Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies--Revision of Medicare Coverage (CMS-10511)

Forms and Documents

Document Name	Status
Attachment A_CMS-10511 Response to 60 Day Public Comments.docx Supplementary Document	2025-12-22
CMS-10511 Supporting Statement A _11-21-25.docx Supporting Statement A	2025-12-30

IC Document Collections

IC ID	Document Title	Status
209667	Medical Services Coverage Decisions That Relate to Health Care Technology (42 CFR 405.211)	Modified

ICR Details

OMB Control No: 0938-1250	ICR Reference No: 202512-0938-020
Status: Received in OIRA	Previous ICR Reference No: 202207-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies--Revision of Medicare Coverage (CMS-10511)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	118	116
Time Burden (Hours)	236	232
Cost Burden (Dollars)	0	0

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Abstract: Section 1862(m) of the Act (established by section 731(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003)) allows for payment of the routine costs of care furnished to Medicare beneficiaries in a Category A investigational device exemption (IDE) trial and authorizes the Secretary to establish criteria to ensure that Category A IDE trials conform to appropriate scientific and ethical standards. By providing Medicare coverage of routine costs in Category A trials, the Congress removed a financial barrier that may have discouraged beneficiaries from participating in these trials. It also gives Medicare beneficiaries the opportunity to have earlier access to new medical devices. Based on our rulemaking authority in section 1871 of the Act, we are applying the same Medicare coverage requirements and scientific and ethical standards to Medicare coverage related to Category B IDE studies/trials that would be applicable to Category A IDE studies/trials. CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study criteria in ?405.212 are met for purposes of coverage of items and services described in paragraphs (a) and (b) of this section: (1) FDA IDE approval letter. (2) IDE study protocol. (3) IRB approval letter. (4) National Clinical Trials (NCT) number. (5) Supporting materials, as needed.

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Authorizing Statute(s): US Code: 42 USC 1102 Name of Law: Social Security Act: RULES AND REGULATIONS
   US Code: 42 USC 1861 Name of Law: Social Security Act: Part E--Miscellaneous Provisions DEFINITIONS OF SERVICES, INSTITUTIONS, ETC
   US Code: 42 USC 205(a) Name of Law: Social Security Act: EVIDENCE, PROCEDURE, AND CERTIFICATION FOR PAYMENT
  

Citations for New Statutory Requirements: US Code: 42 USC 1861 Name of Law: Social Security Act
US Code: 42 USC 205(a) Name of Law: Social Security Act
US Code: 42 USC 1102 Name of Law: Social Security Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 45214	09/19/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 61154	12/30/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Medical Services Coverage Decisions That Relate to Health Care Technology (42 CFR 405.211)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	118	116	0	2	0	0
Annual Time Burden (Hours)	236	232	0	4	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The number of responses increased from 116 to 118. The burden hours increased from 232 to 236.

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Annual Cost to Federal Government: $367,160

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/30/2025

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