Tuesday’s Tidbits

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the government employment front,

Performance.gov informs us that OPM Director Kiran Ahuja is one of three Leads on implementing Priority One of the President’s Management Agenda — “Strengthen and Empower the Federal Workforce.” Good luck, Director Ahuja.

FedSmith identifies “ten steps federal employees should take at least a decade before retiring to ensure they are prepared to head into their golden years.”

Step 2 of 10 is “Enroll or Stay in FEHB.”

If you plan to continue your federal health benefits in retirement, you must be entitled to retire on an immediate annuity and:

be enrolled for the 5 years immediately before retiring or, during all your federal employment since your first opportunity to enroll if less than 5 years.

Coverage under FEHB, Tricare, or the Civilian Health and Medical Program of Uniformed Services (CHAMPUS) all count toward the 5 year requirement.

In yesterday’s post, the FEHBlog pointed out a Fierce Healthcare interview with the CEO of dialysis heavyweight, Davita. Today, Fierce Healthcare reports

Three big players in kidney care—Fresenius Health Partners, Cricket Health, and InterWell Health—plan to form a new value-based care company focused on services for the earlier stages of kidney disease.

The deal, announced Monday morning, will create a company valued at $2.4 billion, according to the companies.

The merger brings together expertise in value-based kidney care contracting of Fresenius Health Partners, a division of Fresenius Medical Care North America, InterWell Health’s network of more than 1,600 nephrologists and startup Cricket Health’s technology-enabled care model and patient engagement platform. Fresenius Medical Care is the world’s largest operator of dialysis centers.

Healthcare Dive delves into the case for hybrid care models, meaning the marriage of hospital systems and telehealth vendors.

Though the pandemic greatly accelerated the use of telehealth, use of pure-play virtual care has waned as COVID-19 cases drop off across the U.S. But telehealth is increasingly being woven into hospitals’ digital roadmaps, and some are even upping their investments in the modality despite moderating visits, experts said at the annual HIMSS healthcare conference.

That’s giving hope to proponents of hybrid care models, who point to the value of meeting patients where they are to lower costs and improve outcomes.

Intriguing.

Health Payer Intelligence reports

The National Committee for Quality Assurance (NCQA) has awarded [health insurer] Centene the Innovation Award for Health Equity for the company’s Health Equity Improvement model.

“Advancing health equity has a real and positive impact on the health of our members across the country,” said Sarah Bezeredi, senior vice president and chief quality officer for Centene. * * *

At its core, the model uses qualitative and quantitative data to target certain health equity gaps. Centene engaged communities and activated community coalitions in order to empower its strategy. The company’s approach included carefully selecting leaders who would help create and promote the model as well as soliciting community feedback.

In Arizona, Centene sent HbA1c at-home testing kits, which became a common method of chronic disease prevention during the pandemic. The kits were outfitted with a range of delivery modalities to cover the spectrum of members’ needs. Members also received telehealth and telemonitoring tools. The payer incentivized compliance with certain diabetes care measures.

The model tackled patient education in addition to delivering access to care interventions. Centene mailed qualifying members resources about the HbA1c test and comprehensive diabetes care measures.

The payer tracked progress using its Health Equity Dashboard, which leverages HEDIS data and other social determinants of health and demographic data to assess care disparities.

“By using a data-driven process, we are identifying disparity reduction opportunities and tracking performance and success year-over-year,” Bezeredi added. 

Mazaal Tov, Centene.

Weekend Update

Photo by Tomasz Filipek on Unsplash

Today has been the first day of Spring. But, it is the first day of Fall for my youngest son, who is studying medicine at Queensland University in Brisbane, Australia.

The House of Representatives is on a district work break this week. Meanwhile, the Senate will be engaged in committee business and floor voting on Capitol Hill.

Fedweek discusses the highlights of the call letter for 2023 benefit and rate proposal letters that OPM released last week.

OPM has told FEHB carriers to continue with increased levels of telehealth and other services related to the pandemic in the 2023 plan year, while also either ordering or encouraging them to expand benefits for certain other conditions.

While Fedweek gets the facts right, its article overlooks that OPM’s orders diminish FEHB competition which Congress relies upon to control premiums.

From the cost management front, Fierce Healthcare tells us

While prior authorization is a key tool in an insurer’s arsenal as it thinks about managing costs, the process remains a key source of friction with physicians.

Amid a nationwide conversation around addressing physician burnout and stress, plans are seeking ways to grow automated and virtual prior auth technologies to ease those barriers. At eviCore Healthcare, the benefit management arm of Cigna’s Evernorth subsidiary, the team has found one of the keys to success in this endeavor is bringing physicians into the conversation early on.

Eric Gratias, M.D., eviCore’s chief medical officer, told Fierce Healthcare that prior authorization programs are often built by people who, while well-intentioned, lack first-hand knowledge of what a clinical encounter is like.

The company’s own prior authorization technology, intelliPath, is built on collaboration with physicians who are actively practicing, he said.

“That partnership with our provider clients is absolutely critical for our success,” Gratias said.

Good point.

From the Rx coverage front

  • NPR Shots points out significant problems with the distribution of Covid treatments.

