Medicare Program; Solicitation of Independent Accrediting Organizations To Participate in the Home Infusion Therapy Supplier Accreditation Program, 7057-7061 [2019-03621]
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Federal Register / Vol. 84, No. 41 / Friday, March 1, 2019 / Notices
D At least one letter of
recommendation from person(s) not
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(Candidates may submit letter(s) from
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[FR Doc. 2019–03666 Filed 2–28–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3376–N]
Medicare Program; Solicitation of
Independent Accrediting Organizations
To Participate in the Home Infusion
Therapy Supplier Accreditation
Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
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AGENCY:
SUMMARY: This notice informs national
accrediting organizations that accredit
home infusion therapy suppliers of an
opportunity to submit applications to
participate in the home infusion therapy
supplier accreditation program. This
notice contains information on how to
apply for CMS approval.
DATES: Complete applications will be
considered for the January 1, 2021
designation deadline if received at the
address, provided in the ADDRESSES
section of this notice, by 5 p.m. eastern
daylight time (e.d.t.) on February 1,
2020.
ADDRESSES: Applications should be sent
to: Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244. Mail stop
C2–21–16, Attention: Christina MisterWard.
FOR FURTHER INFORMATION CONTACT:
Christina Mister-Ward (410) 786–2441.
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SUPPLEMENTARY INFORMATION:
I. Background
Section 1861(iii)(1) of the Social
Security Act (‘‘the Act’’) defines ‘‘home
infusion therapy’’ as the items and
services described furnished by a
qualified home infusion therapy
supplier which are furnished in the
individual’s home. The individual must
be—
• Under the care of an applicable
provider; and
• With respect to whom a plan
prescribing the type, amount, and
duration of infusion therapy services
that are to be furnished such individual
has been established by a physician and
is periodically reviewed by a physician
in coordination with the furnishing of
home infusion drugs under part B.
According to section 1861(iii)(3)(A) of
the Act, ‘‘Applicable provider’’ means a
physician, a nurse practitioner, or a
physician assistant. In accordance with
section 1834(u)(5) of the Act, we
defined ‘‘National accrediting
organization’’ at 42 CFR 488.1005 as an
organization that accredits provider or
supplier entities under a specific
program and whose accredited provider
or supplier entities under each program
are widely dispersed geographically
across the United States. In addition, the
specific program is active, fully
implemented, and operational.
In the November 13, 2018 Federal
Register (83 FR 56406),we published a
final rule titled, ‘‘Medicare and
Medicaid Programs; CY 2019 Home
Health Prospective Payment System
Rate Update and CY 2020 Case-Mix
Adjustment Methodology Refinements;
Home Health Value-Based Purchasing
Model; Home Health Quality Reporting
Requirements; Home Infusion Therapy
Requirements; and Training
Requirements for Surveyors of National
Accrediting Organizations.’’ The
November 2018 final rule implemented
health and safety standards that home
infusion therapy suppliers must meet;
the temporary transitional payments for
home infusion therapy services for CYs
2019; and an approval and oversight
process for accrediting organizations
(AOs) that accredit home infusion
therapy suppliers. For more detailed
information on the home therapy
organization accreditation requirements
see the November 2018 final rule (83 FR
56563 through 56584).
Section 1861(iii)(3)(D)(i)(III) of the
Act, as added by section 5012(b) of the
21st Century Cures Act, requires that a
home infusion therapy supplier be
accredited by an AO designated by the
Secretary in accordance with section
1834(u)(5) of the Act. Section
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7057
1834(u)(5)(A) of the Act identifies
factors for designating AOs and
modifying the list of designated AOs.
These statutory factors are as follows:
• The ability of the organization to
conduct timely reviews of accreditation
applications.
• The ability of the organization take
into account the capacities of suppliers
located in a rural area (as defined in
section 1886(d)(2)(D) of the Act).
• Whether the organization has
established reasonable fees to be
charged to suppliers applying for
accreditation.
• Such other factors as the Secretary
determines appropriate.
Section 1834(u)(5)(B) of the Act
requires the Secretary to designate AOs
to accredit home infusion therapy
suppliers furnishing home infusion
therapy not later than January 1, 2021.
II. Provisions of the Notice
This notice solicits applications from
AOs with the ability to accredit home
infusion therapy suppliers.
A. Eligible Organizations
An accreditation organization that can
show evidence of the ability to accredit
qualified home infusion therapy
suppliers as defined in section
1861(iii)(3)(D)(i) of the Act are eligible
to apply for approval as a designated
accreditation organization.
To be considered for approval as a
Medicare-designated home infusion
therapy AO under 42 CFR part 488,
subpart L (§§ 488.1000 through
488.1050), an accrediting organization
must meet the following requirements:
• The AO must have a home infusion
therapy accreditation program that it
separates and distinguishes from any of
its other accreditation programs (if
applicable).
• The AO must have home infusion
therapy accreditation standards that
meet or exceed the Medicare home
infusion therapy health and safety
standards codified at §§ 486.500 through
486.525 of our regulations.
B. Application Requirements
To be considered for approval by
Medicare as a home infusion therapy
accrediting organization, an accrediting
organization must submit an application
to CMS requesting approval of its home
infusion therapy accreditation program.
The home infusion therapy accrediting
organization’s application must contain
all of the following information to
demonstrate that the AO’s home
infusion therapy accreditation program
meets or exceeds the applicable
Medicare requirements:
• Documentation to demonstrate that
they meet the definition of a ‘‘national
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accrediting organization’’ as required by
42 CFR 488.1010(a)(1).
• The Medicare provider or supplier
type for which the organization is
requesting approval or re-approval
(§ 488.1010(a)(2)).
• Documentation that demonstrates
the home infusion therapy accrediting
organization’s ability to take into
account the capacities of rural home
infusion therapy suppliers (as required
by section 1834(u)(5)(A)(ii) of the Act
and 42 CFR 488.1010(a)(3)).
• Information that demonstrates the
home infusion therapy accrediting
organization’s knowledge, expertise,
and experience in home infusion
therapy (see § 488.1010(a)(4)).
• A detailed crosswalk (in table
format) that identifies, for each of the
applicable Medicare requirements, the
exact language of the organization’s
comparable accreditation requirements
and standards (see § 488.1010(a)(5)).
