CDC cancels publication of study touting COVID-19 vaccine benefits

Acting CDC director Jay Bhattacharya has canceled the publication of a study finding that COVID-19 vaccines significantly reduced the odds of hospitalizations and emergency visits last winter, arguing the study painted an inaccurate picture of the vaccines' effectiveness.

The study, which was conducted by scientists at CDC, determined the effectiveness of COVID-19 vaccines by looking at the vaccination status of people who sought care at hospitals and EDs and found that vaccination reduced the likelihood of emergency visits due to COVID-19 by 50% and hospitalizations by 55%.

The study was supposed to be published in CDC's Morbidity and Mortality Weekly Report (MMWR) but was pulled following a dispute about the study's methodology, according to an HHS spokesperson. Officials at HHS didn't say exactly why the methodology used in the CDC study was a problem but argued that prior infection, behavior, and differences in those who seek care can affect results.

"I've never seen a case where an article in the MMWR that got to that stage was not published," said Michael Iademarco, who led the center that included the MMWR's operations from 2014 to 2022.

Andrew Nixon, a spokesperson for HHS, said "scientific reports are routinely reviewed at multiple levels to ensure they meet the highest standards before publication," adding that the department's assessment "identified concerns regarding the methodological approach to estimating vaccine effectiveness, and the manuscript was not accepted for publication."

(Mandavilli, New York Times, 4/22; Stobbe, Associated Press, 4/22)

CMS proposes deadlines for prior authorization requests for drugs

CMS earlier this month issued a proposed rule requiring health insurance companies and states to resolve prior authorization requests for drugs more quickly and publicly disclose their denial rates.

This proposed rule would require all Medicaid and Children's Health Insurance Program (CHIP) insurers, as well as state Medicaid and CHIP administrators, to respond to nonurgent prior authorization requests for prescription drugs within 24 hours of receipt. Insurers operating on Affordable Care Act exchanges would have to respond to standard requests for drugs within 72 hours and urgent requests within 24 hours.

Insurers would be required to justify their denials and publicly report data on their prior authorization decisions for medications. The rule would also require Medicare Advantage (MA) insurers to publicly release data on their prior authorization decisions for medications. CMS noted that MA and stand-alone Medicare Part D insurers are already subject to similar deadline requirements for outpatient drugs.

"Last year, we got 80% of the insurance industry to agree to eliminate prior authorization for common medical services such as diagnostic imaging, physical therapy, and outpatient surgery," said HHS Secretary Robert F. Kennedy Jr. "This rule builds on that agreement by making it easier for patients to get the medications they need by minimizing delays and enabling real-time decisions."

CMS Administrator Mehmet Oz said the proposed rule "moves prior authorization into the digital age, replacing fax machines and fragmented systems with real-time electronic workflows. "We are … ensuring providers can focus on caring for patients instead of navigating red tape."

CMS proposed an Oct. 1, 2027, compliance start date.

(Morse, Healthcare Finance News, 4/13; Frieden, MedPage Today, 4/13; Tepper, Modern Healthcare, 4/10)

CMS to require 50-state audit of Medicaid oversight

CMS administrator Mehmet Oz last week announced at a POLITICO healthcare summit that his agency intends to ask states to "own" the problem of healthcare fraud and will require all 50 states to explain their plans to revalidate some of their Medicaid providers within 30 days.

"It's an example of what we'd like them to do to prove that they're serious about this," Oz said. "And if you don't take it seriously, it indicates to us that we might have to take the audits that we're doing to the different states more aggressively."

Oz justified the decision by saying that federal health programs in some states have enrolled large numbers of providers who aren't providing real care to patients and are instead profiting from fraud, adding that the requests for states to verify the legitimacy of Medicaid providers will specifically be focused on "high risk areas," though he didn't elaborate beyond that.

Last month, President Donald Trump signed an executive order creating an anti-fraud task force across all federal benefit programs led by Vice President JD Vance, however it's unclear whether this effort from CMS is part of that initiative.

When asked during the interview whether there was a risk that initiatives from the Trump administration could eliminate, slow down, or otherwise harm essential healthcare programs, Oz said that he anticipates the exact opposite will happen, saying that Medicaid and Medicare are the "crown jewels" of the United States.

"I believe this audit and others like it will save the programs we care most about," he said.

(Swenson, Associated Press, 4/21)