Friday Stats and More

Rx coverage

Friday Stats and More

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

Based on the CDC’s Covid Data Tracker and using Thursday as the first day of the week, here are the FEHBlog’s weekly charts of new Covid cases and deaths beginning with the 27th week of 2021 and ending with the 7th week of 2022.

At last, both charts are headed down.

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered beginning with the 51st week of 2020, when the vaccination program launched, and the 7th week of this year.

As of today, nearly 75% of Americans aged 18 and older (74.7%) are fully vaccinated, and 46.5% of Americans in that age group are boostered.

Precision Vaccines reports

More than one year after the first COVID-19 vaccine was administered in the United States, new data from a recent survey conducted online by The Harris Poll show 73% of consumers would like to see additional COVID-19 vaccines become available.

Currently, the World Health Organization has listed ten different COVID-19 vaccines based on various technologies.

But the U.S. FDA has only authorized/approved three COVID-19 vaccines.

Moreover, consumers would like to see COVID-19 vaccines developed from traditional methods, such as technologies used to produce diphtheria, mumps, chickenpox, or polio vaccines.

Novavax’s traditionally developed Covid vaccine is pending Food and Drug Administration emergency use authorization. The FDA’s Vaccines Advisory Committee will consider the EUA application first. That Committee’s next meeting will be held on March 3, 2022. The agenda is not available yet.

In great news, Bloomberg reports

[W]ith [Covid] cases plummeting thanks to the omicron decline, and government orders continuing to roll into pharmacies, doctors and health officials in New York and across the country say the supply is looking plentiful in many areas.

“You have lots of the drug and very few cases — that’s the best place you could possibly be,” says Infectious Diseases Society of America spokesman Aaron E. Glatt. The pills are broadly available, he said, though not at every corner drugstore.

The federal government tracks Paxlovid on a public-facing website that names which pharmacies have it, and a federal website for health-care providers indicates more than 130,000 courses are available.

Dare we hope that the country will be prepared for the next Covid variant if it crops up?

Here are links to the CDC’s Covid Data Tracker weekly review and its FluView. The top line of FluView reads, “Sporadic influenza activity continues across the country. In some areas, influenza activity is increasing.” The current winter continues to mirror the 2020-21 winter, with Omicron edging out the flu.

From the Covid fallout front, Health Payer Intelligence informs us

Senior members might continue to see canceled or delayed care even as coronavirus cases decline, a trend which has had significant impacts on payer revenues and spending in 2020 and 2021, a report from the University of Michigan’s National Poll on Healthy Aging found.

Nearly three out of ten adults over 50 (28 percent) delayed care due to the coronavirus pandemic in 2021.

“Whether they chose to postpone or their provider did, these patients missed opportunities for preventive care and for early detection and effective management of chronic conditions, not to mention operations and procedures to address a pressing health need,” said Jeffrey Kullgren, MD, associate director of the poll and a health care researcher and associate professor of internal medicine at Michigan Medicine in the University of Michigan’s academic medical center.

The National Poll on Healthy Aging surveyed 1,011 adults ages 50 and older in late January 2022. Seniors could complete the survey by phone or online.

Considering the FEHB’s demographics, this report should be relevant to FEHB carriers.

Speaking earlier of the FDA, here is a link to the FDA’s roundup for February 18, 2022. Moreover, Fierce Healthcare reports

Hospitals on average charge double the price for the same drugs compared to those offered by specialty pharmacies, according to a new insurer-funded study released as federal regulators ponder a probe into the pharmacy benefit management industry.

The study (PDF), released Wednesday by insurance lobbying group AHIP, comes as specialty pharmacies have grown in use among PBMs and payers to dispense specialty products. The study was released a day before a scheduled meeting Thursday of the Federal Trade Commission on whether to probe the competitive impact of PBM contracts and how they could disadvantage independent and specialty pharmacies.

“The data are clear, specialty pharmacies lower patient costs by preventing hospitals and physicians from charging patients, families, and employers excessively high prices to buy and store specialty medicines themselves,” said Matt Eyles, president and CEO of AHIP, in a statement.

From the telehealth front, mHealth Intelligence notes

Though patients have previously made their preference for virtual waiting rooms over traditional ones known, new survey results show that a majority of telehealth patients would rather just be notified by a text or call when their doctor is ready to see them.

