Weekend update

Congress

Weekend update

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

The U.S. House of Representatives and the Senate again will be engaged in Committee business and floor voting this week. According to the Hill, the House leadership is aiming to vote on the massive social spending / budget reconciliation bill next Sunday October 31. “We have 90 percent of the bill agreed to and written. We just have some of the last decisions to be made,” [Speaker Nancy] Pelosi said on CNN’s “State of the Union.”

From the Delta variant front —

  • Bloomberg reports that “Top U.S. health officials signaled confidence that children ages 5 to 11 will begin getting Covid-19 vaccines by early November. The Pfizer vaccines will likely be given at pediatricians’ offices rather than at pharmacies or large sites.”
  • Medpage Today informs us that “The CDC has begun to provide weekly data on COVID-19 cases and deaths by vaccination status, illustrating the stark differences between those who have received the shots and those who haven’t — and even revealing some differences [among] vaccines.”
  • Precision Vaccinations discusses the likely evolution of the fully vaccinated against COVID definition in our country.

From the healthcare business front —

  • Healthcare Dive tells us that Lyft named Buck Poropatich as its new head of healthcare, according to an email statement sent Friday. Poropatich joined the company in 2019 and previously served as the director of healthcare strategy. * * * The ride-hailing giant wants to continue capitalizing on non-emergency medical transportation, and Poropatich has been instrumental in that expansion, along with finding new use cases in the sector, Lyft said.”
  • Fierce Healthcare reports that “Consumer genetic testing company 23andMe plans to buy Lemonaid Health, a virtual care and pharmacy provider, to integrate its personalized genetics service more deeply into primary care. 23andMe, which went public in June via a merger with Richard Branson’s blank check company, will pay $400 million for Lemonaid Health, with 25% of the purchase price in cash and the rest in shares of 23andMe. The acquisition is expected to close by the end of 2021. The acquisition adds Lemonaid Health’s telemedicine and prescription drug delivery services to 23andMe’s consumer business.”
  • Health Dive also lets us know that “Oak Street Health, a value-based primary care network for seniors, has acquired virtual specialty provider RubiconMD for $130 million, integrating specialty care into its existing care model. New-York based RubiconMD offers a platform providing access to medical specialists across 230 specialties, including cardiology, nephrology and pulmonology. The deal, announced Thursday, comes as major U.S. clinical networks increasingly build out their suite of services to jockey for employer and payer clients in the increasingly competitive space.”
  • Mobihealth News reports that “Virtual addiction treatment Workit Health raised $118 million in Series C funding led by Insight Partners. Other investors participating in the round include CVS Health Ventures, FirstMark Capital, BCBS Venture Fund, and 3L Capital. ‘Workit is at the forefront of massive acceleration in telemedicine adoption, which is key to solving the overdose crisis that was exacerbated by COVID-19. The risk factors associated with substance use have dramatically increased,’ Lisa McLaughlin, Workit Health’s co-CEO, said in a statement.  ‘This latest funding round helps us grow our relationship-based, telehealth-first, value-based approach into new regions that are in desperate need of simple and trusted solutions like Workit.’

Last Friday, the FEHBlog spoke with a group of federal annuitants at a client’s membership conference. Suffice it to say the FEHBlog thinks it is important for plans to promote OPM’s FEHB Fast Facts on FEHB and Medicare on their websites.

Last Thursday, the FEHBlog post about an OPM edit to Section 3 of the 2022 FEHB Significant Events Changes benefit administration letter. The FEHBlog noticed that he unintentionally cut off the copy of the edited section of the BAL. For that reason, here is a link to a complete copy of the revised BAL. Lo siento readers.

Thursday Miscellany

David Ermer–Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, HIPAA Privacy and Security Rules, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From the Delta variant front, AHIP informs us that

Today, the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) convened its final day of a scheduled meeting to discuss and vote on recommendations for booster doses of the Moderna and Janssen (Johnson & Johnson) COVID-19 vaccines, and to review data from the National Institutes of Health on mix-and-match booster doses.

