Across the country, there have been notable developments in legislation covering Medicaid, drug prices, vaccines, and more.
Medicaid
Legislation was signed in:
- Arkansas (SB 143) requiring Arkansas Medicaid to cover all new FDA-approved pharmacy benefit therapies and label expansions prior to review by the Medicaid Drug Utilization Review Board (DURB).
- Ohio (HB 110) encouraging the state’s Medicaid program to work with manufacturers on value-based payment models.
- Pennsylvania (HB 1348) authorizing the PA Department of Health to submit a state plan amendment to the Centers for Medicare & Medicaid Services (CMS) for review and approval of value-based contracting with pharmaceutical manufacturers.
New Drug Price Review Commissions
- Colorado (SB 175) now has the Colorado Prescription Drug Affordability Review Board. Unlike commissions established in other states, this one can set prices by establishing an upper payment limit on therapies.
- Oregon (SB844) established the Oregon Prescription Drug Affordability Board.
- Commissions have already been established in Maryland, Maine, and New Hampshire.
Price Transparency
Several states passed legislation on prescription drug price transparency or notice of price increase legislation:
- Maine (LD 686)
- North Dakota (HB 1032)
- Nevada (SB 380)
- South Dakota (HB 1263)
- Texas (HB 1033)
- Virginia (HB 2007)
International Price Indexing
Legislation allowing states to set drug prices based on prices in Canada is catching momentum, including in:
- North Dakota: SB 2170 failed—but the Governor did sign SB 2212, authorizing the legislature to study prescription drug pricing, foreign reference pricing, and drug importation. The Joint Health Committee held its first hearing on August 6.
- Maine: LR 1636 is pending, pushed to 2022 for consideration.
- Rhode Island: SB 167 and HB 5842 failed.
Biologic Substitution
With passage of the Biologics Price Competition and Innovation Act (BPCIA) by Congress in 2010, FDA has authority to review and approve biosimilar and interchangeable biologics, which are intended to be lower cost versions of innovator biologics. Since 2013, BIO has worked in all 50 states to amend pharmacy practice statutes so pharmacists can substitute these types of biologics. This year, Oklahoma (SB 4) became the last state to permit pharmacists to dispense an interchangeable biological product in certain situations.
340B
States are actively considering legislation that would regulate interactions between manufacturers and pharmacies contracted by 340B-designated entities (hospitals, federal clinics). They include:
- Arkansas, where HB 1881 was signed into law, barring manufacturers from denying or prohibiting 340B pricing for 340B-contracted pharmacies. The bill also prohibits payers from requiring pharmacies to identify 340B-discounted claims.
- Tennessee (HB 1398) and Indiana (HB 1405) also passed 340B legislation.
Data Privacy
- Florida: HB 833 creates criminal penalties for handling another individual’s DNA without their consent.
- Virginia: HB 2307 establishes a framework for controlling and processing personal data; it includes amendments exempting biomedical research.
Rare Disease Advisory Council (RDAC)
There are now 22 RDACs nationwide, with new ones in:
- Florida (SB 272)
- Louisiana (HB 460)
- Maine (LD 972)
- New Jersey (AB 4016 & SB 2682)
- South Carolina (introduced as HB 3956)
- Virginia (HB 1995)
What about vaccines? A multitude of vaccine laws have passed in several states over the past six months, including 27 pieces of anti-vaccine legislation—read more.
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