Monday Roundup

COVID-19 vaccine

Monday Roundup

David Ermer–COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare, No Surprises Act, Telehealth–
Photo by Sven Read on Unsplash

From the COVID vaccination front, the CDC’s COVID Data Tracker indicates that over two-thirds of the U.S. population over five years old in fully vaccinated.

The American Medical Association’s column about “What Doctors Wish Patient Knew” explains

A Kaiser Family Foundation poll found that one-third of parents say they planned to get their children vaccinated right away. Yet other parents are taking a wait-and-see approach to COVID-19 vaccination for kids. But with the Delta-Omicron variant tag team, widespread vaccination is an essential tool for preventing COVID-19 deaths, hospitalizations and illnesses.

To help parents move from that “wait-and-see” mentality and calm their fears, two physicians shared what to know about COVID-19 vaccine safety for children.

Check it out.

From the Omicron treatment front, the Food and Drug Administration announced today that the agency has

revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) [which are made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc.] – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.

Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions. 

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we’re making changes today. * * *

Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Healthcare providers should consult the NIH panel’s COVID-19 treatment guidelines and assess whether these treatments are right for their patients.

From the COVID vaccination mandate front, Federal News Network reports that

Last week’s court injunction that blocked the Biden Administration’s vaccine requirement for federal employees will put a temporary halt to disciplinary actions in federal agencies. But it won’t be of much help to feds who’d already been disciplined or fired for refusing the vaccine prior to last Friday.

That’s according to new guidance the administration’s Safer Federal Workforce Task Force issued Monday. The four-page document answers some basic questions on exactly how agencies should deal with the federal employee mandate now that a Texas judge has temporarily barred its implementation and enforcement.

Among the nuances: workers who’ve been suspended for failing to comply need to have their suspensions lifted, and new proposals to fire or suspend employees need to be “held in abeyance” for as long as the injunction is in place, the task force said. But agencies don’t need to reverse other disciplinary procedures that have already taken full effect.

From the free OTC tests front, Govexec.com asks

What group is especially vulnerable to the ravages of COVID-19 even if fully vaccinated and boosted? Seniors. And who will have an especially tough time getting free at-home COVID tests under the Biden administration’s plan? Yes, seniors.

As of Jan. 15, private insurers will cover the cost of eight at-home rapid COVID tests each month for their members — for as long as the public health emergency lasts.

Finding the tests will be hard enough, but Medicare beneficiaries face an even bigger hurdle: The administration’s new rule doesn’t apply to them.

It turns out that the laws governing traditional Medicare don’t provide for coverage of self-administered diagnostic tests, which is precisely what the rapid antigen tests are and why they are an important tool for containing the pandemic. * * *

The Medicare program does cover rapid antigen or PCR testing done by a lab without charging beneficiaries, but there’s a hitch: It’s limited to one test per year unless someone has a doctor’s order.

Because the article describes orignal Medicare as exempt, one must assume that Medicare Advantage plans also are offering reimbursement for OTC COVID tests. The original Medicare exemption is a weak cup of tea because no commercial health plans covered OTC testing before the mandate.

From the No Suprises Act front, The American Hospital Association informs us that

The Centers for Medicare & Medicaid Services will host a conference call for health care providers Jan. 26 at 1 p.m. ET on the balance billing provisions of the No Surprises Act. To participate in the Special Open Door Forum, dial 888-455-1397 and reference passcode 5109694. Slides for the call are available here. P

Participants may email questions in advance to Provider_Enforcement@cms.hhs.gov, noting “Questions for 1/26 Open Door Forum” in the subject line. A replay will be available after the call through Jan. 28 by dialing 800-308-7855 and entering the passcode.

The CMS slides are helpful.

From the telehealth front, Fierce Healthcare tells us that

Integrating virtual care can save the healthcare system significant amounts of money, as well as avoid unnecessary visits to the emergency department or urgent care center, according to a new study from Cigna.

