FEHBlog

Weekend update

Vince Lombardi Trophy

Happy Super Bowl Sunday!

The House of Representatives will engage in limited Committee business this week while the Senate will convene for Committee business and floor voting. Indeed, tomorrow the Senate will resumes consideration of the motion to proceed to H.R.3076, Postal Service Reform Act of 2022.

The Wall Street Journal observes that Congress has passed several bills on a bipartisan basis since the President’s Build Back Better plan stalled on Capitol Hill.

Already, bills to make the U.S. Postal Service more financially viable, boost U.S. competitiveness with China and ban mandatory arbitration in cases of sexual assault and harassment have picked up steam in Congress. Senators passed the arbitration bill by voice vote, sending it to the president’s desk without a single member of either party demanding a roll call to record yeas and nays.

Legislators also announced an agreement on a framework for legislation to fund the federal government through fiscal year 2022, and a deal to reauthorize a landmark domestic-violence bill, which lapsed in 2019.

Pretty, pretty good.

From the national health emergency front, Vox tells us the latest about the second Omicron variant, and The New York Times’ Morning column reviewed the disgraceful course of our country’s opioid epidemic. The article concludes

“The solutions are costly. A plan that President Biden released on the campaign trail, which experts praised, would total $125 billion over ten years. That’s far more than Congress has committed to the crisis. Lawmakers haven’t taken up Biden’s plan, and the White House hasn’t pushed for it, so far embracing smaller steps.
“But inaction carries a price, too. Overdose deaths cost the economy $1 trillion a year in health expenses, reduced productivity and other losses, a new  report concluded — equivalent to nearly half of America’s economic growth last year.”

While the FEHBlog has not read the President’s plan, he does believe that a solution is desperately needed.

From the healthcare business front, Fierce Healthcare reviews the fourth quarter of 2021 financial results of significant health payers. At the top of the head were United Health Group and CVS Health /Aetna. “Both healthcare giants expect to top $300 billion in revenue this year, according to their forecasts.”

From the compliance front, Healthcare Dive reports

An analysis of 1,000 U.S. hospitals found that only 14.3% were complying with federal price transparency rulesand about 38% of hospitals posted a “sufficient amount of negotiated rates” on their websites.

The PatientRightsAdvocate.org analysis follows a report in July 2021 that showed only 5.6% of 500 random hospitals were in compliance with the rules that were introduced at the start of 2021.

“The largest hospital systems are effectively ignoring the law with no consequences,” the 61-page report said, noting that only two hospitals of 361 at three of the largest hospital systems were in compliance.

The FEHBlog wonders whether compliance would be higher if the compliance deadline (January 1, 2021) had not been at the height of a COVID surge in the ongoing pandemic.

From the preventive care front, the FEHBlog noticed in Health Payer Intelligence a Medicare national coverage determination on lung cancer screening that aligned Medicare coverage with a 2021 U.S. Preventive Services Task Force B graded recommendation.

This in turn reminded the FEHBlog that FEHB plans must cover all 21 USPSTF A and B graded recommendations made in 2021 with no member cost-sharing when delivered in-network beginning January 1, 2023. The FEHBlog counted a dozen such 2021 recommendations in the USPSTF list. Standing alone, those are a lot of changes to include in the 2023 benefit and rate proposals at the end of May 2022.

From the general healthcare front, NPR explains that the surprising details of the 65-year-old actor and comedian Bob Saget disclosed last week illustrate the importance of seeking immediate medical attention if you suffer a blow to your head.

According to his family, [Mr. Saget] “accidentally hit the back of his head on something, thought nothing of it and went to sleep.” No drugs or alcohol were involved, according to a coroner’s report.

Saget had “fractures to the back of his head and around his eyes” at the time of his death, according to an autopsy report from the Orange County, Fla., medical examiner obtained by People. Saget was also COVID-19 positive at the time of his death, the autopsy noted.

While details of how exactly Saget hit his head were not released, doctors stress the importance of seeking medical care immediately if you sustain a head or brain injury.

If you are concerned that you may have a head injury, consider getting yourself checked out,” said Dr. Amit Sachdev, medical director in the department of neurology at Michigan State University.

