The Department of Health and Human Services (HHS) has issued a proposed rule that would modify the current HIPAA transaction standard for retail pharmacy transactions (the August 2007 revision of NCPDP telecommunications standard D.0) with respect to claims and similar transactions for Schedule II drugs.  HHS states that the change would enable covered entities to clearly distinguish whether a prescription fill for a Schedule II drug is a “partial fill” (i.e., less than the full amount prescribed is dispensed) or a refill, which it believes is not consistently reflected under the current D.0 standard.  Specifically, HHS would change the current NCPDP D.0 requirements for use of an existing field in the D.0 standard, “Quantity Prescribed (460-ET),” to make the use of such field mandatory for Schedule II drugs.  HHS notes that the Comprehensive Addiction and Recovery Act (CARA), enacted on July 22, 2016, changed the criteria for partial fills of Schedule II drugs, and states that it believes “CARA’s implementation will result in an upsurge of partial refills, which supports the need for this proposed modification.”

HHS also believes this policy “would support and improve the Administration’s and the health care industry’s data collection and research efforts by, among other things, enabling policymakers, health care researchers, and other health care stakeholders that monitor the volume of opioids billed to health plans across the country to correctly identify partial fills in claims and prior authorization transactions.”  Notably, we are not aware of HHS having previously proposed a single change to one aspect of a HIPAA transaction standard, rather than adoption of an overall update recommended by the organization promulgating such standard.  In this case, HHS is not proposing to adopt the NCPDP October 2017 Telecommunication Standard Implementation Guide, Version F2 (Version F2), stating that it “requires further evaluation” and, given the other changes that it would require of covered entities, its adoption “would delay the ability of covered entities to accurately capture partial fills of Schedule II drugs.”

The proposed rule was published on January 31, 2019, and HHS will accept comments until April 1, 2019.