The study, conducted alongside its telehealth arm MDLive, found that patients who saw virtual providers also saw 19% fewer visits to the ER or urgent care. In addition, virtual urgent care visits reduced duplication of care by 16% compared to other virtual primary care providers or specialists.

Cigna notes that these reductions in unneeded visits are especially crucial as hospitals face down the current COVID-19 surge, caused by the highly infectious omicron variant. 

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.

Friday Stats and More

David Ermer–CDC, COVID treatment, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare, Mental health care, OPM, Telehealth, U.S. Healthcare–

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

My word, could that be a cresting of the Omicron surge as discussed in this week’s posts?

The FEHBlog’s weekly chart of new Covid deaths has bounced up and down after climbing to just over 10,000 weekly deaths during the Delta surge. .

Last but not least here is the FEHBlog’s weekly chart of new Covid vaccinations distributed and administered from the 51st week of 2020 through the third week of 2022.

Here are links to the CDC’s Covid data tracker weekly review and its weekly Fluview.

In other COVID vaccination news —

  • The Wall Street Journal reports that

Vaccines and booster shots offer superior protection from the Delta and Omicron variants, according to three new studies released by the Centers for Disease Control and Prevention.

The data back up earlier findings supporting booster shots and offer the first comprehensive insight into how vaccines fare against the Omicron variant. In one of the studies published Friday, a CDC analysis found that a third dose of either the vaccine from Pfizer Inc.and BioNTech SE or Moderna Inc. was at least 90% effective against preventing hospitalization from Covid-19 during both the Delta and Omicron periods.

The American Hospital Association adds

According to data from 25 state and local health departments, adults who were unvaccinated against COVID-19 as the omicron variant emerged in December had nearly three times higher risk of infection than adults fully vaccinated against COVID-19 and five times higher risk than adults who had received a booster, the Centers for Disease Control and Prevention reported today. The highest impact of COVID-19 booster doses compared with full vaccination was recorded among persons aged 50 and older. Because of reporting lags, the influence of the omicron variant on COVID-19-associated deaths could not be evaluated by vaccination status in December, the authors note.

The FDA could authorize Pfizer’s COVID-19 vaccine for children under age 5 in the next month, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Wednesday.

“My hope is that it’s going to be within the next month or so and not much later than that, but I can’t guarantee that because I can’t out-guess the FDA,” he said during an interview with Blue Star Families, a nonprofit group that supports military families.

The younger age group will likely need three vaccine doses, he said, since two shots didn’t provide enough of an immune response during Pfizer’s clinical trials for kids ages 2-4.

In Covid vaccine mandate news, Govexec tells us

A federal court in Texas has issued an injunction against President Biden’s COVID-19 vaccine mandate for the federal workforce, pausing implementation of a requirement for more than 2 million civilian servants. 

The Biden administration has already had sweeping success with the mandate, as most agencies have seen virtually their entire workforces come into compliance. Still, federal offices across the country were just beginning to move forward with suspensions—which could eventually result in firings—for those who did not meet the requirements. Biden issued the mandate by executive order in September.    

Judge Jeffrey Brown, appointed by President Trump to the U.S. Court for the Southern District of Texas, said the case was not about whether individuals should be vaccinated or even about federal power generally. 

“It is instead about whether the president can, with the stroke of a pen and without the input of Congress, require millions of federal employees to undergo a medical procedure as a condition of their employment,” Brown wrote. “That, under the current state of the law as just recently expressed by the Supreme Court, is a bridge too far.” 

The Justice Department has appealed the decision to the U.S. Court of Appeals for the Fifth Circuit. The FEHBlog expects that the Fifth Circuit will lift the stay as soon as this weekend. The Society for Human Resource Management offers a helpful article for employers trying to keep track of the vaccine mandate decisions from the courts.

