagnostic imaging orders that also
apply to portable x-ray services at
§ 410.32, and are finalizing this change.
We believe that it is appropriate to
require documentation regarding why
this unique service is necessary in place
of the more traditional facility-based xray service, and are continuing this
longstanding element as part of the
revised requirements for portable x-ray
orders.
Comment: We received several
comments related to Medicare payment
policies and Medicare payment manuals
related to portable x-ray services. We
also received a comment related to the
2018 Crosswalk for Medicare Provider/
Supplier to Healthcare Provider
Taxonomy, and the Medicare provider
and supplier enrollment process.
Response: These comments are
outside of the scope of this rule, and
have been shared with the CMS
components that are responsible for
these subject matter areas.
Final Rule Action: We are finalizing
the changes to §§ 486.104(a) and
486.106(a)(2).
Contact: Sonia Swancy, 410–786–
8445.
11. Rural Health Clinics (RHCs) and
Federally Qualified Health Centers
(FQHCs)
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a. Provision of Services (§ 491.9(b)(4))
We proposed to change the
requirement at § 491.9(b)(4), related to
reviewing patient care policies, from an
‘‘annual’’ review to a ‘‘biennial’’ review.
b. Program Evaluation (§ 491.11(a))
We proposed to revise the current
requirement at § 491.11(a) by changing
the frequency of the RHC or FQHC
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evaluation from annually to every other
year.
We received 30 timely public
comments on our proposed changes to
the RHC and FQHC requirements.
Commenters included industry
associations, healthcare systems,
individual RHCs and FQHCs and
clinicians. Overall, the majority of
commenters were supportive of the goal
of the proposed changes. Summaries of
the major issues and our responses are
set forth below.
Comment: Overall, the majority of
comments submitted regarding this
topic expressed support for both of the
proposed changes to require biennial
provision of services policy reviews and
clinic or center total program
evaluation. Some of the commenters
were completely supportive of the
proposed biennial change, while some
of the commenters stated they were
unsure whether it will provide
meaningful burden reduction. Other
commenters were appreciative of the
CMS goal to reduce burden on the RHC
or FQHC and stated that the flexibility
and opportunity to allow the clinic or
center to decide how to most
appropriately use their staff time and
resources is critical to maintaining the
highest standard of care for their
patients. One commenter suggested that,
in addition to revising the time frame
for review, CMS should also reduce the
burden of this regulation by removing
the requirement that someone in the
group of professional personnel that
reviews the policies must be from
outside the clinic or center’s staff.
Response: We continue to believe
these two changes are appropriate, and
are finalizing them as proposed.
We agree that the requirement to have
someone in the group of professional
personnel that reviews the policies be
from outside of the clinic or center’s
own staff can be difficult to meet in
medically underserved areas or those
where there are health professional
shortages. Administrative burden would
be decreased by the time often spent
trying to find a qualified professional
who is not on payroll, but is willing to
come in and review RHC policies. We
will consider this change for future
rulemaking.
Final Rule Action:
1. We are finalizing the proposal to
revise the requirement at § 491.9(b)(4)
requiring RHCs and FQHCs to review
their patient care policies at least
biennially by a group of professional
personnel and RHC or FQHC staff.
2. We are finalizing the proposal to
revise the requirement at § 491.11(a)
that requires the clinic or center to carry
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out or arrange for, a biennial evaluation
of its total program.
Contact: CAPT Jacqueline Leach,
USPHS, 410–786–4282.
12. Emergency Preparedness for
Providers and Suppliers
On September 16, 2016, we published
a final rule entitled, ‘‘Medicare and
Medicaid Programs; Emergency
Preparedness Requirements for
Medicare and Medicaid Participating
Providers and Suppliers’’ (81 FR 63860),
which established national emergency
preparedness requirements for Medicare
and Medicaid participating providers
and suppliers (referred to collectively as
‘‘facilities’’ in the subsequent section) to
plan adequately for both natural and
man-made disasters and coordinate with
Federal, State, tribal, regional, and local
emergency preparedness systems. In
that final rule, we emphasized the need
for facilities to maintain access to
healthcare services during emergencies,
safeguard human resources, and
maintain business continuity and
protect physical resources. A facility’s
emergency preparedness program must
include the following elements:
• Risk assessment and emergency
planning
• Policies and procedures
• Communication plan
• Training and testing
We received over 300 comments
centered around the proposed revisions
to the Emergency preparedness
requirements. Some of the comments
were supportive of one or more of the
proposed provisions, others were not
supportive of the proposed revisions
and expressed the commenters
concerns. We have organized our
responses to the comments as follows:
(1) General Comments; (2) Annual
Review of Emergency Preparedness
Program; (3) Documentation of
Cooperation Efforts; (4) Annual
Emergency Preparedness Training
Program; (5) Annual Emergency
Preparedness Testing.
General Comments
Comment: One commenter suggested
that we delay any changes to emergency
preparedness for 5 years. The
commenter states that revisions set forth
in the September 2016 Emergency
Preparedness final rule (81 FR 63860)
just went into effect within the past year
and some facilities are still working to
come into compliance with those
changes. Commenters assert that
implementing additional revisions at
this time would be burdensome.
Response: The September 2016
Emergency Preparedness final rule (81
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FR 63860) was a comprehensive change
in our requirements for all provider
types. Therefore, we allowed additional
time for providers and suppliers to
come into compliance. We do not agree
that it is necessary to extend the
effective date because (1) the original
compliance date was 2017, so providers
and suppliers should be complete with
implementation; (2) the proposed
changes in this rule decrease burden, so
implementation should not impose a
hardship on providers and suppliers to
come into compliance. Therefore, we
are not delaying the implementation of
this requirement. Once this rule is
published, providers/suppliers will
have 60 days from the publication date
to be in compliance with the finalized
changes.
Comment: One commenter requested
that we leave the emergency
preparedness regulations as they are and
work instead on strengthening standards
as proposed in Sheltering in Danger, a
report written by Minority Staff of the
Senate Finance Committee. The report
discusses efforts to improve nursing
home quality by calling attention to
specific issues such as heat index/
temperature/humidity, sheltering and
evacuations and community
engagement.
Response: We appreciate the
Committee’s work on the Sheltering in
Danger report. We updated Appendix Z
of the State Operations Manual in
February 2019 to clarify the emergency
preparedness requirements. This
includes adding emerging infectious
diseases to the definition of all-hazards
approach; clarifications and additional
guidance on the use of portable
generators and alternate source power
and a cross reference to the nursing
home requirements for safe
temperatures; and technical changes to
the home health citations. We are
always looking for ways to improve
quality and safety oversight efforts in
nursing homes, and are continuing to
consider the report’s recommendations
as we move forward.
Comment: A few commenters stated
that the current emergency
preparedness requirements are overly
burdensome for outpatient providers/
suppliers and the requirements should
be different for outpatient versus
inpatient providers and suppliers. The
commenters expressed that providers/
suppliers that provide inpatient services
should have stronger requirements as
the patients or residents may be
incapable of self-preservation in the
event of an emergency. Whereas,
outpatient providers and suppliers
generally have patients that are capable
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of self-preservation in the event of an
emergency.
Response: We understand that for
many smaller, rural providers and
suppliers and for outpatient facilities
that do not have full-time patients the
emergency preparedness requirements
may seem excessive. Many of the
requirements are similar for inpatient
and outpatient providers and suppliers.
We believe these emergency
preparedness requirements are
important for all providers and
suppliers. However, we recognize that
there are some differences in inpatient
and outpatient facilities with regard to
emergency preparedness and have made
changes in this rule that recognize these
differences. In addition, we note that
LTC facilities have some changes in
requirements for the emergency plan
updates and training that are discussed
in detail below. We will take your
recommendation and consider it for
future rulemaking.
a. Annual Review of Emergency
Preparedness Program (§§ 403.748,
416.54, 418.113, 441.184, 460.84,
482.15, 483.73, 483.475, 484.102,
485.68, 485.625, 485.727, 485.920,
486.360, 491.12, and 494.62 (a), (b), (c),
and (d))
We proposed to change the
requirement for facilities to review their
emergency preparedness program at
least every 2 years. This would increase
the facility’s flexibility to review their
programs as they determine best fits
their needs. We are finalizing this
proposal with modifications to LTC
facilities only.
The comments received in response to
the proposed revision were mostly
supportive and the comments that were
not supportive were mostly centered
around LTC facilities. Below is a
summary of the comments we received
and our responses.
Comment: Many commenters
supported the emergency preparedness
updates for biennially revisions to the
emergency plan. One commenter stated
that annual revisions are not always
necessary, as urgent changes are made
as needed; otherwise, facilities are
reviewing procedures that have not
changed. The proposed revisions to
emergency preparedness requirements
would increase facilities’ flexibility to
build, train, test and review an effective
program that meets the needs of each
facility and community in which the
facility is located.
Response: We agree that requiring
facilities to review their emergency
preparedness plan biennially allows for
more flexibility for providers and
suppliers. We expect that facilities
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would routinely revise and update their
policies and operational procedures to
ensure that they are operating based on
best practices. In addition, facilities
should update their emergency
preparedness program more frequently
than every 2 years as needed (for
example, if staff changes occur or
lessons-learned are acquired from a reallife event or exercise). Therefore, we are
finalizing this proposal for all
providers/suppliers to update their
emergency preparedness plan
biennially. As discussed in greater
detail below, due to the vulnerability of
residents in LTC facilities, we are not
finalizing the proposal for those
facilities only and will require them to
update their emergency plan annually,
as is currently required. This will allow
the staff and residents to be fully aware
of the emergency preparedness program
and any changes made.
Comment: As noted above, we
received many comments that asked us
to not finalize the proposed emergency
preparedness requirements for LTC
facilities. One commenter stated that
ongoing communication and
collaboration are very important. The
current regulations sensibly require
annual updates to emergency plans,
policies and procedures,
communications plan, training and
testing. The success of a preparedness
plan often depends on frequent updates.
Significant changes can occur in a 2
year period, the resident population, as
well as local health care providers,
transportation companies, staff,
facilities, patient population and other
vendors. The LTC facility should know
about changes in their community. Staff
turnover is a concern and for that reason
emergency preparedness plans need to
be revisited yearly to be sure everyone
is prepared. Many commenters stated
that changing the requirements to
biennial updates creates additional
opportunities for errors and for facility
residents and staff to be unprepared,
lack appropriate response and endanger
more residents’ lives. Residents depend
heavily on the staff and rely on their
preparedness during an emergency. The
effort and expense of annual updating is
far outweighed by the benefit of a LTC
facility being prepared for an
emergency. Moving to biennial review
could exacerbate the issue of emergency
preparedness in LTC facilities more
than already exists.
Response: We recognize that LTC
facility residents are generally a very
vulnerable population that rely on the
staff to be knowledgeable and prepared
in the event of an emergency. For that
reason, we are not finalizing the
proposal for biennial updates to the
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emergency plan for LTC facilities only.
All other providers and suppliers will
be required to update their emergency
preparedness plan biennially. We would
like to point out that this is the
minimum requirement for non-LTC
facility providers and suppliers and that
non-LTC facility providers and
suppliers are encouraged to review and
update their facilities plan more
frequently if providers and suppliers
feel the need to.
b. Documentation of Cooperation Efforts
(§§ 403.748(a)(4), 416.54(a)(4),
418.113(a)(4), 441.184(a)(4),
460.84(a)(4), 482.15(a)(4), 483.73(a)(4),
483.475(a)(4), 484.102(a)(4),
485.68(a)(4), 485.625(a)(4),
485.920(a)(4), 486.360(a)(4),
491.12(a)(4), and 494.62(a)(4))
We proposed to eliminate the
requirement that facilities document
efforts to contact local, tribal, regional,
State, and Federal emergency
preparedness officials and facilities’
participation in collaborative and
cooperative planning efforts. Facilities
will still be required to include a
process for cooperation and
collaboration with local, tribal, regional,
State and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
The comments received regarding this
proposal were mostly supportive. Below
we have summarized the comments
received and our responses.
Comment: Many commenters support
the elimination of documentation of
efforts to contact local, tribal, regional,
State and Federal emergency
preparedness officials and, when
applicable, document the facility’s
participation in collaborative and
cooperative planning efforts.
Commenters state that documenting
efforts to contact emergency
preparedness officials are overly
burdensome. The commenters also
stated that eliminating this requirement
allows for smaller facilities to focus on
patient care.
Response: We agree that the
documentation requirement can be
overly burdensome, as some comments
have raised, and are finalizing the
proposal to remove the requirement. We
believe that eliminating this
documentation requirement would
reduce burden by not requiring facilities
to demonstrate that they have contacted
local, tribal, regional, State, and Federal
emergency preparedness officials or
participated in collaborative and
cooperative planning in the community,
while still requiring facilities to have a
process for cooperation and
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collaboration. Therefore, we are
finalizing this requirement as proposed
and eliminating the documentation
requirement for collaboration with
emergency preparedness officials.
Providers and suppliers would still be
required to have a process for
cooperation and collaboration as part of
the emergency plan.
Comment: Commenters stated that
removing documentation requirements
will reduce transparency of cooperation
efforts, increasing the likelihood of
disjointed responses and weakening
accountability. Documentation proves
that the facility has actually contacted
and collaborated with EP officials, is the
only way a state survey agency can
verify that efforts have been made for
compliance, and is invaluable to
incoming staff.
Response: We would like to point out
that providers would still be required at
the respective emergency preparedness
requirements for each provider and
supplier to include a process for
collaboration/cooperation with officials;
however, they would not be required to
document efforts to contact these
officials. Therefore, this maintains the
existence of a process for collaboration
with officials without posing additional
documentation burdens. Therefore, we
are finalizing this requirement as
proposed and eliminating the
documentation requirement for
collaboration with emergency
preparedness officials.
c. Annual Emergency Preparedness
Training Program (§§ 403.748(d)(1)(ii),
416.54(d)(1)(ii), 418.113(d)(1)(ii),
441.184(d)(1)(ii), 460.84(d)(1)(ii),
482.15(d)(1)(ii), 483.73(d)(1)(ii),
483.475(d)(1)(ii), 484.102(d)(1)(ii),
485.68(d)(1)(ii), 485.625(d)(1)(ii),
485.727(d)(1)(ii), 485.920(d)(1)(ii),
486.360(d)(1)(ii), 491.12(d)(1)(ii), and
494.62(d)(1)(ii))
Facilities are required to develop and
maintain a training program that is
based on the facility’s emergency plan.
This emergency preparedness training
must be provided at least annually and
a well-organized effective training
program must include initial training in
emergency preparedness policies and
procedures. We revisited the public
comments received on the Emergency
Preparedness proposed rule (81 FR
63890 through 63891) and determined
that requiring facilities to provide
annual training may be unduly
burdensome. Therefore, we proposed to
require facilities to provide training
biennially or every 2 years, after
facilities conduct initial training on
their emergency program. In addition,
we proposed to require additional
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training when the emergency plan is
significantly updated.
Overall, the majority of commenters
opposed our proposal to require
emergency preparedness training
biennially. We received a significant
number of comments on this proposal
from nursing home resident advocates.
We received a few supportive and
negative comments from other
stakeholders, including Congressional
representatives and emergency
management professionals. A summary
of the major issues and our responses
are set forth below:
Comment: Nursing home resident
advocates overwhelmingly opposed our
proposal to require emergency
preparedness training biennially. These
commenters noted that training every 2
years is not sufficient to maintain
readiness in the event of an emergency.
Commenters noted that nursing homes
specifically experience high staff
turnover, changes in ownership, and
changes in resident conditions/needs,
and cited these conditions as reasons to
support annual training. Commenters
also noted recent emergency events and
the lack of readiness displayed by
nursing homes as an indication that
more emergency preparedness training,
not less, is needed.
In addition to the large number of
comments from nursing home resident
advocates, we also received a few
comments opposed to the proposal from
non-LTC facility providers. These
commenters also noted high staff
turnover, changes in community
resources, closure of receiving
providers, changes in patient/resident
census, and the need to incorporate
recent best practices and lessons learned
as the main reasons to support annual
training. Commenters indicated that the
effort and expense of annual training
would be outweighed by the benefit of
being prepared in the case of an
emergency or natural disaster.
Response: We appreciate the feedback
and thoughtful comments provided on
this proposal. We especially appreciate
the comments that provided a very
detailed analysis of the lack of
emergency response in nursing homes
following recent emergency events. We
believe that these comments have
provided compelling evidence to revise
our proposal specific to LTC facilities.
Therefore, for LTC facilities only, we are
not finalizing our proposal to revise the
annual training requirement to biennial
training. LTC facilities will be required
to continue to meet the current
requirement for annual training.
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d. Annual Emergency Preparedness
Testing (§§ 403.748(d)(2), 416.54(d)(2),
418.113(d)(2), 441.184(d)(2),
460.84(d)(2), 482.15(d)(2), 483.73(d)(2),
483.475(d)(2), 484.102(d)(2),
485.68(d)(2), 485.625(d)(2),
485.727(d)(2), 485.920(d)(2),
486.360(d)(2), 491.12(d)(2), and
494.62(d)(2))
Facilities are currently required to
conduct exercises to test the emergency
plan at least annually. The facility must
conduct two emergency preparedness
testing exercises every year.
Specifically, facilities must:
• Participate in a full-scale exercise
that is community-based or when a
community-based exercise is not
accessible, an individual, facility-based.
If the facility experiences an actual
natural or-man made emergency that
requires activation of the emergency
plan (including their communication
plan and revision of the plan as
needed), the facility is exempt from
engaging in a community-based or
individual, facility based full-scale
exercise for 1 year following the onset
of the actual event;
• Conduct an additional exercise that
may include either a second full-scale
exercise that is community-based or
individual, facility-based or a tabletop
exercise that includes a group
discussion led by a facilitator.
Upon further analysis of this
requirement, and taking into account
stakeholder feedback, we determined
that there was a need to clarify and
revise some of the requirements
included in the Emergency
Preparedness final rule (81 FR 63860).
Therefore, for all provider and supplier
types, we proposed to clarify our intent
with regard to the types of testing
exercises, specifically full-scale
exercises and functional exercises.
For providers of inpatient services
(inpatient hospice facilities, Psychiatric
Residential Treatment Facilities
(PRTFs), hospitals, long-term care
facilities (LTCFs), ICFs/IIDs, and CAHs),
we proposed to retain the existing
requirement for these provider and
supplier types to conduct two
emergency preparedness testing
exercises annually. We proposed to
expand the testing requirement options,
such that one of the two annually
required testing exercises could be an
exercise of their choice, which could
include one community-based full-scale
exercise (if available), an individual
facility-based functional exercise, a
drill, or a tabletop exercise or workshop
that included a group discussion led by
a facilitator. We noted that although
RNHCIs provide inpatient services, we
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determined that changing their existing
requirements to make them consistent
with this proposed provision would be
unduly burdensome, as they are
currently only required to conduct a
paper-based, tabletop exercise at least
annually.
For providers of outpatient services
(ASCs, freestanding/home-based
hospice, Program for the All-Inclusive
Care for the Elderly (PACE), HHAs,
CORFs, Organizations (which include
Clinics, Rehabilitation Agencies, and
Public Health Agencies as Providers of
Outpatient Physical Therapy and
Speech-Language Pathology Services),
CMHCs, Organ Procurement
Organizations (OPOs), RHCs, FQHCs,
and ESRD facilities), we proposed to
require that providers of outpatient
services conduct only one testing
exercise per year. Furthermore, we
proposed to require that these providers
participate in either a community-based
full-scale exercise (if available) or
conduct an individual facility-based
functional exercise every other year. In
the opposite years, we proposed to
allow these providers to conduct the
testing exercise of their choice, which
may include either a community-based
full-scale exercise (if available), an
individual, facility-based functional
exercise, a drill, or a tabletop exercise or
workshop that includes a group
discussion led by a facilitator. We noted
that due to the nature of services
provided by OPOs, we proposed to
require that they have the option of
providing either a tabletop exercise or
workshop every year.
Lastly, we proposed to clarify the
testing requirement exemption by
noting that if a provider experiences an
actual natural or man-made emergency
that requires activation of their
emergency plan, inpatient and
outpatient providers will be exempt
from their next required full-scale
community-based exercise or
individual, facility-based functional
exercise following the onset of the
actual event.
The majority of the comments
received were supportive of our
proposal to differentiate the emergency
preparedness testing requirements
between inpatient and outpatient
providers and to clarify the types of
testing exercises that will satisfy the
proposal. A summary of the major
comments and our responses are below:
Comment: While many commenters
supported our requirement to
differentiate the emergency
preparedness testing requirements
between inpatient and outpatient
providers, one commenter noted that
the varying requirements may
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51757
discourage coordination and
collaboration amongst providers within
a community.
Response: We appreciate the feedback
in support of our proposal. It is not our
intention to discourage coordination
among providers, but rather to provide
facilities with a requirement for
emergency preparedness testing that is
realistic and attainable, without
impacting the health and safety of the
patients that they serve. We believe that
differentiating the testing requirements
by inpatient and outpatient provider
and supplier types takes into
consideration the unique characteristics
of not only the provider type, but also
the population that they serve. We
expect that facilities will continue to
make best efforts to collaborate with
providers within their community to not
only maximize efforts and resources, but
to also meet the many other emergency
preparedness requirements for
coordination and collaboration. We note
that all provider and supplier types are
required to develop an emergency
preparedness communication plan that,
among other things, includes
information for other providers; and to
develop a method for sharing
information and medical documentation
for individuals under the provider’s care
with other health care providers, as
necessary to maintain the continuity of
care.
Comment: Commenters supported the
clarification of the types of testing
exercises that would satisfy the testing
requirements. However some
commenters indicated that the proposal,
and terminology we used, remain
confusing. These commenters urged us
to follow the principles of exercise
programs established under the
Homeland Security Exercise and
Evaluation Program (HSEEP). One
commenter indicated that we use
functional exercise and full-scale
exercise interchangeably, when the two
exercises are vastly different types of
exercises. This commenter suggested
further that we use a more broad
definition of the types of testing
exercises to align with HSEEP.
Specifically, the commenter
recommended that we require facilities
to participate in an annual operationsbased exercise in conjunction with
local, county, or other state stakeholders
(if available) or conduct an operationsbased exercise at the facility level. The
commenter noted that, as defined by
HSEEP, an ‘‘operations-based exercise’’
could include any of the following types
of exercises: Drill, functional exercise,
or full-scale exercise. Furthermore, the
commenter indicated that as a choice of
testing exercises we should specify that
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facilities may choose a ‘‘discussion
based exercise’’ that, as defined by
HSEEP, would include a tabletop
exercise or workshop.
Response: We appreciate the feedback
and want to ensure that the language
used in our regulations and the intent
behind our regulations are as clear as
possible. As indicated in the proposed
rule and as well in the 2016 Emergency
Preparedness final rule (81 FR 63860),
we have attempted to align our
terminology with that used by HSEEP.
We note that functional exercise and
full-scale exercise are specific testing
exercise types as defined by HSEEP.
Furthermore, in the proposed rule (83
FR 47714) we provided definitions for
both functional and full-scale exercises,
as defined by HSEEP. Therefore, we
disagree with the commenters who
suggested that we have not aligned our
proposal with the guiding principles of
HSEEP.
It is our intent that providers and
suppliers make an attempt to conduct a
full-scale exercise within their
community, while understanding that
this may not always be feasible.
Therefore, we provide that when a fullscale exercise is not available, facilities
must conduct a functional exercise at
the individual facility level in order to
satisfy our requirement. The
commenter’s suggestion to broaden the
language to ‘‘operations-based exercise’’
would mean that a drill could also
satisfy our requirement, and that is not
our intention. We specifically refer to a
full-scale exercise and functional
exercise because those are the two
testing exercises that would satisfy the
requirement. We encourage readers to
refer to the proposed rule (83 FR 47714)
and the HSEEP guidelines located at
https://preptoolkit.fema.gov/
documents/1269813/1269861/HSEEP_
Revision_Apr13_Final.pdf/65bc78431d10-47b7-bc0d-45118a4d21da for
additional details regarding the
definition of these types of exercises.
While we have not made any
modifications to the terminology used to
highlight the testing types, we have
reviewed the regulatory text for
opportunities to improve readability
and have made minor revisions to the
regulatory language in hopes of
providing clarity about what is required.
Final Rule Action:
• We are not finalizing our proposal
to require biennial updates to the
emergency preparedness program for
LTC facilities only. All other affected
providers are required to update the
emergency preparedness program
biennially.
• We are finalizing our proposal to
eliminate the requirement that facilities
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document efforts to contact local, tribal,
regional, State, and Federal emergency
preparedness officials and facilities’
participation in collaborative and
cooperative planning efforts.
• We are not finalizing our proposal
to require biennial emergency
preparedness training for LTC facilities
only. All other affected providers are
required to provide emergency
preparedness training biennially.
• We are finalizing our proposal to
require inpatient providers to conduct
two testing exercises annually and
outpatient providers to conduct one
testing exercise annually with only
minor modification to improve the
readability and clarity of the
requirement.
Contact: Kristin Shifflett, 410–786–
4133, Ronisha Blackstone, 410–786–
6882.
13. Technical Corrections
In response to public comments, we
are revising that language used to
reference doctors of dental surgery that
appear in the regulatory text for
hospitals. The hospital CoPs reference
these physicians in the Medical Staff
CoP (§§ 482.22(c)(5)(1) and 482.22(c)(6))
as oromaxillofacial surgeons. The
accurate and current terminology to use
for these physicians is oral and
maxillofacial surgeons. We are revising
the regulatory text for these provisions.
Although we did not propose this in
the proposed rule, in response to public
comments regarding home health aide
competency training, we are revising the
language used to describe the process
for conducting home health aide
competency evaluations to restore
longstanding official CMS policy. In the
July 18, 1991 (56 FR 32967) final rule,
‘‘Medicare Program; Home Health
Agencies: Conditions of Participation,’’
issued by CMS, we explicitly permitted
the use of pseudo-patients and
laboratory environments for purposes of
home health aide competence
evaluations, even though the regulatory
text did not specifically mention
‘‘pseudo-patients.’’ We stated, ‘‘[W]e
believe that it is acceptable to conduct
aide training with a mannequin and to
conduct competency evaluations in a
laboratory setting using ‘pseudo
patients’ such as another aide or
volunteer. We do not believe it is
necessary to revise the regulations to
clarify this point.’’ (56 FR 32972). We
agree with commenters that it is
necessary to make a technical correction
to the HHA CoPs as finalized on January
13, 2017 (82 FR 4584) to explicitly
permit the use of pseudo-patients for
purposes of home health aide
competency evaluations in order to
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assure that the home health agency
regulations and Interpretive Guidelines
are consistent with the policy originally
set forth in 1991.
This technical correction restores
longstanding CMS policy, as stated in
the 1991 rule, that permitted the use of
pseudo-patients, and is consistent with
the original intent of the January 2017
HHA CoPs final rule. We are making
conforming changes to the definitions
section of the HHA CoPs at § 484.2 to
define the terms ‘‘pseudo-patient’’ and
‘‘simulation’’ as follows:
• ‘‘Pseudo patient means a person
trained to participate in a role-play
situation, or a computer-based
mannequin device. A pseudo-patient
must be capable of responding to and
interacting with the home health aide
trainee, and must demonstrate the
general characteristic to the primary
patient population served by the HHA
in key areas such as age, frailty,
functional status, and cognitive status.’’
• ‘‘Simulation means a training and
assessment technique that mimics the
reality of the homecare environment,
including environmental distractions
and constraints that evoke or replicate
substantial aspects of the real world in
a fully interactive fashion, in order to
teach and assess proficiency in
performing skills, and to promote
decision making and critical thinking.’’
Because this is a clarification of an
already-existing rule to codify
longstanding policy, we do not believe
that notice and comment rulemaking is
necessary; we are therefore waiving
notice and comment as indicated in
Section I.C.14 below.
General Comments
Comment: We received many
comments regarding issues that are out
of scope of this rule, such as payment
and reimbursement, Medicare
advantage, prior authorization, physical
therapy requirements and more. Some
of these issues were for specific
providers or suppliers and some were
blanket comments.
Response: We have read and received
all of the comments that are out of the
scope of this rule. We will not be
addressing them in this rule; however,
we will consider them for future
rulemaking.
14. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule. The notice of
proposed rulemaking includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substances of the proposed
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rule or a description of the subjects and
issues involved. This procedure can be
waived, however, if an agency finds
good cause that a notice-and-comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued.
A notice-and-comment rulemaking
procedure is unnecessary for the change
related to adding the phrase ‘‘or with a
pseudo-patient as part of a simulation’’
to the HHA aide competency evaluation
requirement at § 484.80(c)(1) because
this regulatory revision simply restores
official CMS policy as stated in
rulemaking dating back to 1991, and
does not constitute a change in CMS
policy. We are adding conforming
changes to the definitions section at
§ 484.2 for the terms ‘‘pseudo-patient’’
and ‘‘simulation.’’ These changes are
technical in nature. These changes to
restore longstanding CMS policies are in
the public interest, in order to assure
that HHAs are adequately staffed with
aides that have proven their competency
to serve HHA patients. Home health
aides may not provide services to
patients until they have demonstrated
their skill competencies. Allowing
HHAs to use pseudo-patients as part of
a simulation in order to demonstrate
skill competencies facilitates timely
placement of properly trained and
evaluated aides in patient homes to
provide much needed services in
accordance with each patient’s
individualized plan of care. In the
absence of this regulatory change to
conform to longstanding CMS policy, in
a survey conducted by the National
Home Care Association 45 percent of
responding HHAs reported being unable
to provide full competency
examinations for newly hired home
health aides, creating a delay in
delivering physician-ordered aide
services to HHA patients. This delay in
direct patient care services may be
harmful to patients, and the technical
change will resolve the underlying aide
competency evaluation backlog problem
that is creating the delay.
Therefore, we find good cause to
waive the notice of proposed
rulemaking and to issue these
provisions on an interim basis. We are
providing a 60-day public comment
period.
C. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995 (PRA), we are required to
provide 30-day notice in the Federal
Register and solicit public comment
before a collection of information
requirement is submitted to the Office of
51759
Management and Budget (OMB) for
review and approval. In order to fairly
evaluate whether an information
collection should be approved by OMB,
section 3506(c)(2)(A) of the PRA
requires that we solicit comment on the
following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We solicited public comment on each
of the section 3506(c)(2)(A)-required
issues for the following information
collection requirements (ICRs).
1. Wage Costs
To derive average costs, we used data
from the U.S. Bureau of Labor Statistics’
May 2017 National Occupational
Employment and Wage Estimates for all
salary estimates (https://www.bls.gov/
oes/2017/may/oes_nat.htm). In this
regard, the following table presents the
mean hourly wage, the cost of fringe
benefits and overhead costs (calculated
at 100 percent of salary), and the
adjusted hourly wage cost.
TABLE 2—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES
Occupation
code
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Occupation title
Healthcare Support Worker .............................................................................
Physicians and Surgeons ................................................................................
Physicians and Surgeons, All Other ................................................................
Physicians, Psychiatrists .................................................................................
Surgeons ..........................................................................................................
Registered Nurse—(RN-Quality Improvement, Home Care Coordinator,
HealthCare Trainer, Quality Assurance Nurse, QAPI Nurse Coordinator,
Infection Control Nurse Coordinator, Psychiatric RN) .................................
Medical Secretary (Clerical, Administrative Assistant) ....................................
Administrative Services Manager (Facility Director) ........................................
Management Occupations (Director, Community Relations Manager, Administrator) .........................................................................................................
Pharmacist .......................................................................................................
Medical and Health Services Manager (Administrator, Transplant Program
Senior Administrator/Hospital Administrator/Medical and Health Services
Managers, Program Director, Risk Management Director. QAPI Director,
Organ Procurement Coordinator, Nurse manager, Director of Nursing,
Nursing care facilities/skilled nursing facilities) ............................................
Managers, All Others (Administrator) ..............................................................
*Activities Specialist (Recreational Therapists, Nursing Care Facilities/SNFs)
Internists (Medical Director, General Physician) .............................................
Family and General Practitioner (Medical Director) ........................................
Physical Therapist (Director of Rehab) ...........................................................
Healthcare Social Worker (Social Worker) ......................................................
Mental Health and Substance Abuse Social Worker (Social Worker) ............
Nurse Practitioner (Clinician, Nurse Practitioner Outpatient Care Center) .....
Mental Health Counselor .................................................................................
Physician Assistant ..........................................................................................
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Mean hourly
wage
($/hour)
Fringe
Benefits and
overhead
cost
($/hour)
Adjusted hourly wage cost
($/hour)
31–9099
29–1060
29–1069
29–1066
29–1067
$18.56
103.22
101.63
103.89
121.10
$18.56
103.22
101.63
103.89
121.10
$37
206
203
208
242
29–1141
43–6013
11–3011
35.36
17.25
49.70
35.36
17.25
49.70
71
35
99
11–0000
29–1051
57.65
58.52
57.65
58.52
115
117
11–9111
11–9199
29–1125
29–1063
29–1062
29–1123
21–1022
21–1023
29–1171
21–1018
29–1071
53.69
54.41
20.64
95.37
100.27
42.34
27.31
22.99
51.68
22.38
50.37
53.69
54.41
20.64
95.37
100.27
42.34
27.31
22.99
51.68
22.38
50.37
107
109
41
191
201
85
55
46
103
45
101
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TABLE 2—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES—Continued
Occupation
code
Occupation title
Licensed Practical and Licensed Vocational Nurses (Director of Nursing) ....
First Line Supervisors of Office and Administrative Support Workers (Office
Manager) ......................................................................................................
Office Clerks, General (Clerical staff) ..............................................................
Secretaries and Administrative Assistants (Clerical staff) ...............................
Chief Executive ................................................................................................
Mean hourly
wage
($/hour)
Fringe
Benefits and
overhead
cost
($/hour)
Adjusted hourly wage cost
($/hour)
29–2061
21.98
21.98
44
43–1011
43–9061
43–6010
11–1011
28.14
16.30
19.74
94.25
28.14
16.30
19.74
94.25
56
33
39
189
* Salary information used is for Nursing Care Facility/SNF industry.
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2. ICRs Regarding RNHCI Discharge
Planning (§ 403.736(a) and (b))
It was discovered during review that
the burden for existing requirements at
42 CFR 403.724(a), 403.730(a), 403.732,
403.736(a)(b), and 403.736(d) was
erroneously not accounted for nor
approved under the PRA prior to this
rulemaking. Accordingly, the burden
associated with these requirements is
currently pending OMB approval (OMB
control number 0938–NEW). Section
403.736 will reduce the extensive
requirements for an RNHCI to
coordinate with other medical providers
for post-RNHCI care. Based on recent
claims data, there was a combined
annual total of 619 beneficiaries that
stayed in the 18 facilities.
We estimate that the time currently
required to develop and document
discharge plans and activities is 1,238
burden hours (2 hours for each of the
619 beneficiaries discharged) and that it
would be reduced by half. Of the
approximately 619 annual discharges,
we estimate that a RNHCIs burden
would be reduced to one hour for each
discharged individual. A RNHCI would
not need to develop a discharge plan
that includes medical care once a
patient leaves the RNHCI because doing
so would not be in keeping with the
religious tenets of the patients they
serve. We estimate that the healthcare
support worker responsible for a
patients discharge plan costs $37 an
hour, including hourly wage and an
estimated 100 percent add-on for fringe
benefit costs and overhead costs (this is
an HHS standard calculation). Based on
our experience with RNHCIs, we
estimate that it would take 1 hour to
develop the proposed discharge
instructions and discuss them with the
patient or caregiver. We estimate a total
of 619 annual discharges from RNHCIs
at a savings of $37 per discharge for a
total savings of $22,903 ($37 × 619
hours).
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3. ICRs Regarding ASC Governing Body
and Management (§ 416.41(b)(3)(i) and
(ii))
customary practice in accordance with
the implementing regulations of the
PRA at 5 CFR 1320.3(b)(2).
We are finalizing our proposal with
changes to eliminate the requirements at
§ 416.41(b)(3) that states the ASC must
have a written transfer agreement with
a hospital or ensure all physicians
performing surgery in the ASC have
admitting privileges at a local hospital
that meets CMS hospitalization
requirements. However, we will require
that the ASCs have a notice requirement
with hospitals and encourage a transfer
agreement when possible. All ASCs
easily meet this requirement and have
established a relationship with their
local hospital and obtained an
agreement as usual and customary
practice for running an ASC, with the
exception of approximately twenty
ASCs that have difficult relationships
with their local hospitals. The savings
would not be significant, however, it
does affect the 20 ASCs by removing the
requirement. The current information
collection request for the ASC rules
(OMB control number 0938–1071) does
not address any potential burden
associated with this requirement. We
believe that having and maintaining
written agreements is standard practice.
Therefore, removing this requirement
would not alter the current information
collection burden for ASCs.
5. ICRs Regarding ASC Patient
Admission, Assessment and Discharge
(§ 416.52(a)(1), (2), (3) and (4))
At § 416.52 we are finalizing our
proposal to replace the requirement that
every patient have a comprehensive
medical history and physical
examination (H&P) within 30 days prior
to surgery in an ASC with a requirement
that allows the operating physician and
ASC to determine which patients would
require more extensive testing and
assessment prior to surgery. The burden
associated with this requirement would
be the time and effort necessary to
create new policies for when, and
whether, to require some form of history
and physical that would require preoperative examination and testing, and
on what time schedule. The current
information collection request for the
ASC rules (OMB control number 0938–
1071) does not account for any
information collection related burden
associated with the comprehensive H&P
requirement. We assume that creating
these policies (which could leave such
decisions to the surgeon’s discretion in
most or all cases) would require 10
hours of physician time, 10 hours of RN
time, and 10 hours of clerical time, at
the preceding hourly rates, for a total of
30 hours per facility. This would be a
one-time cost of $3,460 per facility ([10
× $242] + [10 × $71] + [10 × $33]), and
$19.2 million for all 5,557 facilities.
Therefore, this proposed requirement
would increase the information
collection related burden by $19.2
million and 166,710 hours (30 hours ×
5,557 facilities) on a one-time basis for
all ASCs.
4. ICR Regarding ASC Medical Records
(§ 416.47(b)(2))
We are finalizing our proposal to
revise § 416.47(b)(2) by adding the
phrase ‘‘(as applicable)’’ to the
significant medical history and results
of physical examination requirement of
documents that must be included in the
medical record in order to conform to
the changes that we proposed to the
mandatory medical history and physical
examination requirement. There are no
collection of information requirements
associated with this proposed change
because maintaining a medical record
for each patient is a usual and
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6. ICRs Regarding Hospice Aide and
Homemaker Services (§ 418.76)
At § 418.76(a) we are finalizing our
proposal to defer to State training and
competency requirements, where they
exist, for hospice aides. The information
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collection request for the hospice
requirements (OMB control number
0938–1067) estimates that a hospice
would spend 5 minutes per newly hired
hospice aide to document verification
that an aide meets the required training
and competency requirements, for a
total of 372 annual burden hours for all
hospices at a cost of $11,540. This
change to the actual training and
competency requirements would not
alter the requirement to document the
fact that a hospice aide meets one of the
training and competency requirements
set forth in the rule; therefore there
would be no change to the existing
collection of information estimates
because the estimates relate to the
unchanged documentation requirements
rather than the actual training and
competency requirements that would be
revised by this change.
7. ICRs Regarding Drugs and Biologicals,
Medical Supplies, and Durable Medical
Equipment (§ 418.106(a))
At § 418.106(a) we are finalizing our
proposal to remove the requirement that
a hospice ensure that the
interdisciplinary group confers with an
individual with education and training
in drug management as defined in
hospice policies and procedures and
State law, who is an employee of or
under contract with the hospice to
ensure that drugs and biologicals meet
each patient’s needs. The information
collection request for the hospice
requirements (OMB control number
0938–1067) states that the burden
associated with this requirement is the
time necessary to document the results
of this consultation in each patient’s
clinical record. In the information
collection request we assumed that an
average hospice would confer with a
pharmacist, and that the pharmacist
would document the results of his or
her consultation. We estimated that it
requires 5 minutes to document the
initial review of a patient’s drug and
biologicals. Additionally, we estimated
that it requires 5 minutes of the
pharmacist’s time to document a review
of updates to the patient’s drug profile.
Based on a 17 day median length of
service, we assumed that each patient
would likely receive one update to their
plans of care. At an average hourly rate
of $117 for a pharmacist, we estimated
that it would cost a hospice $19.50 per
patient ($117 × [5 minutes for initial +
5 minutes for 1 update]) and an annual
cost of $6,942 ($19.50 × 356 patients).
The total annual burden hours for all
hospices was estimated to be 264,588
hours (1,587,527 patients × .1666 hour
per patient), and the total annual burden
cost for all hospices (taking into account
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new wage data) is estimated to be
$30,956,777 ($19.50 per patient ×
1,587,527 patients). Therefore, removing
the requirement that a hospice must
ensure that the interdisciplinary group
confers with an individual with
education and training in drug
management would result in a burden
reduction of 264,588 hours and
$30,956,777.
The information collection request
will be revised and sent to OMB.
We estimate the necessary policy
changes needed to comply with the
requirements proposed in this rule
would cost $2,472 per year ($1,624 +
$568 + $280) for each of the 424
hospital systems that would be eligible
to do so and that would choose to
exercise this option. Therefore, the total
annual cost for all eligible hospital
systems to meet these information
collection requirements would be
approximately $1 million.
H. ICRs Regarding Hospices That
Provide Hospice Care to Residents of a
SNF/NF or ICF/IID (§ 418.112(c)(10) and
(f))
At § 418.112(f) we are finalizing a
requirement to allow hospices and long
term care facilities the additional
flexibility to negotiate the format and
schedule for orienting long term care
facility staff regarding certain hospicespecific information. This change does
not effect the existing hospice
information collection request (OMB
control number 0938–1067).
10. ICRs Regarding Hospital Medical
Staff, Medical Records Services, and
Surgical Services (§§ 482.22, 482.24,
and 482.51)
At § 416.52, we are finalizing our
proposal to replace the requirement that
every patient have a comprehensive
H&P within 30 days prior to surgery in
an ASC with a requirement that allows
the operating physician and ASC to
determine which patients would require
more extensive testing and assessment
prior to surgery. As discussed in
‘‘Provisions of the Proposed
Regulations,’’ section II.D.2 of the
proposed rule, there is a similar
regulatory requirement for hospital
outpatient surgery. Based on the
substantial similarity between these two
service settings, we proposed, through
the revisions to §§ 482.22, 482.24, and
482.51 discussed in section II.D.2, to
provide an exception to these
requirements for outpatient surgery in
hospitals.
As stated in the information
collection request for the hospital
requirements (expired OMB control
number 0938–0328), which is in the
process of being reinstated, we estimate
that the burden associated with
updating and, in some instances,
writing new hospital policies directly
related to patient care would be an
average of eight (8) hours annually for
each member of hospital staff involved
in the specific patient care policies
addressed.
Patient care policy development (and
revision) by hospital medical staff is
essential to patient health and safety
because it provides the framework
within which all patient care services
are furnished. Thus, we have included
the involvement of a physician at
approximately $1,624 annually (8
burden hours × $203), a nurse
coordinator at $568 annually (8 burden
hours × $71), and a medical secretary at
$280 annually (8 burden hours × $35).
We estimate that the necessary policy
changes needed to comply with the
requirements in this rule would cost
$2,472 per year ($1,624 + $568 + $280)
for each of the 4,823 hospitals that
might choose to exercise this option.
9. ICRs Regarding Hospital Quality
Assessment and Performance
Improvement (QAPI) Program (§ 482.21)
We are finalizing the proposed new
standard at § 482.21(f), ‘‘Unified and
integrated QAPI program for multihospital systems’’. We would allow that
for a hospital that is part of a hospital
system consisting of two or more
separately certified hospitals subject to
a system governing body legally
responsible for the conduct of each
hospital, the system governing body
could elect to have a unified and
integrated QAPI program for all of its
member hospitals after determining that
such a decision is in accordance with all
applicable State and local laws.
As stated in the information
collection request for the hospital
requirements (expired OMB control
number 0938–0328), we estimate that
the burden associated with updating
and, in some instances, writing new
hospital policies directly related to
patient care would be an average of
eight (8) hours annually for each
member of hospital staff involved in the
specific patient care policies addressed.
Patient care policy development (and
revision) by hospital medical staff is
essential to patient health and safety
because it provides the framework
within which all patient care services
are furnished. Thus, we have included
the involvement of a physician at
approximately $1,624 annually (8
burden hours × $203), a QAPI nurse
coordinator at $568 annually (8 burden
hours × $71), and a medical secretary at
$280 annually (8 burden hours × $35).
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Therefore, the total annual cost for all
hospitals to meet these information
collection requirements would be
approximately $11.9 million.
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11. ICRs Regarding Hospital Medical
Staff: Autopsies (§ 482.22)(d))
We are finalizing our proposal to
remove the requirement at § 482.22(d),
which states that a hospital’s medical
staff should attempt to secure autopsies
in all cases of unusual deaths and of
medical-legal and educational interest.
Hospitals are further required to define
a mechanism for documenting
permission to perform an autopsy, and
they must have a system for notifying
the medical staff, and specifically the
attending practitioner, when an autopsy
is being performed. Since more detailed,
specific requirements regarding
medical-legal investigations and
autopsies for hospitals are covered by
the individual State laws in which the
hospital is located, there are no
collection of information requirements
associated with this proposed change.
12. ICRs Regarding Hospital Infection
Control (§ 482.42)
We are finalizing the proposed new
standard at § 482.42(d), ‘‘Unified and
integrated infection control program for
multi-hospital systems.’’ Like the
proposed requirements for a unified and
integrated QAPI program, the proposed
standard for infection control would
allow that for a hospital that is part of
a hospital system consisting of multiple
separately certified hospitals subject to
a system governing body legally
responsible for the conduct of each
hospital, such system governing body
could elect to have a unified and
integrated infection control program for
all of its member hospitals after
determining that such a decision was in
accordance with all applicable State and
local laws.
As stated in the information
collection request for the hospital
requirements (OMB control number
0938–0328), which is in the process of
being reinstated, we estimate that the
burden associated with updating and, in
some instances, writing new hospital
policies directly related to patient care
would be an average of eight (8) hours
annually for each member of hospital
staff involved in the specific patient
care policies addressed.
Patient care policy development (and
revision) by hospital medical staff is
essential to patient health and safety
because it provides the framework
within which all patient care services
are furnished. Thus, we have included
the involvement of a physician at
approximately $1,624 annually (8
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burden hours × $203), an infection
control nurse coordinator at $568
annually (8 burden hours × $71), and a
medical secretary at $280 annually (8
burden hours × $35).
We estimate the necessary policy
changes needed to comply with the
requirements proposed in this rule
would cost $2,472 per year ($1,624 +
$568 + $280) for each of the 424
hospital systems that would be eligible
to do so and that would elect to exercise
this option. Therefore, the total annual
cost for all eligible hospital systems to
meet these information collection
requirements would be approximately
$1 million.
13. ICRs Regarding Special
Requirements for Hospital Providers of
Long-Term Care Services (‘‘SwingBeds’’) (§ 482.58(b)(1), (4), (5), and (8),
and Parallel CAH Requirements:
§ 485.645(d)(1), (4), (5), and (8))
At §§ 482.58(b)(1) and 485.645(d)(1)
(cross-referenced long-term care
requirement at § 483.10(f)(9)) we are
finalizing our proposal to remove the
requirement for hospital and CAH
swing-bed providers to provide the right
for patients to choose to or refuse to
perform services for the facility and if
they so choose; (a) document in the
resident’s plan of care, (b) noting
whether the services are voluntary or
paid and (c) provide wages for the work
being performed given the location
quality, and quantity of work requiring
comparable skills.
We assume that each of the hospital
swing-bed providers (478 hospitals) and
CAH swing-bed providers (1,246 CAHs)
has an activities specialist employed at
$41 per hour who would oversee the
residents who have chosen to perform
services for the facility, and document
and update the plan of care accordingly.
We believe that given the limited budget
of most rural providers, services are
being provided to the CAH on a
voluntary basis and that these providers
are not compensating patients for
providing these services. The current
regulatory burden for compliance with
this requirement is approximately $29.4
million for all hospital and CAH swingbed providers, or $17,056 per hospital
or CAH swing-bed provider (1,724
hospital and CAH swing-bed providers
× $41 an hour for an activities specialist
× 8 hours per week × 52 weeks per year),
which are the cost savings to the
providers as a result of the removal of
this requirement.
At § 482.58(b)(4) (and § 485.645(d)(4))
(cross-referenced long-term care
requirement at § 483.24(c)), we are
finalizing our proposal to remove the
requirement for hospital and CAH
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swing-bed providers to provide an
ongoing activity program that is directed
by a qualified therapeutic recreation
specialist or an activities professional
who meets certain requirements as
listed at § 483.24(c)(2). We assume that
each of the hospital swing-bed providers
(478 hospitals) and CAH swing-bed
providers (1,246 CAHs) has an activities
specialist employed at least part time at
$41 per hour. The current regulatory
burden for compliance with this
requirement is based on the activities
specialist organizing, overseeing, and
scheduling the activity. The cost savings
as a result of the removal of this
requirement are approximately $73.5
million for all hospital and CAH swingbed providers, or $42,640 per hospital
or CAH swing-bed provider (1,724
hospital and CAH swing-bed providers
× $41 an hour for an activities specialist
× 1,040 hours per year) which are the
cost savings to the providers.
We are finalizing our proposal to
remove the requirement at
§§ 482.58(b)(5) and 485.645(d)(5) (crossreferenced long-term care requirement
at § 483.70(p) for hospital and CAH
swing-bed providers to employ a
qualified social worker on a full-time
basis if the facility has more than 120
beds. Given that this provision is not
applicable to either provider type due to
the regulatory requirements for each, it
does not impose a burden upon
hospitals and as such, its removal
would not result in a savings of
economic burden hours or dollars.
At §§ 482.58(b)(8) and 485.645(d)(8)
(cross-referenced long-term care
requirement at § 483.55(a)(1)) we are
finalizing our proposal to remove the
requirement for hospital and CAH
swing-bed providers to assist in
obtaining routine and 24-hour
emergency dental care to its residents.
Under the current CoPs, hospitals and
CAHs are currently required to address
the emergent dental care needs of their
patients at § 482.12(f)(2) for hospitals,
and at § 485.618 (emergency services)
for CAHs. As a result, we have
calculated the burden associated with
the provision of routine dental care for
hospital and swing-bed patients. The
American Dental Association
recommends annual dental checkups for
routine dental care for adults over 60
years of age. With an average length of
stay in a hospital or CAH swing-bed of
1–2 weeks and an average daily census
of 2 patients, we assume that 1 patient
receiving swing-bed services will
require routine dental services per
month. While a dentist and dental
hygienist provide the dental services,
Medicare is billed for the provision of
these services. The costs to the provider
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are related to the nursing activities
associated with the patient receiving the
dental services. The current regulatory
burden for compliance with this
requirement is approximately $2.9
million for all hospital and CAH swingbed providers, or $1,704 per hospital or
CAH swing-bed provider (1,724 hospital
and CAH swing-bed providers × $71 an
hour for a RN × 24 hours per year),
which are the cost savings to the
providers as a result of the removal of
this requirement. The information
collection requests will be revised and
sent to OMB for approval (OMB control
number 0938–0328 for hospitals and
0938–1043 for CAHs).
14. ICRs Regarding Special
Requirements for Psychiatric Hospitals
(§ 482.61(d))
At § 482.61(d) we are finalizing our
proposal to clarify the requirement
allowing non-physician practitioners to
document progress notes in accordance
with State laws and scope of practice
requirements. In accordance with the
information collection request for the
hospital requirements, which includes
the special requirements for psychiatric
hospitals (OMB control number 0938–
0328), no burden is associated with
recordkeeping, as the documentation
and maintenance of medical records is
usual and customary. However, since
we believe that clarification of the intent
of the regulation is necessary and will
result in non-physician practitioners
(specifically physician assistants, nurse
practitioners, psychologists, and clinical
nurse specialists) documenting in the
progress notes for patients receiving
services in psychiatric hospitals, we
have calculated savings for this
provision in the RIA which are
essentially identical to those we would
estimate under the PRA.
15. ICRs Regarding Special Requirement
for Transplant Centers and Definitions
(§§ 482.68 and 482.70)
We are finalizing the proposed
nomenclature change at part 482 and
the transplant center regulations at
§§ 482.68, 482.70, 482.72 through
482.104, and at § 488.61. Because this
change would update the terminology
used in the regulations to conform to the
terminology that is widely used and
understood within the transplant
community, there are no collection of
information requirements associated
with this proposal.
16. ICRs Regarding Data Submission,
Clinical Experience, and Outcome
Requirements for Re-Approval of
Transplant Centers (§ 482.82)
Section 482.82 requires that, except as
specified in § 488.61, transplant centers
must meet all the data submission,
clinical experience, and outcome
requirements to be re-approved for
Medicare participation. Section
482.82(a) requires that no later than 90
days after the due date established by
the OPTN, a transplant center must
submit to the OPTN at least 95 percent
of the required data submissions on all
transplants (deceased and living donors)
it has performed over the 3 year
approval period. Furthermore,
§ 482.82(b) requires transplant centers to
perform an average of 10 transplants per
year during the prior 3 years and
§ 482.82(c) requires transplant centers to
meet the outcome requirements for
Medicare re-approval. The burden
associated with this requirement would
be the time it would take a transplant
program to submit the required
information (OMB control number
0938–1069). However, as required by
§§ 482.72 and 482.45(b), a hospital in
which a transplant program is located,
must belong to the OPTN, and the
OPTN requires that these hospitals
submit this data to the OPTN. Therefore,
we believe that the requirements under
§ 482.82 do not impose an additional
burden on transplant programs because
all Medicare participating transplant
programs are already submitting this
information to the OPTN. Removing
these requirements will have no effect
51763
on the collection of information burden
on transplant programs.
17. ICRs Regarding Special Procedures
for Approval and Re-Approval of Organ
Transplant Centers (§ 488.61(f) Through
(h))
Section 488.61(f) through (h) sets out
the process for our consideration of a
transplant center’s mitigating factors in
initial approval and re-approval
surveys, certifications, and enforcement
actions for transplant centers. The
provisions also set out definitions and
rules for transplant systems
improvement agreements. We are
finalizing our proposal to remove the
requirements at § 488.61(f) through (h)
for mitigating factors and transplant
systems improvement agreements for
the re-approval process for transplant
centers. This change is complementary
to the removal of § 482.82, described
previously. The information collection
request (OMB control number 0938–
1069) does not account for any
information collection related burden
associated with the requirements in
§ 488.61(f) through (h) for the reapproval process. Therefore, we
estimate that the requirements under
§ 488.61(f) would require a transplant
program to write and submit the initial
formal notice of the program’s intent to
seek mitigating factors re-approval, and
write and submit a request for
consideration of mitigating factors
(which would include all of the content
listed in § 488.61(f)(2)). We estimate that
this would take a medical director, a
transplant center senior administrator,
and a hospital administrator
approximately 5 hours, or 2 hours for
the medical director and the transplant
program senior administrator and 1
hour for the hospital administrator, to
complete and submit these mitigating
factors for re-approval, as described in
Table 3.
TABLE 3—ANNUAL BURDEN HOURS AND COST FOR TRANSPLANT PROGRAMS TO SUBMIT MITIGATING FACTORS FOR REAPPROVAL
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Position
Hourly
Hours
required
Total
cost estimate
Medical Director ...........................................................................................................................
Transplant Program Senior Administrator ...................................................................................
Hospital Administrator ..................................................................................................................
$191
107
107
2
2
1
$382
214
107
Totals ....................................................................................................................................
........................
5
703
In total, we estimate that an average
of 14 programs would submit mitigating
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factors annually. Thus, for those 14
programs we estimate that it would
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hours × 14 programs) at a cost of $9,842
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($703 × 14 programs). Removing this
requirement would yield an estimated
savings to transplant programs of 5
burden hours each and a total of 70
burden hours for all 14 programs, with
a total cost savings of $9,842.
In addition, we estimate that the
transplant hospital in conjunction with
the transplant program that is located in
the hospital, would submit mitigating
factors and then would also enter into
systems improvement agreements, as
described under § 488.61(h) annually.
This would require the hospital to enter
into a binding agreement with CMS to
allow the program additional time to
achieve compliance with the CoPs. We
estimate that this would take a medical
director, a transplant program senior
administrator, a hospital administrator,
and an administrative assistant
approximately 14 hours, or 4 hours for
the medical director, transplant program
senior administrator, and an
administrative assistant, and 2 hours for
the hospital administrator to complete
these activities (including notifying
patients about the degree of
noncompliance by mail and organizing
and completing the other tasks listed in
§ 488.61(h)(1) as required by the terms
in the systems improvement agreement),
as described in Table 4.
TABLE 4—ANNUAL BURDEN HOURS AND COST FOR TRANSPLANT PROGRAMS TO ENTER INTO A SYSTEMS IMPROVEMENT
AGREEMENT FOR RE-APPROVAL
Position
Hourly
Hours
required
Total
cost estimate
Medical Director ...........................................................................................................................
Transplant Program Senior Administrator ...................................................................................
Hospital Administrator ..................................................................................................................
Administrative Assistant ...............................................................................................................
$191
107
107
35
4
4
2
4
$764
428
214
140
Totals ....................................................................................................................................
........................
14
1,546
In total, we estimate that an average
of 14 programs will submit mitigating
factors annually. Thus, for those 14
programs we estimate that it would
require 196 burden hours (14 burden
hours × 14 programs) at a cost of
$21,644 ($1,546 × 14 transplant
programs). In the context of the
proposed rule, removing this
requirement would yield an estimated
savings to transplant programs of 14
burden hours each and a total of 196
burden hours for all 14 programs, with
a total cost savings of $21,644.
change to permit HHAs to use either
patients or pseudo-patients when
conducting competency evaluations for
home health aides. The content of an
aide competency examination and
whether patients or pseudo-patients are
used in the process do not have an
associated collection of information
requirement. Therefore, this proposed
change would neither impose nor
remove any collection of information
burdens.
18. ICRs Regarding HHA Home Health
Aide Services (§ 484.80(h)(3))
As discussed in section I.B.6.c. of this
final rule, we are not finalizing the
proposal to allow HHAs 4 business days
to provide patients with information
from their clinical records upon request.
Consequently, there are no new
information collection requirements.
We are finalizing the proposal to
eliminate the requirement at
§ 484.80(h)(3) that the HHA conduct a
full competency evaluation of deficient
home health aides, and replace it with
a requirement to retrain the aide
regarding the identified deficient skill(s)
and require the aide to complete a
competency evaluation related only to
those skills. We are also finalizing a
19. ICRs Regarding HHA Clinical
Records (§ 484.110(e))
20. ICRs Regarding CORF Utilization
Review Plan (§ 485.66)
We are finalizing the proposal to
reduce the required frequency in which
CORFs would be required to complete a
‘‘utilization review plan’’ from quarterly
to annually. Changing from a quarterly
implementation of the utilization review
plan to an annual implementation
would reduce the current
documentation requirements (OMB
control number 0938–1091) on CORFs
by 75 percent each year. For the
purposes of our analysis, we estimate
that it would take a CORF
approximately 8 hours for
administrative, clinical and clerical staff
to review and evaluate the necessary
and efficient use of services provided by
the facility on a quarterly basis, for a
total of 32 hours per year per CORF and
6,016 hours for all 188 CORFs. In a 1year period, we estimate a savings of
$1,680 per facility ($560 × 3 quarters),
and a combined total savings of
$315,840 for all CORFs ($1,680 × 188
CORFs). We will submit the revised
information collection request to OMB
for approval.
TABLE 5—CORF—HOURLY COSTS AND BURDEN HOURS
Hourly costs
per CORF
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Position
Burden hours
per CORF
Cost estimate
per CORF
Administrator ................................................................................................................................
Clerical Staff ................................................................................................................................
Physical Therapist .......................................................................................................................
Social Worker ..............................................................................................................................
$107
33
85
55
2
2
2
2
$214
66
170
110
Total ......................................................................................................................................
........................
8
560
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21. ICRs Regarding CAH Organizational
Structure (§ 485.627(b)(1))
As of 2017, there were approximately
1,353 CAHs that were certified by
Medicare. We are finalizing our
proposal for revision of the CAH
disclosure requirements imposed on
CAHs removes the requirement for
CAHs to disclose to CMS its owners, or
those with a controlling interest in the
CAH or in any subcontractor in which
the CAH directly or indirectly has a 5
percent or more ownership interest, in
accordance with 42 CFR part 420,
subpart C (OMB control number 0938–
1043). While we estimate that these
changes occur at 2 CAHs per year on
average between all 1,353 CAHs, with
the vast majority not experiencing any
such changes throughout the lifetime of
the CAH, each CAH is still required to
review the duplicative documentation.
As discussed in our rule, Medicare
Program; Criteria and Standards for
Evaluating Regional Durable Medical
Equipment, Prosthetics, Orthotics and
Supplies (DMEPOS); Final Rule and
Request for Comments (57 FR 2790,
June 18, 1992), the burden associated
with this requirement is 1-hour per
facility. As a result, this will save all
CAHs an estimated $144,771 and will
save each CAH $107 (1-burden hour for
an administrator at $107 per hour ×
1,353 CAHs).
22. ICRs Regarding CAH Provision of
Services (§ 485.635(a)(4))
Section 485.635(a)(4) requires CAHs
to conduct an annual review of all its
policies and procedures (OMB control
number 0938–1043). We are finalizing
our proposal for revision of the patient
care policies requirements imposed on
51765
CAHs would reduce the frequency that
is currently required for CAHs to
perform a review of all their policies
and procedures. We anticipate that a
change from an annual review to a
biennial review would reduce the
burden on CAHs by half in a given
period of time. For the purposes of our
analysis, we estimate that it would take
a CAH approximately 16 hours for
administrative and clinical staff to
review and make changes to policies
and procedures annually. In a 2-year
period, we estimate a savings of $1,968
per facility, and a combined total
savings of $2.7 million for CAHs ($1,968
× 1,353 CAHs), or annualized savings of
approximately $1.3 million.
We estimate that the CAH staff time
and associated costs would be assigned
to a biennial review as shown in Table
6.
TABLE 6—HOURLY COSTS AND BURDEN HOURS
Hourly cost
per CAH
Position
Cost estimate
per CAH
Administrator ................................................................................................................................
Clerical staff .................................................................................................................................
Registered Nurse .........................................................................................................................
Nurse practitioner ........................................................................................................................
Physician ......................................................................................................................................
$189
39
71
103
191
4
3
3
3
3
$756
117
213
309
573
Totals ....................................................................................................................................
........................
16
1,968
23. ICRs Regarding Special
Requirements for CAH Providers of
Long-Term Care Services (‘‘SwingBeds’’) (§ 485.645(d)(1), (4), (5) and (8))
We have included the discussion of
the ICRs regarding special requirements
for CAH providers of long-term care
services in the discussion of the ICRs
regarding special requirements for
hospital providers of long-term care
services, which can be found in section
I.C.13 of this rule (ICRs Regarding
Special Requirements for Hospital
Providers of Long-Term Care Services
(‘‘Swing Beds’’) (§ 482.58(b)(1), (4), (5),
and (8), and Parallel CAH requirements:
§ 485.645(d)(1), (4), (5), and (8))).
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Burden hours
per CAH
24. ICRs Regarding CMHCs
(§ 485.914(d))
Section 485.914(d)(1) requires each
CMHC to update each client’s
comprehensive assessment via the
CMHC interdisciplinary treatment team,
in consultation with the client’s primary
health care provider (if any), no less
frequently than every 30 days. We are
modifying the requirement at
§ 485.914(d) to remove the 30-day
assessment update timeframe for those
clients who do not receive PHP services.
Under the current 30-day time frame
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requirement, each client receives an
updated assessment 12 times per year
(OMB control number 0938–1245). We
estimate that, in accordance with the
proposed need-based assessment update
requirements, each non-PHP client
would receive 2 assessment updates in
a year. Therefore, we estimate that this
change would reduce the burden of 10
assessments per client, per year.
As of August 2017 there are 161
Medicare participating CMHCs serving
3,122 Medicare beneficiaries and an
estimated 2,080 non-Medicare clients,
for an average of 32 clients per CMHC.
In order to develop the estimated
number of non-Medicare clients we
divided the total number of Medicare
beneficiaries who received partial
hospitalization services by the total
number of Medicare-participating
CMHCs to establish the average number
of Medicare beneficiaries per CMHC.
This resulted in 19 beneficiaries per
CMHC. We then assumed that, in order
to comply with the 40 percent
requirement (§ 485.918(b)(1)(v)), those
19 beneficiaries only accounted for 60
percent of an average CMHC’s total
patient population. This means that an
average CMHC also treated another 13
clients who did not have Medicare as a
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payer source, for a total of 32 clients
(Medicare + non-Medicare) in an
average CMHC. Therefore, all CMHCs
combined would have approximately
2,093 non-PHP clients per year (13 per
CMHC), and approximately 20,930
assessments would be reduced
nationwide per year (2,093 patients × 10
assessments per patient). We estimate
that documenting each assessment
update requires 10 minutes of a CMHC
clinician’s time, for a total savings of
3,487 hours nationwide (0.1666 hours ×
20,930 assessment updates). At a cost of
$7.50 for a mental health counselor to
document each assessment, the total
cost savings would be $156,975 ($7.50
× 20,930 assessments).
25. ICRs Regarding Portable X-Ray
Services (§§ 486.104(a) and 486.106(a))
We are finalizing our proposal to
revise the requirements for portable xray technologist personnel
qualifications at § 486.104 to align the
current requirements at § 486.104(a)(1),
(2), (3), and (4) with those for hospital
radiologic technologists at § 482.26(c)(2)
which are focused on the qualifications
of the individual performing services as
permitted by State law. Although
changing the qualifications would
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require management time, with the
associated cost of those hours, in order
to revise the internal personnel
descriptions and qualifications, we
believe that this proposed change would
impose no burden because maintaining
internal personnel descriptions and
qualifications is a standard business
practice. Therefore, this burden would
not be subject to the PRA in accordance
with the implementing regulations of
the PRA at 5 CFR 1320.3(b)(2).
We are finalizing our proposal to
revise the requirements for portable xray orders at § 486.106(a)(2). We
proposed to remove the requirement
that physician or non-physician
practitioner’s orders for portable x-ray
services must be written and signed. We
also proposed to replace the specific
requirements related to the content of
each portable x-ray order with a crossreference to the requirements at 42 CFR
410.32, which also apply to portable xray services. These changes would
simplify the ordering process for
portable x-rays and promote the use of
more efficient ordering methods, such
as electronic orders.
In the information collection request
(OMB control number 0938–0338) we
estimate that the current order
requirements would impose the
following burdens:
• 3 minutes to write an order ×
3,986,000 portable x-rays exams ordered
= 199,300 hours × $71/hour for a nurse
= $14,150,300.
• $1 for printing and faxing verbal
orders to physician offices for signature
× 2,500,000 verbal orders = $2,500,000.
• 2,000,000 follow-up calls regarding
the status of faxes × 10 minutes of time
for clerical staff (5 minutes for portable
x-ray clerical staff + 5 minutes for
ordering physician clerical staff) =
333,333 hours × $33/hour =
$10,999,989.
All of these burdens would be
eliminated by revising the current
ordering standards. Therefore, we
estimate a proposed information
collection savings of $27.7 million from
this proposed change.
26. ICRs Regarding RHC and FQHC
Provision of Services (§ 491.9(b)(4))
There are currently more than 4,100
RHCs and approximately 1,400 FQHC
organizations furnishing services at
approximately 12,000 or more total
locations. Many FQHC organizations
have multiple delivery sites, and as of
May 2017 there were 4,160 RHC and
7,874 FQHC delivery sites. All CMScertified sites are subject to our
requirements and we are therefore
utilizing the total number of current
sites in our burden reduction
calculations.
We are finalizing our proposal to
revise § 491.9(b)(4) to reduce the
number of times that RHCs and FQHCs
perform a review of all their policies
and procedures. Changing from an
annual review to a review every other
year would reduce the burden on RHCs
and FQHCs by half in a given period of
time. In the currently approved
information collection request (OMB
control number 0938–0334), we only
included burden estimates for RHCs.
However, we recognize that the
information collection applies to FQHCs
as well. Therefore, we estimate that it
would take a RHC or FQHC
approximately 4 hours for clinical staff
to review and make changes to policies
and procedures annually, for a total of
48,136 hours for all 12,034 RHC and
FQHC locations. In a 2-year period,
RHCs and FQHCs would use 96,272
total hours to comply with the
requirements to annually review all of
their policies and procedures. Under the
proposed change to review policies
every other year, we estimate that in a
2-year period, it will take a total of
48,136 hours, for a savings of 48,136
hours per year. We estimate a savings of
$608 per facility (see Table 7) for a
combined total savings of $7.3 million
biennially for 12,034 RHCs or FQHCs
($608 × 12,034 RHCs and FQHCs), or
annualized savings of half these
amounts. We will submit a revised
information collection request to OMB
for approval.
TABLE 7—HOURLY WAGES AND BURDEN HOURS
Hourly cost per
RHC/FQHC
(includes 100%
for benefits
and overhead)
Position
Cost estimate per
RHC/FQHC
Physician ........................................................................................................
Mid-Level Provider (PA or NP) ......................................................................
$203
101
2
2
$406
202
Total ........................................................................................................
..................................
4
608
27. ICRs Regarding RHC and FQHC
Program Evaluation (§ 491.11(a))
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Burden hours per
RHC/FQHC
We are finalizing the proposal to
revise § 491.11(a) to reduce the number
of times that RHCs and FQHCs carry out
or arrange for an annual evaluation of
the total program. Changing from an
annual evaluation to an evaluation
every other year would reduce the
burden on RHCs and FQHCs by half in
a given period of time. In the currently
approved information collection request
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(OMB control number 0938–0334), we
only included burden estimates for
RHCs, however we recognize that the
information collection applies to FQHCs
as well. Therefore, we estimate that it
would take a RHC or FQHC
approximately 6 hours for
administrative and clinical staff to
perform an evaluation of its total
program annually for a total of 72,204
hours for all 12,034 RHC and FQHC
locations. In a 2-year period, RHCs and
FQHCs would use 144,408 total hours to
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comply with the requirement for an
evaluation of the total program. Under
the proposed change to evaluate the
total program every other year, we
estimate an hourly savings of 72,204
total hours and a cost savings of $822
per facility (see Table 8), for a combined
total savings of $9.9 million biennially
for 12,034 RHCs or FQHCs ($822 ×
12,034 RHC and FQHC locations), or
annualized savings of half these
amounts.
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51767
TABLE 8—HOURLY WAGES AND BURDEN HOURS
Hourly cost per
RHC/FQHC
(includes 100% for
benefits
and overhead)
Position
Cost estimate per
RHC/FQHC
Administrator/Health Services Manager ........................................................
Physician ........................................................................................................
Mid-Level Provider (PA or NP) ......................................................................
$107
203
101
2
2
2
$214
406
202
Total ........................................................................................................
..................................
6
822
28. ICRs Regarding Emergency
Preparedness for Providers and
Suppliers
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Burden hours per
RHC/FQHC
a. Review of the Emergency
Preparedness Program
At § 482.15(a), (b), (c), and (d) for
hospitals and parallel regulatory
citations for other facilities, we are
finalizing our proposal to allow
providers to review their program at
least every 2 years. However, we are
withdrawing the proposal for LTC
facilities. As of May 2017, there were
approximately 72,646 total facilities, or
56,983 excluding LTC facilities. All are
required to review their emergency
preparedness program annually, which
includes a review of their emergency
plan, policies and procedures,
communication plan, and training and
testing program.
For our analysis, we estimate that
reducing this requirement from
annually to biennially would reduce
compliance costs related to review of
the emergency plan by 50 percent. The
methodology used for our cost estimate
analysis generally mirrors the
methodology used for the annual review
of the emergency plan Emergency
Preparedness final rule (81 FR 63930)
with a 50 percent reduction in the cost
estimate calculation; however, after
receiving additional feedback from
stakeholders, we have determined that
we underestimated the amount of time
it would take to review the emergency
plan. As a result, we have presented
current burden hours associated with
reviewing the emergency plan that
reflects the increased associated burden
hours relative to the information
collection request for this provision
(OMB control number 0938–1325). As
in the Emergency Preparedness final
rule (81 FR 63930), we assume that the
individuals involved in the review of
the emergency plan include an
administrator, director of nursing, a RN,
a physician, a social worker, a
counselor, and an office manager,
depending on the facility type. Based on
May 2017 BLS salary data, we
calculated the hourly mean wage for
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each position for this requirement
identified in the Emergency
Preparedness final rule (81 FR 63930).
We estimate that the finalized change
will accrue total annualized cost savings
of $69,639,324 and 657,345 burden
hours saved, or biennial savings of
double these amounts. We list a detailed
calculation for each facility below,
based on facility numbers available as of
2017:
• RNHCIs: Combined total savings of
$9,684 for 18 RNHCIs ((8 burden hours
for an administrator at $107 plus 5
burden hours for a director of nursing at
$44 per hour) × 18 RNHCIs × 50
percent).
• ASCs: Combined total savings of
$6,257,182 for 5,557 ASCs ((8 burden
hours for an administrator at $109 per
hour plus 4 burden hours for a
physician at $203 per hour plus 8
burden hours for a quality improvement
RN at $71 per hour) × 5,557 ASCs × 50
percent).
• Hospices: Combined total savings of
$5,916,502 for 4,489 hospice facilities
((8 burden hours for an administrator at
an hourly wage of $107 per hour plus
4 burden hours for a physician at $203
per hour plus 4 burden hours for a
counselor at $45 per hour plus 4 burden
hours for a social worker at $55 per hour
plus 8 burden hours for a RN at $71 per
hour) × 4,489 hospices × 50 percent).
• PRTFs: Combined total savings of
$569,976 for 374 PRTFs ((8 burden
hours for an administrator $107 per our
plus 8 burden hours for a physician at
$203 per hour plus 8 burden hours for
a RN at $71 per hour) × 374 PRTFs × 50
percent).
• PACE: Combined total savings of
$232,068 for 233 PACE organizations ((8
burden hours for an administrator at
$107 per hour plus 8 burden hours for
a home care coordinator at $71 per hour
plus 8 burden hours for a RN at $71 per
hour) × 233 PACE organizations × 50
percent).
• Hospitals: Combined total savings
of $11,700,598 for 4,823 hospitals ((8
burden hours for an administrator at
$109 per hour plus 8 burden hours for
a physician at $203 per hour plus 8
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burden hours for a risk management
director at $107 per hour plus 8 burden
hours for a quality assurance nurse at
$71 per hour plus 8 burden hours for a
facility director at $99 per hour plus 4
burden hours for a medical secretary at
$35 per hour) × 4,823 hospitals × 50
percent).
• ICF/IID: Combined total savings
$3,475,290 for 6,097 ICF/IIDs ((8 burden
hours for an administrator at $107 per
hour plus 4 burden hours for a RN $71
per hour) × 6,097 ICF/IIDs × 50 percent).
• HHA: Combined total savings of
$16,512,192 for 12,624 HHAs ((8 burden
hours for an administrator at $107 per
hour plus 8 burden hours for a nursing
director at $107 per hour plus 8 burden
hours for a director of rehab at $85 per
hour plus 4 burden hours for an office
manager at $56 per hour) × 12,624
HHAs × 50 percent).
• CORF: Combined total savings of
$144,384 for 188 CORFs ((8 burden
hours for an administrator at $107 per
hour plus 8 burden hours for a physical
therapist at $85 per hour) × 188 CORFs
× 50 percent).
• CAH: Combined total savings of
$1,693,956 for 1,353 CAHs ((8 burden
hours for an administrator at $107 per
hour plus 8 burden hours for a director
of nursing at $107 per hour plus 8
burden hours for a facility director at
$99 per hour) × 1,353 CAHs × 50
percent).
• Organizations: Combined total
savings of $1,241,448 for 2,076
Organizations ((8 burden hours for an
administrator at $107 per hour plus 4
burden hours for a physical therapist at
$85 per hour) × 2,076 Organizations ×
50 percent).
• CMHCs: Combined total savings of
$150,052 for 161 CMHCs ((8 burden
hours for an administrator at $107 per
hour plus 8 burden hours for a RN at
$71 per hour plus 8 burden hours for a
social worker at $55 per hour) × 161
CMHCs × 50 percent).
• OPOs: Combined total savings of
$121,568 for 58 OPOs ((8 burden hours
for an OPO director at $107 per hour
plus 8 burden hours for a physician at
$203 per hour plus 8 burden hours for
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a QAPI director at $107 per hour plus
8 burden hours for an organ
procurement coordinator at $107 per
hour) × 58 OPOs × 50 percent).
• RHC/FQHC: Combined total savings
of $10,108,560 ((8 burden hours for an
administrator at $107 per hour plus 8
burden hours for a nurse practitioner/
physician assistant at $103 per hour) ×
4,160 RHCs × 50 percent) $3,494,400 +
((8 burden hours for an administrator at
$107 per hour plus 8 burden hours for
a nurse practitioner/physician assistant
at $103 per hour × 7,874 FQHCs × 50
percent) $6,614,160).
• ESRD Facilities: Combined total
savings of $11,505,864 for 6,898 dialysis
facilities ((8 burden hours for an
administrator at $107 per hour plus 8
burden hour for a medical director/
physician at $203 per hour plus 8
burden hours for a nurse manager at
$107) × 6,898 dialysis facilities × 50
percent) as shown in Table 9.
TABLE 9—COST SAVINGS FOR ANNUAL REVIEW OF EMERGENCY PREPAREDNESS PLAN
Provider/supplier
Cost savings per
provider/supplier
RNHCIs .........................
ASCs .............................
Hospices ........................
PRTFs ...........................
PACEs ...........................
Hospitals ........................
ICFs/IIDs .......................
HHAs .............................
CORFs ..........................
CAHs .............................
Organizations ................
CMHCs ..........................
OPOs .............................
RHCs/FQHCs ................
$538
1,126
1,318
1,524
996
2,426
570
1,308
768
1,252
598
932
2,096
840
ESRD Facilities .............
1,668
b. Contents of the Emergency Plan
At § 482.15(a)(4) for hospitals, and
other parallel citations for the facilities
mentioned in section II.J.2 of the rule,
we are finalizing our proposal to
eliminate the requirement that facilities
document efforts to contact local, tribal,
regional, State, and Federal emergency
preparedness officials and that facilities
document participation in collaborative
and cooperative planning efforts (OMB
control number 0938–1325). We
estimate that an administrator, or in the
case of a hospital a community relations
manager, a program director for a PACE,
or a QAPI director for OPOs, would take
1 hour to document efforts to contact
local, tribal, regional, State and Federal
emergency preparedness officials and,
when applicable, document the
facility’s participation in collaborative
and cooperative planning efforts. We
note that The Joint Commission (TJC)-
Combined total savings
$9,684 for 18 RNHCIs.
$6,257,182 for 5,557 ASCs.
$5,916,502 for 4,489 hospice facilities both inpatient and freestanding/home based.
$569,976 for 374 PRTFs.
$232,068 for 233 PACEs.
$11,700,598 for 4,823 hospitals.
$3,475,290 for 6,097 ICF/IIDs.
$16,512,192 for 12,624 HHAs.
$144,384 for 188 CORFs.
$1,693,956 for 1,353 CAHs.
$1,241,448 for 2,076 Organizations.
$150,052 for 161 CMHCs.
$121,568 for 58 OPOs.
$10,108,560 for RHCs and FQHCs ($3,494,400 for 4,160 RHCs and $6,614,160 for 7,874
FQHCs).
$11,505,864 for 6,898 dialysis facilities.
accredited ASCs, TJC-accredited CAHs,
and TJC-accredited hospitals have
emergency preparedness requirements
for developing an emergency
preparedness plan that are comparable
to the current emergency preparedness
CoPs (81 FR 63937, 63954, and 63978
through 63979). Utilizing the same
assumptions we used in the Emergency
Preparedness final rule (81 FR 63937,
63954, and 63978 through 63979), we
estimate that cost savings will
accumulate from non-TJC accredited
ASC, CAHs, and hospitals, since TJCaccredited ASCs, CAHs and hospitals
are already required by the TJC to
develop emergency preparedness plans.
As a result, these facilities are excluded
from the analysis given the
requirements of their accreditation
organization standards. Based on May
2017 BLS salary data, we calculate an
hourly mean wage of $107 for an
administrator, a PACE Program Director,
or QAPI director and a cost savings of
$107 per facility for RNHCIs, non-TJC
accredited ASCs, hospices (both
inpatient and freestanding), PRTFs,
PACEs, LTCFs, ICF/IIDs, HHAs, CORFs,
non-TJC accredited CAHs,
Organizations, CMHCs, OPOs, RHC/
FQHCs, and dialysis facilities ($107
hourly mean wage × 1 burden hour). For
non-TJC accredited hospitals, we
estimate an hourly mean wage of $115
for a community relations manager, and
a $115 cost per facility ($115 × 1 hour).
Therefore, we estimate the following for
each facility affected by the proposed
change, for a total savings of $7,316,489
and 68,275 burden hours. We list a
summary of the calculation for savings
accrued by removing this requirement
for each facility in Table 10, based on
facility numbers available as of May
2017.
TABLE 10—COST SAVINGS: DOCUMENTATION OF THE FACILITY’S PARTICIPATION IN COLLABORATIVE AND COOPERATIVE
PLANNING EFFORTS
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Provider/supplier
Cost savings per
provider/supplier
RNHCIs .........................
ASCs (Non-TJC accredited).
Hospices ........................
PRTFs ...........................
PACEs ...........................
Hospitals (Non-TJC accredited).
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$107
107
107
107
107
115
Jkt 247001
Combined total savings
$1,926 for 18 RNHCIs.
$532,325 for 4,975 non-TJC accredited ASCs.
$480,323 for 4,489 hospice facilities both inpatient and freestanding/home based.
$40,018 for 374 PRTFs.
$24,931 for 233 PACEs.
$159,045 for 1,383 non-TJC accredited hospitals.
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TABLE 10—COST SAVINGS: DOCUMENTATION OF THE FACILITY’S PARTICIPATION IN COLLABORATIVE AND COOPERATIVE
PLANNING EFFORTS—Continued
Provider/supplier
Cost savings per
provider/supplier
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LTCFs ............................
ICFs/IIDs .......................
HHAs .............................
CORFs ..........................
CAHs (Non-TJC accredited).
Organizations ................
CMHCs ..........................
OPOs .............................
RHCs/FQHCs ................
ESRD Facilities .............
107
107
107
107
107
$1,675,941 for 15,663 LTCFs.
$652,379 for 6,097 ICF/IIDs.
$1,350,768 for 12,624 HHAs.
$20,116 for 188 CORFs.
$107,428 for 1,004 non-TJC accredited CAHs.
107
107
107
107
107
$222,132 for 2,076 Organizations.
$17,227 for 161 CMHCs.
$6,206 for 58 OPOs.
$1,287,638 for RHCs and FQHCs ($445,120 for 4,160 RHCs and $842,518 for 7,874 FQHCs).
$738,086 for 6,898 dialysis facilities.
c. Training
At § 482.15(d)(1)(ii) for hospitals, and
other parallel citations for other
facilities mentioned in section II.J.2 of
the rule, we are finalizing our proposal
to require that facilities provide training
biennially, or every 2 years, after
facilities conduct initial training on
their emergency program, as well as
requiring additional training when the
emergency plan is significantly updated.
However, we are withdrawing this
proposal for LTC facilities only. We are
maintaining the requirement that
providers and suppliers develop a wellorganized, effective training program
that includes initial training for new
and existing staff in emergency
preparedness policies and procedures
and would require training when the
emergency plan is significantly updated.
Facilities will have the flexibility to
determine what is considered a
significant update to the emergency
plan.
For our analysis, we estimate that
reducing this requirement from
annually to biennially will reduce
compliance costs related to providing
emergency preparedness training by 50
percent (OMB control number 0938–
1325). The methodology used for our
cost estimate analysis mirrors the
methodology used for the annual
training requirement in the Emergency
Preparedness final rule (81 FR 63930)
with a 50 percent reduction in the cost
estimate calculation. As in the
Emergency Preparedness final rule (81
FR 63930), we assume that the
individuals involved in the
development and provision of training
include an administrator, director of
nursing, a RN, and an office manager,
depending on the facility type.
Providers and suppliers are expected to
provide initial training in emergency
preparedness policies and procedures to
all new and existing staff, individuals
providing services under arrangement,
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Combined total savings
and volunteers, consistent with their
expected roles, and maintain
documentation of the training. Based on
May 2017 BLS salary data, we
calculated the hourly mean wage for
each position for this requirement
identified in the Emergency
Preparedness final rule (81 FR 63930).
We estimate that the proposed change
will accrue annualized cost savings of
$25,593,781 and 288,266 burden hours,
or biennial savings of double these
amounts. We list a detailed calculation
for each facility below, based on facility
numbers available as of May 2017 with
a summary of these calculations
provided in Table 11:
• RNHCIs: Combined total savings of
$3,906 for 18 RNHCIs ((2 burden hours
for an administrator at $107 plus 5
burden hours for a director of nursing at
$44 per hour) × 18 RNHCIs × 50
percent).
• ASCs: Combined total savings of
$1,289,224 for 5,557 ASCs ((1 burden
hour for an administrator at $109 per
hour plus 5 burden hours for a quality
improvement RN at $71 per hour) ×
5,557 ASCs × 50 percent).
• Hospices: Combined total savings of
$956,157 for 4,489 hospice facilities (6
burden hours for a RN at $71 per hour
× 4,489 hospices × 50 percent).
• PRTFs: Combined total savings of
$132,770 for 374 PRTFs (10 burden
hours for a RN at $71 per hour × 374
PRTFs × 50 percent).
• PACE: Combined total savings of
$99,258 for 233 PACE organizations (3
burden hours for a home care
coordinator at $71 per hour plus 9
burden hours for a RN at $71 per hour
× 233 PACE organizations × 50 percent).
• Hospitals: As we stated in the
Emergency Preparedness final rule (81
FR 63958), TJC-accredited hospitals are
required to train their staff for their
assigned roles during emergencies
(CAMH, Standard EC.4.16, Eps 1–2, p.
EC–13e). In addition, the TJC-accredited
hospitals also must provide on-going
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Sfmt 4700
training to their staff, including training
on specific job-related safety (CAMH,
Standard HR–2.30, EP 4, CAMH
Refreshed Core, January 2008, p. HR–
11), and we expect that emergency
preparedness is part of such on-going
training. As a result, we estimate a
combined total savings of $2,066,202 for
1,383 non-TJC accredited hospitals (2
burden hours for an administrator at
$109 per hour plus 6 burden hours for
a risk management director at $107 per
hour plus 28 hours for a healthcare
trainer (RN) at $71 per hour plus 4
burden hours for a medical secretary at
$35 per hour × 1,383 hospitals × 50
percent).
• ICF/IID: Combined total savings
$1,734,597 for 6,097 ICF/IIDs (2 burden
hours for an administrator at $107 per
hour plus 5 burden hours for a RN $71
per hour × 6,097 ICF/IIDs × 50 percent).
• HHA: Combined total savings of
$8,066,736 for 12,624 HHAs (2 burden
hours for an administrator at $107 per
hour plus 2 burden hours for a nursing
director at $107 per hour plus 2 burden
hours for a director of rehab at $85 per
hour plus 2 burden hours for an office
manager at $56 per hour plus 8 burden
hours for a director of training at $71 ×
12,624 HHAs × 50 percent).
• CORF: Combined total savings of
$74,260 for 188 CORFs (5 burden hours
for an administrator at $107 per hour
plus 3 burden hours for a physical
therapist at $85 per hour × 188 CORFs
× 50 percent).
• CAH: Combined total savings of
$997,161 for 1,353 CAHs (2 burden
hours for an administrator at $107 per
hour plus 9 burden hours for a director
of nursing at $107 per hour plus 3
burden hours for a facility director at
$99 per hour × 1,353 CAHs × 50
percent).
• Organizations: Combined total
savings of $842,856 for 2,076
Organizations (6 burden hours for an
administrator at $107 per hour plus 2
burden hours for a physical therapist at
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$85 per hour × 2,076 Organizations × 50
percent).
• CMHCs: Combined total savings of
$57,155 for 161 CMHCs (10 burden
hours for a psychiatric RN at $71 per
hour × 161 CMHCs × 50 percent).
• OPOs: Combined total savings of
$113,448 for 58 OPOs (2 burden hours
for a director at $115 per hour plus 2
burden hours for a medical director/
physician at $203 per hour plus 12
burden hours for a QAPI director at
$107 per hour plus 8 hours for an organ
procurement coordinator at $107 per
hour plus 16 burden hours for an
education coordinator at $71 per hour ×
58 OPOs × 50 percent).
• RHC/FQHC: Combined total savings
of $6,245,646 ((2 burden hours for an
administrator at $107 per hour plus 8
burden hours for a nurse practitioner/
physician assistant at $103 per hour ×
4,160 RHCs × 50 percent) $2,159,040 +
(2 burden hours for an administrator at
$107 per hour plus 8 burden hours for
a nurse practitioner/physician assistant
at $103 per hour × 7,874 FQHCs × 50
percent) $4,086,606).
• ESRD Facilities: Combined total
savings of $2,914,405 for 6,898 dialysis
facilities (3 burden hours for an
administrator at $107 per hour plus 1
burden hour for a medical director/
physician at $203 per hour plus 3
burden hours for a nurse manager at
$107 × 6,898 dialysis facilities × 50
percent).
TABLE 11—COST SAVINGS: TRAINING
Provider/
supplier
Cost savings per
provider/
supplier
RNHCIs .............................
ASCs .................................
Hospices ...........................
PRTFs ...............................
PACEs ..............................
Hospitals (Non-TJC accredited).
ICFs/IIDs ...........................
HHAs .................................
CORFs ..............................
CAHs .................................
Organizations ....................
CMHCs .............................
OPOs ................................
RHCs/FQHCs ....................
$217
232
213
355
426
1,494
$3,906 for 18 RNHCIs.
$1,289,224 for 5,557 ASCs.
$956,157 for 4,489 hospice facilities both inpatient and freestanding/home based.
$132,770 for 374 PRTFs.
$99,258 for 233 PACE organizations.
$2,066,202 for 1,383 non-TJC accredited hospitals.
285
639
395
737
406
355
1,956
519
ESRD Facilities .................
423
$1,734,597 for 6,097 ICF/IIDs.
$8,066,736 for 12,624 HHAs.
$74,260 for 188 CORFs.
$997,161 for 1,353 CAHs.
$842,856 for 2,076 Organizations.
$57,155 for 161 CMHCs.
$113,448 for 58 OPOs.
$6,245,646 for RHCs and FQHCs ($2,159,040 for 4,160 RHCs and $4,086,606 for 7,874
FQHCs).
$2,914,405 for 6,898 dialysis facilities.
d. Testing
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Combined total savings
Finally, at § 482.15(d)(2), we are
finalizing our proposal to require that
providers of inpatient services
mentioned in section II.J.2 of the rule
conduct two testing exercises annually,
one of which may be an exercise of their
choice that must be either a communitybased full-scale exercise (if available),
an individual facility-based functional
exercise, a drill, a tabletop exercise or
workshop that includes a group
discussion led by a facilitator. Given
that these providers are currently
required to conduct two testing
exercises annually, and because they
may choose to conduct the same types
of testing exercises, we do not anticipate
that this requirement will impose a
burden upon providers of inpatient
services and as such, this revision will
not result in a savings of burden hours
or dollars (OMB control number 0938–
1325).
We are also finalizing our proposal to
require that providers of outpatient
services mentioned in section II.J.2 of
the rule conduct one testing exercise
annually which must be either a
community-based full-scale exercise (if
available) or an individual facility-based
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functional exercise every other year, and
in the opposite years, may be either a
community-based full-scale exercise (if
available), a facility-based functional
exercise, a drill, or a tabletop exercise or
workshop that includes a group
discussion led by a facilitator.
For our analysis, we estimate that
reducing this requirement from
biannually to annually for outpatient
providers will reduce compliance costs
related to conducting emergency
preparedness testing by 50 percent. The
methodology used for our cost estimate
analysis mirrors the methodology used
for the biannual testing requirement in
the Emergency Preparedness final rule
(81 FR 63930) with a 50 percent
reduction in the cost estimate
calculation. As in the Emergency
Preparedness final rule (81 FR 63930),
we will assume that the same
individuals involved with developing
training would typically also develop
the scenarios, materials, as well as any
accompanying documentation
associated with testing exercises. Based
on May 2017 BLS salary data, we
calculated the hourly mean wage for
each position for this requirement
identified in the Emergency
Preparedness final rule (81 FR 63930)
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and decreased the cost by 50 percent
due to the 50 percent reduction in the
frequency requirement.
We estimate that the proposed change
will accrue a total annual cost savings
of $9,296,423 and 100,969 burden
hours. We list a detailed calculation for
each facility below, based on facility
numbers available as of May 2017 with
a summary of these calculations
provided in Table 12:
• ASCs: Combined total savings of
$1,091,951 for 5,557 ASCs ((1 burden
hour for an administrator at $109 per
hour plus 4 burden hours for a quality
improvement RN at $71 per hour) ×
5,557 ASCs × 50 percent).
• Freestanding/home-based hospices:
Combined total savings of $573,680 for
4,040 hospice facilities (4 burden hours
for a RN at $71 per hour × 4,040
hospices × 50 percent).
• PACE: Combined total savings of
$41,358 for 233 PACE organizations (4
burden hours for a home care
coordinator at $71 per hour plus 1
burden hours for a RN at $71 per hour
× 233 PACE organizations × 50 percent).
• HHA: Combined total savings of
$4,039,680 for 12,624 HHAs (1 burden
hour for an administrator at $107 per
hour plus 3 burden hours for a nursing
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director at $107 per hour plus 1 burden
hours for a director of rehab at $85 per
hour plus 1 burden hour for an office
manager at $56 per hour plus 1 burden
hours for a director of training at $71 ×
12,624 HHAs × 50 percent).
• CORF: Combined total savings of
$56,212 for 188 CORFs (4 burden hours
for an administrator at $107 per hour
plus 2 burden hours for a physical
therapist at $85 per hour × 188 CORFs
× 50 percent).
• Organizations: Combined total
savings of $310,362 for 2,076
organizations (2 burden hours for an
administrator at $107 per hour plus 1
burden hour for a physical therapist at
$85 per hour × 2,076 organizations × 50
percent).
• CMHCs: Combined total savings of
$22,862 for 161 CMHCs (4 burden hours
for a psychiatric RN at $71 per hour ×
161 CMHCs × 50 percent).
• OPOs: Combined total savings of
$13,427 for 58 OPOs (3 burden hours for
a QAPI director at $107 per hour plus
2 burden hours for an education
coordinator at $71 per hour × 58 OPOs
× 50 percent).
• RHC/FQHC: Combined total savings
of $3,146,891 ((2 burden hours for an
administrator at $107 per hour plus 3
burden hours for a nurse practitioner/
physician assistant at $103 per hour ×
51771
4,160 RHCs × 50 percent) $1,087,840 +
(2 burden hours for an administrator at
$107 per hour plus 3 burden hours for
a nurse practitioner/physician assistant
at $103 per hour × 7,874 FQHCs × 50
percent) $2,059,051).
• ESRD: As identified in the
Emergency Preparedness final rule (81
FR 64006), the current CFCs already
require dialysis facilities to evaluate
their emergency preparedness plan at
least annually (§ 494.60(d)(4)(ii)); thus,
we expect that all dialysis facilities are
already conducting some type of tests to
evaluate their emergency preparedness
plans. As a result, Dialysis facilities are
not included in the burden calculation.
TABLE 12—COST SAVINGS: TESTING
Provider/
supplier
Cost savings per
provider/supplier
ASCs .................................
Hospices (freestanding/
home-based).
PACEs ..............................
HHAs .................................
CORFs ..............................
Organizations ....................
CMHCs .............................
OPOs ................................
RHCs/FQHCs ....................
$197
142
178
320
299
150
142
232
262
We received few comments
specifically addressing our information
collection cost and burden estimates.
Many comments, as previously
discussed, did address specific
regulatory changes and with only a few
exceptions, mainly related to long term
care facilities, endorsed those proposals
to reduce information collection
burdens.
We will submit a revised information
collection request to OMB to account for
the burden hour and cost savings.
II. Final Rule: Fire Safety Requirements
for Certain Dialysis Facilities
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A. Background
1. Overview
The Life Safety Code (LSC) is a
compilation of fire safety requirements
for new and existing buildings, and is
updated and published every 3 years by
the National Fire Protection Association
(NFPA), a private, nonprofit
organization dedicated to reducing loss
of life due to fire. The Medicare and
Medicaid regulations have historically
incorporated these requirements by
reference, along with Secretarial waiver
authority. The statutory basis for
incorporating NFPA’s LSC into the
regulations we apply to Medicare and,
as applicable, Medicaid providers and
suppliers is the Secretary of the
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Combined total savings
$1,091,951 for 5,557 ASCs.
$573,680 for 4,040 hospices.
$41,358 for 233 PACE organizations.
$4,039,680 for 12,624 HHAs.
$56,212 for 188 CORFs.
$310,362 for 2,076 Organizations.
$22,862 for 161 CMHCs.
$13,427 for 58 OPOs.
$3,146,891 ($1,087,840 for 4,160 RHCs and $2,059,051 for 7,874 FQHCs).
Department of Health and Human
Services’ (the Secretary) authority to
stipulate health, safety and other
regulations for each type of Medicare
and (if applicable) Medicaidparticipating facility. Specifically,
section 1881(b)(1)(A) of the Social
Security Act (the Act) provides for
payments for ‘‘providers of services and
renal dialysis facilities which meet such
requirements as the Secretary shall by
regulation prescribe for institutional
dialysis services and supplies. . . .’’
Under this statutory authority, the
Secretary has set out ‘‘Conditions for
Coverage,’’ including LSC compliance
requirements, at 42 CFR part 494,
subpart B. Our current LSC provisions
are set out at § 494.60(d).
In implementing the LSC provisions,
we have given ourselves the discretion
to waive specific provisions of the LSC
for facilities if application of our rules
would result in unreasonable hardship
for the facility, and if the health and
safety of its patients would not be
compromised by such waiver. For
dialysis facilities, that authority is set
out at § 494.60(d)(4). In addition, the
Secretary may accept a State’s fire and
safety code instead of the LSC if the
Centers for Medicare & Medicaid
Services (CMS) determines that the
protections of the State’s fire and safety
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code are equivalent to, or more stringent
than, the protections offered by the LSC;
dialysis facility provisions to that effect
are set out at § 494.60(d)(3). These
flexibilities mitigate the potential
unnecessary burdens of applying the
requirements of the LSC to all affected
health care facilities.
On May 12, 2012, we published a
final rule in the Federal Register,
entitled ‘‘Medicare and Medicaid
Program; Regulatory Provisions to
Promote Program Efficiency,
Transparency, and Burden Reduction’’
(77 FR 29002). In that final rule, we
limited the application of LSC
requirements to dialysis facilities either
located adjacent to industrial high
hazard areas, and those that did not
provide one or more exits to the outside
at grade level from the patient treatment
area level. Subsequently, we proposed
to update Life Safety Code provisions
for CMS providers and suppliers,
‘‘Medicare and Medicaid Programs; Fire
Safety Requirements for Certain Health
Care Facilities; Proposed Rule’’ (79 FR
21552, April 16, 2014). However, we
inadvertently neglected to include
dialysis facilities in this proposal.
Therefore, we issued a proposal
specifically for dialysis facilities,
‘‘Medicare and Medicaid Programs; Fire
Safety Requirements for Certain Dialysis
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Facilities’’ (81 FR 76899, November 4,
2016). We are finalizing these
provisions now, with some
modifications to the terms of the LSC to
address the unique needs of dialysis
facilities. The finalized update would
apply only to dialysis facilities that do
not provide one or more exits to the
outside at grade level from the treatment
area level (for instance, in upper floors
of a mid-rise or high-rise building). We
would not require other dialysis
facilities to comply with NFPA 99®
2012 edition of the Health Care
Facilities Code (NFPA 99) and NFPA
101® 2012 edition of the Life Safety
Code (NFPA 101) because we believe
that patients in dialysis facilities are
generally capable of unhooking
themselves from dialysis machines and
self-evacuating without additional
assistance in the event of an emergency.
We believe that in all facilities with atgrade exits, patients would be able to
evacuate the building in a timely
fashion. Consequently, we believe that
state and local requirements are
sufficient to protect these patients and
staff in the event of an emergency. In
accordance with NFPA 101 sections
20.1.3.7 and 21.1.3.7, we would prohibit
Medicare-approved dialysis facilities
from being located adjacent to industrial
high hazard facilities. ‘‘Adjacent to’’ is
defined as sharing a wall, ceiling or
floor, with a facility.
requirements for certain dialysis
facilities (81 FR 76899) that do not
provide one or more exits to the outside
at grade level from the patient treatment
area to comply with the 2012 edition of
the NFPA 101 and NFPA 99.
We are finalizing those requirements
for dialysis facilities that do not provide
one or more exits to the outside at grade
level from the patient treatment area
level, by incorporating a reference to the
2012 edition of NFPA 101 and NFPA 99.
Certified dialysis facilities without one
or more exits to the outside at grade
level from the patient treatment area
level are already required to meet the
2000 edition of the LSC, while other
provider and supplier types are required
to comply with the 2012 edition of the
NFPA 101 and the NFPA 99 (LSC final
rule published May 4, 2016 at 81 FR
26872).
The NFPA 101® 2012 edition of the
LSC provides minimum requirements,
with due regard to function, for the
design, operation and maintenance of
buildings and structures for safety to life
from fire. Its provisions also aid life
safety in similar emergencies.
The NFPA 99® 2012 edition of the
Health Care Facilities Code provides
minimum requirements for health care
facilities for the installation, inspection,
testing, maintenance, performance, and
safe practices for facilities, material,
equipment, and appliances.
Defining ‘‘Exit to the Outside at Grade
Level From the Patient Treatment Area
Level’’
The phrase ‘‘exit to the outside at
grade level from the patient treatment
area level’’ applies to dialysis facilities
that are on the ground or grade level of
a building where patients do not have
to traverse up or down stairways within
the building to evacuate to the outside.
Accessibility ramps in the exit area that
provide an ease of access between the
patient treatment level and the outside
ground level are not considered
stairways.
A dialysis facility which provides one
or more exits to the outside at grade
level from patient treatment level and
which has a patient exit path to the
outside (which may include an
accessibility ramp that is compliant
with NFPA and the Americans with
Disabilities Act (ADA)) would be
exempt from compliance with the
applicable provisions of NFPA 99 and
NFPA 101.
1. 2012 Edition of the Life Safety Code
The 2012 edition of the LSC includes
new provisions that we believe are vital
to the health and safety of all patients
and staff. Our intention is to ensure that
patients and staff continue to experience
the highest degree of fire safety possible.
We do review each edition of the NFPA
101 and NFPA 99 every 3 years to see
if there are any significant provisions
that we need to adopt. CMS will
continue to review revisions to ensure
we meet proper standards for patient
safety. We have reviewed the 2015 and
2018 edition of the NFPA 101 and
NFPA 99 and do not believe that there
are any significant provisions that need
to be addressed at this time. Newer
buildings are typically built to comply
with the newer versions of the LSC
because state and local jurisdictions
often adopt and enforce newer versions
of the LSC as they become available.
We must emphasize that the LSC is
not an accessibility code, and
compliance with the LSC does not
ensure compliance with the
requirements of the ADA. State and
local government programs and
services, including health care facilities,
are required to comply with Title II of
the ADA. Private entities that operate
B. Provisions of the Proposed Rule and
Analysis and Response to Public
Comments
On November 4, 2016 we published a
proposed rule to update the
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public accommodations such as nursing
homes, hospitals, and social service
center establishments are required to
comply with Title III of the ADA.
Entities that receive federal financial
assistance from the Department of
Health and Human Services, including
Medicare and Medicaid, are also
required to comply with section 504 of
the Rehabilitation Act of 1973. The
same accessibility standards apply
regardless of whether health care
facilities are covered under Title II or
Title III of the ADA or section 504 of the
Rehabilitation Act of 1973.1 For more
information about the ADA’s
requirements, see the Department of
Justice’s website at https://www.ada.gov
or call 1–800–514–0301 (voice) or 1–
800–514–0383 (TTY).
2. Incorporation by Reference
This final rule will incorporate by
reference the NFPA 101® 2012 edition
of the LSC, issued August 11, 2011, and
Tentative Interim Amendments (TIAs)
issued prior to April 16, 2014; and the
NFPA 99®2012 edition of the Health
Care Facilities Code, issued August 11,
2011, and TIAs issued prior to April 16,
2014 in § 494.60(f).
(1) NFPA 101, Life Safety Code, 2012
edition, issued August 11, 2011;
(i) TIA 12–1 to NFPA 101, issued
August 11, 2011.
(ii) TIA 12–2 to NFPA 101, issued
October 30, 2012.
(iii) TIA 12–3 to NFPA 101, issued
October 22, 2013.
(iv) TIA 12–4 to NFPA 101, issued
October 22, 2013.
(2) NFPA 99, Standards for Health
Care Facilities Code of the National Fire
Protection Association 99, 2012 edition,
issued August 11, 2011.
(i) TIA 12–2 to NFPA 99, issued
August 11, 2011.
(ii) TIA 12–3 to NFPA 99, issued
August 9, 2012.
(iii) TIA 12–4 to NFPA 99, issued
March 7, 2013.
(iv) TIA 12–5 to NFPA 99, issued
August 1, 2013.
(v) TIA 12–6 to NFPA 99, issued
March 3, 2014.
These materials have been previously
incorporated by reference for other
1 Facilities newly constructed or altered after
March 15, 2012 must comply with the 2010
Standards for Accessible Design (2010 Standards).
Facilities newly constructed or altered between
September 15, 2010 and March 15, 2012 had the
option of complying with either the 1991 Standards
for Accessible Design (1991 Standards) or the 2010
Standards. Facilities newly constructed between
January 26, 1993 and September 15, 2010, or altered
between January 26, 1992 and September 15, 2010
were required to comply with the 1991 Standards
under Title III and either the 1991 Standards or the
Uniform Federal Accessibility Standards under
Title II.
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provider and supplier types by the final
rule, ‘‘Medicare and Medicaid Programs;
Fire Safety Requirements for Certain
Health Care Facilities’’ published on
May 4, 2016 (81 FR 26872).
The materials that are incorporated by
reference can be found for interested
parties and are available for inspection
at the CMS Information Resource
Center, 7500 Security Boulevard,
Baltimore, MD 21244, or from the
National Fire Protection Association, 1
Batterymarch Park, Quincy, MA 02269.
If any changes to these editions of the
Codes are incorporated by reference,
CMS will publish a document in the
Federal Register to announce those
changes.
The 2012 edition of the NFPA 101
(including the TIAs) provides minimum
requirements, with due regard to
function, for the design, operation and
maintenance of buildings and structures
for safety to life from fire. Its provisions
also aid life safety in similar
emergencies.
The 2012 edition of the NFPA 99
(including the TIAs) provides minimum
requirements for health care facilities
for the installation, inspection, testing,
maintenance, performance, and safe
practices for facilities, material,
equipment, and appliances, including
other hazards associated with the
primary hazards.
3. Ambulatory Health Care Occupancies
According to our memorandum,
‘‘Survey & Certification: 13–47–LSC/
ESRD,’’ issued July 12, 2013, dialysis
facilities that are subject to the LSC
provisions must meet the requirements
of the Ambulatory Health Care
Occupancy chapters 20 and 21 of the
LSC. Dialysis facilities that are not
subject to our LSC regulations must
continue to meet State and local fire
codes. (See https://www.cms.gov/
Medicare/Provider-Enrollment-andCertification/
SurveyCertificationGenInfo/Downloads/
Survey-and-Cert-Letter-13-47.pdf.)
The following are key provisions in
the 2012 edition of the LSC from
Chapter 20, ‘‘New Ambulatory Health
Care Occupancies’’ and Chapter 21,
‘‘Existing Ambulatory Health Care
Occupancies.’’ We have provided the
LSC citation and a description of the
requirement.
The 2012 edition of the LSC defines
an ‘‘Ambulatory Health Care
Occupancy’’ as a facility capable of
treating 4 or more patients
simultaneously on an outpatient basis.
We believe that dialysis facilities that do
not provide one or more exits to the
outside at grade level from the patient
treatment area should also be required
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to meet the provisions applicable to
Ambulatory Health Care Occupancy
Chapters, regardless of the number of
patients served, as a matter of health
and safety of patients receiving services
in these facilities. In the burden
reduction final rule, published in the
Federal Register on May 12, 2012
entitled, ‘‘Medicare and Medicaid
Program; Regulatory Provisions to
Promote Program Efficiency,
Transparency, and Burden Reduction’’
(77 FR 29002), we removed the
provision’s applicability to dialysis
facilities with at-grade exits directly
from the treatment area because, in our
view, there was, and continues to be, an
extremely low risk of fire in dialysis
facilities. Medicare-approved dialysis
facilities that provide exits to the
outside at grade level would continue to
be required to follow State and local fire
codes, which we believe provide for
sufficient patient protection in the event
of an emergency. If a facility’s exits were
located above or below grade, patients
would require more time to evacuate.
Consequently, we believe that the LSC
would still be required due to the
additional risk entailed in longer exit
times.
Sections 20.3.2.1 and 21.3.2.1—Doors
This provision requires all doors to
hazardous areas be self-closing or close
automatically.
Sections 20.3.2.6 and 21.3.2.6—Alcohol
Based Hand Rubs
This provision explicitly allows
aerosol dispensers, in addition to gel
hand rub dispensers. The aerosol
dispensers are subject to limitations on
size, quantity, and location, just as gel
dispensers are limited. Automatic
dispensers are also now permitted in
ambulatory care facilities, provided,
among other things, that—(1) they do
not release contents unless they are
activated; (2) the activation occurs only
when an object is within 4 inches of the
sensing device; (3) any object placed in
the activation zone and left in place
must not cause more than one
activation; (4) the dispenser must not
dispense more than the amount required
for hand hygiene consistent with the
label instructions; (5) the dispenser is
designed, constructed and operated in a
way to minimize accidental or
malicious dispensing; and (6) all
dispensers are tested in accordance with
the manufacturer’s care and use
instructions each time a new refill is
installed. The provision further defines
prior language regarding ‘‘above or
adjacent to an ignition source’’ as being
‘‘within 1 inch’’ of the ignition source.
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Sections 20.3.5 and 21.3.5—
Extinguishment Requirements
This provision is related to sprinkler
system requirements and requires the
evacuation of a building or the
instituting of an approved fire watch
when a sprinkler system is out of
service for more than 10 hours in a 24hour period until the system has been
returned to service. A facility must
evacuate the building or portion of the
building affected by the system outage
until the system is back in service, or
establish a fire watch until the system
is back in service.
4. 2012 Edition of the Health Care
Facilities Code
The 2012 edition of the NFPA 99,
‘‘Health Care Facilities Code,’’ addresses
requirements for both health care
occupancies and ambulatory care
occupancies, and serves as a resource
for those who are responsible for
protecting health care facilities from fire
and associated hazards. The purpose of
this Code is to provide minimum
requirements for the installation,
inspection, testing, maintenance,
performance, and safe practices for
health care facility materials, equipment
and appliances. This Code is a
compilation of documents that have
been developed over a 40-year period by
NFPA, and is intended to be used by
those persons involved in the design,
construction, inspection, and operation
of health care facilities, and in the
design, manufacture, and testing of
appliances and equipment used in
patient care areas of health care
facilities. It provides information on
subjects, for example, medical gas and
vacuum systems, electrical systems,
electrical equipment, and gas
equipment. The NFPA 99 applies
specific requirements in accordance
with the results of a risk-based
assessment methodology. A risk-based
approach allows for the application of
requirements based upon the types of
treatment and services being provided
to patients or residents rather than the
type of facility in which they are being
performed. In order to ensure the
minimum level of protection afforded
by NFPA 99 is applicable to all patient
and resident care areas within a health
care facility, we proposed adoption of
the 2012 edition of NFPA 99, with the
exception of chapters 7—‘‘Information
Technology and Communications
Systems for Health Care Facilities’’; 8—
‘‘Plumbing’’; 12—‘‘Emergency
Management’’; and 13—‘‘Security
Management’’. The first three chapters
of the NFPA 99 address the
administration of the NFPA 99, the
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referenced publications, and definitions.
Short descriptions of some of the more
important provisions of NFPA 99
follow:
Chapter 4—Fundamentals
Chapter 4 provides guidance on how
to apply NFPA 99 requirements to
health care facilities based upon
‘‘categories’’ determined when using a
risk-based methodology.
There are four categories utilized in
the risk assessment methodology,
depending on the types of treatment and
services being provided to patients or
residents. Section 4.1.1 of NFPA 99
describes Category 1 as, ‘‘Facility
systems in which failure of such
equipment or system is likely to cause
major injury or death of patients or
caregivers. . . .’’ Section A.4.1.1
provides examples of what a major
injury could include, such as
amputation or a burn to the eye. Section
4.1.2 describes Category 2 as, ‘‘Facility
systems in which failure of such
equipment is likely to cause minor
injury to patients or caregivers. . . .’’
Section A.4.1.2 describes a minor injury
as one that is not serious or involving
risk of life. Section 4.1.3 describes
Category 3 as, ‘‘Facility systems in
which failure of such equipment is not
likely to cause injury to patients or
caregivers, but can cause patient
discomfort. . . .’’ Section 4.1.4
describes Category 4 as, ‘‘Facility
systems in which failure of such
equipment would have no impact on
patient care. . . .’’
Section 4.2 requires that each facility
that is a health care or ambulatory
occupancy define its risk assessment
methodology, implement the
methodology, and document the results.
We did not propose to require the use
of any particular risk assessment
procedure. However, if future situations
indicate the need to define a particular
risk assessment procedure, we would
pursue that through a separate notice
and comment rulemaking.
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Chapter 5—Gas and Vacuum Systems
The hazards addressed in Chapter 5
include the ability of oxygen and
nitrous oxide to exacerbate fires, safety
concerns from the storage and use of
pressurized gas, and the reliance upon
medical gas and vacuum systems for
patient care. Chapter 5 does not
mandate the installation of any systems;
rather, if they are installed or are
required to be installed, the systems will
be required to comply with NFPA 99.
Chapter 5 covers the performance,
maintenance, installation, and testing of
the following:
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• Non-flammable medical gas systems
with operating pressure below a gauge
pressure of 300 psi;
• Vacuum systems in health care
facilities;
• Waste anesthetic gas disposal
systems (WAGD); and
• Manufactured assemblies that are
intended for connection to the medical
gas, vacuum, or WAGD systems.
Chapter 6—Electrical Systems
The hazards addressed in Chapter 6
are related to the electrical power
distribution systems in health care
facilities, and address issues such as
electrical shock, power continuity, fire,
electrocution, and explosions that might
be caused by faults in the electrical
system. Chapter 6 also covers the
performance, maintenance, and testing
of the electrical systems in health care
facilities.
Chapter 9—Heating, Ventilation, and
Air Conditioning (HVAC)
Chapter 9 requires HVAC systems
serving spaces or providing health care
functions to be in accordance with the
American Society of Heating,
Refrigeration and Air-Conditioning
Engineers (ASHRAE) Standard 170—
Ventilation of Health Care Facilities
(2008 edition) (https://www.ashrae.org).
Chapter 9 does not apply to existing
HVAC systems, but applies to the
construction of new health care
facilities, and the altered, renovated, or
modernized portions of existing systems
or individual components. Chapter 9
ensures minimum levels of heating,
ventilation and air conditioning
performance in patient and resident care
areas. Some of the issues discussed in
Chapter 9 are as follows:
• HVAC system energy conservation;
• Commissioning;
• Piping;
• Ductwork;
• Acoustics;
• Requirements for the ventilation of
medical gas storage and trans-filling
areas;
• Waste anesthetic gases;
• Plumes from medical procedures;
• Emergency power system rooms;
and
• Ventilation during construction.
Chapter 10—Electrical Equipment
Chapter 10 covers the performance,
maintenance, and testing of electrical
equipment in health care facilities.
Much of this chapter applies to
requirements for portable electrical
equipment in health care facilities, but
there are also requirements for fixedequipment and information on
administrative issues.
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Chapter 11—Gas Equipment
The hazards addressed in Chapter 11
relate to general fire, explosions, and
mechanical issues associated with gas
equipment, including compressed gas
cylinders.
Chapter 14—Hyperbaric Facilities
Chapter 14 addresses the hazards
associated with hyperbaric facilities in
health care facilities, including
electrical, explosive, implosive, as well
as fire hazards. Chapter 14 sets forth
minimum safeguards for the protection
of patients and personnel administering
hyperbaric therapy and procedures.
Chapter 14 contains requirements for
hyperbaric chamber manufacturers,
hyperbaric facility designers, and
personnel operating hyperbaric
facilities. It also contains requirements
related to construction of the hyperbaric
chamber itself and the equipment used
for supporting the hyperbaric chamber,
as well as administration and
maintenance. Many requirements in this
chapter are applicable only to new
construction and new facilities.
Chapter 15—Features of Fire Protection
Chapter 15 covers the performance,
maintenance, and testing of fire
protection equipment in health care
facilities. Issues addressed in this
chapter range from the use of flammable
liquids in an operating room to special
sprinkler protection. These fire
protection requirements are
independent of the risk-based approach,
as they are applicable to all patient care
areas in both new and existing facilities.
Chapter 15 has several sections taken
directly from the NFPA 101, including
requirements for the following:
• Construction and
compartmentalization of health care
facilities.
• Laboratories.
• Utilities.
• Heating, ventilation and air
conditioning systems.
• Elevators.
• Escalators.
• Conveyors.
• Rubbish Chutes.
• Incinerators.
• Laundry Chutes.
• Fire detection, alarm and
communication systems.
• Automatic sprinklers and other
extinguishing equipment.
• Compact storage including mobile
storage and maintenance.
• Testing of water based fire
protection systems.
These sections have requirements for
inspection, testing and maintenance
which apply to all facilities, as well as
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specific requirements for existing
systems and equipment that also apply
to all facilities.
• The prospective timeline for
applicability of these requirements
would be 60 days after the publication
of the final rule in the Federal Register.
We solicited comments on the proposal
of the adoption of the 2012 NFPA 101
and the 2012 NFPA 99 for dialysis
facilities that do not provide one or
more exits to the outside at grade level
from the treatment area level in the
proposed rule ‘‘Fire Safety
Requirements for Certain Dialysis
Facilities,’’ published November, 4,
2016 (81 FR 76899).
We received 4 comments and all
commenters were in support of the
proposal. Therefore, we are finalizing
the adoption of the 2012 NFPA 101 and
the 2012 NFPA 99 for dialysis facilities
that do not provide one or more exits to
the outside at grade level from the
treatment area level.
Technical Correction
We inadvertently left out the update
of § 494.60(d)(2) from the 2000 edition
of the Life Safety Code to the 2012
edition of the Life Safety Code. This
update goes along with the overall
adoption of the 2012 edition of the Life
Safety Code. This will have no impact
on facilities as they are all already
meeting the 2012 edition of the Life
Safety Code in accordance with state
and local requirements.
C. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
III. Final Rule: Hospital and Critical
Access Hospital (CAH) Changes To
Promote Innovation, Flexibility, and
Improvement in Patient Care
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A. Background
On June 16, 2016, we published a
proposed rule in the Federal Register,
‘‘Medicare and Medicaid Programs;
Hospital and Critical Access Hospital
(CAH) Changes To Promote Innovation,
Flexibility, and Improvement in Patient
Care’’ (81 FR 39447), to revise a number
of hospital and CAH requirements,
including those focused on infection
control, antibiotic use, and
antidiscrimination. We are now
finalizing several of the proposed
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changes in order to modernize the
hospital and critical access hospital
(CAH) requirements, improve quality of
care, and support HHS and CMS
priorities. We believe that benefits of
these finalized requirements will
include: Reduced incidence of hospitalacquired conditions (HACs), including
reduced incidence of healthcareassociated infections (HAIs); reduced
inappropriate antibiotic use; reduced
regulatory burden and increased cost
savings for hospitals, CAHs, and
insurers; and strengthened patient
protections overall. Specifically, we
proposed to revise the conditions of
participation (CoPs) for hospitals and
CAHs to address:
• Discriminatory behavior by
healthcare providers that may create
real or perceived barriers to care;
• A requirement regarding a patient’s
right to access his or her own medical
records, including in an electronic
format;
• Continued use of the term
‘‘Licensed Independent Practitioners’’
(LIPs), which might inadvertently
exacerbate workforce shortage concerns,
might unnecessarily impose regulatory
burden on hospitals by restricting a
hospital’s ability to allow non-physician
practitioners such as physician
assistants (PAs) to operate within the
scope of practice allowed by state law,
and does not recognize the benefits to
patient care that might be derived from
fully utilizing PAs and their clinical
skills to the highest levels of their
training, education, and experience as
allowed by hospital policy in
accordance with state law;
• The use of quality reporting
program data by hospital Quality
Assessment and Performance
Improvement (QAPI) programs;
• Requirements in the Nursing
services CoP to improve clarity and
provide some regulatory flexibility and
burden relief;
• Requirements in the Medical
records services CoP to improve clarity
regarding the distinctions between a
patient’s inpatient and outpatient status
and the subtle differences between
certain aspects of medical record
documentation related to each status;
• Requirements that do not fully
conform to current standards for
infection control for both hospitals and
CAHs;
• Requirements for antibiotic
stewardship programs to help reduce
inappropriate antibiotic use and
antimicrobial resistance for both
hospitals and CAHs;
• A requirement for CAHs that would
allow a patient’s nutritional needs to be
met in accordance with recognized
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dietary practices and the orders of the
practitioner responsible for the care of
the patients, or by a qualified dietician
or qualified nutrition professional as
authorized by the medical staff in
accordance with State law; and
• Requirements for CAHs to establish
a quality assessment and performance
improvement program (QAPI).
B. Provisions of the Proposed
Regulations and Responses to Public
Comments for Hospitals (42 CFR Part
482)
1. General Comments
In response to the proposed rule, we
received 200 public comments.
Commenters included individuals,
healthcare professionals and
corporations, national associations and
coalitions, state health departments,
patient advocacy organizations, and
individual facilities that would be
impacted by the regulation.
Generally, most comments expressed
support for the regulatory changes. We
have provided a summary of the public
comments, our responses to those
comments, and any changes made as a
result of those comments in the
proceeding sections. Several
commenters expressed concern that we
underestimated the time and effort
required for compliance with the
antibiotic stewardship and QAPI
requirements, especially for smaller
hospitals, including CAHs. Commenters
requested a delayed implementation for
these requirements.
2. Implementation Timeframe
Comment: We received several
comments stating that we have
underestimated the time necessary to
implement some of the requirements
contained in this rule. Some
commenters stated that the proposed
hospital and CAH infection control and
antibiotic stewardship and QAPI
provisions required additional time to
implement. These commenters
requested that we grant additional time
for the implementation for these
requirements. Commenters cited
challenges associated with
implementing these requirements,
especially for small, rural hospitals and
CAHs including obtaining and training
appropriate staff for the required
positions.
Response: We understand the
complexities of the required changes in
this rule for hospitals and CAHs,
particularly the effects on CAHs and
small, rural hospitals. As a result, we
are using the following implementation
schedule for the provisions of this final
rule:
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• CAH QAPI requirements—an
implementation date that is 18 months
after the effective date of this final rule;
• Hospital and CAH compliance with
the antibiotic stewardship
requirements—an implementation date
that is six months from the effective
date of this final rule; and
• All other requirements, including
those for patient’s rights—an
implementation date that is 60 days
from the publication of this final rule.
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3. Non-Discrimination
We proposed to establish at
§ 482.13(i) for hospitals and § 485.635
(g) for CAHs, explicit requirements that
a hospital (or CAH) not discriminate on
the basis of race, color, religion, national
origin, sex (including gender identity),
sexual orientation, age, or disability and
that the hospital (or CAH) establish and
implement a written policy prohibiting
discrimination on the basis of race,
color, religion, national origin, sex
(including gender identity), sexual
orientation, age, or disability.
We proposed to further require that
each patient, (and/or support person,
where appropriate), is informed, in a
language he or she can understand, of
the right to be free from discrimination
against them on any of these bases when
he or she is informed of his or her other
rights under § 482.13(i) (or § 485.635(g)).
In addition, we proposed to require that
the hospital (or CAH) inform the patient
and/or representative, and/or support
person, on how he or she can seek
assistance if they encounter
discrimination.
Comment: We received numerous
comments that expressed support for
this proposal and also discussed the
potential benefits of the proposal to
patients. In addition, we received
comments that expressed concern about
the consequences of the implementation
of this proposal and suggested
modifications to our proposed
requirement. Commenters also
discussed potential technical difficulties
that may exist when implementing this
proposal and they expressed concern
that the proposed requirement may be
duplicative of other current federal
requirements.
Response: In response to these
comments, we are not finalizing the
proposal to require explicit nondiscrimination requirements in the CoPs
and we are instead deferring to the nondiscrimination requirements of Section
1557 of the Affordable Care Act.
Final Action: We are not finalizing
proposed § 482.13(i) and § 485.635(g).
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4. Licensed Independent Practitioner
We proposed to delete the modifying
term ‘‘independent’’ from the CoPs at
§ 482.13(e)(5), as well as at
§ 482.13(e)(8)(ii), and also proposed to
revise the provision to be in keeping
with the language of the Children’s
Health Act of 2000 (Pub. L. 106–310)
(CHA) regarding restraint and seclusion
orders and licensed practitioners.
Therefore, we proposed that
§ 482.13(e)(5) read that the use of
restraint or seclusion must be in
accordance with the order of a
physician or other licensed practitioner
who is responsible for the care of the
patient and authorized to order restraint
or seclusion by hospital policy in
accordance with State law. We proposed
that § 482.13(e)(8)(ii) would state that,
after 24 hours, before writing a new
order for the use of restraint or seclusion
for the management of violent or selfdestructive behavior, a physician or
other licensed practitioner who is
responsible for the care of the patient
and authorized to order restraint or
seclusion by hospital policy in
accordance with State law would have
to see and assess the patient.
We proposed to revise the provisions
in sections § 482.13(e)(10),
§ 482.13(e)(11), § 482.13(e)(12)(i)(A),
§ 482.13(e)(14), and § 482.13(g)(4)(ii)
that contain the term ‘‘licensed
independent practitioner’’ by changing
the term from ‘‘licensed independent
practitioner’’ to simply ‘‘licensed
practitioner.’’ We also proposed to
remove the term ‘‘physician assistant’’
from the current provisions at
§ 482.13(e)(12)(i)(B) and § 482.13(e)(14).
Comment: The majority of
commenters were supportive of this
change. Specifically, commenters noted
that the proposed language change will
remove uncertainty regarding these
provisions and clearly demonstrates that
Physician Assistants (PAs) are
authorized to order restraint and
seclusion, in accordance with state law
and facility policy, when medically
necessary to protect patients and health
professionals. One commenter did not
support the removal of the term
‘‘independent’’ from this requirement.
The commenter stated that removing the
term ‘‘independent’’ may make this
requirement applicable to other care
providers, such as registered nurses.
Response: We thank commenters for
their support of this requirement. We
believe this revision reflects our goal to
have health professionals operate within
the scope of practice allowed by state
law, and recognizes the need to fully
utilize the healthcare workforce. We
also believe that this change will reduce
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unnecessary burden for hospitals and
remove obstacles PAs face when
ordering seclusion and restraints. We
disagree with the commenters who
stated that the removal of the term
‘‘independent’’ will cause confusion
over the applicability of this
requirement. Our proposed removal of
the term ‘‘independent’’ is consistent
with the language used in the CHA,
which utilizes the term ‘‘other licensed
practitioner’’, without the independent
modifying term. In addition, the order of
restraint or seclusion must be ordered
by a licensed practitioner who is
authorized by hospital policy in
accordance with State law to do so. This
would exclude Registered Nurses or
other hospital staff, who either through
State law or hospital policy, would not
have the authorization to order the use
of restraints and seclusion.
After consideration of the comments
we received, we are finalizing this
proposal, without modification.
Final Action: We are finalizing the
following revisions to § 482.13:
1. Remove the modifying term
‘‘independent’’ from the CoPs at
§ 482.13(e)(5) and § 482.13(e)(8)(ii).
2. Revise § 482.13(e)(5) to state that
the use of restraint or seclusion must be
in accordance with the order of a
physician or other licensed practitioner
who is responsible for the care of the
patient and authorized to order restraint
or seclusion by hospital policy in
accordance with State law.
3. Revise the provisions in sections
§ 482.13(e)(10), § 482.13(e)(11),
§ 482.13(e)(12)(i)(A), § 482.13(e)(14),
and § 482.13(g)(4)(ii) that contain the
term ‘‘licensed independent
practitioner’’ by changing the term to
simply ‘‘licensed practitioner.’’
4. Remove the term ‘‘physician
assistant’’ from the current provisions at
§ 482.13(e)(12)(i)(B) and § 482.13(e)(14).
5. Quality Assessment and Performance
Improvement (QAPI) Program (§ 482.21)
We proposed a minor change to the
program data requirements at
§ 482.21(b), which would require that
the hospital QAPI program incorporate
quality indicator data including patient
care data submitted to or received from
quality reporting and quality
performance programs, including but
not limited to data related to hospital
readmissions and hospital-acquired
conditions
Comment: We received mostly
positive feedback regarding this
requirement; however, some
commenters asked that we remove the
provided example of ‘‘data related to
hospital readmissions and hospitalacquired conditions.’’ Commenters
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believed that the inclusion of this
information makes it unclear to
hospitals that they should utilize all
data available to them. One commenter
also disagreed with any proposal that
would restrict quality improvement
work to a limited number of areas.
Response: We thank the commenters
for their feedback. We believe that this
requirement affords hospitals increased
flexibility, while continuing to promote
patient safety and quality of care. As
revised by this final rule, the regulation
at § 482.21(b)(1) now requires that the
QAPI program ‘‘incorporate quality
indicator data including patient care
data, and other relevant data such as
data submitted to or received from
Medicare quality reporting and quality
performance programs, including but
not limited to data related to hospital
readmissions and hospital-acquired
conditions.’’ We believe the intent of the
regulation is clear as the language states
that the data that must be incorporated
is not limited to data related to hospital
readmissions and hospital-acquired
conditions; however, we will ensure
that the intent is also clear in the
Interpretive Guidelines for this
requirement. Note that CMS historically
releases Interpretive Guidelines for new
regulations after the final rule has been
published. Furthermore, we note that
these requirements would not restrict
hospitals to a certain number of quality
improvement areas, but they are instead
minimum requirements that hospitals
can choose to exceed as they strive to
improve the quality of the services that
they provide.
Final Action: We are finalizing
§ 482.21(b) as proposed.
6. Nursing Services (482.23)
As a result of our internal review of
the CoPs for nursing services, we
recognized that some of our
requirements might be ambiguous and
confusing due to unnecessary
distinctions between inpatient and
outpatient services, or might fail to
account for the variety of ways through
which a hospital might meet its nurse
staffing requirements. We proposed to
make revisions to the nursing services
CoP to improve clarity. Specifically, we
proposed to revise § 482.23(b), which
currently states that there must be
supervisory and staff personnel for each
department or nursing unit to ensure,
when needed, the immediate
availability of a registered nurse for
bedside care of any patient. We
proposed to delete the term ‘‘bedside,’’
which might imply only inpatient
services to some readers. The nursing
service would have to ensure that
patient needs were being met by
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ongoing assessments of patients’ needs
and would have to provide nursing staff
to meet those needs regardless of
whether the patient was an inpatient or
an outpatient. There would have to be
sufficient numbers and types of
supervisory and staff nursing personnel
to respond to the appropriate nursing
needs and care of the patient population
of each department or nursing unit.
When needed, a registered nurse would
have to be available to care for any
patient. We understand that the term
‘‘immediate availability’’ has been
interpreted to mean physically present
on the unit or in the department. We
further understand that there are some
outpatient services where it might not
be necessary to have a registered nurse
physically present. For example, while
it is clearly necessary to have an RN
present in an outpatient ambulatory
surgery recovery unit, it might not be
necessary to have an RN on-site at a
hospital MRI facility that is outside the
hospital building, but still on the
hospital campus. We proposed to allow
a hospital to establish a policy that
would specify which, if any, outpatient
departments would not be required to
have an RN physically present as well
as the alternative staffing plans that
would be established under such a
policy. We would require such a policy
to take into account factors such as the
services delivered, the acuity of patients
typically served by the facility, and the
established standards of practice for
such services. In addition, we would
propose that the policy must be
approved by the medical staff and be
reviewed at least once every three years.
We solicited comments on the need for,
the risks of establishing, and the
appropriate criteria we should require
for such an exception.
We also proposed to clarify in (b)(4)
(which currently requires that the
hospital must ensure that the nursing
staff develops, and keeps current, a
nursing care plan for each patient and
that the plan may be part of an
interdisciplinary care plan) that while a
nursing care plan was needed for every
patient, the care plan would be expected
to reflect the needs of the patient and
the nursing care to be provided to meet
those needs. The care plan for a patient
with complex medical needs and a
longer anticipated hospitalization
would be more extensive and detailed
than the care plan for a patient with a
less complex medical need expecting
only a brief hospital stay. We expect
that a nursing care plan would be
initiated and implemented in a timely
manner, include patient goals as part of
the patient’s nursing care assessment
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51777
and, as appropriate, physiological and
psychosocial factors (such as specific
physical limitations and available
support systems), physical and
behavioral health comorbidities, and
patient discharge planning. In addition,
it would have to be consistent with the
plan for the patient’s medical care and
demonstrate evidence of reassessment of
the patient’s nursing care needs,
response(s) to nursing interventions,
and, as needed, revisions to the plan.
Finally, we proposed to revise (b)(6)
(which currently states that nonemployee licensed nurses working in
the hospital must adhere to the policies
and procedures of the hospital and that
the director of nursing service must
provide for the adequate supervision
and evaluation of the clinical activities
of non-employee nursing personnel) to
clarify that all licensed nurses who
provide services in the hospital must
adhere to the policies and procedures of
the hospital. In addition, the director of
nursing service must provide for the
adequate supervision and evaluation of
the clinical activities of all nursing
personnel (that is, all licensed nurses
and any non-licensed personnel such as
nurse aides, orderlies, or other nursing
support personnel who are under the
direction of the nursing service) which
occur within the responsibility of the
nursing service, regardless of the
mechanism through which those
personnel were obtained. We recognize
that there are a variety of arrangements
under which hospitals obtain the
services of licensed nurses. Mechanisms
may include direct employment, the use
of contract or agency nurses, a leasing
agreement, volunteer services or some
other arrangement. No matter how the
services of a licensed nurse were
obtained, in order to ensure the health
and safety of patients, all nurses would
have to know and adhere to the policies
and procedures of the hospital and there
must be adequate supervision and
evaluation of the clinical activities of all
nursing personnel who provide services
that occur within the responsibility of
the nursing service. We would expect
non-licensed personnel to be supervised
by a licensed nurse.
In addition, we proposed to delete
inappropriate references to § 482.12(c)
that are currently in (c)(1) and (3). We
discuss these technical corrections in
detail below.
Comment: Commenters expressed
concern regarding the removal of the
word ‘‘bedside’’ under § 482.23(b),
(which stated that there must be
supervisory and staff personnel for each
department or nursing unit to ensure,
when needed, the immediate
availability of a registered nurse for
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bedside care of any patient).
Commenters noted that our proposed
revision could create confusion in
certain inpatient departments and asked
that CMS clarify that each hospital
department or nursing unit should
ensure that nurse staffing should be
immediately available, when needed.
Commenters also asked that we clarify
that policies related to nurse staffing are
approved by the hospital’s medical staff
in conjunction with nursing leadership.
One commenter stated that the approval
of any policies regarding nursing
services would be under the authority of
the hospital’s director of nursing and
medical staff approval would not be
needed as proposed here.
Response: The nursing service must
ensure that patient needs are met by
continuously assessing the needs of
patients and must provide nursing staff
to meet those needs, regardless of
whether the patient is an inpatient or an
outpatient. There must be sufficient
numbers and types of supervisory and
staff nursing personnel to meet the
nursing needs and to care for the patient
population of each department or
nursing unit. A registered nurse must be
available to care for any patient, as
determined by the needs of the patient
and hospital policy. Note that the term
‘‘immediate availability’’ has been
interpreted to mean physically present
on the unit or in the department. Also
note that there are some outpatient
services where it might not be necessary
to have a registered nurse physically
present. For example, while it is clearly
necessary to have an RN present in an
outpatient ambulatory surgery recovery
unit, it might not be necessary to have
an RN on-site at an off-campus
outpatient department where radiology
services are offered. Hospitals are
provided the flexibility to establish a
policy that would specify which, if any,
outpatient departments would not be
required to have an RN physically
present as well as the alternative staffing
plans that would be established under
such a policy. Such a policy must take
into account factors such as the services
delivered, the acuity of patients
typically served by the facility, and the
established standards of practice for
such services. We agree with the
comment that stated that the approval of
any nursing services policy falls under
the authority of the hospital’s nursing
leadership and we have modified the
proposed requirement at
§ 482.23(b)(7)(iii) to reflect that in this
final rule.
Comment: We received positive
comments about the requirement under
§ 482.23(b)(4), which requires that the
nursing care plan, which is needed for
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every patient, reflect the needs of the
patient and the nursing care to be
provided to meet those needs.
Commenters stated these changes help
ensure that the clinical team is working
together with the patient and the
patient’s family to ensure that the team
is continuously working towards
meeting the established patient goals.
However, as evidenced by some
comments, there appears to exist some
confusion over whether a nursing care
plan is required for both inpatients and
outpatients or if it is required for
inpatients only.
Response: We appreciate the positive
feedback received for this requirement.
Initiating a nursing care plan for
patients that reflects the needs of the
patient will lead to better patient
outcomes and has the potential to
decrease length of stay.
Regarding the question of which
patients (all patients or only inpatients)
are required to have a nursing care plan,
we must look at both the regulatory text
and the interpretive guidance contained
in the SOM, Appendix A, Section A–
0396, for this provision. While the
actual regulatory text has always simply
used the term, ‘‘patient,’’ implying both
inpatients and outpatients, other areas
of the CoPs specifically use the term
‘‘inpatient’’ as does the language of the
Act (specifically with regard to nursing
services) as well as other instances in
the CoPs that refer to patient
‘‘admissions,’’ which further implies
inpatients. Additionally, the
interpretive guidance for this provision
in the SOM, Appendix A, has
traditionally held that the requirement
for a nursing care plan only applies to
patients after their ‘‘admission,’’ (that is,
inpatients only) (https://www.cms.gov/
Regulations-and-Guidance/Guidance/
Manuals/Downloads/som107ap_a_
hospitals.pdf, p. 224).
While we believe that nursing care
plans most appropriately, and in most
instances, apply only to inpatients, we
urge hospitals to review their policies
and procedures in this area to determine
if there are outpatients where a nursing
care plan would be appropriate and
should be required for the benefit of the
patient’s health and safety and for
improved outcomes. For instance,
hospitals should look at the policies that
they develop for the provisions that we
are finalizing here, at § 482.23(b)(7),
regarding those policies and procedures
that must be in place to establish which
outpatient departments, if any, are not
required under hospital policy to have
a registered nurse present. As we
discussed previously, that while it is
clearly necessary to have an RN present
in an outpatient ambulatory surgery
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recovery unit, it might not be necessary
to have an RN on-site at a hospital MRI
facility that is outside the hospital
building, but still on the hospital
campus. In exercising this policy
flexibility provided in this final rule for
reviewing the need for establishing
which outpatient units must have an RN
present for patient care and safety, we
likewise encourage hospitals to exercise
a similar regulatory flexibility in
reviewing their policies for establishing
which types of outpatients would
require a nursing care plan through a
similar lens—that is, based on the
services that a patient is receiving and
the location in which he or she is
receiving those services. We further
believe that the example provided here
regarding the requirement differences in
the patient’s needs for having an RN
present, which clearly exist between an
outpatient undergoing ambulatory
surgery and one receiving an MRI or
other radiologic services, is entirely
relevant to the considerations for
determining which patient needs a
nursing care plan.
Comment: We received positive
feedback regarding § 482.23(b)(6), in
which we proposed to clarify that all
licensed nurses who provide services in
the hospital must adhere to the policies
and procedures of the hospital and
addresses the supervision and
evaluation of the clinical activities of all
nursing personnel. Commenters
appreciated the clarification of the
requirements in this in calling for
adequate supervision and evaluation of
all nursing personnel. One commenter
asked that we clarify that nursing
leadership is responsible for ensuring
that there are clear lines of reporting
and supervision.
Response: We appreciate the
comments received on the proposed
requirement. We expect all nursing
personnel to have a clear understanding
of the reporting and supervisory
structure and it is the responsibility of
nursing leadership to ensure that there
are clear lines of reporting and
supervision. This requirement must be
met regardless of the employment type
or status of the nursing personnel,
including but not limited to those
employed via direct employment, the
use of contract or agency nurses, a
leasing agreement, volunteer services or
some other arrangement. No matter how
the services of a licensed nurse are
obtained, in order to ensure the health
and safety of patients, all nurses must
know and adhere to the policies and
procedures of the hospital and there
must be adequate supervision and
evaluation of the clinical activities of all
nursing personnel who provide services
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that occur within the responsibility of
the nursing service. We would expect
non-licensed personnel to be supervised
by a licensed nurse.
Final Decision: After consideration of
the comments we received on the
proposed rule, we are finalizing § 482.23
as proposed with the exception of the
proposed requirement at
§ 482.23(b)(7)(iii), which we have
revised in response to comments by
replacing ‘‘medical staff’’ with ‘‘director
of nursing,’’ and which we are finalizing
here.
7. Medical Record Services (§ 482.24)
We proposed to revise § 482.24(c) to
require that the content of the medical
record contain information to justify all
admissions and continued
hospitalizations, support the diagnoses,
describe the patient’s progress and
responses to medications and services,
and document all inpatient stays and
outpatient visits to reflect all services
provided to the patient.
Similarly, we proposed to revise
§ 482.24(c)(4)(ii) to include ‘‘all
diagnoses specific to each inpatient stay
and outpatient visit,’’ which would
include specifying any admitting
diagnoses. At § 482.24(c)(4)(iv), we
proposed to require that the content of
the record include documentation of
complications, hospital-acquired
conditions, healthcare-associated
infections, and adverse reactions to
drugs and anesthesia. We also propose
changes to § 482.24(c)(4)(vi) to add
‘‘progress notes. . . interventions,
responses to interventions . . .’’ to the
required documentation of
‘‘practitioners’ orders’’ to emphasize the
necessary documentation for both
inpatients and outpatients. We also
proposed to add the phrase ‘‘to reflect
all services provided to the patient,’’ so
that the entire provision would now
read that the content of the record must
contain all practitioners’ progress notes
and orders, nursing notes, reports of
treatment, interventions, responses to
interventions, medication records,
radiology and laboratory reports, and
vital signs and other information
necessary to monitor the patient’s
condition and to reflect all services
provided to the patient.
We proposed to change
§ 482.24(c)(4)(vii) to require that all
patient medical records document
discharge and transfer summaries with
outcomes of all hospitalizations,
disposition of cases, and provisions for
follow-up care for all inpatient and
outpatient visits to reflect the scope of
all services received by the patient.
Finally, we proposed to revise
§ 482.24(c)(4)(viii) so that the content of
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the medical record would contain final
diagnoses with completion of medical
records within 30 days following all
inpatient stays, and within 7 days
following all outpatient visits.
Comment: The comments we received
on these proposed changes were
concerned that the medical records
documentation revisions would be
unduly burdensome and confusing
regarding distinctions between the
requirements for inpatients versus
outpatients. Commenters also expressed
concerns over the ongoing interplay
between EHRs and paper-based records
systems and EHR interoperability issues
that may arise.
Response: We appreciate the
commenter’s feedback regarding these
proposals. We agree that the proposed
changes to the medical records
documentation requirements would
impose an additional undue burden on
hospitals and we are therefore not
finalizing this proposal at this time.
Final Action: Based on the public
comments, we are not finalizing the
proposed changes to the Medical
Records requirements at § 482.24.
8. Infection Prevention and Control and
Antibiotic Stewardship Programs
(§ 482.42)
We proposed a change to the title of
this CoP to ‘‘Infection prevention and
control and antibiotic stewardship
programs.’’ By adding the word
‘‘prevention’’ to the CoP name, our
intent is to promote larger, cultural
changes in hospitals such that
prevention initiatives are recognized on
balance with their current, traditional
control efforts. And by adding
‘‘antibiotic stewardship’’ to the title, we
would emphasize the important role
that a hospital should play in
combatting antimicrobial resistance
through implementation of a robust
stewardship program that follows
nationally recognized guidelines for
appropriate antibiotic use. Along with
these changes, we proposed to change
the introductory paragraph to require
that a hospital’s infection prevention
and control and antibiotic stewardship
programs be active and hospital-wide
for the surveillance, prevention, and
control of HAIs and other infectious
diseases, and for the optimization of
antibiotic use through stewardship. We
would also require that a program
demonstrate adherence to nationally
recognized infection prevention and
control guidelines for reducing the
transmission of infections, as well as
best practices for improving antibiotic
use where applicable, and for reducing
the development and transmission of
HAIs and antibiotic-resistant organisms.
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While these particular changes are new
to the regulatory text, it is worth noting
that these requirements, with the
exception of the new requirement for an
antibiotic stewardship program, have
been present in the Interpretive
Guidelines for hospitals since 2008 (See
A0747 at Appendix A—Survey Protocol,
Regulations and Interpretive Guidelines
for Hospitals, https://cms.gov/manuals/
Downloads/som107ap_a_hospitals.pdf).
We also proposed to introduce the
term ‘‘surveillance’’ into the text of the
regulation. The addition of this term,
which is also already in use in CMS
Interpretive Guidelines for hospitals, is
being proposed to bring the regulation
up to date by reflecting current
terminology in the field. As has been
described in the Interpretive Guidelines
for this regulation, ‘‘surveillance’’
includes infection detection, data
collection, and analysis; monitoring;
and evaluation of preventive
interventions. (See SOM, Appendix A—
Survey Protocol, Regulations and
Interpretive Guidelines for Hospitals,
pp. 361–362, https://cms.gov/manuals/
Downloads/som107ap_a_hospitals.pdf).
In collaboration with the hospital’s
QAPI program, the hospital would be
required to develop and implement
appropriate infection prevention and
control interventions to address issues
identified through its detection
activities.
We also proposed a new requirement
that hospitals demonstrate adherence to
nationally recognized infection
prevention and control guidelines, as
well as best practices for improving
antibiotic use where applicable, and for
reducing the development and
transmission of HAIs and antibioticresistant organisms. We realize that, in
developing the patient health and safety
requirements that are the hospital CoPs,
particular attention must be paid to the
ever-evolving nature of medicine and
patient care. Moreover, a certain degree
of latitude must be left in the
requirements to allow for innovations in
medical practice that improve the
quality of care and move toward the
reduction of medical errors and patient
harm.
Therefore, we intentionally built
flexibility into the revised regulations
by proposing language that requires
hospitals to demonstrate adherence to
nationally recognized guidelines (and
best practices where applicable) rather
than requiring that all hospitals
demonstrate adherence to a specific
guideline or set of guidelines for
infection prevention and control and for
antibiotic stewardship. While the CDC
guidelines and guidance (for example,
guidelines from the Healthcare Infection
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Control Practices Advisory Committee
(HICAPC) and Core Elements of
Hospital Antibiotic Stewardship
Programs) represent one set, there are
other sets of nationally recognized
guidelines from which hospitals might
choose, such as those established by the
Association for Professionals in
Infection Control and Epidemiology
(APIC), the Society for Healthcare
Epidemiology of America (SHEA), and
the Association of periOperative
Registered Nurses (AORN). The U.S.
Occupational Health and Safety
Administration (OSHA) also issues
federal regulations applicable to
infection control practices. We believe
this approach will provide hospitals the
flexibility they need to select and
integrate those standards that best suit
their individual infection prevention
and control and antibiotic stewardship
programs. We also believe this approach
will allow hospitals the flexibility to
adapt their policies and procedures in
concert with any updates in the
guidelines they have elected to follow.
Comment: A few commenters were
concerned that the proposed
requirements for antibiotic stewardship
programs would dictate the treatment
options for patients with conditions
such as Lyme disease. Some of these
commenters were particularly
concerned about the proposed rule’s
reference to IDSA antibiotic stewardship
program guidelines.
Response: We proposed to
intentionally build flexibility into the
regulation by proposing language that
requires hospitals to demonstrate
adherence to nationally recognized
guidance and guidelines, rather than
any specific guidance, guideline, or set
of guidelines, for best practices in
infection prevention and control and for
implementing antibiotic stewardship
programs. For infection control best
practices, CDC guidelines represent a
fundamental set of practices, while
other sets of nationally recognized
infection control guidance and
guidelines provide further setting- and
procedure-specific options from which
hospitals might choose, such as those
established by APIC, SHEA, and IDSA.
For the implementation of antibiotic
stewardship programs, guidance is
available from several organizations,
including IDSA, SHEA, American
Society for Health System Pharmacists,
and CDC’s Core Elements.
We appreciate the concerns expressed
about the inclusion of guidelines
developed by individual organizations,
specifically, the Infectious Disease
Society of America (IDSA). The
intention in the proposed rule was to
reference guidance for the
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implementation of antibiotic
stewardship programs, not treatment
guidelines for any particular infection.
The reference to IDSA guidelines
explicitly refers to guidelines for
implementing stewardship programs
and even references guidelines from
other societies. These guidelines are
referenced specifically because they are
the only guidelines that we are aware of
that are dedicated solely to the
implementation of antibiotic
stewardship programs in hospitals. We
are not requiring that hospitals choose
the IDSA guidelines for antibiotic
stewardship programs specifically, but
rather that they choose guidance on
implementing antibiotic stewardship
programs from a nationally recognized
source.
Comment: One commenter
recommended that rather than focusing
on the explicit roles of two distinct staff,
the CoPs instead focus on the overall
process of clinical care and infection
management and permit some flexibility
in how hospitals establish each of their
programs. They stated that in their
experience, the ASP [antibiotic
stewardship program] is part of the
overall ICP [infection control program],
which is broader than antibiotics.
Response: We agree that careful
coordination between the infection
prevention and control and antibiotic
stewardship programs is essential and
this is stated explicitly in the regulatory
text. However, we believe it is also
important to highlight the distinctions
between the two programs. Infection
prevention and control programs are
almost exclusively staffed by infection
preventionists, the overwhelming
majority of whom do not prescribe or
manage antibiotics. Antibiotic
stewardship programs must be staffed
by people who are very familiar with
antibiotics. Also, though both groups
share some common goals of reducing
antibiotic resistance and C. difficile, the
types of interventions the two programs
seek to implement are also
fundamentally different. Finally, the
ultimate goals of both programs are
different; infection prevention and
control programs seek to eliminate
healthcare-associated infections, while
antibiotic stewardship programs seek to
ensure that all patients get optimal
antibiotic therapy.
Comment: One commenter stated that,
given the size and overall staff of freestanding IRFs and LTCHs, some
facilities may need additional time to
incorporate these new ASP staffing
requirements.
Response: We agree that these new
provisions might require additional time
to implement beyond the standard 60
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days for all facilities, not just IRFs and
LTCHs. Therefore, as discussed above,
the provisions regarding antibiotic
stewardship will become effective and
be enforced 6 months after the effective
date of this final rule for all facilities.
IRFs and LTCHs are still required to
comply with the hospital CoPs, so
changes to the hospital CoPs also apply
to IRFs and LTCHs.
Comment: One commenter
appreciated the flexibility afforded in
the requirements regarding the leader of
the ASP, but believes there is value in
that position being further defined, and
recommend that the ASP professional
requirements be clarified and explicitly
state the person must hold either a
formal M.D. or Pharm. D. degree in
order to comply with the regulation.
Response: While this most likely will
be the case in practice, we believe that
the requirements should remain flexible
for hospitals and CAHs to make these
determinations for themselves.
Therefore, we believe that the hospital
leadership should determine the
appropriate qualifications for the leader
of the ASP. However, we note here that
the CDC Core Elements of Hospital
Antibiotic Stewardship Programs
(https://www.cdc.gov/antibiotic-use/
healthcare/implementation/coreelements.html#lead) recommend
including both a physician and a
pharmacist (especially those with
formal training and experience in
infectious diseases and/or antibiotic
stewardship) to co-lead the hospital AS
program and to be accountable for it. We
urge hospitals and CAHs to consider
these recommendations when they set
their ASP leadership qualifications and
when hiring the appropriate staff to
develop and lead these programs.
Comment: One commenter suggested
that in smaller facilities CMS should
give some consideration to flexibility in
staffing if the goals of the program are
met and a single person is capable of
handling both roles and ensuring that
both priorities are met.
Response: The leaders of the infection
prevention and control and the
antibiotic stewardship programs must
have the training required to do those
jobs effectively. While there are specific
types of knowledge required to lead
each program (that is, knowledge about
infection prevention and control best
practices and knowledge about
antibiotic prescribing and antimicrobial
resistance), there is nothing in the
regulatory language that would preclude
a properly trained person from leading
both programs.
Comment: Several commenters urged
us to be flexible in the implementation
of these provisions for all hospitals, but
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especially for smaller hospitals and
CAHs, due to the time and effort it will
take to fill leadership positions and
develop their programs.
Response: We appreciate this
comment and agree. We also agree that
some smaller hospitals and CAHs may
need extra technical assistance to
implement the new provisions in a way
that truly improves patient care. We are
committed to partnering with federal
and other partners to provide that
assistance. For example, the CDC
initiated an effort with The American
Hospital Association, the Federal Office
of Rural Health Policy, and the Pew
Charitable Trusts to work with several
CAHs that have successful antibiotic
stewardship programs to learn best
practices and implementation
suggestions that can be shared with
other critical access hospitals. The
Implementation of Antibiotic
Stewardship Core Elements at Small
and Critical Access Hospitals and
related tools released in 2017 provides
guidance on practical strategies to
implement antibiotic stewardship
programs in small and critical access
hospitals (https://www.cdc.gov/
antibiotic-use/healthcare/
implementation/core-elements-smallcritical.html).
Comment: One commenter did not
support our proposal to require that the
leaders of the infection prevention and
control and antibiotic stewardship
programs be specifically appointed by
the governing body of a hospital or
CAH.
Response: We appreciate this concern.
The goal of this proposed requirement
was to ensure that the infection
prevention and antibiotic stewardship
leaders are vested with authority from
the leadership of the hospital or CAH.
To maintain this concept while allowing
more flexibility, we have changed these
requirements for hospitals and CAHs.
Specifically, we have revised sections
§§ 482.42(a)(1) and 485.640(a)(1) of the
final rule to provide that the hospital (or
CAH) must ensure that an individual (or
individuals), who are qualified through
education, training, experience, or
certification in infection prevention and
control, are appointed as the infection
preventionist(s)/infection control
professional(s) responsible for the
infection prevention and control
program. The selection process must
include meaningful opportunity for
input from members of the medical and
nursing staffs and leadership.
We have also revised §§ 482.42(b)(1)
and 485.640(b)(1) to now provide that
the hospital (or CAH) ensure that an
individual (or individuals), who is
qualified through education, training, or
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experience in infectious diseases and/or
antibiotic stewardship, is appointed as
the leader(s) of the antibiotic
stewardship program. The selection
process must include meaningful
opportunity for input from members of
the medical, nursing, and pharmacy
staffs.
Comment: One commenter urged
CMS to modify the proposed standards
regarding the demonstration of
improvements in antibiotic stewardship.
The commenter does not believe it is
appropriate or accurate to solely use
antibiotic resistance within the hospital
to demonstrate antibiotic stewardship
program success or evaluate a hospital’s
antibiotic stewardship efforts. The
commenter states that numerous
external factors contribute to resistance
patterns, including prescribing patterns
of local practitioners who may not be
connected to the hospital, communityonset infections, and patient transfers
from other facilities. The commenter
further noted that it can be difficult to
demonstrate meaningful improvement
over a short period of time.
Response: We appreciate the
suggestion and have modified and also
deleted elements of this language for
both hospitals and CAHs at
§§ 482.42(b)(2)(iii) and
485.640(b)(2)(iii), respectively, to
require that hospital and CAH ASPs
must ‘‘document any’’ improvements,
including sustained improvements, in
proper antibiotic use. We agree that it
would not be appropriate to use
antibiotic resistance within the hospital
(or CAH) as the sole criterion to
demonstrate antibiotic stewardship
program success or to evaluate a
hospital’s (or CAH’s) antibiotic
stewardship efforts. Therefore, we have
deleted this portion of the regulatory
language at §§ 482.42(b)(2)(iii) and
485.640(b)(2)(iii). We believe that this
will provide hospitals and CAHs the
ability to record any category of
improvement in proper antibiotic use
and will not restrict ASPs to
demonstrating specific types of
improvements like decreased antibiotic
resistance (though ASPs are still
encouraged to document any
improvements in this area). These
revisions will also implicitly
acknowledge that there often external
factors, as noted by the commenter, that
can negatively contribute to antibiotic
resistance in the facility and that can
also negatively impact meaningful
improvements in this area in the short
term. Hospitals and CAHs will still need
to ensure that their ASPs are following
nationally recognized guidelines and
best practices while documenting the
evidence-based use of antibiotics.
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Comment: One commenter
recommended that in order to clarify the
organization of the antibiotic
stewardship and infection prevention
and control programs, the following
change be made to the existing language
in the preamble of the proposed rule:
‘‘Antibiotic Stewardship, as a
component of controlling infection, has
long been recognized as one of the
special challenges that hospitals must
meet in order to address the problems
of multidrug-resistant organisms and
Clostridium difficile infections (CDIs) in
hospitals and outpatient settings.’’
Response: We appreciate this
commenter’s recognition of the
importance of the antibiotic stewardship
and infection prevention and control
programs.
Final Decision: After consideration of
the comments we received on the
proposed rule, we are finalizing § 482.42
with some minor modifications to the
overall regulatory language and with the
following more substantive
modifications:
• Revise and finalize the language of
§§ 482.42(a)(1) and 485.640(a)(1) to now
require: ‘‘An individual (or individuals),
who is qualified through education,
training, experience, or certification in
infection prevention and control, is
appointed as the infection
preventionist(s)/infection control
professional(s) responsible for the
infection prevention and control
program. The selection process must
include meaningful opportunity for
input from members of the medical and
nursing staffs.’’
• Revise and finalize the language of
§§ 482.42(b)(1) and 485.640(b)(1) to now
require: ‘‘An individual (or individuals),
who is qualified through education,
training, or experience in infectious
diseases and/or antibiotic stewardship,
is appointed as the leader(s) of the
antibiotic stewardship program. The
selection process must include
meaningful opportunity for input from
members of the medical, nursing, and
pharmacy staffs.’’
• Revise and finalize the language at
§§ 482.42(b)(2)(iii) and 485.640(b)(2)(iii)
to now require: ‘‘Documents any
improvements, including sustained
improvements, in proper antibiotic
use.’’
9. Technical Corrections
Technical Amendments to
§ 482.27(b)(7)(ii) and § 482.27(b)(11)
In the final rule ‘‘Medicare and
Medicaid Programs; Hospital Conditions
of Participation: Laboratory Services,’’
amending 42 CFR 482.27 (72 FR 48562,
48573, Aug. 24, 2007), we stated that
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HCV notification requirements for
donors tested before February 20, 2008,
would expire on August 24, 2015, in
accordance with 21 CFR 610.48. Since
the notification requirement period has
expired, we proposed to remove
§ 482.27(b)(11), ‘‘Applicability’’ and the
corresponding requirements set out at
§ 482.27(b)(7)(ii).
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Corrected Reference in § 482.58
In our review of the Hospital
Conditions of Participation, we found
an incorrect cross-reference at
§ 482.58(b)(6), which currently reads
‘‘Discharge planning (§ 483.20(e))’’.
Subsection 483.20(e) addresses
coordination of the preadmission
screening and resident review program,
not discharge planning. SNF
requirements for discharge plans are set
out at § 483.20(l). Therefore, we
proposed to correct the reference to read
‘‘Discharge summary (§ 483.20(l))’’.
Removal of Inappropriate References to
§ 482.12(c)(1)
Upon our review of the Hospital CoPs
for the proposed rule, we discovered
that there were several provisions that
incorrectly reference § 482.12(c)(1),
which lists the types of physicians and
applies only to patients who are
Medicare beneficiaries. Section
482.12(c) states that the governing body
of the hospital must ensure that every
Medicare patient is under the care of
one of the following practitioners:
• A doctor of medicine or osteopathy;
• A doctor of dental surgery or dental
medicine who is legally authorized to
practice dentistry by the State and who
is acting within the scope of his or her
license;
• A doctor of podiatric medicine, but
only with respect to functions which he
or she is legally authorized by the State
to perform;
• A doctor of optometry who is
legally authorized to practice optometry
by the State in which he or she
practices;
• A chiropractor who is licensed by
the State or legally authorized to
perform the services of a chiropractor,
but only with respect to treatment by
means of manual manipulation of the
spine to correct a subluxation
demonstrated by x-ray to exist; and
• A clinical psychologist as defined
in § 410.71 of this chapter, but only with
respect to clinical psychologist services
as defined in § 410.71 of this chapter
and only to the extent permitted by
State law.
The reference of this ‘‘Medicare
beneficiary-only’’ requirement in certain
other provisions of the hospital CoPs
(which we have listed below)
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inappropriately links it to all patients
and not Medicare beneficiaries
exclusively. In fact, the Act at
§ 1861(e)(4) states that ‘‘every patient
with respect to whom payment may be
made under this title must be under the
care of a physician except that a patient
receiving qualified psychologist services
(as defined in subsection (ii)) may be
under the care of a clinical psychologist
with respect to such services to the
extent permitted under State law.’’ In
accordance with that provision, we have
chosen to apply § 482.12(c) to Medicare
patients. With the exception of a few
provisions in the CoPs such as those
directly related to § 482.12(c) described
here, the remainder of the CoPs apply to
all patients, regardless of payment
source, and not just Medicare
beneficiaries. For example, the Nursing
Services CoP, at § 482.23(c)(1), requires
that all ‘‘drugs and biologicals must be
prepared and administered in
accordance with Federal and State laws,
the orders of the practitioner or
practitioners responsible for the
patient’s care as specified under
§ 482.12(c), and accepted standards of
practice.’’ Since the CoPs clearly allow
hospitals to determine which categories
of practitioners would be responsible for
the care of other patients, outside the
narrow Medicare beneficiary restrictions
of § 482.12(c), this reference is
inappropriate and unnecessarily
restrictive of hospitals and their medical
staffs to make these determinations
based on State law and practitioner
scope of practice.
In order to clarify that these
provisions apply to all patients and not
only Medicare beneficiaries, we
proposed to delete any inappropriate
references to § 482.12(c). Therefore, we
proposed to delete references to
§ 482.12(c) found in the following
provisions: §§ 482.13(e)(5),
482.13(e)(8)(ii), 482.13(e)(14), and
482.13(g)(4)(ii) in the Patients’ Rights
CoP; and §§ 482.23(c)(1) and
482.23(c)(3) in the Nursing Services
CoP. Additionally, and in the course of
finalizing this rule, we discovered that
we inadvertently failed to propose to
delete an inappropriate reference to
§ 482.12(c), which is contained in the
current provision at § 482.61(d) in the
Special Medical Record Requirements
for Psychiatric Hospitals CoP under the
Special Requirements for Psychiatric
Hospitals (regarding which hospital
personnel may complete progress
notes). Therefore, in the interests of
consistency with the other revisions
here, we are also deleting this reference
in this final rule. We believe this to be
a technical correction, for which notice
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and comment are unnecessary. We have
noted this revision in the ‘‘Waiver of
Proposed Rulemaking’’ discussion
found above at section at I.B.14. With
respect to all of these provisions, the
reference to services provided under the
order of a physician or other
practitioner would still apply. We did
not receive any comments on these
proposed changes and are therefore
finalizing them without change.
C. Provisions of the Proposed
Regulations and Responses to Public
Comments for Critical Access Hospitals
(42 CFR Part 485)
We identified several priority areas in
the CoPs for CAHs (42 CFR part 485,
subpart F) for updates and revisions. We
believe that these proposed regulations
would benefit the quality of care
provided with a positive impact on
patient satisfaction, length of stay, and,
ultimately, cost per patient.
Additionally, we have proposed the
following changes to the CAH CoPs,
after considering the resource
restrictions of remote and frontier
CAHs.
1. Organizational Structure
(§ 485.627(b))
This proposal was also included in
the Medicare and Medicaid Programs;
Regulatory Provisions To Promote
Program Efficiency, Transparency, and
Burden Reduction, Proposed Rule (83
FR 47686). We are finalizing this
proposal in that final rule. We refer
readers to the discussion under Section
I.B.8.a for further information regarding
this provision.
2. Periodic Review of Clinical Privileges
and Performance (§ 485.631(d)(1)
Through (2))
We proposed to change the current
CoP at § 485.641 to reflect the current
QAPI format used in hospitals. As such,
we proposed to retain the requirements
under paragraphs § 485.641(b)(3)
through (4), that are currently found
under the ‘‘Periodic evaluation and
quality assurance’’ CoP, and relocate
them under a new standard under the
‘‘Staffing and staff responsibilities’’ CoP
at § 485.631. We are not changing these
requirements and believe that they are
still appropriate for the CAH
regulations. Since the current CoP under
§ 485.631 discusses staffing
requirements and responsibilities, we
believe that relocating the requirement
under a new standard, entitled
‘‘Periodic Review of Clinical Privileges
and Performance’’ (§ 485.631(d)) is a
more appropriate placement for the
current provisions requiring a CAH to
evaluate the quality of care provided by
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specialists, certified nurse midwives,
physician assistants, doctors of
medicine, or doctors of osteopathy.
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3. Provision of Services
(§ 485.635(a)(3)(vii))
We currently require CAHs at
§ 485.635(a)(3)(vii) to have procedures
that ensure that the nutritional needs of
inpatients are met in accordance with
recognized dietary practices and the
orders of the practitioner responsible for
the care of the patients and that the
requirement of § 483.25(i) of this
chapter is met with respect to inpatients
receiving post-hospital SNF care.
We proposed revisions to
§ 485.635(a)(3)(vii) that would require
that individual patient nutritional needs
be met in accordance with recognized
dietary practices and the orders of the
practitioner responsible for the care of
the patients, or by a qualified dietician
or qualified nutrition professional as
authorized by the medical staff in
accordance with State law governing
dietitians and nutrition professionals. In
addition, we also proposed that the
requirement of § 483.25(i) of this
chapter is met with respect to inpatients
receiving post hospital SNF care.
Comment: Commenters support CMS’
efforts to allow clinicians to practice to
the fullest extent of their credentials.
The commenters stated that this
proposed change at § 485.635 requiring
diets to be ordered by the practitioner
responsible for the patient or a qualified
dietitian or qualified nutrition
professional as authorized by the
medical staff and in accordance with
state law, recognizes the specialized
knowledge and training of dietitians and
the benefit available to patients.
Response: We appreciate the
comments and will finalize this change
as proposed.
4. Provision of Services (485.635(g))
At § 485.635(g) we proposed a new
requirement regarding nondiscriminatory behavior. Similar to our
non-discrimination proposal for
hospitals, we proposed to require that a
CAH not discriminate on the basis of
race, color, religion, national origin, sex
(including gender identity), sexual
orientation, age, or disability. We
further proposed to require that CAHs
establish and implement a written
policy prohibiting discrimination on the
aforementioned bases and that they
inform each patient (and/or support
person, where appropriate), in a
language he or she can understand, of
his or her right to be free from
discrimination against them and how to
file a complaint if they encounter
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discrimination. After consideration of
the comments that we received, we are
not finalizing our proposal and are
instead deferring to the nondiscrimination requirements of Section
1557 of the Affordable Care Act. We
refer readers to section III.B.3 of this
final rule for a more detailed discussion.
5. Infection Prevention and Control and
Antibiotic Stewardship Programs
(§ 485.640)
We proposed to remove the current
requirements at § 485.635(a)(3)(vi) and
§ 485.641(b)(2) and are adding a new
infection prevention and control and
antibiotic stewardship CoP at § 485.640
for CAHs because the existing standards
for infection control do not reflect the
current nationally recognized standards
of practice for the prevention and
elimination of healthcare-associated
infections and for the appropriate use of
antibiotics.
We are finalizing the proposal that
each CAH has facility-wide infection
prevention and control and antibiotic
stewardship programs that are
coordinated with the CAH QAPI
program, for the surveillance,
prevention, and control of HAIs and
other infectious diseases and for the
optimization of antibiotic use through
stewardship.
Comment: Commenters were
supportive of the proposal to require
each CAH to have facility-wide
infection prevention and control and
antibiotic stewardship programs that are
coordinated with the CAH QAPI
program. Commenters recognized that
these changes will support a culture of
antibiotic stewardship that will increase
patient safety and quality of care.
Response: We appreciate the
comments received on the proposed
changes for the CAH infection control
and antibiotic stewardship programs
and will finalize the changes as
proposed.
Comment: Commenters noted that
CAHs would need time, resources,
flexibility and support to adapt to the
antibiotic stewardship requirements,
especially given the fact that many do
not have staff pharmacists available at
all times.
Response: We also appreciate these
comments. While we understand that
CAHs may have less resources available,
we encourage CAHs to utilize the
existing available resources to ensure
the antibiotic stewardship requirements
are met. While small and critical access
hospitals face special challenges in
implementing antibiotic stewardship
programs, antibiotic stewardship is no
less important in these settings. Small
and critical access hospitals also have
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some factors that can support
improvements in care, as they are often
tight-knit communities where
collaboration is the norm. The CDC has
resources available for training and
education as well as support for
providers implementing antibiotic
stewardship programs specifically for
CAHs. We also encourage CAHs to work
with other hospitals or CAHs in their
network (if available) for
pharmaceutical support. CAHs should
also be encouraged to work with their
respective quality improvement
network(s)/organization(s) and health
departments for additional support and
resources. Additionally, we encourage
CAHs to use the technical assistance
available from their State Flex Program.
CAHs can find contact information for
their State Flex Program at https://
www.ruralcenter.org/tasc/flexprofile.
Final Rule Action: We are finalizing
the proposed changes without revision.
§ 485.640(a)(1) Through (2) Infection
Control Officer(s); and Prevention and
Control of Infections Within the CAH
and Between the CAH and Other
Healthcare Settings
At § 485.640(a)(1) we proposed that
the CAH ensure that an individual (or
individuals), who are qualified through
education, training, experience, or
certified in infection, prevention and
control, are appointed by the governing
body, or responsible individual, as the
infection preventionist(s)/infection
control professional(s) responsible for
the infection prevention and control
program at the CAH and that the
appointment is based on the
recommendations of medical staff and
nursing leadership.
We proposed at § 485.640(a)(2) that
the infection prevention and control
program, as documented in its policies
and procedures, employ methods for
preventing and controlling the
transmission of infections within the
CAH and between the CAH and other
healthcare settings. The program, as
documented in its policies and
procedures, would have to employ
methods for preventing and controlling
the transmission of infection within the
CAH setting (for example, among
patients, personnel, and visitors) as well
as between the CAH (including
outpatient services) and other
institutions and healthcare settings.
Comment: Commenters were
generally supportive of the proposal for
CAHs to have a qualified individual (or
individuals) in the role of the infection
preventionist(s)/infection control
professional(s).
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Response: We appreciate the
comments received on the proposed
changes for this CAH proposal.
Final Rule Action: We are finalizing
the proposed changes without revision.
§ 485.640(a)(3) Healthcare-Associated
Infections (HAIs)
We proposed at § 485.640(a)(3) that
the infection prevention and control
program include surveillance,
prevention, and control of HAIs,
including maintaining a clean and
sanitary environment to avoid sources
and transmission of infection, and that
the program also address any infection
control issues identified by public
health authorities.
Comment: Commenters were
supportive of the proposal for CAHs to
have an infection prevention and
control program that includes
surveillance, prevention, and control of
HAIs.
Response: We appreciate the
comments received on the proposed
changes for this CAH proposal.
Final Rule Action: We are finalizing
the proposed changes without revision.
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§ 485.640(a)(4) Scope and Complexity
We proposed at § 485.640(a)(4) that
the infection prevention and control
program reflects the scope and
complexity of the services provided by
the CAH.
Comment: Commenters were
supportive of the proposal for CAHs to
have an infection and prevention and
control program that reflects the scope
and complexity of the services provided
by the CAH, with one commenter
requesting that specific language stating
that CRNAs and other anesthesia
professionals should be included in the
development and leadership of infection
prevention and control programs in
hospitals and CAHs.
Response: We appreciate the
comments received on the proposed
changes for this CAH proposal. As noted
in the preamble, as it relates to CAHs,
staffing for these programs should be
appropriate to the scope and complexity
of the services offered at the CAH. We
believe that CAHs should have the
flexibility to include the individuals
who are deemed appropriate by the
CAH to be included in the development
and leadership of these programs.
Final Rule Action: We are finalizing
the proposed changes.
§ 485.640(b)(1) Leader of the Antibiotic
Stewardship Program
We proposed at § 485.640(b)(1) that
the CAH’s governing body ensure that
an individual, who is qualified through
education, training, or experience in
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infectious diseases and/or antibiotic
stewardship is appointed as the leader
of the antibiotic stewardship program
and that the appointment is based on
the recommendations of medical staff
and pharmacy leadership.
Comment: Commenters were
supportive of the proposal for the CAH’s
governing body to ensure that an
individual with the appropriate
experience is appointed as the leader of
the antibiotic stewardship program. One
commenter noted that this role will be
fulfilled by a nurse who also has other
related responsibilities and may not
have the specialized training necessary
for the infection preventionist role. The
commenter encouraged CMS to ensure
that cost effective and accessible
education and training are available for
CAH infection preventionists, and that
ongoing technical assistance be
provided. Additionally, the commenter
requested infection preventionist
expertise be available through shared
services agreements across CAH
networks or similar arrangements.
Response: We appreciate the
comments received on the proposed
changes for this CAH proposal. The
proposal requires that the leader of the
antibiotic stewardship program be
qualified through education, training, or
experience in infectious diseases and/or
antibiotic stewardship. We encourage
CAHs to utilize the infection control
training available and resources that are
available through the CDC (https://
www.cdc.gov/infectioncontrol/training/
index.html). We encourage CAHs to
reach out to other CAHs (within their
network or otherwise) to collaboratively
meet their needs of ensuring that a
leader of the antibiotic stewardship
program is available to meet the needs
of the CAH and its patients.
Final Rule Action: We are finalizing
the proposed changes.
§ 485.640(b)(2)(i), (ii), and (iii) Goals of
the Antibiotic Stewardship Program
The proposed requirements at
§ 485.640(b)(2)(i),(ii), and (iii) would
ensure that the following goals for an
antibiotic stewardship program are met:
(i) Demonstrate coordination among all
components of the CAH responsible for
antibiotic use and resistance, including,
but not limited to, the infection
prevention and control program, the
QAPI program, the medical staff, and
nursing and pharmacy services; (ii)
document the evidence-based use of
antibiotics in all departments and
services of the CAH; and (iii)
demonstrate improvements, including
sustained improvements, in proper
antibiotic use, such as through
reductions in, CDI and antibiotic
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resistance in all departments and
services of the hospital. We believe that
these three components are essential for
an effective program.
We did not receive any comments on
this proposal.
Final Rule Action: We are finalizing
the proposed changes.
§ 485.640(b)(3) and (4) Nationally
Recognized Guidelines; and Scope and
Complexity
These provisions would require the
CAH to ensure that the antibiotic
stewardship program adheres to the
nationally recognized guidelines, as
well as best practices, for improving
antibiotic use. The CAH’s stewardship
program would have to reflect the scope
and complexity of services offered.
Comments for the identical hospital
proposal are discussed with the hospital
proposal in section II.B.4.
Final Rule Action: We are finalizing
the proposed changes.
§ 485.640(c)(1), (2), and (3) Governing
Body; Infection Prevention and Control
Professionals’; and Antibiotic
Stewardship Program Leader’s
Responsibilities
We proposed at § 485.640(c)(1)(i) and
(ii) requirements that the governing
body or responsible individual ensure
that:
• Systems are in place and
operational for the tracking of all
infection surveillance, prevention, and
control, and antibiotic use activities in
order to demonstrate the
implementation, success, and
sustainability of such activities; and
• All HAIs and other infectious
diseases identified by the infection
prevention and control program and
antibiotic use issues identified by the
antibiotic stewardship program are
addressed in collaboration with CAH
QAPI leadership.
At § 485.640(c)(2)(i)–(vi), we proposed
that the responsibilities of the infection
prevention and control professionals
would include the development and
implementation of facility-wide
infection surveillance, prevention, and
control policies and procedures that
adhere to nationally recognized
guidelines.
The governing body or responsible
individual would be responsible for all
documentation, written or electronic, of
the infection prevention and control
program and its surveillance,
prevention, and control activities.
Additionally, the infection
preventionist(s)/infection control
professional(s) would be responsible for:
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• Communication and collaboration
with the CAH’s QAPI program on
infection prevention and control issues;
• Competency-based training and
education of CAH personnel and staff
including professional health care staff
and, as applicable, personnel providing
services in the CAH under agreement or
arrangement, on the practical
applications of infection prevention and
control guidelines, policies and
procedures;
• Prevention and control of HAIs,
including auditing of adherence to
infection prevention and control
policies and procedures by CAH
personnel; and
• Communication and collaboration
with the antibiotic stewardship
program.
Finally in this CoP, at § 485.640(c)(3),
we proposed requirements for the leader
of the antibiotic stewardship program
similar to the proposed responsibilities
for the CAH’s designated infection
preventionist(s)/infection control
professional(s) at paragraph (c)(2). We
believe that a CAH’s antibiotic
stewardship program is the most
effective means for ensuring appropriate
antibiotic use. We also believe that such
a program would require a leader
responsible and accountable for its
success. Therefore, we proposed that the
leader of the antibiotic stewardship
program would be responsible for the
development and implementation of a
facility-wide antibiotic stewardship
program, based on nationally recognized
guidelines, to monitor and improve the
use of antibiotics. We also propose that
the leader of the antibiotic stewardship
program would be responsible for all
documentation, written or electronic, of
antibiotic stewardship program
activities. The leader would also be
responsible for communicating and
collaborating with medical and nursing
staff, pharmacy leadership, and the
CAH’s infection prevention and control
and QAPI programs, on antibiotic use
issues.
Finally, we proposed that the leader
would be responsible for the
competency-based training and
education of CAH personnel and staff,
including medical staff, and, as
applicable, personnel providing
contracted services in the CAHs, on the
practical applications of antibiotic
stewardship guidelines, policies, and
procedures.
We did not receive any comments on
this proposal.
Final Rule Action: We are finalizing
the proposed changes.
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6. Quality Assessment and Performance
Improvement (QAPI) Program
(§ 485.641)
Since May 26, 1993 (58 FR 30630), the
‘‘Periodic evaluation and quality
assurance review’’ CoP (§ 485.641) has
not been updated to reflect current
industry standards that utilize the QAPI
model (§ 482.21) to assess and improve
patient care.
We proposed to revise § 485.641 (81
FR 39464) to establish new
requirements for a QAPI program at a
CAH. This new requirement for CAHs
would replace the existing reactive
annual evaluation and quality assurance
review requirement with a proactive
approach of a QAPI program. A QAPI
program that enables the CAH to review
its operating systems and processes of
care to identify and implement
opportunities to provide high quality
and safe care to its patients focusing on
improving health outcomes and
preventing and reducing medical errors.
We believe that much of the work and
resources that are currently required
under the existing periodic evaluation
and quality assurance CoP would be
utilized to adhere to the new QAPI
requirement. We proposed to retain the
requirements under paragraphs
§ 485.641(b)(3)–(4) regarding the
evaluation of the diagnosis and
treatment furnished by physicians and
non-physician practitioners and relocate
them to a new standard under the
‘‘Staffing and staff responsibilities’’ CoP
at § 485.631.
Comment: Commenters generally
agree with requiring CAHs to have a
QAPI program that is integrated with all
of the departments within a CAH.
Commenters also agree with
encouraging CAHs to use proven quality
improvement data to improve the
quality and safety of care provided. One
commenter asked about requiring CAHs
to report externally for comparative
benchmarking and performance
improvement activities. A few
commenters stated that we should
require CAHs to make informed choices
about where they focus improvement
work to ensure their efforts have a
greater benefit to the patients and
communities served. Some commenters
were concerned that we underestimated
the time and effort it would take CAH’s
to implement a new QAPI program.
Also, commenters requested an
implementation date that is one year
after the publication of this final rule
and that we provide technical assistance
to CAHs for the implementation of these
requirements.
Response: We have taken into
consideration the comment that we
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underestimated the time and effort it
would take CAH’s to implement these
new QAPI requirements. We agree with
an extended timeframe for
implementation to allow CAHs
additional time to prepare and
ultimately comply with the
requirements. Therefore, the
requirements at § 485.641 must be
implemented by 18 months after the
effective date of this final rule. We also
encourage CAHs to utilize the technical
assistance and services for CAHs that
are available through the State Flex
Programs, including the Medicare
Beneficiary Quality Improvement
Project (MBQIP), supported by HRSA’s
Federal Office of Rural Health Policy.
CAHs can find contact information for
their State Flex Program on this page,
https://www.ruralcenter.org/tasc/
flexprofile. We do not require external
reporting for comparative benchmarking
and performance improvement activities
as a condition of participation; however,
we do require that CAHs maintain and
demonstrate evidence of the
effectiveness of its QAPI program.
Finally, we have re-evaluated our
proposed requirements to eliminate
unnecessary prescriptiveness proposed
under paragraph (c)(1) through (6);
paragraph (e); and paragraph (f)(2)
through (3) and are withdrawing those
proposed provisions. These changes to
the proposal will allow each CAH the
flexibility to implement its QAPI
program in the most efficient manner for
its unique circumstances.
We will require that the CAH meet the
objectives of the QAPI program, but will
allow the CAH to determine the best
way to do so with respect to
determining detailed program
requirements, requirements related to
distinct improvement projects, and
details of data use. In accordance with
the new requirements under
§ 465.641(e), CAHs will be required to
incorporate quality indicator data,
including patient care data and other
relevant data, in order to achieve the
goals of the QAPI program. We noted in
our proposal suggesting that CAHs
incorporate other relevant data, such as
data submitted to or received from
national quality reporting and quality
performance programs, into their data
collection analysis; however, we have
removed the language referencing
national quality reporting and quality
performance program data from the
regulatory text. We will expand on this
and other examples of relevant data in
the subregulatory guidance.
This data must be used by the CAH
to achieve the objectives of the QAPI
program, including addressing outcome
indicators related to improved health
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outcomes and the prevention and
reduction of medical errors, adverse
events, CAH-acquired conditions, and
transitions of care, including
readmissions. This will ensure that the
CAH’s quality improvement efforts are
evidenced based and focused on the
needs of the population served by the
CAH in a manner that best suits the
unique characteristics of the CAH.
In addition, since the QAPI
requirement will replace the annual
evaluation requirement, we believe that
a large portion of the cost can be
utilized for the QAPI program because
CAHs are conducting many of the
functions required for an effective QAPI
program. CAHs are currently required to
carry out an annual evaluation of its
total program. They are to evaluate their
health care policies and the
appropriateness of the services they
provide. All patient care services and
other services affecting patient health
must be evaluated. Also, we have
removed some of the prescriptive
requirements under proposed
485.641(f)(2) through (3) for the QAPI
program and recalculated the cost for
implementation.
Final Rule Decision: We are finalizing
the proposal, but eliminating the
following proposed requirements:
• Proposed paragraph (c)(1) through
(6);
• Proposed paragraph (e);
Performance improvement projects
• Revise the proposed requirement
under paragraph (e) to remove the
phrase, ‘‘. . . such as data submitted to
or received from national quality
reporting and quality performance
programs . . .’’ and
• Proposed paragraph (f)(2 through
(f)(3); Program data collection and
analysis.
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7. Technical Corrections
We proposed to correct a
typographical error in the regulations at
§ 485.645 by correcting the word
‘‘provided’’ to ‘‘provide’’ in the lead first
sentence. As proposed, the lead
sentence would read as follows: ‘‘A
CAH must meet the following
requirements in order to be granted an
approval from CMS to provide posthospital SNF care, as specified in
§ 409.30 of this chapter, and to be paid
for SNF-level services, in accordance
with paragraph (c) of this section.’’ As
noted, we are also deleting an obsolete
cross-reference to § 482.12(c) in our
revision of the regulations text at
§ 482.61(d).
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D. Requirements for Issuance of
Regulations
This final rule finalizes provisions set
forth in ‘‘Regulatory Provisions to
Promote Program Efficiency,
Transparency, and Burden Reduction
(CMS–3346–P,’’ published September
20, 2018 (83 FR 47686), ‘‘Hospital and
Critical Access Hospital (CAH) Changes
to Promote Innovation, Flexibility, and
Improvement in Patient Care (CMS–
3295–P),’’ published June 16, 2016 (81
FR 39448); and ‘‘Fire Safety
Requirements for Certain Dialysis
Facilities (CMS–3334–P),’’ published
November 4, 2016 (81 FR 76899).
Section 902 of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA)
amended section 1871(a) of the Act and
requires the Secretary, in consultation
with the Director of the Office of
Management and Budget, to establish
and publish timelines for the
publication of Medicare final
regulations based on the previous
publication of a Medicare proposed or
interim final regulation. Section 902 of
the MMA also states that the timelines
for these regulations may vary but shall
not exceed 3 years after publication of
the preceding proposed or interim final
regulation except under exceptional
circumstances.
This final rule has been published
within the 3-year time limit imposed by
section 902 of the MMA for ‘‘Hospital
and Critical Access Hospital (CAH)
Changes to Promote Innovation,
Flexibility, and Improvement in Patient
Care (CMS–3295–P),’’ and ‘‘Fire Safety
Requirements for Certain Dialysis
Facilities (CMS–3334–P),’’ published
November, 4, 2016 (81 FR 76899).
Additionally, a continuation notice
for ‘‘Hospital and Critical Access
Hospital (CAH) Changes to Promote
Innovation, Flexibility, and
Improvement in Patient Care (CMS–
3295–P) was published on June 11,
2019, (84 FR 27069). Therefore, the final
rule is in accordance with the Congress’
intent to ensure timely publication of
final regulations.
E. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 30day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the Paperwork
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Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
information collection requirements
(ICRs).
1. ICRs Regarding Quality Assessment
and Performance Improvement
(§ 482.21)
The existing QAPI CoP requires each
hospital to:
• Develop, implement, maintain, and
evaluate its’ own QAPI program;
• Establish a QAPI program that
reflects the complexity of its
organization and services;
• Establish a QAPI program that
involves all hospital departments and
services and focuses on improving
health outcomes and preventing and
reducing medical errors; and
• Maintain and demonstrate evidence
of its QAPI program for review by CMS.
We are finalizing a minor change to
the program data requirements at
§ 482.21(b). Currently, we require that
hospitals incorporate quality indicator
data including patient care data, and
other relevant data, for example,
information submitted to, or received
from, the hospital’s Quality
Improvement Organization.
We are updating this requirement to
reflect and capitalize on the wealth of
important quality data available to
hospitals through several quality data
reporting programs. Specifically, we are
requiring that the hospital QAPI
program must incorporate quality
indicator data including patient care
data, and other relevant data such as
data submitted to or received from
quality reporting and quality
performance programs, including, but
not limited to, data related to hospital
readmissions and hospital-acquired
conditions. Hospitals are likely to be
participating in one or more existing
quality reporting and quality
performance programs such as the
Hospital Inpatient Quality Reporting
program, the Hospital Value-Based
Purchasing Program, the Hospital
Acquired Condition Reduction program,
Hospital Compare, the Medicare and
Medicaid Electronic Health Record
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Incentive Programs, the Hospital
Outpatient Quality Reporting program,
and the Joint Commission’s Quality
CheckTM. Since a hospital is already
collecting and reporting quality
measures data for these programs, we do
not believe that this change would
increase the information collection
burden for hospitals.
2. ICRs Regarding Nursing Services
(§ 482.23)
We are finalizing our proposal to
revise § 482.23(b), which currently
states ‘‘There must be supervisory and
staff personnel for each department or
nursing unit to ensure, when needed,
the immediate availability of a
registered nurse for bedside care of any
patient,’’ to delete the term ‘‘bedside,’’
which might imply only inpatient
services to some readers. The nursing
service must ensure that patient needs
are met by ongoing assessments of
patients’ needs and must provide
nursing staff to meet those needs
regardless of whether the patient is an
inpatient or an outpatient. We are
allowing a hospital to establish a policy
that would specify which, if any,
outpatient units would not be required
to have an RN physically present as well
as the alternative staffing plans that
would be established under such a
policy. The policy must take into
account factors such as the services
delivered; the acuity of patients
typically served by the facility; and the
established standards of practice for
such services. In addition, the policy
must be approved by the director of
nursing and be reviewed at least once
every 3 years.
TJC-accredited hospitals are already
allowed this flexibility in nursing
services policy. Those hospitals that use
their TJC accreditation for deeming
purposes are required to have ‘‘Leaders
[who] provide for a sufficient number
and mix of individuals to support safe,
quality care, treatment, and services.
(Note: The number and mix of
individuals is appropriate to the scope
and complexity of the services offered.)’’
(CAMH, Standard LD.03.06.01, EP 3).
Further, TJC-accredited hospitals also
require the ‘‘nurse executive, registered
nurses, and other designated nursing
staff [to] write: Nursing policies and
procedures.’’ (CAMH, Standard
NR.02.02.01, EP 3). Therefore, we
expect that TJC-accredited hospitals
already have the policies and
procedures that satisfy the requirements
in this subsection, including medical
staff approval and regular review. If
there are any tasks that a TJC-accredited
hospital may need to complete to satisfy
the requirement for this subsection, we
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expect that the burden imposed would
be negligible. Thus, for the
approximately 3,900 TJC-accredited
hospitals the development of policies
and procedures that would satisfy this
subsection would constitute a usual and
customary business practice in
accordance with 5 CFR 1320.3(b)(2).
The non TJC-accredited hospitals
would need to review their current
policies and procedures and update
them so that they comply with the
requirements in § 482.23(b). This would
be a one-time burden on the hospital.
We estimate that this would require a
physician, a nurse, and one
administrator. Including fringe benefits
and overhead calculated at 100% of
one’s hourly wage, we estimate that
physicians earn a total hourly
compensation of $191, administrators
earn an average hourly compensation of
$189, and registered nurses earn an
hourly compensation of $71 (2017 BLS
Wage Data by Area and Occupation at
(https://www.bls.gov/oes/2017/may/
oes_nat.htm). We estimate that each
person would spend three hours on this
activity for a total of nine hours at a cost
of $1,353 (3 hours × $71 for a nurse’s
hourly wage + 3 hours × $189 for an
administrator’s hourly wage + 3 hours ×
$191 for a physician’s hourly wage). For
all 1,193 non-TJC-accredited hospitals
to comply with this requirement, we
estimate a total one-time cost of
approximately $1.6 million (1,193
hospitals × $1,353). We estimate that
review of the policies and procedures
once every 3 years would take one hour
for each individual included for a total
cost of $538,043 ((1 hour × $71 for a
nurse’s hourly wage + 1 hour × $189 for
an administrator’s hourly wage + 1 hour
× $191 for a physician’s hourly wage) ×
1,193 hospitals), or an annualized cost
of $179,347. The burden associated with
these requirements will be captured in
an existing information collection
request (OMB Control No. 0938–0328).
3. ICRs Regarding Condition of
Participation: Quality Assessment and
Performance Improvement Program
(§ 485.641)
§ 485.641 would require CAHs to
develop, implement, and maintain an
effective, ongoing, CAH-wide, datadriven QAPI program. The QAPI
program must be appropriate for the
complexity of the CAH’s organization
and the services it provides. In addition,
CAHs must comply with all of the
requirements set forth in § 485.641(b)
through (e).
The current CAH CoPs at § 485.641
require CAHs to have an effective
quality assurance program to evaluate
the quality and appropriateness of the
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51787
diagnosis and treatment furnished in the
CAH and the treatment outcomes. CAHs
are currently required to conduct a
periodic evaluation and quality
assurance review (42 CFR 485.641(a)).
They are required to evaluate its total
program (for example, policies and
procedures and services provided)
annually. The evaluation must include
reviewing the utilization of the CAH
services using a representative sample
of both active and closed clinical
records, as well as reviewing the
facility’s health care policies. The
purpose of the evaluation is to
determine whether the utilization of
services was appropriate, the
established policies were followed, and
if any changes are needed. The CAH’s
staff considers the findings of the
evaluation and takes corrective action, if
necessary (42 CFR 485.641(b)(5)(i)).
Thus, we believe that all of the CAHs
are performing the activities that are
required to comply with many of the
requirements in § 485.641. However, we
also believe that the CAHs would need
to review their current quality assurance
program and revise and, if needed,
develop new provisions to ensure
compliance with the requirements.
TJC accreditation standards for
performance improvement (PI) already
require that CAHs collect, compile, and
analyze to monitor their performance
(TJC Accreditation Standard PI.01.01.01
and PI.02.01.01). These TJC-accredited
CAHs must also improve their
performance on an ongoing basis (TJC
Accreditation Standard PI.03.01.01).
Thus, we believe that the 349 TJCaccredited CAHs are already in
compliance with the new requirements
in § 485.641. However, each CAH would
need to review their current practice to
ensure that they are in compliance with
all of the requirements under § 485.641.
Any additional tasks those CAHs would
need to comply with the requirements
for this section should result in a
negligible burden, if any. Thus, the
burden for these activities for the 349
TJC-accredited CAHs will be excluded
from the burden analysis because they
constitute usual and customary business
practices in accordance with 5 CFR
1320.3(b)(2).
The 1,004 non TJC-accredited CAHs
would need to review their current
programs and then revise and develop
new provisions of their programs to
ensure compliance with the new
requirements. We believe that the CAH
QAPI leadership (consisting of a
physician, and/or administrator, midlevel practitioner, and a nurse) would
need to have at least two meetings to
ensure that the current annual
evaluation and quality assurance (QA)
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program is transitioned into the QAPI
format. The first meeting would be to
discuss the current quality assurance
program and what needs to be included
based on the new QAPI provision. The
second meeting would be to discuss
strategies to update the current policies,
and then to discuss the process for
incorporating those changes. We believe
that these meetings would take
approximately two hours each. We
estimate that the physician would have
a limited amount of time, approximately
1 hour to devote to the QAPI activities.
Additionally, we estimate these
activities would require 4 hours of an
administrator’s time, 4 hours of a midlevel practitioner’s time, 8 hours of a
nurse’s time, and 2 hours of a clerical
staff person’s time for a total of 19
burden hours. We believe that the
CAH’s QAPI leadership (formerly the
periodic evaluation and quality
assurance leadership) would need to
meet periodically to review and discuss
the changes that would need to be made
to their program. We also believe that a
nurse would likely spend more time
developing the program with the midlevel practitioner. The physician would
likely review and approve the program.
The clerical staff member would
probably assist with the program’s
development and ensure that the
program was disseminated to all of the
necessary parties in the CAH. This
burden estimate is slightly lower than
what was published in the proposed
rule because we re-evaluated our
proposed requirements to eliminate
unnecessary prescriptiveness. The
finalized requirements are expected to
allow more flexibility, and therefore
slightly less burden. Since a CAH is
currently required to evaluate its total
program and evaluate the quality and
appropriateness of the services
furnished, take appropriate action to
address deficiencies and document such
activities, we believe that the resources
utilized on the current QA program
would be utilized for the ongoing QAPI
activities under § 485.641(b)–(e). Thus,
we estimate that for each CAH to
comply with the requirements in this
section it would require 19 burden
hours (1 for a physician + 4 for an
administrator + 4 for a mid-level
practitioner + 8 for a nurse + 2 for a
clerical staff person) at a cost of $1,657
($191 for a physician + $428 for an
administrator (4 hours × $107) + $404
for a mid-level practitioner (4 hours ×
$101) + $568 (8 hours × $71 for a nurse)
+ $66 for a clerical staff person (2 hours
× $33). Therefore, for all 1,004 non TJCdeemed CAHs to comply with these
requirements, it would require 19,076
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burden hours (19 × 1,004 non TJCdeemed CAHs) at a cost of
approximately $1.7 million ($1,657 for
each CAH × 1,004 non TJC-deemed
CAHs). We note here the difference in
hourly wage between a hospital CEO/
administrator ($189) and a CAH CEO/
administrator ($107). This is estimated
to be an additional 15,431 hours and
$1.3 million in cost compared to the
existing QA burden. The burden
associated with these requirements will
be captured in an existing information
collection request (OMB Control No.
0938–1043).
IV. Economic Analyses
A. Regulatory Impact Analysis for
Regulatory Provisions To Promote
Program Efficiency, Transparency, and
Burden Reduction
1. Statement of Need
All major and many ostensibly minor
government regulations should undergo
periodic review to ensure that they do
not unduly burden regulated entities or
the American people, and to reflect
current knowledge as to their regulatory
effects. In recent years, we have revised
the CoPs and CfCs to reduce the
regulatory burden on providers and
suppliers. In doing so, we identified
obsolete and burdensome regulations
that could be eliminated or reformed to
improve effectiveness or reduce
unnecessary reporting requirements and
other costs, with a particular focus on
freeing up resources that health care
providers, health plans, and States
could use to improve or enhance patient
health and safety. We also examined
policies and practices not codified in
rules that could be changed or
streamlined to achieve better outcomes
for patients while reducing burden on
providers of care, and we identified
non-regulatory changes that would
increase transparency and allow CMS to
become a better business partner.
These final rule provisions are a
continuation of our efforts to reduce
regulatory burden. We are finalizing
changes to the current CoPs or CfCs that
will simplify and streamline the current
regulations and thereby increase
provider flexibility and reduce
excessively burdensome regulations,
while also allowing providers to focus
on providing high-quality healthcare to
their patients. The final rule provisions
will also reduce the frequency of certain
required activities and, where
appropriate, revise timelines for certain
requirements for providers and
suppliers and remove obsolete,
duplicative, or unnecessary
requirements. Ultimately, these
requirements balance patient safety and
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quality, while also providing broad
regulatory relief for providers and
suppliers, and reducing the associated
burden on patients.
2. Overall Impact
We have examined the impacts of the
regulatory provisions to Promote
Program Efficiency, Transparency, and
Burden Reduction as required by
Executive Order 12866 on Regulatory
Planning and Review (September 30,
1993), Executive Order 13563 on
Improving Regulation and Regulatory
Review (January 18, 2011), the
Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354),
section 1102(b) of the Social Security
Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (March
22, 1995; Pub. L. 104–4), Executive
Order 13132 on Federalism (August 4,
1999), the Congressional Review Act (5
U.S.C. 804(2)), and Executive Order
13771 on Reducing Regulation and
Controlling Regulatory Costs (January
30, 2017).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule: (1) Having an annual
effect on the economy of $100 million
or more in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or state, local or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). We
estimate that this rulemaking is
‘‘economically significant’’ as measured
by the $100 million threshold, and
hence also a major rule under the
Congressional Review Act. Accordingly,
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we have prepared an RIA that, to the
best of our ability, presents the costs
and benefits of these provisions of the
rulemaking.
This final rule will create ongoing
cost savings to providers and suppliers
in many areas. Other changes we are
finalizing will clarify existing policy
and relieve some administrative
burdens. We have identified other kinds
of savings that providers and patients
will realize throughout this preamble,
and substantial lifesaving benefits.
These life-saving effects arise by
removing the incentives that were
created by the current transplant center
regulations to decline to transplant
patients with slightly lower
probabilities of success, or to decline to
use organs with slightly lower
probabilities of success.
We sought public comment on our
burden assumptions and estimates as
well as comments identifying additional
reforms that should be considered for
future rulemakings. As discussed later
in this regulatory impact analysis,
substantial uncertainty surrounds these
estimates and we solicited comments on
either our estimates of likely impacts or
the specific regulatory changes that
drive these estimates. We received,
however, few comments specifically
addressing our estimates. In the
proposed rule, we solicited additional
suggestions for things to consider that
could potentially reduce burden for
providers/suppliers in the future.
Comment: We received many
submissions related to possible
additional changes in CoP/CfCs to
reduce burden. For example, we
received a number of suggestions related
to additional reforms regarding the
removal of barriers to the use of nurse
anesthetists that could be considered for
future rulemakings.
Response: Thank you for all the
comments that were submitted with
suggestions on how we can improve the
CoPs/CfCs. Some of the suggestions are
burden reducing, however some of the
suggestions would be burdensome.
Regardless, we will take all the
suggestions in to consideration for
future rulemaking.
Comment: Several commenters
expressed that costs or savings
attributed to QAPI, infection prevention,
recertification efforts, and emergency
training may have been underestimated
due to the exclusion of consideration for
technology changes, or other factors, in
the proposed rule estimates.
Response: We thank you for your
comments and recognize the uncertainty
involved in our estimates. Some of our
estimates have been updated to reflect
new information to the extent that we
are able; however, we lack the data that
would be necessary to make major
adjustments to many of the estimates.
Comment: One commenter inquired
about what happens with all the savings
51789
being estimated for each provider or
supplier.
Response: The estimated savings from
reducing burden for the providers/
suppliers will allow the providers and
suppliers to use those savings towards
other necessary needs. We anticipate
that they will have more time for patient
care, and that the savings represent
expenses that providers and suppliers
will no longer have to incur now that
we have finalized these proposals or
made modifications. Some of these
savings will be passed on to patients in
reduced charges, but most will reduce
costs charged to insurers, which will
over time reduce insurance premiums to
enrollees, public programs, and
employer payers.
In the analysis that follows, we
address the economic effects of all the
major provisions of the final rule
provisions. As pertinent, we indicate
any significant changes from the
proposed rule estimate. The analysis
generally follows the typology used
earlier in the preamble, and in the table
that follows. As stated in the ICR section
of the rule, we obtained all salary
information from the May 2017 National
Occupational Employment and Wage
Estimates by the Bureau of Labor
Statistics (BLS) at https://www.bls.gov/
oes/2017/may/oes_nat.htm and
calculated the total cost per hour by
adding a cost of 100 percent for
overhead costs and fringe benefits.
TABLE 13—SECTION-BY-SECTION ECONOMIC IMPACT ESTIMATES
Provider and supplier type and description
of proposed provisions
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Religious Nonmedical Health Care Institutions:
• Discharge Planning .......................................
Ambulatory Surgical Centers:
• Governing Body and Management ...............
• Patient Admission, Assessment and Discharge (History and Physical).
• Medical Records ...........................................
Hospices:
• Drugs and Biologicals, Medical Supplies,
and Durable Medical Equipment ***.
• Hospices That Provide Hospice Care to
residents of a SNF/NF or ICF/IID.
• Hospice Aide and Homemaker Services ......
Hospitals:
• Quality Assessment and Performance Improvement Program.
• Medical staff: Autopsies ................................
• Infection Control ............................................
• Special requirements for hospital providers
of long-term care services (‘‘swing-beds’’).
• Special Requirements for Psychiatric Hospitals.
• Patient Admission, Assessment and Discharge (History and Physical).
Transplant programs:
• Various provisions related to performance **
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Number of
affected
entities
Frequency
Estimated savings
(annualized,
$millions)
As patients are discharged (Estimated 619 annual
discharges).
18
Upon failed hospital transfer agreement attempts ..
Every patient registration at an ASC or at a hospital outpatient/ambulatory surgery department.
Recurring annually ..................................................
5,557
5,557
(*)
77.
5,557
0.
Recurring annually ..................................................
4,602
94.
Recurring annually ..................................................
4,602
1.
Recurring annually ..................................................
4,602
2.
Recurring annually ..................................................
4,823
31.
Recurring annually ..................................................
Recurring annually ..................................................
Recurring annually ..................................................
4,823
4,823
478
0.
115.
30.
Recurring annually ..................................................
620
154.
Every patient registration at an ASC or at a hospital outpatient/ambulatory surgery department.
4,823
Recurring annually ..................................................
750
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(*)
77.
Not Quantified.
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TABLE 13—SECTION-BY-SECTION ECONOMIC IMPACT ESTIMATES—Continued
Provider and supplier type and description
of proposed provisions
Number of
affected
entities
Frequency
Home Health Agencies:
• Patient rights .................................................
• Home health aide services ...........................
• Clinical records .............................................
Critical Access Hospitals:
• Provision of Services ....................................
• Organizational structure ................................
• Special requirements for CAH providers of
long-term care services (‘‘swing-beds’’)..
Comprehensive Outpatient Rehabilitation Facilities:
• Utilization Review Plan .................................
Community Mental Health Centers:
• Assessment Update ......................................
Portable X-Ray Services:
• Qualifications of X-ray technicians *** ...........
• Removing written orders ...............................
RHC (4,160 clinics) & FQHC (7,874 center locations):
• Patient Care Policies Review .......................
• Program Evaluation ......................................
Emergency Preparedness for Providers and Suppliers:
• Review of Emergency Preparedness Program.
• Emergency Plan ............................................
• Training and Testing—Training Program .....
• Training and Testing—Testing ......................
Estimated savings
(annualized,
$millions)
Recurring annually ..................................................
Recurring annually ..................................................
Recurring annually ..................................................
12,624
12,624
12,624
57.
Not Quantified.
Not Quantified.
Recurring biennially .................................................
Recurring annually ..................................................
Recurring annually ..................................................
1,353
1,353
1,246
Recurring annually ..................................................
188
(*)
Recurring annually ..................................................
52
(*)
Recurring annually ..................................................
Recurring annually ..................................................
500
500
31.
28.
Recurring biennially .................................................
Recurring biennially .................................................
12,034
12,034
4.
5.
Recurring biennially .................................................
56,983
70.
Recurring annually ..................................................
Recurring biennially .................................................
Recurring annually ..................................................
68,275
53,543
36,971
7.
26.
21.
1.
(*)
77.
* Amount is less than half a million dollars and rounds to zero.
** These include proposed changes to the following requirements: Special Requirements for Transplant Programs; Data submission, Clinical
Experience, and Outcome Requirement for Re-approval of Transplant Programs; and Special Procedures for Approval and Re-Approval of Organ
Transplant Programs.
*** This estimate is for first full year savings only and will differ in future years.
3. Anticipated Effects
a. Effects on Religious Nonmedical
Health Care Institutions
As detailed in the Collection of
Information section addressing these
provisions, we reduced the discharge
planning requirements for RNHCIs
because RNHCIs do not provide medical
treatment or services. Most patients are
discharged to home or to another facility
that also does not provide medical
treatment or services. Although all
patients must have a discharge planning
evaluation, not all patients require a
discharge plan. The discharge planning
cost would be reduced by an estimated
$22,903.
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b. Effects on Ambulatory Surgical
Centers and Hospital Outpatient/
Ambulatory Surgery Departments
As of May 2017 there were 5,557
Medicare-participating ASCs. We
finalized our proposal to revise the ASC
CfCs in order to reduce unnecessary
duplications and streamline processes
in order to reduce ASC compliance
burden while maintaining minimum
standards for patient safety and care.
The specific savings for each change are
described later in this section of the
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rule. At § 416.41(b)(3), we are removing
transfer agreements and admitting
privileges requirements and replacing it
by mandating ASCs must periodically
provide the local hospital with written
notice of its operation and patient
population served. This change
eliminates the administrative burden
associated with preparing an agreement
for signature and going through the
hospital credentialing process in order
to obtain admitting privileges.
Currently, all Medicare-certified ASCs
are meeting the transfer agreement or
admitting privileges requirement with
the exception of approximately twenty
ASCs that have tenuous relationships
with their local hospital. We estimate
the ASCs that do have difficulty with
meeting this requirement would
appreciate the annual burden savings of
2 to 4 administrator hours spent on
paperwork and documentation. For
those ASCs that already have transfer
agreements with their local hospitals,
the administrative burden is removed
since transfer agreements and admitting
privileges are eliminated, however,
administrative burden is then replaced
by the preparation and completion of
the notice of operation requirement. For
this reason, we have not assigned any
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additional burden created by the notice
to the local hospital requirement. We
estimate the savings at less than $10,000
overall and largely believe this change
will not produce significant savings,
however, it does affect twenty or more
ASCs in the short term by removing the
transfer agreement requirement. We
welcomed any feedback related to the
time and effort for those ASCs that have
secured an agreement, and if we have
underestimated the savings of removing
this transfer agreement in the future. As
previously discussed, the enactment of
EMTALA and its increasingly effective
enforcement over time has rendered
these transfer and admitting privileges
obsolete and unnecessary. To put this
point in perspective, emergencies or
other unforeseen adverse events can
arise in any ambulatory medical or
dental setting, or in home settings. Over
time, ‘‘911’’ emergency calls and direct
ambulance responses have become
standard operating procedures virtually
nationwide, regardless of the place in
which the problem arose. Under modern
procedures, emergency responders (and
patients themselves) take patients to
hospital emergency rooms without
regard to prior agreements between
particular physicians and particular
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hospitals. Indeed, the most appropriate
emergency treatment setting for a
particular patient may not be one
involving such an agreement, even
where the agreement exists. Of course,
nothing prevents particular
arrangements where a hospital and ASC
agree that this is beneficial for a
particular type of surgery or patient
condition and where patient transport
can be appropriately arranged to reflect
this. Accordingly, we estimate that there
will be no consequential adverse health
effects of this change, and therefore
estimate no medical costs.
There will be competitive benefits in
those places where an ASC will now be
allowed to operate and provide care at
reduced cost compared to inpatient
treatment. Nonetheless, we believe that
the number of affected areas and
facilities are few, and that annual
benefits are unlikely to reach the
million dollar range. We sought
comments on all these effects and on the
preceding analysis of health effects and
the majority of those we received agreed
with our proposed reform.
At § 416.52 we are replacing the
requirement that every patient must
have a comprehensive H&P within 30
days prior to surgery in an ASC, with a
requirement that allows the operating
physician and ASC to determine which
patients would require more extensive
testing and assessment prior to surgery.
We believe that this change reduces
patient and provider burden in a
multitude of ways that includes the
community-based physician, the ASC,
and the patient. We believe that in
almost all situations ASCs can
reasonably rely on existing H&P results
that are more than 30 days old and then
are updated by patient responses just
prior to surgery.
For ASCs, we believe this change
would reduce administrative burden by
decreasing the amount of time that ASC
personnel spend following up on
patient visits to obtain the necessary
H&P information and that it will
provide for an increase in scheduling
flexibility for the facility. We believe
these changes may have the effect of
improving patient satisfaction and
increasing positive patient referrals for
the ASC.
For community-based healthcare
providers, to include primary care
providers, we believe this change would
reduce unnecessary examinations that
are required to be performed and reduce
administrative paperwork burden
associated with providing ASCs with
the necessary H&P documentation and
additional testing requirements. This
change may potentially provide an
opportunity for increased access to
community-based providers because of
available appointments that are not
being filled by unnecessary patient
appointments for H&P requirements for
surgery in an ASC. Those vacant
appointments may also generate more
revenue.
51791
For patients, we believe this change
reduces the time spent to prepare for
surgery (time in community-based
physician office, travel time and costs,
time missed from the work place and
lost productivity) and the cost
associated with co-pays and other
healthcare cost sharing requirements.
Finally, we believe this change
reduces expenses for healthcare insurers
to include Medicare, Medicaid, and
private healthcare insurance companies.
This change would reduce costs
associated with reduced pre-operative
exams, laboratory testing, chest
radiographs, and echocardiograms.
In the proposed rule we stated that it
is difficult to estimate the savings from
this change, because they depend on a
number of factors previously described,
and additional factors for which we do
not have precise measures, such as the
number of patients (both Medicare and
non-Medicare) who received two or
more ASC services within the 30-day
window allowed for one physical
examination. This is a common
occurrence because, for example,
patients often receive cataract surgery
on one eye and then, a week later, on
the other eye. Furthermore, there are an
immense number of different outpatient
surgical services. At present, for
example, there are about 137 services
that account for about 90 percent of ASC
volume, and these services are highly
diverse, as shown in Table 14.
TABLE 14—TWENTY MOST FREQUENT ASC SERVICES IN 2015
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Surgical service
Percent of
volume
Rank
Cataract surgery w/IOL insert ..................................................................................................................................
Upper GI endoscopy, biopsy ...................................................................................................................................
Colonoscopy and biopsy .........................................................................................................................................
Lesion removal colonoscopy (snare technique) ......................................................................................................
Inject foramen epidural: Lumbar, sacral ..................................................................................................................
After cataract laser surgery .....................................................................................................................................
Injection spine: Lumbar, sacral (caudal) .................................................................................................................
Inject paravertebral: Lumbar, sacral ........................................................................................................................
Diagnostic colonoscopy ...........................................................................................................................................
Colorectal screen, high-risk individual .....................................................................................................................
Colorectal screen, not high-risk individual ...............................................................................................................
Cataract surgery, complex .......................................................................................................................................
Injection procedure for sacroiliac joint, anesthetic ..................................................................................................
Cystoscopy ..............................................................................................................................................................
Upper GI endoscopy, diagnosis ..............................................................................................................................
Inject spine, cervical or thoracic ..............................................................................................................................
Revision of upper eyelid ..........................................................................................................................................
Lesion removal colonoscopy (hot biopsy forceps) ..................................................................................................
Upper GI endoscopy, insertion of guide wire ..........................................................................................................
Carpal tunnel surgery ..............................................................................................................................................
1
2
3
4
7
6
8
9
5
10
12
11
19
15
13
17
16
14
18
20
18.6
8.2
6.8
5.6
4.8
4.4
3.3
3.1
2.3
2.0
1.9
1.6
1.3
1.2
1.0
1.0
0.9
0.8
0.8
0.7
Total ..................................................................................................................................................................
........................
70.4
Source: MEDPAC. Ambulatory surgical center services. 2017, p. 140.
In total, ASCs provided about 6.4
million services in 2015 (MEDPAC.
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Ambulatory surgical centers services,
2017, p. 139). If we assume that 25
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percent of these patients had two or
more services within the 30-day
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‘‘window’’ allowed in the current rule,
then another H&P with its associated
battery of tests were required for each of
the remaining 4.8 million individuals.
Assuming that 5 percent of these
patients would otherwise have already
had an overall H&P and associated tests
within 30 days of the surgery, 4.56
million persons would then require a
new H&P and tests before surgery under
the current requirements. In the great
majority of cases involving eye or eyelid
surgery of one kind or another, the
ophthalmology examination preceding
the ASC surgery would not have
involved a comprehensive H&P or
battery of tests, and a similar situation
would be involved for most other
surgeries preceded by specialist rather
than primary care visits.
Although we are unable to estimate
the likely number of cases, one way to
estimate the costs of these examinations
and tests would be as follows. First, the
H&P itself would cost approximately
$100 (the exact amount depending on
diagnostic details, and not necessarily
corresponding to any particular
payment schedule). The battery of tests
would cost approximately $100,
assuming both urine and blood testing,
and, in some cases, an
electrocardiogram, but only half of
physical examinations (for example, few
or no ophthalmologist exams) would
include such tests. The travel of the
patient to and from the physician office
to obtain the examination and tests
would on average require 1 hour, which
when valued at the average wage rate in
the economy of $24 (increased by 50
percent to include fringe benefits but
not overhead) would cost about $36. In
addition, ASCs incur substantial costs
for the time and trouble needed to
contact physician offices and arrange for
the results to be delivered. The
physician offices themselves would be
put through the trouble of transferring
those medical records. Assuming
average time spent (the median would
be less but a small number of difficult
cases would bring the average well
above the median) would reach 10
minutes, and the use of a general office
clerk at $33 an hour, the cost per patient
would average $5.50 per patient. A
further cost arises because in many
cases the examination and test results
simply cannot be obtained timely, and
a scheduled surgery has to be
postponed. Assuming that in such cases
a half hour of surgeon time (at $242 an
hour) and a half hour of registered nurse
(RN) time (at $71 an hour) is wasted,
and that clerical time ($33 an hour) to
reschedule averages 10 minutes, the
average cost per postponement would
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be $162. (In some of these cases patient
time would be wasted, as well as the
time of family members accompanying
the patient—we have not estimated
these costs.)
Aggregating these calculations, one
estimate of the annual costs of the
current regulatory requirement, as
shown in Table 15, could be as much as
$908 million for ASCs and a similar
amount for hospital outpatient surgery.
For many and perhaps most cases,
however, either the surgeon or the
facility would decide that H&P
information is needed for particular
patients or particular procedures,
whether or not this regulatory
requirement existed. Of course, it is
unlikely that in such cases a strict 30day window would be insisted on.
Assuming that such examination and
testing information would continue to
be needed for 10 percent of all patients,
and that in half of these cases the
information would require a new
examination and tests within a 30-day
window, the net costs of the regulatory
reform we proposed would be 95
percent less than the preceding
calculations.
As support for the proposed rule’s 50
percent upper bound, the proposed rule
preamble (83 FR 47733) noted that Chen
et al. found that approximately 53
percent of Medicare cataract patients
undergo pre-operative testing, none of
which is mandated by CMS regulation.2
If these patients’ physicians are cautious
enough to currently pursue more
preoperative activity (for example,
testing and H&P) than what is required,
or state or hospital rules are driving
physician behavior beyond what
Medicare necessitates, then this study
might be interpreted to suggest that
there is little reason to believe that that
behavior will change with the
finalization of this rule. This study did
not, however, address the 30-day time
frame. We are unaware of any study or
body of opinion suggesting that 30 days
or any such arbitrary time limit can be
medically justified, or that any
providers would adhere to such a limit
if not a regulatory requirement. The
same points apply to other procedures
performed in outpatient settings, even
those such as hernia and plastic
surgeries. In order to more successfully
tailor the upper bound of potential cost
savings to H&P activity—rather than just
extrapolating from testing behavior—we
requested comment on the possibility of
2 Chen CL, Lin GA, Bardach NS, Clay TH,
Boscardin WJ, Gelb AW, Maze M, Gropper MA and
Dudley RA, Preoperative Medical Testing in
Medicare Patients Undergoing Cataract Surgery.
New England Journal of Medicine 372:1530–1538,
April 16, 2015.
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building on Chen et al.’s data and
methodology to estimate the increased
frequency of within-30-day office visits
(presumed to be H&P) when
ophthalmologist visits are at least 31
days prior to surgery relative to when
ophthalmologist visits are no more than
30 days prior. We received no
comments supporting (or opposing)
such an estimating procedure.
Regardless, laboratory testing and
physical examinations have no
particular dependence on each other in
terms of time or place. A physician, for
example, can order a laboratory test for
a patient without a physical
examination at all, relying on a one or
two year old examination or other
information. Hence, the literature on the
necessity of testing is not directly
germane to the question of whether a
routine physical examination should
occur, with or without routine blood
and urine tests. To take a common
example, it is universal practice for
highly detailed eye tests to be performed
in the surgeon’s office, a week or so
before cataract surgery. It is that testing
on that highly specialized equipment,
not a recent physical examination or
blood tests ordered by a general
practitioner, that determines whether,
how, and with what techniques and lens
inserts the cataract surgery will be
performed.
As noted in the medical literature
previously discussed, Chung F, Yuan H,
Yin L, Vairavanathan S, and Wong DT.
Elimination of preoperative testing in
ambulatory surgery. Anesth Analg. 2009
Feb, 108(s):467–75, there are no known
consequential medical benefits from the
testing often performed in association
with the current regulatory
requirements for general physical
examinations. This study covered
hernia patients but similar results have
been found in studies of cataract
surgery. Accordingly, eliminating the
testing that occurs during or after H&P
could in theory produce very substantial
annual ASC cost savings with no
offsetting medical cost increases or
harm to patients. H&P itself, however, is
distinct from testing, and literature
indicating that testing is wasteful does
not necessarily speak to the importance
of H&P. There are, however, no known
studies supporting the proposition that
H&P procedures should be performed
within 30 days of surgery to avoid
adverse consequences to patients. We
received no public comments making
such a claim and the great majority of
those addressing this issue
recommended removing at least the 30day rule, and usually the entire
requirement.
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In addition, Schein et al. and Bass et
al. suggest that regulations play a
prominent role in the persistence of
low-value H&Ps and testing. They note
that prior research indicates that it may
often be the case that each member of
a care team individually believes there
is little value in preoperative testing for
certain procedures, but those same
individual physicians may fear that one
or more of the other specialists or the
institution may require certain tests.3 4
Therefore, the requirement for a
preoperative H&P, especially within 30
days of a surgery, greatly increases the
likelihood for miscommunication
among the care team regarding what
tests may or may not be required. It
follows that the persistence of low-value
testing may simply be due to our
requirement for what are often lowvalue H&Ps, as opposed to an indication
that care teams are consciously pursuing
preoperative care beyond what
Medicare requires, or that they would
continue to do so in the absence of such
a requirement.
As discussed in ‘‘Provisions of the
Proposed Regulations,’’ section II.D. 2.
of the proposed rule, there is a similar
regulatory requirement for hospital
outpatient surgery. Based on the
substantial similarity between these two
service settings, we also proposed to
eliminate these requirements for such
surgery. Although we do not have
detailed data for hospital outpatient
surgery, it is widely agree to be roughly
equal in size and composition to ASC
surgery, though spending is higher
because a higher payment schedule is
used by some insurers, including
Medicare, for most hospital outpatient
surgery. Regardless, estimates should be
based on economic costs, not any
particular payment schedules.
Accordingly, potential total annual
savings, and hence benefits, for both
settings taken together could be as much
as $1.7 billion or more. This would
depend on whether hospital-based
outpatient surgery decisions parallel
those of independent ASCs.
If, after ASCs and hospitals make
policy decisions on which types of
outpatient/ambulatory surgery patients
would continue to require a
comprehensive H&P, and only 50
percent of current costs were continued,
potential total annual savings, and
hence benefits, for both settings taken
together would be about $908 million,
assuming that hospital-based outpatient
surgery H&P policy decisions parallel
those of independent ASCs.
Alternatively, if 75 percent of current
costs were continued, potential savings
would be about $454 million annually.
While the literature shows that we can
be reasonably certain that for some
procedures, such as cataract surgery,
few or possibly even no costs would be
self-imposed, there may be other
procedures where ensuing policy
decisions would retain all current
history and physical requirements other
51793
than the strict 30-day rule. Because of
the new requirements, and other
uncertainties, the potential savings from
lifting the current requirements
encompass at least this broad range and
quite possibly more. Because there was
great uncertainty in these estimates as to
future decisions by ASCs and hospital
outpatient departments, we decided not
to present a predetermined figure in the
proposed rule. Instead, we requested
public comments on all the parameters
of our estimates to inform the estimates
we would make in the final rule. We
welcomed information on likely
decisions in both ASC and hospital
outpatient settings, and if possible for
the most common procedures shown in
Table 14 and for the likelihood and cost
saving effects for procedure and patient
categories where the facility chooses to
retain an external H&P requirement, but
extends the time window to a year or
some other period that is far longer than
30 days. We did not receive any public
comments on the dollar estimates but
did receive a large number of public
comments stating that the current H&P
requirements in their entirety and/or the
30-day limit did not rest on any medical
evidence of benefits to patients, and
should be removed. Even those few
comments supporting retention
provided no medical evidence as to the
necessity of applying either an H&P
requirement or a 30-day requirement to
most outpatient surgeries.
TABLE 15—CURRENT COSTS AND POTENTIAL ANNUAL SAVINGS FROM CREATING AND OBTAINING EXAMINATION AND TEST
RESULTS
Unit
cost
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Type of cost
Number
(M)
Current
total cost
($M)
Twentyfive
percent
retained
($M)
Fifty
percent
retained
($M)
Seventyfive
percent
retained
($M)
Eightyfive
percent
retained
($M)
Physical Examinations .........................................................
Test Batteries .......................................................................
Patient Travel Cost ..............................................................
Administrative Cost to ASC .................................................
Surgery Cancellations * ........................................................
$100
100
36
5
162
4.56
2.28
4.56
4.56
0.228
$456
228
164
23
37
$114
57
41
6
9
$228
114
82
11
18
$342
171
123
17
28
$388
194
140
19
31
Total Cost, ASCs ..........................................................
................
................
908
227
454
681
772
Total Cost, Hospital Outpatient ** .................................
................
................
908
227
454
681
772
Total Cost .....................................................................
................
................
1,816
454
908
1,362
1,544
Total Savings ................................................................
................
................
................
1,362
908
454
272
* Based on information from a major ambulatory surgery facility, this estimate assumes that 5 percent of scheduled cataract operations are
cancelled at the last minute since the required H&P information has not arrived from the physician office where the examination was performed
and the tests ordered or performed. Staff salaries must still be paid. Our estimates assume one half hour of surgeon time wasted (at $242 an
hour), one half hour of RN time wasted (at $71 an hour), and ten minutes of clerical time (at $33 an hour) to reschedule.
** Hospital outpatient savings assumed to be equal to ASC savings.
3 Schein OD, Pronovost PJ. A Preoperative
Medical History and Physical Should Not Be a
Requirement for All Cataract Patients. J Gen Intern
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Med. 2017;32(7):813–814. doi:10.1007/s11606–017–
4043–9.
4 Bass EB, Steinberg EP, Luthra R, et al. Do
Ophthalmologists, Anesthesiologists, and Internists
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Agree About Preoperative Testing in Healthy
Patients Undergoing Cataract Surgery? Arch
Ophthalmol. 1995;113(10):1248–1256. doi:10.1001/
archopht.1995.01100100036025.
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We assume that the one-time costs of
developing such policies for hospital
outpatient surgery in 4,823 Medicareparticipating hospitals would be the
same in the aggregate, though the mix of
personnel used would be somewhat
different and the cost at free-standing
hospitals would likely be several times
higher (for example, for involvement of
the governing body and legal review).
About 3,200 of these hospitals are in
multi-hospital systems that would,
however, reap economies of scale, and
about 574 are psychiatric hospitals that
we assume rarely perform surgery. In
total, we estimate that, first year savings
for both types of facilities would be $38
million less, regardless of the
replacement rules that each facility
imposed on itself.
There are possible alternatives,
including limiting the regulatory reform
to the lowest risk procedures, which
would probably mean almost all
procedures, excluding certain
procedures from the regulatory reform,
exempting ASCs, but not hospital
outpatient departments, changing the
30-day requirement to something much
longer in duration such as 6 months or
a year, and likely others. Absent
contrary evidence, however, we believe
that relying on physician and facility
judgment maximizes benefits and
presents no consequential costs.
We welcomed comments on these
estimates and on both the proposal and
any alternatives, and particularly
welcomed any evidence-based
information that would inform both our
ability to provide cost savings estimates
and a policy choice between either the
proposed reform or an alternative. We
did not receive any public comments
specific to our cost estimates or
recommending any alternative reform.
In the proposed rule we stated that we
could not forecast with any precision
what medical specialty societies, ASC
governing bodies, hospital governing
bodies, or accreditation bodies would
decide to do in replacing the current
requirement. For these reasons, we did
not forecast a specific level of cost
savings in the proposed rule, and
simply presented a range of from 25%
to 75% (and possibly even higher or
lower). The comments we received from
a wide range of stakeholders suggest
that there might be more ASCs than we
anticipated that take advantage of the
new flexibility to reduce either the
numbers and types of procedures for
which H&P would be required, or to
expand the 30-day limitation to a greater
time window, or both. Moreover, the
largest organization deemed by CMS to
provide standards at least equal to those
of CMS, and allowed to accredit
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20:43 Sep 27, 2019
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providers based on those standards,
strongly endorsed replacing the current
standard with one allowing procedurespecific medical judgment, as did
several organizations representing
professional societies or large provider
organizations. There are, however, some
organizations in some states and some
providers that indicated they opposed
any loosening of current restrictions.
Our final rule would allow them to selfimpose identical restrictions, and allow
all affected providers to retain current
restrictions for some categories of
surgery.
As noted previously, in order to more
successfully tailor the upper bound of
potential cost savings, we built on Chen
et al.’s methodology to estimate the
increased frequency of within-30-day
office visits (presumed to be H&P) when
ophthalmologist visits are at least 31
days prior to surgery relative to when
ophthalmologist visits are no more than
30 days prior (and thus aspects of their
own medical examinations could be
used to satisfy time-sensitive regulatory
requirements). More specifically, we
used Medicare fee-for-service claims
data for procedures performed in
hospitals on an outpatient basis or in
ambulatory surgical centers; following
Chen et al., we limited our 2017 data set
to cataract surgeries performed on
patients of at least age 66 and assumed
office visits within 30 days prior to
surgery were associated with H&P if the
provider specialty was noted as general
practice, anesthesiology, cardiology,
family practice, internal medicine,
geriatric medicine, nurse practitioner or
physician assistant. The dependent
variable in our logistic regression took
the value 1 if an office visit, with a
specialty as listed above, had been
conducted within 30 days prior to
cataract surgery and 0 otherwise. The
key explanatory variable took the value
1 if an ophthalmologist visit (identified
if the provider specialty was noted as
ophthalmology) was within 30 days
prior to surgery and 0 if it was at least
31 days prior. Control variables
included patient year of birth, sex and
race.
Using this methodology to model the
probability that the dependent variable
is equal to 1, the odds ratio of the key
explanatory variable is 0.654 (95 percent
confidence interval: 0.633–0.676). There
are, however, several limitations to this
method of analysis. Most notably,
identifying ophthalmology visits by the
physician specialty code proved to be
unreliable, and it is unclear how many
ophthalmology visits may have been
missed because the physician specialty
field was either blank or noted as
unknown. We removed all beneficiaries
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from our analysis who underwent a
cataract surgery in 2017, yet did not
have any identifiable ophthalmology
visits within that same calendar year,
which limited our data set substantially.
Our overall estimate is that
approximately 28 percent of cataract
surgeries were preceded, within 30
days, by office visits. In the vicinity of
a 28-percent rate, a roughly 8- or 9percentage-point difference in rates
yields an odds ratio of 0.654. Therefore,
8.5 percent will be used in the
calculation of our primary savings
estimate, with an upper bound on
savings of 17 percent and a lower bound
of zero.
c. Effects on Hospices
As of May 2017 there are 4,602
Medicare participating hospices. We are
finalizing our revisions the hospice
CoPs in order to reduce unnecessary
duplications and streamline processes
in order to reduce hospice compliance
burden while maintaining minimum
standards for patient safety and care.
At § 418.76(a) we finalized our
proposal to defer to State training and
competency requirements, where they
exist, for hospice aides. Deferring to
state requirements will streamline the
hiring process because hospices would
not have to verify that a job candidate’s
qualifications meet or exceed the
Federal standard in addition to verifying
that the candidate meets State
requirements.
According to the BLS, 408,920 aides
are currently employed in ‘‘home care’’.
The term ‘‘home care’’ encompasses
both home health agency and hospice
employers. There are 12,624 HHAs and
4,602 hospices, meaning that hospices
represent 27 percent of the ‘‘home care’’
employer market. Thus, we conclude
that hospices employ 110,408 aides (27
percent of all aide positions in ‘‘home
care’’). Based on an informal survey
conducted by the largest hospice
industry association, 76 percent of
States have their own training and
competency requirements, accounting
for approximately 83,910 aide positions.
Hospices in these states would benefit
from the change because they would be
permitted to rely on the completion of
state mandated training and competency
programs to assure that a candidate is
qualified for employment, and would no
longer have to take the additional step
of verifying that each potential job
candidate also meet the Federal
requirements. We assume a 25 percent
turnover rate based on discussions with
industry experts, or 20,978 aide job
listings per year. Based on an assumed
20 candidates that would require the
qualifications verification per job
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listing, we estimate that hospices must
verify the training and competency
program content and format for 419,560
candidates per year. We assume that it
would take 10 minutes per candidate to
verify compliance with the Federal
requirements, for a total of 69,927 hours
per year nationwide. At a cost of $33 per
hour for a general office clerk to perform
this check, we estimate that hospices
will save $2,307,591 annually.
At § 418.106(a) we are finalizing our
proposal to delete the requirement that
a hospice must ensure that the
interdisciplinary group confers with an
individual with education and training
in drug management as defined in
hospice policies and procedures and
State law, who is an employee of or
under contract with the hospice to
ensure that drugs and biologicals meet
each patient’s needs. Not requiring the
specific pharmacy advisement function
will allow for more streamlined
interdisciplinary group meetings. We
assume that 25 percent of hospices
currently use their own staff (employee
or contract) for this function, and that
this staff member is typically the nurse
member of the interdisciplinary group.
The nurse member of the
interdisciplinary group is also required
by § 418.56(a); therefore we believe that
removing this requirement will not
result in removing the expertise from
the group. Rather, we believe that
removing this requirement will remove
the formulaic approach to
interdisciplinary discussions whereby
the group allots time in each meeting
specifically for this discussion in order
to assure regulatory compliance. In the
absence of regulation, the
interdisciplinary group would have the
authority to decide whether the
discussion is pertinent for a given
patient and the information can be
woven into the discussion at large. This
approach has the potential to reduce the
overall group discussion time,
particularly for the 3 members of the
interdisciplinary group that are not
charged with being the pharmacology
expert. Based on 1.6 million hospice
patients and an assumed 3
interdisciplinary group meetings per
patient, there are a total of 4,800,000
interdisciplinary group meetings per
year. We assume that each
interdisciplinary group meeting
includes 2 minutes of time specifically
related to discussing the results of the
pharmacy advisement service for
purposes of complying with the
regulation, or 160,000 hours per year
nationwide. At a cost of $307 per hour
($203 physician + $55 social worker +
$49 pastoral counselor (BLS Occupation
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code 21–1010)), we estimate that
removing this requirement would save
$49,120,000 annually. There are
additional savings detailed in the
Collection of Information section of
$30,956,777 annually due to removing
this requirement.
Additionally, we believe that this
change will reduce the specialist
nursing time spent specifically on
advisement services. We believe that
moving away from a regulatory
compliance ‘‘check box’’ approach
would allow the specialist nurse to
incorporate medication management
more seamlessly into regular clinical
practice. The 2008 Hospice CoP final
rule (73 FR 32088) estimated a 1 hour
burden per patient for expert pharmacy
services (30 minute initial advisement
per patient + 2 15 minute update
advisements) for a total cost of $71 per
patient for all advisement services
(updated to 2017 dollars). We estimate
that this change will reduce that time by
50 percent, to 30 minutes per patient,
resulting in a $35.50 per patient savings.
Based on the assumption that 25 percent
of hospices use their own employee to
perform this function, we estimate that
this reduction will occur for 400,000
patients nationwide (25 percent of 1.6
million hospice patients), for a total
annual savings of $14,200,000.
Together with the previously stated
estimates, total savings would be
$49,120,000 + $30,956,777 +
$14,200,000 million = $94,276,777
annually.
At § 418.112(f) we are finalizing our
proposal to allow hospices and long
term care facilities the additional
flexibility to negotiate the format and
schedule for orienting long term care
facility staff regarding certain hospicespecific information. We believe that
this will allow for innovation and
streamlining, and reduce hospice
compliance costs related to this
requirement by 20 percent. For purposes
of our analysis only, we assume that a
typical hospice conducts 6 orientation
sessions per year, and that each
orientation requires 2 hours of time
from a hospice nurse. At a cost of $71
per hour, a typical hospice would spend
$852 each year to orient long term care
facility staff. Assuming a 20 percent
reduction in burden that can be
achieved through innovation and
streamlining, a typical hospice would
save $170 a year, or $782,340 savings
annually for all 4,602 hospices.
Taken together, these reforms will
generate annual savings of
approximately $97.4 million ($80.1
million for reduced interdisciplinary
group meeting time + $14.2 million for
reduced specialty nursing time + $2.3
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million for streamlined hospice aide
qualification requirements + $0.8
million for streamlined facility staff
orientation). We requested public
comment regarding these burden
estimates, and additional regulatory
reforms to reduce the burden of the
hospice CoPs, but did not receive any
comments specific to our solicitation.
d. Effects on Hospitals
As of 2017, there were 4,823 Medicare
participating hospitals. We revised the
hospital CoPs in order to simplify some
requirements and streamline processes
in order to reduce burden associated
with hospital compliance with the
Medicare CoPs while maintaining
minimum health and safety standards.
The specific savings for each change are
described below.
At § 482.21, we are allowing for multihospital systems using a system
governing body, as allowed under the
CoPs, and that is legally responsible for
two or more separately certified member
hospitals, to have a unified QAPI
program for the member hospitals
subject to the system governing body.
This will afford hospitals flexibility and
the ability to gain efficiencies and
achieve significant progress in quality
by sharing best practices among all
hospitals subject to the system
governing body. This will be similar to
current allowances for system governing
bodies and unified medical staffs.
While there are no current
requirements that explicitly prohibit the
sharing of best practices across a system,
the current requirements for each
hospital to have its own separate and
distinct QAPI program and Infection
Control program certainly have
inhibited and stifled sharing of best
practices and innovations among
individual hospitals within a system as
we point out in the preamble to the
proposed rule, and which we support
with our reference to the Health
Research and Educational Trust, in
partnership with the American Hospital
Association March 2010 publication
entitled, ‘‘A Guide to Achieving High
Performance in Multi-Hospital Health
Systems.’’ This publication, along with
positive public comments regarding
unified medical staffs that we discussed
in the May 2014 final rule and to which
we refer in the proposed rule, clearly
point to multi-hospitals more efficiently
and effectively collecting,
disseminating, and sharing innovations,
solutions, and best practices for patient
care to each of its member hospitals
through these unified patient care
programs.
Approximately 3,493 of the 4,823
Medicare-participating hospitals
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participated in a hospital system in
2017 (American Hospital Association
(AHA), Fast Facts 2019 (https://
www.aha.org/statistics/fast-facts-ushospitals)). According to the 2017 AHA
Guide, there are 424 multi-hospital
systems. The current regulatory burden
for compliance with the QAPI program
requirement is approximately $10,000
annually per hospital or $48.2 million
annually for all 4,823 hospitals. If we
were to allow a unified QAPI program
for multi-hospital systems, this would
remove 3,493 hospitals from the total
4,823 (replaced by the 424 multihospital systems) for a total of 1,754
hospitals/multi-hospital systems that
would still need to comply. The new
regulatory burden will be a total of
approximately $17.5 million annually
(1,754 × $10,000), for an annual total
savings of approximately $31 million.
We welcomed comments on the
quantitative and non-quantitative
portions of the preceding discussion
and seek any empirical evidence that
would improve the accuracy and
thoroughness of the relevant benefits
estimation, but did not receive any
comments specific to our solicitation.
We are removing the requirement for
hospitals at § 482.22(d), which states
that a hospital’s medical staff should
attempt to secure autopsies in all cases
of unusual deaths and of medical-legal
and educational interest. Because this
requirement is redundant and more
detailed, specific requirements
regarding medical-legal investigative
autopsies are required by individual
state law, we do not anticipate that
hospitals would accrue additional
savings from this change. The benefit to
hospitals from eliminating this
requirement is realized through a
reduction in burden from no longer
having to comply with two similar
requirements of the Federal government
and the State government. Hospitals
would instead be required to follow the
more detailed, specific regulations of
the state in which they are located.