[D]ata on COVID treatment utilization, shared with NPR by the U.S. Department of Health and Human Services, indicates that millions of COVID treatments are sitting on shelves unused. 

“We are still in a public health emergency,” said Dr. Derek Eisnor, who leads the government’s distribution of COVID drugs, on a call with national health organizations on March 16. He urged health leaders to try to get the drugs to communities that have a demand for them, rather than let them go to waste. 

“There’s an assumption that there’s not enough of [these drugs] around but it does seem when you look at the numbers that there is a lot around — it’s just not being used,” says Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security. “They clearly are not getting to people at high enough rates to have their maximum impact.” * * *

It can be hard to know which pharmacies have the pills in stock or which infusion clinics have appointments available. A patient needs to be able to quickly find a clinician, get a diagnosis and prescription, and be able to access the treatment, all within a few days. 

“It’s multifactorial why these drugs are underutilized,” Adalja says. “It’s likely all of those things are playing some role in the discrepancies between what’s been ordered and and what’s actually been administered.”

The Biden administration launched the Test to Treat initiative this month to address these gaps. “We know the challenges that are involved with patients obtaining therapeutics,” said Dr. Meg Sullivan, acting chief medical officer for HHS’ Office of the Assistant Secretary for Preparedness and Response, in a call with clinicians on March 12. The program aims to improve access to rapid testing and to bolster public and provider awareness of available COVID treatments and how to get them.

Here is a link to the HHS website that offers a U.S map that “displays public locations that have received shipments of U.S. Government-procured COVID-19 therapeutics under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authority. The long-acting antibody combination, Evusheld; monoclonal antibody treatments, bebtelovimab and sotrovimab; as well as the oral antiviral therapies, Paxlovid and molnupiravir are products authorized by the FDA for either prevention (Evusheld) or treatment (Paxlovid, sotrovimab, bebtelovimab, and molnupiravir) of COVID-19.   The locations displayed in the locator have reported available courses within the last seven days.”

The test to treat program’s website is not online yet as far as the FEHBlog can tell.

On March 30, the Food and Drug Administration is bringing together outside experts in neurology to review an experimental drug from Amylyx for the treatment of amyotrophic lateral sclerosis, or ALS. The hearing is expected to be closely watched by ALS patients and their advocates, given the significant need for new treatments for the disease.

But the hearing is likely to garner extra attention because it’s the first meeting of the FDA advisory group since it met in November 2020 and voted unanimously against the approval of Aduhelm, Biogen’s drug for Alzheimer’s disease. The FDA later ignored that recommendation and approved the medication, leading to the resignation of three members of the panel and an uproar over whether the agency had compromised its standards.

Sixteen months removed from all the Aduhelm drama, the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee, restocked with new members, is back to tackle another high-stakes review of a drug targeting a progressive, fatal nervous system disease. The Amylyx treatment — called AMX0035 — isn’t likely to generate the same acrimony as Aduhelm, but it could similarly force the FDA to bend its standards.

Here’s what you need to know about AMX0035, the data from its single clinical trial, and the issues that are likely to take center stage at the FDA advisory panel meeting.

Thursday Miscellany

From Capitol Hill, the Hill reports

The Senate has locked in a deal to quickly pass a massive government funding bill that includes $13.6 billion in Ukraine aid.

The agreement, announced by Senate Majority Leader Charles Schumer (D-N.Y.), puts the funding bill on a glide path to pass on Thursday night, capping off hours of would-they-won’t-they drama. 

Mazaal tov to Congress.

Also on Capitol Hill today, the Senate Homeland Security and Governmental Affairs Committee held a confirmation hearing for Krista Boyd, the President’s nominee to serve as OPM Inspector General. Fedweek notes that “Ms. Boyd is a senior staff member of the House Oversight and Reform Committee with long experience on Capitol Hill in federal workplace matters.”

From the Omicron front, Becker’s Hospital Review informs us “The rate of new COVID-19 cases involving the omicron subvariant BA.2 appears to be slowing in the U.S., according to variant proportion estimates from the CDC.”

Also, the Justice Department announced “Effective immediately, Associate Deputy Attorney General Kevin Chambers will serve as the Director for COVID-19 Fraud Enforcement.”

From the litigation front, Reuters reports “The judge overseeing Purdue Pharma’s bankruptcy on Wednesday approved a $6 billion opioid settlement funded by its Sackler family owners, overruling objections from the Department of Justice and 20 states that opposed the deal.”

From the healthcare business front

Healthcare Dive tells us

Anthem plans to change its name to Elevance Health, if the move is approved by shareholders, the company said Thursday.

The new name is meant to reflect the company’s offerings beyond traditional health insurance. “Elevance Health’s companies will serve people across the entire care journey, connecting them to the care, support, and resources they need to lead healthy lives,” Anthem CEO Gail Boudreaux said in a statement.

Elevance was chosen as a combination of the words “elevate” and “advance.” There will not be any changes to leadership or organizational structure accompanying the new name.

If approved, the Elevance name will start being used at the end of the second quarter of this year. Anthem Blue Cross and Blue Shield plans will still use the Anthem name.