• A detailed description of the home
infusion therapy accrediting
organization’s survey processes to
confirm that a home infusion therapy
supplier’s processes are comparable to
those of Medicare (see § 488.1010(a)(6)).
This description must include all of the
following:
++ The types and frequency of
surveys performed, and a rationale for
which accreditation requirements will
be evaluated via onsite surveys and
which will be evaluated via offsite
audits, or other strategies for ensuring
accredited home infusion therapy
suppliers maintain adherence to the
home infusion therapy accreditation
program requirements, including an
explanation of how the accrediting
organization will maintain the schedule
it proposes (§ 488.1010(a)(6)(i)).
++ Copies of the home infusion
therapy accrediting organizations survey
and audit forms, guidelines, and
instructions to surveyors
(§ 488.1010(a)(6)(ii)).
++ Documentation demonstrating
that the home infusion therapy
accrediting organization’s onsite survey
or offsite audit reports identify, for each
finding of non-compliance with
accreditation standards, the comparable
Medicare home infusion therapy
accreditation requirements, as
applicable (§ 488.1010(a)(6)(iii)).
++ A description of the home
infusion therapy accrediting
organization’s accreditation survey
review process (§ 488.1010(a)(6)(iv)).
++ A description of the home
infusion therapy accrediting
organization’s procedures and timelines
for notifying a surveyed or audited
home infusion therapy supplier of noncompliance with the home infusion
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therapy accreditation program’s
standards (§ 488.1010(a)(6)(v)).
++ A description of the home
infusion therapy accrediting
organization’s procedures and timelines
for monitoring the home infusion
therapy supplier’s correction of
identified non-compliance with the
accreditation program’s standards
(§ 488.1010(a)(6)(vi)).
++ The ability of the home infusion
therapy accrediting organization to
conduct timely reviews of accreditation
applications (§ 488.1010(a)(6)(vii)).
++ A statement acknowledging that,
as a condition for CMS approval of a
national accrediting organization’s
accreditation program, the home
infusion therapy accrediting
organization agrees to provide CMS
with information extracted from each
home infusion therapy accreditation
onsite survey, offsite audit or other
evaluation strategies as part of its data
submissions required under
§ 488.1010(a)(19), and, upon request
from CMS, a copy of the most recent
accreditation onsite survey, offsite
audit, or other evaluation strategy
together with any other information
related to the survey as CMS may
require (including corrective action
plans) (§ 488.1010(a)(6)(viii)).
++ A statement acknowledging that
the home infusion therapy accrediting
organization will provide timely
notification to CMS when an
accreditation survey or complaint
investigation identifies an immediate
jeopardy as that term is defined at
§ 488.1005. Using the format specified
by CMS, the home infusion therapy
accrediting organization must notify
CMS within 2 business days from the
date the accrediting organization
identifies the immediate jeopardy
(§ 488.1010(a)(6)(ix)).
• Procedures to ensure either of the
following:
++ Unannounced onsite surveys, as
appropriate, will be conducted
periodically, including procedures that
protect against unannounced surveys
becoming known to the provider or
supplier in advance of the visit
(§ 488.1010(a)(7)(i)).
++ Offsite survey audits are
performed to evaluate the quality of
services provided which may be
followed up with periodic onsite visits
(§ 488.1010(a)(7)(ii)).
• The criteria for determining the size
and composition of the home infusion
therapy accrediting organization’s
survey, audit and other evaluation
strategy teams for individual supplier
onsite surveys. The home infusion
therapy accrediting organization’s
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criteria should include, but not be
limited to the following information:
++ The expected number of
individual home infusion therapy
supplier locations to be surveyed using
an onsite survey (§ 488.1010(a)(8)(i)).
++ The number of home infusion
therapy suppliers to be surveyed using
off-site audits (§ 488.1010(a)(8)(ii)).
++ A description of other types of
home infusion therapy accreditation
review activities to be used
(§ 488.1010(a)(8)(iii)).
++ The reasons for each type of
survey (that is, initial accreditation
survey, reaccreditation survey, and
complaint survey) (§ 488.1010(a)(8)(iv)).
• The overall adequacy of the number
of the home infusion therapy
accrediting organization’s surveyors,
auditors, and other staff available to
perform survey related activities,
including how the organization will
increase the size of the survey, audit,
and other evaluation staff to match
growth in the number of accredited
facilities or programs while maintaining
re-accreditation intervals for existing
accredited facilities or programs
(§ 488.1010(a)(9)).
• Detailed information about the
individuals who perform onsite surveys,
offsite audits or other strategies for
ensuring accredited home infusion
therapy suppliers maintain adherence to
the home infusion therapy accreditation
program requirements, including all of
the following information:
++ The number and types of
professional and technical staff
available for conducting onsite surveys,
offsite audits, or other strategies for
ensuring accredited home infusion
therapy suppliers maintain adherence to
the home infusion therapy accreditation
program requirements.
(§ 488.1010(a)(10)(i)).
++ The education, employment, and
experience requirements surveyors an
auditors must meet
(§ 488.1010(a)(10)(ii)).
++ The content and length of the
orientation program
(§ 488.1010(a)(10)(iii)).
• The content, frequency and types of
in-service training provided to survey
and audit personnel (§ 488.1010(a)(11)).
• The evaluation systems used to
monitor the performance of individual
surveyors, auditors and survey teams
(§ 488.1010(a)(12)).
• The home infusion therapy
accrediting organization’s policies and
procedures to avoid conflicts of interest,
including the appearance of conflicts of
interest, involving individuals who
conduct surveys, audits or participate in
accreditation decisions
(§ 488.1010(a)(13)).
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• The policies and procedures used
when a home infusion therapy supplier
has a dispute regarding survey or audit
findings, or an adverse decision
(§ 488.1010(a)(14)).
• Procedures for the home infusion
therapy supplier to use to notify the
home infusion therapy accrediting
organization when the accredited home
infusion therapy supplier does the
either of the following
(§ 488.1010(a)(15)):
++ Removes or ceases furnishing
services for which they are accredited.
++ Adds services for which they are
not accredited.
