On January 31, 2019, the U.S. Department of Health and Human Services (HHS) Office of the Secretary published in the Federal Register a Proposed Rule entitled: “Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) D.0 Standard.” The Summary of the Rule, as published, is:

“This proposed rule would adopt a modification to the requirements for the use of the Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, National Council for Prescription Drug Programs by requiring covered entities to use the Quantity Prescribed (460–ET) field for retail pharmacy transactions for Schedule II drugs. The modification would enable covered entities to clearly distinguish whether a prescription is a ‘‘partial fill,’’ where less than the full amount prescribed is dispensed, or a refill, in the HIPAA retail pharmacy transactions. We believe this modification is important to ensure information is available to help prevent impermissible refills of Schedule II drugs, which would help to address the public health concerns associated with prescription drug abuse in the United States.”

In the January 31, 2019, HIPAA Administrative Simplification Information Bulletin, HHS states: “We believe this modification is necessary, particularly in light of the fact that the opioid crisis is a nationwide public health emergency, and the modification, if adopted, would further the Administration’s efforts to address the crisis.”

The deadline for comments on this proposed rule is next Monday, April 1, by 5 PM, with instructions for submitting comments in the referenced Federal Register on page 633.

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