Regulatory Review: Legislative Actions Poised to Impact Pharmacy Inventory Management

Pharmacy is flush with rules and regulations that can change at any time, which is why it is vital that pharmacists keep track of the regulatory processes and the latest bills and proposed legislation that could impact their business.

“Pharmacists should stay informed about regulatory changes related to pharmacy inventory, especially around controlled substances,” said Weston Humphreys, operations manager and pharmacy technician for Tyson Drugs, the parent store of 4 local pharmacies throughout Mississippi. “It is important for pharmacists to stay informed and comply with all regulations to ensure patient safety and prevent potential legal and financial penalties.”

Recent updates include the implementation of HR 6, the SUPPORT for Patients and Communities Act,¹ which requires electronic prescribing for all controlled substances covered under Medicare Part D, as well as the Drug Enforcement Administration’s revised rule on electronic prescriptions,² which allows for greater flexibility and convenience for patients and prescribers.

With 27 years in retail pharmacy, Jon Villanova, RPh, with Marley Drug in Winston Salem, North Carolina, knows how important it is to keep an eye on new and proposed laws; Villanova has seen his share of new regulations come along that have shifted the way business is done.

“Recently there have been changes put in place limiting the amount of controlled substances a pharmacy can order,” he said. “Wholesalers look at the previous 30-day ordering history of a particular controlled substance and if it is above the pharmacy’s usual ordering pattern, the product will not be shipped. A perpetual inventory is required for all [Schedule II] medicines.”

Another change that Humphreys is preparing for is the Drug Supply Chain Security Act (DSCSA),³ known as “track and trace,” which was passed in 2013 but needs to be fully implemented by November 2023.

“It’s been a hot topic for a while and we know there are some things we have to do differently,” he said.

Pharmacists should also be aware of state-specific regulations, such as prescription drug monitoring programs (PDMPs) and drug take-back programs.

Earlier this year, bipartisan legislation was re-introduced by Reps. Buddy Carter (R-Georgia), Vicente Gonzalez (D-Texas), Rick Allen (R-Georgia), Jake Auchincloss (D-Massassachusetts), Elise Stefanik (R-New York), and Deborah Ross (D-North Carolina) in the House to improve transparency and prevent the use of spread pricing in Medicaid managed care programs.

The National Community Pharmacists Association (NCPA) noted that a broad ban on Medicaid managed care spread pricing and a move to fair and transparent pharmacy reimbursement would save the federal government more than $1 billion over the next decade, with individual states saving hundreds of millions of dollars in Medicaid costs as well.

H.R. 1613, known as the Drug Transparency in Medicaid Act,⁴ would also require pharmacy reimbursements in all state Medicaid managed care programs to be at a rate of pharmacy’s average acquisition costs based on the National Average Drug Acquisition Cost (NADAC) survey plus the state’s Medicaid fee for service dispensing fee.

Additionally, the proposed legislation would limit payments to PBMs to solely administrative fees and mandate NADAC reporting to the Centers for Medicare & Medicaid Services by all pharmacies participating in state Medicaid programs, allowing reimbursements to reflect the true acquisition costs of prescription drugs in Medicaid plus a fair professional dispensing fee.

Ronna Houser, senior vice president for policy and pharmacy affairs for NCPA, explained that it’s a busy time with the new Congress in session, and the association is tracking several other bills in the House, including H.R. 501, the Block, Report, and Suspend Suspicious Shipments Act⁵—though it is in the very early stages.

“We are supportive of these efforts, to make sure there is a more consistent and level playing field when it comes to suspicious orders and the way we interact with our wholesale partners,” she said.

References

1. H.R. 6. SUPPORT for Patients and Communities Act; 115th Cong (2017-2018). https://www.congress.gov/bill/115th-congress/house-bill/6

2. 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes. Code of Federal Regulations. Accessed April 13, 2023. https://www.ecfr.gov/current/title-21/chapter-II/part-1306/subject-group-ECFRe4ae2bfb4eae102/section-1306.25

3. Drug Supply Chain Security Act (DSCSA). FDA. Reviewed November 2, 2022. Accessed April 13, 2023. https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

4. H.R. 1613. Drug Price Transparency in Medicaid Act of 2023; 118th Cong (2023-2024). https://www.congress.gov/bill/118th-congress/house-bill/1613

5. H.R. 501. Block, Report, and Suspend Suspicious Shipments Act; 118th Cong (2023-2024). https://www.congress.gov/bill/118th-congress/house-bill/501