Will Congress tackle the ongoing drug shortages in PAHPA after all?

House Republicans cracked open the door yesterday to including drug shortage reforms in must-pass pandemic-preparedness legislation — a day after senators added new FDA authorities on the issue to their own pandemic bill. The Senate health committee today marks up that bill to renew biodefense and pandemic-preparedness programs, my colleague John Wilkerson reports.

House Republicans excluded drug shortage measures from the must-pass pandemic bill at an Energy and Commerce Committee markup on Wednesday, even as the scarcity of chemotherapy drugs continues to make headlines. They want to keep the issue separate from pandemic preparedness, but committee Chair Cathy McMorris Rodgers (R-Wash.) made somewhat positive comments about the drug shortage measures in the Senate pandemic bill, raising hopes for those who like what's in the upper chamber measure. The Senate's drug shortage measures are minor compared to House Democrat proposals, which include giving the FDA authority to recall drugs.

The E&C markup on Wednesday was a mixed bag of bipartisan cooperation and partisan disagreement. The highest-profile measure on the agenda was PAHPA, but they also took up legislation to reduce premature births and respond to the drug overdose crisis. Of the 15 bills they passed, about half had unanimous support.

CONGRESS

SCOOPLET: A new, bipartisan PBM reform bill

Sens. Tom Carper (D-Del.) and Chuck Grassley (R-Iowa) today are introducing a bill that would increase oversight of drug formularies that drug middlemen create, my colleague John Wilkerson reports. The bipartisan duo is on the Senate Finance Committee, which will mark up PBM reforms next week.

PBMs would be required to give Medicare officials information on their interactions with the panels, called pharmacy and therapeutics committees, that provide advice on drug options to PBMs. PBMs would have to disclose what the committees recommend and how often PBMs follow those recommendations. The bill also would direct the Government Accountability Office to analyze this information in a report to Congress that could be used for further reforms.

"This is intended to steer practices back to the original goal of a Pharmacy & Therapeutics (P&T) Committee's role without it being overridden by practices that pursue profit," according to a description of the bill.

payment

Tides changing for CAR-T care?

Hospitals for years have complained that Medicare pays so little for CAR-T cancer treatments that they actually lose money administering the expensive treatments. But that could soon change: if drug companies succeed in making the cancer treatments safer, hospitals could provide them more often in outpatient departments, where payment is higher, writes John.

Doctors are getting more comfortable managing side effects in outpatient departments, in some ways making the business more predictable. But it also means a big cost shift because Medicare generally pays far more for CAR-T drugs administered in that setting (one estimate is roughly $423,000 inpatient and $450,000 to $493,000 outpatient).

But that can be hard to generalize, especially because Medicare's rates vary significantly depending on hospitals. Still, this could be welcome news for providers and cancer patients. Medicare's CAR-T payments – or lack of them, as it took two years to come up with a plan – have been a source of frustration for years. Read more from John here.

states

The next frontier of hospital reform

The latest trend in state legislatures has been to tackle unexpected "facility fees" that hospitals charge for services in physician offices and outpatient clinics, my colleague Bob Herman reports. Facility fees often blindside patients, since hospitals do not always disclose them. Those charges are also a lot higher for people who have commercial health insurance — usually hundreds or thousands of dollars.

Momentum for solutions is growing, along with consumer outrage. Some states in New England, like Connecticut and Maine, have laws that prohibit hospitals from charging facility fees for certain services or in specific settings. Others have more modest regulations, like transparency reporting requirements.

Senate health committee Chair Bernie Sanders (I-Vt.) also proposed a ban on facility fees for care that can safely be provided offsite in a health workforce bill he introduced Wednesday, along with site-neutral payments in the commercial market. (His Republican counterpart, Sen. Bill Cassidy, called it "irresponsible legislating.")

public health

A Gavi exit interview

My colleague Helen Branswell sat down with Seth Berkley, who spent the last dozen years running Gavi, which helps lower-income countries buy vaccines. He's planning to leave at the beginning of August.

He defended COVAX's efforts to get Covid-19 vaccines to lower-income countries, and chatted about the possibility of annual boosters, what he would have done differently, and whether Gavi should exist in the future. Read more.

medicaid

Florida isn't budging on Medicaid waivers

Medicaid officials "are in collaborative discussions" with Montana about implementing temporary waivers to let the program auto-renew scores of people at risk of being kicked out because of so-called redetermination, Medicaid Director Daniel Tsai told reporters Wednesday. If that happens, "there would only be one state across the country that has not taken up any of the many policy waivers and flexibilities we have put out." (Officials said they weren't going to name names on the call. But, hint: It's Florida).

Florida has kicked 303,000 people off Medicaid rolls as of this month, falling behind only Texas, which has booted half a million people according to a KFF data tracker. While roughly 17 million people leave Medicaid programs each year — because of jobs, income changes, or red tape around renewals — the speed of change this year is "unprecedented," said Tsai.

The agency has ordered "half a dozen" states to pause terminations or reinstate people after identifying redetermination problems and is "in discussion with probably a dozen other states" about potential errors in their process, Tsai said. Still, roughly a third of Medicaid enrollees nationwide are getting removed from the rolls — though Tsai said the agency is seeing a slight uptick in people picking up Obamacare plans.

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