Agency Information Collection Activities: Proposed Collection; Comment Request

CourtCenters For Medicare & Medicaid Services
Citation86 FR 67473
Record Number2021-25816
Publication Date26 November 2021
67473
Federal Register / Vol. 86, No. 225 / Friday, November 26, 2021 / Notices
FOR FURTHER INFORMATION CONTACT
:
Maria Elena Jefferds, National Center for
Chronic Disease Prevention and Health
Promotion, Centers for Disease Control
and Prevention, 4770 Buford Highway,
MS S107–5, Atlanta, GA 30341,
Telephone: 770.488.5862, email: mnj5@
cdc.gov.
SUPPLEMENTARY INFORMATION
: The
single-source award will focus on
assessments of micronutrient status and
the design and implementation of
systems to monitor and evaluate
micronutrient interventions, such as
vitamin and mineral supplementation
and fortification programs, and other
nutrition interventions, such as infant
and young child feeding, dietary
counseling, and growth monitoring, in
select countries. Specifically, the award
will focus on the development of
recommendations that inform country-
specific nutrition strategies. The award
will build in-country capacity to
implement standardized national
nutrition programs and micronutrient
interventions to reduce the worldwide
burden of micronutrient deficiencies.
Key strategies include collaborating
with ministries of health (MOH) and
other key partners in developing
countries. This work will advance the
knowledge base about micronutrient
deficiencies, and has the potential to
benefit other countries, including the
U.S.
UNICEF has a unique position among
the world’s health agencies as the
technical agency for maternal and child
health within the United Nations, with
access to all national health promotion
and disease prevention programs and
potential surveillance sites through its
regional offices located in seven (7)
regions (Central and Eastern Europe and
the Commonwealth of Independent
States, East Asia and the Pacific, Eastern
and Southern Africa, Latin America and
the Caribbean, Middle East and
Northern Africa, South Asia, West and
Central Africa) and in 190 country
offices.
Summary of the Award
Recipient: United Nations Children’s
Fund (UNICEF).
Purpose of the Award: The purpose of
this award is to develop
recommendations that inform country-
specific nutrition strategies and build
in-country capacity to implement
standardized national nutrition
programs and micronutrient
interventions to reduce the worldwide
burden of micronutrient deficiencies.
Amount of Award: $750,000 in
Federal Fiscal Year (FFY) 2022 funds,
and a total of $3,750,000 for a five-year
period of performance, subject to
availability of funds.
Authority: Public Health Service Act,
Title 42, Sections 307 and 301 U.S.C.
241l and 241(a).
Period of Performance: January 1,
2022 through December 31, 2026.
Dated: November 19, 2021.
Terrance Perry,
Chief Grants Management Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2021–25764 Filed 11–24–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10599, CMS–
10433, CMS–10330 and CMS–10780]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
AGENCY
: Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION
: Notice.
SUMMARY
: The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES
: Comments must be received by
January 25, 2022.
ADDRESSES
: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRA-
Listing.html.
FOR FURTHER INFORMATION CONTACT
:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION
:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES
).
CMS–10599 Review Choice
Demonstration for Home Health
Services
CMS–10433 Continuation of Data
Collection to Support QHP
Certification and other Financial
Management and Exchange
Operations
CMS–10330 Notice of Rescission of
Coverage and Disclosure
Requirements for Patient Protection
under the Affordable Care Act
CMS–10780 Requirements Related to
Surprise Billing: Qualifying
Payment Amount, Notice and
Consent, and Disclosure on Patient
Protections Against Balance Billing,
and State Law Opt-in
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
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
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67474
Federal Register / Vol. 86, No. 225 / Friday, November 26, 2021 / Notices
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
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Review Choice
Demonstration for Home Health
Services; Use: Section 402(a)(1)(J) of the
Social Security Amendments of 1967
(42 U.S.C. 1395b–1(a)(1)(J)) authorizes
the Secretary to ‘‘develop or
demonstrate improved methods for the
investigation and prosecution of fraud
in the provision of care or services
under the health programs established
by the Social Security Act (the Act).’’