“Unfortunately, it’s all too common and we in neurology see it quite frequently that head injuries lead to bleeding,” said Sachdev.

The FEHBlog wonders what would have happened if Mr. Saget had been wearing an Apple watch with a fall detection monitor.

Cybersecurity Saturday

Today is the 113th anniversary of the birth of President Abraham Lincoln who, in the FEHBlog’s opinion, is the best President our Nation ever had.

From the federal legislative and regulatory proposals front —

Nextgov tells us

[On February 8, 2022] Leaders of the Homeland Security and Governmental Affairs Committee introduced the Strengthening American Cybersecurity Act bundling provisions they view as crucial in the wake of vulnerabilities like one found in open-source software library log4j, but couldn’t get over the finish line in previous attempts.

“This landmark, bipartisan legislative package will provide our lead cybersecurity agency, [the Cybersecurity and Infrastructure Security Agency], with the information and tools needed to warn of potential cybersecurity threats to critical infrastructure, prepare for widespread impacts, coordinate the government’s efforts, and help victims respond to and recover from online breaches,” Committee Chairman Gary Peters, D-Mich., said in a press release Tuesday. “Our efforts will significantly bolster and modernize federal cybersecurity as new, serious software vulnerabilities continue to be discovered, such as the one in log4j. This combined bill will also ensure that agencies can procure cloud-based technology quickly, while ensuring these systems, and the information they store, are secure.” 

Health IT Security adds that also last week, “US Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduced the Health Data Use and Privacy Commission Act intending to modernize health data privacy laws to reflect the current tech landscape. * * * If passed, the act would establish a commission to review existing health data protections and assess current practices for health data use. The commission, whose members would be appointed by the Comptroller General, would also submit a report to Congress and the President six months after formation with recommendations on modernizing health data privacy.”

Evidently, in furtherance of this legislative proposal, AHIP announced  its “core guiding priorities and a detailed roadmap to further protect the privacy, confidentiality, and cybersecurity of consumer health information.”

Reginfo.gov tells us that the Office of Management and Budgets’ Office of Information and Regulatory Affairs has received for its review the following: “HIPAA Rules: Request for Information on Sharing Civil Money Penalties or Monetary Settlements With Harmed Individuals, and Recognized Security Practices Under HITECH.” As the HITECH Act of 2009 asked the Department of Health and Human Services to issue such a rule, this RFI falls into the better late than never category.

From the Apache Log4j vulnerability front, Cybersecurity Dive reports

Apache Software Foundation President David Nalley on Tuesday told the Senate Homeland Security & Government Affairs Committee it could take months, or even years, to fully eliminate the Log4j vulnerability. 

Every stakeholder in the software industry, especially the federal government and major customers, should be investing in supply chain security, Nalley said. He endorsed efforts like the software bill of materials (SBOM), but said the legislation won’t prevent vulnerabilities, only uncover them more quickly. 

Sen. Alex Padilla, D-Calif., raised questions over whether there is a “free rider” problem where large companies benefit from open source contributors, while providing very little compensation in return.

Another Cybersecurity Dive article explains

Security flaws in free and open-source software (FOSS) will be a recurring source of cyber risk, Moody’s Investors Service found. It could take organizations three to five years to fully resolve issues related to the Log4j vulnerability.

Certain industries vary in their ability to respond to vulnerabilities, according to 2021 data from BitSight, a Moody’s partner on cyber issues. The telecommunications industry trails other sectors, remediating only 29% of critical vulnerabilities within 90 days. The legal industry, with the quickest response time, remediated 68% of critical vulnerabilities in the same time frame.

The use of FOSS can save organizations considerable time and funding. But issues remain about the lack of financial support and, due to the voluntary participation of many contributors, developers experience high levels of burnout. * * *

While open source helps organizations save considerable time and effort on development, security concerns must be accounted for, said Sandy Carielli, a principal analyst at Forrester.

“However, the mistake is to assume that you can grab an open source library and then never look at it or update it again,” Carielli said via email. “Organizations need to get better about managing their open source — understanding where it is used and automating updates so that when something like Log4j happens, it’s a blip on the radar and can be remediated with practiced upgrade procedures.”

