- CMS is almost ready to release a rule making sure Medicare beneficiaries can access eventual coronavirus vaccines for free, agency head Seema Verma said Tuesday at the virtual HLTH conference.
- "I think you'll see more from the agency by the end of the month on this issue," Verma said. "It was very clear that Congress wants to make sure that Medicare beneficiaries have this vaccine and that there isn't any cost-sharing, so stay tuned."
- Usually it takes between one to three years for CMS to work out payment issues for new treatments or vaccines, Verma said. It's unclear if CMS has the regulatory authority to reimburse for a vaccine if approved by the FDA under an emergency use authorization, as public health officials expect.
Medicare Part B, which usually covers vaccines for Medicare beneficiaries, doesn't extend that coverage to vaccines approved under an EUA. That's resulted in the need for CMS action like rulemaking in this case to ensure Medicare beneficiaries get timely access to a coronavirus vaccine approved in that speedier pathway.
CMS been working with Operation Warp Speed on a vaccine payment strategy, along with making sure providers are reimbursed for the administration fee and commercial payers don't hamstring broader access, Verma said.
Along with Medicare, the cost of the vaccine should be covered by the federal government for those with commercial insurance. The Coronavirus Aid, Relief, and Economic Security Act passed by Congress in March made a vaccine a "preventable health service," meaning plans must cover the cost for their members without implementing out-of-pocket costs.
CARES also says Medicare beneficiaries cannot have cost-sharing for a vaccine, once available.
However, figuring out how much the administration will reimburse for the vaccines in Medicare is an ongoing process, as the goalposts shift along with the frontrunners in the vaccine race. For example, there may be additional costs to store a coronavirus vaccine at cold temperatures, or because some of the candidates require two doses, experts say.
On Monday, drugmaker Johnson & Johnson said it was pausing clinical trials of its vaccine candidate due to an illness in one study participant. It's the second Phase 3 coronavirus vaccine trial to be halted in the U.S. for a safety review, following a pause in AstraZeneca's U.S. trial last month.
Many experts think COVID-19 vaccines will first be made available in the U.S. under an EUA during the public health emergency, though more stringent guidelines out from FDA make it unlikely a vaccine would be cleared for emergency use before the November election.
Verma on Tuesday also teased the agency is evaluating ways to nudge providers to take on more risk in its value-based payment models, taking inspiration from COVID-19 relief waivers issued by the agency earlier in the pandemic. Some of those flexibilities could translate to CMS' value-based models to encourage provider participation while incentivizing them to take on more risk.
"Going forward, I think we can look at the types of waivers we provided [during the pandemic], and maybe use that as an incentive for some of our value-based models," Verma said. "Because I think the way they were set up before was just to encourage participation, that didn't necessarily lead to lower costs."