83_FR_50293 83 FR 50100 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

83 FR 50100 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 193 (October 4, 2018)

Page Range50100-50102
FR Document2018-21590

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.

Federal Register, Volume 83 Issue 193 (Thursday, October 4, 2018)
[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50100-50102]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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

[[Page 50101]]

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: 
OIRA_submission@omb.eop.gov.
    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 Paperwork@cms.hhs.gov.
    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.

[[Page 50102]]

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



                                               50100                        Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices

                                               burden estimates or any other aspect of                 CMS–10391 Methods for Assuring                        Medicaid program, and to inform any
                                               this collection of information, including               Access to Covered Medicaid Services                   necessary programmatic changes to
                                               the necessity and utility of the proposed               Under 42 CFR 447.203 and 447.204                      address issues with access to care. CMS
                                               information collection for the proper                     Under the PRA (44 U.S.C. 3501–                      uses the information to make informed
                                               performance of the agency’s functions,                  3520), federal agencies must obtain                   approval decisions on State plan
                                               the accuracy of the estimated burden,                   approval from the Office of Management                amendments that propose to make
                                               ways to enhance the quality, utility, and               and Budget (OMB) for each collection of               Medicaid rate reductions or restructure
                                               clarity of the information to be                        information they conduct or sponsor.                  payment rates and to provide the
                                               collected, and the use of automated                     The term ‘‘collection of information’’ is             necessary information for CMS to
                                               collection techniques or other forms of                                                                       monitor ongoing compliance with
                                                                                                       defined in 44 U.S.C. 3502(3) and 5 CFR
                                               information technology to minimize the                                                                        section 1902(a)(30)(A). Beneficiaries,
                                                                                                       1320.3(c) and includes agency requests
                                               information collection burden.                                                                                providers and other affected
                                                                                                       or requirements that members of the
                                                                                                                                                             stakeholders may use the information to
                                                    Comments must be received by
                                               DATES:                                                  public submit reports, keep records, or
                                                                                                                                                             raise access issues to state Medicaid
                                               December 3, 2018.                                       provide information to a third party.
                                                                                                                                                             agencies and work with agencies to
                                                                                                       Section 3506(c)(2)(A) of the PRA
                                               ADDRESSES:   When commenting, please                                                                          address those issues. Form Number:
                                                                                                       requires federal agencies to publish a
                                               reference the document identifier or                                                                          CMS–10391 (OMB control number:
                                                                                                       60-day notice in the Federal Register
                                               OMB control number. To be assured                                                                             0938–1134); Frequency: Annually;
                                                                                                       concerning each proposed collection of
                                               consideration, comments and                                                                                   Affected Public: State, Local, or Tribal
                                                                                                       information, including each proposed
                                               recommendations must be submitted in                                                                          Governments); Number of Respondents:
                                                                                                       extension or reinstatement of an existing
                                               any one of the following ways:                                                                                51; Number of Responses: 212; Total
                                                                                                       collection of information, before
                                                                                                                                                             Annual Hours: 12,262. (For questions
                                                 1. Electronically. You may send your                  submitting the collection to OMB for
                                                                                                                                                             regarding this collection contact Jeremy
                                               comments electronically to http://                      approval. To comply with this
                                                                                                                                                             Silanskis at 410–786–1592.)
                                               www.regulations.gov. Follow the                         requirement, CMS is publishing this
                                               instructions for ‘‘Comment or                           notice.                                                  Dated: September 28, 2018.
                                               Submission’’ or ‘‘More Search Options’’                                                                       William N. Parham, III,
                                                                                                       Information Collection                                Director, Paperwork Reduction Staff, Office
                                               to find the information collection
                                               document(s) that are accepting                             1. Title of Information Collection:                of Strategic Operations and Regulatory
                                               comments.                                               Methods for Assuring Access to Covered                Affairs.
                                                                                                       Medicaid Services Under 42 CFR                        [FR Doc. 2018–21587 Filed 10–3–18; 8:45 am]
                                                 2. By regular mail. You may mail
                                                                                                       447.203 and 447.204; Type of                          BILLING CODE 4120–01–P
                                               written comments to the following
                                                                                                       Information Collection Request:
                                               address: CMS, Office of Strategic
                                                                                                       Extension of a currently approved
                                               Operations and Regulatory Affairs,                                                                            DEPARTMENT OF HEALTH AND
                                                                                                       collection; Use: Current regulations at
                                               Division of Regulations Development,                                                                          HUMAN SERVICES
                                                                                                       42 CFR 447.203(b) require states to
                                               Attention: Document Identifier/OMB
                                                                                                       develop an access monitoring review
                                               Control Number _____, Room C4–26–05,                                                                          Centers for Medicare & Medicaid
                                                                                                       plan (AMRP) that is updated at least
                                               7500 Security Boulevard, Baltimore,                                                                           Services
                                                                                                       every three years for: Primary care
                                               Maryland 21244–1850.
                                                                                                       services, physician specialist services,              [Document Identifier: CMS–10008, CMS–R–
                                                 To obtain copies of a supporting                      behavioral health services, pre and post-             234, and CMS–R–194]
                                               statement and any related forms for the                 natal obstetric services (including labor
                                               proposed collection(s) summarized in                    and delivery), and home health services.              Agency Information Collection
                                               this notice, you may make your request                  When states reduce rates for other                    Activities: Submission for OMB
                                               using one of following:                                 Medicaid services, they must add those                Review; Comment Request
                                                 1. Access CMS’ website address at                     services to the AMRP and monitor the                  AGENCY: Centers for Medicare &
                                               https://www.cms.gov/Regulations-and-                    effects of the rate reductions for 3 years.           Medicaid Services, Department of
                                               Guidance/Legislation/Paperwork                          If access issues are detected, a state                Health and Human Services.
                                               ReductionActof1995/PRA-Listing.html.                    must submit a corrective action plan to               ACTION: Notice.
                                                 2. Email your request, including your                 CMS within 90 days and work to
                                               address, phone number, OMB number,                      address the issues within 12 months.                  SUMMARY:    The Centers for Medicare &
                                               and CMS document identifier, to                         Section 447.203(b)(7) requires that states            Medicaid Services (CMS) is announcing
                                               Paperwork@cms.hhs.gov.                                  have mechanisms to obtain ongoing                     an opportunity for the public to
                                                                                                       beneficiary and provider feedback. A                  comment on CMS’ intention to collect
                                                 3. Call the Reports Clearance Office at               state is also required to maintain a                  information from the public. Under the
                                               (410) 786–1326.                                         record of data on public input and how                Paperwork Reduction Act of 1995
                                               FOR FURTHER INFORMATION CONTACT:                        the state responded to the input. Prior               (PRA), federal agencies are required to
                                               William Parham at (410) 786–1326.                       to submitting proposals to reduce or                  publish notice in the Federal Register
                                                                                                       restructure Medicaid service payment                  concerning each proposed collection of
                                               SUPPLEMENTARY INFORMATION:                              rates, states must receive input from                 information, including each proposed
                                               Contents                                                beneficiaries, providers, and other                   extension or reinstatement of an existing
                                                                                                       affected stakeholders on the extent of                collection of information, and to allow
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                                                 This notice sets out a summary of the                 beneficiary access to the affected                    a second opportunity for public
                                               use and burden associated with the                      services.                                             comment on the notice. Interested
                                               following information collections. More                    The information is used by states to               persons are invited to send comments
                                               detailed information can be found in                    document that access to care is in                    regarding the burden estimate or any
                                               each collection’s supporting statement                  compliance with section 1902(a)(30)(A)                other aspect of this collection of
                                               and associated materials (see                           of the Social Security Act, to identify               information, including the necessity and
                                               ADDRESSES).                                             issues with access within a state’s                   utility of the proposed information


