We caught up with Patrick Plues, BIO’s VP of State Government Affairs, to get an exclusive look at what to expect from state legislatures in 2022.
The state of play: The 2022 state legislative sessions are shaping up to be just as active as they were in 2021—though many sessions will be quick as it’s the second year of a two-year session in most states. We also face a major election this November, with all state legislatures up (except New Jersey and Virginia) and 36 gubernatorial races.
Many states are grappling with redistricting. States are required to redraw their political boundaries every 10 years as a result of the national census. This will impact the balance of power in Congress for the next 10 years because this process includes not only redrawing state legislative districts, but also congressional districts. To date, 35 states have approved new maps, while 15 are still under deliberation.
Meanwhile, states are actively pursuing legislation on a slew of issues that impact the biotech industry:
Drug pricing: Washington, Rhode Island, and New Jersey are considering legislation to create prescription drug affordability boards. Similar to boards already created in Maryland, Maine, Colorado, and Oregon, these boards call into question the price of a therapy, and in some instances set a price if the board deems the therapy’s price is not in line with a value they determine.
Vaccine-related legislation: We’re seeing a tremendous increase in vaccine-related legislation as some conservative state policymakers are pushing back on vaccine mandates imposed on employees, school-aged children, and healthcare workers. The recent U.S. Supreme Court ruling striking down the Biden administration’s employer vaccine mandate has only emboldened conservative state policymakers who believe vaccine mandates are a government overreach. There are over 900 bills under consideration in 47 of the 50 states.
“Off-Label” bills: We’re seeing an uptick in bills that, among other things, indemnify a prescribing physician in the event the therapy they prescribe for off-label use harms their patient. These bills are also being pushed by conservative legislators seemingly in response to guidance from the Biden administration and medical community writ large against using ivermectin and hydroxychloroquine as COVID-19 treatments.
Federal 340B discount drug program: This program was created by Congress in 1992 and refers to Section 340B of the Public Health Service Act of 1992. Under this program, manufacturers provide outpatient drugs at a heavily discounted price to 340B-covered entities such as Disproportionate Share Hospitals (DSH), Children’s Hospitals, Federally Qualified Health Centers (FQHC), and Black Lung clinics. State legislation is being introduced to regulate how insurers, PBMs, and manufacturers handle 340B claims, rebates, and discounts with pharmacies contracted by 340B entities to dispense prescription drugs. BIO is increasingly concerned with these bills and the impact the they will have on expanding the program well beyond its federal statutory scope.
Medicaid access: BIO continues to advocate for protecting Medicaid access to important therapies. Recent efforts are focused on a 1115 Medicaid Waiver in Oregon that proposes to limit Medicaid coverage and access to therapies approved under the FDA’s Accelerated Approval Pathway. BIO has been heavily engaged in opposition to this waiver, and is working to convince the Oregon Health Authority to remove that particular proposal from their 1115 waiver prior to submitting it to Centers for Medicare and Medicaid Services (CMS) for approval.
BIO also continues to push for clean fuels standards across the country. A New Mexico clean fuel standard bill that Governor Michelle Lujan Grisham is spearheading and BIO is strongly supporting passed the state Senate. Similar measures will be considered in Minnesota and New York.
