Monday Roundup

David Ermer

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

Monday Roundup

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Capitol Hill —

Roll Call reports that

House Democrats introduced a government funding stopgap Monday that would extend current spending levels through March 11 as appropriators continue to negotiate topline spending levels for a fiscal 2022 omnibus bill. 

The move would buy Congress an extra three weeks to complete work on an overdue omnibus package for the fiscal year that began last October. The government is currently operating on a continuing resolution that expires on Feb. 18.

Per the Roll Call article, Congress expects to meet the March 11 deadline with a consolidated appropriations bill for the current government fiscal year.

Reuters reports that the House also will vote on the Postal Reform bill (HR 3706) tomorrow. Here is a link to the House Rules Committee website describing the actions that the Rules Committee took on HR 3706 today to line up a vote for tomorrow.

From the Omicron front —

According to the CDC’s COVID Data Tracker, as of today, 90 million out of 213 fully vaccinated Americans (42%) have received a Covid booster. In his New York Times column this morning, David Leonhardt writes that the relatively slow adoption of boosters is not a function purely of skepticism. Rather

The vaccinated-but-unboosted more closely resemble the country as a whole. Millions of Americans who have already received two vaccine shots — eagerly, in many cases — have not yet received a follow-up. The unboosted include many Republicans, Democrats and independents and span racial groups. * * *

The most urgent problem involves the unboosted elderly. (About 14 percent of Americans over 65 eligible for a booster had not received one as of mid-January, according to Kaiser.) But some younger adults are also getting sick as their vaccine immunity wears off.

A recent study from Israel, published in The New England Journal of Medicine, was clarifying. For both the elderly and people between 40 and 59, severe illness and death were notably lower among the boosted than the merely vaccinated. For adults younger than 40, serious illness was rare in both groups — but even rarer among the boosted: Of the almost two million vaccinated people ages 16 to 39 in the study, 26 of the unboosted got severely ill, compared with only one boosted person.

“Boosters reduce hospitalization across all ages,” Dr. Eric Topol of Scripps Research has said. As Dr. Leana Wen wrote in The Washington Post, “The evidence is clear that it is at least a three-dose vaccine

Mr. Leonhardt places responsibility for the booster gap on the fragmented U.S. health system and the failure of government experts to make themselves understood to the American people. Health plans may want to lend a hand here.

The National Institutes of Health informed us

Pregnant women with COVID-19 appear to be at greater risk for common pregnancy complications — in addition to health risks from the virus — than pregnant women without COVID-19, suggests a study funded by the National Institutes of Health.

The study, which included nearly 2,400 pregnant women infected with SARS-CoV-2, found that those with moderate to severe infection were more likely to have a cesarean delivery, to deliver preterm, to die around the time of birth, or to experience serious illness from hypertensive disorders of pregnancy, postpartum hemorrhage, or from infection other than SARS-CoV-2. They were also more likely to lose the pregnancy or to have an infant die during the newborn period. Mild or asymptomatic infection was not associated with increased pregnancy risks.

“The findings underscore the need for women of child-bearing age and pregnant individuals to be vaccinated and to take other precautions against becoming infected with SARS-CoV-2,” said Diana Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which funded the study. “This is the best way to protect pregnant women and their babies.”

The American Hospital Association offers six tips for health care leaders looking to build vaccine confidence among pregnant women.

The Wall Street Journal reports today

Drugmaker Shionogi & Co. said it plans to seek approval this month to sell its Covid-19 treatment pill in Japan after the company found that in human trials the pill had strong virus-fighting ability compared with Pfizer Inc.’s Paxlovid. 

Shionogi acknowledged that studies of its drug are much smaller than Pfizer’s and have yet to prove effectiveness in preventing serious Covid-19 cases. Pfizer said its final-stage trial, which included more than 2,000 patients, showed Paxlovid cut the risk of hospitalization or death by 89% if patients took the pill within three days of diagnosis. 

Still, Shionogi said it believed its trials to date, covering about 400 mostly Japanese patients, would offer sufficient evidence to seek approval in Japan, where the Pfizer drug is expected to be approved shortly, but is likely to be in limited supply. Shionogi said its trial found the pill, code-named S-217622, neutralized the virus quickly and didn’t cause serious or lasting side effects. 

The more, the merrier.

In other news, Fierce Healthcare tells us

CVS Health is teaming up with Medable to access and engage around clinical trials at select MinuteClinics, the healthcare giant announced Monday.

CVS Health Clinical Trial Services, a new arm at the company launched last May, will harness Medable’s software platform to deliver clinical trials with a focus on accessibility and retention to enhance the effectiveness of research, according to the announcement.

The companies note that while clinical trials are crucially important to test the efficacy of innovative pharmaceuticals, less than 4% of Americans actually participate in them. In addition, 30% of participants drop out before trials are completed, and 80% of studies are unable to make enrollment deadlines.

Tony Clapsis, general manager and senior vice president of CVS Health Clinical Trial Services, said in a statement that CVS has the ability to make a significant impact on outreach about trials to underrepresented people as more than 40% of vulnerable populations live within five miles of one of its pharmacies.

Smart move.

STAT News reports

  • “Some of the nation’s most influential doctors and public health groups are orchestrating a mad-dash effort to convince senators to confirm Robert Califf, President Biden’s pick to lead the Food and Drug Administration. * * * The pressure campaign comes amid growing signs that Califf’s nomination is in serious trouble. Five Democrats in the Senate have already expressed serious concerns with Califf’s nomination and at least 10 more are still undecided about his candidacy. Quite a few Republicans in the chamber also have concerns. ‘It’s … the ‘break glass in case of emergency’ moment,’ said one patient advocate, who noted that many advocacy groups had, until recently, thought Califf would sail through his confirmation process easily.”

and

  • “When President Biden tapped Eric Lander as White House science adviser in January 2021, he tasked the renowned genomics researcher with “reinvigorating” American science. Following Lander’s stunning resignation on Monday evening, however, the question is no longer whether he’ll reinvigorate the U.S. scientific enterprise. It’s whether he’s derailed it. Lander resigned after an all-staff apology for abusive workplace behavior, which Politico first reported. In an email, Lander admitted speaking in a “disrespectful and demeaning way,” acknowledging he had failed to set a “respectful tone” for the office and that his actions reflected poorly on the administration.”