The Moody’s report follows a January report from Fitch warning about the increased cyber risk of Log4j to public finance entities, including local governments, small utilities and critical infrastructure providers. 

From the cybersecurity business front, Cyberscoop informs us

Sustained demand for cybersecurity services and continued innovation across the industry helped 2021 become a record-setting year for deals involving cyber companies, analysts say.

The funding that flowed into cyber companies increased 136% over 2020 levels, to $29.3 billion, up from $12.4 billion the previous year, according to a report published Wednesday by Momentum Cyber, which advises cyber companies on mergers and acquisitions.

Likewise, the total volume of mergers and acquisitions activity reached $77.5 billion, up 294% from calendar year 2020, according to the report.

Several trends are driving those numbers, analysts and executives say: Companies across the economy have expanded their budgets for reliable cybersecurity services, boosting revenues for the industry. In turn, big investors — including private equity groups and venture capitalists — are following that money. And as cyberthreats increase in severity and complexity, smaller firms continue to develop valuable expertise in niche areas of information security.

From the government alert front, the HHS Cybersecurity Program issued an alert last week captioned “Indicators of Compromise Associated with LockBit 2.0 Ransomware and Additional Mitigations.”

Also,

“The Cybersecurity and Infrastructure Security Agency (CISA), along with the Federal Bureau of Investigation (FBI), National Security Agency (NSA), Australian Cyber Security Centre (ACSC), and the United Kingdom’s National Cyber Security Centre (NCSC-UK) issued a joint Cybersecurity Advisory outlining the growing international threat posed by ransomware over the past year.  

“The advisory titled “2021 Trends Show Increased Globalized Threat of Ransomware” outlines top trends seen across three nations including:

  • Cybercriminals are increasingly gaining access to networks via phishing, stolen Remote Desktop Protocols (RDP) credentials or brute force, and exploiting software vulnerabilities.
  • The market for ransomware became increasingly “professional” and there has been an increase in cybercriminal services-for-hire.
  • More and more, ransomware groups are sharing victim information with each other, including access to victims’ networks.
  • Cybercriminal are diversifying their approaches extorting money.
  • Ransomware groups are having an increasing impact thanks to approaches targeting the cloud, managed service providers, industrial processes and the software supply chain.
  • Ransomware groups are increasingly targeting organizations on holidays and weekends.

“Importantly, today’s Cybersecurity Advisory also lays out mitigations to help network defenders reduce their risk of compromise, appropriate responses to ransomware attacks, and key resources from each respective cyber agency.”

Here is a link to that advisory and, of course, a link to Bleeping Computer’s The Week in Ransomware.

Happy Super Bowl weekend.

Friday Stats and More

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog’s latest chart of weekly new Covid cases from the 27th week of 2021 through the 6th week of 2022.

The chart shows a steep drop in Covid cases this year. Yet, according to the CDC, the rate of Omicron transmission remains high across our country. The CDC also reports

The current 7-day daily average for February 2–February 8, 2022, was 12,099 [new Covid hospitalizations]. This is a 25.4% decrease from the prior 7-day average (16,212) from January 26–February 1, 2022.

For the reasons explained in this Medscape article, the weekly count of Covid deaths continues to increase.

Finally, here is the FEHBlog’s chart of weekly Covid vaccinations distributed and administered.

New vaccinations, including boosters, have run under four million weekly for the past two weeks.

Here is a link to the CDC’s weekly review of its Covid statistics. The CDC’s critical observation is as follows:

COVID Data Tracker shows that as of February 10, 2022, about 213.4 million people, or 64.3% percent of the total U.S. population, have received a primary series of a COVID-19 vaccine.

However, only about half of those eligible to receive a booster dose have done so. Everyone ages 12 years and older should get a booster shot after they have completed their COVID-19 vaccine primary series. Omicron is extremely contagious, and even though overall severity is lower, the high volume of hospitalizations has strained the healthcare system. Being up to date with vaccination, in coordination with other key prevention strategies, is critical for preventing severe illness from COVID-19 and for reducing the likelihood of new variants from emerging. Find a vaccine provider and get your booster dose as soon as you can.

