Notice2025-18506
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 24, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 183 (Wednesday, September 24, 2025)</title>
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[Federal Register Volume 90, Number 183 (Wednesday, September 24, 2025)]
[Notices]
[Pages 45941-45942]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18506]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10749, CMS-855O, CMS-10328, CMS-10148 and
CMS-10572]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (PRA), federal agencies are required to publish notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension or reinstatement of an
existing collection of information, and to allow a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate or any other aspect of this
collection of information, including the necessity and utility of the
proposed information 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 October 24, 2025.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>.
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 without
change of a previously approved collection; Title of Information
Collection: National Plan and Provider Enumeration System (NPPES)
Supplemental Data Collection; Use: The adoption by the Secretary of HHS
of the standard unique health identifier for health care providers is a
requirement of the Health Insurance Portability and Accountability Act
of 1996 (HIPAA). The unique identifier is to be used on standard
transactions and may be used for other lawful purposes in the health
care system. The CMS Final Rule published on January 23, 2004 adopts
the National Provider Identifier (NPI) as the standard unique health
identifier for health care providers. Health care providers that are
covered entities under HIPAA must apply for and use NPIs in standard
transactions. The law requires that data collection standards for these
measures be used, to the extent that it is practical, in all national
population health surveys. It applies to self-reported optional
information only. The law also requires any data standards published by
HHS to comply with standards created by the Office of Management and
Budget (OMB).
The web based optional data fields can be seen in Appendix A1: Data
Collected for the Office of Minority and Appendix A2: Data collected
for the 21st Century Cures Act, interoperability. The standards apply
to population health surveys sponsored by HHS, where respondents either
self-report information or a knowledgeable person responds for all
members of a household. HHS is implementing these data standards in all
new surveys. Form Number: CMS-10749 (OMB control number: 0938-1427);
Frequency: Yearly; Affected Public: Private Sector, Business or other
for-profits, Not-for-profit institutions; Number of Respondents:
545,648; Total Annual Responses: 545,648; Total Annual Hours: 92,760.
(For policy questions regarding this collection contact Nora Simmons at
410-786-1981.)
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare
Registration Application; Use: Various sections of the Social Security
Act (Act), the United States Code (U.S.C.), Internal Revenue Service
Code (Code) and the Code of Federal Regulations (CFR) require providers
and suppliers to furnish information concerning the amounts due and the
identification of individuals or entities that furnish medical services
to beneficiaries before allowing payment. The principal function of the
CMS-855O is to gather information from a physician or other eligible
professional to help CMS determine whether he or she meets certain
qualifications to enroll in the Medicare program for the sole purpose
of ordering or certifying certain Medicare items or services. The CMS-
855O allows a physician or other eligible professional to enroll in
Medicare without approval for billing privileges.
The collection and verification of this information protects our
beneficiaries from illegitimate providers/suppliers. These procedures
also protect the Medicare Trust Funds against fraud. The CMS-855O
gathers information that allow Medicare contractors to ensure that the
physician or eligible professional is not sanctioned from the Medicare
and/or Medicaid program(s), or debarred, or excluded from any other
Federal agency or program. Furthermore, the data collected also ensures
that the applicant has the necessary credentials to order and certify
health care services. This is the
[[Page 45942]]
sole instrument implemented for this purpose. Form Number: CMS-855O
(OMB control number 0938-1135); Frequency: Occasionally; Affected
Public: Private Sector (Business or other for-profits), State, Local,
or Tribal Governments; Number of Respondents: 2,250; Number of
Responses: 2,250; Total Annual Hours: 1,125. (For policy questions
regarding this collection contact Frank Whelan at 410-786-1302).
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Self-
Referral Disclosure Protocol; Use: Section 6409 of the ACA requires the
Secretary to establish a voluntary self-disclosure process that allows
providers of services and suppliers to self-disclose actual or
potential violations of section 1877 of the Act. The SRDP is a
voluntary self-disclosure process that allows providers of services and
suppliers to disclose actual or potential violations of section 1877 of
the Act. For purposes of the SRDP, a person submitting a disclosure to
the SRDP will be referred to as a ``disclosing party.'' CMS analyzes
the disclosed conduct to determine compliance with section 1877 of the
Act and the application of the exceptions to the physician self-
referral prohibition.
