Trump administration to require insurers cover coronavirus vaccines

• The Trump administration will require most private health plans to cover an approved coronavirus vaccine and its administration with no cost-sharing once the shot is recommended by a Centers for Disease Control and Prevention panel.
• Medicare will also cover any vaccine at no cost to beneficiaries, while Medicaid will reimburse vaccination with no cost sharing for most plan members through the public health emergency declaration in the U.S.
• Providers administering the vaccine to people without insurance will be reimbursed by the federal government and are prohibited from charging consumers if they receive the vaccine from the government, according to an interim final rule published Wednesday.

A third surge in COVID-19 cases in the U.S., with many hospital systems warning of strained capacity, underscores how much hopes for a return to normalcy could hinge on a safe and effective vaccine.

More than 40 vaccines are in clinical testing worldwide, with four in late-stage studies in the U.S. Should data from the trials of those four prove positive, their developers plan to seek an emergency use authorization form the FDA. Results from both Pfizer and Moderna are likely to come next month.

If any vaccine is authorized, or later approved, distribution will likely be a major hurdle. With the Wednesday's rule, the Centers for Medciare and Medicaid Services is attempting to get ahead of one piece of that puzzle by spelling out requirements for how that process will be paid for.

In a statement, CMS Administrator Seema Verma said the department "is acting now to remove bureaucratic barriers while ensuring that states, providers and health plans have the information and direction they need."

Per the interim final rule, Medicare will reimburse $28.39 for a single dose vaccine, while for a vaccine with two doses, $16.94 will be paid for first administration and another $28.39 for the second dose. Rates will be adjusted geographically.

Advance purchase deals between the U.S. government and vaccine makers for early supplies have implied the Trump administration is acquiring doses for between $15 and $20 a piece, roughly in line with what the U.S. pays for influenza vaccines. Those agreements only cover specific amounts ordered by the U.S.

Administration officials have pledged that any vaccine doses acquired by the U.S. would be given to people in the country for free. The interim rule would help address coverage for the cost of administration as well.

Commercial payers have likely modeled the costs of a vaccine and considered that when setting rates. Anthem CEO Gail Boudreaux, for example, said in an earnings call Wednesday the insurer had considered multiple variables when determining its pricing and will follow CMS guidance.

Medicare Advantage plans will be paid for costs of the vaccine through the Medicare fee-for-service program for contract years 2021 and 2021.

America's Health Insurance Plans, a lobby group of insurers, supported the CMS rule, as did group purchasing organization Premier.

Premier, however, cautioned that more action would needed to ensure successful widespread administration of a vaccine. "This vaccination program is unlike any other — the scale, multi-dose administration and ultra-cold storage requirements make it a particular challenge," the group said.

The Trump administration's Operation Warp Speed has pledged about $11 billion toward seven vaccine candidates.

In the U.S., shots developed by Moderna, partners Pfizer and BioNTech, Johnson & Johnson and AstraZeneca are now in advanced testing. Each aims to have initial data from their late-stage studies and, potentially, first supplies, available by the end of this year or early next.

Last week, the FDA granted the first full approval for a medicine to treat COVID-19: Gilead's Veklury. The drug is infused, and treatment is typically given over five or 10 days.

https://www.biopharmadive.com/news/trump-cms-vaccine-insurance-coverage-rule/588033/