In other COVID vaccine mandate news, the Labor Department’s Wage and Hour Division announced today that

Employees [who are not exempt from the Fair Labor Standards Act] must be paid for time spent going to, waiting for, and receiving medical attention required by the employer or on the employer’s premises during normal working hours. Therefore, if an employer requires an employee to obtain a COVID-19 vaccine dose, undergo a COVID-19 test, or engage in a COVID-19 related health screening or temperature check during the employee’s normal working hours, the time that the employee spends engaged in the activity is compensable. Employees must be paid for such time during normal working hours, regardless of where the activity occurs. This is true regardless of whether the employer is subject to the OSHA Vaccination and Testing ETS.

In Covid treatment news, the Food and Drug Administration announced today that the agency “took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization.”

From the Covid OTC testing coverage mandate department, the Kaiser Family Foundation has surveyed the coverage approaches of 13 large health insurers. Don’t blame the insurers on this one because health insurers don’t typically cover OTC products and the government only allow four days to implement the mandate.

From the and more department

  • In telehealth news, mHealth Intelligence tells us that

Telehealth utilization peaked in the first half of 2020 and decreased as the year came to a close, with providers predicting that virtual care use would continue to decline in upcoming years, according to the 2021 Medical Group Telehealth Survey.

AMGA Consulting conducted the survey and gathered responses from 56 medical groups representing more than 38,000 healthcare providers.

The majority of the participants (86 percent) were part of multispecialty groups with primary care, while the remaining were either multispecialty without primary care, primary care, or single-specialty groups. * * *

The survey results suggest that although telehealth use skyrocketed during the COVID-19 pandemic, virtual care may see the most success with patients who prefer the modality over in-person care or whose health concerns can be easily addressed virtually.

The FEHBlog remains a strong proponent of hub and spoke telehealth for mental health care because every televisit is in network.

  • The American Hospital Association informs us that “The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology seeks comments through March 25 to inform potential future rulemaking on how the ONC Health IT Certification Program could incorporate standards, implementation specifications and certification criteria to reduce the burden of prior authorization.”
  • The Congressional Budget Office released a report titled “The Prices That Commercial Health Insurers and Medicare Pay for Hospitals’ and Physicians’ Services.”

CBO examined potential explanations for why the prices paid by commercial insurers are higher and more variable than those paid by Medicare FFS. CBO’s analysis and literature review suggest the following conclusions:

— Greater market power among providers consistently leads to prices for commercial insurers that are higher than Medicare FFS’s prices and that vary more widely, both among and within areas. Hospitals and physicians’ groups may have market power because they have a dominant share of the market in an area or because an insurer sees them as essential to its network of providers.

— Some of the variation in the prices that commercial insurers pay for hospitals’ and physicians’ services is explained by differences in the prices of inputs needed to deliver those services.

— Higher hospital quality is associated with higher prices paid by commercial insurers, although whether there is a causal link between quality and prices, and the direction of any such link, is not clear.

— The share of providers’ patients who are covered by Medicare and Medicaid is not related to higher prices paid by commercial insurers. That finding suggests that providers do not raise the prices they negotiate with commercial insurers to offset lower prices paid by government programs (a concept known as cost-shifting).

IBM is selling the data and analytics assets of its Watson Health business to a private equity firm as it looks to refocus on its core cloud business.

The sale, which is expected to close in the second quarter this year has been anticipated for quite some time, and comes following the limited success of Watson Health, despite a spate of high-profile acquisitions of health information companies to bolster the enterprise.

Financial terms of the deal were not disclosed.

[F]ederal civilian employees in the U.S. will now be paid at least $15 per hour.

OPM issued a memorandum for heads of Executive departments and agencies that provides implementing guidance for how agencies should adjust pay rates for General Schedule (GS) and Federal Wage System (FWS) employees stationed in the U.S., and how to use administrative authority for other pay systems to lift the pay of federal employees who currently make less than $15 per hour. In total, these changes will impact 67,000 out of 2.2 million federal employees. The largest share of these workers, over 56,000 of them, currently work at the Department of Defense. OPM’s guidance directs agencies to implement these changes by January 30, 2022

  • To tide you over the weekend, here is a link to Healthcare Dive’s Deep Dive on four 2022 key trends for providers and payers.

