With the comment deadline only a few days away, opposition to the Centers for Medicare & Medicaid Services’ (CMS) proposed changes to the Medicare Advantage and Part D prescription drug programs is boiling over.

The nearly 700-page rule, intended to go into effect in 2015, could be finalized as early as next month, Rep. Marsha Blackburn (R-Tenn.) said Monday during a media briefing hosted by the Healthcare Leadership Council (HLC).

Although CMS Principal Deputy Administrator Jonathan Blum repeatedly assured a House subcommittee last week that the agency would listen to all stakeholder concerns about the revisions, Blackburn said there’s no indication CMS is listening to the negative feedback it’s getting. If the agency goes ahead with the rule, Congress may seek legislative action, she added. (See BioWorld Today, Feb. 27, 2014.)

The proposed changes would limit the number of plans Medicare beneficiaries could choose from, as well as the drugs covered under Part D.

Testifying before the House Energy and Commerce Subcommittee on Health Wednesday, Blum said the program needed to be streamlined because all the choices were confusing to Medicare beneficiaries.

Noting the 94 percent satisfaction with Part D, Blackburn said Monday that she found it hard to believe the program is as confusing as CMS is trying to portray.

HLC President Mary Grealey agreed, saying there’s “no compelling reason to make such drastic changes.” The choice that was built into the program has heated up competition, leading to better service and lower drug prices, she said. And that has resulted in high beneficiary satisfaction and stable premiums over the past decade.

One of the most opposed changes is the proposed lifting of protected class status for immunosuppressants and antidepressants. Andrew Sperling, of the National Alliance on Mental Illness, explained during the briefing that the protected classes were created to protect low-income, dual-eligible beneficiaries being switched from Medicaid to Part D so they wouldn’t lose coverage for drugs that were working for them. (See BioWorld Today, Jan. 8, 2014.)

Given the many Medicare beneficiaries with co-morbidities, choice is still a necessity, Sperling said, as it is more challenging to manage medications and drug interactions for patients with multiple prescriptions. That also makes fixed-dose combination drugs more crucial, and yet the revised rule would not require plans to include combination drugs, even in the protected classes. (Antiretrovirals used to treat HIV would be the lone exception.)

Former Democrat Congressman Patrick Kennedy echoed Sperling’s concerns about the proposed changes and called for a better appeals process so beneficiaries could still get the drugs they need.

The briefing came on the heels of a letter the HLC sent to CMS Administrator Marilyn Tavenner Monday, asking her to withdraw the rule. The letter was signed by 279 groups, including drugmakers, patient advocates, medical societies, trade associations, insurance companies, chambers of commerce and state granges.

Late last week, the Senate Finance Committee, led by committee Chairman Ron Wyden (D-Ore.) and Ranking Member Orrin Hatch (R-Utah), also urged Tavenner to withdraw the rule. Given the success of the program, the senators said they were perplexed as to why CMS would propose to “fundamentally restructure Part D by requiring immediate, large-scale changes to the program that have direct consequences for beneficiaries.”

In their Feb. 28 letter, the senators noted that “many of the proposed changes are untested and unstudied and could result in significant loss of beneficiary choice, access and consumer protections.”

Comments on the proposed rule are due by Friday.

FDA CLARIFIES REPRINT GUIDANCE

In response to stakeholder questions, the FDA is revising its 2009 guidance on the distribution of medical journal and scientific articles on off-label uses of drugs and medical devices to clarify how its best reprint practices should apply to clinical practice guidelines (CPGs) and scientific or medical reference texts.

The draft revised guidance, published in the Federal Register Monday, contains separate sections with guidelines for each type of publication. The section on reference texts includes best practices for entire texts and individual chapters. In both instances, the texts:

• should be generally available in bookstores or other independent distribution channels where textbooks are sold and not written or published specifically at the request of the manufacturer;

• should not be edited or significantly influenced by the manufacturer or anyone who has a financial relationship with the manufacturer;

• should not be marked, highlighted, summarized or characterized by the manufacturer, in writing or orally, to emphasize or promote the unapproved use;

• should not be abridged or excerpted;

• should not be attached to specific product information, other than the approved labeling or approved indications-for-use statement.

The CPG section incorporates the Institute of Medicine’s “trustworthiness” standards to ensure that CPGs, distributed either in their entirety or by section, reflect a systematic review of the evidence and a benefit-harm assessment of alternative care options.

Comments on the draft are due by May 2.