legislation & regulation

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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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.

Biden Admin Issues New Price Transparency Rule for Insurers

The Biden administration — having already opted to keep Trump administration-era health care price transparency regulations on the books — has now issued a new set of transparency requirements aimed at health insurers specifically.

The interim final rule with request for comments (IFC), titled “Prescription Drug and Health Care Spending,” will require group and individual market health plans as well as Federal Employees Health Benefits Program carriers to submit a wealth of prescription drug and health care spending data to the federal government no later than Dec. 27, 2022. At least one industry analyst doesn’t anticipate the regulation will have a particularly significant effect on health insurers — though that may not stop them from protesting.

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Insurers Get Their Wish With Repeal of Medical Device Rule

CMS repealed a proposed Trump-era regulation that would have required Medicare to cover experimental “breakthrough” medical devices that have been approved by the FDA but not cleared for Medicare use through a national coverage determination. Insurer groups opposed the rule and urged the Biden administration to revoke it, while the medical device industry’s largest trade group championed it as a breakthrough for patients.

“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries. The Medicare program needs to implement policies that balance access and appropriate safeguards,” said CMS Administrator Chiquita Brooks-LaSure in a Nov. 12 press release on the decision. CMS said it will begin to develop an alternative policy to ensure speedy access to breakthrough technologies.

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Medication Abortion Regulations, at a Glance

Medication abortion — which involves using two drugs, mifepristone and misoprostol — accounts for 54% of all pregnancy terminations before nine weeks of gestation in the U.S., according to a recent Kaiser Family Foundation analysis. The FDA’s Center for Drug Evaluation and Research exercised “enforcement discretion” of the Risk Evaluation and Mitigation Strategy requirement that asks prescribers to dispense mifepristone to patients in-person during the pandemic. This allows providers in 32 states and the District of Columbia that do not have laws that ban medication abortion to dispense mifepristone via telehealth. Currently, 18 states and D.C. allow both advance practice clinicians and medical doctors to dispense abortion pills.

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.