Part D proposal includes prior authorization, step therapy


Rules governing the six protected medication classes covered by Medicare Part D could change under a proposal that would allow for utilization management or potential formulary exclusion of a drug for price increases.

Seema Verma CMS administrator

Seema Verma

Currently, Medicare Part D prescription drug benefit plans must cover “all or substantially all” approved drugs in six classes (antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics). The proposed rule would allow three exceptions aimed at giving plans more negotiating leverage to help lower prices.

Plans would be allowed to implement prior authorization and step therapy for protected-class drugs, “including to determine use for a protected class indication,” according to a fact sheet. They also could exclude a protected-class drug from their formulary “if the drug represents only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market.”

This does not change requirements that at least two drugs per class be covered, Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said at a briefing. “In some classes, there are lots of competitors. For example, for antidepressants, there are lots of new generics available, so we see plans being in a very strengthened negotiating position. But in other classes, where there may not be as many drugs that are available, you might not see the same type of step therapy and prior authorization because there are just not that many options. It is really going to depend on the class of drugs and what’s available and the plans’ ability to negotiate discounts with manufacturers.”

Plans could exclude a protected-class drug if its price had increased greater than inflation, Ms. Verma said, but they could not use this to not cover any drugs in a class if available options are limited to one or two drugs.

“Foremost in our minds was the impact on patients and ensuring affordability and access to prescription drugs,” Ms. Verma said.

Oncologists don’t seem to agree.

“For the first time ever, Medicare patients with cancer and other serious diseases [who] rely on drugs in these protected therapeutic categories, will no longer have guaranteed access to potentially life-saving drugs. Instead, they will be subjected to ‘fail first’ step therapy and formulary restrictions that potentially restrict them from receiving the evidence-based therapies that their trained physicians prescribe as first-line cancer treatment,” Jeff Vacirca, MD, president of the Community Oncology Alliance, said in a statement. “Step therapy requirements are driven by financial interests to save money and not by what is in the best medical interest of patients. Treatment decisions are made by nameless and faceless corporate bureaucrats who are often not board certified in the diseases they are making coverage decisions over.”

AGA is concerned that these proposed changes will limit access for current and future beneficiaries and will add to the growing regulatory burden that physicians already face.

The proposal also would codify a policy implemented for 2019 that allows Medicare Advantage to implement step therapy tools for Part B drugs. And like the 2019 policy, the proposal would apply to new medication starts only, must be reviewed by a plan’s pharmacy and therapeutics committee, and must have an expedited exceptions process.

The proposal also specifically allows pharmacists to advise Part D beneficiaries on lower-cost options – something current regulations prohibit – and would require Part D explanation of benefits forms to include drug pricing information and lower-cost therapeutic alternatives.

The proposal is part of a broader update for Medicare Parts C and D in 2020 issued by CMS. It was published online Nov. 26 and is scheduled for publication in the Federal Register on Nov. 30. Comments can be made at www.regulations.gov through Jan. 25, 2019.


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