Thursday Miscellany

Thursday Miscellany

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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

Photo by Patrick Fore on Unsplash

From Capitol Hill, the Wall Street Journal reports that on Tuesday the Senate Republicans refused to give unanimous consent to the Democrat effort to solve the debt ceiling issue without Republican support. Secretary of the Treasury Yellen advised Congress yesterday that she expects that current emergency measures used since August 1 to deal with the debt ceiling problem would soon be exhausted and “the government would be unable to pay all of its bills on time starting Oct. 18 unless Congress acts.” That of course is an unprecedented situation. The FEHBlog finds it interesting that the Congressional Democrat leadership has not lead with the bipartisan crafted continuing appropriation bill instead of the debt ceiling bill because the federal fiscal year ends on Thursday.

From the Delta variant front

  • The National Institutes of Health Director summarizes where we stand on the COVID-19 booster effort in his weekly blog post. The FEHBlog who has received two doses of the Pfizer vaccine over six months ago checked a major retail pharmacy chain site to see whether the booster is readily available and he found that it is which happily is a stark difference from last winters efforts to find the initial doses.
  • The Wall Street Journal reports that

Regulatory clearance of the Pfizer Inc. and BioNTech SE vaccine for young children may not come until November, according to a person familiar with the matter, after the companies said they won’t ask for the green light for a few weeks.

The companies said Tuesday they provided U.S. health regulators with data from a recent study of their vaccine in children 5 to 11 years old. They said they would file an application asking the Food and Drug Administration to authorize use in the coming weeks, though they had previously targeted submitting the application as early as the end of September.

  • The Kaiser Family Foundation released an interesting survey on the current public response to COVID. As of today, according to the CDC, just over 75% of Americans eligible to receive the vaccine (ages 12 and older) have receive at least one dose.
  • Healthcare Dive adds that

As of Tuesday, hospitalizations in the U.S. are down 16% over the past two weeks, according to the 14-day average from data compiled by The New York Times.

The U.S. reached a turning point in this year’s summer surge earlier this month, according to the seven-day averages. The average hospitalizations reached a peak on Sept. 3, started to decline the next day and have been trending down ever since, according to data compiled by the Times.

In the tidbits department

  • The Department of Health and Human Services announced awarding “nearly $1 billion in American Rescue Plan funding to nearly 1,300 Health Resources and Services Administration (HRSA) Health Center Program-funded health centers in all 50 states, the District of Columbia, and the U.S. territories to support major health care construction and renovation projects. These awards will strengthen our primary health care infrastructure and advance health equity and health outcomes in medically underserved communities, including through projects that support COVID-19 testing, treatment, and vaccination. The awards were made through the Health Resources and Services Administration.”
  • Health Payer Intelligence discusses a Manatt Health report on episode based care.
  • HHS also announced “the appointment of Lisa J. Pino as Director of the Office for Civil Rights (“OCR”). OCR is the HHS agency which enforces the HIPAA Privacy and Security Rules among other things. As it is a small world, Ms. Pino previously was “Senior Counselor [at Homeland Security] and drove the 2015 U.S. cyber breach mitigation of 4 million federal personnel and 22 million surrogate profiles, the largest hack in federal history, by renegotiating 700 vendor procurements and establishing new cybersecurity regulatory protections.”

Midweek Update

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Yesterday was the deadline for submitting public comments on the first No Surprises Act (“NSA”) interim final rule. The first IFC concerns the surprise billing protections afforded to consumers in emergency case, out of network care at in-network facilities and air ambulance care.

Here is potpourri of pertinent articles from Becker’s Payer Issues (about AHIP’s comments), the American Hospital Association, and Health Leaders Media (MGMA’s comments). When the same tri-agencies issued interim final rules implementing the Affordable Care Act (“ACA”) in 2011, those agencies did not issue “final final” rules until four or five years later.

While the NSA law is narrower in scope than the ACA, it poses much more complicated administration issues than those ACA provisions. Consequently the final final NSA rules may be accelerated. Sensibly, AHIP suggests that the tri-agencies create a good faith safe harbor for health plans and insurers during 2022 and 2023 to allow them to come into full compliance with this complex law.

In other healthcare news

  • A friend of the FEHBlog called his attention to the September 2021 issue of NIH in the News which may provide useful article for health plan newsletters to members.
  • The Journal of AHIMA breaks down the ICD-10 diagnosis code changes that will take effect on October 1, 2021, under the HIPAA transactions and code sets rule.
  • NCQA has made available a kidney health toolkit.
  • Fierce Healthcare reports that “Anthem is teaming up with The Clinic by Cleveland Clinic to offer virtual second opinions to members. The Clinic is a digital health joint venture from Cleveland Clinic and Amwell that provides video consultations, digital record collection and concierge service to insurers, providers, employers and patients. Through the partnership, eligible members can seek online second opinions from the health system’s 3,500 physicians. Anthem will initially make these consults available to its large employer clients, with the potential to expand to other employers and other insurance programs, according to the announcement.”
  • Health Payer Intelligence tells us that “In 2020, the prevalence of employer-sponsored health plan coverage fell during the coronavirus pandemic even as employment rebounded, according to a recent study published in the JAMA Health Forum. * * * In 2021, the data forms a clearer picture. Employer-sponsored healthcare coverage declined even as employment levels recovered, potentially indicating a shift to Affordable Care Act marketplace or Medicaid plans.” That is hardly surprising given the enormous funding that Congress has provided to the ACA marketplace.

Finally, the Wall Street Journal’s the Future of Everything series today discusses how

Researchers around the world are trying to turn the humble cough into an inexpensive tool to diagnose and stop respiratory-disease killers like tuberculosis and Covid-19. They’re collecting recordings of millions of the explosive sounds from patients and consumers on smartphones and other devices. And they’re training artificial intelligence to find patterns to try to identify the type and severity of disease from the cough itself. 

“We call it acoustic epidemiology,” says Peter Small, a tuberculosis expert and chief medical officer of Hyfe Inc., a Delaware-based company with two free smartphone apps—one for consumers, another for researchers—that use AI to detect and track how often someone coughs.

Tuesday’s Tidbits

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The FEHBlog had been wondering what was going on with the Postal Reform bill that includes a new Postal Service Health Benefits Program. It turns out that the House Oversight and Reform Committee plans to mark up the latest draft of that bill on Thursday morning. The FEHBlog plans to tune in for this meeting.

In health equity developments —

  • The Wall Street Journal reports that “Ride-sharing companies Uber Technologies Inc. and Lyft Inc. will make all rides to and from vaccination sites free until July 4 under a new partnership with the White House. * * * While the companies were already providing free or discounted rides in some circumstances, the rides will now be free to anyone in the U.S. who is going to a vaccination site to get the shot, and Lyft and Uber will promote the rides to and from tens of thousands of vaccination sites through their apps. The feature will launch in the next two weeks and run until July 4.”
  • Health Leaders Media informs us about Horizon Blue Cross’s ongoing efforts to advance health equity in New Jersey in cooperation with healthcare and community organizations as well as solid data.
  • The American Medical Association released a “strategic plan to embed racial justice and advance health equity.” “With the input of many both inside and outside of AMA, this strategic plan serves as a three-year roadmap to plant the initial seeds for action and accountability to embed racial justice and advance health equity for years to come.”

In regulatory developments –

  • Professor Katie Keith in the Health Affairs blog provides background on yesterday HHS decision to “interpret Section 1557 and Title IX, which prohibit discrimination on the basis of sex, to include discrimination on the basis of sexual orientation and gender identity.”
  • Fierce Healthcare reports that “The Centers for Medicare & Medicaid Services has sent its first wave of warning letters out to hospitals breaking federal rules requiring them to disclose payer-negotiated prices, a spokesperson for the agency confirmed.”
  • Healthcare Dives discusses healthcare organization comments to HHS’s Office for Civil Rights on its proposed rule that would make generally helpful adjustments to the HIPAA Privacy Rule, in the FEHBlog’s opinion.

