Medicare and Medicaid Programs; Approval of the Community Health Accreditation Program for Continued Deeming Authority for Hospices, 64344-64346 [2012-25467]
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64344
Federal Register / Vol. 77, No. 203 / Friday, October 19, 2012 / Notices
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: New collection; Title of
Information Collection: Minimum Data
Set for Medicaid Incentives for
Prevention of Chronic Diseases Program
Grantees; Use: The Medicaid Incentives
for Prevention of Chronic Diseases
(MIPCD) demonstration program
provides grants to states to implement
programs that provide incentives to
Medicaid beneficiaries of all ages who
participate in prevention programs and
demonstrate changes in health risk and
outcomes, including the adoption of
healthy behaviors. The prevention
programs address at least one of the
following prevention goals: tobacco
cessation, controlling or reducing
weight, lowering cholesterol, lowering
blood pressure, and avoiding the onset
of diabetes or in the case of a diabetic,
improving the management of the
condition. The programs are also
comprehensive, widely available, easily
accessible, and based on relevant
evidence-based research and resources,
including: the Guide to Community
Preventive Services; the Guide to
Clinical Preventive Services; and the
National Registry of Evidence-Based
Programs.
The proposed information collection,
the MIPCD Minimum Data Set (MDS), is
intended to collect data for program
performance monitoring and evaluation.
The MDS is a secondary data collection
that assembles information already
collected by grantees in the course of
tracking beneficiary participation and
outcomes and performing their own
evaluation activities. Data collected
through the MDS will be used to report
on program implementation and
evaluation to CMS and the Congress.
Form Number: CMS–10444 (OCN:
0938–New); Frequency: Quarterly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
10; Total Annual Responses: 40; Total
Annual Hours: 3,467. (For policy
questions regarding this collection
contact Sherrie Fried at 410–786–6619.
For all other issues call 410–786–1326.)
2. Type of Information Collection
Request: Extension without change of a
currently approved collection. Title of
Information Collection: Medicaid
Statistical Information System (MSIS).
Use: The Balanced Budget Act of 1997
mandated that states report their
Medicaid data via MSIS. MSIS is used
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by states and other jurisdictions to
report fundamental statistical data on
the operation of their Medicaid
program. Data provided on eligibles,
beneficiaries, payments and services are
vital to those studying and assessing
Medicaid policies and costs. Medicaid
statistical data are routinely requested
by CMS, Department agencies, the
Congress and their research offices, state
Medicaid agencies, research
organizations, social service interest
groups, universities and colleges, and
the health care industry. The data
provides the only national level
information available on enrollees,
beneficiaries, and expenditures. It also
provides the only national level
information available on Medicaid
utilization. This information is the basis
for analyses and for cost savings
estimates for the Department’s cost
sharing legislative initiatives to the
Congress. The data is also crucial to
CMS and HHS actuarial forecasts. Form
Number: CMS–R–284 (OCN 0938–0345).
Frequency: Quarterly. Affected Public:
State, Local, or Tribal Governments.
Number of Respondents: 51. Total
Annual Responses: 204. Total Annual
Hours: 2,040. (For policy questions
regarding this collection contact Kay
Spence at 410–786–1617. For all other
issues call 410–786–1326.)
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on November 19, 2012.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395–
6974, Email:
OIRA_submission@omb.eop.gov.
Dated: October 16, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–25772 Filed 10–18–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3266–FN]
Medicare and Medicaid Programs;
Approval of the Community Health
Accreditation Program for Continued
Deeming Authority for Hospices
Centers for Medicare &
Medicaid Services (CMS), HHS.
AGENCY:
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ACTION:
Final notice.
This notice announces our
decision to approve the Community
Health Accreditation Program (CHAP)
for continued recognition as a national
accrediting organization for hospices
that wish to participate in the Medicare
or Medicaid programs. A hospice that
participates in Medicaid must also meet
the Medicare conditions of participation
(CoPs) as referenced in our regulations.
DATES: Effective Date: This final notice
is effective November 20, 2012 through
November 20, 2018.
FOR FURTHER INFORMATION CONTACT:
Lillian Williams, (410) 786–8636.