Friday Stats and More

David Ermer–CDC, CMS, Congress, COVID vaccine mandate, COVID-19, COVID-19 testing, COVID-19 vaccine, U.S. Healthcare–

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

Four million new cases of COVID in a week. Wow. The Delta surge is the long hill that starts at the left of the chart. Omicron is Mount Everest by comparison.

Here’s the FEHBlog’s weekly chart of new COVID deaths for the same time span.

Weekly COVID deaths haven’t crossed 10,000 since the Delta surge peaked. Of course deaths are a lagging indicator.

The FEHBlog does think based on his reading that we are close to turning another corner but it’s not showing in these charts yet. We remain in the soup.

Here’s the FEHBlog’s chart of weekly Covid vaccinations distributed and administered since COVID shots were made available to the public in December 2020.

For the first time since before the holidays the number of administered vaccines, including boosters, exceeded 10 million last week. We are closing on 75% of the U.S. population aged 18 and older being fully vaccinated and over 65% of the U.S. population aged 65 and older being boostered.

Here are links the the CDC’s interpretation of its recent Covid and Flu statistics. The American Hospital Association informs us that

As urged by the AHA, the Department of Health and Human Services today renewed the COVID-19 public health emergency declaration for another 90 days effective Jan. 16. The extension will help hospitals and health systems combat COVID-19 in their communities.

In the wake of the Supreme Court lifting the stay on the CMS healthcare worker stay mandate, the American Hospital Association explains

The Centers for Medicare & Medicaid Services today released updated interpretive guidance on its Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule for states affected by yesterday’s Supreme Court’s decision  on the rule. The guidance does not apply to Texas, where the Interim Final Rule is still subject to a preliminary injunction in a separate legal action that was not before the Supreme Court. Under the guidance, the first dose compliance date for those states is Feb. 14, 2022, with full compliance expected from providers by March 15, 2022. For states not impacted by the Supreme Court decision, the previously announced compliance dates of Jan. 28 and Feb. 27 remain in effect. For both groups, the underlying interpretive guidance released on Dec. 28 applies and all members can still refer to the previously released Frequently Asked Questions for additional information. 

Tomorrow is the implementation date for the President’s mandate that health plans cover over-the-counter COVID tests. It’s worth noting that health plans generally don’t cover any products sold over-the-counter so needless to say plans needed many more than the four days that federal govenment gave them to implement. The New York Times delves into the details.

The Wall Street Journal reports that

The U.S. public can begin ordering free at-home rapid Covid-19 tests through a new government website on Jan. 19, senior Biden administration officials said.

Initially, orders will be limited to four tests per residential address. Tests will ship via mail within 7-12 days of ordering, the officials said. The administration expects that timeline to shorten as the program ramps up, one of the officials said.

The public will be able to order tests at covidtests.gov. Those without access to the internet can place orders via phone, and the administration will work with community groups to help people request tests, the officials said. The government will give priority to orders from areas that have been hard-hit by the pandemic and low-income parts of the country.

Here’s a link to the White House’s fact sheet on these programs. Govexec discusses the Postal Service’s important role in distributing the tests ordered over the government website.

From the masking front, STAT News reports that

U.S. health officials on Friday encouraged more Americans to wear the kind of N95 or KN95 masks used by health-care workers to slow the spread of the coronavirus.

Those kinds of masks are considered better at filtering the air. But they were in short supply previously, and Centers for Disease Control and Prevention officials had said they should be prioritized for health care workers.Related: Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson

In updated guidance posted late Friday afternoon, CDC officials removed concerns related to supply shortages and more clearly said that properly fitted N95 and KN95 masks offer the most protection.

However, agency officials noted some masks are harder to tolerate than others, and urged people to choose good-fitting masks that they will wear consistently.

“Our main message continues to be that any mask is better than no mask,” Kristen Nordlund, a CDC spokeswoman, said in a statement.

In other news —

  • Regulatory News informs us that “The Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday voted 13-8 to advance the nomination of Robert Califf for a second stint as commissioner of the US Food and Drug Administration (FDA).”