Let’s hope Lander didn’t derail efforts like the Cancer Moonshot.

Weekend Update

David Ermer–Congress, COVID vaccine mandate, COVID-19, COVID-19 vaccine, OPM, SCOTUS–
Photo by JOSHUA COLEMAN on Unsplash

Both the House and the Senate will be in session this week for Committee business and floor voting. The FEHBlog will be keeping an eye on the House Rules Committee hearing on the Postal Reform Act (HR 3706) scheduled for tomorrow at 2 pm ET.

Roll Call reports

The House could take up a three-week stopgap funding extension through March 11 as soon as Tuesday to buy more time for appropriators to write final fiscal 2022 spending bills, according to sources who spoke on condition of anonymity because details haven’t been made public.

The temporary spending bill under discussion would only move to the floor if an agreement on topline funding allocations for defense and nondefense programs is reached first. But there was enough apparent progress behind the scenes to warrant talk of a short-term extension rather than a longer continuing resolution that could delay needed funds for the Pentagon, infrastructure programs and more. * * *

It wasn’t immediately clear whether the Senate would be on board with a three-week extension, and the length was still under discussion, according to sources. During the weekly House floor colloquy on the chamber’s schedule, [House] Majority Whip James E. Clyburn, D-S.C., wouldn’t comment on timing or specifics but said he hopes it will be a “short, short-term CR” if negotiators can’t write an omnibus before Feb. 18.

From the COVID vaccine front, the Wall Street Journal’s excellent Saturday Essay concerns efforts to extend mRNa vaccines beyond Covid. The FEHBlog just finished reading Wall Street Journal reporter Gregory Zuckerman’s book “A Shot to Save the World” which offers an inside look at the development of the various COVID vaccines. Moderna and BioNTech among other drug manufacturers were working on mRNA vaccines for many years before Covid struck. Their preparation led them to rapidly develop mRNA vaccines against Covid. The BioNTech and Moderna mRNA vaccines against Covid were the first mRNA vaccines approved by the Food and Drug Administration. Researchers in those companies and others now are continuing their work on the development of mRNA vaccines for the flu, cancer, HIV, among other diseases. Hope springs eternal.

The Wall Street Journal also provides an overview of the cases in which federal courts are considering the legality of the Biden administration’s Covid vaccination mandates for federal employees and federal government contractor employees in the wake of two recent U.S. Supreme Court rulings on other vaccine mandates.

Sean Marotta, a partner with law firm Hogan Lovells, said the rulings, taken together, send a message about the federal government’s power: “A vaccine mandate that targets problems specific to a federal regulatory program will likely be upheld. A mandate that is simply an attempt to get as many people vaccinated as possible, or is a workaround for the government not having a general power of vaccination, will probably be struck down

Well put, sir.

From the federal employment front, Federal News Network tells us

The Biden administration wants to give federal employees their largest pay raise in 15 years.

Federal News Network has learned that the White House will propose a 4.6% pay increase for federal employees as part of its fiscal 2023 budget request. The budget request is expected to go to Congress after the State of the Union, which is on March 1,  Shalanda Young, the nominee to be director of the Office of Management and Budget, told the Senate Budget Committee on Feb. 1.

Cybersecurity Saturday

David Ermer–Cybersecurity–

Cyberscoop tells us

The Homeland Security Department is establishing a Cyber Safety Review Board that will convene after major cyber events to review and act on them, according to a Federal Register notice.

The notice brings to fruition an idea long circulated among cybersecurity policymakers and thinkers, one set in motion by an executive order President Joe Biden signed in May 2021. The idea is to mimic the National Transportation Safety Board that reviews civil aviation accidents.

The board (CSRB) will have no more than 20 members, with one each required from DHS, its Cybersecurity and Infrastructure Security Agency, the Department of Justice, the National Security Agency and the FBI. The DHS undersecretary for strategy, policy and plans — a post held by Rob Silvers — will serve as the inaugural two-year chair.

It will kick into effect when an incident prompts formation of a Cyber Unified Coordination Group, a National Security Council-established organization for unifying government response to cyber incidents such as those that hit critical infrastructure owners and operators. The 2020 SolarWinds breach, which caused the compromise of both federal agencies and major tech companies, led to a public announcement of a coordination group forming.

From the breach and vulnerability front —

Health IT Security reports

Cyberattacks targeted at health plans and third-party business associates increased last year, while attacks against healthcare providers dipped slightly, a report by Critical Insight discovered.

Researchers analyzed 2021 data from the Office for Civil Rights (OCR) data breach portal and compared it to years past. The report revealed that health plan cyberattacks increased by 35 percent from 2020 to 2021, and attacks against third-party business associates increased by 18 percent.

Interestingly, cyberattacks aimed at healthcare providers declined by approximately 4 percent. Although the decrease is not extreme, it shows that cybercriminals are adapting their tactics and targets as organizations continue to implement safeguards against common exploitation techniques.

and

Threat actors continually leverage unpatched vulnerabilities as their primary ransomware attack vector, a new report by Ivanti in partnership with Cyware and Cyber Security Works found. Researchers discovered 65 new vulnerabilities connected to ransomware in 2021, which signified a 29 percent growth compared to 2020.

Over a third of the 65 newly discovered vulnerabilities were being actively searched for on the internet, further stressing the need to prioritize patching.

More specifically, Bleeping Computer informs us in a report posted yesterday

The Cybersecurity and Infrastructure Security Agency (CISA) has ordered federal agencies to patch their systems against an actively exploited Windows vulnerability that enables attackers to gain SYSTEM privileges.

Per a binding operational directive (BOD 22-01) issued in November and today’s announcement, all Federal Civilian Executive Branch Agencies (FCEB) agencies are now required to patch all systems against this vulnerability, tracked as CVE-2022-21882 within two weeks, until February 18th.