Pursuant to this authority, the CMS
seeks to develop and implement a
Medicare demonstration project, which
CMS believes will help assist in
developing improved procedures for the
identification, investigation, and
prosecution of Medicare fraud occurring
among Home Health Agencies (HHA)
providing services to Medicare
beneficiaries.
This revised demonstration helps
assist in developing improved
procedures for the identification,
investigation, and prosecution of
potential Medicare fraud. The
demonstration helps make sure that
payments for home health services are
appropriate through either pre-claim or
postpayment review, thereby working
towards the prevention and
identification of potential fraud, waste,
and abuse; the protection of Medicare
Trust Funds from improper payments;
and the reduction of Medicare appeals.
CMS has implemented the
demonstration in Illinois, Ohio, North
Carolina, Florida, and Texas with the
option to expand to other states in the
Palmetto/JM jurisdiction. Under this
demonstration, CMS offers choices for
providers to demonstrate their
compliance with CMS’ home health
policies. Providers in the demonstration
states may participate in either 100
percent pre-claim review or 100 percent
postpayment review. These providers
will continue to be subject to a review
method until the HHA reaches the target
affirmation or claim approval rate. Once
a HHA reaches the target pre-claim
review affirmation or post-payment
review claim approval rate, it may
choose to be relieved from claim
reviews, except for a spot check of their
claims to ensure continued compliance.
Providers who do not wish to
participate in either 100 percent pre-
claim or postpayment reviews have the
option to furnish home health services
and submit the associated claim for
payment without undergoing such
reviews; however, they will receive a 25
percent payment reduction on all claims
submitted for home health services and
may be eligible for review by the
Recovery Audit Contractors.
The information required under this
collection is required by Medicare
contractors to determine proper
payment or if there is a suspicion of
fraud. Under the pre-claim review
option, the HHA sends the pre-claim
review request along with all required
documentation to the Medicare
contractor for review prior to submitting
the final claim for payment. If a claim
is submitted without a pre-claim review
decision one file, the Medicare
contractor will request the information
from the HHA to determine if payment
is appropriate. For the postpayment
review option, the Medicare contractor
will also request the information from
the HHA provider who submitted the
claim for payment from the Medicare
program to determine if payment was
appropriate. Form Number: CMS–10599
(OMB control number: 0938–1311);
Frequency: Frequently, until the HHA
reaches the target affirmation or claim
approval threshold and then
occasionally; Affected Public: Private
Sector (Business or other for-profits and
Not-for-profits); Number of
Respondents: 3,631; Number of
Responses: 1,467,243; Total Annual
Hours: 744,5143. (For questions
regarding this collection contact Jennifer
McMullen (410)786–7635.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Continuation of
Data Collection to Support QHP
Certification and other Financial
Management and Exchange Operations;
Use: As directed by the rule
Establishment of Exchanges and
Qualified Health Plans; Exchange
Standards for Employers (77 FR 18310)
(Exchange rule), each Exchange is
responsible for the certification and
offering of Qualified Health Plans
(QHPs). To offer insurance through an
Exchange, a health insurance issuer
must have its health plans certified as
QHPs by the Exchange. A QHP must
meet certain necessary minimum
certification standards, such as network
adequacy, inclusion of Essential
Community Providers (ECPs), and non-
discrimination. The Exchange is
responsible for ensuring that QHPs meet
these minimum certification standards
as described in the Exchange rule under
45 CFR 155 and 156, based on the
Patient Protection and Affordable Care
Act (PPACA), as well as other standards
determined by the Exchange. Issuers can
offer individual and small group market
plans outside of the Exchanges that are
not QHPs. Form Number: CMS–10433
(OMB control number: 0938–1187);
Frequency: Annually; Affected Public:
Private sector, State, Local, or Tribal
Governments, Business or other for-
profits; Number of Respondents: 2,925;
Number of Responses: 2,925; Total
Annual Hours: 71,660. (For questions
regarding this collection, contact Nicole
Levesque at (617) 565–3138).