Miscellaneous tidbits —

  • Reg Jones discusses the Federal Employees Group Life Insurance Program in FedWeek.
  • The Society for Human Resources Management writes about “Supporting Mental Health in the Post-Pandemic Workplace.”
  • Health Payer Intelligence discusses Blue Cross of North Carolina’s successful effort to consolidate member experience data from across the company to boost member satisfaction.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

There are a boatload of tidbits today.

Roll Call reports that “The House [of Representatives] will vote to clear the $1.9 trillion pandemic relief package for President Joe Biden’s signature on Wednesday, Majority Leader Steny H. Hoyer told reporters.”

From the COVID-19 front

  • Fierce Pharma informs us that “Vaccine doses are fanning out around the globe, but officials worry that surging coronavirus variants could make the immunization push less effective. Thanks to a new lab study, Pfizer and BioNTech have some good news for them. “Pfizer and BioNTech’s mRNA shot [which the FEHBlog has received] appeared to work against three worrisome variants in a lab study, researchers from both companies and the University of Texas Medical Branch wrote in the New England Journal of Medicine. That includes the P.1 variant that arose in Brazil and has raised concerns about re-infections.”
  • Fierce Healthcare reports ” As the COVID-19 vaccine rollout continues, payers are gearing up to play a key role in easing vaccine fears and hesitancy. At Humana, for example, this has meant connecting with members at multiple touch points over the past year, and ensuring that vaccine education was not their first conversation with their health plan during the pandemic, Chief Medical Officer William Shrank, M.D., said. “I don’t think any of our members see this as our first outreach,” Shrank said.” But bear in mind health plans better late than never.
  • The Society for Human Resource Management discusses how employers can take steps now to reduce pandemic fatigue in their employees.

From the general healthcare front —

  • The Wall Street Journal informs us that “A federal medical panel is calling for a significant expansion of CT scanning for smokers to detect lung cancer, citing studies that found the imaging studies can save more lives than previously known. The U.S. Preventive Services Task Force is advising people ages 50 to 80 to get the screening if they have smoked on average a pack of cigarettes daily for 20 years, and who currently smoke or have quit within the past 15 years. The panel’s previous recommendation, in 2013, recommended people get screened between ages 55 and 80, and have smoked the equivalent of a pack of cigarettes a day for 30 years, and currently smoke or have quit within the past 15 years.” The USPSTF recommendation will result in FEHB coverage of the CT scan for FEHBP members in the expanded group without member cost sharing in 2023.
  • Health Affairs helpfully reports “Bundled payment has shown promise in reducing medical spending while maintaining quality. However, its impact among commercially insured populations has not been well studied. We examined the impacts on episode cost and patient cost sharing of a program that applies bundled payments for orthopedic and surgical procedures in a commercially insured population. The program we studied negotiates preferred prices for selected providers that cover the procedure and all related care within a thirty-day period after the procedure and waives cost sharing for patients who receive care from these providers. After implementation, episode prices for three selected surgical procedures declined by $4,229, a 10.7 percent relative reduction. Employers captured approximately 85 percent of the savings, or $3,582 per episode (a 9.5 percent relative decrease), and patient cost-sharing payments decreased by $498 per episode (a 27.7 percent relative decrease).” Interesting.
  • Health Payer Intelligence discusses how payers can take action against racial and ethnic healthcare disparities. Because “the payer industry’s core function is to pay for medical care, insurers can play a key role in overturning local care disparities through their payment strategies, offering funds to organizations that reduce disparities, and by spending locally in a way that is conscious of systemic inequities by purchasing from black and minority-owned businesses,” [Kedar] Mate [president and chief executive officer at the Institute for Healthcare Improvement (IHI), president of the IHI Lucian Leape Institute, and a member of the faculty at Weill Cornell Medical College] said.

