FEHBlog

Weekend Update

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

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.

Friday Stats and More

From the Centers for Disease Control’s COVID Data Tracker website, the FEHBlog’s weekly chart of new COVID cases for 2021 (using Wednesday as the last day of the week) is trending down:

The CDC’s chart of weekly chart of new hospital admissions for COVID is also trending down.

The FEHBlog’s weekly chart of new COVID deaths, a lagging indicator, also is beginning to trend down.

Meanwhile COVID vaccinations are up according to the FEHBlog’s chart (also based on CDC statistics)

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The number of COVID vaccines administered in the United States topped 400 million today. Medscape adds that

The number of Americans receiving booster shots is now outpacing those receiving their first or second initial vaccine doses.

The jump in booster shots during the past week has led to a modest increase in COVID-19 vaccinations in October, NBC News reported.

From Sept. 30 to Oct. 6, about 6.7 million total shots were administered, according to CDC data. Among those, about 2.7 million were booster shots, 2 million were second doses, and 2 million were first doses.

The FEHBlog got his Pfizer booster at a local CVS pharmacy last evening.

Here’s a link to the CDC’s Weekly Interpretative Report of COVID statistics.

In other Delta variant news

  • Medscape explains why the COVID Mu variant fizzled.
  • Nature explains why no one was awarded a Nobel prize for the mRNA COVID vaccines this year.

If the vaccines are awarded a Nobel prize, the committee will need to make some difficult decisions about whom to recognize and for what, say scientists. “I’m not surprised they held their fire,” says David Naylor, a physician-scientist at the University of Toronto, Canada. He expects the committee to look past the academic and corporate teams that developed the vaccines, and instead focus on more foundational work, such as that underlying mRNA vaccines. But even there, it’s not clear-cut who the recipients ought to be. 

“I think the mRNA vaccines are obvious candidates,” agrees Arturo Casadevall, a microbiologist at John Hopkins Bloomberg School of Public Health in Baltimore, Maryland, who notes that the vaccines’ development has deep roots in several disciplines. “I can imagine the committee taking its time to sort out which contributions to recognize since many fields contributed to their deployment.”

Working all this out takes time, Hansson says. “We want to give credit to the right people. And for the right discovery,” he says. “So stay tuned.”

  • Govexec offers an update on the VA’s COVID vaccine mandate for its employees.

Friday marked the deadline for the vast majority of Veterans Affairs Department employees to complete their COVID-19 vaccination, though more than 45,000 have yet to demonstrate that they have done so. 

Those employees may eventually face disciplinary action, including being fired, but VA is giving them 10 more days to submit the requisite documentation or request an exemption. The 380,000 VA employees working in or near the health care field faced a deadline of Oct. 8 to receive their vaccines, about six weeks earlier than the rest of the federal workforce, due to the department issuing its own mandate independently of the one put in place by President Biden. 

About 88% of the impacted workforce has so far received a shot, according to data VA has collected. 

From the Federal Benefits Open Season front, OPM today issued its annual Significant FEHB Plan Changes for 2022 benefit administration letter together with a list of those changes and a Fast Facts sheet explaining what to do if your FEHB plan is no longer participating in your locale (or anywhere) for 2022.

The Federal Times interviews retired OPM official Reg Jones about conducting a self-assessment in preparation for the Federal Benefits Open Season.

Thursday Miscellany

Photo by Juliane Liebermann on Unsplash

From Capitol Hill, Roll Call reports that

The Senate passed a temporary debt limit increase along party lines Thursday evening, a move that would give the Treasury Department at least a couple of months before it once again bumps up against its legal borrowing cap.

The 50-48 vote sent the bill to the House, where that chamber will need to clear the measure before it heads to President Joe Biden. That vote, likely next week, could be tricky given GOP opposition to the short-term patch and Democrats in that chamber barely backing a longer suspension of the debt limit late last month.

Karine Jean-Pierre, the White House’s principal deputy press secretary, said Biden “looks forward to signing” the debt limit measure after it clears.

The Senate amended the House bill, which passed 219-212, replacing a longer debt ceiling suspension with a $480 billion increase in Treasury’s borrowing cap designed to last into early December, though it may go a little longer.

