CMS will not finalize several controversial policy changes in its recent proposed rule for Medicare prescription drug plans, including the removal of several drug classes from “protected” status on plan formularies, Administrator Marilyn Tavenner wrote in a letter to Congress March 10.

The decision comes in response to strong criticism from stakeholders and many members of Congress.

“We heard concerns about the proposals to lift the protected class definition on three drug classes, to set standards on Medicare Part D plans’ requirements to participate in preferred pharmacy networks, to reduce the number of Part D plans a sponsor may offer, and clarifications to the non-interference provisions. Given the complexities of these issues and stakeholder input, we do not plan to finalize these proposals at this time,” Tavenner said.

Those policy changes were contained in a proposed rule on Medicare Part C and D published in the Federal Register Jan. 10; the public comment period ended March 7 Also see "CMS Proposes Part D Protected Drug Criteria, Drops Antidepressants And Immunosuppressants" - Pink Sheet, 6 January, 2014.. The three classes that would have been affected by the change in protected class policy were antidepressants, antipsychotics and immunosuppressants.

Because the proposed changes would have altered the Part D landscape significantly for such a wide range of stakeholders – drug manufacturers, plan sponsors, providers and patients – those groups came together in writing to ask CMS to withdraw the entire proposed rule ([A#14140218009]).

A bipartisan group of leaders in the House and Senate soon joined in the criticism of the proposed rule, and numerous letters seeking to reverse the proposal were written to CMS, HHS and even the White House, including one signed by every member of the Senate Finance Committee ([A#14140207004]). A House hearing also was held for members to publicly air their opposition ([A#14140226006]).

The letter acknowledges that this pressure was successful in getting CMS to back down from the controversial proposals, saying, “During the rule’s comment period, we received numerous concerns about some elements of the proposal from members of Congress and stakeholders.” The letter is broadly addressed to each member of Congress: “Dear Senator/Member of Congress.”

From manufacturers’ perspective, the most harmful proposal was the one to remove three classes of drugs from protected status, under which Part D plans must cover “all or substantially all” drugs in the class Also see "Mental Health Drugs Face Contracting Challenges From Part D Formulary Proposal" - Pink Sheet, 20 January, 2014.. Patient groups also chafed at this change in formulary standards.

Plan sponsors, although they long have urged CMS to eliminate the protected class policy, since it inhibits their ability to negotiate favorable pricing in those classes, joined with manufacturers in seeking the proposed rule’s withdrawal because of the provisions that would have allowed CMS to regulate plan sponsors’ negotiations with pharmacies, placed restrictions on plans’ use of preferred pharmacy networks and restricted the number of plans they could offer ([A#14140107005]).

Tavenner suggested that CMS is still interested in making changes in these areas, but that the agency would work closely with stakeholders to develop future policy changes. “We will engage in further stakeholder input before advancing some or all of the changes in these areas in future years,” the letter says.

However, the provisions that did not cause the outcry against the rule will continue through the normal rulemaking process, Tavenner wrote.

“We plan to finalize proposals related to consumer protections (e.g., ensuring access to care during natural disasters), anti-fraud provisions that have bipartisan support (e.g., strengthening standards for prescribers of prescription drugs), and transparency (e.g., broadening the release of privacy-protected Part D data) after taking into consideration the comments received during the public comment period,” the letter says.

CMS Drops Proposal To Change Part D Protected Drug Classes

More from United States

More from North America