From the telehealth front, Healthcare Dive reports

[Virtual care vendor] Amwell and LG Electronics are teaming up to jointly develop new digital health devices and tools, starting with hospital care in the U.S., the companies announced Wednesday.

South Korea-based LG, which manufactures a wide range of devices from refrigerators to computer monitors, already provides smart TVs for inpatient rooms.

Now, through the partnership, LG will also create devices that can host services from Amwell’s virtual care platform, Converge.

PYMTS.com reports this electronic health records news from the Vive conference being held in Miami

Electronic health records containing some of the most guarded personal data about people are making headlines again as a consortium of players join forces to create a universal single sign-in, allowing patients secure access to unified health data via digital identity.

Coming out of the ViVE health technology conference happening this week in Miami Beach, the effort is led by consumer-directed healthcare advocacy group the CARIN Alliance, working together with the Department of Health and Human Services (HHS) and other stakeholders.

On Tuesday (Mar. 8), Politico reported that HHS “is working with several health systems, insurers and health tech groups to roll out a single way for patients to log in and access their medical records across multiple systems. The launch later this month will set up a test environment for integrating the technology, said Ryan Howells, principal at Leavitt Partners and program manager at the CARIN Alliance, which is spearheading the efforts.”

CARIN is working with the Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services (CMS), which will act as “government observers.”

From the FEHB front, benefits consultant Tammy Flanagan writes in Govexec about the Postal Service Health Benefits Program which will launch in 2025 as part of the Postal Reform Act of 2022. She observes

The version of the postal bill that eventually passed balances the risk pools, and the Office of Personnel Management now estimates premiums should go down for postal and non-postal employees and retirees alike.

The new law keeps all postal workers in FEHB, in their own group. All workers will be able to keep their current plans and avail themselves of the annual open season to choose other options within FEHB. 

Future postal retirees will be required to enroll in Medicare A and B at 65. Retiree health coverage will then become a combination of Medicare and FEHB. 

The question now is whether that requirement will eventually be extended to all federal employees, and what effect that would have on the premiums retirees pay. If that happens, at least federal employees will face one less tough decision at the time of retirement.

The FEHBlog expects that PSHBP premiums will be materially lower than FEHB premiums because PSHBP will accept Medicare funding for prescription drug benefits in the form of Part D EGWPs. Federal law has permitted the FEHB to offer premium-reducing Part D EGWPs for nearly twenty years. Nevertheless, OPM and a string of Administrations from George W. Bush to Joe Biden have refused to implement that law. Implementing that law in 2005 when it first took effect likely would have avoided the balkanization of the FEHB that we will soon experience with the PSHBP.

The FEHBlog does not expect the FEHB to adopt the mandatory Part B approach being taken by the PSHBP. Fewer retiring federal employees are picking up Part B because of the income-adjusted Part B premiums. As basic and income-adjusted Part B premiums continue to climb and climb, the FEHBlog expects that the PSHBP will liberalize, and then do away with, mandatory Part B. Meanwhile, the PSHBP’s undoubtedly favorable experience with Medicare funding of prescription drugs will lead OPM to allow FEHB the same opportunity.

With both branches of the Program using Part D EGWPs and integrated Medicare Advantage plans, everyone will enjoy reasonable premiums for high-quality healthcare. That in turn could lead to a reunion of the two branches. Hopefully, the PSHBP will be a relatively brief experiment that leaves the FEHB Program stronger.

The saving grace of the FEHB Program is that everyone in a plan option pays the same premium and the premiums are pooled to cover all plan option enrollees. That’s the bedrock principle of group health insurance that the FEHB Program has shown to work.

Thursday Miscellany

From Capitol Hill, Govexec reports that “The Senate on Thursday cleared 65-27 a three-week stopgap bill to avoid a government shutdown, sending the measure to President Biden with just one day before the deadline.”

From the Omicron front, the American Hospital Association provides us with its most recent Covid snapshot

From the Covid treatment front, The American Medical Association reports

Efforts to boost production of [Covid] therapeutics are underway, a Food and Drug Administration (FDA) official said during an episode of the AMA-sponsored webinar series, “COVID-19: What Physicians Need to Know.” 

Recommended usage in therapeutics is an important step in counseling patients and providing the most timely and relevant information about defeating this virus, said AMA President Gerald E. Harmon, MD, who moderated the webinar. Physicians facing supply issues of hard-to-get antivirals such as Paxlovid (PDF) also want to know about the timeline of any new antivirals or antibody treatments, he said.

For doctors and other health professionals, “it’s been a very difficult winter and it’s not over yet,” acknowledged John Farley, MD, MPH, director of FDA’s Office of Infectious Diseases in the Center for Drug Evaluation and Research’s Office of New Drugs. Monitoring the situation with these drugs is a complex process that involves FDA, the Centers for Disease Control and Prevention and several branches of government, he added.

Distribution of therapeutics should improve over time. However, at least for the combination of antiviral nirmatrelvir and ritonavir tablets marketed as Paxlovid, “we have a period of continued short supply ahead,” said Dr. Farley, who joined two other FDA experts to discuss the efficacy of the treatments.

In the FEHBlog’s view, Pfizer’s Paxlovid appears to offer the best opportunity for lowering Covid hospital admissions which have been a major cost for health plans over the past year which has seen three major Covid surges.