The Committee unanimously voted (15-0) to approve the use of a single COVID-19 vaccine booster dose as follows:

1. Single booster dose of Moderna COVID-19 vaccine to be administered at least 6 months after completion of the primary series for individuals:

2. Single booster dose of the Janssen COVID-19 vaccine to be administered at least 2 months after completion of the primary regimen to individuals 18 years and older

3. Use of each of the available COVID-19 vaccines can be used as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine

Data presented by Moderna showed a slow decline in neutralizing antibodies generated from the primary series over time.  Data from Janssen showed lower overall vaccine effectiveness compared to those who received an mRNA vaccine, and that evidence is not sufficient to determine if vaccine effectiveness is waning.

ACIP evaluated the benefits and risks of a booster dose for both the Moderna mRNA vaccine and for the Janssen vaccine.  The booster dose for the Moderna vaccine is half the dosage of the primary series shots, while those receiving a Janssen booster will receive the same dosage as the primary series.  CDC recommends that people receiving a booster dose receive the same vaccine as the primary series unless unavailable or another product is preferred.  Today’s vote created the pathway for heterologous booster doses for all vaccines, following FDA authorization yesterday.

The Committee also reviewed updates on the safety of all approved COVID-19 vaccines regarding incidences of myocarditis, pericarditis, and thrombocytopenia (TTS) and found no increased rates of these serious adverse events following additional booster doses of the vaccines. The data indicated that serious side effects for all vaccines are extremely rare. More research needs to be done on the safety of heterologous vaccine administration.

The final stop for these recommendations is the CDC Director Rochelle Walensky. The Wall Street Journal reports that Dr. Walensky approved the Committee’s recommendations this evening.

STAT News points out

When the [COVID] shots arrived late last year, the message from health officials was simple: Get vaccinated when you become eligible, and get whichever jab is offered to you. But with boosters becoming available for select groups of people, and a lower-dose shot for young children expected shortly, the campaign is moving from a simple set of instructions to more of a messy flow chart for people organizing and delivering the jabs. * * *

Sorting all this out will fall to pharmacies, immunization programs, pediatricians, and vaccine administrators, many already stretched thin, who will also have to track inventory and try to minimize waste. It will be a quick turnaround, as well: As soon as the CDC checks the final box for boosters with its recommendations, people will start demanding them.

Under ACA FAQ 50 issued October 4, 2021, health plans must immediately begin to cover administration of these boosters without member cost-sharing.

From the vaccine mandate front, Federal News Network reports that

A memo released by the Defense Department states that civilian [employees] will ultimately be fired from their jobs if they are not fully vaccinated. DoD wants all of its civilians to get the shot and go through the required waiting period for antibodies to flourish by Nov. 22.

DoD civilians who refuse to get the shot will go through “progressive enforcement actions,” the first of which is a five-day counseling and education period.

If an employee is still recalcitrant, they will be suspended without pay for less than 14 days. If the refusal continues, DoD will then terminate the employee for “failing to follow a direct order.”

The memo states that DoD will designate officials to handle the disciplinary process and “ensure consistent application of disciplinary measures.”

There are some exceptions to the rule. DoD will provide waivers to those who cannot get the vaccine due to medical conditions or for religious reasons. Further guidance will be available soon on the exceptions and DoD is currently not taking any action on exemption requests.

From the FEHB Open Season front, OPM made the following edit to its FEHB 2022 Significant Events chart:

StateFEHB CarrierPlan NameTerminatingOptions (endof 2021)TerminatingCodes (end of2021)Automatic EnrollmentOption and Codes for2022
IndianaHumana Health Plan,Inc.Humana Health Plan,Inc.HighLouisvilleMetropolitan areaMH1, MH3, MH2StandardLouisville Metropolitanarea – MH4, MH6, MH5
IndianaHumana Health Plan of Ohio, Inc.Humana Health Plan of Ohio, IncHighA61, A63, A62BasicW61,W63,W62
KentuckyHumana Health Plan of Ohio, Inc.Humana Health Plan of Ohio, Inc.HighA61, A63, A62Basic W61,W63,W62

From the federal employment benefits front, Reg Jones in Fedweek discusses death benefits available to surviving beneficiaries following a federal annuitant’s post-retirement death.

From the HLTH2.0 conference, Healthcare Dive provides more Amazon Health news and Fierce Healthcare discusses how to attract younger health plan members.

