83 FR 25012 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 105 (May 31, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 105 (May 31, 2018)
| Page Range | 25012-25013 | |
| FR Document | 2018-11492 |
[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)] [Notices] [Pages 25012-25013] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11492] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers CMS-10599] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. 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 July 30, 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-10599 Pre-Claim Review Demonstration for Home Health Services 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 requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Pre-Claim Review Demonstration for Home Health Services; Use: Section 402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)) authorizes the Secretary to ``develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act (the Act).'' Pursuant to this authority, the CMS seeks to develop and implement a Medicare demonstration project, which CMS believes will help assist in developing improved procedures for the identification, investigation, and prosecution of Medicare fraud occurring among Home Health Agencies (HHA) providing services to Medicare beneficiaries. This revised demonstration would help assist in developing improved procedures for the identification, investigation, and prosecution of potential Medicare fraud. The demonstration would help make sure that payments for home health services are appropriate through either pre- claim or postpayment review, thereby working towards the prevention and identification of potential fraud, waste, and abuse; the protection of Medicare Trust Funds from improper payments; and the reduction of Medicare appeals. CMS proposes initially implementing the demonstration in Illinois, Ohio, North Carolina, Florida, and Texas with the option to expand to other states in the Palmetto/JM jurisdiction. Under this demonstration, CMS proposes to offer choices for providers to demonstrate their compliance with CMS' home health policies. Providers in the demonstration states may participate in either 100 percent pre- claim review or 100 percent postpayment review. These providers will continue to be subject to a review method until the HHA reaches the target affirmation or claim approval rate. Once a HHA reaches the target pre-claim review affirmation or post-payment review claim approval rate, it may choose to be relieved from claim reviews, except for a spot check of their claims to ensure continued compliance. Providers who do not wish to participate in either 100 percent pre- claim or postpayment reviews have the option to furnish home health services and submit the associated claim for payment without undergoing such reviews; however, they will receive a 25 percent payment reduction on all claims [[Page 25013]] submitted for home health services and may be eligible for review by the Recovery Audit Contractors. The information required under this collection is required by Medicare contractors to determine proper payment or if there is a suspicion of fraud. Under the pre-claim review option, HHA will send the pre-claim review request along with all required documentation to the Medicare contractor for review prior to submitting the final claim for payment. If a claim is submitted without a pre-claim review decision one file, the Medicare contractor will request the information from the HHA to determine if payment is appropriate. For the postpayment review option, the Medicare contractor will also request the information from the HHA provider who submitted the claim for payment from the Medicare program to determine if payment was appropriate. Form Number: CMS-10599 (OMB control number: 0938-1311); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profits and Not-for-profits); Number of Respondents: 941,287; Total Annual Responses: 1,330,980; Total Annual Hours: 670,375. (For questions regarding this collection contact Jennifer McMullen (410) 786-7635). Dated: May 23, 2018. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2018-11492 Filed 5-29-18; 4:15 pm] BILLING CODE 4120-01-P
![25012 Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices
rates; clinic-specific discrepancy rates www.regulations.gov. Follow the Information Collection
are not reported. Any footnote added to instructions for ‘‘Comment or 1. Type of Information Collection
a clinic’s success rates page in the ART Submission’’ or ‘‘More Search Options’’ Request: Revision of a currently
Fertility Clinic Success Rates Report to find the information collection approved collection; Title of
will appear only for the reporting year document(s) that are accepting Information Collection: Pre-Claim
that the clinic was selected for comments. Review Demonstration for Home Health
validation; it will be removed the 2. By regular mail. You may mail Services; Use: Section 402(a)(1)(J) of the
following reporting year. written comments to the following Social Security Amendments of 1967
address: CMS, Office of Strategic (42 U.S.C. 1395b–1(a)(1)(J)) authorizes
Dated: May 24, 2018.
Operations and Regulatory Affairs, the Secretary to ‘‘develop or
Sandra Cashman,
Division of Regulations Development, demonstrate improved methods for the
Executive Secretary, Centers for Disease Attention: Document Identifier/OMB
Control and Prevention. investigation and prosecution of fraud
Control Number ll, Room C4–26–05,
[FR Doc. 2018–11628 Filed 5–30–18; 8:45 am] in the provision of care or services
7500 Security Boulevard, Baltimore,
under the health programs established
BILLING CODE 4163–18–P Maryland 21244–1850.