Researchers at Weill Cornell Medicine and the University of Oxford announced on January 10, 2022, their new study shows that common vaccines could help reduce the health burden of the COVID-19 pandemic. 

A peer-reviewed study published in the Proceedings of the National Academy of Sciences crystallizes decades of evidence suggesting that the generalized immune-boosting properties of many vaccines can cross-protect people against multiple pathogens.

While these researchers did not specify particular vaccines, they chose values for cross-protection consistent with data from earlier studies on measles, influenza, tuberculosis, and other immunizations.

  • Fierce Healthcare tells us that “A top Medicare advisory board [MEDPAC] did not recommend any new payment hikes for acute care hospitals or doctors for 2023, stating that targeted relief funding has helped blunt the impact of the COVID-19 pandemic.” We shall see.

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.

Monday Roundup

David Ermer–CDC, COVID treatment, COVID-19, COVID-19 testing, COVID-19 vaccine, Medicare–
Photo by Sven Read on Unsplash

From the Omicron front, the Labor Department’s Employee Benefit Security Administration has released guidance for health plans and the Centers for Medicare and Medicaid Services has released guidance for consumers on the President’s mandate that health plans cover over the counter COVID tests for their members.

Basically, under this mandate guidance, if a health plan offers its members an online program to obtain the OTC Covid tests at no cost (for the test or shipping), then the plan can limit out of network reimbursement of OTC Covid tests to the lesser of the actual price or $12 per test. (Binax and Quickvue include two tests in a package. Consequently the maximum reimbursement for one package would be $24.)  

If a health plan plan does not offer such an online program, then it must reimburse member claims in full. (There is an section in the EBSA guidance on FWA issues.)

The guidance also allows the health plan to limit coverage of OTC Covid tests to eight tests per member / belly button per month.

The mandate takes effect this coming Saturday January 15. That’s not a lot of time for implementation. Also, in this regard, ECRI has issued a report on the usability of COVID at home antigen test kits.

On the COVID vaccine front, Medscape informs us that

The FDA on Friday shortened the time that people who received Moderna’s COVID-19 vaccine need to wait for a booster — from 6 months to 5 months.

That means Americans 18 years old and older who received their second shot of the two-dose Moderna vaccine at least 5 months ago can now get a third dose.

“The country is in the middle of a wave of the highly contagious Omicron variant, which spreads more rapidly than the original SARS-CoV-2 virus and other variants that have emerged,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. * * *

On Friday afternoon, Rochelle Walensky, MD, the director of the CDC, said she also approved of shortening the timeline for the Moderna booster dose, according to CNN. The CDC’s vaccine advisory committee recommended the FDA’s decision, and she signed off on it.

Last Wednesday, the government authorities approved the same six to five month reduction for the Pfizer vaccine.

Medscape adds that

Some Americans with a weakened immune system who face high risks for severe COVID-19 become eligible this week to receive a fourth dose of a coronavirus vaccine.

The CDC endorsed a third dose of the Pfizer or Moderna vaccines for moderately and severely immunocompromised people on Aug. 13, which is considered part of their first immunization series rather than a booster shot.

In October, the CDC said moderately and severely immunocompromised people could receive a booster shot, or a fourth dose of the vaccine, 6 months after their third dose.

But the CDC last week shortened the timeline to 5 months for a booster shot of the Pfizer or Moderna vaccines. That means immunocompromised people could begin signing up for a fourth shot later this week,  The New York Times reported.   

Bloomberg reports that

Pfizer Inc. is developing a hybrid vaccine that combines its original shot with a formulation that shields against the highly transmissible omicron variant, the drug giant’s top executive said. 

While research continues, Pfizer will evaluate the new hybrid formulation against an omicron-specific shot, and determine which is best suited to move forward by March, Chief Executive Officer Albert Bourla said at the JPMorgan Healthcare Conference on Monday. Pfizer will be ready in March to approach U.S. regulators for clearance of the modified vaccine and bring it to market, and it has already begun production, Bourla said.

