[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50100-50102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21590]


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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: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human 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 (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

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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 November 5, 2018.

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 http://www.cms.hhs.gov/PaperworkReductionActof1995.
    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: 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: 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 Pub. L. 
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.

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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: September 28, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-21590 Filed 10-3-18; 8:45 am]
 BILLING CODE 4120-01-P