The current continuing appropriations resolution is set to expire relatively contemporaneously on December 3, 2021.

From the Federal Benefits Open Season front, federal benefits consultant Tammy Flanagan has posted her first GovExec column on this year’s Open Season while GEHA, the second largest plan in the FEHB, has posted information on its 2022 benefits.

From the Delta variant front, Healthcare Dive informs us that

Pfizer and BioNTech have officially asked U.S. regulators for emergency clearance of their coronavirus vaccine in children between 5 and 11 years old, making the developers the first to seek authorization for younger kids.

Thursday’s announcement, which Pfizer made on Twitter, comes nine days after the companies said they had started submitting data to the Food and Drug Administration in support of their application, which, if authorized, could make more than 28 million children in the U.S. eligible for vaccination.

The FDA has already scheduled an Oct. 26 advisory panel to discuss the vaccine’s potential authorization in children, more and more of whom have been infected and hospitalized as the delta variant spread and the school year began. Clearance is reportedly expected in November, though the evaluation could be complicated by turnover within the agency’s vaccine review office.

From the healthcare business front —

Healthcare Dive tells us that

Total revenue of hospital M&A so far this year dipped only slightly from last year despite the number of deals being nearly cut in half, according to a Wednesday report from Kaufman Hall.

The average seller size of $659 million was well above year-to-date average going back to 2015, the earliest year featured in the report. This year’s third quarter included the Intermountain Health merger with SCL Health to create an $11 billion system and HCA’s buy of five Steward Health hospitals in Utah.

Hospitals are increasing looking outside traditional care delivery methods to diversify business models by pursuing stakes in home health, virtual care and post-acute services. They are also identifying strategic partnership with payers, physicians groups and other adjacent sectors, Kaufman Hall said.

United Healthcare’s subsidiary Optum announced a collaboration with SSM Health, a Catholic health system in the Midwest.

Together, the organizations will work to improve the overall well-being of individuals and communities – while addressing the complex social and economic factors affecting each person’s health.

SSM Health and Optum will partner across certain functions – including inpatient care management, digital transformation and revenue cycle management – to improve health outcomes and patients’ health care experiences. The organizations also will collaborate to redefine the consumer health care journey through the design and development of a seamless digital experience to simplify patient access to the care and services they need.

“Creating a new ecosystem of care requires bringing together the best and the brightest to collaborate for the common good,” said Laura S. Kaiser, FACHE, president and chief executive officer, SSM Health. “The commitment of UnitedHealth Group and Optum to improving health care experiences and outcomes for everyone aligns well with SSM Health’s Mission to ensure all people have access to high-quality, compassionate and affordable care. We are excited to partner with them to achieve our vision of transforming health care in America – and address the health equity gap for the most vulnerable in society.”

To help advance health equity, UnitedHealth Group and SSM Health will jointly invest in vital community health programs to ensure the disadvantaged and vulnerable have equal access to quality health care services. These efforts will focus on closing the health equity gap and critical health priorities in the communities SSM Health serves throughout the Midwest.

Medcity News reports that

Primary and urgent care provider Carbon Health is expanding its service offerings with a new acquisition.

The San Francisco-based company has bought Alertive Healthcare, a remote patient monitoring provider, for an undisclosed sum. Alertive Healthcare provides a suite of RPM tools across a range of specialties, including primary care, cardiology, neurology and nephrology. * * *

Carbon Health launched in 2015 and has raised upwards of $522 million in funding, according to Crunchbase. Its goal is to become the “Starbucks of healthcare.”

As of August, Carbon Health operated 83 clinics across 12 states following its acquisition of Tucson, Arizona-based Southern Arizona Urgent Care and Sacramento, California-based Med7 Urgent Care.

From the telehealth front, Healthcare Dive reports that

Teladoc Health on Wednesday announced it is making its virtual primary care pilot broadly available to commercial health plans, employers and other benefits sponsors nationwide.

The Primary360 service, which the New York-based telemedicine giant has been piloting for the past few years, is currently being used by several large companies, and will be available through CVS Health-owned payer Aetna early next year, Teladoc said in a release.