Speaking of innovations, Cleveland.com tells us

The next generation of mRNA vaccines, as well as treatments for type 2 diabetes and postpartum depression are among the innovations that earned spots on the Cleveland Clinic’s Top 10 Medical Innovations for 2022.

The list of breakthrough technologies, chosen by a committee of Clinic experts, was announced Wednesday.

These medical advancements have the potential to transform healthcare in the coming year, the Clinic said. The committee considered technologies developed by the Clinic as well as other research centers.

From the Federal Trade Commission front, Healthcare Dive reports

The Federal Trade Commission will not launch a study into pharmacy benefit managers’ pricing and contractual practices after a 2-2 vote at a Thursday meeting. The measure needed a simple majority to commence the investigation, which would have compelled large PBMs to turn over information and documents to the agency.

The two commissioners appointed by former President Donald Trump, Noah Phillips and Christine Wilson, voted against the study after raising concerns about its design and whether the current draft asks the proper questions for the answers the agency is seeking. Phillips also complained about receiving a “substantially revised” draft from staff “just hours” before the meeting.

FTC Chair Lina Khan said she was disappointed with Thursday’s vote, and said this is an area the agency has “a real moral imperative” to act upon.

From the Rx coverage front, Fierce Healthcare informs us

Optum has launched a new solution for specialty drugs that aims to lower costs and improve care management for people with complex conditions.

Specialty Fusion arms payers and providers with real-time insights into which specialty therapies are the most effective for the patient at the lowest cost. The platform leads to quicker treatment approvals for patients as well as a similar experience for providers at the point of care, Optum said in an announcement.

Internal analysis of the solution suggests it can drive cost savings of 17%.

From the healthcare business front, Healthcare Dive notes

Pharmacy giant Walgreens and value-based medical network VillageMD are on pace to open more than 200 co-branded primary care practices by the end of the year.

On Wednesday, the companies opened their first clinic in a new Florida market, Jacksonville, bringing their total markets in the state up to three, including Orlando and Tampa. Walgreens and VillageMD plan to open five new Village Medical at Walgreens primary care practices in total in the Jacksonville area through this summer.

With the Jacksonville openings, Walgreens and VillageMD have now opened more than 80 primary care practices across 12 markets in Arizona, Florida, Texas, Kentucky and Indiana.

Last but not least FedWeek explains how to guard against losing FEHB coverage in retirement.

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.

Holiday weekend update

Happy King Day! Here is a link to the NPR website that includes a video and a transcript of his “I Have a Dream” speech given August 28, 1963. Dr. King proves that you don’t have to be President to lead the country. He accomplished so much in his tragically shortened life for which we all should be grateful.

From the Congress front, the House of Representatives remains in session this week for Committee business and floor voting while the Senate is on State work period. Govexec lets us know that last Thursday

Lawmakers sounded a rare note of optimism about reaching a spending agreement for the remainder of fiscal 2022 as they look to avoid yet another stopgap measure.  Leaders in both parties called a bicameral, bipartisan meeting “constructive,” saying they shared the goal of setting full-year appropriations by their Feb. 18 deadline. 

From the Omicron front, STAT News informs us that

As the coronavirus continues to wreak havoc, an expert panel at the World Economic Forum delivered a mix of good news and bad news on Monday: More variants will emerge, but vaccine production is accelerating and research is progressing toward a combined shot that may be able to attack these different variants.

On one hand, the world needs to prepare for newer strains that could be more vexing, or the “worst case scenario,” said Annelies Wilder-Smith, a professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine. “Omicron will not be the last variant. There’s a high probability we will have another variant coming up. The question is when and will it be less dangerous?”

Wall Street Journal columnist Alyssia Finley offers a column on the benefits of natural immunity created by Omicron breakthrough infections.

study last month by the Oregon Health and Science University found that vaccinated people who experienced breakthrough infections produced higher levels of antibodies that were up to 1,000% more effective than those generated two weeks after a second dose of the Pfizer vaccine. The researchers described this as superimmunity. 

“I think this speaks to an eventual end game,” said co-author Marcel Curlin. “It doesn’t mean we’re at the end of the pandemic, but it points to where we’re likely to land: Once you’re vaccinated and then exposed to the virus, you’re probably going to be reasonably well-protected from future variants.” Dr. Curlin added: “Our study implies that the long-term outcome is going to be a tapering off of the severity of the worldwide epidemic.” * * *

All of this suggests that infection with Omicron is likely to stimulate potent and durable protection against Covid-19—and potentially other coronaviruses—even if it mutates to become more virulent. As Omicron rapidly spreads, people who have been vaccinated or previously infected will develop superimmunity. Covid-19 will become a virus that causes cold- and sometimes flulike symptoms—annoying but rarely deadly or disruptive.

One caveat is that older people generate weaker T-cell responses and memories to infections and vaccines. They’re likely to need annual booster shots. Omicron will end the pandemic by making Covid-19 endemic.

The Journal also offers masking advice which help the FEHBlog finally understand the difference between N-95 and KN-95 masks. “If you can’t get an N95 [which is certified in the US], doctors suggest KN95, KF94 and FFP2 masks, which are certified in China, South Korea and Europe, respectively.”

