Monday Roundup

David Ermer

I am an attorney who practices law in Washington DC. My practice has involved the Federal Employees Health Benefits Program since 1983.

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, Federal employment benefits, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Delta variant front, Health Magazine informs us that “Former FDA Chief Scott Gottlieb, MD, calls for research into UK Surge of New Delta Plus Variant, AY.4.2 While not yet singled out as a concern in the US, the new Delta subtype prompted a reminder that the world needs ‘robust systems’ to identify up-and-coming threats.” Ruh roh?

The Wall Street Journal reports that

The Food and Drug Administration [FDA] is moving to soon allow people to receive booster shots that are different from their first Covid-19 vaccine doses, people familiar with the matter said. 

The FDA won’t recommend any booster over the others but will permit people to get a booster shot that is different from the shot they first received, one of the people familiar with the matter said.

The FDA is seeking to authorize mixing and matching as soon as this week, the people familiar with the matter said. The FDA is also expected to approve Moderna Inc. and Johnson & Johnson boosters this week, according to a person familiar with the matter.

If you find the last sentence somewhat confusing, at this point, only the FDA’s vaccine advisory committee has approved the Moderna and Johnson & Johnson boosters. The acting FDA commissioner Janet Woodcock has to act on that guidance. Once Dr. Woodcock acts then her decision moves to the Centers for Disease Control for its decision.

The FEHBlog noticed today that the Office of Management and Budget’s Office of Information and Regulatory Affairs has held twenty five stakeholder listening sessions so far on the OSHA vaccination screening program rule that will apply to businesses with 100 or more employees. The rule arrived at OIRA last Tuesday October 12. The large number of listening sessions suggests to the FEHBlog that OIRA wants to wrap up its work expeditiously. The OIRA approved rule will be published in the Federal Register.

From the federal employee benefits front, Federal News Network informs us that

The Office of Personnel Management has proposed expanding eligibility for the Federal Employees Dental and Vision Insurance Program (FEDVIP) to include certain temporary and seasonal workers, among others.

OPM will publish a draft rule Tuesday in the Federal Register, which will describe several recommended FEDVIP changes, including new clarifications and provisions designed to make it easier for certain employees to alter their enrollment with the program outside of the traditional open season window.

Federal employees on temporary, seasonal or intermittent schedules — specifically those who work 130 hours a month for at least 90 days — [plus seasonal firefighters] would become eligible to enroll in FEDVIP under OPM’s draft policy.

OPM expanded eligibility for the Federal Employees Health Benefits Program (FEHBP) to this group back in 2014, and the agency’s proposed rule would simply allow temporary and seasonal workers to enroll in FEDVIP as well.

[T]o give [the 86,000] federal and USPS workers on temporary, seasonal and intermittent schedules a chance to enroll for the first time in FEDVIP, OPM envisions giving newly eligible employees a 60-day window after the date that it finalizes this new policy.

The preamble to the proposed rule notes that “As of August 3, 2021, FEDVIP has 5.4 million enrollees with approximately 7.3 million covered individuals.” The FEHB Program’s enrollment is evenly split between 2 million employed enrollees and 2 million retired enrollees plus 4 million eligible family members for a grand total of eight million. The FEHBlog understands why they are more enrollees in FEDVIP because Congress recently added certain TRICARE eligible folks to the FEDVIP program. But why does FEDVIP have the only half the number of eligible family members found in the FEHB Program? Does the FEHB Program offer adequate dental coverage for children? The FEHBlog has never explored that angle.

OPM has bulked up the family member status information and documentation found on its FEHB eligibility website.

From the Rx coverage front, the FDA today approved for marketing “the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for),  its reference product Humira (adalimumab) for Cyltezo’s approved uses.” Humira is a blockbuster drug which suggests big health system savings from this action. However, STAT News adds that those savings will not be realizable until June 2023 due to a Humira patent settlement. Furthermore

The FDA approved a biosimilar version that will only be available in low-dose concentrations. But three years ago, AbbVie began shifting patients to high-dose concentrations of Humira, which contain fewer excipients that often cause burning and discomfort when the medicine is injected. In fact, high-dose concentrations now account for 80% of the market, according to Bernstein analyst Ronny Gal.

The situation “is not so straightforward,” Evercore ISI analyst Josh Schimmer wrote in an investor note.

In its view, however, Boehringer Ingelheim believes Cyltezo should be considered to have the same “strength” as the corresponding original concentration and high-concentration versions of Humira, because they contain the same total drug content per container.

Nothing is simple when it comes to specialty drugs.

From the benefit design front, STAT News tells us that

The pandemic prompted a mad dash to figure out how to deliver health care virtually. As the dust settles, UnitedHealthcare, the country’s largest insurer, is laying the foundation for the future with a health plan built primarily around telemedicine services designed to be more affordable and accessible.

Called NavigateNOW, the new virtual-first plan will offer care for common services without a copay, including both in-person and virtual primary and behavioral health care, virtual urgent care, and most generic medications. UnitedHealthcare said plan premiums will be about 15% cheaper. The new offering, announced Monday, comes as both legacy insurers and startups are beginning to offer new flavors of health plans that combine conventional and digital services to offer a hybrid kind of care.

