Health plans, meanwhile, suggest the changes could empower them to reduce drug spending while continuing to meet beneficiary needs.
Patient advocacy groups have objected swiftly to a proposal that would grant Medicare Part D health plans new liberty to reject or restrict certain protected-class drugs, which the plans have been required for more than a decade to cover.
The proposal—which the Centers for Medicare & Medicaid Services announced Monday, with the stated objective of giving Part D plans greater negotiating power to control rising drug costs—would allow insurers to erect new barriers to care that could impede progress in treating serious conditions, such as cancer and HIV, advocates warned.
"What is the point of having protected therapeutic classes if they are not truly protected?" Jeff Vacirca, MD, FACP, president of the Community Oncology Alliance, said in a statement.
"In oncology there are few therapeutic and generic-to-brand equivalents that can be substituted when formularies are restricted, so patients need uninhibited access to the therapies their oncologists prescribe," Vacirca added.
"Although CMS claims this proposal includes patient safeguards, navigating those hurdles while dealing with cancer is cumbersome, agonizing, and an unnecessary burden," he said. "Additionally, delays in starting cancer treatment can have grave consequences and are inexcusable."
Chris Hansen, president of the American Cancer Society Cancer Action Network, said the proposal "could have life or death consequences" for Medicare beneficiaries with cancer, noting that cancer disproportionately affects older populations, who are covered by this program.
"The proposals aim to save the Medicare program money, but in their current form could actually have the inverse effect, raising costs in other parts of the program and likely resulting in tremendous cost-shifting to patients," Hansen said in a statement.
Similarly, the AIDS Institute said the proposal—which would also permit plans to expand prior authorization and step therapy restrictions into protected-class drugs—will, if finalized, endanger efforts to treat those living with HIV.
"Step therapy is unheard of in the treatment of HIV due to the danger of developing resistance to an entire class of drugs and potential side effects," the institute said in a statement.
"Not all HIV medications are the same, and not very person living with HIV is the same," the institute added. "Providers are best able to prescribe the HIV drug that works best for the patient, who may have resistance to certain drugs, comorbidities, or side-effects that dictate the drug that they are able to take."
The proposal could hurt certain drug makers harder than others from a business perspective, but analysts are saying the impact will likely be modest, and the final version will look different from the current draft proposal, as Bloomberg's Cristin Flanagan reported.
But the proposal could bolster business for insurers and pharmacy benefit managers. UnitedHealth, Humana, and WellCare stand to gain the most, as Aetna, Anthem, and Cigna see more subdued impacts, Bloomberg reported, citing Leerink analyst Ana Gupte.
This could explain the rosier response the CMS proposal received from America's Health Insurance Plans (AHIP) President and CEO Matt Eyles, who commended the Trump administration's efforts.
"The problem is the price, driven by monopolies in a broken market that empower branded drug makers to raise prices on the same product year after year," Eyles said in a statement. "With more price hikes already announced for 2019—enough is enough."
Steven Porter is an associate content manager and Strategy editor for HealthLeaders, a Simplify Compliance brand.
New exceptions to protected classes of drugs could lead to new barriers to care, advocates warn.
Some organizations warn that Medicare beneficiaries with cancer or HIV could face especially dire consequences if this proposal is finalized.
Health plans could benefit as the Trump administration aims to endow them with more negotiating power.