[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
[Notices]
[Pages 68936-68938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27139]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10638, CMS-R-5, CMS-287-19, and CMS-10088]


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 16, 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: Revision with change of 
a currently approved collection; Title of Information Collection: 
Application for New Medical Services and Technologies Seeking to 
Qualify for Add-On Payments Under the Hospital Inpatient Prospective 
Payment System; Use: Section 1886(d)(5)(K) authorizes the Secretary to 
establish a special payment methodology for new medical services and 
technologies used in inpatient procedures. To qualify for additional 
payments under this provision; a new technology must represent a 
substantial clinical improvement; data reflecting the cost of new 
technology must not yet be available in the data used to recalibrate 
the Medicare severity diagnosis-related groups (MS-DRGs); and the MS-
DRG payment rate otherwise applicable to the new technology would be 
inadequate (see 42 CFR 412.87(b)). we are revising the estimated annual 
number of respondents from 32 to 62, based on the proposed alternative 
new technology add-on payment pathway for certain devices included in 
the FY 2020 IPPS proposed rule (CMS-1716-P). The existing regulations 
at 42 CFR 412.87 implement these provisions and specify three criteria 
for a new medical service or technology to receive the additional 
payment: (1) The medical service or technology must be new; (2) the 
medical service or technology must be costly such that the DRG rate 
otherwise applicable to discharges involving the medical service or 
technology is determined to be inadequate; and (3) the service or 
technology must demonstrate a substantial clinical improvement over 
existing services or technologies.
    In the FY 2020 IPPS proposed rule (84 FR 19371--19373), we proposed 
an alternative new technology add-on payment pathway for certain 
devices. Specifically, for applications received for new technology 
add-on payments for FY 2021 and subsequent fiscal years, we proposed 
that a medical device that has received Federal Drug Administration 
(FDA) marketing authorization (that is,

[[Page 68937]]

has been approved or cleared by, or had a De Novo classification 
request granted by, the FDA) and that is part of the FDA's Breakthrough 
Devices Program would need to meet the cost criterion (that is, the 
medical device must be costly such that the DRG rate otherwise 
applicable to discharges involving the medical device is determined to 
be inadequate). To implement this proposal, we proposed to revise the 
existing regulations at 42 CFR 412.87. We use the application in order 
to determine if a technology meets the new technology criteria under 
the existing pathway, and would revise the application to reflect the 
information required to determine if a device meets the new technology 
criteria the proposed alternative pathway for certain devices. The 
revise application that would be used if the proposed alternative new 
technology add-on payment pathway for certain devices is finalized in 
the FY 2020 IPPS final rule, which is expected to be issued by August 
1, 2019. Form Number: CMS-10638 (OMB control number: 0938-1347); 
Frequency: Yearly; Affected Public: Private Sector: Business or Other 
for-profits, Not for-profit Institutions; Number of Respondents: 62; 
Total Annual Responses: 62; Total Annual Hours: 1,655. (For policy 
questions regarding this collection contact Michele Hudson at 410-786-
5490.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Physician 
Certifications/Recertifications in Skilled Nursing Facilities Manual 
Instructions; Use: Section 1814(a) of the Social Security Act (the Act) 
requires specific certifications in order for Medicare payments to be 
made for certain services. Before the enactment of the Omnibus Budget 
Reconciliation Act of 1989 (OBRA1989, Pub. L. 101-239), section 
1814(a)(2) of the Act required that, in the case of post-hospital 
extended care services, a physician certify that the services are or 
were required to be given because the individual needs or needed, on a 
daily basis, skilled nursing care (provided directly by or requiring 
the supervision of skilled nursing personnel) or other skilled 
rehabilitation services that, as a practical matter, can only be 
provided in a SNF on an inpatient basis. The physician certification 
requirements were included in the law to ensure that patients require a 
level of care that is covered by the Medicare program and because the 
physician is a key figure in determining the utilization of health 
services. In addition, it set forth qualification requirements that a 
nurse practitioner or clinical nurse specialist must meet in order to 
sign certification or recertification statements (these requirements 
were later revised in the Balanced Budget Act of 1997).
    Effective with items and services furnished on or after January 1, 
2011, section 3108 of the Affordable Care Act added physician 
assistants to the existing authority for nurse practitioners and 
clinical nurse specialists. Regulations implementing this provision 
were promulgated in the calendar year (CY) 2011 Medicare Physician Fee 
Schedule (MPFS) final rule with comment period (75 FR 73387, 73602, 
73626-27, November 29, 2010). The requirements at 42 CFR 424.20(a) and 
(b) concern the initial certification of a beneficiary's need for a SNF 
level of care, which must be made upon admission or as soon thereafter 
as is reasonable and practicable. The requirements at 42 CFR 424.20(c) 
and (d) concern recertification of a beneficiary's need for continued 
SNF level of care, and also require an estimate of the time the 
individual will need to remain in the SNF, plans for home treatment, 
and, if appropriate, whether continued services are needed for a 
condition that occurred after admission to the SNF and while still 
receiving treatment for the condition for which he or she had received 
inpatient hospital services. These sections require recertification at 
specific intervals (the initial recertification must occur no later 
than the 14th day of SNF care, with subsequent recertification at least 
every 30 days thereafter) that posthospital SNF care is or was required 
because the individual needs or needed skilled care on a daily basis. 
The following CMS internet-Only Manuals provide more detailed 
instructions regarding the required certification and recertification 
of covered post-hospital extended care services for a Medicare 
beneficiary: Chapter 4, sections 40ff and 80 in the Medicare General 
Information, Eligibility, and Entitlement Manual (CMS Pub. 100-01), 
chapter 8, sections 40ff. in the Medicare Benefit Policy Manual (CMS 
Pub. 100-02), and chapter 6, section 6.3 in the Medicare Program 
Integrity Manual (CMS Pub. 100-08). Form Number: CMS-R-5 (OMB control 
number: 0938-0454); Frequency: Occasionally; Affected Public: Private 
Sector (Not-for-profit institutions); Number of Respondents: 2,746,550; 
Total Annual Responses: 2,746,550; Total Annual Hours: 615,149. (For 
policy questions regarding this collection contact Kia Sidbury at 410-
786-7816.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Home Office Cost 
Statement; Use: Home offices of chain organizations vary greatly in 
size, number of locations, staff, mode of operations, and services 
furnished to the facilities in the chain. The home office of a chain is 
not in itself certified by Medicare. The relationship of the home 
office is that of a related organization to participating providers 
(See 42 CFR 413.17). When a provider claims costs on its cost report 
that are allocated from a home office, the Home Office Cost Statement 
constitutes the documentary support required of the provider to be 
reimbursed for home office costs in the provider's cost report. Each 
contractor servicing a provider in a chain must be furnished with a 
detailed Home Office Cost Statement as a basis for reimbursing the 
provider for cost allocations from a home office or chain organization. 
Home offices usually furnish central management and administrative 
services, e.g., centralized accounting, purchasing, personnel services, 
management direction and control, and other services. To the extent 
that the home office furnishes services related to patient care to a 
provider, the reasonable costs of such services are included in the 
provider's cost report and are reimbursable as part of the provider's 
costs. If the home office of the chain provides no services related to 
patient care, the costs of the home office may not be recognized in 
determining the allowable costs of the providers in the chain. Under 
the authority of sections 1815(a) and 1833(e) of the Social Security 
Act (42 U.S.C. 1395g), CMS requires that providers of services 
participating in the Medicare program submit information to determine 
costs for health care services rendered to Medicare beneficiaries. CMS 
requires that providers follow reasonable cost principles under 
1861(v)(1)(A) of the Act when completing the Medicare cost report. 
Under the regulations at 42 CFR 413.20 and 413.24, CMS defines adequate 
cost data and requires cost reports from providers on an annual basis. 
Providers receiving Medicare reimbursement must provide adequate cost 
data based on financial and statistical records, which can be verified 
by qualified auditors. The Form CMS-287-19 home office cost statement 
is needed to determine a provider's reasonable cost incurred in 
furnishing medical services to Medicare beneficiaries and reimbursement 
due to or from a provider. Form Number:

[[Page 68938]]

CMS-287-19 (OMB control number: 0938-0202); Frequency: Annually; 
Affected Public: Private Sector (Business or other for-profit and Not-
for-profit institutions); Number of Respondents: 1,507; Total Annual 
Responses: 1,507; Total Annual Hours: 702,262. (For policy questions 
regarding this collection contact Yaakov Feinstein at 410-786-3137.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Notification of 
FLS and CMS of Co-Located Medicare Providers; Use: Many long-term care 
hospitals (LTCHs) are co-located with other Medicare providers (acute 
care hospitals, inpatient rehabilitation facilities (IRFs), skilled 
nursing facilities (SNFs), inpatient psychiatric facilities (IPFs)), 
which could lead to potential gaming of the Medicare system based on 
inappropriate patient shifting. In regulations at 42 CFR 412.22(e)(3) 
and (h)(6) CMS requires LTCHs to notify Medicare Administrative 
Contractors (MACs) and CMS of co-located providers. The requirement 
regarding collection of information at Sec.  412.22 concerning a LTCH's 
(or a LTCH satellite's) notification to its MAC and CMS of its co-
located status is needed in order for Medicare to appropriately pay co-
located hospitals-within-hospitals (HwHs) and satellites. Under 
Sec. Sec.  412.22(e)(3) and (h)(6), an LTCH or a satellite of an LTCH 
that occupies space in a building used by another hospital, or in one 
or more entire buildings located on the same campus as buildings used 
by another hospital must notify its MAC and CMS in writing of its co-
location within 60 days of its first cost reporting period that began 
on or after October 1, 2002. Form Number: CMS-10088 (OMB control 
number: 0938-0897); Frequency: Yearly; Affected Public: Private Sector 
(Business or other for-profit, not-for-profit institutions); Number of 
Respondents: 25; Total Annual Responses: 25; Total Annual Hours: 6. 
(For policy questions regarding this collection contact Emily Lipkin at 
410-786-3633.)

    Dated: December 12, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-27139 Filed 12-16-19; 8:45 am]
 BILLING CODE 4120-01-P