Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Roll Call tells us “A disagreement between Speaker Kevin McCarthy and House conservatives that jammed up legislative business last week eased Monday evening, but members of the rebel bloc made clear it may not be the end of trouble for their leadership.”
  • Govexec informs us
    • “After multiple years of significant spending increases at non-defense agencies, Congress has reverted to austerity by demanding an overall freeze of discretionary funding for domestic agencies. 
    • “The pullback, agreed to as part of a deal struck by President Biden and House Republicans to meet GOP demands for raising the debt ceiling, will force agencies to make difficult decisions as they abandon some efforts to launch new programs and grow existing ones. The 2023 Fiscal Responsibility Act set only a top-level cap for non-defense spending, leaving it to Congress to establish line-by-line funding levels across government. 
    • “The impacts will look different agency to agency,” said Rachel Snyderman, a senior associate director at the Bipartisan Policy Center and former Office of Management and Budget official.”
  • Federal News Network helpfully reviews the 71 public comments submitted to OPM in response to its April 6, 2023, interim final rule implementing the Postal Service Health Benefits Program.
  • Health Payer Intelligence relates, “AHIP offered four recommendations to the Senate Finance Committee on Consolidation and Competition (the Committee) [last week] to support healthy competition and lower healthcare spending in the healthcare industry.”

From the litigation front —

  • Yahoo News reports,
    • “The Biden administration on Monday finalized a deal to preserve the federal mandate requiring U.S. health insurers to cover preventive care like cancer screenings and HIV-preventing medication at no extra cost to patients while a legal challenge continues.
    • “The agreement, first disclosed on Friday and now finalized in a filing in the New Orleans-based 5th U.S. Circuit Court of Appeals, leaves the mandate in place nationwide while the administration appeals a court order striking it down.
    • “It does allow Texas-based Braidwood Management, one of a group of businesses and individuals that sued to challenge the mandate, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services for its employees for now. The administration agreed not to take any retroactive enforcement action against the company, which operates an alternative health center if the mandate is restored on appeal.”
  • STAT News adds,
    • “The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts.
    • “The lawsuit is the second to challenge the new program, enacted by Democrats last August in the Inflation Reduction Act, within a week’s time, but relies on different legal reasoning. Merck, which makes a diabetes drug that could be subject to negotiation, sued on Tuesday.
    • “Medicare is supposed to choose the first ten drugs to be negotiated by the program by Sept. 1. The goal of the lawsuits is to slow down or stop the process from going into effect.”

From the public health front —

  • Politico relates,
    • “The FDA’s independent advisers will discuss and recommend this week which strain of SARS-CoV-2 should be included in the newest Covid booster to be rolled out ahead of fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does.
    • “Since the beginning of the year, the regulatory agency has made it clear that it will shift gears to prepare for annual Covid-19 shots as the virus becomes endemic. Now that we’re four months out from the intended rollout, the FDA must select a strain that will most likely be prevalent so manufacturers can start developing vaccines.
    • “Novavax, Pfizer-BioNTech and Moderna, the companies that manufacture the three vaccines available in the U.S., need the FDA’s recommendations to begin tweaking their existing platforms. They must also conduct clinical trials to show that the updated formulas generate a similar immune response to their existing products.”
  • MedPage Today reports,
    • “Oseltamivir (Tamiflu) has not panned out for reducing the risk of influenza hospitalization, according to a large meta-analysis.
    • “Among over 6,000 flu patients across 15 studies, the 0.14-percentage point difference in hospitalization rate between those who took oseltamivir and those who did not was not significant (RR 0.77, 95% CI 0.47-1.27), Emily McDonald, MD, MSc, of McGill University Health Centre in Montreal, and colleagues reported in JAMA Internal Medicine.
    • “I wouldn’t prescribe it to an otherwise healthy person,” McDonald told MedPage Today. “There was little evidence that it would prevent you from going to the hospital.”
    • “What’s more, she added, “it’s not completely benign. It does cause uncomfortable side effects.”
  • The Wall Street Journal reports,
    • “During the pandemic, Carl Prudhomme of Alpine, Texas, got his cancer drugs mailed directly to him from his oncologist.
    • “No longer. With the end of the Covid-19 public-health emergency, independent cancer doctors can no longer send prescriptions directly to their Medicare patients—creating hurdles for some people in rural areas who say they have to travel to get their medications. Prudhomme plans to drive the 569 miles each way to his oncologist’s office in Houston every three months to pick up his drugs in person.
    • “The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
    • “Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.
    • “Roughly 30% of the more than 5,000 independent oncologists in the U.S. have on-site pharmacies in their practices, according to an analysis led by the University of Pennsylvania’s Perelman School of Medicine. 
    • “The restriction was suspended during the pandemic public-health emergency. Its return has alarmed cancer doctors who are lobbying Congress and CMS to rescind the restriction, even if that means undergoing new rule-making to do so.”

From the U.S. healthcare business front —

  • Fierce Healthcare tells us,
    • “Prior authorization has been a flashpoint for providers, and, while insurers have taken steps to ease these utilization management protocols, they still play a key role as the industry shifts to value-based care.
    • “David Brailer, M.D., executive vice president and chief health officer at the Cigna Group, told Fierce Healthcare in an interview that ultimately the goal is to ensure patients are receiving the best treatment option for them.
    • “And the insurer has seen that in more advanced value-based arrangments, it can relax prior authorization and other utilization management tools, Brailer said. 
    • “That’s going to be a few years before the market shifts,” he said. “We’ve already announced that we’re starting to step down the number of prior auths that we have.”
  • STAT News relates,
    • “Novartis said on Monday it would purchase Chinook Therapeutics for $3.2 billion upfront, picking up two drugs for a chronic kidney disease that are in late-stage clinical trials.
    • “The transaction values Seattle-based Chinook at $40 a share, compared to Friday’s closing price of under $24. The agreement includes another $300 million if certain regulatory milestones are reached.”
  • Healthcare Dive points out
    • CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
    • “It may sort of spook some pharma companies who may think that if CVS exited, maybe these other companies will also exit, and it may make them a little bit more hesitant to partner up with the retailers,” said Sari Kaganoff, general manager of consulting at Rock Health. “At the same time, there’s a lot of opportunity, we believe, for pharma companies to use retailers for clinical trials.”
    • CVS will fully exit the clinical trials business by the end of 2024, winding down the business in phases and working with trial sponsors to ensure patients continue to receive care. 

From the Rx coverage front —

  • The Wall Street Journal informs us,
    • Kristen Ireland struggled with bulimia nervosa for years, working with a therapist and taking medications for anxiety and depression.
    • It wasn’t until her psychiatrist prescribed Victoza, a diabetes medication that works much like Ozempic, Wegovy and Mounjaro, that her binges and purges faded away.
    • “I feel free now,” said Ireland, 27 years old, who manages sports-merchandise stores in Jackson Hole, Wyo. 
    • Treating eating disorders is another potential application for a class of drugs that has taken the weight-loss world by storm. The drugs, synthetic versions of the GLP-1 hormone that act on appetite centers in the brain and gut, have helped patients lose 15% of their body weight on average
    • Some studies and the experience of doctors in the field suggest they could also help people stop binge eating.
  • CBS News discusses the side effects of these new weight loss drugs.