Good morning. Are Cassie and Caelynn here for the right reasons? We're not sure, just like some Democrats are not sure that Amy Klobuchar is here for Medicare for All.
Some of the best-selling drugs in the U.S. have stacked up extra federal protections that were initially intended to spark research into drugs that couldn't make money on their own.
By the numbers: 6 of the 8 best-selling biologic drugs in 2017 have orphan approvals, and 3 — Humira, Rituxan and Avastin — still have extra exclusivity for some of those uses.
The bottom line: It'll be up to insurance companies and providers to decide whether an orphan approval makes a biologic more desirable than a biosimilar, even for the non-orphan uses that drive most sales.
FDA commissioner Scott Gottlieb told Axios that while he thinks the orphan drug market is too small to seriously dampen competition, he's open to changes in the law.
Details: Gottlieb's top priority is giving drugmakers an incentive to develop treatments for the rarest of diseases, or diseases that aren't getting much pharma attention.
Medicare Advantage plans that have poor quality marks for 3 straight years are eligible again to get kicked out of the program, according to a recent memo from the Centers for Medicare and Medicaid Services, Axios' Bob Herman reports.
Details: When Congress passed the 21st Century Cures Act in December 2016, lawmakers slipped in a provision that prevented the feds from terminating the worst Medicare Advantage performers through 2018. A former CMS official called the policy "a stay of execution for crappy plans."
Why it matters: Medicare Advantage is arguably the fastest-growing business for health insurers. This small policy saved companies with the lowest-rated customer service and care from losing a lot of money.
The Affordable Care Act's cost-sharing reduction payments saga continues: The Trump administration ended the payments in 2017, Congress failed to fund them, and now 3 judges have said the government is still on the hook for the payments.
The bottom line: It's looking unlikely that any final decision, if insurers win, will take into account that insurers have made up for the lost subsidy money by raising premiums and, thus, premium subsidies — the ACA's other form of government assistance.
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