On January 23, 2020, HHS issued its final rule adopting a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D.0, National Council for Prescription Drug Programs (NCPDP) by requiring that covered entities use the Quantity Prescribed field for retail pharmacy transactions for Schedule II drugs (Final Rule). The Final Rule enables covered entities to distinguish whether a prescription is a “partial fill” (where less than the amount prescribed is dispensed) or a refill (where the full amount prescribed is dispensed) in HIPAA retail pharmacy transactions.
As background, the Controlled Substances Act prohibits the refilling of Schedule II drugs (those defined, in part, as having a high potential for abuse) but permits partial refills in limited circumstances where a pharmacist has less than the prescribed amount in stock, the prescription is for a patient in a long-term care facility, or a patient has a terminal illness.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires HHS to adopt standards for the electronic transmission of certain healthcare administrative transactions between providers, health plans, healthcare clearinghouses, and others. In January 2009, HHS adopted the NCPDP Telecommunication Standard Implementation Guide, Version D.0, August 2007 (Version D.0), for the following retail pharmacy transactions: (1) healthcare claims or equivalent transactions; (2) referral certification and authorization; and (3) coordination of benefits. Version D.0 includes a data field titled “Fill Number,” and specifies that a “0” be entered for a new prescription and the number be sequentially increased by “1” for each refill.
In 2012, OIG issued a report titled “Inappropriate Medicare Part D Payments for Schedule II Drugs Billed as Refills,” that analyzed 2009 prescription drug event records for Schedule II drug refills. OIG focused on the Fill Number field and concluded that Medicare had inappropriately paid $25 million for Schedule II drug refills and that long-term care facilities billed for 75% of such refills. CMS, however, believed OIG’s findings were based in part on a misinterpretation of Schedule II drug partial fills dispensed to long-term care facility residents as refills. An NCPDP work group formed at CMS’s request also found that the industry used the Fill Number field to represent the amount actually dispensed, and not necessarily the refill number. As a result, the NCPDP work group recommended a change to Version D.0 to require the use of the “Quantity Prescribed” field, which previously was not used in claim billing transactions, to indicate the actual quantity prescribed in the transmission of the claim. NCPDP noted this change in its November 2012 publication of Version D.0 and advised CMS that the modification would make data available to validate whether there are inappropriate fills in excess of the quantity prescribed. However, HHS has not adopted the November 2012 publication of Version D.0, so HIPAA covered entities may not use it for HIPAA transactions.
The Final Rule, which takes effect on September 21, 2020, modifies the requirements for the use of the Quantity Prescribed (460-ET) field, as set forth in Version D.0. The modification requires that covered entities treat that field as required where a transmission uses Version D.0 for a Schedule II drug for the following transactions: (1) healthcare claims or equivalent encounter information; (2) referral certification and authorization; and (3) coordination of benefits. HHS believes that this modification would enable covered entities to clearly distinguish whether a prescription is a “partial fill,” or a refill in HIPAA retail pharmacy transactions. HHS also explained that the Final Rule supported “one of its top opioid strategic priorities calling for better data, which may ultimately help in reducing the drug supply.”
The Final Rule is available here.
