- Serves as outside counsel to an industry association that represents the major providers of clinical laboratory services, working on a wide variety of topic areas: helped draft comments on key CMS and OIG regulations, including proposals on physician self-referrals, “substantially in excess” provisions, reassignment and physician fee schedule requirements; helped develop strategy and responses for FDA initiatives related to Analyte Specific Reagents, IVDMIAs and other issues; has been involved on issues related to the implementation of CMS’s proposed competitive bidding program for clinical laboratories and was involved in advising on the legislation that established a negotiated rulemaking procedure for laboratories; and advised the association in the negotiated rulemaking proceedings.
- Assisted a major manufacturer of a medical device used in bariatric (weight reduction) surgery in obtaining a National Coverage Decision from Medicare for its product.
- Assisted several diagnostic companies on due diligence in connection with planned acquisitions of other companies.
- Advised a supplier of a wound care technology on billing, coding and reimbursement issues related to its product.
- Counsels a major provider of anatomic pathology services on Medicare regulatory and compliance issues.
Senior Counsel,
- Phone: +1 202 239 3334
- Email: peter.kazon@alston.com
Faced with complex legal and regulatory issues, including reimbursement and Medicare coverage, health care providers call on Peter for his 25-plus years of industry experience. His experience allows him to effectively advise laboratory and diagnostic company clients on diverse matters including reimbursement and regulatory issues, compliance, the FDA and Stark self-referral rules.