This post originally appeared in POLITICO on May 17, 2019.
Assorted health care interests expressed relief Thursday following CMS' decision not to move forward with changes that would have let Medicare Part D and Medicare Advantage plans limit coverage of drugs in six categories known as “protected classes.” Some of the interests even expressed optimism policymakers won’t try to change the benefit again now that both Donald Trump and Barack Obama each failed to generate the needed political support for modification. Under the status quo, Part D plans must cover all drugs in the six protected classes: antidepressants, anti-psychotics, anticonvulsants, immunosupressants for transplant rejection, antiretrovirals and cancer drugs.
“Medicare beneficiaries with the most complex, chronic conditions are breathing a sigh of relief. This rule cements Medicare’s protected classes policy as an essential patient safeguard in Medicare’s prescription drug program,” said Chuck Ingoglia, the executive director of the Partnership for Part D Access, a coalition of drug companies, disease and patient groups, among others.
The agency backed off a November proposal that would have allowed health plans to exclude protected-class drugs from formularies in instances where prices rise more than inflation or when only minor changes are made to older medicines. CMS also did not alter step therapy or prior authorization in Part D as originally planned, but it did formally codify through rulemaking the prior authorization and step therapy capabilities plans already had through guidance documents. More on the final rule from Sarah Karlin-Smith here.
Lawmakers in both parties, patient groups and the drug industry had predicted the changes to the protected classes would hurt seniors.
“Cancer care often requires specialized treatment targeted at a patient’s specific tumor and these treatments are rarely interchangeable,” said Lisa Lacasee President of the American Cancer Society Cancer Action Network in a statement praising CMS' reversal.
The AIDS Institute also cheered the news, saying that changes to the protected classes would have undermined the administration's goal of ending HIV transmissions in the Untied States in the next ten years. And PhRMA used its praise of the CMS walk-back to make another push for the administration's proposed rule to eliminate rebates in Medicare, as a better way to provide drug savings to seniors.