At § 482.42, we are allowing for multihospital systems using a system
governing body as currently allowed
under the CoPs, and that is legally
responsible for two or more separately
certified member hospitals, to have a
unified infection control program for
those member hospitals subject to the
system governing body. This will allow
hospitals flexibility and the ability to
gain efficiencies and achieve significant
progress in infection prevention and
control. This would also be similar to
current allowances for system governing
bodies and unified medical staffs. The
current regulatory burden for
compliance with the Infection Control
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program requirement is approximately
$183 million annually for all hospitals
or $38,000 per hospital. If we were to
allow a unified Infection Control
program for multi-hospital systems, this
would remove 3,493 hospitals from the
total 4,823 (replaced by the 424 multihospital systems) for a total of 1,754
hospitals/multi-hospital systems that
would still need to comply. The new
regulatory burden would be a total of
approximately $66.7 million annually
(1,754 × $38,000), for an annual total
savings of approximately $116 million,
less the estimated cost of $1 million
described in the Collection of
Information Requirements section, for
an annual net savings of approximately
$115 million. We welcomed comments
on the quantitative and non-quantitative
portions of the preceding discussion
and seek any empirical evidence that
would improve the accuracy and
thoroughness of the relevant benefits
estimation.
At §§ 482.58(b)(1) and 485.645(d)(1)
(cross-referenced long-term care
requirement at § 483.10(f)(9)) we are
removing the requirement for hospital
and CAH swing-bed providers to
provide the right for patients to choose
to or refuse to perform services for the
facility and if they so choose, (a)
document in the resident’s plan of care,
(b) noting whether the services are
voluntary or paid and (c) provide wages
for the work being performed given the
location quality, and quantity of work
requiring comparable skills. We discuss
the economic impact for this provision
in the ICR section of this rule, which is
estimated to be $29.4 million.
At § 482.58(b)(4) (and § 485.645(d)(4))
(cross-referenced long-term care
requirement at § 483.24(c)), we are
removing the requirement for hospital
and CAH swing-bed providers to
provide an ongoing activity program
that is directed by a qualified
therapeutic recreation specialist or an
activities professional who meets
certain requirements as listed at
§ 483.24(c)(2). We discuss the economic
impact for this provision in the ICR
section of this rule, which is estimated
to be a savings of $73.5 million.
We are finalizing our proposal to
remove the requirement at
§§ 482.58(b)(5) and 485.645(d)(5) (crossreferenced long-term care requirement
at § 483.70(p)) for hospital and CAH
swing-bed providers to employ a
qualified social worker on a full-time
basis if the facility has more than 120
beds. Given that this provision is not
applicable to either provider type due to
the regulatory requirements for each, it
does not impose a burden upon
hospitals and as such, its removal will
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not result in a savings of burden hours
or dollars.
At §§ 482.58(b)(8) and 485.645(d)(8)
(cross-referenced long-term care
requirement at § 483.55(a)(1)) we are
removing the requirement for hospital
and CAH swing-bed providers to assist
in obtaining routine and 24-hour
emergency dental care to its residents.
We discuss the economic impact for this
provision in the ICR section of this rule,
which is estimated to be $2.9 million for
all hospital and CAH swing-bed
providers.
At § 482.61(d), we are finalizing our
proposal to allow non-physician
practitioners to document progress
notes in accordance with State laws and
scope of practice requirements. We
believe that clarification of the intent of
the regulation is necessary and will
result in non-physician practitioners
(specifically, physician assistants, nurse
practitioners, psychologists, and clinical
nurse specialists) documenting in the
progress notes for patients receiving
services in psychiatric hospitals. We
estimate that MDs/DOs currently spend
approximately 30 minutes documenting
progress notes in psychiatric hospitals,
and that 33 percent of this time would
be covered by non-physician
practitioners. Of the 4,823 Medicare
participating hospitals, approximately
620 (or 13 percent) are psychiatric
hospitals. According to AHA, there were
36,510,207 inpatient hospital stays in
2017, and therefore an estimated 13
percent of these stays were at
psychiatric hospitals. The proposed
change would result in a savings of
$153.5 million (4,746,327 psychiatric
hospital stays × 2 progress notes per stay
× 0.5 hours of physician/psychiatrist
time × $98 per hourly wage difference
between physicians/psychiatrists ($198)
and non-physician practitioners ($100,
the average wage between nurse
practitioners and physician assistants) ×
33 percent of physician time spent
writing progress notes covered by
nonphysician practitioners). This
savings is equivalent to $247,575 per
psychiatric hospital per year.
Comment: We received a comment
expressing concern over this estimate
and whether the 30 minutes applies to
each note, each patient per day, all
patients per day, or some other measure;
and that in any case, the total calculated
amount of time spent on progress notes
appears grossly underestimated.
Response: We thank you for your
feedback and for calling this to our
attention. We agree that our original
estimate was low, and have revised our
estimates to reflect 30 minutes spent on
each note, assuming one progress note
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per week during an average length of
stay of 12 days per patient.
e. Effects on Transplant Programs and
Patients
We are finalizing the proposed
revisions unchanged. For the
convenience of current readers we are
also repeating, essentially unchanged,
the data and analysis that indicate that
the proposed (and hence final) rule
would have substantial life-extending
benefits, perhaps in the billion dollar a
year range, but that we are unable to
provide a robust estimate of their overall
magnitude.
There are approximately 750
Medicare approved transplant programs
in the United States, of which 250 are
kidney transplant programs. All
Medicare approved transplant programs
must be a part of a Medicare approved
hospital, and many hospitals have
several types of organ programs.
Oversight of these programs occurs in
two major ways: By the Organ
Procurement and Transplantation
Network (OPTN), which is a non-profit
membership-based organization
operated under a Federal contract
administered by the Health Resources
and Services Administration (HRSA),
and by CMS under the CoPs. The
current and long-term OPTN contractor
is the United Network for Organ Sharing
(UNOS), which performs many
transplantation functions, including
matching donated organs to waiting lists
of patients who have failing organs, and
reviewing the performance of transplant
centers on a variety of criteria, including
patient and organ survival. There is a
third mechanism encouraging better
transplant program performance, the
SRTR (accessed at https://www.srtr.org).
The SRTR, also operated under a HRSA
contract, provides detailed data on the
performance of all transplant programs,
and allows the OPTN, individual
transplant programs, and patients
themselves to compare results on such
vital metrics as patient survival rates
after transplant.
For patients with most types of organ
failure, a transplant is the only option
for long-term survival. In the case of
kidney failure, however, kidney dialysis
is a viable medium-term and sometimes
long-term option for most patients. On
average these patients can survive a
dozen or more years on dialysis;
however, without a transplant, they
suffer increasingly high morbidity and
mortality rates. We provide Medicare
coverage for such patients through the
ESRD program. Under the ESRD
program, patients receive dialysis
treatment, usually three times a week,
through machines that cleanse their
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blood in much the same way as healthy
kidneys would do. Since its inception in
1973, more than one million patients
have received treatment under this
program. Kidney failure patients are
unique in another way: Unlike most
other organs, with the partial exception
of some liver donations, it is possible for
living individuals to donate ‘‘live’’
kidneys, whether the living donor is a
relative or an unrelated altruistic donor.
In the case of ESRD patients, the
Medicare ESRD program serves almost
all kidney failure patients, regardless of
age, and these patients receive costly
dialysis for a prolonged period of time.
As is the case for all CoPs, our
regulations for Medicare-approved
organ transplant programs have the
potential to protect all patients, not just
Medicare beneficiaries.
As discussed earlier in this preamble,
we have long regulated transplant
programs, but put in place additional
CoPs in the March 2007 final rule (72
FR 15198) in an effort to increase the
quality of care by specifying minimal
health and safety standards. In addition,
outcome metrics (1 year graft and
patient survival) were included in the
regulation and mirrored the OPTN
outcomes metrics as calculated by the
SRTR. Over time, increased emphasis
on organ and patient survival rates, as
key metrics of transplant performance,
created incentives for transplant
programs to select organs most likely to
survive after transplant without
rejection, and to select recipients most
likely to survive after the transplant. In
particular, due to the increasing patient
and organ survival rates over time, the
2007 standards have become
increasingly stringent over time as an
artifact of the performance calculation
method established in the 2007 rule, an
outcome that was never intended by
CMS. In addition, the 2007 rule created
performance standards that focused
only on organ and patient survival rates
for those who received a transplant, not
on survival rates of patients awaiting
transplant. We refer readers to a
discussion of this problem in the
following CMS compliance Guidelines
that could only partially lighten this
unintended regulatory burden at https://
www.cms.gov/Medicare/ProviderEnrollment-and-Certification/
SurveyCertificationGenInfo/Downloads/
Survey-and-Cert-Letter-16-24.pdf.
There is extensive literature on these
incentives and other phenomena in
transplant medicine that strongly
suggests some unintended consequences
on organ utilization (decreased use of
‘‘marginal’’ organs in their patients) and
de-selection of some patients who are
slightly less likely to survive for an
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51797
extended period post-transplant. These
unintended consequences have been
anecdotal and measuring the extent to
which they have occurred is difficult. In
addition to the studies previously cited
in the preamble (Adler et al., Schold et
al., Dolgin et al., Stewart et al., Husain
et al.), other studies on this issue
include Kasiske B, Salkowski N, Wey A,
Israni A, and Snyder J, ‘‘Potential
Implications of Recent and Proposed
Changes in the Regulatory Oversight of
Solid Organ Transplantation in the
United States,’’ American Journal of
Transplantation, Volume 16, Issue 12,
December 2016, pages 3371–3377;
Howard R, Cornell D, and Schold J,
‘‘CMS Oversight, OPOs and transplant
centers and the law of unintended
consequences, Clinical Transplantation,
Volume 23, Issue 6, November/
December 2009, pages 778–783; and
Abecassis M, Burke R, Klintmaim G,
Matas A, Merion R, Millman D, Olhoff
K, and Roberts J, ‘‘American Society of
Transplant Surgeons Transplant Center
Outcome Requirements—A Threat to
Innovation,’’ American Journal of
Transplantation, Volume 9, Issue 6,
June 2009, pages 1279–1286; and
Schold J, Miller C, Mitchell H, Buccine
L, Flechner S, Goldfarb D, Poggio E, and
Andreoni K, ‘‘Evaluation of Flagging
Criteria of United States Kidney
Transplant Performance: How to Best
Define Outliers,’’ Transplantation, June
2017, Volume 101, Issue 6, pages 1373–
1380. These studies regarding the
reduced number of transplants that
would otherwise have occurred, yielded
several relevant facts. The number of
deceased donor organs that are
discarded has been increasing over time
and for kidneys, is above 20 percent. For
example, about 33 percent of kidneys
recovered from donors age 50 to 64 are
discarded, as are about 62 percent of
kidneys recovered from donors age 65 or
older (Hart A et al., OPTN/SRTR 2015
‘‘Annual Data Report: Kidney.’’
Accessed at https://
onlinelibrary.wiley.com/doi/10.1111/
ajt.14124/full). Officials of the UNOS
have stated at public meetings that in
their judgment up to 1,000 kidneys of
the approximately 3,000 that are
discarded each year are of good enough
quality to be transplanted successfully.
The number of organ transplantations
reached record highs in 2016 (33,500),
about 20 percent more than 5 years
earlier, due mainly to increased
donation rates (OPTN, ‘‘United States
organ transplants and deceased donors
set new records in 2016.’’ Accessed at
https://optn.transplant.hrsa.gov/news/
us-organ-transplants-and-deceaseddonors-set-new-records-in-2016/).
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For purposes of this analysis, one
approach to estimating effects is to
isolate the number of kidneys (and other
organs) that have been discarded as a
result of the March 2007 rule; indeed, a
reasonable assumption would be that
the proposed rule’s rescission of the
2007 requirements would have an equal
and opposite effect. A slide presentation
by UNOS researcher Darren Stewart
(2017; accessed at https://
www.myast.org/sites/default/files/
ceot2017/AST
%20CEOT%2001%20Stewart%20%20No%20Organ%20Left
%20Behind%20-%20S3.pdf), presents
an estimate that about 1,110 of about
2,759 kidneys discarded in 2012 were of
transplant quality and that between 500
and 1,000 of these could have been used
in transplants (the most recent discard
numbers, for 2016, are about 20 percent
higher than in 2012 and one-third
higher than in 2007). This presentation
cites the study previously discussed in
this preamble (Stewart et al. (2017)),
that shows kidney discard rates rising
from between 5 and 7 percent in the late
1980s to 19.2 percent in 2015. Notably,
the discard rate had already reached
approximately 18 percent by 2007,
making the rate of increase much lower
after the March 2007 rule was
implemented than it had been in the
previous two decades. Although this
contrary evidence is far from definitive,
it suggests that the effect of the March
2007 rule was too small to be observable
in the kidney discard data.
Unfortunately, these and other studies
have had to deal with other trends
during the last two decades that greatly
complicate measuring the independent
effect of the 2007 rule. These include
the increasing age of the donor pool and
the attendant decline in some
dimensions of organ quality, and the
opposite effects of improved techniques
for maintaining organ quality between
the time of donation and the time of
transplantation. As a result, the
published studies using data on organ
discards have had to use complicated
multivariate statistical procedures in
attempting to estimate the effects of the
2007 rule, and invariably conclude that
their findings are subject to considerable
uncertainty.
The preceding analysis focuses on
discard rates as a tool that transplant
programs can use to reduce risk of lower
patient or organ survival rates, and
hence risk of closure under the 2007
rule. A second tool that a transplant
program can use to reduce its risk of
lower overall patient survival rates is to
remove patients who are slightly less
likely to survive from its waiting list,
most commonly by making a judgmental
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decision that the patient is ‘‘too sick for
transplantation.’’ Programs that are on
the margin of receiving regulatory
sanctions, or that have received such
sanctions already, are particularly likely
to exercise such judgments to reduce
regulatory risk. Several studies have
estimated specific numbers of transplant
reductions due to the 2007 rule by
comparing the number of patients
removed from the waiting list at
programs that have received regulatory
sanctions to those that have not. To
provide a baseline, these studies make
the conservative assumption that those
programs with zero sanctions have not
removed any patients from their
transplant waiting list in order to avoid
sanctions. For kidneys, one study
estimated that in the seven year period
from 2007 to 2014, the lower performing
programs removed from waiting lists
over 2500 patients more than would
have been expected absent sanctions, an
average of over 350 per year (J.D. Schold
et al., ‘‘Association of Candidate
Removals From the Kidney Transplant
Waiting List and Center Performance
Oversight,’’ American Journal of
Transplantation 2016, 1276–1284). The
implications, for the present time, of
wait list changes initiated in 2007 is
unclear. Increased mortality in 2007
among the very sick patients who were
dropped from the wait list would have
freed up organs for 2007’s moderately
sick patients; these patients otherwise
would have declined in health so as to
be the very sick population in 2008.
Thus the absolute level of health in
2008 would have been relatively good,
in which case the phenomenon of
patients being dropped from the wait
list might not have perpetuated into the
future, leaving little or no scope for
benefits to be achieved now as a result
of the proposed CoP revision. (We note
that one year, from 2007 to 2008, may
be an exaggeration as to the short-term
nature of this wait list-related effect, but
a somewhat longer tapering period
could still have reached completion
now, more than a decade after the
implementation of the 2007 CoP, thus
leaving little scope for benefits.) On the
other hand, if the sickest patients in
2008 were dropped based on their
relative health levels—in spite of their
improved absolute health relative to the
sickest patients in 2007—there would be
potential wait list-related benefits from
revising this CoP at the present time.
The benefits of shifting transplants to
the sickest patients from relatively less
sick patients have not been quantified,
but because the harm to the less sick
patients would need to be netted off the
benefit to the sickest patients, the per-
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transplant magnitude would be much
lower than the per-transplant benefits of
avoided organ discards.
Another quantitative study of kidney
transplant effects used a similar
methodology and estimated that as a
result of the 2007 rule, in 2011
sanctioned programs performed 766
fewer kidney transplants than would
otherwise have been the case.5 White et
al.’s finding of reduced transplant
volumes at particular kidney transplant
centers does not necessarily indicate
decreased transplant volumes overall,
with the authors stating that their
aggregate results ‘‘do not indicate that
the introduction of the [2007] CoPs has
systematically reduced opportunities for
marginal candidates or that there has
been a systematic shift away from
utilization of higher risk deceased donor
kidneys.’’ In other words, regulatory
sanctions could have triggered
behavioral responses by some patients,
some transplant surgeons, or some
health insurance plans to shift patients
away from these centers (many insurers
restrict coverage through ‘‘centers of
excellence’’ programs). Schold et al.
(2013) find additional support for this
phenomenon, describing their empirical
result as follows: ‘‘Among 203 [adult
kidney transplant] centers, 46 (23%)
were low performing (LP) . . . Among
LP centers, there was a mean decline in
transplant volume of 22.4 cases
compared to a mean increase of 7.8
transplants among other centers.’’ The
estimated decrease per low-performing
transplant center is roughly three times
the increase per other center, but there
are also roughly three times as many
other centers as low-performing centers;
as such, the most straightforward
interpretation of this paper is that the
same number of transplants is being
concentrated in a smaller number of
transplant centers. This outcome could
still have real impacts, such as changes
in travel time for patients, but although
these impacts are valid for inclusion in
a regulatory impact assessment, they
would be much smaller in magnitude
than the longevity benefits emphasized
elsewhere in this analysis.
A feature common to most of these
studies that is that they use data that are
already several years old when the
study is published, both because of the
usual publishing lag and because
performance data such as one-year
survival rates necessarily make
transplant program results less timely.
None of these studies covers the last two
5 Sarah L. White et al., ‘‘Patient Selection and
Volume in the Era Surrounding Implementation of
Medicare Conditions of Participation for Transplant
Programs,’’ Health Services Research, April 2015,
330–350.
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or three years of transplant program
performance. As a result, none of these
studies has been able to use actual data
to assess the effects of the May 13, 2016
CMS changes that slightly reduced the
performance level for finding a
‘‘condition-level’’ violation that
threatens program closure. For recent
reviews of potential effects of those
changes see BL Kasiske et al, Potential
Implications of Recent and Proposed
Changes in the Regulatory Oversight of
Solid Organ Transplantation in the
United States,’’ Am J Transplant,
December 2016, 16(12), 3371–3377, and
Colleen Jay and Jesse Schold, Measuring
transplant center performance: The
goals are not controversial but the
methods and consequences can be, Curr
Transplant Rep, March 2017, 4(1), 52–
58. Using past data to measure potential
effects, these studies predict little or no
positive effect from the revised
standards (which both studies conclude
will still mis-identify lower performing
programs), but cannot evaluate actual
effects because post-issuance evidence
is not yet available. This may not be
relevant policy-wise, since we proposed
to eliminate those standards, but it is a
key question for estimating the
remaining scope (if any) of CoPassociated unnecessary organ discards,
and it does flag the pervasive problem
of timeliness of data and timeliness of
study findings.
There are several studies that make
similar estimates for liver transplant
programs (for example, L.D. Buccini, et
al., ‘‘Association Between Liver
Transplant Center Performance
Evaluations and Transplant Volume,’’
American Journal of Transplantation
2014, 2097–2105). This study found a
large difference in transplant volume
between programs rated as lower
performing by the SRTR (average
decrease of 39.9 transplants from 2007
to 2012) and those not receiving adverse
SRTR ratings (average increase of 9.3
transplants over the same period). The
27 lower performing centers thus
reduced their total number of liver
transplants by over 1,000, and compared
to the higher performing centers the
decrease was even larger. This study did
not, however, tie its estimates to the
performance standards in the 2007 rule
(which are similar but not identical to
SRTR standards), to sanctions under
that rule, or to specific center decisions,
such as removing candidates from the
wait list. Hence, while it certainly
contributes to the body of scholarship
indicating that since 2007 transplants
have been performed in a more
concentrated set of programs, it does not
appear to provide direct estimates of the
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quantitative effects of the 2007 rule on
overall numbers of liver transplants.
Taking into account all the various
uncertainties involved in these studies,
we did not and do not believe that we
can estimate the effects of the 2007 rule
on numbers of transplantations for any
organ other than kidneys, and that even
for kidneys there is no clear central
estimate of likely quantitative effects.
The wide variation in published results,
and the disclaimers as to the various
uncertainties involved, make a precise
as well as reliable estimate all but
impossible and would render arbitrary
any non-zero lower bound estimate of
health and longevity impacts. (As noted
above, however, even in the absence of
health and longevity effects, there may
be other benefits, such as reduced travel
costs, if the proposed rule reduces
concentration of transplants in a smaller
number of facilities.) Therefore, we have
shown the effects of the final rule
change as ‘‘not quantified.’’ This is not
unusual in regulatory impact analyses
that address complex phenomena that
cannot be measured directly, or whose
effects are intertwined with other
changing circumstances.
Every transplant quality organ that is
used for transplantation rather than
discarded has a very high probability of
substantially extending the life of the
recipient. There is a particularly
extensive literature on life expectancy
before and after transplant, quality of
life, and cost savings for kidney
patients. A literature synthesis on ‘‘The
Cost-Effectiveness of Renal
Transplantation,’’ by Elbert S. Huang,
Nidhi Thakur, and David O. Meltzer, in
Sally Satel, When Altruism Isn’t Enough
(AEI Press, 2008) found essentially
universal agreement that kidney
transplants were not only substantially
life extending, but also cost reducing.
The authors performed an extensive
literature search and found that from
1968 to 2007 seventeen studies assessed
the cost-effectiveness of renal
transplantation. The authors concluded
that ‘‘Renal transplantation . . . is the
most beneficial treatment option for
patients with end-stage renal disease
and is highly cost-effective compared to
no therapy. In comparison to dialysis,
renal transplantation has been found to
reduce costs by nontrivial amounts
while improving health both in terms of
the number of years of life and the
quality of those years of life’’ (page 31).
More recent studies have reached
similar conclusions, as have other
syntheses. For example, the ‘‘Systematic
Review: Kidney Transplantation
Compared with Dialysis in Clinically
Relevant Outcome’’ (M. Tonelli, N.
Wiebe, G. Knoll, A. Bello, S. Browne, D.
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Jadhov, S. Klarenbach, and J. Gill,
American Journal of Transplantation
2011: 2093–2109) focused on life
expectancy and quality of life. This
article reviewed 110 studies, and
concluded that the vast majority showed
major improvement in life quality and
reductions in mortality among
transplant recipients compared to those
remaining on dialysis. The Annual Data
Report of the United States Renal Data
System utilizes national data on ESRD,
and reports that deaths per 1,000 patient
years are about 180 for dialysis patients
and about 32 for transplant recipients
(see 2016 report, volume 2, Figure i.13
and Tables H.4 and H.10); accessed at
https://www.usrds.org/adr.aspx). There
are similar data on other organs. For
example, in 1998, HHS published a final
rule with comment period that
established governance procedures for
the OPTN (63 FR 16296). In the RIA for
that rule, the Department estimated that
‘‘the annual benefits of organ
transplantation include about eleven
thousand lives vastly improved by
kidney transplantation, and another
eight thousand lives both vastly
improved and prolonged by
transplantation of other major organs’’
(63 FR 16323).
Even without a robust aggregate
estimate of likely increases in organ
utilization as a result of this proposed
regulatory change, the potential benefits
are very substantial. For each new
kidney transplantation, there would be
an average of 10 additional life years per
transplant patient compared to those on
dialysis (see Wolfe A et al.,
‘‘Comparisons of Mortality in All
Patients on Dialysis, Patients on Dialysis
Awaiting Transplantation, and
Recipients of a First Cadaveric
Transplant,’’ NEJM, 1999, 341:1725–30;
accessed at https://www.nejm.org/doi/
full/10.1056/
NEJM199912023412303#t=article).
Valuing each year of life gained using a
‘‘value of a statistical life year’’ (VSLY)
of $490,000 in 2014 dollars, the total
benefits from each additional
transplantation in 2018 would be $4.9
million before discounting and $4.4
million after inflating to 2016 dollars
and discounting at either 3 or 7 percent
over the 10-year period (life-year figure
for 2014 from Office of the Assistant
Secretary for Planning and Evaluation,
HHS, Guidelines for Regulatory Impact
Analysis, 2016, page 21, accessed at
https://aspe.hhs.gov/pdf-report/
guidelines-regulatory-impact-analysis).
The HHS methodology produces the
same result at either discount rate in
order to reach the same predetermined
‘‘real’’ value. For an explanation and
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justification of this VSLY approach, see
Cass R. Sunstein, ‘‘Lives, Life-Years, and
Willingness to Pay,’’ 104 Columbia Law
Review [i] (2004).
Those HHS guidelines also explain in
some detail the concept of quality
adjusted life years. The key point to
understand is that these are researchbased estimates of the value that people
are willing to pay for life-prolonging
and life-improving health care
interventions of any kind (see sections
3.2 and 3.3 of the HHS Guidelines for
a detailed explanation). The QALY
amount used in any estimate of overall
benefits is not meant to be a precise
estimate, but instead is a rough
statistical measure that allows an overall
estimate of benefits expressed in dollars.
An alternative and more sophisticated
analysis would take into account that
the life-extending effect of a kidney
transplant is not its first effect, but
typically follows a number of years off
dialysis, until the organ fails and the
patient returns to dialysis or is
retransplanted. Such an analysis can be
found in a recent study by P.J. Held et
al., ‘‘A Cost-Benefit Analysis of
Government Compensation of Kidney
Donors,’’ American Journal of
Transplantation, 2016, pages 877–885
(plus 65 pages of supplementary details
explaining all assumptions, data
sources, and calculations). The largest
differences between the base case
estimated in that study and the
preceding estimates is that this RIA uses
the considerably higher value of a
statistical year of life under HHS
guidelines, and this RIA uses the full
value of a statistical life year without a
‘‘quality’’ adjustment for the added
years of life (we use QALYs only for the
improved quality of life during years
that would otherwise be on kidney
dialysis). Under such an estimation
approach, potential life-extending
benefits could be somewhat larger. For
example, if the proposed reform
increased the number of life-extending
kidney transplants by only 100 a year,
and the benefits of both additional life
years and QALY gains were estimated at
$5.1 million per patient, its total annual
benefits for kidney patients would be
approximately $510 million a year (100
× $5.1 million).
There are additional benefits from
kidney transplantation. As previously
discussed, kidney transplants do reduce
medical costs, with ‘‘breakeven’’ after
about 5 years and net savings of several
hundred thousand dollars per patient.
Other organ transplants create lesser or
no medical savings because the
alternative is not dialysis. Clearly,
however, these kidney transplant
savings are small in relation to the life-
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extending benefits. We have not
estimated medical savings or costs for
kidneys or other organs in this RIA
because any such estimates would
depend on the number of additional
transplants that we have not estimated.
We note that life-extending estimates
are averages across patients who vary
widely in age, medical condition, and
life expectancy, as well as type of organ
failure. For example, the sickest patients
typically have very low life
expectancies without transplant, and
hence stand to gain the most years of
life from a transplant. Partly offsetting
this, these same patients, on average,
have slightly lower survival rates posttransplant. Organ and patient survival
issues are complex and dealt with by
detailed policies and procedures
developed and used by the transplant
community under the auspices of the
OPTN. These policies are reviewed and
revised frequently based on actual
experience and changing technology—
over time the success rate from
previously marginal organs, and in older
patients, have both increased
substantially. For purposes of this
analysis, the proper measure is the
average gain across all patients who
would receive transplants as a result of
eliminating the 2007 rule, net of these
other factors.
There could be potential offsets to
these calculated and uncalculated
benefits and cost reductions. However,
the particular regulatory requirements
we proposed to remove are unlikely to
drive any further significant increases in
graft and patient survival. For renal
transplants, the expected 1-year graft
and patient survival rates are already at
95 percent or better. Transplant program
outcomes will continue to be monitored
by the OPTN and programs that are not
in compliance with the OPTN outcomes
are referred to their Membership and
Professional Standards Committee for
quality improvement activities. The
SRTR also publishes detailed data on
transplant program performance that
allows patients and their physicians to
compare transplant programs and this
transparency creates pressures to
maintain and improve survival rates in
order to attract these patients.
The current regulatory requirements
for transplant centers, as discussed in
section II.E ‘‘Transplant Centers’’ of the
proposed rule, have created both
positive and adverse incentives for
transplant programs, with unanticipated
side effects on both utilization of
donated organs and the ability of the
highest risk patients to obtain
transplants. We expect the changes
made by this final rule to provide
substantial net benefits, particularly
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since other regulatory and informational
incentives remain in place.
We requested comments on this
analysis as well as information that
would enable a more robust quantitative
analysis of the impacts of this change
and on any alternative reforms that
might provide even higher benefits. We
did not, however, receive comments
specifically addressing these requests.
f. Effects on HHAs
As of May 2017 there are 12,624
HHAs that participate in Medicare and
Medicaid. In the January 2017 HHA CoP
final rule (82 FR 4504) we estimated
that compliance with the requirements
at § 484.50(a)(3) related to providing
oral notice of all rights to each patient
would impose a burden of 5 minutes per
patient, or 1,330,246 hours of burden
nationwide at a cost of $80,030,370,
annually. The cost estimate was based
on a $63 per hour estimate for the
services of a RN as derived from the BLS
Occupational Handbook, 2014–2015
edition, including a 100 percent benefit
and overhead package. Adjusted to
reflect more updated salary information,
as described previously, we estimate
that compliance with this provision
would impose a $94,447,466 burden,
based on a RN earning $71 per hour.
We proposed to revise the verbal
notification requirements to limit them
to those that are required by section
1891 of the Act. Limiting the amount of
information that is required to be
provided orally will reduce the time per
patient that is required to comply with
the revised requirement. For purposes of
this analysis only, we assume that
providing oral notice regarding financial
liability only will require 2 minutes per
patient, reducing burden by 60 percent.
Based on this assumption, this proposed
change would reduce the burden of the
patient rights notification requirement
by 198,148 hours (1,330,246 hours
originally estimated × 0.6) and
$56,668,480 ($94,447,466 burden as
updated to reflect more recent salary
estimates × 0.6).
We are also finalizing three changes
that do not have a savings estimate.
First, we are eliminating the
requirement at § 484.80(h)(3) that the
HHA conduct a full competency
evaluation of deficient home health
aides, and replace it with a requirement
to retrain the aide regarding the
identified deficient skill(s) and require
the aide to complete a competency
evaluation related to those skills. As we
stated in the January 2017 HHA CoP
final rule (82 FR 4575), it is standard
practice within the HHA industry to
supervise home health aides, and the
regulatory requirements for such
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supervision do not impose any
additional burden. We are also
finalizing a change to permit HHAs to
use either patients or pseudo-patients
when conducting home health aide
competency evaluations. While this
change does not have a monetary
savings estimate, we believe that this
additional flexibility will increase the
speed for aides completing their
competency evaluations, thus increasing
the pool of aides eligible to provide
services and reducing patient wait times
for aide services.
We requested public comment
regarding these burden estimates, and
additional regulatory reforms to reduce
the burden of the HHA CoPs, but did
not receive any specific to our burden
estimates. Comments regarding
additional regulatory reforms to reduce
the burden on HHAs are addressed
earlier in the preamble.
g. Effects on CAHs
We proposed to remove the
requirement at § 485.627(b)(1) for CAHs
to disclose to CMS its owners or those
with a controlling interest in the CAH
or any subcontractor in which the CAH
directly or indirectly has a 5 percent or
more ownership interest in accordance
with 42 CFR part 420, subpart C. We
discuss the economic impact of this
provision in the ICR section, which is
estimated at $143,701 in total savings
for all CAHs. We also discussed the
burden reduction for our proposed
revision of the ‘‘patient care policies’’
requirements imposed on CAHs in the
ICR section of this rule, which is
estimated at $2.6 million. Finally, the
effects of the CAH swing-bed provisions
are covered in the ICR section of the
rule, and estimated to be $76.5 million
for all CAHs.
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h. Effects on CORFs
We discussed the burden reduction
for our proposed revision of the
‘‘utilization review plan’’ requirements
imposed on CORFs in the ICR section of
this rule, which is estimated at
$315,840.
i. Effects on CMHCs
We discussed the burden reduction
for our proposed revision of
§ 485.914(d)(1) ‘‘update of the
comprehensive assessment’’
requirements imposed on CMHCs in the
ICR section, which is an estimated
savings of $156,975.
j. Effects on Portable X-Ray Services
At § 486.104 we proposed to revise
the portable x-ray CfCs to focus on the
qualifications of the technologist
performing the diagnostic test. As of
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May 2017 there were approximately 500
Medicare-participating portable x-ray
suppliers employing an estimated 5,000
portable x-ray technologists. Hiring
limited x-ray technologists or those with
State licensure would allow portable xray suppliers to fill vacant positions at
a lower hourly cost. Assuming a 10
percent annual turnover rate, all
technologists could be hired at the
lower salary over a period of 10 years.
Limited x-ray technologists can be hired
for approximately $30 an hour ($62,400
per year), whereas, according to the
BLS, x-ray technologists with advanced
certification (ARRT) are hired at a rate
of approximately $60 dollars per hour
($124,800 per year). This creates a
savings opportunity of $30 per hour, or
$62,400 per year, per technologist
position. Based on an assumed 10
percent turnover rate, or 500 positions
filled in any given year, this change
would create a savings of $31,200,000
savings in the first year. We believe that
these savings would be increased every
year as more positions are filled at the
lower salary rate.
We discuss the economic impact for
the requirements regarding written
orders in the ICR section of this rule,
which represents $27.7 million in
savings.
We requested public comment
regarding these burden estimates, and
additional regulatory reforms to reduce
the burden of the portable x-ray CfCs,
but did not receive any comments
specific to our solicitation.
k. Effects on RHCs and FQHCs
We discussed the burden reduction
for our revision of § 491.9(b)(4) ‘‘review
of patient care policies’’ requirements
imposed on RHCs and FQHCs in the ICR
section, which is an estimated savings
of $7.3 million biennially, or
approximately $3.7 million annually.
In addition, the burden reduction for
our revision of § 491.11(a) ‘‘program
evaluation’’ requirements imposed on
RHCs and FQHCs in the ICR section of
this rule, which is an estimated savings
of $9.9 million biennially, or
approximately $5 million annually.
l. Effects of Emergency Preparedness
Requirements on Providers and
Suppliers
The revisions to the emergency
preparedness requirements for Medicare
and Medicaid participating providers
and suppliers, as discussed in section
II.M, either simplify the requirements,
eliminate duplicative requirements, or
reduce the frequency in which
providers would need to comply with
the emergency preparedness
requirements. We estimate that the
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51801
finalized changes to the emergency
preparedness requirements would
accrue an annual cost savings of $124
million in total. The potential, estimated
cost savings for each revised emergency
preparedness requirement is outlined in
detail below. The methodology used to
calculate the economic impact and the
costs associated with the changes to the
emergency preparedness requirements
is the same methodology used to
calculate the economic impact in the
Emergency Preparedness final rule (81
FR 63860).
At § 482.15(a), (b), (c), and (d) for
hospitals and parallel regulatory
citations for other facilities, we are
finalizing our proposal for all providers,
except LTC facility providers, to review
their program at least every 2 years. We
discuss the economic impact for this
requirement in the ICR section of this
rule, which represents annualized cost
savings of $69,639,324, or
approximately $139 million biennially.
At § 482.15(a)(4) for hospitals, and
other parallel citations for the facilities
mentioned in section II.J.2 of the rule,
we eliminated the requirement that
facilities document efforts to contact
local, tribal, regional, State, and Federal
emergency preparedness officials and
that facilities document participation in
collaborative and cooperative planning
efforts. We discuss the economic impact
for this requirement in the ICR section
of this rule, which represents
$7,319,255 in savings.
At § 482.15(d)(1)(ii) for hospitals, and
other parallel citations for other
facilities mentioned in section II.J.2 of
the rule, we are finalizing our proposal
for all providers, except LTC facilities,
to require that facilities provide training
biennially, or every 2 years, after
facilities conduct initial training on
their emergency program. In addition,
we are requiring additional training
when the emergency plan is
significantly updated. We discuss the
economic impact for this requirement in
the ICR section of this rule, which
represents annualized cost savings of
$25,593,781, or approximately $51
million biennially.
Finally, at § 482.15(d)(2), we are
finalizing our proposal to require that
providers of inpatient services
mentioned in section II.J.2 of the rule
conduct two testing exercises annually,
one of which may be an exercise of their
choice that must be either a communitybased full-scale exercise (if available),
an individual facility-based functional
exercise, a drill, a tabletop exercise or
workshop that includes a group
discussion led by a facilitator. We are
requiring that providers of outpatient
services mentioned in section II.J.2 of
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the rule conduct one testing exercise
annually which must be either a
community-based full-scale exercise (if
available) or an individual facility-based
functional exercise every other year, and
in the opposite years, may be either a
community-based full-scale exercise (if
available), a facility-based functional
exercise, a drill, or a tabletop exercise or
workshop that includes a group
discussion led by a facilitator. We
discuss the other economic impacts for
this requirement in the ICR section,
which represents $9,296,422 in savings.
We do not estimate any economic
impact for the providers of inpatient
services as we did not propose any
changes to the number of testing
exercises that must be conducted by
these providers; however, we estimate
an additional economic impact for this
provision for each outpatient provider
due to a reduction in the testing
requirement from two exercises per year
to one exercise per year. We would like
to note that for CORFs and
Organizations, consistent with the
Emergency Preparedness Final Rule
(Medicare and Medicaid Programs;
Emergency Preparedness Requirements
for Medicare and Medicaid Participating
Providers and Suppliers; Final Rule, 81
FR 63860), the CoPs for these providers
previously required them to have
ongoing drills and exercises to test their
disaster plans. Therefore, we continue
to expect, as we did in the Emergency
Preparedness final rule, that the
economic impact to comply with this
requirement will be minimal, if any.
Therefore, the total economic impact of
this provision for CORFs and
Organizations will be limited to the
estimated ICR burden of $56,212 and
$310,362, respectively.
We estimate a total impact savings of
$11,238,093 for this change. With an
estimated ICR savings of $9,296,422, we
estimate that the total economic impact
of this policy for the affected providers
will be $20,534,515. We list a summary
of the calculation for the impact savings
accrued by removing this requirement
for each facility in Table 16, based on
facility numbers available as of May
2017.
• ASCs: Combined total savings of
$2,000,520 for 5,557 ASCs ((4 hours for
an administrator at $109 per hour plus
4 hours for a registered nurse at $71 per
hour) × 5,557 ASCs × 50 percent).
• Outpatient Hospice: Combined total
savings of $1,438,240 ((4 hours for an
administrator at $107 per hour plus 4
hours for a registered nurse at $71 per
hour) × 4,040 outpatient hospices × 50
percent).
• PACE: Combined total savings of
$16,543 ((1 hour home for a care
coordinator at $71 per hour plus 1 hour
for a quality improvement nurse at $71)
× 233 PACEs × 50 percent).
• HHAs: Combined total savings of
$2,695,224 ((2 hours for an
administrator at $107 per hour plus 3
hours for a director of training at $71
per hour) × 12,624 HHAs × 50 percent).
• CMHCs: Combined total savings of
$60,214 ((5 hours for an administrator at
$107 per hour plus 3 hours for a nurse
at $71 per hour) × 161 CMHCs × 50
percent).
• OPOs: Combined total savings of
$5,162 ((1 hour for a QAPI Director at
$107 per hour plus 1 hour for an
education coordinator at $71 per hour)
× 58 OPOs × 50 percent).
• RHCs/FQHCs: Combined total
savings of $4,284,104 (((4 hours for an
administrator at $107 per hour plus 4
hours for a registered nurse at $71 per
hour) × 4,160 RHCs × 50 percent)
$1,480,960+ (4 hours for an
administrator at $107 per hour plus 4
hours for a registered nurse at $71 per
hour) × 7,874 FQHCs × 50 percent)
2,803,144.
• ESRDs: Combined total savings of
$738,086 ((1 hour for an administrator at
$107 per hour plus 1 hour for a nurse
manager at $107 per hour) × 6,898
dialysis facilities × 50 percent).
TABLE 16—COST SAVINGS FOR EMERGENCY PREPAREDNESS TESTING
Provider/supplier
Cost savings per
provider/supplier
ASCs .............................
Hospices (outpatient) ....
PACEs ...........................
HHAs .............................
CMHCs ..........................
OPOs .............................
RHCs/FQHCs ................
$360
356
71
214
374
89
356
ESRD Facilities .............
107
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m. One-Time Implementation Costs
All of the changes presented above
will necessarily have to be read, and
understood, and implemented by
affected providers. This will create onetime costs even though the underlying
change reduces burden. In most cases
these costs will be very low, and may
be as simple as observing that a
particular procedure will need only to
be performed once rather than twice a
year, and changing the schedule
accordingly. In some cases, the facility
will need to adjust in response to
multiple burden reduction changes. In
still other cases, time will have to be
spent deciding how to change existing
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Combined total savings
$2,000,520 for 5,557 ASCs.
$1,438,240 for 4,040 outpatient hospice facilities.
$16,543 for 233 PACEs.
$2,695,224 for 12,624 HHAs.
$60,214 for 161 CMHCs.
$5,162 for 58 OPOs.
$4,284,104 for RHCs and FQHCs ($1,480,960 for 4,160 RHCs and $2,803,144 for 7,874
FQHCs).
$738,086 for 6,898 dialysis facilities.
policy. For example, as discussed
previously, ASCs and hospital
outpatient facilities will need to decide
whether and in what circumstances
medical histories and physical
examinations will be required or
encouraged as a matter of policy. Rather
than attempt to estimate these
situational variables in detail for each
facility type, we believe it possible to
make reasonable overall estimates of
these one-time costs, recognizing that
there will be considerable variations
among provider types and among
individual providers.
In total, there are about 122 thousand
affected entities, as shown in the Table
17 that follows. We assume that on
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average there will be 1 hour of time
spent by a lawyer, 2 hours of time by an
administrator or health services
manager, and 2 hours of time by other
staff (we assume registered nurses or
equivalent in wage costs) of each
affected provider to understand the
regulatory change(s) and make the
appropriate changes in procedures. We
further estimate that for one tenth of
these providers, 2 hours of physician
time will be needed to consider changes
in facility policy. Average hourly costs
for these professions, with wage rates
doubled to account for fringe benefits
and overhead costs, are $136 for
lawyers, $107 for managers, $71 for
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registered nurses, and $203 for
physicians based on 2017 BLS data.
The estimated costs for an average
provider would therefore be 1 hour at
$136 and in total for the lawyers, 2
hours at $107 or $214 in total for the
managers, 2 hours at $71 or $142 in total
for the other staff, and 0.2 hours at $203
or $41 in total for the physicians. These
one-time costs add up to $533 per
provider on average, and in total to
about $65 million.
TABLE 17—ONE-TIME
IMPLEMENTATION COSTS
Provider type
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Religious Nonmedical Health Care
Institutions ....................................
Ambulatory Surgical Centers and
hospital outpatient .......................
Hospices ..........................................
Hospitals ..........................................
Transplant programs .......................
Home Health Agencies ...................
Critical Access Hospitals .................
Comprehensive Outpatient Rehabilitation Facilities ........................
Community Mental Health Centers
Portable X-Ray Services .................
Rural Health Clinics and Federally
Qualified Health Centers .............
Emergency Preparedness of Providers and Suppliers ....................
Number of
affected
providers
18
10,587
4,602
4,823
750
12,624
1,353
188
52
500
12,034
74,246
Total Number of Providers ..........
Average Cost Per Provider .............
121,982
$533
Total One-Time Cost ...................
$65,016,406
n. Effects on Small Entities, Effects on
Small Rural Hospitals, Unfunded
Mandates, and Federalism
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, we
estimate that almost all health care
providers regulated by CMS are small
entities as that term is used in the RFA
(including small businesses, nonprofit
organizations, and small governmental
jurisdictions). The great majority of
hospitals and most other health care
providers and suppliers are small
entities, either by being nonprofit
organizations or by meeting the SBA
definition of a small business (having
revenues of less than $8 million to $41.5
million in any 1 year, varying by type
of provider and highest for hospitals).
Accordingly, almost all of the savings
that the rule will create benefits small
entities. We note that individual
persons are not small entities for
purposes of the RFA, and hence the lifeextending transplantation benefits of the
rule are not relevant to the RFA.
The RFA requires that a final
regulatory flexibility analysis (FRFA) be
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prepared if a final rule would have a
‘‘significant impact on a substantial
number’’ of such entities. HHS
interprets the statute as mandating this
analysis only the impact is adverse,
though there are differing
interpretations. Regardless, there is no
question that the final rule would affect
a ‘‘substantial number’’ of small entities.
As shown in Table 17, the total number
of affected entities will be about
122,000, including those affected by
more than one provision. The rule of
thumb used by HHS for determining
whether an impact is ‘‘significant’’ is an
effect of 3 percent or more of annual
revenues. These savings do not
approach that threshold. Hospitals
account for about one-third of all health
care spending and even if all these
savings accrued to hospitals this
threshold would not be approached.
Therefore, the Secretary has determined
that these provisions of the final rule
will not have a significant economic
impact on a substantial number of small
entities.
In addition, section 1102(b) of the
Social Security Act requires us to
prepare a regulatory impact analysis if
a rule may have a significant impact on
the operations of a substantial number
of small rural hospitals. This analysis
must conform to the provisions of
section 604 of the RFA. For purposes of
section 1102(b) of the Act, we define a
small rural hospital as a hospital that is
located outside of a metropolitan
statistical area and has fewer than 100
beds. For the reasons previously given,
the Secretary has determined that these
provisions of the final rule will not have
a significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2019, that
threshold is approximately $154
million. These provisions of the final
rule contain no mandates that will
impose spending costs on State, local, or
tribal governments, or on the private
sector. Indeed, it substantially reduces
existing private sector mandates.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has federalism implications.
The final rule imposes no such
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51803
requirements. Importantly, it would
remove Federal requirements setting
qualification standards for hospice
aides. Setting qualifications for health
care workers is traditionally a State
function, and this change would
therefore remove an infringement on
State prerogatives.
o. Effects on Costs to Facilities,
Providers, Medicare, Other Insurance,
and Patients
Most of the individual proposals
addressed in the preceding analysis
involve reducing burdensome costs on
facilities, health care professionals, and
patients. Most of those reductions save
time and effort currently performed on
tasks that we proposed to eliminate or
reform and those reductions will result
ultimately in reduced medical care costs
in these facilities, some of which will
result in further effects on public and
private insurance costs. In this regard, it
is important to emphasize that the CoPs
and CfCs generally apply to all patients
served by a Medicare and/or Medicaid
participating provider or supplier, not
just Medicare or Medicaid patients, and
to the entire operations of the provider.
Revisions to those requirements apply
broadly to the entire health care system.
We are hopeful that cost reductions
ultimately flow to reductions in charges,
to reductions in third party payments,
and hence to reductions in insurance
costs and to those who pay those costs.
Initial savings will accrue primarily to
providers. How much of these savings
will flow to insurers and patients
depends primarily on the payment and
reimbursement mechanisms in place for
each affected entity for those particular
costs. According to the National Health
Expenditure Accounts, approximate
payer shares in 2016 were 11 percent for
consumer out of pocket, 35 percent for
private health insurance, 21 percent for
Medicare, 18 percent for Medicaid, and
15 percent for other public and private
payers such as the Department of
Veteran Affairs and the Department of
Defense. We would expect savings to
approximate these shares. Ultimately,
all costs are paid by workers and
taxpayers who pay for all health care
directly or indirectly, quite apart from
immediate cost subsidies or cost
sharing.
Two provisions directly reduce
Medicare and other insurance costs.
Eliminating unnecessary patient history
and physical examinations and medical
tests for procedures (such as cataract
surgery) performed in ASCs and in
hospital outpatient surgery will
disproportionately reduce Medicare
costs, since use of these services rises
with age. Additional transplantation of
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kidneys will reduce Medicare’s ESRD
costs, partially offset by increased
transplantation costs. Because of the
difficulty in finding evidence of the
volume of such savings, we cannot
estimate the likely effects on Medicare
spending.
Most of the facility and provider
savings will accrue to Medicare and
other insurers over time as payment rate
increases are slightly reduced, and the
remainder will accrue to other payers
and to patients.
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p. Benefits to Patients
We discussed life-extending and lifesaving benefits at length in the analysis
of increases in transplantation. These
result from removal of disincentives to
transplant patients, or to use organs,
where this could reduce success rates by
a few percent and possibly trigger
closure of transplant centers or
programs under current rules. As
previously explained, we do not have
robust estimates. There are additional
and substantial patient benefits likely to
result from the cost-reducing reforms
that we proposed. Time not wasted by
medical care providers or facilities on
unnecessary tasks is time that can be
used to focus on better care. While such
effects could be measured in principal,
there is little existing data on
magnitudes of such effects. We
requested but did not receive public
comments on these or any other aspects
of costs and benefits of the proposed
rule.
4. Alternatives Considered
From within the entire body of CoPs
and CfCs, we selected what we believe
to be the most viable candidates for
reform as identified by stakeholders, by
recent research, or by experts as
unusually burdensome. This subset of
the universe of standards is the focus of
the proposed rule. For all of the
proposed provisions, we considered not
making these changes. Ultimately, we
saw no good reasons not to finalize
these burden reducing changes.
We welcomed comments on whether
we properly selected the best candidates
for change, and welcomed suggestions
for additional reform candidates from
the entire body of CoPs and other
regulatory provisions that fall directly
on providers. As discussed earlier in
this preamble, we did receive
suggestions for additional reforms and
will consider those in future reform
efforts.
5. Uncertainty
Our estimates of the effects of this
regulation are subject to significant
uncertainty. While the Department is
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confident that these reforms will
provide flexibilities to facilities that will
yield major cost savings, there are
uncertainties about the magnitude of
these effects. Despite these
uncertainties, we are confident that the
rule will yield substantial overall cost
reductions and other benefits. In this
analysis we have provided estimates to
suggest the potential savings these
reforms could achieve under certain
assumptions. We appreciate that those
assumptions are simplified, and that
actual results could be substantially
higher or lower. Although there is
uncertainty concerning the magnitude
of all of our estimates, we do not have
the data to provide specific estimates for
each reform proposed, as to the range of
possibilities, or to estimate all categories
of possible benefits, including health
effects.
6. Conclusion
These provisions of the final rule will
substantially reduce existing regulatory
requirements imposed on health care
providers through the CoPs and related
regulatory provisions that Medicare and
Medicaid providers must meet. For
some provisions, health benefits to
patients will be substantial and direct.
Other provisions will free up time and
efforts of health care providers to focus
on improving health care quality and
service delivery. Although this rule does
not require a final regulatory flexibility
analysis, we believe the preceding
analysis meets the requirements for
such an analysis as set out in § 604 of
the Regulatory Flexibility Act. In
addition, the analysis above, together
with the remainder of this preamble,
provides a regulatory impact analysis.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
B. Regulatory Impact Statement for Fire
Safety Requirements for Certain Dialysis
Facilities
We have examined the impact of
these regulatory provisions as required
by Executive Order 12866 on Regulatory
Planning and Review (September 30,
1993), Executive Order 13563 on
Improving Regulation and Regulatory
Review (January 18, 2011), the
Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354),
section 1102(b) of the Social Security
Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (March
22, 1995; Pub. L. 104–4), Executive
Order 13132 on Federalism (August 4,
1999), the Congressional Review Act (5
U.S.C. 804(2)), and Executive Order
13771 on Reducing Regulation and
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Controlling Regulatory Costs (January
30, 2017).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
(RIA) must be prepared for major rules
with economically significant effects
($100 million or more in any 1 year).
We do not know how many, if any,
dialysis facilities would be affected by
this adoption of the 2012 editions of the
NFPA 101 and NFPA 99. All States have
adopted the 2012 editions, so as a
practical matter, all dialysis facilities are
already following the 2012
requirements. Therefore, we do not
anticipate any impact on the applicable
dialysis facilities.
Accordingly, these provisions do not
reach the economic threshold and thus
are neither economically significant
under Executive Order 12866, nor a
major rule under the Congressional
Review Act.
The RFA requires agencies to analyze
options for regulatory relief of small
entities, and to prepare a final
regulatory flexibility analysis if a rule is
found to have a significant impact on a
substantial number of small entities. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and small governmental
jurisdictions. Most hospitals and most
other providers and suppliers are small
entities, either by nonprofit status or by
having revenues of less than $7.5
million to $38.5 million in any 1 year.
Individuals and States are not included
in the definition of a small entity. We
are not preparing a final regulatory
flexibility analysis because we have
determined, and the Secretary certifies,
that these provisions of the final rule
will not have a significant economic
impact on a substantial number of small
entities.
In addition, section 1102(b) of the
Social Security Act (the Act) requires us
to prepare a regulatory impact analysis
if a rule may have a significant impact
on the operations of a substantial
number of small rural hospitals. This
analysis must conform to the provisions
of section 604 of the RFA. For purposes
of section 1102(b) of the Act, we define
a small rural hospital as a hospital that
is located outside of a Metropolitan
Statistical Area for Medicare payment
regulations and has fewer than 100
beds. We are not preparing an analysis
for section 1102(b) of the Act because
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we have determined, and the Secretary
certifies, that these provisions of the
final rule will not have a significant
impact on the operations of a substantial
number of small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2019, that threshold is approximately
$154 million. These provisions will
have no consequential effect on State,
local, or tribal governments or on the
private sector.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
Since these provisions do not impose
any costs on State or local governments,
the requirements of Executive Order
13132 are not applicable.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
F. Regulatory Impact Analysis for
Hospital and Critical Access Hospital
Changes To Promote Innovation,
Flexibility, and Improvement in Patient
Care
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1. Statement of Need
CMS is aware, through conversations
with stakeholders and federal partners,
and as a result of internal evaluation
and research, of outstanding concerns
about CoPs for hospitals and CAHs,
despite recent revisions. We believe that
the revisions will alleviate many of
those concerns. In addition,
modernization of the requirements
would cumulatively result in improved
quality of care and improved outcomes
for all hospital and CAH patients. We
believe that benefits would include
reduced readmissions, reduced
incidence of hospital-acquired
conditions (including healthcareassociated infections), improved use of
antibiotics at reduced costs (including
the potential for reduced antibiotic
resistance), and improved patient and
workforce protections.
These benefits are consistent with
former HHS Quality Initiatives,
including efforts to prevent HAIs; the
national action plan for adverse drug
event (ADE) prevention; the national
strategy for Combating AntibioticResistant Bacteria (CARB); and the
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Department’s National Quality Strategy
(https://www.ahrq.gov/
workingforquality/).
Principles of the National Quality
Strategy supported by the proposed rule
include eliminating disparities in care;
improving quality; promoting consistent
national standards while maintaining
support for local, community, and Statelevel activities that are responsive to
local circumstances; care coordination;
and providing patients, providers, and
payers with the clear information they
need to make choices that are right for
them (https://www.ahrq.gov/
workingforquality/nqs/principles.htm).
Our proposal to prohibit discrimination
would support eliminating disparities in
care, and we believe our proposals
about QAPI and infection prevention
and control and antibiotic stewardship
programs will improve quality and
promote consistent national standards.
Our proposals regarding the term
licensed independent practitioners and
establishing policies and protocols for
when the presence of an RN is needed
will support care coordination and
quality of care. In sum, we believe our
proposed changes are necessary, timely,
and beneficial. We are finalizing most of
the aforementioned proposals.
2. Overall Impact
We have examined the impacts of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999), the Congressional
Review Act (5 U.S.C. 804(2)), and
Executive Order 13771 on Reducing
Regulation and Controlling Regulatory
Costs (January 30, 2017).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule: (1) Having an annual
effect on the economy of $100 million
or more in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
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51805
jobs, the environment, public health or
safety, or state, local or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). We
estimate that this rulemaking is
‘‘economically significant’’ as measured
by the $100 million threshold, and
hence also a major rule under the
Congressional Review Act. Accordingly,
we have prepared a regulatory impact
analysis (RIA) that, to the best of our
ability, presents the costs and benefits of
the rulemaking.
The Congressional Review Act, 5
U.S.C. 801 et. seq., as added by the
Small Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each chamber of the
Congress and to the Comptroller General
of the United States. HHS will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register.
The final rule would create ongoing
cost savings to hospitals and CAHs in
many areas. We believe these savings
would largely, but not necessarily
entirely, offset any costs to hospitals
and CAHs that would be incurred by
other changes we are finalizing in this
rule. The financial savings and costs are
summarized in Table 18.
We sought public comment on our
burden assumptions and estimates as
well as comments identifying additional
reforms that should be considered for
future rulemakings. As is usually the
case in impact analysis, substantial
uncertainty surrounds these estimates
and we solicited comments on any
suggestions or data that would inform
our estimates for the final rule.
Comment: We received a comment
that was generally in support of the
changes proposed and the goals of those
changes; however, the commenter was
concerned that the rule dramatically
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underestimates the time and effort
required for compliance with the
antibiotic stewardship and Quality
Assessment and Performance
Improvement (QAPI) programs.
Response: We note that since the
QAPI requirement will replace the
annual evaluation requirement, we
believe many of those resources could
be reallocated to QAPI activities to
minimize burden. In addition, we have
re-evaluated our proposed requirements
and eliminated unnecessary
prescriptiveness, allowing each CAH the
flexibility to implement its QAPI
program in the most efficient manner for
its unique circumstances. With regards
to the antibiotic stewardship program,
we have expanded on our cost estimates
to account for a more robust
intervention, and presented a range of
estimates to account for uncertainty.
Comment: We received a comment
expressing concern over whether the
costs of implementing the infection
prevention and control program were
underestimated due to the additional
training and technical assistance that
would be required for the individual
fulfilling the infection preventionist role
in CAHs.
Response: We thank you for your
comment, and we agree that the burden
for CAHs due to the infection
preventionist role was underrepresented
in the proposed rule. We have revised
our estimates to account for that error in
this final rule.
TABLE 18—SECTION-BY-SECTION ECONOMIC IMPACT ESTIMATES
Number of
affected
entities
Issue
Frequency
Hospitals .......................................................................
• Patients’ rights (RIA) ..........................................
• Nursing services (ICR) ......................................
• Nursing services (ICR) ......................................
• Infection Prevention & Control ...........................
and Antibiotic Stewardship (RIA) .......................
CAHs ............................................................................
• QAPI (ICR) .........................................................
• Food and dietary (RIA) ......................................
• Infection Prevention & Control ...........................
.......................................................................................
One-time .......................................................................
Every 3 years ...............................................................
One-time .......................................................................
One-time .......................................................................
Recurring annually ........................................................
.......................................................................................
Recurring annually ........................................................
Recurring annually ........................................................
One-time .......................................................................
Recurring annually ........................................................
Recurring annually ........................................................
and Antibiotic Stewardship (RIA) .......................
4,823
4,823
1,193
1,193
4,823
482
1,353
1,004
677
1,353
1,004
501
Estimated
net costs
($ millions) *
........................
Not estimated
1
2
20
¥23
........................
1
¥5
6
148
¥27
Note: This table includes entries only for those proposed reforms that we believe would have a measurable economic effect; includes estimates from ICRs and RIA. Negative costs indicate cost savings.
* Amounts rounded to the nearest million.
3. Anticipated Effects
There are about 4,823 hospitals and
1,353 CAHs that are certified by
Medicare and/or Medicaid. We use
these figures to estimate the potential
impacts of the final rule. In the
estimates that were shown in the
Collection of Information Requirements
section of the preamble and in the RIA
here, we estimate hourly costs as
follows. Using May 2017 data from the
Bureau of Labor Statistics, we have
obtained estimates of the national
average hourly wage for all medical
professions (https://www.bls.gov/oes/
2017/may/oes_nat.htm). We have
adjusted these rates by adding 100
percent to the hourly wage to account
for overhead costs and fringe benefit
costs. We use the following average
hourly wages in our estimates:
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TABLE 19—HOURLY COSTS BY
PROFESSION
Registered dietitians and nutrition professionals ..........................................
Registered nurses ................................
Advanced practice registered nurses ...
Physician assistants .............................
Pharmacists ..........................................
Network data analysts ..........................
Hospital CEO/administrators ................
CAH CEO/administrators ......................
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$58
71
103
101
117
89
189
107
TABLE 19—HOURLY COSTS BY
PROFESSION—Continued
Clerical staff workers ............................
Physicians .............................................
Clinical Laboratory Technicians ...........
33
191
51
a. Effects on Hospitals
(1) Licensed Independent Practitioners
(Patients’ Rights § 482.13)
We are finalizing our proposal to
delete the modifying term
‘‘independent’’ from the CoP at
§ 482.13(e)(5), as well as at
§ 482.13(e)(8)(ii). While we believe that
hospitals might be able to achieve some
costs savings through these changes (by
having additional licensed practitioners
such as PAs allowed to write restraint
and seclusion orders and thus relieve
some of the burden from physicians),
we do not have a reliable means of
quantifying these possible cost savings.
We solicited comments as to whether
the assumption of cost savings is
reasonable and welcomed any data that
may help inform the costs and benefits
of this provision, but did not receive
any comments specific to our
solicitation.
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(2) Infection Control and Antibiotic
Stewardship (Infection Prevention and
Control § 482.42)
We are revising the hospital
requirements at 42 CFR 482.42,
‘‘Infection control,’’ which currently
require hospitals to provide a sanitary
environment to avoid sources and
transmission of infections and
communicable diseases. Hospitals are
also currently required to have a
designated infection control officer, or
officers, who are required to develop a
system to identify, report, investigate
and control infections and
communicable diseases of patients and
personnel. The hospital’s CEO, medical
staff, and director of nursing services are
charged with ensuring that the problems
identified by the infection control
officer or officers are addressed in
hospital training programs and their
QAPI program. The CEO, medical staff,
and director of nursing services are also
responsible for the implementation of
successful corrective action plans in
affected problem areas.
We are finalizing our proposal to
change to the title of this CoP to
‘‘Infection prevention and control and
antibiotic stewardship programs.’’ By
adding the word ‘‘prevention’’ to the
CoP name, our intent is to promote
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larger, cultural changes in hospitals
such that prevention initiatives are
recognized on balance with their
current, traditional control efforts. And
by adding ‘‘antibiotic stewardship’’ to
the title, we would emphasize the
important role that a hospital could play
in improving patient care and safety and
combatting antimicrobial resistance
through implementation of a robust
stewardship program that follows
nationally recognized guidelines for
appropriate antibiotic use. Along with
these changes, we proposed to change
the introductory paragraph to require
that a hospital’s infection prevention
and control and antibiotic stewardship
programs be active and hospital-wide
for the surveillance, prevention, and
control of HAIs and other infectious
diseases, and for the optimization of
antibiotic use through stewardship. We
will also require that a program
demonstrate adherence to nationally
recognized infection prevention and
control guidelines for reducing the
transmission of infections, as well as
best practices for improving antibiotic
use, for reducing the development and
transmission of HAIs and antibioticresistant organisms. While these
particular changes are new to the
regulatory text, it is worth noting that
these requirements, with the exception
of the new requirement for an antibiotic
stewardship program, have been present
in the Interpretive Guidelines (IGs) for
hospitals since 2008 (See A0747 at
Appendix A—Survey Protocol,
Regulations and Interpretive Guidelines
for Hospitals, https://cms.gov/manuals/
Downloads/som107ap_a_hospitals.pdf).
(a) Infection Prevention and Control
Each hospital will be required to
review their current infection control
program and compare it to the new
requirements contained in this section.
After performing this comparison, each
hospital will be required to revise their
program so that it complies with the
requirements in this section. Based on
our experience with hospitals, we
believe that a physician and a nurse on
the infection control team will conduct
this review and revision of the program.
We believe both the physician and the
nurse will spend 16 hours each for a
total of 32 hours. According to BLS data,
doubled to account for overhead costs
and fringe benefits, physician time costs
an average of $191 an hour, and nurses’
time costs an average wage of $71 an
hour. Thus, to ensure their infection
control program complied with the
requirements in this section, we
estimate that each hospital will require
32 burden hours (16 hours for a
physician and 16 hours for a nurse) at
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a cost of $4,192 ($3,056 ($191 an hour
for a physician × 16 burden hours) +
$1,136 ($71 an hour for a nurse × 16
burden hours)). Based on the estimate,
for all 4,823 hospitals, complying with
this requirement will require 154,336
burden hours (32 hours for each
hospital × 4,823 hospitals) at a one-time
cost of approximately $20 million
($4,192 for each hospital × 4,823
hospitals).
At § 482.42(a)(1), we are finalizing our
proposal to require the hospital to
appoint an infection preventionist(s)/
infection control professional(s). Within
this change we are deleting the outdated
term, ‘‘infection control officer,’’ and
replacing it with the more current and
accurate terms, ‘‘infection preventionist/
infection control professional.’’ CDC has
defined ‘‘infection control professional
(ICP)’’ as ‘‘a person whose primary
training is in either nursing, medical
technology, microbiology, or
epidemiology and who has acquired
specialized training in infection
control.’’ In designating infection
preventionists/ICPs, hospitals should
ensure that the individuals so
designated are qualified through
education, training, experience, or
certification (such as that offered by the
CBIC, or by the specialty boards in adult
or pediatric infectious diseases offered
for physicians by the American Board of
Internal Medicine (for internists) and
the American Board of Pediatrics (for
pediatricians).
Since this requirement has been
present in the IGs since 2008, we
believe that hospitals have been aware
of CMS’ expectations for the
qualifications of infection control
officers. The Joint Commission has a
similar requirement (TJC Accreditation
Standard IC.01.01.01). We believe that
hospitals accredited by TJC (over 75
percent of all hospitals (https://
www.jointcommission.org/facts_about_
hospital_accreditation/)) should already
be in compliance, or near compliance,
with this requirement. The Joint
Commission requires that a hospital
identify the individual(s) responsible for
its infection prevention and control
program, including the individual(s)
with clinical authority over the
infection prevention and control
program. For these reasons, we do not
anticipate any new recurring burden to
hospitals attributable to appointing an
infection preventionist.
(b) Antibiotic Stewardship (AS)
At § 482.42(b), we believe that the
finalized requirements for a hospital to
have an active antibiotic stewardship
program, and for its organization and
policies, would constitute additional
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51807
regulatory burden, as will be discussed
in more detail below. However, we
believe that the estimated costs of an AS
program would be greatly offset by the
savings that a hospital would achieve
through such a program. The most
obvious savings would be from
decreased inappropriate antibiotic use
leading to overall decreased drug costs
for a hospital. Antimicrobial costs,
particularly antibiotic costs, often
constitute a significant percentage of the
pharmacy budget for a hospital, so
reducing overall antibiotic use would
most likely have a substantial impact in
lowering overall drug costs for a
hospital. In fact, our review of the
literature showed significant savings in
this area, with annual savings
proportional to bed size of the hospital
or hospital unit. Reported annual
savings ranged from $27,917 (Canadian
dollars) for a 12-bed medical/surgical
intensive care unit to $2.1 million for an
880-bed academic medical center.6 7
We specifically note the $177,000 in
annual drug cost savings achieved by a
120-bed community hospital with its AS
program for the year of 2000 compared
to 1999, and would use that as the
average cost savings for the averagesized 124-bed hospital discussed above
(LaRocco 2003, CID ‘‘Concurrent
antibiotic review programs—a role for
infectious diseases specialists at small
community hospitals’’). Inflating this
number to 2017 dollars using the
consumer price index yields
approximately $258,000. According to
NHSN survey data, almost 82 percent of
hospitals were implementing all 7 of
CDC’s core elements of hospital
antibiotic stewardship programs in
2017. This is significantly higher than
the estimate published in the proposed
rule, because the number of hospitals
implementing AS programs has
increased dramatically in the past
several years. This is primarily driven
by large accrediting organizations
announcing and implementing their
own antimicrobial stewardship
standards. Preliminary 2018 data
suggest that this upward trend of AS
programs is likely to continue to some
degree; however, since the the
antimicrobial stewardship standards are
already in effect for one of the largest
6 Leung V., Gill S., Sauve J., Walker K., Stumpo
C., Powis J. Growing a ‘‘positive culture’’ of
antimicrobial stewardship in a community hospital.
The Canadian journal of hospital pharmacy. 2011;
64(5):314–20.
7 Beardsley J.R., Williamson J.C., Johnson J.W.,
Luther V.P., Wrenn R.H., Ohl C.C. Show me the
money: Long-term financial impact of an
antimicrobial stewardship program. Infection
control and hospital epidemiology: The official
journal of the Society of Hospital Epidemiologists
of America. 2012; 33(4):398–400.
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accrediting bodies as of January 2017,
we would expect a sharp decline in the
marginal rate of AS implementation in
2017 and beyond without further
intervention. Therefore, for our baseline
we have projected that approximately
90% of hospitals would have AS
programs in 2018 were the rate of
adoption to decrease by half, and we
assume that is approximately where the
market would level off absent further
intervention. We have accounted for
this uncertainty by providing estimates
in the accounting statement that are 25
percent higher or lower than our
primary estimate. Accordingly, we
estimate that the annual drug cost
savings for 10 percent of all 4,823
hospitals under the rule would be
approximately $124 million (482
hospitals × $258,000). While most of the
evidence we reviewed showed clear
savings through reduced hospital
pharmacy costs that was a direct result
of reduced antibiotic use, some studies
also demonstrated other financial
benefits for hospitals with AS programs,
such as decreases in patient length of
stay and readmission rates as well as
reductions in CDI rates and costs (as we
discuss in more detail in the paragraphs
to follow).
Based on the published studies that
we previously noted, we therefore also
believe that the proposed requirement
for an AS program would assist
hospitals in significantly reducing rates
of CDI and the attendant costs. Based on
an AS program model developed by the
CDC, a hospital combined IC/AS
program with an average effectiveness
rate of 50 percent would reduce the
number of CDIs among Medicare
beneficiaries annually by 101,000.8 The
costs examined in the model were costs
for patients who developed CDIs while
they were in the hospital or had to be
re-admitted to the hospital for a case of
CDI that was a result of a recent
hospitalization, so the costs are much
higher than what would be associated
with outpatient cases. The 101,000reduction is an annual reduction in the
number of cases of CDI among patients
who develop the infection because of
medical care; that is, they were admitted
for something else and then acquired
CDI while getting care. It should be
noted that the 101,000 number actually
comprises two types of CDI—cases that
occur while the patient is in the hospital
8 Rachel B. Slayton, Ph.D., MPH; R. Douglas Scott
II, Ph.D.; James Baggs, Ph.D.; Fernanda C. Lessa,
MD; L. Clifford McDonald, MD; John A. Jernigan,
MD. ‘‘The Cost–Benefit of Federal Investment in
Preventing Clostridium difficile Infections through
the Use of a Multifaceted Infection Control and
Antimicrobial Stewardship Program,’’ Infection
Control & Hospital Epidemiology 2015;00(0):1–7.
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and cases that are directly attributable to
a recent hospitalization, but which
manifest after the patient is discharged
and requires a readmission. Their study
found that the cost for patients who
develop the infection while they are
already in the hospital is between
$4,323 and $8,146. However, the
infections related to a recent hospital
stay that require readmission are more
expensive, on average, because they
require an entirely new admission; the
cost of those cases is between $7,061
and $11,601. A more recent CDC study
found the attributable patient cost
savings for health care-associated
clostridioides difficile (HCA–CDI) to be
$6,844 per prevented case, and $12,703
per prevented case of recurrent CDI
(2015 $).9 Inflating these numbers to
2017 dollars using the consumer price
index returns approximately $7,133 and
$13,240 respectively. Scott et al. built
their economic model with a range from
10 to 50 percent effectiveness, which
represents a range of between
approximately 200,000 and 1.1 million
inpatient cases of HCA–CDI averted in
a 5 year period.
For our purposes, we have based our
central estimate on the middle of the
aforementioned range, or approximately
30 percent effectiveness, resulting in
546,000 inpatient cases of HCA–CDI
averted, and 117,000 recurrent cases
averted. It is not clear exactly how many
of these averted cases would occur in
hospitals versus CAHs, but the
prevalence of existing AS programs (or
lack thereof) suggest CAHs may have
more potential for improvement despite
their smaller number of beds; there is
also a limited amount of research that
suggests the rate of CDI may be higher
in hospitals with fewer beds, possibly
due to rates of testing or other factors;
and it is also possible that CAHs serve
an older population that is more at risk
for healthcare-associated infections than
patients at non-CAHs.10 11 Therefore, we
assume an equal number of cases
averted per facility, meaning
approximately 78 percent of these
would occur in hospitals and 22 percent
in CAHs. As previously explained, we
9 R. Douglas Scott II, Rachel B. Slayton, Fernanda
C. Lessa, James Baggs, Steven D. Culler, L. Clifford
McDonald and John A. Jernigan; ‘‘Assessing the
social cost and benefits of a national requirement
establishing antibiotic stewardship programs to
prevent Clostridioides difficile infection in US
hospitals’’; Antimicrobial Resistance & Infection
Control, 2019, 8:17.
10 Kamboj M, Brite J, Aslam A, et al. Artificial
Differences in Clostridium difficile Infection Rates
Associated with Disparity in Testing. Emerging
Infectious Diseases. 2018;24(3):584–587.
11 Joynt, K. E., Harris, Y., Orav, E. J., & Jha, A. K.
(2011). Quality of care and patient outcomes in
critical access rural hospitals. JAMA, 306(1), 45–52.
doi:10.1001/jama.2011.902.
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estimate that 90 percent of hospitals
already have AS programs, and
therefore 10 percent of those averted
cases would be attributable to this
regulation. This comes to a total of
42,588 HCA–CDI cases averted, and
9,126 recurrent cases averted for
hospitals in a 5 year period. Multiplying
these averted cases by the attributable
patient cost savings, and annualizing
the amount, comes to approximately
$85 million in annualized patient cost
savings. These patient cost savings do
not include the cost savings attributable
to any averted or modified antibiotic
regimen, which was calculated above.
Thus, we estimate that the combined
annual drug cost savings and patient
cost savings will be approximately $209
million. These savings will accrue to
patients (reduced out-of-pocket costs),
hospitals (reduced costs and improved
balance sheets), as well as healthcare
insurers, including Medicare (over time,
payment rates will be adjusted
downward as hospital costs fall).
However, we are not able to apportion
the savings that would accrue to each
group with any accuracy and it will
inevitably change over time as
insurance rates change. Regardless,
healthcare-associated infections are
known to be expensive to insurers,
including CMS. Preventing these
infections will reduce CMS and other
insurer expenditures, both on direct
hospital costs and through reduced readmissions. The cost-savings estimates
for CDI included in the RIA provide an
example of the savings Medicare and
other insurers could realize through
reductions in just one HAI. Ultimately,
of course, insurance costs (and the
medical care they pay for) are paid by
taxpayers and workers. Even the
employer contribution to insurance
costs is generally regarded by
economists as part of worker
compensation. We requested comment
regarding data that would allow for
more robust quantification of the rule’s
impacts on HAIs other than CDI, but did
not receive any such comments.
We believe that the burden of
implementing and maintaining an AS
program includes the costs of the
qualified personnel needed to establish
and manage such a hospital program. In
the proposed rule, our review of the
literature, consultations with CDC, and
experience with hospitals suggested that
the establishment and maintenance of a
hospital antibiotic stewardship program
for an average-size hospital
(approximately 124 beds), would
require at least the leadership of a
physician (preferably one with training
in infectious diseases) and a clinical
pharmacist, and also the services of a
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network data analyst, at the following
proportions of full-time employee
salaries respectively: 0.10, 0.25, and
0.05. However, the latest research on the
resources required for an effective AS
program suggest that the minimum fulltime equivalent support recommended
for a hospital of this size may be
somewhat more burdensome, due to the
leadership of a pharmacist and
physician at the full time equivalents of
their salaries of 1.0 and 0.4
respectively.12 We also based our
estimates on the prior assumption that
10 percent of hospitals do not yet have
programs that implement all of the CDC
core elements. Based on these
assumptions, the minimum annual cost
of the essential team members for a
hospital to establish and maintain an
antibiotic stewardship program would
be $386,800 (($191 × 0.40 × 2,000 hours
per year = $152,800 for a physician) +
($117 × 1.00 × 2,000 hours per year =
$234,000 for a clinical pharmacist)). The
annual labor cost for 10 percent of
hospitals ($386,800 × 482) would be
approximately $186 million.
We invited public comment regarding
the amount by which costs may exceed
savings in cases of non-voluntary IC/AS
program adoption, but did not receive
comments with specific estimates.
b. Effects on CAHs
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(1) Ordering Privileges for Qualified
Dietitians (RDs) and Qualified Nutrition
Professionals (Provision of Services
§ 485.635)
We are finalizing our proposal to
revise the CAH requirements at 42 CFR
485.635 (a)(3)(vii), which currently
require that the nutritional needs of
inpatients are met in accordance with
recognized dietary practices and the
orders of the practitioner responsible for
the care of the patients. Specifically, we
proposed revisions that would change
the CMS requirements to allow for
flexibility in this area by requiring that
all patient diets, including therapeutic
diets, must be ordered by a practitioner
responsible for the care of the patient,
or by a qualified dietitian or qualified
nutrition professional as authorized by
the medical staff in accordance with
State law governing dietitians and
nutrition professionals.
With these changes to the current
requirements, a CAH will have the
12 Sarah B Doernberg, Lilian M Abbo, Steven D
Burdette, Neil O Fishman, Edward L Goodman,
Gary R Kravitz, James E Leggett, Rebekah W
Moehring, Jason G Newland, Philip A Robinson,
Emily S Spivak, Pranita D Tamma, Henry F
Chambers, Essential Resources and Strategies for
Antibiotic Stewardship Programs in the Acute Care
Setting, Clinical Infectious Diseases, Volume 67,
Issue 8, 15 October 2018, Pages 1168–1174
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regulatory flexibility to grant qualified
dietitians/nutrition professionals
specific dietary ordering privileges
(including the capacity to order specific
laboratory tests to monitor nutritional
interventions and then modify those
interventions as needed). We believe
that this is another area of change to the
requirements that might produce
savings since this will allow physicians
to delegate to a qualified dietitian or
qualified nutrition professional the task
of prescribing patient diets, including
therapeutic diets, to the extent allowed
by state law. We further believe that
dietitians or other clinically qualified
nutrition professionals are already
performing patient dietary assessments
and making dietary recommendations to
the physician (or PA or APRN) who
then evaluates the recommendations
and writes orders to implement them.
Our analysis does not take into account
improved quality of life nor improved
clinical outcomes for the patient. We do
not currently have data to more
precisely estimate the savings that this
revision could produce in CAHs.
However, we believe that it might allow
for better use of both physician/PA/
APRN and dietitian/nutrition
professional time and could result in
improved quality of life and improved
clinical outcomes for CAH patients.
More obviously, dietitians/nutrition
professionals with ordering privileges
will be able to provide dietary/
nutritional services at lower costs than
physicians (as well as APRNs and PAs,
two categories of non-physician
practitioners that have traditionally also
devised and written patient dietary
plans and orders). This cost savings
stems in some part from significant
differences in the average salaries
between the professions and the time
savings achieved by allowing dietitians/
nutrition professionals to autonomously
plan, order, monitor, and modify
services as needed and in a more
complete and timely manner than they
are currently allowed. Savings would be
realized by CAHs through the
physician/APRN/PA time and salaries
saved.
Physicians, APRNs, and PAs often
lack the training and educational
background to manage the nutritional
needs of patients with the same
efficiency and skill as dietitians/
nutrition professionals. The addition of
ordering privileges enhances the ability
that dietitians/nutrition professionals
already have to provide timely, costeffective, and evidence-based nutrition
services as the recognized nutrition
experts on a CAH interdisciplinary
team.
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51809
It might seem natural to calculate
these cost savings for CAHs based on
the following assumptions:
• There is an average hourly cost
difference of $74 between dietitians/
nutrition professionals on one side ($58
per hour) and the hourly cost average
for physicians, APRNs, and PAs ($132
per hour) on the other;
• There were 282,584 inpatient visits
by Medicare beneficiaries in 2011
(According to a December 2013 OIG
report (https://oig.hhs.gov/oei/reports/
oei-05-12-00081.pdf)) with each of these
stays requiring at least one dietary plan
and orders;
• On average, each dietary order,
including ordering and monitoring of
laboratory tests, subsequent
modifications to orders, and dietary
orders for discharge/transfer/outpatient
follow-up as needed, will take 30
minutes (0.5 hours) of a physician’s/
APRN’s/PA’s/dietitian’s/nutrition
professional’s time per patient during an
average stay; and
• We estimate that approximately 50
percent of CAHs (or approximately 677
CAHs) have not already granted
ordering privileges to dietitians and
nutrition professionals, reducing the
number of total number of CAH
inpatient stays to 141,292.
The resulting savings would be $7,722
annually on average for each CAH
(141,292 inpatient hospital stays × 0.50
hours of a physician’s/APRN’s/PA’s/
dietitian’s/nutrition professional’s time
× $74 per hourly cost difference ÷ 677
CAHs) for a total annual savings of
approximately $5.2 million. We note
that these estimates exclude some
categories of cost increases (for example,
internal CAH meetings to plan changes
and the time and other costs of training
physicians, dietitians/nutrition
professionals, and other staff on the new
dietary ordering procedures). Even more
importantly, this estimate does not
account for barriers, other than federal
regulation, to RDs receiving ordering
privileges; Weil et al. (2008) provide
evidence on the existence of such
barriers, which would likely prevent at
least some of these cost savings from
being realized.13 If such barriers are not
relevant, then there is another
adjustment that would need to be made
to the calculation. Specifically, the
dietitian wage estimate would need to
be revised because the wage data do not
account for the increase in demand for
dietitians we projected would result
from the hospital burden reduction rule
13 Weil, Sharon D., et al. ‘‘Registered Dietitian
Prescriptive Practices in Hospitals.’’ Journal of the
American Dietetic Association 108:1688–1692.
October 2008.
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finalized that same month. For the
savings estimates accompanying that
rule to be achieved would require at
least 6.7 percent of the dietitian FTEs in
the U.S. to be newly allocated to
providing nutrition services to hospital
patients.14 This shift in activity entails
a substantial movement along the
supply curve for dietitian labor, thus
raising the dietitian wage and reducing
the cost savings estimated with the
method outlined. For these reasons, as
well as our lack of data on CAH
outpatient visits for nutritional services
and the impact that the proposed
regulatory changes might have on
hospital costs in this area, we present
the estimate for discussion purposes
only.
(2) § 485.640 Condition of
Participation: Infection Prevention and
Control and Antibiotic Stewardship
Programs
As we finalized for hospitals, we are
also finalizing the new infection
prevention and control and antibiotic
stewardship requirements for CAHs.
The infection control requirements for
CAHs have remained unchanged since
1997. We are adding a new infection
prevention and control (as well as
antibiotic stewardship) CoP for CAHs
because the existing standards for
infection control do not reflect the
current nationally recognized practices
for the prevention and elimination of
healthcare-associated infections.
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(a) Infection Prevention and Control
Each CAH will be required to review
their current infection control program
and compare it to the new requirements.
After performing this comparison, each
CAH will be required to revise their
program so that it complies with the
new requirements. Based on our
experience with CAHs, we believe that
a physician and a nurse on the infection
control team would conduct this review
and revision of the program. We believe
both the physician and the nurse will
spend 16 hours each for a total of 32
hours. Physicians earn an average of
$191 an hour, and nurses earn an
average wage of $71 an hour, including
14 BLS data show employment of 59,490
dietitians, with a mean hourly wage of $27.62.
Assuming all dietitians are employed full-time
(2,080 hours annually) yields a total sector value of
$3.4 billion, or $6.8 billion when doubled to
account for fringe benefits and overhead. For the
May, 2014, final rule, we estimated $459 million of
loaded wage savings associated with dietary
ordering switching from physicians, nurse
practitioners and physician assistants to lower-paid
dietitians. Thus the relevant portion of the savings
estimate equals roughly 6.7 percent (= $459 million
÷ $6.8 billion) of the sector as a whole—and would
exceed 6.7 percent, to the extent that some current
dietitian positions are part-time.
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overhead and fringe benefits. Thus, to
ensure their infection control program
complies with the new requirements,
we estimate that each CAH would
require 32 burden hours (16 hours for a
physician and 16 hours for a nurse) at
a cost of $4,192 ($3,056 ($191 an hour
for a physician × 16 burden hours) +
$1,136 ($71 an hour for a nurse × 16
burden hours)). Based on the estimate,
for all 1,353 CAHs, complying with this
requirement will require 43,296 burden
hours (32 hours for each CAH × 1,353
CAHs) at a one-time cost of
approximately $5.7 million ($4,192 for
each CAH × 1,353 CAHs).
CAHs will also incur a recurring cost
due to the new requirement that they
appoint an infection preventionist. The
Joint Commission has a similar
requirement (TJC Accreditation
Standard IC.01.01.01), and so we believe
that the 349 CAHs accredited by TJC
should already be in compliance, or
near compliance, with this requirement.
The Joint Commission requires that a
CAH identify the individual(s)
responsible for its infection prevention
and control program, including the
individual(s) with clinical authority
over the infection prevention and
control program. For the remaining
CAHs not accredited by TJC, we are
calculating the burden for them to come
into compliance with this requirement.
Based on our experience with CAHs,
we believe that most ICPs would be
registered nurses with experience,
education, and training in infection
control. As of 2017, approximately
1,004 CAHs are not accredited by TJC.
For the purposes of a burden estimate,
we assume that each CAH will choose
to employ one ICP full-time (52 weeks
× 40 hours = 2,080 hours) at $71 per
hour, although the regulation does not
require the hiring of a new individual,
and this position and its associated
burden may overlap with that calculated
for antibiotic stewardship below.
Nonetheless, the cost per facility is
estimated to be $147,680 annually
(2,080 hours × $71), and the total cost
for all non-TJC-accredited CAHs would
be approximately $148 million annually
(1,004 × $147,680).
(b) Antibiotic Stewardship
Similarly, we believe that the
finalized requirements for a CAH to
have an active antibiotic stewardship
program, and for its organization and
policies, would constitute additional
regulatory burden. We believe that the
burden of implementing and
maintaining an AS program includes the
costs of the qualified personnel needed
to establish and manage such a CAH
program. In the proposed rule, our
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review of the literature, consultations
with CDC, and experience with CAHs
suggested that the establishment and
maintenance of a CAH antibiotic
stewardship program for a statutorily
mandated 25-bed CAH, would require at
least the leadership of a physician
(preferably an infectious disease
physician or physician with training in
antibiotic stewardship) and a clinical
pharmacist (preferably with training in
infectious diseases or antibiotic
stewardship), and also the services of a
network data analyst at the following
proportions of full-time employee
salaries respectively: 0.05, 0.10, 0.025.
However, the latest research on the
resources required for an effective AS
program suggest that the minimum fulltime equivalent support needed for a
CAH may be somewhat more
burdensome. Doernberg et al. were
unable to make specific
recommendations for hospitals with
fewer than 100 beds, however, the
average self-reported burden for
hospitals under 100 beds was larger
than we anticipated. Therefore, for our
purposes we assume 25-bed CAHs will
incur half of the average costs that were
reported by hospitals with fewer than
100 beds. Thus, we estimate each CAH
will require the leadership of a
pharmacist and physician at the full
time equivalents of their salaries of 0.45
and 0.19 respectively. According to
NHSN survey data, approximately 58
percent of CAHs reported having an AS
program that meets all of the CDC’s core
elements in 2017. As previously
mentioned, this number is significantly
higher than the estimate published in
the proposed rule because the number
of CAHs implementing AS programs has
increased dramatically in the past
several years. This is primarily driven
by large accrediting organizations
announcing and implementing their
own antimicrobial stewardship
standards. Preliminary 2018 data
suggest that this upward trend of AS
programs is likely to continue to some
degree; however, since the antimicrobial
stewardship standards are already in
effect for one of the largest accrediting
bodies as of January 2017, we would
expect a sharp decline in the marginal
rate of AS implementation in 2017 and
beyond without further intervention.
Therefore, for our baseline we have
projected that approximately 63% of
CAHs would have AS programs in 2018
were the rate of adoption to decrease by
half, and we assume that is
approximately where the market would
level off absent further intervention. We
have accounted for this uncertainty by
providing estimates in the accounting
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Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Rules and Regulations
statement that are 25 percent higher or
lower than our primary estimate.
Accordingly, we estimate that
approximately 501 CAHs (or 37 percent)
have not implemented an AS program.
Based on these assumptions, the
minimum annual cost of the essential
team members for a CAH to establish
and maintain an antibiotic stewardship
program would be $177,880 (($191 per
hour × 0.19 × 2,000 hours per year =
$72,580 for a physician) + ($117 per
hour × 0.45 × 2,000 hours per year =
$105,300 for a clinical pharmacist). The
annual labor cost for 37 percent of CAHs
($177,880 × 501) would be
approximately $89 million.
However, we believe that the
estimated costs of an AS program would
be somewhat offset by the savings that
a CAH would achieve through such a
program. The most obvious savings
would be from decreased inappropriate
antibiotic use leading to overall
decreased drug costs for a CAH. Our
review of the literature showed
significant savings in this area, with
annual savings proportional to bed size
of the hospital. Reported annual savings
ranged from $27,917 for a 12-bed
medical/surgical intensive care unit to
$2.1 million for an 880-bed academic
medical center. We specifically note the
$177,000 in annual drug cost savings
achieved by a 120-bed community
hospital with its AS program for the
year of 2000 compared to 1999 (LaRocco
2003, CID ‘‘Concurrent antibiotic review
programs-a role for infectious diseases
specialists at small community CAHs’’),
and would use that as the basis to
calculate average annual cost savings for
a 25-bed CAH. Inflating this number to
2017 dollars using the consumer price
index yields approximately $258,000.
Therefore, ($258,000 annual savings ÷
120 beds = $2,150 annual cost savings
per bed) at $53,750 per CAH ($2,150
annual cost savings x 25 beds). Using
this assumption, we believe that the
annual drug cost savings for 37 percent
of all 1,353 CAHs under the rule will be
approximately $27 million (501 CAHs ×
$53,750 in drug cost savings).
As previously explained, patient cost
savings for CAHs has been estimated
based on data from Scott et al., and we
assume approximately 22% of HCA–CDI
and recurrent cases averted would occur
in CAHs. Based on the estimated 63
percent of CAHs that already have AS
programs, approximately 37 percent of
those averted cases would be
attributable to this regulation. This
comes to a total of 44,444 HCA–CDI
cases averted, and 9,524 recurrent cases
averted for CAHs in a 5 year period.
Multiplying these averted cases by the
attributable patient cost savings, and
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20:43 Sep 27, 2019
Jkt 247001
annualizing the amount, comes to
approximately $89 million in
annualized patient cost savings.
Accordingly, we estimate that the
combined annual drug cost savings and
patient cost savings will be
approximately $116 million. These
savings will accrue to patients (reduced
out-of-pocket costs), CAHs (reduced
costs and improved balance sheets), as
well as healthcare insurers, including
Medicare (over time, payment rates will
be adjusted downward as CAH costs
fall). However, we are not able to
apportion the savings that would accrue
to each group with any accuracy and it
will inevitably change over time as
insurance rates change. Regardless,
healthcare-associated infections are
known to be expensive to insurers,
including CMS. Preventing these
infections will reduce CMS and other
insurer expenditures, both on direct
hospital costs and through reduced readmissions. The cost-savings estimates
for CDI included in the RIA provide an
example of the savings Medicare and
other insurers could realize through
reductions in just one HAI. Ultimately,
of course, insurance costs (and the
medical care they pay for) are paid by
taxpayers and workers. Even the
employer contribution to insurance
costs is generally regarded by
economists as part of worker
compensation.
c. Effects on Patients
As previously mentioned, some of the
estimated cost savings will accrue to
patients due to decreased morbidity and
associated health care costs. Although
this RIA has mainly focused on the costs
associated with CDI, there will be
savings associated with other infections,
such as staphylococcus aureus, that we
have not quantified here. Nor have we
quantified any savings to patients due to
averted travel costs for medical
appointments, reduced absence from
work, or other miscellaneous costs that
would be evaded by patients.
Antibiotic stewardship and infection
control has also been proven to
significantly reduce morbidity and
mortality due to healthcare associated
infections. Research by Scott et al.,
which has been referenced throughout
this RIA, thoroughly explored the social
costs and benefits of a national
requirement establishing antibiotic
stewardship programs to prevent CDI.
The direct applicability of their study to
this RIA is hindered only by differing
methods of counting the effects of
antimicrobial resistance and infection
control. Their study quantifies the
effects of AS on the entirety of hospitals
with the argument that without these
PO 00000
Frm 00081
Fmt 4701
Sfmt 4700
51811
finalized requirements, there would be
nothing holding hospitals accountable
for maintaining their AS programs.
However, this RIA takes into account a
baseline of the current market
conditions, which we believe have been
strengthened by new standards set by
large accrediting bodies. Nonetheless,
they estimate CDI infection prevention
alone to avert as many as 1.1 million
inpatient cases and 44,000 deaths at a 3
percent discount rate over a 5 year
period. Using estimates for quality
adjusted life years, their central estimate
for the value of morbidity risk reduction
at a 3 percent discount rate is as much
as $3 billion worth of lost quality
adjusted life years from HCA–CDI, and
their central estimate for the benefits of
mortality risk reduction is as much as
$401 billion utilizing estimates for the
value of a statistical life.
d. Effects on Small Entities
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, we
estimate that the great majority of the
providers that would be affected by
CMS rules are small entities as that term
is used in the RFA. The great majority
of hospitals and most other healthcare
providers and suppliers are small
entities, either by being nonprofit
organizations or by meeting the SBA
definition of a small business.
Accordingly, the usual practice of HHS
is to treat all providers and suppliers as
small entities in analyzing the effects of
our rules.
These provisions of the final rule are
anticipated to cost CAHs as much as
$119 million in the first year. While this
is a large amount in total, the average
cost per affected CAH is approximately
$88,000 in the first year, and slightly
less in future years. Although the
overall magnitude of the paperwork,
staffing, and related cost reductions to
hospitals and CAHs under this rule is
economically significant, the net effect
is likely to be a fraction of 1 percent of
total hospital costs. Total national
hospital care expenditure are
approximately 1,143 billion dollars a
year, or an average of about $185
million per hospital, and our primary
estimate of the net effect of these
proposals on hospital costs is
approximately $79 million annually.
Under HHS guidelines for regulatory
flexibility analyses, actions that do not
negatively affect costs or revenues by
more than 3 percent a year are generally
not considered to be significant. We do
not believe that hospitals of any size
will be negatively affected to this
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Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Rules and Regulations
degree. Accordingly, we have
determined that the rule will not have
a significant economic impact on a
substantial number of small entities,
and certify that a final regulatory
flexibility analysis is not required.
Notwithstanding this conclusion, we
believe that this RIA and the preamble
as a whole meet the requirements of the
RFA for a final regulatory flexibility
analysis.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 604 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a metropolitan statistical area and has
fewer than 100 beds. For the preceding
reasons, we have determined that these
provisions of the final rule will not have
a significant negative impact on the
operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2019, that is
approximately $154 million. These
provisions of the final rule do contain
private sector mandates, but their costs
are generally anticipated to be mostly
offset by savings. Nevertheless, this RIA
and the preamble, taken together, would
meet the requirements of an analysis
under section 202.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it issues a proposed
rule (and subsequent final rule) that
would impose substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
These provisions of the rule will not
have a substantial direct effect on State
or local governments, preempt State
law, or otherwise have federalism
implications.
4. Alternatives Considered
As we stated, CMS is aware, through
conversations with stakeholders and
federal partners, and as a result of
internal evaluation and research, of
outstanding concerns about the CoPs for
hospitals and CAHs, despite recent
revisions. This subset of the universe of
standards is the focus of the final rule.
One alternative we did consider was
combining the infection prevention and
control leader position with that of the
antibiotic stewardship leader position.
While this would certainly reduce the
costs for hospitals by eliminating one of
these positions, we also believe that it
might reduce the overall effectiveness of
the program and, thus, the overall
societal benefits that might be achieved.
The skills needed to lead each program
are different. Infection prevention
programs are often led by nursing staff
who do not prescribe antibiotics.
Antibiotic stewardship programs are led
by physicians and pharmacists who
have direct knowledge and experience
with antibiotic prescribing. For these
reasons, we decided to finalize the
requirement as it is contained in this
rule.
For all of the finalized provisions, we
considered not making these changes.
Ultimately, based on our analysis of
these issues and for the reasons stated
in this preamble, we believe that it is
best to propose changes at this time. We
welcomed comments on whether we
properly selected the best candidates for
change, and welcomed suggestions for
additional reform candidates from the
entire body of CoPs.
5. Conclusion
The financial impact of these
provisions of the final rule will lie
primarily with the balance between
estimated costs and savings for the
antibiotic stewardship program for
hospitals. Nevertheless, the total costs of
these provisions are anticipated to be
mostly offset by savings. Moreover, the
life-saving benefits of some of these
provisions, including antibiotic
stewardship, have been thoroughly
studied and substantiated by
independent researchers. However, we
note that although savings and
morbidity/mortality risk reductions on
average are consistent with the literature
we’ve reviewed, the outcomes for
individual hospitals and CAHs will vary
depending on their specific
implementation strategies for AS.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
D. Accounting Statement and Table
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/sites/
whitehouse.gov/files/omb/circulars/A4/
a-4.pdf), in Table 20, we have prepared
an accounting statement showing the
classification of the transfers and costs
associated with the various provisions
of the final rule.
While most provisions of the final
rule have clearly predictable effects we
do not in most cases have detailed
empirical information on the precise
magnitude of efforts involved (for
example, time spent in meeting
paperwork or other administrative tasks
that apply to a particular provider type).
Other provisions (notably those related
to organ transplantation and removal of
strict H&P requirements before
ambulatory or outpatient surgery) have
even more uncertain effect sizes.
Therefore, we have estimated an upper
and lower level for benefit and cost
reduction estimates that is 25 percent
higher or lower than our primary
estimate for all quantified reforms other
than those related to ambulatory
surgery, and in that area our upper
bound for costs is zero cost reductions
and our lower bound is a 17 percent
reduction in H&P and associated
laboratory testing costs.
TABLE 20—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED BENEFITS AND SAVINGS
[$ millions]
Units
Primary
estimate
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Category
Low
estimate
High
estimate
Year
dollars
Benefits:
Life-Extending Benefits (monetized) .....................................
Not Quantified
Medical Cost Reduction Benefits (monetized) .....................
Not Quantified
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20:45 Sep 27, 2019
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30SER2
Discount
rate
Period
covered
51813
Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Rules and Regulations
TABLE 20—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED BENEFITS AND SAVINGS—Continued
[$ millions]
Units
Primary
estimate
Category
Qualitative .............................................................................
Low
estimate
High
estimate
¥801
¥803
¥1,127
¥1,128
¥485
¥487
Transfers
Period
covered
2017
2017
7%
3%
2019–2028
2019–2028
None
42 CFR Part 482
E. Regulatory Reform Analysis Under
E.O. 13771
Executive Order 13771, titled
Reducing Regulation and Controlling
Regulatory Costs, was issued on January
30, 2017 and requires that the costs
associated with significant new
regulations ‘‘shall, to the extent
permitted by law, be offset by the
elimination of existing costs associated
with at least two prior regulations.’’
This final rule is considered an E.O.
13771 deregulatory action. We estimate
that this rule generates $647 million in
annualized cost savings in 2016 dollars,
discounted at 7 percent relative to year
2016, over a perpetual time horizon.
Details on the estimated cost savings of
this rule can be found in the preceding
analyses.
Grant program—health, Hospitals,
Medicaid, Medicare, Reporting and
recordkeeping requirements.
Grant programs—health, Health
facilities, Health professions, Health
records, Medicaid, Medicare, Nursing
home, Nutrition, Reporting and
recordkeeping requirements, Safety.
42 CFR Part 484
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 485
42 CFR Part 403
42 CFR Part 486
Grant programs—health, Health
insurance, Hospitals, Intergovernmental
relations, Medicare, Reporting and
recordkeeping requirements.
Grant programs—health, Health
facilities, Medicare, Reporting and
recordkeeping requirements, X-rays.
42 CFR Part 488
Health facilities, Health professions,
Medicare, Reporting and recordkeeping
requirements.
Administrative practice and
procedures, Health facilities, Health
professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 418
42 CFR Part 491
Health facilities, Hospice care,
Medicare, Reporting and recordkeeping
requirements.
Grant programs—health, Health
facilities, Medicaid, Medicare,
Reporting and recordkeeping
requirements, Rural and urban areas.
Aged, Family planning, Grant
programs—health, Infants and children,
Medicaid, Penalties, Reporting and
recordkeeping requirements.
42 CFR Part 460
Aged, Health care, Health records,
Medicaid, Medicare, Reporting and
recordkeeping requirements.
20:43 Sep 27, 2019
Jkt 247001
1. The authority citation for part 403
is revised to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
List of Subjects
42 CFR Part 441
PART 403—SPECIAL PROGRAMS AND
PROJECTS
42 CFR Part 483
Grant programs—health, Health
facilities, Medicaid, Reporting and
recordkeeping requirements.
42 CFR Part 416
jbell on DSK3GLQ082PROD with RULES2
Discount
rate
Potential reductions in morbidity and mortality for hospital and CAH patients
Costs:
Annualized Monetized Costs (+) or Savings (¥) ($million/
year) ..................................................................................
VerDate Sep<11>2014
Year
dollars
42 CFR Part 494
Diseases, Health facilities,
Incorporation by Reference, Medicare,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
PO 00000
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2. Section 403.736 is amended by—
a. Removing the introductory text;
b. Revising paragraph (a);
c. Removing paragraph (b); and
d. Redesignating paragraphs (c) and
(d) as paragraphs (b) and (c).
The revision reads as follows:
■
■
■
■
■
§ 403.736 Condition of participation:
Discharge planning.
(a) Discharge planning and
instructions. The RNHCI must have in
effect a discharge planning process that
applies to all patients. The process must
assure that appropriate post-institution
services are obtained for each patient, as
necessary. The RNHCI must assess the
need for a discharge plan for any patient
likely to suffer adverse consequences if
there is no planning.
(1) Discharge instructions must be
provided at the time of discharge to the
patient or the patient’s caregiver as
necessary.
(2) If the patient assessment indicates
a need for a discharge plan, the
discharge plan must include
instructions on post-RNHCI care to be
used by the patient or the caregiver in
the patient’s home, as identified in the
discharge plan.
(3) If the RNHCI’s patient assessment
does not indicate a need for a discharge
plan, the beneficiary or his or her legal
representative may request a discharge
plan. In this case, the RNHCI must
develop a discharge plan for the
beneficiary.
*
*
*
*
*
■ 3. Section 403.748 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii); and
■ b. Adding paragraph (d)(1)(v).
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The revisions and addition read as
follows:
PART 416—AMBULATORY SURGICAL
SERVICES
§ 403.748 Condition of participation:
Emergency preparedness.
■
jbell on DSK3GLQ082PROD with RULES2
*
*
*
*
*
(a) Emergency plan. The RNHCI must
develop and maintain an emergency
preparedness plan that must be
reviewed, and updated at least every 2
years. The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The
RNHCI must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The RNHCI
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The RNHCI
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the RNHCI must conduct
training on the updated policies and
procedures.
*
*
*
*
*
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20:43 Sep 27, 2019
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4. The authority citation for part 416
continues to read as follows:
Authority: 42 U.S.C. 273, 1302, 1320b–8,
and 1395hh.
5. Section 416.41 is amended by
revising paragraph (b)(3) to read as
follows:
■
§ 416.41 Condition for coverage—
Governing body and management.
*
*
*
*
*
(b) * * *
(3) The ASC must periodically
provide the local hospital with written
notice of its operations and patient
population served.
■ 6. Section 416.47 is amended by
revising paragraph (b)(2) to read as
follows:
§ 416.47 Condition for coverage—Medical
records.
*
*
*
*
*
(b) * * *
(2) Significant medical history and
results of physical examination (as
applicable).
*
*
*
*
*
■ 7. Section 416.52 is amended by
revising paragraph (a) to read as follows:
§ 416.52 Condition for coverage—Patient
admission, assessment and discharge.
*
*
*
*
*
(a) Standard: Patient assessment and
admission. (1) The ASC must develop
and maintain a policy that identifies
those patients who require a medical
history and physical examination prior
to surgery. The policy must—
(i) Include the timeframe for medical
history and physical examination to be
completed prior to surgery.
(ii) Address, but is not limited to, the
following factors: Patient age, diagnosis,
the type and number of procedures
scheduled to be performed on the same
surgery date, known comorbidities, and
the planned anesthesia level.
(iii) Be based on any applicable
nationally recognized standards of
practice and guidelines, and any
applicable State and local health and
safety laws.
(2) Upon admission, each patient
must have a pre-surgical assessment
completed by a physician who will be
performing the surgery or other
qualified practitioner in accordance
with applicable State health and safety
laws, standards of practice, and ASC
policy.
(3) The pre-surgical assessment must
include documentation of any allergies
to drugs and biologicals.
PO 00000
Frm 00084
Fmt 4701
Sfmt 4700
(4) The patient’s medical history and
physical examination (if any) must be
placed in the patient’s medical record
prior to the surgical procedure.
*
*
*
*
*
■ 8. Section 416.54 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
§ 416.54 Condition for coverage—
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The ASC must
develop and maintain an emergency
preparedness plan that must be
reviewed, and updated at least every 2
years. The plan must do the following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The ASC
must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The ASC
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The ASC
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
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(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the ASC must conduct training
on the updated policies and procedures.
(2) Testing. The ASC must conduct
exercises to test the emergency plan at
least annually. The ASC must do the
following:
(i) Participate in a full-scale exercise
that is community-based every 2 years;
or
(A) When a community-based
exercise is not accessible, conduct a
facility-based functional exercise every
2 years; or
(B) If the ASC experiences an actual
natural or man-made emergency that
requires activation of the emergency
plan, the ASC is exempt from engaging
in its next required community-based or
individual, facility-based functional
exercise following the onset of the
emergency event.
(ii) Conduct an additional exercise at
least every 2 years, opposite the year the
full-scale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based, or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the ASC’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events and revise the ASC’s emergency
plan, as needed.
*
*
*
*
*
PART 418—HOSPICE CARE
9. The authority citation for part 418
is revised to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
10. Section 418.76 is amended by
revising paragraph (a)(1)(iv) to read as
follows:
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■
§ 418.76 Condition of participation:
Hospice aide and homemaker services.
*
*
*
*
*
(a) * * *
(1) * * *
(iv) A State licensure program.
*
*
*
*
*
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§ 418.106
[Amended]
11. Section 418.106 is amended by—
a. Removing paragraph (a)(1);
b. Redesignating paragraph (a)(2) as
paragraph (a)(1); and
■ c. Adding a new reserved paragraph
(a)(2).
■ 12. Section 418.112 is amended by
revising paragraph (f) to read as follows:
■
■
■
§ 418.112 Condition of participation:
Hospices that provide hospice care to
residents of a SNF/NF or ICF/IID.
*
*
*
*
*
(f) Standard: Orientation and training
of staff. Hospice staff, in coordination
with SNF/NF or ICF/IID facility staff,
must assure orientation of such staff
furnishing care to hospice patients in
the hospice philosophy, including
hospice policies and procedures
regarding methods of comfort, pain
control, symptom management, as well
as principles about death and dying,
individual responses to death, patient
rights, appropriate forms, and record
keeping requirements.
■ 13. Section 418.113 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(iii);
■ b. Adding paragraph (d)(1)(vi);
■ c. Revising paragraph (d)(2); and
■ d. Adding paragraph (d)(3).
The revisions and additions read as
follows:
§ 418.113 Condition of participation:
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The hospice must
develop and maintain an emergency
preparedness plan that must be
reviewed, and updated at least every 2
years. The plan must do the following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, or Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The
hospice must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The hospice
must develop and maintain an
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emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The hospice
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(iii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(vi) If the emergency preparedness
policies and procedures are significantly
updated, the hospice must conduct
training on the updated policies and
procedures.
(2) Testing for hospices that provide
care in the patient’s home. The hospice
must conduct exercises to test the
emergency plan at least annually. The
hospice must do the following:
(i) Participate in a full-scale exercise
that is community-based every 2 years;
or
(A) When a community-based
exercise is not accessible, conduct an
individual facility-based functional
exercise every 2 years; or
(B) If the hospice experiences a
natural or man-made emergency that
requires activation of the emergency
plan, the hospital is exempt from
engaging in its next required full-scale
community-based exercise or individual
facility-based functional exercise
following the onset of the emergency
event.
(ii) Conduct an additional exercise
every 2 years, opposite the year the fullscale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or a facility-based
functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
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(3) Testing for hospices that provide
inpatient care directly. The hospice
must conduct exercises to test the
emergency plan twice per year. The
hospice must do the following:
(i) Participate in an annual full-scale
exercise that is community-based; or
(A) When a community-based
exercise is not accessible, conduct an
annual individual facility-based
functional exercise; or
(B) If the hospice experiences a
natural or man-made emergency that
requires activation of the emergency
plan, the hospice is exempt from
engaging in its next required full-scale
community-based or facility-based
functional exercise following the onset
of the emergency event.
(ii) Conduct an additional annual
exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or a facility-based
functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
led by a facilitator that includes a group
discussion using a narrated, clinicallyrelevant emergency scenario, and a set
of problem statements, directed
messages, or prepared questions
designed to challenge an emergency
plan.
(iii) Analyze the hospice’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events and revise the hospice’s
emergency plan, as needed.
*
*
*
*
*
PART 441—SERVICES:
REQUIREMENTS AND LIMITS
APPLICABLE TO SPECIFIC SERVICES
14. The authority citation for part 441
is revised to read as follows:
■
Authority: 42 U.S.C. 1302.
15. Section 441.184 is amended by—
a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
■
■
§ 441.184
Emergency preparedness.
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*
*
*
*
*
(a) Emergency plan. The PRTF must
develop and maintain an emergency
preparedness plan that must be
reviewed, and updated at least every 2
years. The plan must do the following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
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regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The PRTF
must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The PRTF
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The PRTF
must develop and maintain an
emergency preparedness training
program that is based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, policies and
procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(ii) After initial training, provide
emergency preparedness training every
2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the PRTF must conduct
training on the updated policies and
procedures.
(2) Testing. The PRTF must conduct
exercises to test the emergency plan
twice per year. The PRTF must do the
following:
(i) Participate in an annual full-scale
exercise that is community-based; or
(A) When a community-based
exercise is not accessible, conduct an
annual individual, facility-based
functional exercise; or
(B) If the PRTF experiences an actual
natural or man-made emergency that
requires activation of the emergency
plan, the PRTF is exempt from engaging
in its next required full-scale
community-based or individual, facilitybased functional exercise following the
onset of the emergency event.
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(ii) Conduct an additional annual
exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or individual, a
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the PRTF’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events and revise the PRTF’s emergency
plan, as needed.
*
*
*
*
*
PART 460—PROGRAMS OF ALLINCLUSIVE CARE FOR THE ELDERLY
(PACE)
16. The authority citation for part 460
is revised to read as follows:
■
Authority: 42 U.S.C. 1302, 1395,
1395eee(f), and 1396u–4(f).
17. Section 460.84 is amended by—
a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
■
■
§ 460.84
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The PACE
organization must develop and maintain
an emergency preparedness plan that
must be reviewed, and updated at least
every 2 years. The plan must do the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The
PACE organization must develop and
implement emergency preparedness
policies and procedures, based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must address management
of medical and nonmedical
emergencies, including, but not limited
to: Fire; equipment, power, or water
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failure; care-related emergencies; and
natural disasters likely to threaten the
health or safety of the participants, staff,
or the public. Policies and procedures
must be reviewed and updated at least
every 2 years. At a minimum, the
policies and procedures must address
the following:
*
*
*
*
*
(c) Communication plan. The PACE
organization must develop and maintain
an emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The PACE
organization must develop and maintain
an emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the PACE must conduct
training on the updated policies and
procedures.
(2) Testing. The PACE organization
must conduct exercises to test the
emergency plan at least annually. The
PACE organization must do the
following:
(i) Participate in a full-scale exercise
that is community-based or;
(A) When a community-based
exercise is not accessible, conduct an
annual individual, facility-based
functional exercise every 2 years; or
(B) If the PACE experiences an actual
natural or man-made emergency that
requires activation of the emergency
plan, the PACE is exempt from engaging
in its next required full-scale
community-based or individual, facilitybased functional exercise following the
onset of the emergency event.
(ii) Conduct an additional exercise
every 2 years opposite the year the fullscale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
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(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the PACE’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events and revise the PACE’s emergency
plan, as needed.
*
*
*
*
*
PART 482—CONDITIONS OF
PARTICIPATION FOR HOSPITALS
18. The authority citation for part 482
is revised to read as follows:
■
Authority: 42 U.S.C. 1302, 1395hh, and
1395rr, unless otherwise noted.
19. Section 482.13 is amended by
revising paragraphs (e)(5), (e)(8)(ii),
(e)(10) and (11), (e)(12)(i), (e)(14), and
(g)(4)(ii) to read as follows:
■
§ 482.13 Condition of participation:
Patient’s rights.
*
*
*
*
*
(e) * * *
(5) The use of restraint or seclusion
must be in accordance with the order of
a physician or other licensed
practitioner who is responsible for the
care of the patient and authorized to
order restraint or seclusion by hospital
policy in accordance with State law.
*
*
*
*
*
(8) * * *
(ii) After 24 hours, before writing a
new order for the use of restraint or
seclusion for the management of violent
or self-destructive behavior, a physician
or other licensed practitioner who is
responsible for the care of the patient
and authorized to order restraint or
seclusion by hospital policy in
accordance with State law must see and
assess the patient.
*
*
*
*
*
(10) The condition of the patient who
is restrained or secluded must be
monitored by a physician, other
licensed practitioner, or trained staff
that have completed the training criteria
specified in paragraph (f) of this section
at an interval determined by hospital
policy.
(11) Physician and other licensed
practitioner training requirements must
be specified in hospital policy. At a
minimum, physicians and other
licensed practitioners authorized to
order restraint or seclusion by hospital
policy in accordance with State law
must have a working knowledge of
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51817
hospital policy regarding the use of
restraint or seclusion.
(12) * * *
(i) By a—
(A) Physician or other licensed
practitioner.
(B) Registered nurse who has been
trained in accordance with the
requirements specified in paragraph (f)
of this section.
*
*
*
*
*
(14) If the face-to-face evaluation
specified in paragraph (e)(12) of this
section is conducted by a trained
registered nurse, the trained registered
nurse must consult the attending
physician or other licensed practitioner
who is responsible for the care of the
patient as soon as possible after the
completion of the 1-hour face-to-face
evaluation.
*
*
*
*
*
(g) * * *
(4) * * *
(ii) Each entry must document the
patient’s name, date of birth, date of
death, name of attending physician or
other licensed practitioner who is
responsible for the care of the patient,
medical record number, and primary
diagnosis(es).
*
*
*
*
*
■ 20. Section 482.15 is amended—
■ a. By revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. By adding paragraph (d)(1)(v);
■ c. By revising paragraph (d)(2);
■ d. In paragraph (g) introductory text,
by removing the phrase ‘‘transplant
centers’’ and adding into its place the
phrase ‘‘transplant programs’’; and
■ e. In paragraphs (g)(1) and (2), by
removing the phrase ‘‘transplant center’’
and adding into its place the phrase
‘‘transplant program’’.
The revisions and addition read as
follows:
§ 482.15 Condition of participation:
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The hospital
must develop and maintain an
emergency preparedness plan that must
be reviewed, and updated at least every
2 years. The plan must do the following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The
hospital must develop and implement
emergency preparedness policies and
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procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The hospital
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The hospital
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the hospital must conduct
training on the updated policies and
procedures.
(2) Testing. The hospital must
conduct exercises to test the emergency
plan at least twice per year. The hospital
must do all of the following:
(i) Participate in an annual full-scale
exercise that is community-based; or
(A) When a community-based
exercise is not accessible, conduct an
annual individual, facility-based
functional exercise; or.
(B) If the hospital experiences an
actual natural or man-made emergency
that requires activation of the
emergency plan, the hospital is exempt
from engaging in its next required fullscale community-based exercise or
individual, facility-based functional
exercise following the onset of the
emergency event.
(ii) Conduct an additional annual
exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
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(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the hospital’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events, and revise the hospital’s
emergency plan, as needed.
*
*
*
*
*
■ 21. Section 482.21 is amended by
revising paragraph (b)(1) and adding
paragraph (f) to read as follows:
§ 482.21 Condition of participation: Quality
assessment and performance improvement
program.
*
*
*
*
*
(b) * * *
(1) The program must incorporate
quality indicator data including patient
care data, and other relevant data such
as data submitted to or received from
Medicare quality reporting and quality
performance programs, including but
not limited to data related to hospital
readmissions and hospital-acquired
conditions.
*
*
*
*
*
(f) Standard: Unified and integrated
QAPI program for multi-hospital
systems. If a hospital is part of a hospital
system consisting of multiple separately
certified hospitals using a system
governing body that is legally
responsible for the conduct of two or
more hospitals, the system governing
body can elect to have a unified and
integrated QAPI program for all of its
member hospitals after determining that
such a decision is in accordance with all
applicable State and local laws. The
system governing body is responsible
and accountable for ensuring that each
of its separately certified hospitals
meets all of the requirements of this
section. Each separately certified
hospital subject to the system governing
body must demonstrate that:
(1) The unified and integrated QAPI
program is established in a manner that
takes into account each member
hospital’s unique circumstances and
any significant differences in patient
populations and services offered in each
hospital; and
(2) The unified and integrated QAPI
program establishes and implements
policies and procedures to ensure that
the needs and concerns of each of its
separately certified hospitals, regardless
of practice or location, are given due
consideration, and that the unified and
integrated QAPI program has
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mechanisms in place to ensure that
issues localized to particular hospitals
are duly considered and addressed.
■ 22. Section 482.22 is amended by—
■ a. Revising paragraphs (c)(5)(i) and
(ii);
■ b. Adding paragraphs (c)(5)(iii), (iv),
and (v); and
■ c. Removing paragraph (d).
The revisions and additions read as
follows:
§ 482.22 Condition of participation:
Medical staff.
*
*
*
*
*
(c) * * *
(5) * * *
(i) A medical history and physical
examination be completed and
documented for each patient no more
than 30 days before or 24 hours after
admission or registration, but prior to
surgery or a procedure requiring
anesthesia services, and except as
provided under paragraph (c)(5)(iii) of
this section. The medical history and
physical examination must be
completed and documented by a
physician (as defined in section 1861(r)
of the Act), an oral and maxillofacial
surgeon, or other qualified licensed
individual in accordance with State law
and hospital policy.
(ii) An updated examination of the
patient, including any changes in the
patient’s condition, be completed and
documented within 24 hours after
admission or registration, but prior to
surgery or a procedure requiring
anesthesia services, when the medical
history and physical examination are
completed within 30 days before
admission or registration, and except as
provided under paragraph (c)(5)(iii) of
this section. The updated examination
of the patient, including any changes in
the patient’s condition, must be
completed and documented by a
physician (as defined in section 1861(r)
of the Act), an oral and maxillofacial
surgeon, or other qualified licensed
individual in accordance with State law
and hospital policy.
(iii) An assessment of the patient (in
lieu of the requirements of paragraphs
(c)(5)(i) and (ii) of this section) be
completed and documented after
registration, but prior to surgery or a
procedure requiring anesthesia services,
when the patient is receiving specific
outpatient surgical or procedural
services and when the medical staff has
chosen to develop and maintain a policy
that identifies, in accordance with the
requirements at paragraph (c)(5)(v) of
this section, specific patients as not
requiring a comprehensive medical
history and physical examination, or
any update to it, prior to specific
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outpatient surgical or procedural
services. The assessment must be
completed and documented by a
physician (as defined in section 1861(r)
of the Act), an oral and maxillofacial
surgeon, or other qualified licensed
individual in accordance with State law
and hospital policy.
(iv) The medical staff develop and
maintain a policy that identifies those
patients for whom the assessment
requirements of paragraph (c)(5)(iii) of
this section would apply. The
provisions of paragraphs (c)(5)(iii), (iv),
and (v) of this section do not apply to
a medical staff that chooses to maintain
a policy that adheres to the
requirements of paragraphs of (c)(5)(i)
and (ii) of this section for all patients.