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski, (410) 786–6899.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a hospice, provided certain
requirements are met. Section
1861(dd)(1) of the Social Security Act
(the Act) establishes distinct criteria for
entities seeking designation as a hospice
program. Regulations concerning
provider agreements are at 42 CFR part
489 and those pertaining to activities
relating to the survey and certification
of facilities are at 42 CFR part 488. The
regulations at 42 CFR part 418 specify
the conditions that a hospice must meet
in order to participate in the Medicare
program, the scope of covered services,
and the conditions for Medicare
payment for hospice care.
Generally, to enter into an agreement,
a hospice must first be certified by a
State survey agency as complying with
conditions or requirements set forth in
part 418. Thereafter, the hospice is
subject to regular surveys by a State
survey agency to determine whether it
continues to meet these requirements.
However, there is an alternative to
surveys by State agencies.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by an approved
national accrediting organization that all
applicable Medicare conditions are met
or exceeded, we will deem those
provider entities as having met the
requirements. Accreditation by an
accrediting organization is voluntary
and is not required for Medicare
participation.
If an accrediting organization is
recognized by the Secretary as having
standards for accreditation that meet or
exceed Medicare requirements, any
provider entity accredited by the
national accrediting body’s approved
program would be deemed to meet the
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Federal Register / Vol. 77, No. 203 / Friday, October 19, 2012 / Notices
Medicare conditions. A national
accrediting organization applying for
approval of its accreditation program
under part 488, subpart A, must provide
us with reasonable assurance that the
accrediting organization requires the
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning reapproval
of accrediting organizations are set forth
at § 488.4 and § 488.8(d)(3). The
regulations at § 488.8(d)(3) require
accrediting organizations to reapply for
continued approval of deeming
authority every 6 years, or sooner as
determined by CMS. CHAP’s current
term of approval for their hospice
accreditation program expires
November 20, 2012.
II. Deeming Application Approval
Process
Section 1865(a)(3)(A) of the Act
provides a statutory timetable to ensure
that our review of applications for CMSapproval of an accreditation program is
conducted in a timely manner. The Act
provides us with 210 calendar days after
the date of receipt of an application to
complete our survey activities and
decision-making process. Within 60
days of receiving a complete
application, we must publish a notice in
the Federal Register that identifies the
national accrediting body making the
request, describes the request, and
provides no less than a 30-day public
comment period. At the end of the 210day period, we must publish a notice in
the Federal Register of approving or
denying the application.
tkelley on DSK3SPTVN1PROD with NOTICES
III. Provisions of the Proposed Notice
On May 25, 2012, we published a
proposed notice (77 FR 31362)
announcing CHAP’s request for
approval of its hospice accreditation
program. In the proposed notice, we
detailed our evaluation criteria. Under
section 1865(a)(2) of the Act and in our
regulations at § 488.4 (Application and
reapplication procedures for accrediting
organizations), we conducted a review
of CHAP’s application in accordance
with the criteria specified by our
regulations, which include, but are not
limited to the following:
• An onsite administrative review of
CHAP’s—(1) Corporate policies; (2)
financial and human resources available
to accomplish the proposed surveys; (3)
procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to
investigate and respond appropriately to
complaints against accredited facilities;
and (5) survey review and decisionmaking process for accreditation.
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• The comparison of CHAP’s hospice
accreditation standards to our current
Medicare conditions of participation.
• A documentation review of CHAP’s
survey processes to—
++ Determine the composition of the
survey team, surveyor qualifications,
and the ability of CHAP to provide
continuing surveyor training.
++ Compare CHAP’s processes to that
of State survey agencies, including
survey frequency, and the ability to
investigate and respond appropriately to
complaints against accredited facilities.
++ Evaluate CHAP’s procedures for
monitoring providers or suppliers found
to be out of compliance with CHAP
program requirements. The monitoring
procedures are used only when the
CHAP identifies noncompliance. If
noncompliance is identified through
validation reviews, the survey agency
monitors corrections as specified at
§ 488.7(d).
