The Department of Health and Human Services (HHS) has issued a final rule modifying the pharmacy HIPAA transaction requirements concerning use of the National Council for Prescription Drug Programs (NCPDP) D.0 Standard.

The CPDP D.0 Standard was adopted in 2009 and applies to retail pharmacy claims, referral certification and authorization, and coordination of benefits. The change is part of the HHS’s efforts tackle the opioid crisis in the United States.

The update will require pharmacies to record when prescriptions for Schedule II drugs have been partially filled in retail pharmacy transactions. The rule change requires pharmacies to use the 460-ET “Quantity Prescribed” field to distinguish between refills and partially filled prescriptions, those where less than the prescribed amount of Schedule II drugs have been dispensed.

Under the Controlled Substances Act, pharmacies are not permitted to refill prescriptions for Schedule II drugs, but they are permitted to dispense partial refills in certain circumstances, namely when a patient is in a long-term care facility, for patients with a terminal illness, and if the pharmacy does not have enough medication in stock to fully fill a prescription.

Concern was raised in 2012 when the HHS’ Office of Inspector General (OIG) published an analysis of prescription drug refills for 2009. The analysis revealed $25 million had been inappropriately paid by Medicare Part D plan sponsors for 397,203 Schedule II drug refills. Three quarters of those refills had been billed by long term care facilities.

The HHS’ Centers for Medicare and Medicaid Services (CMS) disagreed with the OIG analysis. OIG data suggested there had been refills, but CMS believed these were partial fills. Pharmacies had no way of recording whether a prescription had been legitimately partially filed, unless the Fill Number (403-D3) field was used.

To differentiate between refills and partial fills, the NCPDP D.0 standard was updated to include the use of the 460-ET field for claims, but HIPAA-covered pharmacies were not able to use that field for HIPAA transactions as the HHS had not adopted the 2012 version of the NCPDP D.0.

The final rule has now been published in the federal register which requires the use of the 460-ET field for partially filled Schedule II drug prescriptions.

The final rule takes effect on March 24, 2020 and pharmacies are required to comply no later than September 21, 2020.