The Centers for Medicare and Medicaid Services said it will pay for any Covid-19 vaccine that is authorized or approved by the US Food and Drug Administration to allow for "broad vaccine access and coverage for all Americans."
The agency also announced it will help cover a larger portion of the cost of new Covid-19 treatments that may be coming down the pipeline for Medicare recipients.
"There are several vaccines in Phase 3 trials, production and distribution plans are well underway, and CMS is doing its part by laying the essential groundwork for coverage and payment when a vaccine does arise. It'll be widely available and accessible to seniors and every American," CMS administrator Seema Verma said during a briefing Wednesday.
She said that while the federal government is paying for the vaccine, insurers including Medicare, Medicaid and private plans must cover the cost of administering it.
For Medicare recipients, any future vaccine would be covered by Medicare Part B as a preventative vaccine at no cost to beneficiaries. Medicare Part B covers doctor visits and outpatient services such as lab tests, diagnostic screenings and medical equipment.
"The rule removes any existing ambiguity surrounding Medicare's coverage of the Covid-19 vaccine and allows us to focus on the paramount goal of ensuring that all of Medicare's 62 million beneficiaries, including those enrolled in a Medicare Advantage plan, can receive the vaccine at their provider, their choice, again, at no cost," said Verma.
She estimated that if "literally every senior got immunized," it would cost "likely around $2.6 billion -- that's if everybody got vaccinated in the Medicare program."
The new CMS rule requires most private health insurance plans, including individual health insurance and employer health plans -- representing about 200 million Americans, according to Verma -- to provide both in-network and out-of-network coverage of the vaccine, at no cost to their members.
The agency said that as a condition of receiving free Covid-19 vaccines from the federal government, providers may not charge people for administration of the vaccine.
"Providers who receive free Covid-19 vaccines from the federal government will be prohibited from charging consumers any additional costs for the administration of the vaccine beyond what their insurance covers. Surprise or balanced billing for vaccine costs is strictly prohibited," she said.
The 68 million beneficiaries on Medicaid and the Children's Health Insurance Programs will also be covered for their Covid-19 vaccines during the public health emergency; the Provider Relief Fund will cover the cost for those without insurance coverage.
In addition to covering the cost of a vaccine, the new CMS rule also outlines how Medicare plans to cover the "new generation of Covid-19 treatments" for its recipients.
"Our job at Medicare is to make sure that these medications, when they come into the market, that they can be immediately accessed by seniors who need them. To that end, we are announcing changes to improve Medicare payments to hospitals for emerging Covid-19 therapeutics for both the inpatient and outpatient settings. This will eliminate financial disincentives that hospitals may face for furnishing potentially life-saving treatments to America's seniors," she said.
Hospitals would qualify for additional payments when they treat patients with new products approved or authorized to treat Covid-19, such as monoclonal antibodies, to mitigate any losses they may experience from making these therapies available, Verma said.
The new rule also covers reimbursement for outpatient hospital services and provides information to prepare hospitals to bill for the outpatient administration of a monoclonal antibody product in the event one is approved under an emergency use authorization.
"In short, we are bridging the gap between the standard payment and the outlier payment," she said. "Unlike our current policy for new technology add-on payments that require a year-long application process, new Covid-19 therapeutics will automatically qualify for the additional payments during the public health emergency after they've just been approved by the FDA."
When asked about how a potential change in administration would impact the new CMS rule, Verma said, "I think every American wants to make sure that everyone has access to vaccines. The rules that we're putting in place ... should stand, really, any administration."