NavigateNOW enrollees will have 24-hour access to a virtual health team that includes primary, behavioral, and urgent care through UnitedHealth Group subsidiary Optum, which will also provide in-person care when necessary. Unlike some competitors, United will use its homegrown technology infrastructure to deliver the virtual care.

On a related note Healthcare Dive reports that

Seven months after announcing plans to merge, virtual care company Doctor on Demand and clinical navigator Grand Rounds are launching a new brand for their combined company: Included Health.

The name is meant to stress how the entity offers mental and behavioral healthcare, primary care, chronic care, specialty care, care for LGBTQ individuals and patient navigation tools all under the same roof, Included President Robin Glass and Chief Medical Officer Ian Tong told Healthcare Dive.

The inspiration for the rebrand came from Included Health, a care navigation platform for the LGBTQ community, which Doctor on Demand and Grand Rounds acquired in May in a bid to strengthen their offerings for the underserved population. Included, which covers just under 100 million members, declined to share how much it is investing in the rebrand.

Weekend update

David Ermer–Congress, Rx coverage, Telehealth, U.S. Healthcare–

Both the U.S. House of Representatives and the Senate will be engaged in Committee business and floor voting this coming week.

From the telehealth front —

Fierce Healthcare discusses the state of the telehealth marketplace.

“Ten years ago, Doctor On Demand, MDLive and Amwell had the market onto themselves. Largely, in part, due to pandemic, but also with reimbursement policy changes and innovation and an emerging tech side of the market, this has all driven new entrants to what you think of as the classic telehealth space,” Jeff Becker, principal healthcare analyst at CB Insights, told Fierce Healthcare.

The competition is “coming from everywhere,” Becker said, noting that the incumbent telehealth players traditionally generated revenue from one-off urgent care, low-acuity care and primary care visits handled virtually.

“Now you have Heal and DispatchHealth sending clinicians to your house or workplace to compete for that same urgent care book of business. You have Forward and One Medical with direct primary care and they, with a lot of venture backing, are competing for that one-off primary care, urgent care telehealth book of business,” he said.

There are also startups providing remote patient monitoring and virtual chronic disease management with a focus on specialty conditions, such as Monogram Health for chronic kidney disease patients and Hinge Health, which focuses on musculoskeletal pain. And there are digital health companies like Hims & Hers and Ro that offer prescription drug delivery and telehealth visits.

  • What’s more, on Friday October 15, Walmart, which also is engaged in the telehealth market, and Transcarent, which sells in the digital marketplace,

announced they would be working together as go-to-market partners for self-insured employers across the country. The agreement allows Transcarent, which offers employees and their dependents a new, different, and better health and care experience, to share Walmart’s everyday low-cost on pharmaceuticals and other services with self-insured employers and their employees for the first time.

The collaboration makes it easier for millions of employees and the families of self-insured employers to access high-value care – no matter where they live – at affordable prices. This new offering will allow employers of all sizes to leverage Walmart’s healthcare size and scale to more easily provide their employees convenient care and cost-effective health and wellness options.

  • mHealth Intelligence further informs us that

Several large health systems have formed a coalition to support strategies that use telehealth and remote patient monitoring to provide acute care for patients at home.

The Advanced Care at Home Coalition builds on both the surge in remote patient monitoring [RPM] programs during the pandemic and the Acute Hospital at Home Program, launched in late 2020 by the Centers for Medicare & Medicaid Services. That program, which now involves more than 100 hospitals and health systems across the country, offers CMS waivers for a home-based care management plan to treat patients who would otherwise require hospitalizations for a broad range of acute conditions, including asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD). Treatment plans combine RPM and telehealth with in-person care.

The coalition was launched by the Mayo Clinic, Medically Home and Kaiser Permanente, and includes Adventist Health, ChristianaCare, Geisinger Health, Integris, Johns Hopkins Medicine, Michigan Medicine (the University of Michigan), Novant Health, ProMedica, the Sharp Rees-Stealy Medical Group, UNC Health and UnityPoint Health.

From the Rx coverage front, this coming Saturday October 23 is the latest Drug Enforcement Administration National Rx Take Back Day allowing consumers to conveniently and safely dispose of unused prescription and over the counter drugs.

From the medical research front, Health Payer Intelligence tells us that

Using predictive analytics, University of Chicago researchers have developed a method to determine an eventual diagnosis of autism spectrum disorder (ASD) in young children. The new computational approach gathers data using diagnostic codes from previous doctor’s visits, eliminating the need for blood work or procedures to make a diagnosis.

According to researchers, this method reportedly reduced the number of false-positive ASD diagnoses produced by traditional screening methods by half. ASD can be diagnosed as early as two years old. However, false positives flagged by the initial screens commonly used today can delay confirming a true diagnosis.

With the importance of early intervention and the limited number of trained professionals, tools that can potentially reduce the number of patients required to undergo the lengthy, multistep process to receive an official positive diagnosis can significantly impact patient care.

