Senators Urge CMS to Keep Six Protected Classes in Drug Benefit

Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.

By Mindy Yochelson

July 5 — Medicare should continue its policy of requiring prescription drug plans to include substantially all covered drugs in six categories, two members of the Senate Finance Committee told the CMS in a letter released July 5.

Sens. Charles Grassley (R-Iowa) and Sherrod Brown (D-Ohio) said they objected to recommendations by a congressional advisory panel that would permit removal of two classes from the six that are protected. The policy is intended to protect vulnerable beneficiaries, they said.

“Despite Part D’s success and the effectiveness of the six protected classes policy, the Medicare Payment Advisory Commission (MedPAC) report released earlier this month included a recommendation to make changes to this popular policy,” Grassley and Brown wrote to acting CMS Administrator Andy Slavitt in a June 30 letter.

Antidepressants, Immunosuppressants

The bipartisan letter was in response to Part D recommendations in MedPAC's June report to Congress that would permit drug plans to remove antidepressants and immunosuppressants for transplant rejection from protected classes requirements.

MedPAC said the protected classes requirement can result in financial disadvantages for the Part D program due to increased drug prices and overutilization.

The two classes recommended for removal have a number of generic versions of drugs available, MedPAC said. A number of commercial plans, which aren't subject to the CMS’s formulary requirements, already include various generic antidepressants, each with different molecular structures, as therapeutic alternatives.

Grassley and Brown, however, said that regardless of potential savings, the policy was created to “safeguard access to lifesaving medicines” for beneficiaries without having to face a therapy interruption.

Agency Activity

In 2014, the Centers for Medicare & Medicaid Services proposed removing three of the classes—a move that was criticized by committee members as well as drugmakers, beneficiary advocates and others.

The provision, however, was never finalized.

A year later, Grassley and Brown introduced a bill (S. 648) that would require Part D sponsors to include all covered drugs in the six categories on their formularies.

“After a variety of input from Congress and other stakeholders, CMS decided not to move forward with its proposal,” the two said in the letter to Slavitt. “Two years later, Congress remains steadfast in its commitment to maintaining this important patient protection.”

Patient Group Comments

The Partnership for Part D Access, a coalition of national patient groups and others, praised the senators for sending the letter in a July 5 statement that included comments from members.

“Undermining access to immunosuppressants and antidepressants would jeopardize care for the vulnerable patient populations that have come to rely on the full range of drugs available in the six protected classes,” Angela Ostrom, chief operating officer and vice president of public policy for the Epilepsy Foundation, said. “MedPAC’s proposal fails to consider the serious impact a change to the six protected classes policy would have on patient adherence to their treatment regimen.”

To contact the reporter on this story: Mindy Yochelson in Washington at

To contact the editor responsible for this story: Kendra Casey Plank at

For More Information

The letter is at

Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.

Request Health Care on Bloomberg Law