Agency Information Collection Activities: Submission for OMB Review; Comment Request, 12456-12458 [2022-04644]
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Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices
Colorado; and Vandy Sears, Cheyenne,
Wyoming; to become members of the
Wiens Family Group, a group acting in
concert, to acquire voting shares of
FirsTier II Bancorp., Cheyenne,
Wyoming, and thereby indirectly
acquire voting shares of FirsTier Bank,
Kimball, Nebraska.
In addition, Jan Wiens, Westminster,
Colorado; T. Jordan Wiens, Broomfield,
Colorado; Lindsey Sears, Cheyenne,
Wyoming; Diana Wiens and Travis
Wiens, both of Sedalia, Colorado;
Lauren Bocci, Erie, Colorado; Hannah
Nelson, Ellisville, Missouri; Sarah Swor,
Chico, Texas; and Terry Wiens,
Edmond, Oklahoma; to become
members of the Wiens Family Group,
and with Timothy D. Wiens and
Thomas J. Wiens, to retain voting shares
of FirsTier II Bancorp., and thereby
indirectly retain shares of FirsTier Bank.
2. The Alice M. Dittman 2011
Irrevocable Trust, John F. Dittman, as
trustee, and Susan G. Dittman, all of
Lincoln, Nebraska; to join the Dittman
Family Group, a group acting in concert,
to retain voting shares of Cornhusker
Growth Corporation, and thereby
indirectly retain voting shares of
Cornhusker Bank, both of Lincoln,
Nebraska
Board of Governors of the Federal
Reserve System, March 1, 2022.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2022–04647 Filed 3–3–22; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–367a–e, CMS–
10330, CMS–10780, CMS–10524 and CMS–
906]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
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extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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.
Comments on the collection(s) of
information must be received by the
OMB desk officer by April 4, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
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-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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 (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-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 that summarizes
DATES:
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the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicaid Drug
Rebate Program Labeler Reporting
Format; Use: Labelers transmit drug
product and pricing data to CMS within
30 days after the end of each calendar
month and quarter. CMS calculates the
unit rebate amount (URA) and the unit
rebate offset amount (UROA) for each
new drug application (NDC) and
distributes to all State Medicaid
agencies. States use the URA to invoice
the labeler for rebates and the UROA to
report onto CMS–64. The monthly data
is used to calculate Federal Upper Limit
(FUL) prices for applicable drugs and
for states that opt to use this data to
establish their pharmacy reimbursement
methodology. In this November 2021
iteration, CMS–367d (Manufacturer
Contact Form) is being revised to
include a signature/date line for the
submitter to confirm that the
information provide is accurate, and we
have additionally updated the entire
367d to a fillable format, per multiple
labeler requests. CMS–367e (Quarterly
VBP–MBP Data) is a new form that is
intended for manufacturers to use (as
needed) on a quarterly basis, to transmit
pricing data (best prices associated with
value-based purchasing (VBP)
arrangements) for each of their covered
outpatient drugs (CODs) to CMS either
via direct file upload to the MDP System
or manual on-line entry. The CMS–367e
form is optional. We are not proposing
any changes to the CMS–367a
(Quarterly Pricing), CMS–367b
(Monthly Pricing), or CMS–367c
(Product Data) forms. Form Number:
CMS–367a, b, c, d, and e (OMB control
number: 0938–0578); Frequency:
Monthly, quarterly, and on occasion;
Affected Public: Private sector (Business
or other for-profits); Number of
Respondents: 780; Total Annual
Responses: 15,020; Total Annual Hours:
564,394. (For policy questions regarding
this collection contact Andrea
Wellington at 410–786–3490.)
2. 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
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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 recodified 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,
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-ofnetwork 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.)
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3. 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, nonemergency 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
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12457
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.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Program; Prior Authorization Process for
Certain Durable Medical Equipment,
Prosthetic, Orthotics, and Supplies
(DMEPOS); Use: Section 1834(a)(15) of
the Social Security Act (the Act)
authorizes the Secretary to develop and
periodically update a list of DMEPOS
that the Secretary determines, on the
basis of prior payment experience, are
frequently subject to unnecessary
utilization and to develop a prior
authorization process for these items.
Pursuant to this authority, CMS
published final rules CMS–6050–F and
CMS–1713–F.