++ Assess CHAP’s ability to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ Establish CHAP’s ability to
provide CMS with electronic data and
reports necessary for effective validation
and assessment of CHAP’s survey
process.
++ Determine the adequacy of staff
and other resources.
++ Review CHAP’s ability to provide
adequate funding for performing
required surveys.
++ Confirm CHAP’s policies with
respect to whether surveys are
announced or unannounced.
++ Obtain CHAP’s agreement to
provide CMS with a copy of the most
current accreditation survey together
with any other information related to
the survey as we may require, including
corrective action plans.
In accordance with section
1865(a)(3)(A) of the Act, the May 25,
2012 proposed notice (77 FR 31362) also
solicited public comments regarding
whether CHAP’s requirements meet or
exceed the Medicare CoPs for hospices.
We received no public comments in
response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between CHAP’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
We compared the standards contained
in CHAP’s accreditation requirements
and survey process with the Medicare
hospice CoPs and survey process as
outlined in the State Operations Manual
(SOM). Our review and evaluation of
CHAP’s deeming application, which
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64345
were conducted as described in section
III of this final notice, yielded the
following:
• To meet the requirements at
§ 488.4(a)(4), CHAP implemented a
monitoring plan to ensure all personnel
files include a current license.
• To meet the requirements at
§ 488.4(a)(5), CHAP modified its
policies and procedures related to the
establishment of an accreditation
effective date for participation in
Medicare.
• To meet the requirements in
Appendix M of the SOM, CHAP
developed a monitoring plan to ensure
the minimum number of medical record
reviews with home visits is completed
during a survey.
• To meet the requirements at section
2728B of the SOM, CHAP revised its
policies to ensure accepted plans of
correction include a monitoring plan to
ensure deficiencies stay corrected.
• To meet the requirements at section
5075.9 of the SOM, CHAP revised its
policies to ensure complaint
investigations triaged as non-immediate
jeopardy medium are conducted within
45 calendar days following receipt of a
complaint.
• To meet the requirements at
§ 418.54(c)(7), CHAP revised its
standards to address the needs of ‘‘other
individuals’’ in the bereavement
assessment. In addition, CHAP included
language to ensure ‘‘information
gathered from the initial bereavement
assessment must be incorporated into
the plan of care and considered in the
bereavement plan of care.’’
• To meet the requirements at
§ 418.64(b)(3), CHAP revised its
standards to include language that
addresses the provision of highly
specialized nursing services provided so
infrequently by direct hospice
employees would be impracticable and
prohibitively expensive.
• To meet the requirements at
§ 418.100, CHAP revised its standards to
address the hospice’s responsibility to
‘‘organize, manage, and administer its
resources to provide hospice care and
services.’’
• To meet the requirements at
§ 418.100(c), CHAP revised its standards
to specify that a hospice must be
primarily engaged in providing care and
services consistent with accepted
standards of practice.
• To meet the requirements at
§ 418.110(d), CHAP revised its
standards to include language that
addresses the waiver of space and
occupancy and alcohol-based hand rub
requirements.
• CHAP revised its crosswalk to
ensure that all current CHAP standards
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Federal Register / Vol. 77, No. 203 / Friday, October 19, 2012 / Notices
clearly address the following sections of
the CFRs: § 418.52, § 418.54(e)(2),
§ 418.56(a), § 418.56(d), § 418.56(e),
§ 418.58, § 418.58(a)(2), § 418.58(c)(2),
§ 418.58(d)(1), § 418.60(b)(2)(ii),
§ 418.62(b), § 418.62(c), § 418.64(a)(1–3),
§ 418.64(b)(1), § 418.64(d)(3)(iv),
§ 418.72, § 418.76(a)(1), § 418.76(b)(3)(i),
§ 418.76(c), § 418.76(e), § 418.76(h)(1),
§ 418.76(j)(2), § 418.76(k), § 418.76(k)(2),
§ 418.100(b), § 418.100(c)(2),
§ 418.100(f)(1)(i), § 418.100(g)(3),
§ 418.104(d), § 418.104(f),
§ 418.106(b)(1), § 418.106(c)(1),
§ 418.106(e)(1), § 418.108(c)(3),
§ 418.110(a), § 418.110(c)(1)(i),
§ 418.110(c)(1)(ii), § 418.110(e),
§ 418.110(e)(2), § 418.110(f)(1),
§ 418.110(f)(3)(iv), § 418.110(f)(3)(vi),
§ 418.112(f), and § 418.116(b)(2).
