MAY 28, 2014 01:30 PM PDT

Legal and Regulatory Developments Affecting Molecular Testing

  • Attorney, Alston & Bird, LLP
      Peter Kazon has over 25 years of experience assisting companies and individuals in negotiating the complex legal and regulatory issues that health care providers routinely face. He counsels providers on matters involving Medicare coverage, reimbursement, billing, fraud and abuse and Stark self-referral issues. Among his specialties are advising clinical laboratories and diagnostic companies on regulatory and compliance matters, and assisting companies with emerging medical technologies with coverage, coding and reimbursement issues. In addition, Peter assists companies on compliance with the Food, Drug and Cosmetic Act and its recent amendments, with particular attention to FDA actions affecting in vitro diagnostic products. Mr. Kazon is a frequent speaker and writer on health care issues and sits on the editorial advisory board of BNAs Plan and Provider Report. His recent speeches have addressed a variety of topics, including Medicare medical necessity requirements, regulatory requirements applicable to genetic tests, new federal requirements applicable to the provision of electronic medical record technology and Medicare reimbursement issues. After receiving a B.A., magna cum laude, from Tufts University in 1975, Mr. Kazon earned his J.D. from Temple University in 1978. After law school, Mr. Kazon worked for five years at the Federal Trade Commissions Bureau of Competition, where he specialized in health care antitrust matters. 


    The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by CMS. This session will discuss recent developments in these areas. While FDA has not acted to explicitly regulate molecular testing that is performed as a Laboratory Developed Test, the agency continues to suggest that new requirements will soon be forthcoming. In the meantime, FDA has acted to limit the use of tests labeled as Research Use Only or Investigational Use Only, and to increase its oversight of innovative Companion Diagnostics. Meanwhile, Medicare has developed new processes for determining whether or not to pay for developing molecular tests, such as the MolDx Program, created by Palmetto Government Services, one of the Medicare Administrative Contractors, which requires special coding of and technical assessment of new molecular tests. Finally, the payment for this testing has been in turmoil, as a result of Medicares year-long gapfilling process that occurred in 2013. As part of legislation passed in April, however, pricing will go through yet another major change, as the Medicare Program moves away from the current fee schedule approach to one that is designed to reflect market prices beginning in 2017. That legislation also includes special payment provisions affecting Advanced Diagnostic Laboratory Tests, which could affect many new molecular tests. Before any of that happens, however, there will need to be a complex regulatory approach to define what is to be reported to CMS and how that reporting will occur. This program will examine these developments and attempt to make some predictions about their likely impact

    Show Resources
    Loading Comments...