Speaking of the JPMorgan Healthcare conference, being held this week, Fierce Healthcare offers a full report on other news from that event from earlier today.

Also, the FEHBlog suggests that his readers check out this week’s episode of Econtalk in which host Russ Roberts chats with Wall Street Journal reporter Greg Zuckerman about his recent book on the development of the COVID vaccines.

From the COVID treatment front, Bloomberg reports that

U.S. regulators may decide within a week or two whether to approve a shorter course of Gilead Sciences Inc.’s Covid-19 drug remdesivir that could be used for patients outside the hospital, Chief Executive Officer Daniel O’Day said in an interview.

A five-day course of the infused drug is already a mainstay for hospitalized Covid patients. Gilead has applied for U.S. clearance of a three-day course that could be used in the outpatient setting, after a big trial last year showed it could sharply reduce hospitalizations in at-risk patients. * * * Officials at the U.S. Food and Drug Administration “are working really collaboratively with us, quickly with us,” O’Day said in the interview. “Everything is moving really fast.” * * *

An an infused drug, remdesivir is more complicated to administer than the Pfizer Inc. Covid pill Paxlovid. But Gilead has an abundance of supply on hand, O’Day said in the interview. By contrast, supplies of Pfizer’s drug are limited in the short term as the company ramps up supply. * * *

Meanwhile, O’Day said that Gilead is working hard to develop a chemical cousin of remdesivir that could be given as a pill. That oral drug is about to begin human trials. If it works, it could be combined with other drugs to treat Covid, he said.

In interesting Medicare news, Healthcare Dive explains that

HHS Secretary Xavier Becerra has instructed CMS to reassess its recommendation for Medicare premiums this year after Biogen cut the price for its controversial Alzheimer’s drug Aduhelm in half.

CMS in November published a historic 14.5% hike in monthly premiums for outpatient care in 2022 — the program’s largest premium increase ever. One of the factors regulators cited for the increase was uncertainty over the cost of Aduhelm, a new and pricey drug that has raised eyebrows for unclear effectiveness.

It’s an unusual step for HHS, given the plan year has already begun, and comes just days before a CMS deadline to issue a draft decision that will shape Aduhelm coverage nationwide.

Given Medicare’s shaky financial position, one wonders why the HHS Secretary is interested in turning away additional revenue.

STAT News adds

Biogen cut the price of Aduhelm nearly in half from $56,000 a year to $28,200 in December following disappointing sales, a price some still maintain is higher than necessary. Despite the pharma giant’s high hopes for the drug, other healthcare operators have proved less certain of its efficacy.

A number of health systems have said they wouldn’t prescribe the drug to patients. Meanwhile, most major payers are waiting on CMS to issue a national coverage determination before deciding whether to cover the expensive drug.

CMS is currently hammering out a single, nationwide policy for all amyloid-targeting treatments for Alzheimer’s, which purport to slow dementia by reducing clumps of plaque in the brain. * * *

Another major variable is which patients will be eligible to receive Aduhelm, which is still unknown. Medicare is scheduled to release a draft coverage decision that could make or break the drug’s future by Wednesday. Officials are not supposed to consider a drug’s cost in deciding whether to cover it for Medicare beneficiaries.

The final coverage decision, which is scheduled to be released by April 12, could cause significant changes in how much Aduhelm could cost the Medicare program, depending on how much patient access is restricted by diagnostic test results, which physicians could prescribe the drug or other limitations.

Friday Stats and More

David Ermer–ACA, CMS, COVID vaccine mandate, COVID-19, COVID-19 vaccine, SCOTUS, U.S. Healthcare–

Based on the Centers for Disease Control’s COVID Data Tracker and using Thursday as the first day of the week, here is the FEHBlog chart of weekly new COVID cases for the end of June 2021 through the first week of 2022:

Omicron has produced a staggering number of new COVID cases while the number of weekly new COVID deaths has remained with a stable range for several months.

