Good Day BIO: Mid-year state legislature update

August 12, 2021
Today, we’re giving the floor to BIO’s State Government Affairs team to review major state legislation enacted in 2021. We’re running slightly longer today (1,100 words, 6 minutes) but we hope this gives you a good overview of state legislature activity so far this…
BIO

Today, we’re giving the floor to BIO’s State Government Affairs team to review major state legislation enacted in 2021. We’re running slightly longer today (1,100 words, 6 minutes) but we hope this gives you a good overview of state legislature activity so far this year.

 

Key state activity on health care

 
 

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.

 

More Health Care News:

Endpoints: ‘The consummate mentor’: Bill Clinton, Jim Wilson and others reflect on Tachi Yamada's life and legacy
“Yamada passed away Thursday morning at 76, leaving behind a legacy as sweeping and peripatetic as any physician scientist in recent memory, along with a long list of protégés and mentees across the top ranks of academia and industry who modeled themselves upon his compassionate but uncompromising style.” 

POLITICO: FDA set to authorize extra COVID vaccine doses for immunocompromised patients
“The Food and Drug Administration on Thursday will authorize third doses of Pfizer and Moderna's COVID-19 vaccines for people with weakened immune systems, in a bid to bolster their protection against infection as the highly contagious Delta variant circulates.”

 
Click to Watch BIO's Dr. Michelle on MSNBC
 

Questions about routine vaccines? Visit the CDC’s National Immunization Awareness Month resource center or Stronger, an initiative to stop the spread of vaccine misinformation. 

Questions about COVID vaccines? Visit www.COVIDVaccineFacts.org.  

 

More Health Care News:

Science: The overlooked superpower of mRNA vaccines
“They prevent symptomatic disease, curb hospitalization, and reduce death. But for public health purposes, a vaccine's mastery at something less obvious is equally important: the ability to prevent even asymptomatic infection.”

 
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Key state activity on agriculture, environment, and economic and workforce development

 
 

There have been many legislative achievements over the past six months in agricultural and environmental policy, too.

Gene Editing (GE) and Genetically Modified Organisms (GMOs)
Legislation has been enacted in several states, including Vermont, where Gov. Phil Scott signed legislation in June eliminating the state’s Pesticide Advisory Committee, replacing it with a more broadly focused Agricultural Innovation Board (AIB). It’s worth noting the state’s former Seed Review Committee’s responsibilities are now within the AIB. In addition, legislation is pending in:

  • New Jersey (S. 2011) for labeling GE food
  • Puerto Rico (HB 117/SB 316, HB 735, HB 815) regarding the prohibition of glyphosate use in weeding as well as freezing rates for irrigation and water fees, and labeling GE food.

Plant Biostimulants
Plant biostimulants, which enhance plant growth and development, are a relatively new category of ag technology—and they’re appearing more often in legislation. New laws defining the term and regulating its distribution have been passed by:

  • Delaware (S. 96)
  • New Hampshire (HB 199)
  • Vermont (S. 102, Act 41)

Clean Fuels

  • Washington State (HB 1091, Chapter 317) established a clean fuels standard.
  • Nevada (AB 411, Chapter 372) now permits the sale of E15 (ethanol).
  • Oregon (HB 3051, Chapter 368) now mandates that gas sold in the state contain at least 10% ethanol.

Renewable Chemicals
Maine (LD 1216, Chapter 181) amended state tax laws, including technical changes to the renewable chemical tax credit. 

Economic & Workforce Development
Legislation passed in:

  • Alabama (HB 473, Act 2021-492): The Alabama Rural, Agribusiness, and Opportunity Zone Jobs Act creates incentives for investment in certain agribusinesses, including biotechnology and biofuels.
  • Connecticut (HB 6689, Special Act 21-15 & SB 1202, Special Session Public Act 21-2): The FY21-23 budget restores the R&D tax credit to 70%, which will be phased in from its present 50% over the next two years. In addition, legislation (HB 5182) increases the cap on R&D tax credits to 70% of a corporation’s annual tax liability, phased in over two years.
  • Illinois (2019 SB 1608): This law creates a Small Business Innovation Research (SBIR) matching grant program, providing a state match of 50% (up to $50,000).
  • Maryland (SB 19, Chapter 112; SB 196, Chapter 114): Allows for an approximately $12 million appropriation to benefit more Maryland companies by lowering qualification from 50% to 33% of the investment and limiting the credit award to 10% (approximately $1.2 million) of the total appropriation instead of 15%.
  • West Virginia (H2760/S447): This law specifies an economic opportunity tax credit for new jobs, with a credit of 10% corresponding to the creation of 10 new jobs, eliminates superannuated reference to the business franchise tax, eliminating superannuated reporting requirements, and specifies manufacturing activities that qualify for high technology manufacturing tax credit.

Want to catch up on priorities for the state legislatures in 2021? Read our state legislature preview from March.
 
 
 
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BIO Beltway Report
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President Biden’s Thursday: He’s expected to give a speech on how his Build Back Better agenda will lower prescription drug prices in the East Room at 11:15 AM ET. This afternoon, he’ll travel to his residence in Delaware. 

What’s Happening on Capitol Hill: It’s officially recess. ICYMI: the House is cutting its August recess short to vote on the $3.5 trillion budget and lawmakers will have to return to Washington on the week of August 23rd instead of September 20th as originally scheduled, per Roll Call. The House will also be voting on the $550 billion bipartisan infrastructure bill that passed in the Senate, according to NBC News.

 
 
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