The Journal also reports that

One year into her tenure as director of the Centers for Disease Control and Prevention, Rochelle Walensky acknowledges that she should have communicated certain things better to the American public.

She says the pandemic threw curveballs that she should have anticipated. She thinks she should have made it clearer to the public that new rules and guidelines were subject to change if the nature of the fight against Covid-19 shifted again.

“I think what I have not conveyed is the uncertainty in a lot of these situations,” Dr. Walensky said in an interview with The Wall Street Journal.

Dr. Walensky deserves credit for making these remarks.

From the FEHB and TRICARE fronts, benefits consultant Tammy Flanagan discusses the merits of enrolling in Medicare Part B when you retire from federal employment at or over age 65.

From the healthcare business front, Revcycle Intelligence calls to our attention the fact that “2021 did not set any records for the number of hospital mergers and acquisitions, but data shows a shift to larger deals between well-established organizations”

The report identified eight “mega-mergers” in which the seller or smaller partner by revenue had over $1 billion in annual revenue. Out of all the announced transactions, that is the largest percentage of announced mega-mergers in the last six years at 16.3 percent. It was also nearly double the percentage of mega-mergers announced in 2020.

The average size of the smaller party in hospital merger and acquisition deals was also up significantly compared to previous years, according to the report. The average size by annual receive increased to $619 million from $388 million in 2020.

The data may point to a new trend in healthcare consolidation.

From the benefit design front, Health Payer Intelligence reports that

Although acupuncture utilization has grown in recent years, only half of acupuncture visits had any form of coverage in 2019, according to a research letter published in JAMA Network Open.

The researchers analyzed acupuncturist visits in Medical Expenditure Panel Survey (MEPS) data from 2010 to 2019. Their aim was to uncover the total cost of the visit, the annual out-of-pocket healthcare spending for these visits, the portion of these visits that were covered under the patients’ insurance plans, and the percent of out-of-pocket costs.

The majority of the participants were female and nearly six in ten were White individuals.

Finally MedPage Today gives us a community-oriented story written by “a physician [Avik Chatterjee, MD, MPH] in a shelter-based clinic in Boston, near the intersection of Massachusetts Avenue and Melnea Cass Boulevard, where a large encampment of people experiencing homelessness has emerged. Injection drug use in this area has picked up recently, and overdoses are not uncommon. When people need help, outreach workers and shelter staff run in and call for us.” And clinic doctors and nurses respond to the calls.” His story concludes as follows:

The skills, knowledge, and compassion necessary to address the overdose crisis exist in the community of people who use drugs. Historically, this group of people has been particularly marginalized by healthcare institutions. But people who use drugs are finally starting to demand a seat at the table where decisions are made around research and treatment of substance use disorders. Researchers, clinicians, and policymakers need to come up with creative ways to partner with this community to meaningfully incorporate lived and living experience in designing research and clinical programs.

In the face of one of the biggest health crises of our generation, it’s time to realize that “we’re all family here.”

And the post comes full circle.

Happy New Year!

Happy New Year 2022 from unsplash.com.

Welcome 2022!!

  • Federal Benefits Open Season changes took effect yesterday for annuitants and today for employees.
  • The Senate reconvenes for the second session of the 117th Congress tomorrow. The Wall Street Journal reminds us that “The Senate returns for a new session on Monday with Democrats focused on trying to change the chamber’s rules to muscle through elections legislation over Republican opposition, as lawmakers also hope to revive President Biden’s stalled economic and climate agenda.” The Senate also will hold some Committee business this week.
  • The House of Representatives reconvenes on January 10, a week from tomorrow.
  • The Supreme Court will hear oral argument on Friday January 7 about whether or not to stay the OSHA ETS creating a COVID vaccination or testing program for business with 100 or more employees and the CMS vaccination mandate for most healthcare workers.
  • From the Omicron front, David Leonhardt writing in the New York Times illustrates with charts why we have reason to hope that the pandemic will become endemic / a part of life rather than gripping our lives in 2022.

[W]hen the current surge begins receding, it will likely have left a couple of silver linings: Omicron is so contagious that it will have infected a meaningful share of the population, increasing the amount of Covid immunity and helping defang the virus. Omicron has also helped focus Americans on the importance of booster shots, further increasing immunity.

As important, the world has more powerful weapons to fight Covid than it did only a few weeks ago: two new post-infection treatments, one from Merck and a more powerful one from Pfizer, that lower the risk of hospitalization and death. With Pfizer’s treatment, the reduction is by almost 90 percent, according to early research trials.

All of which suggests that the U.S. could emerge from the Omicron wave significantly closer to the only plausible long-term future for Covid — one in which it becomes an endemic disease and a more normal part of daily life. It will still cause illness and death; a typical flu season kills more than 30,000 Americans, most of them elderly. For the foreseeable future, battling Covid — through vaccination, treatment and research — will remain important.

The FEHBlog heartily agrees with these sentiments.

Midweek Update / At Last a COVID Pill!

