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HHS Issues Final Rule Requiring Pharmacies to Track Partially Filled Prescriptions of Schedule II Drugs

The Department of Health and Human Services has issued a final rule modifying the HIPAA National Council for Prescription Drug Programs (NCPDP) D.0 Telecommunication Standard that requires pharmacies to track partially filled prescriptions for Schedule II drugs. The modification is part of HHS efforts to curb opioid abuse in the United States and will provide a greater quantum of data that may help prevent impermissible refills of Schedule II drugs.

The final rule takes effect on March 24, 2020. The compliance date is September 21, 2020.

By September 21, 2020, pharmacies will be required to use the Quantity Prescribed (460-ET) field for retail pharmacy transactions for all Schedule II drugs. Pharmacies must distinguish in retail pharmacy transactions whether the full prescribed amount of a Schedule II drug has been dispensed in a refill, or if the prescription has only been partially filled.


The NCPDP Telecommunication Standard was adopted by the Secretary of the HHS in January 2009 for pharmacy transactions (health care claims or equivalent encounter information, referral certification and authorization, and coordination of benefits).

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Under the Controlled Substances Act, the refilling of Schedule II drugs is prohibited, but partial fills are permitted if a pharmacist has less than the prescribed amount in stock, for patients in long-term care facilities, and for patients with terminal illnesses.

An analysis of prescription drug refill records by the HHS’ Office of Inspector General in 2012 revealed that in 2009, $25 million has been inappropriately paid by Medicare Part D plan sponsors for 397,203 Schedule II drug refills. 75% of those refills were billed by long-term care facilities. There was considerable concern that these prohibited refills could contribute to the diversion of Schedule II drugs and their being resold on the street.

The HHS’ Centers for Medicare and Medicaid services believed the OIG figures were incorrect due to a misinterpretation of the data in the Fill Number (403-D3) field, which resulted in partial fills being confused with refills dispensed to patients in long-term care facilities. A CMS review confirmed pharmacies could not distinguish between partial fills of Schedule II drugs and refills for billing purposes without using the Fill Number (403-D3) field.

The NCPDP D.0 standard was then updated to include the Quantity Prescribed (460-ET) field for claims, which should include the actual quantity supplied. That data could then be used to determine whether inappropriate fills had been made over and above the amount prescribed.

The change was detailed in the November 2012 publication of Version D.0 which required the Quantity Prescribed (460–ET) field to be completed when submitting claims to Medicare Part D for Schedule II drugs. However, since the HHS has not adopted the November 2012 publication, pharmacies could not use the Quantity Prescribed field for HIPAA transactions. The final rule addresses this issue.

The 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 has been published in the federal register on January 24, 2020 and can be viewed on this link.

Author: Steve Alder is the editor-in-chief of HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered on HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has several years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics.