Good Day BIO: HHS' payment models, long COVID symptoms, and more

HHS will test three pilot payment models—here’s BIO’s take. Plus, reactions to Mexico’s modified biotech corn ban and what you need to know about long COVID symptoms and R&D. (699 words, 3 minutes, 29 seconds)

An online conference organized by BIO on February 21, will explore research and opportunities in the fight against —Bio.News has an exclusive preview. 

Long COVID symptoms—like fatigue, brain fog, and memory issues—are similar to other post-infection conditions, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Past ME/CFS research could advance long COVID solutions and vice versa.

These conditions apparently involve an immune disorder, says Oved Amitay, CEO of ME/CFS patient organization Solve M.E., who will speak at the event. 

What’s the trigger? “It could be in some cases bacteria or other infectious agents, but it has to do much more with the immune system,” says Amitay. “So, it’s not just about what was the trigger; it’s really much more about what was the response.”

The event takes place Tuesday, February 21 at 1 PM ET—click here to register. This will be the first event in a long COVID series, with the next gathering taking place during the BIO International Convention in Boston. 

Read more about long COVID at Bio.News.

HHS releases new drug payment models – here's what you need to know

In response to President Biden’s plan to lower prescription drug costs, Health and Human Services (HHS) will test three payment models for Medicare and Medicaid—and while two would advance BIO's long-standing policies to reduce patients' out-of-pocket costs and increase access, one would undermine the Accelerated Approval pathway and needed cures. 

The news: HHS released three payment models for testing by the Centers for Medicare & Medicaid Services (CMS) Innovation Center, which HHS believes will lower the cost of prescription drugs.

2 out of 3 are positive: a proposal to test generic co-pay caps ($2 per month/drug) in the Medicare Part D program, and a proposal to enhance access to cell and gene therapies through multi-state outcomes-based payment arrangements.

Here’s why: These two models address patient out-of-pocket expenses while providing “better payment systems that reward the value a medicine brings to the patient and overall healthcare system,” says BIO’s Chief Policy Officer John Murphy.

But the Accelerating Clinical Evidence Model “misses the mark significantly,” because it would “penalize companies for utilizing surrogate endpoints in an effort to get groundbreaking and necessary treatments to patients,” says Murphy.

BIO’s take: BIO looks forward to working with HHS on the first two programs, which would “deliver true relief to patients at the pharmacy counter while also ensuring incentives remain for innovation,” says Murphy. However, “BIO opposes this attack on the Accelerated Approval Pathway and will continue efforts to support scientists, innovators, and the millions of patients desperate for new cures.”   

Read BIO’s full statement. 

Read more about the value of the Accelerated Approval pathway.

What USDA, BIO say about Mexico's updated corn ban 

Mexico announced a modified decree regarding imports of biotech corn—and government and industry agree that it’s a problem. 

ICYMI: According to Mexico's new decree, biotech corn for animal feed would eventually be replaced through “gradual substitution,” though the ban on corn for human consumption would remain in place.

The U.S. is “disappointed,”said Agriculture Secretary Tom Vilsack. “We are carefully reviewing the details of the new decree and intend to work with USTR to ensure our science-based, rules-based commitment remains firm.”

The new decree “creates more questions than answers,”says BIO, as it “wrongly calls into question” the safety of biotech corn for human consumption and “does not provide any commitment that Mexico’s regulators will return to a science- and risk-based regulatory approval process for all agricultural biotechnology products in the future.”

And it puts U.S.-Mexico trade at risk: “Singling out corn—our number one ag export to Mexico—and hastening an import ban on numerous food-grade uses makes [the U.S.-Mexico-Canada Agreement] a dead letter unless it’s enforced,” said the National Corn Growers Association.

The next steps: “While BIO has supported dialogue to resolve this issue, it has become necessary for USTR to request consultations with Mexico over its treatment of agricultural biotechnology in order to provide a framework and timeline to resolve this issue,” says BIO’s statement.

President Biden’s Wednesday: Delivering remarks on the economy at 2:30 PM ET. 

What’s Happening on Capitol Hill: The Senate Budget Committee will hold a hearing on climate-related economic risks, while the Senate Environment and Public Works Committee will hold a hearing on low-carbon transportation fuels. The House is not in session.