Updated April 30, 2024.
By Myles Starr
The Centers for Medicare & Medicaid Services (CMS) has released the final part 1 guidance for the new Medicare Prescription Payment Plan, part of President Joe Biden’s changes to prescription drug pricing law. 
These new rules, which come into effect in 2025, will allow people with Medicare prescription drug coverage (Medicare Part D) to pay out-of-pocket costs in monthly payments rather than requiring full payment each time they fill a prescription. Although the plan will likely be a boon to consumers, the announcement poses a challenge for pharmacies and pharmacists who will have about a year to set up systems to be compliant with the new rules.
“Implementation of the program will be complex, and AMCP [the Academy of Managed Care Pharmacy] is concerned about the short timeline that health plans have to [comply],” said Susan Cantrell, the CEO of AMCP. “Health plans will likely see challenges and impacts in several areas, including cash flow, the need to provide information and education to patients and providers, and possibly on future Star Ratings. Pharmacy benefit managers will need to be involved in the implementation as well.”
The guidance explains how pharmacies can prepare to identify Medicare Part D enrollees likely to benefit from the program, the opt-in process for enrollees, program participant protections and the data collection needed to evaluate the program.
When the rules take effect, Part D sponsors will be required to notify pharmacies to provide information on the program to any patient who meets a $600 out-of-pocket threshold based on a single prescription at the point of sale. A requirement for communications to be provided to people with Medicare Part D before and during the coverage year is outlined in the draft part 2 guidance.
“For many patients with fixed incomes, being better able to predict their monthly prescription drug costs may lead to a greater ability to afford and follow their healthcare provider’s prescribed course of treatment,” Ms. Cantrell said. “This improved medication adherence will likely lead to better health outcomes for patients with high out-of-pocket costs.”
As the program rolls out, she added, pharmacies also must be prepared to field patients’ questions about the program and educate them on how to navigate it.
“Pharmacies will need to implement new processes to notify patients who may benefit from the program at the point of sale,” Ms. Cantrell emphasized. “The point-of-sale notification requirements will also require coordination between health plans and pharmacies, potentially via a standardized NCPDP [National Council for Prescription Drug Programs] message code.”
For health plans, she continued, “there will be a variety of operational challenges, including IT [information technology] changes, new processes for patients who opt in to the program, and new billing processes.”
As a result of these manifold changes, AMCP has encouraged CMS to exercise enforcement discretion during the first year of the law’s effect.
A CMS spokesperson told Specialty Pharmacy Continuum that the agency has been "actively engaged with stakeholders on the implementation of the Medicare Prescription Payment Plan. A list of guidance published to date and the requirements for the program can be found here. We look forward to continuing to work with stakeholders to educate beneficiaries about the program and prepare for operations leading up to January 1, 2025."
The sources reported no relevant financial disclosures.
This story was updated to include a comment from CMS.
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