Tuesday’s Tidbits

Rx coverage

Tuesday’s Tidbits

David Ermer–COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Omicron front, the Wall Street Journal reports that

Covid-19 deaths in the U.S. have reached the highest level since early last year, eclipsing daily averages from the recent Delta-fueled surge, after the newer Omicron variant spread wildly through the country and caused record-shattering case counts.

The seven-day average for newly reported Covid-19 deaths reached 2,191 a day by Monday, up about 1,000 from daily death counts two months ago, before Omicron was first detected, data from Johns Hopkins University show. While emerging evidence shows Omicron is less likely to kill the people it infects, because the variant spreads with unmatched speed the avalanche of cases can overwhelm any mitigating factors, epidemiologists say.

“You can have a disease that is for any particular person less deadly than another, like Omicron, but if it is more infectious and reaches more people, then you’re more likely to have a lot of deaths,” said Robert Anderson, chief of the mortality-statistics branch at the National Center for Health Statistics, which is part of the Centers for Disease Control and Prevention.

Bloomberg adds that

Covid-19’s deadly effects manifest long after some patients leave the hospital, according to a new study that points to the pandemic’s grave aftermath. 

Hospitalized patients who survived at least a week after being discharged were more than twice as likely to die or be admitted again within months, scientists from the London School of Hygiene and Tropical Medicine and the University of Oxford found. The Covid survivors also had an almost five times greater risk of dying in the following 10 months than a sample taken from the general population.

The findings, published Tuesday in the journal PLOS Medicine, add to evidence that the pandemic’s effects on health and wellbeing extend well beyond an initial infection. A Dutch study on Monday showed that three-quarters of Covid patients treated in intensive care were still suffering fatigue, impaired fitness and other physical symptoms a year later, and one in four reported anxiety and other mental symptoms.

“Covid-19 isn’t just an acute respiratory viral illness — like a cold or some other inconsequential infection — that goes away in a few days or a few weeks,” said Ziyad Al-Aly, director of the clinical epidemiology center at the Veterans Affairs St. Louis Health Care System in Missouri, who has led similar studies in the U.S. “It carries serious long-term consequences, including higher risk of death.” * * *

Needless to stay these articles illustrate the importance of being vaccinated with a booster against Covid.

From the free COVID tests front, MedCity News reports that

In the days since the Biden Administration announced on January 15 that insurers would be required to cover eight over-the-counter Covid-19 tests per month for members, digital health company Truepill has been busy developing a platform to help health plans meet that mandate.

In May, the San Mateo, California-based startup, which provides pharmacy fulfillment and telehealth services for brands like Hims, Nurx and Lemonaid, added home testing. Co-founder and President Sid Viswanathan said in an earlier interview that the company had planned to also offer diagnostics from the beginning.

The Covid-19 test coverage platform will give clients a behind-the-scenes partner who can assist with everything from checking member eligibility for coverage of tests to delivering those tests to their homes and providing shipping updates en route.

“We found a lot of plans are having to react to this on very short timelines, and so we’re building out a white-labeled, e-commerce experience that a plan can utilize,” said Varun Boriah, senior vice president of diagnostics at Truepill, in a phone interview. “We can put any plan’s logo on that asset and manage their patient experience for them.”

Cool.

From the OSHA vaccinate or test mandate front, the Society for Human Resource Management informs us

The Occupational Safety and Health Administration (OSHA) is withdrawing its emergency temporary standard (ETS) that would have required by Feb. 9 that large businesses ensure employees are vaccinated against the coronavirus or undergo weekly COVID-19 testing. Nonetheless, the agency is moving forward with its proposal to make the temporary directive a permanent standard. 

On Jan. 13, the U.S. Supreme Court halted the ETS while the 6th U.S. Circuit Court of Appeals considered the merits of the challenge against the vaccination-or-testing directive. OSHA announced on Jan. 25 that it will no longer seek to enforce the ETS, which will end the lawsuit, but the temporary directive served a dual purpose. The ETS also acts as a proposal for a permanent standard, which is separate from the litigation. “OSHA is not withdrawing the ETS to the extent that it serves as a proposed rule,” according to the agency.  * * *

OSHA said in a statement that it is prioritizing a proposal for a permanent COVID-19 safety standard for health care workers. 

“Notwithstanding the withdrawal of the [ETS], OSHA continues to strongly encourage the vaccination of workers against the continuing dangers posed by COVID-19 in the workplace,” the agency said.

The FEHBlog noticed that the Justice Department has asked the U.S. Court of Appeals for the Sixth Circuit to dismiss the consolidated challenge to the OSHA ETS as moot citing this OSHA action.

From the mental health parity front, the Department of Health and Human Services announced the release of the government’s

2022 Report to Congress on the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 – PDF. The report includes information that suggests health plans and health insurance issuers are failing to deliver parity for mental health and substance-use disorder benefits to those they cover. The report also highlights the departments’ recent emphasis on greater MHPAEA enforcement in addition to guidance to correct those failures, and makes recommendations to strengthen MHPAEA’s consumer protections and enhance the departments’ enforcement abilities.

The FEHBlog is not surprised at allegations on non-compliance because this is a very complicated. The law requires carriers to build walls between physical and mental health benefits and then ensure parity in quantitative and nonquantitative treatment limits. Why not break down the wall and define general coverage rules to embrace mental and substance use disorder care? Simply put, establish one set of rules for both types of care.

From the healthcare business front, Bloomberg reports that

Change Healthcare Inc. is considering selling some assets to clear the way for its $8 billion acquisition by UnitedHealth Group Inc., according to people with knowledge of the matter. 

The company is working with advisers on a possible divestiture of its payment integrity business, ClaimsXten, said the people, who asked not to be identified because the information is private. ClaimsXten could fetch a value of more than $1 billion, the people said. The business generates $130 million to $150 million in annual earnings before interest, taxes, depreciation and amortization, they said.

There’s no certainty a deal for ClaimsXten will be reached or that it will be enough to satisfy regulators, the people said.

A representative for Change Healthcare didn’t immediately respond to requests for comment. A spokesperson for UnitedHealth declined to comment.

UnitedHealth and Change Healthcare have been caught in a regulatory limbo over their proposed merger since the U.S. Justice Department opened an investigation into the deal in March, two months after it was announced.

Can’t blame Change for trying.

From the benefit design front, Govexec offers a helpful article about the advantage of enrolling in a high deductible plan which permits funding a health savings account. Contributions to an HSA are tax deductible when contributed; grow tax free, and tax exempt when withdrawn for healthcare purposes. You can’t beat that.

Drug Channels offers a January news roundup featuring an Insulin G2N Update; OptumRx “Data,” HDHPs, 340B Projections, and Fun with the CDC. What’s not to like?

Weekend Update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Electronic health records, Rx coverage, U.S. Healthcare–

Both Houses of Congress will be engaged in Committee business and floor voting this week as we are now less than one month away from the expiration of the current continuing resolution funding the federal government. That resolution runs through February 18.

