CMS Prescription Drug Final Rule Addresses AAFP Concerns

May 29, 2019 01:14 pm News Staff – CMS recently published a final rule intended to lower prescription drug prices and increase transparency in the Medicare Advantage and Medicare Part D programs.

Specifically, the changes were made to, among other things, ensure patients have access to information on the cost of their Part D prescription drugs. The final rule also will allow Medicare Advantage plans to negotiate for better prices for physician-administered medicines.

CMS Administrator Seema Verma, M.P.H., discussed the final rule in a May 16 press release. 

"Today's rule requires Part D plans to adopt tools that provide clinicians with information that they can discuss with patients on out-of-pocket costs for prescription drugs at the time a prescription is written," she said. "By empowering patients with information on the cost of their prescription drugs, today's rule will ensure that pharmaceutical companies have to compete on the basis of price."

According to a CMS fact sheet posted the same day, the final rule

• codifies an existing policy on prior authorization and step therapy allowances for six classes of drugs,
  
• requires use of electronic real-time benefit tools in the Part D program,
  
• helps finalize policy that could implement step therapy for Part B drugs in Medicare Advantage plans as a recognized utilization management tool,
  
• requires that Part D plans include drug price increases and lower-cost alternatives in member explanation of benefit communications, and
  
• prohibits Part D sponsors from implementing gag clauses that would restrict pharmacies from informing beneficiaries about lower cash prices for drugs.

The AAFP has been tracking the progress of this rule since CMS posted the proposal in November 2018.

In fact, in a Jan. 25 letter(2 page PDF) to Verma, the AAFP firmly stated its opposition to any action that would limit a patient's access to medications prescribed by his or her physician.

Notably, CMS did not finalize the portion of the proposed rule that would have excluded a protected class drug from a formulary if its price increased beyond a certain threshold or if the drug represented a new formulation of an existing single-source drug or biological product.

In the same letter, the AAFP noted its support for steps that have indeed been cemented in the final rule -- specifically, proposals to reduce costs to beneficiaries in Medicare Part C and D programs by including information about drug prices and lower-cost therapeutic alternatives in patients' explanation of benefit documents.

"The inclusion of drug pricing information in the Part D EOB will allow patients to make more informed decisions in the future that minimize their out-of-pocket costs and total expenditures borne by the Part C and D programs," the AAFP wrote in January.

The AAFP also joined more than 140 other professional medical organizations when it signed on to a second Jan. 25 letter(6 page PDF) -- this one initiated by the Partnership for Part D Access -- that expressed concerns with parts of the proposed rule, including the proposed changes to the protected drug classes.

In that letter, the signing organizations said the proposal could make it more difficult for Medicare Part D enrollees to "access and maintain the right treatment regime for their situation," and they urged CMS to continue discussions with patient groups and other stakeholders to ensure patient access to critical medications. This was the same objection the AAFP had raised separately.

Related AAFP News Coverage
Medicare Part D Proposed Rule Triggers AAFP Response
(1/28/2019)