Washington Roundup

Congress has been out of session this week following Memorial Day.

The No Surprises Act’s RxDC reporting deadline for the 2023 calendar year is this coming Saturday, June 1.

Healthcare Dive tells us,

“The House Budget Committee met Thursday [May 23, 2024] to discuss the impact of healthcare mergers and acquisitions on cost, quality and access and arrived at a bipartisan consensus: Something needs to be done to halt the rampant pace of consolidation before it inflates medical costs further.
“What, exactly, remains unclear, though lawmakers and witnesses during the hearing expressed support for standardizing Medicare payments between hospital-owned outpatient sites and independent physician offices for the same services.
“Such site-neutral policies are “very bipartisan,” testified Sophia Tripoli, the senior director of health policy at patient advocacy group Families USA. “It is a no brainer.”
“Congress has been increasingly interested in tamping down on healthcare consolidation amid a mountain of evidence it increases costs without a corresponding increase in care quality, harming Americans’ ability to access and afford medical care. After a merger, hospitals can jack up their prices anywhere from 3% to 65%, according to a Rand review from 2022.
“We just can’t afford to have this continued increase in prices,” said Rep. Ron Estes, R-Kan., during the hearing.”

“A top Food and Drug Administration official on Friday [May 24, 2024] again advocated for the speedy approval of gene therapies for rare diseases. But he didn’t drop any clues on where the agency stands on a coming decision to possibly broaden use of one of them, a Duchenne muscular dystrophy treatment the regulator cleared last year.
“At a meeting hosted by the patient advocacy group CureDuchenne, Peter Marks, head of the FDA office that reviews gene therapies, said the agency’s thinking has changed in recent years to become more patient focused. That mindset has led it to more aggressively look for ways to speed the development of rare disease gene therapies.
“Although we’re a regulatory agency,” he said, the regulations “have to ultimately serve getting products to patients. So we’re trying to focus on the patient, and use that to negotiate the regulations to get there as rapidly as possible.”
“Those comments build on points Marks has made before. Last year, at a meeting held by a different advocacy group, he advocated for flexibility in reviewing rare disease gene therapies while fighting off criticism about accelerated approvals, which allow drugmakers to bring therapies to market based on interim measures of benefit. On Friday, he again threw support behind speedy clearances, noting that they are a “very important” tool in bringing forward rare disease treatments.”

On May 23, the Health Subcommittee of the House Ways and Means Committee held a hearing on the collapse of private medical practices in our country.

Healthcare Dive reports,

"Drugmakers are allowed to limit and impose conditions on pharmacies they send discounted drugs to under the 340B program, [the U.S. Court of Appeals for the D.C. Circuit] ruled Tuesday.
“The ruling is a win for drug manufacturers, who were previously threatened with fines from the federal government for violating guidance regarding which pharmacies they would send discounted drugs to.
“The Court of Appeals upholds a prior District Court ruling, which sided with drugmakers Novartis Pharmaceuticals and United Therapeutics after they sued the HHS in 2021. It’s the latest ruling regarding the controversial 340B drug program — a separate appellate court also ruled with drugmakers early last year.”

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