Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2020, 23030-23046 [2020-08719]
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23030
Federal Register / Vol. 85, No. 80 / Friday, April 24, 2020 / Notices
Information must be received by
June 30, 2020.
ADDRESSES: Written comments should
be submitted by email to: Opioids_
OlderAdults@abtassoc.com.
FOR FURTHER INFORMATION CONTACT:
Parivash Nourjah, Parivash.nourjah@
ahrq.gov, or 301–427–1106.
SUPPLEMENTARY INFORMATION:
The United States is in the midst of
an unprecedented opioid epidemic that
is affecting people from all walks of life.
Regulators and policy makers have
initiated many activities to curb the
epidemic, but relatively little attention
has been paid to the growing toll of
opioid use, opioid misuse and opioid
use disorder (OUD) among older adults.
The opioid crisis in older adults is
strongly related to challenges in
prescription opioid management in this
population. Older adults have a high
prevalence of chronic pain and are
especially vulnerable to suffering
adverse events from opioid use, making
safe prescribing more challenging even
when opioids are an appropriate
therapeutic choice. Identifying adverse
effects due to opioid use, misuse or
abuse is complicated further by factors
such as co-occurring medical disorders
that can mimic the effects of opioid use.
There is also a risk of attributing clinical
findings in older adults (e.g. personality
changes, falls/balance problems,
difficulty sleeping, and heart problems)
to other conditions that are also
common with age. If adverse events due
to opioid prescriptions are identified,
finding appropriate alternatives for pain
management can be challenging if other
pharmacologic options (such as
NSAIDS) are contraindicated or
mobility issues limit access to other
therapeutic options.
Diagnosis of substance use disorders
is also more complicated in this
population. Clinicians may not associate
drug misuse or addiction with older
adults or they may be inadequately
trained in identification and treatment
of opioid misuse and OUD among older
adults, and hence may not monitor for
the signs of opioid use disorder in this
population.
Successfully optimizing the
prescribing and use of opioids in older
adults will require addressing the issue
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DATES:
at many points along the care
continuum where older adults may need
additional attention or a different
approach. AHRQ wants to identify
specific tools, strategies and approaches
to opioid management in older adults
throughout the breadth of the care
delivery continuum, from avoiding
opioid initiation to screening for opioid
misuse and opioid use disorder, as well
as approaches to opioid tapering in
older adults.
AHRQ is interested in all innovative
approaches that address the opioid
management concerns in older adults
listed above, but respondents are
welcome to address as many or as few
as they choose and to address additional
areas of interest not listed.
Strategies and approaches could come
from a variety of health care settings
including, but not limited to, primary
care and other ambulatory care clinics,
emergency departments, home health
care organizations, skilled nursing care
settings, and inpatient care. Other
sources of these strategies might include
health care payers, accountable care
organizations, and organizations that
provide external quality improvement
support. Some of the examples of the
types of innovations we are looking for
might be specific tools or workflows
that support providers to assess the risk/
benefit balance of opioids within a
multidisciplinary approach in pain
management; to optimize and monitor
the opioid prescribing when
appropriate, including tapering
strategies; to screen and treat for opioid
misuse or opioid use disorder; or to
involve family or other caregivers of an
older adult in conversations about
opioid safety. Descriptions of strategies
or approaches should include the
setting where it is deployed and the
type of patient population served.
This RFI is for planning purposes
only and should not be construed as a
policy, solicitation for applications, or
as an obligation on the part of the
Government to provide support for any
ideas in response to it. AHRQ will use
the information submitted in response
to this RFI at its discretion, and will not
provide comments to any respondent’s
submission. However, responses to the
RFI may be reflected in future
solicitation(s) or policies. Respondents
are advised that the Government is
under no obligation to acknowledge
receipt of the information received or
provide feedback to respondents with
respect to any information submitted.
No proprietary, classified, confidential
or sensitive information should be
included in your response. The
Government reserves the right to use
any non-proprietary technical
information in any resultant
solicitation(s). The contents of all
submissions will be made available to
the public upon request. Submitted
materials must be publicly available or
able to be made public.
