Thursday Miscellany

Employee Wellness Programs

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, OPM, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill

Roll Call tells us

Senators negotiating a COVID-19 supplemental funding package have an “agreement in principle” to provide roughly $10 billion for the Department of Health and Human Services to stock up on waning domestic supplies for combating the virus, according to Sen. Roy Blunt, R-Mo.

Blunt, the top Republican on the Senate Labor-HHS-Education Appropriations Subcommittee, said both parties have tentatively agreed to offsets for the $10 billion that would repurpose unspent funds from prior pandemic relief laws.

The offsets negotiators agreed to include $2.2 billion from unused grant funds for venues like zoos and theaters and $2 billion in untapped assistance to the aviation and manufacturing industry, Blunt said. His comments to reporters came after a Republican Conference lunch in which lead GOP negotiator Sen. Mitt Romney of Utah briefed his colleagues on the agreement in principle. 

Fierce Healthcare informs us

The House [of Representatives] passed a bill on Thursday that caps the out-of-pocket cost of insulin at $35 a month for beneficiaries in Medicare Part D and for certain group and individual plans.

The Affordable Insulin Now Act, which passed the House via a 232 to 193 vote, comes as work in the Senate continues on a bipartisan alternative that could bring additional changes. * * *

Private plans would also be required to offer first-dollar coverage of insulin without any deductible, according to an analysis from the Congressional Budget Office. 

The cap on cost-sharing for private insurance plans would implement in 2023.

The Hill offers a related article explaining why insulin prices are so “troubling” high.

HR Dive reports

Among the provisions of this month’s $1.5 trillion omnibus spending bill, Congress included a revival of an exemption that allowed high-deductible health plans to cover telehealth before individuals meet their deductible.

The provision was originally created by the Coronavirus Aid, Relief, and Economic Security Act, which sunset at the end of 2021. The provision will resume April 1 but will again sunset at the end of this year.

From the Omicron and siblings front, the Wall Street Journal discusses the state of Covid treatments and offers its advice on who should seek out a second Covid booster besides the immunocompromised.

From the OPM front, Govexec projects OPM’s actions over the next 18 months based on the FY 2022 to FY 2026 strategic plan released last Monday. In short, “Hire, Hire, Hire.”

Govexec also discusses efforts underway by OPM, the Social Security Administration and the Thrift Savings Plan to improve the customer service experience of federal employees and retirees. Good luck with that.

From the research front the National Institutes of Health announced

Scientists have published the first complete, gapless sequence of a human genome, two decades after the Human Genome Project produced the first draft human genome sequence. According to researchers, having a complete, gap-free sequence of the roughly 3 billion bases (or “letters”) in our DNA is critical for understanding the full spectrum of human genomic variation and for understanding the genetic contributions to certain diseases. The work was done by the Telomere to Telomere (T2T) consortium, which included leadership from researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health; University of California, Santa Cruz; and University of Washington, Seattle. NHGRI was the primary funder of the study.

Analyses of the complete genome sequence will significantly add to our knowledge of chromosomes, including more accurate maps for five chromosome arms, which opens new lines of research. This helps answer basic biology questions about how chromosomes properly segregate and divide. The T2T consortium used the now-complete genome sequence as a reference to discover more than 2 million additional variants in the human genome. These studies provide more accurate information about the genomic variants within 622 medically relevant genes. * * *

The now-complete human genome sequence will be particularly valuable for studies that aim to establish comprehensive views of human genomic variation, or how people’s DNA differs. Such insights are vital for understanding the genetic contributions to certain diseases and for using genome sequence as a routine part of clinical care in the future. Many research groups have already started using a pre-release version of the complete human genome sequence for their research.  

From the mental healthcare front, the American Hospital Association calls our attention to a new GAO report.

Consumers with health coverage experience challenges finding in-network mental health providers, who may not be accepting new patients or have long wait times to see them, according to a new report from the Government Accountability Office. Factors contributing to these challenges include low reimbursement rates for mental health services and inaccurate or out-of-date information on provider networks, GAO said. The report also looks at ongoing and planned federal efforts to address these challenges, for example by increasing the mental health workforce, mental health system capacity and oversight of health plan compliance with mental health parity laws.

This squib caused the FEHBlog to recall a comment that he heard at a conference — Four out of five doctors are in-network but only one out of five mental health providers are in-network with the notable exception of hub and spoke telemental services.

