UPDATE: May 20, 2019: The American Medical Association commended the administration for tossing the proposal that targeted protected drug classes. In a statement, AMA President Barbara McAneny said, "Seriously ill patients who faced the prospect of new hurdles to accessing their medication can breathe a sigh of relief now that the Trump administration has discarded the proposal."
- CMS pulled back on some of its initial proposals to rein in spending in Medicare Part D. Some advocacy groups applauded the choice to forgo implementing certain provisions, including one that targeted protected drug classes.
- The agency is moving forward with other provisions including allowing plans to introduce step therapy for Part B drugs, or injectables, and it will strip away the gag clauses that had prevented pharmacists from alerting patients to a lower-cost option if they were to pay with cash. The final rule released Thursday would require Part D plans use EHR tools so doctors can see which drug choice is cheaper under the patient's insurance plan.
- After receiving a large volume of feedback, CMS will not implement a provision that would have ensured patients pay the lowest price at the pharmacy by redefining the negotiated price. Currently, it is possible for the negotiated price to be higher than the final payment to the pharmacy.
The final rule turned out to be less stringent than the initial proposal and is seen as a win for biopharma, plans and some advocacy groups.
Ana Gupte, an analyst for SVB Leerink, said the rule walks back key provisions the agency proposed in November, "pointing to less appetite for the Administration to follow through on their reform initiatives in the face of industry opposition."
Not everyone was happy with the final rule, though.
The National Community Pharmacists Association and the National Association of Chain Drug Stores were disappointed CMS failed to take action on redefining the negotiated price.
But NCPA and NACDS wanted to see "all pharmacy price concessions be included at the point of sale" to provide both seniors with lower costs and pharmacies with more certainty.
"The agency was considering redefining the negotiated price as the lowest possible payment to the pharmacy, effectively passing on the price concession negotiated by the pharmacy (DIR Fees) to the patient," Gupte said.
Backing off this proposal is a solid win for plans and PBMs, she said.
Pharmaceutical Care Management Association, the industry group representing PBMs, was pleased with the administration's rule.
"These competitive negotiations between PBMs and pharmacies generate significant savings for the federal government and beneficiaries, while incentivizing pharmacies to meet quality standards, such as generic dispensing rates," PCMA CEO JC Scott said in a statement.