• The home infusion therapy
accrediting organization’s procedures
for responding to, and investigating
complaints against accredited facilities,
including policies and procedures
regarding referrals, when applicable, to
appropriate licensing bodies,
ombudsmen offices, and CMS
(§ 488.1010(a)(16)).
• A description of the home infusion
therapy accrediting organization’s
accreditation status decision-making
process. The home infusion therapy
accrediting organization must furnish
the following (§ 488.1010(a)(17)):
++ Its process for addressing
deficiencies identified with
accreditation program requirements,
and the procedures used to monitor the
correction of deficiencies identified
during an accreditation survey and
audit process.
++ A description of all types and
categories of accreditation decisions
associated with the program, including
the duration of each of the
organization’s accreditation decisions.
++ Its policies and procedures for the
granting, withholding or removal of
accreditation status for facilities that fail
to meet the accrediting organization’s
standards or requirements, assignment
of less than full accreditation status or
other actions taken by the organization
in response to non-compliance with its
standards and requirements.
++ A statement acknowledging that
the home infusion therapy accrediting
organization agrees to notify CMS (in a
manner CMS specifies) of any decision
to revoke, terminate, or revise the
accreditation status of a home infusion
therapy supplier, within 3 business days
from the date the organization takes an
action.
• A list of all currently accredited
home infusion therapy suppliers, the
type and category of accreditation,
currently held by each, and the
expiration date for each home infusion
therapy supplier’s current accreditation
(§ 488.1010(a)(18)).
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• A schedule of all survey activity
(such as onsite surveys, offsite audits
and other types if survey strategies)
expected to be conducted by the
organization during the 6-month period
following submission of an initial or
renewal application (§ 488.1010(a)(19)).
• A written presentation that
demonstrates the organization’s ability
to furnish CMS with electronic data
(§ 488.1010(a)(20)).
• A description of the home infusion
therapy accrediting organization’s data
management and analysis system with
respect to its surveys and accreditation
decisions, including all of the following
(§ 488.1010(a)(21)):
++ A detailed description of how the
home infusion therapy accrediting
organization uses its data to assure the
compliance of its home infusion therapy
accreditation program with the
Medicare home infusion therapy
accreditation program requirements.
++ A written statement
acknowledging that the home infusion
therapy accrediting organization agrees
to submit timely, accurate, and
complete data that CMS has determined
is both necessary to evaluate the
accrediting organization’s performance
and is not unduly burdensome for the
accrediting organization to submit.
++ The organization must submit
necessary data according to the
instructions and timeframes CMS
specifies.
++ Data to be submitted includes the
following:
—Accredited home infusion therapy
supplier identifying information.
—Survey findings.
—Quality measures.
—Notices of accreditation decisions.
• The three most recent annual
audited financial statements of the
home infusion therapy accrediting
organization that demonstrate that the
organization’s staffing, funding, and
other resources are adequate to perform
the required surveys, audits, and related
activities to maintain the accreditation
program (§ 488.1010(a)(22)).
• A written statement acknowledging
that, as a condition for approval, the
home infusion therapy accrediting
organization agrees to the following
(§ 488.1010(a)(23)):
++ Voluntary termination. Provide
written notification to CMS and all
home infusion therapy suppliers
accredited under its CMS-approved
home infusion therapy accreditation
program at least 180 calendar days in
advance of the effective date of a
decision by the home infusion therapy
accrediting organization to voluntarily
terminate its CMS-approved home
infusion therapy accreditation program
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and the implications for the suppliers’
payment status once their current term
of accreditation expires in accordance
with the requirements at § 488.1045(a).
++ Involuntary termination. Provide
written notification to all accredited
home infusion therapy suppliers
accredited under its CMS-approved
home infusion therapy accreditation
program no later than 30 calendar days
after the notice is published in the
Federal Register announcing that CMS
is withdrawing its approval of its
accreditation program and the
implications for the home infusion
therapy supplier’s payment status in
accordance with the requirements at
§ 488.1045(b) once their current term of
accreditation expires.
—For both voluntary and involuntary
terminations, provide a second written
notification to all accredited home
infusion therapy suppliers 10 calendar
days prior to the organization’s
accreditation program effective date of
termination.
—Notify CMS, in writing
(electronically or hard copy), within 2
business days of a deficiency identified
in any accredited home infusion therapy
supplier from any source where the
deficiency poses an immediate jeopardy
to the home infusion therapy supplier’s
beneficiaries or a hazard to the general
public.
++ Summary accreditation activity
data and trends. Provide, on an annual
basis, summary accreditation activity
data and trends including the following:
—Deficiencies.
—Complaints.
—Terminations.
—Withdrawals.
—Denials.
—Accreditation decisions.
—Other survey-related activities as
specified by CMS.
++ Termination of an accreditation
organization. If CMS terminates a home
infusion therapy accrediting
organization’s approved status, the
home infusion therapy accrediting
organization must work collaboratively
with CMS to direct its accredited home
infusion therapy suppliers to the
remaining CMS-approved accrediting
organizations within a reasonable
period of time.
++ Notification of proposed changes.
Notify CMS at least 60 days in advance
of the implementation date of any
significant proposed changes in its
CMS-approved home infusion therapy
accreditation program and that it agrees
not to implement the proposed changes
without prior written notice of
continued program approval from CMS,
except as provided for at
§ 488.1040(b)(2).
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++ Response to a written notice from
CMS. A statement acknowledging that,
in response to a written notice from
CMS to the home infusion therapy
accrediting organization of a change in
the applicable home infusion therapy
accreditation requirements or survey
process, the organization will provide
CMS with proposed corresponding
changes in the accrediting
organization’s home infusion therapy
accreditation requirements for its CMSapproved home infusion therapy
accreditation program to ensure that its
accreditation standards continue to
meet or exceed those of Medicare, or
survey process remains comparable
with that of Medicare. The home
infusion therapy accrediting
organization must comply with the
following requirements:
—The proposed changes must be
submitted within 30 calendar days of
the date of the written CMS notice to the
home infusion therapy accrediting
organization or by a date specified in
the notice, whichever is later. CMS
gives due consideration to a home
infusion therapy accrediting
organization’s request for an extension
of the deadline as long as it is submitted
prior to the due date.
