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Congress is making another attempt at requiring Medicare insurers to speed up reviews of requests to cover treatments after an earlier effort was derailed by its high price tag.

Why it matters: A bipartisan bill taking aim at a practice detested by patients and doctors has a much better shot at passage after lawmakers made changes that will slash its cost to the federal government, Axios' Maya Goldman writes.

The bill reintroduced yesterday would codify recent reforms from the Biden administration cracking down on prior authorization.

By doing so, it would help guard against the possibility of rollbacks by a future administration and an upcoming Supreme Court decision that could curtail federal rulemaking.

Context: The bill would require Medicare Advantage plans to create electronic prior authorization systems that can streamline coverage decisions.

The insurers would have to provide more reporting on their prior authorization decisions to the Department of Health and Human Services, which would also be given the power to set deadlines for insurers to respond to different types of prior authorization requests.

The bill applies just to Medicare Advantage plans, while the Biden administration's recent prior authorization changes also apply to Medicaid and Affordable Care Act insurers.

State of play: The legislation has its best chance at being approved since it was first introduced five years ago.

Nearly 400 health organizations back it, including Humana, the second largest Medicare insurer.

Notably, the bill shouldn't cost the federal government anything, said Peggy Tighe of the Regulatory Relief Coalition, a group leading efforts to pass the bill.

A previous version passed unanimously through the House of Representatives in 2022, but it stalled after congressional scorekeepers found it would cost $16 billion as fewer treatments would be denied.

One big reason the last version cost so much was a requirement that insurers provide real-time prior authorization decisions on services and items that they frequently approve.

The revamped bill instead asks regulators to report on how such a system could work.

Between the lines: The prospect that the Supreme Court could soon overturn a 40-year-old legal doctrine that gives agencies leeway to issue regulations adds urgency to the bill, advocates say.

Pulling back the doctrine, known as Chevron deference, could make it easier for regulations to be challenged in court.

In light of that possibility, it's "very important" to codify new prior authorization requirements for Medicare Advantage, Tighe said.

What we're watching: The bill could be rolled into a year-end legislative package, or it could be passed earlier through a simpler process reserved for noncontroversial legislation.

"With the improvements we've made there is no reason we should not quickly get this bill signed into law," Sen. Roger Marshall (R-Kan.), a lead sponsor of the bill, said in a statement.

1 big thing: Congress tries again to crack down on prior authorization

Animated illustration of a loading icon over a medical cross.

The Supreme Court threw out its biggest abortion-related case since overturning Roe v. Wade two years ago, saying today that doctors opposed to a commonly used abortion pill lacked legal standing.

Why it's the BFD: Rejecting the highly anticipated case preserves access to mifepristone but allows the court to skirt a ruling on the case's merits.

The Supreme Court held that the plaintiffs — a group of doctors who oppose abortion but don't take or prescribe mifepristone — couldn't show they were directly injured, as the Biden administration asserted during oral arguments.

Zoom in: The plaintiff's argument would lead courts down an "uncharted path" that would allow citizens to challenge "virtually every government action that they do not like," Justice Brett Kavanaugh wrote in the  unanimous decision.

"Doctors have never had standing to challenge FDA's drug approvals simply on the theory that use of the drugs by others may cause more visits to doctors," he wrote.

The court compared this to other fields: "Firefighters could sue to object to relaxed building codes that increase fire risks. Police officers could sue to challenge a government decision to legalize certain activities that are associated with increased crime."

The big picture: Medication abortion accounts for 63% of abortions in the U.S., per the Guttmacher Institute, a research organization that supports abortion rights.

Mifepristone is commonly used in tandem with a second FDA-approved drug, misoprostol, in the first 10 weeks of pregnancy. Both pills have long safety and efficacy records.

The pills are increasingly prescribed online and mailed to patients after the FDA eliminated the requirement that they be picked up in person.

Walgreens and CVS announced plans in March to start selling abortion pills in states where the procedure is legal.

Context: The federal government argued during oral arguments in March that the group of doctors who objected to abortion and brought the case against the FDA didn't have the legal standing to do so.

Solicitor general Elizabeth Prelogar argued that the doctors don't prescribe mifepristone and haven't suffered any real injury from the FDA's regulatory decisions.

The doctors argued that the injury is the time spent in the emergency room treating women who have taken the drug.

What they're saying: The Supreme Court's ruling maintains the stability of the FDA's drug approval process, Abigail Long, a spokesperson for abortion pill distributor Danco Laboratories, said in a statement.

"Danco is proud to have led the way in obtaining FDA approval of this essential reproductive health option and of modifications to the conditions under which it can be used," Long said.

