WASHINGTON – Sen. Chuck Grassley of Iowa and Sen. Sherrod Brown of Ohio have introduced legislation to require that Medicare prescription drug plans carry six categories of prescription drugs offered to participating beneficiaries.  The legislation comes after the federal Centers for Medicare and Medicaid Services tried to limit the categories by regulation, then dropped its plans after public outcry.

“These classes of drugs are important to the health of Medicare beneficiaries,” Grassley said.  “The process for considering covered medicines is important, too.  A federal agency shouldn’t operate with a silo mentality in making coverage decisions that affect a large number of people. The decision-making should be transparent and logical between the agency and Congress.  Affected beneficiaries and their doctors should have a chance to weigh in, and congressional intent should matter.” 

“For many years, Medicare has ensured that seniors enrolled in prescription drug plans can easily access critical drugs that treat sensitive diseases and health conditions,” Brown said.  “This bipartisan bill will ensure that seniors don’t have to jump through hoops like prior authorization to access the prescription drugs they need.  We know access to the right drugs saves lives and costs, and any changes to Medicare’s prescription drug plan must not jeopardize patient choice and safety.”

The Grassley-Brown legislation would require that Medicare Part D sponsors include all covered drugs in six protected categories and classes in their plan formularies: anticonvulsants, antidepressants; antineoplastics, antipsychotics, antiretrovirals,  and immunosuppressants for the treatment of transplant rejection. The Secretary of Health and Human Services could use the formal regulatory process, including public notice and a comment period, to establish exceptions that would allow Part D plan sponsors to exclude a drug in one of the six protected classes or to limit access to a protected drug through utilization controls such as requiring prior authorization. The legislation would take effect beginning in plan year 2015.
Under current Centers for Medicare and Medicaid Services regulatory policy, Part D sponsor formularies must include all or substantially all drugs in these six classes and plan sponsors may not implement prior authorization or step therapy requirements intended to steer beneficiaries to preferred alternatives within these classes for enrollees who are currently taking a drug.  In January 2014, CMS issued proposed rules that would have narrowed the protected classes to anticonvulsants, antiretrovirals, and antineoplastics, beginning in plan year 2015. Antipsychotic drugs would have continued to be treated as a class of clinical concern in 2015 and until CMS determined that it was appropriate to change the criteria for these products.  In May 2014, CMS announced it would not finalize the proposed regulations relating to the six protected classes.