CDC’s Fluview adds “Sporadic influenza activity continues across the country.” The 2021 and 2002 winters have featured many Covid infections, but not that many flu infections.

The Wall Street Journal reports

U.S. drug regulators authorized the use of a new Covid-19 antibody drug from Eli Lilly & Co. that retains effectiveness against the Omicron variant of the virus, filling a void after authorities stopped distributing some older antibody drugs that lost effectiveness against the strain.

The Food and Drug Administration on Friday cleared the drug, bebtelovimab, for the treatment of mild to moderate Covid-19 in nonhospitalized individuals 12 and older who are at high risk of getting severely sick. The drug is intended for people who can’t get access to alternative Covid-19 treatments, or for whom those treatments aren’t appropriate.

Yesterday, the Biden administration announced the purchase of 600,000 courses of this drug.

From the Covid vaccine front, the Journal further reports that the Food and Drug delayed consideration of granting emergency use authorization to the Pfizer BioNTech Covid vaccine for children ages six months through four years.

The FDA had been considering a request by the companies to clear the use of two doses of the vaccine. The agency was then going to look at expanding the authorization to a third dose, should the study show it works safely.

The new move [to consider all three dose at one time] will delay the rollout of the shot for children younger than 5, the last age group without access to vaccination.

Pfizer and BioNTech said they expect results on whether three doses of the vaccine works safely in early April. Researchers are collecting more data, including from more children in the study who have become infected as more time has passed.

The FEHBlog, who has young grandchildren, honestly does not understand why the government has been pushing so hard to vaccinate this age group.

From the opioid epidemic front, the American Medical Association informs us

The New York Times (2/10, Hoffman) reports that on Thursday, the CDC “proposed new guidelines for prescribing opioid[s]…that remove its previous recommended ceilings on doses for chronic pain patients and instead encourage doctors to use their best judgment.” Although they are “still in draft form, the 12 recommendations…are the first comprehensive revisions of the agency’s opioid prescribing guidelines since 2016,” and “they walk a fine line between embracing the need for doctors to prescribe opioids to alleviate some cases of severe pain while guarding against exposing patients to the well-documented perils of opioids.”

The AP (2/10, Stobbe) reports that the proposed changes are “contained in a 229-page draft update in the Federal Register,” and “the CDC will consider comments before finalizing the updated guidance.”

The Washington Post (2/10, Bernstein) reports that in a statement, AMA Board of Trustees Chair Bobby Mukkamala, M.D., said, “for nearly six years, the AMA has urged the CDC to reconsider its problematic guideline on opioid prescriptions that proved devastating for patients with pain. The CDC’s new draft guideline – if followed by policymakers, health insurance companies and pharmacy chains – provides a path to remove arbitrary prescribing thresholds, restore balance and support comprehensive, compassionate care.”

From the quality metrics front, NCQA released its proposed HEDIS and CAHPS changes for the 2023 measurement year today. NCQA is proposing to retire the CAHPS flu vaccination measure, which currently is included in OPM’s set of QCR measures used in the Plan Performance Assessment program. NCQA’s public comment period on the proposed changes closes on March 11.

From the Rx coverage front, STAT News tells us

In a move hailed by pharmacies, the U.S. Federal Trade Commission plans to vote later this month on whether to examine pharmacy benefits managers and how their controversial practices affect independent and specialty pharmacy operations.

The agency disclosed the planned Feb. 17 vote in a brief notice that specified interest in the “competitive impact of contractual provisions and reimbursement adjustments, and other practices affecting drug prices,” but did not provide any further detail. An FTC spokesperson wrote us that additional information will not be released until the upcoming meeting.

The FEHBlog will keep an eye on this vote.

From the Aduhelm front, Health Payer Intelligence discusses AHIP’s comments supporting CMS’s decision to provide very limited coverage of this drug in Medicare.

