MAY 28, 2014 01:30 PM PDT

Legal and Regulatory Developments Affecting Molecular Testing

Speakers
  • Attorney, Alston & Bird, LLP
    Biography
      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. 

    Abstract:

    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
    You May Also Like
    MAY 22, 2018 08:00 AM PDT
    C.E. CREDITS
    MAY 22, 2018 08:00 AM PDT
    DATE: May 22, 2018TIME: 08:00AM PDT The nuclear receptors pregnane X receptor (PXR) and constitutive androstane receptor (CAR) are closely related transcription factors that...
    MAY 03, 2018 11:00 AM PDT
    MAY 03, 2018 11:00 AM PDT
    DATE: May 3, 2018TIME: 11:00AM PDT, 2:00PM EDTWhile stress is one of the leading causes of neuropsychiatric disorders, the molecular underpinnings of how stress induces alterations in b...
    MAY 24, 2018 09:30 AM PDT
    C.E. CREDITS
    MAY 24, 2018 09:30 AM PDT
    DATE: May 24, 2018 TIME: 9:30PM PDT The current gold standard in in vitro pre-clinical cancer treatment screening remain cell lines,...
    JUN 26, 2018 06:00 AM PDT
    C.E. CREDITS
    JUN 26, 2018 06:00 AM PDT
    Date: June 26, 2018Time: 6:00 a.m. PDT, 9:00 a.m. EDT, 1500 CEST Today’s hematology analyzers employ various methods for enumerating platelets. These methods include: e...
    JUN 20, 2018 10:00 AM EDT
    C.E. CREDITS
    JUN 20, 2018 10:00 AM EDT
    DATE: June 20, 2018TIME: 07:00AM PDT, 10:00AM EDTIntroducing GE’s New Lyo-StableTM service. Sepsis is one of the top challenges facing hospitals in terms of clinical outcomes...
    APR 27, 2018 10:00 AM PDT
    C.E. CREDITS
    APR 27, 2018 10:00 AM PDT
    DATE: April 27, 2018TIME: 10:00am PST, 1:00pm ESTGlioblastoma (GBM) and Medulloblastoma (MB) are the most common adult and paediatric brain tumours, both of which can have devastating c...
    Loading Comments...