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HHS - 2529 - Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests - Statutory (Congress Created)

GENERAL INFORMATION

Committee Name	Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	2529
Original Establishment Date	7/1/2015	Committee Status	Chartered
Actual Termination Date		Committee URL	https://www.cms.gov/Regulations-and-Guidance/Gu...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	15
Terminated This FY	No	Designated Fed Officer Position Title*	DFO
Merged This FY		Designated Federal Officer Prefix	Dr.
Current Charter Date	4/26/2023	Designated Federal Officer First Name*	Rasheeda
Date Of Renewal Charter	4/26/2025	Designated Federal Officer Middle Name	Jameeka
Projected Termination Date		Designated Federal Officer Last Name*	Arthur
Exempt From Renewal*	No	Designated Federal Officer Suffix
Specific Termination Authority		Designated Federal Officer Phone*	(410) 786-3434
Establishment Authority*	Statutory (Congress Created)	Designated Federal Officer Fax*	410-786-0681
Specific Establishment Authority*	Section 1834A(f)(1) of the Social Security Act (the Act) (42 USC 1395m-1)	Designated Federal Officer Email*	rasheeda.arthur@cms.hhs.gov
Effective Date Of Authority*	7/1/2015
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Regulatory Negotiations Committee

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	The Panel may advise the Secretary of the Department of Health and Human Services (HHS), and the Administrator of the Centers for Medicare & Medicaid Services (CMS), on the following: 1) the establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use cross-walking or gap-filling processes to determine payment for a specific new test; and 2) the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests. In addition, the Panel may provide recommendations to the Secretary of HHS and the Administrator of CMS under section 1834A of the Act.
How is membership balanced?*	The Panel shall consist of up to 15 individuals with expertise in issues related to clinical diagnostic laboratory tests, which may include representatives of clinical laboratories, molecular pathologists, clinical laboratory researchers, and individuals with expertise in clinical laboratory science or health economics, with regard to issues related to the development, validation, performance, safety, and application of such tests. Members shall be appointed by the Secretary, or CMS Administrator, or CMS Administrator’s designee.
How frequent & relevant are cmte mtgs?*	Estimated Number of Meetings per Year - 4. The Panel is relevant because it considers and advises on the following issues:•Calculation of weighted medians of private payor rates for laboratory tests.•Phase-in of reductions in Medicare payment rates based on private payor rates, as required.•Application of market rates to establishment of Medicare payment rates.•Evaluation and designation of tests as advanced diagnostic laboratory tests as defined in section 1834A of the Act.•Whether to use crosswalking or gapfilling to determine payment for a specific new test.•The factors used in determining coverage or payment processes for new clinical diagnostic laboratory tests.
Why advice can't be obtained elsewhere?*	The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) is required by law under section 1834A(f)(1) of the Social Security Act (42 U.S.C. 1395m-1) (the Act), as established by section 216 of Public Law 113-93, enacted April 1, 2014.
Why close or partially close meetings?	Meetings are not closed; in fact, they are open to the public. Notices of meetings are given to the public in the Federal Register, and there will be records of the meeting proceedings kept, as required by applicable laws and departmental regulations. In the event that a portion of a meeting is closed to the public, a report will be prepared that contains at a minimum a list of members and their business addresses, the Panel’s function, dates and places of meetings, and a summary of Panel activities and recommendations made during the fiscal year. A copy of the report will be provided to the Department Committee Management Officer.
Recommendation Remarks	The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests does not currently have a Chairperson. The former Chairperson retired in 2023 and a new Chairperson has not yet been selected. We currently have two panel members that are serving as the "interim co-chairs" until a Chairperson is selected.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	No	Action Reorganize Priorities*	No
Outcome Trust In Government	No	Action Reallocate Resources	No
Outcome Major Policy Changes	No	Action Issued New Regulations	No
Outcome Advance In Scientific Research	No	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	No
Outcome Increased Customer Satisfaction	No	Action Comment	Not Applicable
Outcome Implement Laws/Reg Requirements	No	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	Not Applicable	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	Not Applicable	Grants Review Comment	Not Applicable
Number Of Recommendations*	1,004	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	Approximately 1004 recommendations since 2015 were generated for the life of the committee.	Access Agency Website	Yes
% of Recs Fully Implemented*	85.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	Approximately 85 percent of the CDLT Panel recommendations are fully implemented by the Agency.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	Of the 15 percent that are not fully implemented, approximately 10 percent are partially implemented. For the remaining 5 percent, CMS may not be able to address these issues due to statutory constraints, or they may be addressed in future years as we are able to do so.	Access Other	No
Agency Feedback*	Yes	Access Comment	Not Applicable
Agency Feedback Comment*	Panel recommendations are verified before they are made final and then posted on CMS website.	Narrative Description*	The Panel may advise the Secretary of the Department of Health and Human Services (HHS), and the Administrator of the Centers for Medicare & Medicaid Services (CMS), on the following: 1)the establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for a specific new test; and 2)the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests.

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:59 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Health Health Care

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