The Trump administration on Thursday released a final rule aimed at boosting transparency of drug costs on Medicare Part D, but it does not include a proposal to pass on price concessions negotiated by the pharmacy to patients.
CMS' final drug price rule doesn't include price concessions
While the agency had wanted to implement the new policy in 2020, the CMS said in a release that it is not implementing it after receiving more than 4,000 comments.
"CMS will continue to carefully review these comments as we continue to consider policies that would lower prescription drug costs, address challenges that independent pharmacies face, and improve the quality of pharmacy care," the agency said.
But pharmacy groups were not happy with the decision by the CMS to back off on changes to such price concessions, which are called direct to renumeration fees. Pharmacists charge that pharmacy benefit managers and insurers often assign an expensive copay for a drug well beyond its actual price. The PBM or insurer then recovers the extra money, pharmacy groups charge.
"In its proposed rule the administration cited the recent 45,000% increase in pharmacy price concessions, an increase that is unsustainable," according to a statement from the National Community Pharmacists Association and National Association of Chain Drug Stores. "Pharmacies are in a tenuous situation, and our organizations are exploring all options to accomplish desperately needed reforms to pharmacy DIR."
The rule also codified an earlier policy that requires Part D plans to include drugs from six protected classes on their formulary, such as antidepressants and immunosuppressants. However, the agency did not finalize proposals to allow drug companies to knock the product off the formulary if the price increases or if the drug represents a new formulation of an existing single-source drug.
This isn't the first time that the federal government has backed off wholesale changes to protected drug classes. In 2014, the Obama administration sought to remove antidepressants, immunosuppressants and antipsychotics as protected classes but the changes were scrapped.
Patient advocates cheered the decision to back off the protected class changes.
"We are glad HHS and Secretary (Alex) Azar listened to the countless patients who voiced their serious concern over the proposed rule," said Lisa Lacasse, president of the American Cancer Society Cancer Action Network. "We will closely monitor implementation of this rule working to make sure all cancer patients have timely access to the therapies best suited to treat their disease."
The rule finalized regulations on how a Medicare Advantage plan can apply step therapy to physician-administered drugs under Part B, saying the policy only covers the first time the patient tries a medication and can be reviewed. Part D plans have similar step therapy requirements.
The agency also included several measures aimed at boosting transparency of drug prices.
Starting on Jan. 1, 2021, the CMS will require the Part D explanation of benefits sent to members to include drug price hikes and any low-cost therapeutic alternatives.
"This information will include Medicare beneficiaries about possible ways to lower their out of pocket costs by considering a lower cost medication," the CMS said in a release.
The rule also requires that starting in 2021, each Part D plan adopt one or more electronic real time benefit tools that can integrate with at least one prescriber's electronic health record.
The benefit tools can help inform prescribers of a cheaper of a lower-cost drug available under their drug benefit.
The rule also codifies an earlier requirement that restricts any Part D sponsor from implementing a "gag clause" into a contract with a pharmacy that prevents a pharmacist from telling a customer they can get a drug cheaper if they buy it out-of-pocket instead of through their insurance. President Donald Trump has also signed into law legislation to ban "gag clauses" in commercial plans.
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