From the healthcare industry front

  • Forbes informs us that “In the largest advertising blitz ever undertaken by the health insurance lobby, America’s Health Insurance Plans will spend at least $10 million on a national education campaign to show how health plans are ‘are working together to deliver affordable and accessible care and coverage.’”
  • Fierce Healthcare explains that “If there was one key word to come out of Cigna’s investor day on Monday [March 8], it would be “growth.” The insurer spotlighted its ambitions to expand across its enterprise, from its insurance plans to pharmacy to digital tools, at the virtual event for investors Monday morning. CEO David Cordani said that its growth plans “fuel our purpose.”
  • Fierce Healthcare also reports that “COVID-19 accelerated a number of trends already brewing in the healthcare industry, and that’s not likely to change this year, according to a new report from CVS Health. The healthcare giant released its annual Health Trends Report on Tuesday [March 9], and the analysis projects several industry trends that are likely to define 2021 in healthcare, ranging from technology to behavioral health to affordability. “We are facing a challenging time, but also one of great hope and promise,” CVS CEO Karen Lynch said in the report. “As the pandemic eventually passes, its lessons will serve to make our health system more agile and more responsive to the needs of consumers.”
  • Drug Channels lists that fifteen largest U.S. pharmacy chains in terms of market share and revenue. CVS Health leads the pack.

From the regulatory front, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced today “a 45-day extension of the public comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. OCR first released the NPRM to the public on the HHS website on December 10, 2020, and it was published in the Federal Register on January 21, 2021.  The 45-day extension moves the current deadline for the public to submit comments from March 22, 2021, to May 6, 2021. The notice of extension of the comment period is available at – PDF.” The FEHBlog is pleased that the Biden Administration is giving serious consideration to this proposed rule.

Cybersecurity Saturday

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The Wall Street Journal reports today that

Investigators probing a massive hack of the U.S. government and businesses say they have found concrete evidence the suspected Russian espionage operation went far beyond the compromise of the small software vendor publicly linked to the attack.

Close to a third of the victims didn’t run the SolarWinds Corp. software initially considered the main avenue of attack for the hackers, according to investigators and the government agency digging into the incident. The revelation is fueling concern that the episode exploited vulnerabilities in business software used daily by millions. * * *

The attackers “gained access to their targets in a variety of ways. This adversary has been creative,” said Mr. Wales, whose agency, part of the U.S. Department of Homeland Security, is coordinating the government response. “It is absolutely correct that this campaign should not be thought of as the SolarWinds campaign.”

That is chilling news. What should be done?

In that regard, Fortune seeks to untangle the U.S. cybersecurity “mess” for us. The article explains

Restructuring [the U.S. cybersecurity] system is core to the work of the Cyberspace Solarium Commission, a task force commissioned by Congress to help reform U.S. cybersecurity. “Our focus [is] on making the market more effective at driving good behavior,” says commissioner Suzanne Spaulding, a senior adviser for cybersecurity and counterterrorism at the Center for Strategic and International Studies. “If the market isn’t performing the way it should, why isn’t it?” 

The commission spent the past year drawing up a wide-ranging list of recommendations, and in January, 26 of them became law as part of the 2021 National Defense Authorization Act. The NDAA creates a White House–level Office of the National Cyber Director and grants new private-sector threat-response powers to the federal Cybersecurity and Infrastructure Security Agency—significant changes that commission members hope will prompt closer collaboration between government and industry on security standards. “A lot of the recommendations, some of us have been making for years,” says Cilluffo, who’s also a commissioner. “But the political will was not where it needed to be. Now, we don’t need any reminders.”

Solarium’s mandate has been extended for at least another year, and its next round of advocacy and recommendations will focus more squarely on the private sector. The goal: creating better incentives for building secure software and sharing intelligence about cyberthreats.

On the personnel front, GovConWire reported last week that

Sources said Biden is likely to name [Jen] Easterly to the newly created role of national cyber director at the White House to help guide the current administration’s cybersecurity strategy and oversee digital security efforts of agencies.

Easterly is head of resilience at Morgan Stanley and previously served as deputy director for counterterrorism at the National Security Agency between 2011 and 2013. She served in the National Security Council as special assistant to the president and senior director for counterterrorism during the Obama administration.

Healthcare Dive also noted that “The Biden administration hired Chris DeRusha as federal CISO, tasking him with coordinating cybersecurity policy across federal agencies. DeRusha previously served as the top cybersecurity officer for the Biden presidential campaign.”

Cyber Scoop adds with respect to the ongoing investigation that

[L]awmakers are demanding answers from the National Security Agency about another troubling supply chain breach that was disclosed five years ago.