The vendor hopes Primary360 will serve as an access point to the primary care system while enticing patients to its other services like specialty care and mental health to boost business.

From the miscellany department, Healthcare Dive interviewed the CEO of Morgan Health.

The mission of J.P. Morgan’s new healthcare venture is to innovate employer-sponsored healthcare, not just for the investment bank’s massive employee base but eventually for all 150 million Americans receiving coverage through their job. But it’s a lofty goal for the small business unit, called Morgan Health, launched late May, and there are many skeptics of efforts from major employers looking to disrupt the deep-rooted and complex healthcare industry.

Check it out.

Midweek Update

From Capitol Hill, the Wall Street Journal reports that

Senate Democrats were poised to accept a GOP proposal to defer the showdown over the debt ceiling until later this year, lawmakers said, as administration officials and corporate executives issued dire warnings about the dangers of a possible government default.

The proposed agreement would extend the debt ceiling into December, provided that Democrats affix a dollar amount to the debt level. A deal could pave the way for a procedural vote in the Senate soon, to be followed by final passage sometime later this week. The House will still have to pass the legislation, which is expected to be signed into law by President Biden.

OPM Director Kiran Ahuja was interviewed today for a Washington Post Live online event. Ms. Ahuja principally discussed implementing the COVID vaccine mandate for the federal workforce and implementing the President’s June 2021 executive order on enhancing diversity, equity and inclusion in the federal workforce.

From the Delta variant front, David Leonhardt in the New York Times posted another column on the need for more rapid COVID tests in our country.

If you wake up with a runny nose or scratchy throat, you should be able to grab a Covid-19 test from your bathroom shelf and find out the result within minutes. The tests exist. They are known as antigen tests and are widely available not only in Britain but also France, Germany and some other places. Rapid tests can identify roughly 98 percent of infectious Covid cases and have helped reduce the virus’s spread in Europe.

In the U.S., by contrast, rapid tests are hard to find, because the Food and Drug Administration has been slow to approve them. F.D.A. officials have defended their reluctance by saying that they need to make sure the tests work — which they certainly do. But many outside scientists have criticized the agency for blocking even those antigen tests with a demonstrated record of success in other countries. * * *

[At long last,] The F.D.A. announced Monday that it would allow the sale of an antigen test known as Flowflex. The test has been available in Europe but not here, even though the company that makes it — Acon Laboratories — is based in San Diego.

The decision suggests that the F.D.A. has become willing to approve other rapid tests too, Alex Tabarrok, an economist at George Mason University and an advocate of expanded testing, told me. Separately, the Biden administration plans to announce an expansion of rapid testing today, a White House official told me last night. It will be a $1 billion government purchase of tests, meant to accelerate their production, on top of other money the administration has already dedicated to rapid tests.

[I]t is not too late for rapid tests to improve day-to-day life. The Biden administration finally seems to be taking significant steps in that direction.

From the health equity front, Becker’s Payer Issues tells us that

United Health Foundation’s “America’s Health Rankings 2021 Health of Women and Children Report” report cites an increase in maternal mortality and a decrease in women and child physical activity.

The annual report from the UnitedHealth Group’s philanthropic arm, shared in an Oct. 6 announcement, called out a range of physical and behavioral health trends among women and children.

Among key findings is a 16 percent spike in average maternal mortality, shifting from 17.4 deaths per 100,000 births to 20.1 deaths. Florida was the state with the highest jump, up 70 percent to 26.8 deaths per 100,000 births.

Physical activity in children and women is also down, with only 20.6 percent of children and 21.5 percent of women meeting federal physical activity standards, according to the report. 

The report’s executive summary also pointed to rising mental health burdens on youths, including a 1.6 percentage point increase in childhood anxiety. Teen suicide is up 26 percent over 2014-2016 numbers to 11.2 deaths per 100,000 adolescents. 