Cybersecurity Saturday

David Ermer–Cybersecurity–

Tech Republic reports on a White House sponsored “virtual ransomware summit this week with over 30 countries in attendance—although a few notable nations were excluded, such as China, Russia and North Korea. Australia, Brazil, Canada, France, Germany, India, Japan, United Arab Emirates and the United Kingdom were among the attendees.”

Cyberscoop adds that

Nations must better clamp down on money laundering in order to disrupt ransomware gangs’ illicit financial transactions, according to a statement Thursday from more than 30 countries that participated in two days of White House meetings focused on slowing hackers and digital extortion.

The joint statement also included commitments to other methods of countering ransomware, such as encouraging cyber hygiene practices to the private sector, collaborating across law enforcement and national security agencies and using diplomatic pressure against nations that harbor cybercriminals. 

Bleeping Computer’s This Week in Ransomware discusses the summit and more.

ZDNet reports that

More than $5 billion in bitcoin transactions has been tied to the top ten ransomware variants, according to a report released by the US Treasury on Friday. 

The department’s Financial Crimes Enforcement Network (FinCen) and Office of Foreign Assets Control (OFAC) released two reports illustrating just how lucrative cybercrime related to ransomware has become for the gangs behind them. Parts of the report are based on suspicious activity reports (SAR) financial services firms filed to the US government.

FinCen said the total value of suspicious activity reported in ransomware-related SARs during the first six months of 2021 was $590 million, which exceeds the $416 million reported for all of 2020.

Finally at this week’s CISA summit event marking Cybersecurity Awareness Week, the Acting U.S. Assistant Attorney General for the Civil Division Brian M. Boyton spoke about the Department’s Civil Cyber-fraud Initiative which leverages the False Claims Act to” identify, pursue and deter cyber vulnerabilities and incidents that arise with government contracts and grants and that put sensitive information and critical government systems at risk.”

We have identified at least three common cybersecurity failures that are prime candidates for potential False Claims Act enforcement through this initiative. 

First, the False Claims Act is a natural fit to pursue knowing failures to comply with cybersecurity standards. When government agencies acquire cyber products and services, they often require contractors and grantees to meet specific contract terms, which are often based on uniform contracting language or agency-specific requirements. For example, cybersecurity standards may require contractors to take measures to protect government data, to restrict non-U.S. citizen employees from accessing systems or to avoid using components from certain foreign countries. The knowing failure to meet these cybersecurity standards deprives the government of what it bargained for. 

Second, False Claims Act liability may be based on the knowing misrepresentation of security controls and practices. In seeking a government contract, or performing under it, companies often make representations to the government about their products, services, and cybersecurity practices. These representations may be about a system security plan detailing the security controls it has in place, the company’s practices for monitoring its systems for breaches, or password and access requirements. Misreporting about these practices may cause the government to choose a contractor who should not have received the contract in the first place. Or it could cause the government to structure a contract differently than it otherwise would have. Knowing misrepresentations of this kind also deprive the government of what it paid for and violate the False Claims Act.   

Finally, the knowing failure to timely report suspected breaches is another way a company may run afoul of the Act. Government contracts for cyber products, as well as for other goods and services, often require the timely reporting of cyber incidents that could threaten the security of agency information and systems. Prompt reporting by contractors often is crucial for agencies to respond to a breach, remediate the vulnerability and limit the resulting harm. 

At bottom, the department’s Civil Cyber-Fraud Initiative will hold accountable entities or individuals that put U.S. information or systems at risk.     

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine–

Based on the Centers for Disease Control’s COVID Data tracker, the FEHBlog offers his 2021 chart of new weekly COVID cases using Wednesday as the last day of week:

Here is a link to the CDC’s chart of weekly new COVID hospitalizations which also is trending down:

The FEHBlog also offers his 2021 chart of new weekly COVID deaths, a lagging indicator, that at worst has plateaued for now.

Finally the FEHBlog offers his chart of new weekly COVID vaccinations distributed and administered over 51st week of 2020 through the 41st week of 2021 which end last Wednesday October 13.

As of today, 66.5% of vaccination eligible Americans (age 12 and older) and 84.3% of Americans over age 65 are fully vaccinated. Moreover, 13.4% of the over age 65 cadre have received a booster.

Here is a link to the CDC’s weekly interpretation of current COVID statistics. Also today the HHS Secretary renewed the COVID national public health emergency for another 90 days into January 2022, and the CDC issued its first FluView for the current flu season – “Seasonal influenza activity in the United States remains low.”

Also from the Delta variant front, AHIP informs us

Today, the Food and Drug Administration (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted to unanimously (19-0) endorse emergency use authorization for an additional, booster dose of the Johnson & Johnson (J&J) COVID-19 vaccine for adults 18 and older at least 2 months after the primary single-dose vaccine.

The Committee discussed the sustained durability and vaccine effectiveness (VE) of the single-dose J&J vaccine against severe disease and hospitalization. Data from J&J demonstrated that an additional dose of the J&J vaccine given at 2-6 months following the primary dose was safe, well-tolerated, and could increase protection against symptomatic COVID-19.