The information required under this
collection is used to determine proper
payment and coverage for DMEPOS
items. The information requested
includes all documents and information
that demonstrate the DMEPOS item
requested is reasonable and necessary
for the beneficiary and meets applicable
Medicare requirements. The
documentation will be reviewed by
trained registered nurses, therapists, or
physician reviewers to determine if
item(s) or service requested meets all
applicable Medicare coverage, coding
and payment rules. Form Number:
CMS–10524 (OMB control number:
0938–1293); Frequency: Occasionally;
Affected Public: Private Sector (Business
or other for-profits, Not-for-Profit
Institutions); Number of Respondents:
273,305; Total Annual Responses:
273,305; Total Annual Hours: 136,652.
(For policy questions regarding this
collection contact Stephanie Collins at
(410) 786–0959.)
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Fiscal
Soundness Reporting Requirements
(FSRR); Use: Title 18 Section
1857(d)(4)(A)(i) requires that contracting
organizations such as Medicare Health
Plans (including Medicare Advantage
(MA) organizations, Medicare-Medicaid
Capitated Financial Alignment
Demonstrations (MMPs)) and 1876 Cost
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Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices
Plans), Prescription Drug Plan sponsors
(PDPs), and Programs of All-Inclusive
Care for the Elderly (PACE)
organizations report financial
information demonstrating the
organization has a fiscally sound
operation. The FSRR is designed to
capture financial data of these
contracting entities. The Division of
Finance and Benefits (DFB) within the
Medicare Advantage Contract
Administration Group (MCAG) of CMS
is assigned the responsibility of
reviewing ongoing financial
performance of the contracting entities.
All contracting organizations must
submit audited annual financial
statements one time per year. In
addition to the audited annual
submission, Health Plans with a
negative net worth and/or a net loss and
the amount of that loss is greater than
one-half of the organization’s total net
worth submit quarterly financial
statements for fiscal soundness
monitoring. Part D organizations are
required to submit three (3) quarterly
financial statements. Lastly, PACE
organizations are required to file four (4)
quarterly financial statements for the
first three (3) years in the program. After
the first three (3) years, PACE
organizations with a negative net worth
and/or a net loss and the amount of that
loss is greater than one-half of the
organization’s total net worth must
submit quarterly financial statements for
fiscal soundness monitoring. Form
Number: CMS–906 (OMB control
number: 0938–0496); Frequency:
Quarterly and Yearly; Affected Public:
Private Sector (Business or other forprofits, Not-for-Profit Institutions);
Number of Respondents: 936; Total
Annual Responses: 1,958; Total Annual
Hours: 652. (For policy questions
regarding this collection contact Christa
M. Zalewski at (410) 786–1971.)
Dated: March 1, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–04644 Filed 3–3–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10108]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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
May 3, 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 https://
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: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
SUMMARY:
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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/PRAListing.
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–10108 Medicaid Managed Care
Regulations
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
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: Medicaid
Managed Care Regulations; Use:
Information collected includes
information about managed care
programs, grievances and appeals,
enrollment broker contracts, and
managed care organizational capacity to
provide health care services. Medicaid
enrollees use the information collected
and reported to make informed choices
regarding health care, including how to
access health care services and the
grievance and appeal system. States use
the information collected and reported
as part of its contracting process with
managed care entities, as well as its
compliance oversight role. We use the
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]]>Agencies
[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Pages 12456-12458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04644]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-367a-e, CMS-10330, CMS-10780, CMS-10524 and
CMS-906]
Agency Information Collection Activities: Submission for OMB
Review; 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 (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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by April 4, 2022.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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 Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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 (44 U.S.C. 3506(c)(2)(A)) requires
federal agencies to publish a 30-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 that
summarizes the following proposed collection(s) of information for
public comment:
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug
Rebate Program Labeler Reporting Format; Use: Labelers transmit drug
product and pricing data to CMS within 30 days after the end of each
calendar month and quarter. CMS calculates the unit rebate amount (URA)
and the unit rebate offset amount (UROA) for each new drug application
(NDC) and distributes to all State Medicaid agencies. States use the
URA to invoice the labeler for rebates and the UROA to report onto CMS-
64. The monthly data is used to calculate Federal Upper Limit (FUL)
prices for applicable drugs and for states that opt to use this data to
establish their pharmacy reimbursement methodology. In this November
2021 iteration, CMS-367d (Manufacturer Contact Form) is being revised
to include a signature/date line for the submitter to confirm that the
information provide is accurate, and we have additionally updated the
entire 367d to a fillable format, per multiple labeler requests. CMS-
367e (Quarterly VBP-MBP Data) is a new form that is intended for
manufacturers to use (as needed) on a quarterly basis, to transmit
pricing data (best prices associated with value-based purchasing (VBP)
arrangements) for each of their covered outpatient drugs (CODs) to CMS
either via direct file upload to the MDP System or manual on-line
entry. The CMS-367e form is optional. We are not proposing any changes
to the CMS-367a (Quarterly Pricing), CMS-367b (Monthly Pricing), or
CMS-367c (Product Data) forms. Form Number: CMS-367a, b, c, d, and e
(OMB control number: 0938-0578); Frequency: Monthly, quarterly, and on
occasion; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 780; Total Annual Responses: 15,020;
Total Annual Hours: 564,394. (For policy questions regarding this
collection contact Andrea Wellington at 410-786-3490.)