From the healthcare business front, Fierce Healthcare reports

Kaiser Permanente [the third largest carrier in the FEHB Program] reported $3 billion in net income for the second quarter of the year as membership in its health plan remains steady.

The health system and insurer posted total operating revenues of $23.7 billion against total operating expenses of $23.3 billion. The revenue was slightly above the $22.1 billion it earned in the second quarter of 2020.

Kaiser noted in its earnings statement Friday that favorable financial market conditions resulted in $3 billion in net income, compared with $4.5 billion for the second quarter of 2020.

“The COVID-19 health threat is not over, and we will continue to focus our resources on providing needed care for our patients and increasing vaccination rates to protect the health and safety of our workforce, members and the communities we serve,” said Kaiser CEO Greg Adams in a statement.

If you have time over the Super Bowl weekend, listen to or read Econtalk host Russ Robert’s discussion with macroeconomist John Taylor about inflation. Mr. Taylor created the Taylor Rule “that prescribes a value for the federal funds rate—the short-term interest rate targeted by the Federal Open Market Committee (FOMC)—based on the values of inflation and economic slack such as the output gap or unemployment gap.”

Thrsday Miscellany

Photo by Juliane Liebermann on Unsplash

From the Postal Reform front, health benefits expert Robert Moffitt, whose work the FEHBlog admires, wrote a column titled “It’s a bad idea to use the Medicare to bail out the Postal Service.” On this occasion, the FEHBlog finds himself in disagreement with Mr. Moffitt.

  1. Medicare is not bailing out the Postal Service. Since 1984, the Postal Service and its employees has paid and continues to pay Medicare taxes for its employees until they retire. At that point, Medicare becomes primary to FEHB and other group health coverage by law.
  2. Every other business in America that provides health benefits coverage to its retirees essentially follows the same approach as the Postal Service will be authorized to do by this bill.
  3. The Postal reform bill is unique in that it creates a special Part B enrollment period for current annuitants as of January 1, 2024, who have Part A but declined to enroll for Part B, an option which OPM encourages. Under the bill that that House passed this week, the Postal Service will bear the cost of the late enrollment penalties associated with this special enrollment period.
  4. Mr. Moffitt suggests that Postal Service Health Benefit Program (PSHBP) Medicare annuitants may find it necessary to purchase Medicare supplement insurance. However, we know from experience that PSHBP plans will follow the practice of existing FEHB plans and wrap their benefits around Medicare to fill those Medicare gaps. The PSHBP coverage is the Medicare supplemental coverage available to Medicare annuitants in FEHB and the PSHBP, and more tightly integrating PSHBP and Medicare coverage will result in lower premiums for all PSHBP enrollees.

Bear in mind that studies have shown the group health plans subsidize Medicare by making payments to healthcare providers that substantially exceed Medicare’s low reimbursements.

From the No Surprises Act (“NSA”) front —

  • CMS issued more FAQs on the federal independent dispute resolution (“IDR”) process today.
  • Consumer Reports identifies five healthcare scenarios which fall outside the scope of the No Surprises Act.
  • Fierce Healthcare brings us up to date on the healthcare provider association lawsuits challenging the federal government’s decision to treat the NSA’s qualifying payment amount as the lodestar in federal IDR arbitrations.

From the Omicron front, Medscape reports that “The U.S. government is planning to roll out COVID-19 shots for children under the age of 5 as soon as Feb. 21, according to a document from the U.S. Centers for Disease Control and Prevention. * * * Young children [beginning at six months] will receive a lower dose of the vaccine, if it is authorized. Pfizer/BioNTech tested a 3-microgram dose of the vaccine in the age group, compared with a 10-microgram dose in 5- to 11-year-olds and 30 micrograms for people aged 12 and older.”

Also, the Department of Health and Human Services announced that “the federal government has purchased 600,000 treatment courses of a new monoclonal antibody treatment that data shows works against the Omicron variant. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge.”

