HHS Changes Final Rule That Require Pharmacies to Monitor Partially Filled Schedule II Drugs Prescriptions

The Department of Health and Human Services announced the changes to a final rule of the HIPAA National Council for Prescription Drug Programs (NCPDP) D.0 Telecommunication Standard requiring pharmacies to keep tabs on partly filled prescription medications for Schedule II drugs. The change is part of the efforts of HHS to control opioid abuse in the U.S.A. and give more data that could help stop impermissible Schedule II drug refills.

The final rule is effective beginning March 24, 2020 with a compliance date set on September 21, 2020.

On September 21, 2020, pharmacies need to fill-up the Quantity Prescribed (460-ET) field when making retail pharmacy transactions associated with all Schedule II drugs. Pharmacies should write in retail pharmacy transactions if the entire prescribed quantity of a Schedule II drug was dispensed in a refill, or if the prescription was just partly filled.


The Secretary of the HHS adopted the NCPDP Telecommunication Standard in January 2009 to be used for pharmacy transactions, which include referral certification and authorization, health care claims or equivalent encounter data, and benefits coordination.

According to the Controlled Substances Act, it is prohibited to refill Schedule II drugs, however, partial fills are allowed when a pharmacist has a fewer supply than the prescribed amount for patients with terminal ailments and those in long-term care facilities.

The HHS’ Office of Inspector General performed an audit of the prescription drug refill records in 2012 and discovered the $25 million payment made by Medicare Part D plan sponsors for 397,203 Schedule II drug refills in 2009. Long-term care facilities billed 75% of the refills. There was a big concern that these forbidden refills were diverting Schedule II drugs for reselling on the street.

The HHS’ Centers for Medicare and Medicaid services think that the OIG statistics were wrong because of data misinterpretation in the Fill Number (403-D3) field. There was confusion that the partial fills were for refills dispensed to long-term care facilities patients. A CMS evaluation confirmed that pharmacies were not able to differentiate between refills and partial fills of Schedule II drugs for billing requirements without utilizing the Fill Number (403-D3) field.

The NCPDP D.0 standard was subsequently modified to add the Quantity Prescribed (460-ET) field for claims, which must consist of the actual amount provided. That data can then be employed to know whether there were inappropriate fills made beyond the prescribed amount.

The November 2012 publication of Version D.0 detailed the change, which necessitated the completion of the Quantity Prescribed (460-ET) field when processing Medicare Part D for Schedule II drug claims. Nevertheless, because the HHS hasn’t implemented the November 2012 publication, pharmacies cannot utilize the Quantity Prescribed field for HIPAA orders. The final rule deals with this issue.

The federal register published on January 24, 2020 the Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act (HIPAA) of 1996 on the National Council for Prescription Drug Programs (NCPDP) D.0 Standard. It can be downloaded from this link.

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Christine Garcia is the staff writer on Calculated HIPAA. Christine has several years experience in writing about healthcare sector issues with a focus on the compliance and cybersecurity issues. Christine has developed in-depth knowledge of HIPAA regulations. You can contact Christine at [email protected]. You can follow Christine on Twitter at https://twitter.com/ChrisCalHIPAA