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                                                                            Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices                                         50101

                                               collection for the proper performance of                a previously approved collection; Title               Annual Hours: 480. (For policy
                                               the agency’s functions, the accuracy of                 of Information Collection: Eligibility of             questions regarding this collection
                                               the estimated burden, ways to enhance                   Drugs, Biologicals, and                               contact Raymond Bulls at 410–786–
                                               the quality, utility, and clarity of the                Radiopharmaceutical Agents for                        7267).
                                               information to be collected, and the use                Transitional Pass-Through Status Under                   2. Type of Information Collection
                                               of automated collection techniques or                   the Hospital Outpatient Prospective                   Request: Extension of a currently
                                               other forms of information technology to                Payment System (OPPS); Use: Section                   approved collection; Title of
                                               minimize the information collection                     201(b) of the BBRA 1999 amended                       Information Collection: Subpart D—
                                               burden.                                                 section 1833(t) of the Act by adding new              Private Contracts; Use: Section 4507 of
                                               DATES: Comments on the collection(s) of                 section 1833(t)(6). This provision                    the Balanced Budget Act of 1997 (BBA
                                               information must be received by the                     requires the Secretary to make                        1997) amended section 1802 of the
                                               OMB desk officer by November 5, 2018.                   additional payments to hospitals for a                Social Security Act (the Act) to permit
                                                                                                       period of 2 to 3 years for certain drugs,             certain physicians and practitioners to
                                               ADDRESSES: When commenting on the
                                                                                                       radiopharmaceuticals, biological agents,              opt-out of Medicare and to provide
                                               proposed information collections,                                                                             through private contracts services that
                                               please reference the document identifier                medical devices and brachytherapy
                                                                                                       devices. Section 1833(t)(6)(A)(iv)                    would otherwise be covered by
                                               or OMB control number. To be assured                                                                          Medicare. Under such contracts the
                                               consideration, comments and                             establishes the criteria for determining
                                                                                                       the application of this provision to new              mandatory claims submission and
                                               recommendations must be received by                                                                           limiting charge rules of section 1848(g)
                                               the OMB desk officer via one of the                     items. Section 1833(t)(6)(C)(i) provides
                                                                                                                                                             of the Act would not apply. Subpart D
                                               following transmissions: OMB, Office of                 that the additional payment for drugs
                                                                                                                                                             and the supporting regulations
                                               Information and Regulatory Affairs,                     and biologicals be the amount by which
                                                                                                                                                             contained in 42 CFR 405.410, 405.430,
                                               Attention: CMS Desk Officer, Fax                        the amount determined under section
                                                                                                                                                             405.435, 405.440, 405.445, and 405.455,
                                               Number: (202) 395–5806 or Email:                        1842(o) of the Act exceeds the portion
                                                                                                                                                             counters the effect of certain provisions
                                               OIRA_submission@omb.eop.gov.                            of the otherwise applicable hospital
                                                                                                                                                             of Medicare law that, absent section
                                                 To obtain copies of a supporting                      outpatient department fee schedule
                                                                                                                                                             1802 of the Act, preclude physicians
                                               statement and any related forms for the                 amount that the Secretary determines to
                                                                                                                                                             and practitioners from contracting
                                               proposed collection(s) summarized in                    be associated with the drug or
                                                                                                                                                             privately with Medicare beneficiaries to
                                               this notice, you may make your request                  biological. Section 1833(t)(6)(D)(i) of the           pay without regard to Medicare limits.
                                               using one of following:                                 Act sets the payment rate for pass-                   The most recent approval of this