B. Term of Approval
Based on the review and observations
described in section III of this final
notice, we have determined that CHAP’s
accreditation program for hospices meet
or exceed our requirements. Therefore,
we approve CHAP as a national
accreditation organization for hospices
that request participation in the
Medicare program, effective November
20, 2012 through November 20, 2018.
V. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
VI. Regulatory Impact Statement
In accordance with the provisions of
Executive Order 12866, this proposed
notice was not reviewed by the Office of
Management and Budget.
tkelley on DSK3SPTVN1PROD with NOTICES
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 10, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–25467 Filed 10–18–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Endocrinologic and Metabolic Drugs
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the
Endocrinologic and Metabolic Drugs
Advisory Committee. This meeting was
announced in the Federal Register of
October 10, 2012 (77 FR 61609). The
amendment is being made to reflect a
change in the Location and Procedure
portions of the document. There are no
other changes.
FOR FURTHER INFORMATION CONTACT: Paul
Tran, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001; FAX:
301–847–8533, email:
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of October 10, 2012,
FDA announced that a meeting of the
Endocrinologic and Metabolic Drugs
Advisory Committee would be held on
November 8, 2012. On page 61609, in
the second column, the Location portion
of the document is changed to read as
follows:
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room,
(Rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
On page 61609, in the third column,
the Procedure portion of the document
is changed to read as follows:
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
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before the committee. Written
submissions may be made to the contact
person on or before November 2, 2012.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before October
25, 2012. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 26, 2012.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: October 15, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–25741 Filed 10–18–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Nonprescription Drugs Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the
Nonprescription Drugs Advisory
Committee. This meeting was
announced in the Federal Register of
August 30, 2012 (77 FR 52743). The
amendment is being made to reflect a
change in the Location and Contact
Person portions of the document. There
are no other changes.
FOR FURTHER INFORMATION CONTACT:
Minh Doan, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Building 31, Rm. 2417, Silver
Spring, MD 20993–0002, 301–796–9001,
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]]>Agencies
[Federal Register Volume 77, Number 203 (Friday, October 19, 2012)]
[Notices]
[Pages 64344-64346]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25467]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3266-FN]
Medicare and Medicaid Programs; Approval of the Community Health
Accreditation Program for Continued Deeming Authority for Hospices
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces our decision to approve the Community
Health Accreditation Program (CHAP) for continued recognition as a
national accrediting organization for hospices that wish to participate
in the Medicare or Medicaid programs. A hospice that participates in
Medicaid must also meet the Medicare conditions of participation (CoPs)
as referenced in our regulations.
DATES: Effective Date: This final notice is effective November 20, 2012
through November 20, 2018.
FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636.
Cindy Melanson, (410) 786-0310.
Patricia Chmielewski, (410) 786-6899.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Medicare program, eligible beneficiaries may receive
covered services in a hospice, provided certain requirements are met.
Section 1861(dd)(1) of the Social Security Act (the Act) establishes
distinct criteria for entities seeking designation as a hospice
program. Regulations concerning provider agreements are at 42 CFR part
489 and those pertaining to activities relating to the survey and
certification of facilities are at 42 CFR part 488. The regulations at
42 CFR part 418 specify the conditions that a hospice must meet in
order to participate in the Medicare program, the scope of covered
services, and the conditions for Medicare payment for hospice care.
Generally, to enter into an agreement, a hospice must first be
certified by a State survey agency as complying with conditions or
requirements set forth in part 418. Thereafter, the hospice is subject
to regular surveys by a State survey agency to determine whether it
continues to meet these requirements. However, there is an alternative
to surveys by State agencies.