From the Omicron front, STAT News reports that

The Food and Drug Administration on Wednesday authorized Paxlovid, a pill developed and made by Pfizer, as a treatment for Covid-19, a significant step in the battle against the SARS-CoV-2 virus.

The drug was authorized for use in people as young as 12 so long as they weigh at least 88 pounds.

The authorization of an oral antiviral to beat back Covid has been eagerly anticipated because such a medicine could reach large numbers of people infected with the virus and prevent them from becoming seriously ill or hospitalized. Existing medicines, such as monoclonal antibodies, must be given intravenously or as injections.

Still, initial supplies of Paxlovid will be limited. Pfizer has said it expects to produce more than 180,000 courses of the treatment this year. The company said Wednesday it now expects to provide 120 million courses by the end of 2022, up from 80 million previously, thanks in part to new contract manufacturers. Pfizer has contracted with the U.S. government to provide 10 million courses by the end of 2022 at a cost of $5.29 billion.

Once readily available, Paxlovid will be the answer to a positive COVID test, rather than 10 days of quarantine or hospitalization. Jingle bells, indeed.

Speaking of the FDA, MedPage Today informs us that

The FDA approved the first monotherapy for bipolar-related depressive episodes, Intra-Cellular Therapies announced Monday.

The atypical antipsychotic lumateperone (Caplyta) gained an indication for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. It was first approved for adults with schizophrenia in December 2019. * * *

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” said Roger McIntyre, MD, of the University of Toronto, in a statement released by the manufacturer. “Caplyta is approved for a broad range of adult patients including those patients with bipolar II depression who have been underserved with limited treatment options.”

Switching back to the Omicron front, the Wall Street Journal reports that

New data from Scotland and South Africa suggest people infected with the Omicron variant of coronavirus are at markedly lower risk of hospitalization than those who contracted earlier versions of the virus, promising signs that immunity as a result of vaccination or prior infection remains effective at warding off severe illness with the fast-spreading strain.

The findings begin to fill in unknowns around the severity of the disease caused by Omicron, a major variable critical to health authorities around the world as they gauge how to react to the new variant.

Scientists are still unsure how the positive findings around hospitalizations will stack up against another major variable: Omicron’s much increased transmissibility. Both variables are likely to change depending on local conditions, such as the proportion of the population that has been vaccinated against Covid-19.

“This is a qualified good news story,” said Jim McMenamin, incident director for Covid-19 at Public Health Scotland, and one of the authors of the Scottish study, at a briefing. “It’s important we don’t get ahead of ourselves. A smaller proportion of a much greater number of cases can still mean a substantial number of people that might experience severe Covid infections that could lead to hospitalization.”

From the COVID vaccine mandate challenge front, the Journal also tells us that

The Supreme Court on Wednesday said it would hold fast-track oral arguments early next month to consider whether the Biden administration can enforce Covid-19 vaccine-or-testing rules for large private employers, as well as vaccine requirements for many healthcare workers.

The cases, set for argument on Jan. 7, could go a long way to determining how much latitude the administration has to combat the coronavirus pandemic in the workplace.

The high court issued a pair of short, written orders to schedule the arguments, in response to a growing pile of emergency appeals asking the justices to intervene.

The cases haven’t yet been fully litigated in the lower courts; the Supreme Court will be deciding whether the Biden administration rules can be implemented for now. But practically speaking, the court’s decision is likely to determine whether the requirements survive. 

Curiously, it does not appear that the stay of the government contractor mandate will be presented to the Supreme Court. Instead the parties have agreed to expedite briefing and the oral arguments on the merits of the case.

From the OSHA ETS front, the Society for Human Resource Management reports that


Now that a federal appeals court has revived the Occupational Safety and Health Administration’s (OSHA’s) emergency temporary standard (ETS), covered employers will need to prepare a written COVID-19 vaccination-or-testing policy by Jan. 10.

Under the ETS, employers may choose to require vaccination or allow covered employees who are unvaccinated to wear a mask and provide proof of a negative COVID-19 test on a weekly basis. The start date for the testing requirement has been extended to Feb. 9, but many other components of the ETS take effect on Jan. 10, such as the requirement for employers to determine the vaccination status of each employee and develop a written policy.

“Keep it simple,” recommended Eric Hobbs, an attorney with Ogletree Deakins in Milwaukee. “Do not include anything in the plan that you can’t follow through on.”

The Supreme Court is unlikely to rule on the OSHA ETS mandate stay before January 10, 2022.

From the Federal employee compensation front, Federal News Network reports that

President Joe Biden on Wednesday signed an executive order making federal pay raises official for many civilian employees in 2022.

As expected, General Schedule employees will receive an across-the-board federal pay raise of 2.2% in 2022, plus an additional 0.5% locality pay adjustment, to total a 2.7% average increase.

An Office of Personnel Management official confirmed the 2.7% federal pay raise to Federal News Network Wednesday evening. The agency hasn’t yet posted detailed pay tables describing pay rates for each locality pay area.

The raises take effect Jan. 1, or more specifically during the first pay period in January.

Under OPM’s regulations, Open Season changes take place on January 1 for annuitants and on the first day of the first pay period in the new year for employees. GSA’s federal employee calendar for 2022 shows that January 2 is the first day of the first pay period for next year.