Yesterday the FEHBlog suggested that in return for three free primary care visits and three behavioral health visits, plan members should name and use their in-network primary care provider and primary mental health provider. The FEHBlog is sticking with this idea for the in-network primary care provider but he recognizes the idea may be premature for the in-network primary mental health provider. Of course, creating a looser standard for free mental health care compared to primary care is compliant with the federal health parity rule. The reverse would violate the often fuzzy non-quantitative treatment limitations created by the law.

From the miscellany department —

  • STAT News tells us “With Medicare expected to cover a projected 80 million people by 2030,He entrepreneurs and investors are cashing in on what analysts see as an inevitable shift in health care away from the hospital and into the homes of aging patients.” The publication identifies five related technology trends.
  • Fierce Healthcare reports “Virtual care startup Hims & Hers is teaming up with Carbon Health to offer patients in California with direct access to providers for in-person medical appointments at clinics. The collaboration will provide easy and comprehensive access to a broader range of care options through the Hims & Hers platform, company executives said.”
  • Health Payer Intelligence informs us “Large employers are investing more in their wellness program design in 2022 and their programs revolve around hybrid work environments, job satisfaction, and equity, the Business Group on Health found in a survey.”

Midweek update

David Ermer–CDC, COVID-19, COVID-19 vaccine, Employee Wellness Programs, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Piron Guillaume on Unsplash

In addition to being Wednesday, today is September 1 which marks the beginning of at least three healthcare related observances”

  • Each September, the American Medical Association’s (AMA) Women Physicians Section (WPS) honors physicians who have offered their time, wisdom and support to advance women with careers in medicine.
  • September is Sepsis Awareness Month. Here is a link to the Center for Disease Control’s Sepsis awareness page.
  • September is also National Recovery Month. The AMA identifies four ways that the Biden Administration can reduce the number of drug overdose deaths.

From the Delta variant front

The FEHBlog’s favorite newspaper columnist is David Leonhardt who writes a morning column for the New York Times. Mr. Leonhardt raises questions often on the FEHBlog’s mind after exploring the question with experts.This morning he pondered whether

the Delta-fueled Covid-19 surge in the U.S. finally peaked?

The number of new daily U.S. cases has risen less over the past week than at any point since June. * * *

Since the pandemic began, Covid has often followed a regular — if mysterious — cycle. In one country after another, the number of new cases has often surged for roughly two months before starting to fall. The Delta variant, despite its intense contagiousness, has followed this pattern. * * *

In the U.S., the start of the school year could similarly spark outbreaks this month. The country will need to wait a few more weeks to know. In the meantime, one strategy continues to be more effective than any other in beating back the pandemic: “Vaccine, vaccine, vaccine,” as [University of Minnesota epidemiologist Michael] Osterholm says. Or as [Johns Hopkins epidemiologist Jennifer] Nuzzo puts it, “Our top goal has to be first shots in arms.”

Hope springs eternal.

Regading increasing the number of vaccinations, Bloomberg reports today that

Vaccine mandates are set to get more common in the workplace. 

A majority of U.S. employers — 52% — are planning or considering requirements for a Covid-19 shot by the end of the year, according to a survey released Wednesday by consultant Willis Towers Watson. That’s more than double the 21% of companies polled that currently have some form of mandate. 

The options vary, ranging from a strict order for all employees to limiting access to certain areas to inoculated workers. About 14% of respondents also said they are weighing a health-care surcharge for people who choose not to get the vaccine, while 1% are planning to impose one, according to the survey of 961 employers, conducted Aug. 18-25.

Also Fierce Biotech explores what’s next in the mRNA pipeline. Principally for the two COVID mRNA vaccine companies with large war chests

Moderna executives tout the company’s pipeline often—so we’ll be brief here. A cytomegalovirus candidate is the furthest along in the company’s prophylactic vaccine program, while other mid-stage assets include a personalized cancer vaccine and a localized regenerative therapeutic for the heart condition myocardial ischemia.

BioNTech, meanwhile, has dozens of assets in development for a host of common conditions: malaria, tuberculosis and even certain allergies. But where the German biotech is really making a mark is in oncology, where dozens of vaccines and therapeutics are in development. Just one is in phase 2: the Roche-partnered melanoma therapy BNT122. That drug is combined with Merck & Co.’s blockbuster Keytruda to treat metastatic melanoma in a study conducted with Roche’s Genentech.

The article also discusses where other large drug manufacturers stand in the developing market.

