A Fully Approved Vaccine, a Budget Blueprint, and No Surprises Act FAQs

Busy week in Washington on domestic issues.

Last week, the Food and Drug Administration (FDA) fully approved the COVID-19 vaccine developed by Pfizer-BioNTech for individuals 16 and older. Pfizer’s full approval immediately triggered the U.S. Department of Defense to require all military personnel to get vaccinated, and will likely open the way for more schools and private companies to require the vaccine for their employees.

Both the Moderna and the Johnson and Johnson vaccines have yet to receive full approval, but Moderna has applied for the approval, and Johnson and Johnson hopes to apply later this year.

The U.S. House of Representatives passed a $3.5 trillion budget blueprint along party lines last week. The blueprint included numerous safety-net provisions, as well as climate and healthcare-related programs, including the expansion of Medicare to include dental, hearing, and vision coverage. Under the plan, Medicaid would be expanded as well, to include the 12 states that have not yet expanded under the Patient Protection and Affordable Care Act (PPACA), and subsidies would be increased for PPACA marketplace plans.

The budget has a ways to go – both Senate and House Democrats are expected to produce their own bills, and they’ll be negotiated over the next few months. But if Democrats stick together on it, Biden is expected to sign.

And a little over a week ago, the Centers for Medicare & Medicaid Services (CMS) released FAQs with guidance on the No Surprises Act, delaying the Jan. 1, 2022 compliance date for many of the compliance deadlines associated with the Act.

As listeners to Monitor Mondays are probably aware, there are two categories of requirements within the No Surprises Act. The first category of provisions is associated with the title of the Act; that is, the provisions address out-of-network claims (specifically, a small group of out-of-network claims in which the patient does not voluntarily choose the provider and later gets billed for the out-of-network care, otherwise known as surprise balance billing).

The recent FAQs did not change the Jan. 1, 2022 compliance date regarding the prohibition on surprise balance billing, or the manner in which providers are reimbursed or can negotiate payers for these kind of claims.

However, the recent FAQs did change the Jan. 1, 2022 deadline for many of the price transparency requirements included in the Act.

For instance, CMS delayed indefinitely the requirements regarding what is called the Advanced Explanation of Benefits (AEOB), whereby providers are required to send a good-faith cost estimate to a patient’s payer every time a healthcare item or service is scheduled.

The FAQs noted that compliance with the AEOB is being delayed until CMS has established standards for the data transfers, and payers and providers have enough time to build the infrastructure to support the transactions.

Programming Note: Listen to Matthew Albright and his Legislative Update sponsored by Zelis, Monday on Monitor Mondays, 10 Eastern.