Friday Stats and More

CMS

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.

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.”

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.

Weekend update

David Ermer–ACA, CMS, Congress, COVID vaccine mandate, COVID-19, Federal employment benefits, OPM, SCOTUS, U.S. Healthcare–
Photo by Jessica Delp on Unsplash

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

Roll Call reports that

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

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

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

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

From the Omicron front, Bloomberg reports that

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

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

From the COVID mandate challenge front —

Since last Wednesday

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

In Affordable Care Act news, CMS announced on Friday that

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

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

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

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

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

If federal employee compensation news, Govexec tells us that

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

Tuesday’s Tidbits

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, U.S. Healthcare–

From the Open Season advice front, here are recent articles from FedSmith and Govexec .

From Capitol Hill, FedWeek reports that last Wednesday Nov. 3

The Senate Homeland Security and Governmental Affairs Committee has approved:

HR-2662, to give agency IGs authority to subpoena former federal employees; require an administration to provide a “substantive rationale, including detailed and case-specific reasons” prior to removing an IG; limit the use of administrative leave for IGs, including during the 30 days following the removal announcement; require acting IGs to be selected from among senior-level employees within the watchdog community; and require regular training to IG employees on their whistleblower rights.

The House already has passed the HR 2662. The Senate Committee amended the House bill before voting to sending the “favorable” substitute bill to the Senate floor for a vote.

From the Delta variant front Medscape informs us that

Pfizer and its European partner BioNTech have asked the US Food and Drug Administration (FDA) to expand emergency authorization of its COVID vaccine to allow everybody 18 and older to get a booster dose.

If it goes through, the broader use of Pfizer boosters would be a step toward President Joe Biden’s goal of boosters for all adults. He announced the goal last August but backed off to let the regulatory process by the FDA and the Centers for Disease Control and Prevention (CDC) play out.

Pfizer is submitting a study of booster effects on 10,000 people to make its case, according to a company news release.

This would be Pfizer’s second bite at the FDA apple for this approach to its booster.

Govexec informs us from the Delta variant vaccine mandate front that

VA Secretary Denis McDonough spoke at the National Press Club in Washington, D.C. on Tuesday afternoon, which came after the October 8 deadline for health care employees to get vaccinated but before the November 22 deadline for the rest of the federal workforce. 

“We’re still getting all of our data together,” he said. As of this morning, about 91% of the health care professionals at VA “have uploaded their data,” which could be proof of vaccination or requests for one of the exemptions. This is up from about 70% about two and a half weeks ago. 

“We’re not going to question the legitimacy of anyone’s individual declaration of a religious exception,” McDonough said. However, “we may find ourselves in a situation where, for example, in an oncology department or in a spinal cord injury facility or in an intensive care unit…or community living center[s], we may have so many people who have claimed a religious exemption that we can’t safely provide care to our veterans in those vulnerable situations, in which case we reserve the right to deny religious exemptions.” 

Fedweek cautions that “Both supporters and opponents of the Coronavirus vaccine mandate expect it to increase turnover among federal employees, although it is hard to say how large that increase will be and how much of it will be involuntary versus voluntary.”

From the No Surprises Act (NSA) front, the FEHBlog noticed that the Centers for Medicare and Medicaid Services has created a public NSA website. Posted on the site is an October 25, 2021, CMS letter announcing required federal government website and contact information to be included in the consumer notice about the NSA and other NSA related documents.

Website: https://www.cms.gov/nosurprises/consumers. Note, consumer and provider functionality for complaints inquiry and triage will not be operational until January 2022.

Phone number for information and complaints: 1-800-985-3059.

We ask regulated entities not to include the above phone number in any plan documents for any plan or policy years that begin before January 1, 2022.

In other healthcare news

Per Fierce Healthcare, here are the 10 most cost-efficient hospitals in the U.S., according to the Lown Institute: 

  1. Pinnacle Hospital (Crown Point, Indiana)
  2. Saint Mary’s Regional Medical Center (Reno, Nevada)
  3. Mercy Medical Center Dubuque (Dubuque, Iowa)
  4. Encino Hospital Medical Center (Encino, California)
  5. Park Ridge Health (Hendersonville, North Carolina)
  6. Oroville Hospital (Oroville, California)
  7. Saint Michael’s Medical Center (Newark, New Jersey)
  8. UnityPoint Health – Meriter (Madison, Wisconsin)
  9. East Liverpool City Hospital (East Liverpool, Ohio)
  10. Maple Grove Hospital (Maple Grove, Minnesota)

“Overall, if all hospitals performed as well as the most cost-efficient hospitals, Medicare would save $8 billion each year.”