—The proposed changes are not to be
implemented without prior written
notice of continued program approval
from CMS, except as provided for at
§ 488.1040(b)(2)(ii).
• The organization’s proposed fees for
accreditation, including any plans for
reducing the burden and cost of
accreditation to small and rural
suppliers (§ 488.1010(a)(2)).
• Acknowledgement agreeing to
release of accreditation surveys. The
home infusion accreditation
organization must include a statement
within its accreditation application and
accreditation agreement with each home
infusion therapy supplier, agreeing to
release its most current accreditation
survey and any information related to
the survey that CMS may require,
including the home infusion therapy
supplier’s corrective action plans
(§ 488.1025).
• Acknowledgement of Onsite
Observation of Accrediting
Organizations. The home infusion
accreditation organization must include
a statement its accreditation application
to permit CMS to conduct an onsite
inspection of the home infusion therapy
accreditation organizations operations
and offices at any time to verify the
organization’s representation and to
assess the organizations compliance
with its own policies and procedures
(§ 488.1040).
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• Acknowledgement of
Reconsideration Process. The home
infusion therapy accreditation
organization must include a statement
acknowledging understanding of the
reconsideration process. The home
infusion therapy accreditation
organization may request
reconsideration of an unfavorable
decision made by CMS, as stated at
(§ 488.1050).
C. Requests for Additional Information
by CMS (§ 488.1010(b))
If CMS determines that additional
information is necessary to make a
determination for approval or denial of
the home infusion therapy accrediting
organization’s initial application (or
reapplication) for CMS-approval of an
accreditation program, CMS may require
that the home infusion therapy
accrediting organization submit any
additional documentation and
attestations necessary as a condition of
approval of accreditation. If such
additional information is required, CMS
will notify the home infusion therapy
accrediting organization and afford it an
opportunity to provide the additional
information.
D. Withdrawal of an Application
(§ 488.1010(c))
A home infusion therapy accrediting
organization may withdraw its initial
application seeking CMS’ approval of its
home infusion therapy accreditation
program at any time before CMS
publishes the final notice as provided in
§ 488.1020(b).
E. Evaluation of Applications
An application review team will
evaluate all applications submitted by
accrediting organizations seeking
designation as CMS-approved home
infusion therapy accrediting
organizations under section
1834(u)(5)(B) of the Act using the
processes for consideration set forth in
part 488, subpart L.
F. Notice of Approval or Disapproval of
Application (§ 488.1010(d))
We are required to send a notice of its
decision to approve or disapprove the
home infusion therapy accrediting
organization’s application within 210
calendar days from the date CMS
determines the home infusion therapy
accrediting organization’s application is
complete. The final notice will specify
the following:
• The basis for the decision.
• The effective date.
• The term of the approval (not
exceed 6 years).
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G. Public Notice and Comment
(§ 488.1020)
We are required to publish a notice in
the Federal Register when the following
conditions are met:
• Proposed notice. CMS publishes a
notice after the receipt of a completed
application from a national home
infusion therapy accrediting
organization seeking CMS’s approval of
a home infusion therapy accreditation
program. The notice identifies the home
infusion therapy accrediting
organization, the type of suppliers
covered by the home infusion therapy
accreditation program, and provides at
least a 30-day public comment period
(beginning on the date of publication)
(§ 488.1020(a)).
• Final notice. The final notice
announces CMS decision to approve or
deny a national accrediting organization
application. The notice specifies the
basis for the CMS decision
(§ 488.1020(b)).
++ Approval or re-approval. If CMS
approves or re-approves the home
infusion therapy accrediting
organization’s home infusion therapy
accreditation program, the final notice
at a minimum includes the following
information:
++ A description of how the home
infusion therapy accreditation program
meets or exceeds Medicare home
infusion therapy accreditation program
requirements.
++ The effective date of approval (no
later than the publication date of the
notice).
++ The term of the approval (6 years
or less).
• Denial. If CMS does not approve the
home infusion therapy accrediting
organization’s accreditation program,
the final notice describes the following:
++ How the home infusion therapy
accrediting organization fails to meet
Medicare home infusion therapy
accreditation program requirements.
++ The effective date of the decision.
III. 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.).
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Dated: February 19, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–03621 Filed 2–27–19; 11:15 am]
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HUMAN SERVICES
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[CMS–1705–N]
Medicare Program; Public Meetings in
Calendar Year 2019 for All New Public
Requests for Revisions to the
Healthcare Common Procedure Coding
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Determinations
Centers for Medicare &
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AGENCY:
SUMMARY: This notice announces the
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our preliminary coding and payment
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2. Tuesday, May 14, 2019, 9 a.m. to
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Imaging Agents.
3. Wednesday, May 15, 2019, 9 a.m.
to 5 p.m., e.d.t., for Drugs/Biologicals/
Radiopharmaceuticals/Radiologic
Imaging Agents.
4. Tuesday, June 11, 2019, 9 a.m. to
5 p.m., e.d.t., for Durable Medical
Equipment (DME) and Accessories,
Orthotics and Prosthetics (O&P)
Supplies, and Other for DME and
Accessories, O&P Supplies, and Other.
5. Wednesday, June 12, 2019, 9 a.m.
to 5 p.m., e.d.t., for DME and
Accessories, O&P Supplies, and Other.
VerDate Sep<11>2014
18:13 Feb 28, 2019
Jkt 247001
Deadlines for Primary Speaker
Registration and Presentation Materials:
The deadline for registering to be a
primary speaker and submitting
materials and writings that will be used
in support of an oral presentation are as
follows:
• Monday, April 29, 2019, for the
May 13, 14 and 15, 2019 Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents public
meetings.
• Tuesday, May 28, 2019, for the June
11 and 12, 2019 DME and Accessories,
O&P Supplies, and Other public
meetings.
Registration Deadline for Attendees
that are Foreign Nationals: CMS’
registration deadlines for attendees that
are foreign nationals (including the
deadlines for providing necessary
information for security clearance) are
as follows:
• Monday, April 22, 2019, for the
May 13, 14 and 15, 2019 Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents public
meetings.
• Tuesday, May 21, for the June 11
and 12, 2019 DME and Accessories,
O&P Supplies, and Other public
meetings.
