The U.S. Department of Health and Human Services finalized a rule last week that will require pharmacies to track when prescriptions are partially filled. This rule is part of an ongoing effort by HHS to stem the tide of opioid abuse. The rule becomes effective March 24, 2020, with a compliance date of Sept. 21, 2020.
The rule modifies the requirements of the Health Insurance Portability and Accountability Act of 1996 National Council for Prescription Drug Programs (NCPDP) D.0 Standard. The rule will require covered entities to use the “Quantity Prescribed” (460–ET) field for retail pharmacy transactions for Schedule II drugs. Covered entities will have to distinguish, as part of the HIPAA retail pharmacy transaction, whether a prescription is a “partial fill,” meaning less than the full amount prescribed is dispensed, or a refill, where the full amount prescribed is dispensed.
By way of background, HHS adopted the NCPDP D.0 Standard in 2009 for retail pharmacy healthcare claims or equivalent encounter information, referral certification and authorization, and coordination of benefits. Additionally, the Controlled Substances Act prohibits the refilling of Schedule II drugs, but permits partial refills of such drugs in the following circumstances: when a pharmacist has less than the prescribed amount of a medication in stock, when the prescription is for a patient in a long-term care facility, or when a patient has a terminal illness.
In 2012, the HHS Office of Inspector General issued an analysis of prescription drug refill records and concluded that during the year 2009, Medicare Part D plan sponsors inappropriately paid $25 million for 397,203 Schedule II drug refills and that long-term care facility pharmacies billed for 75 percent of such refills. Notwithstanding these findings, the Centers for Medicare and Medicaid Services (CMS) deemed this report a misinterpretation of partial refills dispensed by long-term care pharmacies to residents. Accordingly, a CMS inquiry revealed that pharmacies had no way of distinguishing partial fills of a controlled substance prescription for billing purposes without using the “Fill Number” (403-D3) field. To address the deficiency, the NCPDP D.0 standard was updated to include the use of the “Quantity Prescribed” (460-ET) field for claims; however, HHS had not yet adopted the 2012 publication of version D.0. Therefore, HIPAA-covered entities were not able to use it for HIPAA transactions.
HHS noted that it anticipates an upsurge in partial fills in response to a recent amendment to the Controlled Substances Act allowing pharmacists to partially fill prescriptions for Schedule II controlled substances in certain circumstances. Given the concern around the opioid crisis and drugs that are susceptible to abuse, this rule change will apply to Schedule II drugs only and will not apply to Schedule II through V drugs.
For questions related to this rule change, please consult the author or another member of the McGuireWoods Life Sciences Team.