[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66990-66993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23335]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10752, CMS-10137, CMS-R-262 and CMS-10549]


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

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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 December 21, 2020.

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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Call the Reports Clearance Office at (410) 786-1326.

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-10752 Submissions of 1135 Waiver Request Automated Process
CMS-10137 Solicitation for Applications for Medicare Prescription Drug 
Plan 2022 Contracts
CMS-R-262 CMS Plan Benefit Package (PBP) and Formulary CY 2022
CMS-10549 Generic Clearance: Questionnaire Testing and Methodological 
Research for the Medicare Current Beneficiary Survey (MCBS)

    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: Submissions of 
1135 Waiver Request Automated Process; Use: Waivers under Section 1135 
of the Social Security Act (the Act) and certain flexibilities allow 
the CMS to relax certain requirements, known as the Conditions of 
Participation (CoPs) or Conditions of Coverage to promote the health 
and safety of beneficiaries. Under Section 1135 of the Act, the 
Secretary may temporarily waive or modify certain Medicare, Medicaid, 
and Children's Health Insurance Program (CHIP) requirements to ensure 
that sufficient health care services are available to meet the needs of 
individuals enrolled in Social Security Act programs in the emergency 
area and time periods. These waivers ensure that providers who provide 
such services in good faith can be reimbursed and exempted from 
sanctions.
    During emergencies, such as the current COVID-19 public health 
emergency (PHE), CMS must be able to apply program waivers and 
flexibilities under section 1135 of the Social Security Act, in a 
timely manner to respond quickly to unfolding events. In a disaster or 
emergency, waivers and flexibilities assist health care providers/
suppliers in providing timely healthcare and services to people who 
have been affected and enables states, Federal districts, and U.S. 
territories to ensure Medicare and/or Medicaid beneficiaries have 
continued access to care. During disasters and emergencies, it is not 
uncommon to evacuate Medicare-participating facilities and relocate 
patients/residents to other provider settings or across state lines, 
especially, during hurricane and tornado events. CMS must collect 
relevant information for which a provider is requesting a waiver or 
flexibility to make proper decisions about approving or denying such 
requests. Collection of this data aids in the prevention of gaps in 
access to care and services before, during, and after an emergency. CMS 
must also respond to inquiries related to a PHE from providers and 
beneficiaries. CMS is not collecting information from these inquiries; 
we are merely responding to them.
    Prior to this request, CMS did not have a standard process or OMB 
approval for providers/suppliers impacted to submit 1135 waiver/
flexibility requests or inquiries, as these were generally seen on a 
smaller scale (natural disasters) prior to the COVID-19 public health 
emergency. CMS has provided general guidance to Medicare-participating 
facilities which can be viewed at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/1135-Waivers. 
The requests and inquiries would be sent directly, via email, to the 
Survey Operations Group in each CMS Location (previously known as CMS 
Regional Offices) and the entity would provide a brief summary to CMS 
for a waiver/flexibility request or an answer to an inquiry. We are now 
developing a streamlined, automated process to standardize the 1135 
waiver requests and inquiries submitted based on lessons learned during 
COVID-19 PHE, primarily based on the volume of requests to ensure 
timely response to facility needs. The waiver request form was approved 
under an Emergency information collection request on October 15, 2020.
    Furthermore, the normal operations of a healthcare provider are 
disrupted by emergencies or disasters occasionally. When this occurs, 
State Survey Agencies (SA) deliver a provider/beneficiary tracking 
report regarding the current status of all affected healthcare 
providers and their beneficiaries. This report includes demographic 
information about the provider, their operational status, beneficiary 
status, and planned resumption of normal operations. This information 
is provided whether or not a PHE has been declared. We are now 
developing a streamlined, automated process to standardize submission 
of this information directly by the provider during emergencies and 
eliminating the need for SA to provide it. It will consist of a public 
facing web form.
    This information will be used by CMS to receive, triage, respond to 
and report on requests and/or inquiries for Medicare, Medicaid, and 
CHIP beneficiaries. This information will be

