Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April Through June 2022, 47751-47765 [2022-16717]
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47751
Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Notices
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
jspears on DSK121TN23PROD with NOTICES
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title: Hospital
Wage Index Occupational Mix Survey;
Use: Section 304(c) of Public Law 106–
554 amended section 1886(d)(3)(E) of
the Social Security Act to require CMS
to collect data every 3 years on the
occupational mix of employees for each
short-term, acute care hospital
participating in the Medicare program,
in order to construct an occupational
mix adjustment to the wage index, for
application beginning October 1, 2004
(the FY 2005 wage index). The purpose
of the occupational mix adjustment is to
control for the effect of hospitals’
employment choices on the wage index.
For example, hospitals may choose to
employ different combinations of
registered nurses, licensed practical
nurses, nursing aides, and medical
assistants for the purpose of providing
nursing care to their patients. The
varying labor costs associated with these
choices reflect hospital management
decisions rather than geographic
differences in the costs of labor.
CMS takes the data collected from the
approximately 3,200 IPPS providers
participating in the Medicare program
and runs the data through mathematical
formulas to create the occupational mix
adjustment to the wage index. CMS
informs hospitals of the occupational
mix adjusted wage indexes through
notice and comment rulemaking each
year. Form Number: CMS–10079 (OMB
Control Number: 0938–0907);
Frequency: Annually; Affected Public:
Private Sector, Business or other forprofit and not-for-profit institutions;
Number of Respondents: 3,200; Number
of Responses: 3,200; Total Annual
Hours: 1,536,000. (For policy questions
regarding this collection contact Noel
Manlove at 410–786–5161.)
2. Type of Information Collection
Request: Reinstatement, with change, of
a previously approved collection for
which approval has expired; Title: Basic
Health Program (BHP) Supporting
Regulations; Use: In accordance with
Section 1331 of the Patient Protection
and Affordability Care Act, Public Law
111–148 (ACA), BHP is federally funded
by determining the amount of payments
that the federal government would have
made through premium tax credits and
cost-sharing reductions for people
enrolled in BHP had they instead been
enrolled in an Exchange. States must
submit a BHP Blueprint to CMS for
certification prior to the state
implementing a BHP and must submit a
revised Blueprint in the event that a
state seeks to make significant changes
that alter program operations; the BHP
benefit package; or enrollment,
disenrollment, and verification policies
described in the Blueprint. Such States
must also submit a BHP annual report.
In addition to the reinstatement, this
2022 iteration proposes changes that are
associated with the March 12, 2014 (79
FR 14112) BHP final rule that have not
previously received PRA approval;
Form Number: CMS–10510 (OMB
Control Number: 0938–1218);
Frequency: Monthly and annually;
Affected Public: State, Local or Tribal
Government; Number of Respondents: 2;
Number of Responses: 27; Total Annual
Hours: 2,568. (For policy questions
regarding this collection contact Cassie
Lagorio at 443–721–8022.)
Dated: July 29, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–16681 Filed 8–3–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–9137–N]
Medicare and Medicaid Programs;
Quarterly Listing of Program
Issuances—April Through June 2022
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 April through June
2022, 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 .....................................................
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 ......
Ismael Torres ..........................................
Terri Plumb .............................................
Tiffany Lafferty ........................................
Wanda Belle, MPA .................................
John Manlove .........................................
William Parham ......................................
Sarah Fulton, MHS .................................
Sarah Fulton, MHS .................................
(410) 786–1864
(410) 786–4481
(410)786–7548
(410) 786–7491
(410) 786–6877
(410) 786–4669
(410) 786–2749
(410) 786–2749
JoAnna Baldwin, MS ..............................
JoAnna Baldwin, MS ..............................
David Dolan, MBA ..................................
David Dolan, MBA ..................................
(410)
(410)
(410)
(410)
Sarah Fulton, MHS .................................
Sarah Fulton, MHS .................................
David Dolan, MBA ..................................
(410) 786–2749
(410) 786–2749
(410) 786–3365
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Phone No.
786–7205
786–7205
786–3365
786–3365
47752
Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Notices
Addenda
Contact
All Other Information ................................................................................................
Annette Brewer .......................................
SUPPLEMENTARY INFORMATION:
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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.
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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) 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 Trenesha FultzMimms, who is the Federal Register
Liaison, to electronically sign this
document for purposes of publication in
the Federal Register.
Dated: July 28, 2022.
Trenesha Fultz-Mimms,
Federal Register Liaison, Department of
Health and Human Services.
BILLING CODE 4120–01–P
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[FR Doc. 2022–16717 Filed 8–3–22; 8:45 am]
BILLING CODE 4120–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0297]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Production,
Storage and Transportation of Shell
Eggs (Preventing Salmonella
Enteritidis (SE))
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
6, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0660. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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SUPPLEMENTARY INFORMATION:
Production, Storage and Transportation
of Shell Eggs (Preventing Salmonella
Enteritidis (SE))
OMB Control Number 0910–0660—
Extension—21 CFR 118.10 and 118.11
This information collection supports
Agency regulations in part 118 (21 CFR
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Jkt 256001
part 118), Production, Storage, and
Transportation of Shell Eggs, and Form
FDA 3733, Shell Egg Producer
Registration Form. The Public Health
Service Act (PHS Act) (42 U.S.C. 264)
authorizes the Secretary of Health and
Human Services to make and enforce
such regulations as ‘‘are necessary to
prevent the introduction, transmission,
or spread of communicable diseases
from foreign countries into the States
. . . or from one State . . . into any
other State’’ (section 361(a) of the PHS
Act (42 U.S.C. 264(a))). This authority
has been delegated to the Commissioner
of Food and Drugs. Under section
402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
342(a)(4)), a food is adulterated if it is
prepared, packed, or held under
insanitary conditions whereby it may
have been contaminated with filth or
rendered injurious to health. Under
section 701(a) of the FD&C Act (21
U.S.C. 371(a)), FDA is authorized to
issue regulations for the efficient
enforcement of the FD&C Act.