A group of lawmakers led by Sen. Ron Wyden, D-Ore., is asking the NSAwhat steps it took to secure defense networks following a years-old breach of software made by Juniper Networks, a major provider of firewall devices for the federal government.

Juniper revealed its incident in December 2015, saying that hackers had slipped unauthorized code into the firm’s software that could allow access to firewalls and the ability to decrypt virtual private network connections. Despite repeated inquiries from Capitol Hill— and concern in the Pentagon about the potential exposure of its contractors to the hack — there has been no public U.S. government assessment of who carried out the hack, and what data was accessed.

Lawmakers are now hoping that, by cracking open the Juniper cold case, the government can learn from that incident before another big breach of a government vendor provides attackers with a foothold into U.S. networks. 

Tuesday Tidbits

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The Wall Street Journal has performed a tremendous public service by publishing a state-by-state guide to obtaining a COVID-19 vaccination. The information is current as of yesterday and will be updated weekly.

STAT News reports that Regeneron and Eli Lilly are pleased with progress being made in their respective trials of monoclonal antibody cocktails to treat COVID-19. “George Yancopoulos, Regeneron’s chief scientific officer, said in a statement that even with vaccines available, the antibody will be able help break the chain of infection, and may prove useful for individuals who are immunocompromised or unable to be vaccinated.”

Employee Benefits News offers an interesting story about how employers are confronting the opioid public health emergency.

Health Payer Intelligence discusses Blue Shield of California’s efforts to consolidate and simplify medical billing. What’s more,

[Blue Shield of California] aim[s] to achieve real-time claims settlement. In 2020, Blue Shield of California shortened its claim settlement timeframe from a maximum of 30 days down to six days, but in 2021 the company plans to reduce that timeframe further.

“For us, ‘real-time’ claims settlement means anywhere from three to nine seconds,” [Shayna] Schulz[, senior vice president of transformation and operations at Blue Shield of California] explained.

“We have a proof of concept that we’ve already done where we’ve been able to process one claim—but it starts with one—in nine seconds. We’re highly optimistic that we can rapidly scale this in 2022. And that’s going to be a game-changer for many hospitals.”


Because the FEHBlog cannot forget the SolarWinds backdoor hack, Cyber Scoop lets us know that

Email security firm Mimecast on Tuesday confirmed that the hackers behind the SolarWinds espionage campaign compromised a software certificate the firm uses to secure connections to Microsoft cloud services. The revelation underscores how deeply embedded the suspected Russian hackers have been in major technology companies as part of a campaign that has also breached multiple U.S. federal agencies. * * * Mimecast is one of many big tech firms to be implicated in the hacking campaign, which has also exploited bugged software made by SolarWinds, a Texas-based federal contractor. The attackers have viewed Microsoft’s source code and stolen the red-team tools that security firm FireEye uses to test clients’ defenses.

Finally, STAT News published today the story written by one of its star reporters Sharon Begley about lung cancer contracted by never-smokers.

Cigarette smoking is still the single greatest cause of lung cancer, which is why screening recommendations apply only to current and former smokers and why 84% of U.S. women and 90% of U.S. men with a new diagnosis of lung cancer have ever smoked, according to a study published in December in JAMA Oncology. Still, 12% of U.S. lung cancer patients are never-smokers.

Scientists disagree on whether the absolute number of such patients is increasing, but the proportion who are never-smokers clearly is. Doctors and public health experts have been slow to recognize this trend, however, and now there is growing pressure to understand how never-smokers’ disease differs from that of smokers, and to review whether screening guidelines need revision.

“Since the early 2000s, we have seen what I think is truly an epidemiological shift in lung cancer,” said surgeon Andrew Kaufman of Mount Sinai Hospital in New York, whose program for never-smokers has treated some 3,800 patients in 10 years. “If lung cancer in never-smokers were a separate entity, it would be in the top 10 cancers in the U.S.” for both incidence and mortality.

Ms. Begley was a never-smoker who succumbed to lung cancer on January 16, 2021. RIP.

