[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