Registration Deadlines for all Other
Attendees: The registration deadlines
are different for each meeting.
Registration deadlines are as follows:
• Monday, April 29, 2019, for the
May 13, 14 and 15, 2019 Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents public
meetings.
• Tuesday, May 28, 2019, for the June
11 and 12, 2019 DME and Accessories,
O&P Supplies, and Other public
meetings.
Deadlines for Requesting Special
Accommodations: Individuals who plan
to attend the public meetings and
require sign-language interpretation or
other special assistance must request
these services by the following
deadlines:
• Monday, April 29, 2019, for the
May 13, 14 and 15, 2019 Drugs/
Biologicals/Radiopharmaceuticals/
Radiologic Imaging Agents public
meetings.
• Tuesday, May 28, 2019, for the June
11 and 12, 2019 DME and Accessories,
O&P Supplies, and Other public
meetings.
Deadline for Submission of Written
Comments: Written comments and other
documentation in response to a
preliminary coding or payment
determination that are received by no
later than the date of the public meeting
at which the code request is scheduled
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
7061
for discussion, will be considered in
formulating a final coding decision.
ADDRESSES:
Meeting Location: The public
meetings will be held in the main
auditorium of the central building of the
Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1850.
Submission of Written Comments:
Written comments may either be
emailed to HCPCS@cms.hhs.gov or sent
via regular mail to Irina Akelaitis or
Felicia Kyeremeh at the Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Mail Stop C5–09–
14, Baltimore, MD 21244–1850.
Registration and Special
Accommodations: Individuals wishing
to participate or who need special
accommodations or both must register
by completing the on-line registration
located at www.cms.hhs.gov/
medhcpcsgeninfo or by contacting the
staff listed in the FOR FURTHER
INFORMATION CONTACT section of this
notice.
FOR FURTHER INFORMATION CONTACT: Irina
Akelaitis, (410) 786–4602, or
Irina.Akelaitis@cms.hhs.gov; or Felicia
Kyeremeh, (410) 786–1898 or
Felicia.Kyeremeh@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Congress
passed the Medicare, Medicaid, and
SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA) (Pub. L.
106–554). Section 531(b) of BIPA
mandated that we establish procedures
that permit public consultation for
coding and payment determinations for
new durable medical equipment (DME)
under Medicare Part B of title XVIII of
the Social Security Act (the Act). In the
November 23, 2001 Federal Register (66
FR 58743), we published a notice
providing information regarding the
establishment of the public meeting
process for DME. The procedures and
public meetings announced in that
notice for new DME were in response to
the mandate of section 531(b) of BIPA.
As part of HCPCS reform, we expanded
the public meeting forum to include all
public requests as of the 2005–2006
coding cycle.
It is our intent to distribute any
submitted materials to CMS’ Healthcare
Common Procedure Coding System
(HCPCS) workgroup members for their
consideration. CMS HCPCS workgroup
members require sufficient preparation
time to review all relevant materials.
Therefore, we are implementing a 10page submission limit and firm
deadlines for receipt of any presentation
E:\FR\FM\01MRN1.SGM
01MRN1
Agencies
[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Notices]
[Pages 7057-7061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03621]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3376-N]
Medicare Program; Solicitation of Independent Accrediting
Organizations To Participate in the Home Infusion Therapy Supplier
Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice informs national accrediting organizations that
accredit home infusion therapy suppliers of an opportunity to submit
applications to participate in the home infusion therapy supplier
accreditation program. This notice contains information on how to apply
for CMS approval.
DATES: Complete applications will be considered for the January 1, 2021
designation deadline if received at the address, provided in the
ADDRESSES section of this notice, by 5 p.m. eastern daylight time
(e.d.t.) on February 1, 2020.
ADDRESSES: Applications should be sent to: Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244.
Mail stop C2-21-16, Attention: Christina Mister-Ward.
FOR FURTHER INFORMATION CONTACT: Christina Mister-Ward (410) 786-2441.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1861(iii)(1) of the Social Security Act (``the Act'')
defines ``home infusion therapy'' as the items and services described
furnished by a qualified home infusion therapy supplier which are
furnished in the individual's home. The individual must be--
Under the care of an applicable provider; and
With respect to whom a plan prescribing the type, amount,
and duration of infusion therapy services that are to be furnished such
individual has been established by a physician and is periodically
reviewed by a physician in coordination with the furnishing of home
infusion drugs under part B.
According to section 1861(iii)(3)(A) of the Act, ``Applicable
provider'' means a physician, a nurse practitioner, or a physician
assistant. In accordance with section 1834(u)(5) of the Act, we defined
``National accrediting organization'' at 42 CFR 488.1005 as an
organization that accredits provider or supplier entities under a
specific program and whose accredited provider or supplier entities
under each program are widely dispersed geographically across the
United States. In addition, the specific program is active, fully
implemented, and operational.
In the November 13, 2018 Federal Register (83 FR 56406),we
published a final rule titled, ``Medicare and Medicaid Programs; CY
2019 Home Health Prospective Payment System Rate Update and CY 2020
Case-Mix Adjustment Methodology Refinements; Home Health Value-Based
Purchasing Model; Home Health Quality Reporting Requirements; Home
Infusion Therapy Requirements; and Training Requirements for Surveyors
of National Accrediting Organizations.'' The November 2018 final rule
implemented health and safety standards that home infusion therapy
suppliers must meet; the temporary transitional payments for home
infusion therapy services for CYs 2019; and an approval and oversight
process for accrediting organizations (AOs) that accredit home infusion
therapy suppliers. For more detailed information on the home therapy
organization accreditation requirements see the November 2018 final
rule (83 FR 56563 through 56584).
Section 1861(iii)(3)(D)(i)(III) of the Act, as added by section
5012(b) of the 21st Century Cures Act, requires that a home infusion
therapy supplier be accredited by an AO designated by the Secretary in
accordance with section 1834(u)(5) of the Act. Section 1834(u)(5)(A) of
the Act identifies factors for designating AOs and modifying the list
of designated AOs. These statutory factors are as follows:
The ability of the organization to conduct timely reviews
of accreditation applications.
The ability of the organization take into account the
capacities of suppliers located in a rural area (as defined in section
1886(d)(2)(D) of the Act).