                                                 1. Access CMS’ website address at                     through eligible drugs and biologicals                information collection request (ICR) was
                                               http://www.cms.hhs.gov/Paperwork                        (assuming that no pro rata reduction in               issued by the Office of Management and
                                               ReductionActof1995.                                     pass-through payment is necessary) as                 Budget on March 2, 2016. We are now
                                                 2. Email your request, including your                 the amount determined under section                   seeking to renew this approval before it
                                               address, phone number, OMB number,                      1842(o) of the Act. Section 303(c) of                 expires on March 31, 2019. We have
                                               and CMS document identifier, to                         Pub. L. 108–173 amended Title XVIII of                made no changes to the information
                                               Paperwork@cms.hhs.gov.                                  the Act by adding new section 1847A.                  being collected. We updated our burden
                                                 3. Call the Reports Clearance Office at               This new section establishes the use of               estimate to reflect changes in the
                                               (410) 786–1326.                                         the average sales price (ASP)                         number of physicians and practitioners
                                               FOR FURTHER INFORMATION CONTACT:                        methodology for payment for drugs and                 who have opted out and refinements to
                                               William Parham at (410) 786–4669.                       biologicals described in section                      our methodology for estimating the
                                               SUPPLEMENTARY INFORMATION: Under the                    1842(o)(1)(C) of the Act furnished on or              burden associated with contracts. We
                                               Paperwork Reduction Act of 1995 (PRA)                   after January 1, 2005. Therefore, as we               have also updated the cost estimate to
                                               (44 U.S.C. 3501–3520), federal agencies                 stated in the November 15, 2004 Federal               account for the current Bureau of Labor
                                               must obtain approval from the Office of                 Register (69 FR 65776), in CY 2005, we                Statistics (BLS) wage estimates and to
                                               Management and Budget (OMB) for each                    will pay under the OPPS for drugs,                    include the estimated costs for Medicare
                                               collection of information they conduct                  biologicals and radiopharmaceuticals                  Advantage plans. Form Number: CMS–
                                               or sponsor. The term ‘‘collection of                    with pass-through status consistent with              R–234 (OMB control number 0938–
                                               information’’ is defined in 44 U.S.C.                   the provisions of section 1842(o) of the              0730); Frequency: Yearly; Affected
                                               3502(3) and 5 CFR 1320.3(c) and                         Act as amended by Public Law 108–173                  Public: Private sector (Business or other
                                               includes agency requests or                             at a rate that is equivalent to the                   for-profits); Number of Respondents:
                                               requirements that members of the public                 payment these drugs and biologicals                   57,722; Total Annual Responses:
                                               submit reports, keep records, or provide                will receive in the physician office                  57,722; Total Annual Hours: 23,557.
                                               information to a third party. Section                   setting, and established in accordance                (For policy questions regarding this
                                               3506(c)(2)(A) of the PRA (44 U.S.C.                     with the methodology described in the                 collection contact Frederick Grabau at
                                               3506(c)(2)(A)) requires federal agencies                CY 2005 Physician Fee Schedule final                  410–786–0206).
                                               to publish a 30-day notice in the                       rule. Information on Average Sales Price                 3. Type of Information Collection
                                               Federal Register concerning each                        is found at http://www.cms.hhs.gov/                   Request: Reinstatement without a
                                               proposed collection of information,                     McrPartBDrugAvgSalesPrice/. The                       change of a previously approved
                                               including each proposed extension or                    intent of these provisions is to ensure               collection; Title of Information
                                               reinstatement of an existing collection                 that timely beneficiary access to new                 Collection: Medicare Disproportionate
                                               of information, before submitting the                   pharmacological technologies is not                   Share Adjustment Procedures and
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                                               collection to OMB for approval. To                      jeopardized by inadequate payment                     Criteria; Use: Section 1886(d)(5)(F) of
                                               comply with this requirement, CMS is                    levels. Form Number: CMS–10008                        the Social Security Act established the
                                               publishing this notice that summarizes                  (OMB control number 0938–0802);                       Medicare disproportionate share
                                               the following proposed collection(s) of                 Frequency: Yearly; Affected Public:                   adjustment (DSH) for hospitals, which
                                               information for public comment:                         Private sector (Business or other for-                provides additional payment to
                                                 1. Type of Information Collection                     profits); Number of Respondents: 30;                  hospitals that serve a disproportionate
                                               Request: Reinstatement with a change of                 Total Annual Responses: 30; Total                     share of the indigent patient population.


