OMB is approving this information collection request for a period of three years during which time CMS will request approval to extend or revise the collection if the Agency seeks to continue the information collection activity beyond the period approved under this action.
Inventory as of this Action
Requested
Previously Approved
03/31/2022
36 Months From Approved
100
0
0
200
0
0
0
0
0
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.
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
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
US Code: 42 USC 205(a) Name of Law: Social Security Act
US Code: 42 USC 1102 Name of Law: Social Security Act
The annual costs and associated collection burden has reduced from a 2013 estimated potential average of 240 annual requests down to a more accurate average of approximately 100 annual requests. This new estimate is based on the actual number of requests received since January 2015, when the centralized IDE review process was implemented. We expect this burden to increase in the future as we receive more requests each year than the previous year.
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:
(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;
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.
Supporting Statement A - CMS-10511 OMB 0938-1250.pdf
Medical Services Coverage Decisions That Relate to Health Care Technology (42 CFR 405.211)