Whether the organization has established reasonable fees
to be charged to suppliers applying for accreditation.
Such other factors as the Secretary determines
appropriate.
Section 1834(u)(5)(B) of the Act requires the Secretary to
designate AOs to accredit home infusion therapy suppliers furnishing
home infusion therapy not later than January 1, 2021.
II. Provisions of the Notice
This notice solicits applications from AOs with the ability to
accredit home infusion therapy suppliers.
A. Eligible Organizations
An accreditation organization that can show evidence of the ability
to accredit qualified home infusion therapy suppliers as defined in
section 1861(iii)(3)(D)(i) of the Act are eligible to apply for
approval as a designated accreditation organization.
To be considered for approval as a Medicare-designated home
infusion therapy AO under 42 CFR part 488, subpart L (Sec. Sec.
488.1000 through 488.1050), an accrediting organization must meet the
following requirements:
The AO must have a home infusion therapy accreditation
program that it separates and distinguishes from any of its other
accreditation programs (if applicable).
The AO must have home infusion therapy accreditation
standards that meet or exceed the Medicare home infusion therapy health
and safety standards codified at Sec. Sec. 486.500 through 486.525 of
our regulations.
B. Application Requirements
To be considered for approval by Medicare as a home infusion
therapy accrediting organization, an accrediting organization must
submit an application to CMS requesting approval of its home infusion
therapy accreditation program. The home infusion therapy accrediting
organization's application must contain all of the following
information to demonstrate that the AO's home infusion therapy
accreditation program meets or exceeds the applicable Medicare
requirements:
Documentation to demonstrate that they meet the definition
of a ``national
[[Page 7058]]
accrediting organization'' as required by 42 CFR 488.1010(a)(1).
The Medicare provider or supplier type for which the
organization is requesting approval or re-approval (Sec.
488.1010(a)(2)).
Documentation that demonstrates the home infusion therapy
accrediting organization's ability to take into account the capacities
of rural home infusion therapy suppliers (as required by section
1834(u)(5)(A)(ii) of the Act and 42 CFR 488.1010(a)(3)).
Information that demonstrates the home infusion therapy
accrediting organization's knowledge, expertise, and experience in home
infusion therapy (see Sec. 488.1010(a)(4)).
A detailed crosswalk (in table format) that identifies,
for each of the applicable Medicare requirements, the exact language of
the organization's comparable accreditation requirements and standards
(see Sec. 488.1010(a)(5)).
A detailed description of the home infusion therapy
accrediting organization's survey processes to confirm that a home
infusion therapy supplier's processes are comparable to those of
Medicare (see Sec. 488.1010(a)(6)). This description must include all
of the following:
++ The types and frequency of surveys performed, and a rationale
for which accreditation requirements will be evaluated via onsite
surveys and which will be evaluated via offsite audits, or other
strategies for ensuring accredited home infusion therapy suppliers
maintain adherence to the home infusion therapy accreditation program
requirements, including an explanation of how the accrediting
organization will maintain the schedule it proposes (Sec.
488.1010(a)(6)(i)).
++ Copies of the home infusion therapy accrediting organizations
survey and audit forms, guidelines, and instructions to surveyors
(Sec. 488.1010(a)(6)(ii)).
++ Documentation demonstrating that the home infusion therapy
accrediting organization's onsite survey or offsite audit reports
identify, for each finding of non-compliance with accreditation
standards, the comparable Medicare home infusion therapy accreditation
requirements, as applicable (Sec. 488.1010(a)(6)(iii)).
++ A description of the home infusion therapy accrediting
organization's accreditation survey review process (Sec.
488.1010(a)(6)(iv)).
++ A description of the home infusion therapy accrediting
organization's procedures and timelines for notifying a surveyed or
audited home infusion therapy supplier of non-compliance with the home
infusion therapy accreditation program's standards (Sec.
488.1010(a)(6)(v)).
++ A description of the home infusion therapy accrediting
organization's procedures and timelines for monitoring the home
infusion therapy supplier's correction of identified non-compliance
with the accreditation program's standards (Sec. 488.1010(a)(6)(vi)).
++ The ability of the home infusion therapy accrediting
organization to conduct timely reviews of accreditation applications
(Sec. 488.1010(a)(6)(vii)).
++ A statement acknowledging that, as a condition for CMS approval
of a national accrediting organization's accreditation program, the
home infusion therapy accrediting organization agrees to provide CMS
with information extracted from each home infusion therapy
accreditation onsite survey, offsite audit or other evaluation
strategies as part of its data submissions required under Sec.
488.1010(a)(19), and, upon request from CMS, a copy of the most recent
accreditation onsite survey, offsite audit, or other evaluation
strategy together with any other information related to the survey as
CMS may require (including corrective action plans) (Sec.
488.1010(a)(6)(viii)).
++ A statement acknowledging that the home infusion therapy
accrediting organization will provide timely notification to CMS when
an accreditation survey or complaint investigation identifies an
immediate jeopardy as that term is defined at Sec. 488.1005. Using the
format specified by CMS, the home infusion therapy accrediting
organization must notify CMS within 2 business days from the date the
accrediting organization identifies the immediate jeopardy (Sec.
488.1010(a)(6)(ix)).
Procedures to ensure either of the following:
++ Unannounced onsite surveys, as appropriate, will be conducted
periodically, including procedures that protect against unannounced
surveys becoming known to the provider or supplier in advance of the
visit (Sec. 488.1010(a)(7)(i)).
++ Offsite survey audits are performed to evaluate the quality of
services provided which may be followed up with periodic onsite visits
(Sec. 488.1010(a)(7)(ii)).
The criteria for determining the size and composition of
the home infusion therapy accrediting organization's survey, audit and
other evaluation strategy teams for individual supplier onsite surveys.
The home infusion therapy accrediting organization's criteria should
include, but not be limited to the following information:
++ The expected number of individual home infusion therapy supplier
locations to be surveyed using an onsite survey (Sec.
488.1010(a)(8)(i)).
++ The number of home infusion therapy suppliers to be surveyed
using off-site audits (Sec. 488.1010(a)(8)(ii)).