While BOD 22-01 only applies to FCEB agencies, CISA strongly urges all private and public sector organizations to reduce their exposure to ongoing cyberattacks by adopting this Directive and prioritizing mitigation of vulnerabilities included in its catalog of actively exploited security flaws.

Cybersecurity Dive discusses four cyberthreat trends to watch this year.

If there is one predictable constant in cybersecurity, it’s the omnipresence of ransomware. As Mandiant put it best, “There’s no end in sight for ransomware.”

But don’t expect ransomware to continue as we kow it today. Mandiant predicts threat actors will develop new ways to gain a profit from ransomware, starting with a shift to globalized attacks. * * *

The common thread around these trends is cybercriminals finding a way to manipulate corporate data, and for that problem, there really is no end in sight. 

Of course this quote naturally leads the FEHBlog to offer a link to the Bleeping Computer’s The Week in Ransomware.

From the cyberdefense front

  • Healthcare Dives discusses three tactics shaping ransomware mitigation this year.
  • A Wall Street Journal commentator who is the Cato Network‘s CEO explains

Just as Software as a Service revolutionized the internet by letting everyone access applications online rather than buying, installing and managing expensive software, [Cato Network offers] a new [cybersecurity] model, Secure Access Service Edge, promises to do the same thing for network security. To understand roughly what it does, look at your iPhone, which is a telephone, a computer, a high-resolution camera and a global positioning device all in one machine. Secure Access Service Edge will do something similar for network access and security, allowing businesses of all sizes, including small and medium-size ones, network access and security without a host of costly components.

Cool.

Friday Stats and More

David Ermer–CDC, Congress, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Federal employment benefits, Mental health care, Uncategorized–

Based on the Centers for Disease Control’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s chart of weekly new Covid cases from the 27th week of 2021 through the 5th week of this year:

The Omicron surge is subsiding. The CDC’s weekly interpretation of its COVID statistics indicates that

COVID-19 cases and hospitalizations are continuing to decline across the United States. As of February 2, 2022, cases are down 53.1% from their peak on January 15. However, community transmission is still high nationwide.

Unfortunately Covid-related deaths, a lagging indicator, continue to rise:

Here’s the FEHBlog’s chart of weekly Covid vaccinations administered and distributed from the 51st week of 2020 through the 5th week of 2022.

The pace of COVID vaccinations is slowing again. 212.5 million out of 303 million Americans (net of 23.6 million children under 5 years old) are fully vaccinated and of that cadre, 89.3 million have been boostered.

The American Medical Association offers seven reasons why parents should get their kids ages 5 to 11 vaccinated against Covid.

Also today the CDC’s Advisory Committee on Vaccination Practices unanimously ratified the FDA’s decision to award full marketing approval to the Moderna mRNA vaccine Spikevax for use with adults age 18 and older.

For the hardcore Covid statistics folks check out this tidbit from the CDC’s weekly interpretative report

Wastewater (sewage) surveillance is a promising tool for tracking the spread of SARS-CoV-2, the virus that causes COVID-19. Many people with COVID-19 shed the virus in their feces, so testing wastewater can help us find COVID-19 in communities. Wastewater testing has been successfully used as a method for detection of other diseases, such as polio. Wastewater surveillance results can provide an early warning of increasing COVID-19 cases and help communities prepare.

On February 3, 2022, COVID Data Tracker released a Wastewater Surveillance tab, which tracks SARS-CoV-2 levels in sewage at more than 400 testing sites across the country. This marks the first time CDC’s wastewater surveillance data is available for download. See “A Closer Look” below for more information about this method of data collection.

From the Covid testing mandate front, the Affordable Care Act regulators issued ACA FAQ 52 late this afternoon. The regulators use this FAQ to provide helpful clarifications to the mandate. Check it out.

From the Covid treatment front, Medscape tells us that

A little more than a month after receiving FDA authorization, Merck has delivered 1.4 million courses of its COVID-19 antiviral pill in the United States and expects to deliver its total commitment of 3.1 million treatment courses soon, company CEO Rob Davis said on CNBC.

Merck has also shipped 4 million courses of the pill, molnupiravir, to 25 nations across the world, he said.

“We’ve shown that molnupiravir works against Omicron, which is important against that variant,” Davis said Thursday morning. “And obviously we’ll have to see how this plays out and what is the initial uptake, but right now we feel we’re off to a good start.”

The CDC’s weekly Fluview report summarizes the flu situation as follows: “Influenza activity has decreased in recent weeks, but sporadic activity continues across the country.”

From the Postal reform front, Federal News Network reports that

The Postal Service’s best shot at a long-term legislative reform in recent years is finally moving ahead in Congress next week.

The House expects to vote on the Postal Service Reform Act next week. The House Oversight and Reform Committee approved the legislation last May.

Notably, the most recent version of the bill now has the support of the National Active and Retired Federal Employees (NARFE), which raised significant concerns about an earlier version.

NARFE, in a letter of support Friday, said an earlier version of the bill contained “onerous provisions” that could have increased health insurance premiums for all non-postal federal employees and retires.

The earlier version of the bill, the association added, would have also required current postal retirees to pay additional premiums for mostly duplicative health insurance coverage through Medicare.

Moreover, this afternoon, the Congressional Budget Office released its report on the House Rules Committee Print 117-32 for H.R. 3076, the Postal Service Reform Act of 2022. The FEHBlog does not see any showstoppers in that CBO report. The House Rules Committee has scheduled a hearing on this bill for Monday at 2 pm ET. You can read the current version of the bill here.

Finally, Healthcare Dive reports that

Congress appears poised to work on a bipartisan mental health and substance misuse package this year, following a series of hearings this week stressing the need to boost the workforce, insurer benefits and telehealth access.

Legislators also seemed to support giving federal departments more power to force health insurers to comply with parity laws, following a report in late January finding widespread inequities between mental and medical benefits in the U.S. that sent physician groups up in arms.