The Advisory Committee additionally reviewed data from the National Institutes of Health (NIH) on the use of heterologous booster doses following a primary series of the currently authorized or approved COVID-19 vaccines, e.g. administering an mRNA COVID-19 vaccine to recipients of the J&J adenoviral-based COVID-19 vaccine.  Heterologous boosters proved to be more effective at boosting antibody titers in study participants than homologous boosters, though the response differed depending on formulation of the primary series and booster.  It should be noted, though, that the NIH study was not designed to compare across boosters, as the study did not control for patient characteristics across booster options, among other factors.

The American Medical Association (AMA) has not yet announced updates to the Current Procedural Terminology® (CPT) COVID-19 vaccine and vaccine administration code set to account for authorization of the Johnson & Johnson additional dose. AHIP will keep members apprised of coding developments as they are announced via the AMA’s CPT COVID-19 landing page.

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommending the Moderna and Johnson & Johnson vaccine boosters on October 20-21.

For an insightful perspective on the FDA Advisory Committee’s work, check out David Leonhardt’s column in today’s New York Times. He accurately predicted that Committee would punt on the booster mix and match question.

The Wall Street Journal reports

The Food and Drug Administration is delaying a decision on authorizing ModernaInc.’s MRNA -2.31% Covid-19 vaccine for adolescents to assess whether the shot may lead to heightened risk of a rare inflammatory heart condition, according to people familiar with the matter.

After four Nordic countries strengthened their stances against giving Moderna vaccines to younger adults last week, the FDA has been taking another look at the risk of the condition, known as myocarditis, among younger men who took Moderna’s vaccine, especially compared with those who received the vaccine from Pfizer Inc. PFE -0.43% and BioNTech SE, BNTX -1.06% the people said.

So far, the regulators haven’t determined whether there is an elevated risk, the people said. The delay could be several weeks, but the timing is unclear, one of the people said.

Thursday Miscellany

David Ermer–COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Delta variant front, AHIP informs us

Today, the Food and Drug Administration (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted to unanimously (19-0) endorse a booster dose for the Moderna COVID-19 vaccine for persons:

  • 65 years of age and older;
  • 18 through 64 years of age at high risk of severe COVID-19; and
  • 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

The Moderna booster dose is 50 micrograms – half the dosage of each of the first two doses in the series.  Individuals who are immunocompromised will receive the larger dose as was administered for earlier doses, as the third dose is considered part of the original series rather than a booster. * * *

The VRBPAC will convene again tomorrow to discuss recommendations for booster doses of the Johnson & Johnson vaccine and NIH will present data on heterologous use of booster doses following primary series of the three currently authorized or approved vaccines.

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommending the Moderna and Johnson & Johnson vaccine boosters on October 20-21

Yesterday, the Equal Employment Opportunity Commission updated its COVID 19 vaccine incentive and mandate FAQ guidance for employers. The EEOC enforces the Title VII, the Americans with Disabilities Act and the Genetic Information Non-Discrimination Act among other measures. No surprises, as far as the FEHBlog can tell. Search for 10/13/2021 to find the new FAQs.

In related news, Politico reports that “President Joe Biden is likely to nominate former Food and Drug Administration Commissioner Robert Califf to return to the top role at the sweeping regulatory agency, according to four people with knowledge of the situation. * * * Califf previously served as commissioner for nearly a year in Obama’s second administration after an overwhelming vote in his favor. The White House has not finalized its decision, and the people with knowledge cautioned the situation could still change. But nine months into its search for a permanent FDA chief, Califf is now viewed as the leading candidate for the job.

In healthcare business news —

Healthcare Dive tells us that

  • UnitedHealth Group expects its planned $13 billion acquisition of data analytics firm Change Healthcare that’s been held up by DOJ review to close “in the first part of 2022,” COO Dirk McMahon told investors on a Thursday morning call.
  • The news is likely to anger hospital groups, which have raised concerns — some direct to regulators — that the deal could lower health IT competition and give its payer arm UnitedHealthcare an unfair advantage in contract negotiations.
  • The news comes as the diversified healthcare [company] beat Wall Street expectations on both earnings and revenue in the third quarter, with a topline of $72.3 billion, up 11% year over year, due to double-digit percentage growth in both UnitedHealthcare and health services business Optum. Profit was $4.2 billion, up 29% compared to the third quarter last year. As a result, Minnetonka, Minnesota-based UnitedHealth bumped its full-year guidance.

The Wall Street Journal reports that

Walgreens Boots Alliance Inc. will pay $5.2 billion to acquire a controlling stake in primary-care network VillageMD as the pharmacy chain seeks to remodel itself as a healthcare provider.

VillageMD operates more than 200 clinics where it has acquired or hired its own physicians and medical staff. Walgreens said the investment will enable it to open doctors’ offices at 600 or more of its drugstore locations by 2025, and a further 400 by 2027.

The drugstore company already owns a stake in VillageMD after agreeing last summer to pay $1 billion in equity and debt over the three years in exchange for a 30% stake in the Chicago-based startup. Under the deal announced Thursday, Walgreens will hold a 63% stake in VillageMD.

