[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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