The American College of Rheumatology is calling on President Donald Trump’s administration and CMS to reverse a new guidance that would allow Medicare Part D plans to select drugs for their formularies based solely on the disease indications they want to use, rather than requiring plans to cover each on-formulary drug for all FDA-approved indications.
According to the ACR, the new guidance, which is slated to take effect in 2020, would “take clinical decision-making out of the hands of providers and put insurance companies in control of patient treatment plans.” In addition, the proposed change would exacerbate and compound many of the issues and policies currently restricting patient access, including step therapy, the group said.
“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,” noted the ACR statement. “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.”
The ACR is calling on the Trump administration and CMS to reverse a new guidance that would allow Medicare Part D plans to select drugs for their formularies based solely on the disease indications they want to use, rather than requiring plans to cover each on-formulary drug for all FDA-approved indications.
CMS announced the new Medicare Part D guidance on Wednesday, touting the policy change as a way to offer plans the “flexibility to tailor their formularies so that different drugs can be included for different indications.” According to the agency, the policy — known as “indication-based formulary design” — will enable Part D plans to negotiate lower prices, provide more drug choices for patients and “empower beneficiaries to select a plan that is designed to meet their unique health needs.”
In addition, if a Part D plan limits formulary coverage of a drug to certain indications, the plan must ensure that there are other therapeutically similar drugs on formulary for the drug’s non-covered indications, CMS said.
“This action delivers on President Trump’s drug pricing blueprint by offering Medicare plans new tools to negotiate lower drug prices and offer patients better choices,” HHS Secretary Alex Azar said in a CMS press release. “This is a significant step in modernizing the successful Medicare Part D program by giving plans the tools that serve patients well in the private sector.”
However, the ACR on Thursday responded the plan with dismay, warning that it would “place an undue burden on the physician or patient in gaining access to needed medications.”
“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,” the ACR said in their statement. “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.”
The ACR later added: “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.”
According to CMS, negotiations between Part D plan sponsors and prescription drug manufacturers for formulary placement in contract year 2020 are scheduled to begin in the fall of 2018. The agency added that its announcement this week means the policy’s effects should be seen by 2020. – by Jason Laday