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                                               50102                        Federal Register / Vol. 83, No. 193 / Thursday, October 4, 2018 / Notices

                                               This payment is an add-on to the set                    DEPARTMENT OF HEALTH AND                              anyone else’s Social Security number, or
                                               amount per case the Centers for                         HUMAN SERVICES                                        confidential business information, such
                                               Medicare and Medicaid Services (CMS)                                                                          as a manufacturing process. Please note
                                               pays to hospitals under the Medicare                    Food and Drug Administration                          that if you include your name, contact
                                               Inpatient Prospective Payment System                    [Docket No. FDA–2014–N–1721]                          information, or other information that
                                               (IPPS). Under current regulations at 42                                                                       identifies you in the body of your
                                               CFR 412.106, in order to meet the                       Agency Information Collection                         comments, that information will be
                                               qualifying criteria for this additional                 Activities; Proposed Collection;                      posted on https://www.regulations.gov.
                                                                                                       Comment Request; Investigational                        • If you want to submit a comment
                                               DSH payment, a hospital must prove
                                                                                                       New Drug Applications                                 with confidential information that you
                                               that a disproportionate percentage of its
                                                                                                                                                             do not wish to be made available to the
                                               patients are low income using                           AGENCY:    Food and Drug Administration,              public, submit the comment as a
                                               Supplemental Security Income (SSI)                      HHS.                                                  written/paper submission and in the
                                               and Medicaid as proxies for this                        ACTION:   Notice.                                     manner detailed (see ‘‘Written/Paper
                                               determination. This percentage includes                                                                       Submissions’’ and ‘‘Instructions’’).
                                               two computations: (1) The ‘‘Medicare                    SUMMARY:    The Food and Drug
                                               fraction’’ or the ‘‘SSI ratio’’ which is the            Administration (FDA, Agency, or we) is                Written/Paper Submissions
                                               percent of patient days for beneficiaries               announcing an opportunity for public                     Submit written/paper submissions as
                                               who are eligible for Medicare Part A and                comment on the proposed collection of                 follows:
                                               SSI and (2) the ‘‘Medicaid fraction’’                   certain information by the Agency.                       • Mail/Hand delivery/Courier (for
                                                                                                       Under the Paperwork Reduction Act of                  written/paper submissions): Dockets
                                               which is the percent of patient days for
                                                                                                       1995 (PRA), Federal Agencies are                      Management Staff (HFA–305), Food and
                                               patients who are eligible for Medicaid                  required to publish notice in the
                                               but not Medicare. Once a hospital                                                                             Drug Administration, 5630 Fishers
                                                                                                       Federal Register concerning each                      Lane, Rm. 1061, Rockville, MD 20852.
                                               qualifies for this DSH payment, CMS                     proposed collection of information,                      • For written/paper comments
                                               also determines a hospital’s payment                    including each proposed extension of an               submitted to the Dockets Management
                                               adjustment based on these two fractions.                existing collection of information, and               Staff, FDA will post your comment, as
                                               42 CFR 412.106 allows hospitals to                      to allow 60 days for public comment in                well as any attachments, except for
                                               request that the Medicare fraction of the               response to the notice. This notice                   information submitted, marked and
                                               DSH adjustment be calculated on a cost                  solicits comments on regulations under                identified, as confidential, if submitted
                                               reporting basis rather than a federal                   which the clinical investigation of the               as detailed in ‘‘Instructions.’’
                                               fiscal year. Once requested, the hospital               safety and effectiveness of unapproved                   Instructions: All submissions received
                                               must accept the result irrespective of                  new drugs and biological products can                 must include the Docket No. FDA–
                                               whether it increases or decreases their                 be conducted.                                         2014–N–1721 for ‘‘Agency Information
                                               DSH payment. The routine use                            DATES: Submit either electronic or                    Collection Activities; Proposed
                                               procedure and the DUA allows hospitals                  written comments on the collection of                 Collection; Comment Request;