Thursday Miscellany

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President Biden has issued a blizzard of executive orders over the last day and a half. The Hill summarizes them in this article, and for more details you can find the text of each order on

STAT News reports that

The Biden administration is willing to consider almost anything to boost the nation’s dwindling supply of Covid-19 vaccines.

A new strategy document released Thursday, totaling nearly 200 pages, offers the first clear list of the options President Biden has before him, though it doesn’t specifically say he’ll actually take all of the steps. On the list are some controversial ideas, like cutting the amount of vaccine being administered to each American. He’s also made it clear he wants to utilize the Defense Production Act to ramp up production of key supplies, and some more straightforward options like buying more doses.

Governors and mayors around the country have complained in recent weeks that they do not have enough vaccines to meet current demand. Biden, too, has acknowledged that the supply of physical vaccines is not where it needs to be to vaccinate a majority of Americans. Already, the Trump administration stopped holding vials in reserve, in hopes of releasing more vaccines to the public.

As of today, the CDC reports that nearly 38 million doses of the two dose vaccines have been distributed and around 17.5 million have been administered. 2.1 million of those doses have been administered at long term care facilities.

In that regard, the AP reports that

Drugmaker Eli Lilly said Thursday its antibody drug can prevent COVID-19 illness in residents and staff of nursing homes and other long-term care locations.

It’s the first major study to show such a treatment may prevent illness in a group that has been devastated by the pandemic. 

Residents and staff who got the drug had up to a 57% lower risk of getting COVID-19 compared to others at the same facility who got a placebo, the drugmaker said. Among nursing home residents only, the risk was reduced by up to 80%.

The study involved more than 1,000 residents and staff at nursing homes and other long-term care locations like assisted living homes. The vast majority tested negative at the start of the study. Some were assigned to get the drug, called bamlanivimab and which is given through an IV, and others got placebo infusions.

Also on the prescription drug front, STAT News informs us that

The Food and Drug Administration has approved a monthly injectable medication, a regimen designed to rival pills that must be taken daily.

The newly approved medicine, which is called Cabenuva, represents a significant advance in treating what continues to be a highly infectious disease. In 2018, for instance, there were approximately 36,400 newly infected patients living with HIV in the U.S., according to the Centers for Disease Control and Prevention. About 1.7 million people worldwide became newly infected in 2019, according to UNAIDS.

Although several medicines exist for treating HIV, ViiV Healthcare is banking on the improved convenience of getting a monthly shot, even if it must be administered by a health care provider. The company, which is largely controlled by GlaxoSmithKline (GSK), gathered data showing nine of 10 patients in pivotal studies claimed to prefer the shot over taking pills each day.

The Wall Street Journal reports on a phenomenon that has attracted the FEHBlog’s attention — the low levels of flu infections this winter across the Northern Hemisphere, including the U.S.

The WHO says the measures people and governments are taking to prevent the spread of Covid-19, such as wearing masks and limiting public gatherings, have probably helped keep the flu in check. Increased flu vaccination rates may also be contributing, it says.

Another hypothesis holds that the broad spread of SARS-CoV-2, the virus that causes Covid-19, in countries like the U.S. may play a role in blocking the flu by lifting people’s immunity against other viruses. One study in the spring of 2020 in New York City found that people testing positive for SARS-CoV-2 were far less likely to be carrying other common viruses such as influenza viruses. Still, research into that hypothesis is just beginning.

What is clear is the historically low number of people with the flu.

The FEHBlog also ran across another interesting Cyberscoop article with more of the backstory on the SolarWinds backdoor hack as uncovered by Microsoft.

Attackers behind an espionage campaign that exploited software built by the federal contractor SolarWinds separated their most prized hacking tool from other malicious code on victim networks to avoid detection, Microsoft said Wednesday.

The findings make clear that, while the hackers have relied on a variety of tools in their spying, the tampered SolarWinds software functioned as the cornerstone of an operation that Microsoft described as “one of the most sophisticated and protracted” of the decade. Multiple U.S. federal agencies focused on national security have been breached in the campaign, which U.S. officials have linked to Russia. * * *

After the SolarWinds trojan was delivered to organizations, the attackers spent about a month pinpointing victims, according to Microsoft. As early as May 2020, the hackers were doing the “real hands-on-keyboard activity” of moving through victim networks for valuable data, Microsoft said.

