Policy & Regulation News

CMS Creating Advisory Panel for Clinical Lab Tests

By Ryan Mcaskill

An ‘expert outside advisory panel’ will help establish payment rates for new clinical diagnostic lab tests.

- This week, the Centers for Medicare & Medicaid Services announced that it is establishing an Advisory Panel on Clinical Diagnostic Laboratory Tests. CMS is currently taking requests for nominations to serve in it.

The new panel is authorized under the Social Security Act and the Protecting Access to Medicare Act of 2014 (PAMA) and is subject to the Federal Advisory Committee Act (FACA). Those chosen will serve on an “expert outside advisory panel” to help advise the Secretary of Health and Human Services. The expertise will be related to clinical diagnostic laboratory tests and could come from representatives of a clinical laboratory, molecular pathologists, clinical researchers or individuals with expertise in laboratory science or economics of clinical lab services.

The main input from the panel will focus on the establishment of payment rates for new clinical diagnostic lab tests and the factors used in determining coverage and payment processes for new clinical tests.

The new panel will provide recommendations to CMS on several issues. These include:

  • Nonprofit Hospitals Saw High Tax Breaks, Low Charity Care Spending
  • OIG: Medicare Overpayments Due to Coding Discrepancies Totaled $22.5M
  • Humana Pays Physician Groups $77M for Value-Based Outcomes
  • • Calculation of weighted median for laboratory service using private payor rates.

    • Phase-in of reductions for private payor rate implementation.

    • Application of market rates.

    • Evaluation and designation of tests as advanced diagnostic laboratory tests.

    • Whether to use crosswalking or gapfilling to determine payment for specific new tests.

    • Factors used in determining coverage or payment processes for new clinical diagnostic laboratory tests.

    “The subject matter before the Panel will be limited to these and related topics. Unrelated topics will not be subjects for discussion,” the report reads. “Unrelated topics will include, but are not limited to, definition of an applicable laboratory for purposes of reporting private payor data, definition of a data collection period, treatment of discounts, reporting of more than one payment rate for the same payor, certification of data, definition of a private payor, civil monetary penalties for noncompliance with reporting requirements, and generally, Medicare conditions of payment for clinical diagnostic laboratory tests.”

    The panel will meet up to four times a year and consist of up to 15 individuals and a chair. The Panel Chair will be a federal official who is designated by the Secretary of the Administrator of CMS. The chair will facilitate all meetings, which will be open to the public unless otherwise designated. Notice of meetings will also be posted in the Federal Register and conducted and recorded.

    Members of the panel will serve on a voluntary basis, without compensation, pursuant to advance written agreement. All nominees will be evaluated based on expertise and factors needed to maintain a balance of representation. This includes geography, female and minority representation, points of view and areas of expertise. All nominations will be considered if they arrive no later than 5 p.m. EST on November 26, 2014.