Tuesday’s Tidbits

COVID-19 testing

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?

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. 

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.

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.

Tuesday Tidbits

David Ermer–COVID treatment, COVID-19, COVID-19 testing, Electronic health records–
Photo by Patrick Fore on Unsplash

Back in President George W. Bush’s first term, health information professionals were talking about the linking budding health information exchanges with a “national backbone.” That backbone was finally unveiled today and it has been named TEFCA. Hopefully TEFCA will be the answer to nationwide FEHB plan prayers for interoperability.

An Office of National Coordination press release explains,

The Trusted Exchange Framework and Common Agreement is now available. Within the health information technology (health IT) world, few things have been as elusive as a governance framework for nationwide health information exchange. When ONC was formed in 2004, the concept of a nationwide health information network—where your information could be located across the country in a click—was a big picture vision that drove the federal government’s early health IT infrastructure, standards, policy actions, and investments.

What’s followed as a result of two laws (HITECH Act and 21st Century Cures Act) and remarkable continuity across four administrations has been steady growth, maturity, and investment from both the public and private sectors. Most health care providers use electronic health records.1,2,3 Many are connected to and engage in at least one form of electronic health information exchange.4,5,6 And health information networks are now dotted across the US map supporting communities with a wide range of services.7

Today’s milestone marks the beginning of a new era of electronic health information exchange in the US. That world we wanted to see back in 2004—it’s here—and now it’s time to put what we’ve built to use.

Our goals for the Trusted Exchange Framework and Common Agreement (TEFCA) are:

Goal 1: Establish a universal policy and technical floor for nationwide interoperability.

Goal 2: Simplify connectivity for organizations to securely exchange information to improve patient care, enhance the welfare of populations, and generate health care value.

Goal 3: Enable individuals to gather their health care information.

The Trusted Exchange Framework is a set of non-binding principles to facilitate data-sharing among health information networks. The Common Agreement will operationalize simplified electronic health information exchange for many across the US and will provide easier ways for individuals and organizations to securely connect. Most notably, the Common Agreement sets a new baseline for the exchange purposes that need to be supported—a common source of friction across networks today. The Common Agreement includes support for treatment, payment, health care operations, individual access services, public health, and government benefits determination.

The Common Agreement is a new legal contract that ONC’s Recognized Coordinating Entity (RCE), The Sequoia Project, will sign with each Qualified Health Information Network (QHIN). QHINs will then execute certain corresponding policies within their own networks. Published in tandem is the QHIN Technical Framework, which sets the functional and technical requirements that QHINs need to support to make this new connectivity come online. While road-tested production standards are being used at the start, we are also actively working with the RCE to develop a TEFCA Health Level Seven (HL7®) Fast Healthcare Interoperability Resource (FHIR®) Roadmap (TEFCA FHIR Roadmap) to outline how FHIR will also become an established part of TEFCA-based exchange over time.

The FEHBlog is happy that the Biden Administration hit the regulatory accelerator to launch TEFCA in the Administration’s first year in office. Here’s a link to the Sequoia Projects’ TEFCA website which offers a wealth of resources.

From the Omicron front, the Wall Street Journal reports that

Pfizer Inc.’s new Covid-19 pill, Paxlovid, was effective against the Omicron variant in laboratory tests, an encouraging early sign the drug will be an important tool while the strain spreads. 

Pfizer said Tuesday the drug’s main component, nirmatrelvir, worked in three separate laboratory studies. Patients take two tablets of nirmatrelvir with one tablet of another antiviral called ritonavir twice a day for five days.

The company issued the results by news release. The research hasn’t been published in a peer-reviewed medical journal.

PBS recently posted this helpful article on U.S. distribution plans for the Merck and Pfizer COVID pills. The pills are helping some folks already, but access to the medication seems serendipitous just like access to the COVID vaccines seemed a year ago.

From the OTC testing front, the Federal Government launched its COVIDTest.gov website today. The site appears to be user friendly. Let’s hope it’s holds up better than healthcare.gov did in 2014 when stress tested by the public.

The COVIDtests.gov reminds users that health plans will reimburse the costs of OTC Covid tests, and by golly Blue Cross FEP has an OTC tests coverage page on its website and so does GEHA.

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.

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.”

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.

Weekend update

David Ermer–Congress, COVID-19, COVID-19 testing, U.S. Healthcare–
Photo by Cristina Gottardi on Unsplash

The House of Representatives convenes tomorrow for its second session of the 117th Congress. Both House and the Senate expect to engage in Committee business and floor votes this week.

The Wall Street Journal reports that the President has accepted the House Speaker’s invitation to give his State of the Union address on March 1. The date of the address was push back to March to avoid conflicting with the 2022 Winter Olympics, which will be held from February 4 to 24. Roll Call adds that the Administration plans to release the President’s Fiscal Year 2023 budget proposal following the State of the Union address.