"We thank the court for its careful analysis and remain committed to developing and bringing to market safe and effective products in this crucial area of public health."

Kiki Freedman, the CEO of telemedicine abortion care company Hey Jane, said in an emailed statement to Axios that the company was pleased with the decision. 

"Mifepristone is safe, effective and a crucial part of expanding abortion access in this post-Roe world," Freedman says. "This baseless case attacked essential health care and sought to cause confusion at a time when abortion pills by mail have become the most viable option for much of the country."

Catch up quick: The 5th U.S. Circuit Court of Appeals found the FDA failed to take into account safety concerns last August when it expanded the time frame in which mifepristone could be used in pregnancy and when it dropped a requirement that the pills be prescribed in person.

The three-judge panel on the appeals court partially blocked a lower court ruling that struck the FDA's original 2000 approval of the drug in response to a suit from anti-abortion forces.

The maker of mifepristone, Danco Laboratories, and the Department of Justice asked justices to review the 5th Circuit ruling, and the Supreme Court agreed in December to review the decision.

💭 Erin's thought bubble: The ruling appears to preserve access to telehealth-facilitated abortion care — which now accounts for nearly 1 in 5 abortions nationwide — after months of confusion over the method's legal status.

Abortion provider protections prove crucial in a post-Roe world

Where abortion is on the ballot in November

Roe reversal fuels women's health deal market

2. The BFD: Supreme Court preserves abortion pill access

Abortion rights and anti-abortion supporters clash outside the Supreme Court on April 24

Abortion rights and anti-abortion supporters clash outside the Supreme Court on April 24. Photo: Andrew Harnik/Getty Images

Want more health tech deals? Check out the Axios Pro Deals Tracker.

• Better Health, an SF medical supply provider, raised an unlabeled $14m from Healthworx, UHealth, and Mosaic General Partnership. joinbetter.com

• Koda Health, a Houston digital advance care planning startup, raised an undisclosed seed led by Ecliptic Capital with participation from Memorial Hermann Health System, AARP and the Texas Medical Center Venture Fund. axios.link/4elncDe

• Great Point Partners, a Greenwich health care PE firm, acquired Lyocontract GmbH, a German independent drug product CDMO. axios.link/3yWqT2a

• Leonard Green Partners invested in RedSail Technologies, a Spartanburg, S.C., pharmacy software company, alongside Francisco Partners, which reinvested in the company. axios.link/3XlDPZh

• EQT made a majority investment in CluePoints, a Belgian software provider for data quality oversight in clinical trials. axios.link/4cBVcd5

• Sellers Dorsey, a Philadelphia health care consulting firm, acquired HealthDataViz, a Boston consulting and data analytics provider. axios.link/4aZP5Oj 

•EPAM Systems (NYSE: EPAM), a Pennsylvania software engineering and consulting firm, acquired Odysseus Data Services, a health data analytics company. axios.link/3VlLDYG

• Perceptive Capital Solutions, a health care SPAC formed by Perceptive Advisors, raised $75m in its IPO. axios.link/3QWdEnY

3. Deals o' the day

• At Noom, Adonis Saremi, former executive medical director at Safe Health, joined as chief medical officer; Peter Scherr, former chief marketing officer (CMO) at Incredible Health, joined as CMO; and Aaron Severs, former chief product officer (CPO) at DocGo, joined as CPO. noom.com

• Kate Shields, former chief customer officer at Vertex, was appointed chief customer officer at mPulse. axios.link/3RqsS5g

• Evan Karp, former managing director of equity derivatives at Cowen, joined Leerink Partners' health care practice as senior managing director of derivatives. axios.link/3VnSyQP

• Santosh Mohan, former VP of digital at the Moffitt Cancer Center, joined Advocate Health as VP of innovation. advocatehealth.org

4. It's Personnel

⚕️ When your insurer is also your doctor and pharmacist — WSJ

📈 Nation's health care tab projected to hit $8T in a decade — Axios

🏥 Hospital-at-home waiver drives adoption amid risks — Modern Health Care

👨‍💻 Ransomware attacks surged after Change Healthcare hack — Axios

5. Your daily dose

Illustration of a pill capsule as the bell hammer on an alarm clock.

Happy almost-Friday, Health Tech readers!

🍵 Erin finished pottery classes with a handful of pieces to take home, including chopstick rests, air plant holders and an infinity vase.

🎨 Thanks for reading, and extra thanks to newsletter editor Claire Rychlewski and copy editor Jay Bennett. Please ask your colleagues, friends and family to sign up.

June 13, 2024

1 big thing: Congress tries again to crack down on prior authorization