Women also experienced 14 percent increased mental distress over 2016-2017 numbers

Health Affairs digs deeper into the maternal mortality issue and finds using data from fourteen state Maternal Mortality Review Committees (MMRCs) over the period 2008–17 that

Among 421 pregnancy-related deaths with an MMRC-determined underlying cause of death, 11 percent were due to mental health conditions. Pregnancy-related mental health deaths were more likely than deaths from other causes to be determined by an MMRC to be preventable (100 percent versus 64 percent), to occur among non-Hispanic White people (86 percent versus 45 percent), and to occur 43–365 days postpartum (63 percent versus 18 percent). Sixty-three percent of pregnancy-related mental health deaths were by suicide. Nearly three-quarters of people with a pregnancy-related mental health cause of death had a history of depression, and more than two-thirds had past or current substance use. MMRC recommendations can be used to prioritize interventions and can inform strategies to enable screening, care coordination, and continuation of care throughout pregnancy and the year postpartum.

From the Rx front, MedPage Today reports that

A national antibiotic stewardship program at ambulatory care centers was associated with reduced antibiotic prescribing during the pandemic, both overall and for acute respiratory infection (ARI) cases, researchers found.

In an analysis involving nearly 300 practices who took part in the Agency for Healthcare Research and Quality’s (AHRQ) program for improving antibiotic use, there were nine fewer antibiotic prescriptions for every 100 visits by the end of the intervention (95% CI -10 to -8), as well as 15 fewer prescriptions for every 100 ARI-related visits (95% CI -17 to -12), reported Sara Keller, MD, MPH, MSPH, of Johns Hopkins University in Baltimore. * * *

AHRQ’s Safety Program for Improving Antibiotic Use is a national program that involves presentations, webinars, patient handouts, and other educational tools (including the Four Moments of Antibiotic Decision Making tool) and emphasizes three key areas for clinicians: developing and improving antibiotic stewardship; learning strategies for discussing antibiotic prescribing with colleagues, patients, and their families; and best practices for diagnosing and managing common infectious syndromes, as well as allergies to antibiotic.

Fierce Healthcare informs us about a recently established prescription drug manager “Prescryptive Health, a blockchain-powered prescription data platform.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From the Delta variant front

  • The New York Time reports that “Johnson & Johnson on Tuesday morning asked federal regulators to authorize a booster shot for adults, becoming the third coronavirus vaccine manufacturer to do so.”
  • Fierce Healthcare tells us that

AstraZeneca has taken another step toward bringing its COVID-19 antibody cocktail to market, filing for emergency use authorization of the long-acting candidate in coronavirus prophylaxis in the U.S. 

Last month, AstraZeneca delivered evidence that the candidate prevents COVID-19 in people who are unlikely to respond well to vaccines, bouncing back from an earlier failure to report a 77% reduction in the risk of symptomatic coronavirus infection. With all three cases of severe COVID-19 happening in the placebo cohort, AstraZeneca emerged from the study with evidence that it can protect some of the most vulnerable people from the coronavirus.

“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” Mene Pangalos, executive vice president for biopharmaceuticals R&D at AstraZeneca, said in a statement. 

In his final National Institutes of Health Director’s blog today. Dr. Francis Collins optimistically supports his opinion that most COVID vaccine hesitant people are willing to change their minds. “Over the course of this pandemic, hesitancy has decreased, and many who initially said no are now getting their shots. Many others who remain unvaccinated lean toward making an appointment. The findings come from Aaron Siegler and colleagues, Emory University, Atlanta.”

Dr. Collins today submitted his resignation from his position as NIH Director following over 12 years in that role. His statement reads in part “It has been an incredible privilege to lead this great agency for more than a decade,” said Dr. Collins. “I love this agency and its people so deeply that the decision to step down was a difficult one, done in close counsel with my wife, Diane Baker, and my family. I am proud of all we’ve accomplished. I fundamentally believe, however, that no single person should serve in the position too long, and that it’s time to bring in a new scientist to lead the NIH into the future. I’m most grateful and proud of the NIH staff and the scientific community, whose extraordinary commitment to lifesaving research delivers hope to the American people and the world every day.” Good luck, Dr. Collins, who will continue working in his genetics laboratory.

From the COVID vaccine mandate front, the Safer Federal Workforce Taskforce released more FAQs on the vaccine mandate for federal employees yesterday. Federal News Network summarizes those FAQs here:

Employees have a few more details about what they should expect if they’re planning to declare a medical or religious exception to the Biden administration’s recent federal vaccine mandate.