From the Omicron front, NPR informs us that

Scientists at Case Western Reserve University have preliminary evidence that the risk of being admitted to the hospital or the intensive care unit during the omicron surge in the U.S. is about half of the risk observed during the delta surge. And this reflects what doctors across the country are now seeing firsthand with their patients. * * *

[A]s with any variant of SARS-CoV-2, your absolute risk depends on many factors, including whether you’re vaccinated and boosted, your age, your overall health and your economic situation.

“In the older age group, it’s still a nasty disease, even if it’s less [nasty] than the delta variant,” says Dr. Pamela Davis, who’s a pulmonologist at Case Western Reserve University and a senior author on the new study. “You don’t get off scot-free just because you happen to be infected in the time of omicron.”

As with previous variants, the vast majority of people infected with omicron have a mix of symptoms that resolve relatively quickly and don’t require hospital care. * * *

And doctors are finding many of these cases tend to look like an ordinary upper respiratory infection. In other words, what you think of as the common cold.

“It’s mostly that runny nose, sore throat and nasal congestion,” says Dr. John Vanchiere, the associate director of the Center for Emerging Viral Threats at LSU Health Shreveport. “The cough is milder [than previous variants], if there’s any cough at all, and fever seems to be a little less common.”

The New York Times discusses an increase in Omicron-related hospitalizations of children aged 4 and younger.

The number of hospitalized young children infected with the coronavirus rose precipitously last week to the highest levels since the beginning of the pandemic, according to data released on Friday by the Centers for Disease Control and Prevention.

The increase was observed in children who were 4 and younger, who are not eligible for vaccination, and the data included children who were admitted to hospitals for reasons other than Covid.

The rise may be partly explained by the surge of Omicron cases, which affects all populations, and the spread of other respiratory infections.

But the data do not show a similar steep rise in coronavirus infections among hospitalized children of other ages, and federal health officials were considering the possibility that Omicron may not be as mild in young children as it is older children.

According to the article the youngest among us are most at risk for upper respiratory infections such as Omicron.

“They’re smaller, their airways are smaller,” Dr. Kristin Oliver, a pediatrician at Mount Sinai Hospital in New York, said of young children.

“It does seem reasonable in a disease that if it looks like it’s affecting the upper airway more, that they would be more impacted,” she added. “They are more at risk for that — for longer, prolonged cases, as well as the hospitalization that can come along with a more severe case.”

That may explain why more hospitalized children aged 4 and younger have tested positive for the coronavirus throughout the pandemic than those 5 and older. It’s also why young children are more vulnerable to other pathogens, like respiratory syncytial virus, and to having the seal-like cough associated with croup.

Healthline summarizes the situation as follows:

A record number of children have recently been hospitalized with COVID-19. Still, health officials say many of these kids are not in the hospital because of COVID-19 but instead incidentally tested positive when admitted for other health issues. Still, due to the sheer volume of pediatric COVID-19 cases right now, children’s hospitals across the country are seeing an increase in kids being hospitalized for COVID-19. Severe illness in kids remains rare, and even hospitalized kids tend to recover well. Still, others require intravenous fluids, steroids, and antivirals. Doctors recommend that families mask up, avoid crowded spaces, and get all eligible kids vaccinated.

From the COVID testing front, PBS reports that

Starting Jan. 15, private insurers will be required to cover the cost of at-home testing, the same way they cover the cost of PCR lab tests. People will have the option of buying tests at a store or online, then seeking reimbursement from their health insurance provider. Those with public health insurance through Medicare or Medicaid, or without insurance, will be directed to the forthcoming website to order tests or to community health centers in their area offering free testing.

However, the FEHBlog sees this program as making a change to current testing coverage rules. According to ACA FAQ 44, a healthcare provider acting within the scope of his or her license must provide an individualized clinical assessment regarding COVID-19 diagnostic testing in order to obtain health plan coverage. The provision of such assessment can be demonstrated by the provider conducting the PCR test or referring the patient to a testing facility.

That individualized clinical assessment does not occur when a consumer decides on his or her own initiative to purchase a rapid at home antigen test kit. Indeed in ACA FAQ 44, the regulators stated that

Plans and issuers are not required to provide coverage of testing such as for public health surveillance or employment purposes. But there is also no prohibition or limitation on plans and issuers providing coverage for such tests.

Thus the new at home test coverage guidance expected this week may involve a material change to the current COVID testing coverage rule. In that event, you can expect a lawsuit challenging the mandate.

The FEHBlog also expected the guidance by January 15, not implementation by that date. The regulators have to allow an opportunity for insurer feedback and then implementing this new program. We shall see.