Notice2022-04644
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 4, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 43 (Friday, March 4, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Pages 12456-12458]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04644]
=======================================================================
-----------------------------------------------------------------------
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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html</a>.
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
</pre></body>
</html>Indexed from Federal Register on March 4, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.