Healthcare Dive informs us that

Nonprofit health giant Kaiser Permanente’s operating margin continued to shrink in the third quarter as expenses grew faster than revenue, spurred by labor unrest and surging COVID-19 patients, the Oakland, California-based integrated health system said.

Kaiser reported $38 million in operating income in the quarter, on $23.2 billion in revenue. That’s a 0.2% operating margin — exceedingly low compared to a margin of 2.1% same time last year. 

The 39-hospital system’s expenses in the third quarter grew 7.5% year over year to $23.1 billion, while revenue only increased 5.5%. Kaiser said the expense growth was due to higher costs from COVID-19 patients and workforce requirements, as — like other hospital operators — Kaiser has had to pay more for travel nurses and other contract labor to meet rising patient levels during the pandemic.

Weekend update

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Telehealth, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

Happy Halloween!

The U.S. House of Representatives and the Senate will be engaged in floor voting and Committee business this coming week. The Hill brings us up to date on Democrat Congressional leadership negotiations over the social spending budget reconciliation bill. Bloomberg adds

While the $500 billion infrastructure bill has already passed the Senate, the larger economic package will have to return there for another vote. Some Democratic Senators are signaling they may seek changes to what is passed in the House, possibly adding further delays. 

From the Open Season front, the ACA marketplace open season resumes tomorrow. The Federal Employee Benefits Open Season begins a week from tomorrow. OPM’s 2022 online FEHB Plan Comparison Tool is now available.

From the Delta variant front, the Wall Street Journal tells us that

The Food and Drug Administration is delaying a decision on Moderna Inc.’s application to authorize use of its Covid-19 vaccine in adolescents to assess whether the shot leads to a heightened risk of myocarditis, the company said.

The FDA notified Moderna on Friday evening that an analysis may not be completed until January of next year while the agency reviews recent international data on the risk of myocarditis after vaccination, the company said Sunday.

The Wall Street Journal reported earlier this month that the FDA was delaying a decision on Moderna’s application for authorization in 12- to 17-year-olds after several Nordic countries limited use due to myocarditis reports. 

Moderna also said it would delay asking the FDA to authorize use of a lower dose of its shot in even younger children, ages 6 to 11, while the agency continues to review its request to clear the shots in adolescents.

From the CMS front, Medicare offers coverage for those under age 65 who are afflicted with End Stage Renal Disease (“ESRD”). On Friday, CMS finalized its ESRD prospective payment rule for calendar year 2022. In its announcement CMS explained that

Through the ESRD Prospective Payment System (PPS) annual rulemaking, CMS is making changes to the ESRD Quality Incentive Program (QIP) and the ESRD Treatment Choices (ETC) Model, and updating ESRD PPS payment rates. The changes to the ETC Model policies aim to encourage dialysis facilities and health care providers to decrease disparities in rates of home dialysis and kidney transplants among ESRD patients with lower socioeconomic status, making the model one of the agency’s first CMS Innovation Center models to directly address health equity.

“Today’s final rule is a decisive step to ensure people with Medicare with chronic kidney disease have easy access to quality care and convenient treatment options,” said CMS Administrator Chiquita Brooks-LaSure. “Enabling dialysis providers to offer more dialysis treatment options for Medicare patients will catalyze better health outcomes, greater autonomy and better quality of life for all patients with kidney disease.”

That makes sense to the FEHBlog.

From the healthcare network front, the Yale School of Public Health (YSPH”) informs use that “a new survey analysis from a researcher at the YSPH suggests that privately insured adults are significantly more likely to rate their mental health provider network as inadequate compared to their medical provider network.” With due respect to Yale, this finding is hardly surprising given the fact that relative few mental health therapists join a health plan network because they don’t need patient referrals. That’s why it so important for the hub and spoke telehealth services to offer ongoing mental health care over their networks.

From the OPM front, Federal News Network reports that

As agencies contemplate and continue to plan for the future of work, the Office of Personnel Management is trying to let agencies know they have some help — and some new resources — to guide them through the unknown.

The agency is preparing to release more guidance on telework and remote work “very soon,” OPM Director Kiran Ahuja said in an interview with Federal News Network.

It’s all part of an effort to help agencies establish themselves as model employers that can meet the moment — and part of OPM’s own plans to reestablish itself as a human capital resource for the rest of government. They’re priorities Ahuja set in the early days since becoming OPM director, and they’ll continue well into 2022 and beyond, she said.

The guide will offer, in some detail, advice for agencies on making the shift to remote and hybrid work.

“We want to support what’s involved in our lives around flexibilities and child care but also knowing that we can be really productive,” Ahuja said. “We have this guide coming out. We’re also pulling together trainings and information around how to manage in a hybrid work environment and how to operate well in a work environment, as well as a new website focused on future of work.”