(v) The medical staff, if it chooses to
develop and maintain a policy for the
identification of specific patients to
whom the assessment requirements in
paragraph (c)(5)(iii) of this section
would apply, must demonstrate
evidence that the policy applies only to
those patients receiving specific
outpatient surgical or procedural
services as well as evidence that the
policy is based on:
(A) Patient age, diagnoses, the type
and number of surgeries and procedures
scheduled to be performed,
comorbidities, and the level of
anesthesia required for the surgery or
procedure.
(B) Nationally recognized guidelines
and standards of practice for assessment
of specific types of patients prior to
specific outpatient surgeries and
procedures.
(C) Applicable state and local health
and safety laws.
*
*
*
*
*
■ 23. Section 482.23 is amended by
■ a. Revising paragraphs (b)
introductory text and (b)(4) and (6);
■ b. Adding paragraph (b)(7); and
■ c. Revising (c)(1) introductory text and
(c)(3).
The revisions and addition read as
follows:
§ 482.23 Condition of participation:
Nursing services.
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*
*
*
*
*
(b) Standard: Staffing and delivery of
care. The nursing service must have
adequate numbers of licensed registered
nurses, licensed practical (vocational)
nurses, and other personnel to provide
nursing care to all patients as needed.
There must be supervisory and staff
personnel for each department or
nursing unit to ensure, when needed,
the immediate availability of a
registered nurse for the care of any
patient.
*
*
*
*
*
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(4) The hospital must ensure that the
nursing staff develops and keeps current
a nursing care plan for each patient that
reflects the patient’s goals and the
nursing care to be provided to meet the
patient’s needs. The nursing care plan
may be part of an interdisciplinary care
plan.
*
*
*
*
*
(6) All licensed nurses who provide
services in the hospital must adhere to
the policies and procedures of the
hospital. The director of nursing service
must provide for the adequate
supervision and evaluation of the
clinical activities of all nursing
personnel which occur within the
responsibility of the nursing service,
regardless of the mechanism through
which those personnel are providing
services (that is, hospital employee,
contract, lease, other agreement, or
volunteer).
(7) The hospital must have policies
and procedures in place establishing
which outpatient departments, if any,
are not required under hospital policy to
have a registered nurse present. The
policies and procedures must:
(i) Establish the criteria such
outpatient departments must meet,
taking into account the types of services
delivered, the general level of acuity of
patients served by the department, and
the established standards of practice for
the services delivered;
(ii) Establish alternative staffing plans;
(iii) Be approved by the director of
nursing;
(iv) Be reviewed at least once every 3
years.
(c) * * *
(1) Drugs and biologicals must be
prepared and administered in
accordance with Federal and State laws,
the orders of the practitioner or
practitioners responsible for the
patient’s care, and accepted standards of
practice.
*
*
*
*
*
(3) With the exception of influenza
and pneumococcal vaccines, which may
be administered per physician-approved
hospital policy after an assessment of
contraindications, orders for drugs and
biologicals must be documented and
signed by a practitioner who is
authorized to write orders in accordance
with State law and hospital policy, and
who is responsible for the care of the
patient.
(i) If verbal orders are used, they are
to be used infrequently.
(ii) When verbal orders are used, they
must only be accepted by persons who
are authorized to do so by hospital
policy and procedures consistent with
Federal and State law.
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51819
(iii) Orders for drugs and biologicals
may be documented and signed by other
practitioners only if such practitioners
are acting in accordance with State law,
including scope-of-practice laws,
hospital policies, and medical staff
bylaws, rules, and regulations.
*
*
*
*
*
■ 24. Section 482.24 is amended by
revising paragraphs (c)(4)(i)(A) and (B),
and adding paragraph (c)(4)(i)(C) to read
as follows:
§ 482.24 Condition of participation:
Medical record services.
*
*
*
*
*
(c) * * *
(4) * * *
(i) * * *
(A) A medical history and physical
examination completed and
documented no more than 30 days
before or 24 hours after admission or
registration, but prior to surgery or a
procedure requiring anesthesia services,
and except as provided under paragraph
(c)(4)(i)(C) of this section. The medical
history and physical examination must
be placed in the patient’s medical
record within 24 hours after admission
or registration, but prior to surgery or a
procedure requiring anesthesia services.
(B) An updated examination of the
patient, including any changes in the
patient’s condition, when the medical
history and physical examination are
completed within 30 days before
admission or registration, and except as
provided under paragraph (c)(4)(i)(C) of
this section. Documentation of the
updated examination must be placed in
the patient’s medical record within 24
hours after admission or registration,
but prior to surgery or a procedure
requiring anesthesia services.
(C) An assessment of the patient (in
lieu of the requirements of paragraphs
(c)(4)(i)(A) and (B) of this section)
completed and documented after
registration, but prior to surgery or a
procedure requiring anesthesia services,
when the patient is receiving specific
outpatient surgical or procedural
services and when the medical staff has
chosen to develop and maintain a policy
that identifies, in accordance with the
requirements at § 482.22(c)(5)(v),
specific patients as not requiring a
comprehensive medical history and
physical examination, or any update to
it, prior to specific outpatient surgical or
procedural services.
*
*
*
*
*
■ 25. Section 482.27 is amended by
revising paragraph (b)(7) and removing
paragraph (b)(11).
The revision reads as follows:
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§ 482.27 Condition of participation:
Laboratory services.
*
*
*
*
*
(b) * * *
(7) Timeframe for notification— For
donors tested on or after February 20,
2008. For notifications resulting from
donors tested on or after February 20,
2008 as set forth at 21 CFR 610.46 and
610.47 the notification effort begins
when the blood collecting establishment
notifies the hospital that it received
potentially HIV or HCV infectious blood
and blood components. The hospital
must make reasonable attempts to give
notification over a period of 12 weeks
unless—
(i) The patient is located and notified;
or
(ii) The hospital is unable to locate
the patient and documents in the
patient’s medical record the extenuating
circumstances beyond the hospital’s
control that caused the notification
timeframe to exceed 12 weeks.
*
*
*
*
*
■ 26. Section 482.42 is revised to read
as follows:
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§ 482.42 Condition of participation:
Infection prevention and control and
antibiotic stewardship programs.
The hospital must have active
hospital-wide programs for the
surveillance, prevention, and control of
HAIs and other infectious diseases, and
for the optimization of antibiotic use
through stewardship. The programs
must demonstrate adherence to
nationally recognized infection
prevention and control guidelines, as
well as to best practices for improving
antibiotic use where applicable, and for
reducing the development and
transmission of HAIs and antibioticresistant organisms. Infection
prevention and control problems and
antibiotic use issues identified in the
programs must be addressed in
collaboration with the hospital-wide
quality assessment and performance
improvement (QAPI) program.
(a) Standard: Infection prevention and
control program organization and
policies. The hospital must demonstrate
that:
(1) An individual (or individuals),
who is qualified through education,
training, experience, or certification in
infection prevention and control, is
appointed by the governing body as the
infection preventionist(s)/infection
control professional(s) responsible for
the infection prevention and control
program and that the appointment is
based on the recommendations of
medical staff leadership and nursing
leadership;
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(2) The hospital infection prevention
and control program, as documented in
its policies and procedures, employs
methods for preventing and controlling
the transmission of infections within the
hospital and between the hospital and
other institutions and settings;
(3) The infection prevention and
control program includes surveillance,
prevention, and control of HAIs,
including maintaining a clean and
sanitary environment to avoid sources
and transmission of infection, and
addresses any infection control issues
identified by public health authorities;
and
(4) The infection prevention and
control program reflects the scope and
complexity of the hospital services
provided.
(b) Standard: Antibiotic stewardship
program organization and policies. The
hospital must demonstrate that:
(1) An individual (or individuals),
who is qualified through education,
training, or experience in infectious
diseases and/or antibiotic stewardship,
is appointed by the governing body as
the leader(s) of the antibiotic
stewardship program and that the
appointment is based on the
recommendations of medical staff
leadership and pharmacy leadership;
(2) The hospital-wide antibiotic
stewardship program:
(i) Demonstrates coordination among
all components of the hospital
responsible for antibiotic use and
resistance, including, but not limited to,
the infection prevention and control
program, the QAPI program, the medical
staff, nursing services, and pharmacy
services;
(ii) Documents the evidence-based use
of antibiotics in all departments and
services of the hospital; and
(iii) Documents any improvements,
including sustained improvements, in
proper antibiotic use;
(3) The antibiotic stewardship
program adheres to nationally
recognized guidelines, as well as best
practices, for improving antibiotic use;
and
(4) The antibiotic stewardship
program reflects the scope and
complexity of the hospital services
provided.
(c) Standard: Leadership
responsibilities. (1) The governing body
must ensure all of the following:
(i) Systems are in place and
operational for the tracking of all
infection surveillance, prevention, and
control, and antibiotic use activities, in
order to demonstrate the
implementation, success, and
sustainability of such activities.
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(ii) All HAIs and other infectious
diseases identified by the infection
prevention and control program as well
as antibiotic use issues identified by the
antibiotic stewardship program are
addressed in collaboration with hospital
QAPI leadership.
(2) The infection preventionist(s)/
infection control professional(s) is
responsible for:
(i) The development and
implementation of hospital-wide
infection surveillance, prevention, and
control policies and procedures that
adhere to nationally recognized
guidelines.
(ii) All documentation, written or
electronic, of the infection prevention
and control program and its
surveillance, prevention, and control
activities.
(iii) Communication and collaboration
with the hospital’s QAPI program on
infection prevention and control issues.
(iv) Competency-based training and
education of hospital personnel and
staff, including medical staff, and, as
applicable, personnel providing
contracted services in the hospital, on
the practical applications of infection
prevention and control guidelines,
policies, and procedures.
(v) The prevention and control of
HAIs, including auditing of adherence
to infection prevention and control
policies and procedures by hospital
personnel.
(vi) Communication and collaboration
with the antibiotic stewardship
program.
(3) The leader(s) of the antibiotic
stewardship program is responsible for:
(i) The development and
implementation of a hospital-wide
antibiotic stewardship program, based
on nationally recognized guidelines, to
monitor and improve the use of
antibiotics.
(ii) All documentation, written or
electronic, of antibiotic stewardship
program activities.
(iii) Communication and collaboration
with medical staff, nursing, and
pharmacy leadership, as well as with
the hospital’s infection prevention and
control and QAPI programs, on
antibiotic use issues.
(iv) Competency-based training and
education of hospital personnel and
staff, including medical staff, and, as
applicable, personnel providing
contracted services in the hospital, on
the practical applications of antibiotic
stewardship guidelines, policies, and
procedures.
(d) Standard: Unified and integrated
infection prevention and control and
antibiotic stewardship programs for
multi-hospital systems. If a hospital is
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part of a hospital system consisting of
multiple separately certified hospitals
using a system governing body that is
legally responsible for the conduct of
two or more hospitals, the system
governing body can elect to have unified
and integrated infection prevention and
control and antibiotic stewardship
programs for all of its member hospitals
after determining that such a decision is
in accordance with all applicable State
and local laws. The system governing
body is responsible and accountable for
ensuring that each of its separately
certified hospitals meets all of the
requirements of this section. Each
separately certified hospital subject to
the system governing body must
demonstrate that:
(1) The unified and integrated
infection prevention and control and
antibiotic stewardship programs are
established in a manner that takes into
account each member hospital’s unique
circumstances and any significant
differences in patient populations and
services offered in each hospital;
(2) The unified and integrated
infection prevention and control and
antibiotic stewardship programs
establish and implement policies and
procedures to ensure that the needs and
concerns of each of its separately
certified hospitals, regardless of practice
or location, are given due consideration;
(3) The unified and integrated
infection prevention and control and
antibiotic stewardship programs have
mechanisms in place to ensure that
issues localized to particular hospitals
are duly considered and addressed; and
(4) A qualified individual (or
individuals) with expertise in infection
prevention and control and in antibiotic
stewardship has been designated at the
hospital as responsible for
communicating with the unified
infection prevention and control and
antibiotic stewardship programs, for
implementing and maintaining the
policies and procedures governing
infection prevention and control and
antibiotic stewardship as directed by the
unified infection prevention and control
and antibiotic stewardship programs,
and for providing education and
training on the practical applications of
infection prevention and control and
antibiotic stewardship to hospital staff.
■ 27. Section 482.51 is amended by
revising paragraphs (b)(1)(i) and (ii) and
adding paragraph (b)(1)(iii) to read as
follows:
§ 482.51 Condition of participation:
Surgical services.
*
*
*
(b) * * *
(1) * * *
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*
*
(i) A medical history and physical
examination must be completed and
documented no more than 30 days
before or 24 hours after admission or
registration, and except as provided
under paragraph (b)(1)(iii) of this
section.
(ii) An updated examination of the
patient, including any changes in the
patient’s condition, must be completed
and documented within 24 hours after
admission or registration when the
medical history and physical
examination are completed within 30
days before admission or registration,
and except as provided under paragraph
(b)(1)(iii) of this section.
(iii) An assessment of the patient must
be completed and documented after
registration (in lieu of the requirements
of paragraphs (b)(1)(i) and (ii) of this
section) when the patient is receiving
specific outpatient surgical or
procedural services and when the
medical staff has chosen to develop and
maintain a policy that identifies, in
accordance with the requirements at
§ 482.22(c)(5)(v), specific patients as not
requiring a comprehensive medical
history and physical examination, or
any update to it, prior to specific
outpatient surgical or procedural
services.
*
*
*
*
*
■ 28. Section 482.58 is amended by—
■ a. Revising paragraph (b)(1);
■ b. Removing paragraph (b)(4);
■ c. Redesignating paragraphs (b)(5)
through (8) as paragraphs (b)(4) through
(7); and
■ d. Revising newly redesignated
paragraphs (b)(4), (5), and (7).
The revisions read as follows:
§ 482.58 Special requirements for hospital
providers of long-term care services
(‘‘swing-beds’’).
*
*
*
*
*
(b) * * *
(1) Resident rights (§ 483.10(b)(7),
(c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4),
(f)(4)(ii) and (iii), (h), (g)(8) and (17), and
(g)(18) introductory text of this chapter).
*
*
*
*
*
(4) Social services (§ 483.40(d) of this
chapter).
(5) Discharge summary (§ 483.20(l)).
*
*
*
*
*
(7) Dental services (§ 483.55(a)(2), (3),
(4), and (5) and (b) of this chapter).
■ 29. Section 482.61 is amended by
revising paragraph (d) to read as
follows:
§ 482.61 Condition of participation:
Special medical record requirements for
psychiatric hospitals.
*
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*
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*
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*
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51821
(d) Standard: Recording progress.
Progress notes must be recorded by the
physicians(s), psychologists, or other
licensed independent practitioner(s)
responsible for the care of the patient as
specified in § 482.12(c); nurse, social
worker and, when appropriate, others
significantly involved in active
treatment modalities. The frequency of
progress notes is determined by the
condition of the patient but must be
recorded at least weekly for the first 2
months and at least once a month
thereafter and must contain
recommendations for revisions in the
treatment plan as indicated as well as
precise assessment of the patient’s
progress in accordance with the original
or revised treatment plan.
*
*
*
*
*
§ 482.68
[Amended]
30. Section 482.68 is amended—
a. In the section heading by removing
the phrase ‘‘transplant centers’’ and
adding in its place the phrase
‘‘transplant programs’’; and
■ b. In the introductory text and in
paragraph (b) by removing the phrase
‘‘transplant center’’ and adding in its
place the phrase ‘‘transplant program’’.
■ 31. Section 482.70 is amended—
■ a. In the definition of ‘‘Adverse event’’
by removing the phrase ‘‘transplant
centers’’ and adding in its place the
phrase ‘‘transplant programs’’;
■ b. By removing the definition of
‘‘Heart-Lung transplant center’’;
■ c. By adding definitions for ‘‘HeartLung transplant program’’ and
‘‘Intestine transplant program’’ in
alphabetical order;
■ d. By removing the definition of
‘‘Intestine transplant center’’;
■ e. By adding a definition for ‘‘Intestine
transplant program’’ in alphabetical
order;
■ f. By removing the definition of
‘‘Pancreas transplant center’’;
■ g. By adding a definition for
‘‘Pancreas transplant program’’ in
alphabetical order;
■ h. By removing the definition of
‘‘Transplant center’’; and
■ i. By revising the definition of
‘‘Transplant program’’.
The additions and revision read as
follows:
■
■
§ 482.70
Definitions.
*
*
*
*
*
Heart-Lung transplant program means
a transplant program that is located in
a hospital with an existing Medicareapproved heart transplant program and
an existing Medicare-approved lung
program that performs combined heartlung transplants.
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Intestine transplant program means a
Medicare-approved liver transplant
program that performs intestine
transplants, combined liver-intestine
transplants, or multivisceral transplants.
*
*
*
*
*
Pancreas transplant program means a
Medicare-approved kidney transplant
program that performs pancreas
Section
§ 482.72
§ 482.74
§ 482.74
§ 482.74
§ 482.74
§ 482.74
§ 482.74
§ 482.74
§ 482.78
§ 482.78
§ 482.78
§ 482.78
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.80
§ 482.82
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
.................................................................
(a) introductory text .................................
(a) introductory text .................................
(a)(1) .......................................................
(a)(1) .......................................................
(a)(2) .......................................................
(a)(3) .......................................................
(b) introductory text .................................
Section heading ......................................
Introductory text ......................................
(a) ............................................................
(b) ............................................................
Section heading ......................................
Introductory text ......................................
(a) ............................................................
(a) ............................................................
(b) ............................................................
(c) introductory text .................................
(c)(1) ........................................................
(c)(1) ........................................................
(c)(1) ........................................................
(c)(2) ........................................................
(d)(1) .......................................................
(d)(1) .......................................................
(d)(2) .......................................................
(d)(2) .......................................................
(d)(3) .......................................................
(d)(3) .......................................................
(d)(4) .......................................................
(d)(4) .......................................................
(d)(5) .......................................................
transplant center .....................................
transplant center .....................................
center’s ....................................................
transplant center .....................................
center’s ....................................................
transplant center .....................................
transplant center .....................................
transplant center .....................................
transplant centers ...................................
transplant center .....................................
transplant center .....................................
transplant center .....................................
transplant centers ...................................
transplant centers ...................................
transplant center .....................................
beneficiary ...............................................
transplant center .....................................
center ......................................................
transplant center’s ...................................
center-specific report ..............................
beneficiaries ............................................
center’s ....................................................
transplant center .....................................
center ......................................................
transplant center .....................................
center ......................................................
transplant center .....................................
center ......................................................
transplant center .....................................
center ......................................................
transplant center .....................................
33. Section 482.82 is removed.
34. The undesignated center heading
preceding § 482.90 is revised to read
‘‘Transplant Program Process
Requirements’’.
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VerDate Sep<11>2014
32. In the following table, for each
section and paragraph indicated in the
first two columns, remove the phrase
indicated in the third column each time
it appears and add the reference
indicated in the fourth column:
■
Remove
[Removed]
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
§§ 482.72, 482.74, 482.78, and 482.80
[Amended]
Paragraphs
■
§ 482.90
§ 482.90
§ 482.90
§ 482.90
§ 482.90
§ 482.90
§ 482.90
§ 482.92
§ 482.92
§ 482.92
§ 482.92
§ 482.92
§ 482.92
§ 482.92
§ 482.92
§ 482.92
§ 482.94
§ 482.94
§ 482.94
transplants alone or subsequent to a
kidney transplant as well as kidneypancreas transplants.
*
*
*
*
*
Transplant program means an organspecific transplant program within a
transplant hospital (as defined in this
section).
§§ 482.90, 482.92, 482.94, 482.96, 482.98,
482.100, and 482.102 [Amended]
Add
it appears and add the reference
indicated in the fourth column:
35. In the following table, for each
section and paragraph indicated in the
first two columns, remove the phrase
indicated in the third column each time
■
Paragraphs
Remove
Introductory text ......................................
Introductory text ......................................
(a)(1) .......................................................
(a)(2) .......................................................
(a)(3) .......................................................
(a)(4) .......................................................
(b) introductory text .................................
Introductory text ......................................
Introductory text ......................................
Introductory text ......................................
Introductory text ......................................
(a) ............................................................
(a) ............................................................
(b) ............................................................
(b) ............................................................
(b) ............................................................
Introductory text ......................................
Introductory text ......................................
Introductory text ......................................
transplant center .....................................
center ......................................................
center’s waiting list ..................................
transplant center .....................................
center’s waiting list ..................................
transplant center .....................................
Transplant centers ..................................
donor-beneficiary ....................................
beneficiary ...............................................
Transplant centers ..................................
transplant center .....................................
transplant center .....................................
beneficiary ...............................................
center ......................................................
beneficiary ...............................................
beneficiary’s ............................................
Transplant centers ..................................
transplant center .....................................
the center also ........................................
20:43 Sep 27, 2019
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transplant program.
transplant program.
hospital’s.
transplant program.
program’s.
transplant program.
transplant program.
transplant program.
transplant programs.
transplant program.
transplant program.
transplant program.
transplant programs.
transplant programs.
transplant program.
recipient.
transplant program.
program.
transplant program’s.
program-specific report.
recipients.
program’s.
transplant program.
program.
transplant program.
program.
transplant program.
program.
transplant program.
program.
transplant program.
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Add
transplant program.
program.
program’s waiting list.
transplant program.
program’s waiting list.
transplant program.
Transplant programs.
donor-recipient.
recipient.
Transplant programs.
transplant program.
transplant program.
recipient.
program.
recipient.
recipient’s.
Transplant programs.
transplant programs.
the program also.
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Section
Paragraphs
Remove
Add
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.94 ..........
§ 482.96 ..........
§ 482.96 ..........
§ 482.96 ..........
§ 482.96 ..........
§ 482.96 ..........
§ 482.96 ..........
§ 482.96 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.98 ..........
§ 482.100 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
§ 482.102 ........
(a) introductory text .................................
(a)(2) .......................................................
(b) introductory text .................................
(b)(2) .......................................................
(b)(3) .......................................................
(c) introductory text .................................
(c) introductory text .................................
(c)(1)introductory text ..............................
(c)(1)introductory text ..............................
(c)(1)(i) ....................................................
(c)(1)(ii) ....................................................
(c)(1)(iii) ...................................................
(c)(2) ........................................................
(c)(3) introductory text .............................
(d) introductory text .................................
(d)(2) .......................................................
(e) ............................................................
Introductory text ......................................
(a) ............................................................
(a) ............................................................
(a) ............................................................
(b) introductory text .................................
(b)(2) .......................................................
(b)(2) .......................................................
Introductory text ......................................
Introductory text ......................................
(a) heading and introductory text ............
(a) introductory text .................................
(a)(1) .......................................................
(b) introductory text .................................
(c) introductory text .................................
(c)(2) ........................................................
(d) introductory text .................................
(d) heading ..............................................
(d)(1) .......................................................
(d)(2) introductory text ............................
(d)(3) introductory text ............................
(e) ............................................................
(f) .............................................................
.................................................................
Introductory text ......................................
(a) introductory text .................................
(a)(8) .......................................................
(a)(8) .......................................................
(b) introductory text .................................
(b)(1) .......................................................
(b)(4) .......................................................
(b)(6) .......................................................
(b)(6) .......................................................
(b)(6) .......................................................
(b)(9) .......................................................
(b)(9) .......................................................
(c) introductory text .................................
(c) introductory text .................................
(c) introductory text .................................
(c)(1) introductory text .............................
(c)(1) introductory text .............................
(c)(2) introductory text .............................
(c)(2)(i) ....................................................
(c)(2)(i) ....................................................
(c)(2)(ii) ....................................................
(c)(2)(ii) ....................................................
(c)(2)(ii) ....................................................
(c)(2)(ii) ....................................................
(c)(3) ........................................................
(c)(3) ........................................................
(c)(3) ........................................................
(c)(3) ........................................................
transplant center’s ...................................
center ......................................................
Transplant centers ..................................
center’s ....................................................
center’s ....................................................
Transplant centers ..................................
center’s waiting list ..................................
center’s waiting list ..................................
center ......................................................
center’s waiting list ..................................
center’s ....................................................
center’s ....................................................
transplant center .....................................
transplant centers ...................................
transplant center .....................................
transplant center .....................................
Transplant centers ..................................
Transplant centers ..................................
transplant center’s ...................................
beneficiary ...............................................
transplant center .....................................
transplant center .....................................
transplant center .....................................
transplant center’s ...................................
transplant center .....................................
the center ................................................
transplant center .....................................
center’s ....................................................
transplant center .....................................
transplant center .....................................
transplant center .....................................
transplant center .....................................
transplant center .....................................
living donor advocate team .....................
living donor advocate ..............................
living donor advocate team .....................
living donor advocate team .....................
transplant center .....................................
transplant center .....................................
transplant center .....................................
transplant center .....................................
Transplant centers ..................................
transplant center .....................................
beneficiary’s ............................................
Transplant centers ..................................
transplant center .....................................
beneficiary ...............................................
transplant center-specific ........................
beneficiaries ............................................
center-specific outcomes ........................
transplant center .....................................
beneficiary’s ............................................
Transplant centers ..................................
center’s ....................................................
center ......................................................
transplant center .....................................
center’s waiting list ..................................
center’s Medicare approval .....................
center’s waiting list ..................................
transplant center .....................................
beneficiaries ............................................
center’s waiting list ..................................
the center ................................................
center’s termination of approval .............
transplant center’s ...................................
the center ................................................
center’s waiting list ..................................
transplant center .....................................
transplant program’s.
program.
Transplant programs.
program’s.
program’s.
Transplant programs.
program’s waiting list.
program’s waiting list.
program.
program’s waiting list.
progam’s.
progam’s.
transplant program.
transplant programs.
transplant program.
transplant program.
Transplant programs.
Transplant programs.
transplant program’s.
recipient.
transplant program.
transplant program.
transplant program.
transplant program’s.
transplant program.
the program.
transplant program.
program’s.
transplant program.
transplant program.
transplant program.
transplant program.
transplant program.
independent living donor advocate team.
independent living donor advocate.
independent living donor advocate team.
independent living donor advocate team.
transplant program.
transplant program.
transplant program.
transplant program.
Transplant programs.
transplant program.
recipient’s.
Transplant programs.
transplant program.
recipient.
transplant program-specific.
recipients.
transplant-specific outcomes.
transplant program.
recipient’s.
Transplant programs.
program’s.
program.
transplant program.
program’s waiting list.
program’s Medicare approval.
program’s waiting list.
transplant program.
recipients.
program’s waiting list.
the program.
program’s termination of approval.
transplant program’s.
the program.
program’s waiting list.
transplant program.
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20:43 Sep 27, 2019
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Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Rules and Regulations
36. Section 482.102 is further
amended by revising paragraph (a)(5) to
read as follows:
■
§ 482.102 Condition of participation:
Patient and living donor rights.
*
*
*
(a) * * *
*
*
(5) National and transplant programspecific outcomes, from the most recent
SRTR program-specific report, including
(but not limited to) the transplant
program’s observed and expected 1-year
patient and graft survival, and national
1-year patient and graft survival;
*
*
*
*
*
Paragraphs
PART 483—REQUIREMENTS FOR
STATES AND LONG TERM CARE
FACILITIES
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator includes a
group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the LTC facility’s
response to and maintain
documentation of all drills, tabletop
exercises, and emergency events, and
revise the LTC facility’s emergency
plan, as needed.
*
*
*
*
*
■ 40. Section 483.475 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
38. The authority citation for part 483
is revised to read as follows:
■
Authority: 42 U.S.C. 1302, 1320a–7, 1395i,
1395hh and 1396r.
39. Section 483.73 is amended by
revising paragraphs (a)(4) and (d)(2) to
read as follows:
■
Emergency preparedness.
jbell on DSK3GLQ082PROD with RULES2
*
*
*
*
*
(a) * * *
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, or Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
*
*
*
*
*
(d) * * *
(2) Testing. The LTC facility must
conduct exercises to test the emergency
plan at least twice per year, including
unannounced staff drills using the
emergency procedures. The LTC facility
must do the following:
(i) Participate in an annual full-scale
exercise that is community-based; or
(A) When a community-based
exercise is not accessible, conduct an
annual individual, facility-based
functional exercise.
(B) If the LTC facility experiences an
actual natural or man-made emergency
that requires activation of the
emergency plan, the LTC facility is
exempt from engaging its next required
a full-scale community-based or
individual, facility-based functional
exercise following the onset of the
emergency event.
(ii) Conduct an additional annual
exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
20:43 Sep 27, 2019
37. For § 482.104, in the following
table, for the heading and each
paragraph indicated in the first column,
remove the phrase indicated in the
second column each time it appears and
add the reference indicated in the third
column:
■
Add
transplant
transplant
transplant
transplant
transplant
VerDate Sep<11>2014
[Amended]
Remove
Section heading .................................................
(a) ......................................................................
(a) ......................................................................
(b) ......................................................................
(c) .......................................................................
§ 483.73
§ 482.104
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centers .............................................
centers .............................................
center ...............................................
centers .............................................
centers .............................................
§ 483.475 Condition of participation:
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The ICF/IID must
develop and maintain an emergency
preparedness plan that must be
reviewed, and updated at least every 2
years The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The ICF/
IID must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
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transplant
transplant
transplant
transplant
transplant
programs.
programs.
program.
programs.
programs.
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The ICF/IID
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include the following:
*
*
*
*
*
(d) Training and testing. The ICF/IID
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years. The ICF/IID must meet the
requirements for evacuation drills and
training at § 483.470(i).
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the ICF/IID must conduct
training on the updated policies and
procedures.
(2) Testing. The ICF/IID must conduct
exercises to test the emergency plan at
least twice per year. The ICF/IID must
do the following:
(i) Participate in an annual full-scale
exercise that is community-based; or
(A) When a community-based
exercise is not accessible, conduct an
annual individual, facility-based
functional exercise; or.
(B) If the ICF/IID experiences an
actual natural or man-made emergency
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that requires activation of the
emergency plan, the ICF/IID is exempt
from engaging in its next required fullscale community-based or individual,
facility-based functional exercise
following the onset of the emergency
event.
(ii) Conduct an additional annual
exercise that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the ICF/IID’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events, and revise the ICF/IID’s
emergency plan, as needed
*
*
*
*
*
PART 484—HOME HEALTH SERVICES
41. The authority citation for part 484
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh
unless otherwise indicated.
42. Section 484.2 is amended by
adding definitions for ‘‘Pseudo-patient’’
and ‘‘Simulation’’ in alphabetical order
to read as follows:
■
§ 484.2
Definitions.
jbell on DSK3GLQ082PROD with RULES2
*
*
*
*
*
Pseudo-patient means a person
trained to participate in a role-play
situation, or a computer-based
mannequin device. A pseudo-patient
must be capable of responding to and
interacting with the home health aide
trainee, and must demonstrate the
general characteristics of the primary
patient population served by the HHA
in key areas such as age, frailty,
functional status, and cognitive status.
*
*
*
*
*
Simulation means a training and
assessment technique that mimics the
reality of the homecare environment,
including environmental distractions
and constraints that evoke or replicate
substantial aspects of the real world in
a fully interactive fashion, in order to
teach and assess proficiency in
performing skills, and to promote
decision making and critical thinking.
*
*
*
*
*
■ 43. Section 484.50 is amended by
removing and reserving paragraph (a)(3)
VerDate Sep<11>2014
20:43 Sep 27, 2019
Jkt 247001
and revising paragraph (c)(7)
introductory text.
The revision reads as follows:
§ 484.50
rights.
Condition of participation: Patient
*
*
*
*
*
(c) * * *
(7) Be advised, orally and in writing,
of—
*
*
*
*
*
■ 44. Section 484.80 is amended by
revising paragraphs (c)(1) and (h)(3) to
read as follows:
§ 484.80 Condition of participation: Home
health aide services.
*
*
*
*
*
(c) * * *
(1) The competency evaluation must
address each of the subjects listed in
paragraph (b)(3) of this section. Subject
areas specified under paragraphs
(b)(3)(i), (iii), (ix), (x), and (xi) of this
section must be evaluated by observing
an aide’s performance of the task with
a patient or pseudo-patient. The
remaining subject areas may be
evaluated through written examination,
oral examination, or after observation of
a home health aide with a patient, or
with a pseudo-patient as part of a
simulation.
*
*
*
*
*
(h) * * *
(3) If a deficiency in aide services is
verified by the registered nurse or other
appropriate skilled professional during
an on-site visit, then the agency must
conduct, and the home health aide must
complete, retraining and a competency
evaluation related to the deficient
skill(s).
*
*
*
*
*
■ 45. Section 484.102 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, and (d)
introductory text and the first paragraph
(d)(1)(ii);
■ b. Redesignating the second paragraph
(d)(1)(ii) as paragraph (d)(1)(iv);
■ c. Adding paragraph (d)(1)(v); and
■ d. Revising paragraph (d)(2).
The revisions and addition read as
follows:
§ 484.102 Condition of participation:
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The HHA must
develop and maintain an emergency
preparedness plan that must be
reviewed, and updated at least every 2
years. The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
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51825
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The HHA
must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The HHA
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The HHA
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the HHA must conduct
training on the updated policies and
procedures.
(2) Testing. The HHA must conduct
exercises to test the emergency plan at
least annually. The HHA must do the
following:
(i) Participate in a full-scale exercise
that is community-based; or
(A) When a community-based
exercise is not accessible, conduct an
annual individual, facility-based
functional exercise every 2 years; or.
(B) If the HHA experiences an actual
natural or man-made emergency that
requires activation of the emergency
plan, the HHA is exempt from engaging
in its next required full-scale
community-based or individual, facilitybased functional exercise following the
onset of the emergency event.
(ii) Conduct an additional exercise
every 2 years, opposite the year the full-
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Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Rules and Regulations
scale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the HHA’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events, and revise the HHA’s emergency
plan, as needed
*
*
*
*
*
PART 485—CONDITIONS OF
PARTICIPATION: SPECIALIZED
PROVIDERS
46. The authority citation for part 485
is revised to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395(hh).
47. Section 485.66 is amended by
revising the introductory text to read as
follows:
■
§ 485.66 Condition of participation:
Utilization review plan.
The facility must have in effect a
written utilization review plan that is
implemented annually, to assess the
necessity of services and promotes the
most efficient use of services provided
by the facility.
*
*
*
*
*
■ 48. Section 485.68 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
§ 485.68 Condition of participation:
Emergency preparedness.
jbell on DSK3GLQ082PROD with RULES2
*
*
*
*
*
(a) Emergency plan. The CORF must
develop and maintain an emergency
preparedness plan that must be
reviewed and updated at least every 2
years. The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
VerDate Sep<11>2014
20:43 Sep 27, 2019
Jkt 247001
maintain an integrated response during
a disaster or emergency situation.
*
*
*
*
*
(b) Policies and procedures. The
CORF must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The CORF
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The CORF
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the CORF must conduct
training on the updated policies and
procedures.
(2) Testing. The CORF must conduct
exercises to test the emergency plan at
least annually. The CORF must do the
following:
(i) Participate in a full-scale exercise
that is community-based every 2 years;
or
(A) When a community-based
exercise is not accessible, conduct an
individual, facility-based functional
exercise every 2 years; or
(B) If the CORF experiences an actual
natural or man-made emergency that
requires activation of the emergency
plan, the CORF is exempt from engaging
in its next required community-based or
individual, facility-based functional
exercise following the onset of the
emergency event.
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(ii) Conduct an additional exercise
every 2 years, opposite the year the fullscale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the CORF’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events, and revise the CORF’s
emergency plan, as needed.
*
*
*
*
*
■ 49. Section 485.625 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
§ 485.625 Condition of participation:
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The CAH must
develop and maintain an emergency
preparedness plan that must be
reviewed and updated at least every 2
years. The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The CAH
must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The CAH
must develop and maintain an
emergency preparedness
communication plan that complies with
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Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The CAH
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the CAH must conduct
training on the updated policies and
procedures.
(2) Testing. The CAH must conduct
exercises to test the emergency plan at
least twice per year. The CAH must do
the following:
(i) Participate in an annual full-scale
exercise that is community-based; or
(A) When a community-based
exercise is not accessible, conduct an
annual individual, facility-based
functional exercise; or.
(B) If the CAH experiences an actual
natural or man-made emergency that
requires activation of the emergency
plan, the CAH is exempt from engaging
in its next required full-scale
community-based or individual, facilitybased functional exercise following the
onset of the emergency event.
(ii) Conduct an annual additional
exercise, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the CAH’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events, and revise the CAH’s emergency
plan, as needed.
*
*
*
*
*
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§ 485.627
[Amended]
50. Section 485.627 is amended by
removing paragraph (b)(1) and
redesignating paragraphs (b)(2) and (3)
as paragraphs (b)(1) and (2),
respectively.
■ 51. Section 485.631 is amended by
adding paragraph (d) to read as follows:
■
§ 485.631 Condition of participation:
Staffing and staff responsibilities.
*
*
*
*
*
(d) Standard: Periodic review of
clinical privileges and performance. The
CAH requires that—
(1) The quality and appropriateness of
the diagnosis and treatment furnished
by nurse practitioners, clinical nurse
specialist, and physician assistants at
the CAH are evaluated by a member of
the CAH staff who is a doctor of
medicine or osteopathy or by another
doctor of medicine or osteopathy under
contract with the CAH.
(2) The quality and appropriateness of
the diagnosis and treatment furnished
by doctors of medicine or osteopathy at
the CAH are evaluated by—
(i) One hospital that is a member of
the network, when applicable;
(ii) One Quality Improvement
Organization (QIO) or equivalent entity;
(iii) One other appropriate and
qualified entity identified in the State
rural health care plan;
(iv) In the case of distant-site
physicians and practitioners providing
telemedicine services to the CAH’s
patient under an agreement between the
CAH and a distant-site hospital, the
distant-site hospital; or
(v) In the case of distant-site
physicians and practitioners providing
telemedicine services to the CAH’s
patients under a written agreement
between the CAH and a distant-site
telemedicine entity, one of the entities
listed in paragraphs (d)(2)(i) through
(iii) of this section.
(3) The CAH staff consider the
findings of the evaluation and make the
necessary changes as specified in
paragraphs (b) through (d) of this
section.
■ 52. Section 485.635 is amended by—
■ a. Removing paragraph (a)(3)(vi);
■ b. Redesignating paragraph (a)(3)(vii)
as paragraph (a)(3)(vi); and
■ c. Revising newly designated
paragraph (a)(3)(vi) and paragraph (a)(4).
The revisions read as follows:
§ 485.635 Condition of participation:
Provision of services.
(a) * * *
(3) * * *
(vi) Procedures that ensure that the
nutritional needs of inpatients are met
in accordance with recognized dietary
PO 00000
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practices. All patient diets, including
therapeutic diets, must be ordered by
the practitioner responsible for the care
of the patients or by a qualified dietitian
or qualified nutrition professional as
authorized by the medical staff in
accordance with State law governing
dietitians and nutrition professionals
and that the requirement of § 483.25(i)
of this chapter is met with respect to
inpatients receiving post CAH SNF care.
(4) These policies are reviewed at
least biennially by the group of
professional personnel required under
paragraph (a)(2) of this section and
updated as necessary by the CAH.
*
*
*
*
*
■ 53. Section 485.640 is added to read
as follows:
§ 485.640 Condition of participation:
Infection prevention and control and
antibiotic stewardship programs.
The CAH must have active facilitywide programs, for the surveillance,
prevention, and control of HAIs and
other infectious diseases and for the
optimization of antibiotic use through
stewardship. The programs must
demonstrate adherence to nationally
recognized infection prevention and
control guidelines, as well as to best
practices for improving antibiotic use
where applicable, and for reducing the
development and transmission of HAIs
and antibiotic-resistant organisms.
Infection prevention and control
problems and antibiotic use issues
identified in the programs must be
addressed in coordination with the
facility-wide quality assessment and
performance improvement (QAPI)
program.
(a) Standard: Infection prevention and
control program organization and
policies. The CAH must demonstrate
that:
(1) An individual (or individuals),
who is qualified through education,
training, experience, or certification in
infection prevention and control, is
appointed by the governing body, or
responsible individual, as the infection
preventionist(s)/infection control
professional(s) responsible for the
infection prevention and control
program and that the appointment is
based on the recommendations of
medical staff leadership and nursing
leadership;
(2) The infection prevention and
control program, as documented in its
policies and procedures, employs
methods for preventing and controlling
the transmission of infections within the
CAH and between the CAH and other
healthcare settings;
(3) The infection prevention and
control includes surveillance,
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prevention, and control of HAIs,
including maintaining a clean and
sanitary environment to avoid sources
and transmission of infection, and that
the program also addresses any
infection control issues identified by
public health authorities; and
(4) The infection prevention and
control program reflects the scope and
complexity of the CAH services
provided.
(b) Standard: Antibiotic stewardship
program organization and policies. The
CAH must demonstrate that:
(1) An individual (or individuals),
who is qualified through education,
training, or experience in infectious
diseases and/or antibiotic stewardship,
is appointed by the governing body, or
responsible individual, as the leader(s)
of the antibiotic stewardship program
and that the appointment is based on
the recommendations of medical staff
leadership and pharmacy leadership;
(2) The facility-wide antibiotic
stewardship program:
(i) Demonstrates coordination among
all components of the CAH responsible
for antibiotic use and resistance,
including, but not limited to, the
infection prevention and control
program, the QAPI program, the medical
staff, nursing services, and pharmacy
services;
(ii) Documents the evidence-based use
of antibiotics in all departments and
services of the CAH; and
(iii) Documents any improvements,
including sustained improvements, in
proper antibiotic use;
(3) The antibiotic stewardship
program adheres to nationally
recognized guidelines, as well as best
practices, for improving antibiotic use;
and
(4) The antibiotic stewardship
program reflects the scope and
complexity of the CAH services
provided.
(c) Standard: Leadership
responsibilities. (1) The governing body,
or responsible individual, must ensure
all of the following:
(i) Systems are in place and
operational for the tracking of all
infection surveillance, prevention and
control, and antibiotic use activities, in
order to demonstrate the
implementation, success, and
sustainability of such activities.
(ii) All HAIs and other infectious
diseases identified by the infection
prevention and control program as well
as antibiotic use issues identified by the
antibiotic stewardship program are
addressed in collaboration with the
CAH’s QAPI leadership.
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(2) The infection prevention and
control professional(s) is responsible
for:
(i) The development and
implementation of facility-wide
infection surveillance, prevention, and
control policies and procedures that
adhere to nationally recognized
guidelines.
(ii) All documentation, written or
electronic, of the infection prevention
and control program and its
surveillance, prevention, and control
activities.
(iii) Communication and collaboration
with the CAH’s QAPI program on
infection prevention and control issues.
(iv) Competency-based training and
education of CAH personnel and staff,
including medical staff, and, as
applicable, personnel providing
contracted services in the CAH, on the
practical applications of infection
prevention and control guidelines,
policies and procedures.
(v) The prevention and control of
HAIs, including auditing of adherence
to infection prevention and control
policies and procedures by CAH
personnel.
(vi) Communication and collaboration
with the antibiotic stewardship
program.
(3) The leader(s) of the antibiotic
stewardship program is responsible for:
(i) The development and
implementation of a facility-wide
antibiotic stewardship program, based
on nationally recognized guidelines, to
monitor and improve the use of
antibiotics.
(ii) All documentation, written or
electronic, of antibiotic stewardship
program activities.
(iii) Communication and collaboration
with medical staff, nursing, and
pharmacy leadership, as well as the
CAH’s infection prevention and control
and QAPI programs, on antibiotic use
issues.
(iv) Competency-based training and
education of CAH personnel and staff,
including medical staff, and, as
applicable, personnel providing
contracted services in the CAHs, on the
practical applications of antibiotic
stewardship guidelines, policies, and
procedures.
■ 54. Section 485.641 is revised to read
as follows:
§ 485.641 Condition of participation:
Quality assessment and performance
improvement program.
The CAH must develop, implement,
and maintain an effective, ongoing,
CAH-wide, data-driven quality
assessment and performance
improvement (QAPI) program. The CAH
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must maintain and demonstrate
evidence of the effectiveness of its QAPI
program.
(a) Definitions. For the purposes of
this section—
Adverse event means an untoward,
undesirable, and usually unanticipated
event that causes death or serious injury
or the risk thereof.
Error means the failure of a planned
action to be completed as intended or
the use of a wrong plan to achieve an
aim. Errors can include problems in
practice, products, procedures, and
systems; and
Medical error means an error that
occurs in the delivery of healthcare
services.
(b) Standard: QAPI Program Design
and scope. The CAH’s QAPI program
must:
(1) Be appropriate for the complexity
of the CAH’s organization and services
provided.
(2) Be ongoing and comprehensive.
(3) Involve all departments of the
CAH and services (including those
services furnished under contract or
arrangement).
(4) Use objective measures to evaluate
its organizational processes, functions
and services.
(5) Address outcome indicators
related to improved health outcomes
and the prevention and reduction of
medical errors, adverse events, CAHacquired conditions, and transitions of
care, including readmissions.
(c) Standard: Governance and
leadership. The CAH’s governing body
or responsible individual is ultimately
responsible for the CAH’s QAPI program
and is responsible and accountable for
ensuring that the QAPI program meets
the requirements of paragraph (b) of this
section.
(d) Standard: Program activities. For
each of the areas listed in paragraph (b)
of this section, the CAH must:
(1) Focus on measures related to
improved health outcomes that are
shown to be predictive of desired
patient outcomes.
(2) Use the measures to analyze and
track its performance.
(3) Set priorities for performance
improvement, considering either highvolume, high-risk services, or problemprone areas.
(e) Standard: Program data collection
and analysis. The program must
incorporate quality indicator data
including patient care data, and other
relevant data, in order to achieve the
goals of the QAPI program.
■ 55. Section 485.645 is amended by—
■ a. Revising the introductory text;
■ b. Revising paragraph (d)(1);
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c. Removing paragraph (d)(4);
d. Redesignating paragraphs (d)(5)
through (9) as paragraphs (d)(4) through
(8), respectively; and
■ e. Revising newly redesignated
paragraphs (d)(4) and (7).
The revisions read as follows:
■
■
§ 485.645 Special requirements for CAH
providers of long-term care services
(‘‘swing-beds’’)
A CAH must meet the following
requirements in order to be granted an
approval from CMS to provide postCAH SNF care, as specified in § 409.30
of this chapter, and to be paid for SNFlevel services, in accordance with
paragraph (c) of this section.
*
*
*
*
*
(d) * * *
(1) Resident rights (§ 483.10(b)(7),
(c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4),
(f)(4)(ii) and (iii), (g)(8) and (17), (g)(18)
introductory text, and (h) of this
chapter).
*
*
*
*
*
(4) Social services (§ 483.40(d) of this
chapter).
*
*
*
*
*
(7) Dental services (§ 483.55(a)(2), (3),
(4), and (5) and (b) of this chapter).
*
*
*
*
*
■ 56. Section 485.727 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(5), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
§ 485.727 Condition of participation:
Emergency preparedness.
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*
*
*
*
*
(a) Emergency plan. The
Organizations must develop and
maintain an emergency preparedness
plan that must be reviewed and updated
at least every 2 years. The plan must do
all of the following:
*
*
*
*
*
(5) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
*
*
*
*
*
(b) Policies and procedures. The
Organizations must develop and
implement emergency preparedness
policies and procedures, based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
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procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The
Organizations must develop and
maintain an emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The
Organizations must develop and
maintain an emergency preparedness
training and testing program that is
based on the emergency plan set forth
in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this
section, policies and procedures at
paragraph (b) of this section, and the
communication plan at paragraph (c) of
this section. The training and testing
program must be reviewed and updated
at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the Organizations must
conduct training on the updated
policies and procedures.
(2) Testing. The Organizations must
conduct exercises to test the emergency
plan at least annually. The
Organizations must do the following:
(i) Participate in a full-scale exercise
that is community-based every 2 years;
or
(A) When a community-based
exercise is not accessible, an individual,
facility-based functional exercise every
2 years; or.
(B) If the Organizations experience an
actual natural or man-made emergency
that requires activation of the
emergency plan, the organization is
exempt from engaging in its next
required full-scale community-based or
individual, facility-based functional
exercise following the onset of the
emergency event.
(ii) Conduct an additional exercise
every 2 years, opposite the year the fullscale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
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51829
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the Organization’s
response to and maintain
documentation of all drills, tabletop
exercises, and emergency events, and
revise their emergency plan, as needed.
*
*
*
*
*
■ 57. Section 485.914 is amended by
revising paragraphs (d)(1) and (2) to
read as follows:
§ 485.914 Condition of participation:
Admission, initial evaluation,
comprehensive assessment, and discharge
or transfer of the client.
*
*
*
*
*
(d) * * *
(1) The CMHC must update each
client’s comprehensive assessment via
the CMHC interdisciplinary treatment
team, in consultation with the client’s
primary health care provider (if any),
when changes in the client’s status,
responses to treatment, or goal
achievement have occurred and in
accordance with current standards of
practice.
(2) For clients that receive PHP
services, the assessment must be
updated no less frequently than every
30 days.
*
*
*
*
*
■ 58. Section 485.920 is amended by
revising paragraphs (a) introductory
text, (a)(4), (b) introductory text, (c)
introductory text, and (d) to read as
follows:
§ 485.920 Condition of participation:
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The CMHC must
develop and maintain an emergency
preparedness plan that must be
reviewed, and updated at least every 2
years. The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The
CMHC must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
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procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The CMHC
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The CMHC
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years. If the emergency preparedness
policies and procedures are significantly
updated, the CMHC must conduct
training on the updated policies and
procedures.
(1) Training. The CMHC must provide
initial training in emergency
preparedness policies and procedures to
all new and existing staff, individuals
providing services under arrangement,
and volunteers, consistent with their
expected roles, and maintain
documentation of the training. The
CMHC must demonstrate staff
knowledge of emergency procedures.
Thereafter, the CMHC must provide
emergency preparedness training at
least every 2 years.
(2) Testing. The CMHC must conduct
exercises to test the emergency plan at
least annually. The CMHC must:
(i) Participate in a full-scale exercise
that is community-based every 2 years;
or
(A) When a community-based
exercise is not accessible, conduct an
individual, facility-based every 2 years;
or.
(B) If the CMHC experiences an actual
natural or man-made emergency that
requires activation of the emergency
plan, the CMHC is exempt from
engaging in its next required
community-based or individual, facilitybased functional exercise following the
onset of the emergency event.
(ii) Conduct an additional exercise
every 2 years, opposite the year the fullscale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted, that may include, but is not
limited to following:
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(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the CMHC’s response to
and maintain documentation of all
drills, tabletop exercises, and emergency
events, and revise the CMHC’s
emergency plan, as needed.
*
*
*
*
*
PART 486—CONDITIONS FOR
COVERAGE OF SPECIALIZED
SERVICES FURNISHED BY
SUPPLIERS
59. The authority citation for part 486
continues to read as follows:
■
Authority: 42 U.S.C. 1302, and 1395hh.
60. Section 486.104 is amended by
revising paragraph (a) to read as follows:
■
§ 486.104 Condition for coverage:
Qualifications, orientation and health of
technical personnel.
*
*
*
*
*
(a) Standard: Qualifications of
technologists. All operators of the
portable X-ray equipment meet the
requirements of paragraph (a)(1) or (2) of
this section.
(1) Successful completion of a
program of formal training in X-ray
technology at which the operator
received appropriate training and
demonstrated competence in the use of
equipment and administration of
portable x-ray procedures; or
(2) Successful completion of 24 full
months of training and experience
under the direct supervision of a
physician who is certified in radiology
or who possesses qualifications which
are equivalent to those required for such
certification.
*
*
*
*
*
■ 61. Section 486.106 is amended by
revising paragraph (a)(2) to read as
follows:
§ 486.106 Conditions for coverage:
Referral for service and preservation of
records.
*
*
*
*
*
(a) * * *
(2) Such physician or non-physician
practitioner’s order meets the
requirements at § 410.32 of this chapter,
and includes a statement concerning the
condition of the patient which indicates
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why portable X-ray services are
necessary.
*
*
*
*
*
■ 62. Section 486.360 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2)(i).
The revisions and addition read as
follows:
§ 486.360 Condition for Coverage:
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The OPO must
develop and maintain an emergency
preparedness plan that must be
reviewed and updated at least every 2
years. The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The OPO
must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and, the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The OPO
must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The OPO
must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
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(ii) Provide emergency preparedness
training at every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the OPO must conduct training
on the updated policies and procedures.
(2) * * *
(i) Conduct a paper-based, tabletop
exercise or workshop at least annually.
A tabletop exercise is led by a facilitator
and includes a group discussion, using
a narrated, clinically-relevant
emergency scenario, and a set of
problem statements, directed messages,
or prepared questions designed to
challenge an emergency plan. If the
OPO experiences an actual natural or
man-made emergency that requires
activation of the emergency plan, the
OPO is exempt from engaging in its next
required testing exercise following the
onset of the emergency event.
*
*
*
*
*
PART 488—SURVEY, CERTIFICATION,
AND ENFORCEMENT PROCEDURES
63. The authority citation for part 488
continues to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
§ 488.30
[Amended]
64. Section 488.30(a) is amended in
the definition of ‘‘Provider of services,
provider, or supplier’’ by removing the
phrase ‘‘transplant centers’’ and adding
in its place the phrase ‘‘transplant
programs’’.
■ 65. Section 488.61 is amended—
■ a. By revising the section heading;
■ b. In the introductory text by
removing the phrase ‘‘transplant
centers’’ and adding in its place the
phrase ‘‘transplant programs’’;
■ c. In paragraph (a) introductory text by
removing the words ‘‘centers’’ and
‘‘center’’ each time they appear and
adding in their place the words
‘‘programs’’ and ‘‘program,’’
respectively;
■ d. In paragraph (a)(2) by removing the
phrase ‘‘Scientific Registry of
Transplant Beneficiary (SRTR) centerspecific’’ and adding in its place the
phrase ‘‘Scientific Registry of
Transplant Recipient (SRTR) programspecific’’;
■ e. By revising paragraph (a)(5);
■ f. By removing paragraph (c);
■ g. By redesignating paragraphs (d)
through (h) as paragraphs (c) through
(g), respectively;
■ h. By revising newly redesignated
paragraphs (c) and (d), the newly
redesignated paragraph (e) subject
heading, and newly redesignated
paragraphs (e)(1) introductory text,
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■
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(e)(1)(iv), (e)(3), and (f)(1)(i) through
(iii); and
■ i. In newly redesignated paragraph
(g)(1)(x) by removing the reference
‘‘paragraphs (h)(1)(v), (h)(1)(vi),
(h)(1)(vii) or (h)(1)(viii)’’ and adding in
its place the reference ‘‘paragraph
(g)(1)(v), (vi), (vii) or (viii)’’ .
The revisions read as follows:
§ 488.61 Special procedures for approval
and re-approval of organ transplant
programs.
*
*
*
*
*
(a) * * *
(5) If CMS determines that a
transplant program has met the data
submission, clinical experience, and
outcome requirements, CMS will review
the program’s compliance with the
conditions of participation contained at
§§ 482.72 through 482.76 and §§ 482.90
through 482.104 of this chapter using
the procedures described in subpart A
of this part. If the transplant program is
found to be in compliance with all the
conditions of participation at §§ 482.72
through 482.104 of this chapter, CMS
will notify the transplant program in
writing of the effective date of its
Medicare-approval. CMS will notify the
transplant program in writing if it is not
Medicare-approved.
*
*
*
*
*
(c) Loss of Medicare approval.
Programs that have lost their Medicare
approval may seek re-entry into the
Medicare program at any time. A
program that has lost its Medicare
approval must:
(1) Request initial approval using the
procedures described in paragraph (a) of
this section;
(2) Be in compliance with §§ 482.72
through 482.104 of this chapter at the
time of the request for Medicare
approval; and
(3) Submit a report to CMS
documenting any changes or corrective
actions taken by the program as a result
of the loss of its Medicare approval
status.
(d) Transplant program inactivity. A
transplant program may remain inactive
and retain its Medicare approval for a
period not to exceed 12 months. A
transplant program must notify CMS
upon its voluntary inactivation as
required by § 482.74(a)(3) of this
chapter.
(e) Consideration of mitigating factors
in initial approval survey, certification,
and enforcement actions for transplant
programs—(1) Factors. Except for
situations of immediate jeopardy or
deficiencies other than failure to meet
requirements at § 482.80 of this chapter,
CMS will consider such mitigating
factors as may be appropriate in light of
PO 00000
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51831
the nature of the deficiency and
circumstances, including (but not
limited to) the following, in making a
decision of initial approval of a
transplant program that does not meet
the data submission, clinical
experience, or outcome requirements:
*
*
*
*
*
(iv) Program improvements that
substantially address root causes of graft
failures or patient deaths, that have been
implemented and institutionalized on a
sustainable basis, and that are supported
by outcomes more recent than the latest
available SRTR report, for which there
is a sufficient post-transplant patient
and graft survival period and a
sufficient number of transplants such
that CMS finds that the program
demonstrates present-day compliance
with the requirements at
§ 482.80(c)(2)(ii)(C) of this chapter;
*
*
*
*
*
(3) Timing. Within 14 calendar days
after CMS has issued formal written
notice of a condition-level deficiency to
the program, CMS must receive
notification of the program’s intent to
seek mitigating factors approval, and
receive all information for consideration
of mitigating factors within 120 calendar
days of the CMS written notification for
a deficiency due to data submission,
clinical experience or outcomes at
§ 482.80 of this chapter. Failure to meet
these timeframes may be the basis for
denial of mitigating factors. CMS may
permit an extension of the timeline for
good cause, such as a declared public
health emergency.
(f) * * *
(1) * * *
(i) Approve initial approval of a
program’s Medicare participation based
upon approval of mitigating factors.
(ii) Deny the program’s request for
Medicare approval based on mitigating
factors.
(iii) Offer a time-limited Systems
Improvement Agreement, in accordance
with paragraph (g) of this section, when
a transplant program has waived its
appeal rights, has implemented
substantial program improvements that
address root causes and are
institutionally supported by the
hospital’s governing body on a
sustainable basis, and has requested
more time to design or implement
additional improvements or
demonstrate compliance with CMS
outcome requirements. Upon
completion of the Systems Improvement
Agreement or a CMS finding that the
hospital has failed to meet the terms of
the Agreement, CMS makes a final
determination of whether to approve or
deny a program’s request for Medicare
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approval based on mitigating factors. A
Systems Improvement Agreement
follows the process specified in
paragraph (g) of this section.
*
*
*
*
*
PART 491—CERTIFICATION OF
CERTAIN HEALTH FACILITIES
66. The authority citation for part 491
is revised to read as follows:
■
Authority: 42 U.S.C. 263a and 1302.
67. Section 491.9 is amended by
revising paragraph (b)(4) to read as
follows:
■
§ 491.9
Provision of services.
*
*
*
*
*
(b) * * *
(4) These policies are reviewed at
least biennially by the group of
professional personnel required under
paragraph (b)(2) of this section and
reviewed as necessary by the RHC or
FQHC.
*
*
*
*
*
■ 68. Section 491.11 is amended by
revising paragraph (a) to read as follows:
§ 491.11
Program evaluation.
(a) The clinic or center carries out, or
arranges for, a biennial evaluation of its
total program.
*
*
*
*
*
■ 69. Section 491.12 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(v); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
§ 491.12
Emergency preparedness.
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*
*
*
*
*
(a) Emergency plan. The RHC or
FQHC must develop and maintain an
emergency preparedness plan that must
be reviewed and updated at least every
2 years. The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation.
(b) Policies and procedures. The RHC
or FQHC must develop and implement
emergency preparedness policies and
procedures, based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
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procedures must be reviewed and
updated at least every 2 years. At a
minimum, the policies and procedures
must address the following:
*
*
*
*
*
(c) Communication plan. The RHC or
FQHC must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training and testing. The RHC or
FQHC must develop and maintain an
emergency preparedness training and
testing program that is based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, policies
and procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training and testing program must be
reviewed and updated at least every 2
years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(v) If the emergency preparedness
policies and procedures are significantly
updated, the RHC/FQHC must conduct
training on the updated policies and
procedures.
(2) Testing. The RHC or FQHC must
conduct exercises to test the emergency
plan at least annually. The RHC or
FQHC must do the following:
(i) Participate in a full-scale exercise
that is community-based every 2 years;
or
(A) When a community-based
exercise is not accessible, an individual,
facility-based functional exercise every
2 years; or.
(B) If the RHC or FQHC experiences
an actual natural or man-made
emergency that requires activation of
the emergency plan, the RHC or FQHC
is exempt from engaging in its next
required full-scale community-based or
individual, facility-based functional
exercise following the onset of the
emergency event.
(ii) Conduct an additional exercise
every 2 years, opposite the year the fullscale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted, that may include, but is not
limited to following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
PO 00000
Frm 00102
Fmt 4701
Sfmt 4700
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the RHC or FQHC’s
response to and maintain
documentation of all drills, tabletop
exercises, and emergency events, and
revise the RHC or FQHC’s emergency
plan, as needed.
*
*
*
*
*
PART 494—CONDITIONS FOR
COVERAGE FOR END–STAGE RENAL
DISEASE FACILITIES
70. The authority citation for part 494
is revised to read as follows:
■
Authority: 42 U.S.C. l302 and l395hh.
71. Section 494.60 is amended by
revising paragraphs (d)(1), (2), and (4)
and adding paragraphs (d)(5), (e), and (f)
to read as follows:
■
§ 494.60
Condition: Physical environment.
*
*
*
*
*
(d) * * *
(1) Except as provided in paragraph
(d)(2) of this section, dialysis facilities
that do not provide one or more exits to
the outside at grade level from the
patient treatment area level must
comply with provisions of the Life
Safety Code (NFPA 101 and its
Tentative Interim Amendments TIA 12–
1, TIA 12–2, TIA 12–3, and TIA 12–4)
applicable to Ambulatory Health Care
Occupancies, regardless of the number
of patients served.
(2) Notwithstanding paragraph (d)(1)
of this section, dialysis facilities
participating in Medicare as of October
14, 2008 that require sprinkler systems
are those housed in multi-story
buildings construction Types II(000),
III(200), or V(000), as defined in the Life
Safety Code, section 21.1.6.1, which
were constructed after January 1, 2008,
and those housed in high rise buildings
over 75 feet in height, which were
constructed after January 1, 2008.
*
*
*
*
*
(4) In consideration of a
recommendation by the State survey
agency or at the discretion of the
Secretary, the Secretary may waive, for
periods deemed appropriate, specific
provisions of the Life Safety Code,
which would result in unreasonable
hardship upon an ESRD facility, but
only if the waiver will not adversely
affect the health and safety of the
patients.
(5) No dialysis facility may operate in
a building that is adjacent to an
industrial high hazard area, as described
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Federal Register / Vol. 84, No. 189 / Monday, September 30, 2019 / Rules and Regulations
in sections 20.1.3.7 and 21.1.3.7 of the
Health Care Facilities Code (NFPA 99
and its Tentative Interim Amendments
TIA 12–2, TIA 12–3, TIA 12–4, TIA 12–
5, and TIA 12–6).
(e) Standard: Building safety. (1)
Dialysis facilities that do not provide
one or more exits to the outside at grade
level from the patient treatment area
level must meet the applicable
provisions of the Health Care Facilities
Code, regardless of the number of
patients served.
(2) Chapters 7, 8, 12, and 13 of the
Health Care Facilities Code do not apply
to a dialysis facility.
(3) If application of the Health Care
Facilities Code would result in
unreasonable hardship for the dialysis
facility, CMS may waive specific
provisions of the Health Care Facilities
Code for such facility, but only if the
waiver does not adversely affect the
health and safety of patients.
(f) Incorporation by reference. The
standards incorporated by reference in
this section are approved for
incorporation by reference by the
Director of the Office of the Federal
Register in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain the material from the sources
listed below. You may inspect a copy at
the CMS Information Resource Center,
7500 Security Boulevard, Baltimore, MD
or at the National Archives and Records
Administration (NARA). For
information on the availability of this
material at NARA, email fedreg.legal@
nara.gov, or go to: www.archives.gov/
federal_register/cfr/ibr-locations.html. If
any changes in the editions of the Codes
are incorporated by reference, CMS will
publish a document in the Federal
Register to announce the changes.
(1) National Fire Protection
Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1–
617–770–3000.
(i) NFPA 99, Health Care Facilities
Code, 2012 edition, issued August 11
2011.
(ii) TIA 12–2 to NFPA 99, issued
August 11, 2011.
(iii) TIA 12–3 to NFPA 99, issued
August 9, 2012.
(iv) TIA 12–4 to NFPA 99, issued
March 7, 2013.
(v) TIA 12–5 to NFPA 99, issued
August 1, 2013.
(vi) TIA 12–6 to NFPA 99, issued
March 3, 2014.
(vii) NFPA 101, Life Safety Code,
2012 edition, issued August 11, 2011.
(viii) TIA 12–1 to NFPA 101, issued
August 11, 2011.
(ix) TIA 12–2 to NFPA 101, issued
October 30, 2012.
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(x) TIA 12–3 to NFPA 101, issued
October 22, 2013.
(xi) TIA 12–4 to NFPA 101, issued
October 22, 2013.
(2) [Reserved]
■ 72. Section 494.62 is amended by—
■ a. Revising paragraphs (a)
introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d)
introductory text, and (d)(1)(ii);
■ b. Adding paragraph (d)(1)(vii); and
■ c. Revising paragraph (d)(2).
The revisions and addition read as
follows:
§ 494.62 Condition of participation:
Emergency preparedness.
*
*
*
*
*
(a) Emergency plan. The dialysis
facility must develop and maintain an
emergency preparedness plan that must
be evaluated and updated at least every
2 years. The plan must do all of the
following:
*
*
*
*
*
(4) Include a process for cooperation
and collaboration with local, tribal,
regional, State, and Federal emergency
preparedness officials’ efforts to
maintain an integrated response during
a disaster or emergency situation. The
dialysis facility must contact the local
emergency preparedness agency at least
annually to confirm that the agency is
aware of the dialysis facility’s needs in
the event of an emergency.
(b) Policies and procedures. The
dialysis facility must develop and
implement emergency preparedness
policies and procedures, based on the
emergency plan set forth in paragraph
(a) of this section, risk assessment at
paragraph (a)(1) of this section, and the
communication plan at paragraph (c) of
this section. The policies and
procedures must be reviewed and
updated at least every 2 years. These
emergencies include, but are not limited
to, fire, equipment or power failures,
care-related emergencies, water supply
interruption, and natural disasters likely
to occur in the facility’s geographic area.
At a minimum, the policies and
procedures must address the following:
*
*
*
*
*
(c) Communication plan. The dialysis
facility must develop and maintain an
emergency preparedness
communication plan that complies with
Federal, State, and local laws and must
be reviewed and updated at least every
2 years. The communication plan must
include all of the following:
*
*
*
*
*
(d) Training, testing, and orientation.
The dialysis facility must develop and
maintain an emergency preparedness
training, testing and patient orientation
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51833
program that is based on the emergency
plan set forth in paragraph (a) of this
section, risk assessment at paragraph
(a)(1) of this section, policies and
procedures at paragraph (b) of this
section, and the communication plan at
paragraph (c) of this section. The
training, testing, and patient orientation
program must be evaluated and updated
at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness
training at least every 2 years.
*
*
*
*
*
(vii) If the emergency preparedness
policies and procedures are significantly
updated, the dialysis facility must
conduct training on the updated
policies and procedures.
(2) Testing. The dialysis facility must
conduct exercises to test the emergency
plan at least annually. The dialysis
facility must do all of the following:
(i) Participate in a full-scale exercise
that is community-based every 2 years;
or
(A) When a community-based
exercise is not accessible, an individual,
and a facility-based functional exercise
every 2 years; or
(B) If the dialysis facility experiences
an actual natural or man-made
emergency that requires activation of
the emergency plan, the dialysis facility
is exempt from engaging in its next
required full-scale community-based or
individual, facility-based functional
exercise following the onset of the
emergency event.
(ii) Conduct an additional exercise
every 2 years, opposite the year the fullscale or functional exercise under
paragraph (d)(2)(i) of this section is
conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is
community-based or an individual,
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop
that is led by a facilitator and includes
a group discussion, using a narrated,
clinically-relevant emergency scenario,
and a set of problem statements,
directed messages, or prepared
questions designed to challenge an
emergency plan.
(iii) Analyze the dialysis facility’s
response to and maintain
documentation of all drills, tabletop
exercises, and emergency events, and
revise the dialysis facility’s emergency
plan, as needed.
*
*
*
*
*
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Dated: September 6, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: September 17, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2019–20736 Filed 9–25–19; 11:15 am]
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]]>Agencies
[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Rules and Regulations]
[Pages 51732-51834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20736]
[[Page 51731]]
Vol. 84
Monday,
No. 189
September 30, 2019
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid
-----------------------------------------------------------------------
42 CFR Parts 403, 416, 418, 441, et al.
Medicare and Medicaid Programs; Regulatory Provisions To Promote
Program Efficiency, Transparency, and Burden Reduction; Fire Safety
Requirements for Certain Dialysis Facilities; Hospital and Critical
Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and
Improvement in Patient Care; Final Rule
Federal Register / Vol. 84 , No. 189 / Monday, September 30, 2019 /
Rules and Regulations
[[Page 51732]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 416, 418, 441, 460, 482, 483, 484, 485, 486, 488,
491, and 494
[CMS-3346-F; CMS-3334-F; CMS-3295-F]
RIN 0938-AT23
Medicare and Medicaid Programs; Regulatory Provisions To Promote
Program Efficiency, Transparency, and Burden Reduction; Fire Safety
Requirements for Certain Dialysis Facilities; Hospital and Critical
Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and
Improvement in Patient Care
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule reforms Medicare regulations that are
identified as unnecessary, obsolete, or excessively burdensome on
health care providers and suppliers. This final rule also increases the
ability of health care professionals to devote resources to improving
patient care by eliminating or reducing requirements that impede
quality patient care or that divert resources away from furnishing high
quality patient care. Additionally, this rule updates fire safety
standards for Medicare and Medicaid participating End-Stage Renal
Disease (ESRD) facilities by adopting the 2012 edition of the Life
Safety Code and the 2012 edition of the Health Care Facilities Code.
Finally, this final rule updates the requirements that hospitals and
Critical Access Hospitals (CAHs) must meet to participate in the
Medicare and Medicaid programs. These requirements are intended to
conform to current standards of practice and support improvements in
quality of care, reduce barriers to care, and reduce some issues that
may exacerbate workforce shortage concerns.
DATES:
Effective date: These regulations are effective on November 29,
2019. The incorporation by reference of certain publications listed in
the rule is approved by the Director of the Federal Register as of
November 29, 2019.
Implementation dates: The regulations at Sec. 485.641 regarding
Quality Assessment and Performance Improvement Programs (QAPI) in
critical access hospitals (CAHs) must be implemented by March 30, 2021.
The regulations at Sec. 482.42(b) and Sec. 485.640(b) regarding
hospital and critical access hospital (CAH) antibiotic stewardship
programs must be implemented by March 30, 2020.
FOR FURTHER INFORMATION CONTACT:
For issues related to Regulatory Provisions to Promote Program
Efficiency, Transparency, and Burden Reduction, contact Kristin
Shifflett, (410) 786-4133.
For issues related to Fire Safety Requirements for Certain Dialysis
Facilities, contact Kristin Shifflett, (410) 786-4133.
For issues related to the Hospital and Critical Access Hospital
(CAH) Changes to Promote Innovation, Flexibility, and Improvement in
Patient Care, contact CAPT Scott Cooper, USPHS, (410) 786-9465, Mary
Collins, (410) 786-3189, Alpha-Banu Wilson, (410) 786-8687, or Kianna
Banks, (410) 786-3498.
SUPPLEMENTARY INFORMATION: We note that this rule finalizes provisions
that were proposed in three separate proposed rules that were published
in the Federal Register on separate dates. Specifically, we are
finalizing the provisions of the following proposed rules, discussed as
follows:
``Regulatory Provisions to Promote Program Efficiency,
Transparency, and Burden Reduction,'' published September 20, 2018 (83
FR 47686);
``Hospital and Critical Access Hospital (CAH) Changes to
Promote Innovation, Flexibility, and Improvement in Patient Care,''
published June 16, 2016 (81 FR 39448); and
``Fire Safety Requirements for Certain Dialysis
Facilities,'' published November, 4, 2016 (81 FR 76899)
To assist readers in referencing sections contained in this
preamble, we are providing a table of contents.
Table of Contents
I. Final Rule: Regulatory Provisions To Promote Program Efficiency,
Transparency, and Burden Reduction
A. Executive Summary and Background
1. Purpose
2. Summary of Major Provisions
3. Summary of Costs and Benefits for Regulatory Provisions To
Promote Program Efficiency, Transparency, and Burden Reduction
B. Provisions of the Proposed Rule and Analysis and Response to
Public Comments
1. Religious Nonmedical Health Care Institutions (RNHCIs)--
Discharge Planning
2. Ambulatory Surgical Centers
3. Hospice
4. Hospitals
5. Transplant Centers
6. Home Health Agencies
7. Comprehensive Outpatient Rehabilitation Facility (CORF)--
Utilization Review Plan
8. Critical Access Hospitals
9. Community Mental Health Center
10. Portable X-Ray Services
11. Rural Health Clinics (RHCs) and Federally Qualified Health
Centers (FQHCs)
12. Emergency Preparedness for Providers and Suppliers
13. Technical Corrections
14. Waiver of Proposed Rulemaking
C. Collection of Information Requirements
II. Final Rule: Fire Safety Requirements for Certain Dialysis
Facilities
A. Background
B. Provisions of the Proposed Rule and Analysis and Response to
Public Comments
1. 2012 Edition of the Life Safety Code
2. Incorporation by Reference
3. Ambulatory Health Care Occupancies
4. 2012 Edition of the Health Care Facilities Code
5. Technical Corrections
C. Collection of Information Requirements
III. Final Rule: Hospital and Critical Access Hospital (CAH) Changes
To Promote Innovation, Flexibility, and Improvement in Patient Care
A. Background
B. Provisions of the Proposed Rule and Analysis and Response to
Public Comments for Hospitals
1. General Comments
2. Implementation Timeframe
3. Non-Discrimination
4. Licensed Independent Practitioner
5. Quality Assessment and Performance Improvement (QAPI) Program
6. Nursing Services
7. Medical Record Services
8. Infection Prevention and Control and Antibiotic Stewardship
Programs
9. Technical Corrections
C. Provisions of the Proposed Regulations and Responses to
Public Comments for Critical Access Hospitals
1. Organization Structure
2. Periodic Review of Clinical Privileges and Performance
3. Provision of Services (Sec. 485.635(a)(3)(vii))
4. Provision of Services (Sec. 485.635(g))
5. Infection Prevention and Control and Antibiotic Stewardship
Programs (Sec. 485.640)
6. Quality Assessment and Performance Improvement (QAPI) Program
(Sec. 485.641)
7. Technical Corrections
D. Requirements for Issuance of Regulations
E. Collection of Information Requirements for Hospital and
Critical Access Hospital (CAH) Changes To Promote Innovation,
Flexibility, and Improvement in Patient Care
IV. Economic Analyses
A. Regulatory Impact Analysis for Regulatory Provisions To
Promote Program Efficiency, Transparency, and Burden Reduction
1. Statement of Need
2. Overall Impact
3. Anticipated Effects
[[Page 51733]]
4. Alternatives Considered
5. Uncertainty
6. Conclusion
B. Regulatory Impact Statement for Fire Safety Requirements for
Certain Dialysis Facilities
C. Regulatory Impact Analysis for Hospital and Critical Access
Hospital (CAH) Changes to Promote Innovation, Flexibility, and
Improvement in Patient Care
1. Statement of Need
2. Overall Impact
3. Anticipated Effects
4. Effects on Small Entities
5. Alternatives Considered
6. Conclusion
D. Accounting Statement and Table
E. Regulatory Reform Analysis Under E.O. 13771
I. Final Rule: Regulatory Provisions To Promote Program Efficiency,
Transparency, and Burden Reduction
A. Executive Summary and Background
1. Purpose
Over the past several years, we have revised our requirements,
Conditions of Participation (CoPs) and Conditions for Coverage/
Conditions for Certification (CfCs) to reduce the regulatory burden on
providers and suppliers while emphasizing health and safety. We
identified obsolete and burdensome regulations that could be eliminated
or reformed to improve effectiveness or reduce unnecessary reporting
requirements and other costs, with a particular focus on freeing up
resources that health care providers, health plans, and States could
use to improve or enhance patient health and safety. We also examined
policies and practices not codified in rules that could be changed or
streamlined to achieve better outcomes for patients while reducing
burden on providers and suppliers of care, and we identified non-
regulatory changes to increase transparency and to become a better
business partner. In addition, the Centers for Medicare & Medicaid
Services (CMS) and the Department of Health and Human Services (HHS)
have reaffirmed their commitment to the vision of creating an
environment where agencies incorporate and integrate the ongoing
retrospective review of regulations into Department operations to
achieve a more streamlined and effective regulatory framework. The
objectives were to improve the quality of existing regulations
consistent with statutory requirements; streamline procedural solutions
for businesses to enter and operate in the marketplace; maximize net
benefits (including benefits that are difficult to quantify); and
reduce costs and other burdens on businesses to comply with
regulations.
In accordance with these goals, we published three final rules that
identified unnecessary, obsolete, or excessively burdensome regulations
on health care providers, suppliers, and beneficiaries. These rules
further increased the ability of health care professionals to devote
resources to improving health care by eliminating or reducing
requirements that impede quality patient care or that divert providing
high quality patient care:
``Reform of Hospital and Critical Access Hospital
Conditions of Participation'', published May 16, 2012 (77 FR 29034);
``Regulatory Provisions to Promote Program Efficiency,
Transparency, and Burden Reduction'', published May 16, 2012 (77 FR
29002) and;
``Regulatory Provisions to Promote Program Efficiency,
Transparency, and Burden Reduction; Part II'', published May 12, 2014
(79 FR 27105).
This final rule is a continuation of our efforts to reduce
regulatory burden and is in accordance with the January 30, 2017
Executive Order ``Reducing Regulation and Controlling Regulatory
Costs'' (Executive Order 13771). We are finalizing changes to the
current requirements, CoPs, and CfCs that will simplify and streamline
the current regulations and thereby increase provider flexibility and
reduce excessively burdensome regulations, while also allowing
providers to focus on providing high-quality healthcare to their
patients. This final rule will also reduce the frequency of certain
required activities and, where appropriate, revise timelines for
certain requirements for providers and suppliers and remove obsolete,
duplicative, or unnecessary requirements. We believe these policies
balance patient safety and quality, while also providing broad
regulatory relief for providers and suppliers.
In the proposed rule, we stated that we seek to reduce burdens for
health care providers and patients, improve the quality of care,
decrease costs, and ensure that patients and their providers and
physicians are making the best health care choices possible. Therefore,
we solicited public comments on additional regulatory reforms for
burden reduction in future rulemaking. Specifically, we sought public
comment on additional proposals or modifications to the proposals set
forth in the proposed rule, ``Regulatory Provisions to Promote Program
Efficiency, Transparency, and Burden Reduction,'' published September
20, 2018 (83 FR 47686) that would further reduce burden on Medicare and
Medicaid participating providers and suppliers and create cost savings,
while also preserving quality of care and patient health and safety. We
also noted in the proposed rule (83 FR 47686), consistent with our
``Patients Over Paperwork'' Initiative, that we are particularly
interested in improving existing requirements, within our statutory
authority, where the requirements as currently written make providing
quality care difficult or less effective. We also noted that such
suggestions could include or expand upon comments submitted in response
to Requests for Information (RFIs) that were included in the 2017
prospective payment regulations for most provider types.
2. Summary of Major Provisions
We are reducing regulatory burden on providers and suppliers by
modifying, removing, or streamlining current regulations that we now
believe are unnecessary, obsolete or excessively burdensome.
Specifically, we are finalizing the following revisions:
a. Discharge Planning in Religious Nonmedical Health Care Institutions
(RNHCIs)
We have revised the requirements at 42 CFR 403.736(a) and (b)
pertaining to a discharge plan. This revision simplifies the discharge
process for RNHCIs by requiring them to assess the need for a discharge
plan and provide discharge instructions to the patient and the
patient's caregiver as necessary when the patient is discharged home.
b. Ambulatory Surgical Center (ASC): Transfer Agreements With Hospitals
We are replacing the requirement at Sec. 416.41(b)(3), that ASCs
have written transfer agreements or privileges with the local hospital
with a requirement that ASCs must periodically provide the local
hospital with written notice of its operation and patient population
served.
c. ASC Requirements for Comprehensive Medical History and Physical
Assessment
We are removing the current requirements at Sec. 416.52(a) for a
History and Physical within 30 days of the procedure and replacing them
with requirements that defer, to a certain extent, to the ASC policy
and operating physician's clinical judgment to ensure that patients
receive the appropriate pre-surgical assessments tailored to the
patient and the type of surgery being performed. We still require the
operating physician to document any pre-existing medical conditions and
appropriate test results, in the medical record, before, during and
after surgery.
[[Page 51734]]
In addition, we have retained the requirement that all pre-surgical
assessments include documentation regarding any allergies to drugs and
biologicals, and that the medical history and physical examination
(H&P), if completed, be placed in the patient's medical record prior to
the surgical procedure.
d. Hospice Requirements for Medication Management
We are removing the procedural requirements at Sec. 418.106(a)(1),
related to having on the hospice staff, an individual with specialty
knowledge of hospice medications.
e. Hospice Requirements: Orientation of Skilled Nursing Facility (SNF)
and Intermediate Care Facilities for Individuals With Intellectual
Disabilities (ICF/IID) Staff
We are revising the requirements at Sec. 418.112(f) to explicitly
require hospices to coordinate with SNFs/NFs and ICFs/IID for assuring
orientation of facility staff.
f. Hospital Quality Assessment and Performance Improvement Program
(QAPI Program)
We are finalizing a new standard at 42 CFR 482.21(f), ``Unified and
integrated QAPI program for multi-hospital systems.'' For a hospital
that is part of a hospital system, consisting of multiple separately
certified hospitals using a system governing body that is legally
responsible for the conduct of two or more hospitals, the system
governing body can elect to have a unified and integrated QAPI program
for all of its member hospitals if the arrangement is in accordance
with all applicable State and local laws. The system governing body is
responsible and accountable for ensuring that each of its separately
certified hospitals meets all of the requirements of this section.
g. Hospital Requirements for Comprehensive Medical History and Physical
Examinations (Sec. Sec. 482.22, 482.24, and 482.51)
We are allowing hospitals the flexibility to establish a medical
staff policy describing the circumstances under which such hospitals
can utilize a pre-surgery/pre-procedure assessment for an outpatient,
instead of a comprehensive medical history and physical examination
(H&P). We believe that allowing this option will greatly reduce the
burden on the hospital, the practitioner, and the patient. In order to
exercise this option, a hospital must document the assessment in a
patient's medical record. The hospital's policy must consider patient
age, diagnoses, the type and number of surgeries and procedures
scheduled to be performed, comorbidities, and the level of anesthesia
required for the surgery or procedure; nationally recognized guidelines
and standards of practice for assessment of specific types of patients
prior to specific outpatient surgeries and procedures; and applicable
state and local health and safety laws.
h. Hospital Infection Control Program
We are broadly revising Sec. 482.42, and issuing a new standard at
Sec. 482.42(d), ``Unified and integrated infection prevention and
control and antibiotic stewardship programs for multi-hospital
systems.'' Like the requirement for a unified and integrated QAPI
program, the standard for infection control permits a hospital that is
part of a hospital system consisting of multiple separately certified
hospitals using a single governing body, such body can elect to have a
unified and integrated infection prevention and control program for all
of its member hospitals in accordance with all applicable State and
local laws. The system governing body is responsible and accountable
for ensuring that each of its separately certified hospitals meets all
of the requirements of this section. Each separately certified hospital
within the system must demonstrate that--the unified and integrated
infection control program is established in a manner that takes into
account each member hospital's unique circumstances and any significant
differences in patient populations and services offered in each
hospital; the unified and integrated infection control program
establishes and implements policies and procedures to ensure that the
needs and concerns of each of its separately certified hospitals,
regardless of practice or location, are given due consideration, and
that the unified and integrated infection control program has
mechanisms in place to ensure that issues localized to particular
hospitals are duly considered and addressed; and a qualified individual
(or individuals) has been designated at the hospital as responsible for
communicating with the unified infection control program and for
implementing and maintaining the policies and procedures governing
infection control as directed by the unified infection control program.
i. Special Requirements for Psychiatric Hospitals
At Sec. 482.61(d), we are clarifying the scope of authority for
non-physician practitioners or Doctors of Medicine and Doctors of
Osteopathic Medicine (MD/DOs) to document progress notes of patients
receiving services in psychiatric hospitals.
j. Special Requirement for Transplant Centers and Definitions
We are making a nomenclature change at 42 CFR part 482 and the
transplant center regulations at Sec. Sec. 482.68, 482.70, 482.72
through 482.104, and at Sec. 488.61. This change updates the
terminology used in the regulations to conform to the terminology that
is widely used and understood within the transplant community, thereby
reducing provider confusion.
k. Data Submission, Clinical Experience, and Outcome Requirements for
Re-Approval of Transplant Centers
We are removing the requirements at Sec. 482.82 that state that
transplant centers must meet all data submission, clinical experience,
and outcome requirements in order to obtain Medicare re-approval.
Transplant centers will still be required to comply with the CoPs at
Sec. Sec. 482.72 through 482.104 and the data submission, clinical
experience, and outcome requirements for initial Medicare approval
under Sec. 482.80.
l. Special Procedures for Approval and Re-Approval of Organ Transplant
Centers
We are revising Sec. 488.61(f) through (h) to remove the
requirements with respect to the re-approval process for transplant
centers. This change corresponds to the proposed removal of the
provisions at Sec. 482.82. We are retaining the requirements in Sec.
488.61(f) through (h) that pertain to the initial approval process for
transplant centers.
m. Home Health Agency (HHA) Requirements for Verbal Notification of
Patient Rights and Responsibilities
We are removing the requirements for verbal (meaning spoken)
notification of all patient rights at Sec. 484.50(a)(3), and replacing
it with a requirement that verbal notice must be provided for those
rights related to payments made by Medicare, Medicaid, and other
federally funded programs, and potential patient financial liabilities
as specified in the Social Security Act (the Act).
n. Personnel Requirements for Portable X-Ray Technologists
We are revising Sec. 486.104(a), ``Condition for coverage:
Qualifications, orientation and health of technical personnel'', to
focus on the qualifications of the individual performing services.
[[Page 51735]]
o. Portable X-Ray Requirements for Orders
We are revising the requirements for portable x-ray orders at Sec.
486.106(a)(2) by removing the requirement that physician or non-
physician practitioner's orders for portable x-ray services must be
written and signed and replacing the specific requirements related to
the content of each portable x-ray order with a cross-reference to the
requirements at 42 CFR 410.32, which also apply to portable x-ray
services.
p. Emergency Preparedness Requirements: Requirements for Emergency
Plans
We are removing the requirements from our emergency preparedness
rules for Medicare and Medicaid providers and suppliers that facilities
document efforts to contact local, tribal, regional, State, and Federal
emergency preparedness officials, and that facilities document their
participation in collaborative and cooperative planning efforts.
q. Emergency Preparedness Requirements: Requirements for Annual Review
of Emergency Program
We are revising this requirement so that applicable providers and
suppliers review their Emergency program biennially, except for Long
Term Care facilities, which will still be required to review their
emergency program annually.
r. Emergency Preparedness Requirements: Requirements for Training
We are revising the requirement that facilities develop and
maintain a training program based on the facility's emergency plan
annually by requiring facilities to provide training biennially (every
2 years) after facilities conduct initial training for their emergency
program, except for long term care facilities which will still be
required to provide training annually. In addition, we are requiring
additional training when the emergency plan is significantly updated.
s. Emergency Preparedness Requirements: Requirements for Testing
For inpatient providers, we are expanding the types of acceptable
testing exercises that may be conducted. For outpatient providers, we
are revising the requirement such that only one testing exercise is
required annually, which may be either one community-based full-scale
exercise, if available, or an individual facility-based functional
exercise, every other year and in the opposite years, these providers
may choose the testing exercise of their choice.
2. Proposals That Reduce the Frequency of Activities and Revise
Timelines
a. Comprehensive Outpatient Rehabilitation Facility (CORF) Utilization
Review Plans
We are amending the utilization review plan requirements at Sec.
485.66 to reduce the frequency of utilization reviews from quarterly to
annually. This would allow an entire year to collect and analyze data
to inform changes to the facility and the services provided.
b. CAH Annual Review of Policies and Procedures
We are changing the requirement at Sec. 485.635(a)(4) to require a
CAH's professional personnel to, at a minimum, conduct a biennial
review of its policies and procedures instead of an annual review.
c. Community Mental Health Center (CMHC) Requirements for Updating the
Client Assessment
At Sec. 485.914, we are removing the requirement that all CMHC
clients receive an updated assessment every 30 days. Instead, we would
require updates of the patient assessment in accordance with client
needs and standards of practice. For clients receiving partial
hospitalization services, we are retaining the 30-day assessment update
time frame to be consistent with existing Medicare payment requirements
for recertification of partial hospitalization services.
d. Rural Health Clinic (RHC) and Federally Qualified Health Center
(FQHC) Review of Patient Care Policies
We are revising the requirement at Sec. 491.9(b)(4) that RHC and
FQHC patient care policies be reviewed at least annually by a group of
professional personnel, to review every other year in order to reduce
the frequency of policy reviews.
e. RHC and FQHC Program Evaluation
We are revising the requirement at Sec. 491.11(a) by changing the
frequency of the required RHC or FQHC evaluation from annually to every
other year.
3. Proposals That Are Obsolete, Duplicative, or That Contain
Unnecessary Requirements
a. Hospice Aide Training and Competency Requirements
We are revising Sec. 418.76(a)(1)(iv) to remove the requirement
that a State licensure program meet the specific training and
competency requirements set forth in Sec. 418.76(b) and (c) in order
for such licensure to qualify a hospice aide to work at a Medicare-
participating hospice, deferring to State licensure requirements.
b. Medical Staff: Autopsies
We are finalizing our proposal to remove the requirement for
hospitals at Sec. 482.22(d), which states that a hospital's medical
staff should attempt to secure autopsies in all cases of unusual deaths
and of medical-legal and educational interest. We are deferring to
State law regarding such medical-legal requirements.
c. Hospital and CAH Swing-Bed Requirements
We are removing the cross reference to Sec. 483.10(f)(9) at Sec.
482.58(b)(1) (for hospital swing-bed providers) and Sec. 485.645(d)(1)
(for CAH swing-bed providers); the repealed provisions gave a resident
the right to choose to, or refuse to, perform services for the facility
if they so choose.
We are removing the cross-reference to Sec. 483.24(c) at Sec.
482.58(b)(4) (for hospital swing-bed providers) and Sec. 485.645(d)(4)
(for CAH swing-bed providers) requiring that the facility provide an
ongoing activity program based on the resident's comprehensive
assessment and care plan directed by a type of qualified professional
specified in the regulation.
We are removing the cross-reference to Sec. 483.70(p) at Sec.
482.58(b)(5) (for hospital swing-bed providers) and Sec. 485.645(d)(5)
(for CAH swing-bed providers requiring facilities with more than 120
beds to employ a social worker on full-time basis).
We are removing the cross-reference to Sec. 483.55(a)(1) at Sec.
482.58(b)(8) (for hospital swing-bed providers) and Sec. 485.645(d)(8)
(for CAH swing-bed providers) requiring that the facility assist
residents in obtaining routine and 24-hour emergency dental care.
d. Home Health Agency Home Health Aide Requirements
We are revising Sec. 484.80(c)(1) to clarify that skill
competencies may be assessed by observing an aide performing the skill
with either a patient or a pseudo-patient as part of a simulation. We
are defining the terms ``pseudo-patient'' and ``simulation'' in Sec.
484.2.
We are revising the requirement at Sec. 484.80(h) related to
completing a full competency evaluation when an aide is found to be
deficient in one or more skills. Instead of completing a full
competency evaluation, an aide would only be required to complete
retraining
[[Page 51736]]
and a competency evaluation directly related to the deficient skills.
e. CAH Disclosure Requirements
We are removing Sec. 485.627(b)(1), the requirement for CAHs to
disclose the names of people with a financial interest in the CAH. This
is currently a requirement under the program integrity requirements at
42 CFR 420.206, which are referenced in the provider agreement rules in
42 CFR 489.53(a)(8), making this CAH CoP requirement duplicative of
those regulations.
3. Summary of Costs and Benefits for Regulatory Provisions To Promote
Efficiency, Transparency, and Burden Reduction
1. Overall Impact
This final rule will create savings and reduce burden in many
areas. Several of the changes will create measurable monetary savings
for providers and suppliers, while others will create less quantifiable
savings of time and administrative burden. We anticipate a total first
year net savings of approximately $843 million, and slightly more in
future years.
2. Section-by-Section Economic Impact Estimates
Table 1 summarizes the provisions for which we are able to provide
specific estimates for savings or burden reductions (these estimates
are uncertain and could be substantially higher or lower, as explained
in the regulatory impact analysis section of this final rule):
Table 1--Summary of Net Savings by Provision
----------------------------------------------------------------------------------------------------------------
Number of
Provider and supplier type and Frequency affected Estimated savings (annualized,
description of proposed provisions entities $millions)
----------------------------------------------------------------------------------------------------------------
Religious Nonmedical Health Care
Institutions:
Discharge Planning..... As patients are 18 (*)
discharged (Estimated
619 annual discharges).
Ambulatory Surgical Centers:
Governing Body and Upon failed hospital 5,557 (*)
Management. transfer agreement
attempts.
Patient Admission, Every patient 5,557 77.
Assessment and Discharge registration at an ASC
(History and Physical). or at a hospital
outpatient/.
ambulatory surgery
department.
Medical Records........ Recurring annually..... 5,557 0.
Hospices:
Drugs and Biologicals, Recurring annually..... 4,602 94.
Medical Supplies, and Durable
Medical Equipment ***.
Hospices That Provide Recurring annually..... 4,602 1.
Hospice Care to residents of a
SNF/NF or ICF/IID.
Hospice Aide and Recurring annually..... 4,602 2.
Homemaker Services.
Hospitals:
Quality Assessment and Recurring annually..... 4,823 31.
Performance Improvement Program.
Medical staff: Recurring annually..... 4,823 0.
Autopsies.
Infection Control...... Recurring annually..... 4,823 115.
Special requirements Recurring annually..... 478 30.
for hospital providers of long-
term care services (``swing-
beds'').
Special Requirements Recurring annually..... 620 154.
for Psychiatric Hospitals.
Patient Admission, Every patient 4,823 77.
Assessment and Discharge registration at an ASC
(History and Physical). or at a hospital
outpatient/ambulatory
surgery department.
Transplant programs:
Various provisions Recurring annually..... 750 Not Quantified.
related to performance **.
Home Health Agencies:
Patient rights......... Recurring annually..... 12,624 57.
Home health aide Recurring annually..... 12,624 Not Quantified.
services.
Clinical records....... Recurring annually..... 12,624 Not Quantified.
Critical Access Hospitals:
Provision of Services.. Recurring biennially... 1,353 1.
Organizational Recurring annually..... 1,353 (*)
structure.
Special requirements Recurring annually..... 1,246 77.
for CAH providers of long-term
care services (``swing-beds'').
Comprehensive Outpatient
Rehabilitation Facilities:
Utilization Review Plan Recurring annually..... 188 (*)
Community Mental Health Centers:
Assessment Update...... Recurring annually..... 52 (*)
Portable X-Ray Services:
Qualifications of X-ray Recurring annually..... 500 31.
technicians ***.
Removing written orders Recurring annually..... 500 28.
RHC (4,160 clinics) & FQHC (7,874
center locations):
Patient Care Policies Recurring biennially... 12,034 4.
Review.
Program Evaluation..... Recurring biennially... 12,034 5.
Emergency Preparedness for Providers
and Suppliers:
Review of Emergency Recurring biennially... 56,983 70.
Preparedness Program.
Emergency Plan......... Recurring annually..... 68,275 7.
Training and Testing-- Recurring biennially... 53,543 26.
Training Program.
[[Page 51737]]
Training and Testing-- Recurring annually..... 36,971 21.
Testing.
----------------------------------------------------------------------------------------------------------------
* Amount is less than half a million dollars and rounds to zero.
** These include changes to the following requirements: Special Requirements for Transplant Programs; Data
submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and Special
Procedures for Approval and Re-Approval of Organ Transplant Programs.
*** This estimate is for first full year savings only and will increase in future years.
B. Provisions of the Proposed Rule and Analysis and Response to Public
Comments on ``Medicare and Medicaid Programs; Regulatory Provisions To
Promote Program Efficiency, Transparency, and Burden Reduction''
In response to our September 20, 2018 proposed rule (83 FR 47686),
we received 620 public comments. Commenters included individuals,
healthcare professionals and corporations, national associations,
health departments and emergency management professionals, and
individual facilities that would be impacted by the regulation.
Generally, the comments received were supportive. Most comments were
centered around the proposed revisions to the emergency preparedness
regulations for Medicare and Medicaid providers and suppliers. We have
organized our responses to the comments as follows: (1) Comments
specific to individual types of providers and suppliers (2); general
comments; and (3) comments regarding our savings estimates.
1. Religious Nonmedical Health Care Institutions (RNHCIs)--Discharge
Planning (Sec. 403.736(a) and (b))
Section 1861(ss)(1) of the Act defines the term ``Religious
Nonmedical Health Care Institution'' (RNHCI) and lists the requirements
that a RNHCI must meet to be eligible for Medicare participation.
Section 403.736(a) and (b) of the RNHCI's CoPs, as amended in the
November 28, 2003 Federal Register (68 FR 66710), requires RNHCIs to
have a discharge planning process for patients.
Since the RNHCI's religious tenets prohibit conventional or
unconventional medical treatment of a beneficiary, and medical post-
institution services are not utilized by RNHCI patients, we believe
that extensive discharge requirements are unnecessarily burdensome.
Therefore, we proposed a more condensed and flexible process for
discharge planning and instructions for RNHCIs. We proposed to remove
the requirements at Sec. 403.736(a) and (b), and proposed instead to
require RNHCIs to provide discharge instructions to the patient or the
patient's caregiver when the patient is discharged home.
The majority of commenters expressed strong support for the
proposed changes to the RNHCIs discharge planning process. We did not
receive any comments in opposition to the proposed requirement;
therefore, we are incorporating the changes as proposed in this final
rule.
Comment: One commenter stated that they agreed with allowing
flexibility and giving the institution the freedom to determine which
patients should be provided a discharge plan. However, they commented
that there should be a way to monitor this process to make institutions
accountable and not omit providing a discharge plan if a patient needs
one.
Response: As for all providers and suppliers, Medicare surveys
RNHCIs for compliance with the CoPs. We believe this enforcement
process adequately ensures that RNHCIs are correctly interpreting and
following our requirements.
Comment: The majority of the commenters stated that they agree with
the changes proposed to the discharge planning process at Sec.
403.736(a) and (b). They stated that this change would reduce burden
and allow greater flexibility to the RNHCIs.
Response: We appreciate the comments received on the proposed
changes for RNHCIs and will finalize the changes as proposed.
Final Rule Action: We are finalizing the proposed changes without
changes.
Contact: Mary Collins, (410) 786-3189.
2. Ambulatory Surgical Centers
Section 416.2 of our rules defines an ambulatory surgical center
(ASC) as any distinct entity that operates exclusively for the purpose
of providing surgical services to patients not requiring
hospitalization, in which the expected duration of services would not
exceed 24 hours following an admission. The surgical services performed
at ASCs are scheduled, primarily elective, non-life-threatening
procedures that can be safely performed in an ambulatory setting. We
received 99 timely public comments on our proposed changes to the ASC
CfC requirements. Commenters included ASC industry associations,
healthcare systems, national accreditation organizations, clinician
associations, individual ASCs, and clinicians. Overall, the majority of
the commenters were supportive of the goals of the proposed changes.
Summaries of the major issues and our responses are set forth below.
a. Governing Body and Management; Hospitalization Requirements (Sec.
416.41(b)(3)(i) and (ii))
We proposed to remove the requirement for a written hospital
transfer agreement or hospital physician admitting privileges at Sec.
416.41(b)(3). The requirements in Sec. 416.41(b)(1) and (2) continue
to require the ASC to have an effective procedure for the immediate
transfer, to a hospital, of patients requiring emergency medical care
beyond the capabilities of the ASC and that the hospital must be a
local hospital that meets the requirements for payment for emergency
services under Sec. 482.2. As part of this revision, ASCs are not
precluded from obtaining hospital transfer agreements or hospital
physician admitting privileges when possible.
Comment: The comments submitted regarding the removal of the
transfer agreement were almost evenly split between supporters and
opponents. Specifically, the ASCs supported the removal of the transfer
agreement and hospitals were opposed to the removal of the transfer
agreement. Comments in support of removal of the written hospital
transfer agreement stated that the current requirement is unnecessary,
obsolete and extremely burdensome because of the small number of
patient transfers, the creation of The Emergency Medical Treatment and
Labor Act (EMTALA), and the exhaustive administrative paperwork and
negotiation burden that is required when the local hospital system
refuses to sign the written hospital transfer agreement. Comments in
support of the
[[Page 51738]]
removal also stated that ASCs should not be forced to close their
businesses because regulations cannot be met due to competition issues
with the local hospital and their outpatient surgery center. Comments
opposing removal of the written hospital transfer agreement stated that
transfer agreements have the potential to ensure that there is a plan
for emergencies, that appropriate continued care will be delivered, and
that both the ASC and hospital communicate with one another. In
addition, we received several comments that suggested the regulation
should instead specify that the ASC would be deemed to have met the
hospital transfer agreement provision if a ``good faith effort'' was
documented. One commenter suggested that instead of an all or nothing
provision, ASCs should periodically provide local hospitals with a
written notice. The commenter contended that this requirement would
notify the hospital of ASC services in the community and the types of
patients that are receiving care that may need additional care beyond
the capability of the ASC.
Response: We continue to believe that, because of the existing
EMTALA regulations, the small number of transfers, and the burden ASCs
incur when faced with local hospital competition issues, removing this
requirement is necessary and appropriate. We agree that communication
between ASCs and hospitals is important; however, we do not agree that
a mandated transfer agreement is a necessary or effective method to
assure this communication. In response to the commenter's suggestions
described above, and to assure that hospitals are aware of the
potential for receiving patient transfers from an ASC, we are revising
our proposal at Sec. 416.41(b)(3) to require the ASC to periodically
provide the local hospital with written notice of its operation and
patient population served. For example, the notice would include
details such as hours of operation and the procedures that are
performed in the ASC. Providing written notice, rather than securing a
transfer agreement, will alleviate the administrative burden of
negotiating or being denied negotiating opportunities associated with
the requirement of a written transfer agreement between the ASC and
hospital. We are requiring that the notice be provided ``periodically''
to the local hospital to ensure the ASC keeps the local hospital
informed and up-to-date on ASC information and any patient population
changes. The ``periodically'' phrasing is similar to the reappraisal
requirement for the medical staff privileges in ASCs located at Sec.
416.45(b), ``Medical staff- Standard: Reappraisals'', and is meant to
have the same meaning. This change does not preclude those ASCs and
hospitals with functional working relationships to continue to have
written transfer agreements, which we encourage, and prior preparations
in place for patient transfers in the event of an emergency.
b. Patient Admission, Assessment and Discharge (Sec. 416.52(a)(1),
(2), (3) and (4))
The current regulations at Sec. 416.52 require ASCs to ensure that
a physician or other qualified practitioner provide a comprehensive
medical history and physical assessment (H&P) completed not more than
30 days before the date of the scheduled surgery.
We proposed to remove the current requirements at Sec. 416.52(a)
and replace them with requirements under the facility's established
policies for pre-surgical medical histories and physical examinations
(H&P), including any associated testing, and the operating physician's
clinical judgment, to ensure patients receive the appropriate pre-
surgical assessments that are tailored for the patient and the type of
surgery being performed. We proposed to require each ASC to establish
and implement a policy that identifies patients who require an H&P
prior to surgery. We proposed that the policy would include the time
frame for the H&P to be completed prior to surgery. We proposed that
the policy would be required to consider the age of patients, their
diagnoses, the type and number of surgeries that are scheduled to be
performed at one time, all known comorbidities, and the planned level
of anesthesia for the surgery to be performed. ASCs would not be
limited to these factors, and would be permitted to include others to
meet the needs of their patient populations. Furthermore, we proposed
that each ASC's policy would be required to follow nationally
recognized standards of practice and guidelines, as well as applicable
state and local health and safety laws. To conform to the proposed
changes to the medical history and physical examination requirements at
Sec. 416.52(a), we proposed to revise the requirement at Sec.
416.47(b)(2), that states ``Significant medical history and results of
physical examination,'' by adding ``as applicable.''
Comment: A majority of commenters supported the proposed change to
remove the medical H&P examination requirement no more than 30 days
before the date of the scheduled surgery, and defer to the ASCs
established policies for pre-surgical H&Ps and the operating
physician's clinical judgment. The comments agreed that allowing ASCs
flexibility to establish patient policies, and encouraging the use of
clinician judgment, are appropriate to assure patient health and safety
while also reducing the burden on patients and providers, and reducing
expenditures on potentially unnecessary pre-operative testing that is
performed because it is required by policy. However, a small number of
comments supported only part of this change, suggesting instead that
CMS should retain the H&P requirement while allowing the ASC the
discretion to determine the timeframe for the H&P relative to the date
of surgery. Another commenter opposed any changes and recommended
retaining the H&P requirement and 30-day time frame. One commenter
stated that they believe the burden of assessing patients prior to
surgery would be shifted from one provider (the primary care physician)
to another (the anesthesiologist), and that allowing ASCs the
flexibility to establish their own policies based on their clinical
judgment and patient population needs would burden ASCs and healthcare
workers, create inefficiencies, and lead to variations in standards of
care from facility to facility.
Response: We appreciate the support of the vast majority of
commenters, and continue to believe that the change is appropriate to
support patient health and safety while eliminating the burdens of
potentially unnecessary examinations and tests. The content of ASC-wide
policies surrounding the appropriate use of medical histories and
physicals, as well as pre-operative testing, could be informed by
specialty societies, medical literature, past experience, or other
factors. We disagree that variations between facilities would be an
inherently undesirable effect of the change; variations to take into
account unique patient needs and facility characteristics are
preferable to a ``one size fits all'' approach of mandatory 30 day
H&Ps. Allowing ASCs and physicians to work together to implement their
own policies, based on their clinical judgment and patient population
served, will provide the most optimal balance between burden and
necessary examinations and testing, by identifying when a medical H&P
examination should be completed, if appropriate. We are finalizing the
proposal to require ASCs to address certain patient characteristics,
such as age, diagnosis, the type and number of procedures,
comorbidities and the planned anesthesia level, when
[[Page 51739]]
developing their policies and procedures for pre-surgical examinations
and testing. We believe this change will ensure those patients who
would actually be protected by a medical H&P examination will receive
one based on ASC policy, and in a time frame established by that
policy, thereby reducing burden on physicians, facilities, and
patients. We reiterate that ASCs are still required to perform a
patient assessment upon admission before surgery, that the ASC is not
precluded from retaining the H&P requirement in facility policies, and
that we are not discouraging pre-surgical H&Ps where clinically
indicated.
Comment: One commenter expressed concern over the wording of the
proposed regulation text in Sec. 416.52(a)(1)(iii), stating that the
ASC policy must follow nationally recognized standards of practice and
guidelines. The commenter believed the term ``follow'' could be
problematic for ASCs, and be interpreted as being required to
``adhere'' to national guidelines that are not delineated, thus
depriving the ASC of the ability to determine what clinical practices
make the best sense for its patients.
Response: We agree and have revised the regulation text to be
consistent with the regulation text that is being finalized for
hospital outpatient H&P requirements. We are finalizing the regulation
text to state that the ASC policy must be based on any applicable
nationally recognized standards of practice and guidelines, and any
applicable State and local health and safety laws.
Comment: One commenter asked CMS to coordinate any changes to the
regulations with updates to the accreditation organizations (AOs)
standards.
Response: National accreditation organizations must meet or exceed
CMS standards, and their standards must be updated, as appropriate, to
reflect changes in the CMS regulations. As AOs may choose to exceed CMS
requirements, so they may choose to retain any or all of the
requirements that we are removing in this final rule to the extent that
they do not conflict with any of our revisions.
We did not receive any public comments on the proposed technical
change to the medical records proposed at Sec. 416.47(b)(2) and are
finalizing the technical change to the medical records section as
proposed.
Final Rule Action:
1. Rather than deleting, we are finalizing revisions to Sec.
416.41(b)(3) to require ASCs to periodically provide the local hospital
with written notice of its operation and patient population served.
2. We are finalizing the proposal to revise the requirement at
Sec. 416.47(b)(2), to state ``Significant medical history and results
of physical examination, as applicable.''
3. We are finalizing the proposal to eliminate the requirement at
Sec. 416.52(a) for each patient to have a medical history and physical
assessment completed by a physician not more than 30 days before the
scheduled surgery, and replace it with the requirement for ASCs to
develop and maintain a policy that identifies those patients who
require a medical history and physical examination prior to surgery. In
addition, require the policy to include the timeframe for the medical
history and physical examination to be completed prior to surgery. The
policy must also address, but not be limited to, the following factors:
Patient age, diagnosis, the type and number of procedures scheduled to
be performed on the same surgery date, known comorbidities, and the
planned anesthesia level. Upon admission, each patient must have a pre-
surgical assessment completed by a physician or other qualified
practitioner in accordance with applicable State health and safety
laws, who will be performing the surgery.
4. We are revising Sec. 416.52(a)(1)(iii) to clarify that the ASC
policy must be based on nationally recognized standards of practice and
guidelines, and applicable State and local health and safety laws.
Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.
3. Hospice
a. Hospice Aide and Homemaker Services (Sec. 418.76)
We proposed to revise Sec. 418.76(a)(1)(iv) to remove the
requirement that a hospice aide training State licensure program must
meet the specific training and competency requirements set forth in
Sec. 418.76(b) and (c) in order to be deemed an appropriate
qualification for employment. This change would defer to State
licensure requirements, except in states where no requirements exist.
Comment: Many comments supported the proposed revision to defer to
existing state requirements for hospice aide training, and only impose
Federal requirements in the absence of state standards. However, other
comments did not support this proposed change, arguing that state
education and training standards for hospice aides should not be
accepted as being sufficient to assure patient health and safety.
Response: Deference to state-established standards regarding the
training and competency of health care professionals is standard
practice. States already establish such standards for health care
professions such as nursing, laboratory technicians, phlebotomists, and
therapists, to name a few. Seventy-six percent of states have already
established their own qualification standards for aides, aides
furnishing services in those states are already permitted to provide
services to individuals through private pay agencies without meeting
the Medicare standards, and there is no indication that these already
applicable standards are insufficient to assure patient health and
safety. As deference to state standards is the norm across the health
care spectrum, and as current state standards are already demonstrated
to be sufficient to assure patient health and safety, we see no reason
to impose a separate Federal standard. Therefore, we are finalizing
this proposed change. In the absence of state requirements, hospices
will continue to be required to assure that an aide meets the Federal
training standards. Furthermore, all hospices in all states will
continue to be required to comply with the existing requirements that
hospice aides may only perform those skills that are consistent with
the training that the aide has received (Sec. 418.76(g)(2)(iv)), and
that, if an area of concern is verified by the hospice during an on-
site aide supervision visit, then the hospice must conduct, and the
hospice aide must complete, a competency evaluation in accordance with
Sec. 418.76(c) and (h)(1)(iii).
b. Drugs and Biologicals, Medical Supplies, and Durable Medical
Equipment (Sec. 418.106(a)(1) and (e)(2)(i))
We proposed to delete the requirements at Sec. 418.106(a)(1),
which required hospices to ensure that the interdisciplinary group
confers with an individual with education and training in drug
management as defined in hospice policies and procedures and State law,
who is an employee of or under contract with the hospice, to ensure
that drugs and biologicals meet each patient's needs. Meeting each
patient's needs would continue to be the responsibility of all
Medicare-participating hospices in accordance with the requirements of
all other hospice CoPs.
Comment: We received numerous comments that both supported and
opposed the proposal to eliminate the process requirement that a
hospice must confer with an individual with expertise in medication
management regarding
[[Page 51740]]
the plan of care for each patient. Many commenters agreed that this
process requirement is no longer necessary because this is standard
practice in hospices. However, other commenters, while agreeing that it
is standard practice, still believe that there is value in having a
distinct regulatory requirement to this effect, due to the important
role that medications play in hospice care and the potential for safety
lapses.
Response: Hospices would continue to be required to comprehensively
assess patients on a regular schedule and on an as needed basis in
accordance with the requirements of Sec. 418.54(a), (b) and (d), and
to assure that each patient's plan of care is developed and continually
updated to meet each patient's needs as identified in the assessment
process in accordance with the requirements ofSec. 418.56(b) through
(d). These existing regulations, which we are not revising, focus on
assuring the outcomes of safe, effective, patient-centered care.
Furthermore, hospices will still be required to comply with the quality
assessment and performance improvement (QAPI) CoP at Sec. 418.58,
which requires hospices to monitor patient outcomes and implement
improvement projects to address identified areas of concern. To the
extent that patient outcomes are not being achieved due to problems
with medication management, both the hospice's internal QAPI program
and the external hospice survey process will be capable of identifying
and addressing those problems, regardless of the removal of this
process requirement. In light of these existing requirements, and in
response to the support for the proposed change expressed by a variety
of commenters, we are finalizing the proposed change to remove the
process requirement at Sec. 418.106(a)(1) without revisions.
We proposed to replace the requirement at Sec. 418.106(e)(2) that
hospices provide a physical paper copy of policies and procedures,
which are written to guide the actions of hospice staff, with a
requirement that hospices provide information regarding the use,
storage, and disposal of controlled drugs to the patient or patient
representative, and family, which can be developed in a manner that
speaks to the perspectives and information needs of patients, families,
and caregivers. This information would be provided in a more user-
friendly manner, as decided by each hospice. Hospices would be free to
choose the content and format(s) that best suits their needs and the
needs of their patient population. We proposed to require that,
regardless of the format chosen, this information would have to be
provided to patients, families and caregivers in a manner that allowed
for access to the information on a continual, as-needed basis.
We would continue to require that hospices discuss the information
regarding the safe use, storage and disposal of controlled drugs with
the patient or representative, and the family/caregiver(s), in a
language and manner that they understand to ensure that these parties
are effectively educated. This requirement is included in the current
hospice CoPs and is consistent with Department of Health and Human
Services guidance regarding Title VI of the Civil Rights Act
(``Guidance to Federal Assistance Recipients Regarding Title VI
Prohibition Against National Origin Discrimination Affecting Limited
English Proficient Persons,'' 68 FR 47311, August 8, 2003, https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-Federal-financial-assistance-recipients-title-VI/). We continue to expect hospices to utilize technology, such
as telephonic interpreting services and any other available resources
for oral communication in the individual's primary or preferred
language. We would also continue to require that hospices document in
the patient's clinical record that the information was provided and
discussed.
Comment: We received many comments regarding the proposed change to
allow hospices to determine the content and form of the controlled drug
storage, use, and disposal notice for patients and families. Commenters
universally supported the goal of improving patient and family
education on this subject and supported the shift away from providing
policies and procedures. However, a few commenters raised concern about
the intersection of this change with section 3222 of the recently
adopted Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act (``SUPPORT Act'') (Pub.
L. 115-271), that requires hospices, which permit their employees to
dispose of medications in the patient's home, to provide their written
policies and procedures to patients, families and caregivers. This
provision, which amends section 302 of the Controlled Substances Act
(21 U.S.C. 822), is under the jurisdiction of the Department of
Justice.
While most commenters expressed appreciation for the proposal to
allow hospices to determine the form and content of the notice, other
commenters suggested that CMS should develop education materials that
hospices must provide to patients and families. Whether hospice or CMS-
generated, commenters suggested that using alternative formats such as
pictorial infographics and videos may be valuable tools in
communicating this important information. Commenters also suggested
that the information should be accessible to all individuals,
regardless of impairments or language spoken.
Response: In light of the changes included in section 3222 of the
SUPPORT Act, it is not appropriate to finalize this proposed change.
However, we encourage hospices to develop easily understood materials
that explain safe storage, use, and disposal of controlled drugs to
patients, their families, and caregivers in addition to meeting the
regulatory requirement to provide a copy of the hospice's clinical
policies and procedures. We continue to believe that providing such
materials is a positive practice for improving comprehension of this
crucial information and improving compliance with safe handling, use,
and disposal practices.
c. Hospices That Provide Hospice Care to Residents of a SNF/NF or ICF/
IID (Sec. 418.112(c)(10) and (f))
Section 418.112(f) of the hospice CoPs, as finalized in the 2008
Hospice CoP final rule (73 FR 32088), requires hospices to assure
orientation of Skilled Nursing Facility/Nursing Facility (SNF/NF) or
ICF/IID staff furnishing care to hospice patients. We proposed to
remove Sec. 418.112(f) and add a new requirement at Sec.
418.112(c)(10), ``Written agreement,'' to permit both entities to
negotiate the mechanism and schedule for assuring orientation of
facility staff.
Comment: While comments supported the intent behind the proposed
change to permit hospices and long term care facilities to negotiate
the roles and responsibilities for orienting long term care facility
staff to the hospice philosophy of care and hospice procedures, some
comments did not support moving the topic into the content of the
written agreement. Comments stated that requiring this subject to be
addressed in the written agreement would create a onetime burden for
hospices of renegotiating the written agreement with each long term
care facility, and that this burden was not acceptable even in light of
the potential long-term regulatory relief of the proposed change. Some
comments suggested that the current regulations at
[[Page 51741]]
Sec. 418.112(f) instead be revised to allow for hospices and
facilities to negotiate their respective roles and responsibilities
outside of the written agreement.
Response: We agree with commenters that the goal of regulatory
flexibility is worthwhile, and we appreciate the feedback regarding the
scope of the regulatory burden that would be incurred when
renegotiating existing contracts with long term care facilities. In
light of the burden concerns raised in the comments, we agree that a
different approach to achieving the same goal is warranted. We are not
finalizing the proposal to move the requirements related to facility
staff orientation and training from a standalone requirement to a
provision in the written agreement. In order to achieve the original
regulatory goal of adding flexibility and reducing hospice costs for
this activity, we are revising existing Sec. 418.112(f), Orientation
and training of staff, to clarify that a hospice must consult with and
thus share responsibility with the facility to assure facility staff
orientation and training. We received 26 timely public comments
pertaining to all proposed changes to the hospice requirements.
Commenters included hospice industry associations, individual hospice
providers, national accrediting organizations, clinician associations,
and consumer advocacy groups. Overall, the majority of commenters were
supportive of the goal of the proposed changes. Comments not directly
related to our proposals are summarized below.
Comment: A few comments specifically related to the hospice CoPs
were submitted in response to the solicitation for ideas for further
burden reduction efforts. Comments included removing the core services
requirement for dietary counseling and providing waivers for social
worker supervision.
Response: We appreciate the suggestions, and will consider revising
the social work supervision requirements in future rulemaking. The
hospice interpretive guidelines related to Sec. 418.114(b)(3) (State
Operations Manual, Pub. 100-07, Appendix M, https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf, accessed on January 16, 2019) state, ``Each
hospice must employ or contract with at least one MSW to serve in the
supervisor role. . . .'' We believe that this existing flexibility
regarding contracting for this service, when coupled with the fact that
the supervision role can be performed remotely, is adequate to address
concerns regarding the provision of social work supervision at this
time while we consider this waiver suggestion. Dietary counseling as a
core service is a statutory requirement (see section
1861(dd)(2)(A)(ii)(I) of the Act)) and cannot be repealed through
regulatory mechanisms.
