Healthcare and life sciences lawyers will likely have plenty of work in 2022 thanks to pending legislative and regulatory actions throughout the healthcare, health insurance, and drug and device industries.
According to this Law360 article, surprise billing, abortion and drug pricing are some of the major issues facing lawmakers and regulators in the year ahead. McDermott Partner Michael Ryan noted that changes to the Medical Device User Fee Amendments (MDUFA) also could be in order.
The Biden administration is giving insurers more time to follow the insurer price transparency rule and the ban on surprise billing. Federal regulators will delay enforcement of machine-readable file provider rates until July 1, rather than the start of 2022. In this article published in Modern Healthcare, McDermott Partner Kate McDonald noted that the initial timeline was “very aggressive.”
The US Departments of Health and Human Services, Treasury and Labor, and the Office of Personnel Management issued an Interim Final Rule with comment implementing portions of the No Surprises Act, legislation enacted in December 2020 that bars surprise billing beginning January 1, 2022. Under the law, payers and providers (including hospitals, facilities, individual practitioners and air ambulance providers) are prohibited from billing patients more than in-network cost-sharing amounts in emergency and non-emergency circumstances. This IFR establishes regulations defining the payment methodology. The regulation proposes the methodology payers must use to determine cost sharing; the information payers must share with out-of-network providers; the process for submitting and receiving consumer complaints; and the format and details of the notice and consent requirements.
The No Surprises Act, which was tucked into the year-end spending bill, protects patients from getting slapped with surprise bills after visits to the emergency room or their regular medical providers, leaving any payment disputes up to their plan and provider to resolve.
A recent article in Law360 covers three key takeaways from the legislation that employers should know, with McDermott partner Judith Wethall weighing in.
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