Midweek update

David Ermer–CMS, COVID-19, Rx coverage, U.S. Healthcare–

From the Delta variant front —

The Boston Globe informs us that

U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially. * * *

Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.

As for mixing and matching, the FDA said it’s OK to use any brand for the booster regardless of which vaccination people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time. * * *

The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.

The Wall Street Journal adds that

A panel of outside experts at the FDA is scheduled to review the data [on Pfizer’s modified COVID mRNA vaccine for children ages 5 to 11] Tuesday. Although the agency doesn’t have to follow the group’s recommendation, it typically does. The CDC’s independent advisory committee will meet on Nov. 2-3 to consider the vaccine. 

The White House said the administration has been coordinating with state and local leaders on plans to distribute the vaccines. If authorized, young children would receive two injections of the vaccine, three weeks apart, just like adolescents and adults do but at a lower dosage.

Mr. Zients said the doses will be shipped with all the supplies necessary to administer the shots, including smaller needles. The vaccines will also be shipped in smaller packages containing about 100 doses each, the White House said, and can be stored for up to 10 weeks at standard refrigeration temperatures and for 6 months at ultracold temperatures. * * *

[Furthermore,] the Biden administration is preparing to distribute shots to children at doctors’ offices, pharmacies and schools should federal regulators clear the inoculations for kids ages 5-11.

Also, Govexec reminds us that the Veterans Administration is acting as the guinea pig agency for the President’s vaccine mandate for federal employees. The VA initiated a mandate program while the President was still in the vaccination screening program stage so its discipline deadlines are occurring earlier.

The Veterans Affairs Department has begun disciplining employees who have not proven that they are vaccinated against COVID-19, sending an untold number into counseling following a deadline to turn over their documentation. 

Just 70% of the 380,000 employees at the Veterans Health Administration met the Oct. 18 deadline to show proof of vaccination, VA Secretary Denis McDonough said on Wednesday, leaving 114,000 workers who have yet to do so. VA previously reported that 88% of their health care workforce had said they were vaccinated, but that was based on data from self-reported “attestation forms.” Under stricter guidance the Biden administration has rolled out, VA employees must now submit paperwork to actually demonstrate that they have been inoculated.

From the third quarter financial results department —

Healthcare Dive reports that

  • Anthem’s medical costs during the third quarter beat Wall Street expectations despite the wave of COVID-19 hospitalizations and cases that were fueled by the delta variant during the quarter. The medical cost results are likely to ease investor fears, SVB Leerink analysts said in a Wednesday note.
  • On top of that, Anthem increased medical membership by nearly 6% over the prior-year quarter, ending the period with 45.1 million members. The largest membership gains were recorded in its government book of business, a continuing trend throughout the pandemic.
  • Anthem generated a $1.5 billion profit for the third quarter, a dramatic leap from the prior-year period when net income was $222 million. The payer again hiked its outlook for the remainder of the year on the results released Wednesday.

STAT News tells us that

Biogen made just $300,000 from the Alzheimer’s disease treatment Aduhelm in the first full quarter since its approval, a number far below Wall Street’s expectations and the company’s internal goals.

Aduhelm’s third-quarter sales, disclosed Wednesday, are nowhere near the roughly $14 million analyst consensus estimate, calculated by the investment bank Cowen. Last month, STAT reported that only about 100 patients had received a dose of Aduhelm between its June approval and Sept. 11. The final revenue number suggests Biogen failed to accelerate the drug’s commercial launch.

Also from the Rx coverage front, Fierce Healthcare informs us that

Express Scripts will prefer the first Food and Drug Administration-approved interchangeable biosimilar product, a move it says will lead to millions in savings.

Semglee, which was developed by Viatris, was approved by the FDA in late July. Express Scripts will move the product to its National Preferred Formulary, which reaches 28 million members. By making the change, the pharmacy benefit manager estimates it could achieve $20 million in savings in 2022.

In addition, Express Scripts said Sanofi’s biologic insulin injection Lantus will be excluded from its National Preferred Formulary.

From the reports and studies front

  • The CMS Center for Medicare and Medicaid Innovation issued a strategic plan for its second decade.
  • NCQA and Grantmakers in Health released a valuable report on how federal action is needed to improve race and ethnicity data in federal public health programs such as Medicare and Medicaid.

Weekend Update

David Ermer–CMS, Congress, COVID-19, COVID-19 vaccine, Rx coverage–
Photo by Dane Deaner on Unsplash

The U.S. House of Representative both will be engaged in committee work through Wednesday this week until Yom Kippur begins on Wednesday evening. The Senate also will be engaged in floor voting for the same period. Committee work principally will focus on the details of the $3.5 trillion budget reconciliation bill and a related Plan B measures including a stopgap extension of federal funding past September 30 and addressing the debt ceiling.