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Notice of
Rescission of Coverage and Disclosure
Requirements for Patient Protection
under the Affordable Care Act; Use:
Sections 2712 and 2719A of the Public
Health Service Act (PHS Act), as added
by the Affordable Care Act, contain
rescission notice, and patient protection
disclosure requirements that are subject
to the Paperwork Reduction Act of 1995.
The No Surprises Act, enacted as part of
the Consolidated Appropriations Act,
2021, amended section 2719A of the
PHS Act to sunset when the new
emergency services protections under
the No Surprises Act take effect. The
provisions of section 2719A of the PHS
Act will no longer apply with respect to
plan years beginning on or after January
1, 2022. The No Surprises Act re-
codified the patient protections related
to choice of health care professional
under section 2719A of the PHS Act in
newly added section 9822 of the
Internal Revenue Code, section 722 of
the Employee Retirement Income
Security Act, and section 2799A–7 of
the PHS Act and extended the
applicability of these provisions to
grandfathered health plans for plan
years beginning on or after January 1,
2022. The rescission notice will be used
by health plans to provide advance
notice to certain individuals that their
coverage may be rescinded as a result of
fraud or intentional misrepresentation
of material fact. The patient protection
notification will be used by health plans
to inform certain individuals of their
right to choose a primary care provider
or pediatrician and to use obstetrical/
gynecological services without prior
authorization. The related provisions
are finalized in the 2015 final
regulations titled ‘‘Final Rules under the
Affordable Care Act for Grandfathered
Plans, Preexisting Condition Exclusions,
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67475
Federal Register / Vol. 86, No. 225 / Friday, November 26, 2021 / Notices
Lifetime and Annual Limits,
Rescissions, Dependent Coverage,
Appeals, and Patient Protections’’ (80
FR 72192, November 18, 2015) and 2021
interim final regulations titled
‘‘Requirements Related to Surprise
Billing; Part I’’ (86 FR 36872, July 13,
2021). The 2015 final regulations also
require that, if State law prohibits
balance billing, or a plan or issuer is
contractually responsible for any
amounts balanced billed by an out-of-
network emergency services provider, a
plan or issuer must provide a
participant, beneficiary or enrollee
adequate and prominent notice of their
lack of financial responsibility with
respect to amounts balanced billed in
order to prevent inadvertent payment by
the individual. Plans and issuers will
not be required to provide this notice for
plan years beginning on or after January
1, 2022. Form Number: CMS–10330
(OMB control number: 0938–1094);
Frequency: On Occasion; Affected
Public: State, Local, or Tribal
Governments, Private Sector; Number of
Respondents: 2,277; Total Annual
Responses: 15,752; Total Annual Hours:
814. (For policy questions regarding this
collection, contact Usree
Bandyopadhyay at (410) 786–6650.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Requirements
Related to Surprise Billing: Qualifying
Payment Amount, Notice and Consent,
Disclosure on Patient Protections
Against Balance Billing, and State Law
Opt-in; Use: On December 27, 2020, the
Consolidated Appropriations Act, 2021
(Pub. L. 116–260), which included the
No Surprises Act, was signed into law.