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used to make decisions about approving or denying waiver and 
flexibility requests and may be used to identify trends that inform CMS 
Conditions for Coverage or Conditions for Participation policies during 
public health emergencies, when declared by the President and the HHS 
Secretary.
    Subsequent to the Emergency information collection request, we are 
revising the package to include a second form, Healthcare Facility 
Status Workflow, which is for operational status information which will 
be used to assist providers in delivering critical care to 
beneficiaries during emergencies. Form Number: CMS-10752 (OMB control 
number: 0938-1384); Frequency: Occasionally; Affected Public: Private 
Sector: Business or other for-profits and Not-for-profit institutions 
and State, Local or Tribal Governments; Number of Respondents: 3,730; 
Total Annual Responses: 3,730; Total Annual Hours: 3,730. (For policy 
questions regarding this collection, contact Adriane Saunders at 404-
562-7484.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Solicitation for 
Applications for Medicare Prescription Drug Plan 2022 Contracts; Use: 
Coverage for the prescription drug benefit is provided through 
contracted prescription drug plans (PDPs) or through Medicare Advantage 
(MA) plans that offer integrated prescription drug and health care 
coverage (MA-PD plans). Cost Plans that are regulated under Section 
1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP) 
may also provide a Part D benefit. Organizations wishing to provide 
services under the Prescription Drug Benefit Program must complete an 
application, negotiate rates, and receive final approval from CMS. 
Existing Part D Sponsors may also expand their contracted service area 
by completing the Service Area Expansion (SAE) application.
    Collection of this information is mandated in Part D of the 
Medicare Prescription Drug, Improvement, and Modernization Act of 2003 
(MMA) in Subpart 3. The application requirements are codified in 
Subpart K of 42 CFR 423 entitled ``Application Procedures and Contracts 
with PDP Sponsors.''
    The information will be collected under the solicitation of 
proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for 
the Elderly (PACE), and EGWP applicants. The collected information will 
be used by CMS to: (1) Ensure that applicants meet CMS requirements for 
offering Part D plans (including network adequacy, contracting 
requirements, and compliance program requirements, as described in the 
application), (2) support the determination of contract awards. Form 
Number: CMS-10137 (OMB control number: 0938-0936); Frequency: Yearly; 
Affected Public: Private Sector: Business or other for-profits and Not-
for-profit institutions and State, Local or Tribal Governments; Number 
of Respondents: 658; Total Annual Responses: 331; Total Annual Hours: 
1,550. (For policy questions regarding this collection, contact Arianne 
Spaccarelli at 410-786-5715.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: CMS Plan Benefit 
Package (PBP) and Formulary CY 2022; Use: Under the Medicare 
Modernization Act (MMA), Medicare Advantage (MA) and Prescription Drug 
Plan (PDP) organizations are required to submit plan benefit packages 
for all Medicare beneficiaries residing in their service area. The plan 
benefit package submission consists of the Plan Benefit Package (PBP) 
software, formulary file, and supporting documentation, as necessary. 
MA and PDP organizations use the PBP software to describe their 
organization's plan benefit packages, including information on 
premiums, cost sharing, authorization rules, and supplemental benefits. 
They also generate a formulary to describe their list of drugs, 
including information on prior authorization, step therapy, tiering, 
and quantity limits.
    CMS requires that MA and PDP organizations submit a completed PBP 
and formulary as part of the annual bidding process. During this 
process, organizations prepare their proposed plan benefit packages for 
the upcoming contract year and submit them to CMS for review and 
approval. CMS uses this data to review and approve the benefit packages 
that the plans will offer to Medicare beneficiaries. This allows CMS to 
review the benefit packages in a consistent way across all submitted 
bids during with incredibly tight timeframes. This data is also used to 
populate data on Medicare Plan Finder, which allows beneficiaries to 
access and compare Medicare Advantage and Prescription Drug plans. Form 
Number: CMS-R-262 (OMB control number: 0938-0763); Frequency: Yearly; 
Affected Public: Private Sector: Business or other for-profits and Not-
for-profit institutions and State, Local or Tribal Governments; Number 
of Respondents: 753; Total Annual Responses: 8,090; Total Annual Hours: 
74,038. (For policy questions regarding this collection, contact Kristy 
Holtje at 410-786-2209.)
    4. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Generic 
Clearance: Questionnaire Testing and Methodological Research for the 
Medicare Current Beneficiary Survey (MCBS); Use: The current generic 
clearance for MCBS Questionnaire Testing and Methodological Research 
encompasses development and testing of MCBS questionnaires, 
instrumentation, and data collection protocols, as well as a mechanism 
for conducting methodological experiments. The current clearance 
includes conducting field tests and experiments, including split ballot 
experiments, within the MCBS production environment, and conducting 
usability tests. The purpose of this OMB clearance package is to revise 
the current clearance to expand the methods to allow for field tests 
outside of MCBS production Field tests conducted within production do 
not incur any additional burden on respondents whereas tests conducted 
outside production must account for additional respondent burden. The 
MCBS is a continuous, multipurpose survey of a nationally 
representative sample of aged, disabled, and institutionalized Medicare 
beneficiaries. The MCBS, which is sponsored by the Centers for Medicare 
& Medicaid Services (CMS), is the only comprehensive source of 
information on the health status, health care use and expenditures, 
health insurance coverage, and socioeconomic and demographic 
characteristics of the entire spectrum of Medicare beneficiaries. The 
core of the MCBS is a series of interviews with a stratified random 
sample of the Medicare population, including aged and disabled 
enrollees, residing in the community or in institutions. Questions are 
asked about enrollees' patterns of health care use, charges, insurance 
coverage, and payments over time. Respondents are asked about their 
sources of health care coverage and payment, their demographic 
characteristics, their health and work history, and their family living 
circumstances. In addition to collecting information through the core 
questionnaire, the MCBS collects information on special topics. Form 
Number: CMS-10549 (OMB control number: 0938-1275); Frequency: 
Occasionally; Affected Public: Individuals or Households; Number of 
Respondents: 11,655; Total Annual Responses: 11,655; Total Annual 
Hours:

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3,947. (For policy questions regarding this collection, contact William 
Long at 410-786-7927.)

    Dated: October 16, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-23335 Filed 10-20-20; 8:45 am]
BILLING CODE 4120-01-P