The hackers were meticulous in covering their tracks. They prepared unique malicious code implants for each victim machine, according to Microsoft, and changed timestamps of the digital clues they left behind to complicate the recovery process for organizations. Microsoft called the former technique an “incredible effort normally not seen with other adversaries and done to prevent full identification of all compromised assets.”

Tuesday Tidbits

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Surprise! The FEHBlog mentioned the other day that he considered the Trump Administration’s proposed HIPAA Privacy Rule amendments to be a dead letter because they had not been scheduled to be published in the Federal Register today, the last day of the Trump Administration’s Federal Register. Well, as it turns out, that proposed rule showed up in the Federal Register public inspection list today with a Federal Register publication date of Thursday January 21. In any event. as the FEHBlog mentioned, the Biden Administration will be decide the fate of this rule making, which for what it’s worth the FEHBlog considers to be a helpful improvement.

Also today, OPM released a preview of the 2020 Federal Employee Viewpoint Survey results. “A preview of the governmentwide results are heartening,” said Acting Director Michael Rigas. “Through the toughest times, employees have been resilient and motivated while supervisors and senior leaders alike have served employees well by embracing their roles to keep employees safe and informed.”  Well done, OPM and federal agency employers and employes.

The FEHBlog is a fan of new health plan designs. Fierce Healthcare reports that

UnitedHealthcare is launching a new, virtual primary care option as part of an effort to expand access to local clinicians in its employer-sponsored plans.

Virtual primary care will be available to members in certain employer plans across 11 states, UnitedHealthcare said in an announcement. The insurer expects to expand the offering to additional states over the course of the year.

The goal, UnitedHealth said, is to make it easier for patients to establish and maintain an ongoing relationship with a primary care provider.

“The UnitedHealthcare Virtual Primary Care service and updated policy help expand the use of virtual care from delivering care to people who are sick, to now also focusing on preventing and detecting disease before it starts and, if needed, helping people more conveniently manage certain chronic conditions,” said Anne Docimo, M.D., chief medical officer at UnitedHealthcare,” in a statement.


In another creative move, Fierce Healthcare calls our attention to the following:

As healthcare continues to evolve, legacy players are aiming to be the first to gain access to the latest innovations.

At Anthem, that effort has meant launching its own Digital Incubator, which pairs financial backing with mentorship and opportunities for partnerships with universities and corporations.

“Essentially, we are looking to get access to cutting-edge healthcare products,” said Kate Merton, staff vice president and head of Anthem Digital Incubator, in an interview with Fierce Healthcare. “We work with our entrepreneurs early in the cycle to make sure they’re developed with the mindset of the payer, of the consumer and the provider all in one.”

ADI offers a number of pathways for innovators to take and operates in both digital and physical platforms, with its first incubation space opening in Palo Alto, California.

On the mental healthcare front —

  • IFEBP informs us that the Department of Labor’s Employees Benefit Security Administration, which enforces ERISA, “released the Fiscal Year (FY) 2020 Mental Health Parity and Addiction Equity Act (MHPAEA) fact sheet on investigations.”
  • “The U.S. Department of Health and Human Services (HHS) and the Office of the Surgeon General (OSG)—in collaboration with the National Action Alliance for Suicide Prevention (Action Alliance)—released The Surgeon General’s Call to Action to Implement the National Strategy for Suicide Prevention. This new report outlines the actions that communities and individuals can take to reduce the rates of suicide and help improve resilience.”

Midweek Update

Photo by Manasvita S on Unsplash

Bloomberg reports that Johnson & Johnson now expects to receive Food and Drug Administration emergency use authorization for its single dose COVID-19 vaccination in late February or early March 2021 which is later than initially anticipated.

