[Federal Register Volume 86, Number 225 (Friday, November 26, 2021)]
[Notices]
[Pages 67473-67475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25816]


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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.

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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 (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: ___, 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

[[Page 67474]]

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,

[[Page 67475]]

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