Proposed new pharmacy rules draw crowd, comments

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Pharmacy benefit management regulation was a top priority issue during the 2023 Session, and now implementation of the new law appears to be an equally hot issue.

Lobbyists and lawyers tuned into an Office of Insurance Regulation (OIR) public meeting on proposed new rules to implement SB 1550.

Not surprisingly, lobbyists and lawyers representing the insurance industry and pharmacists attended the public meeting both in person and through a teleconference call. But only those representing the latter group made public comments.

Florida Pharmacy Association (FPA) lobbyist Eric Larson told OIR staff the $5 fee third-party association (TPA) registration fee in the draft rules is too low and won’t cover the office’s regulatory costs.

The proposed rule requires PBMs to notify the state within 30 days of any complaint settlement or discipline against it or its affiliates. But small pharmacy owner William Mincy said applicants should be required to notify the state of any administrative, civil or criminal complaints, settlements or discipline in the 36 months prior to applying for the TPA registration.

Mincy said a three-year lookback would “educate OIR and its investigators about past and perhaps current patterns of behavior that will be prohibited in Florida and should be monitored.”

Mincy also wants the state to be “proactive” and require PBMs currently operating in the state to notify the OIR of their plans to adhere to the maximum allowable cost reimbursement appeal and denial provisions in the law. Moreover, he said the OIR should receive a copy of any communication sent to pharmacy providers describing the changes being made due to the new law.

“Additionally, we suggest that the OIR provide consumers and pharmacies an easily accessible method, including phone number and email address, to report instances where the pharmacy benefit manager doesn’t comply with the law’s maximum allowable cost appeal and denial process,” said Mincy, who also is a member of the PPSC board of directors.

PPSC is a Tallahassee-based pharmacy services corporation for independent pharmacists from across the state.

The OIR should also make available to the public documentation that shows executive agencies are adhering to the new law — as well as a 2022 executive order on PBMs issued by Gov. Ron DeSantis — when it comes to procuring PBM services. Mincy specifically cited the Agency for Health Care Administration’s Medicaid ITN as an example of information that should be disclosed.

Prescription drug costs continue to increase and DeSantis, who is running for President, decided regulating PBMs would be a way to bring down those costs. While the Legislature tried in the past to regulate PBMs, usually referred to as third-party “middlemen” between insurers and manufacturers, legislation often was stalled or watered down.

But DeSantis’ interest in the issue all but guaranteed its passage in 2023. The high-profile debate was lobbied by pharmaceutical manufacturers, pharmacists, pharmacies and insurers. And while DeSantis’ priorities were often partisan, the PBM regulation passed the Legislature unanimously.

OIR staff attorney Michael Lawrence said the OIR wants to take the proposed rules to the Financial Services Commission on Aug. 22. To that end, the office will take written comments on the draft rules until Aug. 11 at noon.