Comment: We received numerous comments with suggestions related to
Medicare payment requirements for hospice services (for example, notice
of election requirements and the coverage requirements for continuous
home care level of care), use of the CMS Common Working File, hospice
quality measures, Medicaid payment issues, and Medicare audits.
Response: These comments are not within the scope of this
regulation, which is related to the health and safety standards for
Medicare providers. We publish an annual proposed hospice payment rule,
and comments related to payment policies and rates may also be
submitted to that rule for consideration. All out of scope comments
have been shared with the appropriate components within CMS.
Final Rule Action:
1. We are finalizing the proposed changes to Sec. Sec.
418.76(a)(1)(iv) and 418.106(a)(1) without change. We are not
finalizing our proposed change to 418.106(e)(2)(i).
2. Revise Sec. 418.112(f) to require hospice and facilities to
share responsibility for facility staff orientation and training.
Contact: Danielle Shearer, 410-786-6617.
4. Hospitals
a. Quality Assessment and Performance Improvement Program (Sec.
482.21)
We proposed a new standard at Sec. 482.21(f), ``Unified and
integrated QAPI program for multi-hospital systems.'' We would allow
that for a hospital that is part of a hospital system consisting of two
or more separately certified hospitals subject to a system governing
body legally responsible for the conduct of each hospital, the system
governing body could elect to have a unified and integrated QAPI
program for all of its member hospitals after determining that such a
decision is in accordance with all applicable State and local laws. The
system governing body would be responsible and accountable for ensuring
that each of its separately certified hospitals meets all of the
requirements of this section. Each separately certified hospital
subject to the system governing body would have to demonstrate that:
The unified and integrated QAPI program was established in a manner
that took into account each member hospital's unique circumstances and
any significant differences in patient populations and services offered
in each hospital; and the unified and integrated QAPI program
establishes and implements policies and procedures to ensure that the
needs and concerns of each of its separately certified hospitals,
regardless of practice or location, are given due consideration, and
that the unified and integrated QAPI program has mechanisms in place to
ensure that issues localized to particular hospitals are duly
considered and addressed.
Comment: Most commenters supported the proposal to allow hospitals
that are part of a multi-hospital system to have a unified and
integrated QAPI program. A few commenters expressed appreciation for
the expanded flexibility that this proposal would afford hospitals by
reducing burden, increasing efficiencies, and eliminating the
duplication of efforts.
A few commenters generally supported this proposal, but recommended
that individual, hospital-specific data be recorded and made available
to the system's governing body and the public. These data, the
commenters stated, would help to identify best practices and processes
from facilities that are excelling in certain areas and will account
for and address performance outliers across the broader hospital
system. Finally, another commenter expressed concern that the proposed
requirement might group QAPI scores together and hide poor performance,
which they stated may mislead consumers about the site-specific care
they are receiving.
Response: We thank the commenters for their support. We believe
that a hospital's governing body should be afforded the option of
unifying and integrating the various member hospitals within their
multi-hospital system into a unified QAPI program. Such a model would
incorporate each individual hospital's QAPI program, which would enable
increased efficiencies, innovations, provider flexibility, and allow
for the dissemination of best practices for patient care while also
potentially improving patient safety and outcomes. We also believe that
a unified QAPI model is a natural progression for a multi-hospital
system that utilizes a system governing body (as allowed at Sec.
482.12) and a unified medical staff (as allowed at Sec. 482.22).
In response to the commenter's concerns regarding individual
hospital data, we agree that hospital specific data should be used to
address specific
[[Page 51742]]
individual hospital issues and to identify and disseminate best
practices. As we have proposed, ``the system governing body is
responsible and accountable for ensuring that each of its separately
certified hospitals meets all of the requirements of this section.'' We
do not see this requirement as prohibiting an individual hospital from
reporting its own data to the governing body and most especially to the
unified and integrated QAPI program, since we are requiring that each
separately certified hospital in the system demonstrate that the
unified and integrated QAPI program takes into account each member
hospital's unique circumstances as well as any significant differences
in patient populations and services offered in each hospital. Each
hospital must also demonstrate that the unified and integrated program
has mechanisms in place to ensure that issues localized to particular
hospitals are duly considered and addressed.
We are unclear as to what the commenter means by ``QAPI scores''
and to what the commenter is referring regarding the grouping of ``QAPI
scores together'' in order to ``hide poor performance.'' The current
QAPI CoP does not require anything related to ``QAPI scores'' and we
are not finalizing any such requirements in this rule. We believe that
the commenter might have been confusing QAPI with the various data that
are collected for the Inpatient Quality Reporting Program. These
programs are unrelated and the quality reporting program remains
unchanged by this rule.
Comment: One commenter recommended that CMS include the following
language in proposed Sec. 482.21(f)(2) regarding a hospital's medical
staff: ``. . . Including consulting with each of its separately
certified hospital's medical staff.'' The commenter stated that a
hospital's medical staff brings a unique clinical perspective to the
activities of the governing body with regard to quality and safety
issues. The commenter also urged CMS to clarify that the proposed
requirement will not include an Ongoing Professional Practice
Evaluation and Focused Professional Practice Evaluation, which they
state, is the responsibility of the hospital's medical staff.
Response: While we agree with the commenter that a hospital's
organized medical staff brings a unique clinical perspective to the
activities of the governing body with regard to quality and safety
issues, we believe that a number of the hospital CoPs already
effectively ensure that this clinical perspective is heard by the
governing body while also holding the medical staff responsible and
accountable for these patient safety and quality of care issues. For
example, the provision at Sec. 482.12(a)(1), under the hospital
Governing body CoP, requires that the hospital's governing body must,
``consult directly with the individual assigned the responsibility for
the organization and conduct of the hospital's medical staff, or his or
her designee. At a minimum, this direct consultation must occur
periodically throughout the fiscal or calendar year and include
discussion of matters related to the quality of medical care provided
to patients of the hospital.'' This requirement applies to all
hospitals, governing bodies, and medical staffs, regardless of
organizational structure.
Additionally, the QAPI CoP itself, at Sec. 482.21(e), contains a
standard that requires the hospital medical staff (among other hospital
leaders) to be responsible and accountable for ensuring that the QAPI
program is focused on improved quality of care and patient safety.
Similarly, the Medical staff CoP requirement at Sec. 482.22(b)
requires that the hospital's medical staff ``must be well organized and
accountable to the governing body for the quality of the medical care
provided to patients.'' And finally, at Sec. 482.22(b)(4)(iii) and
(iv), the CoPs require that a separately certified hospital, which uses
a unified and integrated medical staff accountable to a system
governing body, must demonstrate that its unified and integrated
medical staff: (1) Is established in a manner that takes into account
each member hospital's unique circumstances and any significant
differences in patient populations and services offered in each
hospital and (2) establishes and implements policies and procedures to
ensure that the needs and concerns expressed by members of the medical
staff, at each of its separately certified hospitals, regardless of
practice or location, are given due consideration, and that the unified
and integrated medical staff has mechanisms in place to ensure that
issues localized to particular hospitals are duly considered and
addressed. Therefore, we do not believe that any additional language is
needed here.
Comment: One commenter requested that CMS include ``affiliates''
and CAHs in the unified and integrated QAPI and infection control
requirements. The commenter defines ``affiliates'' as hospitals and
providers within a healthcare system that may bill under separate Tax
Identification Numbers (TINs). The commenter noted that this option
would afford hospitals additional flexibility and ease administrative
burden.
Response: We are not clear on whether the commenter is confusing
TINs and CMS Certification Numbers (CCNs), which CMS uses to
distinguish separately certified hospitals, CAHs, and other Medicare-
participating providers and suppliers for survey and certification
purposes in determining compliance with the CoPs and CfCs specific to
each provider and supplier type. We do not use TINs in our
determination of when a facility requires separate certification.
A CAH must be separately evaluated for its compliance with the CAH
CoPs (found at 42 CFR part 485, subpart F), which would not include the
requirements included in this section of the rule since these are
hospital CoPs. It would not be possible to evaluate the CAH's
compliance as part of an evaluation of a hospital's compliance.
However, this does not preclude a multi-hospital system's single
governing body from also serving as the CAH's governing body, so long
as the governing body clearly identifies the policies and decisions
that are applicable to the CAH.
Final Rule Action: We are finalizing the requirements in Sec.
482.21(f), without modification.
Contact: Alpha-Banu Wilson, 410-786-8687.
b. Medical Staff, Medical Records Services, and Surgical Services
(Sec. Sec. 482.22, 482.24, and 482.51)
Hospital Medical History and Physical Examination Requirements
We proposed to revise the current requirements at Sec.
482.22(c)(5)(i) and (ii) with respect to medical staff bylaws, and to
allow for an exception under the proposed paragraph (c)(5)(iii). We are
retaining the current language in paragraphs (c)(5)(i) and (ii) that
the H&P, and any update to it, must be completed and documented by a
physician (as defined in section 1861(r) of the Act), an oral and
maxillofacial surgeon, or other qualified licensed individual in
accordance with State law and hospital policy. We proposed to include
this same language regarding who can complete and document the
assessment in the proposed provision at Sec. 482.22(c)(5)(iii). This
provision would require the medical staff bylaws to state that an
assessment of the patient (in lieu of the requirements of paragraphs
(c)(5)(i) and (ii)) be completed and documented after registration, but
prior to surgery or a procedure requiring anesthesia services, when the
patient is
[[Page 51743]]
receiving specific outpatient surgical or procedural services and when
the medical staff has chosen to develop and maintain a policy that
identifies, in accordance with the requirements at paragraph (c)(5)(v),
specific patients as not requiring a comprehensive medical history and
physical examination, or any update to it, prior to specific outpatient
surgical or procedural services. The proposed paragraphs (c)(5)(iii)
and (iv) would require the medical staff to develop and maintain a
policy that identifies those patients for whom the assessment
requirements of paragraph (c)(5)(iii) would apply. We also proposed a
new requirement at paragraph (c)(5)(v) for a medical staff that chooses
to develop and maintain a policy for the identification of specific
patients to whom the assessment requirements in paragraph (c)(5)(iii)
would apply. Under this proposed paragraph, if the medical staff
exercised the option to perform a simplified assessment in some cases,
the written policy would have to indicate the specific outpatient
surgical or procedural services to which it applied. The policy for
each procedure would need to indicate the hospital's consideration of
patient age, diagnoses, the type and number of surgeries and procedures
scheduled to be performed, comorbidities, and the level of anesthesia
required for the surgery or procedure; nationally recognized guidelines
and standards of practice for assessment of specific types of patients
prior to specific outpatient surgeries and procedures; and applicable
State and local health and safety laws.
In order to make clear that this proposed requirement would be an
option that a hospital and its medical staff could elect to use at
their discretion, we proposed language that states ``the provisions of
paragraphs (c)(5)(iii), (iv), and (v) do not apply to a medical staff
that chooses to maintain a policy that adheres to the requirements of
paragraphs (c)(5)(i) and (ii) for all patients.'' In other words, a
hospital and its medical staff would be free to exercise their clinical
judgment in determining whether a policy for identifying specific
patients as not requiring a comprehensive H&P (or any update to it)
prior to specific outpatient surgical or procedural services, and
instead requiring only a pre-surgical assessment for these patients,
would be their best course. Or, if a hospital and its medical staff
decided against such a policy, then only the current H&P and update
requirements (at Sec. Sec. 482.22, 482.24, and 482.51) would continue
to apply and the proposed requirements for this CoP, as well as those
proposed for Sec. Sec. 482.24 and 482.51, would not apply.
For the current CoP at Sec. 482.24, ``Medical Record Services,''
we specified that we would revise the provisions at Sec.
482.24(c)(4)(i)(A) and (B) regarding an H&P and its update to allow for
an exception under proposed paragraph (c)(4)(i)(C) where we proposed to
add a new requirement that, if applicable, the medical record would
have to document assessment of the patient (in lieu of the requirements
of paragraphs (c)(4)(i)(A) and (B)) after registration, but prior to
surgery or a procedure requiring anesthesia services, for specific
outpatient surgical or procedural services.
We also proposed to revise the current CoP, Sec. 482.51,
``Surgical Services,'' to allow for an exception to the requirements at
Sec. 482.51(b)(1)(i) and (ii). Under proposed paragraph (b)(1)(iii),
we proposed a new requirement that, prior to surgery or a procedure
requiring anesthesia services and except in the case of emergencies, an
assessment of the patient must be completed and documented after
registration (and in lieu of the requirements of paragraphs (b)(1)(i)
and (ii)). This proposed requirement would only apply in those
instances when the patient is receiving specific outpatient surgical or
procedural services and when the medical staff has chosen to develop
and maintain a policy that identifies, in accordance with the
requirements at Sec. 482.22(c)(5)(v), specific patients as not
requiring a comprehensive medical history and physical examination, or
any update to it, prior to specific outpatient surgical or procedural
services.
Comment: As reflected in the public comments for similar proposed
changes for ASCs that we have previously discussed, the majority of
comments submitted were supportive of the proposed changes that would
give a hospital and its medical staff the flexibility to establish a
policy for a pre-surgical or pre-procedural assessment of the patient
(in lieu of the requirements of paragraphs (c)(5)(i) and (ii) for a
comprehensive pre-surgical or pre-procedural H&P and its update),
provided that the patient assessment is completed and documented after
registration, but prior to surgery or a procedure requiring anesthesia
services, and the patient is receiving specific outpatient surgical or
procedural services as outlined in the policy. Several commenters
stated that they appreciated the regulatory flexibility to establish
specific patient policies such as these as long as they are based on
recognized guidelines and best practices as well as on the clinical
judgment of the medical staff. They stated that they believe such
parameters are necessary to ensure patient health and safety while
still allowing for reasonable methods to reduce the burden on both
patients and providers, including the additional expense of pre-
operative testing that is often performed unnecessarily on many
patients undergoing only minor outpatient procedures and may be an
unintended consequence of the requirement for a comprehensive H&P
within 30 days of admission or registration for all hospital patients
regardless of the surgery or procedure that they are undergoing.
Response: We thank the commenters for their support and agree that
the flexibility provided by these revisions will reduce unnecessary
regulatory burden affecting both patients and providers. We believe
that it also has the potential to greatly reduce unnecessary costs
associated with the current requirements for a comprehensive H&P for a
specific class of patients undergoing low-risk outpatient surgeries and
procedures for which there exist clear guidelines regarding the extent
of pre-operative patient assessment and testing needed.
Comment: Some commenters either did not support these changes or
had certain reservations about them, even though they supported the
overall intent of the changes. One commenter stated that the change
will not serve those beneficiaries with advanced illness well,
recommended that the rule be revised to require that the assessment
must be consistent with the patient's situation, medical complexity,
and the proposed procedure, and believes that the requirements must err
on the side of more, rather than less, comprehensiveness. Another
commenter stated that while they appreciated CMS' recognition that the
timing of H&Ps may, in some instances, be duplicative and cause
unnecessary burden, they were aware of cases where the current H&P
requirements prevented an adverse event. They also stated that the
proposed revisions will be just as, and possibly more, burdensome than
the current requirements; that CMS should consider comments before
proceeding; and that, while they agree that there seems to be no
evidence supporting a strict 30-day requirement, additional flexibility
would be appreciated. One commenter stated that they believe the burden
of assessing patients prior to surgery would be shifted from one
provider (the primary care physician or the surgeon) to another (the
anesthesiologist), and
[[Page 51744]]
expressed concerns over the increased responsibility and liability that
might be then imposed on an anesthesiologist (beyond his or her primary
responsibility for anesthesia services and care provided to a patient)
for a surgery or procedure in which he or she was not the operating
practitioner. A few commenters also expressed concerns over whether
reimbursement requirements and rates would now change for outpatient
surgeries and procedures that would only require an assessment and not
a comprehensive H&P, including concerns over which practitioner would
now be reimbursed for the assessment (for example, the patient's
primary care practitioner versus the operating practitioner).
Response: We appreciate the concerns raised by commenters and have
thoroughly considered them. However, we must again note and emphasize
to readers that this revision will be a regulatory option available to
hospitals and one that a hospital and its medical staff must make the
policy decision to exercise. We expect that this decision will be based
on the clinical judgment and recommendations of the medical staff,
which must be supported by nationally recognized evidence and
guidelines for best practices in this area, in order for the hospital
to determine if the best course would be to establish a policy for
identifying specific patients as not requiring a comprehensive H&P (or
any update to it) prior to specific outpatient surgical or procedural
services, and instead require a more limited pre-surgical assessment
for these patients. We expect that most hospitals and their medical
staffs will perform risk/benefit analyses to inform their decisions. We
also expect that a number of these hospitals, based on their analyses,
will decide to maintain a policy that continues to follow the current
H&P and update requirements (at Sec. Sec. 482.22, 482.24, and 482.51)
and will not choose to exercise this option in any way. Conversely, we
also expect that some will choose to exercise this option fully and to
the broadest extent possible while still remaining in compliance with
the requirements finalized. We further expect that another significant
subset of hospitals will fall somewhere in the middle in their policy
decisions and will most likely elect to exercise this option within an
even more narrow and stringent set of parameters than CMS is requiring
here. The regulatory flexibility and framework of these final
requirements will allow each hospital to establish and tailor its own
policy parameters according to its specific patient populations,
individual institutional needs and resources, and own medical staff
recommendations as long as the policies and procedures established and
implemented meet or exceed the requirements finalized in this rule. As
finalized here, these requirements, while providing a hospital with an
alternative and less burdensome approach to pre-surgical patient
assessment, will also at the same time ensure that a hospital takes
into consideration all patient safety factors and quality of care
issues, such as the degree of complexity of the patient's medical
condition as well as that of the planned procedure itself, when it
establishes a process to identify those patients to whom such a policy
would apply.
In response to the commenter who stated that, under this new
option, the assessment of patients prior to surgery will be ``shifted
from one provider (the primary care physician or the surgeon) to
another (the anesthesiologist),'' we note that the Anesthesia services
CoP contains a separate provision (separate and distinct from the H&P,
update, and pre-surgical assessment requirements in the Surgical
services CoP) that requires that a ``. . . preanesthesia evaluation
[be] completed and documented by an individual qualified to administer
anesthesia . . .'' and that it must be ``. . . performed within 48
hours prior to surgery or a procedure requiring anesthesia services.''
The anesthesiologist is responsible for this evaluation, but not for
the H&P, update, and pre-surgical assessment requirements that we are
finalizing here. While an anesthiologist could certainly qualify to
perform any of these pre-surgical assessments, we expect the operating
practitioner, who is also responsible for the pre-, intra-, and post-
operative care of the patient and must be a physician (as defined in
section 1861(r) of the Act), an oral and maxillofacial surgeon, or, in
accordance with State law and hospital policy, another qualified
licensed individual (who would most likely be a member of the operating
practitioner's team, such as an NP or PA, and who, by extension, would
also be responsible for the care of the patient) to perform the pre-
surgical assessment as required in this final rule. If a hospital and
its medical staff choose to establish policies and procedures that
delineate the duties and responsibilities of any individual
anesthiologist (or any individual qualified to administer anesthesia)
to include performance of the pre-surgical assessments included under
this rule, then the hospital would need to demonstrate that these pre-
surgical assessments are separate and distinct from the pre-anesthesia
evaluations of patients required at Sec. 482.52. Furthermore, a
hospital must also ensure that any such policies and procedures, which
assign these pre-surgical assessment duties and responsibilities to an
individual anesthiologist (or an individual qualified to administer
anesthesia) as discussed here, are not only in accordance with State
law, but are also consistent in this regard with the current standards
of both anesthesia care and surgical care.
The comments regarding reimbursement requirements and rates for
outpatient surgeries and procedures are outside the scope of the CoPs
and this rule.
Comment: A few commenters were concerned about compliance with the
revised requirements if no clear and recognized guidelines or
recommendations exist for pre-surgical patient assessment for specific
classes of patients undergoing certain outpatient surgeries and
procedures.
Response: The revised requirements, which allow for the option of
establishing a policy for identification of specific patients to whom
the assessment requirements in Sec. 482.22(c)(5)(iii) would apply, are
conditioned upon a hospital and its medical staff demonstrating
evidence that the specific parameters required in this final rule are
met. A hospital and its medical staff should not include those classes
of patients and those outpatient surgeries and procedures in its pre-
surgical patient assessment policy if the hospital finds that it cannot
meet the requirements we are finalizing at Sec. Sec. 482.22(c)(5)(v),
including the requirement that the medical staff must demonstrate
evidence that its policy is based on nationally recognized guidelines
and standards of practice for the assessment of specific types of
patients prior to specific outpatient surgeries and procedures.
Final Rule Action: We are finalizing the requirements in Sec. Sec.
482.22, 482.24, and 482.51, with only minor modifications.
Specifically, we are changing the term ``oromaxillofacial surgeon'' to
the correct term of ``oral and maxillofacial surgeon'' where indicated.
Contact: CAPT Scott Cooper, USPHS, 410-786-9465.
c. Medical Staff: Autopsies (Sec. 482.22(d))
We proposed to remove the requirement at Sec. 482.22(d), which
states that a hospital's medical staff should attempt to secure
autopsies in all cases of unusual deaths and of medical-legal
[[Page 51745]]
and educational interest. The mechanism for documenting permission to
perform an autopsy must be defined and there must be a system for
notifying the medical staff, and specifically the attending
practitioner, when an autopsy is being performed.
Comment: Several commenters agreed with the proposal, which they
stated would remove duplicative administrative work and allow hospitals
to defer to State requirements when an autopsy is necessary. Many
commenters, including national associations representing medical
examiners and pathologists, disagreed with the removal of the
requirement that a hospital's medical staff attempt to secure autopsies
for unusual deaths or educational purposes. The commenters stated that
hospitals should attempt to obtain family permission for autopsies
related to deaths resulting from questions about efficacy of treatment,
for educational purposes, or for issues of unintended outcomes of
treatment or medical uncertainty and these commenters also expressed
concern that the removal of this proposal would lead to a further
reduction in an already low national autopsy rate.
However, many of these commenters stated that hospitals should not
be required to attempt to obtain family permission, or perform
autopsies, in cases of medical-legal interest. In those circumstances,
the commenters stated, hospitals should report the death to, and
consult with, the authority of their local medical examiner, coroner,
or medicolegal death investigative authority.
Finally, one commenter requested that CMS specifically state that
hospitals are not prohibited from performing autopsies.
Response: We agree that hospitals should not attempt to secure
autopsies in medical-legal cases without first contacting their State's
medical examiner or medical authority, in accordance with their State's
laws. We will defer to state law on this issue, since each State has
their own standards and laws regarding the performance of autopsies for
medical-legal purposes, and we therefore are removing this as a
requirement in the CoPs for hospitals. Furthermore, we believe that it
is appropriate to remove the duplicative and burdensome requirement
that hospitals attempt to secure autopsies for other cases of unusual
deaths or for educational interest. We clarify that removing this
requirement would not prohibit hospitals from performing autopsies and
we believe that hospitals will implement their own policies regarding
autopsies. While we understand the commenter's concerns regarding the
decline in the national autopsy rate, we disagree that the removal of
this specific requirement will cause a measurable decrease in the
autopsy rate, impact quality of care, or dissuade hospitals from
performing autopsies. As commenters themselves have noted, there are
various causes that may have contributed to the reduction in the
autopsy rate including risk adversion due to litigation concerns and
concerns about reimbursement rates, and we have no additional evidence
that would lead us to the conclusion that the removal of this
requirement would exacerbate these numbers. We therefore are finalizing
our proposal to remove the requirements at Sec. 482.22(d). Although we
are finalizing our proposal, we note that the removal of this
requirement should not be construed as a diminution of our support for
hospitals continuing to perform autopsies for various purposes, and we
encourage hospitals to establish policies regarding autopsies, where
appropriate.
Comment: A few commenters suggested that all hospital admissions
require the patient (or his or her representative) to affirmatively
allow or prohibit an autopsy in the event of death. One commenter also
stated that autopsies should be required for any hospital death, unless
explicitly rejected by next of kin.
Response: Mandating that hospitals perform autopsies, or that
hospitals ask permission to perform an autopsy upon a patient's
admission, would be unduly burdensome to hospitals and contrary to the
purpose of the CoPs, which establish baseline health and safety
requirements. However, hospitals may choose to establish their own
policy that would require patients or their representatives to permit
or decline autopsies upon admission, if they believe such a requirement
is appropriate. As we previously stated, there is no prohibition
against autopsies and hospitals are free to enact policies regarding
autopsies if they choose to do so.
Additionally, requiring hospitals to perform autopsies could
potentially conflict with State and local laws regarding autopsies for
medical-legal cases. For instance, certain State laws require that
hospitals report deaths arising from medical-legal circumstances to
their local medical examiner or other authoritative body, so that a
determination can be made as to whether an autopsy must be performed.
Final Rule Action: We are finalizing the proposal to remove Sec.
482.22(d), without modification.
Contact: Alpha-Banu Wilson, 410-786-8687.
d. Infection Control (Sec. 482.42)
We proposed a new standard at Sec. 482.42(c), ``Unified and
integrated infection control program for multi-hospital systems.'' Like
the proposed requirements for a unified and integrated QAPI program,
the proposed standard for infection control would allow that for a
hospital that is part of a hospital system consisting of multiple
separately certified hospitals subject to a system governing body
legally responsible for the conduct of each hospital, such system
governing body could elect to have a unified and integrated infection
control program for all of its member hospitals after determining that
such a decision was in accordance with all applicable State and local
laws. The system governing body would be responsible and accountable
for ensuring that each of its separately certified hospitals met all of
the requirements of this section. Each separately certified hospital
subject to the system governing body would have to demonstrate that the
unified and integrated infection control program: (1) Was established
in a manner that took into account each member hospital's unique
circumstances and any significant differences in patient populations
and services offered in each hospital; (2) established and implemented
policies and procedures to ensure that the needs and concerns of each
of its separately certified hospitals, regardless of practice or
location, are given due consideration; (3) had mechanisms in place to
ensure that issues localized to particular hospitals are duly
considered and addressed; and (4) designated a qualified individual(s)
at the hospital with expertise in infection prevention and control to
be responsible for communicating with the unified infection control
program, for implementing and maintaining the policies and procedures
governing infection control, and for providing infection prevention
education and training to hospital staff.
Comment: Most commenters supported the proposal to allow hospitals
that are part of a multi-hospital system to have a unified and
integrated infection control program. The proposed rule included a
specific request for public comment on whether there are any other
programs currently required under the CoPs for each separately
certified hospital, beyond the QAPI and Infection control programs
proposed here, that stakeholders believe would likewise be better
managed under a system governing body legally
[[Page 51746]]
responsible for the conduct of each separately certified hospital. In
response, we received comments asking CMS for further revisions to the
CoPs, like those proposed for QAPI and infection control programs here
(and with specific mention of revising the Nursing services CoP in this
way), to allow for similar departmental and operational integration
among hospitals within a multi-hosptial system with a single governing
body. The commenters stated that expansion of this flexibility for
other hospital services, departments, units, and programs would reduce
operational burden for individual hospitals, ensure the proper level of
staff expertise for member hospitals, and improve the quality and
continuity of care for all patients served within the system. A few
commenters also expressed appreciation for the expanded flexibility
that this proposal would afford hospitals by reducing burden,
increasing efficiencies, and eliminating the duplication of efforts.
One commenter encouraged CMS to apply this approach to situations
when a multi-hospital system's providers have to fulfill additional
requirements stemming from Medicaid or Medicare managed care plans or
other external regulatory entities. The commenter suggested the
mandated training related to the special needs plan models of care (42
CFR 422.101(f)(2)(ii)) as an example of how this could be applied. The
commenter stated that a multihospital system with a unified infection
control program as allowed under the requirements finalized in this
rule, and that is also potentially participating in an ACO, would most
certainly meet the Model of Care training requirement. This commenter
also suggested an alternative approach where ACO participants would be
deemed as meeting the Model of Care requirement for all other external
regulatory entities by meeting the unified infection control program
requirements finalized here.
Response: We thank the commenters for their support. We believe
that a hospital's governing body should be afforded the option of
unifying and integrating the various member hospitals within their
multi-hospital system into a unified infection control program. As we
discussed for unified and integrated QAPI programs, such a model would
incorporate each individual hospital's infection control program, which
would enable increased efficiencies, innovations, provider flexibility,
and allow for the dissemination of best practices for patient care
while also potentially improving patient safety and outcomes. We also
believe that a unified infection control model is a natural progression
for a multi-hospital system that utilizes a system governing body (as
allowed at Sec. 482.12), a unified medical staff (as allowed at Sec.
482.22), and a unified QAPI program (as finalized in this rule at Sec.
482.12).
The comments and recommendations regarding the application of the
unified infection control model and its CoP requirements to any
additional requirements mandated by Medicare and Medicaid managed care
plans or other external regulatory entities are outside the scope of
the CoPs and this rule.
Final Rule Action: We are finalizing the proposed requirements in
Sec. 482.42. Moreover, in addition to revisions proposed and finalized
for the Hospital/CAH Innovation Rule regarding Antibiotic Stewardship
Programs (ASPs) (now part of the Infection Prevention and Control CoP
discussed in Section III.B.6. of this final rule and finalized here at
Sec. 482.42), we are finalizing changes to Sec. 482.42 that will now
address the designated and qualified individual(s) at the hospital
responsible for communicating with the unified infection control
program, for implementing and maintaining the policies and procedures
governing infection control, and for providing infection prevention
education and training to hospital staff with regard to the ASP as
well. We are also making other minor modifications to this section to
finalize changes proposed in the Hospital/CAH Innovation Proposed Rule.
All of these changes are discussed later in Section III.B.6. of this
final rule.
Contact: CAPT Scott Cooper, USPHS, 410-786-9465.
e. Special Requirements for Hospital Providers of Long-Term Care
Services (``Swing-Beds'') (Sec. 482.58(b)(1), (4), (5), and (8), and
Identical CAH Requirements: Sec. 485.645(d)(1), (4), (5), (6), and
(7))
Hospitals providing swing-bed services must meet all of the
requirements at 42 CFR part 482, which includes the swing-bed
requirements at Sec. 482.58 for patients receiving swing-bed services,
and CAHs providing swing-bed services must meet all of the requirements
at 42 CFR part 485, subpart F, which includes the swing-bed
requirements at Sec. 485.645 for patients receiving swing-bed
services. The swing-bed requirements within the hospital and CAH CoPs
include a subset of cross-referenced long-term care requirements
contained in 42 CFR part 483, subpart B, for which hospital and CAH
swing-bed providers are surveyed as they are for all of the CoPs in
their respective programs. We have determined that some of the cross-
referenced long-term care requirements for hospitals and CAH swing-bed
providers are unnecessary and unduly burdensome, given their focus on
``residents'' and longer length of stays, which we believe are not
relevant to swing-bed patients. Thus, we proposed to remove the
following requirements: Sec. Sec. 482.58(b)(1) and (c) and
485.645(d)(1) (incorporating long-term care facility requirements at
Sec. 483.10(f)(9)). Under our current regulations at Sec.
483.10(f)(9), the resident has a right to choose to, or refuse to,
perform services for the facility, and the facility must not require a
resident to perform services for the facility. Regulations at
Sec. Sec. 482.58(b)(1) and 485.645(d)(1) incorporate this resident
right by reference.
We expect hospital and CAH swing-bed providers who do offer
patients the option of providing services for the facility to have
current policies and procedures that reflect this policy that includes
protocol for establishing an agreement between the two parties.
Comment: Commenters universally supported the proposal to remove
the provision requiring hospitals and CAH swing-bed providers to
provide residents with the right to choose to, or refuse to, perform
services for the facility, and not requiring a resident to perform
services for the facility. As with the majority of the hospital and CAH
swing-bed proposals, commenters noted that this requirement is
unnecessary, the source of confusion, or is unduly burdensome.
Response: We appreciate the comments received and continue to
believe that this change is appropriate.
Final Rule Action: We are finalizing this proposed change without
revisions.
Sec. Sec. 482.58(b)(4) and 485.645(d)(4) (incorporating long-term
care facility requirements at Sec. 483.24(c)): The facility must
provide, based on the comprehensive assessment and care plan and the
preferences of each resident, an ongoing program to support residents
in their choice of activities and the activities program must be
directed by a qualified professional who is a qualified therapeutic
recreation specialist or an activities professional. Patients receiving
swing-bed services in a hospital or CAH are not long term residents of
the facility and generally only receive swing-bed services for a brief
period of time for transition after the provision of acute care
services. We expect that for those patients who receive swing-bed
services for an extended period of time, their nursing care plan--as
required under Sec. 482.23(b)(4) for hospitals and
[[Page 51747]]
Sec. 485.635(d)(4) for CAHs--is based on assessing the patient's
nursing care needs and will support care that holistically meets the
needs of the patient, taking into consideration physiological and
psychosocial factors.
Comment: The majority of commenters were supportive of the proposed
removal of the requirement for hospital and CAH swing-bed providers to
provide an ongoing program to support residents in their choice of
activities and have an activities program that is directed by a
qualified professional. As with the majority of the hospital and CAH
swing-bed proposals, commenters noted that this requirement is
unnecessary, the source of confusion, or is unduly burdensome due to
the limited length of stay for most patients receiving swing-bed
services. Commenters generally agreed that the activity needs of those
patients who receive swing-bed services for an extended period of time
would be met via the hospital and CAH nursing care plan requirements.
However, one commenter noted that in the event a swing-bed patient
receives care for an extended period of time, the nursing care plan
will not include interest-based group and individual activities that
support the patient's physical, mental and psychosocial well-being. The
commenter noted that therapeutic or recreational activities differ
significantly from the goals that normally would be identified in a
nursing care plan.
Response: We appreciate the comments received and continue to
believe that this change is appropriate. It is expected that hospitals
and CAHs, using an interdisciplinary approach, are providing services
that meet the needs of all of their patients, including those receiving
swing-bed services, regardless of their length of stay. In addition,
nursing care plans are intended to provide direction on the type of
nursing care the needed by the patient, stemming from the patient's
diagnoses, that is organized based on the specific needs of the
patient. The care plan is dynamic and should change as the needs of the
patient change. As a result, if the needs of the patient include
interest-based group and individual activities that support the
patient's physical, mental and psychosocial well-being, we expect that
the hospital or CAH will provide these services to the patient.
Final Rule Action: We are finalizing this proposed change without
revision.
Sec. Sec. 482.58(b)(5) and 485.645(d)(5) (incorporating long-term
care facility requirements at Sec. 483.70(p)): Any facility with more
than 120 beds must employ a qualified social worker on a full-time
basis.
In accordance with the hospital and CAH swing-bed requirements,
hospital swing-bed providers are not permitted to have more than 100
beds while CAH swing-bed providers are not permitted to have more than
25 beds for the provision of inpatient or swing-bed services. Based on
feedback from stakeholders, removing this requirement would eliminate
confusion for providers and accreditation organizations.
Comment: Commenters universally supported the proposal to remove
the provision requiring hospitals and CAH swing-bed providers with more
than 120 beds to employ a full-time social worker. As with the majority
of the hospital and CAH swing-bed proposals, commenters noted that this
requirement is unnecessary, the source of confusion, or is unduly
burdensome.
Response: We appreciate the comments received and continue to
believe that this change is appropriate.
Final Rule Action: We are finalizing this proposed change as
proposed.
Sec. Sec. 482.58(b)(7) and 485.645(d)(7) (incorporating the long-
term care facility requirement at Sec. 483.55(a)(1)): Under our long-
term care facility requirements, the facility, must provide routine and
emergency dental services to meet the needs of each resident, or obtain
them from an outside resource, in accordance with Sec. 483.70(g).
Hospitals and CAHs are required to provide care in accordance with
the needs of the patient that have been identified in such patients'
plans of care; this could include non-emergency dental care. We expect
that hospital swing-bed providers are currently addressing the emergent
dental care needs of their patients under the existing hospital CoP at
Sec. 482.12(f)(2), which requires that hospitals have written policies
and procedures for appraisal of emergencies, initial treatment, and
referral when appropriate. Similarly, we expect that CAH swing-bed
providers are currently addressing the emergent dental care needs of
their patients under the existing emergency services CoP at Sec.
485.618, which requires CAHs to provide emergency care necessary to
meet the needs of its inpatients and outpatients. As a result, we
believe that this portion of the requirement is duplicative, given the
current CoP requirements.
Comment: Commenters universally supported the proposal to remove
the provision requiring hospitals and CAH swing-bed providers provide
or obtain from an outside resource routine and emergency dental
services to meet the needs of each resident. As with the majority of
the hospital and CAH swing-bed proposals, commenters noted that this
requirement is unnecessary, the source of confusion, or is unduly
burdensome.
In addition, the most recent guidelines from the American Dental
Association note that patients should have regular dental visits, with
the frequency determined by their dentist to accommodate for the
patients' current oral health status and health history (American
Dental Association, https://www.ada.org/en/press-room/news-releases/2013-archive/june/american-dental-association-statement-on-regular-dental-visits).
Response: We appreciate the comments received and continue to
believe that this change is appropriate.
Final Rule Action: We are finalizing this proposed change as
proposed.
Contact: Kianna Banks, 410-786-3498.
f. Special Requirements for Psychiatric Hospitals (Sec. 482.61(d))
We believe that as currently written and implemented, this
requirement requires clarification regarding the language that progress
notes ``must be recorded by the doctor of medicine or osteopathy
responsible for the care of the patient as specified in Sec.
482.12(c), nurse, social worker and, when appropriate, others
significantly involved in active treatment modalities.'' We believe
that non-physician practitioners, including physician assistants, nurse
practitioners, psychologists, and clinical nurse specialists, when
acting in accordance with State law, their scope of practice, and
hospital policy, should have the authority to record progress notes of
psychiatric patients for whom they are responsible. Therefore, we
proposed to allow the use of non-physician practitioners or MD/DOs to
document progress notes of patients receiving services in psychiatric
hospitals.
Comment: Commenters were mostly supportive of the proposal to
clarify the documentation requirements for recording progress notes in
the patient's medical records for patients receiving services in
psychiatric hospitals. Commenters noted that the proposed change would
reduce barriers for care providers and will give non-physician
practitioners expanded access to document the provision of the health
care to patients, resulting in improved continuity of care.
Response: We appreciate the comments received and continue to
believe that this change is appropriate.
[[Page 51748]]
Comment: One commenter opposed the proposed change, noting that the
existing regulatory language already permits non-physician
practitioners to document progress notes in the patient's medical
records for patients receiving services in psychiatric hospitals;
therefore, the change would be unlikely to produce costs savings from
incorporating psychologists or other licensed practitioners in this
requirement. Another commenter opposed the inclusion in the proposed
rule of psychologists in the list of non-physician practitioners
allowed to document the patient's progress notes. The commenter notes
that the current regulations permit psychologists to document the
services they provide (psychotherapy, psychological/neuropsychological
testing notes), but they should not be granted the authority to write
medical progress notes due to the current Medicare regulations under
Sec. 482.12(c)(1)(vi).
Response: While we agree with the commenter regarding the intent of
the current regulatory language, we believe that there is a need to
clarify the intent of the language and ensure that the healthcare
providers with the authority to document the progress reports are
clearly identified. The majority of commenters supported the need for
clarification due to the failure of the regulatory text to specify the
non-physician practitioners who could document progress reports.
Additionally, we believe psychologists are appropriately included
in the list of non-physician practitioners who have the authority to
document in progress notes for patients receiving services in
psychiatric hospitals. The regulation at Sec. 482.12(c)(1)(vi),
referenced by the commenter, states that a clinical psychologist, as
defined in Sec. 410.71, has the authority to admit patients and
oversee the care of Medicare patients (but only with respect to
clinical psychologist services as defined in Sec. 410.71 of this
chapter and only to the extent permitted by State law). Furthermore,
non-physician practitioners currently document in the progress notes of
patients in acute care hospitals to the extent of their scope of
practice and hospital policy.
We believe that the revised language in this final rule will
clarify our original intent in the proposed rule (as understood by
readers as evidenced by the comments discussed here that request and
support such clarification on this issue) that non-physician
practitioners, including physician assistants, nurse practitioners,
psychologists, and clinical nurse specialists, when acting in
accordance with applicable State scope of practice laws, and hospital
policies, should have the authority to record progress notes for all
psychiatric and medical problems, which are present upon patient
admission or which develop during hospitalization, for any psychiatric
patient for whom these licensed practitioners are responsible as long
as such patient problems fall within the bounds of a licensed
practitioner's specific State scope of practice laws and hospital
policies.
Comment: One commenter requested that clarification be provided
regarding the use of the phrase ``hospital policy'' as it relates to
the requirement that non-physician practitioners act in accordance with
hospital policy.
Response: Psychiatric hospitals must comply with the hospital CoPs
under 42 CFR part 482, which includes the requirements for psychiatric
hospitals. The hospital CoPs require that the hospital's governing body
approve all hospital policies, and in accordance with Sec.
482.12(a)(4), the governing body must determine (in accordance with
State law) which categories of practitioners are eligible candidates
for appointment to the medical staff. The governing body is required to
appoint members of the medical staff after considering the
recommendations of the existing members of the medical staff and
approve medical staff bylaws and other medical staff rules and
regulations. Non-physician practitioners, whether employees or
contractors, would be subject to all rules, regulations, and policy
manuals utilized by the hospital.
Final Rule Action: We are finalizing the changes as proposed.
Contact: Kianna Banks, 410-786-3498.
5. Transplant Centers
a. Special Requirement for Transplant Centers (Sec. Sec. 482.68 and
482.70)
We proposed to update the terminology within the hospital
regulation at part 482 and the transplant regulations at Sec. Sec.
482.68, 482.70, 482.72 through 482.104, and at Sec. 488.61, for
clarification and consistency. Specifically, we proposed a nomenclature
change which would:
Replace the term transplant ``center'' in the regulation
language with transplant ``program'' (each organ type would be a
transplant program). A transplant program is located within a
transplant hospital that provides transplantation services for a
particular type of organ. Since individual transplant programs are
surveyed for compliance with the CoPs, using the term transplant
program throughout the regulation better aligns with current surveyor
practice and will reduce provider confusion. In order to provide
further clarity, we also proposed to update the definitions at Sec.
482.70.
Consistently use Independent Living Donor Advocate (ILDA)
throughout the regulation.
Change ``beneficiaries'' to ``recipients''.
Comment: All comments we received expressed support for the
proposed nomenclature change, which would make the terminology used in
the regulations consistent with the terminology used by the Organ
Procurement and Transplantation Network (OPTN) and the transplant
community.
Response: We thank the commenters for their support. We are
finalizing this proposal without modification.
b. Data Submission, Clinical Experience, and Outcome Requirements for
Re-Approval of Transplant Centers (Sec. 482.82)
We proposed to remove the requirements at Sec. 482.82 that require
transplant centers to submit data (including, but not limited to,
submission of the appropriate OPTN forms for transplant candidate
registration, transplant beneficiary registration and follow-up, and
living donor registration and follow-up), clinical experience, and
outcome requirements for Medicare re-approval, and make conforming
changes to Sec. 482.102(a)(5) ``Condition of participation, Patient
and living donor rights'' and Sec. 488.61 ``Special Procedures for
Approval and Re-Approval of Organ Transplant Centers.''
Comment: Most commenters, including several major organizations
which represent the interests of transplant surgeons and other
professionals, transplant patients, individual transplant programs,
members of the transplant community, and the OPTN, strongly supported
the proposal to remove the provision that requires transplant centers
that are applying for Medicare re-approval to meet all data submission,
clinical experience, and outcome requirements in order to be re-
approved. These commenters agreed with our analysis of the unintended
consequences that have occurred because of the Medicare re-approval
requirements and many agreed that eliminating this requirement would
improve transplantation in the United States. Many of these commenters
also stated their belief that the proposal would reduce administrative
burdens. A
[[Page 51749]]
few commenters also supported maintaining the requirements for initial
Medicare approval for transplant centers.
Several commenters, including members of the transplant community
and interested individuals, objected to the removal of this proposal.
These commenters as a whole were concerned that removing this proposal
would affect quality of care and patient outcomes. Specifically,
commenters were concerned as to whether information on transplant
centers outcomes would continue to be available to the public, and
whether CMS would still be able to identify underperforming transplant
programs, in order to ensure patient safety and continued positive
outcomes. Other commenters stated that, absent these requirements, CMS
would rely upon transplant programs notifying CMS of changes rather
than having a process in place that would monitor such changes. A few
commenters expressed concerns regarding how CMS would identify
underperforming transplant programs and requested guidance as to how
CMS plans to ensure patient safety and positive outcomes by using the
QAPI program instead of the current re-approval process. Others
requested clarification as to how CMS would continue to monitor
outcomes absent this requirement.
Response: We appreciate the commenters' support. CMS is committed
to ensuring that our regulations support a patient's access to
lifesaving organs. We also strive to protect the quality of care that
the transplant recipient and donor receives while in the transplant
facility and we agree with commenters that the removal of this
requirement will work towards achieving these goals. We appreciate the
numerous studies and professional opinions that were submitted by the
public that further bolstered our understanding of the unintended
consequences that have occurred as a result of the Medicare re-approval
requirements for transplant centers and we therefore are finalizing our
proposal to remove these requirements at Sec. 482.82. We believe that
the removal of these requirements will lead to improved patient
outcomes, increased transplantation opportunities for patients on the
waitlist, improved organ procurement for transplantation, greater organ
utilization, and reduced burden on transplant programs. We note that
the removal of these requirements directly aligns with our goal to
increase access to kidney transplants by increasing the utilization of
available organs from deceased donors and reducing the organ discard
rate, which we outline in the Advancing American Kidney Health Paper,
which can be found on the Office of the Assistant Secretary for
Planning and Evaluation website at https://aspe.hhs.gov/pdf-report/advancing-american-kidney-health.
We understand the concerns that commenters raised regarding the
availability of transplant program outcome data and we remind
commenters that transplant outcomes will still be available to the
public every six months on the Scientific Registry for Transplant
Recipients (SRTR) website at https://www.srtr.org/. In addition, CMS
will continue to survey the program's QAPI program to make sure the
program is tracking adverse events, performing thorough analysis of
each adverse event, and that performance improvement projects ensure
adverse events do not recur. CMS will also do complaint investigations
based on public or confidential reports about outcomes or adverse
events.
It is our expectation that transplant programs will use their QAPI
programs to continue to monitor quality of care, evaluate
transplantation activities and outcomes, and conduct performance
improvements when necessary. We believe that these efforts and the
survey of the CoPs provides sufficient oversight to ensure that
transplant programs will continue to achieve and maintain high
standards of care.
Comment: A few commenters, who were generally supportive of the
proposals, had additional clarifying questions for CMS about the survey
process. One commenter asked whether additional reporting on the part
of the hospital and transplant based QAPI programs would be required. A
few commenters asked whether CMS would monitor hospital and QAPI based
programs through a different mechanism, while one comment asked whether
CMS will be providing published information regarding these reviews.
One commenter also expressed their opposition to a change to the
transplant QAPI regulations, and they expressed concern that changing
these regulations will have unintended negative consequences on
transplant survival outcomes, safety issues, and an increased focused
on transplant volume by programs. Another commenter asked the following
questions:
Whether the monitoring schedule for CMS surveys of
transplant programs will remain the same;
What circumstances will trigger a review from CMS outside
of routine recertification surveys; and
What options will be available to a transplant program
with condition level deficiencies on recertification surveys once the
mitigating factors and SIAs are removed.
Response: We did not propose changes to the transplant program QAPI
requirements and, consistent with other provider types, there is no
public reporting for the hospital and transplant QAPI programs.
Transplant programs must continue to abide by the hospital and
transplant program QAPI CoPs at Sec. Sec. 482.21 and 482.96,
respectively. On survey, documentation of communication between these
QAPI entities is expected and the hospital QAPI program should report
to the Governing Body any issues with transplant outcomes.
In response to the questions about the survey process, we note that
the survey interval will not change, and that public or confidential
reports may trigger a complaint survey. Mitigating factors and systems
improvement agreements were for outcomes non-compliance only and are
therefore unnecessary with the removal of the outcomes re-approval
requirement at Sec. 482.82.
Comment: A few commenters were generally supportive of CMS's goals
to improve organ transplantation by removing provider disincentives,
but the commenters suggested that this could be achieved through
improvements to the quality and outcomes measures. Specifically, the
commenters suggested that reported outcomes focus on long term outcomes
instead of short term outcomes, data on waitlist survival, donor
utilization, total volume of organs transplanted, transplant rate
utilization, cost-effectiveness, and other quality of care measures.
Response: We believe that the wide variety of data and studies
presented in the proposed rule regarding the unintended consequences of
the re-approval requirements sufficiently demonstrates that it is no
longer appropriate to include specific outcome measures as a
requirement for Medicare re-approval. Transplant programs, however,
will still need to abide by these outcome measures for initial Medicare
approval.
Comment: One commenter opposed the transplant center proposals and
suggested that CMS look at Organ Procurement Organization (OPO)
performance in producing quality organs.
Response: We thank the commenters for their feedback regarding OPO
performance measures. However, we note that comments regarding OPOs are
outside the scope of this final rule.
[[Page 51750]]
c. Special Procedures for Approval and Re-Approval of Organ Transplant
Centers (Sec. 488.61(f) Through (h))
We proposed to remove the requirements at Sec. 488.61(f) through
(h) for mitigating factors and transplant systems improvement
agreements for the re-approval process for transplant centers. This
change is complementary to the proposed removal of Sec. 482.82,
described previously.
Comment: The majority of commenters were supportive of the proposal
to remove the mitigating factors and systems improvement agreements
requirement for the re-approval process for transplant centers. These
commenters stated that the removal of this requirement will relieve
undue burden on transplant programs. However, a few commenters opposed
the removal of this provision. The commenters were concerned that the
removal of this provision would negatively impact programs and they
noted that programs that failed to meet the re-approval requirements
would be terminated, which would limit patient access. The commenter
suggested that, if this proposal is finalized, CMS should monitor the
number of programs that have been decertified or that will face
decertification based on conditions.
Response: The proposed change to remove the mitigating factors and
systems improvement agreements afforded to transplant centers for
Medicare re-approval is a complementary change to the removal of the
Medicare re-approval requirements in Sec. 482.82. We are finalizing
the removal of Sec. 482.82, making the existence of the mitigating
factors and systems improvement agreement requirements obsolete.
However, we note that transplant programs are still afforded the
opportunity to submit mitigating factors or enter into systems
improvement agreements for the initial Medicare approval, and that we
are not making additional changes to the current processes other than
the provisions regarding mitigating factors and systems improvement
agreements.
Final Rule Action:
1. We are finalizing the proposal to make nomenclature changes
throughout the transplant center regulations at Sec. Sec. 482.68,
482.70, 482.72 through 482.104, and at Sec. 488.61, without
modification.
2. We are finalizing the proposal to remove Sec. 482.82, without
modification.
3. We are finalizing the proposal to remove the mitigating factor
and systems improvement agreement requirements for Medicare re-approval
at Sec. 488.61(f) through (h), without modification.
Contact: Alpha-Banu Wilson, 410-786-8687.
6. Home Health Agencies
We received 27 timely public comments on our proposed changes to
the HHA requirements. Commenters included industry associations,
healthcare systems, individual HHAs, consumer advocacy organizations,
and clinicians. Overall, the majority of commenters were supportive of
the goal of the proposed changes. Those comments are discussed below.
a. Patient Rights (Sec. 484.50(a)(3) and (c)(7))
We proposed to delete the requirement at Sec. 484.50(a)(3) that
HHAs must provide verbal notification of all patient rights. We
proposed to limit the verbal notification requirements to those
requirements set out in section 1891(a)(1)(E) of the Act for which
verbal notification is mandatory. We proposed to revise Sec.
484.50(c)(7) to implement this more limited verbal notification
requirement. Revised Sec. 484.50(c)(7) would require HHAs to verbally
discuss HHA payment and patient financial liability information with
each HHA patient as described above.
Comment: The majority of comments submitted regarding this topic
expressed support for the proposed change to require written notice of
patient rights for all enumerated rights, and oral notice only for
those rights specifically set forth in the Act as requiring such oral
notice. However, a small number of comments did not support this
change, stating that oral notice of all rights, rather than only those
set forth in the Act, has value to patients and caregivers. One
commenter stated that oral notice is particularly important for
individuals with lower literacy levels due to disabilities.
Response: Consistent with the notice of patient rights requirements
for other outpatient provider types, such as hospices, ambulatory
surgery centers, and community mental health centers, for which written
notice of patient rights is the only requirement, and in light of the
support for this proposed change expressed by the majority of
commenters, we are finalizing this change. We are sensitive to concerns
related to those individuals with lower literacy levels due to
disabilities that may impact understanding of the notice of patient
rights. We remind all HHAs that, as part of their Medicare provider
agreements, and in accordance with the other requirements of Sec.
484.50, they are responsible for complying with the provisions of the
Americans with Disabilities Act and Section 504 of the Rehabilitation
Act when communicating with all patients regarding all subjects,
including the notice of patient rights. HHAs must provide equal access
to individuals with disabilities, including the provision of auxiliary
aids and alternate formats, including, but not limited to, the
provision of qualified interpreters, large print documents, Braille,
digital versions of documents, and audio recordings.
b. Home Health Aide Services (Sec. 484.80(h)(3))
We proposed to eliminate the requirement at Sec. 484.80(h)(3) that
HHAs conduct a full competency evaluation of home health aides, and
replace it with a requirement to retrain the aide regarding the
identified deficient skill(s) and require the aide to complete a
competency evaluation related only to those skills.
Comment: Comments overwhelmingly supported the proposed change to
remove the requirement that a home health aide must complete a full
competency evaluation whenever a skill deficiency is noted during the
aide supervision process.
Response: We continue to believe that this change is appropriate,
and are finalizing it as proposed.
c. Clinical Records (Sec. 484.110(e))
We proposed to remove the requirement at Sec. 484.110(e) that the
requested clinical record copy must be provided at the next home visit,
while retaining the requirement that the information must be provided
within 4 business days.
Comments: Comments universally supported the proposal to remove the
requirement that HHAs must provide to patients a copy of information
contained in the clinical record by the time of the next HHA visit. A
few comments explicitly supported maintaining the requirement to
provide the requested information to patients within 4 days. However,
other comments stated that the proposed change did not provide enough
burden relief, and suggested that the requirement to provide a copy of
such information within 4 days should also be revised to allow HHAs up
to 30 calendar days to provide such information. Commenters stated that
4 business days was insufficient time to access records, which may be
archived offsite, make copies, and send those copies in the mail to
arrive within 4 business days at the patient's home. One comment stated
that the regulations should not include any requirements for HHAs to
provide patients with
[[Page 51751]]
information from their own clinical records. Other commenters suggested
that a shorter timeframe for providing information could be limited to
only the information from the current 60 day episode of care, rather
than to all certification periods from the episode of care or the
patient's entire record of care that may cross several different
episodes of care. Additionally, some commenters stated that HHAs should
be permitted to charge patients a fee for providing information from
the patient's own clinical record. However, other commenters
specifically supported the prohibition on charging patients a fee to
receive information from their own records.
Response: We appreciate the commenters' support for our proposed
revisions, and for their suggestions for further changes regarding the
HHA clinical records provisions. Addressing the evolving need for the
electronic exchange of health information amongst health care providers
and also between patients and their health care providers is an
Administration priority. As such, we will consider the issues raised by
commenters in the broader context of interoperability and health
information exchange, and will use these comments to inform future
rulemaking. We are not finalizing the changes to Sec. 484.110(e) at
this time.
d. Additional Comments
Summaries of the additional suggestions that we received that are
not directly related to our proposals and our responses are set forth
below.
Comment: Several commenters suggested that the requirement for HHAs
to provide certain specified information, such as the upcoming HHA
visit schedule and information about the treatments being furnished by
HHA clinicians (Sec. 484.60(e)) in writing to patients, should be
completely removed or significantly revised to remove most of the
specified information from the list. Commenters specifically cited the
requirement to provide patients with a visit schedule, contact
information for a hospice clinical manager, and information about the
treatments being provided as being overly burdensome requirements.
Response: While we understand the concerns expressed by commenters,
we continue to believe that providing patient-centered, patient-
directed care necessitates the provision of this crucial information to
all patients. Patients cannot be active participants in their own care
and advocates for their own interests without having essential
information about when care will be provided to them, what treatments
are being (or are supposed to be) administered during their care, and
information for how to contact a clinical member of the HHA care team
to discuss their questions and concerns. While it may be challenging
for HHAs to keep patients abreast of their own care, such efforts form
the basis of patient-centered care and cannot be ignored.
Comment: A commenter suggested that the CoP for the comprehensive
assessment should be revised to permit a registered nurse or a
therapist to perform the comprehensive assessment in all cases where
both services are ordered. A few commenters suggested that HHAs should
not be required to provide any clinical services by their own
employees, per the requirements of Sec. 484.105(f), and should instead
be allowed to provide all clinical services under arrangement.
Response: Changes of this magnitude would mark a significant
departure from longstanding CMS policy. As such, we believe that it
would be most appropriate to use the traditional notice and comment
rulemaking process to allow all interested parties the opportunity to
comment on the concepts. We will take these suggestions under
consideration for future rulemaking efforts.
Comment: Several commenters stated that nurse practitioners, in
addition to physicians, should be allowed to write orders for the home
health plan of care and provide care plan oversight.
Response: Section 1861(m) of the Act requires the HHA plan of care
to be under the direction of a physician. Section 1861(r) of the Act
defines ``physician'' in a manner that does not include other licensed
practitioners, such as nurse practitioners and physician assistants.
Therefore, pursuant to statute, other licensed practitioners may not
establish and maintain the home health plan of care, including
reviewing, signing, and ordering services on the home health plan of
care.
Comment: A few commenters submitted comments related to physician
signatures and communication with physicians regarding orders and the
plan of care. Some comments stated that a physician signature should
not be required for therapy orders. The commenters stated that
requiring a physician signature on such orders delays the initiation of
therapy services. Another comment stated that HHAs should not be
required to communicate with all physicians who write orders for the
plan of care when there is a change in the plan of care.
Response: In order to maintain appropriate oversight of the HHA
plan of care, all HHA services, including therapy services, must be
ordered by a physician (Sec. 484.60(b)(1)). The CoPs allow for verbal
orders in order to facilitate a timely initiation of care, requiring
that verbal orders be authenticated and dated by the physician in
accordance with applicable state laws and regulations, and consistent
with the HHA's own internal policies. Typically, a physician writes
orders for a therapist to evaluate and treat the patient. The
requirement for the physician order and subsequent signature in
accordance with State law and HHA policy would not delay therapy
services after the therapist's evaluation and recommended treatment
plan has been communicated to the physician for approval. It is not
necessary to withhold therapy services while waiting for the physician
confirmation of the therapy plan.
We agree with the commenter that communicating with all involved
physician(s) is not necessary for every single change in the plan of
care. Section 484.60(c)(3) requires such communication only when the
change to the plan of care is due to a change in the patient's health
status (for example, initiating a new medication) or a change in the
plan for the patient's discharge from the HHA. The communication of
other changes that do not fall into one of these categories (for
example, adjusting the dose of a current medication) is left to the
discretion of HHA clinical staff and the clinical manager(s)
responsible for the patient's care.
Comment: Numerous commenters submitted suggestions for changes to
HHA payment policies, such as the face to face requirement and the
homebound requirement, which they believe should be addressed as part
of CMS burden reduction efforts. A single commenter suggested a
revision to the Home Health Consumer Assessment of Healthcare Providers
and Systems (HHCAHPS). A small number of commenters submitted comments
regarding information in the HHA interpretive guidelines.
Response: Comments not related to the HHA CoPs are outside of the
scope of this rule. Individuals wishing to submit comments regarding
CMS payment policies may submit those comments as part of the annual
HHA payment policy proposed rule. We have shared these unrelated
comments with the appropriate components within CMS.
Final Rule Action:
1. We are finalizing the proposal to delete the requirement at
Sec. 484.50(a)(3)
[[Page 51752]]
that HHAs must provide verbal notification of all patient rights.
2. We are finalizing the proposal to revise Sec. 484.50(c)(7),
requiring HHAs to verbally discuss HHA payment and patient financial
liability information with each HHA patient.
3. We are finalizing the proposal to eliminate the requirement at
Sec. 484.80(h)(3) to conduct a full competency evaluation, and replace
it with a requirement to retrain the aide regarding the identified
deficient skill(s), and require the aide to complete a competency
evaluation related only to those skills.
4. We are not finalizing the proposal to remove the requirement at
Sec. 484.110(e) that the requested clinical record copy must be
provided at the next home visit.
Contact: Danielle Shearer, 410-786-6617.
7. Comprehensive Outpatient Rehabilitation Facilities (CORFs)--
Utilization Review Plan (Sec. 485.66)
We proposed to amend the utilization review plan requirements at
Sec. 485.66 to reduce the frequency of utilization reviews from a
quarterly basis to an annual requirement.
We received two timely public comments on our proposed changes to
the CORF requirements. Both comments expressed strong support for the
proposed changes; therefore we are finalizing those changes as proposed
in this final rule.
1. Final Rule Action: We are finalizing the proposal to revise
Sec. 485.66, requiring the facility to have a written utilization
review plan that is implemented annually, without modification.
Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.
8. Critical Access Hospitals
a. Organizational Structure (Sec. 485.627(b)(1))
We proposed to remove the requirement for CAHs to disclose the
names and addresses of their owners, those with a controlling interest
in the CAH or in any subcontractor in which the CAH directly or
indirectly has a 5 percent or more ownership interest, in accordance
with 42 CFR part 420, subpart C. This requirement is duplicative, as it
is also a requirement for the provider agreement for Medicare
participation. This proposal was also included in the Medicare and
Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes
To Promote Innovation, Flexibility, and Improvement in Patient Care;
Proposed Rule (81 FR 39447) for the same reason.
Comment: Commenters universally supported the proposal to remove
the CAH disclosure requirement, noting that the requirement duplicates
a provision found elsewhere in our regulations. Comments received
regarding this provision in the Medicare and Medicaid Programs;
Hospital and Critical Access Hospital (CAH) Changes To Promote
Innovation, Flexibility, and Improvement in Patient Care; Proposed Rule
(81 FR 39447, 39460, June 16, 2016) were consistent with those received
for this proposed rule, with commenters also universally supporting the
proposal.
Response: We appreciate the comments received and continue to
believe that this change is appropriate.
Final Rule Action: We are finalizing the proposed changes without
modification.
Contact: Kianna Banks, 410-786-3498.
b. Provision of Services (Sec. 485.635(a)(4))
Current regulations at Sec. 485.635 require a CAH's professional
healthcare staff to review policies and procedures annually; the review
group must include one or more doctors of medicine or osteopathy and
one or more physician assistants, nurse practitioners, or clinical
nurse specialists. Based on our experience with other providers, we
proposed a flexible approach that would allow CAHs to maintain their
health and safety policies in such a manner as to achieve the intended
outcomes for all patients. Thus, we proposed to change the requirement
at Sec. 485.635(a)(4) from ``annual'' to ``biennial''.
We received 20 public comments on our proposed changes to this CAH
requirement. Commenters included hospital industry associations,
individual providers, and national accrediting organizations. Overall
the commenters were supportive of the proposed changes.
Summaries of the comments and our responses are set forth below.
Comment: All of the commenters agreed with the effort to reduce
burden. However, a few of commenters suggested moving to a 3-year
timeframe for reviews and several other commenters suggested aligning
with hospital requirements and removing the timeframe and allow CAHs to
determine when reviews are done.
Response: CAHs are rural providers with separate Conditions of
Participation from hospitals and they do not have the range or number
of personnel, among other requirements we require for hospitals.
We believe that the approach of requiring a biennial review reduces
burden while maintaining the appropriate safeguards for healthy
outcomes for CAH patients. Therefore, we are finalizing this
requirement without modification.
Final Rule Action: We are finalizing the proposed changes to Sec.
485.635(a)(4).
Contact: Mary Collins, 410-786-3189.
c. Special Requirements for CAH Providers of Long-Term Care Services
(``Swing-Beds'') (Sec. 485.645(d)(1), (4), (5) and (8))
The special requirements for CAH swing-bed providers are nearly
identical to the requirements for hospital providers of swing-bed
services. As a result, please refer to the discussion on the special
requirements for hospital providers of swing-bed services under section
II.D.3 for the details of the proposed changes for these requirements
for both hospitals and CAHs. We proposed the following revisions to the
CAH swing-bed requirements:
Revision of Sec. 485.645(d)(1) to remove the cross-
referenced long-term care requirement in Sec. 483.10(f)(9), which
requires that CAH swing-bed providers to offer residents the right to
choose to or refuse to perform services for the facility and prohibits
a facility from requiring a resident to perform services for the
facility;
Removal of Sec. 485.645(d)(4), which requires CAH swing-
bed providers to provide an ongoing activity program that is directed
by a qualified therapeutic recreation specialist or an activities
professional who meets certain requirements (cross-referenced long-term
care requirement Sec. 483.24(c));
Revision of Sec. 485.645(d)(4) (as redesignated) to
remove the cross-referenced long-term care requirement Sec. 483.70(p),
which requires that CAH swing-bed providers with more than 120 beds to
employ a qualified social worker on a full-time basis; and
Revision of Sec. 485.645(d)(7) (as redesignated) to
remove the cross-referenced long-term care requirement Sec.
483.55(a)(1), which requires CAH swing-bed providers to assist in
obtaining routine and 24-hour emergency dental care to its residents.
Contact: Kianna Banks, 410-786-3498.
9. Community Mental Health Centers (Sec. 485.914(d))
We require CMHCs, at Sec. 485.914(d)(1), to update clients'
comprehensive assessments every 30 days. We proposed to revise Sec.
485.914(d)(1) to require that the CMHC update each client's
comprehensive assessment via the CMHC interdisciplinary treatment
[[Page 51753]]
team, in consultation with the client's primary health care provider
(if any), when changes in the client's status, responses to treatment,
or goal achievement have occurred, and in accordance with current
standards of practice. Additionally, at Sec. 485.914(d)(2), we
proposed to retain the minimum 30-day assessment update time frame for
those clients who receive PHP services. We believe this proposed change
will allow for the provider and client to choose a visit schedule that
is appropriate for the client's condition and not cause extra work or
time for documentation that is unnecessary. Ultimately, this proposed
change may allow for greater flexibility for the provider and client,
saving time for both.
We received 4 timely public comments on our proposed changes to the
requirements at Sec. 485.914(d). Commenters included physicians,
associations and health networks. Overall, the majority of commenters
were supportive of the goal of the proposed changes. Summaries of the
major issues and our responses are set forth below.
All of the comments expressed strong support for the proposed
changes to Sec. 485.914(d); therefore, we are incorporating those
changes as proposed in this final rule.
Comment: We received several comments in support of the proposed
change to the CMHC update to the comprehensive assessment requirement.
Most commenters agreed that, for patients admitted for non-PHP
services, it made sense to allow patients care needs, responses to
treatment and care goals to drive decisions about when a patient needs
to have an updated assessment. Commenters also agreed that it was
appropriate to keep the requirement to update to the comprehensive
assessment every 30 days for PHP patients. One commenter raised a
concern regarding the proposed update to the comprehensive assessment
requirement changes as it relates to patients needing to transfer to
the hospital emergency department. The commenter stated that some
emergency departments receive patients directly from CMHCs for
emergency mental health treatment, and that it is important for the
treating physician in the ED to know what medications the patient is
taking. A commenter agreed with the proposed change to the
comprehensive assessment update requirement, and asked for CMS to
consider making similar burden reducing changes to all the requirements
for the ''Persons centered active treatment plan'' under Sec. 485.916.
Response: We appreciate all of the positive feedback on the
proposed changes to remove the 30-day updated assessment timeframe for
non-PHP patients, and are finalizing this proposal without change. We
understand the concerns raised related to how this assessment change
would impact CMHC patients who must be transferred to a hospital
emergency room. In the CMHC CoPs under Sec. 485.914(e)(5)(v)(A)-(E),
we state that when a client becomes an immediate threat to the physical
safety of themselves, staff or other individuals, the CMHC must
document a description of the client's behavior and the intervention(s)
used (including medications), alternatives or other less restrictive
interventions attempted, the client's condition or symptom(s) that
warranted the use of the restraint or seclusion, and the client's
response to the intervention(s) used. Typically, patient transfers from
a CMHC to an emergency room include a transfer note summarizing the
above information, including all current medications and any PRN
medications that were given prior to the transfer to the emergency
room. Furthermore, we agree with the suggestion that conforming changes
should be made to Sec. 485.916, because the requirements of Sec.
485.914 and 485.916 constitute a cycle of care, with assessment and
care planning feeding into one another. However, because we did not
propose any changes to the client centered active treatment plan CoP
(Sec. 485.916), we are legally not permitted to make any changes in a
final rule without proposing the change to the public in a proposed
rule. Therefore we will not be amending the regulatory language in
Sec. 485.916 but will consider proposing a change to the requirements
at a future date.
Final Rule Action: We are finalizing the proposal to revise Sec.
485.914(d) that the CMHC must update each client's comprehensive
assessment via the CMHC interdisciplinary treatment team, in
consultation with the client's primary health care provider (if any),
when changes in the client's status, responses to treatment, or goal
achievement have occurred and in accordance with current standards of
practice. For clients that receive PHP services, the assessment must be
updated no less frequently than every 30 days.
Contact: CAPT Mary Rossi-Coajou, USPHS, 410-786-6051.
10. Portable X-Ray Services (Sec. Sec. 486.104(a) and 486.106(a))
We proposed to revise the personnel qualification requirements at
Sec. 486.104(a)(1), (2), (3), or (4) by removing school accreditation
requirements and simplifying the structure of the requirements. We
proposed that all operators of portable X-ray equipment would meet one
of the following:
(1) Successful completion of a program of formal training in X-ray
technology at which the operator received appropriate training and
demonstrated competence in the use of equipment and administration of
portable x-ray procedures; or
(2) Successful completion of 24 full months of training and
experience under the direct supervision of a physician who is certified
in radiology or who possesses qualifications which are equivalent to
those required for such certification.
We proposed to update Sec. 486.106(a)(2) (specific to portable x-
ray services) to cross reference the requirements at Sec. 410.32
instead of setting forth specific order requirements. We proposed to
retain the requirement that the portable x-ray order must include a
statement on why it is necessary to perform a portable x-ray as opposed
to performing the study in a facility where x-rays are more typically
performed.
We received 9 timely public comments on our proposed changes to the
portable x-ray requirements. Commenters included long-term care
facility associations, portable x-ray associations, portable x-ray
suppliers, and health care systems. Overall, the majority of commenters
were supportive of the goal of the proposed changes. Summaries of the
major issues and our responses are set forth below.
Comment: All of the comments received regarding our proposal to
revise the personnel requirements for individuals who perform portable
x-ray services supported the proposed revision. A single commenter
suggested that option 2, related to 24 full months of training and
experience under the direct supervision of a physician, and should not
be included because these training programs are no longer offered.
Response: We agree with the comments that it is appropriate to
revise the personnel requirements for individuals who perform portable
x-ray services in a manner that focuses on the skills of the individual
rather than the accreditation of the institution that provided the
training, and we are finalizing this change. We do not agree that it is
appropriate to eliminate the qualification option related to 24 full
months of training and experience under the direct supervision of a
physician. The fact that such programs are no longer offered does not
mean that those individuals who completed such programs are no longer
qualified to
[[Page 51754]]
perform portable x-ray services, and thus excluded from performing
their job duties. Excluding those individuals would not benefit patient
health and safety or patient access to portable x-ray services; and
may, in fact, reduce the number of qualified portable x-ray technicians
and negatively impact access to care.
Comment: All of the comments received regarding our proposal to
revise the requirements for portable x-ray orders supported the
proposed revision. One commenter specifically supported, while another
specifically disagreed with, the proposal to retain the requirement
that each order must specify the reason that portable x-ray services
are necessary.
Response: We agree with the comments that it is necessary and
appropriate to revise the requirements for portable x-ray orders to
align with the separate payment requirements for diagnostic imaging
orders that also apply to portable x-ray services at Sec. 410.32, and
are finalizing this change. We believe that it is appropriate to
require documentation regarding why this unique service is necessary in
place of the more traditional facility-based x-ray service, and are
continuing this longstanding element as part of the revised
requirements for portable x-ray orders.
Comment: We received several comments related to Medicare payment
policies and Medicare payment manuals related to portable x-ray
services. We also received a comment related to the 2018 Crosswalk for
Medicare Provider/Supplier to Healthcare Provider Taxonomy, and the
Medicare provider and supplier enrollment process.
Response: These comments are outside of the scope of this rule, and
have been shared with the CMS components that are responsible for these
subject matter areas.
Final Rule Action: We are finalizing the changes to Sec. Sec.
486.104(a) and 486.106(a)(2).
Contact: Sonia Swancy, 410-786-8445.
11. Rural Health Clinics (RHCs) and Federally Qualified Health Centers
(FQHCs)
a. Provision of Services (Sec. 491.9(b)(4))
We proposed to change the requirement at Sec. 491.9(b)(4), related
to reviewing patient care policies, from an ``annual'' review to a
``biennial'' review.
b. Program Evaluation (Sec. 491.11(a))
We proposed to revise the current requirement at Sec. 491.11(a) by
changing the frequency of the RHC or FQHC evaluation from annually to
every other year.
We received 30 timely public comments on our proposed changes to
the RHC and FQHC requirements. Commenters included industry
associations, healthcare systems, individual RHCs and FQHCs and
clinicians. Overall, the majority of commenters were supportive of the
goal of the proposed changes. Summaries of the major issues and our
responses are set forth below.
Comment: Overall, the majority of comments submitted regarding this
topic expressed support for both of the proposed changes to require
biennial provision of services policy reviews and clinic or center
total program evaluation. Some of the commenters were completely
supportive of the proposed biennial change, while some of the
commenters stated they were unsure whether it will provide meaningful
burden reduction. Other commenters were appreciative of the CMS goal to
reduce burden on the RHC or FQHC and stated that the flexibility and
opportunity to allow the clinic or center to decide how to most
appropriately use their staff time and resources is critical to
maintaining the highest standard of care for their patients. One
commenter suggested that, in addition to revising the time frame for
review, CMS should also reduce the burden of this regulation by
removing the requirement that someone in the group of professional
personnel that reviews the policies must be from outside the clinic or
center's staff.
Response: We continue to believe these two changes are appropriate,
and are finalizing them as proposed.
We agree that the requirement to have someone in the group of
professional personnel that reviews the policies be from outside of the
clinic or center's own staff can be difficult to meet in medically
underserved areas or those where there are health professional
shortages. Administrative burden would be decreased by the time often
spent trying to find a qualified professional who is not on payroll,
but is willing to come in and review RHC policies. We will consider
this change for future rulemaking.
Final Rule Action:
1. We are finalizing the proposal to revise the requirement at
Sec. 491.9(b)(4) requiring RHCs and FQHCs to review their patient care
policies at least biennially by a group of professional personnel and
RHC or FQHC staff.
2. We are finalizing the proposal to revise the requirement at
Sec. 491.11(a) that requires the clinic or center to carry out or
arrange for, a biennial evaluation of its total program.
Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.
12. Emergency Preparedness for Providers and Suppliers
On September 16, 2016, we published a final rule entitled,
``Medicare and Medicaid Programs; Emergency Preparedness Requirements
for Medicare and Medicaid Participating Providers and Suppliers'' (81
FR 63860), which established national emergency preparedness
requirements for Medicare and Medicaid participating providers and
suppliers (referred to collectively as ``facilities'' in the subsequent
section) to plan adequately for both natural and man-made disasters and
coordinate with Federal, State, tribal, regional, and local emergency
preparedness systems. In that final rule, we emphasized the need for
facilities to maintain access to healthcare services during
emergencies, safeguard human resources, and maintain business
continuity and protect physical resources. A facility's emergency
preparedness program must include the following elements:
Risk assessment and emergency planning
Policies and procedures
Communication plan
Training and testing
We received over 300 comments centered around the proposed
revisions to the Emergency preparedness requirements. Some of the
comments were supportive of one or more of the proposed provisions,
others were not supportive of the proposed revisions and expressed the
commenters concerns. We have organized our responses to the comments as
follows: (1) General Comments; (2) Annual Review of Emergency
Preparedness Program; (3) Documentation of Cooperation Efforts; (4)
Annual Emergency Preparedness Training Program; (5) Annual Emergency
Preparedness Testing.
General Comments
Comment: One commenter suggested that we delay any changes to
emergency preparedness for 5 years. The commenter states that revisions
set forth in the September 2016 Emergency Preparedness final rule (81
FR 63860) just went into effect within the past year and some
facilities are still working to come into compliance with those
changes. Commenters assert that implementing additional revisions at
this time would be burdensome.
Response: The September 2016 Emergency Preparedness final rule (81
[[Page 51755]]
FR 63860) was a comprehensive change in our requirements for all
provider types. Therefore, we allowed additional time for providers and
suppliers to come into compliance. We do not agree that it is necessary
to extend the effective date because (1) the original compliance date
was 2017, so providers and suppliers should be complete with
implementation; (2) the proposed changes in this rule decrease burden,
so implementation should not impose a hardship on providers and
suppliers to come into compliance. Therefore, we are not delaying the
implementation of this requirement. Once this rule is published,
providers/suppliers will have 60 days from the publication date to be
in compliance with the finalized changes.
Comment: One commenter requested that we leave the emergency
preparedness regulations as they are and work instead on strengthening
standards as proposed in Sheltering in Danger, a report written by
Minority Staff of the Senate Finance Committee. The report discusses
efforts to improve nursing home quality by calling attention to
specific issues such as heat index/temperature/humidity, sheltering and
evacuations and community engagement.
Response: We appreciate the Committee's work on the Sheltering in
Danger report. We updated Appendix Z of the State Operations Manual in
February 2019 to clarify the emergency preparedness requirements. This
includes adding emerging infectious diseases to the definition of all-
hazards approach; clarifications and additional guidance on the use of
portable generators and alternate source power and a cross reference to
the nursing home requirements for safe temperatures; and technical
changes to the home health citations. We are always looking for ways to
improve quality and safety oversight efforts in nursing homes, and are
continuing to consider the report's recommendations as we move forward.
Comment: A few commenters stated that the current emergency
preparedness requirements are overly burdensome for outpatient
providers/suppliers and the requirements should be different for
outpatient versus inpatient providers and suppliers. The commenters
expressed that providers/suppliers that provide inpatient services
should have stronger requirements as the patients or residents may be
incapable of self-preservation in the event of an emergency. Whereas,
outpatient providers and suppliers generally have patients that are
capable of self-preservation in the event of an emergency.
Response: We understand that for many smaller, rural providers and
suppliers and for outpatient facilities that do not have full-time
patients the emergency preparedness requirements may seem excessive.
Many of the requirements are similar for inpatient and outpatient
providers and suppliers. We believe these emergency preparedness
requirements are important for all providers and suppliers. However, we
recognize that there are some differences in inpatient and outpatient
facilities with regard to emergency preparedness and have made changes
in this rule that recognize these differences. In addition, we note
that LTC facilities have some changes in requirements for the emergency
plan updates and training that are discussed in detail below. We will
take your recommendation and consider it for future rulemaking.
a. Annual Review of Emergency Preparedness Program (Sec. Sec. 403.748,
416.54, 418.113, 441.184, 460.84, 482.15, 483.73, 483.475, 484.102,
485.68, 485.625, 485.727, 485.920, 486.360, 491.12, and 494.62 (a),
(b), (c), and (d))
We proposed to change the requirement for facilities to review
their emergency preparedness program at least every 2 years. This would
increase the facility's flexibility to review their programs as they
determine best fits their needs. We are finalizing this proposal with
modifications to LTC facilities only.
The comments received in response to the proposed revision were
mostly supportive and the comments that were not supportive were mostly
centered around LTC facilities. Below is a summary of the comments we
received and our responses.
Comment: Many commenters supported the emergency preparedness
updates for biennially revisions to the emergency plan. One commenter
stated that annual revisions are not always necessary, as urgent
changes are made as needed; otherwise, facilities are reviewing
procedures that have not changed. The proposed revisions to emergency
preparedness requirements would increase facilities' flexibility to
build, train, test and review an effective program that meets the needs
of each facility and community in which the facility is located.
Response: We agree that requiring facilities to review their
emergency preparedness plan biennially allows for more flexibility for
providers and suppliers. We expect that facilities would routinely
revise and update their policies and operational procedures to ensure
that they are operating based on best practices. In addition,
facilities should update their emergency preparedness program more
frequently than every 2 years as needed (for example, if staff changes
occur or lessons-learned are acquired from a real-life event or
exercise). Therefore, we are finalizing this proposal for all
providers/suppliers to update their emergency preparedness plan
biennially. As discussed in greater detail below, due to the
vulnerability of residents in LTC facilities, we are not finalizing the
proposal for those facilities only and will require them to update
their emergency plan annually, as is currently required. This will
allow the staff and residents to be fully aware of the emergency
preparedness program and any changes made.
Comment: As noted above, we received many comments that asked us to
not finalize the proposed emergency preparedness requirements for LTC
facilities. One commenter stated that ongoing communication and
collaboration are very important. The current regulations sensibly
require annual updates to emergency plans, policies and procedures,
communications plan, training and testing. The success of a
preparedness plan often depends on frequent updates. Significant
changes can occur in a 2 year period, the resident population, as well
as local health care providers, transportation companies, staff,
facilities, patient population and other vendors. The LTC facility
should know about changes in their community. Staff turnover is a
concern and for that reason emergency preparedness plans need to be
revisited yearly to be sure everyone is prepared. Many commenters
stated that changing the requirements to biennial updates creates
additional opportunities for errors and for facility residents and
staff to be unprepared, lack appropriate response and endanger more
residents' lives. Residents depend heavily on the staff and rely on
their preparedness during an emergency. The effort and expense of
annual updating is far outweighed by the benefit of a LTC facility
being prepared for an emergency. Moving to biennial review could
exacerbate the issue of emergency preparedness in LTC facilities more
than already exists.
Response: We recognize that LTC facility residents are generally a
very vulnerable population that rely on the staff to be knowledgeable
and prepared in the event of an emergency. For that reason, we are not
finalizing the proposal for biennial updates to the
[[Page 51756]]
emergency plan for LTC facilities only. All other providers and
suppliers will be required to update their emergency preparedness plan
biennially. We would like to point out that this is the minimum
requirement for non-LTC facility providers and suppliers and that non-
LTC facility providers and suppliers are encouraged to review and
update their facilities plan more frequently if providers and suppliers
feel the need to.
b. Documentation of Cooperation Efforts (Sec. Sec. 403.748(a)(4),
416.54(a)(4), 418.113(a)(4), 441.184(a)(4), 460.84(a)(4), 482.15(a)(4),
483.73(a)(4), 483.475(a)(4), 484.102(a)(4), 485.68(a)(4),
485.625(a)(4), 485.920(a)(4), 486.360(a)(4), 491.12(a)(4), and
494.62(a)(4))
We proposed to eliminate the requirement that facilities document
efforts to contact local, tribal, regional, State, and Federal
emergency preparedness officials and facilities' participation in
collaborative and cooperative planning efforts. Facilities will still
be required to include a process for cooperation and collaboration with
local, tribal, regional, State and Federal emergency preparedness
officials' efforts to maintain an integrated response during a disaster
or emergency situation.
The comments received regarding this proposal were mostly
supportive. Below we have summarized the comments received and our
responses.
Comment: Many commenters support the elimination of documentation
of efforts to contact local, tribal, regional, State and Federal
emergency preparedness officials and, when applicable, document the
facility's participation in collaborative and cooperative planning
efforts. Commenters state that documenting efforts to contact emergency
preparedness officials are overly burdensome. The commenters also
stated that eliminating this requirement allows for smaller facilities
to focus on patient care.
Response: We agree that the documentation requirement can be overly
burdensome, as some comments have raised, and are finalizing the
proposal to remove the requirement. We believe that eliminating this
documentation requirement would reduce burden by not requiring
facilities to demonstrate that they have contacted local, tribal,
regional, State, and Federal emergency preparedness officials or
participated in collaborative and cooperative planning in the
community, while still requiring facilities to have a process for
cooperation and collaboration. Therefore, we are finalizing this
requirement as proposed and eliminating the documentation requirement
for collaboration with emergency preparedness officials. Providers and
suppliers would still be required to have a process for cooperation and
collaboration as part of the emergency plan.
Comment: Commenters stated that removing documentation requirements
will reduce transparency of cooperation efforts, increasing the
likelihood of disjointed responses and weakening accountability.
Documentation proves that the facility has actually contacted and
collaborated with EP officials, is the only way a state survey agency
can verify that efforts have been made for compliance, and is
invaluable to incoming staff.
Response: We would like to point out that providers would still be
required at the respective emergency preparedness requirements for each
provider and supplier to include a process for collaboration/
cooperation with officials; however, they would not be required to
document efforts to contact these officials. Therefore, this maintains
the existence of a process for collaboration with officials without
posing additional documentation burdens. Therefore, we are finalizing
this requirement as proposed and eliminating the documentation
requirement for collaboration with emergency preparedness officials.
c. Annual Emergency Preparedness Training Program (Sec. Sec.
403.748(d)(1)(ii), 416.54(d)(1)(ii), 418.113(d)(1)(ii),
441.184(d)(1)(ii), 460.84(d)(1)(ii), 482.15(d)(1)(ii),
483.73(d)(1)(ii), 483.475(d)(1)(ii), 484.102(d)(1)(ii),
485.68(d)(1)(ii), 485.625(d)(1)(ii), 485.727(d)(1)(ii),
485.920(d)(1)(ii), 486.360(d)(1)(ii), 491.12(d)(1)(ii), and
494.62(d)(1)(ii))
Facilities are required to develop and maintain a training program
that is based on the facility's emergency plan. This emergency
preparedness training must be provided at least annually and a well-
organized effective training program must include initial training in
emergency preparedness policies and procedures. We revisited the public
comments received on the Emergency Preparedness proposed rule (81 FR
63890 through 63891) and determined that requiring facilities to
provide annual training may be unduly burdensome. Therefore, we
proposed to require facilities to provide training biennially or every
2 years, after facilities conduct initial training on their emergency
program. In addition, we proposed to require additional training when
the emergency plan is significantly updated.
Overall, the majority of commenters opposed our proposal to require
emergency preparedness training biennially. We received a significant
number of comments on this proposal from nursing home resident
advocates. We received a few supportive and negative comments from
other stakeholders, including Congressional representatives and
emergency management professionals. A summary of the major issues and
our responses are set forth below:
Comment: Nursing home resident advocates overwhelmingly opposed our
proposal to require emergency preparedness training biennially. These
commenters noted that training every 2 years is not sufficient to
maintain readiness in the event of an emergency. Commenters noted that
nursing homes specifically experience high staff turnover, changes in
ownership, and changes in resident conditions/needs, and cited these
conditions as reasons to support annual training. Commenters also noted
recent emergency events and the lack of readiness displayed by nursing
homes as an indication that more emergency preparedness training, not
less, is needed.
In addition to the large number of comments from nursing home
resident advocates, we also received a few comments opposed to the
proposal from non-LTC facility providers. These commenters also noted
high staff turnover, changes in community resources, closure of
receiving providers, changes in patient/resident census, and the need
to incorporate recent best practices and lessons learned as the main
reasons to support annual training. Commenters indicated that the
effort and expense of annual training would be outweighed by the
benefit of being prepared in the case of an emergency or natural
disaster.
Response: We appreciate the feedback and thoughtful comments
provided on this proposal. We especially appreciate the comments that
provided a very detailed analysis of the lack of emergency response in
nursing homes following recent emergency events. We believe that these
comments have provided compelling evidence to revise our proposal
specific to LTC facilities. Therefore, for LTC facilities only, we are
not finalizing our proposal to revise the annual training requirement
to biennial training. LTC facilities will be required to continue to
meet the current requirement for annual training.
[[Page 51757]]
d. Annual Emergency Preparedness Testing (Sec. Sec. 403.748(d)(2),
416.54(d)(2), 418.113(d)(2), 441.184(d)(2), 460.84(d)(2), 482.15(d)(2),
483.73(d)(2), 483.475(d)(2), 484.102(d)(2), 485.68(d)(2),
485.625(d)(2), 485.727(d)(2), 485.920(d)(2), 486.360(d)(2),
491.12(d)(2), and 494.62(d)(2))
Facilities are currently required to conduct exercises to test the
emergency plan at least annually. The facility must conduct two
emergency preparedness testing exercises every year. Specifically,
facilities must:
Participate in a full-scale exercise that is community-
based or when a community-based exercise is not accessible, an
individual, facility-based. If the facility experiences an actual
natural or-man made emergency that requires activation of the emergency
plan (including their communication plan and revision of the plan as
needed), the facility is exempt from engaging in a community-based or
individual, facility based full-scale exercise for 1 year following the
onset of the actual event;
Conduct an additional exercise that may include either a
second full-scale exercise that is community-based or individual,
facility-based or a tabletop exercise that includes a group discussion
led by a facilitator.
Upon further analysis of this requirement, and taking into account
stakeholder feedback, we determined that there was a need to clarify
and revise some of the requirements included in the Emergency
Preparedness final rule (81 FR 63860). Therefore, for all provider and
supplier types, we proposed to clarify our intent with regard to the
types of testing exercises, specifically full-scale exercises and
functional exercises.
For providers of inpatient services (inpatient hospice facilities,
Psychiatric Residential Treatment Facilities (PRTFs), hospitals, long-
term care facilities (LTCFs), ICFs/IIDs, and CAHs), we proposed to
retain the existing requirement for these provider and supplier types
to conduct two emergency preparedness testing exercises annually. We
proposed to expand the testing requirement options, such that one of
the two annually required testing exercises could be an exercise of
their choice, which could include one community-based full-scale
exercise (if available), an individual facility-based functional
exercise, a drill, or a tabletop exercise or workshop that included a
group discussion led by a facilitator. We noted that although RNHCIs
provide inpatient services, we determined that changing their existing
requirements to make them consistent with this proposed provision would
be unduly burdensome, as they are currently only required to conduct a
paper-based, tabletop exercise at least annually.
For providers of outpatient services (ASCs, freestanding/home-based
hospice, Program for the All-Inclusive Care for the Elderly (PACE),
HHAs, CORFs, Organizations (which include Clinics, Rehabilitation
Agencies, and Public Health Agencies as Providers of Outpatient
Physical Therapy and Speech-Language Pathology Services), CMHCs, Organ
Procurement Organizations (OPOs), RHCs, FQHCs, and ESRD facilities), we
proposed to require that providers of outpatient services conduct only
one testing exercise per year. Furthermore, we proposed to require that
these providers participate in either a community-based full-scale
exercise (if available) or conduct an individual facility-based
functional exercise every other year. In the opposite years, we
proposed to allow these providers to conduct the testing exercise of
their choice, which may include either a community-based full-scale
exercise (if available), an individual, facility-based functional
exercise, a drill, or a tabletop exercise or workshop that includes a
group discussion led by a facilitator. We noted that due to the nature
of services provided by OPOs, we proposed to require that they have the
option of providing either a tabletop exercise or workshop every year.
Lastly, we proposed to clarify the testing requirement exemption by
noting that if a provider experiences an actual natural or man-made
emergency that requires activation of their emergency plan, inpatient
and outpatient providers will be exempt from their next required full-
scale community-based exercise or individual, facility-based functional
exercise following the onset of the actual event.
The majority of the comments received were supportive of our
proposal to differentiate the emergency preparedness testing
requirements between inpatient and outpatient providers and to clarify
the types of testing exercises that will satisfy the proposal. A
summary of the major comments and our responses are below:
Comment: While many commenters supported our requirement to
differentiate the emergency preparedness testing requirements between
inpatient and outpatient providers, one commenter noted that the
varying requirements may discourage coordination and collaboration
amongst providers within a community.
Response: We appreciate the feedback in support of our proposal. It
is not our intention to discourage coordination among providers, but
rather to provide facilities with a requirement for emergency
preparedness testing that is realistic and attainable, without
impacting the health and safety of the patients that they serve. We
believe that differentiating the testing requirements by inpatient and
outpatient provider and supplier types takes into consideration the
unique characteristics of not only the provider type, but also the
population that they serve. We expect that facilities will continue to
make best efforts to collaborate with providers within their community
to not only maximize efforts and resources, but to also meet the many
other emergency preparedness requirements for coordination and
collaboration. We note that all provider and supplier types are
required to develop an emergency preparedness communication plan that,
among other things, includes information for other providers; and to
develop a method for sharing information and medical documentation for
individuals under the provider's care with other health care providers,
as necessary to maintain the continuity of care.
Comment: Commenters supported the clarification of the types of
testing exercises that would satisfy the testing requirements. However
some commenters indicated that the proposal, and terminology we used,
remain confusing. These commenters urged us to follow the principles of
exercise programs established under the Homeland Security Exercise and
Evaluation Program (HSEEP). One commenter indicated that we use
functional exercise and full-scale exercise interchangeably, when the
two exercises are vastly different types of exercises. This commenter
suggested further that we use a more broad definition of the types of
testing exercises to align with HSEEP. Specifically, the commenter
recommended that we require facilities to participate in an annual
operations-based exercise in conjunction with local, county, or other
state stakeholders (if available) or conduct an operations-based
exercise at the facility level. The commenter noted that, as defined by
HSEEP, an ``operations-based exercise'' could include any of the
following types of exercises: Drill, functional exercise, or full-scale
exercise. Furthermore, the commenter indicated that as a choice of
testing exercises we should specify that
[[Page 51758]]
facilities may choose a ``discussion based exercise'' that, as defined
by HSEEP, would include a tabletop exercise or workshop.
Response: We appreciate the feedback and want to ensure that the
language used in our regulations and the intent behind our regulations
are as clear as possible. As indicated in the proposed rule and as well
in the 2016 Emergency Preparedness final rule (81 FR 63860), we have
attempted to align our terminology with that used by HSEEP. We note
that functional exercise and full-scale exercise are specific testing
exercise types as defined by HSEEP. Furthermore, in the proposed rule
(83 FR 47714) we provided definitions for both functional and full-
scale exercises, as defined by HSEEP. Therefore, we disagree with the
commenters who suggested that we have not aligned our proposal with the
guiding principles of HSEEP.
It is our intent that providers and suppliers make an attempt to
conduct a full-scale exercise within their community, while
understanding that this may not always be feasible. Therefore, we
provide that when a full-scale exercise is not available, facilities
must conduct a functional exercise at the individual facility level in
order to satisfy our requirement. The commenter's suggestion to broaden
the language to ``operations-based exercise'' would mean that a drill
could also satisfy our requirement, and that is not our intention. We
specifically refer to a full-scale exercise and functional exercise
because those are the two testing exercises that would satisfy the
requirement. We encourage readers to refer to the proposed rule (83 FR
47714) and the HSEEP guidelines located at https://preptoolkit.fema.gov/documents/1269813/1269861/HSEEP_Revision_Apr13_Final.pdf/65bc7843-1d10-47b7-bc0d-45118a4d21da for
additional details regarding the definition of these types of
exercises.
While we have not made any modifications to the terminology used to
highlight the testing types, we have reviewed the regulatory text for
opportunities to improve readability and have made minor revisions to
the regulatory language in hopes of providing clarity about what is
required.
Final Rule Action:
We are not finalizing our proposal to require biennial
updates to the emergency preparedness program for LTC facilities only.
All other affected providers are required to update the emergency
preparedness program biennially.
We are finalizing our proposal to eliminate the
requirement that facilities document efforts to contact local, tribal,
regional, State, and Federal emergency preparedness officials and
facilities' participation in collaborative and cooperative planning
efforts.
We are not finalizing our proposal to require biennial
emergency preparedness training for LTC facilities only. All other
affected providers are required to provide emergency preparedness
training biennially.
We are finalizing our proposal to require inpatient
providers to conduct two testing exercises annually and outpatient
providers to conduct one testing exercise annually with only minor
modification to improve the readability and clarity of the requirement.
Contact: Kristin Shifflett, 410-786-4133, Ronisha Blackstone, 410-
786-6882.
13. Technical Corrections
In response to public comments, we are revising that language used
to reference doctors of dental surgery that appear in the regulatory
text for hospitals. The hospital CoPs reference these physicians in the
Medical Staff CoP (Sec. Sec. 482.22(c)(5)(1) and 482.22(c)(6)) as
oromaxillofacial surgeons. The accurate and current terminology to use
for these physicians is oral and maxillofacial surgeons. We are
revising the regulatory text for these provisions.
Although we did not propose this in the proposed rule, in response
to public comments regarding home health aide competency training, we
are revising the language used to describe the process for conducting
home health aide competency evaluations to restore longstanding
official CMS policy. In the July 18, 1991 (56 FR 32967) final rule,
``Medicare Program; Home Health Agencies: Conditions of
Participation,'' issued by CMS, we explicitly permitted the use of
pseudo-patients and laboratory environments for purposes of home health
aide competence evaluations, even though the regulatory text did not
specifically mention ``pseudo-patients.'' We stated, ``[W]e believe
that it is acceptable to conduct aide training with a mannequin and to
conduct competency evaluations in a laboratory setting using `pseudo
patients' such as another aide or volunteer. We do not believe it is
necessary to revise the regulations to clarify this point.'' (56 FR
32972). We agree with commenters that it is necessary to make a
technical correction to the HHA CoPs as finalized on January 13, 2017
(82 FR 4584) to explicitly permit the use of pseudo-patients for
purposes of home health aide competency evaluations in order to assure
that the home health agency regulations and Interpretive Guidelines are
consistent with the policy originally set forth in 1991.
This technical correction restores longstanding CMS policy, as
stated in the 1991 rule, that permitted the use of pseudo-patients, and
is consistent with the original intent of the January 2017 HHA CoPs
final rule. We are making conforming changes to the definitions section
of the HHA CoPs at Sec. 484.2 to define the terms ``pseudo-patient''
and ``simulation'' as follows:
``Pseudo patient means a person trained to participate in
a role-play situation, or a computer-based mannequin device. A pseudo-
patient must be capable of responding to and interacting with the home
health aide trainee, and must demonstrate the general characteristic to
the primary patient population served by the HHA in key areas such as
age, frailty, functional status, and cognitive status.''
``Simulation means a training and assessment technique
that mimics the reality of the homecare environment, including
environmental distractions and constraints that evoke or replicate
substantial aspects of the real world in a fully interactive fashion,
in order to teach and assess proficiency in performing skills, and to
promote decision making and critical thinking.''
Because this is a clarification of an already-existing rule to
codify longstanding policy, we do not believe that notice and comment
rulemaking is necessary; we are therefore waiving notice and comment as
indicated in Section I.C.14 below.
General Comments
Comment: We received many comments regarding issues that are out of
scope of this rule, such as payment and reimbursement, Medicare
advantage, prior authorization, physical therapy requirements and more.
Some of these issues were for specific providers or suppliers and some
were blanket comments.
Response: We have read and received all of the comments that are
out of the scope of this rule. We will not be addressing them in this
rule; however, we will consider them for future rulemaking.
14. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and
substances of the proposed
[[Page 51759]]
rule or a description of the subjects and issues involved. This
procedure can be waived, however, if an agency finds good cause that a
notice-and-comment procedure is impracticable, unnecessary, or contrary
to the public interest and incorporates a statement of the finding and
its reasons in the rule issued.
A notice-and-comment rulemaking procedure is unnecessary for the
change related to adding the phrase ``or with a pseudo-patient as part
of a simulation'' to the HHA aide competency evaluation requirement at
Sec. 484.80(c)(1) because this regulatory revision simply restores
official CMS policy as stated in rulemaking dating back to 1991, and
does not constitute a change in CMS policy. We are adding conforming
changes to the definitions section at Sec. 484.2 for the terms
``pseudo-patient'' and ``simulation.'' These changes are technical in
nature. These changes to restore longstanding CMS policies are in the
public interest, in order to assure that HHAs are adequately staffed
with aides that have proven their competency to serve HHA patients.
Home health aides may not provide services to patients until they have
demonstrated their skill competencies. Allowing HHAs to use pseudo-
patients as part of a simulation in order to demonstrate skill
competencies facilitates timely placement of properly trained and
evaluated aides in patient homes to provide much needed services in
accordance with each patient's individualized plan of care. In the
absence of this regulatory change to conform to longstanding CMS
policy, in a survey conducted by the National Home Care Association 45
percent of responding HHAs reported being unable to provide full
competency examinations for newly hired home health aides, creating a
delay in delivering physician-ordered aide services to HHA patients.
This delay in direct patient care services may be harmful to patients,
and the technical change will resolve the underlying aide competency
evaluation backlog problem that is creating the delay.
Therefore, we find good cause to waive the notice of proposed
rulemaking and to issue these provisions on an interim basis. We are
providing a 60-day public comment period.
C. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we
solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We solicited public comment on each of the section 3506(c)(2)(A)-
required issues for the following information collection requirements
(ICRs).
1. Wage Costs
To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2017 National Occupational Employment and Wage
Estimates for all salary estimates (https://www.bls.gov/oes/2017/may/oes_nat.htm). In this regard, the following table presents the mean
hourly wage, the cost of fringe benefits and overhead costs (calculated
at 100 percent of salary), and the adjusted hourly wage cost.
Table 2--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Fringe
Occupation Mean hourly Benefits and Adjusted
Occupation title code wage ($/hour) overhead cost hourly wage
($/hour) cost ($/hour)
----------------------------------------------------------------------------------------------------------------
Healthcare Support Worker....................... 31-9099 $18.56 $18.56 $37
Physicians and Surgeons......................... 29-1060 103.22 103.22 206
Physicians and Surgeons, All Other.............. 29-1069 101.63 101.63 203
Physicians, Psychiatrists....................... 29-1066 103.89 103.89 208
Surgeons........................................ 29-1067 121.10 121.10 242
Registered Nurse--(RN-Quality Improvement, Home 29-1141 35.36 35.36 71
Care Coordinator, HealthCare Trainer, Quality
Assurance Nurse, QAPI Nurse Coordinator,
Infection Control Nurse Coordinator,
Psychiatric RN)................................
Medical Secretary (Clerical, Administrative 43-6013 17.25 17.25 35
Assistant).....................................
Administrative Services Manager (Facility 11-3011 49.70 49.70 99
Director)......................................
Management Occupations (Director, Community 11-0000 57.65 57.65 115
Relations Manager, Administrator)..............
Pharmacist...................................... 29-1051 58.52 58.52 117
Medical and Health Services Manager 11-9111 53.69 53.69 107
(Administrator, Transplant Program Senior
Administrator/Hospital Administrator/Medical
and Health Services Managers, Program Director,
Risk Management Director. QAPI Director, Organ
Procurement Coordinator, Nurse manager,
Director of Nursing, Nursing care facilities/
skilled nursing facilities)....................
Managers, All Others (Administrator)............ 11-9199 54.41 54.41 109
*Activities Specialist (Recreational Therapists, 29-1125 20.64 20.64 41
Nursing Care Facilities/SNFs)..................
Internists (Medical Director, General Physician) 29-1063 95.37 95.37 191
Family and General Practitioner (Medical 29-1062 100.27 100.27 201
Director)......................................
Physical Therapist (Director of Rehab).......... 29-1123 42.34 42.34 85
Healthcare Social Worker (Social Worker)........ 21-1022 27.31 27.31 55
Mental Health and Substance Abuse Social Worker 21-1023 22.99 22.99 46
(Social Worker)................................
Nurse Practitioner (Clinician, Nurse 29-1171 51.68 51.68 103
Practitioner Outpatient Care Center)...........
Mental Health Counselor......................... 21-1018 22.38 22.38 45
Physician Assistant............................. 29-1071 50.37 50.37 101
[[Page 51760]]
Licensed Practical and Licensed Vocational 29-2061 21.98 21.98 44
Nurses (Director of Nursing)...................
First Line Supervisors of Office and 43-1011 28.14 28.14 56
Administrative Support Workers (Office Manager)
Office Clerks, General (Clerical staff)......... 43-9061 16.30 16.30 33
Secretaries and Administrative Assistants 43-6010 19.74 19.74 39
(Clerical staff)...............................
Chief Executive................................. 11-1011 94.25 94.25 189
----------------------------------------------------------------------------------------------------------------
* Salary information used is for Nursing Care Facility/SNF industry.
2. ICRs Regarding RNHCI Discharge Planning (Sec. 403.736(a) and (b))
It was discovered during review that the burden for existing
requirements at 42 CFR 403.724(a), 403.730(a), 403.732, 403.736(a)(b),
and 403.736(d) was erroneously not accounted for nor approved under the
PRA prior to this rulemaking. Accordingly, the burden associated with
these requirements is currently pending OMB approval (OMB control
number 0938-NEW). Section 403.736 will reduce the extensive
requirements for an RNHCI to coordinate with other medical providers
for post-RNHCI care. Based on recent claims data, there was a combined
annual total of 619 beneficiaries that stayed in the 18 facilities.
We estimate that the time currently required to develop and
document discharge plans and activities is 1,238 burden hours (2 hours
for each of the 619 beneficiaries discharged) and that it would be
reduced by half. Of the approximately 619 annual discharges, we
estimate that a RNHCIs burden would be reduced to one hour for each
discharged individual. A RNHCI would not need to develop a discharge
plan that includes medical care once a patient leaves the RNHCI because
doing so would not be in keeping with the religious tenets of the
patients they serve. We estimate that the healthcare support worker
responsible for a patients discharge plan costs $37 an hour, including
hourly wage and an estimated 100 percent add-on for fringe benefit
costs and overhead costs (this is an HHS standard calculation). Based
on our experience with RNHCIs, we estimate that it would take 1 hour to
develop the proposed discharge instructions and discuss them with the
patient or caregiver. We estimate a total of 619 annual discharges from
RNHCIs at a savings of $37 per discharge for a total savings of $22,903
($37 x 619 hours).
3. ICRs Regarding ASC Governing Body and Management (Sec.
416.41(b)(3)(i) and (ii))
We are finalizing our proposal with changes to eliminate the
requirements at Sec. 416.41(b)(3) that states the ASC must have a
written transfer agreement with a hospital or ensure all physicians
performing surgery in the ASC have admitting privileges at a local
hospital that meets CMS hospitalization requirements. However, we will
require that the ASCs have a notice requirement with hospitals and
encourage a transfer agreement when possible. All ASCs easily meet this
requirement and have established a relationship with their local
hospital and obtained an agreement as usual and customary practice for
running an ASC, with the exception of approximately twenty ASCs that
have difficult relationships with their local hospitals. The savings
would not be significant, however, it does affect the 20 ASCs by
removing the requirement. The current information collection request
for the ASC rules (OMB control number 0938-1071) does not address any
potential burden associated with this requirement. We believe that
having and maintaining written agreements is standard practice.
Therefore, removing this requirement would not alter the current
information collection burden for ASCs.
4. ICR Regarding ASC Medical Records (Sec. 416.47(b)(2))
We are finalizing our proposal to revise Sec. 416.47(b)(2) by
adding the phrase ``(as applicable)'' to the significant medical
history and results of physical examination requirement of documents
that must be included in the medical record in order to conform to the
changes that we proposed to the mandatory medical history and physical
examination requirement. There are no collection of information
requirements associated with this proposed change because maintaining a
medical record for each patient is a usual and customary practice in
accordance with the implementing regulations of the PRA at 5 CFR
1320.3(b)(2).
5. ICRs Regarding ASC Patient Admission, Assessment and Discharge
(Sec. 416.52(a)(1), (2), (3) and (4))
At Sec. 416.52 we are finalizing our proposal to replace the
requirement that every patient have a comprehensive medical history and
physical examination (H&P) within 30 days prior to surgery in an ASC
with a requirement that allows the operating physician and ASC to
determine which patients would require more extensive testing and
assessment prior to surgery. The burden associated with this
requirement would be the time and effort necessary to create new
policies for when, and whether, to require some form of history and
physical that would require pre-operative examination and testing, and
on what time schedule. The current information collection request for
the ASC rules (OMB control number 0938-1071) does not account for any
information collection related burden associated with the comprehensive
H&P requirement. We assume that creating these policies (which could
leave such decisions to the surgeon's discretion in most or all cases)
would require 10 hours of physician time, 10 hours of RN time, and 10
hours of clerical time, at the preceding hourly rates, for a total of
30 hours per facility. This would be a one-time cost of $3,460 per
facility ([10 x $242] + [10 x $71] + [10 x $33]), and $19.2 million for
all 5,557 facilities. Therefore, this proposed requirement would
increase the information collection related burden by $19.2 million and
166,710 hours (30 hours x 5,557 facilities) on a one-time basis for all
ASCs.
6. ICRs Regarding Hospice Aide and Homemaker Services (Sec. 418.76)
At Sec. 418.76(a) we are finalizing our proposal to defer to State
training and competency requirements, where they exist, for hospice
aides. The information
[[Page 51761]]
collection request for the hospice requirements (OMB control number
0938-1067) estimates that a hospice would spend 5 minutes per newly
hired hospice aide to document verification that an aide meets the
required training and competency requirements, for a total of 372
annual burden hours for all hospices at a cost of $11,540. This change
to the actual training and competency requirements would not alter the
requirement to document the fact that a hospice aide meets one of the
training and competency requirements set forth in the rule; therefore
there would be no change to the existing collection of information
estimates because the estimates relate to the unchanged documentation
requirements rather than the actual training and competency
requirements that would be revised by this change.
7. ICRs Regarding Drugs and Biologicals, Medical Supplies, and Durable
Medical Equipment (Sec. 418.106(a))
At Sec. 418.106(a) we are finalizing our proposal to remove the
requirement that a hospice ensure that the interdisciplinary group
confers with an individual with education and training in drug
management as defined in hospice policies and procedures and State law,
who is an employee of or under contract with the hospice to ensure that
drugs and biologicals meet each patient's needs. The information
collection request for the hospice requirements (OMB control number
0938-1067) states that the burden associated with this requirement is
the time necessary to document the results of this consultation in each
patient's clinical record. In the information collection request we
assumed that an average hospice would confer with a pharmacist, and
that the pharmacist would document the results of his or her
consultation. We estimated that it requires 5 minutes to document the
initial review of a patient's drug and biologicals. Additionally, we
estimated that it requires 5 minutes of the pharmacist's time to
document a review of updates to the patient's drug profile. Based on a
17 day median length of service, we assumed that each patient would
likely receive one update to their plans of care. At an average hourly
rate of $117 for a pharmacist, we estimated that it would cost a
hospice $19.50 per patient ($117 x [5 minutes for initial + 5 minutes
for 1 update]) and an annual cost of $6,942 ($19.50 x 356 patients).
The total annual burden hours for all hospices was estimated to be
264,588 hours (1,587,527 patients x .1666 hour per patient), and the
total annual burden cost for all hospices (taking into account new wage
data) is estimated to be $30,956,777 ($19.50 per patient x 1,587,527
patients). Therefore, removing the requirement that a hospice must
ensure that the interdisciplinary group confers with an individual with
education and training in drug management would result in a burden
reduction of 264,588 hours and $30,956,777.
The information collection request will be revised and sent to OMB.
H. ICRs Regarding Hospices That Provide Hospice Care to Residents of a
SNF/NF or ICF/IID (Sec. 418.112(c)(10) and (f))
At Sec. 418.112(f) we are finalizing a requirement to allow
hospices and long term care facilities the additional flexibility to
negotiate the format and schedule for orienting long term care facility
staff regarding certain hospice-specific information. This change does
not effect the existing hospice information collection request (OMB
control number 0938-1067).
9. ICRs Regarding Hospital Quality Assessment and Performance
Improvement (QAPI) Program (Sec. 482.21)
We are finalizing the proposed new standard at Sec. 482.21(f),
``Unified and integrated QAPI program for multi-hospital systems''. We
would allow that for a hospital that is part of a hospital system
consisting of two or more separately certified hospitals subject to a
system governing body legally responsible for the conduct of each
hospital, the system governing body could elect to have a unified and
integrated QAPI program for all of its member hospitals after
determining that such a decision is in accordance with all applicable
State and local laws.
As stated in the information collection request for the hospital
requirements (expired OMB control number 0938-0328), we estimate that
the burden associated with updating and, in some instances, writing new
hospital policies directly related to patient care would be an average
of eight (8) hours annually for each member of hospital staff involved
in the specific patient care policies addressed.
Patient care policy development (and revision) by hospital medical
staff is essential to patient health and safety because it provides the
framework within which all patient care services are furnished. Thus,
we have included the involvement of a physician at approximately $1,624
annually (8 burden hours x $203), a QAPI nurse coordinator at $568
annually (8 burden hours x $71), and a medical secretary at $280
annually (8 burden hours x $35).
We estimate the necessary policy changes needed to comply with the
requirements proposed in this rule would cost $2,472 per year ($1,624 +
$568 + $280) for each of the 424 hospital systems that would be
eligible to do so and that would choose to exercise this option.
Therefore, the total annual cost for all eligible hospital systems to
meet these information collection requirements would be approximately
$1 million.
10. ICRs Regarding Hospital Medical Staff, Medical Records Services,
and Surgical Services (Sec. Sec. 482.22, 482.24, and 482.51)
At Sec. 416.52, we are finalizing our proposal to replace the
requirement that every patient have a comprehensive H&P within 30 days
prior to surgery in an ASC with a requirement that allows the operating
physician and ASC to determine which patients would require more
extensive testing and assessment prior to surgery. As discussed in
``Provisions of the Proposed Regulations,'' section II.D.2 of the
proposed rule, there is a similar regulatory requirement for hospital
outpatient surgery. Based on the substantial similarity between these
two service settings, we proposed, through the revisions to Sec. Sec.
482.22, 482.24, and 482.51 discussed in section II.D.2, to provide an
exception to these requirements for outpatient surgery in hospitals.
As stated in the information collection request for the hospital
requirements (expired OMB control number 0938-0328), which is in the
process of being reinstated, we estimate that the burden associated
with updating and, in some instances, writing new hospital policies
directly related to patient care would be an average of eight (8) hours
annually for each member of hospital staff involved in the specific
patient care policies addressed.
Patient care policy development (and revision) by hospital medical
staff is essential to patient health and safety because it provides the
framework within which all patient care services are furnished. Thus,
we have included the involvement of a physician at approximately $1,624
annually (8 burden hours x $203), a nurse coordinator at $568 annually
(8 burden hours x $71), and a medical secretary at $280 annually (8
burden hours x $35).
We estimate that the necessary policy changes needed to comply with
the requirements in this rule would cost $2,472 per year ($1,624 + $568
+ $280) for each of the 4,823 hospitals that might choose to exercise
this option.
[[Page 51762]]
Therefore, the total annual cost for all hospitals to meet these
information collection requirements would be approximately $11.9
million.
11. ICRs Regarding Hospital Medical Staff: Autopsies (Sec. 482.22)(d))
We are finalizing our proposal to remove the requirement at Sec.
482.22(d), which states that a hospital's medical staff should attempt
to secure autopsies in all cases of unusual deaths and of medical-legal
and educational interest. Hospitals are further required to define a
mechanism for documenting permission to perform an autopsy, and they
must have a system for notifying the medical staff, and specifically
the attending practitioner, when an autopsy is being performed. Since
more detailed, specific requirements regarding medical-legal
investigations and autopsies for hospitals are covered by the
individual State laws in which the hospital is located, there are no
collection of information requirements associated with this proposed
change.
12. ICRs Regarding Hospital Infection Control (Sec. 482.42)
We are finalizing the proposed new standard at Sec. 482.42(d),
``Unified and integrated infection control program for multi-hospital
systems.'' Like the proposed requirements for a unified and integrated
QAPI program, the proposed standard for infection control would allow
that for a hospital that is part of a hospital system consisting of
multiple separately certified hospitals subject to a system governing
body legally responsible for the conduct of each hospital, such system
governing body could elect to have a unified and integrated infection
control program for all of its member hospitals after determining that
such a decision was in accordance with all applicable State and local
laws.
As stated in the information collection request for the hospital
requirements (OMB control number 0938-0328), which is in the process of
being reinstated, we estimate that the burden associated with updating
and, in some instances, writing new hospital policies directly related
to patient care would be an average of eight (8) hours annually for
each member of hospital staff involved in the specific patient care
policies addressed.
Patient care policy development (and revision) by hospital medical
staff is essential to patient health and safety because it provides the
framework within which all patient care services are furnished. Thus,
we have included the involvement of a physician at approximately $1,624
annually (8 burden hours x $203), an infection control nurse
coordinator at $568 annually (8 burden hours x $71), and a medical
secretary at $280 annually (8 burden hours x $35).
We estimate the necessary policy changes needed to comply with the
requirements proposed in this rule would cost $2,472 per year ($1,624 +
$568 + $280) for each of the 424 hospital systems that would be
eligible to do so and that would elect to exercise this option.
Therefore, the total annual cost for all eligible hospital systems to
meet these information collection requirements would be approximately
$1 million.
13. ICRs Regarding Special Requirements for Hospital Providers of Long-
Term Care Services (``Swing-Beds'') (Sec. 482.58(b)(1), (4), (5), and
(8), and Parallel CAH Requirements: Sec. 485.645(d)(1), (4), (5), and
(8))
At Sec. Sec. 482.58(b)(1) and 485.645(d)(1) (cross-referenced
long-term care requirement at Sec. 483.10(f)(9)) we are finalizing our
proposal to remove the requirement for hospital and CAH swing-bed
providers to provide the right for patients to choose to or refuse to
perform services for the facility and if they so choose; (a) document
in the resident's plan of care, (b) noting whether the services are
voluntary or paid and (c) provide wages for the work being performed
given the location quality, and quantity of work requiring comparable
skills.
We assume that each of the hospital swing-bed providers (478
hospitals) and CAH swing-bed providers (1,246 CAHs) has an activities
specialist employed at $41 per hour who would oversee the residents who
have chosen to perform services for the facility, and document and
update the plan of care accordingly. We believe that given the limited
budget of most rural providers, services are being provided to the CAH
on a voluntary basis and that these providers are not compensating
patients for providing these services. The current regulatory burden
for compliance with this requirement is approximately $29.4 million for
all hospital and CAH swing-bed providers, or $17,056 per hospital or
CAH swing-bed provider (1,724 hospital and CAH swing-bed providers x
$41 an hour for an activities specialist x 8 hours per week x 52 weeks
per year), which are the cost savings to the providers as a result of
the removal of this requirement.
At Sec. 482.58(b)(4) (and Sec. 485.645(d)(4)) (cross-referenced
long-term care requirement at Sec. 483.24(c)), we are finalizing our
proposal to remove the requirement for hospital and CAH swing-bed
providers to provide an ongoing activity program that is directed by a
qualified therapeutic recreation specialist or an activities
professional who meets certain requirements as listed at Sec.
483.24(c)(2). We assume that each of the hospital swing-bed providers
(478 hospitals) and CAH swing-bed providers (1,246 CAHs) has an
activities specialist employed at least part time at $41 per hour. The
current regulatory burden for compliance with this requirement is based
on the activities specialist organizing, overseeing, and scheduling the
activity. The cost savings as a result of the removal of this
requirement are approximately $73.5 million for all hospital and CAH
swing-bed providers, or $42,640 per hospital or CAH swing-bed provider
(1,724 hospital and CAH swing-bed providers x $41 an hour for an
activities specialist x 1,040 hours per year) which are the cost
savings to the providers.
We are finalizing our proposal to remove the requirement at
Sec. Sec. 482.58(b)(5) and 485.645(d)(5) (cross-referenced long-term
care requirement at Sec. 483.70(p) for hospital and CAH swing-bed
providers to employ a qualified social worker on a full-time basis if
the facility has more than 120 beds. Given that this provision is not
applicable to either provider type due to the regulatory requirements
for each, it does not impose a burden upon hospitals and as such, its
removal would not result in a savings of economic burden hours or
dollars.
At Sec. Sec. 482.58(b)(8) and 485.645(d)(8) (cross-referenced
long-term care requirement at Sec. 483.55(a)(1)) we are finalizing our
proposal to remove the requirement for hospital and CAH swing-bed
providers to assist in obtaining routine and 24-hour emergency dental
care to its residents.
