[Federal Register Volume 84, Number 243 (Wednesday, December 18, 2019)]
[Notices]
[Pages 69380-69382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27280]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10108, CMS-10243, CMS-10383, CMS-10609, CMS-
R-131 and CMS-10662]


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 January 17, 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: 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 of a currently 
approved collection; Title of Information Collection: Medicaid Managed 
Care Regulations; Use: The requirements contained in this information 
collection request implement regulations that allow states greater 
flexibility to implement mandatory managed care programs, implement new 
beneficiary protections, and eliminate certain requirements viewed by 
state agencies as impediments to the growth of managed care programs. 
Information collected includes information about managed care programs, 
grievances and appeals, enrollment broker contracts, and managed care 
organizational capacity to provide health care services. Medicaid 
enrollees use the information collected and reported to make informed 
choices regarding health care, including how to access health care 
services and the grievance and appeal system. States use the 
information collected and reported as part of its contracting process 
with managed care entities, as well as its compliance oversight role. 
We use the information collected and reported in an oversight role of 
state Medicaid managed care programs. Form Number:

[[Page 69381]]

CMS-10108 (OMB control number: 0938-0920); Frequency: Occasionally; 
Affected Public: Individuals or households, Private sector (business or 
other for-profit and not-for-profit institutions), and State, local or 
Tribal Government; Number of Respondents: 628; Total Annual Responses: 
22,564,877; Total Annual Hours: 1,371,968. (For policy questions 
regarding this collection contact Amy Gentile at 410-786-3499.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Testing 
Experience and Functional Tools: Functional Assessment Standardized 
Items (FASI) Based on the CARE Tool; Use: In 2012, CMS funded a project 
entitled, Technical Assistance to States for Testing Experience and 
Functional Tools (TEFT) Grants. One component of this demonstration is 
to amend and test the reliability of a setting-agnostic, interoperable 
set of data elements, called ``items,'' that can support standardized 
assessment of individuals across the continuum of care. Items that were 
created for use in post-acute care settings using the Continuity 
Assessment Record and Evaluation (CARE) tool have been adopted, 
modified, or supplemented for use in community-based long-term services 
and supports (CB-LTSS) programs. This project will test the reliability 
and validity of the function-related assessment items, now referred to 
as Functional Assessment Standardized Items (FASI), when applied in 
community settings, and in various populations: Elders (65 years and 
older); younger adults (18-64) with physical disabilities; and adults 
of any age with intellectual or developmental disabilities, with severe 
mental illness, or with traumatic brain injury.
    Individual-level data will be collected two times using the TEFT 
FASI Item Set. The first data collection effort will collect data that 
can be analyzed to evaluate the reliability and validity of the FASI 
items when used with the five waiver populations. Assessors will 
conduct functional assessments in client homes using the TEFT FASI Item 
Set. Changes may be recommended to individual TEFT FASI items, to be 
made prior to releasing the TEFT FASI items for use by the states. The 
FASI Field Test Report will be released to the public.
    The second data collection will be conducted by the states to 
demonstrate their use of the FASI data elements. The assessment data 
could be used by the states for multiple purposes. They may use the 
standardized items to determine individual eligibility for state 
programs, or to help determine levels of care within which people can 
receive services, or other purposes. In the second round of data 
collection, states will demonstrate their proposed uses, manage their 
FASI data collection and conduct their own analysis, to the extent they 
propose to do such tasks. The states have been funded under the 
demonstration grant to conduct the round 2 data collection and 
analysis. These states will submit reports to CMS describing their 
experience in the Round 2 data collection, including the items they 
collected, how they planned to use the data, and the types of 
challenges and successes they encountered in doing so. The reports may 
be used by CMS in their evaluation of the TEFT grants. Form Number: 
CMS-10243 (OMB control number: 0938-1037); Frequency: On occasion; 
Affected Public: Individuals and Households; Number of Respondents: 
5,650; Total Annual Responses: 5,650; Total Annual Hours: 2,825. (For 
policy questions regarding this collection contact Kerry Lida at 410-
786-4826.)
    3. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Review 
and Approval Process for Waivers for State Innovation; Use: The 
information required under this collection is necessary to ensure that 
states comply with statutory and regulatory requirements related to the 
development and implementation of section 1332 waivers. States seeking 
waiver authority under section 1332 of the PPACA are required to meet 
certain requirements for applications, public notice, and reporting. 
The authority for these requirements is found in section 1332 of the 
PPACA. This information collection reflects the requirements provided 
in the final rules, 77 FR 11700, published February 27, 2012. 
Additionally, on October 24, 2018, the Departments published guidance, 
83 FR 53575, that provides supplementary information about the 
requirements that must be met for the approval of a section 1332 
waiver, the Secretaries application review procedures, the calculation 
of pass-through funding, certain analytical requirements, and 
operational considerations. This guidance supersedes the guidance 
related to section 1332 of the PPACA that was previously published on 
December 16, 2015. This information collection also reflects the 
requirements outlined in a state's specific terms and conditions 
(STCs), as part of the approval of a state's section 1332 waiver 
application. Form Number: CMS-10383 (OMB control number 0938-NEW); 
Frequency: Occasionally; Affected Public: State Governments; Number of 
Respondents: 12; Total Annual Responses: 212; Total Annual Hours: 
4,016. (For policy questions regarding this collection contact Michelle 
Koltov at 301-492-4225.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicaid Program 
Face-to-Face Requirements for Home Health Services and Supporting 
Regulations; Use: 42 CFR 440.70(f) and (g) requires that physicians (or 
for medical equipment, authorized non-physician practitioners (NPPs) 
including nurse practitioners, clinical nurse specialists and physician 
assistants) document that there was a face-to-face encounter with the 
Medicaid beneficiary prior to the physician making a certification that 
home health services are required. The burden associated with this 
requirement is the time and effort to complete this documentation. The 
burden also includes writing, typing, or dictating the face-to-face 
documentation and signing/dating the documentation. Form Number: CMS-
10609 (OMB control number: 0938-1319); Frequency: Occasionally; 
Affected Public: Private sector (business or other for-profits); Number 
of Respondents: 381,148; Total Annual Responses: 1,143,443; Total 
Annual Hours: 190,955. (For policy questions regarding this collection 
contact Alexandra Smilow at 410-786-0790.)
    5. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Advance Beneficiary Notice of Noncoverage (ABN); Use: The use of the 
written Advance Beneficiary Notice of Non-coverage (ABN) is to inform 
Medicare beneficiaries of their liability under specific conditions. 
This has been available since the ``limitation on liability'' 
provisions in section 1879 of the Social Security Act (the Act) were 
enacted in 1972 (Pub. L. 92-603). ABNs are not given every time items 
and services are delivered. Rather, ABNs are given only when a 
physician, provider, practitioner, or supplier anticipates that 
Medicare will not provide payment in specific cases.
    An ABN may be given, and the beneficiary may subsequently choose 
not to receive the item or service. An ABN may also be issued because 
of other applicable statutory requirements other than Sec.  1862(a)(1) 
such as when a beneficiary wants to obtain an item from