From the Omnicron front, the New York Times reports that ‘

New coronavirus cases have started to fall nationally, signaling that the Omicron-fueled spike that has infected tens of millions of Americans, packed hospitals and shattered records has finally begun to relent.

More and more states have passed a peak in new cases in recent days, as glimmers of progress have spread from a handful of eastern cities to much of the country. Through Friday, the country was averaging about 720,000 new cases a day, down from about 807,000 last week. New coronavirus hospital admissions have leveled off.

Even as hopeful data points emerge, the threat has by no means passed. The United States continues to identify far more infections a day than in any prior surge, and some states in the West, South and Great Plains are still seeing sharp increases. Many hospitals are full. And deaths continue to mount, with more than 2,100 announced most days.

But following a month of extraordinary rates of case growth, blocklong lines at testing centers and military deployments to bolster understaffed I.C.U.s, the declining new-case tallies offered a sense of relief to virus-weary Americans, especially in the Northeast and parts of the Upper Midwest, where the trends were most encouraging. After another round of masking up or hunkering down, some were considering what life might look like if conditions continued to improve. 

Bloomberg adds

The omicron variant spreads so rapidly that sometimes it feels as if resistance is futile. It’s disheartening to hear of omicron infecting people who are up-to-date on their shots and wear an N95 mask every time they leave home. Even some well-known public-health experts are getting infected. But that doesn’t mean everyone is going to get it. 

What it does mean is that life is profoundly unfair. In some of us, the Covid-19 vaccines work quite robustly, even against omicron. In others, the vaccines’ effect is weaker. Chalk this up to the spectacular diversity of the human immune system, which is partly regulated by some of the most varied genes in the human body. 

A recent study led by Harvard and MIT showed that about 20% of people get much poorer protection from their vaccines against omicron. They’re still better off than completely unvaccinated people, but this variability could account for some of the fully vaccinated people who’ve been hospitalized in the omicron wave.

According to the American Medical Association (AMA), here’s what physicians want their patients to know about Omicron. “The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions (PDF), and another to address physicians’ COVID-19 vaccine questions (PDF).”

From the Rx coverage front, the New York Times offers an interview with CVS Health’s CEO Karen Lynch. For example,

What do you see as the most effective ways that we could reduce health care costs for everyday Americans? And what’s your company’s role in doing that?

There’s a couple of things. One is there’s the site of care. Our role is offering an alternative site of care, either in our retail locations, or in the home with virtual connections. We’re entering into the primary care space because we believe that primary care has real significant influence over the cost of health care.

And I’m pretty passionate about the fact that the head is attached to the body, and most people experience behavioral health issues when they are experiencing physical health issues. We only deal with the physical health. We don’t deal with the behavioral health part, and I think there’s more we can do.

Healthcare Dive provides us with industry perspective on last week’s launch of TEFCA which is intended to vastly improve interoperability by linking together regional health information exchanges.

The goal of TEFCA is to get rid of individual legal agreements between health information networks, health plans, providers and other entities by instituting one common agreement that qualified networks and their participants sign onto, paring back on administrative burden. The framework standardizes the operational side of data exchange, while raising the privacy and security bar for entities that want to be certified as qualified health information networks (QHINs), groups of organizations that agree to the same data-sharing infrastructure. * * *

Getting a nationwide network of groups of organizations that agree to the same data-sharing infrastructure could significantly streamline patient care across different geographies.

For example, if a patient from Virginia takes a vacation to California and ends up in an emergency room, doctors currently do the best they can to treat them without their medical record, which can contain valuable information about preexisting conditions, allergies and other health factors. But with a nationwide QHIN infrastructure, clinicians can query all participating networks for that patient’s data and use it to inform their clinical choices, Barrett said.

That budding future all centers on buy-in. * * *

Many, including ONC, are optimistic on TEFCA adoption, citing the competitive disadvantages to nonparticipation.

The hope is that the more networks use it, the more its value proposition will be proved. Patients will inquire why their provider doesn’t have their data from other facilities, and the provider will then wonder why the exchanges it’s a participant in aren’t qualified to work with other networks, Lee Barrett, CEO of EHR standards development organization EHNAC said.

Thursday Miscellany

David Ermer–COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, No Surprises Act, Rx coverage–

The American Hospital Association released its latest COVID Snapshot today.

Bloomberg adds that

The U.S. hospital-staffing shortage exacerbated by the latest Covid-19 wave is showing signs of easing, but many West Coast and rural states are still seeing the worst of it.

Over the past seven days, about 16.7% of U.S. hospitals have reported critical staffing shortages, down from a recent peak of 18.7% on Jan. 9, according to data from the Department of Health and Human Services. Fewer facilities are reporting shortages in populous New York, Florida and Illinois. 

The numbers are still concerning to state leaders, but are at least returning to the levels seen in October and November, before the omicron spike.

From the Covid treatment front —

The niftiest COVID news that the FEHBlog ran across today is this GoodRx website that provides “Live Updates on How to Find Paxlovid and Molnupiravir,” respectively the Pfizer and Merck Covid pills. Bookmark it.

From the COVID testing front —

SHRM brings us up to date on the unnecessarily rushed rollout of the federal government mandate that health plans cover over the counter Covid tests. Most plans did not have time to create in-network coverage because health plans do not cover OTC drugstor items except when mandated to do so.

From the COVID vaccine mandate front, FedWeek reports that

The impact of the Coronavirus vaccine mandate in terms of turnover in the federal workforce—either voluntary or not—remains largely anecdotal, although the largest agency, DoD has said there have been “no terminations yet.”

“We are still finalizing the guidance to the civilian force in that regard,” a Pentagon spokesman said late last week in a comment that seems to characterize the state of affairs in general.

From the Rx coverage front —

  • Drug Store News reports that

CVS Health is embarking on a collaboration with Uber Health, Uber’s healthcare arm, to provide critical transportation support at no cost to people who need it most when seeking access to medical care, work or educational programs.

The relationship is part of Health Zones, CVS Health’s new initiative that provides concentrated local investments designed to reduce health disparities and advance health equity in high-risk communities across the country. Health Zones is an integrated approach to addressing six key social determinants of health: housing, education, access to food, labor, transportation, and health care access. 

The Health Zones initiative is now active in five markets nationwide: Atlanta, Ga.; Columbus, Ohio; Fresno, Calif.; Hartford, Conn.; and Phoenix, Ariz. with plans to expand into more cities later this year. Working with trusted national and local partners, CVS Health is addressing community health care needs, ensuring at-risk communities have access to resources and opportunities that can help them thrive.

  • Fierce Healthcare tells us that

Mark Cuban Cost Plus Drug Company (MCCPDC) has launched its online pharmacy as part of an ongoing effort to provide consumers with low drug prices. 

The pharmacy claims to offer significant savings, with several prescription drugs reportedly at more than half the cost of the next most affordable option. For instance, leukemia treatment imatinib has a retail price of $9,657 a month, according to MCCPDC, compared to $120 with a common voucher. Its price through the new company, however, is just $47 per month.

The pharmacy’s initial inventory launch consists of 100 generic drugs. 