From the the Capitol Hill front, Healthcare IT News explains that why this may be the year that Congress finally restores funding for a HIPAA patient identification number. Fingers crossed.

Tuesday’s Tidbits

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

From the Delta variant front —

  • The Centers for Disease Control reported today on a study finding that “Among hospitalized U.S. patients aged 12–18 years, vaccine effectiveness of 2 doses of Pfizer-BioNTech vaccine against COVID-19 hospitalization during June–September 2021, was 93% (95% confidence interval = 83%–97%).”
  • The Wall Street Journal tells us that General Electric Co., Union Pacific Corp. and other large U.S. employers are imposing Covid-19 vaccine mandates for their workers to comply with a Dec. 8 deadline set by the Biden administration for companies that are federal contractors. The FEHBlog expects that these companies understandably are taking this approach without prodding from the government contracting officers in order to avoid the OSHA vaccination screening program.
  • David Leonhardt in this morning’s New York Times, wrote about the death of General Colin Powell, who was a great American leader. He points out that

Colin Powell’s death at 84 underscores the continuing risk that Covid-19 presents to older people — even if they are fully vaccinated, as Powell was. For vaccinated Americans in their 70s and 80s, Covid remains more dangerous on average than many other everyday risks, including falls, choking, gunshot wounds or vehicle accidents. * * *

If cases return to their low levels of the spring and early summer, deaths among older adults will probably plummet as well. 

He also encourage older folks to get the COVID booster, which is happening, and the country to expand rapid COVID tests. He concludes

For most Americans, vaccination makes the risk of a serious form of Covid extremely rare. And for children, Covid tends to be mild even without vaccination. But until caseloads decline more, the situation remains frightening for many older people.

From Capitol Hill, the Federal New Network discusses the Senate Budget Committee’s release of the majority’s appropriations bills yesterday.

For federal employees, the draft bills from Senate Democrats are noticeably silent on a pay raise for civilian workers next year.

In their silence, Senate appropriators have essentially deferred to the plan President Joe Biden presented to Congressearlier this year. That plan called for a 2.2% across-the-board pay increase for federal employees, with an additional 0.5% in locality adjustments to total, on average, a 2.7% raise for 2022.

Neither the House nor Senate appears interested in legislating their own federal pay raise for civilian employees next year, making Biden’s planned 2.7% increase all the more likely.

From the waste front, UPI reports that

Medicare spent nearly $600 million over a three-year period to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease for which the Food and Drug Administration approved them, an analysis published Monday by JAMA Internal Medicine found.

More than $170 million of this spending was for products voluntarily withdrawn by their manufacturers after clinical trials showed that they did not improve overall survival in people with various types of cancer, including breast and lung as well as liver and urinary tract cancers, the data showed.

From the over the counter front, Healthcare Dive reports that

  • “FDA proposed a rule creating a new category of over-the-counter hearing aids, allowing the products to be sold directly to consumers in stores and online without a medical exam or being fitted by an audiologist.
  • “The agency’s proposal is meant to increase competition in the lucrative hearing aid market and improve access to the high-cost technology for millions of Americans through a safe, effective and more affordable OTC alternative. While the rule, if finalized, would more clearly define prescription hearing aids, FDA said it would not change the classification of existing device types.
  • “A Cowen analyst said in a Tuesday note the FDA’s proposed rule would effectively allow consumer electronics manufacturers to get into the hearing aid space that has been dominated by companies such as ReSound, Sonova and William Demant. The Wall Street Journal reported last week that Apple is studying ways to make its AirPods into a health device, including for enhancing hearing.”

Competition is good.

It’s worth noting that in contrast to FEHB and employer sponsored coverage generally, Medicare Part B rarely requires prior authorization for any prescribed course of treatment.

From the tidbits department, Fierce Healthcare is offering a series of articles from the ongoing HLTH 2.0 conference

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.

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.

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.

Thursday Miscellany

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

David Ermer–Congress, COVID-19, COVID-19 testing, Mental health care, OPM, Rx coverage, U.S. Healthcare–

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.”

Weekend Update

David Ermer–Congress, COVID-19, Medicare, OPM, U.S. Healthcare–
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.