Under the current CoPs, hospitals and CAHs are currently required
to address the emergent dental care needs of their patients at Sec.
482.12(f)(2) for hospitals, and at Sec. 485.618 (emergency services)
for CAHs. As a result, we have calculated the burden associated with
the provision of routine dental care for hospital and swing-bed
patients. The American Dental Association recommends annual dental
checkups for routine dental care for adults over 60 years of age. With
an average length of stay in a hospital or CAH swing-bed of 1-2 weeks
and an average daily census of 2 patients, we assume that 1 patient
receiving swing-bed services will require routine dental services per
month. While a dentist and dental hygienist provide the dental
services, Medicare is billed for the provision of these services. The
costs to the provider
[[Page 51763]]
are related to the nursing activities associated with the patient
receiving the dental services. The current regulatory burden for
compliance with this requirement is approximately $2.9 million for all
hospital and CAH swing-bed providers, or $1,704 per hospital or CAH
swing-bed provider (1,724 hospital and CAH swing-bed providers x $71 an
hour for a RN x 24 hours per year), which are the cost savings to the
providers as a result of the removal of this requirement. The
information collection requests will be revised and sent to OMB for
approval (OMB control number 0938-0328 for hospitals and 0938-1043 for
CAHs).
14. ICRs Regarding Special Requirements for Psychiatric Hospitals
(Sec. 482.61(d))
At Sec. 482.61(d) we are finalizing our proposal to clarify the
requirement allowing non-physician practitioners to document progress
notes in accordance with State laws and scope of practice requirements.
In accordance with the information collection request for the hospital
requirements, which includes the special requirements for psychiatric
hospitals (OMB control number 0938-0328), no burden is associated with
recordkeeping, as the documentation and maintenance of medical records
is usual and customary. However, since we believe that clarification of
the intent of the regulation is necessary and will result in non-
physician practitioners (specifically physician assistants, nurse
practitioners, psychologists, and clinical nurse specialists)
documenting in the progress notes for patients receiving services in
psychiatric hospitals, we have calculated savings for this provision in
the RIA which are essentially identical to those we would estimate
under the PRA.
15. ICRs Regarding Special Requirement for Transplant Centers and
Definitions (Sec. Sec. 482.68 and 482.70)
We are finalizing the proposed nomenclature change at part 482 and
the transplant center regulations at Sec. Sec. 482.68, 482.70, 482.72
through 482.104, and at Sec. 488.61. Because this change would update
the terminology used in the regulations to conform to the terminology
that is widely used and understood within the transplant community,
there are no collection of information requirements associated with
this proposal.
16. ICRs Regarding Data Submission, Clinical Experience, and Outcome
Requirements for Re-Approval of Transplant Centers (Sec. 482.82)
Section 482.82 requires that, except as specified in Sec. 488.61,
transplant centers must meet all the data submission, clinical
experience, and outcome requirements to be re-approved for Medicare
participation. Section 482.82(a) requires that no later than 90 days
after the due date established by the OPTN, a transplant center must
submit to the OPTN at least 95 percent of the required data submissions
on all transplants (deceased and living donors) it has performed over
the 3 year approval period. Furthermore, Sec. 482.82(b) requires
transplant centers to perform an average of 10 transplants per year
during the prior 3 years and Sec. 482.82(c) requires transplant
centers to meet the outcome requirements for Medicare re-approval. The
burden associated with this requirement would be the time it would take
a transplant program to submit the required information (OMB control
number 0938-1069). However, as required by Sec. Sec. 482.72 and
482.45(b), a hospital in which a transplant program is located, must
belong to the OPTN, and the OPTN requires that these hospitals submit
this data to the OPTN. Therefore, we believe that the requirements
under Sec. 482.82 do not impose an additional burden on transplant
programs because all Medicare participating transplant programs are
already submitting this information to the OPTN. Removing these
requirements will have no effect on the collection of information
burden on transplant programs.
17. ICRs Regarding Special Procedures for Approval and Re-Approval of
Organ Transplant Centers (Sec. 488.61(f) Through (h))
Section 488.61(f) through (h) sets out the process for our
consideration of a transplant center's mitigating factors in initial
approval and re-approval surveys, certifications, and enforcement
actions for transplant centers. The provisions also set out definitions
and rules for transplant systems improvement agreements. We are
finalizing our proposal to remove the requirements at Sec. 488.61(f)
through (h) for mitigating factors and transplant systems improvement
agreements for the re-approval process for transplant centers. This
change is complementary to the removal of Sec. 482.82, described
previously. The information collection request (OMB control number
0938-1069) does not account for any information collection related
burden associated with the requirements in Sec. 488.61(f) through (h)
for the re-approval process. Therefore, we estimate that the
requirements under Sec. 488.61(f) would require a transplant program
to write and submit the initial formal notice of the program's intent
to seek mitigating factors re-approval, and write and submit a request
for consideration of mitigating factors (which would include all of the
content listed in Sec. 488.61(f)(2)). We estimate that this would take
a medical director, a transplant center senior administrator, and a
hospital administrator approximately 5 hours, or 2 hours for the
medical director and the transplant program senior administrator and 1
hour for the hospital administrator, to complete and submit these
mitigating factors for re-approval, as described in Table 3.
Table 3--Annual Burden Hours and Cost for Transplant Programs To Submit Mitigating Factors for Re-Approval
----------------------------------------------------------------------------------------------------------------
Total cost
Position Hourly Hours required estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................ $191 2 $382
Transplant Program Senior Administrator......................... 107 2 214
Hospital Administrator.......................................... 107 1 107
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Totals...................................................... .............. 5 703
----------------------------------------------------------------------------------------------------------------
In total, we estimate that an average of 14 programs would submit
mitigating factors annually. Thus, for those 14 programs we estimate
that it would require 70 burden hours (5 burden hours x 14 programs) at
a cost of $9,842
[[Page 51764]]
($703 x 14 programs). Removing this requirement would yield an
estimated savings to transplant programs of 5 burden hours each and a
total of 70 burden hours for all 14 programs, with a total cost savings
of $9,842.
In addition, we estimate that the transplant hospital in
conjunction with the transplant program that is located in the
hospital, would submit mitigating factors and then would also enter
into systems improvement agreements, as described under Sec. 488.61(h)
annually. This would require the hospital to enter into a binding
agreement with CMS to allow the program additional time to achieve
compliance with the CoPs. We estimate that this would take a medical
director, a transplant program senior administrator, a hospital
administrator, and an administrative assistant approximately 14 hours,
or 4 hours for the medical director, transplant program senior
administrator, and an administrative assistant, and 2 hours for the
hospital administrator to complete these activities (including
notifying patients about the degree of noncompliance by mail and
organizing and completing the other tasks listed in Sec. 488.61(h)(1)
as required by the terms in the systems improvement agreement), as
described in Table 4.
Table 4--Annual Burden Hours and Cost for Transplant Programs To Enter Into a Systems Improvement Agreement for
Re-Approval
----------------------------------------------------------------------------------------------------------------
Total cost
Position Hourly Hours required estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................ $191 4 $764
Transplant Program Senior Administrator......................... 107 4 428
Hospital Administrator.......................................... 107 2 214
Administrative Assistant........................................ 35 4 140
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Totals...................................................... .............. 14 1,546
----------------------------------------------------------------------------------------------------------------
In total, we estimate that an average of 14 programs will submit
mitigating factors annually. Thus, for those 14 programs we estimate
that it would require 196 burden hours (14 burden hours x 14 programs)
at a cost of $21,644 ($1,546 x 14 transplant programs). In the context
of the proposed rule, removing this requirement would yield an
estimated savings to transplant programs of 14 burden hours each and a
total of 196 burden hours for all 14 programs, with a total cost
savings of $21,644.
18. ICRs Regarding HHA Home Health Aide Services (Sec. 484.80(h)(3))
We are finalizing the proposal to eliminate the requirement at
Sec. 484.80(h)(3) that the HHA conduct a full competency evaluation of
deficient home health aides, and replace it with a requirement to
retrain the aide regarding the identified deficient skill(s) and
require the aide to complete a competency evaluation related only to
those skills. We are also finalizing a change to permit HHAs to use
either patients or pseudo-patients when conducting competency
evaluations for home health aides. The content of an aide competency
examination and whether patients or pseudo-patients are used in the
process do not have an associated collection of information
requirement. Therefore, this proposed change would neither impose nor
remove any collection of information burdens.
19. ICRs Regarding HHA Clinical Records (Sec. 484.110(e))
As discussed in section I.B.6.c. of this final rule, we are not
finalizing the proposal to allow HHAs 4 business days to provide
patients with information from their clinical records upon request.
Consequently, there are no new information collection requirements.
20. ICRs Regarding CORF Utilization Review Plan (Sec. 485.66)
We are finalizing the proposal to reduce the required frequency in
which CORFs would be required to complete a ``utilization review plan''
from quarterly to annually. Changing from a quarterly implementation of
the utilization review plan to an annual implementation would reduce
the current documentation requirements (OMB control number 0938-1091)
on CORFs by 75 percent each year. For the purposes of our analysis, we
estimate that it would take a CORF approximately 8 hours for
administrative, clinical and clerical staff to review and evaluate the
necessary and efficient use of services provided by the facility on a
quarterly basis, for a total of 32 hours per year per CORF and 6,016
hours for all 188 CORFs. In a 1-year period, we estimate a savings of
$1,680 per facility ($560 x 3 quarters), and a combined total savings
of $315,840 for all CORFs ($1,680 x 188 CORFs). We will submit the
revised information collection request to OMB for approval.
Table 5--CORF--Hourly Costs and Burden Hours
----------------------------------------------------------------------------------------------------------------
Hourly costs Burden hours Cost estimate
Position per CORF per CORF per CORF
----------------------------------------------------------------------------------------------------------------
Administrator................................................... $107 2 $214
Clerical Staff.................................................. 33 2 66
Physical Therapist.............................................. 85 2 170
Social Worker................................................... 55 2 110
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total....................................................... .............. 8 560
----------------------------------------------------------------------------------------------------------------
[[Page 51765]]
21. ICRs Regarding CAH Organizational Structure (Sec. 485.627(b)(1))
As of 2017, there were approximately 1,353 CAHs that were certified
by Medicare. We are finalizing our proposal for revision of the CAH
disclosure requirements imposed on CAHs removes the requirement for
CAHs to disclose to CMS its owners, or those with a controlling
interest in the CAH or in any subcontractor in which the CAH directly
or indirectly has a 5 percent or more ownership interest, in accordance
with 42 CFR part 420, subpart C (OMB control number 0938-1043). While
we estimate that these changes occur at 2 CAHs per year on average
between all 1,353 CAHs, with the vast majority not experiencing any
such changes throughout the lifetime of the CAH, each CAH is still
required to review the duplicative documentation. As discussed in our
rule, Medicare Program; Criteria and Standards for Evaluating Regional
Durable Medical Equipment, Prosthetics, Orthotics and Supplies
(DMEPOS); Final Rule and Request for Comments (57 FR 2790, June 18,
1992), the burden associated with this requirement is 1-hour per
facility. As a result, this will save all CAHs an estimated $144,771
and will save each CAH $107 (1-burden hour for an administrator at $107
per hour x 1,353 CAHs).
22. ICRs Regarding CAH Provision of Services (Sec. 485.635(a)(4))
Section 485.635(a)(4) requires CAHs to conduct an annual review of
all its policies and procedures (OMB control number 0938-1043). We are
finalizing our proposal for revision of the patient care policies
requirements imposed on CAHs would reduce the frequency that is
currently required for CAHs to perform a review of all their policies
and procedures. We anticipate that a change from an annual review to a
biennial review would reduce the burden on CAHs by half in a given
period of time. For the purposes of our analysis, we estimate that it
would take a CAH approximately 16 hours for administrative and clinical
staff to review and make changes to policies and procedures annually.
In a 2-year period, we estimate a savings of $1,968 per facility, and a
combined total savings of $2.7 million for CAHs ($1,968 x 1,353 CAHs),
or annualized savings of approximately $1.3 million.
We estimate that the CAH staff time and associated costs would be
assigned to a biennial review as shown in Table 6.
Table 6--Hourly Costs and Burden Hours
----------------------------------------------------------------------------------------------------------------
Hourly cost Burden hours Cost estimate
Position per CAH per CAH per CAH
----------------------------------------------------------------------------------------------------------------
Administrator................................................... $189 4 $756
Clerical staff.................................................. 39 3 117
Registered Nurse................................................ 71 3 213
Nurse practitioner.............................................. 103 3 309
Physician....................................................... 191 3 573
-----------------------------------------------
Totals...................................................... .............. 16 1,968
----------------------------------------------------------------------------------------------------------------
23. ICRs Regarding Special Requirements for CAH Providers of Long-Term
Care Services (``Swing-Beds'') (Sec. 485.645(d)(1), (4), (5) and (8))
We have included the discussion of the ICRs regarding special
requirements for CAH providers of long-term care services in the
discussion of the ICRs regarding special requirements for hospital
providers of long-term care services, which can be found in section
I.C.13 of this rule (ICRs Regarding Special Requirements for Hospital
Providers of Long-Term Care Services (``Swing Beds'') (Sec.
482.58(b)(1), (4), (5), and (8), and Parallel CAH requirements: Sec.
485.645(d)(1), (4), (5), and (8))).
24. ICRs Regarding CMHCs (Sec. 485.914(d))
Section 485.914(d)(1) requires each CMHC to update each client's
comprehensive assessment via the CMHC interdisciplinary treatment team,
in consultation with the client's primary health care provider (if
any), no less frequently than every 30 days. We are modifying the
requirement at Sec. 485.914(d) to remove the 30-day assessment update
timeframe for those clients who do not receive PHP services. Under the
current 30-day time frame requirement, each client receives an updated
assessment 12 times per year (OMB control number 0938-1245). We
estimate that, in accordance with the proposed need-based assessment
update requirements, each non-PHP client would receive 2 assessment
updates in a year. Therefore, we estimate that this change would reduce
the burden of 10 assessments per client, per year.
As of August 2017 there are 161 Medicare participating CMHCs
serving 3,122 Medicare beneficiaries and an estimated 2,080 non-
Medicare clients, for an average of 32 clients per CMHC. In order to
develop the estimated number of non-Medicare clients we divided the
total number of Medicare beneficiaries who received partial
hospitalization services by the total number of Medicare-participating
CMHCs to establish the average number of Medicare beneficiaries per
CMHC. This resulted in 19 beneficiaries per CMHC. We then assumed that,
in order to comply with the 40 percent requirement (Sec.
485.918(b)(1)(v)), those 19 beneficiaries only accounted for 60 percent
of an average CMHC's total patient population. This means that an
average CMHC also treated another 13 clients who did not have Medicare
as a payer source, for a total of 32 clients (Medicare + non-Medicare)
in an average CMHC. Therefore, all CMHCs combined would have
approximately 2,093 non-PHP clients per year (13 per CMHC), and
approximately 20,930 assessments would be reduced nationwide per year
(2,093 patients x 10 assessments per patient). We estimate that
documenting each assessment update requires 10 minutes of a CMHC
clinician's time, for a total savings of 3,487 hours nationwide (0.1666
hours x 20,930 assessment updates). At a cost of $7.50 for a mental
health counselor to document each assessment, the total cost savings
would be $156,975 ($7.50 x 20,930 assessments).
25. ICRs Regarding Portable X-Ray Services (Sec. Sec. 486.104(a) and
486.106(a))
We are finalizing our proposal to revise the requirements for
portable x-ray technologist personnel qualifications at Sec. 486.104
to align the current requirements at Sec. 486.104(a)(1), (2), (3), and
(4) with those for hospital radiologic technologists at Sec.
482.26(c)(2) which are focused on the qualifications of the individual
performing services as permitted by State law. Although changing the
qualifications would
[[Page 51766]]
require management time, with the associated cost of those hours, in
order to revise the internal personnel descriptions and qualifications,
we believe that this proposed change would impose no burden because
maintaining internal personnel descriptions and qualifications is a
standard business practice. Therefore, this burden would not be subject
to the PRA in accordance with the implementing regulations of the PRA
at 5 CFR 1320.3(b)(2).
We are finalizing our proposal to revise the requirements for
portable x-ray orders at Sec. 486.106(a)(2). We proposed to remove the
requirement that physician or non-physician practitioner's orders for
portable x-ray services must be written and signed. We also proposed to
replace the specific requirements related to the content of each
portable x-ray order with a cross-reference to the requirements at 42
CFR 410.32, which also apply to portable x-ray services. These changes
would simplify the ordering process for portable x-rays and promote the
use of more efficient ordering methods, such as electronic orders.
In the information collection request (OMB control number 0938-
0338) we estimate that the current order requirements would impose the
following burdens:
3 minutes to write an order x 3,986,000 portable x-rays
exams ordered = 199,300 hours x $71/hour for a nurse = $14,150,300.
$1 for printing and faxing verbal orders to physician
offices for signature x 2,500,000 verbal orders = $2,500,000.
2,000,000 follow-up calls regarding the status of faxes x
10 minutes of time for clerical staff (5 minutes for portable x-ray
clerical staff + 5 minutes for ordering physician clerical staff) =
333,333 hours x $33/hour = $10,999,989.
All of these burdens would be eliminated by revising the current
ordering standards. Therefore, we estimate a proposed information
collection savings of $27.7 million from this proposed change.
26. ICRs Regarding RHC and FQHC Provision of Services (Sec.
491.9(b)(4))
There are currently more than 4,100 RHCs and approximately 1,400
FQHC organizations furnishing services at approximately 12,000 or more
total locations. Many FQHC organizations have multiple delivery sites,
and as of May 2017 there were 4,160 RHC and 7,874 FQHC delivery sites.
All CMS-certified sites are subject to our requirements and we are
therefore utilizing the total number of current sites in our burden
reduction calculations.
We are finalizing our proposal to revise Sec. 491.9(b)(4) to
reduce the number of times that RHCs and FQHCs perform a review of all
their policies and procedures. Changing from an annual review to a
review every other year would reduce the burden on RHCs and FQHCs by
half in a given period of time. In the currently approved information
collection request (OMB control number 0938-0334), we only included
burden estimates for RHCs. However, we recognize that the information
collection applies to FQHCs as well. Therefore, we estimate that it
would take a RHC or FQHC approximately 4 hours for clinical staff to
review and make changes to policies and procedures annually, for a
total of 48,136 hours for all 12,034 RHC and FQHC locations. In a 2-
year period, RHCs and FQHCs would use 96,272 total hours to comply with
the requirements to annually review all of their policies and
procedures. Under the proposed change to review policies every other
year, we estimate that in a 2-year period, it will take a total of
48,136 hours, for a savings of 48,136 hours per year. We estimate a
savings of $608 per facility (see Table 7) for a combined total savings
of $7.3 million biennially for 12,034 RHCs or FQHCs ($608 x 12,034 RHCs
and FQHCs), or annualized savings of half these amounts. We will submit
a revised information collection request to OMB for approval.
Table 7--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
Hourly cost per RHC/
FQHC (includes 100% Burden hours per Cost estimate per
Position for benefits and RHC/FQHC RHC/FQHC
overhead)
----------------------------------------------------------------------------------------------------------------
Physician........................................ $203 2 $406
Mid-Level Provider (PA or NP).................... 101 2 202
--------------------------------------------------------------
Total........................................ ................... 4 608
----------------------------------------------------------------------------------------------------------------
27. ICRs Regarding RHC and FQHC Program Evaluation (Sec. 491.11(a))
We are finalizing the proposal to revise Sec. 491.11(a) to reduce
the number of times that RHCs and FQHCs carry out or arrange for an
annual evaluation of the total program. Changing from an annual
evaluation to an evaluation every other year would reduce the burden on
RHCs and FQHCs by half in a given period of time. In the currently
approved information collection request (OMB control number 0938-0334),
we only included burden estimates for RHCs, however we recognize that
the information collection applies to FQHCs as well. Therefore, we
estimate that it would take a RHC or FQHC approximately 6 hours for
administrative and clinical staff to perform an evaluation of its total
program annually for a total of 72,204 hours for all 12,034 RHC and
FQHC locations. In a 2-year period, RHCs and FQHCs would use 144,408
total hours to comply with the requirement for an evaluation of the
total program. Under the proposed change to evaluate the total program
every other year, we estimate an hourly savings of 72,204 total hours
and a cost savings of $822 per facility (see Table 8), for a combined
total savings of $9.9 million biennially for 12,034 RHCs or FQHCs ($822
x 12,034 RHC and FQHC locations), or annualized savings of half these
amounts.
[[Page 51767]]
Table 8--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
Hourly cost per RHC/
FQHC (includes 100% Burden hours per Cost estimate per
Position for benefits and RHC/FQHC RHC/FQHC
overhead)
----------------------------------------------------------------------------------------------------------------
Administrator/Health Services Manager............ $107 2 $214
Physician........................................ 203 2 406
Mid-Level Provider (PA or NP).................... 101 2 202
--------------------------------------------------------------
Total........................................ ................... 6 822
----------------------------------------------------------------------------------------------------------------
28. ICRs Regarding Emergency Preparedness for Providers and Suppliers
a. Review of the Emergency Preparedness Program
At Sec. 482.15(a), (b), (c), and (d) for hospitals and parallel
regulatory citations for other facilities, we are finalizing our
proposal to allow providers to review their program at least every 2
years. However, we are withdrawing the proposal for LTC facilities. As
of May 2017, there were approximately 72,646 total facilities, or
56,983 excluding LTC facilities. All are required to review their
emergency preparedness program annually, which includes a review of
their emergency plan, policies and procedures, communication plan, and
training and testing program.
For our analysis, we estimate that reducing this requirement from
annually to biennially would reduce compliance costs related to review
of the emergency plan by 50 percent. The methodology used for our cost
estimate analysis generally mirrors the methodology used for the annual
review of the emergency plan Emergency Preparedness final rule (81 FR
63930) with a 50 percent reduction in the cost estimate calculation;
however, after receiving additional feedback from stakeholders, we have
determined that we underestimated the amount of time it would take to
review the emergency plan. As a result, we have presented current
burden hours associated with reviewing the emergency plan that reflects
the increased associated burden hours relative to the information
collection request for this provision (OMB control number 0938-1325).
As in the Emergency Preparedness final rule (81 FR 63930), we assume
that the individuals involved in the review of the emergency plan
include an administrator, director of nursing, a RN, a physician, a
social worker, a counselor, and an office manager, depending on the
facility type. Based on May 2017 BLS salary data, we calculated the
hourly mean wage for each position for this requirement identified in
the Emergency Preparedness final rule (81 FR 63930).
We estimate that the finalized change will accrue total annualized
cost savings of $69,639,324 and 657,345 burden hours saved, or biennial
savings of double these amounts. We list a detailed calculation for
each facility below, based on facility numbers available as of 2017:
RNHCIs: Combined total savings of $9,684 for 18 RNHCIs ((8
burden hours for an administrator at $107 plus 5 burden hours for a
director of nursing at $44 per hour) x 18 RNHCIs x 50 percent).
ASCs: Combined total savings of $6,257,182 for 5,557 ASCs
((8 burden hours for an administrator at $109 per hour plus 4 burden
hours for a physician at $203 per hour plus 8 burden hours for a
quality improvement RN at $71 per hour) x 5,557 ASCs x 50 percent).
Hospices: Combined total savings of $5,916,502 for 4,489
hospice facilities ((8 burden hours for an administrator at an hourly
wage of $107 per hour plus 4 burden hours for a physician at $203 per
hour plus 4 burden hours for a counselor at $45 per hour plus 4 burden
hours for a social worker at $55 per hour plus 8 burden hours for a RN
at $71 per hour) x 4,489 hospices x 50 percent).
PRTFs: Combined total savings of $569,976 for 374 PRTFs
((8 burden hours for an administrator $107 per our plus 8 burden hours
for a physician at $203 per hour plus 8 burden hours for a RN at $71
per hour) x 374 PRTFs x 50 percent).
PACE: Combined total savings of $232,068 for 233 PACE
organizations ((8 burden hours for an administrator at $107 per hour
plus 8 burden hours for a home care coordinator at $71 per hour plus 8
burden hours for a RN at $71 per hour) x 233 PACE organizations x 50
percent).
Hospitals: Combined total savings of $11,700,598 for 4,823
hospitals ((8 burden hours for an administrator at $109 per hour plus 8
burden hours for a physician at $203 per hour plus 8 burden hours for a
risk management director at $107 per hour plus 8 burden hours for a
quality assurance nurse at $71 per hour plus 8 burden hours for a
facility director at $99 per hour plus 4 burden hours for a medical
secretary at $35 per hour) x 4,823 hospitals x 50 percent).
ICF/IID: Combined total savings $3,475,290 for 6,097 ICF/
IIDs ((8 burden hours for an administrator at $107 per hour plus 4
burden hours for a RN $71 per hour) x 6,097 ICF/IIDs x 50 percent).
HHA: Combined total savings of $16,512,192 for 12,624 HHAs
((8 burden hours for an administrator at $107 per hour plus 8 burden
hours for a nursing director at $107 per hour plus 8 burden hours for a
director of rehab at $85 per hour plus 4 burden hours for an office
manager at $56 per hour) x 12,624 HHAs x 50 percent).
CORF: Combined total savings of $144,384 for 188 CORFs ((8
burden hours for an administrator at $107 per hour plus 8 burden hours
for a physical therapist at $85 per hour) x 188 CORFs x 50 percent).
CAH: Combined total savings of $1,693,956 for 1,353 CAHs
((8 burden hours for an administrator at $107 per hour plus 8 burden
hours for a director of nursing at $107 per hour plus 8 burden hours
for a facility director at $99 per hour) x 1,353 CAHs x 50 percent).
Organizations: Combined total savings of $1,241,448 for
2,076 Organizations ((8 burden hours for an administrator at $107 per
hour plus 4 burden hours for a physical therapist at $85 per hour) x
2,076 Organizations x 50 percent).
CMHCs: Combined total savings of $150,052 for 161 CMHCs
((8 burden hours for an administrator at $107 per hour plus 8 burden
hours for a RN at $71 per hour plus 8 burden hours for a social worker
at $55 per hour) x 161 CMHCs x 50 percent).
OPOs: Combined total savings of $121,568 for 58 OPOs ((8
burden hours for an OPO director at $107 per hour plus 8 burden hours
for a physician at $203 per hour plus 8 burden hours for
[[Page 51768]]
a QAPI director at $107 per hour plus 8 burden hours for an organ
procurement coordinator at $107 per hour) x 58 OPOs x 50 percent).
RHC/FQHC: Combined total savings of $10,108,560 ((8 burden
hours for an administrator at $107 per hour plus 8 burden hours for a
nurse practitioner/physician assistant at $103 per hour) x 4,160 RHCs x
50 percent) $3,494,400 + ((8 burden hours for an administrator at $107
per hour plus 8 burden hours for a nurse practitioner/physician
assistant at $103 per hour x 7,874 FQHCs x 50 percent) $6,614,160).
ESRD Facilities: Combined total savings of $11,505,864 for
6,898 dialysis facilities ((8 burden hours for an administrator at $107
per hour plus 8 burden hour for a medical director/physician at $203
per hour plus 8 burden hours for a nurse manager at $107) x 6,898
dialysis facilities x 50 percent) as shown in Table 9.
Table 9--Cost Savings for Annual Review of Emergency Preparedness Plan
------------------------------------------------------------------------
Cost savings per Combined total
Provider/supplier provider/supplier savings
------------------------------------------------------------------------
RNHCIs........................ $538 $9,684 for 18 RNHCIs.
ASCs.......................... 1,126 $6,257,182 for 5,557
ASCs.
Hospices...................... 1,318 $5,916,502 for 4,489
hospice facilities
both inpatient and
freestanding/home
based.
PRTFs......................... 1,524 $569,976 for 374
PRTFs.
PACEs......................... 996 $232,068 for 233
PACEs.
Hospitals..................... 2,426 $11,700,598 for 4,823
hospitals.
ICFs/IIDs..................... 570 $3,475,290 for 6,097
ICF/IIDs.
HHAs.......................... 1,308 $16,512,192 for
12,624 HHAs.
CORFs......................... 768 $144,384 for 188
CORFs.
CAHs.......................... 1,252 $1,693,956 for 1,353
CAHs.
Organizations................. 598 $1,241,448 for 2,076
Organizations.
CMHCs......................... 932 $150,052 for 161
CMHCs.
OPOs.......................... 2,096 $121,568 for 58 OPOs.
RHCs/FQHCs.................... 840 $10,108,560 for RHCs
and FQHCs
($3,494,400 for
4,160 RHCs and
$6,614,160 for 7,874
FQHCs).
ESRD Facilities............... 1,668 $11,505,864 for 6,898
dialysis facilities.
------------------------------------------------------------------------
b. Contents of the Emergency Plan
At Sec. 482.15(a)(4) for hospitals, and other parallel citations
for the facilities mentioned in section II.J.2 of the rule, we are
finalizing our proposal to eliminate the requirement that facilities
document efforts to contact local, tribal, regional, State, and Federal
emergency preparedness officials and that facilities document
participation in collaborative and cooperative planning efforts (OMB
control number 0938-1325). We estimate that an administrator, or in the
case of a hospital a community relations manager, a program director
for a PACE, or a QAPI director for OPOs, would take 1 hour to document
efforts to contact local, tribal, regional, State and Federal emergency
preparedness officials and, when applicable, document the facility's
participation in collaborative and cooperative planning efforts. We
note that The Joint Commission (TJC)-accredited ASCs, TJC-accredited
CAHs, and TJC-accredited hospitals have emergency preparedness
requirements for developing an emergency preparedness plan that are
comparable to the current emergency preparedness CoPs (81 FR 63937,
63954, and 63978 through 63979). Utilizing the same assumptions we used
in the Emergency Preparedness final rule (81 FR 63937, 63954, and 63978
through 63979), we estimate that cost savings will accumulate from non-
TJC accredited ASC, CAHs, and hospitals, since TJC-accredited ASCs,
CAHs and hospitals are already required by the TJC to develop emergency
preparedness plans. As a result, these facilities are excluded from the
analysis given the requirements of their accreditation organization
standards. Based on May 2017 BLS salary data, we calculate an hourly
mean wage of $107 for an administrator, a PACE Program Director, or
QAPI director and a cost savings of $107 per facility for RNHCIs, non-
TJC accredited ASCs, hospices (both inpatient and freestanding), PRTFs,
PACEs, LTCFs, ICF/IIDs, HHAs, CORFs, non-TJC accredited CAHs,
Organizations, CMHCs, OPOs, RHC/FQHCs, and dialysis facilities ($107
hourly mean wage x 1 burden hour). For non-TJC accredited hospitals, we
estimate an hourly mean wage of $115 for a community relations manager,
and a $115 cost per facility ($115 x 1 hour). Therefore, we estimate
the following for each facility affected by the proposed change, for a
total savings of $7,316,489 and 68,275 burden hours. We list a summary
of the calculation for savings accrued by removing this requirement for
each facility in Table 10, based on facility numbers available as of
May 2017.
Table 10--Cost Savings: Documentation of the Facility's Participation in
Collaborative and Cooperative Planning Efforts
------------------------------------------------------------------------
Cost savings per Combined total
Provider/supplier provider/supplier savings
------------------------------------------------------------------------
RNHCIs........................ $107 $1,926 for 18 RNHCIs.
ASCs (Non-TJC accredited)..... 107 $532,325 for 4,975
non-TJC accredited
ASCs.
Hospices...................... 107 $480,323 for 4,489
hospice facilities
both inpatient and
freestanding/home
based.
PRTFs......................... 107 $40,018 for 374
PRTFs.
PACEs......................... 107 $24,931 for 233
PACEs.
Hospitals (Non-TJC accredited) 115 $159,045 for 1,383
non-TJC accredited
hospitals.
[[Page 51769]]
LTCFs......................... 107 $1,675,941 for 15,663
LTCFs.
ICFs/IIDs..................... 107 $652,379 for 6,097
ICF/IIDs.
HHAs.......................... 107 $1,350,768 for 12,624
HHAs.
CORFs......................... 107 $20,116 for 188
CORFs.
CAHs (Non-TJC accredited)..... 107 $107,428 for 1,004
non-TJC accredited
CAHs.
Organizations................. 107 $222,132 for 2,076
Organizations.
CMHCs......................... 107 $17,227 for 161
CMHCs.
OPOs.......................... 107 $6,206 for 58 OPOs.
RHCs/FQHCs.................... 107 $1,287,638 for RHCs
and FQHCs ($445,120
for 4,160 RHCs and
$842,518 for 7,874
FQHCs).
ESRD Facilities............... 107 $738,086 for 6,898
dialysis facilities.
------------------------------------------------------------------------
c. Training
At Sec. 482.15(d)(1)(ii) for hospitals, and other parallel
citations for other facilities mentioned in section II.J.2 of the rule,
we are finalizing our proposal to require that facilities provide
training biennially, or every 2 years, after facilities conduct initial
training on their emergency program, as well as requiring additional
training when the emergency plan is significantly updated. However, we
are withdrawing this proposal for LTC facilities only. We are
maintaining the requirement that providers and suppliers develop a
well-organized, effective training program that includes initial
training for new and existing staff in emergency preparedness policies
and procedures and would require training when the emergency plan is
significantly updated. Facilities will have the flexibility to
determine what is considered a significant update to the emergency
plan.
For our analysis, we estimate that reducing this requirement from
annually to biennially will reduce compliance costs related to
providing emergency preparedness training by 50 percent (OMB control
number 0938-1325). The methodology used for our cost estimate analysis
mirrors the methodology used for the annual training requirement in the
Emergency Preparedness final rule (81 FR 63930) with a 50 percent
reduction in the cost estimate calculation. As in the Emergency
Preparedness final rule (81 FR 63930), we assume that the individuals
involved in the development and provision of training include an
administrator, director of nursing, a RN, and an office manager,
depending on the facility type. Providers and suppliers are expected to
provide initial training in emergency preparedness policies and
procedures to all new and existing staff, individuals providing
services under arrangement, and volunteers, consistent with their
expected roles, and maintain documentation of the training. Based on
May 2017 BLS salary data, we calculated the hourly mean wage for each
position for this requirement identified in the Emergency Preparedness
final rule (81 FR 63930). We estimate that the proposed change will
accrue annualized cost savings of $25,593,781 and 288,266 burden hours,
or biennial savings of double these amounts. We list a detailed
calculation for each facility below, based on facility numbers
available as of May 2017 with a summary of these calculations provided
in Table 11:
RNHCIs: Combined total savings of $3,906 for 18 RNHCIs ((2
burden hours for an administrator at $107 plus 5 burden hours for a
director of nursing at $44 per hour) x 18 RNHCIs x 50 percent).
ASCs: Combined total savings of $1,289,224 for 5,557 ASCs
((1 burden hour for an administrator at $109 per hour plus 5 burden
hours for a quality improvement RN at $71 per hour) x 5,557 ASCs x 50
percent).
Hospices: Combined total savings of $956,157 for 4,489
hospice facilities (6 burden hours for a RN at $71 per hour x 4,489
hospices x 50 percent).
PRTFs: Combined total savings of $132,770 for 374 PRTFs
(10 burden hours for a RN at $71 per hour x 374 PRTFs x 50 percent).
PACE: Combined total savings of $99,258 for 233 PACE
organizations (3 burden hours for a home care coordinator at $71 per
hour plus 9 burden hours for a RN at $71 per hour x 233 PACE
organizations x 50 percent).
Hospitals: As we stated in the Emergency Preparedness
final rule (81 FR 63958), TJC-accredited hospitals are required to
train their staff for their assigned roles during emergencies (CAMH,
Standard EC.4.16, Eps 1-2, p. EC-13e). In addition, the TJC-accredited
hospitals also must provide on-going training to their staff, including
training on specific job-related safety (CAMH, Standard HR-2.30, EP 4,
CAMH Refreshed Core, January 2008, p. HR-11), and we expect that
emergency preparedness is part of such on-going training. As a result,
we estimate a combined total savings of $2,066,202 for 1,383 non-TJC
accredited hospitals (2 burden hours for an administrator at $109 per
hour plus 6 burden hours for a risk management director at $107 per
hour plus 28 hours for a healthcare trainer (RN) at $71 per hour plus 4
burden hours for a medical secretary at $35 per hour x 1,383 hospitals
x 50 percent).
ICF/IID: Combined total savings $1,734,597 for 6,097 ICF/
IIDs (2 burden hours for an administrator at $107 per hour plus 5
burden hours for a RN $71 per hour x 6,097 ICF/IIDs x 50 percent).
HHA: Combined total savings of $8,066,736 for 12,624 HHAs
(2 burden hours for an administrator at $107 per hour plus 2 burden
hours for a nursing director at $107 per hour plus 2 burden hours for a
director of rehab at $85 per hour plus 2 burden hours for an office
manager at $56 per hour plus 8 burden hours for a director of training
at $71 x 12,624 HHAs x 50 percent).
CORF: Combined total savings of $74,260 for 188 CORFs (5
burden hours for an administrator at $107 per hour plus 3 burden hours
for a physical therapist at $85 per hour x 188 CORFs x 50 percent).
CAH: Combined total savings of $997,161 for 1,353 CAHs (2
burden hours for an administrator at $107 per hour plus 9 burden hours
for a director of nursing at $107 per hour plus 3 burden hours for a
facility director at $99 per hour x 1,353 CAHs x 50 percent).
Organizations: Combined total savings of $842,856 for
2,076 Organizations (6 burden hours for an administrator at $107 per
hour plus 2 burden hours for a physical therapist at
[[Page 51770]]
$85 per hour x 2,076 Organizations x 50 percent).
CMHCs: Combined total savings of $57,155 for 161 CMHCs (10
burden hours for a psychiatric RN at $71 per hour x 161 CMHCs x 50
percent).
OPOs: Combined total savings of $113,448 for 58 OPOs (2
burden hours for a director at $115 per hour plus 2 burden hours for a
medical director/physician at $203 per hour plus 12 burden hours for a
QAPI director at $107 per hour plus 8 hours for an organ procurement
coordinator at $107 per hour plus 16 burden hours for an education
coordinator at $71 per hour x 58 OPOs x 50 percent).
RHC/FQHC: Combined total savings of $6,245,646 ((2 burden
hours for an administrator at $107 per hour plus 8 burden hours for a
nurse practitioner/physician assistant at $103 per hour x 4,160 RHCs x
50 percent) $2,159,040 + (2 burden hours for an administrator at $107
per hour plus 8 burden hours for a nurse practitioner/physician
assistant at $103 per hour x 7,874 FQHCs x 50 percent) $4,086,606).
ESRD Facilities: Combined total savings of $2,914,405 for
6,898 dialysis facilities (3 burden hours for an administrator at $107
per hour plus 1 burden hour for a medical director/physician at $203
per hour plus 3 burden hours for a nurse manager at $107 x 6,898
dialysis facilities x 50 percent).
Table 11--Cost Savings: Training
------------------------------------------------------------------------
Cost savings per
Provider/ supplier provider/ Combined total
supplier savings
------------------------------------------------------------------------
RNHCIs........................ $217 $3,906 for 18 RNHCIs.
ASCs.......................... 232 $1,289,224 for 5,557
ASCs.
Hospices...................... 213 $956,157 for 4,489
hospice facilities
both inpatient and
freestanding/home
based.
PRTFs......................... 355 $132,770 for 374
PRTFs.
PACEs......................... 426 $99,258 for 233 PACE
organizations.
Hospitals (Non-TJC accredited) 1,494 $2,066,202 for 1,383
non-TJC accredited
hospitals.
ICFs/IIDs..................... 285 $1,734,597 for 6,097
ICF/IIDs.
HHAs.......................... 639 $8,066,736 for 12,624
HHAs.
CORFs......................... 395 $74,260 for 188
CORFs.
CAHs.......................... 737 $997,161 for 1,353
CAHs.
Organizations................. 406 $842,856 for 2,076
Organizations.
CMHCs......................... 355 $57,155 for 161
CMHCs.
OPOs.......................... 1,956 $113,448 for 58 OPOs.
RHCs/FQHCs.................... 519 $6,245,646 for RHCs
and FQHCs
($2,159,040 for
4,160 RHCs and
$4,086,606 for 7,874
FQHCs).
ESRD Facilities............... 423 $2,914,405 for 6,898
dialysis facilities.
------------------------------------------------------------------------
d. Testing
Finally, at Sec. 482.15(d)(2), we are finalizing our proposal to
require that providers of inpatient services mentioned in section
II.J.2 of the rule conduct two testing exercises annually, one of which
may be an exercise of their choice that must be either a community-
based full-scale exercise (if available), an individual facility-based
functional exercise, a drill, a tabletop exercise or workshop that
includes a group discussion led by a facilitator. Given that these
providers are currently required to conduct two testing exercises
annually, and because they may choose to conduct the same types of
testing exercises, we do not anticipate that this requirement will
impose a burden upon providers of inpatient services and as such, this
revision will not result in a savings of burden hours or dollars (OMB
control number 0938-1325).
We are also finalizing our proposal to require that providers of
outpatient services mentioned in section II.J.2 of the rule conduct one
testing exercise annually which must be either a community-based full-
scale exercise (if available) or an individual facility-based
functional exercise every other year, and in the opposite years, may be
either a community-based full-scale exercise (if available), a
facility-based functional exercise, a drill, or a tabletop exercise or
workshop that includes a group discussion led by a facilitator.
For our analysis, we estimate that reducing this requirement from
biannually to annually for outpatient providers will reduce compliance
costs related to conducting emergency preparedness testing by 50
percent. The methodology used for our cost estimate analysis mirrors
the methodology used for the biannual testing requirement in the
Emergency Preparedness final rule (81 FR 63930) with a 50 percent
reduction in the cost estimate calculation. As in the Emergency
Preparedness final rule (81 FR 63930), we will assume that the same
individuals involved with developing training would typically also
develop the scenarios, materials, as well as any accompanying
documentation associated with testing exercises. Based on May 2017 BLS
salary data, we calculated the hourly mean wage for each position for
this requirement identified in the Emergency Preparedness final rule
(81 FR 63930) and decreased the cost by 50 percent due to the 50
percent reduction in the frequency requirement.
We estimate that the proposed change will accrue a total annual
cost savings of $9,296,423 and 100,969 burden hours. We list a detailed
calculation for each facility below, based on facility numbers
available as of May 2017 with a summary of these calculations provided
in Table 12:
ASCs: Combined total savings of $1,091,951 for 5,557 ASCs
((1 burden hour for an administrator at $109 per hour plus 4 burden
hours for a quality improvement RN at $71 per hour) x 5,557 ASCs x 50
percent).
Freestanding/home-based hospices: Combined total savings
of $573,680 for 4,040 hospice facilities (4 burden hours for a RN at
$71 per hour x 4,040 hospices x 50 percent).
PACE: Combined total savings of $41,358 for 233 PACE
organizations (4 burden hours for a home care coordinator at $71 per
hour plus 1 burden hours for a RN at $71 per hour x 233 PACE
organizations x 50 percent).
HHA: Combined total savings of $4,039,680 for 12,624 HHAs
(1 burden hour for an administrator at $107 per hour plus 3 burden
hours for a nursing
[[Page 51771]]
director at $107 per hour plus 1 burden hours for a director of rehab
at $85 per hour plus 1 burden hour for an office manager at $56 per
hour plus 1 burden hours for a director of training at $71 x 12,624
HHAs x 50 percent).
CORF: Combined total savings of $56,212 for 188 CORFs (4
burden hours for an administrator at $107 per hour plus 2 burden hours
for a physical therapist at $85 per hour x 188 CORFs x 50 percent).
Organizations: Combined total savings of $310,362 for
2,076 organizations (2 burden hours for an administrator at $107 per
hour plus 1 burden hour for a physical therapist at $85 per hour x
2,076 organizations x 50 percent).
CMHCs: Combined total savings of $22,862 for 161 CMHCs (4
burden hours for a psychiatric RN at $71 per hour x 161 CMHCs x 50
percent).
OPOs: Combined total savings of $13,427 for 58 OPOs (3
burden hours for a QAPI director at $107 per hour plus 2 burden hours
for an education coordinator at $71 per hour x 58 OPOs x 50 percent).
RHC/FQHC: Combined total savings of $3,146,891 ((2 burden
hours for an administrator at $107 per hour plus 3 burden hours for a
nurse practitioner/physician assistant at $103 per hour x 4,160 RHCs x
50 percent) $1,087,840 + (2 burden hours for an administrator at $107
per hour plus 3 burden hours for a nurse practitioner/physician
assistant at $103 per hour x 7,874 FQHCs x 50 percent) $2,059,051).
ESRD: As identified in the Emergency Preparedness final
rule (81 FR 64006), the current CFCs already require dialysis
facilities to evaluate their emergency preparedness plan at least
annually (Sec. 494.60(d)(4)(ii)); thus, we expect that all dialysis
facilities are already conducting some type of tests to evaluate their
emergency preparedness plans. As a result, Dialysis facilities are not
included in the burden calculation.
Table 12--Cost Savings: Testing
------------------------------------------------------------------------
Cost savings per Combined total
Provider/ supplier provider/supplier savings
------------------------------------------------------------------------
ASCs.......................... $197 $1,091,951 for 5,557
ASCs.
Hospices (freestanding/home- 142 $573,680 for 4,040
based). hospices.
PACEs......................... 178 $41,358 for 233 PACE
organizations.
HHAs.......................... 320 $4,039,680 for 12,624
HHAs.
CORFs......................... 299 $56,212 for 188
CORFs.
Organizations................. 150 $310,362 for 2,076
Organizations.
CMHCs......................... 142 $22,862 for 161
CMHCs.
OPOs.......................... 232 $13,427 for 58 OPOs.
RHCs/FQHCs.................... 262 $3,146,891
($1,087,840 for
4,160 RHCs and
$2,059,051 for 7,874
FQHCs).
------------------------------------------------------------------------
We received few comments specifically addressing our information
collection cost and burden estimates. Many comments, as previously
discussed, did address specific regulatory changes and with only a few
exceptions, mainly related to long term care facilities, endorsed those
proposals to reduce information collection burdens.
We will submit a revised information collection request to OMB to
account for the burden hour and cost savings.
II. Final Rule: Fire Safety Requirements for Certain Dialysis
Facilities
A. Background
1. Overview
The Life Safety Code (LSC) is a compilation of fire safety
requirements for new and existing buildings, and is updated and
published every 3 years by the National Fire Protection Association
(NFPA), a private, nonprofit organization dedicated to reducing loss of
life due to fire. The Medicare and Medicaid regulations have
historically incorporated these requirements by reference, along with
Secretarial waiver authority. The statutory basis for incorporating
NFPA's LSC into the regulations we apply to Medicare and, as
applicable, Medicaid providers and suppliers is the Secretary of the
Department of Health and Human Services' (the Secretary) authority to
stipulate health, safety and other regulations for each type of
Medicare and (if applicable) Medicaid-participating facility.
Specifically, section 1881(b)(1)(A) of the Social Security Act (the
Act) provides for payments for ``providers of services and renal
dialysis facilities which meet such requirements as the Secretary shall
by regulation prescribe for institutional dialysis services and
supplies. . . .'' Under this statutory authority, the Secretary has set
out ``Conditions for Coverage,'' including LSC compliance requirements,
at 42 CFR part 494, subpart B. Our current LSC provisions are set out
at Sec. 494.60(d).
In implementing the LSC provisions, we have given ourselves the
discretion to waive specific provisions of the LSC for facilities if
application of our rules would result in unreasonable hardship for the
facility, and if the health and safety of its patients would not be
compromised by such waiver. For dialysis facilities, that authority is
set out at Sec. 494.60(d)(4). In addition, the Secretary may accept a
State's fire and safety code instead of the LSC if the Centers for
Medicare & Medicaid Services (CMS) determines that the protections of
the State's fire and safety code are equivalent to, or more stringent
than, the protections offered by the LSC; dialysis facility provisions
to that effect are set out at Sec. 494.60(d)(3). These flexibilities
mitigate the potential unnecessary burdens of applying the requirements
of the LSC to all affected health care facilities.
On May 12, 2012, we published a final rule in the Federal Register,
entitled ``Medicare and Medicaid Program; Regulatory Provisions to
Promote Program Efficiency, Transparency, and Burden Reduction'' (77 FR
29002). In that final rule, we limited the application of LSC
requirements to dialysis facilities either located adjacent to
industrial high hazard areas, and those that did not provide one or
more exits to the outside at grade level from the patient treatment
area level. Subsequently, we proposed to update Life Safety Code
provisions for CMS providers and suppliers, ``Medicare and Medicaid
Programs; Fire Safety Requirements for Certain Health Care Facilities;
Proposed Rule'' (79 FR 21552, April 16, 2014). However, we
inadvertently neglected to include dialysis facilities in this
proposal. Therefore, we issued a proposal specifically for dialysis
facilities, ``Medicare and Medicaid Programs; Fire Safety Requirements
for Certain Dialysis
[[Page 51772]]
Facilities'' (81 FR 76899, November 4, 2016). We are finalizing these
provisions now, with some modifications to the terms of the LSC to
address the unique needs of dialysis facilities. The finalized update
would apply only to dialysis facilities that do not provide one or more
exits to the outside at grade level from the treatment area level (for
instance, in upper floors of a mid-rise or high-rise building). We
would not require other dialysis facilities to comply with NFPA
99[supreg] 2012 edition of the Health Care Facilities Code (NFPA 99)
and NFPA 101[supreg] 2012 edition of the Life Safety Code (NFPA 101)
because we believe that patients in dialysis facilities are generally
capable of unhooking themselves from dialysis machines and self-
evacuating without additional assistance in the event of an emergency.
We believe that in all facilities with at-grade exits, patients would
be able to evacuate the building in a timely fashion. Consequently, we
believe that state and local requirements are sufficient to protect
these patients and staff in the event of an emergency. In accordance
with NFPA 101 sections 20.1.3.7 and 21.1.3.7, we would prohibit
Medicare-approved dialysis facilities from being located adjacent to
industrial high hazard facilities. ``Adjacent to'' is defined as
sharing a wall, ceiling or floor, with a facility.
Defining ``Exit to the Outside at Grade Level From the Patient
Treatment Area Level''
The phrase ``exit to the outside at grade level from the patient
treatment area level'' applies to dialysis facilities that are on the
ground or grade level of a building where patients do not have to
traverse up or down stairways within the building to evacuate to the
outside. Accessibility ramps in the exit area that provide an ease of
access between the patient treatment level and the outside ground level
are not considered stairways.
A dialysis facility which provides one or more exits to the outside
at grade level from patient treatment level and which has a patient
exit path to the outside (which may include an accessibility ramp that
is compliant with NFPA and the Americans with Disabilities Act (ADA))
would be exempt from compliance with the applicable provisions of NFPA
99 and NFPA 101.
B. Provisions of the Proposed Rule and Analysis and Response to Public
Comments
On November 4, 2016 we published a proposed rule to update the
requirements for certain dialysis facilities (81 FR 76899) that do not
provide one or more exits to the outside at grade level from the
patient treatment area to comply with the 2012 edition of the NFPA 101
and NFPA 99.
We are finalizing those requirements for dialysis facilities that
do not provide one or more exits to the outside at grade level from the
patient treatment area level, by incorporating a reference to the 2012
edition of NFPA 101 and NFPA 99. Certified dialysis facilities without
one or more exits to the outside at grade level from the patient
treatment area level are already required to meet the 2000 edition of
the LSC, while other provider and supplier types are required to comply
with the 2012 edition of the NFPA 101 and the NFPA 99 (LSC final rule
published May 4, 2016 at 81 FR 26872).
The NFPA 101[supreg] 2012 edition of the LSC provides minimum
requirements, with due regard to function, for the design, operation
and maintenance of buildings and structures for safety to life from
fire. Its provisions also aid life safety in similar emergencies.
The NFPA 99[supreg] 2012 edition of the Health Care Facilities Code
provides minimum requirements for health care facilities for the
installation, inspection, testing, maintenance, performance, and safe
practices for facilities, material, equipment, and appliances.
1. 2012 Edition of the Life Safety Code
The 2012 edition of the LSC includes new provisions that we believe
are vital to the health and safety of all patients and staff. Our
intention is to ensure that patients and staff continue to experience
the highest degree of fire safety possible. We do review each edition
of the NFPA 101 and NFPA 99 every 3 years to see if there are any
significant provisions that we need to adopt. CMS will continue to
review revisions to ensure we meet proper standards for patient safety.
We have reviewed the 2015 and 2018 edition of the NFPA 101 and NFPA 99
and do not believe that there are any significant provisions that need
to be addressed at this time. Newer buildings are typically built to
comply with the newer versions of the LSC because state and local
jurisdictions often adopt and enforce newer versions of the LSC as they
become available.
We must emphasize that the LSC is not an accessibility code, and
compliance with the LSC does not ensure compliance with the
requirements of the ADA. State and local government programs and
services, including health care facilities, are required to comply with
Title II of the ADA. Private entities that operate public
accommodations such as nursing homes, hospitals, and social service
center establishments are required to comply with Title III of the ADA.
Entities that receive federal financial assistance from the Department
of Health and Human Services, including Medicare and Medicaid, are also
required to comply with section 504 of the Rehabilitation Act of 1973.
The same accessibility standards apply regardless of whether health
care facilities are covered under Title II or Title III of the ADA or
section 504 of the Rehabilitation Act of 1973.\1\ For more information
about the ADA's requirements, see the Department of Justice's website
at https://www.ada.gov or call 1-800-514-0301 (voice) or 1-800-514-0383
(TTY).
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\1\ Facilities newly constructed or altered after March 15, 2012
must comply with the 2010 Standards for Accessible Design (2010
Standards). Facilities newly constructed or altered between
September 15, 2010 and March 15, 2012 had the option of complying
with either the 1991 Standards for Accessible Design (1991
Standards) or the 2010 Standards. Facilities newly constructed
between January 26, 1993 and September 15, 2010, or altered between
January 26, 1992 and September 15, 2010 were required to comply with
the 1991 Standards under Title III and either the 1991 Standards or
the Uniform Federal Accessibility Standards under Title II.
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2. Incorporation by Reference
This final rule will incorporate by reference the NFPA 101[supreg]
2012 edition of the LSC, issued August 11, 2011, and Tentative Interim
Amendments (TIAs) issued prior to April 16, 2014; and the NFPA
99[supreg]2012 edition of the Health Care Facilities Code, issued
August 11, 2011, and TIAs issued prior to April 16, 2014 in Sec.
494.60(f).
(1) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011;
(i) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
(iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
(iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) NFPA 99, Standards for Health Care Facilities Code of the
National Fire Protection Association 99, 2012 edition, issued August
11, 2011.
(i) TIA 12-2 to NFPA 99, issued August 11, 2011.
(ii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iii) TIA 12-4 to NFPA 99, issued March 7, 2013.
(iv) TIA 12-5 to NFPA 99, issued August 1, 2013.
(v) TIA 12-6 to NFPA 99, issued March 3, 2014.
These materials have been previously incorporated by reference for
other
[[Page 51773]]
provider and supplier types by the final rule, ``Medicare and Medicaid
Programs; Fire Safety Requirements for Certain Health Care Facilities''
published on May 4, 2016 (81 FR 26872).
The materials that are incorporated by reference can be found for
interested parties and are available for inspection at the CMS
Information Resource Center, 7500 Security Boulevard, Baltimore, MD
21244, or from the National Fire Protection Association, 1 Batterymarch
Park, Quincy, MA 02269. If any changes to these editions of the Codes
are incorporated by reference, CMS will publish a document in the
Federal Register to announce those changes.
The 2012 edition of the NFPA 101 (including the TIAs) provides
minimum requirements, with due regard to function, for the design,
operation and maintenance of buildings and structures for safety to
life from fire. Its provisions also aid life safety in similar
emergencies.
The 2012 edition of the NFPA 99 (including the TIAs) provides
minimum requirements for health care facilities for the installation,
inspection, testing, maintenance, performance, and safe practices for
facilities, material, equipment, and appliances, including other
hazards associated with the primary hazards.
3. Ambulatory Health Care Occupancies
According to our memorandum, ``Survey & Certification: 13-47-LSC/
ESRD,'' issued July 12, 2013, dialysis facilities that are subject to
the LSC provisions must meet the requirements of the Ambulatory Health
Care Occupancy chapters 20 and 21 of the LSC. Dialysis facilities that
are not subject to our LSC regulations must continue to meet State and
local fire codes. (See https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-47.pdf.)
The following are key provisions in the 2012 edition of the LSC
from Chapter 20, ``New Ambulatory Health Care Occupancies'' and Chapter
21, ``Existing Ambulatory Health Care Occupancies.'' We have provided
the LSC citation and a description of the requirement.
The 2012 edition of the LSC defines an ``Ambulatory Health Care
Occupancy'' as a facility capable of treating 4 or more patients
simultaneously on an outpatient basis. We believe that dialysis
facilities that do not provide one or more exits to the outside at
grade level from the patient treatment area should also be required to
meet the provisions applicable to Ambulatory Health Care Occupancy
Chapters, regardless of the number of patients served, as a matter of
health and safety of patients receiving services in these facilities.
In the burden reduction final rule, published in the Federal Register
on May 12, 2012 entitled, ``Medicare and Medicaid Program; Regulatory
Provisions to Promote Program Efficiency, Transparency, and Burden
Reduction'' (77 FR 29002), we removed the provision's applicability to
dialysis facilities with at-grade exits directly from the treatment
area because, in our view, there was, and continues to be, an extremely
low risk of fire in dialysis facilities. Medicare-approved dialysis
facilities that provide exits to the outside at grade level would
continue to be required to follow State and local fire codes, which we
believe provide for sufficient patient protection in the event of an
emergency. If a facility's exits were located above or below grade,
patients would require more time to evacuate. Consequently, we believe
that the LSC would still be required due to the additional risk
entailed in longer exit times.
Sections 20.3.2.1 and 21.3.2.1--Doors
This provision requires all doors to hazardous areas be self-
closing or close automatically.
Sections 20.3.2.6 and 21.3.2.6--Alcohol Based Hand Rubs
This provision explicitly allows aerosol dispensers, in addition to
gel hand rub dispensers. The aerosol dispensers are subject to
limitations on size, quantity, and location, just as gel dispensers are
limited. Automatic dispensers are also now permitted in ambulatory care
facilities, provided, among other things, that--(1) they do not release
contents unless they are activated; (2) the activation occurs only when
an object is within 4 inches of the sensing device; (3) any object
placed in the activation zone and left in place must not cause more
than one activation; (4) the dispenser must not dispense more than the
amount required for hand hygiene consistent with the label
instructions; (5) the dispenser is designed, constructed and operated
in a way to minimize accidental or malicious dispensing; and (6) all
dispensers are tested in accordance with the manufacturer's care and
use instructions each time a new refill is installed. The provision
further defines prior language regarding ``above or adjacent to an
ignition source'' as being ``within 1 inch'' of the ignition source.
Sections 20.3.5 and 21.3.5--Extinguishment Requirements
This provision is related to sprinkler system requirements and
requires the evacuation of a building or the instituting of an approved
fire watch when a sprinkler system is out of service for more than 10
hours in a 24-hour period until the system has been returned to
service. A facility must evacuate the building or portion of the
building affected by the system outage until the system is back in
service, or establish a fire watch until the system is back in service.
4. 2012 Edition of the Health Care Facilities Code
The 2012 edition of the NFPA 99, ``Health Care Facilities Code,''
addresses requirements for both health care occupancies and ambulatory
care occupancies, and serves as a resource for those who are
responsible for protecting health care facilities from fire and
associated hazards. The purpose of this Code is to provide minimum
requirements for the installation, inspection, testing, maintenance,
performance, and safe practices for health care facility materials,
equipment and appliances. This Code is a compilation of documents that
have been developed over a 40-year period by NFPA, and is intended to
be used by those persons involved in the design, construction,
inspection, and operation of health care facilities, and in the design,
manufacture, and testing of appliances and equipment used in patient
care areas of health care facilities. It provides information on
subjects, for example, medical gas and vacuum systems, electrical
systems, electrical equipment, and gas equipment. The NFPA 99 applies
specific requirements in accordance with the results of a risk-based
assessment methodology. A risk-based approach allows for the
application of requirements based upon the types of treatment and
services being provided to patients or residents rather than the type
of facility in which they are being performed. In order to ensure the
minimum level of protection afforded by NFPA 99 is applicable to all
patient and resident care areas within a health care facility, we
proposed adoption of the 2012 edition of NFPA 99, with the exception of
chapters 7--``Information Technology and Communications Systems for
Health Care Facilities''; 8--``Plumbing''; 12--``Emergency
Management''; and 13--``Security Management''. The first three chapters
of the NFPA 99 address the administration of the NFPA 99, the
[[Page 51774]]
referenced publications, and definitions. Short descriptions of some of
the more important provisions of NFPA 99 follow:
Chapter 4--Fundamentals
Chapter 4 provides guidance on how to apply NFPA 99 requirements to
health care facilities based upon ``categories'' determined when using
a risk-based methodology.
There are four categories utilized in the risk assessment
methodology, depending on the types of treatment and services being
provided to patients or residents. Section 4.1.1 of NFPA 99 describes
Category 1 as, ``Facility systems in which failure of such equipment or
system is likely to cause major injury or death of patients or
caregivers. . . .'' Section A.4.1.1 provides examples of what a major
injury could include, such as amputation or a burn to the eye. Section
4.1.2 describes Category 2 as, ``Facility systems in which failure of
such equipment is likely to cause minor injury to patients or
caregivers. . . .'' Section A.4.1.2 describes a minor injury as one
that is not serious or involving risk of life. Section 4.1.3 describes
Category 3 as, ``Facility systems in which failure of such equipment is
not likely to cause injury to patients or caregivers, but can cause
patient discomfort. . . .'' Section 4.1.4 describes Category 4 as,
``Facility systems in which failure of such equipment would have no
impact on patient care. . . .''
Section 4.2 requires that each facility that is a health care or
ambulatory occupancy define its risk assessment methodology, implement
the methodology, and document the results. We did not propose to
require the use of any particular risk assessment procedure. However,
if future situations indicate the need to define a particular risk
assessment procedure, we would pursue that through a separate notice
and comment rulemaking.
Chapter 5--Gas and Vacuum Systems
The hazards addressed in Chapter 5 include the ability of oxygen
and nitrous oxide to exacerbate fires, safety concerns from the storage
and use of pressurized gas, and the reliance upon medical gas and
vacuum systems for patient care. Chapter 5 does not mandate the
installation of any systems; rather, if they are installed or are
required to be installed, the systems will be required to comply with
NFPA 99. Chapter 5 covers the performance, maintenance, installation,
and testing of the following:
Non-flammable medical gas systems with operating pressure
below a gauge pressure of 300 psi;
Vacuum systems in health care facilities;
Waste anesthetic gas disposal systems (WAGD); and
Manufactured assemblies that are intended for connection
to the medical gas, vacuum, or WAGD systems.
Chapter 6--Electrical Systems
The hazards addressed in Chapter 6 are related to the electrical
power distribution systems in health care facilities, and address
issues such as electrical shock, power continuity, fire, electrocution,
and explosions that might be caused by faults in the electrical system.
Chapter 6 also covers the performance, maintenance, and testing of the
electrical systems in health care facilities.
Chapter 9--Heating, Ventilation, and Air Conditioning (HVAC)
Chapter 9 requires HVAC systems serving spaces or providing health
care functions to be in accordance with the American Society of
Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE) Standard
170--Ventilation of Health Care Facilities (2008 edition) (https://www.ashrae.org).
Chapter 9 does not apply to existing HVAC systems, but applies to
the construction of new health care facilities, and the altered,
renovated, or modernized portions of existing systems or individual
components. Chapter 9 ensures minimum levels of heating, ventilation
and air conditioning performance in patient and resident care areas.
Some of the issues discussed in Chapter 9 are as follows:
HVAC system energy conservation;
Commissioning;
Piping;
Ductwork;
Acoustics;
Requirements for the ventilation of medical gas storage
and trans-filling areas;
Waste anesthetic gases;
Plumes from medical procedures;
Emergency power system rooms; and
Ventilation during construction.
Chapter 10--Electrical Equipment
Chapter 10 covers the performance, maintenance, and testing of
electrical equipment in health care facilities. Much of this chapter
applies to requirements for portable electrical equipment in health
care facilities, but there are also requirements for fixed-equipment
and information on administrative issues.
Chapter 11--Gas Equipment
The hazards addressed in Chapter 11 relate to general fire,
explosions, and mechanical issues associated with gas equipment,
including compressed gas cylinders.
Chapter 14--Hyperbaric Facilities
Chapter 14 addresses the hazards associated with hyperbaric
facilities in health care facilities, including electrical, explosive,
implosive, as well as fire hazards. Chapter 14 sets forth minimum
safeguards for the protection of patients and personnel administering
hyperbaric therapy and procedures. Chapter 14 contains requirements for
hyperbaric chamber manufacturers, hyperbaric facility designers, and
personnel operating hyperbaric facilities. It also contains
requirements related to construction of the hyperbaric chamber itself
and the equipment used for supporting the hyperbaric chamber, as well
as administration and maintenance. Many requirements in this chapter
are applicable only to new construction and new facilities.
Chapter 15--Features of Fire Protection
Chapter 15 covers the performance, maintenance, and testing of fire
protection equipment in health care facilities. Issues addressed in
this chapter range from the use of flammable liquids in an operating
room to special sprinkler protection. These fire protection
requirements are independent of the risk-based approach, as they are
applicable to all patient care areas in both new and existing
facilities.
Chapter 15 has several sections taken directly from the NFPA 101,
including requirements for the following:
Construction and compartmentalization of health care
facilities.
Laboratories.
Utilities.
Heating, ventilation and air conditioning systems.
Elevators.
Escalators.
Conveyors.
Rubbish Chutes.
Incinerators.
Laundry Chutes.
Fire detection, alarm and communication systems.
Automatic sprinklers and other extinguishing equipment.
Compact storage including mobile storage and maintenance.
Testing of water based fire protection systems.
These sections have requirements for inspection, testing and
maintenance which apply to all facilities, as well as
[[Page 51775]]
specific requirements for existing systems and equipment that also
apply to all facilities.
The prospective timeline for applicability of these
requirements would be 60 days after the publication of the final rule
in the Federal Register. We solicited comments on the proposal of the
adoption of the 2012 NFPA 101 and the 2012 NFPA 99 for dialysis
facilities that do not provide one or more exits to the outside at
grade level from the treatment area level in the proposed rule ``Fire
Safety Requirements for Certain Dialysis Facilities,'' published
November, 4, 2016 (81 FR 76899).
We received 4 comments and all commenters were in support of the
proposal. Therefore, we are finalizing the adoption of the 2012 NFPA
101 and the 2012 NFPA 99 for dialysis facilities that do not provide
one or more exits to the outside at grade level from the treatment area
level.
Technical Correction
We inadvertently left out the update of Sec. 494.60(d)(2) from the
2000 edition of the Life Safety Code to the 2012 edition of the Life
Safety Code. This update goes along with the overall adoption of the
2012 edition of the Life Safety Code. This will have no impact on
facilities as they are all already meeting the 2012 edition of the Life
Safety Code in accordance with state and local requirements.
C. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
III. Final Rule: Hospital and Critical Access Hospital (CAH) Changes To
Promote Innovation, Flexibility, and Improvement in Patient Care
A. Background
On June 16, 2016, we published a proposed rule in the Federal
Register, ``Medicare and Medicaid Programs; Hospital and Critical
Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and
Improvement in Patient Care'' (81 FR 39447), to revise a number of
hospital and CAH requirements, including those focused on infection
control, antibiotic use, and antidiscrimination. We are now finalizing
several of the proposed changes in order to modernize the hospital and
critical access hospital (CAH) requirements, improve quality of care,
and support HHS and CMS priorities. We believe that benefits of these
finalized requirements will include: Reduced incidence of hospital-
acquired conditions (HACs), including reduced incidence of healthcare-
associated infections (HAIs); reduced inappropriate antibiotic use;
reduced regulatory burden and increased cost savings for hospitals,
CAHs, and insurers; and strengthened patient protections overall.
Specifically, we proposed to revise the conditions of participation
(CoPs) for hospitals and CAHs to address:
Discriminatory behavior by healthcare providers that may
create real or perceived barriers to care;
A requirement regarding a patient's right to access his or
her own medical records, including in an electronic format;
Continued use of the term ``Licensed Independent
Practitioners'' (LIPs), which might inadvertently exacerbate workforce
shortage concerns, might unnecessarily impose regulatory burden on
hospitals by restricting a hospital's ability to allow non-physician
practitioners such as physician assistants (PAs) to operate within the
scope of practice allowed by state law, and does not recognize the
benefits to patient care that might be derived from fully utilizing PAs
and their clinical skills to the highest levels of their training,
education, and experience as allowed by hospital policy in accordance
with state law;
The use of quality reporting program data by hospital
Quality Assessment and Performance Improvement (QAPI) programs;
Requirements in the Nursing services CoP to improve
clarity and provide some regulatory flexibility and burden relief;
Requirements in the Medical records services CoP to
improve clarity regarding the distinctions between a patient's
inpatient and outpatient status and the subtle differences between
certain aspects of medical record documentation related to each status;
Requirements that do not fully conform to current
standards for infection control for both hospitals and CAHs;
Requirements for antibiotic stewardship programs to help
reduce inappropriate antibiotic use and antimicrobial resistance for
both hospitals and CAHs;
A requirement for CAHs that would allow a patient's
nutritional needs to be met in accordance with recognized dietary
practices and the orders of the practitioner responsible for the care
of the patients, or by a qualified dietician or qualified nutrition
professional as authorized by the medical staff in accordance with
State law; and
Requirements for CAHs to establish a quality assessment
and performance improvement program (QAPI).
B. Provisions of the Proposed Regulations and Responses to Public
Comments for Hospitals (42 CFR Part 482)
1. General Comments
In response to the proposed rule, we received 200 public comments.
Commenters included individuals, healthcare professionals and
corporations, national associations and coalitions, state health
departments, patient advocacy organizations, and individual facilities
that would be impacted by the regulation.
Generally, most comments expressed support for the regulatory
changes. We have provided a summary of the public comments, our
responses to those comments, and any changes made as a result of those
comments in the proceeding sections. Several commenters expressed
concern that we underestimated the time and effort required for
compliance with the antibiotic stewardship and QAPI requirements,
especially for smaller hospitals, including CAHs. Commenters requested
a delayed implementation for these requirements.
2. Implementation Timeframe
Comment: We received several comments stating that we have
underestimated the time necessary to implement some of the requirements
contained in this rule. Some commenters stated that the proposed
hospital and CAH infection control and antibiotic stewardship and QAPI
provisions required additional time to implement. These commenters
requested that we grant additional time for the implementation for
these requirements. Commenters cited challenges associated with
implementing these requirements, especially for small, rural hospitals
and CAHs including obtaining and training appropriate staff for the
required positions.
Response: We understand the complexities of the required changes in
this rule for hospitals and CAHs, particularly the effects on CAHs and
small, rural hospitals. As a result, we are using the following
implementation schedule for the provisions of this final rule:
[[Page 51776]]
CAH QAPI requirements--an implementation date that is 18
months after the effective date of this final rule;
Hospital and CAH compliance with the antibiotic
stewardship requirements--an implementation date that is six months
from the effective date of this final rule; and
All other requirements, including those for patient's
rights--an implementation date that is 60 days from the publication of
this final rule.
3. Non-Discrimination
We proposed to establish at Sec. 482.13(i) for hospitals and Sec.
485.635 (g) for CAHs, explicit requirements that a hospital (or CAH)
not discriminate on the basis of race, color, religion, national
origin, sex (including gender identity), sexual orientation, age, or
disability and that the hospital (or CAH) establish and implement a
written policy prohibiting discrimination on the basis of race, color,
religion, national origin, sex (including gender identity), sexual
orientation, age, or disability.
We proposed to further require that each patient, (and/or support
person, where appropriate), is informed, in a language he or she can
understand, of the right to be free from discrimination against them on
any of these bases when he or she is informed of his or her other
rights under Sec. 482.13(i) (or Sec. 485.635(g)). In addition, we
proposed to require that the hospital (or CAH) inform the patient and/
or representative, and/or support person, on how he or she can seek
assistance if they encounter discrimination.
Comment: We received numerous comments that expressed support for
this proposal and also discussed the potential benefits of the proposal
to patients. In addition, we received comments that expressed concern
about the consequences of the implementation of this proposal and
suggested modifications to our proposed requirement. Commenters also
discussed potential technical difficulties that may exist when
implementing this proposal and they expressed concern that the proposed
requirement may be duplicative of other current federal requirements.
Response: In response to these comments, we are not finalizing the
proposal to require explicit non-discrimination requirements in the
CoPs and we are instead deferring to the non-discrimination
requirements of Section 1557 of the Affordable Care Act.
Final Action: We are not finalizing proposed Sec. 482.13(i) and
Sec. 485.635(g).
4. Licensed Independent Practitioner
We proposed to delete the modifying term ``independent'' from the
CoPs at Sec. 482.13(e)(5), as well as at Sec. 482.13(e)(8)(ii), and
also proposed to revise the provision to be in keeping with the
language of the Children's Health Act of 2000 (Pub. L. 106-310) (CHA)
regarding restraint and seclusion orders and licensed practitioners.
Therefore, we proposed that Sec. 482.13(e)(5) read that the use of
restraint or seclusion must be in accordance with the order of a
physician or other licensed practitioner who is responsible for the
care of the patient and authorized to order restraint or seclusion by
hospital policy in accordance with State law. We proposed that Sec.
482.13(e)(8)(ii) would state that, after 24 hours, before writing a new
order for the use of restraint or seclusion for the management of
violent or self-destructive behavior, a physician or other licensed
practitioner who is responsible for the care of the patient and
authorized to order restraint or seclusion by hospital policy in
accordance with State law would have to see and assess the patient.
We proposed to revise the provisions in sections Sec.
482.13(e)(10), Sec. 482.13(e)(11), Sec. 482.13(e)(12)(i)(A), Sec.
482.13(e)(14), and Sec. 482.13(g)(4)(ii) that contain the term
``licensed independent practitioner'' by changing the term from
``licensed independent practitioner'' to simply ``licensed
practitioner.'' We also proposed to remove the term ``physician
assistant'' from the current provisions at Sec. 482.13(e)(12)(i)(B)
and Sec. 482.13(e)(14).
Comment: The majority of commenters were supportive of this change.
Specifically, commenters noted that the proposed language change will
remove uncertainty regarding these provisions and clearly demonstrates
that Physician Assistants (PAs) are authorized to order restraint and
seclusion, in accordance with state law and facility policy, when
medically necessary to protect patients and health professionals. One
commenter did not support the removal of the term ``independent'' from
this requirement. The commenter stated that removing the term
``independent'' may make this requirement applicable to other care
providers, such as registered nurses.
Response: We thank commenters for their support of this
requirement. We believe this revision reflects our goal to have health
professionals operate within the scope of practice allowed by state
law, and recognizes the need to fully utilize the healthcare workforce.
We also believe that this change will reduce unnecessary burden for
hospitals and remove obstacles PAs face when ordering seclusion and
restraints. We disagree with the commenters who stated that the removal
of the term ``independent'' will cause confusion over the applicability
of this requirement. Our proposed removal of the term ``independent''
is consistent with the language used in the CHA, which utilizes the
term ``other licensed practitioner'', without the independent modifying
term. In addition, the order of restraint or seclusion must be ordered
by a licensed practitioner who is authorized by hospital policy in
accordance with State law to do so. This would exclude Registered
Nurses or other hospital staff, who either through State law or
hospital policy, would not have the authorization to order the use of
restraints and seclusion.
After consideration of the comments we received, we are finalizing
this proposal, without modification.
Final Action: We are finalizing the following revisions to Sec.
482.13:
1. Remove the modifying term ``independent'' from the CoPs at Sec.
482.13(e)(5) and Sec. 482.13(e)(8)(ii).
2. Revise Sec. 482.13(e)(5) to state that the use of restraint or
seclusion must be in accordance with the order of a physician or other
licensed practitioner who is responsible for the care of the patient
and authorized to order restraint or seclusion by hospital policy in
accordance with State law.
3. Revise the provisions in sections Sec. 482.13(e)(10), Sec.
482.13(e)(11), Sec. 482.13(e)(12)(i)(A), Sec. 482.13(e)(14), and
Sec. 482.13(g)(4)(ii) that contain the term ``licensed independent
practitioner'' by changing the term to simply ``licensed
practitioner.''
4. Remove the term ``physician assistant'' from the current
provisions at Sec. 482.13(e)(12)(i)(B) and Sec. 482.13(e)(14).
5. Quality Assessment and Performance Improvement (QAPI) Program (Sec.
482.21)
We proposed a minor change to the program data requirements at
Sec. 482.21(b), which would require that the hospital QAPI program
incorporate quality indicator data including patient care data
submitted to or received from quality reporting and quality performance
programs, including but not limited to data related to hospital
readmissions and hospital-acquired conditions
Comment: We received mostly positive feedback regarding this
requirement; however, some commenters asked that we remove the provided
example of ``data related to hospital readmissions and hospital-
acquired conditions.'' Commenters
[[Page 51777]]
believed that the inclusion of this information makes it unclear to
hospitals that they should utilize all data available to them. One
commenter also disagreed with any proposal that would restrict quality
improvement work to a limited number of areas.
Response: We thank the commenters for their feedback. We believe
that this requirement affords hospitals increased flexibility, while
continuing to promote patient safety and quality of care. As revised by
this final rule, the regulation at Sec. 482.21(b)(1) now requires that
the QAPI program ``incorporate quality indicator data including patient
care data, and other relevant data such as data submitted to or
received from Medicare quality reporting and quality performance
programs, including but not limited to data related to hospital
readmissions and hospital-acquired conditions.'' We believe the intent
of the regulation is clear as the language states that the data that
must be incorporated is not limited to data related to hospital
readmissions and hospital-acquired conditions; however, we will ensure
that the intent is also clear in the Interpretive Guidelines for this
requirement. Note that CMS historically releases Interpretive
Guidelines for new regulations after the final rule has been published.
Furthermore, we note that these requirements would not restrict
hospitals to a certain number of quality improvement areas, but they
are instead minimum requirements that hospitals can choose to exceed as
they strive to improve the quality of the services that they provide.
Final Action: We are finalizing Sec. 482.21(b) as proposed.
6. Nursing Services (482.23)
As a result of our internal review of the CoPs for nursing
services, we recognized that some of our requirements might be
ambiguous and confusing due to unnecessary distinctions between
inpatient and outpatient services, or might fail to account for the
variety of ways through which a hospital might meet its nurse staffing
requirements. We proposed to make revisions to the nursing services CoP
to improve clarity. Specifically, we proposed to revise Sec.
482.23(b), which currently states that there must be supervisory and
staff personnel for each department or nursing unit to ensure, when
needed, the immediate availability of a registered nurse for bedside
care of any patient. We proposed to delete the term ``bedside,'' which
might imply only inpatient services to some readers. The nursing
service would have to ensure that patient needs were being met by
ongoing assessments of patients' needs and would have to provide
nursing staff to meet those needs regardless of whether the patient was
an inpatient or an outpatient. There would have to be sufficient
numbers and types of supervisory and staff nursing personnel to respond
to the appropriate nursing needs and care of the patient population of
each department or nursing unit. When needed, a registered nurse would
have to be available to care for any patient. We understand that the
term ``immediate availability'' has been interpreted to mean physically
present on the unit or in the department. We further understand that
there are some outpatient services where it might not be necessary to
have a registered nurse physically present. For example, while it is
clearly necessary to have an RN present in an outpatient ambulatory
surgery recovery unit, it might not be necessary to have an RN on-site
at a hospital MRI facility that is outside the hospital building, but
still on the hospital campus. We proposed to allow a hospital to
establish a policy that would specify which, if any, outpatient
departments would not be required to have an RN physically present as
well as the alternative staffing plans that would be established under
such a policy. We would require such a policy to take into account
factors such as the services delivered, the acuity of patients
typically served by the facility, and the established standards of
practice for such services. In addition, we would propose that the
policy must be approved by the medical staff and be reviewed at least
once every three years. We solicited comments on the need for, the
risks of establishing, and the appropriate criteria we should require
for such an exception.
We also proposed to clarify in (b)(4) (which currently requires
that the hospital must ensure that the nursing staff develops, and
keeps current, a nursing care plan for each patient and that the plan
may be part of an interdisciplinary care plan) that while a nursing
care plan was needed for every patient, the care plan would be expected
to reflect the needs of the patient and the nursing care to be provided
to meet those needs. The care plan for a patient with complex medical
needs and a longer anticipated hospitalization would be more extensive
and detailed than the care plan for a patient with a less complex
medical need expecting only a brief hospital stay. We expect that a
nursing care plan would be initiated and implemented in a timely
manner, include patient goals as part of the patient's nursing care
assessment and, as appropriate, physiological and psychosocial factors
(such as specific physical limitations and available support systems),
physical and behavioral health comorbidities, and patient discharge
planning. In addition, it would have to be consistent with the plan for
the patient's medical care and demonstrate evidence of reassessment of
the patient's nursing care needs, response(s) to nursing interventions,
and, as needed, revisions to the plan.
Finally, we proposed to revise (b)(6) (which currently states that
non-employee licensed nurses working in the hospital must adhere to the
policies and procedures of the hospital and that the director of
nursing service must provide for the adequate supervision and
evaluation of the clinical activities of non-employee nursing
personnel) to clarify that all licensed nurses who provide services in
the hospital must adhere to the policies and procedures of the
hospital. In addition, the director of nursing service must provide for
the adequate supervision and evaluation of the clinical activities of
all nursing personnel (that is, all licensed nurses and any non-
licensed personnel such as nurse aides, orderlies, or other nursing
support personnel who are under the direction of the nursing service)
which occur within the responsibility of the nursing service,
regardless of the mechanism through which those personnel were
obtained. We recognize that there are a variety of arrangements under
which hospitals obtain the services of licensed nurses. Mechanisms may
include direct employment, the use of contract or agency nurses, a
leasing agreement, volunteer services or some other arrangement. No
matter how the services of a licensed nurse were obtained, in order to
ensure the health and safety of patients, all nurses would have to know
and adhere to the policies and procedures of the hospital and there
must be adequate supervision and evaluation of the clinical activities
of all nursing personnel who provide services that occur within the
responsibility of the nursing service. We would expect non-licensed
personnel to be supervised by a licensed nurse.
In addition, we proposed to delete inappropriate references to
Sec. 482.12(c) that are currently in (c)(1) and (3). We discuss these
technical corrections in detail below.
Comment: Commenters expressed concern regarding the removal of the
word ``bedside'' under Sec. 482.23(b), (which stated that there must
be supervisory and staff personnel for each department or nursing unit
to ensure, when needed, the immediate availability of a registered
nurse for
[[Page 51778]]
bedside care of any patient). Commenters noted that our proposed
revision could create confusion in certain inpatient departments and
asked that CMS clarify that each hospital department or nursing unit
should ensure that nurse staffing should be immediately available, when
needed. Commenters also asked that we clarify that policies related to
nurse staffing are approved by the hospital's medical staff in
conjunction with nursing leadership. One commenter stated that the
approval of any policies regarding nursing services would be under the
authority of the hospital's director of nursing and medical staff
approval would not be needed as proposed here.
Response: The nursing service must ensure that patient needs are
met by continuously assessing the needs of patients and must provide
nursing staff to meet those needs, regardless of whether the patient is
an inpatient or an outpatient. There must be sufficient numbers and
types of supervisory and staff nursing personnel to meet the nursing
needs and to care for the patient population of each department or
nursing unit. A registered nurse must be available to care for any
patient, as determined by the needs of the patient and hospital policy.
Note that the term ``immediate availability'' has been interpreted to
mean physically present on the unit or in the department. Also note
that there are some outpatient services where it might not be necessary
to have a registered nurse physically present. For example, while it is
clearly necessary to have an RN present in an outpatient ambulatory
surgery recovery unit, it might not be necessary to have an RN on-site
at an off-campus outpatient department where radiology services are
offered. Hospitals are provided the flexibility to establish a policy
that would specify which, if any, outpatient departments would not be
required to have an RN physically present as well as the alternative
staffing plans that would be established under such a policy. Such a
policy must take into account factors such as the services delivered,
the acuity of patients typically served by the facility, and the
established standards of practice for such services. We agree with the
comment that stated that the approval of any nursing services policy
falls under the authority of the hospital's nursing leadership and we
have modified the proposed requirement at Sec. 482.23(b)(7)(iii) to
reflect that in this final rule.
Comment: We received positive comments about the requirement under
Sec. 482.23(b)(4), which requires that the nursing care plan, which is
needed for every patient, reflect the needs of the patient and the
nursing care to be provided to meet those needs. Commenters stated
these changes help ensure that the clinical team is working together
with the patient and the patient's family to ensure that the team is
continuously working towards meeting the established patient goals.
However, as evidenced by some comments, there appears to exist some
confusion over whether a nursing care plan is required for both
inpatients and outpatients or if it is required for inpatients only.
Response: We appreciate the positive feedback received for this
requirement. Initiating a nursing care plan for patients that reflects
the needs of the patient will lead to better patient outcomes and has
the potential to decrease length of stay.
Regarding the question of which patients (all patients or only
inpatients) are required to have a nursing care plan, we must look at
both the regulatory text and the interpretive guidance contained in the
SOM, Appendix A, Section A-0396, for this provision. While the actual
regulatory text has always simply used the term, ``patient,'' implying
both inpatients and outpatients, other areas of the CoPs specifically
use the term ``inpatient'' as does the language of the Act
(specifically with regard to nursing services) as well as other
instances in the CoPs that refer to patient ``admissions,'' which
further implies inpatients. Additionally, the interpretive guidance for
this provision in the SOM, Appendix A, has traditionally held that the
requirement for a nursing care plan only applies to patients after
their ``admission,'' (that is, inpatients only) (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_a_hospitals.pdf, p. 224).
While we believe that nursing care plans most appropriately, and in
most instances, apply only to inpatients, we urge hospitals to review
their policies and procedures in this area to determine if there are
outpatients where a nursing care plan would be appropriate and should
be required for the benefit of the patient's health and safety and for
improved outcomes. For instance, hospitals should look at the policies
that they develop for the provisions that we are finalizing here, at
Sec. 482.23(b)(7), regarding those policies and procedures that must
be in place to establish which outpatient departments, if any, are not
required under hospital policy to have a registered nurse present. As
we discussed previously, that while it is clearly necessary to have an
RN present in an outpatient ambulatory surgery recovery unit, it might
not be necessary to have an RN on-site at a hospital MRI facility that
is outside the hospital building, but still on the hospital campus. In
exercising this policy flexibility provided in this final rule for
reviewing the need for establishing which outpatient units must have an
RN present for patient care and safety, we likewise encourage hospitals
to exercise a similar regulatory flexibility in reviewing their
policies for establishing which types of outpatients would require a
nursing care plan through a similar lens--that is, based on the
services that a patient is receiving and the location in which he or
she is receiving those services. We further believe that the example
provided here regarding the requirement differences in the patient's
needs for having an RN present, which clearly exist between an
outpatient undergoing ambulatory surgery and one receiving an MRI or
other radiologic services, is entirely relevant to the considerations
for determining which patient needs a nursing care plan.
Comment: We received positive feedback regarding Sec.
482.23(b)(6), in which we proposed to clarify that all licensed nurses
who provide services in the hospital must adhere to the policies and
procedures of the hospital and addresses the supervision and evaluation
of the clinical activities of all nursing personnel. Commenters
appreciated the clarification of the requirements in this in calling
for adequate supervision and evaluation of all nursing personnel. One
commenter asked that we clarify that nursing leadership is responsible
for ensuring that there are clear lines of reporting and supervision.
Response: We appreciate the comments received on the proposed
requirement. We expect all nursing personnel to have a clear
understanding of the reporting and supervisory structure and it is the
responsibility of nursing leadership to ensure that there are clear
lines of reporting and supervision. This requirement must be met
regardless of the employment type or status of the nursing personnel,
including but not limited to those employed via direct employment, the
use of contract or agency nurses, a leasing agreement, volunteer
services or some other arrangement. No matter how the services of a
licensed nurse are obtained, in order to ensure the health and safety
of patients, all nurses must know and adhere to the policies and
procedures of the hospital and there must be adequate supervision and
evaluation of the clinical activities of all nursing personnel who
provide services
[[Page 51779]]
that occur within the responsibility of the nursing service. We would
expect non-licensed personnel to be supervised by a licensed nurse.
Final Decision: After consideration of the comments we received on
the proposed rule, we are finalizing Sec. 482.23 as proposed with the
exception of the proposed requirement at Sec. 482.23(b)(7)(iii), which
we have revised in response to comments by replacing ``medical staff''
with ``director of nursing,'' and which we are finalizing here.
7. Medical Record Services (Sec. 482.24)
We proposed to revise Sec. 482.24(c) to require that the content
of the medical record contain information to justify all admissions and
continued hospitalizations, support the diagnoses, describe the
patient's progress and responses to medications and services, and
document all inpatient stays and outpatient visits to reflect all
services provided to the patient.
Similarly, we proposed to revise Sec. 482.24(c)(4)(ii) to include
``all diagnoses specific to each inpatient stay and outpatient visit,''
which would include specifying any admitting diagnoses. At Sec.
482.24(c)(4)(iv), we proposed to require that the content of the record
include documentation of complications, hospital-acquired conditions,
healthcare-associated infections, and adverse reactions to drugs and
anesthesia. We also propose changes to Sec. 482.24(c)(4)(vi) to add
``progress notes. . . interventions, responses to interventions . . .''
to the required documentation of ``practitioners' orders'' to emphasize
the necessary documentation for both inpatients and outpatients. We
also proposed to add the phrase ``to reflect all services provided to
the patient,'' so that the entire provision would now read that the
content of the record must contain all practitioners' progress notes
and orders, nursing notes, reports of treatment, interventions,
responses to interventions, medication records, radiology and
laboratory reports, and vital signs and other information necessary to
monitor the patient's condition and to reflect all services provided to
the patient.
We proposed to change Sec. 482.24(c)(4)(vii) to require that all
patient medical records document discharge and transfer summaries with
outcomes of all hospitalizations, disposition of cases, and provisions
for follow-up care for all inpatient and outpatient visits to reflect
the scope of all services received by the patient.
Finally, we proposed to revise Sec. 482.24(c)(4)(viii) so that the
content of the medical record would contain final diagnoses with
completion of medical records within 30 days following all inpatient
stays, and within 7 days following all outpatient visits.
Comment: The comments we received on these proposed changes were
concerned that the medical records documentation revisions would be
unduly burdensome and confusing regarding distinctions between the
requirements for inpatients versus outpatients. Commenters also
expressed concerns over the ongoing interplay between EHRs and paper-
based records systems and EHR interoperability issues that may arise.
Response: We appreciate the commenter's feedback regarding these
proposals. We agree that the proposed changes to the medical records
documentation requirements would impose an additional undue burden on
hospitals and we are therefore not finalizing this proposal at this
time.
Final Action: Based on the public comments, we are not finalizing
the proposed changes to the Medical Records requirements at Sec.
482.24.
8. Infection Prevention and Control and Antibiotic Stewardship Programs
(Sec. 482.42)
We proposed a change to the title of this CoP to ``Infection
prevention and control and antibiotic stewardship programs.'' By adding
the word ``prevention'' to the CoP name, our intent is to promote
larger, cultural changes in hospitals such that prevention initiatives
are recognized on balance with their current, traditional control
efforts. And by adding ``antibiotic stewardship'' to the title, we
would emphasize the important role that a hospital should play in
combatting antimicrobial resistance through implementation of a robust
stewardship program that follows nationally recognized guidelines for
appropriate antibiotic use. Along with these changes, we proposed to
change the introductory paragraph to require that a hospital's
infection prevention and control and antibiotic stewardship programs be
active and hospital-wide for the surveillance, prevention, and control
of HAIs and other infectious diseases, and for the optimization of
antibiotic use through stewardship. We would also require that a
program demonstrate adherence to nationally recognized infection
prevention and control guidelines for reducing the transmission of
infections, as well as best practices for improving antibiotic use
where applicable, and for reducing the development and transmission of
HAIs and antibiotic-resistant organisms. While these particular changes
are new to the regulatory text, it is worth noting that these
requirements, with the exception of the new requirement for an
antibiotic stewardship program, have been present in the Interpretive
Guidelines for hospitals since 2008 (See A0747 at Appendix A--Survey
Protocol, Regulations and Interpretive Guidelines for Hospitals, https://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf).
We also proposed to introduce the term ``surveillance'' into the
text of the regulation. The addition of this term, which is also
already in use in CMS Interpretive Guidelines for hospitals, is being
proposed to bring the regulation up to date by reflecting current
terminology in the field. As has been described in the Interpretive
Guidelines for this regulation, ``surveillance'' includes infection
detection, data collection, and analysis; monitoring; and evaluation of
preventive interventions. (See SOM, Appendix A--Survey Protocol,
Regulations and Interpretive Guidelines for Hospitals, pp. 361-362,
https://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf). In
collaboration with the hospital's QAPI program, the hospital would be
required to develop and implement appropriate infection prevention and
control interventions to address issues identified through its
detection activities.
We also proposed a new requirement that hospitals demonstrate
adherence to nationally recognized infection prevention and control
guidelines, as well as best practices for improving antibiotic use
where applicable, and for reducing the development and transmission of
HAIs and antibiotic-resistant organisms. We realize that, in developing
the patient health and safety requirements that are the hospital CoPs,
particular attention must be paid to the ever-evolving nature of
medicine and patient care. Moreover, a certain degree of latitude must
be left in the requirements to allow for innovations in medical
practice that improve the quality of care and move toward the reduction
of medical errors and patient harm.
Therefore, we intentionally built flexibility into the revised
regulations by proposing language that requires hospitals to
demonstrate adherence to nationally recognized guidelines (and best
practices where applicable) rather than requiring that all hospitals
demonstrate adherence to a specific guideline or set of guidelines for
infection prevention and control and for antibiotic stewardship. While
the CDC guidelines and guidance (for example, guidelines from the
Healthcare Infection
[[Page 51780]]
Control Practices Advisory Committee (HICAPC) and Core Elements of
Hospital Antibiotic Stewardship Programs) represent one set, there are
other sets of nationally recognized guidelines from which hospitals
might choose, such as those established by the Association for
Professionals in Infection Control and Epidemiology (APIC), the Society
for Healthcare Epidemiology of America (SHEA), and the Association of
periOperative Registered Nurses (AORN). The U.S. Occupational Health
and Safety Administration (OSHA) also issues federal regulations
applicable to infection control practices. We believe this approach
will provide hospitals the flexibility they need to select and
integrate those standards that best suit their individual infection
prevention and control and antibiotic stewardship programs. We also
believe this approach will allow hospitals the flexibility to adapt
their policies and procedures in concert with any updates in the
guidelines they have elected to follow.
Comment: A few commenters were concerned that the proposed
requirements for antibiotic stewardship programs would dictate the
treatment options for patients with conditions such as Lyme disease.
Some of these commenters were particularly concerned about the proposed
rule's reference to IDSA antibiotic stewardship program guidelines.
Response: We proposed to intentionally build flexibility into the
regulation by proposing language that requires hospitals to demonstrate
adherence to nationally recognized guidance and guidelines, rather than
any specific guidance, guideline, or set of guidelines, for best
practices in infection prevention and control and for implementing
antibiotic stewardship programs. For infection control best practices,
CDC guidelines represent a fundamental set of practices, while other
sets of nationally recognized infection control guidance and guidelines
provide further setting- and procedure-specific options from which
hospitals might choose, such as those established by APIC, SHEA, and
IDSA. For the implementation of antibiotic stewardship programs,
guidance is available from several organizations, including IDSA, SHEA,
American Society for Health System Pharmacists, and CDC's Core
Elements.
We appreciate the concerns expressed about the inclusion of
guidelines developed by individual organizations, specifically, the
Infectious Disease Society of America (IDSA). The intention in the
proposed rule was to reference guidance for the implementation of
antibiotic stewardship programs, not treatment guidelines for any
particular infection. The reference to IDSA guidelines explicitly
refers to guidelines for implementing stewardship programs and even
references guidelines from other societies. These guidelines are
referenced specifically because they are the only guidelines that we
are aware of that are dedicated solely to the implementation of
antibiotic stewardship programs in hospitals. We are not requiring that
hospitals choose the IDSA guidelines for antibiotic stewardship
programs specifically, but rather that they choose guidance on
implementing antibiotic stewardship programs from a nationally
recognized source.
Comment: One commenter recommended that rather than focusing on the
explicit roles of two distinct staff, the CoPs instead focus on the
overall process of clinical care and infection management and permit
some flexibility in how hospitals establish each of their programs.
They stated that in their experience, the ASP [antibiotic stewardship
program] is part of the overall ICP [infection control program], which
is broader than antibiotics.
Response: We agree that careful coordination between the infection
prevention and control and antibiotic stewardship programs is essential
and this is stated explicitly in the regulatory text. However, we
believe it is also important to highlight the distinctions between the
two programs. Infection prevention and control programs are almost
exclusively staffed by infection preventionists, the overwhelming
majority of whom do not prescribe or manage antibiotics. Antibiotic
stewardship programs must be staffed by people who are very familiar
with antibiotics. Also, though both groups share some common goals of
reducing antibiotic resistance and C. difficile, the types of
interventions the two programs seek to implement are also fundamentally
different. Finally, the ultimate goals of both programs are different;
infection prevention and control programs seek to eliminate healthcare-
associated infections, while antibiotic stewardship programs seek to
ensure that all patients get optimal antibiotic therapy.
Comment: One commenter stated that, given the size and overall
staff of free-standing IRFs and LTCHs, some facilities may need
additional time to incorporate these new ASP staffing requirements.
Response: We agree that these new provisions might require
additional time to implement beyond the standard 60 days for all
facilities, not just IRFs and LTCHs. Therefore, as discussed above, the
provisions regarding antibiotic stewardship will become effective and
be enforced 6 months after the effective date of this final rule for
all facilities. IRFs and LTCHs are still required to comply with the
hospital CoPs, so changes to the hospital CoPs also apply to IRFs and
LTCHs.
Comment: One commenter appreciated the flexibility afforded in the
requirements regarding the leader of the ASP, but believes there is
value in that position being further defined, and recommend that the
ASP professional requirements be clarified and explicitly state the
person must hold either a formal M.D. or Pharm. D. degree in order to
comply with the regulation.
Response: While this most likely will be the case in practice, we
believe that the requirements should remain flexible for hospitals and
CAHs to make these determinations for themselves. Therefore, we believe
that the hospital leadership should determine the appropriate
qualifications for the leader of the ASP. However, we note here that
the CDC Core Elements of Hospital Antibiotic Stewardship Programs
(https://www.cdc.gov/antibiotic-use/healthcare/implementation/core-elements.html#lead) recommend including both a physician and a
pharmacist (especially those with formal training and experience in
infectious diseases and/or antibiotic stewardship) to co-lead the
hospital AS program and to be accountable for it. We urge hospitals and
CAHs to consider these recommendations when they set their ASP
leadership qualifications and when hiring the appropriate staff to
develop and lead these programs.
Comment: One commenter suggested that in smaller facilities CMS
should give some consideration to flexibility in staffing if the goals
of the program are met and a single person is capable of handling both
roles and ensuring that both priorities are met.
Response: The leaders of the infection prevention and control and
the antibiotic stewardship programs must have the training required to
do those jobs effectively. While there are specific types of knowledge
required to lead each program (that is, knowledge about infection
prevention and control best practices and knowledge about antibiotic
prescribing and antimicrobial resistance), there is nothing in the
regulatory language that would preclude a properly trained person from
leading both programs.
Comment: Several commenters urged us to be flexible in the
implementation of these provisions for all hospitals, but
[[Page 51781]]
especially for smaller hospitals and CAHs, due to the time and effort
it will take to fill leadership positions and develop their programs.
Response: We appreciate this comment and agree. We also agree that
some smaller hospitals and CAHs may need extra technical assistance to
implement the new provisions in a way that truly improves patient care.
We are committed to partnering with federal and other partners to
provide that assistance. For example, the CDC initiated an effort with
The American Hospital Association, the Federal Office of Rural Health
Policy, and the Pew Charitable Trusts to work with several CAHs that
have successful antibiotic stewardship programs to learn best practices
and implementation suggestions that can be shared with other critical
access hospitals. The Implementation of Antibiotic Stewardship Core
Elements at Small and Critical Access Hospitals and related tools
released in 2017 provides guidance on practical strategies to implement
antibiotic stewardship programs in small and critical access hospitals
(https://www.cdc.gov/antibiotic-use/healthcare/implementation/core-elements-small-critical.html).
Comment: One commenter did not support our proposal to require that
the leaders of the infection prevention and control and antibiotic
stewardship programs be specifically appointed by the governing body of
a hospital or CAH.
Response: We appreciate this concern. The goal of this proposed
requirement was to ensure that the infection prevention and antibiotic
stewardship leaders are vested with authority from the leadership of
the hospital or CAH. To maintain this concept while allowing more
flexibility, we have changed these requirements for hospitals and CAHs.
Specifically, we have revised sections Sec. Sec. 482.42(a)(1) and
485.640(a)(1) of the final rule to provide that the hospital (or CAH)
must ensure that an individual (or individuals), who are qualified
through education, training, experience, or certification in infection
prevention and control, are appointed as the infection
preventionist(s)/infection control professional(s) responsible for the
infection prevention and control program. The selection process must
include meaningful opportunity for input from members of the medical
and nursing staffs and leadership.
We have also revised Sec. Sec. 482.42(b)(1) and 485.640(b)(1) to
now provide that the hospital (or CAH) ensure that an individual (or
individuals), who is qualified through education, training, or
experience in infectious diseases and/or antibiotic stewardship, is
appointed as the leader(s) of the antibiotic stewardship program. The
selection process must include meaningful opportunity for input from
members of the medical, nursing, and pharmacy staffs.
Comment: One commenter urged CMS to modify the proposed standards
regarding the demonstration of improvements in antibiotic stewardship.
The commenter does not believe it is appropriate or accurate to solely
use antibiotic resistance within the hospital to demonstrate antibiotic
stewardship program success or evaluate a hospital's antibiotic
stewardship efforts. The commenter states that numerous external
factors contribute to resistance patterns, including prescribing
patterns of local practitioners who may not be connected to the
hospital, community-onset infections, and patient transfers from other
facilities. The commenter further noted that it can be difficult to
demonstrate meaningful improvement over a short period of time.
Response: We appreciate the suggestion and have modified and also
deleted elements of this language for both hospitals and CAHs at
Sec. Sec. 482.42(b)(2)(iii) and 485.640(b)(2)(iii), respectively, to
require that hospital and CAH ASPs must ``document any'' improvements,
including sustained improvements, in proper antibiotic use. We agree
that it would not be appropriate to use antibiotic resistance within
the hospital (or CAH) as the sole criterion to demonstrate antibiotic
stewardship program success or to evaluate a hospital's (or CAH's)
antibiotic stewardship efforts. Therefore, we have deleted this portion
of the regulatory language at Sec. Sec. 482.42(b)(2)(iii) and
485.640(b)(2)(iii). We believe that this will provide hospitals and
CAHs the ability to record any category of improvement in proper
antibiotic use and will not restrict ASPs to demonstrating specific
types of improvements like decreased antibiotic resistance (though ASPs
are still encouraged to document any improvements in this area). These
revisions will also implicitly acknowledge that there often external
factors, as noted by the commenter, that can negatively contribute to
antibiotic resistance in the facility and that can also negatively
impact meaningful improvements in this area in the short term.
Hospitals and CAHs will still need to ensure that their ASPs are
following nationally recognized guidelines and best practices while
documenting the evidence-based use of antibiotics.
Comment: One commenter recommended that in order to clarify the
organization of the antibiotic stewardship and infection prevention and
control programs, the following change be made to the existing language
in the preamble of the proposed rule: ``Antibiotic Stewardship, as a
component of controlling infection, has long been recognized as one of
the special challenges that hospitals must meet in order to address the
problems of multidrug-resistant organisms and Clostridium difficile
infections (CDIs) in hospitals and outpatient settings.''
Response: We appreciate this commenter's recognition of the
importance of the antibiotic stewardship and infection prevention and
control programs.
Final Decision: After consideration of the comments we received on
the proposed rule, we are finalizing Sec. 482.42 with some minor
modifications to the overall regulatory language and with the following
more substantive modifications:
Revise and finalize the language of Sec. Sec.
482.42(a)(1) and 485.640(a)(1) to now require: ``An individual (or
individuals), who is qualified through education, training, experience,
or certification in infection prevention and control, is appointed as
the infection preventionist(s)/infection control professional(s)
responsible for the infection prevention and control program. The
selection process must include meaningful opportunity for input from
members of the medical and nursing staffs.''
Revise and finalize the language of Sec. Sec.
482.42(b)(1) and 485.640(b)(1) to now require: ``An individual (or
individuals), who is qualified through education, training, or
experience in infectious diseases and/or antibiotic stewardship, is
appointed as the leader(s) of the antibiotic stewardship program. The
selection process must include meaningful opportunity for input from
members of the medical, nursing, and pharmacy staffs.''
Revise and finalize the language at Sec. Sec.
482.42(b)(2)(iii) and 485.640(b)(2)(iii) to now require: ``Documents
any improvements, including sustained improvements, in proper
antibiotic use.''
9. Technical Corrections
Technical Amendments to Sec. 482.27(b)(7)(ii) and Sec. 482.27(b)(11)
In the final rule ``Medicare and Medicaid Programs; Hospital
Conditions of Participation: Laboratory Services,'' amending 42 CFR
482.27 (72 FR 48562, 48573, Aug. 24, 2007), we stated that
[[Page 51782]]
HCV notification requirements for donors tested before February 20,
2008, would expire on August 24, 2015, in accordance with 21 CFR
610.48. Since the notification requirement period has expired, we
proposed to remove Sec. 482.27(b)(11), ``Applicability'' and the
corresponding requirements set out at Sec. 482.27(b)(7)(ii).
Corrected Reference in Sec. 482.58
In our review of the Hospital Conditions of Participation, we found
an incorrect cross-reference at Sec. 482.58(b)(6), which currently
reads ``Discharge planning (Sec. 483.20(e))''. Subsection 483.20(e)
addresses coordination of the preadmission screening and resident
review program, not discharge planning. SNF requirements for discharge
plans are set out at Sec. 483.20(l). Therefore, we proposed to correct
the reference to read ``Discharge summary (Sec. 483.20(l))''.
Removal of Inappropriate References to Sec. 482.12(c)(1)
Upon our review of the Hospital CoPs for the proposed rule, we
discovered that there were several provisions that incorrectly
reference Sec. 482.12(c)(1), which lists the types of physicians and
applies only to patients who are Medicare beneficiaries. Section
482.12(c) states that the governing body of the hospital must ensure
that every Medicare patient is under the care of one of the following
practitioners:
A doctor of medicine or osteopathy;
A doctor of dental surgery or dental medicine who is
legally authorized to practice dentistry by the State and who is acting
within the scope of his or her license;
A doctor of podiatric medicine, but only with respect to
functions which he or she is legally authorized by the State to
perform;
A doctor of optometry who is legally authorized to
practice optometry by the State in which he or she practices;
A chiropractor who is licensed by the State or legally
authorized to perform the services of a chiropractor, but only with
respect to treatment by means of manual manipulation of the spine to
correct a subluxation demonstrated by x-ray to exist; and
A clinical psychologist as defined in Sec. 410.71 of this
chapter, but only with respect to clinical psychologist services as
defined in Sec. 410.71 of this chapter and only to the extent
permitted by State law.
The reference of this ``Medicare beneficiary-only'' requirement in
certain other provisions of the hospital CoPs (which we have listed
below) inappropriately links it to all patients and not Medicare
beneficiaries exclusively. In fact, the Act at Sec. 1861(e)(4) states
that ``every patient with respect to whom payment may be made under
this title must be under the care of a physician except that a patient
receiving qualified psychologist services (as defined in subsection
(ii)) may be under the care of a clinical psychologist with respect to
such services to the extent permitted under State law.'' In accordance
with that provision, we have chosen to apply Sec. 482.12(c) to
Medicare patients. With the exception of a few provisions in the CoPs
such as those directly related to Sec. 482.12(c) described here, the
remainder of the CoPs apply to all patients, regardless of payment
source, and not just Medicare beneficiaries. For example, the Nursing
Services CoP, at Sec. 482.23(c)(1), requires that all ``drugs and
biologicals must be prepared and administered in accordance with
Federal and State laws, the orders of the practitioner or practitioners
responsible for the patient's care as specified under Sec. 482.12(c),
and accepted standards of practice.'' Since the CoPs clearly allow
hospitals to determine which categories of practitioners would be
responsible for the care of other patients, outside the narrow Medicare
beneficiary restrictions of Sec. 482.12(c), this reference is
inappropriate and unnecessarily restrictive of hospitals and their
medical staffs to make these determinations based on State law and
practitioner scope of practice.
In order to clarify that these provisions apply to all patients and
not only Medicare beneficiaries, we proposed to delete any
inappropriate references to Sec. 482.12(c). Therefore, we proposed to
delete references to Sec. 482.12(c) found in the following provisions:
Sec. Sec. 482.13(e)(5), 482.13(e)(8)(ii), 482.13(e)(14), and
482.13(g)(4)(ii) in the Patients' Rights CoP; and Sec. Sec.
482.23(c)(1) and 482.23(c)(3) in the Nursing Services CoP.
Additionally, and in the course of finalizing this rule, we discovered
that we inadvertently failed to propose to delete an inappropriate
reference to Sec. 482.12(c), which is contained in the current
provision at Sec. 482.61(d) in the Special Medical Record Requirements
for Psychiatric Hospitals CoP under the Special Requirements for
Psychiatric Hospitals (regarding which hospital personnel may complete
progress notes). Therefore, in the interests of consistency with the
other revisions here, we are also deleting this reference in this final
rule. We believe this to be a technical correction, for which notice
and comment are unnecessary. We have noted this revision in the
``Waiver of Proposed Rulemaking'' discussion found above at section at
I.B.14. With respect to all of these provisions, the reference to
services provided under the order of a physician or other practitioner
would still apply. We did not receive any comments on these proposed
changes and are therefore finalizing them without change.
C. Provisions of the Proposed Regulations and Responses to Public
Comments for Critical Access Hospitals (42 CFR Part 485)
We identified several priority areas in the CoPs for CAHs (42 CFR
part 485, subpart F) for updates and revisions. We believe that these
proposed regulations would benefit the quality of care provided with a
positive impact on patient satisfaction, length of stay, and,
ultimately, cost per patient. Additionally, we have proposed the
following changes to the CAH CoPs, after considering the resource
restrictions of remote and frontier CAHs.
1. Organizational Structure (Sec. 485.627(b))
This proposal was also included in the Medicare and Medicaid
Programs; Regulatory Provisions To Promote Program Efficiency,
Transparency, and Burden Reduction, Proposed Rule (83 FR 47686). We are
finalizing this proposal in that final rule. We refer readers to the
discussion under Section I.B.8.a for further information regarding this
provision.
2. Periodic Review of Clinical Privileges and Performance (Sec.
485.631(d)(1) Through (2))
We proposed to change the current CoP at Sec. 485.641 to reflect
the current QAPI format used in hospitals. As such, we proposed to
retain the requirements under paragraphs Sec. 485.641(b)(3) through
(4), that are currently found under the ``Periodic evaluation and
quality assurance'' CoP, and relocate them under a new standard under
the ``Staffing and staff responsibilities'' CoP at Sec. 485.631. We
are not changing these requirements and believe that they are still
appropriate for the CAH regulations. Since the current CoP under Sec.
485.631 discusses staffing requirements and responsibilities, we
believe that relocating the requirement under a new standard, entitled
``Periodic Review of Clinical Privileges and Performance'' (Sec.
485.631(d)) is a more appropriate placement for the current provisions
requiring a CAH to evaluate the quality of care provided by
[[Page 51783]]
their nurse practitioners, clinical nurse specialists, certified nurse
midwives, physician assistants, doctors of medicine, or doctors of
osteopathy.
3. Provision of Services (Sec. 485.635(a)(3)(vii))
We currently require CAHs at Sec. 485.635(a)(3)(vii) to have
procedures that ensure that the nutritional needs of inpatients are met
in accordance with recognized dietary practices and the orders of the
practitioner responsible for the care of the patients and that the
requirement of Sec. 483.25(i) of this chapter is met with respect to
inpatients receiving post-hospital SNF care.
We proposed revisions to Sec. 485.635(a)(3)(vii) that would
require that individual patient nutritional needs be met in accordance
with recognized dietary practices and the orders of the practitioner
responsible for the care of the patients, or by a qualified dietician
or qualified nutrition professional as authorized by the medical staff
in accordance with State law governing dietitians and nutrition
professionals. In addition, we also proposed that the requirement of
Sec. 483.25(i) of this chapter is met with respect to inpatients
receiving post hospital SNF care.
Comment: Commenters support CMS' efforts to allow clinicians to
practice to the fullest extent of their credentials. The commenters
stated that this proposed change at Sec. 485.635 requiring diets to be
ordered by the practitioner responsible for the patient or a qualified
dietitian or qualified nutrition professional as authorized by the
medical staff and in accordance with state law, recognizes the
specialized knowledge and training of dietitians and the benefit
available to patients.
Response: We appreciate the comments and will finalize this change
as proposed.
4. Provision of Services (485.635(g))
At Sec. 485.635(g) we proposed a new requirement regarding non-
discriminatory behavior. Similar to our non-discrimination proposal for
hospitals, we proposed to require that a CAH not discriminate on the
basis of race, color, religion, national origin, sex (including gender
identity), sexual orientation, age, or disability. We further proposed
to require that CAHs establish and implement a written policy
prohibiting discrimination on the aforementioned bases and that they
inform each patient (and/or support person, where appropriate), in a
language he or she can understand, of his or her right to be free from
discrimination against them and how to file a complaint if they
encounter discrimination. After consideration of the comments that we
received, we are not finalizing our proposal and are instead deferring
to the non-discrimination requirements of Section 1557 of the
Affordable Care Act. We refer readers to section III.B.3 of this final
rule for a more detailed discussion.
5. Infection Prevention and Control and Antibiotic Stewardship Programs
(Sec. 485.640)
We proposed to remove the current requirements at Sec.
485.635(a)(3)(vi) and Sec. 485.641(b)(2) and are adding a new
infection prevention and control and antibiotic stewardship CoP at
Sec. 485.640 for CAHs because the existing standards for infection
control do not reflect the current nationally recognized standards of
practice for the prevention and elimination of healthcare-associated
infections and for the appropriate use of antibiotics.
We are finalizing the proposal that each CAH has facility-wide
infection prevention and control and antibiotic stewardship programs
that are coordinated with the CAH QAPI program, for the surveillance,
prevention, and control of HAIs and other infectious diseases and for
the optimization of antibiotic use through stewardship.
Comment: Commenters were supportive of the proposal to require each
CAH to have facility-wide infection prevention and control and
antibiotic stewardship programs that are coordinated with the CAH QAPI
program. Commenters recognized that these changes will support a
culture of antibiotic stewardship that will increase patient safety and
quality of care.
Response: We appreciate the comments received on the proposed
changes for the CAH infection control and antibiotic stewardship
programs and will finalize the changes as proposed.
Comment: Commenters noted that CAHs would need time, resources,
flexibility and support to adapt to the antibiotic stewardship
requirements, especially given the fact that many do not have staff
pharmacists available at all times.
Response: We also appreciate these comments. While we understand
that CAHs may have less resources available, we encourage CAHs to
utilize the existing available resources to ensure the antibiotic
stewardship requirements are met. While small and critical access
hospitals face special challenges in implementing antibiotic
stewardship programs, antibiotic stewardship is no less important in
these settings. Small and critical access hospitals also have some
factors that can support improvements in care, as they are often tight-
knit communities where collaboration is the norm. The CDC has resources
available for training and education as well as support for providers
implementing antibiotic stewardship programs specifically for CAHs. We
also encourage CAHs to work with other hospitals or CAHs in their
network (if available) for pharmaceutical support. CAHs should also be
encouraged to work with their respective quality improvement
network(s)/organization(s) and health departments for additional
support and resources. Additionally, we encourage CAHs to use the
technical assistance available from their State Flex Program. CAHs can
find contact information for their State Flex Program at https://www.ruralcenter.org/tasc/flexprofile.
Final Rule Action: We are finalizing the proposed changes without
revision.
Sec. 485.640(a)(1) Through (2) Infection Control Officer(s); and
Prevention and Control of Infections Within the CAH and Between the CAH
and Other Healthcare Settings
At Sec. 485.640(a)(1) we proposed that the CAH ensure that an
individual (or individuals), who are qualified through education,
training, experience, or certified in infection, prevention and
control, are appointed by the governing body, or responsible
individual, as the infection preventionist(s)/infection control
professional(s) responsible for the infection prevention and control
program at the CAH and that the appointment is based on the
recommendations of medical staff and nursing leadership.
We proposed at Sec. 485.640(a)(2) that the infection prevention
and control program, as documented in its policies and procedures,
employ methods for preventing and controlling the transmission of
infections within the CAH and between the CAH and other healthcare
settings. The program, as documented in its policies and procedures,
would have to employ methods for preventing and controlling the
transmission of infection within the CAH setting (for example, among
patients, personnel, and visitors) as well as between the CAH
(including outpatient services) and other institutions and healthcare
settings.
Comment: Commenters were generally supportive of the proposal for
CAHs to have a qualified individual (or individuals) in the role of the
infection preventionist(s)/infection control professional(s).
[[Page 51784]]
Response: We appreciate the comments received on the proposed
changes for this CAH proposal.
Final Rule Action: We are finalizing the proposed changes without
revision.
Sec. 485.640(a)(3) Healthcare-Associated Infections (HAIs)
We proposed at Sec. 485.640(a)(3) that the infection prevention
and control program include surveillance, prevention, and control of
HAIs, including maintaining a clean and sanitary environment to avoid
sources and transmission of infection, and that the program also
address any infection control issues identified by public health
authorities.
Comment: Commenters were supportive of the proposal for CAHs to
have an infection prevention and control program that includes
surveillance, prevention, and control of HAIs.
Response: We appreciate the comments received on the proposed
changes for this CAH proposal.
Final Rule Action: We are finalizing the proposed changes without
revision.
Sec. 485.640(a)(4) Scope and Complexity
We proposed at Sec. 485.640(a)(4) that the infection prevention
and control program reflects the scope and complexity of the services
provided by the CAH.
Comment: Commenters were supportive of the proposal for CAHs to
have an infection and prevention and control program that reflects the
scope and complexity of the services provided by the CAH, with one
commenter requesting that specific language stating that CRNAs and
other anesthesia professionals should be included in the development
and leadership of infection prevention and control programs in
hospitals and CAHs.
Response: We appreciate the comments received on the proposed
changes for this CAH proposal. As noted in the preamble, as it relates
to CAHs, staffing for these programs should be appropriate to the scope
and complexity of the services offered at the CAH. We believe that CAHs
should have the flexibility to include the individuals who are deemed
appropriate by the CAH to be included in the development and leadership
of these programs.
Final Rule Action: We are finalizing the proposed changes.
Sec. 485.640(b)(1) Leader of the Antibiotic Stewardship Program
We proposed at Sec. 485.640(b)(1) that the CAH's governing body
ensure that an individual, who is qualified through education,
training, or experience in infectious diseases and/or antibiotic
stewardship is appointed as the leader of the antibiotic stewardship
program and that the appointment is based on the recommendations of
medical staff and pharmacy leadership.
Comment: Commenters were supportive of the proposal for the CAH's
governing body to ensure that an individual with the appropriate
experience is appointed as the leader of the antibiotic stewardship
program. One commenter noted that this role will be fulfilled by a
nurse who also has other related responsibilities and may not have the
specialized training necessary for the infection preventionist role.