Employees who have previously had COVID-19 must receive the vaccine, the Safer Federal Workforce Task Force clarified Monday night in another round of frequently asked questions. The task force had previously made such a statement in guidance to contractors, not federal employees.

The Biden administration didn’t detail exactly what kinds of medical or religious reasons might grant an employee an exception to the federal vaccine mandate, but it did offer more hints about what employees might expect if they pursue that route.

More significantly in the FEHBlog’s view, Federal News Network reports that the Defense Department has “issued its guidance for civilian employees on Monday, giving workers [until November 22] to get inoculated.” In order to achieve this goal an employee must have received the Johnson & Johnson one dose vaccine or both doses of the Pfizer or Moderna by November 8 because the full vaccination status accrues two weeks are being fully vaccinated.

From the mergers and acquisitions front, Becker’s Hospital Review tells us that “More than three years after signing a letter of intent to merge [and overcoming regulatory challenges], Jefferson Health and Einstein Healthcare Network have finalized the deal. The combination of the Philadelphia-based organizations brings together two academic medical centers and creates an integrated 18-hospital system with more than 50 outpatient and urgent care locations.”

From the tidbits department:

Allowed in-network charges for fixed-wing air ambulances rose 76% between 2017 and 2020, and now top $15,000, a new study by Fair Health found. The average charge rose 27.6% during the same time period, to more than $24,500 from little more than $19,200. For helicopter transports, the average allowed charge rose 60.8%, from just over $11,600 to more than $18,600.

Meanwhile, the average Medicare reimbursement rose much less dramatically between 2017 and last year, and represents just a fraction of what commercial insurers are charged for air ambulance transports.

Demand may be part of the equation. Fair concluded that air ambulance claims rose 30% between 2016 and 2020. The leading reasons for such transports are digestive issues, heart attacks and bone breaks or fractures. The states with the largest volumes of fixed-wing air transports are rural: Alaska, Wyoming, South Dakota, Montana and New Mexico. For helicopters, it’s Idaho, South Dakota, New Mexico, West Virginia and Wyoming.

  • Health Payer Intelligences delved into the American Medical Association’s annual report on health insurer competition. Kaiser Permanente joined UnitedHealthcare, Anthem, Aetna, and Cigna in the top five.
  • Health Payer Intelligence also tells us that

A new study finds that while telehealth has surged during the pandemic, providers haven’t solved many of the issues that kept adoption low prior to COVID-19.

J.D. Power’s 2021 US Telehealth Satisfaction Survey, released this week, saw a surge in telehealth use from 7 percent in 2019 and 9 percent in 2020 to 36 percent in 2021, reflecting the shift to virtual care as the nation grappled with COVID-19. But the consumer advisory company’s third annual survey also saw a decrease in patient satisfaction, driven by complains over limited services (24 percent), lack of awareness on costs, confusing technology requirements and lack of information about care providers (all at 15 percent).

The more things change, etc.

It’s one of the biggest market failures in modern medicine. The lack of a widely shared data language is effectively blocking adoption of innumerable software applications designed to make health care cheaper, more effective, and personal.

On Tuesday, three large health systems formed a new nonprofit company to fill that gap. The venture, dubbed Graphite Health, is seeking to build an App-Store-like marketplace where digital health entrepreneurs can sell their software tools, and hospitals and consumers can more easily buy and implement them.

Its founders, including Intermountain Healthcare of Utah, previously launched CivicaRX, another hospital-led nonprofit built to create a cheaper, more reliable supply of generic medicines. If it gains the same level of uptake, Graphite could essentially eliminate the long and costly process of vetting and customizing software that hospitals use to do everything from selecting the best treatments for patients to managing their beds and operating rooms. It will also offer a range of apps for patients.

Monday Roundup

Photo by Sven Read on Unsplash

From the COVID variant front, David Leonhardt writes in the New York Times as follows:

Covid-19 is once again in retreat.

The reasons remain somewhat unclear, and there is no guarantee that the decline in caseloads will continue. But the turnaround is now large enough — and been going on long enough — to deserve attention.