J&J’s vaccine offers advantages in ease of distribution and administration [over the currently authorized Pfizer and Moderna vaccines]. Health systems have been navigating relatively complex two-shot campaigns for vaccines from Pfizer and Moderna. J&J’s shot will likely protect people with a single dose, and can be stored at refrigerator temperatures for three months; the Pfizer and Moderna vaccines must be frozen. Speaking Wednesday at a JPMorgan Healthcare Conference event, [Moncef] Slaoui said he expects the J&J shot to have 80% to 85% efficacy, surpassing the objective the company outlined in its clinical trial design.

Speaking of the virtual annual JPMorgan Healthcare Conference, the National Law Review reports on Day 1 of the conference here and Day 2 of the conference there. Take a gander at this interesting tidbit from Day 1

[Blue Shield of California CEO] Paul Markovich spoke to the need for real-time quality information that can result in real-time feedback and incentivization to physicians and other providers, rather than the costly and slow HEDIS pursuits we see today.  One health plan noted that it spends about $500 million a year going into physician offices looking at medical records for HEDIS pursuits, but the information is totally “in the rearview mirror” as it is too old when finally received and digested to allow for real-time treatment changes, improvement or planning.  Markovich suggested four initiatives (including the above, pay for value and shared decision making through better, more open data access) that he thought could save $100 billion per year for the country.  Markovich stressed that all of these four initiatives required a digital ecosystem and asked for help and partnership in creating one. He also noted that the State of California is close to creating a digital mandate and statewide health information exchange that could be the launching point for this exciting vision of data sharing and a digital ecosystem where the electronic health record is the beginning, but not the end of the healthcare data journey.

Health Payer Intelligence informs us that

The tension between payers and pharmaceutical companies over drug pricing has carried into 2021, as evidenced by a press release from America’s Health Insurance Plans (AHIP) criticizing pharmaceutical companies for January 2021 drug pricing increases.

“Americans are being hurt by out-of-control drug prices, which are set and fully controlled by Big Pharma alone,” Matt Eyles, president and chief executive officer of AHIP, said in a related blog post.

“The incoming Biden-Harris administration should focus on bipartisan, workable solutions to protect patients, taxpayers, and all Americans from higher drug prices, especially in the midst of the ongoing COVID-19 crisis.”

Meanwhile STAT News reports that

In an unexpected move, the high-profile billionaire [Mark Cuban] has launched the Mark Cuban Cost Plus Drug Company, which its website says is “dedicated to producing low-cost versions of high-cost generic drugs” and claims that everyone will get the same low price for every drug it makes.

As part of its mission, the company pledged to provide “radical transparency” about its manufacturing, distribution, and marketing costs. The plan is to add a flat 15% margin to wholesale prices to ensure profitability, but Cuban also promised there will be no hidden costs, no middlemen, and no rebates available only to insurers.

“This is our first step towards taking on the pricing of generic drugs,” Cuban tweeted in announcing the company, which will start by producing a medicine to treat parasites, but plans to introduce more than 100 other medicines by the end of 2021. There are also plans to build a factory in Dallas by next year, according to its web site.

The article reminds us that

[In 2018] several large hospital systems form[ed] Civica Rx, a nonprofit that contracts with manufacturers to ensure sufficient supplies to hospitals across the U.S. The idea is to entice companies, which make injectable and infused medicines but have a minimum amount of sales, to ramp up investment in production. The Civica network, which began with $100 million in capital and loans from three philanthropic organizations, now has more than 50 health systems that represent more than 1,200 hospitals and over 30% of all licensed U.S. hospital beds. The nonprofit is also teaming with the Blue Cross Blue Shield Association and 18 of its health plans to supply copycat medicines and combat rising prices.

Bleeping Computer provides us with an update on the SolarWinds backdoor hack, including an explanation of how the hack was implemented and the hacker’s various malware strains.

A week ago, the FBI, CISA, and the NSA also disclosed in a joint statement that a Russian-backed Advanced Persistent Threat (APT) group is likely behind the SolarWinds hack.

“The U.S. government and many private-sector experts have stated the belief that a foreign nation-state conducted this intrusive operation as part of a widespread attack against America’s cyberinfrastructure,” SolarWinds CEO Sudhakar Ramakrishna said today.

“To date, our investigations have not independently verified the identity of the perpetrators.”