[[Page 69382]]

a supplier who has not met Medicare supplier number requirements, as 
listed in section 1834(j)(1) of the Act or when statutory requirements 
for issuance specific to HHAs are applicable.
    ABNs are usually given as hard copy notices during in-person 
patient encounters. In some cases, notification may be done by 
telephone with a follow-up notice mailed. Electronic issuance of ABNs 
is permitted as long as the beneficiary is offered the option to 
receive a paper copy of the notice if this is preferred. Regardless of 
the mode of delivery, the beneficiary must receive a copy of the signed 
ABN for his/her own records. Incorporation of ABNs into other automated 
business processes is permitted, and some limited flexibility in 
formatting the notice in such cases is allowed, as discussed in the 
form instructions. Notifiers may choose to store the required signed 
copy of the ABN electronically. Form Number: CMS-R-131 (OMB control 
number: 0938-0566); Frequency: Yearly; Affected Public: State, Local, 
or Tribal Governments; Number of Respondents: 1,589,060; Total Annual 
Responses: 382,216,385; Total Annual Hours: 44,593,186. (For policy 
questions regarding this collection contact Jennifer McCormick at 410-
786-2852.)
    6. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Administrative Simplification HIPAA Compliance Review; Use: The 
authority for administering and enforcing compliance with the 
Administrative Simplification non-privacy Health Insurance Portability 
and Accountability Act (HIPAA) rules has been delegated to the Centers 
for Medicare & Medicaid Services (CMS). (68 FR 60694 Part F, October 
23, 2003) 45 CFR 160.308 states, ``that the Secretary may conduct 
compliance reviews to determine whether covered entities are complying 
with the applicable administrative simplification provisions.'' These 
reviews are conducted at the discretion of the Secretary. Title 45 CFR 
160.310 requires that a covered entity provide records and compliance 
reports to the Secretary in cooperation with a compliance review. Title 
45 CFR 160.310 provides that a covered entity must permit HHS, or its 
delegated entity, access during normal business hours to its 
facilities, books, records, and other information, and other 
information necessary to determine compliance, but also provides that 
if the Secretary determines that ``exigent circumstances exist, such as 
when documents may be hidden or destroyed,'' the covered entity must 
permit access at any time without notice.
    The purpose of this collection is to retrieve information necessary 
to conduct a compliance review as described in CMS-0014-N (68 FR 
60694). These forms will be submitted to the Centers for Medicare & 
Medicaid Services (CMS), Program Management National Standards Group, 
from entities covered by HIPAA Administrative Simplification 
regulations. This collection is not applicable to HIPAA Privacy and 
Security Rules. Form Number: CMS-10662 (OMB control number: 0938-New); 
Frequency: Occasionally; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 10; Total Annual Responses: 10; 
Total Annual Hours: 425. (For policy questions regarding this 
collection contact Cecily Austin at 410-786-0895.)

    Dated: December 13, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-27280 Filed 12-17-19; 8:45 am]
 BILLING CODE 4120-01-P