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Meet BIO’s new chair, Medicare’s small (business) memo & what the Optum bid means

June 6, 2023
Reporter, D.C. Diagnosis Writer

Hello and happy Tuesday, D.C. Diagnosis readers! Summer's begun, old friends are reconnecting. But D.C. is still abuzz with hearing and post-debt deal legislating. Send news and tips to sarah.owermohle@statnews.com.

industry

BIO's new chair, Ted Love

Ted-Love-headshot-susanna-ling-1600x900

The new chair of biotech companies' major lobby has kind of done it all – but leading BIO might be the biggest challenge yet. The organization still doesn't have a permanent leader after a messy split with former CEO Michelle McMurry-Heath last fall, and it's also still smarting from Democrats' victory on Medicare drug price negotiation, our Rachel Cohrs writes in an exclusive profile of the Alabama native and longtime biotech executive. 

His career has tracked some of the industry's biggest innovations and complications. For instance, FDA in 2019 approved his company's new sickle cell disease therapy. But a few years later, few patients with the hereditary disease are receiving the treatment, which costs roughly $125,000. He and the company (Global Blood Therapeutics) are hoping their recent Pfizer acquisition will change that.

Love, who is also BIO's first Black chair, spoke to Rachel about what he hopes to achieve and how he thinks the embattled industry lobby can get there. Read more here.


drug pricing

Medicare sketches negotiation details, taps acting lead

Medicare is getting the ball rolling on its drug price negotiation plan. CMS late on Friday put out instructions about how small biotechs can ensure their products aren't eligible for cost cuts;  the companies have one month to put in their paperwork, and either the CEO or CFO has to complete the filing.

That's a hard deadline. "Because of the extremely tight statutory deadlines during the first year of the Negotiation Program, CMS will not accept incomplete or late requests," wrote Christina Ritter, a longtime CMS staffer who quietly became acting director of the negotiation program. My D.C. Diagnosis co-author Rachel Cohrs has more on her role and her background here. She was previously the director of the Patient Care Models Group at CMMI.

Wall Street and Washington analysts alike have speculated about the first 10 candidates for Medicare negotiations, which it's said will be calculated by total program expenditure. But exceptions for small companies or certain drug categories mean uncertainty abounds until the Sept. 1 unveiling. Plus, there's the specter of lawsuits stalling the plan.


medicare

What a potential health insurance deal has to do with CMS

UnitedHealth's Optum division on Monday launched an all-cash $3.3 billion bid to snag home care and hospice company Amedisys, upping the acquisition stakes after Option Care Health proposed a $3.6 billion deal last month

What's this have to do with D.C.? Amedisys started talks with both companies as early as 2021, but became a lot more serious about an acquisition after Medicare issued an March 2022 hospice payment rule, STAT's Bob Herman reports. That rule included provisions to crack down on fraudulent behaviors like hospices enrolling Medicare patients if they are not close to dying. 

Medicare's hospice payments are a major source of revenue for Amedisys – and the company's stock price tanked shortly after the agency released the rule. Read details on the bidding war from Bob.



medicaid

Medicaid racial disparities persist

Roughly a quarter of Hispanic adults and American Indian/Alaskan populations in America were uninsured in 2021, even as the coronavirus emergency prevented state governments from kicking people out of the program. Post emergency, those numbers are likely to grow, according to recent KFF data.

People are especially vulnerable in the 10 states that still haven't expanded their Medicaid programs to include a broader income band. KFF projected that 24% of people falling into that coverage gap are Hispanic, 32% are Black, and 39% are white.

Some positives: Most states have or are soon implementing equity initiatives like outreach programs, especially those targeting maternal health. But those don't solve the eligibility problem, especially in states, mostly red, that won't expand Medicaid. Delve into the KFF analysis.


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What we're reading

  • Carbon Health is already using AI to write patient records, STAT
  • Robert F. Kennedy Jr. tests the conspiratorial appetite of Democrats, The Washington Post
  • More than 200 FDA staffers have retired in less than a year, STAT
  • FDA pulls paid Eisai consultant from temporary role on advisory committee reviewing new Alzheimer's drug, Endpoints
  • FDA oncology head wants advisory panels to keep voting on new drugs, STAT

Thanks for reading! More on Thursday,


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