Position Statements

Letter to CMS on the Hospital Outpatient Prospective Payment (OPPS) Proposed Rule for Calendar Year 2016

On behalf of the Coalition for 21st Century Medicine (the Coalition), we appreciate the opportunity to comment on the CY 2016 Hospital Outpatient Prospective Payment (OPPS) Proposed Rule. We are writing to comment on the Centers for Medicare & Medicaid Services (CMS) proposal to continue its policy of “conditionally packaging” certain clinical laboratory diagnostic tests listed on the Clinical Laboratory Fee Schedule (CLFS).

Amicus Curiae Brief of The Coalition for 21st Century Medicine in Support of Akami Technologies, Inc.’s and The Massachusetts Institute of Technology’s Petition for Rehearing En Banc

…The Coalition is concerned about the restrictive interpretation of ยง 271(a) adopted by the panel majority in this case, Akamai Techs., Inc. v. Limelight Networks, Inc., Nos. 2009-1372, -1380, -1416, -1417, (Fed. Cir. May 13, 2015). This standard permits potential infringers to divide the steps of diagnostic method claims among multiple parties to circumvent patent infringement liability, jeopardizing the ability of innovators to enforce their patents.

Comments on the “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and the “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” Draft Guidances

…Since its inception, the Coalition has worked closely with FDA to ensure that any new regulatory framework proposed by FDA for LDTs is reasonable, not overly burdensome, and acknowledges the differences between laboratory services and kits that are distributed to laboratories for performance. We appreciate the time and attention the agency has given to considering the Coalition’s views over the years, and in particular since releasing these latest draft guidances. The Coalition seeks to continue our efforts to work with the FDA toward the development of an appropriate regulatory model for advanced diagnostic tests that both protects public health and promotes innovation. It is critical that the Agency remains open to stakeholder views and adopts well-reasoned changes to the draft guidance that are both clear and not overly burdensome for laboratories.