[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.

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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

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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 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