EVP, Clinical Affairs and Strategic Planning
America's Health Insurance Plans (AHIP)
Stuart Caplan RN, MAS
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850
Dear Mr. Caplan:
Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) National Coverage Analysis Tracking Sheet for Positron Emission Tomography (CAG-00065R2). America’s Health Insurance Plans (AHIP) is the national association for the health insurance industry. Our members provide
coverage to more than 200 million Americans, offering a broad range of health insurance products in the commercial market and demonstrating a strong commitment to participation in public programs.
AHIP and our member health plans encourage the use of robust evidence-based research to ensure safe and
effective treatments. This proposed amendment has the potential for significant expansion of PET without a definitive assessment of improving patient outcomes. Coverage based purely on FDA approval would be a departure from the previously successful CMS model of using a well-defined and rigorous evidentiary framework for making coverage decisions.
The National Oncologic PET Registry (NOPR) was designed to determine if the results of PET scans influence physicians' intended plans of patient management. In August 2008, Medicare's Evidence Development and Coverage Advisory Committee (MedCAC) reviewed the NOPR results as well as a technology assessment on FDG-PET scanning for 6 cancers which included 112 research studies. In January 2009, CMS issued a proposed decision memorandum outlining its intended coverage determination of FDG-PET scanning on the basis of the results of the NOPR, the technology assessment, and other published literature. The NOPR process – a consistent approach to nationwide coverage of new indications for PET, with evidence development – has been judged to be a success[i].
FDA approval alone does not ensure that a test will be accurate, reliable and clinically useful to the same degree as those tests previously evaluated using CMS’s successful MedCAC model or a similar rigorous evidentiary model. It is unlikely that the local Medicare Administrative Contractors will have the resources to replicate such a model. Developing these infrastructures in each region would be inefficient, costly, likely less effective, and subject to market influence. Continuing with the national model will also promote uniformity in coverage, preventing confusion among providers and especially patients who may move from one region to another. Our members believe that the process described in the request letter from the Medical Imaging & Technology Alliance to have coverage of particular uses of PET be determined locally would represent the abandonment of a proven effective deliberative process without any clear clinical advantages associated with the proposed replacement.
Executive Vice President
Clinical Affairs and Strategic Planning
[i] Tunis S, Whicher D. 2009. The National Oncologic PET Registry: Lessons Learned for Coverage With Evidence Development. Journal of the American College of Radiology: v.6(5); p. 360-5.