While last year's FDA user-fee reauthorization gave Congress an opening to revamp the agency's drug-approval process, some lawmakers want another crack at reforms, Victoria reports.

Driving the news: Senate Aging Committee Ranking Member Mike Braun aired out the "promising pathway" proposal at a hearing last month, with a focus on a bill that would give priority reviews to treatments for terminal diseases with limited or no other options, such as ALS.

• Drugs that have shown some efficacy would get a two-year approval that could be renewed. The plan would also create patient registries of data on the drug's use until fully approved.
• Braun has promoted the idea since 2019, but hasn't had Democratic co-sponsors in the Senate until this year.

The intrigue: Braun has convinced five Democrats to sign on — with Sen. Kirsten Gillibrand a primary co-sponsor and Joe Manchin, Raphael Warnock, Jeanne Shaheen and Alex Padilla recently joining the effort.

• A companion House version from Rep. Mike Gallagher also has some Democratic support.

What they're saying: "It's a practical common-sense idea," Braun told Axios. "Once it [a drug] starts showing results, promise, you shouldn't have to wait ... It gives hope to people that would have none."

• Braun said the FDA can be structured, "to where it doesn't treat every disease in the same way and it differentiates between diseases that have nothing currently that's approved, versus diseases that have all kinds of options."
• Gillibrand told Axios she joined the effort after talking to her New York constituents about their rare diseases.
• "Some of these diseases are so life-threatening ... they don't have 10 years to wait," she said.
• Both Braun and Gillibrand were bullish on getting a vote and even passage this year.

Yes, but: There's been mounting skepticism about an existing FDA fast-track process that lets drugmakers sell their products based on preliminary evidence and finish clinical trials once they're already on the market.

• The 2022 omnibus included limited reforms to this accelerated approval pathway allowing the FDA to more easily pull drugs from the market if there is poor efficacy data and to require certain types of trial design and data as a condition for approval.
• Procedurally, the Aging Committee has no legislative authority, meaning Braun's bill would need to move through the Senate HELP Committee or go straight to the floor if it got enough additional co-sponsors.

Context: FDA reform was a big topic last year as Congress moved to renew programs that generate user fees to fund agency reviews.

• But after Senate Republicans insisted on a clean reauthorization, no significant changes were made through riders. The few changes that were made got rolled into last year's omnibus.
• But ALS and other patient advocacy groups have continued to push for options like Braun's promising pathway measure.
• Some bioethicists worry that more provisional approvals could leave patients taking unproven drugs that could be hard to pull from the market and weaken FDA's regulatory control.

We told you last week about the behavioral health and PBM proposals the Senate Finance Committee is marking up on Wednesday. But certain major mental health policies didn't make the cut, Peter reports.

Why it matters: The dropped measures include proposals aimed at boosting the supply of therapists, counselors and other mental health providers as well as measures to help prevent people who've left prison from overdosing.

Driving the news: Finance leaders omitted from the package a proposal the committee put together last year for a Medicaid demonstration program to provide more funding for states to expand the capacity of mental health and substance use disorder providers.

• Instead, there is a smaller, less expensive proposal to expand incentives through Medicare for health professionals to work in areas where there are shortages of providers.
• Also missing is "Medicaid reentry," a proposal to provide Medicaid coverage to inmates 30 days before they are released from prison, to avoid overdoses soon after release.
• Instead, there's a narrower proposal to allow seven days of Medicaid coverage for inmates with substance use disorder pending disposition of the charges against them.

The bottom line: The scaling back underscores how senators seeking bipartisan agreement and a consensus on the payfors face limits on their legislative ambitions.

• "Cost was the biggest issue," a Senate aide said. "The package had to scale back a number of provisions to keep everything budget-neutral/net saver."

Employers and insurers are using a re-launched advocacy group to ride the momentum building in Congress to address hospital prices and transparency rules, Victoria reports.

• Better Solutions for Healthcare is one of the newer organizations pushing for site-neutral and other hospital payment reforms.
• The group is staffed by the Republican-aligned firm Targeted Victory and the bipartisan communications agency Seven Letter. It has also recently hired two former GOP health staffers as lobbyists.
• Its new executive director, Connie Partoyan, who's also president of Targeted Victory, recently sat down with Axios to talk about the group's work. Partoyan previously served as the chief of staff to current House Energy and Commerce Chair Cathy McMorris Rodgers.

What she's saying: "There is consensus around this right now," she said. "There is an understanding that there have been bad actors and we have to figure out, how do we control some of these costs?"

• The group started in 2018 as a state-level endeavor for employer and business groups to push for lowering health care costs.
• "But in April, we really did a big reset to kind of prepare for what's happening on the federal level because we felt there was a lot of momentum around hospitals, the cost of health care, and we really wanted to be part of that conversation," said Partoyan.
• Better Solutions enlisted AHIP, Blue Cross Blue Shield Association, the American Benefits Council, National Alliance of Healthcare Purchaser Coalitions and the Public Sector HealthCare Roundtable to join its group.

Zoom in: Better Solutions' main policy priorities include promoting site-neutral facility payments, addressing what critics call "dishonest billing," cracking down on consolidation of corporate health systems and enforcing transparency measures.

• For the remainder of this year, the group is focused on pushing for the House's transparency bill to get a vote on the floor and also for Senate action, such as the Finance Committee taking up the SITE Act.
• In August, the group hired two former Senate HELP Republican staff members to lobby to both parties on the hospital issues: Adam Buckalew and Katy Spangler.

The other side: Hospitals argue that site-neutral policies would be harmful as systems are already navigating a tough financial environment, Medicare doesn't fully reimburse for how much patient care costs and that outpatient departments provide essential services.