[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)]
[Notices]
[Pages 33223-33224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15169]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10008, CMS-R-234, and CMS-R-194]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates 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 must be received by September 17, 2018.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number _________, Room C4-26-05, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.
    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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: 

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10008 Eligibility of Drugs, Biologicals, and Radiopharmaceutical 
Agents for Transitional Pass-Through Status Under the Hospital 
Outpatient Prospective Payment System (OPPS)
CMS-R-234 Subpart D-Private Contracts
CMS-R-194 Medicare Disproportionate Share Adjustment Procedures and 
Criteria

    Under the 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 requires federal agencies 
to publish a 60-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

[[Page 33224]]

requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Reinstatement with a 
change of a previously approved collection; Title of Information 
Collection: Eligibility of Drugs, Biologicals, and Radiopharmaceutical 
Agents for Transitional Pass-Through Status Under the Hospital 
Outpatient Prospective Payment System (OPPS); Use: Section 201(b) of 
the BBRA 1999 amended section 1833(t) of the Act by adding new section 
1833(t)(6). This provision requires the Secretary to make additional 
payments to hospitals for a period of 2 to 3 years for certain drugs, 
radiopharmaceuticals, biological agents, medical devices and 
brachytherapy devices. Section 1833(t)(6)(A)(iv) establishes the 
criteria for determining the application of this provision to new 
items. Section 1833(t)(6)(C)(i) provides that the additional payment 
for drugs and biologicals be the amount by which the amount determined 
under section 1842(o) of the Act exceeds the portion of the otherwise 
applicable hospital outpatient department fee schedule amount that the 
Secretary determines to be associated with the drug or biological. 
Section 1833(t)(6)(D)(i) of the Act sets the payment rate for pass-
through eligible drugs and biologicals (assuming that no pro rata 
reduction in pass-through payment is necessary) as the amount 
determined under section 1842(o) of the Act. Section 303(c) of Public 
Law 108-173 amended Title XVIII of the Act by adding new section 1847A. 
This new section establishes the use of the average sales price (ASP) 
methodology for payment for drugs and biologicals described in section 
1842(o)(1)(C) of the Act furnished on or after January 1, 2005. 
Therefore, as we stated in the November 15, 2004 Federal Register (69 
FR 65776), in CY 2005, we will pay under the OPPS for drugs, 
biologicals and radiopharmaceuticals with pass-through status 
consistent with the provisions of section 1842(o) of the Act as amended 
by Public Law 108-173 at a rate that is equivalent to the payment these 
drugs and biologicals will receive in the physician office setting, and 
established in accordance with the methodology described in the CY 2005 
Physician Fee Schedule final rule. Information on Average Sales Price 
is found at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/. The 
intent of these provisions is to ensure that timely beneficiary access 
to new pharmacological technologies is not jeopardized by inadequate 
payment levels. Form Number: CMS-10008 (OMB Control Number 0938-0802); 
Frequency: Yearly; Affected Public: Private sector (Business or other 
for-profits); Number of Respondents: 30; Total Annual Responses: 30; 
Total Annual Hours: 480. (For policy questions regarding this 
collection contact Raymond Bulls at 410-786-7267).
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Subpart D--
Private Contracts; Use: Section 4507 of the Balanced Budget Act of 1997 
(BBA 1997) amended section 1802 of the Social Security Act (the Act) to 
permit certain physicians and practitioners to opt-out of Medicare and 
to provide through private contracts services that would otherwise be 
covered by Medicare. Under such contracts the mandatory claims 
submission and limiting charge rules of section 1848(g) of the Act 
would not apply. Subpart D and the supporting regulations contained in 
42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455, 
counters the effect of certain provisions of Medicare law that, absent 
section 1802 of the Act, preclude physicians and practitioners from 
contracting privately with Medicare beneficiaries to pay without regard 
to Medicare limits. The most recent approval of this information 
collection request (ICR) was issued by the Office of Management and 
Budget on March 2, 2016. We are now seeking to renew this approval 
before it expires on March 31, 2019. We have made no changes to the 
information being collected. We updated our burden estimate to reflect 
changes in the number of physicians and practitioners who have opted 
out and refinements to our methodology for estimating the burden 
associated with contracts. We have also updated the cost estimate to 
account for the current Bureau of Labor Statistics (BLS) wage estimates 
and to include the estimated costs for Medicare Advantage plans. Form 
Number: CMS-R-234 (OMB Control Number 0938-0730); Frequency: Yearly; 
Affected Public: Private sector (Business or other for-profits); Number 
of Respondents: 57,722; Total Annual Responses: 57,722; Total Annual 
Hours: 23,557. (For policy questions regarding this collection contact 
Frederick Grabau at 410-786-0206).
    3. Type of Information Collection Request: Reinstatement without a 
change of a previously approved collection; Title of Information 
Collection: Medicare Disproportionate Share Adjustment Procedures and 
Criteria; Use: Section 1886(d)(5)(F) of the Social Security Act 
established the Medicare disproportionate share adjustment (DSH) for 
hospitals, which provides additional payment to hospitals that serve a 
disproportionate share of the indigent patient population. This payment 
is an add-on to the set amount per case the Centers for Medicare and 
Medicaid Services (CMS) pays to hospitals under the Medicare Inpatient 
Prospective Payment System (IPPS). Under current regulations at 42 CFR 
412.106, in order to meet the qualifying criteria for this additional 
DSH payment, a hospital must prove that a disproportionate percentage 
of its patients are low income using Supplemental Security Income (SSI) 
and Medicaid as proxies for this determination. This percentage 
includes two computations: (1) The ``Medicare fraction'' or the ``SSI 
ratio'' which is the percent of patient days for beneficiaries who are 
eligible for Medicare Part A and SSI and (2) the ``Medicaid fraction'' 
which is the percent of patient days for patients who are eligible for 
Medicaid but not Medicare. Once a hospital qualifies for this DSH 
payment, CMS also determines a hospital's payment adjustment based on 
these two fractions. 42 CFR 412.106 allows hospitals to request that 
the Medicare fraction of the DSH adjustment be calculated on a cost 
reporting basis rather than a federal fiscal year. Once requested, the 
hospital must accept the result irrespective of whether it increases or 
decreases their DSH payment. The routine use procedure and the DUA 
allows hospitals to request the detailed Medicare data so they can make 
an informed choice before deciding whether to request that the Medicare 
fraction be calculated on the basis of a cost reporting period rather 
than a federal fiscal year. Form Number: CMS-R-194 (OMB Control Number 
0938-0691); Frequency: Yearly; Affected Public: Private sector 
(Business or other for-profits); Number of Respondents: 800; Total 
Annual Responses: 800; Total Annual Hours: 400. (For policy questions 
regarding this collection contact Emily Lipkin at 410-786-3633).

    Dated: July 11, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-15169 Filed 7-16-18; 8:45 am]
 BILLING CODE 4120-01-P