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)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 193 (October 4, 2018)
| Page Range | 50100-50102 | |
| FR Document | 2018-21590 |
[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] ----------------------------------------------------------------------- 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
daltland on DSKBBV9HB2PROD with NOTICES
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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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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on the collection(s) of information must be received by the OMB desk officer by November 5, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 50100 |
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