These declines are consistent with a pattern that regular readers of this newsletter will recognize: Covid’s mysterious two-month cycle. Since the Covid virus began spreading in late 2019, cases have often surged for about two months — sometimes because of a variant, like Delta — and then declined for about two months. * * *

The recent declines, for example, have occurred even as millions of American children have again crowded into school buildings. * * *

I need to emphasize that these declines may not persist. Covid’s two-month cycle is not some kind of iron law of science. * * *

Eventually, immunity will become widespread enough that another wave as large and damaging as the Delta wave will not be possible. “Barring something unexpected,” Dr. Scott Gottlieb, a former F.D.A. commissioner and the author of “Uncontrolled Spread,” a new book on Covid, told me, “I’m of the opinion that this is the last major wave of infection.”

The New York Times reports that

Johnson & Johnson is planning to ask federal regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least the elderly and other high-risk groups need more protection.

NBC Boston discusses where the regulators stand in terms of approving a Moderna booster. Moderna submitted its emergency use application on September 1. “Adding to the complexity of further decisions on booster shots, Moderna wants its third dose to be half of the original shots.”

The Food and Drug Administration announced

[issuing] an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. This action highlights our continued commitment to increasing the availability of appropriately accurate and reliable OTC tests to meet public health needs and increase access to testing for consumers.

Today’s authorization for the ACON Laboratories Flowflex COVID-19 Home Test should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks. By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.

The manufacturer’s press release adds that

The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test which will soon be available for purchase without a prescription in major retail stores and online. It may be used for self-testing by individuals aged 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.

In contrast to other home tests which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms. This will allow for the distribution of more affordable single-test packaging, resulting in greater access to home testing.

Flowflex COVID-19 tests are already available in many countries outside the U.S., including widespread distribution in the UK through the National Health Service (NHS). The international popularity of this test has led ACON to greatly expand global production capacity at multiple manufacturing sites. This emergency use authorization will now allow ACON to quickly respond to the unmet demand for simple and inexpensive home diagnostics as a critical tool in the fight against COVID-19.

STAT News discusses the pricing considerations for Merck’s pill under development to treat COVID at its symptomatic onset. The article notes

Last June, the U.S. government signed a $1.2 billion deal with Merck for 1.7 million doses, which works out to a $712 unit cost for a five-day treatment course, according to the contract. This assumes the U.S. Food and Drug Administration will authorize emergency use of the pill. Separately, the company has indicated there are plans to produce 10 million doses by the end of this year.

This action suggests to the FEHBlog that Merck can charge a substantially lower price for subsequently manufactured pills.

In today’s column David Leonhardt reminds us that COVID has been a national tragedy, which is unquestionably true in the FEHBlog’s opinion. In that regard, Kaiser Health News explains how COVID deaths have struck rural, black, Hispanic, and Native Americans harder than others which also happens to be the pattern of opioid pandemic deaths as the FEHBlog recalls.

From the COVID regulatory front, the federal departments that regulate the Affordable Care Act and related laws issued ACA FAQ 50. AHIP helpfully explains

The first two FAQs address the recent ACIP and CDC announcements regarding booster doses. The FAQ is intended to notify plans and issuers that the December 12, 2020 ACIP recommendation is the applicable recommendation for purposes of the definition of qualifying coronavirus preventive services under section 3203 of the CARES Act and its implementing regulations.

Plans must cover COVID-19 vaccines and their administration, without cost sharing, immediately once the particular vaccine becomes authorized or approved under an Emergency Use Authorization (EUA) or approved under a Biologics License Application (BLA). This coverage must be provided consistent with the scope of the EUA or BLA for the particular vaccine, including any EUA or BLA amendment, such as to allow for the administration of an additional dose to certain individuals, administration of booster doses, or the expansion of the age demographic for whom the vaccine is authorized or approved.

The prior Q8 in FAQs Part 44 is superseded to the extent it provides that the coverage requirement effective date is related to the vaccine-specific recommendations of ACIP.