Dated: April 21, 2020.
Virginia L. Mackay-Smith,
Associate Director, Office of the Director,
AHRQ.
[FR Doc. 2020–08727 Filed 4–23–20; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–9124–N]
Medicare and Medicaid Programs;
Quarterly Listing of Program
Issuances—January Through March
2020
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice lists
CMS manual instructions, substantive
and interpretive regulations, and other
Federal Register notices that were
published from January through March
2020, relating to the Medicare and
Medicaid programs and other programs
administered by CMS.
FOR FURTHER INFORMATION CONTACT: It is
possible that an interested party may
need specific information and not be
able to determine from the listed
information whether the issuance or
regulation would fulfill that need.
Consequently, we are providing contact
persons to answer general questions
concerning each of the addenda
published in this notice.
SUMMARY:
Addenda
Contact
I. CMS Manual Instructions ..............................................................................................................
II. Regulation Documents Published in the Federal Register ........................................................
III. CMS Rulings ................................................................................................................................
IV. Medicare National Coverage Determinations .............................................................................
V. FDA-Approved Category B IDEs .................................................................................................
VI. Collections of Information ...........................................................................................................
VII. Medicare-Approved Carotid Stent Facilities ..............................................................................
Ismael Torres .....................
Terri Plumb .........................
Tiffany Lafferty ...................
Wanda Belle, MPA .............
John Manlove .....................
William Parham ..................
Sarah Fulton, MHS ............
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Phone No.
(410)
(410)
(410)
(410)
(410)
(410)
(410)
786–1864
786–4481
786–7548
786–7491
786–6877
786–4669
786–2749
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Addenda
Contact
VIII. American College of Cardiology-National Cardiovascular Data Registry Sites .......................
IX. Medicare’s Active Coverage-Related Guidance Documents ......................................................
X. One-time Notices Regarding National Coverage Provisions .......................................................
XI. National Oncologic Positron Emission Tomography Registry Sites ...........................................
XII. Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities .......................
XIII. Medicare-Approved Lung Volume Reduction Surgery Facilities ..............................................
XIV. Medicare-Approved Bariatric Surgery Facilities .......................................................................
XV. Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ...............................
All Other Information .........................................................................................................................
Sarah Fulton, MHS ............
JoAnna Baldwin, MS ..........
JoAnna Baldwin, MS ..........
David Dolan, MBA ..............
David Dolan, MBA ..............
Sarah Fulton, MHS ............
Sarah Fulton, MHS ............
David Dolan, MBA ..............
Annette Brewer ..................
SUPPLEMENTARY INFORMATION:
I. Background
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The Centers for Medicare & Medicaid
Services (CMS) is responsible for
administering the Medicare and
Medicaid programs and coordination
and oversight of private health
insurance. Administration and oversight
of these programs involves the
following: (1) Furnishing information to
Medicare and Medicaid beneficiaries,
health care providers, and the public;
and (2) maintaining effective
communications with CMS regional
offices, state governments, state
Medicaid agencies, state survey
agencies, various providers of health
care, all Medicare contractors that
process claims and pay bills, National
Association of Insurance Commissioners
(NAIC), health insurers, and other
stakeholders. To implement the various
statutes on which the programs are
based, we issue regulations under the
authority granted to the Secretary of the
Department of Health and Human
Services under sections 1102, 1871,
1902, and related provisions of the
Social Security Act (the Act) and Public
Health Service Act. We also issue
various manuals, memoranda, and
statements necessary to administer and
oversee the programs efficiently.
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Section 1871(c) of the Act requires
that we publish a list of all Medicare
manual instructions, interpretive rules,
statements of policy, and guidelines of
general applicability not issued as
regulations at least every 3 months in
the Federal Register.
