[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63657-63659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10611, CMS-R-282 and CMS-R-235]


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 December 18, 2019.

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

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following transmissions: OMB, Office of Information and Regulatory 
Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR, 
Email: [email protected].
    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 without change 
of a currently approved collection; Title of Information Collection: 
Medicare Outpatient Observation Notice (MOON); Use: On August 6, 2015, 
Congress enacted the Notice of Observation Treatment and Implication 
for Care Eligibility Act (NOTICE Act) Public Law 114-42, amending 
Section 1866(a)(1) of the Social Security Act (the Act) (42 U.S.C. 
1395cc(a)(1)), by adding a new subparagraph (Y). The NOTICE Act 
requires hospitals and CAHs to provide written notification and oral 
explanation to individuals who receive observation services as 
outpatients for more than 24 hours.
    The MOON is a standardized notice delivered to persons entitled to 
Medicare benefits under Title XVIII of the Act who receive more than 24 
hours of observation services, informing them that their hospital stay 
is outpatient and not inpatient, and the implications of being an 
outpatient. This information collection applies to beneficiaries in 
Original Medicare and enrollees in Medicare health plans.
    The Medicare Outpatient Observation Notice (MOON) serves as the 
written notice component of this mandatory notification process. The 
standardized content of the MOON includes all informational elements 
required by statute, in language understandable to beneficiaries, and 
fulfils the regulatory requirements at 42 CFR part 489.20(y).
    The MOON is not given every time items and services are furnished 
in a hospital or CAH. Rather, hospitals are only required to deliver 
the MOON to individuals receiving observation services as outpatients 
for more than 24 hours. Form Number: CMS-10611 (OMB control number: 
0938-1308); Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 4,373; Total Annual Responses: 
946,209; Total Annual Hours: 236,552. (For policy questions regarding 
this collection contact Janet Miller at [email protected].)
    2. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: 
Health Plan Appeals and Grievance Data Collection and Reporting 
Requirements, Data Disclosure Requirements under section 422.111; Use: 
Part 422 of Title 42 of the Code of Federal Regulations (CFR) 
distinguishes between certain information a Medicare Advantage (MA) 
organization must provide to each enrollee (on an annual basis) and 
information that the MA organization must disclose to any MA eligible 
individual (upon request). This requirement can be found in Sec.  
1852(c)(2)(C) of the Social Security Act and in 42 CFR 422.111(c)(3) 
which states that MA organizations must disclose information pertaining 
to the number of disputes, and their disposition in the aggregate, with 
the categories of grievances and appeals, to any individual eligible to 
elect an MA organization who requests this information.
    The appeals and grievance data form is an OMB approved form for use 
by Medicare Advantage organizations to disclose grievance and appeal 
data, upon request, to individuals eligible to elect an MA 
organization. By utilizing the form, MA organizations will meet the 
disclosure requirements set forth in regulations at 42 CFR 
422.111(c)(3).
    In an effort to identify opportunities to reduce burden for this 
collection, we compared data provided by plans to CMS in Part C 
reporting requirements (OMB 0938-1054) with the requirements to provide 
aggregate grievance and appeals data to MA eligible beneficiaries. We 
found that data reported to CMS in the Part C reporting requirements 
was data that would meet the disclosure requirements at Sec.  
1852(c)(2)(C) of the Social Security Act and 42 CFR 422.111(c).
    We are proposing to revise this form by allowing plans to use data 
collected for Part C reporting requirements (OMB 0938-1054) that also 
meet requirements for this collection. This change merges and aligns 
the collection and reporting periods, so MA plans do not need to keep 
two separate sets of data and reports each year.
    For CMS Part C reporting requirements, data is collected quarterly, 
but only reported annually. To match this and reduce plan burden, CMS 
is revising this form to use the data reported annually to CMS, and 
that data be valid for one year versus creating a new report every six 
months. Further, data provided to enrollees would be consistent with 
data provided to CMS. Form Number: CMS-R-282 (OMB control number: 0938-
0778); Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 733; Total Annual Responses: 
59,133; Total Annual Hours: 5,405. (For policy questions regarding this 
collection contact Staci Paige at 410-786-2045.)
    3. Type of Information Collection Request: Reinstatement with 
change of a currently approved collection; Title of Information 
Collection: Data Use Agreement (DUA) Form; Use: The Privacy Act of 1974 
allows for discretionary releases of data maintained in Privacy Act 
protected systems of records under Sec.  552a(b) (Conditions of 
Disclosure). The mandate to account for disclosures of data under the 
Privacy Act is found at Sec.  552a(c)(Accounting of Certain 
Disclosures). This section states that certain information must be 
maintained regarding disclosures made by each agency. This information 
is: Date, Nature, Purpose, and Name/Address of Recipient. Section 
552a(e) sets the overall Agency Requirements that each agency must meet 
in order to maintain records under the Privacy Act.
    The Data Use Agreement (DUA) form is needed as part of the review 
of each CMS data request to ensure compliance with the requirements of 
the Privacy Act

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for disclosures that contain PII. The DUA form also provides data 
requestors and custodians with a formal means to agree to the data 
protection and destruction statutory and regulatory requirements of 
CMS' PII data.
    When entities, such as academic, federal or state agency 
researchers or CMS contractors request CMS PII/PHI data, they enter 
into a Data Use Agreement (DUA) with CMS. The DUA stipulates that the 
recipient of CMS data must properly protect the data according to all 
applicable data security standards and also provide for its appropriate 
destruction at the completion of the project/study or the expiration 
date of the DUA. The DUA form enables the data recipient and CMS to 
document the request and approval for release of CMS data. Form Number: 
CMS-R-235 (OMB control number: 0938-0734); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 
9,200; Total Annual Responses: 9,200; Total Annual Hours: 2,900. (For 
policy questions regarding this collection contact Kari A Gaare at 410-
786-8612.)

    Dated: November 13, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-24929 Filed 11-15-19; 8:45 am]
 BILLING CODE 4120-01-P