The deal is the first major strategic move under Walgreens Chief Executive Rosalind Brewer, who came to the company from Starbucks in January.

Also Thursday, Walgreens said it would acquire a majority stake in CareCentrix Inc., a Hartford, Conn.-based home health benefits manager. Walgreens said it derives 85% of its revenue from some 35 million customers who have chronic conditions such as diabetes or heart disease.

Finally, STAT News reports that

Five months ago, weight loss company Noom announced $540 million in funding, dwarfing its previous investments. With locked-down users flocking to its app, revenues in 2020 had surged to $400 million, and the company made an ambitious pitch: It would spend the money to expand its behavioral change approach to other conditions, including diabetes, hypertension, and sleep.

Now, Noom is taking its first big step toward becoming a diversified digital health company with Noom Mood, a smartphone wellness app targeted toward people with daily stress and anxiety. Like the company’s weight loss program, Mood — which the company first rolled out as a beta program last year — primarily draws on concepts from cognitive behavioral therapy. “It was kind of a no-brainer,” said Andreas Michaelides, Noom’s chief of psychology. “These concepts are really what we consider to be the gold standard with psychology.”

Midweek update

David Ermer–COVID-19 vaccine, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–

From the COLA front, FedWeek informs us that

  • A federal retirement COLA of 5.9 percent will be paid in January to those retired under CSRS and 4.9 percent to those retired under FERS who are eligible for COLAs, increases that have been neared in recent decades only twice.
  • The announcement follows completion of the count toward that adjustment with release of the September inflation figure on Wednesday (October 13), which was up 0.4 percent. * * *
  • A 5.9 increase also will be paid on Social Security benefits. That’s primarily of interest to FERS retirees, for whom Social Security is a basic part of the retirement benefit, but also of interest to CSRS Offset retirees who have Social Security coverage as part of their benefit. Also, some “pure” CSRS retirees qualify for Social Security through from military service or earnings covered under that system before, after—and in some cases from outside earnings during—their CSRS working years. In many cases those benefits are reduced by the “windfall elimination provision” however. * * *
  • Congress appears to be on track to accept a raise payout by default of President Biden’s recommendation for a 2.7 percent average raise, with 2.2 percentage points to be paid across the board and the funds for the remainder divided up as locality pay.

From the Delta variant front, MedPage Today offers an interesting article on the efforts of primary care providers to convince their reluctant patients to receive a COVID vaccine.

[Australian social psychologist Matthew] Hornsey [observed] that in a world where the institutional memory of pandemics has been lost, only the perception of vaccine risk remains. With adverse effects making headlines daily, even in mainstream outlets, it’s hard to promote a message of safety.

David M. Oshinsky, PhD, a Pulitzer Prize-winning author and professor of medicine at NYU Grossman School of Medicine in New York City, noted the sense of euphoria with the polio vaccine, dubbed at the time as “the peoples’ vaccine.”

Well put.

Also, the Food and Drug Administration (FDA) staff today released their vaccination advisory committee briefing book on the one dose Johnson & Johnson vaccine. According to the Wall Street Journal’s report

A booster of Johnson & Johnson’s Covid-19 vaccine showed signs of significantly bolstering the immune defenses of study subjects, federal health regulators said Wednesday.  The regulators cautioned, however, that data was limited and that they had to rely on J&J’s own analysis for some of the study findings, rather than conducting their own.

The committee will take up the Modern booster tomorrow and the Johnson & Johnson vaccine as well as the topic of mixing and matching different COVID boosters on Friday.

From the telehealth front, Employee Benefit News reports that

Telehealth providers have found that their platforms are uniquely suited to address gaps in pediatric behavioral healthcare and are expanding their services to adolescents. Brightline, launched just before the pandemic, offers an “on-ramp” to behavioral health services, Allen says. The platform does an intake assessment and then provides education and 30-minute coaching services for parents and their children.

“Kids are actually more resilient using technology than we expected, and now there’s a strong preference for virtual first behavioral healthcare, because of the privacy and the comfort of delivering care in your home,” Allen says. “If Brightline hired every single pediatric therapist in the entire United States, we would still have a national shortage, so we instead use these tools to figure out what’s an appropriate care pathway and measure whether they’re working.”

From the Rx coverage front, STAT News informs us that Pfizer is backing up one of its expensive lung cancer drugs Xalkori with a insurance company backed warranty.

“In reality, this is for Medicare patients,” said Susan Raiola, president of Real Endpoints, an advisory and analytics firm that tracks reimbursement issues. Why? Medicare co-pays are used toward the so-called donut hole, the term used to describe a temporary limit on what Medicare will pay to cover a drug. The co-pays can add up, though, making refunds more desirable. * * *

To what extent warranties may become commonplace remains to be seen. But the concept may find takers among drug makers marketing high-priced treatments that cost $1 million or more, because winning reimbursement is challenging, according to Emad Samad, president of Octaviant Financial, a firm that is promoting the use of warranties in the pharmaceutical industry.