To obtain copies of a supporting by the Social Security Act (the Act).’’
statement and any related forms for the Pursuant to this authority, the CMS
DEPARTMENT OF HEALTH AND proposed collection(s) summarized in seeks to develop and implement a
HUMAN SERVICES this notice, you may make your request Medicare demonstration project, which
using one of following: CMS believes will help assist in
Centers for Medicare & Medicaid 1. Access CMS’ website address at developing improved procedures for the
Services https://www.cms.gov/Regulations-and- identification, investigation, and
[Document Identifiers CMS–10599] Guidance/Legislation/ prosecution of Medicare fraud occurring
PaperworkReductionActof1995/PRA- among Home Health Agencies (HHA)
Agency Information Collection Listing.html. providing services to Medicare
Activities: Proposed Collection; 2. Email your request, including your beneficiaries.
Comment Request address, phone number, OMB number, This revised demonstration would
and CMS document identifier, to help assist in developing improved
AGENCY: Centers for Medicare & Paperwork@cms.hhs.gov. procedures for the identification,
Medicaid Services, HHS. 3. Call the Reports Clearance Office at investigation, and prosecution of
ACTION: Notice. (410) 786–1326. potential Medicare fraud. The
FOR FURTHER INFORMATION CONTACT: demonstration would help make sure
SUMMARY: The Centers for Medicare & that payments for home health services
Medicaid Services (CMS) is announcing William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
are appropriate through either pre-claim
an opportunity for the public to or postpayment review, thereby working
comment on CMS’ intention to collect Contents towards the prevention and
information from the public. Under the identification of potential fraud, waste,
This notice sets out a summary of the
Paperwork Reduction Act of 1995 (the and abuse; the protection of Medicare
use and burden associated with the
PRA), federal agencies are required to Trust Funds from improper payments;
following information collections. More
publish notice in the Federal Register and the reduction of Medicare appeals.
detailed information can be found in
concerning each proposed collection of CMS proposes initially implementing
each collection’s supporting statement
information (including each proposed the demonstration in Illinois, Ohio,
and associated materials (see
extension or reinstatement of an existing North Carolina, Florida, and Texas with
ADDRESSES).
collection of information) and to allow the option to expand to other states in
60 days for public comment on the CMS–10599 Pre-Claim Review the Palmetto/JM jurisdiction. Under this
proposed action. Interested persons are Demonstration for Home Health demonstration, CMS proposes to offer
invited to send comments regarding our Services choices for providers to demonstrate
burden estimates or any other aspect of Under the PRA (44 U.S.C. 3501– their compliance with CMS’ home
this collection of information, including 3520), federal agencies must obtain health policies. Providers in the
the necessity and utility of the proposed approval from the Office of Management demonstration states may participate in
information collection for the proper and Budget (OMB) for each collection of either 100 percent pre-claim review or
performance of the agency’s functions, information they conduct or sponsor. 100 percent postpayment review. These
the accuracy of the estimated burden, The term ‘‘collection of information’’ is providers will continue to be subject to
ways to enhance the quality, utility, and defined in 44 U.S.C. 3502(3) and 5 CFR a review method until the HHA reaches
clarity of the information to be 1320.3(c) and includes agency requests the target affirmation or claim approval
collected, and the use of automated or requirements that members of the rate. Once a HHA reaches the target pre-
collection techniques or other forms of public submit reports, keep records, or claim review affirmation or post-
information technology to minimize the provide information to a third party. payment review claim approval rate, it
information collection burden. Section 3506(c)(2)(A) of the PRA may choose to be relieved from claim
DATES: Comments must be received by requires federal agencies to publish a reviews, except for a spot check of their
July 30, 2018. 60-day notice in the Federal Register claims to ensure continued compliance.
ADDRESSES: When commenting, please concerning each proposed collection of Providers who do not wish to
amozie on DSK3GDR082PROD with NOTICES1
reference the document identifier or information, including each proposed participate in either 100 percent pre-
OMB control number. To be assured extension or reinstatement of an existing claim or postpayment reviews have the
consideration, comments and collection of information, before option to furnish home health services
recommendations must be submitted in submitting the collection to OMB for and submit the associated claim for
any one of the following ways: approval. To comply with this payment without undergoing such
1. Electronically. You may send your requirement, CMS is publishing this reviews; however, they will receive a 25
comments electronically to http:// notice. percent payment reduction on all claims
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![Federal Register / Vol. 83, No. 105 / Thursday, May 31, 2018 / Notices 25013
submitted for home health services and an important consideration in benefit- between 9 a.m. and 4 p.m., Monday
may be eligible for review by the risk assessment. through Friday.