Section 1865(a)(1) of the Act provides that, if a provider entity
demonstrates through accreditation by an approved national accrediting
organization that all applicable Medicare conditions are met or
exceeded, we will deem those provider entities as having met the
requirements. Accreditation by an accrediting organization is voluntary
and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary as
having standards for accreditation that meet or exceed Medicare
requirements, any provider entity accredited by the national
accrediting body's approved program would be deemed to meet the
[[Page 64345]]
Medicare conditions. A national accrediting organization applying for
approval of its accreditation program under part 488, subpart A, must
provide us with reasonable assurance that the accrediting organization
requires the accredited provider entities to meet requirements that are
at least as stringent as the Medicare conditions. Our regulations
concerning reapproval of accrediting organizations are set forth at
Sec. 488.4 and Sec. 488.8(d)(3). The regulations at Sec. 488.8(d)(3)
require accrediting organizations to reapply for continued approval of
deeming authority every 6 years, or sooner as determined by CMS. CHAP's
current term of approval for their hospice accreditation program
expires November 20, 2012.
II. Deeming Application Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to
ensure that our review of applications for CMS-approval of an
accreditation program is conducted in a timely manner. The Act provides
us with 210 calendar days after the date of receipt of an application
to complete our survey activities and decision-making process. Within
60 days of receiving a complete application, we must publish a notice
in the Federal Register that identifies the national accrediting body
making the request, describes the request, and provides no less than a
30-day public comment period. At the end of the 210-day period, we must
publish a notice in the Federal Register of approving or denying the
application.
III. Provisions of the Proposed Notice
On May 25, 2012, we published a proposed notice (77 FR 31362)
announcing CHAP's request for approval of its hospice accreditation
program. In the proposed notice, we detailed our evaluation criteria.
Under section 1865(a)(2) of the Act and in our regulations at Sec.
488.4 (Application and reapplication procedures for accrediting
organizations), we conducted a review of CHAP's application in
accordance with the criteria specified by our regulations, which
include, but are not limited to the following:
An onsite administrative review of CHAP's--(1) Corporate
policies; (2) financial and human resources available to accomplish the
proposed surveys; (3) procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to investigate and respond
appropriately to complaints against accredited facilities; and (5)
survey review and decision-making process for accreditation.
The comparison of CHAP's hospice accreditation standards
to our current Medicare conditions of participation.
A documentation review of CHAP's survey processes to--
++ Determine the composition of the survey team, surveyor
qualifications, and the ability of CHAP to provide continuing surveyor
training.
++ Compare CHAP's processes to that of State survey agencies,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities.
++ Evaluate CHAP's procedures for monitoring providers or suppliers
found to be out of compliance with CHAP program requirements. The
monitoring procedures are used only when the CHAP identifies
noncompliance. If noncompliance is identified through validation
reviews, the survey agency monitors corrections as specified at Sec.
488.7(d).
++ Assess CHAP's ability to report deficiencies to the surveyed
facilities and respond to the facility's plan of correction in a timely
manner.
++ Establish CHAP's ability to provide CMS with electronic data and
reports necessary for effective validation and assessment of CHAP's
survey process.
++ Determine the adequacy of staff and other resources.
++ Review CHAP's ability to provide adequate funding for performing
required surveys.
++ Confirm CHAP's policies with respect to whether surveys are
announced or unannounced.
++ Obtain CHAP's agreement to provide CMS with a copy of the most
current accreditation survey together with any other information
related to the survey as we may require, including corrective action
plans.
In accordance with section 1865(a)(3)(A) of the Act, the May 25,
2012 proposed notice (77 FR 31362) also solicited public comments
regarding whether CHAP's requirements meet or exceed the Medicare CoPs
for hospices. We received no public comments in response to our
proposed notice.
IV. Provisions of the Final Notice
A. Differences Between CHAP's Standards and Requirements for
Accreditation and Medicare's Conditions and Survey Requirements
We compared the standards contained in CHAP's accreditation
requirements and survey process with the Medicare hospice CoPs and
survey process as outlined in the State Operations Manual (SOM). Our
review and evaluation of CHAP's deeming application, which were
conducted as described in section III of this final notice, yielded the
following:
To meet the requirements at Sec. 488.4(a)(4), CHAP
implemented a monitoring plan to ensure all personnel files include a
current license.