That, dear readers, is a big bowl of wrong because the outrage stems from the “non-quantitative treatment limit” mental health parity standard set by the Obama era regulation, not the original law. That standard, in the FEHBlog’s view, is amorphous. The FEHBlog favors mental health parity but please Congress don’t make the standard impossible to achieve consistently. Keep it simple.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, COVID-19 testing, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Juliane Liebermann on Unsplash

From Capitol Hill, Roll Call reports that Congress is not making much progress toward replacing the current continuing resolution funding the federal government with an omnibus bill resolving FY 2022 appropriations. The deadline for Congressional action is February 18. It is starting to look like Congress is headed toward passing another short-term continuing resolution according to the article. Time will tell.

From the Covid testing front, the Biden administration announced today that Medicare will begin direct coverage of over-the-counter Covid tests in the early Spring of this year.

Health Payer Intelligence informs us that America’s Health Insurance Plans wrote a statement to Congress describing the numerous administrative problems created by the “free” Covid test coverage mandates that started nearly two years ago with the CARES Act.

MedPage Today tells us about a human challenge study of the Covid incubation period conducted in London which found that the Covid incubation is only two rather than five days after exposure. Instead the symptoms tend to peak at five days and the virus remains detectable 10 days after exposure.

The Institute for Clinical and Economical Review released a draft assessment of outpatient treatments for Covid including the Pfizer and Merck pills, an intravenously administered recombinant monoclonal antibody (Sotrovimab), and an off-label use of an obsessive-compulsive SSRI drug (Fluvoxamine) for which researchers are seeking an emergency use authorization for Covid. The draft conclusion is that

Our analyses suggest that each outpatient intervention produces improved clinical outcomes. At their current prices, each intervention is estimated to meet standard cost-effectiveness levels in the US health care system, even under a scenario with a lower hospitalization risk that may reflect the current Omicron wave. The cost-effectiveness findings are primarily driven by a treatment’s ability to reduce hospitalization and the baseline probability of hospitalization.

From the No Surprises Act front, the Labor Department helpfully released a transcript of the January 19, 2022, listening session regarding provider nondiscrimination under Section 2706(a) of the Public Health Service Act. The NSA requires the ACA regulators to issue implementing rules for this law which has been in force since 2014.

Also, Kaiser Health News discusses mental health therapist concerns about the good faith pricing estimate for healthcare services that the NSA applies across the board. The law also requires health plans to issue advance explanations of benefits in response to a good faith estimate from a provider. The FEHBlog will never understand why Congress failed to direct HHS to create HIPAA standard transactions for the GFE and the AEOB. In any event, providers and health plans await implementing rules from the ACA regulators.

From the Rx coverage front, Biopharma Dive provide us with two insights

  1. “Biogen recorded $1 million in revenue from its new treatment for Alzheimer’s disease in the last quarter of 2021, offering the latest evidence that the drug, which came to market with multi-billion dollar sales expectations, continues to struggle commercially.”
  2. “AbbVie may soon face competition for its top-selling eye drug Restasis after the Food and Drug Administration on Wednesday approved a generic version.”

From the healthcare business front, Fierce Healthcare fills us in on Cigna’s fourth quarter 2021 financial report.

Midweek update

David Ermer–Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–

Happy Groundhog Day! The Pittsburgh Post Gazette informs us that “There will be six more weeks of winter, Punxsutawney Phil predicted as he emerged from his burrow Wednesday morning to perform his Groundhog Day duties.”

From the White House, we have the President’s fact sheet on his Cancer Moonshot initiative. Federal Times also has a report on today’s announcement.

A STAT News article on cancer markers suggests that the President’s timing may be right

Back in 2000, when President Clinton called a tie in the race to map the human genome, scientists forecasted a medicinal revolution, one in which scientists could ferret out the genetic roots of every known cancer and match patients with personalized treatments.

That did not happen, for reasons of biological complexity, technological immaturity, and perhaps a little scientific hubris. But after two decades of mapping the kaleidoscopic details of human DNA, researchers believe they finally have the tools and techniques to live up to those lofty promises.

“It’s almost like back to the future,” said Anna Barker, an oncologist who serves as chief strategy officer at the Ellison Institute for Transformative Medicine of USC. “Where we would like to have been 21 years ago is where we are now.” * * *

But many cancers don’t fit neatly into the field’s existing paradigm, said Suzanne Topalian, professor of surgery and oncology at Johns Hopkins University School of Medicine. Improving outcomes for those tumors will rely on multidimensional biomarkers, measurements that can take a systematic look at how cancer evolves rather than providing a snapshot.

To Barker, the field’s next major challenge is to find better biomarkers for “the big killers,” diseases including pancreatic cancer and glioblastoma.

“These are the cancers that — what are the unknown unknowns here? What are we missing?” she said. “We can’t seem to detect them early enough to stop them.”

From the opioid epidemic front, the National Institutes of Health informs us that

A new study of intentional drug overdose deaths, or suicides by an overdose of a medication or drug, found an overall decline in recent years in the United States, but an increase in young people aged 15-24, older people aged 75-84, and non-Hispanic Black women. The study also found that women were consistently more likely than men to die from intentional drug overdoses, with the highest rates observed in women ages 45 to 64. In addition, factors such as time of year, length of day, and day of the week appeared to be associated with intentional overdose death rates. The study published today in the American Journal of Psychiatry and was led by investigators at the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

Nearly 92,000 people died from drug overdoses overall in the U.S. in 2020. This represents the largest increase ever recorded in a calendar year and reflects a nearly five-fold increase in the rate of overdose deaths since 1999. About 5% to 7% of these overdose deaths are recorded as intentional. Because it can be difficult to determine whether overdose deaths are intentional, the actual numbers are likely even higher. Many people who have a substance use disorder also develop other mental illnesses, such as mood and anxiety disorders, which are independently associated with increased suicide risk. In addition, many people who are diagnosed with other mental illnesses are often diagnosed with a substance use disorder, emphasizing the need to address co-occurring mental health conditions holistically. 