II. Format for the Quarterly Issuance
Notices
This quarterly notice provides only
the specific updates that have occurred
in the 3-month period along with a
hyperlink to the full listing that is
available on the CMS website or the
appropriate data registries that are used
as our resources. This is the most
current up-to-date information and will
be available earlier than we publish our
quarterly notice. We believe the website
list provides more timely access for
beneficiaries, providers, and suppliers.
We also believe the website offers a
more convenient tool for the public to
find the full list of qualified providers
for these specific services and offers
more flexibility and ‘‘real time’’
accessibility. In addition, many of the
websites have listservs; that is, the
public can subscribe and receive
immediate notification of any updates to
the website. These listservs avoid the
need to check the website, as
notification of updates is automatic and
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Phone No.
(410)
(410)
(410)
(410)
(410)
(410)
(410)
(410)
(410)
786–2749
786–7205
786–7205
786–3365
786–3365
786–2749
786–2749
786–3365
786–6580
sent to the subscriber as they occur. If
assessing a website proves to be
difficult, the contact person listed can
provide information.
III. How To Use the Notice
This notice is organized into 15
addenda so that a reader may access the
subjects published during the quarter
covered by the notice to determine
whether any are of particular interest.
We expect this notice to be used in
concert with previously published
notices. Those unfamiliar with a
description of our Medicare manuals
should view the manuals at https://
www.cms.gov/manuals.
The Director of the Office of Strategic
Operations and Regulatory Affairs of the
Centers for Medicare & Medicaid
Services (CMS), Kathleen Cantwell,
having reviewed and approved this
document, authorizes Evell J. Barco
Holland, who is the Federal Register
Liaison, to electronically sign this
document for purposes of publication in
the Federal Register.
Dated: April 15, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of
Health and Human Services.
BILLING CODE 4120–01–P
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[FR Doc. 2020–08719 Filed 4–23–20; 8:45 am]
BILLING CODE 4120–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3390–FN]
Medicare Program; Approval of
Application by the Accreditation
Commission for Healthcare for Initial
CMS-Approval of Its Home Infusion
Therapy Accreditation Program
Centers for Medicare and
Medicaid Services, HHS.
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve the
Accreditation Commission for
Healthcare for initial recognition as a
national accrediting organization for
home infusion therapy suppliers that
wish to participate in the Medicare
program. A home infusion therapy
supplier that participates must meet the
Medicare conditions for coverage (CfCs).
DATES: The approval announced in this
final notice is effective April 23, 2020
through April 23, 2024.
FOR FURTHER INFORMATION CONTACT:
Christina Mister-Ward, (410) 786–2441.
Lillian Williams, (410) 786–8636.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
Home Infusion therapy (HIT) is a
treatment option for Medicare
beneficiaries with a wide range of acute
and chronic conditions. Section 5012 of
the 21st Century Cures Act (Pub. L. 114–
255, enacted December 13, 2016) added
section 1861(iii) to the Social Security
Act (the Act), establishing a new
Medicare benefit for HIT services.
Section 1861(iii)(1) of the Act defines
HIT as professional services, including
nursing services; training and education
not otherwise covered under the
Durable Medical Equipment (DME)
benefit; remote monitoring; and other
monitoring services. Home infusion
therapy must be furnished by a qualified
HIT supplier and furnished in the
individual’s home. The individual must:
• Be under the care of an applicable
provider (that is, physician, nurse
practitioner, or physician assistant); and
• Have a plan of care established and
periodically reviewed by a physician in
coordination with the furnishing of
home infusion drugs under Part B, that
prescribes the type, amount, and
duration of infusion therapy services
that are to be furnished.
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Section 1861(iii)(3)(D)(i)(III) of the Act
requires that a qualified HIT supplier be
accredited by an accrediting
organization (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 in
reviewing 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 HIT suppliers furnishing HIT
not later than January 1, 2021. Section
1861(iii)(3)(D) of the Act defines
‘‘qualified home infusion therapy
suppliers’’ as being accredited by a
CMS-approved AO.