From the bankruptcy front, the Wall Street Journal reports that

OxyContin maker Purdue Pharma LP won court approval of a $4.5 billion bankruptcy settlement that shields its owners, members of the Sackler family, from lawsuits accusing them of contributing to the nation’s opioid epidemic in exchange for providing funding to combat the crisis.

Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, N.Y., said Wednesday he will confirm a restructuring plan that will transform Purdue into a public benefit company and settle civil lawsuits filed by governments and opioid victims against the drugmaker and its owners. 

The ruling can be appealed by the handful of federal and state authorities that opposed Purdue’s bankruptcy-exit plan and argued at trial that the settlement structure is unconstitutional and the Sacklers aren’t contributing enough of their wealth. Purdue’s family owners collected more than $10 billion from the company between 2008 and 2017, about half of which went to taxes or was reinvested in the business.

From the miscellany front

  • Homeland Security Today informs us that “The Biden Administration, in a collaboration between the General Services Administration, the White House Office of Management and Budget, the Office of Personnel Management, the Cybersecurity and Infrastructure Security Agency, and the White House Office of Science and Technology Policy, announced the U.S. Digital Corps, a new two-year fellowship that will recruit early-career technologists to contribute to high-impact efforts across the federal government. This program will work to advance the Administration priorities of coronavirus response, economic recovery, cybersecurity, and streamlining government services.” Best of luck with this initiative.
  • The Washington Post reports that “Childhood obesity rose significantly during the pandemic,according to a new study. The greatest change was among children ages 5 to 11, who gained an average of more than five pounds, adjusted for height, according to the study published in Journal of the American Medical Association (JAMA) Network. For the average 5-year-old (about 40 pounds), that’s a 12.5 percent weight gain. For the average 11-year-old (about 82 pounds), it’s a 6 percent weight gain, according to the study. Before the pandemic, about 36 percent of 5- to 11-year-olds were considered overweight or obese, and that increased to 45.7 percent. ‘Significant weight gain occurred during the covid-19 pandemic among youths in Kaiser Permanente Southern California, especially among the youngest children,’ the study concluded. ‘These findings, if generalizable to the U.S., suggest an increase in pediatric obesity due to the pandemic.’” No bueno.
  • Employee Benefits News offers an engaging article titled “Affordable ways to help your employees tend to their mental health.

Monday Roundup

David Ermer–COVID-19, Employee Wellness Programs, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

Bloomberg reports that

The Covid-19 variant that’s become the dominant strain in the U.S isn’t as deadly as earlier research indicated, although it’s confirmed to be faster-spreading than other versions, according to a study.

Among 339 patients with the coronavirus, 36% of those infected with the B.1.1.7 strain that arose in the U.K. became severely ill or died, according to research published Monday in the Lancet Infectious Diseases journal, compared with 38% of those who had non-B.1.1.7 infections.

“We’re not saying it’s nothing, but it’s not worse in terms of outcome in our study, in our setting,” said Eleni Nastouli, a co-author of the study and an associate professor at University College London. She noted that the study differed from some earlier research, looking at patients in hospitals, rather than in the community, and making precise identifications of variants with whole-genome sequencing.

Earlier data released by a U.K. advisory group and cited by the U.S. Centers for Disease Control and Prevention indicated that B.1.1.7 might be as much as a third more deadly than other variants of the virus. 

FLASH: Bloomberg reports Tuesday morning that

U.S. health officials recommended a pause in the use of Johnson & Johnson’s Covid-19 vaccine on concerns about rare and severe blood clotting side effects. A type of brain blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets in six women between the ages of 18 and 48, the U.S. Centers for Disease Control and Prevention and Food and Drug Administration said Tuesday in a joint statement. As of April 12, more than 6.8 million doses of the vaccine have been administered, the agencies said.

If you had to pause one of the vaccines this would be the week to pause the Johnson & Johnson vaccine due to the manufacturing / distribution problems. Fingers crossed for a short pause.

The Department of Health and Human Services today

marked Black Maternal Health Week by announcing actions to expand access to continuous health care coverage and access to preventative care in rural areas to improve maternal health outcomes. HHS Secretary Xavier Becerra announced that Illinois is the first state to provide continuity of full Medicaid benefit coverage for mothers by offering extended eligibility for a woman during the entire first year after delivery. A new data brief shows that more than half of pregnant women in Medicaid experienced a coverage gap in the first 6 months post-partum and disruptions in Medicaid coverage often lead to periods of uninsurance, delayed care, and less preventive care. The American Rescue Plan provides an easier pathway for states to extend Medicaid postpartum coverage from 60 days to 12 months.