Doximity, an online networking service and telehealth platform for healthcare professionals, conducted the new survey last November, polling 2,000 US adults, of whom 1,000 identified as having a chronic illness.

As telehealth becomes integrated into care delivery, questions around patient preferences arise. The survey helps shed some light, showing that 79 percent of patients would prefer a call or text letting them know that their doctor is ready to see them versus having to wait in a virtual waiting room. Even among chronic illness patients only, an overwhelming majority (81 percent) would prefer to receive a call or text.

Patients also displayed a strong preference for familiarity with a provider. Overall, 83 percent of patients surveyed said they would wait one to three days to see their current doctor rather than seeing a new physician immediately.

If these statistics float your boat, you will find many more exciting telehealth stats in the article.

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–

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.

Midweek Update

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

From Capitol Hill —

Today, the Senate invoked cloture on the resolution to continue funding the federal government until March 11 by unanimous consent. Consequently, the new resolution should be approved by Congress tomorrow, which is the day before funding expires under the current resolution.

The House of Representatives has returned the correct version of the Postal Reform Act, H.R. 3076, to the Senate, and the Senate has had the correct version read twice. We will have to wait and see if anything happens with the bill tomorrow.

In the meantime, check out the Congressional Research Service’s February 11, 2022, report on the Postal Reform bill approved by the House, H.R. 3076. In the FEHBlog’s view, a unique feature of the House version compared to earlier versions is that the bill destined to become law creates a transitional Open Season. The Transitional Open Season will auto-enroll those Postal employees and annuitants who failed to transfer over to the PSHBP in the 2024 Open Season for the 2025 plan year. The receiving PSHBP plan will be the lowest premium nationwide PSHBP plan that is not a high deductible plan and does not require dues payments. Also, the House version makes the Postal Service financially responsible for the late Medicare Part B enrollment fees otherwise owed by the Postal annuitants with Part A only who take advantage of a special Part B enrollment period in 2024.

Following up on Robert Califf’s second confirmation as Food and Drug Administrator yesterday, STAT News identified the six major drug approval decisions awaiting him, including Pfizer’s toddler COVID vaccine, the Novovax Covid vaccine, and Alzheimer’s Disease treatments. Good luck, Mr. Califf.

Also among those drug approval decisions awaiting Mr. Califf is a Covid treatment discussed in Bloomberg

After omicron weakened some of the defenses that doctors have against Covid, an experimental treatment being developed by Novartis and a small Swiss biotech partner holds some promise as a new therapy.

Last week, Novartis sought emergency approval from the U.S. Food and Drug Administration for an intravenous drug, called ensovibep, that’s similar in some ways to monoclonal antibody treatments. However, the way it works is significantly different, which might allow it to succeed where antibody therapies fail against omicron.

The compound uses tiny proteins to attack the coronavirus’s spike protein in not just one, but multiple places. That appears to give it a leg up in fighting the virus even as it mutates.

In other federal leadership changes, STAT News adds

President Joe Biden is replacing a top science adviser who resigned under a cloud with two individuals who will split his duties on an interim basis.

Biden is tapping [Alondra Nelson, ]a deputy in the White House science and technology office along with [Dr. Francis Collins] the recently retired director of the National Institutes of Health, according to a personal familiar with the president’s plans.

From the Omicron front, Beckers Hospital Review tells us

The COVID-19 omicron subvariant BA.2, dubbed “stealth omicron,” has spread to at least 74 countries and 47 states across the U.S., according to data from outbreak.info.

Four more updates: 

1. BA.2 is most prevalent in HHS’ region 3, which includes Pennsylvania, West Virginia, Virginia, Delaware and Maryland, according to CDC data.

2. Region 7, which includes Iowa, Kansas, Missouri and Nebraska, had the lowest percentage of BA.2 cases last week, according to CDC data. 

3. BA.2 currently accounts for 3.9 percent of total COVID-19 cases in the U.S., with omicron subvariant BA.1.1 accounting for 73.2 percent of cases, CDC data shows. 

4. A South African study analyzing nearly 100,000 COVID-19 cases found that BA.2 doesn’t cause significantly more severe illness than the original omicron variant, Bloomberg reported Feb. 16.