From the No Suprises Act front, Health Payer Intelligence discusses how the new law is likely to spur collaboration between providers and payers to improve the accuracy of provider directories. The FEHBlog has always thought the providers should post the a notice about the networks in which they participate at their offices and on their websites.

Midweek update

David Ermer–COVID treatment, COVID vaccine mandate, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by JOSHUA COLEMAN on Unsplash

In this morning’s New York Times, columnist David Leonhardt writes

Omicron appears to be in retreat, even if the official national data doesn’t yet reflect that reality. Omicron also appears to be mild in a vast majority of cases, especially for the vaccinated. This combination means that the U.S. may be only a few weeks away from the most encouraging Covid situation since early last summer, before the Delta variant emerged.

If that happens — and there is no guarantee it will, as Katherine Wu of The Atlantic explains — it will be time to ask how society can move back toward normalcy and reduce the harsh toll that pandemic isolation has inflicted, particularly on children and disproportionately on low-income children.

When should schools resume all activities? When should offices reopen? When should masks come off? When should asymptomatic people stop interrupting their lives because of a Covid exposure? Above all, when does Covid prevention do more harm — to physical and mental health — than good?

These are tricky questions, and they could often sound inappropriate during the Omicron surge. Now, though, the surge is receding.

Yes, indeed. Helen Branswell, writing in STAT News, offers an array of expert opinions on what could be next on the COVID front.

John Moore, a virologist at Weill Cornell Medical College, said a post-Omicron decrease in transmission “is certainly a plausible scenario,” suggesting it might take until late February or early March for most of the country to get there. But equally possible, he suggested, is that another variant will emerge, with the transmissibility of Omicron but without its reticence to replicate in the deep lungs [like Alpha and Delta did].

“This is where it’s all so freaking difficult. There are scenarios. You don’t know what the future’s going to hold. All these people who say ‘This is what’s going to happen.’ Well, this is what they think might happen, if they’re being honest,” he said.

While the situation remains unsettling, the FEHBlog thinks that Mr. Leonhardt’s thinking is on the right track.

From the masking front, the Wall Street Journal reports that

The Biden administration on Wednesday announced plans to make 400 million N95 masks available for free at pharmacies and community health centers across the country.

The move comes as President Biden has stepped up the federal government’s response to a nationwide surge in Covid-19 cases triggered by the highly transmissible Omicron variant. Some scientists and doctors have said popular single-layer cloth masks may not be sufficient to protect against Omicron and called on the administration to expand access to high-filtration masks such as N95s.

The nonsurgical N95 masks will start to be available at pharmacies and community health centers late next week and the program will be fully up and running by early February, the White House official said. The masks will be sourced from the Strategic National Stockpile, the nation’s safety net of medical-equipment supplies. * * *

Three masks will be available per person, the official said, to ensure broad access. Most of the pharmacies that are part of the federal pharmacy vaccine program will distribute the masks, the official said.

Following up on yesterday’s post on distribution of the Pfizer and Merck Covid pills, the New York Times offers a reporter’s saga of tracking down the Pfizer treatment for her ailing mother.

The fact that the process was so hard for a journalist whose job it is to understand how Paxlovid gets delivered is not encouraging. I worry that many patients or their family would give up when told “no” as many times as I was.

I was also reminded that even a “free” treatment can come with significant costs.

The federal government has bought enough Paxlovid for 20 million Americans, at a cost of about $530 per person, to be distributed free of charge. But I spent $256.54 getting the pills for my mother. I paid $39 for the telemedicine visit with the provider who told my mother that she would need to visit in person. The rest was the Uber fare and tip. Many patients and their families can’t afford that.

President Biden recently called the Pfizer pills a “game changer.” My experience suggests it won’t be quite so simple.

FEHB and other health plans hopefully are looking into helping their members navigate this complicate process.

From the COVID vaccine mandate front, Fierce Healthcare reports

All 50 states are now subject to the Centers for Medicare & Medicaid Services’ (CMS’) healthcare workforce mandate after a federal court tossed Texas’ lawsuit and preliminary injunction contesting the requirement.

Today’s dismissal comes less than a week after the Supreme Court removed a stay of the federal government’s industry-wide vaccine requirement in 24 states that opposed the policy. The Biden administration filed an appeal of Texas’ injunction the following day.

Although CMS’ requirement may now be enforced across the country, the agency has set varying compliance deadlines reflecting whether its initial interim final rule was enjoined in a particular state.

Healthcare Dive adds

Healthcare workers in the 24 states that legally challenged the requirement will now be on a different vaccine deadline than the rest of the nation. For these states, healthcare workers must be fully inoculated by March 15, CMS confirmed with Healthcare Dive.        

But for the healthcare workers in the other 25 states and D.C., which were not a part of the litigation, workers will need to be fully vaccinated by Feb. 28, per CMS.         

From the healthcare business front —

Healthcare Dive tells us that

UnitedHealth reiterated its 2022 enrollment targets for Medicare Advantage on Wednesday, easing recent concerns that rising competition could hamstring future growth in the fruitful market.

The forecast was released along with its fourth-quarter and full-year 2021 results. The Minnetonka, Minnesota-based healthcare behemoth also reported no serious change in utilization trends despite skyrocketing COVID-19 case counts due to the highly infectious omicron variant.

UnitedHealth beat Wall Street expectations on both earnings and revenue in the fourth quarter, with revenue of $73.7 billion, up 13% year over year, thanks in part to the outsized growth of its health services business Optum. Net earnings of $4.2 billion were almost double the $2.4 billion in profit brought in at the same time last year.

Healthcare Dive adds that

Antitrust regulators said Tuesday they are looking to modernize merger guidelines in an effort to crack down on tie-ups amid a flood of merger filings that has more than doubled in the past year.

Leaders of the Federal Trade Commission and Department of Justice are launching a review of the current guidelines that are used to detect and analyze potentially unlawful mergers. Those policing guidelines have not been updated in 12 years, potentially excluding realities of a modern economy, leaders said.

To bring the guidelines up to date, the FTC and DOJ are calling on the public to submit information and new evidence, about the potential effects of mergers so the agencies can ultimately beef up tools to block anticompetitive deals.

From the Rx coverage front —

  • Drug Channels offers five takeaways from the Big Three PBM’s exclusion lists.
  • The Congressional Budget Office released a report titled “Prescription Drugs: Spending, Use, and Prices.”

In general healthcare news —

  • The American Medical Association discusses what drives Black maternal health inquities in the U.S.

Researchers at the University of Wisconsin-Madison have spent years making sure that their meditation app, called the Healthy Minds Program, passes clinical muster and delivers positive outcomes. Designing studies to test the app’s efficacy led Simon Goldberg, an assistant professor at UW, to confront the mountain of thousands of studies of different mobile mental health tools, including apps, text-message based support, and other interventions.

Researchers had taken the time to synthesize some of the studies, but it was hard, even for someone steeped in the science like Goldberg, to draw definitive conclusions about what works and what doesn’t. So Goldberg teamed up with a few other researchers and took a step back to see if they could put order to the work collected in these meta-analyses — a kind of deep meditation on the existing research inspired by UW’s meditation app.