Secretary Becerra also announced a Notice of Funding Opportunity (NOFO) that will make $12 million available over four years for the Rural Maternity and Obstetrics Management Strategies (RMOMS) program that will allow awardees to test models to address unmet needs for their target population. For the first time, applicants are required to focus on populations that have historically suffered from poorer health outcomes, health disparities, and other inequities.

For more information on the fourth Black Maternal Health Week, check out the Black Mamas Matter Alliance’s website.

From the prescription drug front —

  • Cigna’s Evernorth unit, which includes the Express Scripts PBM, has released its 2020 Drug Trends report. The report’s by the numbers webpage is quite illuminating.
  • STAT News informs us that

Patrizia Cavazzoni has been named the permanent leader of the Food and Drug Administration’s Center for Drug Evaluation and Research, the agency’s acting commissioner, Janet Woodcock, announced Monday morning. The position of CDER director is one of the most influential at the sprawling agency. Cavazzoni, who is in her late 50s, was handpicked by Woodcock to join the agency in 2018 and has been leading the drug center in an acting role since last spring. Cavazzoni is known as a problem-solver who has taken on some of the FDA’s most pressing problems, former top FDA officials told STAT last year.

From the healthcare technology front —

Healthcare Dive lets us know that

Microsoft is acquiring clinical documentation and artificial intelligence company Nuance Communications for $19.7 billion, two years after first inking an R&D partnership with the speech-to-text market leader. The Redmond, Washington-based tech giant said Monday it has entered into a definitive agreement to acquire Nuance for $56 a share — a hefty price tag, representing a 23% premium on the closing price on Friday. Nuance develops conversational artificial intelligence and cloud-based ambient clinical intelligence for doctor’s offices and hospitals.

Jingle bells to Nuance Communications. Healthcare AI is obviously a big deal.

  • Becker’s Hospital Review reports that “Google is in the early stages of a new project that aims to explore and develop a new consumer-facing health records tool for Android users, according to an April 9 STAT report. * * * The project could support the development of a medical records tool similar to Apple’s Health Records app, according to the report.”

Finally here’s an interesting smoking cessation twist from Healio:

A parental smoking intervention was effective and “inexpensive” to implement in pediatric primary care practices, with costs per quit that were comparable to other interventions, according to researchers. * * * “The impetus for screening parents for tobacco use in the pediatric setting is to protect children from exposure to secondhand smoke,” Douglas E. Levy, PhD, MPH, associate professor of medicine at Harvard Medical School and associate investigator at the Mongan Institute Health Policy Center at Massachusetts General Hospital, told Healio Primary Care. “Parents may be more receptive to smoking cessation messages when the recommendation comes from pediatric health care providers because the benefits are framed in terms of protecting their child’s health.”

Tuesday’s Tidbits

David Ermer–CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Employee Wellness Programs, Federal employment benefits, Mental health care, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Bloomberg reports that “President Joe Biden said [today] he wants all American adults eligible for a coronavirus vaccine by April 19, two weeks earlier than his previous goal. All but two states are already set to meet that goal, with Oregon and Hawaii having planned to open up vaccines to all non-minors on May 1.”

Yesterday, the Centers for Disease Control (“CDC”) released a report finding that “The principal mode by which people are infected with SARS-CoV-2 (the virus that causes COVID-19) is through exposure to respiratory droplets carrying infectious virus. It is possible for people to be infected through contact with contaminated surfaces or objects (fomites), but the risk is generally considered to be low.” As this BBC News article illustrates, last Spring we were quite worried about contracting COVID-19 from contaminated surfaces. In any event, thank heavens that we have the vaccines.

Federal News Network reports that front line federal employee access to the COVID-19 vaccine depends upon their employing agency.

If you are a federal employee working in the field, like Food and Drug Administration inspectors, Forest Service rangers or Custom and Border Protection officers, getting a COVID-19 vaccine from your agency isn’t a sure thing.

The Department of Homeland Security is making an all-out effort to vaccinate all 300,000 employees.

Other agencies like the Agriculture Department or the IRS are asking employees to take a path through their state and local governments.

This inconsistent application of agency support for “frontline” workers to receive one of the three inoculations has the potential to create a have and have nots among agencies.

