[Federal Register Volume 85, Number 57 (Tuesday, March 24, 2020)]
[Notices]
[Pages 16634-16636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06080]
[[Page 16634]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10302, CMS-R-297/CMS-L564, CMS-4040, CMS-379
and CMS-10316]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid 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 23, 2020.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions:
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.
1. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
2. Call the Reports Clearance Office at (410) 786-1326.
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: Extension of a currently
approved collection; Title of Information Collection: Collection
Requirements for Compendia for Determination of Medically-accepted
Indications for Off-label Uses of Drugs and Biologicals in an Anti-
cancer Chemotherapeutic Regimen; Use: Section 182(b) of the Medicare
Improvement of Patients and Providers Act (MIPPA) amended section
1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by
adding at the end the following new sentence: `On and after January 1,
2010, no compendia may be included on the list of compendia under this
subparagraph unless the compendia has a publicly transparent process
for evaluating therapies and for identifying potential conflicts of
interest.' We believe that the implementation of this statutory
provision that compendia have a ``publicly transparent process for
evaluating therapies and for identifying potential conflicts of
interests'' is best accomplished by amending 42 CFR 414.930 to include
the MIPPA requirements and by defining the key components of publicly
transparent processes for evaluating therapies and for identifying
potential conflicts of interests.
All currently listed compendia will be required to comply with
these provisions, as of January 1, 2010, to remain on the list of
recognized compendia. In addition, any compendium that is the subject
of a future request for inclusion on the list of recognized compendia
will be required to comply with these provisions. No compendium can be
on the list if it does not fully meet the standard described in section
1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA.
Form Number: CMS-10302 (OMB control number: 0938-1078); Frequency:
Annually; Affected Public: Business and other for-profits and Not-for-
profit institutions; Number of Respondents: 845; Total Annual
Responses: 900; Total Annual Hours: 5,135. (For policy questions
regarding this collection contact Sarah Fulton at 410-786-2749.)
2. Type of Information Collection Request: Reinstatement without
change of a currently approved collection; Title of Information
Collection: Request for Employment Information; Use: The form CMS-L564,
also referred to as CMS-R-297, is used, in conjunction with form CMS-
40-B, Application for Supplementary Medical Insurance, during an
individual's special enrollment period (SEP). Completed by an employer,
the CMS-L564 provides proof of an applicant's employer group health
coverage. The Social Security Administration (SSA) uses it to obtain
information from employers regarding whether a Medicare beneficiary's
coverage under a group health plan is based on current employment
status. This form is available in both English and Spanish.
Section 1837(i) of the Social Security Act (the Act) provides a SEP
for individuals who delay enrolling in Medicare Part B because they are
covered by a group health plan based on their own or a spouse's current
employment status. Disabled individuals with Medicare may also delay
enrollment because they have large group health plan coverage based on
their own or a family member's current employment status. When these
individuals apply for Medicare Part B, they must provide proof that the
group health plan coverage is (or was) based on current employment
status. Form CMS L564 provides this proof so that
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SSA can determine eligibility for the SEP. Individuals eligible for the
SEP can enroll in Part B without incurring a late enrollment penalty.
Individuals may also use this form to prove that their group health
plan coverage is based on current employment status and to have the
assessed Medicare late enrollment penalty reduced. The form is
available online via Medicare.gov and CMS.gov for individuals who are
requesting the SEP to obtain and submit to their employer for
completion. The employer must complete and sign the form, and submit it
to the individual to accompany their enrollment or late enrollment
penalty reduction request. The information on the completed form is
reviewed manually by SSA. Thus, the collection of this information does
not involve the use of information technology. Form Number: CMS-R-297/
CMS-L564 (OMB control number: 0938-0787); Frequency: Yearly; Affected
Public: State, Local, or Tribal Governments; Number of Respondents:
15,000; Total Annual Responses: 15,000; Total Annual Hours: 1,250. (For
policy questions regarding this collection contact Carla D. Patterson,
at 410-786-1000.)
3. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Request for Enrollment in Supplementary Medical Insurance (SMI) and
Supporting Regulations in 42 CFR 407.10, 407.11 and 408.40(a)(2); Use:
Section 1836 of the Social Security Act, and CMS regulations at 42 CFR
407.10, provide the eligibility requirements for enrollment in Part B
for individuals age 65 and older who are not entitled to premium-free
Part A. The individual must be a resident of the United States, and
either a U.S. Citizen or an alien lawfully admitted for permanent
residence that has lived in the US continually for 5 years. CMS
regulations 42 CFR 407.11 lists the CMS-4040 as the application to be
used by individuals who are not eligible for monthly Social Security/
Railroad Retirement Board benefits or free Part A.