“The distinction between accidental and intentional overdose has important clinical implications, as we must implement strategies for preventing both,” said Nora Volkow, M.D., senior author on the study and director of NIDA. “To do so requires that we screen for suicidality among individuals who use opioids or other drugs, and that we provide treatment and support for those who need it, both for mental illnesses and for substance use disorders.”

From the antibiotic resistance (“AR”) front, we learn that the CDC has updated its AR investment map.

“Highlights of this year’s AR Investment Map release include:

  • An interactive map showcasing CDC’s antibiotic resistance funding to support activities in every U.S. health department and across hundreds of public health partners
  • An updated fact sheet featuring CDC’s global investments with partners in more than 50 countries to improve detection, prevention, and response to AR threats internationally
  • An updated fact sheet showing how CDC’s COVID-19 efforts have also worked to address antibiotic resistance, including investments in infection prevention and control, training, surveillance, and public health personnel.”

Obviously, this is an important government initiative.

From the healthcare business front —

Anthem is betting on a different strategy than some of its competitors as it looks to transition to value-based care.

The payer is partnering with many value-based clinical platforms like Privia and CareMax to bring physicians into alternative payment models aiming to reimburse for the quality of care delivered, as opposed to pure volume. That’s a different tack on value-based primary care than its peers like UnitedHealth and Humana, which have mostly acquired and built their own clinical networks.

But Anthem is betting its capital-light strategy is more sustainable and flexible as the payer looks to push deeper into capitation to really bend the cost curve.

  • Health Payer Intelligence tells us that

Walmart has partnered with a healthcare machine intelligence company to offer a personalized provider recommendation tool to associates who receive healthcare coverage through the retail giant’s health plan.

The company, Health at Scale, will provide the technology that Walmart intends to integrate into its health plan administrator’s search engine and virtual care referrals, according to the press release.

Associates and their families who are enrolled in Walmart’s health plan and work at select locations will have access to the resource, which aims to facilitate the process of finding a healthcare provider that fits a member’s health needs.

From the Rx coverage front, the always thought provoking Drug Channels opines that

The boffins at the Centers for Medicare & Medicaid Services (CMS) recently dropped the latest National Health Expenditure (NHE) data, which measures all U.S. spending on healthcare. (See links below.) These data provide our first official look at how the pandemic has affected U.S. healthcare spending.

Today, I examine the key insights from these latest figures.

As you will see, outpatient drug spending remains a small—and shrinking—share of the $4.1 trillion spent on U.S. healthcare. What’s more, drug spending again grew more slowly than overall healthcare spending.

Meanwhile, consumers shoulder a much higher portion of this spending compared with their share of hospital spending.

Speaking of CMS that agency today released “the Calendar Year (CY) 2023 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will accept comments on the CY 2023 Advance Notice through Friday, March 4, 2022, before publishing the final Rate Announcement by April 4, 2022.” Here’s a link to the CMS fact sheet.

The FEHBlog wishes that OPM would release a draft call letter for carrier comment before finalizing it. In fairness OPM does solicit carrier input before it draft the call letter. Nevertheless, it would be more collaborative for OPM to seek carrier comment before drafting and then on the first draft.

From the HR front, Federal News Network reports that

A new memo from the Office of Personnel Management released today, offers them performance management tips for a hybrid workplace.

“Effective performance management requires engagement and commitment from individuals at all
levels of an agency,” the memo says. “As such, these performance management tips have been uniquely tailored to assist Non-supervisory Employees, Supervisors, and Leadership throughout the various phases of the performance management cycle.”

And now with agencies expected to begin returning employees to the office in the coming months, OPM wants to make sure managers are “equipped to manage employee performance equitably and effectively—regardless of whether the employees are in the office or not.”

Tuesday’s Tidbits

David Ermer–Congress, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The FEHBlog nearly fell off his office chair when he noticed a Govexec headline this afternoon reading “The House finally plans to vote on Postal reform [HR 3706] next week. The long sought after bill could make it to the President’s desk by the end of the month.” This Postal reform saga has been going on for over a decade.

The Postal reform act (HR 3706) would relieve the Postal Service of the obligation to prefund the cost of FEHB coverage in retirement for its employees. The bill also would create a Postal Service Health Benefits Program (“PSHBP”) within the FEHB Program. The PSHBP would tightly integrate Medicare annuitant coverage with primary Medicare A, B, and D. Medicare Part A (hospital care) is premium free while Medicare Part B (medical care) and Part D (prescription drugs) charge premiums.

OPM encourages Medicare age annuitants to pick up Part B but it prohibits FEHB carriers from using integrated Part D arrangements knowsn as EGWPs even though every other U.S. employer that provides drug coverage to its retirees uses a Part D EGWP or takes the retiree drug subsidy. What’s more Congress in the Medicare Modernization Act of 2003 expressly authorized FEHB plans to use Medicare EGWPs. Go figure.

In any event, all enrollee costs are included in FEHB risk pools which is an important feature of the FEHB Plan and its constituent PSHBP. The cost of Medicare Prime annuitants in the PSHBP will be much lower than those in legacy FEHB, and Medicare Prime annuitants are a signficant cadre of enrollment, PSHBP premiums will be noticeably lower than legacy FEHB premiums.

The CBO has projected that 3/5s of the Medicare integration savings for the PSHBP will come from the Part D EGWPs. The FEHBlog looks forward to the day later this decade when OPM finally permits legacy FEHB carriers to offer Medicare Part D EGWPs.

From the Covid vaccine front —

  • Pfizer and BioNTech have a submitted an emergency use authorization request for an mRNA Covid vaccine for little children aged six months through four years. The FDA and CDC are likely to approve the application by the end of February according to Medscape.

Novavax announced Monday that it has formally submitted a request to the FDA for emergency use authorization of its COVID-19 vaccine for ages 18 and older.

The request includes results from two large clinical trials that showed an overall efficacy of about 90% and a “reassuring safety profile,” the company said.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Stanley Erck, the president and CEO of Novavax, said in the statement.