The meta-review, published on Tuesday in PLOS Digital Health, examined 14 meta-analyses that focused specifically on randomized control trials for mental health interventions, including treatments for depression, anxiety, and smoking cessation. In total, the review included 145 trials that enrolled nearly 50,000 patients. The review found universal shortcomings in study design, leading the researchers to write that they “failed to find convincing evidence in support of any mobile phone-based intervention on any outcome.”

Ruh roh.

Thursday Miscellany

David Ermer–AHRQ, CMS, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Patient safety, Rx coverage, SCOTUS, Telehealth, U.S. Healthcare–

In yesterday’s post, the FEHBlog accurately predicted that the Supreme Court would decide today whether to stay the OSHA ETS vaccination screening program and end the partial stay on the CMS healthcare worker vaccination mandate.

This afternoon, the Supreme Court issued its decision reinstating the nationwide stay of the OSHA ETS and its companion decision ending all stays on the CMS mandate. The decisions came down as many, many pundits predicted.

The Secretary of Labor who oversees OSHA commented that

“We urge all employers to require workers to get vaccinated or tested weekly to most effectively fight this deadly virus in the workplace. Employers are responsible for the safety of their workers on the job, and OSHA has comprehensive COVID-19 guidance to help them uphold their obligation. 

“Regardless of the ultimate outcome of these proceedings, OSHA will do everything in its existing authority to hold businesses accountable for protecting workers, including under the Covid-19 National Emphasis Program and General Duty Clause.”

In the OSHA ETS decision, the Supreme Court expressed the key point of administrative law on which the two cases turned:

Administrative agencies are creatures of statute. They accordingly possess only the authority that Congress has provided.

The Court reasoned that Congress had granted CMS the necessary authority to issue its broad mandate but had not granted OSHA the same level of authority.

The cases now return to the courts of appeal for a decision on the merits — 6th Circuit for the OSHA ETS case and 5th Circuit for the CMS mandate case. In the meantime the Court’s decisions on the stays will remain in place.

Given how the Court handled these stay decisions, we have a pretty good idea where the Supreme Court will land should either of those merits decisions return to the Court.Such a return likely only will happen if either appellate court disagrees with the Court’s administrative law conclusion on the merits.

In that regard, Bloomberg Law reports that

The Justice Department will appeal a Louisiana federal court’s ruling that blocked President Joe Biden‘s order for government-contractor workers to get the Covid-19 vaccine. 

The U.S. Court of Appeals for the Fifth Circuit will be the third federal appeals court to consider a challenge to the measure. A coalition of three states—Louisiana, Mississippi, and Indiana—sought to block the mandate for companies that do business with the federal government. U.S. District Court Judge Dee Drell of the Western District of Louisiana granted a preliminary injunction in December. 

The federal contractor mandate—which won’t be enforced while litigation proceeds—would apply to roughly a quarter of the U.S. workforce, and affect businesses including Lockheed Martin Corp., Microsoft Corp., Alphabet Inc.‘s Google, and General Motors Co.

Appeals are ongoing in the Eleventh and Sixth circuits, respectively, over a nationwide injunction against the measure from a Georgia federal court and a narrower one from a Kentucky federal judge for a coalition that includes Ohio and Tennessee. A Missouri federal court also blocked the executive order, but that ruling has yet to be appealed.

From the Omicron front, David Leonhardt writing in today’s New York Times cautiously senses that the Omicron surge is cresting in our country following Europe’s and South Africa’s leads. “To be clear, the current emergency is not on the verge of ending. Cases appear to be peaking only in places where Omicron arrived early, mostly in the Northeast. In much of the country, cases are still soaring.”

From the Covid vaccine front, the AP reports that

Distrust, misinformation and delays because of the holidays and bad weather have combined to produce what authorities say are alarmingly low COVID-19 vaccination rates in U.S. children ages 5 to 11.

As of Tuesday, just over 17% were fully vaccinated, more than two months after shots became available to the age group. While Vermont is at 48%, California is just shy of 19% and Mississippi is at only 5%.

Vaccinations among the elementary school set surged after the shots were introduced in the fall, but the numbers have crept up slowly since then, and omicron’s explosive spread appears to have had little effect.

The low rates are “very disturbing,” said Dr. Robert Murphy, executive director for the Institute for Global Health at Northwestern University’s Feinberg School of Medicine. “It’s just amazing.”

Parents who hesitate “are taking an enormous risk and continuing to fuel the pandemic,” Murphy said.

From the telehealth front, STAT News informs us that

A handful of virtual care companies are inking new types of contracts that reward them for keeping patients’ cost low and penalize them for overspending — a model known as risk-sharing. It’s a departure from the traditional “fee-for-service” billing process, and a move  companies hope could help them get paid for the services they offer in addition to virtual doctors’ appointments, like in-app messaging, medication reminders, and digital health coaching. They’re also betting that embracing risk could endear them to the health plans and employers they depend on for contracts.

Execs from companies like Heartbeat Health and Teladoc say they’re in the very early stages of cementing these contracts. While there’s no clear roadmap for how to structure them, whether they take hold could clarify how virtual care will fit into the brick-and-mortar healthcare system and incentivize those companies to work with traditional providers on prevention, said Jennifer Goldsack, CEO of the Digital Medicine Society. “There is an opportunity to reimagine what health care looks like when it is around the patient,” she told Mohana. Read the full story. 

From the healthcare cost front, STAT News tells us that

— Medical cost growth trailed that of other industries in 2021, though rising pressure from the omicron variant could fuel future increases in healthcare costs.

— Prices for goods and services skyrocketed at the fastest pace in four decades, rising 7% between December 2020 and December 2021, according to new data released Wednesday from the Bureau of Labor Statistics.

— By comparison, prices for healthcare services rose roughly 2.5% last year, while the cost of medical care goods rose just 0.4%. However, that slow rate of growth could accelerate as COVID-19 cases persist in 2022 and beyond.

From the miscellany department —

  • The Agency for Healthcare Quality and Research’s Acting Director Dr. David Meyers looks back at 2021.
  • Biopharma Dive considers five questions facing gene therapy in 2022.
  • Fierce Healthcare notes that

As the healthcare system faces significant labor challenges, a new report suggests pharmacists are well positioned to fill some of the critical gaps.

The analysis, conducted by Express Scripts and the Columbia University Mailman School of Public Health, found that a majority of pharmacists see their roles transitioning to more direct patient care responsibilities over the next decade.

  • AARP’s Public Policy Institute examines the importance of medication literacy in the medication decision-making of older adults.

While health literacy is widely understood as a quality measure of health care decision making, another related measure calls for increased attention, particularly regarding older adults: medication literacy. Medication literacy is the degree to which individuals can obtain, comprehend, communicate, calculate, and process patient-specific information about their medications to make informed medication and health decisions in order to safely and effectively use their medications, regardless of the mode by which the content by which the content is delivered (i.e., written, oral, or visual).

  • Money offers a comprehensive update on the President’s mandate that health plans cover over the counter COVID tests effective on Saturday January 15.

