ACR statement regarding the recent CMS guidance on indication-based formulary design

A statement from the American College of Rheumatology regarding CMS guidance on indication-based formulary design can be found below.

"While we appreciate the agency's efforts to make prescription medications more affordable, we have serious concerns about a new CMS guidance to allow Medicare Part D plan sponsors to implement indication-based formulary designs that allow plans to select drugs for their formularies based only on the disease indications they want to use.

"These changes are a departure from current policy, which requires plans to cover each on-formulary drug for all indications that are approved by the FDA. It takes clinical decision making out of the hands of providers and puts insurance companies in control of patient treatment plans.

"Furthermore, the proposed changes will exacerbate many of the access issues patients currently face with plan usage of existing utilization management practices, such as step therapy. Unlike step therapy, which often delays effective treatments, this proposal would go even further and allow plans to remove therapies from the formulary altogether, leaving patients completely unable to access treatments that doctors and patients choose together. The ACR calls on the Trump administration not to go forward with this plan, or at a minimum to clarify the process for allowing exemptions for patients for whom a specific therapy is medically necessary. This process should be straightforward and not place an undue burden on the physician or patient in gaining access to needed medications.

"We also have concerns on what this would mean for work being done on compendia inclusion to secure off-label drug coverage if plans don't have to cover all approved FDA-approved indications.

"We remain steadfast in our support for policies that lower costs while protecting patient access to needed therapies and look forward to continued dialogue with CMS about the proposed changes."


Media Contact:
Jocelyn Givens
[email protected]
404-633-3777, ext. 810

The American College of Rheumatology (ACR) is the nation's leading advocacy organization for the rheumatology care community, representing more than 7,700 U.S. rheumatologists and rheumatology health professionals who are committed to improving healthcare for Americans living with rheumatic diseases.

Media Contact

Jocelyn Givens
[email protected]
404-633-3777 x810