From the COVID vaccine mandate front, Govexec tells us

A federal appeals court has denied the Biden administration’s request to undo the pause on its COVID-19 vaccine mandate for federal employees, leaving in place a ban on agencies enforcing the requirement. The U.S. Court of Appeals for the Fifth Circuit opted not to weigh in on the Justice Department’s petition for immediate relief, meaning the mandate will likely remain enjoined for at least several months. The only path for quicker resolution would be for the administration to appeal further tNBo the Supreme Court, an option it has not yet said it will explore. A Justice spokeswoman declined to comment. 

From the miscellany department

  • NIH News discusses advances in breast cancer screening and treatment.

The clipboard of paper forms that for decades has been a standard part of Americans’ doctor visits may soon be a thing of the past. 

Federal authorities who oversee health technology have set a deadline for December for the health care industry to support smartphone apps, like Apple Health, that store records electronically. 

Their goal is to have patients use their phones to electronically share records with a doctor’s office or hospital — without a pen and paper, if they choose. 

“Patients ought to be able to use the app of their choice,” said Micky Tripathi, who’s helping to put the federal rules in place as the Biden administration’s national coordinator for health information technology. 

“Every patient has the deep frustration of going to a hospital and they give you a clipboard and you have to fill out all the information, and then you go to another part of the same hospital and they give you the clipboard again,” Tripathi said. 

The FEHBlog has been reading articles about the demise of the clipboard throughout this century. However, he thinks that this worthy idea may soon come to fruition.

Midweek Update

From Capitol Hill, Roll Call informs us

House and Senate Appropriations Committee leaders said Wednesday they have a deal on a “framework” that will allow them to start writing compromise spending bills for the fiscal year that began Oct. 1.

Senate Appropriations Chairman Patrick J. Leahy, D-Vt., and House Appropriations Chair Rosa DeLauro, D-Conn., put out statements Wednesday afternoon announcing the pact. A spokeswoman for Senate Appropriations ranking member Richard C. Shelby confirmed Republicans also view what the Alabama senator described earlier in the day as “an understanding” as an official agreement. 

Neither side revealed any details of what the framework entails.

A source familiar with the negotiations said the agreement is to have “parity,” or equal increases for defense and nondefense spending, and to start further negotiations leaving current law policy riders in place. All four committee leaders would have to agree to remove or add any other riders, the source said.

That means the longstanding Hyde amendment barring federal funding for abortion in most cases will likely be in the final package, since Republicans would object to removing it as Democrats have proposed.

From the Omicron front, the Wall Street Journal reports

Hospitalizations continued tracking downward in the U.S., with the seven-day average of patients with confirmed or suspected Covid-19 falling to about 111,000, down 30% from a peak in January, according to data from the Department of Health and Human Services. * * *

U.S. deaths are holding steady, with the seven-day average standing at 2,531 on Monday, according to data from Johns Hopkins University. Though there is growing evidence that the Omicron variant is less likely to cause severe illness than earlier strains of the virus, particularly among people who have been fully vaccinated, the number of infections means that deaths—a lagging indicator—remain high, public-health experts say. Omicron’s rapid spread means it is reaching people with other illnesses, and Covid-19 wasn’t the cause of death in some of these cases.

From the plan design front —

  • Banner Health and Aetna announced that its joint venture

Banner|Aetna [has created] a strategic relationship with type 2 diabetes reversal leader Virta Health. The collaboration brings Virta’s innovative diabetes care approach to the insurer’s eligible members of fully insured and Administrative Services Only groups. Virta’s first-of-its-kind diabetes treatment helps people actually reverse their condition: combining personalized nutrition and virtual care, patients can achieve normal blood sugar without medications.

  • Fierce Healthcare tells us

Anthem will make virtual primary care available to eligible members of its commercial health plans in 11 states, the insurer announced Tuesday.

The expansion will roll out the offering to fully insured plans and select large group administrative services clients in Colorado, Connecticut, Georgia, Indiana, Kentucky, Missouri, Nevada, New York, Ohio, Virginia and Wisconsin, the company said. Eligible members can access a virtual care team that will conduct an initial health check-in and then craft a personalized care plan.

The insurer is expecting a significant number of its administrative services clients to adopt the platform over the course of this year.