Midweek update

David Ermer–CDC, CMS, COVID vaccine mandate, COVID-19, COVID-19 vaccine, Medicare, Mental health care, Rx coverage, SCOTUS, U.S. Healthcare–

From the Omicron front, Roll Call reports that

The White House COVID-19 Response Team stopped short of announcing major changes to anticipated guidance surrounding masks and instead focused on changes to testing strategy on Wednesday.

Experts have been calling for the Centers for Disease Control and Prevention to update its mask guidance to recommend high-filtration masks such as N95s and KN95s in light of the surge of the omicron variant. * * *

CDC Director Rochelle Walensky also echoed that an update to the CDC’s mask guidance was coming to “best reflect the options that are available to people, as you note, and the different levels of protection different masks provide.”

But she also doubled down on refusing to endorse a certain type of mask, instead repeating that the “best” masks are those that individuals will wear continuously in indoor settings.

“We are updating information on our mask website to provide information to the public,” she said. “We will provide information on improved filtration that occurs with other masks, such as N95s, and information that the public needs about how to make a choice of which mask is the right one for them. But most importantly, we want to highlight the best mask for you is the one that you can wear comfortably.”

For context, Bloomberg tells us that

The omicron variant represents about 98% of cases, Centers for Disease Control and Prevention Director Rochelle Walensky said Tuesday. That number is based on data for the week ending Jan. 8 and is a significant increase from just two weeks prior, when omicron accounted for 71.3% of cases. 

Omicron’s heightened transmissibility coupled with the immunity some have built to combat the delta through vaccination and exposure, have made conditions favor the “more mild” variant, said David Wohl, a professor at the Institute of Global Health and Infectious Diseases at the University of North Carolina-Chapel Hill. But experts warn that for those who remain unvaccinated or who suffer from other health concerns, infection from any Covid-19 variant is a major concern. 

For even additional context, Bloomberg informs us that

Switzerland joined Spain and the U.K. in suggesting that the coronavirus pandemic may be shifting to an endemic phase. 

From the COVID vaccine front, Bloomberg reports that

Almost all teenagers who needed intensive care for Covid-19 were unvaccinated, according to a study published by the New England Journal of Medicine, bolstering the case for using the Pfizer-BioNTech shot in youths.

The vaccine prevented 98% of ICU visits and 94% of Covid-related hospitalizations in the real-world study of more than 1,000 adolescents ages 12 to 18 in 23 states. The research from the Centers for Disease Control and Prevention and a network of 31 hospitals is one is one of the most detailed yet showing that vaccines can prevent severe Covid complications in teenagers.

Following up on yesterday’s proposed national Medicare coverage determination on Aduhelm, Healthcare Finance News provides stakeholder perspectives on that decision. STAT News points out that because the CMS decision, if finalized would apply to all drugs under development to treat Alzheimers Disease that fall into the same drug class as Aduhelm — monoclonal antibody, the proposed decision is bad news for several of Biogen’s competitors too.

Both Eli Lilly and Roche have such treatments in the works, and Biogen has still two more, developed in partnership with Eisai, as well. All of those drug makers now have a big incentive to pressure Medicare to loosen the restrictions in the final version of its policy, which is due out this April.

“While so much of the focus has been on what this means for [the Biogen drug], this recommendation impacts an entire class of drug and is likely to result in a more aligned effort by stakeholders as they try to influence the final version,” said a consultant for different drug makers, including Biogen.

“All of the other companies have to start over,” said George Vradenburg, the founder of the advocacy group UsAgainstAlzheimer’s. “This now applies to three drugs that, in fact, might be better.”

In other healthcare news —

  • Fierce Healthcare reports on the third day of the JPMorgan Healthcare Conference.
  • Health Affairs discusses how to create a stronger Medicare.
  • The director of NIH’s Heal Inititiative which focuses on substance use disorders / overdose deaths offers her ideas on the new year.
  • Forbes reports that “Walgreens Boots Alliance will have more than 160 of its doctor-staffed Village Medical clinics open next to drugstores by the end of this year.”

In Postal Service news, Govexec reports that

The U.S. Postal Service on Wednesday elected a new Republican chairman of its governing board, elevating one of President Trump’s appointees over President Biden’s picks.  

Roman Martinez, who joined the USPS board of governors in 2019, will serve as the panel’s 25th chairman. Anton Hajjar, a former American Postal Workers Union official nominated to his post by Biden, will serve as vice chairman. The board members voted unanimously for the leadership positions at a meeting on Wednesday. * * *

The new chairman has been an ally of Postmaster General Louis DeJoy, defending his controversial decisions, endorsing his 10-year plan to improve postal finances through, among other things, service cuts and price hikes, and calling him the right leader for the Postal Service. Hajjar, meanwhile, has voiced a lukewarm response to DeJoy’s tenure. The new vice chairman has said, however, that there was “a lot to like” in DeJoy’s plan, despite having reservations over some provisions.  * * *

DeJoy said on Wednesday he has “benefited from Martinez’s broad experience and wise counsel throughout my tenure as postmaster general and especially during the development of the Delivering for America plan.”

Keeping DeJoy in charge and one of his allies in charge of the board raises the prospect for sweeping postal reform legislation to make its way through Congress, with a House bill so far earning only tepid Republican support. 

It’s worth noting too that at 10 am ET tomorrow the U.S. Supreme Court will release decisions in pending cases which could include a stay of the OSHA ETS as OSHA began the enforcement clock on that measure last Monday.

Tuesday’s Tidbits

David Ermer–ACA, CDC, CMS, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Centers for Medicare and Medicaid Services (CMS) announced its proposed national coverage decision for Biogen’s Alzheimers Disease FDA-approved treatment, Aduhelm, today.

The proposed National Coverage Determination would cover Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials. The proposed National Coverage Determination is open to public comment for 30 days.

STAT News sums it up as follows:

Normally, Medicare covers drugs if the FDA approves them. Aduhelm has been different because the agency approved the treatment without a guarantee that patients actually will see slower cognitive decline. The process that led to the drug’s approval is the subject of multiple investigations, following STAT’s reporting that Biogen had an extensive back-channel relationship with the FDA. * * *

Medicare officials don’t require participation in clinical studies for beneficiaries very often — there are only about two dozen other health care products with a similar designation, called a Coverage with Evidence Development (CED), listed on Medicare’s website. Most are for medical devices or diagnostic imaging, and are less restrictive than the policy Medicare announced Tuesday. * * *

Sean Tunis, a principal at Rubix Health who helped develop the CED process during his tenure at the Centers for Medicare and Medicaid Services, said the proposal is almost as restrictive as if Medicare had decided not to cover the drug at all. Medicare, he estimated, would pay for drug costs for perhaps a few thousand patients that enroll in randomized trials over the next three to five years.

The CMS national coverage decision if finalized would help the FEHB Program dodge a bullet because it has many annuitant enrollees without Medicare Part B and for whom the FEHB plan would be the primary Aduhelm payer.

Following up on yesterday’s post about Affordable Care Act FAQ 51 implementing the President’s mandate on health plans to cover over the counter COVID tests, the FEHBlog noticed the fourth FAQ in this section of FAQ 51 which reads as follows:

Q4: When providing coverage of OTC COVID-19 tests, are plans and issuers permitted to address suspected fraud and abuse?

