CLARIFYING PAMA REQUIREMENTS FOR DIAGNOSTIC LABORATORY REIMBURSEMENT & STRATEGIES FOR DEMONSTRATING COMPLIANCE

Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA) will result in a massive Medicare reimbursement overhaul for clinical laboratories performing diagnostic tests. As intended by the legislation, PAMA will eventually (in general, starting January 2017) create a modern reimbursement system for laboratory tests paid under the Medicare Clinical Laboratory Fee Schedule linked to private payer rates. The statute and proposed regulations outline requirements for “applicable laboratories”, which make laboratories responsible for reporting all payer rates, which will be used as medians to establish new CMS fee schedules every 3 years. Each “applicable laboratory” will be required to report the payment amount and volume of each test paid by every private payer, Medicare Advantage Plan, and Medicaid managed care plan. This legislation, and its implementing regulations, signify a new peak in the intricacy of CMS laboratory reimbursement, with new reporting requirements and with short time frames for implementation by laboratory professionals. Failure to fully comply with these regulations can result in a variety of penalties for the manufacturer.

• Understanding the scope of “applicable laboratories”
• Data collection timelines and reporting requirements
• Requirements specific to Advanced Diagnostic Laboratory Tests (ADLT)
• Penalties and outcomes of non-compliance

Speaker:
Judith A. Waltz
Partner
Foley & Lardner LLP

Contact:

Brooke Akins | Division Director, Life Science Programs
+1 (312) 224-1693 | bakins@q1productions.com​