Under part 118, shell egg producers
are required to implement measures to
prevent SE from contaminating eggs on
the farm and from further growth during
storage and transportation. Shell egg
producers also are required to maintain
records concerning their compliance
with part 118 and to register with FDA.
As described in more detail about each
information collection provision of part
118, each farm site with 3,000 or more
egg laying hens that sells raw shell eggs
to the table egg market, other than
directly to the consumer, must
refrigerate, register, and keep certain
records. Farms that do not send all their
eggs to treatment are also required to
have an SE prevention plan and to test
for SE.
Section 118.10 of FDA’s regulations
requires recordkeeping for all measures
the farm takes to prevent SE in its
flocks. Since many existing farms
participate in voluntary egg quality
assurance programs, those respondents
may not have to collect any additional
information. Records are maintained on
file at each farm site and examined there
periodically by FDA inspectors.
Section 118.10 also requires each farm
site with 3,000 or more egg laying hens
that sells raw shell eggs to the table egg
market, other than directly to the
consumer, and does not have all of the
shell eggs treated, to design and
implement an SE prevention plan.
Section 118.10 requires recordkeeping
for each of the provisions included in
the plan and for plan review and
modifications if corrective actions are
taken.
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47765
Finally, § 118.11 of FDA’s regulations
requires that each farm covered by
§ 118.1(a) register with FDA using Form
FDA 3733. The term ‘‘Form FDA 3733’’
refers to both the paper version of the
form and the electronic system known
as the Shell Egg Producer Registration
Module, which is available at https://
www.access.fda.gov. We strongly
encourage electronic registration
because it is faster and more convenient.
The system can accept electronic
registrations 24 hours a day, 7 days a
week. A registering shell egg producer
receives confirmation of electronic
registration instantaneously once all the
required fields on the registration screen
are completed. However, paper
registrations will also be accepted. Form
FDA 3733 is available for download for
registration by mail, fax, or CD–ROM.
For more information, we invite you to
visit our websites at: https://
www.fda.gov/food/registration-foodfacilities-and-other-submissions/shellegg-producer-registration and https://
www.fda.gov/Food/
GuidanceRegulation/
FoodFacilityRegistration/
ShellEggProducerRegistration/
ucm217952.htm.
Recordkeeping and registration are
necessary for the success of the SE
prevention measures. Written SE
prevention plans and records of actions
taken due to each provision are essential
for farms to implement SE prevention
plans effectively. Further, they are
essential for us to be able to determine
compliance. Information provided
under these regulations helps us to
quickly notify the facilities that might
be affected by a deliberate or accidental
contamination of the food supply. In
addition, data collected through
registration is used to support our
enforcement activities.
Description of Respondents:
Respondents to this information
collection include farm sites with 3,000
or more egg laying hens that sell raw
eggs to the table egg market, other than
directly to the consumer.
In the Federal Register of January 19,
2022 (87 FR 2797), FDA published a 60day notice requesting public comment
on the proposed collection of
information. Two comments were
received, however only one was
responsive to the four information
collection topics solicited.
The comment suggested that farms
could save money by pooling samples
while conducting environmental testing,
proffering a 2015 research article. FDA
reviewed the 2015 research article by
Kinde et al. and had additional
questions about the equivalency of
pooled versus non-pooled samples. This
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Agencies
[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Notices]
[Pages 47751-47765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16717]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9137-N]
Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--April Through June 2022
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 April through June 2022, 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 Terri Plumb........ (410) 786-4481
Published in the 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 Sarah Fulton, MHS.. (410) 786-2749
Stent Facilities.
VIII American College of Sarah Fulton, MHS.. (410) 786-2749
Cardiology--National
Cardiovascular Data Registry
Sites.
IX Medicare's Active Coverage- JoAnna Baldwin, MS. (410) 786-7205
Related Guidance Documents.
X One-time Notices Regarding JoAnna Baldwin, MS. (410) 786-7205
National Coverage Provisions.
XI National Oncologic Positron David Dolan, MBA... (410) 786-3365
Emission Tomography Registry
Sites.
XII Medicare-Approved David Dolan, MBA... (410) 786-3365
Ventricular Assist Device
(Destination Therapy)
Facilities.
XIII Medicare-Approved Lung Sarah Fulton, MHS.. (410) 786-2749
Volume Reduction Surgery
Facilities.
XIV Medicare-Approved Bariatric Sarah Fulton, MHS.. (410) 786-2749
Surgery Facilities.
XV Fluorodeoxyglucose Positron David Dolan, MBA... (410) 786-3365
Emission Tomography for
Dementia Trials.
[[Page 47752]]
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
Trenesha Fultz-Mimms, who is the Federal Register Liaison, to
electronically sign this document for purposes of publication in the
Federal Register.
Dated: July 28, 2022.
Trenesha Fultz-Mimms,
Federal Register Liaison, Department of Health and Human Services.
BILLING CODE 4120-01-P
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[FR Doc. 2022-16717 Filed 8-3-22; 8:45 am]
BILLING CODE 4120-01-C