In the March 1, 2019 Federal Register,
we published a solicitation notice
entitled, ‘‘Medicare Program;
Solicitation of Independent Accrediting
Organizations To Participate in the
Home Infusion Therapy Supplier
Accreditation Program’’ (84 FR 7057).
This notice informed national AOs that
accredit HIT suppliers of an opportunity
to submit applications to participate in
the HIT supplier accreditation program.
Complete applications will be
considered for the January 1, 2021
designation deadline if received by
February 1, 2020.
Regulations for the approval and
oversight of AOs for HIT organizations
are located at 42 CFR part 488, subpart
L. The requirements for HIT suppliers
are located at 42 CFR part 486, subpart
I.
II. Approval of Accreditation
Organizations
Section 1834(u)(5) of the Act and the
regulations at § 488.1010 require that
our findings concerning review and
approval of a national AO’s
requirements consider, among other
factors, the applying AO’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
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ability to provide CMS with the
necessary data.
Section 488.1020(a) requires that we
publish, after receipt of an
organization’s complete application, a
notice identifying the national
accrediting body making the request,
describing the nature of the request, and
providing at least a 30-day public
comment period. In accordance with
§ 488.1010(d), we have 210 days from
the receipt of a complete application to
approve or deny the application.
III. Provisions of the Proposed Notice
In the November 25, 2019 Federal
Register (84 FR 64904), we published a
proposed notice announcing
Accreditation Commission for Health
Care’s (ACHC’s) request for initial
approval of its Medicare HIT
accreditation program. In the November
25, 2019 proposed notice, we detailed
our evaluation criteria. Under section
1834(u)(5) the Act and in our
regulations at § 488.1010, we conducted
a review of ACHC Medicare home
infusion accreditation application in
accordance with the criteria specified by
our regulations, which included, but are
not limited to the following:
• An onsite administrative review of
ACHC’s: (1) Corporate policies; (2)
financial and human resources available
to accomplish the proposed surveys; (3)
procedures for training, monitoring, and
evaluation of its home infusion therapy
surveyors; (4) ability to investigate and
respond appropriately to complaints
against accredited home infusion
therapies; and (5) survey review and
decision-making process for
accreditation.
• The ability for an ACHC to conduct
timely review of accreditation
applications.
• The ability of an ACHC to take into
account the capacities of suppliers
located in a rural area.
• The comparison of an ACHC’s
Medicare home infusion therapy
accreditation program standards to our
current Medicare home infusion therapy
conditions for coverage (CfCs).
• ACHC’s survey process to
determine the following:
++ The composition of the survey
team, surveyor qualifications, and
ACHC’s ability to provide continuing
surveyor training.
++ ACHC’s processes, including
periodic resurvey and the ability to
investigate and respond appropriately to
complaints against accredited home
infusion therapies.
++ Evaluate ACHC’s procedures for
monitoring home infusion therapies it
has found to be out of compliance with
ACHC’s program requirements.
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Agencies
[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23030-23046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08719]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9124-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--January Through March 2020
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This quarterly notice lists CMS manual instructions,
substantive and interpretive regulations, and other Federal Register
notices that were published from January through March 2020, relating
to the Medicare and Medicaid programs and other programs administered
by CMS.
FOR FURTHER INFORMATION CONTACT: It is possible that an interested
party may need specific information and not be able to determine from
the listed information whether the issuance or regulation would fulfill
that need. Consequently, we are providing contact persons to answer
general questions concerning each of the addenda published in this
notice.
----------------------------------------------------------------------------------------------------------------
Addenda Contact Phone No.
----------------------------------------------------------------------------------------------------------------
I. CMS Manual Instructions.................. Ismael Torres.................................... (410) 786-1864
II. Regulation Documents Published in the Terri Plumb...................................... (410) 786-4481
Federal Register.
III. CMS Rulings............................ Tiffany Lafferty................................. (410) 786-7548
IV. Medicare National Coverage Wanda Belle, MPA................................. (410) 786-7491
Determinations.