From the Covid vaccine front, The American Medical Association reports

The New York Times (2/15, Anthes) reports infants born to mothers who “received two doses of an mRNA coronavirus vaccine during pregnancy are less likely to be admitted to the hospital for COVID-19 in the first six months of life, according to a new study from the Centers for Disease Control and Prevention.” The study found that “overall, maternal vaccination was 61% effective at preventing infant hospitalization.”

Reuters (2/15, Mishra, Steenhuysen) reports, “That protection rose to 80% when the mothers were vaccinated 21 weeks through 14 days before delivery.” Meanwhile, the “effectiveness fell to 32% for the babies whose mothers were inoculated earlier during pregnancy.”

The Hill (2/15, Sullivan) reports the study used data “from 20 pediatric hospitals in 17 states, from July 2021 to January 2022.”

From the Covid front, Fierce Healthcare reports

Anthem has launched a new pilot that aims to offer a digital concierge care experience to members recovering from COVID-19.

Through COVID Concierge Care, eligible members can access an app and fill out a questionnaire that tracks their symptoms on a daily basis. They can connect with a clinician via secure, two-way text-based messages in the app or via text or email.

In addition, based on their reported symptoms, members can access evidence-based educational tools and wellness content to help them self-manage their conditions. For example, members can connect with breathing exercise guides to manage stress or health articles about their symptoms.

From the Covid vaccine mandate front, Federal News Network tells us

The Postal Service is laying the groundwork to track the vaccination and testing status of its workforce amid the COVID-19 pandemic, or any future public health emergency.

USPS, however, says it’s only giving notice as it prepares for “potential future contingencies,” and is not, at this time, updating its COVID-19 vaccine or testing requirements, nor is it seeking to collect data on the vaccination status of its workforce.

In healthcare business news, Healthcare Dive informs us

The Department of Justice is preparing a lawsuit to block UnitedHealth from purchasing Change Healthcare, according to a new report, as regulators take a more aggressive stance on checking consolidation in the healthcare industry.

According to Dealreporter, which cited sources familiar with the matter, UnitedHealth and Change are expected to meet with the DOJ soon for a “last rites” meeting on the proposed deal, first announced early last year. Despite UnitedHealth and Change exploring divestitures to assuage antitrust concerns, the DOJ has not found any that would make the deal acceptable, according to Dealreporter’s sourcing.

From the health savings account front, Health Payer Intelligence offers nine best practices for high deductible health plan design based on a recent report from the National Pharmaceutical Council (NPC) and Gallagher.

From the antibiotic overutilization front, AHIP lets us know

A study published in the CDC’s Morbidity and Mortality Weekly Report found 41% of antibiotic prescriptions for Medicare Part D beneficiaries in 2019 were written by just 10% of prescribers. Researchers found nearly half of these high-volume prescribers practiced in southern states, and they had a median antibiotic prescribing rate of 680 per 1,000 beneficiaries, compared with 426 per 1,000 beneficiaries among low-volume prescribers. 

Friday Stats and More

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 vaccine, Medicare, Rx coverage, U.S. Healthcare, Uncategorized–

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.”

Tuesday’s Tidbits

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

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

From Capitol Hill —

Roll Call reports that

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

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

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

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

From the Omicron front —

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

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

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

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

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

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

The National Institutes of Health informed us

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

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

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

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

The Wall Street Journal reports today

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

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

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

The more, the merrier.

In other news, Fierce Healthcare tells us

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

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

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

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

Smart move.

STAT News reports

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

and

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

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

Thursday Miscellany

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

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

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

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

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

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

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

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

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

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

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

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

Midweek update

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Obviously, this is an important government initiative.

From the healthcare business front —

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

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

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

  • Health Payer Intelligence tells us that

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

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

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

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

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

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

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

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

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

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

From the HR front, Federal News Network reports that

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

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

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

Tuesday’s Tidbits

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

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

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

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

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

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

From the Covid vaccine front —

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

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

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

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

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

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

From the healthcare cost front, Healthcare Dive reports that

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

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

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

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

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

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

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

From the healthcare business front, Fierce Healthcare tells us that

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

The deal was first announced in September.

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

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

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

Monday Roundup

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

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

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

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

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

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

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

Later in the day, AHIP informed us that

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

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

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

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

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

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

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

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

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

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

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

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

Unquestionably so.

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

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

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

In healthcare business news, Healthcare Dive tells us that

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

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

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

From the benefit design front, Axios reports that

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

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

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

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

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

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

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

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

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

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