“So far, no one else has done this,” Samad said of the Pfizer program. “But where warranties will really come into play will be with high-cost treatments, such as gene and cell therapies. These companies will have to change commercial paths with these $1 million to $3 million drugs. They need tools – such as even more innovative warranty structures – so that payers can get comfortable with the varied outcomes potentially transformative therapies could have.”

From the medical devices front, Healthcare Dive informs us that the “FDA has awarded the latest crop of breakthrough device designations, granting regulatory privileges to investigational products including liquid biopsy tests for Alzheimer’s disease and bladder cancer. Check out the list.

From the medical research front, the National Institutes of Health announced that “A commonly available oral diuretic pill approved by the U.S. Food and Drug Administration may be a potential candidate for an Alzheimer’s disease treatment for those who are at genetic risk, according to findings published in Nature Aging. The research included analysis showing that those who took bumetanide — a commonly used and potent diuretic(link is external) — had a significantly lower prevalence of Alzheimer’s disease compared to those not taking the drug.” Fingers crossed.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Capitol Hill front, Roll Call reports that “The House [of Representatives] cleared a temporary debt limit bill Tuesday that will buy lawmakers a little more time [at least until December 3] to negotiate a longer-term solution * * * . The House voted 219-206 to adopt a rule for floor debate on unrelated legislation that “deemed” the Senate-passed debt limit bill as having cleared that chamber. That maneuver sent the bill, which would increase the Treasury Department’s borrowing authority by $480 billion to nearly $28.9 trillion, to President Joe Biden’s desk where he’s expected to sign it this week.”

Here are a few COVID vaccination mandate tidbits for your consideration —

  • Fedweek discusses the status of the President’s mandate that federal employees receive the COVID vaccine.
  • CNBC lets us know that Boeing, which holds large defense contracts, is rolling out a COVID vaccination mandate for its 125,000 U.S. employees.
  • The Wall Street Journal reports that

The Labor Department signaled Tuesday evening that it is close to acting on President Biden’s plan to require private-sector workers get Covid-19 vaccinations or be regularly tested, a move that has drawn a mixed reaction from larger and smaller companies.

The proposed mandate, according to an earlier announcement by the Biden administration, would apply to businesses with 100 or more employees. It would be implemented under a federal rule making known as an emergency temporary standard and affect roughly 80 million workers nationwide, according to Biden administration estimates, or more than half the total U.S. workforce.

The Labor Department said its Occupational Safety and Health Administration submitted the initial text of the proposed standard to the White House for approval, signaling its final release could soon follow. The details could change during the White House review.

Also from the Delta variant front, STAT News tells us that “Food and Drug Administration scientists did not take a clear position as to whether the agency should authorize booster doses of the Moderna Covid-19 vaccine in documents released Tuesday. * * * The FDA has not made available its briefing document on the Johnson & Johnson vaccine. * * * [The briefing documents relate to the FDA vaccine advisory committee meetings scheduled for Thursday and Friday this week.] One of the most interesting topics for the meeting comes at the end of day two: the discussion of a National Institutes of Health study that examines what happens when people get a booster dose of a different vaccine than the one they originally received. Allowing such mix-and-match boosterscould make it much simpler to give people the shots in the future. It would also open the Covid-19 vaccine market up to many more players, instead of giving Pfizer and Moderna an effective lock on the market.”

In miscellaneous tidbits

  • The National Institutes of Health yesterday announced that

A commonly available oral diuretic pill approved by the U.S. Food and Drug Administration may be a potential candidate for an Alzheimer’s disease treatment for those who are at genetic risk, according to findings published in Nature Aging. The research included analysis showing that those who took bumetanide — a commonly used and potent diuretic(link is external) — had a significantly lower prevalence of Alzheimer’s disease compared to those not taking the drug. The study, funded by the National Institute on Aging (NIA), part of the National Institutes of Health, advances a precision medicine approach for individuals at greater risk of the disease because of their genetic makeup.

The research team analyzed information in databases of brain tissue samples and FDA-approved drugs, performed mouse and human cell experiments, and explored human population studies to identify bumetanide as a leading drug candidate that may potentially be repurposed to treat Alzheimer’s.

“Though further tests and clinical trials are needed, this research underscores the value of big data-driven tactics combined with more traditional scientific approaches to identify existing FDA-approved drugs as candidates for drug repurposing to treat Alzheimer’s disease,” said NIA Director Richard J. Hodes, M.D.

  • FEHB plans that offer plan brochures in Spanish may be interested to know that AHRQ has translated its medical visit question builder tool for patients into Spanish.
  • In an interesting business move, Best Buy, according to Healthcare Dive, is expanding its home healthcare business.

Best Buy is acquiring United Kingdom-based at-home care platform Current Health for an undisclosed amount, expanding its push into the health industry.

The massive consumer electronics retailer already owns two healthcare companies, and is now snapping up Current, which has a platform combining remote patient monitoring, telehealth and patient engagement. The move comes as an increasing amount of care is delivered in the home, accelerating consumers’ use of health tech.

The acquisition should allow Best Buy to play a bigger role in virtual care delivery, the company said in a blog post Tuesday. Best Buy expects the deal, which will be financed with cash, to close by the end of the fourth quarter of its 2022 fiscal year, per a filing with the U.S. Securities and Exchange Commission.