From the Affordable Care Act front, the FEHBlog apologizes that he left a sentence off yesterday’s post about the current federal fiscal year’s PCORI fee. To close the unintended loop, IRS Notice 2022-04 states that “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2021, and before October 1, 2022, is $2.79” per bellybutton.

Weekend update

Photo by Jessica Delp on Unsplash

Congress has lowered the curtain on the first session of the current two year long Congress, the 117th in our Nation’s history.

Roll Call reports that

Sen. Joe Manchin III said on Sunday that he can’t support the sweeping social safety net and climate change package that President Joe Biden and Democratic leaders have made their top legislative priority.

The West Virginia Democrat’s opposition is likely the final nail in the massive $2 trillion-plus “Build Back Better” legislation given the Senate’s 50-50 split, unless extensive changes are made that would result in key provisions being scuttled.

“I can’t vote for it and I cannot vote to continue with this piece of legislation,” Manchin told “Fox News Sunday.” “I just can’t. I’ve tried everything humanly possible.  I can’t get there … This is a ‘no.’ “

Of course, the legislative struggle over the BBB bill is not over but at least we should enjoy a peaceful holiday period.

From the Omicron front, Bloomberg reports that

Lockdowns in the U.S. will likely not be necessary even as Covid-19 cases increase, according to President Joe Biden’s top medical adviser, Anthony Fauci. Even so, many hospitals may be strained as the omicron variant spreads, especially in regions with lower levels of vaccination, he said. 

New York City Mayor Bill de Blasio called on the federal government to step up supplies of tests and treatments to the city amid a spike in infections caused by the omicron variant. New York state broke a record for new infections for the third consecutive day.

From the COVID mandate challenge front —

Since last Wednesday

  • The Fifth Circuit U.S. Court of Appeals lifted the nationwide stay on the CMS healthcare provider COVID vaccine mandate, but left the stay in place for 24 states which had obtained their own stays. The federal government has asked the U.S. Supreme Court to lift the stays applicable to those 24 states. The Supreme Court has allowed the respondent states until December 30, 2021, to respond to the federal government’s motion.
  • The American Hospital Association (“AHA”) reports in the wake of the Court action that “CMS’s website states that CMS “has suspended activities related to the implementation and enforcement of [the mandate] pending future developments in the litigation.” AHA has confirmed with CMS that this statement applies nationwide and remains accurate even after the Fifth Circuit’s order staying the nationwide effect of the Louisiana district court’s preliminary injunction. 
  • The Sixth Circuit U.S. Court of Appeals lifted the nationwide stay on the OSHA ETS COVID vaccination screening program. The State of Georgia has asked the U.S. Supreme Court to reinstate the stay.
  • The American Hospital Association reports again in the wake of the Court action that “OSHA has announced that it is ‘exercising enforcement discretion with respect to the compliance dates of the’ mandate. OSHA states that ‘it will not issue citations for noncompliance with any requirements of the [mandate] before January 10 and will not issue citations for noncompliance with the [mandate’s] testing requirements before February 9, so long as an employer is exercising reasonable, good faith efforts to come into compliance with the standard.’ OSHA has also promised to ‘work closely with the regulated community to provide compliance assistance.’”
  • The Eleventh Circuit U.S. Court of Appeals upheld the nationwide stay on the government contractor mandate. The federal government is expected to ask the Supreme Court to lift this stay tomorrow.
  • It certainly appears that all three mandate issues will be presented to the Supreme Court simultaneously. 

In Affordable Care Act news, CMS announced on Friday that

Health insurers have provided approximately $2 billion in rebates for the 2020 reporting year to an estimated 9.8 million consumers, the Centers for Medicare & Medicaid Services (CMS) is announcing today. Insurers were generally required to provide such rebates and notice of any rebates owed to consumers no later than September 30, 2021. Rebate payments can be provided in the form of a premium credit, lump-sum check, or, if a consumer paid the premium using a credit card or direct debit, by lump-sum reimbursement to the account used to pay the premium.

CMS released a list today of all insurers owing Medical Ratio Loss (MLR) rebates for the 2020 reporting year, with total amounts by state and market. The CMS market breakdown estimate includes approximately 4.8 million consumers in the individual market and 5 million employees in the group market (this represents 2.6 million employees in the small group market, and 2.4 million employees in the large group market). 

Today’s release also includes the Public Use Files (PUFs) containing the data from all health insurers’ final MLR filings for the 2020 reporting year. 

For more information visit: https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/Medical-Loss-Ratio

Link to PUFs here: https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr

If federal employee compensation news, Govexec tells us that

[Last] week, the President’s Pay Agent, which is made up of Labor Secretary Marty Walsh, Acting Office of Management and Budget Director Shalanda Young and Office of Personnel Management Director Kiran Ahuja, issued its annual report ahead of President Biden’s executive order finalizing an average 2.7% pay raise in 2022. The pay agent declined to issue waivers based on a locality’s number of authorized positions, but approved Carroll County’s addition to the Davenport, Iowa, locality pay area due to the fact that it recently has met the 2,500 employee threshold.