To meet the requirements at Sec. 488.4(a)(5), CHAP
modified its policies and procedures related to the establishment of an
accreditation effective date for participation in Medicare.
To meet the requirements in Appendix M of the SOM, CHAP
developed a monitoring plan to ensure the minimum number of medical
record reviews with home visits is completed during a survey.
To meet the requirements at section 2728B of the SOM, CHAP
revised its policies to ensure accepted plans of correction include a
monitoring plan to ensure deficiencies stay corrected.
To meet the requirements at section 5075.9 of the SOM,
CHAP revised its policies to ensure complaint investigations triaged as
non-immediate jeopardy medium are conducted within 45 calendar days
following receipt of a complaint.
To meet the requirements at Sec. 418.54(c)(7), CHAP
revised its standards to address the needs of ``other individuals'' in
the bereavement assessment. In addition, CHAP included language to
ensure ``information gathered from the initial bereavement assessment
must be incorporated into the plan of care and considered in the
bereavement plan of care.''
To meet the requirements at Sec. 418.64(b)(3), CHAP
revised its standards to include language that addresses the provision
of highly specialized nursing services provided so infrequently by
direct hospice employees would be impracticable and prohibitively
expensive.
To meet the requirements at Sec. 418.100, CHAP revised
its standards to address the hospice's responsibility to ``organize,
manage, and administer its resources to provide hospice care and
services.''
To meet the requirements at Sec. 418.100(c), CHAP revised
its standards to specify that a hospice must be primarily engaged in
providing care and services consistent with accepted standards of
practice.
To meet the requirements at Sec. 418.110(d), CHAP revised
its standards to include language that addresses the waiver of space
and occupancy and alcohol-based hand rub requirements.
CHAP revised its crosswalk to ensure that all current CHAP
standards
[[Page 64346]]
clearly address the following sections of the CFRs: Sec. 418.52, Sec.
418.54(e)(2), Sec. 418.56(a), Sec. 418.56(d), Sec. 418.56(e), Sec.
418.58, Sec. 418.58(a)(2), Sec. 418.58(c)(2), Sec. 418.58(d)(1),
Sec. 418.60(b)(2)(ii), Sec. 418.62(b), Sec. 418.62(c), Sec.
418.64(a)(1-3), Sec. 418.64(b)(1), Sec. 418.64(d)(3)(iv), Sec.
418.72, Sec. 418.76(a)(1), Sec. 418.76(b)(3)(i), Sec. 418.76(c),
Sec. 418.76(e), Sec. 418.76(h)(1), Sec. 418.76(j)(2), Sec.
418.76(k), Sec. 418.76(k)(2), Sec. 418.100(b), Sec. 418.100(c)(2),
Sec. 418.100(f)(1)(i), Sec. 418.100(g)(3), Sec. 418.104(d), Sec.
418.104(f), Sec. 418.106(b)(1), Sec. 418.106(c)(1), Sec.
418.106(e)(1), Sec. 418.108(c)(3), Sec. 418.110(a), Sec.
418.110(c)(1)(i), Sec. 418.110(c)(1)(ii), Sec. 418.110(e), Sec.
418.110(e)(2), Sec. 418.110(f)(1), Sec. 418.110(f)(3)(iv), Sec.
418.110(f)(3)(vi), Sec. 418.112(f), and Sec. 418.116(b)(2).
B. Term of Approval
Based on the review and observations described in section III of
this final notice, we have determined that CHAP's accreditation program
for hospices meet or exceed our requirements. Therefore, we approve
CHAP as a national accreditation organization for hospices that request
participation in the Medicare program, effective November 20, 2012
through November 20, 2018.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 35).
VI. Regulatory Impact Statement
In accordance with the provisions of Executive Order 12866, this
proposed notice was not reviewed by the Office of Management and
Budget.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program; No. 93.773 Medicare--Hospital Insurance Program;
and No. 93.774, Medicare--Supplementary Medical Insurance Program)
Dated: September 10, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-25467 Filed 10-18-12; 8:45 am]
BILLING CODE 4120-01-P