Hopefully as the COVID-19 vaccine supply continues to expand and access restrictions are removed, these unfortunate quirks in the process will be ironed out quickly.

In other healthcare related tidbits

  • On April 12, the CDC will be sponsoring its decennial meeting on healthcare associated infections.
  • The Food and Drug Administration released a COVID-19 update today. The FEHBlog wonders when the FDA will take up granting full marketing approval for the Pfizer and Moderna vaccines and when AstraZeneca will file an emergency use authorization with the FDA for its COVID-19 vaccine. Those steps take us closer to ironing out the process quirks.
  • MedPage Today reports that

A personalized, hands-on care strategy for patients struggling with addiction was effective at reducing hospital readmission, a randomized trial found. In a comparison of hospitalized adults with substance use disorder involving opioids, cocaine, or alcohol, those who received Navigation Services to Avoid Rehospitalization (NavSTAR) care saw far better outcomes than those who simply received treatment as usual, according to Jan Gryczynski, PhD, of the Friends Research Institute in Baltimore, and colleagues.

  • Health Payer Intelligence informs us that

A digital therapeutic weight loss program led to major medical cost savings, according to a Rally Health Inc. study that points to wellness programs as cost-effective strategies to tackle the obesity epidemic. The study published in Obesity examined program data over a three-year period to analyze medical cost trends for those participating in Rally Health’s Real Appeal weight loss intervention program.

Researchers compared medical costs for a group of participants in the digital therapeutic wellness program with costs for a control group of non-participants. The control group was selected to match the intervention group in terms of health risk, baseline medical costs, age, gender, geographic region, and chronic conditions.

The study found that the wellness programming resulted in significant weight loss. There was an average weight loss of 3 percent for 4,790 program participants who attended at least one session over a 52-week period. In addition to providing positive member outcomes, the wellness program lowered medical expenditures significantly. Costs for the intervention cohort were 12 percent less than costs for the control group. What’s more, the savings of the wellness program cohort were 2.3 times more than program costs, marking significant return on investment.

  • Adam Fein reports in his Drug Channels blog that

The drug channel is consolidating, both vertically and horizontally. For evidence, look no further than Drug Channels Institute’s estimates of pharmacy benefit manager (PBM) market share, which are shown in the chart below. For 2020, DCI estimates that the three biggest PBMs [CVS Health (including Caremark and Aetna), the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group] accounted for more than three-quarters of total equivalent prescription claims. * * * This concentration helps plan sponsors and payers, which can maximize their negotiating leverage by combining their prescription volumes within a small number of PBMs. 

Thursday Miscellany

David Ermer–CDC, COVID-19, Employee Wellness Programs, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

In a welcome spurt of cautious optimism, Bloomberg reports this evening

The U.S. vaccine supply is poised to double in the coming weeks and months, according to an analysis by Bloomberg, allowing a broad expansion of doses administered across the country. * * * A review of drugmakers’ public statements and their supply deals suggests that the number of vaccines delivered should rise to almost 20 million a week in March, more than 25 million a week in April and May, and over 30 million a week June. By summer, it would be enough to give 4.5 million shots a day.  * * * The analysis assumes drugmakers will meet their new delivery targets — not a guarantee in a year-old pandemic where much has gone wrong.

The FEHBlog’s bet, for what it’s worth, is that Bloomberg’s analysis proves correct.

The urgency of rapid COVID-19 vaccine distribution is reinforced by the Centers for Disease Control’s report today that U.S. life expectancy dropped by one year during the first six months of last year.

For perspective, take a look at the American Medical Association’s interview of John Barry, the author of the Great Influenza. To wit –

In 1918, people didn’t buy the government’s take on the pandemic. They saw what was happening. The disease was much more virulent, killing between 50 million and 100 million people. That would be between 225–450 million people today after adjusting for population. In Philadelphia, Barry said, priests would drive horse-drawn carts down the street calling for people to bring out their dead.

Mr. Barry urges truth telling by all parties holding public trust. By the way, the Great Influenza is fascinating reading.

