Help pharmacy fight back with APhA’s Legal Defense Fund
Significant progress has been made in advancing the practice of pharmacy, which has only increased the need
for a strong Legal Defense Fund (LDF) to keep APhA on the offensive in the courtroom.
Keep pharmacy doors open.
Pharmacies are closing at a rate of four per day. We need a strong LDF to keep pharmacy doors open and
protect patients’ access to pharmacist-provided patient care!
Defend science.
Lawsuits have been filed seeking preliminary and permanent injunctions on the HHS secretary’s decision to
remove COVID-19 vaccine recommendations for people who are pregnant and pediatric populations and the
removal of all of the members of ACIP. Those members were replaced with new members who are not experts in
vaccines. The COVID-19 vaccine recommendations were made before a CDC director was confirmed and do not
align with science. These actions could be unlawful because they did not follow a federal law that
establishes procedures that federal agencies follow under the established vaccine approval process. APhA
will use the LDF to defend the science and establish evidence-based processes for the approval of lifesaving
vaccines
What does the LDF do?
The LDF defends the practice of pharmacy in the courts in the face of unprecedented legal
challenges. Every day, we face giants—massive institutions, deep-pocketed interests, and
systemic challenges. While our opponents have millions in funding, lobbyists, and media reach,
we have something they don’t: you. APhA’s LDF amplifies your voice with like-minded
organizations to keep the practice of pharmacy moving forward!
Keep the LDF’s momentum going!
The LDF has made a significant impact on defending and advancing the practice of pharmacy:
- Securing the states’ ability to regulate PBMs: APhA’s LDF brief stood
shoulder to shoulder with Arkansas’s PBM reform law in a legal challenge by the large PBMs,
where the U.S. Supreme Court unanimously ruled, 8-0, in a monumental decision that the
states could pass laws and regulations to rein in the harmful business practices of the
PBMs.
- Ending PBMs use of retroactive DIR fees:Pharmacy DIR, which stands for
direct and indirect remuneration, is a catchall term used to describe various price
concessions required from pharmacies by PBMs to participate in the Medicare Part D program.
Those concessions grew to more than 107,000% since 2010, according to CMS, and ultimately
inflated seniors’ share of their prescription drug costs. They were also assessed
retroactively, often months after the transaction, making it impossible for pharmacies to
keep up with and predict the cost of these transactions. APhA’s LDF joined forces with other
pharmacy organizations in litigation
that targeted the retroactive nature of these fees, resulting in direct changes under
Medicare. While the retroactive nature of DIR has been eliminated, PBMs have already found
new revenue mechanisms in take-it-or-leave-it contracts, and CMS has yet to eliminate the
use of DIR, with more legal battles to come.
What is the LDF doing right now? Why we fight.
The U.S. Supreme Court recently asked the solicitor general (the lawyer who represents the U.S. government)
for arguments regarding a request from the state of Oklahoma, which cited APhA’s LDF joint
brief, for the Supreme Court to clarify that it had already unanimously settled
the issue that Oklahoma and other states maintain the ability to regulate PBMs. The clarification is
necessary due to the existing legal confusion that discourages states from effectively regulating PBMs or
investing resources in enforcing new PBM-related regulations.
However, the solicitor general’s brief supported a lower appeals court ruling that overturned portions of
Oklahoma’s state PBM reform law based on federal preemption for employer-sponsored plans and Medicare Part
D. This is despite the fact that the appeals court’s decision directly conflicts with both district court
and U.S. Supreme Court rulings that had previously found the states have the right to regulate PBMs. As a
result, the Supreme Court did not clarify the current legal disparities.
The Supreme Court’s denial of the petition for review will leave the 10th Circuit decision in place for now
but only for the states within the 10th Circuit (i.e., Colorado, Kansas, New Mexico, Oklahoma, Utah, and
Wyoming). For the rest of the country, this decision sustains the status quo of uncertainty about how far
state laws can go in regulating the PBM practices that harm patients and pharmacies. In addition,
the large PBM trade association is now filing lawsuits against other state PBM reform laws—often through
local business and labor groups—regulating PBMs’ harmful business practices in various states.
Keep the LDF’s momentum going!
Legal battles in the states.
- Iowa: APhA’s LDF recently joined other pharmacy organizations to defend
state PBM reform laws recently signed into law in Iowa. Despite the LDF’s legal efforts, a
federal judge has issued a temporary injunction on Iowa’s new PBM reform law that would have
required PBMs to reimburse pharmacies the average cost of a medication, and pharmacies would
be paid a dispensing fee of $10.68 that was set to take effect on July 1. The judge has
scheduled a hearing on the law. Our advocacy, utilizing the LDF, must continue.
- Tennessee: APhA’s LDF is filing another brief in defense of Tennessee’s PBM
reform law, against a lawsuit by a local employer, who was recruited by the large PBMs, a
tactic that is only expected to continue in additional states.
Congress.
- Federal PBM reform? Unfortunately, Congress removed all federal PBM reforms
from the recent reconciliation bill. These provisions—designed to protect patients and
preserve access to community pharmacies—were removed under procedural rules, not because
they lacked merit. If Congress won't act on PBM reform, we must take matters into our own
hands. The LDF gives pharmacists another avenue in the courts to protect the future of
pharmacy
State practice authority and regulatory agencies
- Pharmacists’ authority to prescribe PrEP for HIV: CMS’s Final National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention prohibits Medicare-enrolled pharmacies to bill for HIV PrEP items or services that pharmacists have prescribed, even though states legally authorize pharmacists to prescribe these items. Not only does this policy infringe on state authority to define and regulate the practice of pharmacy and medicine, but it also denies access to patients who rely on pharmacists to prescribe HIV PrEP, particularly in areas where primary care services are limited. APhA’s LDF has set the stage with legal arguments for this fight on behalf of patients with HIV on the Medicare claims denials of pharmacist-prescribed HIV PrEP services.