From the healthcare business front, Healthcare Dive reports

Lower COVID-19 costs in CVS’s payer business coupled with a sharp increase in vaccine administration from booster shots that benefited its drugstores drove the Rhode Island-based healthcare behemoth to revenue of $76.6 billion in the fourth quarter, up more than 10% year over year. That helped drive CVS, which beat Wall Street expectations on both earnings and revenue in the quarter, to a profit of $1.3 billion, up 33% compared to the fourth quarter of last year.

and

Dallas-based hospital operator Tenet will continue its strategy of acquiring ambulatory surgery centers to drive long-term growth and plans to buy 30 more facilities from SurgCenter Development this year, the company said Tuesday. That’s in addition to 16 it has purchased so far this year, executives said on an earnings call Tuesday. Tenet and its subsidiary United Surgical Partners International last year completed a $1.1 billion acquisition of SCD, giving it an ownership stake in 86 surgery centers and related support services. That deal also gave USPI exclusivity on developing a minimum of 50 new centers with SCD during a five-year period.

From the federal employment front, OPM announced

The White House Task Force on Worker Organizing and Empowerment yesterday publicly released its report detailing nearly 70 recommendations, approved by President Biden, that promote worker organizing and collective bargaining for public and private sector employees. The U.S. Office of Personnel Management is leading several of these recommendations, which focus on improving the ability of federal employees to exercise their right to organize and activate their labor rights.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From Capitol Hill —

Govexec reports that earlier today the House of Representatives passed the Postal Reform bill (HR 3706) by a bipartisan 342 to 92 vote. The bill now heads over the the Senate. Govexec adds “Sen. Gary Peters, D-Mich., who chairs the Homeland Security and Governmental Affairs Committee and authored the companion legislation in the Senate, sounded an optimistic note for the bill’s fate in his chamber. ”

The bill would create a Postal Service Health Benefits Program within the FEHB Program beginning in 2025. The PSHBP would feature tightly integrated coverage with Medicare for its annuitants over age 65.

Roll Call informs us that

The House passed a stopgap appropriations bill Tuesday evening to extend current federal agency funding rates through March 11 as Democrats and Republicans continue to trade offers on topline spending levels for the fiscal year that began Oct. 1.

Both sides claim they’re “close” to a framework deal on the fiscal 2022 omnibus and predict this latest continuing resolution, the third one this fiscal year, will be the last stopgap. The previous CR is set to expire Feb. 18. 

Senate Majority Leader Charles E. Schumer said in floor remarks Tuesday morning that his chamber will take up the stopgap measure “quickly” after House passage, “in time before the Feb. 18 deadline.” The House vote was 272-162, indicating likely bipartisan support in the Senate as well.

Fierce Healthcare tells us

A bipartisan group of senators is crafting a package that tackles several barriers to mental health access, with a major emphasis on pay parity between behavioral and physical health and furthering telehealth use.

The Senate Finance Committee Chairman Ron Wyden, D-Oregon, announced the contours of the mental health legislative package during a hearing Tuesday on youth mental health. Wyden said the goal is to get together a bipartisan bill by the summer.

The anticipated bill would be a gold mine for lawyers unless Congress also simplifies the existing parity standards.

From the Omicron front —

The Wall Street Journal advises

You’ve been exposed to Covid-19 more times than you can count. And yet somehow you’ve never tested positive. Could all these close encounters with Covid-19 be enhancing your immune response to it? The answer isn’t clear-cut, scientists say.

Your immune system probably benefits only if you get infected, many scientists say, because a near miss probably won’t have put enough virus in your body to meaningfully rev up your defenses. You can benefit from an asymptomatic infection that you didn’t realize you had, or a case that was too low-level to show up on a rapid test.

The only safe way to build immunity is vaccination, as any exposure to Covid-19 comes with a risk of serious illness, hospitalization or death. Avoiding infection is still important, but if you are exposed, there are circumstances where you might benefit if you already have antibodies, some scientists say.

Medscape reports

People who have had COVID-19 have an increased risk for and 12-month burden of cardiovascular disease (CVD) that is substantial and spans an array of cardiovascular disorders, a deep dive into federal data suggests.