The Wall Street Journal offers an lab test based explanation for Omicron’s mild nature:

The threat posed by the Omicron variant has now come into sharper focus, with recent clinical data and laboratory studies lending support to early reports suggesting that it is milder but more transmissible than other variants of the new coronavirus.

“It spreads very, very fast, but it doesn’t appear to have the virulence or machismo to really pack as much of a wallop as the Alpha or Delta variants,” James Musser, chairman of Houston Methodist Hospital’s pathology and genomic medicine department and the leader of a new study of Omicron infections, said of the variant.

Recent laboratory studies suggest that Omicron’s lower virulence may reflect its apparent tendency to thrive in cells in the upper respiratory tract rather than in the lungs, where Covid-19 infections can cause potentially fatal breathing problems.

That’s a reassuring tidbit.

Here’s the FEHBlog’s weekly chart of COVID vaccinations from the 51st week of 2020 through the 1st week of 2022:

Throughout the holiday period the number of administered vaccinations averaged six million which is impressive. Nearly two thirds of Americans aged five years and older are fully vaccinated and half of Americans aged 50 and older also have received a booster.

Here are a link to the CDC’s interpretation of its COVID statistics and a link to the CDC’s Fluview.

From the Supreme Court front, the Wall Street Journal reports that

A majority of Supreme Court justices expressed skepticism Friday of the Biden administration’s Covid-19 vaccine-or-testing plan for large employers but somewhat less concern about a vaccination mandate for healthcare workers, in a special [four hour long] session that examined the scope of the federal government’s powers during a fast-moving pandemic.

The Court focused its attention whether the issuing agency has necessary authority to issue its broad mandate. The Court should issue a decision within a month. The Wall Street Journal adds

The Supreme Court took up the vaccine lawsuits with alacrity, acting shortly before Christmas to add a rare Friday argument to its docket, ahead of the year’s first scheduled cases. Some parts of the OSHA rules begin to take effect next week, though the agency is waiting until next month to enforce Covid-19 testing requirements. Several justices signaled the court would seek to rule quickly—and potentially could put the requirements for private employers on hold temporarily for at least a few days to give themselves time to digest the case.

From the Medicare front, the Centers for Medicare and Medicaid Services released a proposed rule with 2023 updates to the Medicare Advantage and Medicare Part D programs. Here are links to the CMS fact sheet and a Fierce Healthcare article on this development. Of note, Fierce Healthcare tells us that

The proposal takes a major aim at price concessions that Part D plans extract from drug makers, but does not affect rebates negotiated between drug makers and insurers. Under the concessions, the plan pays less money to a pharmacy if it doesn’t meet several metrics. CMS is concerned, however, that the end-user doesn’t know about the arrangement and the lower prices are not passed on at the point-of-sale.

The proposed rule also said that the negotiated prices “typically do not reflect any performance-based pharmacy price concessions that lower the price a sponsor ultimately pays for the drug.”

The proposed rule wants to require all Part D plans to apply the concessions at the pharmacy counter.

Fierce Healthcare also calls attention to the November 2020 Kaufmann Hall report on hospital service utilization.

Hospital volumes softened in November overall as operating margins remain depressed, signaling that once again consumers could be delaying or avoiding care due to the pandemic, a new report from consulting firm Kaufman Hall found.

The firm released Tuesday its latest hospital flash report detailing revenues and volumes for November before the omicron-fueled surge of COVID-19 took hold. The report found hospitals are still facing major pressures from rising expenses and labor shortages. * * *

Kaufman found that hospital volumes softened in November, with discharges dropping nearly 5% and adjusted discharges by 3.9% compared to the month before. Discharges were also down 6.1% compared with pre-pandemic levels.

Meanwhile, the average length of stay at hospitals increased by 0.8% compared to October and 8.6% compared with November 2019.

The report estimates consumers could be postponing non-COVID-19 care.  

“The potential impact of the omicron variant in future months may influence this trend further,” Kaufman’s analysis said.

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.