On the Delta variant front

The Wall Street Journal explains that epidemiologists no long think that COVID-19 can be eradicated. We have a good shot at the virus becoming endemic / a routine treatable illness.

When or even whether Covid-19 settles into that status depends on how many more people get vaccinated and how soon, said Adolfo Garcia-Sastre, director of the Global Health and Emerging Pathogens Institute at the Icahn School of Medicine at Mount Sinai in New York.

For Covid-19 to become mild, most people will need some immunity, which studies have shown reduces the severity of the disease. Infections provide some immunity, but at risk of severe illness, death and further spread of the virus, compared with vaccines. People could become vulnerable to SARS-CoV-2 if that immunity erodes or is weak, or if the virus mutates.

“The more people who are vaccinated, the less problems there are going to be,” Dr. Garcia-Sastre said.

The Journal’s Numbers columnist explains why COVID-19 vaccination boosters will be necessary.

“We’re fortunate with tetanus, diphtheria, measles and vaccinia,” Dr. [Mark] Slifka [from the Oregon Health & Science University] said. “We have identified what the threshold of protection is. You track antibody decline over time, and if you know the threshold of protection, you can calculate durability of protection. With Covid, we don’t know.”

Complicating things further, viruses and bacteria that mutate to escape the body’s immune response are harder to control.

Measles, mumps, rubella and chickenpox hardly mutate at all, but at least eight variants of SARS-CoV-2, the virus that causes Covid-19, have been found, according to the British Medical Journal.  

“It does make it more complicated for the vaccine to work,” Dr. Slifka said. “You’re chasing multiple targets over time. Flu also mutates. With flu, we’ve adjusted by making a new flu vaccine each year that as closely as possible matches the new strain of flu.”

The FDA’s Vaccines Advisory Committee meets on the topic of COVID-19 boosters this Friday September 17. The CDC’s Advisory Committee on Immunization Practices has scheduled a complementary meeting for September 29.

The FEHBlog ran across this interesting WebMD article titled “Monoclonal Antibodies vs. Vaccines vs. COVID-19: What to Know.” “‘As hospitalizations go up nationwide, we have a therapy here that can mitigate that,’ says William Fales, MD, medical director of the Michigan Department of Health and Human Services Division of EMS and Trauma. Getting monoclonal antibodies is one of ‘the best things you can do once you’re positive.’” However, the vaccine’s protection against COVID-19 has a much longer duration than this treatment. “There are two authorized uses for monoclonal antibodies: To treat or stop COVID-19’s progression in a high-risk person who tests positive, and to prevent COVID-19 in a high-risk person who’s been exposed.” The treatment is administered while hospitalized or while outpatient at an infusion center.

In RX news, Managed Healthcare Executive reports

The FDA has approved 30 biosimilars and 21 have been launched. But it won’t be till biosimilars for some of the more widely prescribed biologics are on the market before biosimilars really start to have a major impact on American healthcare and its cost, according to a top-ranking executive at OptumRx.

“We’re still a few years away from the point at which the most widely-utilized … products in the U.S. today will be available as biosimilars,” Savitha Vivian, senior vice president of clinical and formulary Services for OptumRx, said in an interview with Managed Healthcare Executive®. “And that’s really what we’re looking for, because that’s going to enable a more sizable and impactful bottom-line savings.”

Ms. Vivian expects Humira to hit the bio-similar market in 2023.

“Another significant biosimilar launch that is still two to three years away from one for Novo Nordisk’s insulin aspart injection (Novolog), a “highly utilized medication, especially in the outpatient setting,” noted Vivian.Biosimilars for Genentech’s Actemra (tocilizumab), a medication for rheumatoid arthritis and other forms of arthritis, and Stelara (ustekinumab), Janssen’s immunosuppressive drug for plaque psoriasis and psoriatic arthritis, are also two or three years away.”

Patient and provider comfort with biosimilars is still a “critical barrier” to the adoption of biosimilars, she said.

Switching therapies in patients who are stable on the biosimilar’s reference product to the biosimilar is not typically recommended, according to Vivian. “So from a clinical perspective, we need to be cautious in implementing strategies that force these types of switching.”Instead, she said, “what we really need is data showing that there’s really no additional risk from switching therapies in these hard-to-treat or hard-to-control chronic diseases. That’s going to really increase the confidence for prescribers to start using biosimilars in … those stable patients.”

Another barrier is a lack of interchangeability in biosimilars, with notable exception of Semglee (insulin glargine-yfgn), which was FDA-approved as biosimilar to, and interchangeable with Lantus (insulin glargine) this summer. In order to demonstrate interchangeability, studies must show there is no additional risk or reduced efficacy if a patient switches back and forth between the interchangeable biosimilar and the reference product.