Senators, BIO oppose proposed Medicaid rule

Happy Halloween. A scary proposed rule on Medicaid drug coverage would harm patient access. Plus, today’s new episode of the I am BIO Podcast explores the possibilities of synbio. (568 words, 2 minutes, 50 seconds)

Senators, BIO oppose proposed Medicaid rule that harms patient access

A proposed new rule on Medicaid drug coverage would harm patient access to innovative treatments while creating fiscal uncertainty for states, says a group of U.S. Senators. (BIO agrees.)

The proposal by the Centers for Medicare and Medicaid Services (CMS) would make manufacturers aggregate, or “stack,” all discounts and rebates received throughout their supply chain when determining the “Best Price” for the Medicaid Drug Rebate Program. The “Best Price” establishes what state Medicaid programs pay for drugs.

The rules change is unworkable, faces “legal headwinds,” and would not achieve desired savings on drug coverage, says a letter to CMS Administrator Chiquita Brooks-LaSure signed by Ranking Member Mike Crapo (R-ID) and 10 other Republicans on the Senate Finance Committee.

Why it matters: “Stacking” and other proposed changes to drug coverage would negatively impact patient access to innovative new treatments that private insurers are able to cover, the letter says.

Opposition to the proposed rule, which awaits a final CMS decision, was expressed in an earlier letter from the Council of State Bioscience Associations (CSBA).

BIO’s take: “Under the guise of ‘technical changes,’ CMS has proposed substantial and legally suspect changes to the Medicaid drug rebate program. These changes jeopardize the grand bargain that has been in place for 30 years, where drug manufacturers pay mandatory rebates to Medicaid to ensure coverage of FDA-approved therapies for vulnerable patients. CMS should withdraw this rule,” says BIO Chief Policy Officer John Murphy.

I am BIO Podcast: Making big change with synthetic biology

Synthetic biology is revolutionizing our approach to drugs, food, fuel, manufacturing, and climate mitigation, as today’s new episode of the I am BIO Podcast explores.

What’s synbio? “A multidisciplinary technology involving genetic engineering, computer science, physics, and more,” synbio lets us “program nature much the same as we program computers,” says BIO CEO Rachel King.

The impact: Synbio applications generate $900 billion—5% of the U.S. GDP.

Pulling carbon from the air: LanzaTech has developed technology that combats climate change by capturing excess carbon and turning it into materials for manufacturing, clothing, and sustainable aviation fuel, says LanzaTech Chief Innovation Officer Michael Koepke.

Nature has evolved remarkable solutions—like adhesives to hold muscles in place better than glue and plants producing energy from sunlight, says Ginkgo Bioworks SVP Jennifer Wipf. Ginkgo’s AI-enhanced platform mimics nature, seeking practical synbio solutions at scale.

Building a better bean:Benson Hill uses AI and machine learning to predict plant breeding that will achieve higher protein, and therefore greater sustainability, from soybeans, “our most efficient protein source in the world,” says company genetic specialist Matt Begemann.

What’s next: “The syn bio revolution could change nearly every facet of our lives,” says King. “These companies are combining multiple scientific disciplines to power up their success in tackling some of our toughest challenges.” 

Listen: Catch the new episode at www.bio.org/podcast or your favorite podcast app.

President Biden’s Tuesday: Delivering remarks on protecting American’s retirement security. ICYMI, he released a new executive order on AI yesterday, which calls for health agencies “to develop a plan for regulating artificial intelligence tools already widely in use within hospitals, insurance companies, and other health-related businesses,” reports STAT News.

What’s Happening on Capitol Hill: The House is off today but a vote on aid to Israel is expected this week, POLITICO reports.

Not too far from the Hill: Food and Drug Administration (FDA) advisors will review exa-cel, the sickle cell gene therapy developed by BIO members Vertex Pharmaceuticals and CRISPR Therapeutics.