With the start of a new plan year, you might be filling prescriptions for Medicare patients who decided to join the Medicare Prescription Payment Plan (M3P). CMS required all Part D Plans to offer the M3P program as of Jan. 1, 2025. If you need a refresher, this explainer has been provided by the Pharmacists Society of Wisconsin and provides a great overview.
Pharmacies should be distributing copies of Medicare’s “Likely to Benefit” notice to patients every time you get a paid claim with Approved Message Code 056. This code is sent with claim copays greater than $600 to alert the patient that they may benefit from opting in to the Medicare Prescription Payment Plan (M3P). You can reach out to your pharmacy software vendor to help with identifying where these message codes appear and how to print the notice. Make sure the newest CMS version with a 12-31-2026 expiration date is printing.
Brush up on the basics of M3P | NCPA
The Centers for Medicare & Medicaid Services released a complaint tool for providers to report issues to CMS regarding Medicare Advantage plans. You can access the CMS tool here. NCPA created a complaint handout for patients with a QR code that you can display or distribute to patients that directs them to a CMS web based complaint form or toll-free phone number.
Provider complaint tool for Medicare Advantage | NCPA
The approved modifications to the iPLEDGE REMS for isotretinoin will take effect on August 8, 2026, which is 180 days after the approval date of February 9, 2026. Important changes for pharmacies under the modifications include:
Changes for prescribers include:
You can view the FDA update here.
FDA approves modifications to iPLEDGE REMS for isotretinoin | NCPA
After years of NCPA advocacy, the president has signed into law provisions instituting the first meaningful federal reforms to pharmacy benefit manager practices. The bill requires the Centers for Medicare & Medicaid Services to define and enforce "reasonable and relevant" Medicare Part D contract terms; allows CMS to track payment trends to pharmacies and pharmacy inclusion in PBM networks, including a new designation of essential retail pharmacies; and prohibits PBM compensation in Medicare Part D from being tied to the manufacturer's list price of a drug in an effort to reduce drug prices and save money for taxpayers. You can read a high-level summary of the PBM reform provisions included here. Click here for a one-pager on additional provisions, including de-linking of PBM compensation, PBM audits, and 100 percent commercial pass-through.
NCPA cheers as Trump signs first major PBM reform in decades | NCPA
NCPA creates one-pager on PBM reforms | NCPA
The White House unveiled TrumpRx.gov, a website acting as a portal to direct patients to the lowest prices for specific drugs. There are currently 43 drugs listed on the website. There are a few different options for patients to get discounts. Some drugs link directly to manufacturer programs, others are only available via mail order at certain pharmacies, but many of the drugs allow for a coupon to be printed and presented at a local pharmacy. Initial claims show that some of these coupons are processing with profitable results for pharmacies, but they may not always be the lowest prices for patients. It is recommended to continue monitoring profitability and be vigilant in following coupon eligibility requirements for abuse, fraud, and compliance in expectation of possible future audits.
TrumpRx prices not always the lowest option
The Federal Trade Commission has reached a landmark settlement with Express Scripts (ESI) after alleging that the PBM used anticompetitive rebate practices that helped inflate insulin list prices and increased patients’ out‑of‑pocket costs. Under the agreement, ESI must stop preferring high‑list‑price insulin over lower‑cost equivalents, base patient cost‑sharing on net prices rather than inflated list prices and increase transparency for plan sponsors. The FTC estimates these changes could lower patient insulin expenses by up to $7 billion over the next decade.
The settlement also carries significant implications for community pharmacies. ESI will be required to shift its reimbursement model toward a more transparent structure based on actual acquisition cost plus a dispensing fee, which is expected to generate millions of dollars in new pharmacy revenue each year. Additional requirements include enhanced reporting, disclosure of broker payments, and reshoring ESI’s group purchasing organization to the U.S. The proposed order is open to public comment for 30 days before being finalized.
The West Virginia Insurance Commissioner, Allan McVey, issued an $800,000 penalty on Navitus for violations of the state's pharmacy audit, pharmacy reimbursement, and rebate pass-through laws between Jan. 1, 2023, and June 1, 2024. Navitus did not allow audited pharmacies the required 30 days to respond to preliminary reports and rejected documents to validate pharmacy records. Rebates totaling $540,000 were kept by the PBM rather than passed through as required by law. Navitus also did not reimburse West Virginia pharmacies at the required rate of National Average Drug Acquisition Cost (NADAC) plus a $10.49 professional dispensing fee. This enforcement action is notable given that Navitus is considered a transparent PBM.
W.Va. fines transparent PBM Navitus | NCPA
A med spa, Pure Indulgence Aesthetics, in Texas recently received a letter from the Food and Drug Administration following an inspection that highlights two of the currently-in-effect requirements of the Drug Supply Chain Security Act (DSCSA).
The requirements:
DSCSA-regulated prescription products that do not have a product identifier (and are not covered by a waiver or exemption) or that have a product identifier that fails verification should be reported to FDA. Click here to read a blog written by a former FDA attorney.
With less than nine months remaining, FDA continues to signal that DSCSA enforcement discretion will end on November 27, 2026. This underscores the importance of DSCSA awareness and compliance. Small dispensers are strongly encouraged by the FDA to:
It is recommended that you reach out to your pharmacy software vendor to inquire about which DSCSA vendors they are partnering with or suggesting to help with DSCSA compliance. As an example: PioneerRx software is partnered with InfiniTrak and LSPedia.
Here is an informational article from ACHC regarding DSCSA: Article - DSCSA: Safeguarding the Drug Supply Chain.
Texas dispenser gets DSCSA warning | NCPA
Can a pharmacy legally refuse to dispense a prescription that is of doubtful, questionable, or suspicious medical legitimacy?
If a policy and procedure exists, inspectors assume it is followed exactly as written. Review policies and procedures and update SOPs to reflect current, not historical, practices.