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Friday brought positive developments: Medicare expanded coverage of a critically important PET scan before Alzheimer’s treatment, and the SEC tightened regulation of speculators who harm biotech. Plus, we have news on the launch of the Women’s Health Opportunity Map. (605 words, 3 minutes, 1 second) |
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Medicare coverage expanded for scan used before Alzheimer's treatment |
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The Centers for Medicare & Medicaid Services (CMS) on Friday announced a decision removing the national coverage determination and ending coverage with evidence development (CED) for amyloid PET scans—and BIO’s long advocated for this change.
What happened: CMS’s decision means Medicare will now cover multiple Positron Emission Tomography (PET) scans for beta amyloid brain plaque in Alzheimer’s patients. CMS will defer to Medicare Administrative Contractors (MACs) to make regional coverage determinations.
Why it matters: These scans help doctors determine whether a patient would benefit from new brain-plaque-targeting drugs. Going forward, it’s important MACs provide robust coverage to ensure equity of access across geographical regions.
BIO’s advocacy: When CMS put a limit on access to this type of scan 10 years ago, BIO advocated against that decision, and has pushed for coverage since.
BIO’s view: “On Friday, CMS announced it was ending its problematic policy regarding PET scans in Alzheimer’s cases—welcome news for patients, caregivers, and providers who are fighting this devastating disease,” said Crystal Kuntz, BIO SVP for Health Policy & Reimbursement. “A longstanding priority at BIO is ensuring that Medicare beneficiaries have access to innovative therapies and treatments." |
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New report identifies opportunities in women’s health |
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The Women’s Health Innovation Opportunity Map (WHOM) identifies 50 opportunities for catalyzing innovation to improve women’s health—we explore what it is and how BIO participated.
Why it matters: Women have unique health needs—ranging from atypical heart attack symptoms to greater incidence of lung cancer. Women in surgery have a 32% higher risk of death when the doctor is a man instead of a woman.
The challenge: Women’s health is understudied and underfunded.
The report: The 120-page report was produced by the Innovation Equity Forum, 250+ experts and stakeholders from 50+ countries—including BIO’s Chief Scientific Officer, Dr. Cartier Esham.
WHOM’s solution: Encourage innovation for women’s health by identifying opportunities for innovators to improve women’s health while building businesses in underserved markets.
BIO’s take: “Improving women’s health is an imperative we should all feel motivated to achieve,” says Dr. Esham. “It was, and will continue to be, an honor working with esteemed thought leaders from around the world together to advance the goals and initiatives discussed in the WHOM.”
Read the full report or executive summary.
Read more in Bio.News. |
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SEC tightens regulation of speculators who harm biotech |
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The U.S. Securities & Exchange Commission (SEC) announced a rule change on Friday to add transparency to short selling, putting a check on malicious speculation that harms biotech firms.
The change: SEC will require greater disclosure of information helping regulators and the public identify potentially illegal behavior when short sellers bet a share price will drop in the near future.
Why it matters: Lengthy development periods and other unique aspects of drug research and discovery leave small biotechs especially vulnerable to unscrupulous actors who profit by driving down the value of the biotechs. This leads to lost equity and reduced investment.
Examples of abuses: Short sellers have been found liable for starting false social media campaigns to drive down a biotech’s share price. Spurious legal challenges to patent rights for a new medicine can temporarily depress a stock price, according to BIO’s comments in favor of the proposed rule.
BIO’s view: “SEC’s decision to provide more market transparency is a critical win for issuers, investors, and patients across the country,” says David Lachmann, Senior Director for Federal Government Relations at BIO. |
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President Biden’s Monday: Heading to Pueblo, Colorado, where he’ll tour CS Wind, the largest wind tower manufacturer in the world. He’ll give remarks on “Bidenomics” and the Inflation Reduction Act’s clean energy investment.
What’s Happening on Capitol Hill: The House and Senate are in session. House Republicans are still working to build consensus around a candidate for Speaker. |
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