Midweek update

Midweek update

Photo by Manasvita S on Unsplash

More good COVID-19 vaccine news today. The Wall Street Journal reports that following up on Monday’s favorable initial report on the phase three study of their COVID-19 vaccine, Pfizer and BioNTech announced the final report on that study.

Pfizer Inc. said it will ask health regulators to authorize its experimental Covid-19 vaccine within days, after reporting the shot was 95% effective in its pivotal study and showed signs of being safe. The company’s plans, announced Wednesday, mean the shot is on track to go into distribution by the end of the year, if the regulators permit.

Pfizer and BioNTech said that of the nearly 44,000 adults in the U.S. and in other countries who took part in the study, 170 developed Covid-19 with at least one symptom. Out of those, just eight had taken the vaccine, while 162 had received a placebo. The resulting 95% effectiveness rate puts the shot’s performance on par with shingles and measles vaccines. It is also consistent with last week’s peek at how it did in an analysis of the first 94 subjects to fall sick.

The infected subjects included 10 severe cases of Covid-19, with nine in the placebo group and one in the vaccine group. The vaccine was effective across different ages, races and ethnic groups, and it was more than 94% effective in adults over 65 years old, the companies said. About 42% of the trial participants are from racial or ethnic minority groups, while 41% are ages 56 to 85, the companies said.

Moreover, medical device manufacturer Lucira Health announced today that

Late yesterday the U.S. Food and Drug Administration (FDA) authorized the first prescription molecular diagnostic test for COVID-19 that can be performed entirely at home. The FDA issued an Emergency Use Authorization (EUA) to Lucira Health, Inc. for its single-use, user-friendly COVID-19 All-In-One Test Kit that can produce a positive or negative result at home within 30 minutes. Lucira’s test kit is differentiated by its simple ‘swab, stir and detect’ design. Clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes. That is significantly faster than labs which currently take two to seven days to generate similarly accurate test results. The Lucira™ COVID-19 All-In-One Test Kit is expected to be available to patients served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale, in the near future. By early spring 2021, it is expected to be available nationally through health care providers.

Healthcare Dive indicates that the initial price for the test will be about $50.

Benefits Pro points us to a CIGNA report titled “Health and Wellness in Workplaces: What Works? ROI Analysis of Health and Wellness Interventions” which “is the largest global review of the impact of workplace wellness interventions, according to researchers.” Top line findings are that focused wellness programs deliver the greatest impact for employers and that mental health interventions yield the most significant return on the employer’s investment.

Fierce Healthcare reports that the American Medical Association’s House of Delegates is on the warpath against employer sponsored high deductible plans. “In 2010, about 25.3% of people were enrolled in a high-deductible plan, with that number rising to 40% in 2016.” The article overlooks the important fact that participating in such a plan is the key to opening a triple tax free health savings account.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

The Senate Judiciary Committee sent Judge Amy Coney Barrett’s Supreme Court nomination to the Senate floor today. The Senate will confirm the nomination on Monday and Judge Barrett will be sworn in soon thereafter. Consequently, Judge Barrett will be sitting on Supreme Court bench when the Court hears the Affordable Care Act constitutionality case on November 10. The FEHBlog predicts a 9-0 decision in favor of the law’s constitutionality with the exception of the zeroed out individual mandate.

On the COVID-19 front, Medscape reports as follows:

  • The Food and Drug Administration gave marketing approval to Gilead Science’s “remdesivir (Veklury) today as a treatment for hospitalized COVID-19 patients age 12 and up, making it the first and only approved treatment for the disease.”
  • The Centers for Disease Control updated its COVID-19 social distancing guidance: “Previously, the CDC cautioned against spending 15 minutes or longer in close proximity to an infected person, particularly in enclosed indoor spaces. In a new report published online October 21 in Morbidity and Mortality Weekly Report, however, investigators ‘determined that an individual who had a series of shorter contacts that over time added up to more than 15 minutes became infected.'”
  • Dr. Anthony Fauci predicts that “People will likely need to wear masks and follow social distancing guidelines through the end of 2021 and into 2022.”

Healthcare Dive informs us about four healthcare story lines that COVID-19 has overshadowed this year — — 1. Price transparency going strong; 2. Companies rush to go public; 3. Surprise billing efforts slow to a crawl, and 4. preference for healthcare at home. The FEHBlog is pleased to reflect that he has been discussing these matters and COVID-19 this year.

Govexec reports on the eight most important birthdays for federal employees from a federal employee retirement standpoint — the birthdays range from ages 50 to 72

The Society for Human Management provides a comprehensive update on employer and health plan sponsored wellness programs which is worth a gander.

Beckers Hospital Review alerts us that “Healthgrades named the recipients of its 2021 Specialty Excellence Awards Oct. 20, which include the top hospitals for critical care.” The article lists the 214 award winners by state.