In regulatory news —

  • Fierce Healthcare informs us that “President Joe Biden has chosen Chiquita Brooks-LaSure to lead the Centers for Medicare & Medicaid Services (CMS), according to a report in The Washington Post.” This post requires Senate confirmation.
  • The National Law Journal reports that “The U.S. Equal Employment Opportunity Commission (EEOC) announced last Friday that it was withdrawing two proposed rules regarding the incentives employers can provide their employees as part of a wellness program without violating the Americans with Disabilities Act (ADA) or Genetic Information Nondiscrimination Act (GINA). Originally, the proposed rules had stated that, for the most part, employers could offer only “de minimis” incentives for employees participating in a wellness program—incentives that potentially could apply to employees receiving a coronavirus (COVID-19) vaccine. With the withdrawal of those rules, employers have little guidance in terms of what incentives, if any, they may offer employees”
  • The Health and Human Services Inspector General announced a court ordered delay in effective date of the Trump Administrations’ rule banning prescription drug rebates in Medicare Part D (but not the FEHBP) to January 1, 2023.
  • The Internal Revenue Service issued guidance implementing the following cafeteria plan changes created by the Consolidated Appropriations Act, 2021. The new law

Provides flexibility with respect to carryovers of unused amounts from the 2020 and 2021 plan years;

Extends the permissible period for incurring claims for plan years ending in 2020 and 2021;

Provides a special rule regarding post-termination reimbursements from health FSAs during plan years 2020 and 2021;

Provides a special claims period and carryover rule for dependent care assistance programs when a dependent “ages out” during the COVID-19 public health emergency; and

Allows certain mid-year election changes for health FSAs and dependent care assistance programs for plan years ending in 2021.

This notice also provides additional relief with respect to mid-year elections for plan years ending in 2021. 

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Employee Wellness Programs–
Photo by Sven Read on Unsplash

The Centers for Medicare and Medicaid Services has released a COVID-19 Vaccine Toolkit for health insurance issuers and Medicare Advantage plans. The toolkit’s purpose is as follows:

CMS is committed to ensuring that the private health insurance industry has the necessary tools to respond to the COVID-19 public health emergency (PHE). As safe and effective COVID- 19 vaccines become available, CMS issued this toolkit to help health insurance issuers and Medicare Advantage plans identify the issues that need to be considered and addressed in order to provide coverage and reimbursement for vaccine administration. Because COVID-19 vaccines will be federally purchased, this toolkit primarily focuses on vaccine administration. CMS remains available to provide technical assistance to issuers, Medicare Advantage plans, and other stakeholders. This toolkit:
• Provides a list of operational considerations for issuers and Medicare Advantage plans as they design their approach to promoting COVID-19 vaccinations and information on how issuers and Medicare Advantage plans can communicate with providers and enrollees on vaccinations and coverage;
• Outlines legislative and regulatory provisions applicable to issuers that ensure that enrollees can receive a COVID-19 vaccine in a convenient setting, with no out-of-pocket costs;
• Encourages issuers and Medicare Advantage plans to implement streamlined processes to quickly administer COVID-19 vaccine coverage; and • Describes how issuers and Medicare Advantage plans can maximize the number of their enrollees who get vaccinated once a COVID-19 vaccine becomes available

Meanwhile the Centers for Disease Control have released facts sheets on what to expect after you receive your first dose of COVID-19 vaccine and how to improve ventilation in your house during the great hunkering down.

Benefits Pro reports that the Equal Employment Opportunity Commission is poised to release proposed rules addressing the level of incentives employers may lawfully offer to encourage employee participation in wellness programs that require disclosure of medical information. “

Because the {Americans with Disabilities Act] ADA and [Genetic Information Non-Discrimination Act] GINA do not define “voluntary,” the NPRM proposes that in order to comply with the acts, employers may offer no more than a “de minimis” incentive to encourage participation in wellness programs. The exception would be for “wellness programs that are part of, or qualify as, group health plans and that require employees to satisfy a standard related to a health factor to receive a reward or avoid a penalty,” according to the proposed rule under the ADA.

Under the GINA regulation, the proposed rule makes an exception that would allow incentives for genetic information “when a wellness program offers an employee an incentive in return for his or her family member providing information about the family member’s manifestation of disease or disorder.”

Midweek update

David Ermer–COVID-19 testing, COVID-19 vaccine, Employee Wellness Programs, Uncategorized–
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

David Ermer–COVID-19, Employee Wellness Programs, Federal employment benefits, SCOTUS, U.S. Healthcare–
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

David Ermer–Congress, COVID-19, Employee Wellness Programs, U.S. Healthcare–

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

David Ermer–CDC, Congress, COVID-19, Employee Wellness Programs, OPM, SCOTUS–

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.