Most of the nation’s attention is currently focused on the development and approval of a coronavirus vaccine. But there are still many hurdles to getting a working vaccine to patients — from the logistics of transporting a vaccine that might need to be refrigerated, to having enough glass vials to contain it. And for some, there’s the lingering question: Will it be covered?

U.S. officials have said they expect private insurers to cover the cost of a vaccine with no co-pay for patients. Under the Affordable Care Act, most health plans are required to cover certain preventive services, such as vaccines, without cost-sharing. The CARES Act, signed into law in March, also requires free Covid-19 immunizations approved for emergency use.

But what about the nation’s largest insurer, Medicare? It doesn’t currently cover drugs approved under emergency use designations, as pointed out by the Wall Street Journal, leaving a big gap in the U.S. if a vaccine receives an emergency use authorization.

Centers for Medicare and Medicaid Services Administrator Seema Verma said the agency was coming up with a plan to ensure a vaccine is covered.

“You’ll see more from the agency by the end of the month on this issue. We’ve figured out a path forward,” she said in a virtual keynote at HLTH. “It’s clear Congress wants to make sure Medicare beneficiaries have this vaccine and that there isn’t any cost sharing.”

At the same time, Food and Drug Administration Commissioner Dr. Stephen Hahn has doubled down on statements that any vaccine approval would be based solely on the scientific data, despite reported pressure from the White House to have a vaccine ready before Election Day.  A guidance published by the FDA earlier this month said that vaccine developers should follow patients for at least two months to rule out significant side effects before seeking an emergency approval — making that date unlikely, at best.

Verma said CMS would ensure the fees Medicare pays for administration of the vaccine are appropriate, taking into account some of the complexities of the coronavirus vaccine, including that it will likely require two doses. Normally, it would take Medicare between one and three years to ensure it is paying adequately for a new treatment.

“We want to make sure that as the FDA is getting approvals for new medications, we are paying for these innovative treatments appropriately,” Verma said. “We’re working across the entire agency — not just Medicare but Medicaid and even private insurers —  to ensure there are no barriers to individuals getting vaccines.”

Verma also discussed another big regulatory hurdle for the agency: telehealth coverage. During the pandemic, the agency has widely expanded coverage of virtual visits, allowing people to access in-home appointments and removing restrictions that limited telehealth coverage to rural areas. Within its authority, the agency also expanded telehealth to 135 services, a much wider variety of specialties.

That said, CMS will need approval from Congress to cover in-home telehealth visits on a permanent basis. Given the recent upswell of support for virtual care, that seems likely to happen.

“We continue to work in Congress. We are exercising all of our regulatory authority,” she said. “It’s never going to replace in-person care, but it’s certainly a tool for our providers and giving them the flexibility for them to decide when telehealth is appropriate for their patients.”

Photo Credit: Geber86, Getty Images



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