The commenter encouraged CMS to ensure that cost effective and
accessible education and training are available for CAH infection
preventionists, and that ongoing technical assistance be provided.
Additionally, the commenter requested infection preventionist expertise
be available through shared services agreements across CAH networks or
similar arrangements.
Response: We appreciate the comments received on the proposed
changes for this CAH proposal. The proposal requires that the leader of
the antibiotic stewardship program be qualified through education,
training, or experience in infectious diseases and/or antibiotic
stewardship. We encourage CAHs to utilize the infection control
training available and resources that are available through the CDC
(https://www.cdc.gov/infectioncontrol/training/). We
encourage CAHs to reach out to other CAHs (within their network or
otherwise) to collaboratively meet their needs of ensuring that a
leader of the antibiotic stewardship program is available to meet the
needs of the CAH and its patients.
Final Rule Action: We are finalizing the proposed changes.
Sec. 485.640(b)(2)(i), (ii), and (iii) Goals of the Antibiotic
Stewardship Program
The proposed requirements at Sec. 485.640(b)(2)(i),(ii), and (iii)
would ensure that the following goals for an antibiotic stewardship
program are met: (i) Demonstrate coordination among all components of
the CAH responsible for antibiotic use and resistance, including, but
not limited to, the infection prevention and control program, the QAPI
program, the medical staff, and nursing and pharmacy services; (ii)
document the evidence-based use of antibiotics in all departments and
services of the CAH; and (iii) demonstrate improvements, including
sustained improvements, in proper antibiotic use, such as through
reductions in, CDI and antibiotic resistance in all departments and
services of the hospital. We believe that these three components are
essential for an effective program.
We did not receive any comments on this proposal.
Final Rule Action: We are finalizing the proposed changes.
Sec. 485.640(b)(3) and (4) Nationally Recognized Guidelines; and Scope
and Complexity
These provisions would require the CAH to ensure that the
antibiotic stewardship program adheres to the nationally recognized
guidelines, as well as best practices, for improving antibiotic use.
The CAH's stewardship program would have to reflect the scope and
complexity of services offered.
Comments for the identical hospital proposal are discussed with the
hospital proposal in section II.B.4.
Final Rule Action: We are finalizing the proposed changes.
Sec. 485.640(c)(1), (2), and (3) Governing Body; Infection Prevention
and Control Professionals'; and Antibiotic Stewardship Program Leader's
Responsibilities
We proposed at Sec. 485.640(c)(1)(i) and (ii) requirements that
the governing body or responsible individual ensure that:
Systems are in place and operational for the tracking of
all infection surveillance, prevention, and control, and antibiotic use
activities in order to demonstrate the implementation, success, and
sustainability of such activities; and
All HAIs and other infectious diseases identified by the
infection prevention and control program and antibiotic use issues
identified by the antibiotic stewardship program are addressed in
collaboration with CAH QAPI leadership.
At Sec. 485.640(c)(2)(i)-(vi), we proposed that the
responsibilities of the infection prevention and control professionals
would include the development and implementation of facility-wide
infection surveillance, prevention, and control policies and procedures
that adhere to nationally recognized guidelines.
The governing body or responsible individual would be responsible
for all documentation, written or electronic, of the infection
prevention and control program and its surveillance, prevention, and
control activities. Additionally, the infection preventionist(s)/
infection control professional(s) would be responsible for:
[[Page 51785]]
Communication and collaboration with the CAH's QAPI
program on infection prevention and control issues;
Competency-based training and education of CAH personnel
and staff including professional health care staff and, as applicable,
personnel providing services in the CAH under agreement or arrangement,
on the practical applications of infection prevention and control
guidelines, policies and procedures;
Prevention and control of HAIs, including auditing of
adherence to infection prevention and control policies and procedures
by CAH personnel; and
Communication and collaboration with the antibiotic
stewardship program.
Finally in this CoP, at Sec. 485.640(c)(3), we proposed
requirements for the leader of the antibiotic stewardship program
similar to the proposed responsibilities for the CAH's designated
infection preventionist(s)/infection control professional(s) at
paragraph (c)(2). We believe that a CAH's antibiotic stewardship
program is the most effective means for ensuring appropriate antibiotic
use. We also believe that such a program would require a leader
responsible and accountable for its success. Therefore, we proposed
that the leader of the antibiotic stewardship program would be
responsible for the development and implementation of a facility-wide
antibiotic stewardship program, based on nationally recognized
guidelines, to monitor and improve the use of antibiotics. We also
propose that the leader of the antibiotic stewardship program would be
responsible for all documentation, written or electronic, of antibiotic
stewardship program activities. The leader would also be responsible
for communicating and collaborating with medical and nursing staff,
pharmacy leadership, and the CAH's infection prevention and control and
QAPI programs, on antibiotic use issues.
Finally, we proposed that the leader would be responsible for the
competency-based training and education of CAH personnel and staff,
including medical staff, and, as applicable, personnel providing
contracted services in the CAHs, on the practical applications of
antibiotic stewardship guidelines, policies, and procedures.
We did not receive any comments on this proposal.
Final Rule Action: We are finalizing the proposed changes.
6. Quality Assessment and Performance Improvement (QAPI) Program (Sec.
485.641)
Since May 26, 1993 (58 FR 30630), the ``Periodic evaluation and
quality assurance review'' CoP (Sec. 485.641) has not been updated to
reflect current industry standards that utilize the QAPI model (Sec.
482.21) to assess and improve patient care.
We proposed to revise Sec. 485.641 (81 FR 39464) to establish new
requirements for a QAPI program at a CAH. This new requirement for CAHs
would replace the existing reactive annual evaluation and quality
assurance review requirement with a proactive approach of a QAPI
program. A QAPI program that enables the CAH to review its operating
systems and processes of care to identify and implement opportunities
to provide high quality and safe care to its patients focusing on
improving health outcomes and preventing and reducing medical errors.
We believe that much of the work and resources that are currently
required under the existing periodic evaluation and quality assurance
CoP would be utilized to adhere to the new QAPI requirement. We
proposed to retain the requirements under paragraphs Sec.
485.641(b)(3)-(4) regarding the evaluation of the diagnosis and
treatment furnished by physicians and non-physician practitioners and
relocate them to a new standard under the ``Staffing and staff
responsibilities'' CoP at Sec. 485.631.
Comment: Commenters generally agree with requiring CAHs to have a
QAPI program that is integrated with all of the departments within a
CAH. Commenters also agree with encouraging CAHs to use proven quality
improvement data to improve the quality and safety of care provided.
One commenter asked about requiring CAHs to report externally for
comparative benchmarking and performance improvement activities. A few
commenters stated that we should require CAHs to make informed choices
about where they focus improvement work to ensure their efforts have a
greater benefit to the patients and communities served. Some commenters
were concerned that we underestimated the time and effort it would take
CAH's to implement a new QAPI program. Also, commenters requested an
implementation date that is one year after the publication of this
final rule and that we provide technical assistance to CAHs for the
implementation of these requirements.
Response: We have taken into consideration the comment that we
underestimated the time and effort it would take CAH's to implement
these new QAPI requirements. We agree with an extended timeframe for
implementation to allow CAHs additional time to prepare and ultimately
comply with the requirements. Therefore, the requirements at Sec.
485.641 must be implemented by 18 months after the effective date of
this final rule. We also encourage CAHs to utilize the technical
assistance and services for CAHs that are available through the State
Flex Programs, including the Medicare Beneficiary Quality Improvement
Project (MBQIP), supported by HRSA's Federal Office of Rural Health
Policy. CAHs can find contact information for their State Flex Program
on this page, https://www.ruralcenter.org/tasc/flexprofile. We do not
require external reporting for comparative benchmarking and performance
improvement activities as a condition of participation; however, we do
require that CAHs maintain and demonstrate evidence of the
effectiveness of its QAPI program.
Finally, we have re-evaluated our proposed requirements to
eliminate unnecessary prescriptiveness proposed under paragraph (c)(1)
through (6); paragraph (e); and paragraph (f)(2) through (3) and are
withdrawing those proposed provisions. These changes to the proposal
will allow each CAH the flexibility to implement its QAPI program in
the most efficient manner for its unique circumstances.
We will require that the CAH meet the objectives of the QAPI
program, but will allow the CAH to determine the best way to do so with
respect to determining detailed program requirements, requirements
related to distinct improvement projects, and details of data use. In
accordance with the new requirements under Sec. 465.641(e), CAHs will
be required to incorporate quality indicator data, including patient
care data and other relevant data, in order to achieve the goals of the
QAPI program. We noted in our proposal suggesting that CAHs incorporate
other relevant data, such as data submitted to or received from
national quality reporting and quality performance programs, into their
data collection analysis; however, we have removed the language
referencing national quality reporting and quality performance program
data from the regulatory text. We will expand on this and other
examples of relevant data in the subregulatory guidance.
This data must be used by the CAH to achieve the objectives of the
QAPI program, including addressing outcome indicators related to
improved health
[[Page 51786]]
outcomes and the prevention and reduction of medical errors, adverse
events, CAH-acquired conditions, and transitions of care, including
readmissions. This will ensure that the CAH's quality improvement
efforts are evidenced based and focused on the needs of the population
served by the CAH in a manner that best suits the unique
characteristics of the CAH.
In addition, since the QAPI requirement will replace the annual
evaluation requirement, we believe that a large portion of the cost can
be utilized for the QAPI program because CAHs are conducting many of
the functions required for an effective QAPI program. CAHs are
currently required to carry out an annual evaluation of its total
program. They are to evaluate their health care policies and the
appropriateness of the services they provide. All patient care services
and other services affecting patient health must be evaluated. Also, we
have removed some of the prescriptive requirements under proposed
485.641(f)(2) through (3) for the QAPI program and recalculated the
cost for implementation.
Final Rule Decision: We are finalizing the proposal, but
eliminating the following proposed requirements:
Proposed paragraph (c)(1) through (6);
Proposed paragraph (e); Performance improvement projects
Revise the proposed requirement under paragraph (e) to
remove the phrase, ``. . . such as data submitted to or received from
national quality reporting and quality performance programs . . .'' and
Proposed paragraph (f)(2 through (f)(3); Program data
collection and analysis.
7. Technical Corrections
We proposed to correct a typographical error in the regulations at
Sec. 485.645 by correcting the word ``provided'' to ``provide'' in the
lead first sentence. As proposed, the lead sentence would read as
follows: ``A CAH must meet the following requirements in order to be
granted an approval from CMS to provide post-hospital SNF care, as
specified in Sec. 409.30 of this chapter, and to be paid for SNF-level
services, in accordance with paragraph (c) of this section.'' As noted,
we are also deleting an obsolete cross-reference to Sec. 482.12(c) in
our revision of the regulations text at Sec. 482.61(d).
D. Requirements for Issuance of Regulations
This final rule finalizes provisions set forth in ``Regulatory
Provisions to Promote Program Efficiency, Transparency, and Burden
Reduction (CMS-3346-P,'' published September 20, 2018 (83 FR 47686),
``Hospital and Critical Access Hospital (CAH) Changes to Promote
Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-
P),'' published June 16, 2016 (81 FR 39448); and ``Fire Safety
Requirements for Certain Dialysis Facilities (CMS-3334-P),'' published
November 4, 2016 (81 FR 76899).
Section 902 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and
requires the Secretary, in consultation with the Director of the Office
of Management and Budget, to establish and publish timelines for the
publication of Medicare final regulations based on the previous
publication of a Medicare proposed or interim final regulation. Section
902 of the MMA also states that the timelines for these regulations may
vary but shall not exceed 3 years after publication of the preceding
proposed or interim final regulation except under exceptional
circumstances.
This final rule has been published within the 3-year time limit
imposed by section 902 of the MMA for ``Hospital and Critical Access
Hospital (CAH) Changes to Promote Innovation, Flexibility, and
Improvement in Patient Care (CMS-3295-P),'' and ``Fire Safety
Requirements for Certain Dialysis Facilities (CMS-3334-P),'' published
November, 4, 2016 (81 FR 76899).
Additionally, a continuation notice for ``Hospital and Critical
Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and
Improvement in Patient Care (CMS-3295-P) was published on June 11,
2019, (84 FR 27069). Therefore, the final rule is in accordance with
the Congress' intent to ensure timely publication of final regulations.
E. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs).
1. ICRs Regarding Quality Assessment and Performance Improvement (Sec.
482.21)
The existing QAPI CoP requires each hospital to:
Develop, implement, maintain, and evaluate its' own QAPI
program;
Establish a QAPI program that reflects the complexity of
its organization and services;
Establish a QAPI program that involves all hospital
departments and services and focuses on improving health outcomes and
preventing and reducing medical errors; and
Maintain and demonstrate evidence of its QAPI program for
review by CMS.
We are finalizing a minor change to the program data requirements
at Sec. 482.21(b). Currently, we require that hospitals incorporate
quality indicator data including patient care data, and other relevant
data, for example, information submitted to, or received from, the
hospital's Quality Improvement Organization.
We are updating this requirement to reflect and capitalize on the
wealth of important quality data available to hospitals through several
quality data reporting programs. Specifically, we are requiring that
the hospital QAPI program must incorporate quality indicator data
including patient care data, and other relevant data such as data
submitted to or received from quality reporting and quality performance
programs, including, but not limited to, data related to hospital
readmissions and hospital-acquired conditions. Hospitals are likely to
be participating in one or more existing quality reporting and quality
performance programs such as the Hospital Inpatient Quality Reporting
program, the Hospital Value-Based Purchasing Program, the Hospital
Acquired Condition Reduction program, Hospital Compare, the Medicare
and Medicaid Electronic Health Record
[[Page 51787]]
Incentive Programs, the Hospital Outpatient Quality Reporting program,
and the Joint Commission's Quality CheckTM. Since a hospital
is already collecting and reporting quality measures data for these
programs, we do not believe that this change would increase the
information collection burden for hospitals.
2. ICRs Regarding Nursing Services (Sec. 482.23)
We are finalizing our proposal to revise Sec. 482.23(b), which
currently states ``There must be supervisory and staff personnel for
each department or nursing unit to ensure, when needed, the immediate
availability of a registered nurse for bedside care of any patient,''
to delete the term ``bedside,'' which might imply only inpatient
services to some readers. The nursing service must ensure that patient
needs are met by ongoing assessments of patients' needs and must
provide nursing staff to meet those needs regardless of whether the
patient is an inpatient or an outpatient. We are allowing a hospital to
establish a policy that would specify which, if any, outpatient units
would not be required to have an RN physically present as well as the
alternative staffing plans that would be established under such a
policy. The policy must take into account factors such as the services
delivered; the acuity of patients typically served by the facility; and
the established standards of practice for such services. In addition,
the policy must be approved by the director of nursing and be reviewed
at least once every 3 years.
TJC-accredited hospitals are already allowed this flexibility in
nursing services policy. Those hospitals that use their TJC
accreditation for deeming purposes are required to have ``Leaders [who]
provide for a sufficient number and mix of individuals to support safe,
quality care, treatment, and services. (Note: The number and mix of
individuals is appropriate to the scope and complexity of the services
offered.)'' (CAMH, Standard LD.03.06.01, EP 3). Further, TJC-accredited
hospitals also require the ``nurse executive, registered nurses, and
other designated nursing staff [to] write: Nursing policies and
procedures.'' (CAMH, Standard NR.02.02.01, EP 3). Therefore, we expect
that TJC-accredited hospitals already have the policies and procedures
that satisfy the requirements in this subsection, including medical
staff approval and regular review. If there are any tasks that a TJC-
accredited hospital may need to complete to satisfy the requirement for
this subsection, we expect that the burden imposed would be negligible.
Thus, for the approximately 3,900 TJC-accredited hospitals the
development of policies and procedures that would satisfy this
subsection would constitute a usual and customary business practice in
accordance with 5 CFR 1320.3(b)(2).
The non TJC-accredited hospitals would need to review their current
policies and procedures and update them so that they comply with the
requirements in Sec. 482.23(b). This would be a one-time burden on the
hospital. We estimate that this would require a physician, a nurse, and
one administrator. Including fringe benefits and overhead calculated at
100% of one's hourly wage, we estimate that physicians earn a total
hourly compensation of $191, administrators earn an average hourly
compensation of $189, and registered nurses earn an hourly compensation
of $71 (2017 BLS Wage Data by Area and Occupation at (https://www.bls.gov/oes/2017/may/oes_nat.htm). We estimate that each person
would spend three hours on this activity for a total of nine hours at a
cost of $1,353 (3 hours x $71 for a nurse's hourly wage + 3 hours x
$189 for an administrator's hourly wage + 3 hours x $191 for a
physician's hourly wage). For all 1,193 non-TJC-accredited hospitals to
comply with this requirement, we estimate a total one-time cost of
approximately $1.6 million (1,193 hospitals x $1,353). We estimate that
review of the policies and procedures once every 3 years would take one
hour for each individual included for a total cost of $538,043 ((1 hour
x $71 for a nurse's hourly wage + 1 hour x $189 for an administrator's
hourly wage + 1 hour x $191 for a physician's hourly wage) x 1,193
hospitals), or an annualized cost of $179,347. The burden associated
with these requirements will be captured in an existing information
collection request (OMB Control No. 0938-0328).
3. ICRs Regarding Condition of Participation: Quality Assessment and
Performance Improvement Program (Sec. 485.641)
Sec. 485.641 would require CAHs to develop, implement, and
maintain an effective, ongoing, CAH-wide, data-driven QAPI program. The
QAPI program must be appropriate for the complexity of the CAH's
organization and the services it provides. In addition, CAHs must
comply with all of the requirements set forth in Sec. 485.641(b)
through (e).
The current CAH CoPs at Sec. 485.641 require CAHs to have an
effective quality assurance program to evaluate the quality and
appropriateness of the diagnosis and treatment furnished in the CAH and
the treatment outcomes. CAHs are currently required to conduct a
periodic evaluation and quality assurance review (42 CFR 485.641(a)).
They are required to evaluate its total program (for example, policies
and procedures and services provided) annually. The evaluation must
include reviewing the utilization of the CAH services using a
representative sample of both active and closed clinical records, as
well as reviewing the facility's health care policies. The purpose of
the evaluation is to determine whether the utilization of services was
appropriate, the established policies were followed, and if any changes
are needed. The CAH's staff considers the findings of the evaluation
and takes corrective action, if necessary (42 CFR 485.641(b)(5)(i)).
Thus, we believe that all of the CAHs are performing the activities
that are required to comply with many of the requirements in Sec.
485.641. However, we also believe that the CAHs would need to review
their current quality assurance program and revise and, if needed,
develop new provisions to ensure compliance with the requirements.
TJC accreditation standards for performance improvement (PI)
already require that CAHs collect, compile, and analyze to monitor
their performance (TJC Accreditation Standard PI.01.01.01 and
PI.02.01.01). These TJC-accredited CAHs must also improve their
performance on an ongoing basis (TJC Accreditation Standard
PI.03.01.01). Thus, we believe that the 349 TJC-accredited CAHs are
already in compliance with the new requirements in Sec. 485.641.
However, each CAH would need to review their current practice to ensure
that they are in compliance with all of the requirements under Sec.
485.641. Any additional tasks those CAHs would need to comply with the
requirements for this section should result in a negligible burden, if
any. Thus, the burden for these activities for the 349 TJC-accredited
CAHs will be excluded from the burden analysis because they constitute
usual and customary business practices in accordance with 5 CFR
1320.3(b)(2).
The 1,004 non TJC-accredited CAHs would need to review their
current programs and then revise and develop new provisions of their
programs to ensure compliance with the new requirements. We believe
that the CAH QAPI leadership (consisting of a physician, and/or
administrator, mid-level practitioner, and a nurse) would need to have
at least two meetings to ensure that the current annual evaluation and
quality assurance (QA)
[[Page 51788]]
program is transitioned into the QAPI format. The first meeting would
be to discuss the current quality assurance program and what needs to
be included based on the new QAPI provision. The second meeting would
be to discuss strategies to update the current policies, and then to
discuss the process for incorporating those changes. We believe that
these meetings would take approximately two hours each. We estimate
that the physician would have a limited amount of time, approximately 1
hour to devote to the QAPI activities. Additionally, we estimate these
activities would require 4 hours of an administrator's time, 4 hours of
a mid-level practitioner's time, 8 hours of a nurse's time, and 2 hours
of a clerical staff person's time for a total of 19 burden hours. We
believe that the CAH's QAPI leadership (formerly the periodic
evaluation and quality assurance leadership) would need to meet
periodically to review and discuss the changes that would need to be
made to their program. We also believe that a nurse would likely spend
more time developing the program with the mid-level practitioner. The
physician would likely review and approve the program. The clerical
staff member would probably assist with the program's development and
ensure that the program was disseminated to all of the necessary
parties in the CAH. This burden estimate is slightly lower than what
was published in the proposed rule because we re-evaluated our proposed
requirements to eliminate unnecessary prescriptiveness. The finalized
requirements are expected to allow more flexibility, and therefore
slightly less burden. Since a CAH is currently required to evaluate its
total program and evaluate the quality and appropriateness of the
services furnished, take appropriate action to address deficiencies and
document such activities, we believe that the resources utilized on the
current QA program would be utilized for the ongoing QAPI activities
under Sec. 485.641(b)-(e). Thus, we estimate that for each CAH to
comply with the requirements in this section it would require 19 burden
hours (1 for a physician + 4 for an administrator + 4 for a mid-level
practitioner + 8 for a nurse + 2 for a clerical staff person) at a cost
of $1,657 ($191 for a physician + $428 for an administrator (4 hours x
$107) + $404 for a mid-level practitioner (4 hours x $101) + $568 (8
hours x $71 for a nurse) + $66 for a clerical staff person (2 hours x
$33). Therefore, for all 1,004 non TJC-deemed CAHs to comply with these
requirements, it would require 19,076 burden hours (19 x 1,004 non TJC-
deemed CAHs) at a cost of approximately $1.7 million ($1,657 for each
CAH x 1,004 non TJC-deemed CAHs). We note here the difference in hourly
wage between a hospital CEO/administrator ($189) and a CAH CEO/
administrator ($107). This is estimated to be an additional 15,431
hours and $1.3 million in cost compared to the existing QA burden. The
burden associated with these requirements will be captured in an
existing information collection request (OMB Control No. 0938-1043).
IV. Economic Analyses
A. Regulatory Impact Analysis for Regulatory Provisions To Promote
Program Efficiency, Transparency, and Burden Reduction
1. Statement of Need
All major and many ostensibly minor government regulations should
undergo periodic review to ensure that they do not unduly burden
regulated entities or the American people, and to reflect current
knowledge as to their regulatory effects. In recent years, we have
revised the CoPs and CfCs to reduce the regulatory burden on providers
and suppliers. In doing so, we identified obsolete and burdensome
regulations that could be eliminated or reformed to improve
effectiveness or reduce unnecessary reporting requirements and other
costs, with a particular focus on freeing up resources that health care
providers, health plans, and States could use to improve or enhance
patient health and safety. We also examined policies and practices not
codified in rules that could be changed or streamlined to achieve
better outcomes for patients while reducing burden on providers of
care, and we identified non-regulatory changes that would increase
transparency and allow CMS to become a better business partner.
These final rule provisions are a continuation of our efforts to
reduce regulatory burden. We are finalizing changes to the current CoPs
or CfCs that will simplify and streamline the current regulations and
thereby increase provider flexibility and reduce excessively burdensome
regulations, while also allowing providers to focus on providing high-
quality healthcare to their patients. The final rule provisions will
also reduce the frequency of certain required activities and, where
appropriate, revise timelines for certain requirements for providers
and suppliers and remove obsolete, duplicative, or unnecessary
requirements. Ultimately, these requirements balance patient safety and
quality, while also providing broad regulatory relief for providers and
suppliers, and reducing the associated burden on patients.
2. Overall Impact
We have examined the impacts of the regulatory provisions to
Promote Program Efficiency, Transparency, and Burden Reduction as
required by Executive Order 12866 on Regulatory Planning and Review
(September 30, 1993), Executive Order 13563 on Improving Regulation and
Regulatory Review (January 18, 2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the
Social Security Act, section 202 of the Unfunded Mandates Reform Act of
1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on
Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C.
804(2)), and Executive Order 13771 on Reducing Regulation and
Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). We estimate that this rulemaking is ``economically significant''
as measured by the $100 million threshold, and hence also a major rule
under the Congressional Review Act. Accordingly,
[[Page 51789]]
we have prepared an RIA that, to the best of our ability, presents the
costs and benefits of these provisions of the rulemaking.
This final rule will create ongoing cost savings to providers and
suppliers in many areas. Other changes we are finalizing will clarify
existing policy and relieve some administrative burdens. We have
identified other kinds of savings that providers and patients will
realize throughout this preamble, and substantial lifesaving benefits.
These life-saving effects arise by removing the incentives that were
created by the current transplant center regulations to decline to
transplant patients with slightly lower probabilities of success, or to
decline to use organs with slightly lower probabilities of success.
We sought public comment on our burden assumptions and estimates as
well as comments identifying additional reforms that should be
considered for future rulemakings. As discussed later in this
regulatory impact analysis, substantial uncertainty surrounds these
estimates and we solicited comments on either our estimates of likely
impacts or the specific regulatory changes that drive these estimates.
We received, however, few comments specifically addressing our
estimates. In the proposed rule, we solicited additional suggestions
for things to consider that could potentially reduce burden for
providers/suppliers in the future.
Comment: We received many submissions related to possible
additional changes in CoP/CfCs to reduce burden. For example, we
received a number of suggestions related to additional reforms
regarding the removal of barriers to the use of nurse anesthetists that
could be considered for future rulemakings.
Response: Thank you for all the comments that were submitted with
suggestions on how we can improve the CoPs/CfCs. Some of the
suggestions are burden reducing, however some of the suggestions would
be burdensome. Regardless, we will take all the suggestions in to
consideration for future rulemaking.
Comment: Several commenters expressed that costs or savings
attributed to QAPI, infection prevention, recertification efforts, and
emergency training may have been underestimated due to the exclusion of
consideration for technology changes, or other factors, in the proposed
rule estimates.
Response: We thank you for your comments and recognize the
uncertainty involved in our estimates. Some of our estimates have been
updated to reflect new information to the extent that we are able;
however, we lack the data that would be necessary to make major
adjustments to many of the estimates.
Comment: One commenter inquired about what happens with all the
savings being estimated for each provider or supplier.
Response: The estimated savings from reducing burden for the
providers/suppliers will allow the providers and suppliers to use those
savings towards other necessary needs. We anticipate that they will
have more time for patient care, and that the savings represent
expenses that providers and suppliers will no longer have to incur now
that we have finalized these proposals or made modifications. Some of
these savings will be passed on to patients in reduced charges, but
most will reduce costs charged to insurers, which will over time reduce
insurance premiums to enrollees, public programs, and employer payers.
In the analysis that follows, we address the economic effects of
all the major provisions of the final rule provisions. As pertinent, we
indicate any significant changes from the proposed rule estimate. The
analysis generally follows the typology used earlier in the preamble,
and in the table that follows. As stated in the ICR section of the
rule, we obtained all salary information from the May 2017 National
Occupational Employment and Wage Estimates by the Bureau of Labor
Statistics (BLS) at https://www.bls.gov/oes/2017/may/oes_nat.htm and
calculated the total cost per hour by adding a cost of 100 percent for
overhead costs and fringe benefits.
Table 13--Section-by-Section Economic Impact Estimates
----------------------------------------------------------------------------------------------------------------
Number of
Provider and supplier type and Frequency affected Estimated savings (annualized,
description of proposed provisions entities $millions)
----------------------------------------------------------------------------------------------------------------
Religious Nonmedical Health Care
Institutions:
Discharge Planning..... As patients are 18 (*)
discharged (Estimated
619 annual discharges).
Ambulatory Surgical Centers:
Governing Body and Upon failed hospital 5,557 (*)
Management. transfer agreement
attempts.
Patient Admission, Every patient 5,557 77.
Assessment and Discharge registration at an ASC
(History and Physical). or at a hospital
outpatient/ambulatory
surgery department.
Medical Records........ Recurring annually..... 5,557 0.
Hospices:
Drugs and Biologicals, Recurring annually..... 4,602 94.
Medical Supplies, and Durable
Medical Equipment ***.
Hospices That Provide Recurring annually..... 4,602 1.
Hospice Care to residents of a
SNF/NF or ICF/IID.
Hospice Aide and Recurring annually..... 4,602 2.
Homemaker Services.
Hospitals:
Quality Assessment and Recurring annually..... 4,823 31.
Performance Improvement Program.
Medical staff: Recurring annually..... 4,823 0.
Autopsies.
Infection Control...... Recurring annually..... 4,823 115.
Special requirements Recurring annually..... 478 30.
for hospital providers of long-
term care services (``swing-
beds'').
Special Requirements Recurring annually..... 620 154.
for Psychiatric Hospitals.
Patient Admission, Every patient 4,823 77.
Assessment and Discharge registration at an ASC
(History and Physical). or at a hospital
outpatient/ambulatory
surgery department.
Transplant programs:
Various provisions Recurring annually..... 750 Not Quantified.
related to performance **.
[[Page 51790]]
Home Health Agencies:
Patient rights......... Recurring annually..... 12,624 57.
Home health aide Recurring annually..... 12,624 Not Quantified.
services.
Clinical records....... Recurring annually..... 12,624 Not Quantified.
Critical Access Hospitals:
Provision of Services.. Recurring biennially... 1,353 1.
Organizational Recurring annually..... 1,353 (*)
structure.
Special requirements Recurring annually..... 1,246 77.
for CAH providers of long-term
care services (``swing-beds'')..
Comprehensive Outpatient
Rehabilitation Facilities:
Utilization Review Plan Recurring annually..... 188 (*)
Community Mental Health Centers:
Assessment Update...... Recurring annually..... 52 (*)
Portable X-Ray Services:
Qualifications of X-ray Recurring annually..... 500 31.
technicians ***.
Removing written orders Recurring annually..... 500 28.
RHC (4,160 clinics) & FQHC (7,874
center locations):
Patient Care Policies Recurring biennially... 12,034 4.
Review.
Program Evaluation..... Recurring biennially... 12,034 5.
Emergency Preparedness for Providers
and Suppliers:
Review of Emergency Recurring biennially... 56,983 70.
Preparedness Program.
Emergency Plan......... Recurring annually..... 68,275 7.
Training and Testing-- Recurring biennially... 53,543 26.
Training Program.
Training and Testing-- Recurring annually..... 36,971 21.
Testing.
----------------------------------------------------------------------------------------------------------------
* Amount is less than half a million dollars and rounds to zero.
** These include proposed changes to the following requirements: Special Requirements for Transplant Programs;
Data submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and
Special Procedures for Approval and Re-Approval of Organ Transplant Programs.
*** This estimate is for first full year savings only and will differ in future years.
3. Anticipated Effects
a. Effects on Religious Nonmedical Health Care Institutions
As detailed in the Collection of Information section addressing
these provisions, we reduced the discharge planning requirements for
RNHCIs because RNHCIs do not provide medical treatment or services.
Most patients are discharged to home or to another facility that also
does not provide medical treatment or services. Although all patients
must have a discharge planning evaluation, not all patients require a
discharge plan. The discharge planning cost would be reduced by an
estimated $22,903.
b. Effects on Ambulatory Surgical Centers and Hospital Outpatient/
Ambulatory Surgery Departments
As of May 2017 there were 5,557 Medicare-participating ASCs. We
finalized our proposal to revise the ASC CfCs in order to reduce
unnecessary duplications and streamline processes in order to reduce
ASC compliance burden while maintaining minimum standards for patient
safety and care. The specific savings for each change are described
later in this section of the rule. At Sec. 416.41(b)(3), we are
removing transfer agreements and admitting privileges requirements and
replacing it by mandating ASCs must periodically provide the local
hospital with written notice of its operation and patient population
served. This change eliminates the administrative burden associated
with preparing an agreement for signature and going through the
hospital credentialing process in order to obtain admitting privileges.
Currently, all Medicare-certified ASCs are meeting the transfer
agreement or admitting privileges requirement with the exception of
approximately twenty ASCs that have tenuous relationships with their
local hospital. We estimate the ASCs that do have difficulty with
meeting this requirement would appreciate the annual burden savings of
2 to 4 administrator hours spent on paperwork and documentation. For
those ASCs that already have transfer agreements with their local
hospitals, the administrative burden is removed since transfer
agreements and admitting privileges are eliminated, however,
administrative burden is then replaced by the preparation and
completion of the notice of operation requirement. For this reason, we
have not assigned any additional burden created by the notice to the
local hospital requirement. We estimate the savings at less than
$10,000 overall and largely believe this change will not produce
significant savings, however, it does affect twenty or more ASCs in the
short term by removing the transfer agreement requirement. We welcomed
any feedback related to the time and effort for those ASCs that have
secured an agreement, and if we have underestimated the savings of
removing this transfer agreement in the future. As previously
discussed, the enactment of EMTALA and its increasingly effective
enforcement over time has rendered these transfer and admitting
privileges obsolete and unnecessary. To put this point in perspective,
emergencies or other unforeseen adverse events can arise in any
ambulatory medical or dental setting, or in home settings. Over time,
``911'' emergency calls and direct ambulance responses have become
standard operating procedures virtually nationwide, regardless of the
place in which the problem arose. Under modern procedures, emergency
responders (and patients themselves) take patients to hospital
emergency rooms without regard to prior agreements between particular
physicians and particular
[[Page 51791]]
hospitals. Indeed, the most appropriate emergency treatment setting for
a particular patient may not be one involving such an agreement, even
where the agreement exists. Of course, nothing prevents particular
arrangements where a hospital and ASC agree that this is beneficial for
a particular type of surgery or patient condition and where patient
transport can be appropriately arranged to reflect this. Accordingly,
we estimate that there will be no consequential adverse health effects
of this change, and therefore estimate no medical costs.
There will be competitive benefits in those places where an ASC
will now be allowed to operate and provide care at reduced cost
compared to inpatient treatment. Nonetheless, we believe that the
number of affected areas and facilities are few, and that annual
benefits are unlikely to reach the million dollar range. We sought
comments on all these effects and on the preceding analysis of health
effects and the majority of those we received agreed with our proposed
reform.
At Sec. 416.52 we are replacing the requirement that every patient
must have a comprehensive H&P within 30 days prior to surgery in an
ASC, with a requirement that allows the operating physician and ASC to
determine which patients would require more extensive testing and
assessment prior to surgery. We believe that this change reduces
patient and provider burden in a multitude of ways that includes the
community-based physician, the ASC, and the patient. We believe that in
almost all situations ASCs can reasonably rely on existing H&P results
that are more than 30 days old and then are updated by patient
responses just prior to surgery.
For ASCs, we believe this change would reduce administrative burden
by decreasing the amount of time that ASC personnel spend following up
on patient visits to obtain the necessary H&P information and that it
will provide for an increase in scheduling flexibility for the
facility. We believe these changes may have the effect of improving
patient satisfaction and increasing positive patient referrals for the
ASC.
For community-based healthcare providers, to include primary care
providers, we believe this change would reduce unnecessary examinations
that are required to be performed and reduce administrative paperwork
burden associated with providing ASCs with the necessary H&P
documentation and additional testing requirements. This change may
potentially provide an opportunity for increased access to community-
based providers because of available appointments that are not being
filled by unnecessary patient appointments for H&P requirements for
surgery in an ASC. Those vacant appointments may also generate more
revenue.
For patients, we believe this change reduces the time spent to
prepare for surgery (time in community-based physician office, travel
time and costs, time missed from the work place and lost productivity)
and the cost associated with co-pays and other healthcare cost sharing
requirements.
Finally, we believe this change reduces expenses for healthcare
insurers to include Medicare, Medicaid, and private healthcare
insurance companies. This change would reduce costs associated with
reduced pre-operative exams, laboratory testing, chest radiographs, and
echocardiograms.
In the proposed rule we stated that it is difficult to estimate the
savings from this change, because they depend on a number of factors
previously described, and additional factors for which we do not have
precise measures, such as the number of patients (both Medicare and
non-Medicare) who received two or more ASC services within the 30-day
window allowed for one physical examination. This is a common
occurrence because, for example, patients often receive cataract
surgery on one eye and then, a week later, on the other eye.
Furthermore, there are an immense number of different outpatient
surgical services. At present, for example, there are about 137
services that account for about 90 percent of ASC volume, and these
services are highly diverse, as shown in Table 14.
Table 14--Twenty Most Frequent ASC Services in 2015
------------------------------------------------------------------------
Percent of
Surgical service Rank volume
------------------------------------------------------------------------
Cataract surgery w/IOL insert........... 1 18.6
Upper GI endoscopy, biopsy.............. 2 8.2
Colonoscopy and biopsy.................. 3 6.8
Lesion removal colonoscopy (snare 4 5.6
technique).............................
Inject foramen epidural: Lumbar, sacral. 7 4.8
After cataract laser surgery............ 6 4.4
Injection spine: Lumbar, sacral (caudal) 8 3.3
Inject paravertebral: Lumbar, sacral.... 9 3.1
Diagnostic colonoscopy.................. 5 2.3
Colorectal screen, high-risk individual. 10 2.0
Colorectal screen, not high-risk 12 1.9
individual.............................
Cataract surgery, complex............... 11 1.6
Injection procedure for sacroiliac 19 1.3
joint, anesthetic......................
Cystoscopy.............................. 15 1.2
Upper GI endoscopy, diagnosis........... 13 1.0
Inject spine, cervical or thoracic...... 17 1.0
Revision of upper eyelid................ 16 0.9
Lesion removal colonoscopy (hot biopsy 14 0.8
forceps)...............................
Upper GI endoscopy, insertion of guide 18 0.8
wire...................................
Carpal tunnel surgery................... 20 0.7
-------------------------------
Total............................... .............. 70.4
------------------------------------------------------------------------
Source: MEDPAC. Ambulatory surgical center services. 2017, p. 140.
In total, ASCs provided about 6.4 million services in 2015 (MEDPAC.
Ambulatory surgical centers services, 2017, p. 139). If we assume that
25 percent of these patients had two or more services within the 30-day
[[Page 51792]]
``window'' allowed in the current rule, then another H&P with its
associated battery of tests were required for each of the remaining 4.8
million individuals. Assuming that 5 percent of these patients would
otherwise have already had an overall H&P and associated tests within
30 days of the surgery, 4.56 million persons would then require a new
H&P and tests before surgery under the current requirements. In the
great majority of cases involving eye or eyelid surgery of one kind or
another, the ophthalmology examination preceding the ASC surgery would
not have involved a comprehensive H&P or battery of tests, and a
similar situation would be involved for most other surgeries preceded
by specialist rather than primary care visits.
Although we are unable to estimate the likely number of cases, one
way to estimate the costs of these examinations and tests would be as
follows. First, the H&P itself would cost approximately $100 (the exact
amount depending on diagnostic details, and not necessarily
corresponding to any particular payment schedule). The battery of tests
would cost approximately $100, assuming both urine and blood testing,
and, in some cases, an electrocardiogram, but only half of physical
examinations (for example, few or no ophthalmologist exams) would
include such tests. The travel of the patient to and from the physician
office to obtain the examination and tests would on average require 1
hour, which when valued at the average wage rate in the economy of $24
(increased by 50 percent to include fringe benefits but not overhead)
would cost about $36. In addition, ASCs incur substantial costs for the
time and trouble needed to contact physician offices and arrange for
the results to be delivered. The physician offices themselves would be
put through the trouble of transferring those medical records. Assuming
average time spent (the median would be less but a small number of
difficult cases would bring the average well above the median) would
reach 10 minutes, and the use of a general office clerk at $33 an hour,
the cost per patient would average $5.50 per patient. A further cost
arises because in many cases the examination and test results simply
cannot be obtained timely, and a scheduled surgery has to be postponed.
Assuming that in such cases a half hour of surgeon time (at $242 an
hour) and a half hour of registered nurse (RN) time (at $71 an hour) is
wasted, and that clerical time ($33 an hour) to reschedule averages 10
minutes, the average cost per postponement would be $162. (In some of
these cases patient time would be wasted, as well as the time of family
members accompanying the patient--we have not estimated these costs.)
Aggregating these calculations, one estimate of the annual costs of
the current regulatory requirement, as shown in Table 15, could be as
much as $908 million for ASCs and a similar amount for hospital
outpatient surgery. For many and perhaps most cases, however, either
the surgeon or the facility would decide that H&P information is needed
for particular patients or particular procedures, whether or not this
regulatory requirement existed. Of course, it is unlikely that in such
cases a strict 30-day window would be insisted on. Assuming that such
examination and testing information would continue to be needed for 10
percent of all patients, and that in half of these cases the
information would require a new examination and tests within a 30-day
window, the net costs of the regulatory reform we proposed would be 95
percent less than the preceding calculations.
As support for the proposed rule's 50 percent upper bound, the
proposed rule preamble (83 FR 47733) noted that Chen et al. found that
approximately 53 percent of Medicare cataract patients undergo pre-
operative testing, none of which is mandated by CMS regulation.\2\ If
these patients' physicians are cautious enough to currently pursue more
preoperative activity (for example, testing and H&P) than what is
required, or state or hospital rules are driving physician behavior
beyond what Medicare necessitates, then this study might be interpreted
to suggest that there is little reason to believe that that behavior
will change with the finalization of this rule. This study did not,
however, address the 30-day time frame. We are unaware of any study or
body of opinion suggesting that 30 days or any such arbitrary time
limit can be medically justified, or that any providers would adhere to
such a limit if not a regulatory requirement. The same points apply to
other procedures performed in outpatient settings, even those such as
hernia and plastic surgeries. In order to more successfully tailor the
upper bound of potential cost savings to H&P activity--rather than just
extrapolating from testing behavior--we requested comment on the
possibility of building on Chen et al.'s data and methodology to
estimate the increased frequency of within-30-day office visits
(presumed to be H&P) when ophthalmologist visits are at least 31 days
prior to surgery relative to when ophthalmologist visits are no more
than 30 days prior. We received no comments supporting (or opposing)
such an estimating procedure. Regardless, laboratory testing and
physical examinations have no particular dependence on each other in
terms of time or place. A physician, for example, can order a
laboratory test for a patient without a physical examination at all,
relying on a one or two year old examination or other information.
Hence, the literature on the necessity of testing is not directly
germane to the question of whether a routine physical examination
should occur, with or without routine blood and urine tests. To take a
common example, it is universal practice for highly detailed eye tests
to be performed in the surgeon's office, a week or so before cataract
surgery. It is that testing on that highly specialized equipment, not a
recent physical examination or blood tests ordered by a general
practitioner, that determines whether, how, and with what techniques
and lens inserts the cataract surgery will be performed.
---------------------------------------------------------------------------
\2\ Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW,
Maze M, Gropper MA and Dudley RA, Preoperative Medical Testing in
Medicare Patients Undergoing Cataract Surgery. New England Journal
of Medicine 372:1530-1538, April 16, 2015.
---------------------------------------------------------------------------
As noted in the medical literature previously discussed, Chung F,
Yuan H, Yin L, Vairavanathan S, and Wong DT. Elimination of
preoperative testing in ambulatory surgery. Anesth Analg. 2009 Feb,
108(s):467-75, there are no known consequential medical benefits from
the testing often performed in association with the current regulatory
requirements for general physical examinations. This study covered
hernia patients but similar results have been found in studies of
cataract surgery. Accordingly, eliminating the testing that occurs
during or after H&P could in theory produce very substantial annual ASC
cost savings with no offsetting medical cost increases or harm to
patients. H&P itself, however, is distinct from testing, and literature
indicating that testing is wasteful does not necessarily speak to the
importance of H&P. There are, however, no known studies supporting the
proposition that H&P procedures should be performed within 30 days of
surgery to avoid adverse consequences to patients. We received no
public comments making such a claim and the great majority of those
addressing this issue recommended removing at least the 30-day rule,
and usually the entire requirement.
[[Page 51793]]
In addition, Schein et al. and Bass et al. suggest that regulations
play a prominent role in the persistence of low-value H&Ps and testing.
They note that prior research indicates that it may often be the case
that each member of a care team individually believes there is little
value in preoperative testing for certain procedures, but those same
individual physicians may fear that one or more of the other
specialists or the institution may require certain tests.3 4
Therefore, the requirement for a preoperative H&P, especially within 30
days of a surgery, greatly increases the likelihood for
miscommunication among the care team regarding what tests may or may
not be required. It follows that the persistence of low-value testing
may simply be due to our requirement for what are often low-value H&Ps,
as opposed to an indication that care teams are consciously pursuing
preoperative care beyond what Medicare requires, or that they would
continue to do so in the absence of such a requirement.
---------------------------------------------------------------------------
\3\ Schein OD, Pronovost PJ. A Preoperative Medical History and
Physical Should Not Be a Requirement for All Cataract Patients. J
Gen Intern Med. 2017;32(7):813-814. doi:10.1007/s11606-017-4043-9.
\4\ Bass EB, Steinberg EP, Luthra R, et al. Do Ophthalmologists,
Anesthesiologists, and Internists Agree About Preoperative Testing
in Healthy Patients Undergoing Cataract Surgery? Arch Ophthalmol.
1995;113(10):1248-1256. doi:10.1001/archopht.1995.01100100036025.
---------------------------------------------------------------------------
As discussed in ``Provisions of the Proposed Regulations,'' section
II.D. 2. of the proposed rule, there is a similar regulatory
requirement for hospital outpatient surgery. Based on the substantial
similarity between these two service settings, we also proposed to
eliminate these requirements for such surgery. Although we do not have
detailed data for hospital outpatient surgery, it is widely agree to be
roughly equal in size and composition to ASC surgery, though spending
is higher because a higher payment schedule is used by some insurers,
including Medicare, for most hospital outpatient surgery. Regardless,
estimates should be based on economic costs, not any particular payment
schedules. Accordingly, potential total annual savings, and hence
benefits, for both settings taken together could be as much as $1.7
billion or more. This would depend on whether hospital-based outpatient
surgery decisions parallel those of independent ASCs.
If, after ASCs and hospitals make policy decisions on which types
of outpatient/ambulatory surgery patients would continue to require a
comprehensive H&P, and only 50 percent of current costs were continued,
potential total annual savings, and hence benefits, for both settings
taken together would be about $908 million, assuming that hospital-
based outpatient surgery H&P policy decisions parallel those of
independent ASCs. Alternatively, if 75 percent of current costs were
continued, potential savings would be about $454 million annually.
While the literature shows that we can be reasonably certain that for
some procedures, such as cataract surgery, few or possibly even no
costs would be self-imposed, there may be other procedures where
ensuing policy decisions would retain all current history and physical
requirements other than the strict 30-day rule. Because of the new
requirements, and other uncertainties, the potential savings from
lifting the current requirements encompass at least this broad range
and quite possibly more. Because there was great uncertainty in these
estimates as to future decisions by ASCs and hospital outpatient
departments, we decided not to present a predetermined figure in the
proposed rule. Instead, we requested public comments on all the
parameters of our estimates to inform the estimates we would make in
the final rule. We welcomed information on likely decisions in both ASC
and hospital outpatient settings, and if possible for the most common
procedures shown in Table 14 and for the likelihood and cost saving
effects for procedure and patient categories where the facility chooses
to retain an external H&P requirement, but extends the time window to a
year or some other period that is far longer than 30 days. We did not
receive any public comments on the dollar estimates but did receive a
large number of public comments stating that the current H&P
requirements in their entirety and/or the 30-day limit did not rest on
any medical evidence of benefits to patients, and should be removed.
Even those few comments supporting retention provided no medical
evidence as to the necessity of applying either an H&P requirement or a
30-day requirement to most outpatient surgeries.
Table 15--Current Costs and Potential Annual Savings From Creating and Obtaining Examination and Test Results
----------------------------------------------------------------------------------------------------------------
Twenty- Seventy- Eighty-
Current five Fifty five five
Type of cost Unit Number total percent percent percent percent
cost (M) cost retained retained retained retained
($M) ($M) ($M) ($M) ($M)
----------------------------------------------------------------------------------------------------------------
Physical Examinations.............. $100 4.56 $456 $114 $228 $342 $388
Test Batteries..................... 100 2.28 228 57 114 171 194
Patient Travel Cost................ 36 4.56 164 41 82 123 140
Administrative Cost to ASC......... 5 4.56 23 6 11 17 19
Surgery Cancellations *............ 162 0.228 37 9 18 28 31
----------------------------------------------------------------------------
Total Cost, ASCs............... ......... ......... 908 227 454 681 772
----------------------------------------------------------------------------
Total Cost, Hospital Outpatient ......... ......... 908 227 454 681 772
**............................
----------------------------------------------------------------------------
Total Cost..................... ......... ......... 1,816 454 908 1,362 1,544
----------------------------------------------------------------------------
Total Savings.................. ......... ......... ......... 1,362 908 454 272
----------------------------------------------------------------------------------------------------------------
* Based on information from a major ambulatory surgery facility, this estimate assumes that 5 percent of
scheduled cataract operations are cancelled at the last minute since the required H&P information has not
arrived from the physician office where the examination was performed and the tests ordered or performed.
Staff salaries must still be paid. Our estimates assume one half hour of surgeon time wasted (at $242 an
hour), one half hour of RN time wasted (at $71 an hour), and ten minutes of clerical time (at $33 an hour) to
reschedule.
** Hospital outpatient savings assumed to be equal to ASC savings.
[[Page 51794]]
We assume that the one-time costs of developing such policies for
hospital outpatient surgery in 4,823 Medicare-participating hospitals
would be the same in the aggregate, though the mix of personnel used
would be somewhat different and the cost at free-standing hospitals
would likely be several times higher (for example, for involvement of
the governing body and legal review). About 3,200 of these hospitals
are in multi-hospital systems that would, however, reap economies of
scale, and about 574 are psychiatric hospitals that we assume rarely
perform surgery. In total, we estimate that, first year savings for
both types of facilities would be $38 million less, regardless of the
replacement rules that each facility imposed on itself.
There are possible alternatives, including limiting the regulatory
reform to the lowest risk procedures, which would probably mean almost
all procedures, excluding certain procedures from the regulatory
reform, exempting ASCs, but not hospital outpatient departments,
changing the 30-day requirement to something much longer in duration
such as 6 months or a year, and likely others. Absent contrary
evidence, however, we believe that relying on physician and facility
judgment maximizes benefits and presents no consequential costs.
We welcomed comments on these estimates and on both the proposal
and any alternatives, and particularly welcomed any evidence-based
information that would inform both our ability to provide cost savings
estimates and a policy choice between either the proposed reform or an
alternative. We did not receive any public comments specific to our
cost estimates or recommending any alternative reform.
In the proposed rule we stated that we could not forecast with any
precision what medical specialty societies, ASC governing bodies,
hospital governing bodies, or accreditation bodies would decide to do
in replacing the current requirement. For these reasons, we did not
forecast a specific level of cost savings in the proposed rule, and
simply presented a range of from 25% to 75% (and possibly even higher
or lower). The comments we received from a wide range of stakeholders
suggest that there might be more ASCs than we anticipated that take
advantage of the new flexibility to reduce either the numbers and types
of procedures for which H&P would be required, or to expand the 30-day
limitation to a greater time window, or both. Moreover, the largest
organization deemed by CMS to provide standards at least equal to those
of CMS, and allowed to accredit providers based on those standards,
strongly endorsed replacing the current standard with one allowing
procedure-specific medical judgment, as did several organizations
representing professional societies or large provider organizations.
There are, however, some organizations in some states and some
providers that indicated they opposed any loosening of current
restrictions. Our final rule would allow them to self-impose identical
restrictions, and allow all affected providers to retain current
restrictions for some categories of surgery.
As noted previously, in order to more successfully tailor the upper
bound of potential cost savings, we built on Chen et al.'s methodology
to estimate the increased frequency of within-30-day office visits
(presumed to be H&P) when ophthalmologist visits are at least 31 days
prior to surgery relative to when ophthalmologist visits are no more
than 30 days prior (and thus aspects of their own medical examinations
could be used to satisfy time-sensitive regulatory requirements). More
specifically, we used Medicare fee-for-service claims data for
procedures performed in hospitals on an outpatient basis or in
ambulatory surgical centers; following Chen et al., we limited our 2017
data set to cataract surgeries performed on patients of at least age 66
and assumed office visits within 30 days prior to surgery were
associated with H&P if the provider specialty was noted as general
practice, anesthesiology, cardiology, family practice, internal
medicine, geriatric medicine, nurse practitioner or physician
assistant. The dependent variable in our logistic regression took the
value 1 if an office visit, with a specialty as listed above, had been
conducted within 30 days prior to cataract surgery and 0 otherwise. The
key explanatory variable took the value 1 if an ophthalmologist visit
(identified if the provider specialty was noted as ophthalmology) was
within 30 days prior to surgery and 0 if it was at least 31 days prior.
Control variables included patient year of birth, sex and race.
Using this methodology to model the probability that the dependent
variable is equal to 1, the odds ratio of the key explanatory variable
is 0.654 (95 percent confidence interval: 0.633-0.676). There are,
however, several limitations to this method of analysis. Most notably,
identifying ophthalmology visits by the physician specialty code proved
to be unreliable, and it is unclear how many ophthalmology visits may
have been missed because the physician specialty field was either blank
or noted as unknown. We removed all beneficiaries from our analysis who
underwent a cataract surgery in 2017, yet did not have any identifiable
ophthalmology visits within that same calendar year, which limited our
data set substantially.
Our overall estimate is that approximately 28 percent of cataract
surgeries were preceded, within 30 days, by office visits. In the
vicinity of a 28-percent rate, a roughly 8- or 9-percentage-point
difference in rates yields an odds ratio of 0.654. Therefore, 8.5
percent will be used in the calculation of our primary savings
estimate, with an upper bound on savings of 17 percent and a lower
bound of zero.
c. Effects on Hospices
As of May 2017 there are 4,602 Medicare participating hospices. We
are finalizing our revisions the hospice CoPs in order to reduce
unnecessary duplications and streamline processes in order to reduce
hospice compliance burden while maintaining minimum standards for
patient safety and care.
At Sec. 418.76(a) we finalized our proposal to defer to State
training and competency requirements, where they exist, for hospice
aides. Deferring to state requirements will streamline the hiring
process because hospices would not have to verify that a job
candidate's qualifications meet or exceed the Federal standard in
addition to verifying that the candidate meets State requirements.
According to the BLS, 408,920 aides are currently employed in
``home care''. The term ``home care'' encompasses both home health
agency and hospice employers. There are 12,624 HHAs and 4,602 hospices,
meaning that hospices represent 27 percent of the ``home care''
employer market. Thus, we conclude that hospices employ 110,408 aides
(27 percent of all aide positions in ``home care''). Based on an
informal survey conducted by the largest hospice industry association,
76 percent of States have their own training and competency
requirements, accounting for approximately 83,910 aide positions.
Hospices in these states would benefit from the change because they
would be permitted to rely on the completion of state mandated training
and competency programs to assure that a candidate is qualified for
employment, and would no longer have to take the additional step of
verifying that each potential job candidate also meet the Federal
requirements. We assume a 25 percent turnover rate based on discussions
with industry experts, or 20,978 aide job listings per year. Based on
an assumed 20 candidates that would require the qualifications
verification per job
[[Page 51795]]
listing, we estimate that hospices must verify the training and
competency program content and format for 419,560 candidates per year.
We assume that it would take 10 minutes per candidate to verify
compliance with the Federal requirements, for a total of 69,927 hours
per year nationwide. At a cost of $33 per hour for a general office
clerk to perform this check, we estimate that hospices will save
$2,307,591 annually.
At Sec. 418.106(a) we are finalizing our proposal to delete the
requirement that a hospice must ensure that the interdisciplinary group
confers with an individual with education and training in drug
management as defined in hospice policies and procedures and State law,
who is an employee of or under contract with the hospice to ensure that
drugs and biologicals meet each patient's needs. Not requiring the
specific pharmacy advisement function will allow for more streamlined
interdisciplinary group meetings. We assume that 25 percent of hospices
currently use their own staff (employee or contract) for this function,
and that this staff member is typically the nurse member of the
interdisciplinary group. The nurse member of the interdisciplinary
group is also required by Sec. 418.56(a); therefore we believe that
removing this requirement will not result in removing the expertise
from the group. Rather, we believe that removing this requirement will
remove the formulaic approach to interdisciplinary discussions whereby
the group allots time in each meeting specifically for this discussion
in order to assure regulatory compliance. In the absence of regulation,
the interdisciplinary group would have the authority to decide whether
the discussion is pertinent for a given patient and the information can
be woven into the discussion at large. This approach has the potential
to reduce the overall group discussion time, particularly for the 3
members of the interdisciplinary group that are not charged with being
the pharmacology expert. Based on 1.6 million hospice patients and an
assumed 3 interdisciplinary group meetings per patient, there are a
total of 4,800,000 interdisciplinary group meetings per year. We assume
that each interdisciplinary group meeting includes 2 minutes of time
specifically related to discussing the results of the pharmacy
advisement service for purposes of complying with the regulation, or
160,000 hours per year nationwide. At a cost of $307 per hour ($203
physician + $55 social worker + $49 pastoral counselor (BLS Occupation
code 21-1010)), we estimate that removing this requirement would save
$49,120,000 annually. There are additional savings detailed in the
Collection of Information section of $30,956,777 annually due to
removing this requirement.
Additionally, we believe that this change will reduce the
specialist nursing time spent specifically on advisement services. We
believe that moving away from a regulatory compliance ``check box''
approach would allow the specialist nurse to incorporate medication
management more seamlessly into regular clinical practice. The 2008
Hospice CoP final rule (73 FR 32088) estimated a 1 hour burden per
patient for expert pharmacy services (30 minute initial advisement per
patient + 2 15 minute update advisements) for a total cost of $71 per
patient for all advisement services (updated to 2017 dollars). We
estimate that this change will reduce that time by 50 percent, to 30
minutes per patient, resulting in a $35.50 per patient savings. Based
on the assumption that 25 percent of hospices use their own employee to
perform this function, we estimate that this reduction will occur for
400,000 patients nationwide (25 percent of 1.6 million hospice
patients), for a total annual savings of $14,200,000.
Together with the previously stated estimates, total savings would
be $49,120,000 + $30,956,777 + $14,200,000 million = $94,276,777
annually.
At Sec. 418.112(f) we are finalizing our proposal to allow
hospices and long term care facilities the additional flexibility to
negotiate the format and schedule for orienting long term care facility
staff regarding certain hospice-specific information. We believe that
this will allow for innovation and streamlining, and reduce hospice
compliance costs related to this requirement by 20 percent. For
purposes of our analysis only, we assume that a typical hospice
conducts 6 orientation sessions per year, and that each orientation
requires 2 hours of time from a hospice nurse. At a cost of $71 per
hour, a typical hospice would spend $852 each year to orient long term
care facility staff. Assuming a 20 percent reduction in burden that can
be achieved through innovation and streamlining, a typical hospice
would save $170 a year, or $782,340 savings annually for all 4,602
hospices.
Taken together, these reforms will generate annual savings of
approximately $97.4 million ($80.1 million for reduced
interdisciplinary group meeting time + $14.2 million for reduced
specialty nursing time + $2.3 million for streamlined hospice aide
qualification requirements + $0.8 million for streamlined facility
staff orientation). We requested public comment regarding these burden
estimates, and additional regulatory reforms to reduce the burden of
the hospice CoPs, but did not receive any comments specific to our
solicitation.
d. Effects on Hospitals
As of 2017, there were 4,823 Medicare participating hospitals. We
revised the hospital CoPs in order to simplify some requirements and
streamline processes in order to reduce burden associated with hospital
compliance with the Medicare CoPs while maintaining minimum health and
safety standards. The specific savings for each change are described
below.
At Sec. 482.21, we are allowing for multi-hospital systems using a
system governing body, as allowed under the CoPs, and that is legally
responsible for two or more separately certified member hospitals, to
have a unified QAPI program for the member hospitals subject to the
system governing body. This will afford hospitals flexibility and the
ability to gain efficiencies and achieve significant progress in
quality by sharing best practices among all hospitals subject to the
system governing body. This will be similar to current allowances for
system governing bodies and unified medical staffs.
While there are no current requirements that explicitly prohibit
the sharing of best practices across a system, the current requirements
for each hospital to have its own separate and distinct QAPI program
and Infection Control program certainly have inhibited and stifled
sharing of best practices and innovations among individual hospitals
within a system as we point out in the preamble to the proposed rule,
and which we support with our reference to the Health Research and
Educational Trust, in partnership with the American Hospital
Association March 2010 publication entitled, ``A Guide to Achieving
High Performance in Multi-Hospital Health Systems.'' This publication,
along with positive public comments regarding unified medical staffs
that we discussed in the May 2014 final rule and to which we refer in
the proposed rule, clearly point to multi-hospitals more efficiently
and effectively collecting, disseminating, and sharing innovations,
solutions, and best practices for patient care to each of its member
hospitals through these unified patient care programs.
Approximately 3,493 of the 4,823 Medicare-participating hospitals
[[Page 51796]]
participated in a hospital system in 2017 (American Hospital
Association (AHA), Fast Facts 2019 (https://www.aha.org/statistics/fast-facts-us-hospitals)). According to the 2017 AHA Guide, there are
424 multi-hospital systems. The current regulatory burden for
compliance with the QAPI program requirement is approximately $10,000
annually per hospital or $48.2 million annually for all 4,823
hospitals. If we were to allow a unified QAPI program for multi-
hospital systems, this would remove 3,493 hospitals from the total
4,823 (replaced by the 424 multi-hospital systems) for a total of 1,754
hospitals/multi-hospital systems that would still need to comply. The
new regulatory burden will be a total of approximately $17.5 million
annually (1,754 x $10,000), for an annual total savings of
approximately $31 million. We welcomed comments on the quantitative and
non-quantitative portions of the preceding discussion and seek any
empirical evidence that would improve the accuracy and thoroughness of
the relevant benefits estimation, but did not receive any comments
specific to our solicitation.
We are removing the requirement for hospitals at Sec. 482.22(d),
which states that a hospital's medical staff should attempt to secure
autopsies in all cases of unusual deaths and of medical-legal and
educational interest. Because this requirement is redundant and more
detailed, specific requirements regarding medical-legal investigative
autopsies are required by individual state law, we do not anticipate
that hospitals would accrue additional savings from this change. The
benefit to hospitals from eliminating this requirement is realized
through a reduction in burden from no longer having to comply with two
similar requirements of the Federal government and the State
government. Hospitals would instead be required to follow the more
detailed, specific regulations of the state in which they are located.
At Sec. 482.42, we are allowing for multi-hospital systems using a
system governing body as currently allowed under the CoPs, and that is
legally responsible for two or more separately certified member
hospitals, to have a unified infection control program for those member
hospitals subject to the system governing body. This will allow
hospitals flexibility and the ability to gain efficiencies and achieve
significant progress in infection prevention and control. This would
also be similar to current allowances for system governing bodies and
unified medical staffs. The current regulatory burden for compliance
with the Infection Control program requirement is approximately $183
million annually for all hospitals or $38,000 per hospital. If we were
to allow a unified Infection Control program for multi-hospital
systems, this would remove 3,493 hospitals from the total 4,823
(replaced by the 424 multi-hospital systems) for a total of 1,754
hospitals/multi-hospital systems that would still need to comply. The
new regulatory burden would be a total of approximately $66.7 million
annually (1,754 x $38,000), for an annual total savings of
approximately $116 million, less the estimated cost of $1 million
described in the Collection of Information Requirements section, for an
annual net savings of approximately $115 million. We welcomed comments
on the quantitative and non-quantitative portions of the preceding
discussion and seek any empirical evidence that would improve the
accuracy and thoroughness of the relevant benefits estimation.
At Sec. Sec. 482.58(b)(1) and 485.645(d)(1) (cross-referenced
long-term care requirement at Sec. 483.10(f)(9)) we are removing the
requirement for hospital and CAH swing-bed providers to provide the
right for patients to choose to or refuse to perform services for the
facility and if they so choose, (a) document in the resident's plan of
care, (b) noting whether the services are voluntary or paid and (c)
provide wages for the work being performed given the location quality,
and quantity of work requiring comparable skills. We discuss the
economic impact for this provision in the ICR section of this rule,
which is estimated to be $29.4 million.
At Sec. 482.58(b)(4) (and Sec. 485.645(d)(4)) (cross-referenced
long-term care requirement at Sec. 483.24(c)), we are removing the
requirement for hospital and CAH swing-bed providers to provide an
ongoing activity program that is directed by a qualified therapeutic
recreation specialist or an activities professional who meets certain
requirements as listed at Sec. 483.24(c)(2). We discuss the economic
impact for this provision in the ICR section of this rule, which is
estimated to be a savings of $73.5 million.
We are finalizing our proposal to remove the requirement at
Sec. Sec. 482.58(b)(5) and 485.645(d)(5) (cross-referenced long-term
care requirement at Sec. 483.70(p)) for hospital and CAH swing-bed
providers to employ a qualified social worker on a full-time basis if
the facility has more than 120 beds. Given that this provision is not
applicable to either provider type due to the regulatory requirements
for each, it does not impose a burden upon hospitals and as such, its
removal will not result in a savings of burden hours or dollars.
At Sec. Sec. 482.58(b)(8) and 485.645(d)(8) (cross-referenced
long-term care requirement at Sec. 483.55(a)(1)) we are removing the
requirement for hospital and CAH swing-bed providers to assist in
obtaining routine and 24-hour emergency dental care to its residents.
We discuss the economic impact for this provision in the ICR section of
this rule, which is estimated to be $2.9 million for all hospital and
CAH swing-bed providers.
At Sec. 482.61(d), we are finalizing our proposal to allow non-
physician practitioners to document progress notes in accordance with
State laws and scope of practice requirements. We believe that
clarification of the intent of the regulation is necessary and will
result in non-physician practitioners (specifically, physician
assistants, nurse practitioners, psychologists, and clinical nurse
specialists) documenting in the progress notes for patients receiving
services in psychiatric hospitals. We estimate that MDs/DOs currently
spend approximately 30 minutes documenting progress notes in
psychiatric hospitals, and that 33 percent of this time would be
covered by non-physician practitioners. Of the 4,823 Medicare
participating hospitals, approximately 620 (or 13 percent) are
psychiatric hospitals. According to AHA, there were 36,510,207
inpatient hospital stays in 2017, and therefore an estimated 13 percent
of these stays were at psychiatric hospitals. The proposed change would
result in a savings of $153.5 million (4,746,327 psychiatric hospital
stays x 2 progress notes per stay x 0.5 hours of physician/psychiatrist
time x $98 per hourly wage difference between physicians/psychiatrists
($198) and non-physician practitioners ($100, the average wage between
nurse practitioners and physician assistants) x 33 percent of physician
time spent writing progress notes covered by nonphysician
practitioners). This savings is equivalent to $247,575 per psychiatric
hospital per year.
Comment: We received a comment expressing concern over this
estimate and whether the 30 minutes applies to each note, each patient
per day, all patients per day, or some other measure; and that in any
case, the total calculated amount of time spent on progress notes
appears grossly underestimated.
Response: We thank you for your feedback and for calling this to
our attention. We agree that our original estimate was low, and have
revised our estimates to reflect 30 minutes spent on each note,
assuming one progress note
[[Page 51797]]
per week during an average length of stay of 12 days per patient.
e. Effects on Transplant Programs and Patients
We are finalizing the proposed revisions unchanged. For the
convenience of current readers we are also repeating, essentially
unchanged, the data and analysis that indicate that the proposed (and
hence final) rule would have substantial life-extending benefits,
perhaps in the billion dollar a year range, but that we are unable to
provide a robust estimate of their overall magnitude.
There are approximately 750 Medicare approved transplant programs
in the United States, of which 250 are kidney transplant programs. All
Medicare approved transplant programs must be a part of a Medicare
approved hospital, and many hospitals have several types of organ
programs. Oversight of these programs occurs in two major ways: By the
Organ Procurement and Transplantation Network (OPTN), which is a non-
profit membership-based organization operated under a Federal contract
administered by the Health Resources and Services Administration
(HRSA), and by CMS under the CoPs. The current and long-term OPTN
contractor is the United Network for Organ Sharing (UNOS), which
performs many transplantation functions, including matching donated
organs to waiting lists of patients who have failing organs, and
reviewing the performance of transplant centers on a variety of
criteria, including patient and organ survival. There is a third
mechanism encouraging better transplant program performance, the SRTR
(accessed at https://www.srtr.org). The SRTR, also operated under a
HRSA contract, provides detailed data on the performance of all
transplant programs, and allows the OPTN, individual transplant
programs, and patients themselves to compare results on such vital
metrics as patient survival rates after transplant.
For patients with most types of organ failure, a transplant is the
only option for long-term survival. In the case of kidney failure,
however, kidney dialysis is a viable medium-term and sometimes long-
term option for most patients. On average these patients can survive a
dozen or more years on dialysis; however, without a transplant, they
suffer increasingly high morbidity and mortality rates. We provide
Medicare coverage for such patients through the ESRD program. Under the
ESRD program, patients receive dialysis treatment, usually three times
a week, through machines that cleanse their blood in much the same way
as healthy kidneys would do. Since its inception in 1973, more than one
million patients have received treatment under this program. Kidney
failure patients are unique in another way: Unlike most other organs,
with the partial exception of some liver donations, it is possible for
living individuals to donate ``live'' kidneys, whether the living donor
is a relative or an unrelated altruistic donor. In the case of ESRD
patients, the Medicare ESRD program serves almost all kidney failure
patients, regardless of age, and these patients receive costly dialysis
for a prolonged period of time. As is the case for all CoPs, our
regulations for Medicare-approved organ transplant programs have the
potential to protect all patients, not just Medicare beneficiaries.
As discussed earlier in this preamble, we have long regulated
transplant programs, but put in place additional CoPs in the March 2007
final rule (72 FR 15198) in an effort to increase the quality of care
by specifying minimal health and safety standards. In addition, outcome
metrics (1 year graft and patient survival) were included in the
regulation and mirrored the OPTN outcomes metrics as calculated by the
SRTR. Over time, increased emphasis on organ and patient survival
rates, as key metrics of transplant performance, created incentives for
transplant programs to select organs most likely to survive after
transplant without rejection, and to select recipients most likely to
survive after the transplant. In particular, due to the increasing
patient and organ survival rates over time, the 2007 standards have
become increasingly stringent over time as an artifact of the
performance calculation method established in the 2007 rule, an outcome
that was never intended by CMS. In addition, the 2007 rule created
performance standards that focused only on organ and patient survival
rates for those who received a transplant, not on survival rates of
patients awaiting transplant. We refer readers to a discussion of this
problem in the following CMS compliance Guidelines that could only
partially lighten this unintended regulatory burden at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-24.pdf.
There is extensive literature on these incentives and other
phenomena in transplant medicine that strongly suggests some unintended
consequences on organ utilization (decreased use of ``marginal'' organs
in their patients) and de-selection of some patients who are slightly
less likely to survive for an extended period post-transplant. These
unintended consequences have been anecdotal and measuring the extent to
which they have occurred is difficult. In addition to the studies
previously cited in the preamble (Adler et al., Schold et al., Dolgin
et al., Stewart et al., Husain et al.), other studies on this issue
include Kasiske B, Salkowski N, Wey A, Israni A, and Snyder J,
``Potential Implications of Recent and Proposed Changes in the
Regulatory Oversight of Solid Organ Transplantation in the United
States,'' American Journal of Transplantation, Volume 16, Issue 12,
December 2016, pages 3371-3377; Howard R, Cornell D, and Schold J,
``CMS Oversight, OPOs and transplant centers and the law of unintended
consequences, Clinical Transplantation, Volume 23, Issue 6, November/
December 2009, pages 778-783; and Abecassis M, Burke R, Klintmaim G,
Matas A, Merion R, Millman D, Olhoff K, and Roberts J, ``American
Society of Transplant Surgeons Transplant Center Outcome Requirements--
A Threat to Innovation,'' American Journal of Transplantation, Volume
9, Issue 6, June 2009, pages 1279-1286; and Schold J, Miller C,
Mitchell H, Buccine L, Flechner S, Goldfarb D, Poggio E, and Andreoni
K, ``Evaluation of Flagging Criteria of United States Kidney Transplant
Performance: How to Best Define Outliers,'' Transplantation, June 2017,
Volume 101, Issue 6, pages 1373-1380. These studies regarding the
reduced number of transplants that would otherwise have occurred,
yielded several relevant facts. The number of deceased donor organs
that are discarded has been increasing over time and for kidneys, is
above 20 percent. For example, about 33 percent of kidneys recovered
from donors age 50 to 64 are discarded, as are about 62 percent of
kidneys recovered from donors age 65 or older (Hart A et al., OPTN/SRTR
2015 ``Annual Data Report: Kidney.'' Accessed at https://onlinelibrary.wiley.com/doi/10.1111/ajt.14124/full). Officials of the
UNOS have stated at public meetings that in their judgment up to 1,000
kidneys of the approximately 3,000 that are discarded each year are of
good enough quality to be transplanted successfully. The number of
organ transplantations reached record highs in 2016 (33,500), about 20
percent more than 5 years earlier, due mainly to increased donation
rates (OPTN, ``United States organ transplants and deceased donors set
new records in 2016.'' Accessed at https://optn.transplant.hrsa.gov/news/us-organ-transplants-and-deceased-donors-set-new-records-in-2016/
).
[[Page 51798]]
For purposes of this analysis, one approach to estimating effects
is to isolate the number of kidneys (and other organs) that have been
discarded as a result of the March 2007 rule; indeed, a reasonable
assumption would be that the proposed rule's rescission of the 2007
requirements would have an equal and opposite effect. A slide
presentation by UNOS researcher Darren Stewart (2017; accessed at
https://www.myast.org/sites/default/files/ceot2017/AST%20CEOT%2001%20Stewart%20-%20No%20Organ%20Left%20Behind%20-%20S3.pdf), presents an estimate that about 1,110 of about 2,759
kidneys discarded in 2012 were of transplant quality and that between
500 and 1,000 of these could have been used in transplants (the most
recent discard numbers, for 2016, are about 20 percent higher than in
2012 and one-third higher than in 2007). This presentation cites the
study previously discussed in this preamble (Stewart et al. (2017)),
that shows kidney discard rates rising from between 5 and 7 percent in
the late 1980s to 19.2 percent in 2015. Notably, the discard rate had
already reached approximately 18 percent by 2007, making the rate of
increase much lower after the March 2007 rule was implemented than it
had been in the previous two decades. Although this contrary evidence
is far from definitive, it suggests that the effect of the March 2007
rule was too small to be observable in the kidney discard data.
Unfortunately, these and other studies have had to deal with other
trends during the last two decades that greatly complicate measuring
the independent effect of the 2007 rule. These include the increasing
age of the donor pool and the attendant decline in some dimensions of
organ quality, and the opposite effects of improved techniques for
maintaining organ quality between the time of donation and the time of
transplantation. As a result, the published studies using data on organ
discards have had to use complicated multivariate statistical
procedures in attempting to estimate the effects of the 2007 rule, and
invariably conclude that their findings are subject to considerable
uncertainty.
The preceding analysis focuses on discard rates as a tool that
transplant programs can use to reduce risk of lower patient or organ
survival rates, and hence risk of closure under the 2007 rule. A second
tool that a transplant program can use to reduce its risk of lower
overall patient survival rates is to remove patients who are slightly
less likely to survive from its waiting list, most commonly by making a
judgmental decision that the patient is ``too sick for
transplantation.'' Programs that are on the margin of receiving
regulatory sanctions, or that have received such sanctions already, are
particularly likely to exercise such judgments to reduce regulatory
risk. Several studies have estimated specific numbers of transplant
reductions due to the 2007 rule by comparing the number of patients
removed from the waiting list at programs that have received regulatory
sanctions to those that have not. To provide a baseline, these studies
make the conservative assumption that those programs with zero
sanctions have not removed any patients from their transplant waiting
list in order to avoid sanctions. For kidneys, one study estimated that
in the seven year period from 2007 to 2014, the lower performing
programs removed from waiting lists over 2500 patients more than would
have been expected absent sanctions, an average of over 350 per year
(J.D. Schold et al., ``Association of Candidate Removals From the
Kidney Transplant Waiting List and Center Performance Oversight,''
American Journal of Transplantation 2016, 1276-1284). The implications,
for the present time, of wait list changes initiated in 2007 is
unclear. Increased mortality in 2007 among the very sick patients who
were dropped from the wait list would have freed up organs for 2007's
moderately sick patients; these patients otherwise would have declined
in health so as to be the very sick population in 2008. Thus the
absolute level of health in 2008 would have been relatively good, in
which case the phenomenon of patients being dropped from the wait list
might not have perpetuated into the future, leaving little or no scope
for benefits to be achieved now as a result of the proposed CoP
revision. (We note that one year, from 2007 to 2008, may be an
exaggeration as to the short-term nature of this wait list-related
effect, but a somewhat longer tapering period could still have reached
completion now, more than a decade after the implementation of the 2007
CoP, thus leaving little scope for benefits.) On the other hand, if the
sickest patients in 2008 were dropped based on their relative health
levels--in spite of their improved absolute health relative to the
sickest patients in 2007--there would be potential wait list-related
benefits from revising this CoP at the present time. The benefits of
shifting transplants to the sickest patients from relatively less sick
patients have not been quantified, but because the harm to the less
sick patients would need to be netted off the benefit to the sickest
patients, the per-transplant magnitude would be much lower than the
per-transplant benefits of avoided organ discards.
Another quantitative study of kidney transplant effects used a
similar methodology and estimated that as a result of the 2007 rule, in
2011 sanctioned programs performed 766 fewer kidney transplants than
would otherwise have been the case.\5\ White et al.'s finding of
reduced transplant volumes at particular kidney transplant centers does
not necessarily indicate decreased transplant volumes overall, with the
authors stating that their aggregate results ``do not indicate that the
introduction of the [2007] CoPs has systematically reduced
opportunities for marginal candidates or that there has been a
systematic shift away from utilization of higher risk deceased donor
kidneys.'' In other words, regulatory sanctions could have triggered
behavioral responses by some patients, some transplant surgeons, or
some health insurance plans to shift patients away from these centers
(many insurers restrict coverage through ``centers of excellence''
programs). Schold et al. (2013) find additional support for this
phenomenon, describing their empirical result as follows: ``Among 203
[adult kidney transplant] centers, 46 (23%) were low performing (LP) .
. . Among LP centers, there was a mean decline in transplant volume of
22.4 cases compared to a mean increase of 7.8 transplants among other
centers.'' The estimated decrease per low-performing transplant center
is roughly three times the increase per other center, but there are
also roughly three times as many other centers as low-performing
centers; as such, the most straightforward interpretation of this paper
is that the same number of transplants is being concentrated in a
smaller number of transplant centers. This outcome could still have
real impacts, such as changes in travel time for patients, but although
these impacts are valid for inclusion in a regulatory impact
assessment, they would be much smaller in magnitude than the longevity
benefits emphasized elsewhere in this analysis.
---------------------------------------------------------------------------
\5\ Sarah L. White et al., ``Patient Selection and Volume in the
Era Surrounding Implementation of Medicare Conditions of
Participation for Transplant Programs,'' Health Services Research,
April 2015, 330-350.
---------------------------------------------------------------------------
A feature common to most of these studies that is that they use
data that are already several years old when the study is published,
both because of the usual publishing lag and because performance data
such as one-year survival rates necessarily make transplant program
results less timely. None of these studies covers the last two
[[Page 51799]]
or three years of transplant program performance. As a result, none of
these studies has been able to use actual data to assess the effects of
the May 13, 2016 CMS changes that slightly reduced the performance
level for finding a ``condition-level'' violation that threatens
program closure. For recent reviews of potential effects of those
changes see BL Kasiske et al, Potential Implications of Recent and
Proposed Changes in the Regulatory Oversight of Solid Organ
Transplantation in the United States,'' Am J Transplant, December 2016,
16(12), 3371-3377, and Colleen Jay and Jesse Schold, Measuring
transplant center performance: The goals are not controversial but the
methods and consequences can be, Curr Transplant Rep, March 2017, 4(1),
52-58. Using past data to measure potential effects, these studies
predict little or no positive effect from the revised standards (which
both studies conclude will still mis-identify lower performing
programs), but cannot evaluate actual effects because post-issuance
evidence is not yet available. This may not be relevant policy-wise,
since we proposed to eliminate those standards, but it is a key
question for estimating the remaining scope (if any) of CoP-associated
unnecessary organ discards, and it does flag the pervasive problem of
timeliness of data and timeliness of study findings.
There are several studies that make similar estimates for liver
transplant programs (for example, L.D. Buccini, et al., ``Association
Between Liver Transplant Center Performance Evaluations and Transplant
Volume,'' American Journal of Transplantation 2014, 2097-2105). This
study found a large difference in transplant volume between programs
rated as lower performing by the SRTR (average decrease of 39.9
transplants from 2007 to 2012) and those not receiving adverse SRTR
ratings (average increase of 9.3 transplants over the same period). The
27 lower performing centers thus reduced their total number of liver
transplants by over 1,000, and compared to the higher performing
centers the decrease was even larger. This study did not, however, tie
its estimates to the performance standards in the 2007 rule (which are
similar but not identical to SRTR standards), to sanctions under that
rule, or to specific center decisions, such as removing candidates from
the wait list. Hence, while it certainly contributes to the body of
scholarship indicating that since 2007 transplants have been performed
in a more concentrated set of programs, it does not appear to provide
direct estimates of the quantitative effects of the 2007 rule on
overall numbers of liver transplants.
Taking into account all the various uncertainties involved in these
studies, we did not and do not believe that we can estimate the effects
of the 2007 rule on numbers of transplantations for any organ other
than kidneys, and that even for kidneys there is no clear central
estimate of likely quantitative effects. The wide variation in
published results, and the disclaimers as to the various uncertainties
involved, make a precise as well as reliable estimate all but
impossible and would render arbitrary any non-zero lower bound estimate
of health and longevity impacts. (As noted above, however, even in the
absence of health and longevity effects, there may be other benefits,
such as reduced travel costs, if the proposed rule reduces
concentration of transplants in a smaller number of facilities.)
Therefore, we have shown the effects of the final rule change as ``not
quantified.'' This is not unusual in regulatory impact analyses that
address complex phenomena that cannot be measured directly, or whose
effects are intertwined with other changing circumstances.
Every transplant quality organ that is used for transplantation
rather than discarded has a very high probability of substantially
extending the life of the recipient. There is a particularly extensive
literature on life expectancy before and after transplant, quality of
life, and cost savings for kidney patients. A literature synthesis on
``The Cost-Effectiveness of Renal Transplantation,'' by Elbert S.
Huang, Nidhi Thakur, and David O. Meltzer, in Sally Satel, When
Altruism Isn't Enough (AEI Press, 2008) found essentially universal
agreement that kidney transplants were not only substantially life
extending, but also cost reducing. The authors performed an extensive
literature search and found that from 1968 to 2007 seventeen studies
assessed the cost-effectiveness of renal transplantation. The authors
concluded that ``Renal transplantation . . . is the most beneficial
treatment option for patients with end-stage renal disease and is
highly cost-effective compared to no therapy. In comparison to
dialysis, renal transplantation has been found to reduce costs by
nontrivial amounts while improving health both in terms of the number
of years of life and the quality of those years of life'' (page 31).
More recent studies have reached similar conclusions, as have other
syntheses. For example, the ``Systematic Review: Kidney Transplantation
Compared with Dialysis in Clinically Relevant Outcome'' (M. Tonelli, N.
Wiebe, G. Knoll, A. Bello, S. Browne, D. Jadhov, S. Klarenbach, and J.
Gill, American Journal of Transplantation 2011: 2093-2109) focused on
life expectancy and quality of life. This article reviewed 110 studies,
and concluded that the vast majority showed major improvement in life
quality and reductions in mortality among transplant recipients
compared to those remaining on dialysis. The Annual Data Report of the
United States Renal Data System utilizes national data on ESRD, and
reports that deaths per 1,000 patient years are about 180 for dialysis
patients and about 32 for transplant recipients (see 2016 report,
volume 2, Figure i.13 and Tables H.4 and H.10); accessed at https://www.usrds.org/adr.aspx). There are similar data on other organs. For
example, in 1998, HHS published a final rule with comment period that
established governance procedures for the OPTN (63 FR 16296). In the
RIA for that rule, the Department estimated that ``the annual benefits
of organ transplantation include about eleven thousand lives vastly
improved by kidney transplantation, and another eight thousand lives
both vastly improved and prolonged by transplantation of other major
organs'' (63 FR 16323).
Even without a robust aggregate estimate of likely increases in
organ utilization as a result of this proposed regulatory change, the
potential benefits are very substantial. For each new kidney
transplantation, there would be an average of 10 additional life years
per transplant patient compared to those on dialysis (see Wolfe A et
al., ``Comparisons of Mortality in All Patients on Dialysis, Patients
on Dialysis Awaiting Transplantation, and Recipients of a First
Cadaveric Transplant,'' NEJM, 1999, 341:1725-30; accessed at https://www.nejm.org/doi/full/10.1056/NEJM199912023412303#t=article). Valuing
each year of life gained using a ``value of a statistical life year''
(VSLY) of $490,000 in 2014 dollars, the total benefits from each
additional transplantation in 2018 would be $4.9 million before
discounting and $4.4 million after inflating to 2016 dollars and
discounting at either 3 or 7 percent over the 10-year period (life-year
figure for 2014 from Office of the Assistant Secretary for Planning and
Evaluation, HHS, Guidelines for Regulatory Impact Analysis, 2016, page
21, accessed at https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis). The HHS methodology produces the same result at
either discount rate in order to reach the same predetermined ``real''
value. For an explanation and
[[Page 51800]]
justification of this VSLY approach, see Cass R. Sunstein, ``Lives,
Life-Years, and Willingness to Pay,'' 104 Columbia Law Review [i]
(2004).
Those HHS guidelines also explain in some detail the concept of
quality adjusted life years. The key point to understand is that these
are research-based estimates of the value that people are willing to
pay for life-prolonging and life-improving health care interventions of
any kind (see sections 3.2 and 3.3 of the HHS Guidelines for a detailed
explanation). The QALY amount used in any estimate of overall benefits
is not meant to be a precise estimate, but instead is a rough
statistical measure that allows an overall estimate of benefits
expressed in dollars.
An alternative and more sophisticated analysis would take into
account that the life-extending effect of a kidney transplant is not
its first effect, but typically follows a number of years off dialysis,
until the organ fails and the patient returns to dialysis or is
retransplanted. Such an analysis can be found in a recent study by P.J.
Held et al., ``A Cost-Benefit Analysis of Government Compensation of
Kidney Donors,'' American Journal of Transplantation, 2016, pages 877-
885 (plus 65 pages of supplementary details explaining all assumptions,
data sources, and calculations). The largest differences between the
base case estimated in that study and the preceding estimates is that
this RIA uses the considerably higher value of a statistical year of
life under HHS guidelines, and this RIA uses the full value of a
statistical life year without a ``quality'' adjustment for the added
years of life (we use QALYs only for the improved quality of life
during years that would otherwise be on kidney dialysis). Under such an
estimation approach, potential life-extending benefits could be
somewhat larger. For example, if the proposed reform increased the
number of life-extending kidney transplants by only 100 a year, and the
benefits of both additional life years and QALY gains were estimated at
$5.1 million per patient, its total annual benefits for kidney patients
would be approximately $510 million a year (100 x $5.1 million).
There are additional benefits from kidney transplantation. As
previously discussed, kidney transplants do reduce medical costs, with
``breakeven'' after about 5 years and net savings of several hundred
thousand dollars per patient. Other organ transplants create lesser or
no medical savings because the alternative is not dialysis. Clearly,
however, these kidney transplant savings are small in relation to the
life-extending benefits. We have not estimated medical savings or costs
for kidneys or other organs in this RIA because any such estimates
would depend on the number of additional transplants that we have not
estimated.
We note that life-extending estimates are averages across patients
who vary widely in age, medical condition, and life expectancy, as well
as type of organ failure. For example, the sickest patients typically
have very low life expectancies without transplant, and hence stand to
gain the most years of life from a transplant. Partly offsetting this,
these same patients, on average, have slightly lower survival rates
post-transplant. Organ and patient survival issues are complex and
dealt with by detailed policies and procedures developed and used by
the transplant community under the auspices of the OPTN. These policies
are reviewed and revised frequently based on actual experience and
changing technology--over time the success rate from previously
marginal organs, and in older patients, have both increased
substantially. For purposes of this analysis, the proper measure is the
average gain across all patients who would receive transplants as a
result of eliminating the 2007 rule, net of these other factors.
There could be potential offsets to these calculated and
uncalculated benefits and cost reductions. However, the particular
regulatory requirements we proposed to remove are unlikely to drive any
further significant increases in graft and patient survival. For renal
transplants, the expected 1-year graft and patient survival rates are
already at 95 percent or better. Transplant program outcomes will
continue to be monitored by the OPTN and programs that are not in
compliance with the OPTN outcomes are referred to their Membership and
Professional Standards Committee for quality improvement activities.
The SRTR also publishes detailed data on transplant program performance
that allows patients and their physicians to compare transplant
programs and this transparency creates pressures to maintain and
improve survival rates in order to attract these patients.
The current regulatory requirements for transplant centers, as
discussed in section II.E ``Transplant Centers'' of the proposed rule,
have created both positive and adverse incentives for transplant
programs, with unanticipated side effects on both utilization of
donated organs and the ability of the highest risk patients to obtain
transplants. We expect the changes made by this final rule to provide
substantial net benefits, particularly since other regulatory and
informational incentives remain in place.
We requested comments on this analysis as well as information that
would enable a more robust quantitative analysis of the impacts of this
change and on any alternative reforms that might provide even higher
benefits. We did not, however, receive comments specifically addressing
these requests.
f. Effects on HHAs
As of May 2017 there are 12,624 HHAs that participate in Medicare
and Medicaid. In the January 2017 HHA CoP final rule (82 FR 4504) we
estimated that compliance with the requirements at Sec. 484.50(a)(3)
related to providing oral notice of all rights to each patient would
impose a burden of 5 minutes per patient, or 1,330,246 hours of burden
nationwide at a cost of $80,030,370, annually. The cost estimate was
based on a $63 per hour estimate for the services of a RN as derived
from the BLS Occupational Handbook, 2014-2015 edition, including a 100
percent benefit and overhead package. Adjusted to reflect more updated
salary information, as described previously, we estimate that
compliance with this provision would impose a $94,447,466 burden, based
on a RN earning $71 per hour.
We proposed to revise the verbal notification requirements to limit
them to those that are required by section 1891 of the Act. Limiting
the amount of information that is required to be provided orally will
reduce the time per patient that is required to comply with the revised
requirement. For purposes of this analysis only, we assume that
providing oral notice regarding financial liability only will require 2
minutes per patient, reducing burden by 60 percent. Based on this
assumption, this proposed change would reduce the burden of the patient
rights notification requirement by 198,148 hours (1,330,246 hours
originally estimated x 0.6) and $56,668,480 ($94,447,466 burden as
updated to reflect more recent salary estimates x 0.6).
We are also finalizing three changes that do not have a savings
estimate. First, we are eliminating the requirement at Sec.
484.80(h)(3) that the HHA conduct a full competency evaluation of
deficient home health aides, and replace it with a requirement to
retrain the aide regarding the identified deficient skill(s) and
require the aide to complete a competency evaluation related to those
skills. As we stated in the January 2017 HHA CoP final rule (82 FR
4575), it is standard practice within the HHA industry to supervise
home health aides, and the regulatory requirements for such
[[Page 51801]]
supervision do not impose any additional burden. We are also finalizing
a change to permit HHAs to use either patients or pseudo-patients when
conducting home health aide competency evaluations. While this change
does not have a monetary savings estimate, we believe that this
additional flexibility will increase the speed for aides completing
their competency evaluations, thus increasing the pool of aides
eligible to provide services and reducing patient wait times for aide
services.
We requested public comment regarding these burden estimates, and
additional regulatory reforms to reduce the burden of the HHA CoPs, but
did not receive any specific to our burden estimates. Comments
regarding additional regulatory reforms to reduce the burden on HHAs
are addressed earlier in the preamble.
g. Effects on CAHs
We proposed to remove the requirement at Sec. 485.627(b)(1) for
CAHs to disclose to CMS its owners or those with a controlling interest
in the CAH or any subcontractor in which the CAH directly or indirectly
has a 5 percent or more ownership interest in accordance with 42 CFR
part 420, subpart C. We discuss the economic impact of this provision
in the ICR section, which is estimated at $143,701 in total savings for
all CAHs. We also discussed the burden reduction for our proposed
revision of the ``patient care policies'' requirements imposed on CAHs
in the ICR section of this rule, which is estimated at $2.6 million.
Finally, the effects of the CAH swing-bed provisions are covered in the
ICR section of the rule, and estimated to be $76.5 million for all
CAHs.
h. Effects on CORFs
We discussed the burden reduction for our proposed revision of the
``utilization review plan'' requirements imposed on CORFs in the ICR
section of this rule, which is estimated at $315,840.
i. Effects on CMHCs
We discussed the burden reduction for our proposed revision of
Sec. 485.914(d)(1) ``update of the comprehensive assessment''
requirements imposed on CMHCs in the ICR section, which is an estimated
savings of $156,975.
j. Effects on Portable X-Ray Services
At Sec. 486.104 we proposed to revise the portable x-ray CfCs to
focus on the qualifications of the technologist performing the
diagnostic test. As of May 2017 there were approximately 500 Medicare-
participating portable x-ray suppliers employing an estimated 5,000
portable x-ray technologists. Hiring limited x-ray technologists or
those with State licensure would allow portable x-ray suppliers to fill
vacant positions at a lower hourly cost. Assuming a 10 percent annual
turnover rate, all technologists could be hired at the lower salary
over a period of 10 years. Limited x-ray technologists can be hired for
approximately $30 an hour ($62,400 per year), whereas, according to the
BLS, x-ray technologists with advanced certification (ARRT) are hired
at a rate of approximately $60 dollars per hour ($124,800 per year).
This creates a savings opportunity of $30 per hour, or $62,400 per
year, per technologist position. Based on an assumed 10 percent
turnover rate, or 500 positions filled in any given year, this change
would create a savings of $31,200,000 savings in the first year. We
believe that these savings would be increased every year as more
positions are filled at the lower salary rate.
We discuss the economic impact for the requirements regarding
written orders in the ICR section of this rule, which represents $27.7
million in savings.
We requested public comment regarding these burden estimates, and
additional regulatory reforms to reduce the burden of the portable x-
ray CfCs, but did not receive any comments specific to our
solicitation.
k. Effects on RHCs and FQHCs
We discussed the burden reduction for our revision of Sec.
491.9(b)(4) ``review of patient care policies'' requirements imposed on
RHCs and FQHCs in the ICR section, which is an estimated savings of
$7.3 million biennially, or approximately $3.7 million annually.
In addition, the burden reduction for our revision of Sec.
491.11(a) ``program evaluation'' requirements imposed on RHCs and FQHCs
in the ICR section of this rule, which is an estimated savings of $9.9
million biennially, or approximately $5 million annually.
l. Effects of Emergency Preparedness Requirements on Providers and
Suppliers
The revisions to the emergency preparedness requirements for
Medicare and Medicaid participating providers and suppliers, as
discussed in section II.M, either simplify the requirements, eliminate
duplicative requirements, or reduce the frequency in which providers
would need to comply with the emergency preparedness requirements. We
estimate that the finalized changes to the emergency preparedness
requirements would accrue an annual cost savings of $124 million in
total. The potential, estimated cost savings for each revised emergency
preparedness requirement is outlined in detail below. The methodology
used to calculate the economic impact and the costs associated with the
changes to the emergency preparedness requirements is the same
methodology used to calculate the economic impact in the Emergency
Preparedness final rule (81 FR 63860).
At Sec. 482.15(a), (b), (c), and (d) for hospitals and parallel
regulatory citations for other facilities, we are finalizing our
proposal for all providers, except LTC facility providers, to review
their program at least every 2 years. We discuss the economic impact
for this requirement in the ICR section of this rule, which represents
annualized cost savings of $69,639,324, or approximately $139 million
biennially.
At Sec. 482.15(a)(4) for hospitals, and other parallel citations
for the facilities mentioned in section II.J.2 of the rule, we
eliminated the requirement that facilities document efforts to contact
local, tribal, regional, State, and Federal emergency preparedness
officials and that facilities document participation in collaborative
and cooperative planning efforts. We discuss the economic impact for
this requirement in the ICR section of this rule, which represents
$7,319,255 in savings.
At Sec. 482.15(d)(1)(ii) for hospitals, and other parallel
citations for other facilities mentioned in section II.J.2 of the rule,
we are finalizing our proposal for all providers, except LTC
facilities, to require that facilities provide training biennially, or
every 2 years, after facilities conduct initial training on their
emergency program. In addition, we are requiring additional training
when the emergency plan is significantly updated. We discuss the
economic impact for this requirement in the ICR section of this rule,
which represents annualized cost savings of $25,593,781, or
approximately $51 million biennially.
Finally, at Sec. 482.15(d)(2), we are finalizing our proposal to
require that providers of inpatient services mentioned in section
II.J.2 of the rule conduct two testing exercises annually, one of which
may be an exercise of their choice that must be either a community-
based full-scale exercise (if available), an individual facility-based
functional exercise, a drill, a tabletop exercise or workshop that
includes a group discussion led by a facilitator. We are requiring that
providers of outpatient services mentioned in section II.J.2 of
[[Page 51802]]
the rule conduct one testing exercise annually which must be either a
community-based full-scale exercise (if available) or an individual
facility-based functional exercise every other year, and in the
opposite years, may be either a community-based full-scale exercise (if
available), a facility-based functional exercise, a drill, or a
tabletop exercise or workshop that includes a group discussion led by a
facilitator. We discuss the other economic impacts for this requirement
in the ICR section, which represents $9,296,422 in savings. We do not
estimate any economic impact for the providers of inpatient services as
we did not propose any changes to the number of testing exercises that
must be conducted by these providers; however, we estimate an
additional economic impact for this provision for each outpatient
provider due to a reduction in the testing requirement from two
exercises per year to one exercise per year. We would like to note that
for CORFs and Organizations, consistent with the Emergency Preparedness
Final Rule (Medicare and Medicaid Programs; Emergency Preparedness
Requirements for Medicare and Medicaid Participating Providers and
Suppliers; Final Rule, 81 FR 63860), the CoPs for these providers
previously required them to have ongoing drills and exercises to test
their disaster plans. Therefore, we continue to expect, as we did in
the Emergency Preparedness final rule, that the economic impact to
comply with this requirement will be minimal, if any. Therefore, the
total economic impact of this provision for CORFs and Organizations
will be limited to the estimated ICR burden of $56,212 and $310,362,
respectively.
We estimate a total impact savings of $11,238,093 for this change.
With an estimated ICR savings of $9,296,422, we estimate that the total
economic impact of this policy for the affected providers will be
$20,534,515. We list a summary of the calculation for the impact
savings accrued by removing this requirement for each facility in Table
16, based on facility numbers available as of May 2017.
ASCs: Combined total savings of $2,000,520 for 5,557 ASCs
((4 hours for an administrator at $109 per hour plus 4 hours for a
registered nurse at $71 per hour) x 5,557 ASCs x 50 percent).
Outpatient Hospice: Combined total savings of $1,438,240
((4 hours for an administrator at $107 per hour plus 4 hours for a
registered nurse at $71 per hour) x 4,040 outpatient hospices x 50
percent).
PACE: Combined total savings of $16,543 ((1 hour home for
a care coordinator at $71 per hour plus 1 hour for a quality
improvement nurse at $71) x 233 PACEs x 50 percent).
HHAs: Combined total savings of $2,695,224 ((2 hours for
an administrator at $107 per hour plus 3 hours for a director of
training at $71 per hour) x 12,624 HHAs x 50 percent).
CMHCs: Combined total savings of $60,214 ((5 hours for an
administrator at $107 per hour plus 3 hours for a nurse at $71 per
hour) x 161 CMHCs x 50 percent).
OPOs: Combined total savings of $5,162 ((1 hour for a QAPI
Director at $107 per hour plus 1 hour for an education coordinator at
$71 per hour) x 58 OPOs x 50 percent).
RHCs/FQHCs: Combined total savings of $4,284,104 (((4
hours for an administrator at $107 per hour plus 4 hours for a
registered nurse at $71 per hour) x 4,160 RHCs x 50 percent)
$1,480,960+ (4 hours for an administrator at $107 per hour plus 4 hours
for a registered nurse at $71 per hour) x 7,874 FQHCs x 50 percent)
2,803,144.
ESRDs: Combined total savings of $738,086 ((1 hour for an
administrator at $107 per hour plus 1 hour for a nurse manager at $107
per hour) x 6,898 dialysis facilities x 50 percent).
Table 16--Cost Savings for Emergency Preparedness Testing
------------------------------------------------------------------------
Cost savings per Combined total
Provider/supplier provider/supplier savings
------------------------------------------------------------------------
ASCs.......................... $360 $2,000,520 for 5,557
ASCs.
Hospices (outpatient)......... 356 $1,438,240 for 4,040
outpatient hospice
facilities.
PACEs......................... 71 $16,543 for 233
PACEs.
HHAs.......................... 214 $2,695,224 for 12,624
HHAs.
CMHCs......................... 374 $60,214 for 161
CMHCs.
OPOs.......................... 89 $5,162 for 58 OPOs.
RHCs/FQHCs.................... 356 $4,284,104 for RHCs
and FQHCs
($1,480,960 for
4,160 RHCs and
$2,803,144 for 7,874
FQHCs).
ESRD Facilities............... 107 $738,086 for 6,898
dialysis facilities.
------------------------------------------------------------------------
m. One-Time Implementation Costs
All of the changes presented above will necessarily have to be
read, and understood, and implemented by affected providers. This will
create one-time costs even though the underlying change reduces burden.
In most cases these costs will be very low, and may be as simple as
observing that a particular procedure will need only to be performed
once rather than twice a year, and changing the schedule accordingly.
In some cases, the facility will need to adjust in response to multiple
burden reduction changes. In still other cases, time will have to be
spent deciding how to change existing policy. For example, as discussed
previously, ASCs and hospital outpatient facilities will need to decide
whether and in what circumstances medical histories and physical
examinations will be required or encouraged as a matter of policy.
Rather than attempt to estimate these situational variables in detail
for each facility type, we believe it possible to make reasonable
overall estimates of these one-time costs, recognizing that there will
be considerable variations among provider types and among individual
providers.
In total, there are about 122 thousand affected entities, as shown
in the Table 17 that follows. We assume that on average there will be 1
hour of time spent by a lawyer, 2 hours of time by an administrator or
health services manager, and 2 hours of time by other staff (we assume
registered nurses or equivalent in wage costs) of each affected
provider to understand the regulatory change(s) and make the
appropriate changes in procedures. We further estimate that for one
tenth of these providers, 2 hours of physician time will be needed to
consider changes in facility policy. Average hourly costs for these
professions, with wage rates doubled to account for fringe benefits and
overhead costs, are $136 for lawyers, $107 for managers, $71 for
[[Page 51803]]
registered nurses, and $203 for physicians based on 2017 BLS data.
The estimated costs for an average provider would therefore be 1
hour at $136 and in total for the lawyers, 2 hours at $107 or $214 in
total for the managers, 2 hours at $71 or $142 in total for the other
staff, and 0.2 hours at $203 or $41 in total for the physicians. These
one-time costs add up to $533 per provider on average, and in total to
about $65 million.
Table 17--One-Time Implementation Costs
------------------------------------------------------------------------
Number of
Provider type affected
providers
------------------------------------------------------------------------
Religious Nonmedical Health Care Institutions........... 18
Ambulatory Surgical Centers and hospital outpatient..... 10,587
Hospices................................................ 4,602
Hospitals............................................... 4,823
Transplant programs..................................... 750
Home Health Agencies.................................... 12,624
Critical Access Hospitals............................... 1,353
Comprehensive Outpatient Rehabilitation Facilities...... 188
Community Mental Health Centers......................... 52
Portable X-Ray Services................................. 500
Rural Health Clinics and Federally Qualified Health 12,034
Centers................................................
Emergency Preparedness of Providers and Suppliers....... 74,246
---------------
Total Number of Providers............................. 121,982
Average Cost Per Provider............................... $533
---------------
Total One-Time Cost................................... $65,016,406
------------------------------------------------------------------------
n. Effects on Small Entities, Effects on Small Rural Hospitals,
Unfunded Mandates, and Federalism
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, we estimate that
almost all health care providers regulated by CMS are small entities as
that term is used in the RFA (including small businesses, nonprofit
organizations, and small governmental jurisdictions). The great
majority of hospitals and most other health care providers and
suppliers are small entities, either by being nonprofit organizations
or by meeting the SBA definition of a small business (having revenues
of less than $8 million to $41.5 million in any 1 year, varying by type
of provider and highest for hospitals). Accordingly, almost all of the
savings that the rule will create benefits small entities. We note that
individual persons are not small entities for purposes of the RFA, and
hence the life-extending transplantation benefits of the rule are not
relevant to the RFA.
The RFA requires that a final regulatory flexibility analysis
(FRFA) be prepared if a final rule would have a ``significant impact on
a substantial number'' of such entities. HHS interprets the statute as
mandating this analysis only the impact is adverse, though there are
differing interpretations. Regardless, there is no question that the
final rule would affect a ``substantial number'' of small entities. As
shown in Table 17, the total number of affected entities will be about
122,000, including those affected by more than one provision. The rule
of thumb used by HHS for determining whether an impact is
``significant'' is an effect of 3 percent or more of annual revenues.
These savings do not approach that threshold. Hospitals account for
about one-third of all health care spending and even if all these
savings accrued to hospitals this threshold would not be approached.
Therefore, the Secretary has determined that these provisions of the
final rule will not have a significant economic impact on a substantial
number of small entities.
In addition, section 1102(b) of the Social Security Act requires us
to prepare a regulatory impact analysis if a rule may have a
significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 604 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a metropolitan statistical area and has fewer than 100 beds. For the
reasons previously given, the Secretary has determined that these
provisions of the final rule will not have a significant impact on the
operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2019, that
threshold is approximately $154 million. These provisions of the final
rule contain no mandates that will impose spending costs on State,
local, or tribal governments, or on the private sector. Indeed, it
substantially reduces existing private sector mandates.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has federalism
implications. The final rule imposes no such requirements. Importantly,
it would remove Federal requirements setting qualification standards
for hospice aides. Setting qualifications for health care workers is
traditionally a State function, and this change would therefore remove
an infringement on State prerogatives.
o. Effects on Costs to Facilities, Providers, Medicare, Other
Insurance, and Patients
Most of the individual proposals addressed in the preceding
analysis involve reducing burdensome costs on facilities, health care
professionals, and patients. Most of those reductions save time and
effort currently performed on tasks that we proposed to eliminate or
reform and those reductions will result ultimately in reduced medical
care costs in these facilities, some of which will result in further
effects on public and private insurance costs. In this regard, it is
important to emphasize that the CoPs and CfCs generally apply to all
patients served by a Medicare and/or Medicaid participating provider or
supplier, not just Medicare or Medicaid patients, and to the entire
operations of the provider. Revisions to those requirements apply
broadly to the entire health care system. We are hopeful that cost
reductions ultimately flow to reductions in charges, to reductions in
third party payments, and hence to reductions in insurance costs and to
those who pay those costs.
Initial savings will accrue primarily to providers. How much of
these savings will flow to insurers and patients depends primarily on
the payment and reimbursement mechanisms in place for each affected
entity for those particular costs. According to the National Health
Expenditure Accounts, approximate payer shares in 2016 were 11 percent
for consumer out of pocket, 35 percent for private health insurance, 21
percent for Medicare, 18 percent for Medicaid, and 15 percent for other
public and private payers such as the Department of Veteran Affairs and
the Department of Defense. We would expect savings to approximate these
shares. Ultimately, all costs are paid by workers and taxpayers who pay
for all health care directly or indirectly, quite apart from immediate
cost subsidies or cost sharing.
Two provisions directly reduce Medicare and other insurance costs.
Eliminating unnecessary patient history and physical examinations and
medical tests for procedures (such as cataract surgery) performed in
ASCs and in hospital outpatient surgery will disproportionately reduce
Medicare costs, since use of these services rises with age. Additional
transplantation of
[[Page 51804]]
kidneys will reduce Medicare's ESRD costs, partially offset by
increased transplantation costs. Because of the difficulty in finding
evidence of the volume of such savings, we cannot estimate the likely
effects on Medicare spending.
Most of the facility and provider savings will accrue to Medicare
and other insurers over time as payment rate increases are slightly
reduced, and the remainder will accrue to other payers and to patients.
p. Benefits to Patients
We discussed life-extending and life-saving benefits at length in
the analysis of increases in transplantation. These result from removal
of disincentives to transplant patients, or to use organs, where this
could reduce success rates by a few percent and possibly trigger
closure of transplant centers or programs under current rules. As
previously explained, we do not have robust estimates. There are
additional and substantial patient benefits likely to result from the
cost-reducing reforms that we proposed. Time not wasted by medical care
providers or facilities on unnecessary tasks is time that can be used
to focus on better care. While such effects could be measured in
principal, there is little existing data on magnitudes of such effects.
We requested but did not receive public comments on these or any other
aspects of costs and benefits of the proposed rule.
4. Alternatives Considered
From within the entire body of CoPs and CfCs, we selected what we
believe to be the most viable candidates for reform as identified by
stakeholders, by recent research, or by experts as unusually
burdensome. This subset of the universe of standards is the focus of
the proposed rule. For all of the proposed provisions, we considered
not making these changes. Ultimately, we saw no good reasons not to
finalize these burden reducing changes.
We welcomed comments on whether we properly selected the best
candidates for change, and welcomed suggestions for additional reform
candidates from the entire body of CoPs and other regulatory provisions
that fall directly on providers. As discussed earlier in this preamble,
we did receive suggestions for additional reforms and will consider
those in future reform efforts.
5. Uncertainty
Our estimates of the effects of this regulation are subject to
significant uncertainty. While the Department is confident that these
reforms will provide flexibilities to facilities that will yield major
cost savings, there are uncertainties about the magnitude of these
effects. Despite these uncertainties, we are confident that the rule
will yield substantial overall cost reductions and other benefits. In
this analysis we have provided estimates to suggest the potential
savings these reforms could achieve under certain assumptions. We
appreciate that those assumptions are simplified, and that actual
results could be substantially higher or lower. Although there is
uncertainty concerning the magnitude of all of our estimates, we do not
have the data to provide specific estimates for each reform proposed,
as to the range of possibilities, or to estimate all categories of
possible benefits, including health effects.
6. Conclusion
These provisions of the final rule will substantially reduce
existing regulatory requirements imposed on health care providers
through the CoPs and related regulatory provisions that Medicare and
Medicaid providers must meet. For some provisions, health benefits to
patients will be substantial and direct. Other provisions will free up
time and efforts of health care providers to focus on improving health
care quality and service delivery. Although this rule does not require
a final regulatory flexibility analysis, we believe the preceding
analysis meets the requirements for such an analysis as set out in
Sec. 604 of the Regulatory Flexibility Act. In addition, the analysis
above, together with the remainder of this preamble, provides a
regulatory impact analysis.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
B. Regulatory Impact Statement for Fire Safety Requirements for Certain
Dialysis Facilities
We have examined the impact of these regulatory provisions as
required by Executive Order 12866 on Regulatory Planning and Review
(September 30, 1993), Executive Order 13563 on Improving Regulation and
Regulatory Review (January 18, 2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the
Social Security Act, section 202 of the Unfunded Mandates Reform Act of
1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on
Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C.
804(2)), and Executive Order 13771 on Reducing Regulation and
Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
We do not know how many, if any, dialysis facilities would be
affected by this adoption of the 2012 editions of the NFPA 101 and NFPA
99. All States have adopted the 2012 editions, so as a practical
matter, all dialysis facilities are already following the 2012
requirements. Therefore, we do not anticipate any impact on the
applicable dialysis facilities.
Accordingly, these provisions do not reach the economic threshold
and thus are neither economically significant under Executive Order
12866, nor a major rule under the Congressional Review Act.
The RFA requires agencies to analyze options for regulatory relief
of small entities, and to prepare a final regulatory flexibility
analysis if a rule is found to have a significant impact on a
substantial number of small entities. For purposes of the RFA, small
entities include small businesses, nonprofit organizations, and small
governmental jurisdictions. Most hospitals and most other providers and
suppliers are small entities, either by nonprofit status or by having
revenues of less than $7.5 million to $38.5 million in any 1 year.
Individuals and States are not included in the definition of a small
entity. We are not preparing a final regulatory flexibility analysis
because we have determined, and the Secretary certifies, that these
provisions of the final rule will not have a significant economic
impact on a substantial number of small entities.
In addition, section 1102(b) of the Social Security Act (the Act)
requires us to prepare a regulatory impact analysis if a rule may have
a significant impact on the operations of a substantial number of small
rural hospitals. This analysis must conform to the provisions of
section 604 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a Metropolitan Statistical Area for Medicare payment regulations and
has fewer than 100 beds. We are not preparing an analysis for section
1102(b) of the Act because
[[Page 51805]]
we have determined, and the Secretary certifies, that these provisions
of the final rule will not have a significant impact on the operations
of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2019, that
threshold is approximately $154 million. These provisions will have no
consequential effect on State, local, or tribal governments or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since these provisions do not impose any costs on State
or local governments, the requirements of Executive Order 13132 are not
applicable.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
F. Regulatory Impact Analysis for Hospital and Critical Access Hospital
Changes To Promote Innovation, Flexibility, and Improvement in Patient
Care
1. Statement of Need
CMS is aware, through conversations with stakeholders and federal
partners, and as a result of internal evaluation and research, of
outstanding concerns about CoPs for hospitals and CAHs, despite recent
revisions. We believe that the revisions will alleviate many of those
concerns. In addition, modernization of the requirements would
cumulatively result in improved quality of care and improved outcomes
for all hospital and CAH patients. We believe that benefits would
include reduced readmissions, reduced incidence of hospital-acquired
conditions (including healthcare-associated infections), improved use
of antibiotics at reduced costs (including the potential for reduced
antibiotic resistance), and improved patient and workforce protections.
These benefits are consistent with former HHS Quality Initiatives,
including efforts to prevent HAIs; the national action plan for adverse
drug event (ADE) prevention; the national strategy for Combating
Antibiotic-Resistant Bacteria (CARB); and the Department's National
Quality Strategy (https://www.ahrq.gov/workingforquality/).
Principles of the National Quality Strategy supported by the proposed
rule include eliminating disparities in care; improving quality;
promoting consistent national standards while maintaining support for
local, community, and State-level activities that are responsive to
local circumstances; care coordination; and providing patients,
providers, and payers with the clear information they need to make
choices that are right for them (https://www.ahrq.gov/workingforquality/nqs/principles.htm). Our proposal to prohibit discrimination would
support eliminating disparities in care, and we believe our proposals
about QAPI and infection prevention and control and antibiotic
stewardship programs will improve quality and promote consistent
national standards. Our proposals regarding the term licensed
independent practitioners and establishing policies and protocols for
when the presence of an RN is needed will support care coordination and
quality of care. In sum, we believe our proposed changes are necessary,
timely, and beneficial. We are finalizing most of the aforementioned
proposals.
2. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs
(January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). We estimate that this rulemaking is ``economically significant''
as measured by the $100 million threshold, and hence also a major rule
under the Congressional Review Act. Accordingly, we have prepared a
regulatory impact analysis (RIA) that, to the best of our ability,
presents the costs and benefits of the rulemaking.
The Congressional Review Act, 5 U.S.C. 801 et. seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each chamber of the Congress and to the Comptroller
General of the United States. HHS will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register.
The final rule would create ongoing cost savings to hospitals and
CAHs in many areas. We believe these savings would largely, but not
necessarily entirely, offset any costs to hospitals and CAHs that would
be incurred by other changes we are finalizing in this rule. The
financial savings and costs are summarized in Table 18.
We sought public comment on our burden assumptions and estimates as
well as comments identifying additional reforms that should be
considered for future rulemakings. As is usually the case in impact
analysis, substantial uncertainty surrounds these estimates and we
solicited comments on any suggestions or data that would inform our
estimates for the final rule.
Comment: We received a comment that was generally in support of the
changes proposed and the goals of those changes; however, the commenter
was concerned that the rule dramatically
[[Page 51806]]
underestimates the time and effort required for compliance with the
antibiotic stewardship and Quality Assessment and Performance
Improvement (QAPI) programs.
Response: We note that since the QAPI requirement will replace the
annual evaluation requirement, we believe many of those resources could
be reallocated to QAPI activities to minimize burden. In addition, we
have re-evaluated our proposed requirements and eliminated unnecessary
prescriptiveness, allowing each CAH the flexibility to implement its
QAPI program in the most efficient manner for its unique circumstances.
With regards to the antibiotic stewardship program, we have expanded on
our cost estimates to account for a more robust intervention, and
presented a range of estimates to account for uncertainty.
Comment: We received a comment expressing concern over whether the
costs of implementing the infection prevention and control program were
underestimated due to the additional training and technical assistance
that would be required for the individual fulfilling the infection
preventionist role in CAHs.
Response: We thank you for your comment, and we agree that the
burden for CAHs due to the infection preventionist role was
underrepresented in the proposed rule. We have revised our estimates to
account for that error in this final rule.
Table 18--Section-by-Section Economic Impact Estimates
----------------------------------------------------------------------------------------------------------------
Number of Estimated net
Issue Frequency affected costs ($
entities millions) *
----------------------------------------------------------------------------------------------------------------
Hospitals.................................. ................................... 4,823 ..............
Patients' rights (RIA)........ One-time........................... 4,823 Not estimated
Nursing services (ICR)........ Every 3 years...................... 1,193 1
Nursing services (ICR)........ One-time........................... 1,193 2
Infection Prevention & Control One-time........................... 4,823 20
and Antibiotic Stewardship (RIA)...... Recurring annually................. 482 -23
CAHs....................................... ................................... 1,353 ..............
QAPI (ICR).................... Recurring annually................. 1,004 1
Food and dietary (RIA)........ Recurring annually................. 677 -5
Infection Prevention & Control One-time........................... 1,353 6
Recurring annually................. 1,004 148
and Antibiotic Stewardship (RIA)...... Recurring annually................. 501 -27
----------------------------------------------------------------------------------------------------------------
Note: This table includes entries only for those proposed reforms that we believe would have a measurable
economic effect; includes estimates from ICRs and RIA. Negative costs indicate cost savings.
* Amounts rounded to the nearest million.
3. Anticipated Effects
There are about 4,823 hospitals and 1,353 CAHs that are certified
by Medicare and/or Medicaid. We use these figures to estimate the
potential impacts of the final rule. In the estimates that were shown
in the Collection of Information Requirements section of the preamble
and in the RIA here, we estimate hourly costs as follows. Using May
2017 data from the Bureau of Labor Statistics, we have obtained
estimates of the national average hourly wage for all medical
professions (https://www.bls.gov/oes/2017/may/oes_nat.htm). We have
adjusted these rates by adding 100 percent to the hourly wage to
account for overhead costs and fringe benefit costs. We use the
following average hourly wages in our estimates:
Table 19--Hourly Costs by Profession
------------------------------------------------------------------------
------------------------------------------------------------------------
Registered dietitians and nutrition professionals................ $58
Registered nurses................................................ 71
Advanced practice registered nurses.............................. 103
Physician assistants............................................. 101
Pharmacists...................................................... 117
Network data analysts............................................ 89
Hospital CEO/administrators...................................... 189
CAH CEO/administrators........................................... 107
Clerical staff workers........................................... 33
Physicians....................................................... 191
Clinical Laboratory Technicians.................................. 51
------------------------------------------------------------------------
a. Effects on Hospitals
(1) Licensed Independent Practitioners (Patients' Rights Sec. 482.13)
We are finalizing our proposal to delete the modifying term
``independent'' from the CoP at Sec. 482.13(e)(5), as well as at Sec.