From the COVID treatment front, the Wall Street Journal reports that providers are having difficulty obtaining the drugs need to treat Omicron because the treatments typically are available under emergency use authorizations and each State makes its own decison on how to distribute EUA treatments. On the brighter side,

Antiviral-pill manufacturers are ramping up production to meet demand. Supplies of Pfizer Inc.’s Paxlovid are expected to increase in the spring, according to Pfizer and state officials. Merck & Co., which manufactures molnupiravir with partner Ridgeback Biotherapeutics LP, said it has delivered two million courses to the U.S. and will deliver the rest of the 3.1 million courses under its contract by the end of this week.

From the healthcare cost front, Healthcare Dive reports that

The omicron variant walloped hospitals in the final month of 2021, driving up both adjusted patient volumes and expenses as the number of COVID-19 cases surged to new highs for the pandemic, according to Kaufman Hall’s latest flash report.

Patient days rose nearly 4% in December compared to November, while emergency department visits jumped more than 7% as patients came in with COVID-19 symptoms. Omicron’s rapid spread drove a 98% jump in COVID-19 hospitalizations over the course of the month, Kaufman Hall said, citing Centers for Disease Control and Prevention data.

The second full year of the pandemic was marked by an increase in severely ill patients requiring longer hospital stays compared to the first year, the report also found.

From the No Surprises Act front, Healthcare Dive examines healthcare provider association legal challenges to the federal regulators’ use as the qualifying payment amount in NSA arbitrations. The FEHBlog has described those cases now pending in federal district courts in Texas and Washington DC as exercises in futility. For example,

Since the qualifying payment amount represents the median in-network rate, it by definition means that half of providers are below the QPA and half are above, according to Chris Garmon, a professor at University of Missouri – Kansas City, who has studied surprise billing. Not all providers are set to see payments decline and some may even see them increase if the QPA is used, he said.

The good professor overlooks the fact that in 2021 out of network doctors caring for patient at in-network facilities were reimbursed at out-of-network rates typically two or perhaps three times the Medicare RBRVS reimbursement. For that reason, the FEHBlog expects that in most cases the QPA will be noticeably higher than pre-NSA reimbursements. Time will tell, but the regulators’ approach is reasonable, and patient advocacy groups have been supporting the regulators in these cases.

From the mental health parity front, Health Payer Intelligence compares provider and payer reactions to the government’s recent report to Congress on payer compliance with complex federal health parity act rules.

From the healthcare business front, Fierce Healthcare tells us that

GuideWell, the parent company of Blue Cross and Blue Shield of Florida, has closed its acquisition of Triple-S Management Corporation, a Puerto Rico-based health services company.

The deal was first announced in September.

GuideWell acquired all shares of Triple-S at $36 per share in cash, according to an announcement from the company. Triple-S will now operate under its existing branding as a wholly owned subsidiary of GuideWell.

From the FDA front, check out this FDA news roundup.

From Capitol Hill, Govexec reports on OMB acting director’s Shalonda Young’s confirmation hearings to be the Presidentially nominated OMB director. Ms. Young appears on her way to confirmation.

Monday Roundup

David Ermer–CDC, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Rx coverage, U.S. Healthcare–

It has been quite a day in COVID vaccine news. This morning, the New York Times reported that

The C.D.C. has begun to publish data on Covid outcomes among people who have received booster shots, and the numbers are striking:

As you can see, vaccination without a booster provides a lot of protection. But a booster takes somebody to a different level.

This data underscores both the power of the Covid vaccines and their biggest weakness — namely, their gradual fading of effectiveness over time, as is also the case with many other vaccines. If you received two Moderna or Pfizer vaccine shots early last year, the official statistics still count you as “fully vaccinated.” In truth, you are only partially vaccinated.

Once you get a booster, your risk of getting severely ill from Covid is tiny. It is quite small even if you are older or have health problems.

The average weekly chance that a boosted person died of Covid was about one in a million during October and November (the most recent available C.D.C. data). Since then, the chances have no doubt been higher, because of the Omicron surge. But they will probably be even lower in coming weeks, because the surge is receding and Omicron is milder than earlier versions of the virus. For now, one in a million per week seems like a reasonable estimate.

Later in the day, AHIP informed us that

Today, the U.S. Food and Drug Administration (FDA) approved a second COVID-19 vaccine.  The Moderna COVID-19 vaccine has been approved for the prevention of COVID-19 in individuals 18 years of age and older.  The vaccine will be marketed as Spikevax.

Spikevax meets the FDA’s standards for safety, effectiveness, and manufacturing quality required for approval.  Spikevax has the same formulation as the Moderna COVID-19 Vaccine which held emergency use authorization (EUA) and is administered as a primary series of two doses, administered one month apart.  Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.

The Moderna vaccine has been available under EUA for individuals 18 years of age and older since December 18, 2020.  The Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine.

Please send any comments or questions to Chris Regal (cregal@ahip.org).

Now both the Pfizer and Moderna mRNA vaccines have FDA marketing approval which allows for wider distribution.

Notwithstanding these advances, the Wall Street Journal calls to our attention the unfortunate fact that

Two years into the Covid-19 pandemic, America’s death toll is closing in on one million. 

Federal authorities estimate that 987,456 more people have died since early 2020 than would have otherwise been expected, based on long-term trends. People killed by coronavirus infections account for the overwhelming majority of cases. Thousands more died from derivative causes, like disruptions in their healthcare and a spike in overdoses.

Covid-19 has left the same proportion of the population dead—about 0.3%—as did World War II, and in less time.

Unlike the 1918 flu pandemic or major wars, which hit younger people, Covid-19 has been particularly hard on vulnerable seniors. It has also killed thousands of front-line workers and disproportionately affected minority populations. 

It robbed society of grandparents, parents, spouses, sons and daughters, best friends, mentors, loyal employees and bosses. Those lost include a 55-year-old Rhode Island correctional officer; a 46-year-old Texas dental-office receptionist who helped care for her granddaughter; a 30-year-old Iowan who fatally overdosed; and an active 72-year-old and grandmother of 15 who was Nashville’s first female city bus driver.

“It’s catastrophic,” said Steven Woolf, director emeritus at the Center on Society and Health at Virginia Commonwealth University. “This is an enormous loss of life.”