Yes. As stated in FAQs Part 44, Q2, although the FFCRA prohibits medical management of coverage of COVID-19 diagnostic testing, plans and issuers may act to prevent, detect, and address fraud and abuse. Examples of permissible activities include the following:

  • A plan or issuer may take reasonable steps to ensure that an OTC COVID-19 test for which a covered individual seeks coverage under the plan or coverage was purchased for the individual’s own personal use (or use by another participant, beneficiary, or enrollee who is covered under the plan or coverage as a member of the individual’s family), provided that such steps do not create significant barriers for participants, beneficiaries, and enrollees to obtain these tests. For example, a plan or issuer could require an attestation, such as a signature on a brief attestation document, that the OTC COVID-19 test was purchased by the participant, beneficiary, or enrollee for personal use, not for employment purposes, has not been (and will not be) reimbursed by another source, and is not for resale. In contrast, the Departments are of the view that fraud and abuse programs that require an individual to submit multiple documents or involve numerous steps that unduly delay a participant’s, beneficiary’s, or enrollee’s access to, or reimbursement for, OTC COVID-19 tests are not reasonable.
  • A plan or issuer may require reasonable documentation of proof of purchase with a claim for reimbursement for the cost of an OTC COVID-19 test. Examples of such documentation could include the UPC code for the OTC COVID-19 test to verify that the item is one for which coverage is required under section 6001 of FFCRA, and/or a receipt from the seller of the test, documenting the date of purchase and the price of the OTC COVID-19 test.

It occurred to the FEHBlog that FSAFeds the flexible spending account program for federal employees must be reimbursing participants for OTC Covid test kits. In fact the FSAFeds does offer reimbursement for OTC test kits on the condition that the participant furnishes a detailed receipt. For OTC products, FSAFeds generally requires a receipt including Vendor name, Date of purchase, Product name, and Cost. This should be a reasonable documentation standard for FEHB plans to adopt.

Also from the testing front, the Wall Street Journal looks into the reliability of rapid antigen COVID tests sold OTC.

Rapid antigen tests are a useful tool if we are smart about how we use them.

Because the data suggest that rapid tests may be yielding more false negatives at the beginning of an Omicron infection, you’ll have a better chance of getting an accurate result if you wait a day or two after developing symptoms to test, says Katelyn Jetelina, assistant professor of epidemiology at the University of Texas Health Science Center at Houston. If your test is negative, take a second test a day or two later, or get a PCR test if you can. (Easier said than done these days.)

Understand the limitations of rapid tests if you’re considering using them to screen people before gatherings. Rapid tests before a wedding or other large indoor gathering could miss early infections that could be contagious, Dr. [Blythe] Adamson says.

If you have a positive rapid test, you almost definitely have Covid-19, Dr. [Gigi] Gronvall says. False positives are rare, especially when case rates are as high as they are now. You likely don’t need to confirm a positive rapid-test result with a follow-up PCR test, unless an employer or other institution requires it.

In other Omicron news —

  • The Journal also tells us that “U.S. officials on Tuesday ordered 600,000 doses of Covid-19 treatment sotrovimab, the only monoclonal antibody therapy thought to work against the Omicron variant, as a record number of cases puts hospitals under increasing pressure in parts of the U.S. and Europe.  Sotrovimab, made by GlaxoSmithKline PLC and Vir Biotechnology Inc., is now the only Covid-19 monoclonal antibody available for patients in the U.S.”

ACA FAQ 51 also includes reminders to health plans about the wide scope of the ACA’s contraceptive mandate.

From the federal employee COVID vaccination front Federal News Network reports that

The first update by the Safer Federal Workforce task force in more than a month is addressing the challenge of testing employees and contractors who work on-site or with the public on a regular basis for COVID-19, the types of tests that are permitted and who is responsible for paying for said tests.

The crux of the updated and new frequently ask questions is agencies have until Feb. 15 to set up a testing program “for employees who are not fully vaccinated, including due to a pending or approved request for exception or extension from the COVID-19 vaccination requirement for federal employees.”

The task force said the testing program is only for employees who work on-site or interact with the public like safety inspectors, and not for those who work remotely.

Fedweek adds that “A period of waiting is continuing on two major federal workplace issues on which action was expected around now—enforcement of the Coronavirus vaccine mandate and the “reentry” from telework to regular worksites by more employees and for more often.”

From the preventive services department, the Department of Health and Human Services announced today that

Today, the U.S. Department of Health & Human Services (HHS) announced that the Health Resources and Services Administration (HRSA) has updated comprehensive preventive care and screening guidelines for women and for infants, children, and adolescents. Under the Affordable Care Act (ACA), certain group health plans and insurance issuers must provide coverage with no out-of-pocket cost for preventive health services within these HRSA-supported comprehensive guidelines. Among a number of updates, for the first time the guidelines will require such group health plans and insurance plans to provide coverage without a co-pay or deductible for double electric breast pumps.

Fierce Healthcare reports news from the second day of the JPMorgan Healthcare Conference.

From the tidbits department —

  • Last week, the Office of National Coordinator for Health Information Technology announced “the release of the Project US@ (“Project USA”) Technical Specification Final Version 1.0 and thereby completed our one year goal to coordinate the creation of a health care specification that could be used across the industry for representing patient addresses (mailing, physical, billing, etc.). This new “tech spec” will advance the health care industry’s proficiency in recording and managing accurate and consistently formatted patient addresses and support more efficient patient matching and record linkage. As a reminder, among the many data elements that are used in patient matching, research has shown patient address to be one of the most sensitive to standardization and therefore impactful on patient matching, especially at scale. However, patient addresses change frequently, are often entered incorrectly or imprecisely.”

Midweek update

David Ermer–COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, OPM, Rx coverage–
Photo by Josh Mills on Unsplash

From the Omicron front —

  • David Leonhardt, writing in the New York Times, informs us that while the surge of Omicron cases is stressing hospitals, Omicron has created less hospitalizations, milder hospitalizations, and fewer deaths compared to the Delta variant which Omicron replaced.
  • Becker’s Hospital Review reports that “The national surge in COVID-19 cases fueled by the highly transmissible omicron variant may last weeks, rather than months, according to the most recent projections from the COVID-19 Scenario Modeling Hub, a consortium of researchers helping the CDC track the pandemic’s trajectory.”
  • Medscape offers expert opinions on whether the current Omicron surge will hasten the transition from pandemic to endemic. For example —

Whether the current surge will mean the predicted switch to endemic COVID-19 will come sooner, however, “is very hard to predict,” Michael Lin, MD MPH, told Medscape Medical News.

“It’s an open question,” he said, “if another highly transmissible variant will emerge.”

On a positive note, “at this point many more people have received their vaccinations or been infected. And over time, repeated infections have led to milder symptoms,” added Lin, hospital epidemiologist at Rush Medical College in Chicago, Illinois.

“It could end up being a seasonal variant,” he said.