Recovery Audit Contractors. DATES: Submit either electronic or • Confidential Submissions—To
The information required under this written comments on the draft guidance submit a comment with confidential
collection is required by Medicare by July 30, 2018 to ensure that the information that you do not wish to be
contractors to determine proper Agency considers your comment on this made publicly available, submit your
payment or if there is a suspicion of draft guidance before it begins work on comments only as a written/paper
fraud. Under the pre-claim review the final version of the guidance. submission. You should submit two
option, HHA will send the pre-claim ADDRESSES: You may submit comments
copies total. One copy will include the
review request along with all required on any guidance at any time as follows: information you claim to be confidential
documentation to the Medicare with a heading or cover note that states
contractor for review prior to submitting Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
the final claim for payment. If a claim Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
is submitted without a pre-claim review following way: Agency will review this copy, including
decision one file, the Medicare • Federal eRulemaking Portal: the claimed confidential information, in
contractor will request the information https://www.regulations.gov. Follow the its consideration of comments. The
from the HHA to determine if payment instructions for submitting comments. second copy, which will have the
is appropriate. For the postpayment Comments submitted electronically, claimed confidential information
review option, the Medicare contractor including attachments, to https:// redacted/blacked out, will be available
will also request the information from www.regulations.gov will be posted to for public viewing and posted on
the HHA provider who submitted the the docket unchanged. Because your https://www.regulations.gov. Submit
claim for payment from the Medicare comment will be made public, you are both copies to the Dockets Management
program to determine if payment was solely responsible for ensuring that your Staff. If you do not wish your name and
appropriate. Form Number: CMS–10599 comment does not include any contact information to be made publicly
(OMB control number: 0938–1311); confidential information that you or a available, you can provide this
Frequency: Occasionally; Affected third party may not wish to be posted, information on the cover sheet and not
Public: Private Sector (Business or other such as medical information, your or in the body of your comments and you
for-profits and Not-for-profits); Number anyone else’s Social Security number, or must identify this information as
of Respondents: 941,287; Total Annual confidential business information, such ‘‘confidential.’’ Any information marked
Responses: 1,330,980; Total Annual as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Hours: 670,375. (For questions regarding that if you include your name, contact except in accordance with 21 CFR 10.20
this collection contact Jennifer information, or other information that and other applicable disclosure law. For
McMullen (410) 786–7635). identifies you in the body of your more information about FDA’s posting
Dated: May 23, 2018. comments, that information will be of comments to public dockets, see 80
William N. Parham, III, posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
Affairs. do not wish to be made available to the 23389.pdf.
[FR Doc. 2018–11492 Filed 5–29–18; 4:15 pm] public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
BILLING CODE 4120–01–P
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
DEPARTMENT OF HEALTH AND www.regulations.gov and insert the
Written/Paper Submissions docket number, found in brackets in the
HUMAN SERVICES
Submit written/paper submissions as heading of this document, into the
Food and Drug Administration follows: ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for and/or go to the Dockets Management
[Docket No. FDA–2018–D–1636] written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Rockville, MD 20852.
Assessment of Pressor Effects of You may submit comments on any
Drug Administration, 5630 Fishers
Drugs; Draft Guidance for Industry; guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
Availability
• For written/paper comments 10.115(g)(5)).
AGENCY: Food and Drug Administration, submitted to the Dockets Management Submit written requests for single
HHS. Staff, FDA will post your comment, as copies of the draft guidance to the
well as any attachments, except for Division of Drug Information, Center for
ACTION: Notice of availability.
information submitted, marked and Drug Evaluation and Research, Food
SUMMARY: The Food and Drug identified, as confidential, if submitted and Drug Administration, 10001 New
Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
announcing the availability of a draft Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
guidance for industry entitled must include the Docket No. FDA– 0002. Send one self-addressed adhesive
‘‘Assessment of Pressor Effects of 2018–D–1636] for ‘‘Assessment of label to assist that office in processing
amozie on DSK3GDR082PROD with NOTICES1
Drugs.’’ This guidance is intended to Pressor Effects of Drugs; Draft Guidance your requests. See the SUPPLEMENTARY
advise sponsors on the premarketing for Industry; Availability.’’ Received INFORMATION section for electronic
assessment of a drug’s effect on blood comments will be placed in the docket access to the draft guidance document.
pressure. Elevated blood pressure is and, except for those submitted as FOR FURTHER INFORMATION CONTACT:
known to increase the risk of stroke, ‘‘Confidential Submissions,’’ publicly Norman Stockbridge, Center for Drug
heart attack, and death. The effect of a viewable at https://www.regulations.gov Evaluation and Research, Food and
drug on blood pressure may therefore be or at the Dockets Management Staff Drug Administration, 10903 New
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Document Created: 2018-05-31 00:48:21
Document Modified: 2018-05-31 00:48:21
| 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 must be received by July 30, 2018. | |
| Contact | William Parham at (410) 786-4669. | |
| FR Citation | 83 FR 25012 |
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