Unquestionably so.

From the Covid vaccine mandate front, Govexec.com reminds us that the federal District Court’s nationwide stay of the President’s September 2021 executive order does not apply to agency mandates that were implemented before the President’s executive order. For example,

The Veterans Affairs Department * * * is keeping its vaccine mandate in place for the vast majority of its workers. All employees of the Veterans Health Administration—about 380,000 workers—will still be subject to a vaccine requirement. VA issued its own mandate for those employees in July, prior to Biden’s executive order for the rest of the federal workforce. * * *

While 98% of the VA workforce was already in compliance with Biden’s order prior to the pandemic, only 89% had been vaccinated—one of the lowest rates of any large federal agency. McDonough had warned in certain medical settings the department would reject exemption requests, meaning those employees would have to get their shots or face discipline. VA is still sorting through those requests for Veterans Health Administration personnel.

In healthcare business news, Healthcare Dive tells us that

The Cleveland Clinic had its strongest financial performance ever in 2021, as the pandemic drove record levels of clinical activity — and subsequent revenue.

The Ohio-based academic medical giant’s total operating revenue reached $12.4 billion last year, up 17% from 2020’s topline. Operating income was $746 million, more than three times 2020’s operating income of $232 million. Both metrics, released last week by CEO Tom Mihaljevic in an annual address, were also notably higher than the system’s pre-pandemic performance in 2019.

Cleveland Clinic conducted 10.4 million outpatient visits — the nonprofit’s first time exceeding 10 million patient visits in a year — and had more than 22,800 COVID-19 admissions.

From the benefit design front, Axios reports that

“Employers are beefing up benefits packages to lure workers in a tight labor market, and many are adding pricey fertility benefits — such as in-vitro fertilization and egg freezing — to their offerings.

“Why it matters: Benefits around fertility and family-building have long been overlooked by employer health care plans, but that’s rapidly changing.

  • “You see couples today that are living child-free, and a lot of times that’s their decision, but a lot of times it’s not,” says Gina Bartasi, founder and CEO of the fertility clinic Kindbody.
  • Employers can play a vital role in helping people find alternative options to grow their families, she says.

“What’s happening: “Earlier in my career, it was so rare for companies to offer this,” says Alice Vichaita, head of global benefits at Pinterest, which covers fertility services for its global workforce. “More and more companies are becoming aware that this is really an inadequacy in our health care system.”

  • In the past, many companies have avoided offering fertility benefits due to concerns about the cost, according to a Mercer report. But the rise in the number of fertility clinics — and growing demand for their services — is driving down the price, Bartasi says.
  • 97% of employers who provide this coverage say it has not resulted in a significant increase in medical plan costs, per a Mercer survey.”

From the Rx coverage front, Fierce Healthcare lets us know that

While much of the energy in the drug pipeline has centered on orphan drugs, novel therapies in more crowded markets have also been marching toward approval, according to a new report from Optum.

Analysts at OptumRx released the pharmacy benefit manager’s quarterly drug pipeline report, which highlights therapies in the pipeline insurers should be keeping an eye on. All three drugs mentioned in this quarter’s report would enter hot markets should they be approved.

“Even in these competitive landscapes, we do see novel therapies approved,” Arash Sadeghi, clinical pharmacist at OptumRx, told Fierce Healthcare.

The report includes three drugs: tezepelumab—which was approved in December under the brand Tezspire [an asthma treatment] —cabotegravir [an injectable for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV] and vadadustat [a pill to treat anemia in adults with chronic kidney disease].

Weekend update

David Ermer–Congress, COVID treatment, COVID-19–

Both Houses of Congress are in session this week for Committee business and floor voting.

The FEHBlog notes that the President’s nominee for Office of Management and Budget, acting Director Shalonda Young, and her designated replacement to serve as Deputy OMB Director, Nani Coloretti, will be attending their Senate confirmation hearings this week.

The current continuing resolution funding the federal goverment expires on February 18, 2022. The Hill reports that

Congressional negotiators are in danger of missing the Feb. 18 deadline for passing an omnibus package of the annual appropriations for fiscal 2022.

A shutdown is unlikely, but members of the Senate Appropriations Committee from both parties warn that if negotiators blow through the mid-February deadline, it increases the likelihood that Biden will have to settle for a yearlong stopgap funding measure to keep the government open.

At this point the budget ball is in the Senate’s hands. The Hill further states

Spokespeople for the two senior negotiators [at the Senate] declined to comment in detail on the talks.  

“The negotiations are ongoing, and it remains the chairman’s goal to complete those negotiations by Feb. 18,” said Jay Tilton, a spokesman for Leahy.  

Blair Taylor, a spokeswoman for Shelby, said, “We are working diligently to create a product that is palatable to everyone — bills that can advance through Congress and be signed into law by the president.”  

From the Omicron front, the Wall Street Journal reports that

The Omicron variant spreads so quickly and generally causes such a mild form of illness among vaccinated populations that countries are tolerating greater Covid-19 outbreaks, willingly letting infections balloon to levels that not long ago would have been treated as public-health crises.

From different starting points, authorities in North America, Europe, and the Asia-Pacific are moving in the same direction, offering a glimpse into a future in which Covid-19 becomes accepted as a fact of everyday life, like seasonal flu.

Health officials everywhere, many for the first time, are forgoing some of the sharpest tools they have to combat Omicron—even as infections soar. They are accepting the virus-like never before to minimize disruptions to economies, education, and everyday life.

At the moment, deaths and hospitalizations are at highs in many countries, and in some, hospitals are overwhelmed. But they are a much lower percentage of total cases than earlier waves. Vaccines have made the disease less deadly, and treatments hold a greater promise of recovery for those who are infected and get seriously ill.

That improving outlook, coupled with the reality that the measures taken to contain earlier surges of the virus don’t work as well against the more-contagious Omicron, is informing the decision by policymakers to abandon restrictive steps aimed at containment amid growing public fatigue over restrictions.

On a related note, Bloomberg tells us that

The omicron subvariant, BA.2, appears to be more contagious but data so far doesn’t show it’s more dangerous or that it evades protection from vaccines, said Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration. 

