From the COVID-19 front

• Sobering news from the Wall Street Journal that “It took less than six months for the globe to record more than 1.88 million Covid-19 deaths this year, according to a Wall Street Journal analysis of data collected by Johns Hopkins University. The university’s count for 2021 edged just ahead of the 2020 death toll on Thursday. These numbers underscore how unevenly the pandemic spread around the globe, often hitting poorer nations later, but before they had access to the vaccines that have benefited Europe and the U.S. * * * Vastly different vaccination rates have sharpened the global divide. Only 2% of people in Africa and just over 6% in Asia have received at least one dose of vaccine, according to Our World in Data. That compares with 22% in South America, more than 40% in the European Union and more than half in the U.S. * * * World leaders are due to discuss their response to the pandemic when they gather in Cornwall, in southwestern England, on Friday.” David Leonhardt sheds light on the vaccinating the world in the New York Times. The bottom line is as he points out: “A rapid global vaccination program — combined with natural immunity in people who have already had Covid — could create the same virtuous cycle that’s underway in the U.S., Britain and other countries: A decline in cases feeds on itself, as there are fewer infected people able to spread the virus to others. And by prioritizing older people for shots, countries can cause deaths to decline even more sharply than cases.”
• To that end, here in the U.S., Moderna “has requested an emergency use authorization (EUA) for its [two dose, mRNA] COVID-19 vaccine in adolescents [ages 12-17] with the U.S. Food and Drug Administration (FDA). Pfizer’s two dose, mRNA vaccine already is being administered to adolescents in this age group.
• Johnson & Johnson announced that “the U.S. Food & Drug Administration (FDA) has authorized an extension of the shelf life for the Johnson & Johnson single-shot COVID-19 vaccine from 3 months to 4.5 months.” Absent this science based extension, large surplus of unused doses of this vaccine would have begun to expire later this month.  The Wall Street Journal adds that the federal government continues to suspend shipments of new doses of the single dose vaccine, evidently to allow the surplus to deplete.
• Fierce Healthcare reports on Kaiser Permanente’s efforts to boost the COVID-19 vaccination numbers. As of today, 64% of Americans over age 18 have received at least one dose and over 75% of Americans over age 65 are fully vaccinated.

In big healthcare legal news, a friend of the FEHBlog pointed out to him today that yesterday the Department of Health and Human Services submitted its interim final rule on No Surprise Billing Act implementation rule to the Office of Management and Budget’s Office of Information and Regulatory Affairs for final review before publication in the Federal Register.

AGENCY: HHS-CMS	RIN: 0938-AU63	Status: Pending Review
TITLE:Requirements Related to Surprise Billing; Part I (CMS-9909)
STAGE: Interim Final Rule	ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 06/08/2021	LEGAL DEADLINE: Statutory

In other healthcare and healthcare business news:

• Healthcare Dive informs us that “UnitedHealthcare, the biggest private payer in the U.S., is delaying a controversial policy that could retroactively deny emergency room bills it deems non-emergent — potentially saddling patients with costly medical bills — following intense backlash from patient advocates and hospital groups. ‘Based on feedback from our provider partners and discussions with medical societies, we have decided to delay the implementation of our emergency department policy until at least the end of the national public health emergency period,’ UnitedHealthcare tweeted on Thursday.
• Health Payer Intelligence identifies four payers that have embraced value based contracting with healthcare providers in the first half of 2021.
• STAT News reports on what’s ahead for Biogen’s new Alzheimer’s Disease drug. The article concludes “Despite the controversies, Mark Miller, the former executive director of the Medicare Payment Advisory Commission, thinks Aduhelm will be widely used and make billions for Biogen. Infusion centers used for cancer patients and others can accommodate Aduhelm patients, said Miller, now the executive vice president at the Arnold Ventures philanthropy. Doctors will make good money providing the drug. Most Medicare patients have supplemental coverage that will pick up the 20 percent copay. ‘There’s not a lot of friction here to say, “Don’t do this,’ he said.”
• STAT News also tells us that “The treatment known as CAR-T, in which white blood cells are genetically modified to attack blood cancer, is one of the most exciting and expensive in medicine. But it has not been directly compared to standard treatments in a randomized trial — until now. Bristol Myers Squibb said Thursday that its CAR-T, Breyanzi, prevented the return of large B-cell lymphoma better than the standard of care treatment, which includes a chemotherapy regimen and a stem cell transplant, in which bone marrow cells are replaced to try to cure blood cancer. The news was released in a terse press release that does not include any details about how the therapy performed. But if the results hold up when published in a medical journal or presented at a medical meeting, they would represent a big step forward for CAR-T therapy.”
• The American Medical Association offers a blueprint for controlling blood pressure.
• NIH Director Dr. Francis Collins in his blog interviews U.S. Surgeon General Vivek Murthy on fighting the ongoing opioid epidemic.

In federal employment news, Federal News Network reports that

The Biden administration has lifted the 25% occupancy limit at federal buildings, though agencies must still jump through several hoops before bringing more employees back for in-person work.

The Office of Management and Budget, along with the Office of Personnel Management and General Services Administration, on Thursday issued detailed guidance on the administration’s approach for reopening agency offices during the pandemic — and offered a highly-anticipated glimpse at their approach for telework, remote work and other workforce flexibilities in a post-pandemic world.