                                               to request the detailed Medicare data so                information by December 3, 2018.                      Investigational New Drug
                                               they can make an informed choice                        ADDRESSES: You may submit comments                    Applications.’’ Received comments,
                                               before deciding whether to request that                 as follows. Please note that late,                    those filed in a timely manner (see
                                               the Medicare fraction be calculated on                  untimely filed comments will not be                   ADDRESSES), will be placed in the docket
                                               the basis of a cost reporting period                    considered. Electronic comments must                  and, except for those submitted as
                                               rather than a federal fiscal year. Form                 be submitted on or before December 3,                 ‘‘Confidential Submissions,’’ publicly
                                               Number: CMS–R–194 (OMB control                          2018. The https://www.regulations.gov                 viewable at https://www.regulations.gov
                                               number 0938–0691); Frequency: Yearly;                   electronic filing system will accept                  or at the Dockets Management Staff
                                               Affected Public: Private sector (Business               comments until 11:59 p.m. Eastern Time                between 9 a.m. and 4 p.m., Monday
                                                                                                       at the end of December 3, 2018.                       through Friday.
                                               or other for-profits); Number of
                                                                                                       Comments received by mail/hand                           • Confidential Submissions—To
                                               Respondents: 800; Total Annual                                                                                submit a comment with confidential
                                               Responses: 800; Total Annual Hours:                     delivery/courier (for written/paper
                                                                                                       submissions) will be considered timely                information that you do not wish to be
                                               400. (For policy questions regarding this                                                                     made publicly available, submit your
                                               collection contact Emily Lipkin at 410–                 if they are postmarked or the delivery
                                                                                                       service acceptance receipt is on or                   comments only as a written/paper
                                               786–3633.)                                                                                                    submission. You should submit two
                                                                                                       before that date.
                                                  Dated: September 28, 2018.                                                                                 copies total. One copy will include the
                                                                                                       Electronic Submissions                                information you claim to be confidential
                                               William N. Parham, III,
                                                                                                         Submit electronic comments in the                   with a heading or cover note that states
                                               Director, Paperwork Reduction Staff, Office
                                               of Strategic Operations and Regulatory                  following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                               Affairs.                                                  • Federal eRulemaking Portal:                       CONFIDENTIAL INFORMATION.’’ The
                                               [FR Doc. 2018–21590 Filed 10–3–18; 8:45 am]
                                                                                                       https://www.regulations.gov. Follow the               Agency will review this copy, including
                                                                                                       instructions for submitting comments.                 the claimed confidential information, in
                                               BILLING CODE 4120–01–P
                                                                                                       Comments submitted electronically,                    its consideration of comments. The
                                                                                                       including attachments, to https://                    second copy, which will have the
                                                                                                       www.regulations.gov will be posted to                 claimed confidential information
daltland on DSKBBV9HB2PROD with NOTICES




                                                                                                       the docket unchanged. Because your                    redacted/blacked out, will be available
                                                                                                       comment will be made public, you are                  for public viewing and posted on
                                                                                                       solely responsible for ensuring that your             https://www.regulations.gov. Submit
                                                                                                       comment does not include any                          both copies to the Dockets Management
                                                                                                       confidential information that you or a                Staff. If you do not wish your name and
                                                                                                       third party may not wish to be posted,                contact information to be made publicly
                                                                                                       such as medical information, your or                  available, you can provide this


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Document Created: 2018-10-04 02:03:08
Document Modified: 2018-10-04 02:03:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on the collection(s) of information must be received by the OMB desk officer by November 5, 2018.
ContactWilliam Parham at (410) 786-4669.
FR Citation83 FR 50100 

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