Across the country, state legislatures are taking up bills covering Medicaid access to innovative and rare disease therapies, vaccines, drug pricing, and more. Here are a few to know about.
Innovative Therapies
- Alternative/Innovative Medicaid Payment Models: One goal is legislation to encourage state Medicaid programs to institute such models for high-cost durable therapies, like gene or cell therapies. CA introduced SB 521.
- “Medicaid best practices” legislation: This is intended to foster increased transparency in individual state Medicaid program processes, as well as push for meaningful manufacturer and patient input into Drug Utilization Board (DURB) proceedings. Bills have been introduced in AR (SB 143) and OR (SB 457).
- MAC PAC and Access for Rare Disease and Cell/Gene Therapies: MAC PAC is a commission that advises Congress and states on Medicaid issues. MAC PAC is entertaining proposals that would impact access to these therapies, such as instituting a higher-standard Medicaid rebate for therapies approved under the FDA’s Accelerated Approval pathway. The standard Medicaid drug rebate is 23.1%; this proposal would increase that rebate for accelerated approval therapies until the manufacturer completes confirmatory studies. MAC PAC could vote on this concept in March, which means it could end up in the June MAC PAC report to Congress.
Genomics Medicine Educational Briefings
Since 2019, BIO has been hosting briefings on genomics medicine jointly with state partners. To date, briefings have been held in CA, CO, FL, MA, NY, NC, OH, MN, and PA. In partnership with MIT NEW Drug Development ParadIGmS (NEWDIGS), we’re engaged in a “2.0 version” of these briefings focused on alternative payment options. We conducted one such briefing in CA on January 26, which was well received; additional “2.0 briefings” are scheduled in MN and OH in the spring.
Vaccines
Unsurprisingly, 2021 is a particularly active year on state vaccine legislation, with more than 400 vaccine-related bills, and bills in almost every state. They include bills BIO supports, such as legislation to allow additional healthcare professionals to administer COVID vaccines, and bills to ensure more equitable vaccine allocation and distribution (MA HB 5164 and VA HB 5005).
We are also seeing troubling bills that would prohibit employers and governments from mandating COVID vaccines, as well as “medical freedom” bills to allow an individual to decline a vaccine without repercussions. These bills are emerging in more conservative states like OK, WI, KY, and LA.
Drug Pricing
Drug pricing remains an issue in 2021, with legislation covering:
- Price Transparency/Drug Importation: California recently introduced a drug importation bill (AB 458), which could be problematic given the significance of the state.
- Drug Price Utilization Boards: We’re seeing bills to establish boards like those in Maryland and Maine. These boards are intended to operate like a public utility board and regulate and penalize manufacturers for high-cost therapies. They can set an “upper-payment limit” (price control) on prescription drug therapies for both older and recently approved therapies. (Active Bills: CO, ND, NJ, NM, MA, RI)
The National Academy of Health Policy (NASHP) is pushing two new types of bills:
- Instituting a state tax on manufacturers of therapies listed in ICER’s annual report of therapies with unsupported price increases. (Active Bills: DE, WA)
- An international price indexing (IPI) bill, which pegs prescription drug prices in both government and private markets to Canadian prices. (Active Bills: HI, ND, OK, RI)
More Health Care News:
The New York Times: An Austrian region becomes a coronavirus vaccine laboratory
“Scientists want to inoculate every adult in one Austrian district, in a real-world test of how the Pfizer-BioNTech vaccine works against the variant first seen in South Africa.”
The Wall Street Journal: Novartis to help make CureVac COVID-19 vaccine
“Novartis, one of the world’s biggest drugmakers by sales, said Thursday it would upgrade its plant in Kundl, Austria, so that it can help make up to 50 million doses of CureVac’s vaccine this year and up to 200 million doses next year.”