482.13(e)(8)(ii). While we believe that hospitals might be able to
achieve some costs savings through these changes (by having additional
licensed practitioners such as PAs allowed to write restraint and
seclusion orders and thus relieve some of the burden from physicians),
we do not have a reliable means of quantifying these possible cost
savings. We solicited comments as to whether the assumption of cost
savings is reasonable and welcomed any data that may help inform the
costs and benefits of this provision, but did not receive any comments
specific to our solicitation.
(2) Infection Control and Antibiotic Stewardship (Infection Prevention
and Control Sec. 482.42)
We are revising the hospital requirements at 42 CFR 482.42,
``Infection control,'' which currently require hospitals to provide a
sanitary environment to avoid sources and transmission of infections
and communicable diseases. Hospitals are also currently required to
have a designated infection control officer, or officers, who are
required to develop a system to identify, report, investigate and
control infections and communicable diseases of patients and personnel.
The hospital's CEO, medical staff, and director of nursing services are
charged with ensuring that the problems identified by the infection
control officer or officers are addressed in hospital training programs
and their QAPI program. The CEO, medical staff, and director of nursing
services are also responsible for the implementation of successful
corrective action plans in affected problem areas.
We are finalizing our proposal to change to the title of this CoP
to ``Infection prevention and control and antibiotic stewardship
programs.'' By adding the word ``prevention'' to the CoP name, our
intent is to promote
[[Page 51807]]
larger, cultural changes in hospitals such that prevention initiatives
are recognized on balance with their current, traditional control
efforts. And by adding ``antibiotic stewardship'' to the title, we
would emphasize the important role that a hospital could play in
improving patient care and safety and combatting antimicrobial
resistance through implementation of a robust stewardship program that
follows nationally recognized guidelines for appropriate antibiotic
use. Along with these changes, we proposed to change the introductory
paragraph to require that a hospital's infection prevention and control
and antibiotic stewardship programs be active and hospital-wide for the
surveillance, prevention, and control of HAIs and other infectious
diseases, and for the optimization of antibiotic use through
stewardship. We will also require that a program demonstrate adherence
to nationally recognized infection prevention and control guidelines
for reducing the transmission of infections, as well as best practices
for improving antibiotic use, for reducing the development and
transmission of HAIs and antibiotic-resistant organisms. While these
particular changes are new to the regulatory text, it is worth noting
that these requirements, with the exception of the new requirement for
an antibiotic stewardship program, have been present in the
Interpretive Guidelines (IGs) for hospitals since 2008 (See A0747 at
Appendix A--Survey Protocol, Regulations and Interpretive Guidelines
for Hospitals, https://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf).
(a) Infection Prevention and Control
Each hospital will be required to review their current infection
control program and compare it to the new requirements contained in
this section. After performing this comparison, each hospital will be
required to revise their program so that it complies with the
requirements in this section. Based on our experience with hospitals,
we believe that a physician and a nurse on the infection control team
will conduct this review and revision of the program. We believe both
the physician and the nurse will spend 16 hours each for a total of 32
hours. According to BLS data, doubled to account for overhead costs and
fringe benefits, physician time costs an average of $191 an hour, and
nurses' time costs an average wage of $71 an hour. Thus, to ensure
their infection control program complied with the requirements in this
section, we estimate that each hospital will require 32 burden hours
(16 hours for a physician and 16 hours for a nurse) at a cost of $4,192
($3,056 ($191 an hour for a physician x 16 burden hours) + $1,136 ($71
an hour for a nurse x 16 burden hours)). Based on the estimate, for all
4,823 hospitals, complying with this requirement will require 154,336
burden hours (32 hours for each hospital x 4,823 hospitals) at a one-
time cost of approximately $20 million ($4,192 for each hospital x
4,823 hospitals).
At Sec. 482.42(a)(1), we are finalizing our proposal to require
the hospital to appoint an infection preventionist(s)/infection control
professional(s). Within this change we are deleting the outdated term,
``infection control officer,'' and replacing it with the more current
and accurate terms, ``infection preventionist/infection control
professional.'' CDC has defined ``infection control professional
(ICP)'' as ``a person whose primary training is in either nursing,
medical technology, microbiology, or epidemiology and who has acquired
specialized training in infection control.'' In designating infection
preventionists/ICPs, hospitals should ensure that the individuals so
designated are qualified through education, training, experience, or
certification (such as that offered by the CBIC, or by the specialty
boards in adult or pediatric infectious diseases offered for physicians
by the American Board of Internal Medicine (for internists) and the
American Board of Pediatrics (for pediatricians).
Since this requirement has been present in the IGs since 2008, we
believe that hospitals have been aware of CMS' expectations for the
qualifications of infection control officers. The Joint Commission has
a similar requirement (TJC Accreditation Standard IC.01.01.01). We
believe that hospitals accredited by TJC (over 75 percent of all
hospitals (https://www.jointcommission.org/facts_about_hospital_accreditation/)) should already be in compliance,
or near compliance, with this requirement. The Joint Commission
requires that a hospital identify the individual(s) responsible for its
infection prevention and control program, including the individual(s)
with clinical authority over the infection prevention and control
program. For these reasons, we do not anticipate any new recurring
burden to hospitals attributable to appointing an infection
preventionist.
(b) Antibiotic Stewardship (AS)
At Sec. 482.42(b), we believe that the finalized requirements for
a hospital to have an active antibiotic stewardship program, and for
its organization and policies, would constitute additional regulatory
burden, as will be discussed in more detail below. However, we believe
that the estimated costs of an AS program would be greatly offset by
the savings that a hospital would achieve through such a program. The
most obvious savings would be from decreased inappropriate antibiotic
use leading to overall decreased drug costs for a hospital.
Antimicrobial costs, particularly antibiotic costs, often constitute a
significant percentage of the pharmacy budget for a hospital, so
reducing overall antibiotic use would most likely have a substantial
impact in lowering overall drug costs for a hospital. In fact, our
review of the literature showed significant savings in this area, with
annual savings proportional to bed size of the hospital or hospital
unit. Reported annual savings ranged from $27,917 (Canadian dollars)
for a 12-bed medical/surgical intensive care unit to $2.1 million for
an 880-bed academic medical center.6 7
---------------------------------------------------------------------------
\6\ Leung V., Gill S., Sauve J., Walker K., Stumpo C., Powis J.
Growing a ``positive culture'' of antimicrobial stewardship in a
community hospital. The Canadian journal of hospital pharmacy. 2011;
64(5):314-20.
\7\ Beardsley J.R., Williamson J.C., Johnson J.W., Luther V.P.,
Wrenn R.H., Ohl C.C. Show me the money: Long-term financial impact
of an antimicrobial stewardship program. Infection control and
hospital epidemiology: The official journal of the Society of
Hospital Epidemiologists of America. 2012; 33(4):398-400.
---------------------------------------------------------------------------
We specifically note the $177,000 in annual drug cost savings
achieved by a 120-bed community hospital with its AS program for the
year of 2000 compared to 1999, and would use that as the average cost
savings for the average-sized 124-bed hospital discussed above (LaRocco
2003, CID ``Concurrent antibiotic review programs--a role for
infectious diseases specialists at small community hospitals'').
Inflating this number to 2017 dollars using the consumer price index
yields approximately $258,000. According to NHSN survey data, almost 82
percent of hospitals were implementing all 7 of CDC's core elements of
hospital antibiotic stewardship programs in 2017. This is significantly
higher than the estimate published in the proposed rule, because the
number of hospitals implementing AS programs has increased dramatically
in the past several years. This is primarily driven by large
accrediting organizations announcing and implementing their own
antimicrobial stewardship standards. Preliminary 2018 data suggest that
this upward trend of AS programs is likely to continue to some degree;
however, since the the antimicrobial stewardship standards are already
in effect for one of the largest
[[Page 51808]]
accrediting bodies as of January 2017, we would expect a sharp decline
in the marginal rate of AS implementation in 2017 and beyond without
further intervention. Therefore, for our baseline we have projected
that approximately 90% of hospitals would have AS programs in 2018 were
the rate of adoption to decrease by half, and we assume that is
approximately where the market would level off absent further
intervention. We have accounted for this uncertainty by providing
estimates in the accounting statement that are 25 percent higher or
lower than our primary estimate. Accordingly, we estimate that the
annual drug cost savings for 10 percent of all 4,823 hospitals under
the rule would be approximately $124 million (482 hospitals x
$258,000). While most of the evidence we reviewed showed clear savings
through reduced hospital pharmacy costs that was a direct result of
reduced antibiotic use, some studies also demonstrated other financial
benefits for hospitals with AS programs, such as decreases in patient
length of stay and readmission rates as well as reductions in CDI rates
and costs (as we discuss in more detail in the paragraphs to follow).
Based on the published studies that we previously noted, we
therefore also believe that the proposed requirement for an AS program
would assist hospitals in significantly reducing rates of CDI and the
attendant costs. Based on an AS program model developed by the CDC, a
hospital combined IC/AS program with an average effectiveness rate of
50 percent would reduce the number of CDIs among Medicare beneficiaries
annually by 101,000.\8\ The costs examined in the model were costs for
patients who developed CDIs while they were in the hospital or had to
be re-admitted to the hospital for a case of CDI that was a result of a
recent hospitalization, so the costs are much higher than what would be
associated with outpatient cases. The 101,000-reduction is an annual
reduction in the number of cases of CDI among patients who develop the
infection because of medical care; that is, they were admitted for
something else and then acquired CDI while getting care. It should be
noted that the 101,000 number actually comprises two types of CDI--
cases that occur while the patient is in the hospital and cases that
are directly attributable to a recent hospitalization, but which
manifest after the patient is discharged and requires a readmission.
Their study found that the cost for patients who develop the infection
while they are already in the hospital is between $4,323 and $8,146.
However, the infections related to a recent hospital stay that require
readmission are more expensive, on average, because they require an
entirely new admission; the cost of those cases is between $7,061 and
$11,601. A more recent CDC study found the attributable patient cost
savings for health care-associated clostridioides difficile (HCA-CDI)
to be $6,844 per prevented case, and $12,703 per prevented case of
recurrent CDI (2015 $).\9\ Inflating these numbers to 2017 dollars
using the consumer price index returns approximately $7,133 and $13,240
respectively. Scott et al. built their economic model with a range from
10 to 50 percent effectiveness, which represents a range of between
approximately 200,000 and 1.1 million inpatient cases of HCA-CDI
averted in a 5 year period.
---------------------------------------------------------------------------
\8\ Rachel B. Slayton, Ph.D., MPH; R. Douglas Scott II, Ph.D.;
James Baggs, Ph.D.; Fernanda C. Lessa, MD; L. Clifford McDonald, MD;
John A. Jernigan, MD. ``The Cost-Benefit of Federal Investment in
Preventing Clostridium difficile Infections through the Use of a
Multifaceted Infection Control and Antimicrobial Stewardship
Program,'' Infection Control & Hospital Epidemiology 2015;00(0):1-7.
\9\ R. Douglas Scott II, Rachel B. Slayton, Fernanda C. Lessa,
James Baggs, Steven D. Culler, L. Clifford McDonald and John A.
Jernigan; ``Assessing the social cost and benefits of a national
requirement establishing antibiotic stewardship programs to prevent
Clostridioides difficile infection in US hospitals''; Antimicrobial
Resistance & Infection Control, 2019, 8:17.
---------------------------------------------------------------------------
For our purposes, we have based our central estimate on the middle
of the aforementioned range, or approximately 30 percent effectiveness,
resulting in 546,000 inpatient cases of HCA-CDI averted, and 117,000
recurrent cases averted. It is not clear exactly how many of these
averted cases would occur in hospitals versus CAHs, but the prevalence
of existing AS programs (or lack thereof) suggest CAHs may have more
potential for improvement despite their smaller number of beds; there
is also a limited amount of research that suggests the rate of CDI may
be higher in hospitals with fewer beds, possibly due to rates of
testing or other factors; and it is also possible that CAHs serve an
older population that is more at risk for healthcare-associated
infections than patients at non-CAHs.10 11 Therefore, we
assume an equal number of cases averted per facility, meaning
approximately 78 percent of these would occur in hospitals and 22
percent in CAHs. As previously explained, we estimate that 90 percent
of hospitals already have AS programs, and therefore 10 percent of
those averted cases would be attributable to this regulation. This
comes to a total of 42,588 HCA-CDI cases averted, and 9,126 recurrent
cases averted for hospitals in a 5 year period. Multiplying these
averted cases by the attributable patient cost savings, and annualizing
the amount, comes to approximately $85 million in annualized patient
cost savings. These patient cost savings do not include the cost
savings attributable to any averted or modified antibiotic regimen,
which was calculated above.
---------------------------------------------------------------------------
\10\ Kamboj M, Brite J, Aslam A, et al. Artificial Differences
in Clostridium difficile Infection Rates Associated with Disparity
in Testing. Emerging Infectious Diseases. 2018;24(3):584-587.
\11\ Joynt, K. E., Harris, Y., Orav, E. J., & Jha, A. K. (2011).
Quality of care and patient outcomes in critical access rural
hospitals. JAMA, 306(1), 45-52. doi:10.1001/jama.2011.902.
---------------------------------------------------------------------------
Thus, we estimate that the combined annual drug cost savings and
patient cost savings will be approximately $209 million. These savings
will accrue to patients (reduced out-of-pocket costs), hospitals
(reduced costs and improved balance sheets), as well as healthcare
insurers, including Medicare (over time, payment rates will be adjusted
downward as hospital costs fall). However, we are not able to apportion
the savings that would accrue to each group with any accuracy and it
will inevitably change over time as insurance rates change. Regardless,
healthcare-associated infections are known to be expensive to insurers,
including CMS. Preventing these infections will reduce CMS and other
insurer expenditures, both on direct hospital costs and through reduced
re-admissions. The cost-savings estimates for CDI included in the RIA
provide an example of the savings Medicare and other insurers could
realize through reductions in just one HAI. Ultimately, of course,
insurance costs (and the medical care they pay for) are paid by
taxpayers and workers. Even the employer contribution to insurance
costs is generally regarded by economists as part of worker
compensation. We requested comment regarding data that would allow for
more robust quantification of the rule's impacts on HAIs other than
CDI, but did not receive any such comments.
We believe that the burden of implementing and maintaining an AS
program includes the costs of the qualified personnel needed to
establish and manage such a hospital program. In the proposed rule, our
review of the literature, consultations with CDC, and experience with
hospitals suggested that the establishment and maintenance of a
hospital antibiotic stewardship program for an average-size hospital
(approximately 124 beds), would require at least the leadership of a
physician (preferably one with training in infectious diseases) and a
clinical pharmacist, and also the services of a
[[Page 51809]]
network data analyst, at the following proportions of full-time
employee salaries respectively: 0.10, 0.25, and 0.05. However, the
latest research on the resources required for an effective AS program
suggest that the minimum full-time equivalent support recommended for a
hospital of this size may be somewhat more burdensome, due to the
leadership of a pharmacist and physician at the full time equivalents
of their salaries of 1.0 and 0.4 respectively.\12\ We also based our
estimates on the prior assumption that 10 percent of hospitals do not
yet have programs that implement all of the CDC core elements. Based on
these assumptions, the minimum annual cost of the essential team
members for a hospital to establish and maintain an antibiotic
stewardship program would be $386,800 (($191 x 0.40 x 2,000 hours per
year = $152,800 for a physician) + ($117 x 1.00 x 2,000 hours per year
= $234,000 for a clinical pharmacist)). The annual labor cost for 10
percent of hospitals ($386,800 x 482) would be approximately $186
million.
---------------------------------------------------------------------------
\12\ Sarah B Doernberg, Lilian M Abbo, Steven D Burdette, Neil O
Fishman, Edward L Goodman, Gary R Kravitz, James E Leggett, Rebekah
W Moehring, Jason G Newland, Philip A Robinson, Emily S Spivak,
Pranita D Tamma, Henry F Chambers, Essential Resources and
Strategies for Antibiotic Stewardship Programs in the Acute Care
Setting, Clinical Infectious Diseases, Volume 67, Issue 8, 15
October 2018, Pages 1168-1174
---------------------------------------------------------------------------
We invited public comment regarding the amount by which costs may
exceed savings in cases of non-voluntary IC/AS program adoption, but
did not receive comments with specific estimates.
b. Effects on CAHs
(1) Ordering Privileges for Qualified Dietitians (RDs) and Qualified
Nutrition Professionals (Provision of Services Sec. 485.635)
We are finalizing our proposal to revise the CAH requirements at 42
CFR 485.635 (a)(3)(vii), which currently require that the nutritional
needs of inpatients are met in accordance with recognized dietary
practices and the orders of the practitioner responsible for the care
of the patients. Specifically, we proposed revisions that would change
the CMS requirements to allow for flexibility in this area by requiring
that all patient diets, including therapeutic diets, must be ordered by
a practitioner responsible for the care of the patient, or by a
qualified dietitian or qualified nutrition professional as authorized
by the medical staff in accordance with State law governing dietitians
and nutrition professionals.
With these changes to the current requirements, a CAH will have the
regulatory flexibility to grant qualified dietitians/nutrition
professionals specific dietary ordering privileges (including the
capacity to order specific laboratory tests to monitor nutritional
interventions and then modify those interventions as needed). We
believe that this is another area of change to the requirements that
might produce savings since this will allow physicians to delegate to a
qualified dietitian or qualified nutrition professional the task of
prescribing patient diets, including therapeutic diets, to the extent
allowed by state law. We further believe that dietitians or other
clinically qualified nutrition professionals are already performing
patient dietary assessments and making dietary recommendations to the
physician (or PA or APRN) who then evaluates the recommendations and
writes orders to implement them. Our analysis does not take into
account improved quality of life nor improved clinical outcomes for the
patient. We do not currently have data to more precisely estimate the
savings that this revision could produce in CAHs. However, we believe
that it might allow for better use of both physician/PA/APRN and
dietitian/nutrition professional time and could result in improved
quality of life and improved clinical outcomes for CAH patients.
More obviously, dietitians/nutrition professionals with ordering
privileges will be able to provide dietary/nutritional services at
lower costs than physicians (as well as APRNs and PAs, two categories
of non-physician practitioners that have traditionally also devised and
written patient dietary plans and orders). This cost savings stems in
some part from significant differences in the average salaries between
the professions and the time savings achieved by allowing dietitians/
nutrition professionals to autonomously plan, order, monitor, and
modify services as needed and in a more complete and timely manner than
they are currently allowed. Savings would be realized by CAHs through
the physician/APRN/PA time and salaries saved.
Physicians, APRNs, and PAs often lack the training and educational
background to manage the nutritional needs of patients with the same
efficiency and skill as dietitians/nutrition professionals. The
addition of ordering privileges enhances the ability that dietitians/
nutrition professionals already have to provide timely, cost-effective,
and evidence-based nutrition services as the recognized nutrition
experts on a CAH interdisciplinary team.
It might seem natural to calculate these cost savings for CAHs
based on the following assumptions:
There is an average hourly cost difference of $74 between
dietitians/nutrition professionals on one side ($58 per hour) and the
hourly cost average for physicians, APRNs, and PAs ($132 per hour) on
the other;
There were 282,584 inpatient visits by Medicare
beneficiaries in 2011 (According to a December 2013 OIG report (https://oig.hhs.gov/oei/reports/oei-05-12-00081.pdf)) with each of these stays
requiring at least one dietary plan and orders;
On average, each dietary order, including ordering and
monitoring of laboratory tests, subsequent modifications to orders, and
dietary orders for discharge/transfer/outpatient follow-up as needed,
will take 30 minutes (0.5 hours) of a physician's/APRN's/PA's/
dietitian's/nutrition professional's time per patient during an average
stay; and
We estimate that approximately 50 percent of CAHs (or
approximately 677 CAHs) have not already granted ordering privileges to
dietitians and nutrition professionals, reducing the number of total
number of CAH inpatient stays to 141,292.
The resulting savings would be $7,722 annually on average for each
CAH (141,292 inpatient hospital stays x 0.50 hours of a physician's/
APRN's/PA's/dietitian's/nutrition professional's time x $74 per hourly
cost difference / 677 CAHs) for a total annual savings of approximately
$5.2 million. We note that these estimates exclude some categories of
cost increases (for example, internal CAH meetings to plan changes and
the time and other costs of training physicians, dietitians/nutrition
professionals, and other staff on the new dietary ordering procedures).
Even more importantly, this estimate does not account for barriers,
other than federal regulation, to RDs receiving ordering privileges;
Weil et al. (2008) provide evidence on the existence of such barriers,
which would likely prevent at least some of these cost savings from
being realized.\13\ If such barriers are not relevant, then there is
another adjustment that would need to be made to the calculation.
Specifically, the dietitian wage estimate would need to be revised
because the wage data do not account for the increase in demand for
dietitians we projected would result from the hospital burden reduction
rule
[[Page 51810]]
finalized that same month. For the savings estimates accompanying that
rule to be achieved would require at least 6.7 percent of the dietitian
FTEs in the U.S. to be newly allocated to providing nutrition services
to hospital patients.\14\ This shift in activity entails a substantial
movement along the supply curve for dietitian labor, thus raising the
dietitian wage and reducing the cost savings estimated with the method
outlined. For these reasons, as well as our lack of data on CAH
outpatient visits for nutritional services and the impact that the
proposed regulatory changes might have on hospital costs in this area,
we present the estimate for discussion purposes only.
---------------------------------------------------------------------------
\13\ Weil, Sharon D., et al. ``Registered Dietitian Prescriptive
Practices in Hospitals.'' Journal of the American Dietetic
Association 108:1688-1692. October 2008.
\14\ BLS data show employment of 59,490 dietitians, with a mean
hourly wage of $27.62. Assuming all dietitians are employed full-
time (2,080 hours annually) yields a total sector value of $3.4
billion, or $6.8 billion when doubled to account for fringe benefits
and overhead. For the May, 2014, final rule, we estimated $459
million of loaded wage savings associated with dietary ordering
switching from physicians, nurse practitioners and physician
assistants to lower-paid dietitians. Thus the relevant portion of
the savings estimate equals roughly 6.7 percent (= $459 million /
$6.8 billion) of the sector as a whole--and would exceed 6.7
percent, to the extent that some current dietitian positions are
part-time.
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(2) Sec. 485.640 Condition of Participation: Infection Prevention and
Control and Antibiotic Stewardship Programs
As we finalized for hospitals, we are also finalizing the new
infection prevention and control and antibiotic stewardship
requirements for CAHs. The infection control requirements for CAHs have
remained unchanged since 1997. We are adding a new infection prevention
and control (as well as antibiotic stewardship) CoP for CAHs because
the existing standards for infection control do not reflect the current
nationally recognized practices for the prevention and elimination of
healthcare-associated infections.
(a) Infection Prevention and Control
Each CAH will be required to review their current infection control
program and compare it to the new requirements. After performing this
comparison, each CAH will be required to revise their program so that
it complies with the new requirements. Based on our experience with
CAHs, we believe that a physician and a nurse on the infection control
team would conduct this review and revision of the program. We believe
both the physician and the nurse will spend 16 hours each for a total
of 32 hours. Physicians earn an average of $191 an hour, and nurses
earn an average wage of $71 an hour, including overhead and fringe
benefits. Thus, to ensure their infection control program complies with
the new requirements, we estimate that each CAH would require 32 burden
hours (16 hours for a physician and 16 hours for a nurse) at a cost of
$4,192 ($3,056 ($191 an hour for a physician x 16 burden hours) +
$1,136 ($71 an hour for a nurse x 16 burden hours)). Based on the
estimate, for all 1,353 CAHs, complying with this requirement will
require 43,296 burden hours (32 hours for each CAH x 1,353 CAHs) at a
one-time cost of approximately $5.7 million ($4,192 for each CAH x
1,353 CAHs).
CAHs will also incur a recurring cost due to the new requirement
that they appoint an infection preventionist. The Joint Commission has
a similar requirement (TJC Accreditation Standard IC.01.01.01), and so
we believe that the 349 CAHs accredited by TJC should already be in
compliance, or near compliance, with this requirement. The Joint
Commission requires that a CAH identify the individual(s) responsible
for its infection prevention and control program, including the
individual(s) with clinical authority over the infection prevention and
control program. For the remaining CAHs not accredited by TJC, we are
calculating the burden for them to come into compliance with this
requirement.
Based on our experience with CAHs, we believe that most ICPs would
be registered nurses with experience, education, and training in
infection control. As of 2017, approximately 1,004 CAHs are not
accredited by TJC. For the purposes of a burden estimate, we assume
that each CAH will choose to employ one ICP full-time (52 weeks x 40
hours = 2,080 hours) at $71 per hour, although the regulation does not
require the hiring of a new individual, and this position and its
associated burden may overlap with that calculated for antibiotic
stewardship below. Nonetheless, the cost per facility is estimated to
be $147,680 annually (2,080 hours x $71), and the total cost for all
non-TJC-accredited CAHs would be approximately $148 million annually
(1,004 x $147,680).
(b) Antibiotic Stewardship
Similarly, we believe that the finalized requirements for a CAH to
have an active antibiotic stewardship program, and for its organization
and policies, would constitute additional regulatory burden. We believe
that the burden of implementing and maintaining an AS program includes
the costs of the qualified personnel needed to establish and manage
such a CAH program. In the proposed rule, our review of the literature,
consultations with CDC, and experience with CAHs suggested that the
establishment and maintenance of a CAH antibiotic stewardship program
for a statutorily mandated 25-bed CAH, would require at least the
leadership of a physician (preferably an infectious disease physician
or physician with training in antibiotic stewardship) and a clinical
pharmacist (preferably with training in infectious diseases or
antibiotic stewardship), and also the services of a network data
analyst at the following proportions of full-time employee salaries
respectively: 0.05, 0.10, 0.025. However, the latest research on the
resources required for an effective AS program suggest that the minimum
full-time equivalent support needed for a CAH may be somewhat more
burdensome. Doernberg et al. were unable to make specific
recommendations for hospitals with fewer than 100 beds, however, the
average self-reported burden for hospitals under 100 beds was larger
than we anticipated. Therefore, for our purposes we assume 25-bed CAHs
will incur half of the average costs that were reported by hospitals
with fewer than 100 beds. Thus, we estimate each CAH will require the
leadership of a pharmacist and physician at the full time equivalents
of their salaries of 0.45 and 0.19 respectively. According to NHSN
survey data, approximately 58 percent of CAHs reported having an AS
program that meets all of the CDC's core elements in 2017. As
previously mentioned, this number is significantly higher than the
estimate published in the proposed rule because the number of CAHs
implementing AS programs has increased dramatically in the past several
years. This is primarily driven by large accrediting organizations
announcing and implementing their own antimicrobial stewardship
standards. Preliminary 2018 data suggest that this upward trend of AS
programs is likely to continue to some degree; however, since the
antimicrobial stewardship standards are already in effect for one of
the largest accrediting bodies as of January 2017, we would expect a
sharp decline in the marginal rate of AS implementation in 2017 and
beyond without further intervention. Therefore, for our baseline we
have projected that approximately 63% of CAHs would have AS programs in
2018 were the rate of adoption to decrease by half, and we assume that
is approximately where the market would level off absent further
intervention. We have accounted for this uncertainty by providing
estimates in the accounting
[[Page 51811]]
statement that are 25 percent higher or lower than our primary
estimate. Accordingly, we estimate that approximately 501 CAHs (or 37
percent) have not implemented an AS program. Based on these
assumptions, the minimum annual cost of the essential team members for
a CAH to establish and maintain an antibiotic stewardship program would
be $177,880 (($191 per hour x 0.19 x 2,000 hours per year = $72,580 for
a physician) + ($117 per hour x 0.45 x 2,000 hours per year = $105,300
for a clinical pharmacist). The annual labor cost for 37 percent of
CAHs ($177,880 x 501) would be approximately $89 million.
However, we believe that the estimated costs of an AS program would
be somewhat offset by the savings that a CAH would achieve through such
a program. The most obvious savings would be from decreased
inappropriate antibiotic use leading to overall decreased drug costs
for a CAH. Our review of the literature showed significant savings in
this area, with annual savings proportional to bed size of the
hospital. Reported annual savings ranged from $27,917 for a 12-bed
medical/surgical intensive care unit to $2.1 million for an 880-bed
academic medical center. We specifically note the $177,000 in annual
drug cost savings achieved by a 120-bed community hospital with its AS
program for the year of 2000 compared to 1999 (LaRocco 2003, CID
``Concurrent antibiotic review programs-a role for infectious diseases
specialists at small community CAHs''), and would use that as the basis
to calculate average annual cost savings for a 25-bed CAH. Inflating
this number to 2017 dollars using the consumer price index yields
approximately $258,000. Therefore, ($258,000 annual savings / 120 beds
= $2,150 annual cost savings per bed) at $53,750 per CAH ($2,150 annual
cost savings x 25 beds). Using this assumption, we believe that the
annual drug cost savings for 37 percent of all 1,353 CAHs under the
rule will be approximately $27 million (501 CAHs x $53,750 in drug cost
savings).
As previously explained, patient cost savings for CAHs has been
estimated based on data from Scott et al., and we assume approximately
22% of HCA-CDI and recurrent cases averted would occur in CAHs. Based
on the estimated 63 percent of CAHs that already have AS programs,
approximately 37 percent of those averted cases would be attributable
to this regulation. This comes to a total of 44,444 HCA-CDI cases
averted, and 9,524 recurrent cases averted for CAHs in a 5 year period.
Multiplying these averted cases by the attributable patient cost
savings, and annualizing the amount, comes to approximately $89 million
in annualized patient cost savings.
Accordingly, we estimate that the combined annual drug cost savings
and patient cost savings will be approximately $116 million. These
savings will accrue to patients (reduced out-of-pocket costs), CAHs
(reduced costs and improved balance sheets), as well as healthcare
insurers, including Medicare (over time, payment rates will be adjusted
downward as CAH costs fall). However, we are not able to apportion the
savings that would accrue to each group with any accuracy and it will
inevitably change over time as insurance rates change. Regardless,
healthcare-associated infections are known to be expensive to insurers,
including CMS. Preventing these infections will reduce CMS and other
insurer expenditures, both on direct hospital costs and through reduced
re-admissions. The cost-savings estimates for CDI included in the RIA
provide an example of the savings Medicare and other insurers could
realize through reductions in just one HAI. Ultimately, of course,
insurance costs (and the medical care they pay for) are paid by
taxpayers and workers. Even the employer contribution to insurance
costs is generally regarded by economists as part of worker
compensation.
c. Effects on Patients
As previously mentioned, some of the estimated cost savings will
accrue to patients due to decreased morbidity and associated health
care costs. Although this RIA has mainly focused on the costs
associated with CDI, there will be savings associated with other
infections, such as staphylococcus aureus, that we have not quantified
here. Nor have we quantified any savings to patients due to averted
travel costs for medical appointments, reduced absence from work, or
other miscellaneous costs that would be evaded by patients.
Antibiotic stewardship and infection control has also been proven
to significantly reduce morbidity and mortality due to healthcare
associated infections. Research by Scott et al., which has been
referenced throughout this RIA, thoroughly explored the social costs
and benefits of a national requirement establishing antibiotic
stewardship programs to prevent CDI. The direct applicability of their
study to this RIA is hindered only by differing methods of counting the
effects of antimicrobial resistance and infection control. Their study
quantifies the effects of AS on the entirety of hospitals with the
argument that without these finalized requirements, there would be
nothing holding hospitals accountable for maintaining their AS
programs. However, this RIA takes into account a baseline of the
current market conditions, which we believe have been strengthened by
new standards set by large accrediting bodies. Nonetheless, they
estimate CDI infection prevention alone to avert as many as 1.1 million
inpatient cases and 44,000 deaths at a 3 percent discount rate over a 5
year period. Using estimates for quality adjusted life years, their
central estimate for the value of morbidity risk reduction at a 3
percent discount rate is as much as $3 billion worth of lost quality
adjusted life years from HCA-CDI, and their central estimate for the
benefits of mortality risk reduction is as much as $401 billion
utilizing estimates for the value of a statistical life.
d. Effects on Small Entities
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, we estimate that the
great majority of the providers that would be affected by CMS rules are
small entities as that term is used in the RFA. The great majority of
hospitals and most other healthcare providers and suppliers are small
entities, either by being nonprofit organizations or by meeting the SBA
definition of a small business. Accordingly, the usual practice of HHS
is to treat all providers and suppliers as small entities in analyzing
the effects of our rules.
These provisions of the final rule are anticipated to cost CAHs as
much as $119 million in the first year. While this is a large amount in
total, the average cost per affected CAH is approximately $88,000 in
the first year, and slightly less in future years. Although the overall
magnitude of the paperwork, staffing, and related cost reductions to
hospitals and CAHs under this rule is economically significant, the net
effect is likely to be a fraction of 1 percent of total hospital costs.
Total national hospital care expenditure are approximately 1,143
billion dollars a year, or an average of about $185 million per
hospital, and our primary estimate of the net effect of these proposals
on hospital costs is approximately $79 million annually.
Under HHS guidelines for regulatory flexibility analyses, actions
that do not negatively affect costs or revenues by more than 3 percent
a year are generally not considered to be significant. We do not
believe that hospitals of any size will be negatively affected to this
[[Page 51812]]
degree. Accordingly, we have determined that the rule will not have a
significant economic impact on a substantial number of small entities,
and certify that a final regulatory flexibility analysis is not
required. Notwithstanding this conclusion, we believe that this RIA and
the preamble as a whole meet the requirements of the RFA for a final
regulatory flexibility analysis.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. For the preceding
reasons, we have determined that these provisions of the final rule
will not have a significant negative impact on the operations of a
substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2019, that
is approximately $154 million. These provisions of the final rule do
contain private sector mandates, but their costs are generally
anticipated to be mostly offset by savings. Nevertheless, this RIA and
the preamble, taken together, would meet the requirements of an
analysis under section 202.
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule (and subsequent final
rule) that would impose substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. These provisions of the rule will not have a substantial
direct effect on State or local governments, preempt State law, or
otherwise have federalism implications.
4. Alternatives Considered
As we stated, CMS is aware, through conversations with stakeholders
and federal partners, and as a result of internal evaluation and
research, of outstanding concerns about the CoPs for hospitals and
CAHs, despite recent revisions. This subset of the universe of
standards is the focus of the final rule.
One alternative we did consider was combining the infection
prevention and control leader position with that of the antibiotic
stewardship leader position. While this would certainly reduce the
costs for hospitals by eliminating one of these positions, we also
believe that it might reduce the overall effectiveness of the program
and, thus, the overall societal benefits that might be achieved. The
skills needed to lead each program are different. Infection prevention
programs are often led by nursing staff who do not prescribe
antibiotics. Antibiotic stewardship programs are led by physicians and
pharmacists who have direct knowledge and experience with antibiotic
prescribing. For these reasons, we decided to finalize the requirement
as it is contained in this rule.
For all of the finalized provisions, we considered not making these
changes. Ultimately, based on our analysis of these issues and for the
reasons stated in this preamble, we believe that it is best to propose
changes at this time. We welcomed comments on whether we properly
selected the best candidates for change, and welcomed suggestions for
additional reform candidates from the entire body of CoPs.
5. Conclusion
The financial impact of these provisions of the final rule will lie
primarily with the balance between estimated costs and savings for the
antibiotic stewardship program for hospitals. Nevertheless, the total
costs of these provisions are anticipated to be mostly offset by
savings. Moreover, the life-saving benefits of some of these
provisions, including antibiotic stewardship, have been thoroughly
studied and substantiated by independent researchers. However, we note
that although savings and morbidity/mortality risk reductions on
average are consistent with the literature we've reviewed, the outcomes
for individual hospitals and CAHs will vary depending on their specific
implementation strategies for AS.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
D. Accounting Statement and Table
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 20, we have prepared an accounting statement showing
the classification of the transfers and costs associated with the
various provisions of the final rule.
While most provisions of the final rule have clearly predictable
effects we do not in most cases have detailed empirical information on
the precise magnitude of efforts involved (for example, time spent in
meeting paperwork or other administrative tasks that apply to a
particular provider type). Other provisions (notably those related to
organ transplantation and removal of strict H&P requirements before
ambulatory or outpatient surgery) have even more uncertain effect
sizes. Therefore, we have estimated an upper and lower level for
benefit and cost reduction estimates that is 25 percent higher or lower
than our primary estimate for all quantified reforms other than those
related to ambulatory surgery, and in that area our upper bound for
costs is zero cost reductions and our lower bound is a 17 percent
reduction in H&P and associated laboratory testing costs.
Table 20--Accounting Statement: Classification of Estimated Benefits and Savings
[$ millions]
----------------------------------------------------------------------------------------------------------------
Units
Primary Low High -----------------------------------
Category estimate estimate estimate Year Discount Period
dollars rate covered
----------------------------------------------------------------------------------------------------------------
Benefits:
----------------------------------------------------------------------------------------------------------------
Life-Extending Benefits (monetized). Not Quantified
----------------------------------------------------------------------------------------------------------------
Medical Cost Reduction Benefits
(monetized)........................ Not Quantified
----------------------------------------------------------------------------------------------------------------
[[Page 51813]]
Qualitative......................... Potential reductions in morbidity and mortality for hospital and CAH
patients
----------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized Costs (+) or -801 -1,127 -485 2017 7% 2019-2028
Savings (-) ($million/year)........ -803 -1,128 -487 2017 3% 2019-2028
----------------------------------------------------------------------------------------------------------------
Transfers None
----------------------------------------------------------------------------------------------------------------
E. Regulatory Reform Analysis Under E.O. 13771
Executive Order 13771, titled Reducing Regulation and Controlling
Regulatory Costs, was issued on January 30, 2017 and requires that the
costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' This final rule is
considered an E.O. 13771 deregulatory action. We estimate that this
rule generates $647 million in annualized cost savings in 2016 dollars,
discounted at 7 percent relative to year 2016, over a perpetual time
horizon. Details on the estimated cost savings of this rule can be
found in the preceding analyses.
List of Subjects
42 CFR Part 403
Grant programs--health, Health insurance, Hospitals,
Intergovernmental relations, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 416
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 418
Health facilities, Hospice care, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 441
Aged, Family planning, Grant programs--health, Infants and
children, Medicaid, Penalties, Reporting and recordkeeping
requirements.
42 CFR Part 460
Aged, Health care, Health records, Medicaid, Medicare, Reporting
and recordkeeping requirements.
42 CFR Part 482
Grant program--health, Hospitals, Medicaid, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 483
Grant programs--health, Health facilities, Health professions,
Health records, Medicaid, Medicare, Nursing home, Nutrition, Reporting
and recordkeeping requirements, Safety.
42 CFR Part 484
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 485
Grant programs--health, Health facilities, Medicaid, Reporting and
recordkeeping requirements.
42 CFR Part 486
Grant programs--health, Health facilities, Medicare, Reporting and
recordkeeping requirements, X-rays.
42 CFR Part 488
Administrative practice and procedures, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 491
Grant programs--health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements, Rural and urban areas.
42 CFR Part 494
Diseases, Health facilities, Incorporation by Reference, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 403--SPECIAL PROGRAMS AND PROJECTS
0
1. The authority citation for part 403 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Section 403.736 is amended by--
0
a. Removing the introductory text;
0
b. Revising paragraph (a);
0
c. Removing paragraph (b); and
0
d. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c).
The revision reads as follows:
Sec. 403.736 Condition of participation: Discharge planning.
(a) Discharge planning and instructions. The RNHCI must have in
effect a discharge planning process that applies to all patients. The
process must assure that appropriate post-institution services are
obtained for each patient, as necessary. The RNHCI must assess the need
for a discharge plan for any patient likely to suffer adverse
consequences if there is no planning.
(1) Discharge instructions must be provided at the time of
discharge to the patient or the patient's caregiver as necessary.
(2) If the patient assessment indicates a need for a discharge
plan, the discharge plan must include instructions on post-RNHCI care
to be used by the patient or the caregiver in the patient's home, as
identified in the discharge plan.
(3) If the RNHCI's patient assessment does not indicate a need for
a discharge plan, the beneficiary or his or her legal representative
may request a discharge plan. In this case, the RNHCI must develop a
discharge plan for the beneficiary.
* * * * *
0
3. Section 403.748 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii); and
0
b. Adding paragraph (d)(1)(v).
[[Page 51814]]
The revisions and addition read as follows:
Sec. 403.748 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The RNHCI must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The RNHCI must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The RNHCI must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The RNHCI must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the RNHCI must conduct training on the updated
policies and procedures.
* * * * *
PART 416--AMBULATORY SURGICAL SERVICES
0
4. The authority citation for part 416 continues to read as follows:
Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.
0
5. Section 416.41 is amended by revising paragraph (b)(3) to read as
follows:
Sec. 416.41 Condition for coverage--Governing body and management.
* * * * *
(b) * * *
(3) The ASC must periodically provide the local hospital with
written notice of its operations and patient population served.
0
6. Section 416.47 is amended by revising paragraph (b)(2) to read as
follows:
Sec. 416.47 Condition for coverage--Medical records.
* * * * *
(b) * * *
(2) Significant medical history and results of physical examination
(as applicable).
* * * * *
0
7. Section 416.52 is amended by revising paragraph (a) to read as
follows:
Sec. 416.52 Condition for coverage--Patient admission, assessment and
discharge.
* * * * *
(a) Standard: Patient assessment and admission. (1) The ASC must
develop and maintain a policy that identifies those patients who
require a medical history and physical examination prior to surgery.
The policy must--
(i) Include the timeframe for medical history and physical
examination to be completed prior to surgery.
(ii) Address, but is not limited to, the following factors: Patient
age, diagnosis, the type and number of procedures scheduled to be
performed on the same surgery date, known comorbidities, and the
planned anesthesia level.
(iii) Be based on any applicable nationally recognized standards of
practice and guidelines, and any applicable State and local health and
safety laws.
(2) Upon admission, each patient must have a pre-surgical
assessment completed by a physician who will be performing the surgery
or other qualified practitioner in accordance with applicable State
health and safety laws, standards of practice, and ASC policy.
(3) The pre-surgical assessment must include documentation of any
allergies to drugs and biologicals.
(4) The patient's medical history and physical examination (if any)
must be placed in the patient's medical record prior to the surgical
procedure.
* * * * *
0
8. Section 416.54 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 416.54 Condition for coverage--Emergency preparedness.
* * * * *
(a) Emergency plan. The ASC must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The ASC must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The ASC must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The ASC must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
[[Page 51815]]
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the ASC must conduct training on the updated
policies and procedures.
(2) Testing. The ASC must conduct exercises to test the emergency
plan at least annually. The ASC must do the following:
(i) Participate in a full-scale exercise that is community-based
every 2 years; or
(A) When a community-based exercise is not accessible, conduct a
facility-based functional exercise every 2 years; or
(B) If the ASC experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the ASC is exempt from
engaging in its next required community-based or individual, facility-
based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise at least every 2 years,
opposite the year the full-scale or functional exercise under paragraph
(d)(2)(i) of this section is conducted, that may include, but is not
limited to the following:
(A) A second full-scale exercise that is community-based, or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ASC's response to and maintain documentation of
all drills, tabletop exercises, and emergency events and revise the
ASC's emergency plan, as needed.
* * * * *
PART 418--HOSPICE CARE
0
9. The authority citation for part 418 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
10. Section 418.76 is amended by revising paragraph (a)(1)(iv) to read
as follows:
Sec. 418.76 Condition of participation: Hospice aide and homemaker
services.
* * * * *
(a) * * *
(1) * * *
(iv) A State licensure program.
* * * * *
Sec. 418.106 [Amended]
0
11. Section 418.106 is amended by--
0
a. Removing paragraph (a)(1);
0
b. Redesignating paragraph (a)(2) as paragraph (a)(1); and
0
c. Adding a new reserved paragraph (a)(2).
0
12. Section 418.112 is amended by revising paragraph (f) to read as
follows:
Sec. 418.112 Condition of participation: Hospices that provide
hospice care to residents of a SNF/NF or ICF/IID.
* * * * *
(f) Standard: Orientation and training of staff. Hospice staff, in
coordination with SNF/NF or ICF/IID facility staff, must assure
orientation of such staff furnishing care to hospice patients in the
hospice philosophy, including hospice policies and procedures regarding
methods of comfort, pain control, symptom management, as well as
principles about death and dying, individual responses to death,
patient rights, appropriate forms, and record keeping requirements.
0
13. Section 418.113 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(iii);
0
b. Adding paragraph (d)(1)(vi);
0
c. Revising paragraph (d)(2); and
0
d. Adding paragraph (d)(3).
The revisions and additions read as follows:
Sec. 418.113 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The hospice must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, or Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The hospice must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The hospice must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The hospice must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(iii) Provide emergency preparedness training at least every 2
years.
* * * * *
(vi) If the emergency preparedness policies and procedures are
significantly updated, the hospice must conduct training on the updated
policies and procedures.
(2) Testing for hospices that provide care in the patient's home.
The hospice must conduct exercises to test the emergency plan at least
annually. The hospice must do the following:
(i) Participate in a full-scale exercise that is community-based
every 2 years; or
(A) When a community-based exercise is not accessible, conduct an
individual facility-based functional exercise every 2 years; or
(B) If the hospice experiences a natural or man-made emergency that
requires activation of the emergency plan, the hospital is exempt from
engaging in its next required full-scale community-based exercise or
individual facility-based functional exercise following the onset of
the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the
year the full-scale or functional exercise under paragraph (d)(2)(i) of
this section is conducted, that may include, but is not limited to the
following:
(A) A second full-scale exercise that is community-based or a
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
[[Page 51816]]
(3) Testing for hospices that provide inpatient care directly. The
hospice must conduct exercises to test the emergency plan twice per
year. The hospice must do the following:
(i) Participate in an annual full-scale exercise that is community-
based; or
(A) When a community-based exercise is not accessible, conduct an
annual individual facility-based functional exercise; or
(B) If the hospice experiences a natural or man-made emergency that
requires activation of the emergency plan, the hospice is exempt from
engaging in its next required full-scale community-based or facility-
based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is
not limited to the following:
(A) A second full-scale exercise that is community-based or a
facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop led by a facilitator that
includes a group discussion using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation
of all drills, tabletop exercises, and emergency events and revise the
hospice's emergency plan, as needed.
* * * * *
PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC
SERVICES
0
14. The authority citation for part 441 is revised to read as follows:
Authority: 42 U.S.C. 1302.
0
15. Section 441.184 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 441.184 Emergency preparedness.
* * * * *
(a) Emergency plan. The PRTF must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The PRTF must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The PRTF must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The PRTF must develop and maintain an
emergency preparedness training program that is based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, policies and procedures at paragraph
(b) of this section, and the communication plan at paragraph (c) of
this section. The training and testing program must be reviewed and
updated at least every 2 years.
(1) * * *
(ii) After initial training, provide emergency preparedness
training every 2 years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the PRTF must conduct training on the updated
policies and procedures.
(2) Testing. The PRTF must conduct exercises to test the emergency
plan twice per year. The PRTF must do the following:
(i) Participate in an annual full-scale exercise that is community-
based; or
(A) When a community-based exercise is not accessible, conduct an
annual individual, facility-based functional exercise; or
(B) If the PRTF experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the PRTF is exempt from
engaging in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the emergency
event.
(ii) Conduct an additional annual exercise that may include, but is
not limited to the following:
(A) A second full-scale exercise that is community-based or
individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PRTF's response to and maintain documentation of
all drills, tabletop exercises, and emergency events and revise the
PRTF's emergency plan, as needed.
* * * * *
PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
0
16. The authority citation for part 460 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).
0
17. Section 460.84 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 460.84 Emergency preparedness.
* * * * *
(a) Emergency plan. The PACE organization must develop and maintain
an emergency preparedness plan that must be reviewed, and updated at
least every 2 years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The PACE organization must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
address management of medical and nonmedical emergencies, including,
but not limited to: Fire; equipment, power, or water
[[Page 51817]]
failure; care-related emergencies; and natural disasters likely to
threaten the health or safety of the participants, staff, or the
public. Policies and procedures must be reviewed and updated at least
every 2 years. At a minimum, the policies and procedures must address
the following:
* * * * *
(c) Communication plan. The PACE organization must develop and
maintain an emergency preparedness communication plan that complies
with Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training and testing. The PACE organization must develop and
maintain an emergency preparedness training and testing program that is
based on the emergency plan set forth in paragraph (a) of this section,
risk assessment at paragraph (a)(1) of this section, policies and
procedures at paragraph (b) of this section, and the communication plan
at paragraph (c) of this section. The training and testing program must
be reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the PACE must conduct training on the updated
policies and procedures.
(2) Testing. The PACE organization must conduct exercises to test
the emergency plan at least annually. The PACE organization must do the
following:
(i) Participate in a full-scale exercise that is community-based
or;
(A) When a community-based exercise is not accessible, conduct an
annual individual, facility-based functional exercise every 2 years; or
(B) If the PACE experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the PACE is exempt from
engaging in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the emergency
event.
(ii) Conduct an additional exercise every 2 years opposite the year
the full-scale or functional exercise under paragraph (d)(2)(i) of this
section is conducted that may include, but is not limited to the
following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of
all drills, tabletop exercises, and emergency events and revise the
PACE's emergency plan, as needed.
* * * * *
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
18. The authority citation for part 482 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise
noted.
0
19. Section 482.13 is amended by revising paragraphs (e)(5),
(e)(8)(ii), (e)(10) and (11), (e)(12)(i), (e)(14), and (g)(4)(ii) to
read as follows:
Sec. 482.13 Condition of participation: Patient's rights.
* * * * *
(e) * * *
(5) The use of restraint or seclusion must be in accordance with
the order of a physician or other licensed practitioner who is
responsible for the care of the patient and authorized to order
restraint or seclusion by hospital policy in accordance with State law.
* * * * *
(8) * * *
(ii) After 24 hours, before writing a new order for the use of
restraint or seclusion for the management of violent or self-
destructive behavior, a physician or other licensed practitioner who is
responsible for the care of the patient and authorized to order
restraint or seclusion by hospital policy in accordance with State law
must see and assess the patient.
* * * * *
(10) The condition of the patient who is restrained or secluded
must be monitored by a physician, other licensed practitioner, or
trained staff that have completed the training criteria specified in
paragraph (f) of this section at an interval determined by hospital
policy.
(11) Physician and other licensed practitioner training
requirements must be specified in hospital policy. At a minimum,
physicians and other licensed practitioners authorized to order
restraint or seclusion by hospital policy in accordance with State law
must have a working knowledge of hospital policy regarding the use of
restraint or seclusion.
(12) * * *
(i) By a--
(A) Physician or other licensed practitioner.
(B) Registered nurse who has been trained in accordance with the
requirements specified in paragraph (f) of this section.
* * * * *
(14) If the face-to-face evaluation specified in paragraph (e)(12)
of this section is conducted by a trained registered nurse, the trained
registered nurse must consult the attending physician or other licensed
practitioner who is responsible for the care of the patient as soon as
possible after the completion of the 1-hour face-to-face evaluation.
* * * * *
(g) * * *
(4) * * *
(ii) Each entry must document the patient's name, date of birth,
date of death, name of attending physician or other licensed
practitioner who is responsible for the care of the patient, medical
record number, and primary diagnosis(es).
* * * * *
0
20. Section 482.15 is amended--
0
a. By revising paragraphs (a) introductory text, (a)(4), (b)
introductory text, (c) introductory text, (d) introductory text, and
(d)(1)(ii);
0
b. By adding paragraph (d)(1)(v);
0
c. By revising paragraph (d)(2);
0
d. In paragraph (g) introductory text, by removing the phrase
``transplant centers'' and adding into its place the phrase
``transplant programs''; and
0
e. In paragraphs (g)(1) and (2), by removing the phrase ``transplant
center'' and adding into its place the phrase ``transplant program''.
The revisions and addition read as follows:
Sec. 482.15 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The hospital must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years. The plan must do the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The hospital must develop and
implement emergency preparedness policies and
[[Page 51818]]
procedures, based on the emergency plan set forth in paragraph (a) of
this section, risk assessment at paragraph (a)(1) of this section, and
the communication plan at paragraph (c) of this section. The policies
and procedures must be reviewed and updated at least every 2 years. At
a minimum, the policies and procedures must address the following:
* * * * *
(c) Communication plan. The hospital must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The hospital must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the hospital must conduct training on the
updated policies and procedures.
(2) Testing. The hospital must conduct exercises to test the
emergency plan at least twice per year. The hospital must do all of the
following:
(i) Participate in an annual full-scale exercise that is community-
based; or
(A) When a community-based exercise is not accessible, conduct an
annual individual, facility-based functional exercise; or.
(B) If the hospital experiences an actual natural or man-made
emergency that requires activation of the emergency plan, the hospital
is exempt from engaging in its next required full-scale community-based
exercise or individual, facility-based functional exercise following
the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is
not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospital's response to and maintain documentation
of all drills, tabletop exercises, and emergency events, and revise the
hospital's emergency plan, as needed.
* * * * *
0
21. Section 482.21 is amended by revising paragraph (b)(1) and adding
paragraph (f) to read as follows:
Sec. 482.21 Condition of participation: Quality assessment and
performance improvement program.
* * * * *
(b) * * *
(1) The program must incorporate quality indicator data including
patient care data, and other relevant data such as data submitted to or
received from Medicare quality reporting and quality performance
programs, including but not limited to data related to hospital
readmissions and hospital-acquired conditions.
* * * * *
(f) Standard: Unified and integrated QAPI program for multi-
hospital systems. If a hospital is part of a hospital system consisting
of multiple separately certified hospitals using a system governing
body that is legally responsible for the conduct of two or more
hospitals, the system governing body can elect to have a unified and
integrated QAPI program for all of its member hospitals after
determining that such a decision is in accordance with all applicable
State and local laws. The system governing body is responsible and
accountable for ensuring that each of its separately certified
hospitals meets all of the requirements of this section. Each
separately certified hospital subject to the system governing body must
demonstrate that:
(1) The unified and integrated QAPI program is established in a
manner that takes into account each member hospital's unique
circumstances and any significant differences in patient populations
and services offered in each hospital; and
(2) The unified and integrated QAPI program establishes and
implements policies and procedures to ensure that the needs and
concerns of each of its separately certified hospitals, regardless of
practice or location, are given due consideration, and that the unified
and integrated QAPI program has mechanisms in place to ensure that
issues localized to particular hospitals are duly considered and
addressed.
0
22. Section 482.22 is amended by--
0
a. Revising paragraphs (c)(5)(i) and (ii);
0
b. Adding paragraphs (c)(5)(iii), (iv), and (v); and
0
c. Removing paragraph (d).
The revisions and additions read as follows:
Sec. 482.22 Condition of participation: Medical staff.
* * * * *
(c) * * *
(5) * * *
(i) A medical history and physical examination be completed and
documented for each patient no more than 30 days before or 24 hours
after admission or registration, but prior to surgery or a procedure
requiring anesthesia services, and except as provided under paragraph
(c)(5)(iii) of this section. The medical history and physical
examination must be completed and documented by a physician (as defined
in section 1861(r) of the Act), an oral and maxillofacial surgeon, or
other qualified licensed individual in accordance with State law and
hospital policy.
(ii) An updated examination of the patient, including any changes
in the patient's condition, be completed and documented within 24 hours
after admission or registration, but prior to surgery or a procedure
requiring anesthesia services, when the medical history and physical
examination are completed within 30 days before admission or
registration, and except as provided under paragraph (c)(5)(iii) of
this section. The updated examination of the patient, including any
changes in the patient's condition, must be completed and documented by
a physician (as defined in section 1861(r) of the Act), an oral and
maxillofacial surgeon, or other qualified licensed individual in
accordance with State law and hospital policy.
(iii) An assessment of the patient (in lieu of the requirements of
paragraphs (c)(5)(i) and (ii) of this section) be completed and
documented after registration, but prior to surgery or a procedure
requiring anesthesia services, when the patient is receiving specific
outpatient surgical or procedural services and when the medical staff
has chosen to develop and maintain a policy that identifies, in
accordance with the requirements at paragraph (c)(5)(v) of this
section, specific patients as not requiring a comprehensive medical
history and physical examination, or any update to it, prior to
specific
[[Page 51819]]
outpatient surgical or procedural services. The assessment must be
completed and documented by a physician (as defined in section 1861(r)
of the Act), an oral and maxillofacial surgeon, or other qualified
licensed individual in accordance with State law and hospital policy.
(iv) The medical staff develop and maintain a policy that
identifies those patients for whom the assessment requirements of
paragraph (c)(5)(iii) of this section would apply. The provisions of
paragraphs (c)(5)(iii), (iv), and (v) of this section do not apply to a
medical staff that chooses to maintain a policy that adheres to the
requirements of paragraphs of (c)(5)(i) and (ii) of this section for
all patients.
(v) The medical staff, if it chooses to develop and maintain a
policy for the identification of specific patients to whom the
assessment requirements in paragraph (c)(5)(iii) of this section would
apply, must demonstrate evidence that the policy applies only to those
patients receiving specific outpatient surgical or procedural services
as well as evidence that the policy is based on:
(A) Patient age, diagnoses, the type and number of surgeries and
procedures scheduled to be performed, comorbidities, and the level of
anesthesia required for the surgery or procedure.
(B) Nationally recognized guidelines and standards of practice for
assessment of specific types of patients prior to specific outpatient
surgeries and procedures.
(C) Applicable state and local health and safety laws.
* * * * *
0
23. Section 482.23 is amended by
0
a. Revising paragraphs (b) introductory text and (b)(4) and (6);
0
b. Adding paragraph (b)(7); and
0
c. Revising (c)(1) introductory text and (c)(3).
The revisions and addition read as follows:
Sec. 482.23 Condition of participation: Nursing services.
* * * * *
(b) Standard: Staffing and delivery of care. The nursing service
must have adequate numbers of licensed registered nurses, licensed
practical (vocational) nurses, and other personnel to provide nursing
care to all patients as needed. There must be supervisory and staff
personnel for each department or nursing unit to ensure, when needed,
the immediate availability of a registered nurse for the care of any
patient.
* * * * *
(4) The hospital must ensure that the nursing staff develops and
keeps current a nursing care plan for each patient that reflects the
patient's goals and the nursing care to be provided to meet the
patient's needs. The nursing care plan may be part of an
interdisciplinary care plan.
* * * * *
(6) All licensed nurses who provide services in the hospital must
adhere to the policies and procedures of the hospital. The director of
nursing service must provide for the adequate supervision and
evaluation of the clinical activities of all nursing personnel which
occur within the responsibility of the nursing service, regardless of
the mechanism through which those personnel are providing services
(that is, hospital employee, contract, lease, other agreement, or
volunteer).
(7) The hospital must have policies and procedures in place
establishing which outpatient departments, if any, are not required
under hospital policy to have a registered nurse present. The policies
and procedures must:
(i) Establish the criteria such outpatient departments must meet,
taking into account the types of services delivered, the general level
of acuity of patients served by the department, and the established
standards of practice for the services delivered;
(ii) Establish alternative staffing plans;
(iii) Be approved by the director of nursing;
(iv) Be reviewed at least once every 3 years.
(c) * * *
(1) Drugs and biologicals must be prepared and administered in
accordance with Federal and State laws, the orders of the practitioner
or practitioners responsible for the patient's care, and accepted
standards of practice.
* * * * *
(3) With the exception of influenza and pneumococcal vaccines,
which may be administered per physician-approved hospital policy after
an assessment of contraindications, orders for drugs and biologicals
must be documented and signed by a practitioner who is authorized to
write orders in accordance with State law and hospital policy, and who
is responsible for the care of the patient.
(i) If verbal orders are used, they are to be used infrequently.
(ii) When verbal orders are used, they must only be accepted by
persons who are authorized to do so by hospital policy and procedures
consistent with Federal and State law.
(iii) Orders for drugs and biologicals may be documented and signed
by other practitioners only if such practitioners are acting in
accordance with State law, including scope-of-practice laws, hospital
policies, and medical staff bylaws, rules, and regulations.
* * * * *
0
24. Section 482.24 is amended by revising paragraphs (c)(4)(i)(A) and
(B), and adding paragraph (c)(4)(i)(C) to read as follows:
Sec. 482.24 Condition of participation: Medical record services.
* * * * *
(c) * * *
(4) * * *
(i) * * *
(A) A medical history and physical examination completed and
documented no more than 30 days before or 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services, and except as provided under paragraph (c)(4)(i)(C) of this
section. The medical history and physical examination must be placed in
the patient's medical record within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services.
(B) An updated examination of the patient, including any changes in
the patient's condition, when the medical history and physical
examination are completed within 30 days before admission or
registration, and except as provided under paragraph (c)(4)(i)(C) of
this section. Documentation of the updated examination must be placed
in the patient's medical record within 24 hours after admission or
registration, but prior to surgery or a procedure requiring anesthesia
services.
(C) An assessment of the patient (in lieu of the requirements of
paragraphs (c)(4)(i)(A) and (B) of this section) completed and
documented after registration, but prior to surgery or a procedure
requiring anesthesia services, when the patient is receiving specific
outpatient surgical or procedural services and when the medical staff
has chosen to develop and maintain a policy that identifies, in
accordance with the requirements at Sec. 482.22(c)(5)(v), specific
patients as not requiring a comprehensive medical history and physical
examination, or any update to it, prior to specific outpatient surgical
or procedural services.
* * * * *
0
25. Section 482.27 is amended by revising paragraph (b)(7) and removing
paragraph (b)(11).
The revision reads as follows:
[[Page 51820]]
Sec. 482.27 Condition of participation: Laboratory services.
* * * * *
(b) * * *
(7) Timeframe for notification-- For donors tested on or after
February 20, 2008. For notifications resulting from donors tested on or
after February 20, 2008 as set forth at 21 CFR 610.46 and 610.47 the
notification effort begins when the blood collecting establishment
notifies the hospital that it received potentially HIV or HCV
infectious blood and blood components. The hospital must make
reasonable attempts to give notification over a period of 12 weeks
unless--
(i) The patient is located and notified; or
(ii) The hospital is unable to locate the patient and documents in
the patient's medical record the extenuating circumstances beyond the
hospital's control that caused the notification timeframe to exceed 12
weeks.
* * * * *
0
26. Section 482.42 is revised to read as follows:
Sec. 482.42 Condition of participation: Infection prevention and
control and antibiotic stewardship programs.
The hospital must have active hospital-wide programs for the
surveillance, prevention, and control of HAIs and other infectious
diseases, and for the optimization of antibiotic use through
stewardship. The programs must demonstrate adherence to nationally
recognized infection prevention and control guidelines, as well as to
best practices for improving antibiotic use where applicable, and for
reducing the development and transmission of HAIs and antibiotic-
resistant organisms. Infection prevention and control problems and
antibiotic use issues identified in the programs must be addressed in
collaboration with the hospital-wide quality assessment and performance
improvement (QAPI) program.
(a) Standard: Infection prevention and control program organization
and policies. The hospital must demonstrate that:
(1) An individual (or individuals), who is qualified through
education, training, experience, or certification in infection
prevention and control, is appointed by the governing body as the
infection preventionist(s)/infection control professional(s)
responsible for the infection prevention and control program and that
the appointment is based on the recommendations of medical staff
leadership and nursing leadership;
(2) The hospital infection prevention and control program, as
documented in its policies and procedures, employs methods for
preventing and controlling the transmission of infections within the
hospital and between the hospital and other institutions and settings;
(3) The infection prevention and control program includes
surveillance, prevention, and control of HAIs, including maintaining a
clean and sanitary environment to avoid sources and transmission of
infection, and addresses any infection control issues identified by
public health authorities; and
(4) The infection prevention and control program reflects the scope
and complexity of the hospital services provided.
(b) Standard: Antibiotic stewardship program organization and
policies. The hospital must demonstrate that:
(1) An individual (or individuals), who is qualified through
education, training, or experience in infectious diseases and/or
antibiotic stewardship, is appointed by the governing body as the
leader(s) of the antibiotic stewardship program and that the
appointment is based on the recommendations of medical staff leadership
and pharmacy leadership;
(2) The hospital-wide antibiotic stewardship program:
(i) Demonstrates coordination among all components of the hospital
responsible for antibiotic use and resistance, including, but not
limited to, the infection prevention and control program, the QAPI
program, the medical staff, nursing services, and pharmacy services;
(ii) Documents the evidence-based use of antibiotics in all
departments and services of the hospital; and
(iii) Documents any improvements, including sustained improvements,
in proper antibiotic use;
(3) The antibiotic stewardship program adheres to nationally
recognized guidelines, as well as best practices, for improving
antibiotic use; and
(4) The antibiotic stewardship program reflects the scope and
complexity of the hospital services provided.
(c) Standard: Leadership responsibilities. (1) The governing body
must ensure all of the following:
(i) Systems are in place and operational for the tracking of all
infection surveillance, prevention, and control, and antibiotic use
activities, in order to demonstrate the implementation, success, and
sustainability of such activities.
(ii) All HAIs and other infectious diseases identified by the
infection prevention and control program as well as antibiotic use
issues identified by the antibiotic stewardship program are addressed
in collaboration with hospital QAPI leadership.
(2) The infection preventionist(s)/infection control
professional(s) is responsible for:
(i) The development and implementation of hospital-wide infection
surveillance, prevention, and control policies and procedures that
adhere to nationally recognized guidelines.
(ii) All documentation, written or electronic, of the infection
prevention and control program and its surveillance, prevention, and
control activities.
(iii) Communication and collaboration with the hospital's QAPI
program on infection prevention and control issues.
(iv) Competency-based training and education of hospital personnel
and staff, including medical staff, and, as applicable, personnel
providing contracted services in the hospital, on the practical
applications of infection prevention and control guidelines, policies,
and procedures.
(v) The prevention and control of HAIs, including auditing of
adherence to infection prevention and control policies and procedures
by hospital personnel.
(vi) Communication and collaboration with the antibiotic
stewardship program.
(3) The leader(s) of the antibiotic stewardship program is
responsible for:
(i) The development and implementation of a hospital-wide
antibiotic stewardship program, based on nationally recognized
guidelines, to monitor and improve the use of antibiotics.
(ii) All documentation, written or electronic, of antibiotic
stewardship program activities.
(iii) Communication and collaboration with medical staff, nursing,
and pharmacy leadership, as well as with the hospital's infection
prevention and control and QAPI programs, on antibiotic use issues.
(iv) Competency-based training and education of hospital personnel
and staff, including medical staff, and, as applicable, personnel
providing contracted services in the hospital, on the practical
applications of antibiotic stewardship guidelines, policies, and
procedures.
(d) Standard: Unified and integrated infection prevention and
control and antibiotic stewardship programs for multi-hospital systems.
If a hospital is
[[Page 51821]]
part of a hospital system consisting of multiple separately certified
hospitals using a system governing body that is legally responsible for
the conduct of two or more hospitals, the system governing body can
elect to have unified and integrated infection prevention and control
and antibiotic stewardship programs for all of its member hospitals
after determining that such a decision is in accordance with all
applicable State and local laws. The system governing body is
responsible and accountable for ensuring that each of its separately
certified hospitals meets all of the requirements of this section. Each
separately certified hospital subject to the system governing body must
demonstrate that:
(1) The unified and integrated infection prevention and control and
antibiotic stewardship programs are established in a manner that takes
into account each member hospital's unique circumstances and any
significant differences in patient populations and services offered in
each hospital;
(2) The unified and integrated infection prevention and control and
antibiotic stewardship programs establish and implement policies and
procedures to ensure that the needs and concerns of each of its
separately certified hospitals, regardless of practice or location, are
given due consideration;
(3) The unified and integrated infection prevention and control and
antibiotic stewardship programs have mechanisms in place to ensure that
issues localized to particular hospitals are duly considered and
addressed; and
(4) A qualified individual (or individuals) with expertise in
infection prevention and control and in antibiotic stewardship has been
designated at the hospital as responsible for communicating with the
unified infection prevention and control and antibiotic stewardship
programs, for implementing and maintaining the policies and procedures
governing infection prevention and control and antibiotic stewardship
as directed by the unified infection prevention and control and
antibiotic stewardship programs, and for providing education and
training on the practical applications of infection prevention and
control and antibiotic stewardship to hospital staff.
0
27. Section 482.51 is amended by revising paragraphs (b)(1)(i) and (ii)
and adding paragraph (b)(1)(iii) to read as follows:
Sec. 482.51 Condition of participation: Surgical services.
* * * * *
(b) * * *
(1) * * *
(i) A medical history and physical examination must be completed
and documented no more than 30 days before or 24 hours after admission
or registration, and except as provided under paragraph (b)(1)(iii) of
this section.
(ii) An updated examination of the patient, including any changes
in the patient's condition, must be completed and documented within 24
hours after admission or registration when the medical history and
physical examination are completed within 30 days before admission or
registration, and except as provided under paragraph (b)(1)(iii) of
this section.
(iii) An assessment of the patient must be completed and documented
after registration (in lieu of the requirements of paragraphs (b)(1)(i)
and (ii) of this section) when the patient is receiving specific
outpatient surgical or procedural services and when the medical staff
has chosen to develop and maintain a policy that identifies, in
accordance with the requirements at Sec. 482.22(c)(5)(v), specific
patients as not requiring a comprehensive medical history and physical
examination, or any update to it, prior to specific outpatient surgical
or procedural services.
* * * * *
0
28. Section 482.58 is amended by--
0
a. Revising paragraph (b)(1);
0
b. Removing paragraph (b)(4);
0
c. Redesignating paragraphs (b)(5) through (8) as paragraphs (b)(4)
through (7); and
0
d. Revising newly redesignated paragraphs (b)(4), (5), and (7).
The revisions read as follows:
Sec. 482.58 Special requirements for hospital providers of long-term
care services (``swing-beds'').
* * * * *
(b) * * *
(1) Resident rights (Sec. 483.10(b)(7), (c)(1), (c)(2)(iii),
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (h), (g)(8) and
(17), and (g)(18) introductory text of this chapter).
* * * * *
(4) Social services (Sec. 483.40(d) of this chapter).
(5) Discharge summary (Sec. 483.20(l)).
* * * * *
(7) Dental services (Sec. 483.55(a)(2), (3), (4), and (5) and (b)
of this chapter).
0
29. Section 482.61 is amended by revising paragraph (d) to read as
follows:
Sec. 482.61 Condition of participation: Special medical record
requirements for psychiatric hospitals.
* * * * *
(d) Standard: Recording progress. Progress notes must be recorded
by the physicians(s), psychologists, or other licensed independent
practitioner(s) responsible for the care of the patient as specified in
Sec. 482.12(c); nurse, social worker and, when appropriate, others
significantly involved in active treatment modalities. The frequency of
progress notes is determined by the condition of the patient but must
be recorded at least weekly for the first 2 months and at least once a
month thereafter and must contain recommendations for revisions in the
treatment plan as indicated as well as precise assessment of the
patient's progress in accordance with the original or revised treatment
plan.
* * * * *
Sec. 482.68 [Amended]
0
30. Section 482.68 is amended--
0
a. In the section heading by removing the phrase ``transplant centers''
and adding in its place the phrase ``transplant programs''; and
0
b. In the introductory text and in paragraph (b) by removing the phrase
``transplant center'' and adding in its place the phrase ``transplant
program''.
0
31. Section 482.70 is amended--
0
a. In the definition of ``Adverse event'' by removing the phrase
``transplant centers'' and adding in its place the phrase ``transplant
programs'';
0
b. By removing the definition of ``Heart-Lung transplant center'';
0
c. By adding definitions for ``Heart-Lung transplant program'' and
``Intestine transplant program'' in alphabetical order;
0
d. By removing the definition of ``Intestine transplant center'';
0
e. By adding a definition for ``Intestine transplant program'' in
alphabetical order;
0
f. By removing the definition of ``Pancreas transplant center'';
0
g. By adding a definition for ``Pancreas transplant program'' in
alphabetical order;
0
h. By removing the definition of ``Transplant center''; and
0
i. By revising the definition of ``Transplant program''.
The additions and revision read as follows:
Sec. 482.70 Definitions.
* * * * *
Heart-Lung transplant program means a transplant program that is
located in a hospital with an existing Medicare-approved heart
transplant program and an existing Medicare-approved lung program that
performs combined heart-lung transplants.
[[Page 51822]]
Intestine transplant program means a Medicare-approved liver
transplant program that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
* * * * *
Pancreas transplant program means a Medicare-approved kidney
transplant program that performs pancreas transplants alone or
subsequent to a kidney transplant as well as kidney-pancreas
transplants.
* * * * *
Transplant program means an organ-specific transplant program
within a transplant hospital (as defined in this section).
Sec. Sec. 482.72, 482.74, 482.78, and 482.80 [Amended]
0
32. In the following table, for each section and paragraph indicated in
the first two columns, remove the phrase indicated in the third column
each time it appears and add the reference indicated in the fourth
column:
------------------------------------------------------------------------
Section Paragraphs Remove Add
------------------------------------------------------------------------
Sec. 482.72...... ................ transplant transplant
center. program.
Sec. 482.74...... (a) introductory transplant transplant
text. center. program.
Sec. 482.74...... (a) introductory center's........ hospital's.
text.
Sec. 482.74...... (a)(1).......... transplant transplant
center. program.
Sec. 482.74...... (a)(1).......... center's........ program's.
Sec. 482.74...... (a)(2).......... transplant transplant
center. program.
Sec. 482.74...... (a)(3).......... transplant transplant
center. program.
Sec. 482.74...... (b) introductory transplant transplant
text. center. program.
Sec. 482.78...... Section heading. transplant transplant
centers. programs.
Sec. 482.78...... Introductory transplant transplant
text. center. program.
Sec. 482.78...... (a)............. transplant transplant
center. program.
Sec. 482.78...... (b)............. transplant transplant
center. program.
Sec. 482.80...... Section heading. transplant transplant
centers. programs.
Sec. 482.80...... Introductory transplant transplant
text. centers. programs.
Sec. 482.80...... (a)............. transplant transplant
center. program.
Sec. 482.80...... (a)............. beneficiary..... recipient.
Sec. 482.80...... (b)............. transplant transplant
center. program.
Sec. 482.80...... (c) introductory center.......... program.
text.
Sec. 482.80...... (c)(1).......... transplant transplant
center's. program's.
Sec. 482.80...... (c)(1).......... center-specific program-
report. specific
report.
Sec. 482.80...... (c)(1).......... beneficiaries... recipients.
Sec. 482.80...... (c)(2).......... center's........ program's.
Sec. 482.80...... (d)(1).......... transplant transplant
center. program.
Sec. 482.80...... (d)(1).......... center.......... program.
Sec. 482.80...... (d)(2).......... transplant transplant
center. program.
Sec. 482.80...... (d)(2).......... center.......... program.
Sec. 482.80...... (d)(3).......... transplant transplant
center. program.
Sec. 482.80...... (d)(3).......... center.......... program.
Sec. 482.80...... (d)(4).......... transplant transplant
center. program.
Sec. 482.80...... (d)(4).......... center.......... program.
Sec. 482.80...... (d)(5).......... transplant transplant
center. program.
------------------------------------------------------------------------
Sec. 482.82 [Removed]
0
33. Section 482.82 is removed.
0
34. The undesignated center heading preceding Sec. 482.90 is revised
to read ``Transplant Program Process Requirements''.
Sec. Sec. 482.90, 482.92, 482.94, 482.96, 482.98, 482.100, and
482.102 [Amended]
0
35. In the following table, for each section and paragraph indicated in
the first two columns, remove the phrase indicated in the third column
each time it appears and add the reference indicated in the fourth
column:
------------------------------------------------------------------------
Section Paragraphs Remove Add
------------------------------------------------------------------------
Sec. 482.90...... Introductory transplant transplant
text. center. program.
Sec. 482.90...... Introductory center.......... program.
text.
Sec. 482.90...... (a)(1).......... center's waiting program's
list. waiting list.
Sec. 482.90...... (a)(2).......... transplant transplant
center. program.
Sec. 482.90...... (a)(3).......... center's waiting program's
list. waiting list.
Sec. 482.90...... (a)(4).......... transplant transplant
center. program.
Sec. 482.90...... (b) introductory Transplant Transplant
text. centers. programs.
Sec. 482.92...... Introductory donor- donor-
text. beneficiary. recipient.
Sec. 482.92...... Introductory beneficiary..... recipient.
text.
Sec. 482.92...... Introductory Transplant Transplant
text. centers. programs.
Sec. 482.92...... Introductory transplant transplant
text. center. program.
Sec. 482.92...... (a)............. transplant transplant
center. program.
Sec. 482.92...... (a)............. beneficiary..... recipient.
Sec. 482.92...... (b)............. center.......... program.
Sec. 482.92...... (b)............. beneficiary..... recipient.
Sec. 482.92...... (b)............. beneficiary's... recipient's.
Sec. 482.94...... Introductory Transplant Transplant
text. centers. programs.
Sec. 482.94...... Introductory transplant transplant
text. center. programs.
Sec. 482.94...... Introductory the center also. the program
text. also.
[[Page 51823]]
Sec. 482.94...... (a) introductory transplant transplant
text. center's. program's.
Sec. 482.94...... (a)(2).......... center.......... program.
Sec. 482.94...... (b) introductory Transplant Transplant
text. centers. programs.
Sec. 482.94...... (b)(2).......... center's........ program's.
Sec. 482.94...... (b)(3).......... center's........ program's.
Sec. 482.94...... (c) introductory Transplant Transplant
text. centers. programs.
Sec. 482.94...... (c) introductory center's waiting program's
text. list. waiting list.
Sec. 482.94...... (c)(1)introducto center's waiting program's
ry text. list. waiting list.
Sec. 482.94...... (c)(1)introducto center.......... program.
ry text.
Sec. 482.94...... (c)(1)(i)....... center's waiting program's
list. waiting list.
Sec. 482.94...... (c)(1)(ii)...... center's........ progam's.
Sec. 482.94...... (c)(1)(iii)..... center's........ progam's.
Sec. 482.94...... (c)(2).......... transplant transplant
center. program.
Sec. 482.94...... (c)(3) transplant transplant
introductory centers. programs.
text.
Sec. 482.94...... (d) introductory transplant transplant
text. center. program.
Sec. 482.94...... (d)(2).......... transplant transplant
center. program.
Sec. 482.94...... (e)............. Transplant Transplant
centers. programs.
Sec. 482.96...... Introductory Transplant Transplant
text. centers. programs.
Sec. 482.96...... (a)............. transplant transplant
center's. program's.
Sec. 482.96...... (a)............. beneficiary..... recipient.
Sec. 482.96...... (a)............. transplant transplant
center. program.
Sec. 482.96...... (b) introductory transplant transplant
text. center. program.
Sec. 482.96...... (b)(2).......... transplant transplant
center. program.
Sec. 482.96...... (b)(2).......... transplant transplant
center's. program's.
Sec. 482.98...... Introductory transplant transplant
text. center. program.
Sec. 482.98...... Introductory the center...... the program.
text.
Sec. 482.98...... (a) heading and transplant transplant
introductory center. program.
text.
Sec. 482.98...... (a) introductory center's........ program's.
text.
Sec. 482.98...... (a)(1).......... transplant transplant
center. program.
Sec. 482.98...... (b) introductory transplant transplant
text. center. program.
Sec. 482.98...... (c) introductory transplant transplant
text. center. program.
Sec. 482.98...... (c)(2).......... transplant transplant
center. program.
Sec. 482.98...... (d) introductory transplant transplant
text. center. program.
Sec. 482.98...... (d) heading..... living donor independent
advocate team. living donor
advocate team.
Sec. 482.98...... (d)(1).......... living donor independent
advocate. living donor
advocate.
Sec. 482.98...... (d)(2) living donor independent
introductory advocate team. living donor
text. advocate team.
Sec. 482.98...... (d)(3) living donor independent
introductory advocate team. living donor
text. advocate team.
Sec. 482.98...... (e)............. transplant transplant
center. program.
Sec. 482.98...... (f)............. transplant transplant
center. program.
Sec. 482.100..... ................ transplant transplant
center. program.
Sec. 482.102..... Introductory transplant transplant
text. center. program.
Sec. 482.102..... (a) introductory Transplant Transplant
text. centers. programs.
Sec. 482.102..... (a)(8).......... transplant transplant
center. program.
Sec. 482.102..... (a)(8).......... beneficiary's... recipient's.
Sec. 482.102..... (b) introductory Transplant Transplant
text. centers. programs.
Sec. 482.102..... (b)(1).......... transplant transplant
center. program.
Sec. 482.102..... (b)(4).......... beneficiary..... recipient.
Sec. 482.102..... (b)(6).......... transplant transplant
center-specific. program-
specific.
Sec. 482.102..... (b)(6).......... beneficiaries... recipients.
Sec. 482.102..... (b)(6).......... center-specific transplant-
outcomes. specific
outcomes.
Sec. 482.102..... (b)(9).......... transplant transplant
center. program.
Sec. 482.102..... (b)(9).......... beneficiary's... recipient's.
Sec. 482.102..... (c) introductory Transplant Transplant
text. centers. programs.
Sec. 482.102..... (c) introductory center's........ program's.
text.
Sec. 482.102..... (c) introductory center.......... program.
text.
Sec. 482.102..... (c)(1) transplant transplant
introductory center. program.
text.
Sec. 482.102..... (c)(1) center's waiting program's
introductory list. waiting list.
text.
Sec. 482.102..... (c)(2) center's program's
introductory Medicare Medicare
text. approval. approval.
Sec. 482.102..... (c)(2)(i)....... center's waiting program's
list. waiting list.
Sec. 482.102..... (c)(2)(i)....... transplant transplant
center. program.
Sec. 482.102..... (c)(2)(ii)...... beneficiaries... recipients.
Sec. 482.102..... (c)(2)(ii)...... center's waiting program's
list. waiting list.
Sec. 482.102..... (c)(2)(ii)...... the center...... the program.
Sec. 482.102..... (c)(2)(ii)...... center's program's
termination of termination of
approval. approval.
Sec. 482.102..... (c)(3).......... transplant transplant
center's. program's.
Sec. 482.102..... (c)(3).......... the center...... the program.
Sec. 482.102..... (c)(3).......... center's waiting program's
list. waiting list.
Sec. 482.102..... (c)(3).......... transplant transplant
center. program.
------------------------------------------------------------------------
[[Page 51824]]
0
36. Section 482.102 is further amended by revising paragraph (a)(5) to
read as follows:
Sec. 482.102 Condition of participation: Patient and living donor
rights.
* * * * *
(a) * * *
(5) National and transplant program-specific outcomes, from the
most recent SRTR program-specific report, including (but not limited
to) the transplant program's observed and expected 1-year patient and
graft survival, and national 1-year patient and graft survival;
* * * * *
Sec. 482.104 [Amended]
0
37. For Sec. 482.104, in the following table, for the heading and each
paragraph indicated in the first column, remove the phrase indicated in
the second column each time it appears and add the reference indicated
in the third column:
------------------------------------------------------------------------
Paragraphs Remove Add
------------------------------------------------------------------------
Section heading................. transplant centers transplant
programs.
(a)............................. transplant centers transplant
programs.
(a)............................. transplant center. transplant
program.
(b)............................. transplant centers transplant
programs.
(c)............................. transplant centers transplant
programs.
------------------------------------------------------------------------
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
0
38. The authority citation for part 483 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.
0
39. Section 483.73 is amended by revising paragraphs (a)(4) and (d)(2)
to read as follows:
Sec. 483.73 Emergency preparedness.
* * * * *
(a) * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, or Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
* * * * *
(d) * * *
(2) Testing. The LTC facility must conduct exercises to test the
emergency plan at least twice per year, including unannounced staff
drills using the emergency procedures. The LTC facility must do the
following:
(i) Participate in an annual full-scale exercise that is community-
based; or
(A) When a community-based exercise is not accessible, conduct an
annual individual, facility-based functional exercise.
(B) If the LTC facility experiences an actual natural or man-made
emergency that requires activation of the emergency plan, the LTC
facility is exempt from engaging its next required a full-scale
community-based or individual, facility-based functional exercise
following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is
not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the LTC facility's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise the LTC facility's emergency plan, as needed.
* * * * *
0
40. Section 483.475 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 483.475 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The ICF/IID must develop and maintain an
emergency preparedness plan that must be reviewed, and updated at least
every 2 years The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The ICF/IID must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The ICF/IID must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include the following:
* * * * *
(d) Training and testing. The ICF/IID must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years. The ICF/IID must meet the
requirements for evacuation drills and training at Sec. 483.470(i).
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the ICF/IID must conduct training on the updated
policies and procedures.
(2) Testing. The ICF/IID must conduct exercises to test the
emergency plan at least twice per year. The ICF/IID must do the
following:
(i) Participate in an annual full-scale exercise that is community-
based; or
(A) When a community-based exercise is not accessible, conduct an
annual individual, facility-based functional exercise; or.
(B) If the ICF/IID experiences an actual natural or man-made
emergency
[[Page 51825]]
that requires activation of the emergency plan, the ICF/IID is exempt
from engaging in its next required full-scale community-based or
individual, facility-based functional exercise following the onset of
the emergency event.
(ii) Conduct an additional annual exercise that may include, but is
not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation
of all drills, tabletop exercises, and emergency events, and revise the
ICF/IID's emergency plan, as needed
* * * * *
PART 484--HOME HEALTH SERVICES
0
41. The authority citation for part 484 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh unless otherwise indicated.
0
42. Section 484.2 is amended by adding definitions for ``Pseudo-
patient'' and ``Simulation'' in alphabetical order to read as follows:
Sec. 484.2 Definitions.
* * * * *
Pseudo-patient means a person trained to participate in a role-play
situation, or a computer-based mannequin device. A pseudo-patient must
be capable of responding to and interacting with the home health aide
trainee, and must demonstrate the general characteristics of the
primary patient population served by the HHA in key areas such as age,
frailty, functional status, and cognitive status.
* * * * *
Simulation means a training and assessment technique that mimics
the reality of the homecare environment, including environmental
distractions and constraints that evoke or replicate substantial
aspects of the real world in a fully interactive fashion, in order to
teach and assess proficiency in performing skills, and to promote
decision making and critical thinking.
* * * * *
0
43. Section 484.50 is amended by removing and reserving paragraph
(a)(3) and revising paragraph (c)(7) introductory text.
The revision reads as follows:
Sec. 484.50 Condition of participation: Patient rights.
* * * * *
(c) * * *
(7) Be advised, orally and in writing, of--
* * * * *
0
44. Section 484.80 is amended by revising paragraphs (c)(1) and (h)(3)
to read as follows:
Sec. 484.80 Condition of participation: Home health aide services.
* * * * *
(c) * * *
(1) The competency evaluation must address each of the subjects
listed in paragraph (b)(3) of this section. Subject areas specified
under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section
must be evaluated by observing an aide's performance of the task with a
patient or pseudo-patient. The remaining subject areas may be evaluated
through written examination, oral examination, or after observation of
a home health aide with a patient, or with a pseudo-patient as part of
a simulation.
* * * * *
(h) * * *
(3) If a deficiency in aide services is verified by the registered
nurse or other appropriate skilled professional during an on-site
visit, then the agency must conduct, and the home health aide must
complete, retraining and a competency evaluation related to the
deficient skill(s).
* * * * *
0
45. Section 484.102 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, and (d) introductory text and the first
paragraph (d)(1)(ii);
0
b. Redesignating the second paragraph (d)(1)(ii) as paragraph
(d)(1)(iv);
0
c. Adding paragraph (d)(1)(v); and
0
d. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 484.102 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The HHA must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The HHA must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The HHA must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The HHA must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the HHA must conduct training on the updated
policies and procedures.
(2) Testing. The HHA must conduct exercises to test the emergency
plan at least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based;
or
(A) When a community-based exercise is not accessible, conduct an
annual individual, facility-based functional exercise every 2 years;
or.
(B) If the HHA experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the HHA is exempt from
engaging in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the emergency
event.
(ii) Conduct an additional exercise every 2 years, opposite the
year the full-
[[Page 51826]]
scale or functional exercise under paragraph (d)(2)(i) of this section
is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
HHA's emergency plan, as needed
* * * * *
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
0
46. The authority citation for part 485 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395(hh).
0
47. Section 485.66 is amended by revising the introductory text to read
as follows:
Sec. 485.66 Condition of participation: Utilization review plan.
The facility must have in effect a written utilization review plan
that is implemented annually, to assess the necessity of services and
promotes the most efficient use of services provided by the facility.
* * * * *
0
48. Section 485.68 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 485.68 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The CORF must develop and maintain an emergency
preparedness plan that must be reviewed and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
* * * * *
(b) Policies and procedures. The CORF must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The CORF must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The CORF must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the CORF must conduct training on the updated
policies and procedures.
(2) Testing. The CORF must conduct exercises to test the emergency
plan at least annually. The CORF must do the following:
(i) Participate in a full-scale exercise that is community-based
every 2 years; or
(A) When a community-based exercise is not accessible, conduct an
individual, facility-based functional exercise every 2 years; or
(B) If the CORF experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the CORF is exempt from
engaging in its next required community-based or individual, facility-
based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the
year the full-scale or functional exercise under paragraph (d)(2)(i) of
this section is conducted, that may include, but is not limited to the
following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CORF's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
CORF's emergency plan, as needed.
* * * * *
0
49. Section 485.625 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 485.625 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The CAH must develop and maintain an emergency
preparedness plan that must be reviewed and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The CAH must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The CAH must develop and maintain an
emergency preparedness communication plan that complies with
[[Page 51827]]
Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training and testing. The CAH must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the CAH must conduct training on the updated
policies and procedures.
(2) Testing. The CAH must conduct exercises to test the emergency
plan at least twice per year. The CAH must do the following:
(i) Participate in an annual full-scale exercise that is community-
based; or
(A) When a community-based exercise is not accessible, conduct an
annual individual, facility-based functional exercise; or.
(B) If the CAH experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the CAH is exempt from
engaging in its next required full-scale community-based or individual,
facility-based functional exercise following the onset of the emergency
event.
(ii) Conduct an annual additional exercise, that may include, but
is not limited to the following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CAH's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
CAH's emergency plan, as needed.
* * * * *
Sec. 485.627 [Amended]
0
50. Section 485.627 is amended by removing paragraph (b)(1) and
redesignating paragraphs (b)(2) and (3) as paragraphs (b)(1) and (2),
respectively.
0
51. Section 485.631 is amended by adding paragraph (d) to read as
follows:
Sec. 485.631 Condition of participation: Staffing and staff
responsibilities.
* * * * *
(d) Standard: Periodic review of clinical privileges and
performance. The CAH requires that--
(1) The quality and appropriateness of the diagnosis and treatment
furnished by nurse practitioners, clinical nurse specialist, and
physician assistants at the CAH are evaluated by a member of the CAH
staff who is a doctor of medicine or osteopathy or by another doctor of
medicine or osteopathy under contract with the CAH.
(2) The quality and appropriateness of the diagnosis and treatment
furnished by doctors of medicine or osteopathy at the CAH are evaluated
by--
(i) One hospital that is a member of the network, when applicable;
(ii) One Quality Improvement Organization (QIO) or equivalent
entity;
(iii) One other appropriate and qualified entity identified in the
State rural health care plan;
(iv) In the case of distant-site physicians and practitioners
providing telemedicine services to the CAH's patient under an agreement
between the CAH and a distant-site hospital, the distant-site hospital;
or
(v) In the case of distant-site physicians and practitioners
providing telemedicine services to the CAH's patients under a written
agreement between the CAH and a distant-site telemedicine entity, one
of the entities listed in paragraphs (d)(2)(i) through (iii) of this
section.
(3) The CAH staff consider the findings of the evaluation and make
the necessary changes as specified in paragraphs (b) through (d) of
this section.
0
52. Section 485.635 is amended by--
0
a. Removing paragraph (a)(3)(vi);
0
b. Redesignating paragraph (a)(3)(vii) as paragraph (a)(3)(vi); and
0
c. Revising newly designated paragraph (a)(3)(vi) and paragraph (a)(4).
The revisions read as follows:
Sec. 485.635 Condition of participation: Provision of services.
(a) * * *
(3) * * *
(vi) Procedures that ensure that the nutritional needs of
inpatients are met in accordance with recognized dietary practices. All
patient diets, including therapeutic diets, must be ordered by the
practitioner responsible for the care of the patients or by a qualified
dietitian or qualified nutrition professional as authorized by the
medical staff in accordance with State law governing dietitians and
nutrition professionals and that the requirement of Sec. 483.25(i) of
this chapter is met with respect to inpatients receiving post CAH SNF
care.
(4) These policies are reviewed at least biennially by the group of
professional personnel required under paragraph (a)(2) of this section
and updated as necessary by the CAH.
* * * * *
0
53. Section 485.640 is added to read as follows:
Sec. 485.640 Condition of participation: Infection prevention and
control and antibiotic stewardship programs.
The CAH must have active facility-wide programs, for the
surveillance, prevention, and control of HAIs and other infectious
diseases and for the optimization of antibiotic use through
stewardship. The programs must demonstrate adherence to nationally
recognized infection prevention and control guidelines, as well as to
best practices for improving antibiotic use where applicable, and for
reducing the development and transmission of HAIs and antibiotic-
resistant organisms. Infection prevention and control problems and
antibiotic use issues identified in the programs must be addressed in
coordination with the facility-wide quality assessment and performance
improvement (QAPI) program.
(a) Standard: Infection prevention and control program organization
and policies. The CAH must demonstrate that:
(1) An individual (or individuals), who is qualified through
education, training, experience, or certification in infection
prevention and control, is appointed by the governing body, or
responsible individual, as the infection preventionist(s)/infection
control professional(s) responsible for the infection prevention and
control program and that the appointment is based on the
recommendations of medical staff leadership and nursing leadership;
(2) The infection prevention and control program, as documented in
its policies and procedures, employs methods for preventing and
controlling the transmission of infections within the CAH and between
the CAH and other healthcare settings;
(3) The infection prevention and control includes surveillance,
[[Page 51828]]
prevention, and control of HAIs, including maintaining a clean and
sanitary environment to avoid sources and transmission of infection,
and that the program also addresses any infection control issues
identified by public health authorities; and
(4) The infection prevention and control program reflects the scope
and complexity of the CAH services provided.
(b) Standard: Antibiotic stewardship program organization and
policies. The CAH must demonstrate that:
(1) An individual (or individuals), who is qualified through
education, training, or experience in infectious diseases and/or
antibiotic stewardship, is appointed by the governing body, or
responsible individual, as the leader(s) of the antibiotic stewardship
program and that the appointment is based on the recommendations of
medical staff leadership and pharmacy leadership;
(2) The facility-wide antibiotic stewardship program:
(i) Demonstrates coordination among all components of the CAH
responsible for antibiotic use and resistance, including, but not
limited to, the infection prevention and control program, the QAPI
program, the medical staff, nursing services, and pharmacy services;
(ii) Documents the evidence-based use of antibiotics in all
departments and services of the CAH; and
(iii) Documents any improvements, including sustained improvements,
in proper antibiotic use;
(3) The antibiotic stewardship program adheres to nationally
recognized guidelines, as well as best practices, for improving
antibiotic use; and
(4) The antibiotic stewardship program reflects the scope and
complexity of the CAH services provided.
(c) Standard: Leadership responsibilities. (1) The governing body,
or responsible individual, must ensure all of the following:
(i) Systems are in place and operational for the tracking of all
infection surveillance, prevention and control, and antibiotic use
activities, in order to demonstrate the implementation, success, and
sustainability of such activities.
(ii) All HAIs and other infectious diseases identified by the
infection prevention and control program as well as antibiotic use
issues identified by the antibiotic stewardship program are addressed
in collaboration with the CAH's QAPI leadership.
(2) The infection prevention and control professional(s) is
responsible for:
(i) The development and implementation of facility-wide infection
surveillance, prevention, and control policies and procedures that
adhere to nationally recognized guidelines.
(ii) All documentation, written or electronic, of the infection
prevention and control program and its surveillance, prevention, and
control activities.
(iii) Communication and collaboration with the CAH's QAPI program
on infection prevention and control issues.
(iv) Competency-based training and education of CAH personnel and
staff, including medical staff, and, as applicable, personnel providing
contracted services in the CAH, on the practical applications of
infection prevention and control guidelines, policies and procedures.
(v) The prevention and control of HAIs, including auditing of
adherence to infection prevention and control policies and procedures
by CAH personnel.
(vi) Communication and collaboration with the antibiotic
stewardship program.
(3) The leader(s) of the antibiotic stewardship program is
responsible for:
(i) The development and implementation of a facility-wide
antibiotic stewardship program, based on nationally recognized
guidelines, to monitor and improve the use of antibiotics.
(ii) All documentation, written or electronic, of antibiotic
stewardship program activities.
(iii) Communication and collaboration with medical staff, nursing,
and pharmacy leadership, as well as the CAH's infection prevention and
control and QAPI programs, on antibiotic use issues.
(iv) Competency-based training and education of CAH personnel and
staff, including medical staff, and, as applicable, personnel providing
contracted services in the CAHs, on the practical applications of
antibiotic stewardship guidelines, policies, and procedures.
0
54. Section 485.641 is revised to read as follows:
Sec. 485.641 Condition of participation: Quality assessment and
performance improvement program.
The CAH must develop, implement, and maintain an effective,
ongoing, CAH-wide, data-driven quality assessment and performance
improvement (QAPI) program. The CAH must maintain and demonstrate
evidence of the effectiveness of its QAPI program.
(a) Definitions. For the purposes of this section--
Adverse event means an untoward, undesirable, and usually
unanticipated event that causes death or serious injury or the risk
thereof.
Error means the failure of a planned action to be completed as
intended or the use of a wrong plan to achieve an aim. Errors can
include problems in practice, products, procedures, and systems; and
Medical error means an error that occurs in the delivery of
healthcare services.
(b) Standard: QAPI Program Design and scope. The CAH's QAPI program
must:
(1) Be appropriate for the complexity of the CAH's organization and
services provided.
(2) Be ongoing and comprehensive.
(3) Involve all departments of the CAH and services (including
those services furnished under contract or arrangement).
(4) Use objective measures to evaluate its organizational
processes, functions and services.
(5) Address outcome indicators related to improved health outcomes
and the prevention and reduction of medical errors, adverse events,
CAH-acquired conditions, and transitions of care, including
readmissions.
(c) Standard: Governance and leadership. The CAH's governing body
or responsible individual is ultimately responsible for the CAH's QAPI
program and is responsible and accountable for ensuring that the QAPI
program meets the requirements of paragraph (b) of this section.
(d) Standard: Program activities. For each of the areas listed in
paragraph (b) of this section, the CAH must:
(1) Focus on measures related to improved health outcomes that are
shown to be predictive of desired patient outcomes.
(2) Use the measures to analyze and track its performance.
(3) Set priorities for performance improvement, considering either
high-volume, high-risk services, or problem-prone areas.
(e) Standard: Program data collection and analysis. The program
must incorporate quality indicator data including patient care data,
and other relevant data, in order to achieve the goals of the QAPI
program.
0
55. Section 485.645 is amended by--
0
a. Revising the introductory text;
0
b. Revising paragraph (d)(1);
[[Page 51829]]
0
c. Removing paragraph (d)(4);
0
d. Redesignating paragraphs (d)(5) through (9) as paragraphs (d)(4)
through (8), respectively; and
0
e. Revising newly redesignated paragraphs (d)(4) and (7).
The revisions read as follows:
Sec. 485.645 Special requirements for CAH providers of long-term care
services (``swing-beds'')
A CAH must meet the following requirements in order to be granted
an approval from CMS to provide post-CAH SNF care, as specified in
Sec. 409.30 of this chapter, and to be paid for SNF-level services, in
accordance with paragraph (c) of this section.
* * * * *
(d) * * *
(1) Resident rights (Sec. 483.10(b)(7), (c)(1), (c)(2)(iii),
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (g)(8) and (17),
(g)(18) introductory text, and (h) of this chapter).
* * * * *
(4) Social services (Sec. 483.40(d) of this chapter).
* * * * *
(7) Dental services (Sec. 483.55(a)(2), (3), (4), and (5) and (b)
of this chapter).
* * * * *
0
56. Section 485.727 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(5), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 485.727 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The Organizations must develop and maintain an
emergency preparedness plan that must be reviewed and updated at least
every 2 years. The plan must do all of the following:
* * * * *
(5) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
* * * * *
(b) Policies and procedures. The Organizations must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and updated at least every 2 years. At a minimum, the
policies and procedures must address the following:
* * * * *
(c) Communication plan. The Organizations must develop and maintain
an emergency preparedness communication plan that complies with
Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training and testing. The Organizations must develop and
maintain an emergency preparedness training and testing program that is
based on the emergency plan set forth in paragraph (a) of this section,
risk assessment at paragraph (a)(1) of this section, policies and
procedures at paragraph (b) of this section, and the communication plan
at paragraph (c) of this section. The training and testing program must
be reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the Organizations must conduct training on the
updated policies and procedures.
(2) Testing. The Organizations must conduct exercises to test the
emergency plan at least annually. The Organizations must do the
following:
(i) Participate in a full-scale exercise that is community-based
every 2 years; or
(A) When a community-based exercise is not accessible, an
individual, facility-based functional exercise every 2 years; or.
(B) If the Organizations experience an actual natural or man-made
emergency that requires activation of the emergency plan, the
organization is exempt from engaging in its next required full-scale
community-based or individual, facility-based functional exercise
following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the
year the full-scale or functional exercise under paragraph (d)(2)(i) of
this section is conducted, that may include, but is not limited to the
following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the Organization's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise their emergency plan, as needed.
* * * * *
0
57. Section 485.914 is amended by revising paragraphs (d)(1) and (2) to
read as follows:
Sec. 485.914 Condition of participation: Admission, initial
evaluation, comprehensive assessment, and discharge or transfer of the
client.
* * * * *
(d) * * *
(1) The CMHC must update each client's comprehensive assessment via
the CMHC interdisciplinary treatment team, in consultation with the
client's primary health care provider (if any), when changes in the
client's status, responses to treatment, or goal achievement have
occurred and in accordance with current standards of practice.
(2) For clients that receive PHP services, the assessment must be
updated no less frequently than every 30 days.
* * * * *
0
58. Section 485.920 is amended by revising paragraphs (a) introductory
text, (a)(4), (b) introductory text, (c) introductory text, and (d) to
read as follows:
Sec. 485.920 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The CMHC must develop and maintain an emergency
preparedness plan that must be reviewed, and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The CMHC must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and the communication plan at
paragraph (c) of this section. The policies and
[[Page 51830]]
procedures must be reviewed and updated at least every 2 years. At a
minimum, the policies and procedures must address the following:
* * * * *
(c) Communication plan. The CMHC must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The CMHC must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years. If the emergency
preparedness policies and procedures are significantly updated, the
CMHC must conduct training on the updated policies and procedures.
(1) Training. The CMHC must provide initial training in emergency
preparedness policies and procedures to all new and existing staff,
individuals providing services under arrangement, and volunteers,
consistent with their expected roles, and maintain documentation of the
training. The CMHC must demonstrate staff knowledge of emergency
procedures. Thereafter, the CMHC must provide emergency preparedness
training at least every 2 years.
(2) Testing. The CMHC must conduct exercises to test the emergency
plan at least annually. The CMHC must:
(i) Participate in a full-scale exercise that is community-based
every 2 years; or
(A) When a community-based exercise is not accessible, conduct an
individual, facility-based every 2 years; or.
(B) If the CMHC experiences an actual natural or man-made emergency
that requires activation of the emergency plan, the CMHC is exempt from
engaging in its next required community-based or individual, facility-
based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the
year the full-scale or functional exercise under paragraph (d)(2)(i) of
this section is conducted, that may include, but is not limited to
following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CMHC's response to and maintain documentation of
all drills, tabletop exercises, and emergency events, and revise the
CMHC's emergency plan, as needed.
* * * * *
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY SUPPLIERS
0
59. The authority citation for part 486 continues to read as follows:
Authority: 42 U.S.C. 1302, and 1395hh.
0
60. Section 486.104 is amended by revising paragraph (a) to read as
follows:
Sec. 486.104 Condition for coverage: Qualifications, orientation and
health of technical personnel.
* * * * *
(a) Standard: Qualifications of technologists. All operators of the
portable X-ray equipment meet the requirements of paragraph (a)(1) or
(2) of this section.
(1) Successful completion of a program of formal training in X-ray
technology at which the operator received appropriate training and
demonstrated competence in the use of equipment and administration of
portable x-ray procedures; or
(2) Successful completion of 24 full months of training and
experience under the direct supervision of a physician who is certified
in radiology or who possesses qualifications which are equivalent to
those required for such certification.
* * * * *
0
61. Section 486.106 is amended by revising paragraph (a)(2) to read as
follows:
Sec. 486.106 Conditions for coverage: Referral for service and
preservation of records.
* * * * *
(a) * * *
(2) Such physician or non-physician practitioner's order meets the
requirements at Sec. 410.32 of this chapter, and includes a statement
concerning the condition of the patient which indicates why portable X-
ray services are necessary.
* * * * *
0
62. Section 486.360 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2)(i).
The revisions and addition read as follows:
Sec. 486.360 Condition for Coverage: Emergency preparedness.
* * * * *
(a) Emergency plan. The OPO must develop and maintain an emergency
preparedness plan that must be reviewed and updated at least every 2
years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The OPO must develop and implement
emergency preparedness policies and procedures, based on the emergency
plan set forth in paragraph (a) of this section, risk assessment at
paragraph (a)(1) of this section, and, the communication plan at
paragraph (c) of this section. The policies and procedures must be
reviewed and updated at least every 2 years. At a minimum, the policies
and procedures must address the following:
* * * * *
(c) Communication plan. The OPO must develop and maintain an
emergency preparedness communication plan that complies with Federal,
State, and local laws and must be reviewed and updated at least every 2
years. The communication plan must include all of the following:
* * * * *
(d) Training and testing. The OPO must develop and maintain an
emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
[[Page 51831]]
(ii) Provide emergency preparedness training at every 2 years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the OPO must conduct training on the updated
policies and procedures.
(2) * * *
(i) Conduct a paper-based, tabletop exercise or workshop at least
annually. A tabletop exercise is led by a facilitator and includes a
group discussion, using a narrated, clinically-relevant emergency
scenario, and a set of problem statements, directed messages, or
prepared questions designed to challenge an emergency plan. If the OPO
experiences an actual natural or man-made emergency that requires
activation of the emergency plan, the OPO is exempt from engaging in
its next required testing exercise following the onset of the emergency
event.
* * * * *
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
0
63. The authority citation for part 488 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
Sec. 488.30 [Amended]
0
64. Section 488.30(a) is amended in the definition of ``Provider of
services, provider, or supplier'' by removing the phrase ``transplant
centers'' and adding in its place the phrase ``transplant programs''.
0
65. Section 488.61 is amended--
0
a. By revising the section heading;
0
b. In the introductory text by removing the phrase ``transplant
centers'' and adding in its place the phrase ``transplant programs'';
0
c. In paragraph (a) introductory text by removing the words ``centers''
and ``center'' each time they appear and adding in their place the
words ``programs'' and ``program,'' respectively;
0
d. In paragraph (a)(2) by removing the phrase ``Scientific Registry of
Transplant Beneficiary (SRTR) center-specific'' and adding in its place
the phrase ``Scientific Registry of Transplant Recipient (SRTR)
program-specific'';
0
e. By revising paragraph (a)(5);
0
f. By removing paragraph (c);
0
g. By redesignating paragraphs (d) through (h) as paragraphs (c)
through (g), respectively;
0
h. By revising newly redesignated paragraphs (c) and (d), the newly
redesignated paragraph (e) subject heading, and newly redesignated
paragraphs (e)(1) introductory text, (e)(1)(iv), (e)(3), and (f)(1)(i)
through (iii); and
0
i. In newly redesignated paragraph (g)(1)(x) by removing the reference
``paragraphs (h)(1)(v), (h)(1)(vi), (h)(1)(vii) or (h)(1)(viii)'' and
adding in its place the reference ``paragraph (g)(1)(v), (vi), (vii) or
(viii)'' .
The revisions read as follows:
Sec. 488.61 Special procedures for approval and re-approval of organ
transplant programs.
* * * * *
(a) * * *
(5) If CMS determines that a transplant program has met the data
submission, clinical experience, and outcome requirements, CMS will
review the program's compliance with the conditions of participation
contained at Sec. Sec. 482.72 through 482.76 and Sec. Sec. 482.90
through 482.104 of this chapter using the procedures described in
subpart A of this part. If the transplant program is found to be in
compliance with all the conditions of participation at Sec. Sec.
482.72 through 482.104 of this chapter, CMS will notify the transplant
program in writing of the effective date of its Medicare-approval. CMS
will notify the transplant program in writing if it is not Medicare-
approved.
* * * * *
(c) Loss of Medicare approval. Programs that have lost their
Medicare approval may seek re-entry into the Medicare program at any
time. A program that has lost its Medicare approval must:
(1) Request initial approval using the procedures described in
paragraph (a) of this section;
(2) Be in compliance with Sec. Sec. 482.72 through 482.104 of this
chapter at the time of the request for Medicare approval; and
(3) Submit a report to CMS documenting any changes or corrective
actions taken by the program as a result of the loss of its Medicare
approval status.
(d) Transplant program inactivity. A transplant program may remain
inactive and retain its Medicare approval for a period not to exceed 12
months. A transplant program must notify CMS upon its voluntary
inactivation as required by Sec. 482.74(a)(3) of this chapter.
(e) Consideration of mitigating factors in initial approval survey,
certification, and enforcement actions for transplant programs--(1)
Factors. Except for situations of immediate jeopardy or deficiencies
other than failure to meet requirements at Sec. 482.80 of this
chapter, CMS will consider such mitigating factors as may be
appropriate in light of the nature of the deficiency and circumstances,
including (but not limited to) the following, in making a decision of
initial approval of a transplant program that does not meet the data
submission, clinical experience, or outcome requirements:
* * * * *
(iv) Program improvements that substantially address root causes of
graft failures or patient deaths, that have been implemented and
institutionalized on a sustainable basis, and that are supported by
outcomes more recent than the latest available SRTR report, for which
there is a sufficient post-transplant patient and graft survival period
and a sufficient number of transplants such that CMS finds that the
program demonstrates present-day compliance with the requirements at
Sec. 482.80(c)(2)(ii)(C) of this chapter;
* * * * *
(3) Timing. Within 14 calendar days after CMS has issued formal
written notice of a condition-level deficiency to the program, CMS must
receive notification of the program's intent to seek mitigating factors
approval, and receive all information for consideration of mitigating
factors within 120 calendar days of the CMS written notification for a
deficiency due to data submission, clinical experience or outcomes at
Sec. 482.80 of this chapter. Failure to meet these timeframes may be
the basis for denial of mitigating factors. CMS may permit an extension
of the timeline for good cause, such as a declared public health
emergency.
(f) * * *
(1) * * *
(i) Approve initial approval of a program's Medicare participation
based upon approval of mitigating factors.
(ii) Deny the program's request for Medicare approval based on
mitigating factors.
(iii) Offer a time-limited Systems Improvement Agreement, in
accordance with paragraph (g) of this section, when a transplant
program has waived its appeal rights, has implemented substantial
program improvements that address root causes and are institutionally
supported by the hospital's governing body on a sustainable basis, and
has requested more time to design or implement additional improvements
or demonstrate compliance with CMS outcome requirements. Upon
completion of the Systems Improvement Agreement or a CMS finding that
the hospital has failed to meet the terms of the Agreement, CMS makes a
final determination of whether to approve or deny a program's request
for Medicare
[[Page 51832]]
approval based on mitigating factors. A Systems Improvement Agreement
follows the process specified in paragraph (g) of this section.
* * * * *
PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES
0
66. The authority citation for part 491 is revised to read as follows:
Authority: 42 U.S.C. 263a and 1302.
0
67. Section 491.9 is amended by revising paragraph (b)(4) to read as
follows:
Sec. 491.9 Provision of services.
* * * * *
(b) * * *
(4) These policies are reviewed at least biennially by the group of
professional personnel required under paragraph (b)(2) of this section
and reviewed as necessary by the RHC or FQHC.
* * * * *
0
68. Section 491.11 is amended by revising paragraph (a) to read as
follows:
Sec. 491.11 Program evaluation.
(a) The clinic or center carries out, or arranges for, a biennial
evaluation of its total program.
* * * * *
0
69. Section 491.12 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 491.12 Emergency preparedness.
* * * * *
(a) Emergency plan. The RHC or FQHC must develop and maintain an
emergency preparedness plan that must be reviewed and updated at least
every 2 years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation.
(b) Policies and procedures. The RHC or FQHC must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and updated at least every 2 years. At a minimum, the
policies and procedures must address the following:
* * * * *
(c) Communication plan. The RHC or FQHC must develop and maintain
an emergency preparedness communication plan that complies with
Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training and testing. The RHC or FQHC must develop and maintain
an emergency preparedness training and testing program that is based on
the emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, policies and procedures
at paragraph (b) of this section, and the communication plan at
paragraph (c) of this section. The training and testing program must be
reviewed and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(v) If the emergency preparedness policies and procedures are
significantly updated, the RHC/FQHC must conduct training on the
updated policies and procedures.
(2) Testing. The RHC or FQHC must conduct exercises to test the
emergency plan at least annually. The RHC or FQHC must do the
following:
(i) Participate in a full-scale exercise that is community-based
every 2 years; or
(A) When a community-based exercise is not accessible, an
individual, facility-based functional exercise every 2 years; or.
(B) If the RHC or FQHC experiences an actual natural or man-made
emergency that requires activation of the emergency plan, the RHC or
FQHC is exempt from engaging in its next required full-scale community-
based or individual, facility-based functional exercise following the
onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the
year the full-scale or functional exercise under paragraph (d)(2)(i) of
this section is conducted, that may include, but is not limited to
following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the RHC or FQHC's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise the RHC or FQHC's emergency plan, as needed.
* * * * *
PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE
FACILITIES
0
70. The authority citation for part 494 is revised to read as follows:
Authority: 42 U.S.C. l302 and l395hh.
0
71. Section 494.60 is amended by revising paragraphs (d)(1), (2), and
(4) and adding paragraphs (d)(5), (e), and (f) to read as follows:
Sec. 494.60 Condition: Physical environment.
* * * * *
(d) * * *
(1) Except as provided in paragraph (d)(2) of this section,
dialysis facilities that do not provide one or more exits to the
outside at grade level from the patient treatment area level must
comply with provisions of the Life Safety Code (NFPA 101 and its
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4) applicable to Ambulatory Health Care Occupancies, regardless of the
number of patients served.
(2) Notwithstanding paragraph (d)(1) of this section, dialysis
facilities participating in Medicare as of October 14, 2008 that
require sprinkler systems are those housed in multi-story buildings
construction Types II(000), III(200), or V(000), as defined in the Life
Safety Code, section 21.1.6.1, which were constructed after January 1,
2008, and those housed in high rise buildings over 75 feet in height,
which were constructed after January 1, 2008.
* * * * *
(4) In consideration of a recommendation by the State survey agency
or at the discretion of the Secretary, the Secretary may waive, for
periods deemed appropriate, specific provisions of the Life Safety
Code, which would result in unreasonable hardship upon an ESRD
facility, but only if the waiver will not adversely affect the health
and safety of the patients.
(5) No dialysis facility may operate in a building that is adjacent
to an industrial high hazard area, as described
[[Page 51833]]
in sections 20.1.3.7 and 21.1.3.7 of the Health Care Facilities Code
(NFPA 99 and its Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA
12-4, TIA 12-5, and TIA 12-6).
(e) Standard: Building safety. (1) Dialysis facilities that do not
provide one or more exits to the outside at grade level from the
patient treatment area level must meet the applicable provisions of the
Health Care Facilities Code, regardless of the number of patients
served.
(2) Chapters 7, 8, 12, and 13 of the Health Care Facilities Code do
not apply to a dialysis facility.
(3) If application of the Health Care Facilities Code would result
in unreasonable hardship for the dialysis facility, CMS may waive
specific provisions of the Health Care Facilities Code for such
facility, but only if the waiver does not adversely affect the health
and safety of patients.
(f) Incorporation by reference. The standards incorporated by
reference in this section are approved for incorporation by reference
by the Director of the Office of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material
from the sources listed below. You may inspect a copy at the CMS
Information Resource Center, 7500 Security Boulevard, Baltimore, MD or
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal_register/cfr/ibr-locations.html. If any changes in the editions of the Codes are
incorporated by reference, CMS will publish a document in the Federal
Register to announce the changes.
(1) National Fire Protection Association, 1 Batterymarch Park,
Quincy, MA 02169, www.nfpa.org, 1-617-770-3000.
(i) NFPA 99, Health Care Facilities Code, 2012 edition, issued
August 11 2011.
(ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
(iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
(iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
(v) TIA 12-5 to NFPA 99, issued August 1, 2013.
(vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
(vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11,
2011.
(viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
(ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
(x) TIA 12-3 to NFPA 101, issued October 22, 2013.
(xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
(2) [Reserved]
0
72. Section 494.62 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(vii); and
0
c. Revising paragraph (d)(2).
The revisions and addition read as follows:
Sec. 494.62 Condition of participation: Emergency preparedness.
* * * * *
(a) Emergency plan. The dialysis facility must develop and maintain
an emergency preparedness plan that must be evaluated and updated at
least every 2 years. The plan must do all of the following:
* * * * *
(4) Include a process for cooperation and collaboration with local,
tribal, regional, State, and Federal emergency preparedness officials'
efforts to maintain an integrated response during a disaster or
emergency situation. The dialysis facility must contact the local
emergency preparedness agency at least annually to confirm that the
agency is aware of the dialysis facility's needs in the event of an
emergency.
(b) Policies and procedures. The dialysis facility must develop and
implement emergency preparedness policies and procedures, based on the
emergency plan set forth in paragraph (a) of this section, risk
assessment at paragraph (a)(1) of this section, and the communication
plan at paragraph (c) of this section. The policies and procedures must
be reviewed and updated at least every 2 years. These emergencies
include, but are not limited to, fire, equipment or power failures,
care-related emergencies, water supply interruption, and natural
disasters likely to occur in the facility's geographic area. At a
minimum, the policies and procedures must address the following:
* * * * *
(c) Communication plan. The dialysis facility must develop and
maintain an emergency preparedness communication plan that complies
with Federal, State, and local laws and must be reviewed and updated at
least every 2 years. The communication plan must include all of the
following:
* * * * *
(d) Training, testing, and orientation. The dialysis facility must
develop and maintain an emergency preparedness training, testing and
patient orientation program that is based on the emergency plan set
forth in paragraph (a) of this section, risk assessment at paragraph
(a)(1) of this section, policies and procedures at paragraph (b) of
this section, and the communication plan at paragraph (c) of this
section. The training, testing, and patient orientation program must be
evaluated and updated at least every 2 years.
(1) * * *
(ii) Provide emergency preparedness training at least every 2
years.
* * * * *
(vii) If the emergency preparedness policies and procedures are
significantly updated, the dialysis facility must conduct training on
the updated policies and procedures.
(2) Testing. The dialysis facility must conduct exercises to test
the emergency plan at least annually. The dialysis facility must do all
of the following:
(i) Participate in a full-scale exercise that is community-based
every 2 years; or
(A) When a community-based exercise is not accessible, an
individual, and a facility-based functional exercise every 2 years; or
(B) If the dialysis facility experiences an actual natural or man-
made emergency that requires activation of the emergency plan, the
dialysis facility is exempt from engaging in its next required full-
scale community-based or individual, facility-based functional exercise
following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the
year the full-scale or functional exercise under paragraph (d)(2)(i) of
this section is conducted, that may include, but is not limited to the
following:
(A) A second full-scale exercise that is community-based or an
individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator
and includes a group discussion, using a narrated, clinically-relevant
emergency scenario, and a set of problem statements, directed messages,
or prepared questions designed to challenge an emergency plan.
(iii) Analyze the dialysis facility's response to and maintain
documentation of all drills, tabletop exercises, and emergency events,
and revise the dialysis facility's emergency plan, as needed.
* * * * *
[[Page 51834]]
Dated: September 6, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: September 17, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-20736 Filed 9-25-19; 11:15 am]
BILLING CODE 4120-01-P