On the COVID vaccine front, AHIP tells us that

Today the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP) recommended a single Pfizer-BioNTech COVID-19 vaccine booster dose for persons aged 12-17 years at least 5 months after their primary series, by a vote of 13-1.

The Committee reviewed real-world data from Israel and the CDC showing there are no new safety concerns following a booster in this population, and that adverse events were less common from a 3rd dose as compared to the primary series.

Members of the Committee also stressed the primary focus continues to be vaccination of unvaccinated individuals, and that there is a need to increase education and understanding of the effects of COVID-19 on children and adolescents in order to help parents make informed decisions.

The FDA noted that it continues to review data on children aged 5-11 and will update recommendations when more data is available.

On the COVID testing front, Bloomberg offers a comprehensive look at the state of the Biden Administration’s efforts to improve availability of rapid at home COVID tests. Of note to health plans —

Private insurers will reimburse for at-home tests beginning at some point next week, when a Biden administration rule is set to take effect. That will allow Americans to submit claims, and could spark an initial spike in demand. But it remains to be seen whether people will take advantage of the reimbursement as filing insurance claims can be a time-consuming and tedious task.

In the FEHBlog’s view the Affordable Care Act converted health plans into public utilities. Aside from the wisdom of imposing this public health responsibility on health plans, this approach does not make sense due to the high administrative cost of processing paper claims. It will become a side show.

On the COVID treatment front, STAT News reports that

The Biden administration doubled its order of Covid-19 pills from Pfizer, a move that will modestly increase the limited U.S. supply of the treatment in the short term amid a record-setting surge in coronavirus cases, The New York Times writes. The new order will eventually provide enough pills for an additional 10 million Americans, bringing the government’s total order of the drug to 20 million treatment courses. But they will not all be available right away. Only 35,000 of the additional courses will be delivered this month, and 50,000 more in February, supplementing 350,000 treatment courses that were already expected over the next two months.

From the COVID vaccine mandate front, Govexec reports that the Postal Service has asked the Occupational Health and Safety Administration for “a 120-day extension to implement the [vaccinate or test] rule, saying that would allow enough time to update its systems for record collection and bargain with its unions over the details.”

From the Rx coverage front

  • Reuters reports that “Pfizer Inc  and Germany’s BioNTech SE  will develop an mRNA-based vaccine for viral infection shingles, collaborating for the third time after th success of their COVID-19 vaccine based on the same technology.
  • Healthcare Dive offers its observations on where drug prices are headed this year.
  • Biopharma Dive identifies five Food and Drug Administration approval decisions to watch in the first quarter of 2022.
  • In related news, mHealth Intelligence tells us that

“Researchers from the University of Massachusetts Amherst, Syracuse University and SUNY Upstate Medical University have collaborated to create a wireless sensor designed to prevent opioid relapses and overdoses. * * *

The opioid epidemic has steadily worsened across the country since the late 1990s. In 2019, nearly 50,000 people in the U.S. died from opioid-related overdoses, according to data from the National Institute on Drug Abuse. Further, around 21 to 29 percent of patients prescribed opioids for chronic pain misuse them, the federal data shows.  

To combat this issue, the research team — headed by Tauhidur Rahman, PhD, an assistant professor in the College of Information and Computer Sciences at UMass Amherst and co-director of the MOSAIC Lab — is developing a sensor, which will use machine learning to pinpoint psychophysiological signs in real time and determine whether they are consistent with opioid cravings. Cravings are one of the main drivers behind relapses and overdoses.

If a craving is identified, the sensor providers the user with mindfulness-based interventions. These ultimately could be customized based on the user’s behaviors and clinician input.

“Nothing like this exists today,” Rahman said in the news release. “And we believe that mobile technologies can provide an effective mechanism for people with addiction to monitor their condition and manage their cravings better.”

Cool.

From the OPM front, Govexec reports that

The Office of Personnel Management is set to publish regulations implementing a 2021 law aimed at improving agency accountability for acts of discrimination and whistleblower retaliation against federal workers.

The Elijah E. Cummings Federal Employee Antidiscrimination Act, named for the late lawmaker who led the House Oversight and Reform Committee and signed on Jan. 1, 2021, encourages agencies to take action against federal employees who are found to be responsible for “intentional” acts of discrimination or retaliation, and be more transparent with the public when such incidents are adjudicated.

In a proposed rule set to be published to the Federal Register Thursday, OPM said that [among other new requirements] agencies will be expected to post a notification on their public-facing websites within 90 days of the finalization of any case in which the agency was found to have discriminated or retaliated against a federal employee.

Tuesday’s Tidbits

David Ermer–ACA, CDC, COVID-19, COVID-19 testing, COVID-19 vaccine, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Lots of updates from the Centers for Disease Control (“CDC”) today

  • “Today, CDC is updating our recommendation for when many people can receive a booster shot, shortening the interval from 6 months to 5 months for people who received the Pfizer-BioNTech COVID-19 Vaccine.  This means that people can now receive an mRNA booster shot 5 months after completing their Pfizer-BioNTech primary series.  The booster interval recommendation for people who received the J&J vaccine (2 months) or the Moderna vaccine (6 months), has not changed.”
  • The CDC released a study of over 40,000 COVID- vaccinated pregnant women.

In a retrospective cohort of >40,000 pregnant women, COVID-19 vaccination during pregnancy was not associated with preterm birth or small-for-gestational-age at birth overall, stratified by trimester of vaccination, or number of vaccine doses received during pregnancy, compared with unvaccinated pregnant women.

These data support the safety of COVID-19 vaccination during pregnancy. CDC recommends COVID-19 vaccination for women who are pregnant, recently pregnant, who are trying to become pregnant now, or who might become pregnant in the future.

  • As expected, the CDC revised and lengthened its revised COVID quarantine and isolation policy by, e.g., adding “at home testing when available,” right at the time that at home COVID test are hard to purchase. What’s more, the Wall Street Journal reports the prices for those tests are jumping at Walmart and Kroger because the White House curiously let a price support program lapse. Govexex informs about how government agencies had been struggling to implement this CDC guidance even before today’s changes.

Also from the Omicron front, Medscape tells us about a British study finding that

Protection against hospitalization from COVID-19 vaccines is “good” against the Omicron variant of SARS-CoV-2, an analysis has found.

The risk for adults of being admitted to hospital with Omicron was approximately one third (Hazard Ratio 0.33, 95% CI 0.30 to 0.37) of that for the Delta variant, the UK Health Security Agency (UKHSA) said in a technical briefing.

The analysis also found that the risk of presentation to emergency care, or being admitted to hospital, with Omicron – whether testing for symptomatic or asymptomatic infection – was approximately half of that for Delta (Hazard Ratio 0.53, 95% CI 0.50 to 0.57).

From the Affordable Care Act front – –

  • The International Foundation of Employee Benefit Plans announced that “The Centers for Medicare and Medicaid Services (CMS) issued the proposed 2023 actuarial value (AV) calculator and methodology.” This should be useful when preparing FEHB 2023 benefit and rate proposals.
  • The Labor Department’s Employee Benefit Security Administration announced that it is seeking speakers to talk at an ACA listening session about the ACA’s provider non-discrimination provision, known as Section 2706. In Division BB of the Consolidated Appropriations Act of 2021, Congress tasked the ACA regulators with adopting a rule interpreting Section 2706. The listening session bears on that effort.

From the healthcare business front

  • Fierce Healthcare tells us that “Centene Corporation has completed its acquisition of Magellan Health, the insurer announced Tuesday. The $2.2 billion deal closes exactly one year after its announcement on Jan. 4, 2021. The combination will create one of the country’s largest behavioral health platforms, including 41 million unique members. * * * In addition to its behavioral health platform, Magellan will add 5.5 million members to Centene’s government program, 16 million pharmacy members and 2 million pharmacy benefit management members.”
  • Healthcare Dive reports that “HCA Healthcare has purchased the largest urgent care chain in Florida, MD Now Urgent Care, the health system said Tuesday. The deal closed at the end of 2021 for an undisclosed sum. The deal gives HCA 59 urgent care centers in a state where it already has a significant presence, with 47 hospitals.” 

From the tidbits department

  • STAT News interviews Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “[2022] will have to be a year where we transition to working alongside the pandemic, as opposed to being dominated by the pandemic,” Dr. Marks told STAT in a wide-ranging interview. Let’s hope so.
  • Medpage Today brings us up to date on Biogen’s Aduhelm saga and considers 2022 biggest hurdles for heathcare in the U.S.
  • The new acting National Institutes of Health director Dr. Larry Tabak is continuing the tradition of writing a weekly director’s blog. This week’s issue concerns science’s 2021 breakthroughs, e.g., the COVID pills.

Monday Roundup

David Ermer–ACA, COVID-19, COVID-19 testing, COVID-19 vaccine, No Surprises Act, Rx coverage–
Photo by Sven Read on Unsplash

From the Omicron front, the Wall Street Journal reports that

The seven-day average of daily reported Covid-19 cases in the U.S. reached a pandemic record 403,385 on Sunday, according to a Wall Street Journal analysis of Johns Hopkins University data. The fresh peak arrived even as most states paused reporting during the New Year’s holiday weekend. Reporting delays will likely lead to spikes in reports of cases this week as states catch up. While Covid-19 tests remain in short supply in much of the U.S., Covid-19 testing was less robust last year, complicating comparisons between pandemic surges.

Hospitalizations for confirmed or suspected Covid-19 reached a seven-day average of 97,855 on Monday, according to data posted by the U.S. Department of Health & Human Services. That is up 41% in the past two weeks but below both the pandemic peak of 137,510 on Jan. 10, 2021, and the smaller peak of 102,967 on Sept. 4, 2021, during the Delta surge.

Bloomberg adds that

While omicron may be good at evading the attacks of antibodies, recent studies have also shown that it has far less success avoiding the second-line defenses of vaccines and prior infections: T-cells and B-cells.

T-cells are responsible for attacking a virus once it makes its way into the body’s cells if antibodies fail to prevent infection in the first place. In a recent study by Burgers and colleagues, scientists used white blood cells from Covid patients to show that about 70-80% of the T-cell response is preserved compared with previous strains of the virus. That means that for those who are either vaccinated or had a Covid infection in the past 6 months, it is likely their T-cells can recognize omicron and fight it off relatively quickly. 

This latest research will need to be followed up with further study. If it holds up to additional scrutiny, it just might explain why current infections appear to be more mild than in previous waves of the virus.

Yet, AP reports that

As the COVID-19 omicron variant surges across the United States, top federal health officials are looking to add a negative test along with its five-day isolation restrictions for asymptomatic Americans who catch the coronavirus, the White House’s top medical adviser said Sunday.

Dr. Anthony Fauci said the Centers for Disease Control and Prevention is now considering including the negative test as part of its guidance after getting significant “pushback” on its updated recommendations last week.

Adding to current mandatory testing is not going to push the COVID ball further toward endemic status particularly when people who actually may be infected soon will need a test to gain access to a COVID pill. It is time for the government to rethink its testing strategy. As a physician explained in a thought provoking Atlantic article

I will admit to being as self-interested as any other human. Despite recognizing the need for vaccine and test equity, I received three Pfizer shots as soon as I was eligible, and I’ve kept a stash of rapid-detection kits in my closet. But my own cognitive dissonance, and that of other privileged people, has become untenable in the face of Omicron’s case surge. Given the reality of our testing shortages, it’s time we started cutting back, where and when we can.

From the COVID vaccine front, AHIP tells us that

“Today the Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to expand the use of a single booster dose of the vaccine to include its use in individuals as young as 12 years of age.

“The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series. The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals.

“The amended EUA additionally:

  • Decreases the time between the completion of primary vaccination of the Pfizer COVID-19 Vaccine and a booster dose to at least five months.
  • Allows for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

“Peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer COVID-19 Vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant. Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant.

“Children 5 through 11 years of age who are fully vaccinated and are not immunocompromised do not need a third dose at this time, but the FDA will continue to review information and communicate with the public if data emerges suggesting booster doses are needed for this pediatric population.”

From the Health and Human Services Department front —

  • Prof. Katie Keith has published in the Health Affairs Forefront the third installment of her review of the proposed 2023 Notice of Benefit and Payment Parameters. This one focuses on the Affordable Care Act’s risk adjustment provisions.
  • The Department issued today its own upbeat discussion of the recently implemented consumer billing protections provided by the No Surprises Act.
  • While the ACA risk adjustment provisions don’t apply the FEHB, the consumer billing protections do. Indeed the consumer billing protections wisely apply to both insured and uninsured folks. All consumers should become familiar with these protections.

From the prescription drug front, STAT News informs us that

As 2022 gets under way, pharmaceutical companies have so far raised wholesale prices by a median of 4.9% on more than 450 prescription medicines, an overall annual increase that is comparable to the price hikes seen over the past three years, according to a new analysis.

The numbers are preliminary, though, because still more price increases are expected to be disclosed by drug makers later this month, since not every company has reported their latest prices to industry databases. Nonetheless, the early indication is that many drug makers are keeping price hikes in check due to ongoing bad publicity that has sparked sustained political pressure.

Analyzing pharmaceutical price hikes has become a ritual each January as drug makers boost prices to meet financial goals. But as poll after poll finds more Americans are complaining about the cost of prescription medicines, these companies have gradually shied away from mid-year increases and also generally limited price hikes below double digits in hopes of avoiding still more negative headlines.

Drug Channels adds

Reality has again failed to cooperate with the politically motivated cries of “skyrocketing drug prices” or anecdotes about companies “jacking up prices” 

Brand-name drug prices continue to decline, while the prices of other healthcare products and services continue to rise. For 2021, brand-name drugs’ net prices dropped for the fourth consecutive year. Meanwhile, brand-name drug list prices grew more slowly than overall inflation. What’s more, we project that the gross-to-net bubble for patent-protected brand-name drugs will exceed $200 billion in 2021. See our updated analysis [that may be found in the linked article]. 

The factors that drive declining brand-name drug prices remain for 2022, suggesting that these trends will continue.