V. FDA-Approved Category B IDEs............. John Manlove..................................... (410) 786-6877
VI. Collections of Information.............. William Parham................................... (410) 786-4669
VII. Medicare-Approved Carotid Stent Sarah Fulton, MHS................................ (410) 786-2749
Facilities.
[[Page 23031]]
VIII. American College of Cardiology- Sarah Fulton, MHS................................ (410) 786-2749
National Cardiovascular Data Registry Sites.
IX. Medicare's Active Coverage-Related JoAnna Baldwin, MS............................... (410) 786-7205
Guidance Documents.
X. One-time Notices Regarding National JoAnna Baldwin, MS............................... (410) 786-7205
Coverage Provisions.
XI. National Oncologic Positron Emission David Dolan, MBA................................. (410) 786-3365
Tomography Registry Sites.
XII. Medicare-Approved Ventricular Assist David Dolan, MBA................................. (410) 786-3365
Device (Destination Therapy) Facilities.
XIII. Medicare-Approved Lung Volume Sarah Fulton, MHS................................ (410) 786-2749
Reduction Surgery Facilities.
XIV. Medicare-Approved Bariatric Surgery Sarah Fulton, MHS................................ (410) 786-2749
Facilities.
XV. Fluorodeoxyglucose Positron Emission David Dolan, MBA................................. (410) 786-3365
Tomography for Dementia Trials.
All Other Information....................... Annette Brewer................................... (410) 786-6580
----------------------------------------------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION:
I. Background
The Centers for Medicare & Medicaid Services (CMS) is responsible
for administering the Medicare and Medicaid programs and coordination
and oversight of private health insurance. Administration and oversight
of these programs involves the following: (1) Furnishing information to
Medicare and Medicaid beneficiaries, health care providers, and the
public; and (2) maintaining effective communications with CMS regional
offices, state governments, state Medicaid agencies, state survey
agencies, various providers of health care, all Medicare contractors
that process claims and pay bills, National Association of Insurance
Commissioners (NAIC), health insurers, and other stakeholders. To
implement the various statutes on which the programs are based, we
issue regulations under the authority granted to the Secretary of the
Department of Health and Human Services under sections 1102, 1871,
1902, and related provisions of the Social Security Act (the Act) and
Public Health Service Act. We also issue various manuals, memoranda,
and statements necessary to administer and oversee the programs
efficiently.
Section 1871(c) of the Act requires that we publish a list of all
Medicare manual instructions, interpretive rules, statements of policy,
and guidelines of general applicability not issued as regulations at
least every 3 months in the Federal Register.
II. Format for the Quarterly Issuance Notices
This quarterly notice provides only the specific updates that have
occurred in the 3-month period along with a hyperlink to the full
listing that is available on the CMS website or the appropriate data
registries that are used as our resources. This is the most current up-
to-date information and will be available earlier than we publish our
quarterly notice. We believe the website list provides more timely
access for beneficiaries, providers, and suppliers. We also believe the
website offers a more convenient tool for the public to find the full
list of qualified providers for these specific services and offers more
flexibility and ``real time'' accessibility. In addition, many of the
websites have listservs; that is, the public can subscribe and receive
immediate notification of any updates to the website. These listservs
avoid the need to check the website, as notification of updates is
automatic and sent to the subscriber as they occur. If assessing a
website proves to be difficult, the contact person listed can provide
information.
III. How To Use the Notice
This notice is organized into 15 addenda so that a reader may
access the subjects published during the quarter covered by the notice
to determine whether any are of particular interest. We expect this
notice to be used in concert with previously published notices. Those
unfamiliar with a description of our Medicare manuals should view the
manuals at https://www.cms.gov/manuals.
The Director of the Office of Strategic Operations and Regulatory
Affairs of the Centers for Medicare & Medicaid Services (CMS), Kathleen
Cantwell, having reviewed and approved this document, authorizes Evell
J. Barco Holland, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Dated: April 15, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
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[FR Doc. 2020-08719 Filed 4-23-20; 8:45 am]
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