2. 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
[[Page 12457]]
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, 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.)
3. 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.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicare Program;
Prior Authorization Process for Certain Durable Medical Equipment,
Prosthetic, Orthotics, and Supplies (DMEPOS); Use: Section 1834(a)(15)
of the Social Security Act (the Act) authorizes the Secretary to
develop and periodically update a list of DMEPOS that the Secretary
determines, on the basis of prior payment experience, are frequently
subject to unnecessary utilization and to develop a prior authorization
process for these items. Pursuant to this authority, CMS published
final rules CMS-6050-F and CMS-1713-F.
The information required under this collection is used to determine
proper payment and coverage for DMEPOS items. The information requested
includes all documents and information that demonstrate the DMEPOS item
requested is reasonable and necessary for the beneficiary and meets
applicable Medicare requirements. The documentation will be reviewed by
trained registered nurses, therapists, or physician reviewers to
determine if item(s) or service requested meets all applicable Medicare
coverage, coding and payment rules. Form Number: CMS-10524 (OMB control
number: 0938-1293); Frequency: Occasionally; Affected Public: Private
Sector (Business or other for-profits, Not-for-Profit Institutions);
Number of Respondents: 273,305; Total Annual Responses: 273,305; Total
Annual Hours: 136,652. (For policy questions regarding this collection
contact Stephanie Collins at (410) 786-0959.)
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Fiscal Soundness
Reporting Requirements (FSRR); Use: Title 18 Section 1857(d)(4)(A)(i)
requires that contracting organizations such as Medicare Health Plans
(including Medicare Advantage (MA) organizations, Medicare-Medicaid
Capitated Financial Alignment Demonstrations (MMPs)) and 1876 Cost
[[Page 12458]]
Plans), Prescription Drug Plan sponsors (PDPs), and Programs of All-
Inclusive Care for the Elderly (PACE) organizations report financial
information demonstrating the organization has a fiscally sound
operation. The FSRR is designed to capture financial data of these
contracting entities. The Division of Finance and Benefits (DFB) within
the Medicare Advantage Contract Administration Group (MCAG) of CMS is
assigned the responsibility of reviewing ongoing financial performance
of the contracting entities.
All contracting organizations must submit audited annual financial
statements one time per year. In addition to the audited annual
submission, Health Plans with a negative net worth and/or a net loss
and the amount of that loss is greater than one-half of the
organization's total net worth submit quarterly financial statements
for fiscal soundness monitoring. Part D organizations are required to
submit three (3) quarterly financial statements. Lastly, PACE
organizations are required to file four (4) quarterly financial
statements for the first three (3) years in the program. After the
first three (3) years, PACE organizations with a negative net worth
and/or a net loss and the amount of that loss is greater than one-half
of the organization's total net worth must submit quarterly financial
statements for fiscal soundness monitoring. Form Number: CMS-906 (OMB
control number: 0938-0496); Frequency: Quarterly and Yearly; Affected
Public: Private Sector (Business or other for-profits, Not-for-Profit
Institutions); Number of Respondents: 936; Total Annual Responses:
1,958; Total Annual Hours: 652. (For policy questions regarding this
collection contact Christa M. Zalewski at (410) 786-1971.)
Dated: March 1, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2022-04644 Filed 3-3-22; 8:45 am]
BILLING CODE 4120-01-P