Monday Roundup

David Ermer–ACA, CDC, COVID-19, COVID-19 vaccine, U.S. Healthcare, Uncategorized–
Photo by Sven Read on Unsplash

From the Delta variant front, the New York Times reports that “The federal government is expected to take a significant step this week toward offering booster doses to a much wider range of Americans as advisers to the Food and Drug Administration meet on Thursday and Friday [this week] to discuss recipients of the Johnson & Johnson and Moderna coronavirus vaccines.”

The Times also informs us that

Merck said on Monday that it had submitted an application to the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid.

Clearance for the drug, molnupiravir, would be a milestone in the fight against the coronavirus, experts said, because a convenient, relatively inexpensive treatment could reach many more high-risk people sick with Covid than the cumbersome antibody treatments currently being used.

The Biden administration is preparing for an authorization that could come within weeks; the pill would likely to be allocated to states, as was the case with the vaccines. States could then distribute the pills how they wish, such as through pharmacies or doctors’ practices, senior administration officials said.

If the pill wins authorization, tens of millions of Americans will most likely be eligible to take it if they get sick with Covid — many more than the supply could cover, at least initially. The federal government has placed an advance order for enough pills for 1.7 million Americans, at a price of about $700 per patient. That is about one-third the price that the government is paying for the monoclonal antibody treatments, which are generally given via intravenous infusion.

Fingers crossed on the pill.

From the hospital transparency front, Fierce Healthcare assesses a New York Times analysis of hospital pricing. Fierce Healthcare finds that cash prices can be lower than prices paid by insurers.

America’s Health Insurance Plans published a statement saying the attempt to look at the data “spotlights a lot of numbers with little context” and “often compares apples and oranges.” 

Because of these complexities, the CMS rule does not help patients “shop for services” as intended, said Delphine O’Rourke, a healthcare attorney and partner at Goodwin Procter. “I, as a consumer, don’t know at the end of the day what I’m going to be responsible for,” she said. 

To O’Rourke, it’s not surprising that at times, a hospital’s cash price is lower for a service. Since people paying cash price are generally a small segment of patients, she explained, and tend to be uninsured or undocumented, hospitals structure cash pay anticipating that it will be “challenging to collect,” O’Rourke said. (Earlier this year, the Wall Street Journal found that many times, patients who pay with cash are actually charged the highest price across hospitals.) 

Be sure to listen to this week’s Econtalk episode during which Russ Roberts interviews Sam Quinones who wrote the FEHBlog’s favorite book of 2017, Dreamland. (While the book was published in 2015, the FEHBlog discovered it from a 2017 Econtalk episode.) This week Mr. Quinones discusses the tremendous impact of fentanyl on growing our opioid epidemic. He explains that dealers learned to lace fentanyl into non-addictive drugs like cocaine and meth thereby creating daily customers for them. Because Econtalk episodes last over an hour, you can find a transcript on the website. The FEHBlog has pre-ordered Mr. Quinones new book, the “Least of Us True Tales of America and Hope in the Time of Fentanyl and Meth,” which is available on Amazon for the Kindle at around nine dollars.

Weekend Update

David Ermer–Congress, Federal employment benefits, Mental health care, Telehealth–

The U.S. House of Representatives is engaged in Committee business this week following Columbus Day and the Senate is on State work break / recess. The House also is expected to vote this week on the temporary debt limit increase.

The Medicare Open Season begins on Friday October 15.

From the Federal Benefits Open Season front, Federal News Network discusses the No Surprises Act (“NSA”) which takes effect on January 1, 2022. The NSA addresses three types of surprising billing — out of network emergency care; out of network care at in-network facilities and out-of-network air ambulance services. It does not address situations where the patient chooses out of network medical or mental health care or ground ambulance services. The article appropriately concludes

Of course, these [NSA] changes shouldn’t mean federal employees toss the basic rules of choosing an appropriate health insurance plan.

[Walt] Francis suggests FEHB participants check with their doctors each year to ensure they’re planning to stay within their preferred network — and then do some research about what new benefits are coming to your current plan and the others.

The plans change every year, and nearly all insurance providers add new benefits or perks to compete with others and respond to OPM’s priorities for the FEHBP.

From the mental healthcare front, the Wall Street Journal reported last week that “Finding a therapist who takes insurance was tough before the pandemic. Now, therapists and patients say, an increase in the need for mental-health care is making the search even harder.”

Especially in big cities such as Los Angeles, New York and Washington, D.C., demand for mental-health care is so strong that many experienced therapists don’t accept any insurance plans, they say. They can easily fill their practices with patients who would pay out of pocket, they add. Therapists who do take insurance are often booked up. And in many smaller towns and rural areas, there are few mental-health professionals at all. Finding a provider who takes insurance, or lowering your rates in other ways, is possible but often takes legwork that can be draining when you are already grappling with mental-health issues.

[Among other approaches] Telehealth can provide access to a broader pool of providers, including therapists who are farther away from you. [Health plan sponsored telehealth providers are always in network.]

