Requiring Pharmacies Must Track Partially Filled Prescriptions of Schedule II Drugs Following HHS Issuing Final Rule

The Department of Health and Human Services has released a final rule amending the HIPAA National Council for Prescription Drug Programs (NCPDP) D.0 Telecommunication Standard that requires pharmacies to record partially filled prescriptions for Schedule II drugs. The modification is an element of HHS efforts to control opioid abuse in the United States and will supply a greater quantum of data that may help stop impermissible refills of Schedule II drugs.

The final rule becomes live on March 24, 2020. The compliance date is September 21, 2020.

By September 21, 2020, pharmacies must use the Quantity Prescribed (460-ET) field for retail pharmacy transactions related to all Schedule II drugs. Pharmacies must outline separately 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 just been partially filled.

Background

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

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

A review of prescription drug refill records by the HHS’ Office of Inspector General in 2012 showed 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 centers. There was serious concern that these prohibited refills could contribute to the diversion of Schedule II drugs and their being resold on the black market.

The HHS’ Centers for Medicare and Medicaid services feel the OIG figures were incorrect due to a misinterpretation of the data in the Fill Number (403-D3) field, which meant that partial fills were being confused with refills dispensed to patients in long-term care centers. A CMS review showed that 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 incorporate the Quantity Prescribed (460-ET) field for claims, which should include the actual quantity supplied. That data could then be manipulated to determine whether inappropriate fills had been made over and above the amount prescribed.

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

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 accessed here.