The Department of Health and Human Services has released a final rule changing the HIPAA National Council for Prescription Drug Programs (NCPDP) D.0 Telecommunication Standard that obligates pharmacies to record partially completed prescriptions for Schedule II drugs. The modification is part of HHS efforts to manage opioid abuse in the United States and will supply a greater quantum of data that may help control impermissible refills of Schedule II drugs.
The final rule becomes enforceable on March 24, 2020. The compliance date is September 21, 2020.
By September 21, 2020, pharmacies will be obligated to implement the Quantity Prescribed (460-ET) field for retail pharmacy transactions for all Schedule II drugs. Pharmacies must list in retail pharmacy transactions whether the total 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 put in place 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 advantages).
Under the Controlled Substances Act, the refilling of Schedule II drugs is forbidden, but partial fills are allowable 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 clinics. There was significant concern that these supposedly prohibited refills could contribute to the diversion of Schedule II drugs and their being sold on on the black market.
The HHS’ Centers for Medicare and Medicaid services felt that the OIG figures were wrong due to a misinterpretation of the data in the Fill Number (403-D3) field, which resulted in partial fills being confused with refills given to patients in long-term care clinics. A CMS review confirmed pharmacies could not differentiate 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 changed to incorporate the Quantity Prescribed (460-ET) field for claims, which should include the precise 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 listed in the November 2012 release of Version D.0 which required the Quantity Prescribed (460–ET) field to be completed when filing claims to Medicare Part D for Schedule II drugs. However, since the HHS has not implemented the November 2012 update, 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 seen here.