At worst, the strain could slow down the decline in omicron infections in the U.S., Gottlieb, a Pfizer Inc. board member, said on CBS’s “Face the Nation.” The subvariant has been found in small numbers in about half of U.S. states. 

“I don’t think it really changes the narrative,” he said. “I don’t think this is going to create a huge wave of infection.”

From the Covid pill front, ABC News informs us that “Promising COVID-19 antiviral pill, Paxlovid, in scarce supply, as doctors, patients compete for access.”

[Due to manufacturing issues,] [t]he current plan calls for 265,000 courses of treatment in January, gradually ramping up to 10 million by the end of June and 20 million by the end of September.

[However, s]carcity isn’t the only problem. Doctors and pharmacists told ABC News the process of obtaining the drug is opaque, even arbitrary.

In Nevada, for example, Paxlovid primarily goes to long-term care facilities like nursing homes. But in neighboring California, state officials use a complex formula that factors in rising case numbers with other risk factors. In the District of Columbia, a few Safeway grocery stores are the primary distributors, although city health officials have asked doctors to give priority to high-risk individuals.

Bloomberg adds that

New York City will provide free antiviral pills, home-delivered, to people who test positive and are at higher risk from Covid-19, Mayor Eric Adams announced on Sunday.  * * * Both oral anti-viral medications approved by the U.S. Food and Drug Administration — paxlovid from Pfizer Inc. and molnupiravir from Merck Inc. — will be available though in limited quantities, according the a City Hall press release. They will be delivered in partnership with Alto Pharmacy. 

Cybersecurity Saturday

David Ermer–Uncategorized–

From inside the Capital Beltway

Cyberscoop reports that cybermeasures are gaining momentum at federal agencies in response to the President’s May 2021 executive order and increased funding from Congress.

Security Week adds that

The White House on Wednesday released its federal zero trust strategy, requiring agencies to meet certain cybersecurity standards and objectives by the end of fiscal year 2024. * * *

When a zero trust model is implemented, no user, system, network or service operating inside or outside the security perimeter is trusted, and every access attempt is verified.

The latest memorandum from the Office of Management and Budget (OMB) requires agencies to achieve certain goals by the end of 2024. These goals focus on identity, devices, networks, applications and workloads, and data — these are the five pillars described by the zero trust model of the DHS’s Cybersecurity and Infrastructure Security Agency (CISA).

From the Log4j vulnerability front, ZDnet warns that the threat is not over yet.

Despite the absence of immediate mass exploitation, Sophos security’s Chester Wisniewski backs the view that it will be a target for exploitation for years to come. 

Microsoft continues to rate the Log4j vulnerabilities as a “high-risk situation” for companies across the globe and reckons there is high potential for their expanded use. But for now, Wisniewski believes an immediate crisis has been swerved.   

“[T]he immediate threat of attackers mass exploiting Log4Shell was averted because the severity of the bug united the digital and security communities and galvanised people into action. This was seen back in 2000 with the Y2K bug and it seems to have made a significant difference here,” says Wisniewski. * * *

As for the duration of Log4Shell, Wisniewski reckons internet-facing applications will be found and patched or taken offline. But that still leaves a ton of internally vulnerable systems that might never be discovered, hence Log4Shell will live on for years as a favorite target for penetration testers and state-backed threat actors. 

From the cyber-agency front —

  • HC3 released an analyst note “with updated information regarding the BlackMatter ransomware-as-a-service (RaaS) program. While HC3 previously identified multiple healthcare and public health (HPH) sector or health sector- affiliated organizations impacted by this malware, the group has not claimed a victim since October 31, 2021 and appears to have shut down operations. HC3 is reducing the threat level posed by BlackMatter to BLUE or GUARDED.”
  • NIST released version 5 of NIST 800-53A.

This publication provides a methodology and set of procedures for conducting assessments of security and privacy controls employed within systems and organizations within an effective risk management framework. The assessment procedures, executed at various phases of the system development life cycle, are consistent with the security and privacy controls in NIST Special Publication 800-53, Revision 5. The procedures are customizable and can be easily tailored to provide organizations with the needed flexibility to conduct security and privacy control assessments that support organizational risk management processes and are aligned with the stated risk tolerance of the organization. Information on building effective security and privacy assessment plans is also provided with guidance on analyzing assessment results.

From the ransomware front, Cyberscoop reports that

The REvil (Sodinokibi) ransomware cooperative’s activity has not slowed down following Russia’s recent move to arrest several alleged members of the group, according to threat intelligence company ReversingLabs.

Two weeks have passed since Russia’s law enforcement agency FSB announced the takedown of the REvil group “at the request of US authorities,” but the ransomware-as-a-service (RaaS) enterprise remains as active as before.

After long being accused of allowing cybercriminals to proliferate within its borders – as long as Russian nationals or organizations are not hurt – Russia appeared set to send a different message with the arrest of 14 members of the REvil gang, even if some saw it as a political move – amidst the increasing tensions at the Ukraine border.

However, as ReversingLabs points out, the high-profile arrests of affiliates did not put a dent in REvil operations. In fact, the group is continuing operations at the very same pace as just before the arrests.

What’s more, here’s a link to the latest edition of Bleeping Computer’s the Week in Ransomware.

This week’s biggest news is about a new ransomware operation called DeadBolt encrypted QNAP [storage] devices worldwide, illustrating how threat actors can still earn a lot of money by targeting consumers and small businesses.

The attacks started on January 25th and have since encrypted over 4,300 QNAP NAS devices where they demand 0.03 bitcoins, worth approximately $1,100, for a decryption key.

The attacks started on January 25th and have since encrypted over 4,300 QNAP NAS devices where they demand 0.03 bitcoins, worth approximately $1,100, for a decryption key.

Finally from the cyberprevention front

  • Cybersecurity Dive informs us about cybersecurity tool trends to watch this year — both from the waxing and waning standpoints.
  • ISACA writes about the important role that company culture plays in maintaining reliable cybersecurity.