++ A description of other types of home infusion therapy
accreditation review activities to be used (Sec. 488.1010(a)(8)(iii)).
++ The reasons for each type of survey (that is, initial
accreditation survey, reaccreditation survey, and complaint survey)
(Sec. 488.1010(a)(8)(iv)).
The overall adequacy of the number of the home infusion
therapy accrediting organization's surveyors, auditors, and other staff
available to perform survey related activities, including how the
organization will increase the size of the survey, audit, and other
evaluation staff to match growth in the number of accredited facilities
or programs while maintaining re-accreditation intervals for existing
accredited facilities or programs (Sec. 488.1010(a)(9)).
Detailed information about the individuals who perform
onsite surveys, offsite audits or other strategies for ensuring
accredited home infusion therapy suppliers maintain adherence to the
home infusion therapy accreditation program requirements, including all
of the following information:
++ The number and types of professional and technical staff
available for conducting onsite surveys, offsite audits, or other
strategies for ensuring accredited home infusion therapy suppliers
maintain adherence to the home infusion therapy accreditation program
requirements. (Sec. 488.1010(a)(10)(i)).
++ The education, employment, and experience requirements surveyors
an auditors must meet (Sec. 488.1010(a)(10)(ii)).
++ The content and length of the orientation program (Sec.
488.1010(a)(10)(iii)).
The content, frequency and types of in-service training
provided to survey and audit personnel (Sec. 488.1010(a)(11)).
The evaluation systems used to monitor the performance of
individual surveyors, auditors and survey teams (Sec.
488.1010(a)(12)).
The home infusion therapy accrediting organization's
policies and procedures to avoid conflicts of interest, including the
appearance of conflicts of interest, involving individuals who conduct
surveys, audits or participate in accreditation decisions (Sec.
488.1010(a)(13)).
[[Page 7059]]
The policies and procedures used when a home infusion
therapy supplier has a dispute regarding survey or audit findings, or
an adverse decision (Sec. 488.1010(a)(14)).
Procedures for the home infusion therapy supplier to use
to notify the home infusion therapy accrediting organization when the
accredited home infusion therapy supplier does the either of the
following (Sec. 488.1010(a)(15)):
++ Removes or ceases furnishing services for which they are
accredited.
++ Adds services for which they are not accredited.
The home infusion therapy accrediting organization's
procedures for responding to, and investigating complaints against
accredited facilities, including policies and procedures regarding
referrals, when applicable, to appropriate licensing bodies, ombudsmen
offices, and CMS (Sec. 488.1010(a)(16)).
A description of the home infusion therapy accrediting
organization's accreditation status decision-making process. The home
infusion therapy accrediting organization must furnish the following
(Sec. 488.1010(a)(17)):
++ Its process for addressing deficiencies identified with
accreditation program requirements, and the procedures used to monitor
the correction of deficiencies identified during an accreditation
survey and audit process.
++ A description of all types and categories of accreditation
decisions associated with the program, including the duration of each
of the organization's accreditation decisions.
++ Its policies and procedures for the granting, withholding or
removal of accreditation status for facilities that fail to meet the
accrediting organization's standards or requirements, assignment of
less than full accreditation status or other actions taken by the
organization in response to non-compliance with its standards and
requirements.
++ A statement acknowledging that the home infusion therapy
accrediting organization agrees to notify CMS (in a manner CMS
specifies) of any decision to revoke, terminate, or revise the
accreditation status of a home infusion therapy supplier, within 3
business days from the date the organization takes an action.
A list of all currently accredited home infusion therapy
suppliers, the type and category of accreditation, currently held by
each, and the expiration date for each home infusion therapy supplier's
current accreditation (Sec. 488.1010(a)(18)).
A schedule of all survey activity (such as onsite surveys,
offsite audits and other types if survey strategies) expected to be
conducted by the organization during the 6-month period following
submission of an initial or renewal application (Sec.
488.1010(a)(19)).
A written presentation that demonstrates the
organization's ability to furnish CMS with electronic data (Sec.
488.1010(a)(20)).
A description of the home infusion therapy accrediting
organization's data management and analysis system with respect to its
surveys and accreditation decisions, including all of the following
(Sec. 488.1010(a)(21)):
++ A detailed description of how the home infusion therapy
accrediting organization uses its data to assure the compliance of its
home infusion therapy accreditation program with the Medicare home
infusion therapy accreditation program requirements.
++ A written statement acknowledging that the home infusion therapy
accrediting organization agrees to submit timely, accurate, and
complete data that CMS has determined is both necessary to evaluate the
accrediting organization's performance and is not unduly burdensome for
the accrediting organization to submit.
++ The organization must submit necessary data according to the
instructions and timeframes CMS specifies.
++ Data to be submitted includes the following:
--Accredited home infusion therapy supplier identifying
information.
--Survey findings.
--Quality measures.
--Notices of accreditation decisions.
The three most recent annual audited financial statements
of the home infusion therapy accrediting organization that demonstrate
that the organization's staffing, funding, and other resources are
adequate to perform the required surveys, audits, and related
activities to maintain the accreditation program (Sec.
488.1010(a)(22)).
A written statement acknowledging that, as a condition for
approval, the home infusion therapy accrediting organization agrees to
the following (Sec. 488.1010(a)(23)):
++ Voluntary termination. Provide written notification to CMS and
all home infusion therapy suppliers accredited under its CMS-approved
home infusion therapy accreditation program at least 180 calendar days
in advance of the effective date of a decision by the home infusion
therapy accrediting organization to voluntarily terminate its CMS-
approved home infusion therapy accreditation program and the
implications for the suppliers' payment status once their current term
of accreditation expires in accordance with the requirements at Sec.
488.1045(a).
++ Involuntary termination. Provide written notification to all
accredited home infusion therapy suppliers accredited under its CMS-
approved home infusion therapy accreditation program no later than 30
calendar days after the notice is published in the Federal Register
announcing that CMS is withdrawing its approval of its accreditation
program and the implications for the home infusion therapy supplier's
payment status in accordance with the requirements at Sec. 488.1045(b)
once their current term of accreditation expires.
--For both voluntary and involuntary terminations, provide a second
written notification to all accredited home infusion therapy suppliers
10 calendar days prior to the organization's accreditation program
effective date of termination.