In response to stakeholder questions around COVID-19 vaccine incentives and surcharges, the Departments released three FAQs:

Premium discounts for COVID-19 vaccinations are permitted if they comply with applicable wellness program regulations including the requirement to provide a reasonable alternative standard to qualify. The vaccine incentive program must not exceed 30 percent of the total cost of employee-only coverage and must give individuals eligible for the program the opportunity to qualify for the reward under the program at least once per year.

Plans and issuers may not discriminate in eligibility for benefits or coverage based on whether or not an individual obtains a COVID-19 vaccination.

Wellness incentives that relate to the receipt of COVID-19 vaccinations are treated as not earned for purposes of determining whether employer-sponsored health coverage is affordable. However, vaccine surcharges would not be disregarded in assessing affordability.

The FEHBlog had called attention to the 15 day deadline for plans to convert their systems to accomodate the new vaccine. The regulators have removed that grace period which likely reflects COVID reality.

Also, Becker’s Hospital Review informs us that “To clear up a lot of misinformation surrounding COVID-19 vaccines and HIPAA, HHS published guidelines Sept. 30 for employees and employers to better understand the privacy rule.”

Weekend Update

Thanks to ACK15 for sharing their work on Unsplash.

This coming week, the U.S. House of Representatives will engage in Committee business and the Senate will engage in both Committee business and the Senate will engage in Committee business and floor voting. Roll Call explains that “President Joe Biden told House Democrats on Friday to hold off on his bipartisan infrastructure bill until they reach agreement on a scaled-back partisan tax and spending package funding the rest of his economic agenda.”

The U.S. Supreme Court opens its October 2021 term tomorrow. Two Affordable Care Act Section 1557 (individual non-discrimination law) cases will be argued this calendar quarter.

On the Delta variant front, the Wall Street Journal reports that

The cost of similar Covid-19 treatments can vary by tens of thousands of dollars a patient, even within the same hospital, according to a Wall Street Journal analysis of pricing data that indicates pandemic care hasn’t escaped the complex economics of the U.S. health system.

One kind of patient, with a type of severe respiratory condition that is common among those admitted with Covid-19, is an example of the wide range. The rates for these patients usually spanned from less than $11,000 to more than $43,000, the analysis found, but some prices could be far higher, depending on the severity of the case.

Federal News Network informs us that

The Office of Personnel Management on Friday offered up more details on how agencies might approach disciplinary action against employees who fail to comply with the Biden administration’s recent federal vaccine mandate.

Because employees aren’t considered fully vaccinated until two weeks after receiving a single-shot series or the second dose of a two-shot series, they must get the vaccine by Nov. 8 to comply with the federal mandate.

Therefore, agencies can begin the disciplinary process for employees who are unvaccinated by Nov. 8 on the following day, Nov. 9, OPM Director Kiran Ahuja said Friday in a new memo.

On the No Surprises Act front, Prof. Katie Keith and her colleagues delves into the details of the second interim final rule on the NSA which concerns the independent dispute resolution process.

On the newly opened Federal Benefits Open Season front, the FEHBlog notes that Blue Cross FEP and Kaiser Permanente have posted information about 2022 benefits on their respective websites. Here’s a belated link to OPM’s announcement of 2022 premiums from last Thursday.

On a related note Healthcare Dive informs us that

Average Medicare Advantage premium rates are dropping 10% to $19 a month next year as nearly 30 million people are expected to be enrolled in the program, an increase of about 2.6 million from this year, CMS said in a Thursday press release.

Cigna and UnitedHealthcare are expanding their MA footprints. Cigna is going into three new states and increasing its geographic coverage by 30%. UnitedHealthcare is entering 276 new counties, giving it access to 94% of Medicare members.

Analysts at Cowen said in a note Friday that after reviewing benefits for the three largest plans from top insurers, it saw stability to modest improvements. That indicates conservative bids among the uncertainty of the COVID-19 pandemic.

Open enrollment for Medicare runs from Oct. 15 to Dec. 7.