“I went into this thinking that this is most likely happening in people to start with who have a higher risk of cardiovascular disorders, smokers, people with high BMI, diabetes, but what we found is something different,” Ziyad Al-Aly, MD, told theheart.org | Medscape Cardiology. “It’s evident in people at high risk, but it was also as clear as the sun even in people who have no cardiovascular risk whatsoever.”

Rates were increased in younger adults, never smokers, White and Black people, males and females, he said. “So the risk confirmed by the SARS-CoV-2 virus seems to spare almost no one.”

Ruh roh.

From the synthetic opioid epidemic front, AP reports

The U.S. needs a nimble, multipronged strategy and Cabinet-level leadership to counter its festering overdose epidemic, a bipartisan congressional commission advises.

With vastly powerful synthetic drugs like fentanyl driving record overdose deaths, the scourge of opioids awaits after the COVID-19 pandemic finally recedes, a shift that public health experts expect in the months ahead.

“This is one of our most pressing national security, law enforcement and public health challenges, and we must do more as a nation and a government to protect our most precious resource — American lives,” the Commission on Combating Synthetic Opioid Trafficking said in a 70-page report released Tuesday.

The report envisions a dynamic strategy. It would rely on law enforcement and diplomacy to shut down sources of chemicals used to make synthetic opioids. It would offer treatment and support for people who become addicted, creating pathways that can lead back to productive lives. And it would invest in research to better understand addiction’s grip on the human brain and to develop treatments for opioid use disorder.

From the telehealth front —

According to mHealth Intelligence

Most [77%] infectious disease (ID) patients were open to using virtual care after they were informed about the toll in-person care took in terms of time, money, and travel, according to a survey conducted by Washington University and published in Open Forum Infectious Diseases.

Although patients are typically accustomed to the setting in which they receive care, information provided about virtual care can change their perspective, the new research shows.

The survey polled patients 18 years old and older who reside 25 or more miles away from their ID clinic. The goal was to acquire information regarding travel distance and time, money spent, and carbon dioxide emissions.

Beckers Hospital Review adds “Amazon Care’s virtual health services are now available nationwide, and its in-person services will be rolled out in more than 20 new cities in 2022, Amazon said Feb. 8 in a post on its website.” Amazon Care also offers in-person care in “Seattle, Baltimore, Boston, Dallas, Los Angeles, Washington, D.C, Austin, Texas, and Arlington, Virginia. This year, the company plans to bring in-person care services to more than 20 additional cities including New York City, Chicago, Miami and San Francisco, according to the post.”

From the healthcare business front

  • Biopharma Dive reports on Pfizer’s zesty 4th quarter 2021 financial report
  • Becker’s Payer Issues reports on health insurer Centene’s positive 4th quarter 2021 results.

From the rankings department, Beckers Hospital Review notes

“Healthgrades has recognized 250 hospitals nationwide for exceptional care via its America’s Best Hospitals awards released Feb. 8. Three lists feature America’s 50, 100 and 250 best hospitals, which represent the top 1 percent, 2 percent and 5 percent of hospitals in the nation, respectively.”

and

Three companies dominate the pharmacy benefit manager market, accounting for 79 percent of all prescription claims in 2020, according to data from Health Industries Research Companies, an independent, non-partisan market research firm. A breakdown of PBM market share, by total adjusted prescription claims managed in 2020:

1. CVS Caremark: 34 percent

2. Express Scripts: 24 percent

3. OptumRx (UnitedHealth): 21 percent

4. Humana Pharmacy Solutions: 8 percent

5. Prime Therapeutics: 6 percent

6. MedImpact Healthcare Systems: 5 percent

7. All other PBMs: 3 percent

Finally, from the good news department, the Wall Street Journal reports

The [CDC’s] new births data, released Monday along with final data for 2020, show the pandemic has had a more muted impact on childbearing than expected. The economists Melissa Kearney and Phillip Levine in December released calculations showing the pandemic led to 60,000 missing births from October 2020 through February 2021. Earlier in the pandemic, they predicted the health crisis and economic uncertainty would lead to 300,000 to a half million fewer births last year.

Monday Roundup

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

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

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

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.