August 17, 2021
Newsletter | Tea Leaves

D.C. News:

  • As soon as this week, the Biden administration will recommend that most Americans get a COVID-19 booster shot eight months after completing their initial immunizations. Officials could start offering the extra doses to nursing home residents and health care workers as soon as mid-September, followed by other older people who were vaccinated last winter. The news comes as Pfizer and BioNTech filed preliminary data on booster shots with the FDA. (Articles here, here, here, and here)

 Life Sciences:

  • Pfizer and BioNTech submitted early-stage clinical trial data to the FDA as part of their U.S. application seeking authorization of a COVID-19 vaccine booster for everyone 16 and older. In the phase one trial, participants received a third shot of the two-dose vaccine about eight to nine months after receiving their second shot. According to the companies, the booster dose generated “significantly higher neutralizing antibodies” against the original COVID-19 strain as well as the beta and delta variants. (Press release here; Articles here, here, here, and here)
  • Merck notified 340B entities last week that if they do not join the company’s program integrity initiative then it will cut off sales to most contract pharmacies starting on September 1. Merck said the requirement is to ensure that it doesn’t provide duplicative discounts for both Medicaid and 340B. It will still offer sales to one contract pharmacy if the hospital doesn’t have its own in-house pharmacy. (Article here)


  • UnitedHealth Group Inc. and health IT company Change Healthcare Inc. won’t complete their $8 billion merger until at least January 2022 under a new agreement with the Justice Department. Company officials have said the deal, originally expected to close in the second half of 2021, would improve connectivity across health care systems, though critics warned it could curb competition. (Article here)


  • ACA exchanges in a handful of states are raising the price on benchmark “silver” plans in an effort to realign coverage and pricing across tiers of health plans. According to regulators, the move will wind up reducing how much most consumers pay for insurance because they’ll get higher premium subsidies for those plans. New Mexico, Colorado, Maryland, Virginia, Pennsylvania, and Texas have already taken action. (Article here)
  • A report from the HHS Office of Inspector General identified significant potential cost savings to Medicare if CMS removes the inpatient prospective payment system (IPPS) exemption for capital payments to new hospitals. For the 112 new hospitals that we reviewed, Medicare paid a total of $283 million more for capital costs than it would have paid if these hospitals had been paid through the IPPS. Nearly 60 percent of new hospitals were part of a chain that might have been able to cover their capital costs if needed. The OIG recommended that CMS evaluate whether to change the policy; the agency agreed. (Report here; Article here)