Policy & Politics

News Briefs: Becerra Defends No Surprises Act Regulation | Nov. 24, 2021

HHS Sec. Xavier Becerra is defending No Surprises Act-related regulations from growing criticism by providers and members of Congress, citing an HHS report on the cost and prevalence of surprise bills. Becerra said on Nov. 22 that providers who overcharge for services will simply have to change: “I don’t think when someone is overcharging, that it’s going to hurt the overcharger to now have to [accept] a fair price,” he told Kaiser Health News. “Those who are overcharging either have to tighten their belt and do it better, or they don’t last in the business. It’s not fair to say that we have to let someone gouge us in order for them to be in business.” The HHS report found that “surprise medical bills are relatively common among privately insured patients and can average more than $1,200 for services provided by anesthesiologists, $2,600 for surgical assistants, and $750 for childbirth-related care.” More than 150 members of Congress from both parties, many of them physicians, sent a letter to Becerra earlier this month protesting the latest rulemaking on the No Surprises Act. In addition, Texas’ largest provider organization filed suit to block the latest interim final rule.

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Will ‘Build Back Better’ Spell Disaster for Pharma Innovation?

The House of Representatives on Nov. 19 passed Democrats’ hard-fought, $1.7 trillion social spending bill, bringing it significantly closer to becoming law and ushering some of the most ambitious drug pricing reforms ever attempted.

With the fate of the Build Back Better Act now in the hands of the Senate, the debate over how its drug pricing provisions will impact innovation in the life sciences industry has never been hotter — especially now that the Congressional Budget Office (CBO) has weighed in.

New FDA Appointee Is Likely to Emphasize Real-World Data

President Joe Biden recently nominated former FDA Commissioner Robert Califf, M.D., to run the agency once more, ending nearly a year of temporary leadership under Acting Commissioner Janet Woodcock, M.D. One insider says that Califf might look to reform and improve the accelerated approval pathway following the controversial Aduhelm (aducanumab) approval earlier this year.

Califf previously led the FDA during the Obama administration, running the agency for roughly the last two years of Obama’s term. Califf advocates for using “real-world evidence” in addition to clinical trial data in medical approvals. Aduhelm, an Alzheimer’s drug, was approved without such data, though studies of the drug relying on real-world evidence — which takes into account electronic medical record and insurance claims data — are underway. During Califf’s initial tenure, Sarepta Therapeutics’ eteplirsen, a muscular dystrophy drug, also earned accelerated approval despite a large outcry from medical researchers.

News Briefs: New MA and Part D Rule Is Pending at OMB | Nov. 18, 2021

The Biden administration’s first Medicare Advantage and Part D regulation is pending review at the Office of Management and Budget. The CMS final rule, titled “Policy and Technical Changes to the Medicare Advantage Program and Medicare Prescription Drug Benefit Program; MOOP and Cost Sharing Limits (CMS-4190),” was received on Nov. 10. It is not economically significant, according to the posting at RegInfo.gov.