Midweek Update

From the Capitol Hill front, Roll Call reports that

The Senate easily passed the annual defense policy bill on Wednesday, authorizing $768 billion in defense spending for fiscal 2022.

The final tally for the fiscal 2022 National Defense Authorization Act was 88-11. * * *

The legislation marks the 61st straight year that Congress has passed the NDAA. President Joe Biden is expected to sign it into law shortly.

The Federal Times discusses the federal employment aspects of the new law.

The Wall Street Journal adds that “Democrats braced for weeks of delay and uncertainty on their roughly $2 trillion education, healthcare and climate package they had hoped to finish by year end, as efforts faltered to secure the pivotal support of Sen. Joe Manchin (D., W.Va.) for the bill.”

From the Omicron front Bloomberg informs us that

The results from initial studies of the omicron variant of the coronavirus are starting to roll in almost daily, and early suspicions are gaining more support. The mutation is much better at infecting—70 times faster than delta and the original strain. But the severity of illness is likely to be much lower, according to a study from the University of Hong Kong, echoing earlier observations from doctors in South Africa where the variant was first observed. The supercharged speed of omicron’s spread in the human bronchus was found 24 hours following infection, according to the university. However, the study found it replicated in lung tissue much less efficiently than earlier mutations, which may signal “lower severity of disease.”

The FEHBlog ran across not one but two articles prognosticating about the extension of no cost sharing coverage of at home rapid antigen COVID tests scheduled for next month:

  • The Society for Human Resource Management points out a Mercer consulting report on the coverage issue.

HR consultancy Mercer explained: “Under existing guidance (see FAQ Part 43, Q/A-4), at-home COVID tests must be covered without participant cost-sharing, but only when ordered by an attending health care provider who has determined the test is medically appropriate based on current accepted standards of medical practice.”

Mercer noted that “group health plans and insurers currently may (but are not required to) provide coverage of at-home tests without participant cost-sharing even absent a health care provider’s determination of medical necessity. While we await important details, it seems quite possible that forthcoming guidance will significantly expand the scope of required coverage of at-home COVID testing without participant cost-sharing, in short, by eliminating the need to involve a health care provider.”

  • Health Payer Intelligence notes that “In a letter to CMS, the Alliance of Community Health Plans (ACHP) has requested that the federal government establish certain requirements for at-home COVID-19 testing coverage.” ACHP letter builds on Mercer’s concerns.

From the substance use disorder front —

Overdose deaths involving the synthetic opioid, illicitly-manufactured fentanyl (IMF), skyrocketed across the country from 2019 to 2020, researchers found.

Between July 2019 and December 2020, IMF-involved overdose deaths nearly doubled in the West (93.9%), increased 65% in the South and 33% in the Midwest, reported Julie O’Donnell, PhD, of the CDC’s National Center for Injury Prevention and Control in New Orleans, and colleagues.

Moreover these deaths were quick, as 56% of people who died from an IMF-involved overdose did not have a pulse when first responders arrived on the scene, and approximately 40% of IMF-involved deaths also involved a stimulant, O’Donnell’s group wrote in the Morbidity and Mortality Weekly Report.

  • The NIH HEAL Initiative reported that texting and related apps can be used to lengthen use of drugs taken to treat opioid use disorder. Here’s the background:

Medications such as methadone, buprenorphine, and naltrexone are highly effective for treating opioid use disorder. Yet only a fraction of people who could benefit actually receive these medications. Worse, about half of those who start taking them discontinue use within the first 6 months of treatment. Research has shown that the longer people continue treatment, the better their outcome is and the lower their risk of overdose.

  • On the bright side, NIH also reports that

The percentage of adolescents reporting substance use decreased significantly in 2021, according to the latest results from the Monitoring the Future survey of substance use behaviors and related attitudes among eighth, 10th, and 12th graders in the United States. In line with continued long-term declines in the use of many illicit substances among adolescents previously reported by the Monitoring the Future survey, these findings represent the largest one-year decrease in overall illicit drug use reported since the survey began in 1975. The Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.

From the this and that department —

  • Health Affairs unveiled the National Health Care Spending Report for 2020:

US health care spending increased 9.7 percent to reach $4.1 trillion in 2020, a much faster rate than the 4.3 percent increase seen in 2019. The acceleration in 2020 was due to a 36.0 percent increase in federal expenditures for health care that occurred largely in response to the COVID-19 pandemic. At the same time, gross domestic product declined 2.2 percent, and the share of the economy devoted to health care spending spiked, reaching 19.7 percent. In 2020 the number of uninsured people fell, while at the same time there were significant shifts in types of coverage.

  • The Wall Street Journal graphically points out that emergency room charges can vary significantly for common emergencies in downtown Boston.
  • Fierce Healthcare tells us that

UnitedHealth Group has pushed back the deadline for its nearly $8 billion acquisition of Change Healthcare, according to a new filing with the Securities and Exchange Commission.

Change said in the filing that UnitedHealth informed the company that it was pushing back the deal’s outside date to April 2022. Previous filings suggested that the acquisition could close as early as late February.

Within the merger agreement, both companies have the right to push back the outside date.

UnitedHealth and Change are awaiting the completion of an investigation into the merger by the Department of Justice, which has been probing the deal on antitrust grounds.