Insurance companies say they are trying to increase access to therapists. Anthem Inc. says it added about 2,000 additional providers to its telehealth platform during the early days of the pandemic to handle increased demand. UnitedHealth Group Inc. says it has grown its network of mental-health-care providers by 50% in the past five years to more than 260,000 nationwide.

As for therapists’ complaints of low reimbursement rates, Anthem health plans “routinely review reimbursements to ensure that providers receive market rates,” the company said in a statement. Margaret-Mary Wilson, UnitedHealth Group’s associate chief medical officer, says the company uses data on how patients are improving to financially “reward providers for delivering care with better outcomes.”

Fortune offers a fascinating article about Aetna’s preventive approach to mental health care. Among other tools the authors point out

Employee Assistance Programs (EAPs) are also valuable modes of preventing escalated mental health concerns, as they provide 24/7 life assistance across a wide range of issues that can lower risks of feeling overwhelmed, anxious or depressed. In fact, one study found that companies with EAPs see a 24% improvement in life satisfaction and a 10% reduction in workplace distress among their workers. But we need to better inform people that EAPs are more than a workplace productivity tool. Aetna’s Resources for Living, which provides EAP services,is one example of a resource that supports those facing stress and anxiety, family conflict, legal and financial issues, grief and loss and even loneliness among our Medicare members.

Federal agencies and the Postal Service offer robust employee assistance programs to their employees independent of the FEHB Program and the FEHBlog’s view OPM should put more emphasis on coordinating such related services.

Cybersecurity Saturday

David Ermer–Congress, Cybersecurity–

From Capitol Hill, the Wall Street Journal reports that “the Senate Homeland Security Committee took a step forward on Wednesday October 6], advancing a bill that would require hospitals and oil and natural-gas pipeline companies, among other critical infrastructure operators, to report cyberattacks and ransom payments within 72 hours. Chairman Gary Peters said he wants the bill tacked onto the broader annual defense authorization package.” More details on this Senate committee meeting is available on Nextgov.

On the regulatory front, the U.S. Justice Department announced on Wednesday October 6 a new Civil Cyber- Fraud Initiative that

will utilize the False Claims Act to pursue cybersecurity related fraud by government contractors and grant recipients. The False Claims Act is the government’s primary civil tool to redress false claims for federal funds and property involving government programs and operations. The act includes a unique whistleblower provision, which allows private parties to assist the government in identifying and pursing fraudulent conduct and to share in any recovery and protects whistleblowers who bring these violations and failures from retaliation. 

The initiative will hold accountable entities or individuals that put U.S. information or systems at risk by knowingly providing deficient cybersecurity products or services, knowingly misrepresenting their cybersecurity practices or protocols, or knowingly violating obligations to monitor and report cybersecurity incidents and breaches.

Cyberscoop adds that “The focus comes after suspected Russian hackers breached the federal contractor SolarWinds in 2020, using the federal contractor as a foothold into nine U.S. agencies.”

Because the False Claims Act is applicable to FEHB carriers and many FEHB subcontractors, it’s worth adding that the False Claims Act defines “knowingly” as having “actual knowledge” or acting “in deliberate ignorance” or “reckless disregard of the truth or falsity of the information.” 31 U.S.C § 3729(b)(1)(A). Courts have recognized that this is more than a mere negligence standard. E.g. United States v. Sci. Applications Int’l Corp., 626 F.3d 1257, 1274-75 (D.C. Cir. 2010) (quoting S. Rep. No. 99-345, at 6, 19 (1986)). 

It strikes the FEHBlog as unusual that the Justice Department laid out its policy without bringing a test lawsuit. However, because the False Claims Act authorizes private parties to bring False Claims Act lawsuits on behalf of the federal government (“qui tam” actions), the Justice Department may have taken this approach to alert the active qui tam bar of the Department’s support for these kinds of False Claim Act lawsuits.

From the ransomware front, Bleeping Computer reports

While most ransomware actors spend time on the victim network looking for important data to steal, one group favors quick malware deployment against sensitive, high-value targets. It can take less than two days for the FIN12 gang to execute on the target network a file-encrypting payload – most of the time Ryuk ransomware.

The group is a close partner of the TrickBot gang and targets high-revenue victims (above $300 million) from various activity sectors and regions on the globe.

FIN12 is characterized by skipping the data exfiltration step that most ransomware gangs have adopted to increase their chances of getting paid. This attribute allows the group to execute attacks at a much faster rate than other ransomware operations, taking them less than two days from the initial compromise to the file encryption stage.

According to data collected from investigations, most ransomware gangs that also steal data have a median dwell time of five days and the average value is 12.4 days.

With FIN12, the average time spent on the victim network dropped each year, getting to less than three days in the first half of 2021. After getting initial access, the group did not waste any time hitting their victims and in most cases they started activity on the same day. * * *

In a profile of the group published today [October 7] by cybersecurity company Mandiant, researchers note that many FIN12 victims are in the healthcare sector.

And here’s a link to Bleeping Computer’s The Week in Ransomware report. What’s more here’s a link to Unit 42’s first supplement to the ransomware report that issued earlier this year. This supplement focuses on ransomware families, like FIN12.