The CMS-4040 solicits the information that is used to determine
entitlement for individuals who meet the requirements in section 1836
as well as the entitlement of the applicant or their spouses to an
annuity paid by OPM for premium deduction purposes. The application
follows the application questions and requirements used by SSA. This is
done not only for consistency purposes but to comply with other Title
II and Title XVIII requirements because eligibility to Title II
benefits and free Part A under Title XVIII must be ruled out in order
to qualify for enrollment in Part B only. Form Number: CMS-4040 (OMB
control number: 0938-0245); Frequency: Yearly; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 29,663; Total
Annual Responses: 29,663; Total Annual Hours: 7,416 hours. (For policy
questions regarding this collection contact Carla D. Patterson, at 410-
786-1000.)
4. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Financial Statement of Debtor Use: When a Medicare Administrative
Contractor (MAC) overpays a physician or supplier, the overpayment is
associated with a single claim, and the amount of the overpayment is
moderate. In these cases, the physician/supplier usually refunds the
overpaid amount in a lump sum. Alternatively, the MAC may recoup the
overpaid amount against future payments. A recoupment is the recovery
by Medicare of any outstanding Medicare debt by reducing present or
future Medicare payments and applying the amount withheld to the
indebtedness. The recoupment can be made only if the physician/supplier
accepts assignment since the MAC makes payment to the physician/
supplier only on assigned claims.
The physician/supplier may be unable to refund a large overpaid
amount in a single payment. The MAC cannot recover the overpayment by
recoupment if the physician/supplier does not accept assignment of
future claims, or is not expected to file future claims because of
going out of business, illness or death. In these unusual
circumstances, the MAC has authority to approve or deny extended
repayment schedules up to 12 months, or may recommend to the Centers
for Medicare and Medicaid Services (CMS) to approve up to 60 months.
Before the MAC takes these actions, the MAC will require full
documentation of the physician's/supplier's financial situation. Thus,
the physician/supplier must complete the CMS-379, Financial Statement
of Debtor.
Section 1893(f)(1)) of the Social Security Act and 42 CFR 401.607
provides the authority for collection of this information. Section 42
CFR 405.607 requires that, CMS recover amounts of claims due from
debtors including interest where appropriate by direct collections in
lump sums or in installments. Form Number: CMS-379 (OMB control number:
0938-0270); Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 500; Total Annual Responses: 500;
Total Annual Hours: 1,000 hours. (For policy questions regarding this
collection contact Anita Crosier, at 410-786-0217.)
5. Type of Information Collection Request: Revision with change of
a currently approved collection; Title of Information Collection:
Implementation of the Medicare Prescription Drug Plan (PDP) and
Medicare Advantage (MA) Plan Disenrollment Reasons Survey; Use: The
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) provides a requirement to collect and report performance data for
Part D prescription drug plans. Specifically, the MMA under Sec. 1860D-
4 (Information to Facilitate Enrollment) requires CMS to conduct
consumer satisfaction surveys regarding the PDP and MA contracts
pursuant to section 1860D-4(d).
The Centers for Medicare & Medicaid Services (CMS) developed the
Disenrollment Survey to capture the reasons for disenrollment at a time
that is as close as possible to the actual date of disenrollment.
Through this survey, CMS seeks to: (1) Obtain information about
beneficiaries' expectations relative to provided benefits and services
(for both MA and PDPs) and (2) determine the reasons that prompt
beneficiaries to voluntarily disenroll. It is important to include such
information from disenrollees as CMS assesses plan performance, because
plan disenrollment can be a broad indicator of beneficiary
dissatisfaction with some aspect of plan services, such as access to
care, customer service, cost, benefits provided, or quality of care.
Information obtained from the Disenrollment Survey also supports the
quality improvement efforts of individual plans and provides data to
assist consumer choice through use of the Medicare Plan Finder website.
The survey results are an important plan monitoring tool for CMS to
ensure that Medicare beneficiaries are receiving high quality services
from contracted providers. CMS uses information from the survey to
track changes in the reasons Medicare beneficiaries cite for
disenrolling to monitor improvements/declines over time nationally and
at the plan level. CMS also uses the disenrollment survey results to
support the quality improvement efforts of individual plans, by
providing plans with a detailed, annual report showing the reasons
disenrollees cited for voluntarily leaving the plan and comparing the
plan's scores to regional and national benchmarks. Additionally, CMS
uses the plan-specific results of the survey to provide Medicare
beneficiaries with information (i.e.,
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reasons cited for disenrolling from a plan and the frequency with which
disenrollees cite each of the reasons) to assist beneficiaries with
their annual consumer choice of plans. Form Number: CMS-10316 (OMB
control number: 0938-1113); Frequency: Yearly; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 43,872; Total
Annual Responses: 43,872; Total Annual Hours: 9,354. (For policy
questions regarding this collection contact Beth Simon at 415-744-
3780.)
Dated: March 18, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2020-06080 Filed 3-23-20; 8:45 am]
BILLING CODE 4120-01-P