Cybersecurity Saturday

October is National Cybersecurity Awareness Month. The FEHBlog reminds readers that

CISA will host its fourth annual National Cybersecurity Summit on Wednesdays during the month of October. The 2021 Summit will be held as a series of four virtual events bringing stakeholders together in a forum for meaningful conversation:

Oct. 6 – Assembly Required: The Pieces of the Vulnerability Management Ecosystem 

Oct. 13 – Collaborating for the Collective Defense 

Oct. 20 – Team Awesome: The Cyber Workforce 

Oct. 27 – The Cyber/Physical Convergence

Register for this free summit and read more about the presentations at CISA.gov/cybersummit2021

Security Week offers an article on ways to support this national effort.

Also yesterday, October 1, according to ZDNet,

The White House plans to convene a 30-country meeting this month to address cybersecurity, President Biden said in a statement Friday. 

The topics of the meeting, Biden said, will include combating cybercrime, improving law enforcement collaboration, stemming the illicit use of cryptocurrency, building trusted 5G technology and better securing supply chains. 

From Capitol Hill, Senator Gary Peters (D Mich.) tells us about American Rescue Plan funding totaling $1 billion that is being used to modernize federal IT systems. Here is a complete list of the unclassified Technology Modernization Funds projects.

With respect to cybersecurity practices

  • Earlier this week, CISA and the National Security Administration “released the cybersecurity information sheet Selecting and Hardening Standards-based Remote Access VPN Solutions to address the potential security risks associated with using Virtual Private Networks (VPNs). Remote-access VPN servers allow off-site users to tunnel into protected networks, making these entry points vulnerable to exploitation by malicious cyber actors.” Here is a Cyberscoop article on this development.
  • Helpnetsecurity.com offers an interesting article about the move from password verification to identity verification to secure networks against cyberattacks. “Identity verification is the most important step in an organization’s system for providing access, and authentication cannot occur until identity is established. This is known as identity-based authentication and it is the foundation of effective security measures. Once identity is established with a high level of efficacy, password-based credentials become obsolete. The end goal is not passwordless solutions – the goal is identity-based authentication, with passwordless as a means to that end.”
  • The National Institute of Standards and Technology issued its 2020 annual report (SP 800-214) last week.

As always, here is a link to Bleeping Computer’s The Week in Ransomware.

Friday Stats and More

Using the CDC’s COVID Data Tracker and Wednesday as the last day of the week, here is the FEHBlog’s latest weekly chart of weekly COVID cases for 2021 through the 39th week (September 29, 2021):

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

Here is the FEHBlog’s latest weekly chart of new COVID deaths this year:

Medscape notes that “COVID-19 deaths are beginning to plateau in the US, adding another promising sign that the latest coronavirus surge has peaked. The 7-day average of daily deaths has hovered around 2000 for more than a week and dropped below 1900 on Thursday. The trend follows a 2-month climb in deaths as the Delta variant hit unvaccinated populations, particularly in Arkansas, Florida, and Louisiana. * * * COVID-19 cases began to level off nationally in early September, and hospitalizations and deaths have followed a similar trend several weeks later.”

Here is the FEHBlog’s latest weekly chart of COVID vaccinations distributed and administered in 2021:

The CDC reports that as of today 65% of the eligible U.S population (over age 12) and 84% of the U.S population over age 65 is fully vaccinated. The CDC COVID Data tracker now is displaying booster administration. For example, 6% of the fully vaccinated population over age 65 has received a booster.

Health Leaders Media reports on stakeholder reaction to the No Surprises Act interim final rule on the independent dispute resolution process. AHIP’s President Matt Eyles remarked that the final rule

“signals a strong commitment to consumer affordability and lower healthcare spending through an independent dispute resolution process that should encourage more providers to join health plan networks.”

“We are particularly encouraged to see the rules conform to the intent of the No Surprises Act and direct that arbitration awards must begin with a presumption that the appropriate out-of-network reimbursement is the qualified payment amount,” Eyles said.

“This is the right approach to encourage hospitals, health care providers, and health insurance providers to work together and negotiate in good faith. It will also ensure that arbitration does not result in unnecessary premium increases for businesses and hardworking American families.”

The FEHBlog’s take is that the interim final rule protects consumers while controlling the cost of care. After all, the surprise was not receiving out of network care; rather the suprise was the eye popping bill.