Agency Information Collection Activities: Submission for OMB Review; Comment Request, 16634-16636 [2020-06080]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[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]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

[[Page 16635]]

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.,

[[Page 16636]]

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