The No Surprises Act provides federal
protections against surprise billing and
limits out-of-network cost sharing under
many of the circumstances in which
surprise medical bills arise most
frequently. The 2021 interim final
regulations ‘‘Requirements Related to
Surprise Billing; Part I’’ (86 FR 36872,
2021 interim final regulations) issued by
the Departments of Health and Human
Services, the Department of Labor, the
Department of Treasury, and the Office
of Personnel Management, implement
provisions of the No Surprises Act that
apply to group health plans, health
insurance issuers offering group or
individual health insurance coverage,
and carriers in the Federal Employees
Health Benefits (FEHB) Program that
provide protections against balance
billing and out-of-network cost sharing
with respect to emergency services, non-
emergency services furnished by
nonparticipating providers at certain
participating health care facilities, and
air ambulance services furnished by
nonparticipating providers of air
ambulance services. The 2021 interim
final regulations prohibit
nonparticipating providers, emergency
facilities, and providers of air
ambulance services from balance billing
participants, beneficiaries, and enrollees
in certain situations unless they satisfy
certain notice and consent
requirements. The No Surprises Act and
the 2021 interim final regulations
require group health plans and issuers
of health insurance coverage to provide
information about qualifying payment
amounts to nonparticipating providers
and facilities and to provide disclosures
on patient protections against balance
billing to participants, beneficiaries and
enrollees. Self-insured plans opting in
to a specified state law are required to
provide a disclosure to participants.
Certain nonparticipating providers and
nonparticipating emergency facilities
may provide participants, beneficiaries,
and enrollees with notice and obtain
their consent to waive balance billing
protections, provided certain
requirements are met. In addition,
certain providers and facilities are
required to provide disclosures on
patient protections against balance
billing to participants, beneficiaries and
enrollees. Form Number: CMS–10780
(OMB control number: 0938–1401);
Frequency: On Occasion; Affected
Public: Individuals, State, Local, or
Tribal Governments, Private Sector;
Number of Respondents: 2,494,683;
Total Annual Responses: 58,696,352;
Total Annual Hours: 4,933,110. (For
policy questions regarding this
collection, contact Usree
Bandyopadhyay at 410–786–6650.)
Dated: November 22, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–25816 Filed 11–24–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Privacy Act of 1974; System of
Records
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION
: Notice of a new system of
records.
SUMMARY
: In accordance with the
requirements of the Privacy Act of 1974,
as amended, the HHS is establishing a
new system of records to be maintained
by HHS’s HRSA, 09–15–0093, ‘‘Provider
Support Records.’’ The new system of
records will include payment-related
records containing information about
any sole proprietor health care
providers (including health care-
practitioners and suppliers) who
applied for payments or
reimbursements, received a payment,
attested to a payment, reported on the
use of a payment, or otherwise
participated in one of HRSA’s provider
support programs, and about patients
identified in certain claims records
submitted to HRSA for payment by
entity providers and sole proprietor
providers. The records are used to
support the health care population and
administer the programs.
DATES
: The new system of records is
applicable November 26, 2021, subject
to a 30-day period in which to comment
on the routine uses. Submit any
comments by December 27, 2021.
ADDRESSES
: The public should address
written comments by email to
OPSInformation.hrsa@hrsa.gov or by
mail to Executive Officer, Provider
Support, HRSA, 5600 Fishers Lane,
Room 9N21, Rockville, MD, 20857.
FOR FURTHER INFORMATION CONTACT
:
General questions about the new system
of records may be submitted to
Executive Officer, Provider Support,
HRSA, 5600 Fishers Lane, Room 9N21,
Rockville, MD, 20857, or to
OPSInformation.hrsa@hrsa.gov.
SUPPLEMENTARY INFORMATION
: New
system of records 09–15–0093 will
cover records HRSA uses to reimburse
claims and make payments to healthcare
providers and to receive reports on the
use of funds for activities under the
following programs:
COVID–19 Claims Reimbursement
to Health Care Providers and Facilities
for Testing, Treatment and Vaccine
Administration for the Uninsured
(Uninsured Program).
COVID–19 Coverage Assistance
Fund (CAF).
Provider Relief Fund (PRF),
including American Rescue Plan Act
(ARPA) Rural Payments.
The records used by HRSA in these
programs include patient and provider
information needed to administer the
programs. HHS provided advance notice
of the new system of records to the
Office of Management and Budget and
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