--Notify CMS, in writing (electronically or hard copy), within 2
business days of a deficiency identified in any accredited home
infusion therapy supplier from any source where the deficiency poses an
immediate jeopardy to the home infusion therapy supplier's
beneficiaries or a hazard to the general public.
++ Summary accreditation activity data and trends. Provide, on an
annual basis, summary accreditation activity data and trends including
the following:
--Deficiencies.
--Complaints.
--Terminations.
--Withdrawals.
--Denials.
--Accreditation decisions.
--Other survey-related activities as specified by CMS.
++ Termination of an accreditation organization. If CMS terminates
a home infusion therapy accrediting organization's approved status, the
home infusion therapy accrediting organization must work
collaboratively with CMS to direct its accredited home infusion therapy
suppliers to the remaining CMS-approved accrediting organizations
within a reasonable period of time.
++ Notification of proposed changes. Notify CMS at least 60 days in
advance of the implementation date of any significant proposed changes
in its CMS-approved home infusion therapy accreditation program and
that it agrees not to implement the proposed changes without prior
written notice of continued program approval from CMS, except as
provided for at Sec. 488.1040(b)(2).
[[Page 7060]]
++ Response to a written notice from CMS. A statement acknowledging
that, in response to a written notice from CMS to the home infusion
therapy accrediting organization of a change in the applicable home
infusion therapy accreditation requirements or survey process, the
organization will provide CMS with proposed corresponding changes in
the accrediting organization's home infusion therapy accreditation
requirements for its CMS-approved home infusion therapy accreditation
program to ensure that its accreditation standards continue to meet or
exceed those of Medicare, or survey process remains comparable with
that of Medicare. The home infusion therapy accrediting organization
must comply with the following requirements:
--The proposed changes must be submitted within 30 calendar days of
the date of the written CMS notice to the home infusion therapy
accrediting organization or by a date specified in the notice,
whichever is later. CMS gives due consideration to a home infusion
therapy accrediting organization's request for an extension of the
deadline as long as it is submitted prior to the due date.
--The proposed changes are not to be implemented without prior
written notice of continued program approval from CMS, except as
provided for at Sec. 488.1040(b)(2)(ii).
The organization's proposed fees for accreditation,
including any plans for reducing the burden and cost of accreditation
to small and rural suppliers (Sec. 488.1010(a)(2)).
Acknowledgement agreeing to release of accreditation
surveys. The home infusion accreditation organization must include a
statement within its accreditation application and accreditation
agreement with each home infusion therapy supplier, agreeing to release
its most current accreditation survey and any information related to
the survey that CMS may require, including the home infusion therapy
supplier's corrective action plans (Sec. 488.1025).
Acknowledgement of Onsite Observation of
Accrediting Organizations. The home infusion accreditation organization
must include a statement its accreditation application to permit CMS to
conduct an onsite inspection of the home infusion therapy accreditation
organizations operations and offices at any time to verify the
organization's representation and to assess the organizations
compliance with its own policies and procedures (Sec. 488.1040).
Acknowledgement of Reconsideration Process. The
home infusion therapy accreditation organization must include a
statement acknowledging understanding of the reconsideration process.
The home infusion therapy accreditation organization may request
reconsideration of an unfavorable decision made by CMS, as stated at
(Sec. 488.1050).
C. Requests for Additional Information by CMS (Sec. 488.1010(b))
If CMS determines that additional information is necessary to make
a determination for approval or denial of the home infusion therapy
accrediting organization's initial application (or reapplication) for
CMS-approval of an accreditation program, CMS may require that the home
infusion therapy accrediting organization submit any additional
documentation and attestations necessary as a condition of approval of
accreditation. If such additional information is required, CMS will
notify the home infusion therapy accrediting organization and afford it
an opportunity to provide the additional information.
D. Withdrawal of an Application (Sec. 488.1010(c))
A home infusion therapy accrediting organization may withdraw its
initial application seeking CMS' approval of its home infusion therapy
accreditation program at any time before CMS publishes the final notice
as provided in Sec. 488.1020(b).
E. Evaluation of Applications
An application review team will evaluate all applications submitted
by accrediting organizations seeking designation as CMS-approved home
infusion therapy accrediting organizations under section 1834(u)(5)(B)
of the Act using the processes for consideration set forth in part 488,
subpart L.
F. Notice of Approval or Disapproval of Application (Sec. 488.1010(d))
We are required to send a notice of its decision to approve or
disapprove the home infusion therapy accrediting organization's
application within 210 calendar days from the date CMS determines the
home infusion therapy accrediting organization's application is
complete. The final notice will specify the following:
The basis for the decision.
The effective date.
The term of the approval (not exceed 6 years).
G. Public Notice and Comment (Sec. 488.1020)
We are required to publish a notice in the Federal Register when
the following conditions are met:
Proposed notice. CMS publishes a notice after
the receipt of a completed application from a national home infusion
therapy accrediting organization seeking CMS's approval of a home
infusion therapy accreditation program. The notice identifies the home
infusion therapy accrediting organization, the type of suppliers
covered by the home infusion therapy accreditation program, and
provides at least a 30-day public comment period (beginning on the date
of publication) (Sec. 488.1020(a)).
Final notice. The final notice announces CMS
decision to approve or deny a national accrediting organization
application. The notice specifies the basis for the CMS decision (Sec.
488.1020(b)).
++ Approval or re-approval. If CMS approves or re-approves the home
infusion therapy accrediting organization's home infusion therapy
accreditation program, the final notice at a minimum includes the
following information:
++ A description of how the home infusion therapy accreditation
program meets or exceeds Medicare home infusion therapy accreditation
program requirements.
++ The effective date of approval (no later than the publication
date of the notice).
++ The term of the approval (6 years or less).
Denial. If CMS does not approve the home infusion therapy
accrediting organization's accreditation program, the final notice
describes the following:
++ How the home infusion therapy accrediting organization fails to
meet Medicare home infusion therapy accreditation program requirements.
++ The effective date of the decision.
III. 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.).
[[Page 7061]]
Dated: February 19, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-03621 Filed 2-27-19; 11:15 am]
BILLING CODE 4120-01-P