Saturday October 24 is National Prescription Drug Take Back Day. “Check DEA’s official Take Back Day website for more information and to find year-round collection sites near you.”

Finally in a man bites dog story, the Wall Street Journal headlines tonight on its website that “Walmart sued the federal government in an attempt to strike a pre-emptive blow against what it said is an impending opioid-related civil lawsuit from the Justice Department.” Best defense, etc. The article notes that “Quicken Loans Inc. tried a similar tactic against the federal government in 2015 to avoid being pegged with mortgage fraud, but the Justice Department sued weeks later in a case Quicken settled last year.” The FEHBlog expects the same outcome with this lawsuit.

Weekend update

Photo by Dane Deaner on Unsplash

Congress remains out of town until next week following Labor Day. The Treasury Secretary Steven Mnuchin appears before the House Oversight and Reform Committee’s COVID-19 subcommittee at 1 pm on Tuesday. You can expect member questions about the Administration’s application of the President’s executive order on employment taxes to the federal workforce which take effect the same day.

Here are a few stories that recently caught the FEHBlog’s eye:

  • Mhealth Intelligence reports that “The crowded, clamorous, stuffy, sniffly waiting room has long been the scourge of healthcare, a sign of both inconvenienced patients and overworked providers. It’s here that patients are asked to announce their presence, fill out forms and check their insurance, while staff sort through the data to match them to the right provider at the right time slot. Prodded by the pandemic, health systems are now using mHealth apps, online portals and telehealth platforms to handle those administrative tasks, so that a patient arriving at the hospital or doctor’s office is seen and treated as quickly as possible.” Hopefully that’s a trend that will continue and grow as it should tamp down contagious diseases.
  • Health Payer Intelligence informs us about a UnitedHealthcare study on employee wellness programs during the COVID-19 emergency. Most notably,

More than three-quarters (77%) of survey respondents who are employed and have access to wellness programs said the initiatives have made a positive impact on their health. Nearly half (48%) said the programs motivated them to pay more attention to their health; 38% said they helped lower stress; 36% said they increased physical activity; and 33% reported improved sleep. According to the survey, wellness programs helped 17% of respondents manage a chronic condition such as diabetes, while 17% said the health initiatives helped detect a disease or medical issue.
As for job performance among those who said the wellness programs made a positive impact on their health, 54% of employees said the initiatives helped reduce stress; 51% said they improved productivity; and 31% said they took fewer sick days. Among employees without access to
wellness programs, 71% of respondents said they would be interested in such initiatives if offered.

  • The University of Alabama at Birmingham announced that “Surgical patients are more likely to experience a postoperative infection if they have low health literacy, which is a limited capacity to understand and act on health information, according to results of a new study presented at the American College of Surgeons 2020 Quality and Safety Conference VIRTUAL.” Health plans should look into filling this literacy gap.
  • The National Law Review reports that

PROGENITY, INC. (“PROGENITY”), a San Diego-based biotechnology company that provides molecular and diagnostic tests agreed to a $49 million settlement for fraudulent billing and kickback practices. The settlement resolves claims that the biotechnology company fraudulently billed federal healthcare programs for prenatal tests and provided kickbacks to physicians to persuade them to order PROGENITY tests for their patients. * * * PROGENITY has agreed to pay $16.4 million to resolve similar fraudulent billing claims related to TRICARE and the Federal Employees Health Benefits Program through a separate civil settlement.

Weekend Update

Happy Fathers’ Day.

The House and Senate are holding committee hearings and floor votes this week. On Tuesday the Senate Health Education Labor and Pensions Committee will hold a hearing on applying lessons learned from the current COVID-19 emergency to prepare for the next pandemic emergency.

Speaking of the current pandemic:

  • The FEHBlog was wondering about whether there has been an uptick in COVID-19 related hospitalizations to accompany the uptick in COVID-19 cases over this month. The FEHBlog was delighted to find this handy CDC website on COVID-19 related hospitalizations which shows that new hospitalizations have continued to trend down this month.
  • On Friday, OPM released guidance on the relationship paid leave / other time off and COVID-19 work by Federal employees. According to the guidance, OPM plans to issue “regulations [that ] will deem the COVID-19 national emergency to be an exigency of the public business for the purpose of restoring forfeited annual leave. The regulations [among other things] will provide that employees who would forfeit annual leave in excess of the maximum annual leave allowable carryover because of their essential work during the national emergency will have their excess annual leave deemed to have been scheduled in advance and subject to leave restoration.”

The U.S. Supreme Court has 15 decisions left to issue before its summer break. The Court is expected to issue some of those decisions tomorrow at 10 am. The Court is continuing to hold its Thursday conferences so all of 15 of the decisions may not be ready for issuance.

Georgetown Law Professor Katie Keith provided a welcome Health Affairs blog analysis of a complicated topic — federal regulation of employee wellness programs. The key complicating factor is that there are so many different applicable federal laws in play.