NCPA Files Lawsuit on Pharmacy Direct & Indirect Remuneration (DIR) Fees
The National Community Pharmacists Association (NCPA) has filed a lawsuit against the U.S. Department of Health & Human Services (HHS) on DIR fees. Specifically, the complaint seeking declaratory and injunctive relief seeks three things according to NCPA’s release:
The rule’s definition of “negotiated price” violates the plain language and intent of Congress when they passed legislation creating the Medicare Part D program.
The rule is invalid as arbitrary and capricious. In 2014 CMS said that the “reasonably determined” exception leading to DIR fees would be “narrow,” but comment letters showed that not to be the case.3 A recent study showed that pharmacy DIR fees have increased 1600% since 2015, with $4 billion in DIR fees being squeezed from pharmacies in 2017 alone.
The Final Rule Was Not Adopted Through Proper Notice-and-Comment Rulemaking. The proposed rule defined negotiated prices to include all price concessions from pharmacies and did not discuss or address any exceptions. In the final rule, without giving interested parties notice or the opportunity to comment, CMS created the exception for price concessions that could not be reasonably determined at the point of sale.
HHS did file a motion to dismiss available here.
Lanton Law will continue to monitor the developments of this important case.
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