Specifically, under the proposal a physician practice disclosing
group practice noncompliance will submit an SRDP form consisting of the
following components: (1) the SRDP Disclosure Form, (2) a single Group
Practice Information Form covering all the physicians in the practice
who made prohibited referrals to the practice, and (3) a Financial
Analysis Worksheet. All other entities will continue to submit
disclosures using the SRDP Disclosure Form, separate Physician
Information Forms for each physician covered in the self-disclosure,
and a Financial Analysis Worksheet. Form Number: CMS-10328 (OMB control
number: 0938-1106); Frequency: Yearly; Affected Public: Private Sector
(Business or other for-profits, Not-for-Profit Institutions); Number of
Respondents: 100; Total Annual Responses: 100; Total Annual Hours:
4,950. (For policy questions regarding this collection contact Caitlin
Bailey at 410-786-9768.)
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: HIPAA
Administrative Simplification (Non-Privacy/Security) Complaint Form;
Use: The Secretary of Health and Human Services (HHS), hereafter known
as ``The Secretary,'' codified 45 CFR parts 160 and 164 Administrative
Simplification provisions that apply to the enforcement of the Health
Insurance Portability and Accountability Act of 1996 Public Law 104-191
(HIPAA). The provisions address rules relating to the investigation of
non-compliance of the HIPAA Administrative Simplification code sets,
unique identifiers, operating rules, and transactions. 45 CFR 160.306,
Complaints to the Secretary, provides for investigations of covered
entities by the Secretary. Further, it outlines the procedures and
requirements for filing a complaint against a covered entity.
Anyone can file a complaint if he or she suspects a potential
violation. Persons believing that a covered entity is not utilizing the
adopted Administrative Simplification provisions of HIPAA are
voluntarily requested to file a complaint with CMS via the
Administrative Simplification Enforcement and Testing Tool (ASETT)
online system, by mail, or by sending an email to the HIPAA mailbox at
<a href="/cdn-cgi/l/email-protection#0b63627b6a6a6864667b676a62657f4b68667825636378256c647d"><span class="__cf_email__" data-cfemail="96feffe6f7f7f5f9fbe6faf7fff8e2d6f5fbe5b8fefee5b8f1f9e0">[email protected]</span></a>. Information provided on the standard form
will be used during the investigation process to validate non-
compliance of HIPAA Administrative Simplification provisions.
This standard form collects identifying and contact information of
the complainant, as well as the identifying and contact information of
the filed against entity (FAE). This information enables CMS to respond
to the complainant and gather more information if necessary, and to
contact the FAE to discuss the complaint and CMS' findings. Form
Number: CMS-10148 (OMB control number: 0938-0948); Frequency:
Occasionally; Affected Public: Private sector, Business or Not-for-
profit institutions, State, Local, or Tribal Governments, Federal
Government, Not-for-profits institutions; Number of Respondents: 400;
Total Annual Responses: 400; Total Annual Hours: 400. (For policy
questions regarding this collection contact Kevin Stewart at 410-786-
6149).
5. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Transparency in Coverage Reporting by Qualified Health Plan
Issuers; Use: Sections 1311(e)(3)(A)-(C) of the ACA, as implemented at
45 CFR 155.1040(a)-(c) and 156.220, establish standards for qualified
health plan (QHP) issuers to submit specific information related to
transparency in coverage. QHP issuers are required to post and make
data related to transparency in coverage available to the public in
plain language and submit this data to the Department of Health and
Human Services (HHS), the Exchange, and the state insurance
commissioner. Section 2715A of the Public Health Service (PHS) Act as
added by the ACA largely extends the transparency provisions set forth
in section 1311(e)(3) to non-grandfathered group health plans and
health insurance issuers offering group and individual health insurance
coverage. Form Number: CMS-10572 (OMB control number: 0938-1310);
Frequency: Annually; Affected Public: Private Sector, Business, and
Not-for Profits; Number of Respondents: 400; Number of Response s: 400;
Total Annual Hours: 22,000. (For questions regarding this collection,
contact Jack Reeves at 301-492-5152.)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-18506 Filed 9-23-25; 8:45 am]
BILLING CODE 4120-01-P
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