Weekend update

COVID-19

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare–

From Capitol Hill, the House of Representatives and the Senate will be engaged in Committee business and floor voting this week. Bloomberg brings us up to date on the status of $3.5 trillion budget reconciliation bill which the President and Democrat leaders in Congress have been pushing.

From the Delta variant front, it must be recalled that before health plans become obligated to cover the mRNA booster for immunized folks over age 65 and a broader group of immuno-compromised Americans, fifteen days must pass from the time that the Centers for Disease Control ratifies the FDA’s decision from last Friday. The CDC’s Advisory Committee on Immunization Practice is scheduled to consider this issue on September 29. The press reports on Friday indicated that the CDC is expected to establish the scope of the expanded coverage of immuno-compromised Americans.

On Sunday’s talk shows, Drs. Fauci and Collins, according to the Wall Street Journal, predict that the FDA will approve the mRNA booster for the general population before long. Kaiser Health News discusses how these leading scientists got in front of their skis on the scope of the mRNA booster coverage issue.

Precision Vaccines discusses where Britain and American stand in terms of achieving at least limited herd immunity.

In the USA, new data from the U.S. CDC published by the JAMA Network on September 2, 2021, indicates herd immunity may be achievable soon.

This review is based on blood donations in the U.S. from July 2020 through May 2021, including both natural infection- and vaccine-induced SARS-CoV-2 seroprevalence. This repeated cross-sectional study included over 1.4 million blood donation specimens representing 74% of the US population.

The estimated SARS-CoV-2 seroprevalence weighted for differences between the study sample and general population increased from 3.5% in July 2020 to 20.2% for infection-induced antibodies and 83.3% for combined infection- and vaccine-induced antibodies in May 2021. 

The coronavirus seroprevalence differed by age, race, ethnicity, and geographic region of residence, and these differences changed over the course of the study.

Since May 2021, the U.S. CDC has reported significant increases in COVID-19 vaccinations, initial infections, and re-infections. More than 4 million of these cases have been reported in the past few weeks.

These new totals may soon push the USA over the 95% herd immunity goal.

It’s worth noting that Britain is ahead of the U.S. because the Delta variant struck Britain first.

In other updates —

  • The American Cancer Society has released the 2021 edition of Cancer Facts and Figures.
  • The American Medical Association provides background of the 2022 changes to the Current Procedure Terminology. The AMA publishes the CPT which is one of the code sets for HIPAA electronic transactions.
  • Fierce Healthcare reports “The Biden administration has delayed enforcement of payer-to-payer data exchange included in a May 2020 final interoperability rule until future regulations are finalized.” The interoperability rules apply to insurers with HHS contracts, not FEHB carriers.
  • Health Payer Intelligence informs us that “Healthcare B2B payment transactions have been high in 2021, potentially signaling the importance of electronic payment transfers as the nation emerges from the coronavirus pandemic, according to a report from National Automated Clearing House Association (NACHA).” What’s more “‘This data from Nacha is good news for payers, providers and members,’ said April Todd, senior vice president of CORE and explorations at CAQH.  ‘The increase in electronic payment volume likely indicates that people who deferred routine medical appointments due to COVID are now able to get the care they need.  And when that care is paid electronically, it is more efficient and cost-effective for the industry.’  Todd’s organization has been tracking the economic impact of transitioning to electronic payment. A CAQH report estimated that the healthcare industry could see $426 million in cost savings by transitioning to electronic payments. Switching to electronic payment for claims submissions could save providers around $2 for each claim. Exact savings can vary based on the type of transaction.”

Friday Stats and More

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

Based on data from the Centers for Disease Control’s COVID Data Tracker, here is the FEHBlog’s weekly chart of new COVID cases for 2021:

The CDC observes “After experiencing a brief decline in COVID-19 cases, the United States is once again seeing an increase in cases in most of the country.”

Here’s a link to the CDC’s weekly chart of COVID hospitalizations which shows a drop in the seven day moving average.

Here’s the FEHBlog’s weekly chart of new COVID deaths for 2021:

Finally here is the FEHBlog’s weekly chart of COVID vaccines distributed and administered from the 51st week of 2020 through the 37th week of 2021, ending last Wednesday September 15.

There are 180.6 million fully vaccinated Americans, or 63.6% of the vaccination eligible population (age 12 and older) and 31 million more who are waiting for their second dose.

The Wall Street Journal informs us that

The Covid-19 vaccine made by Moderna Inc. is more effective at keeping people out of the hospital than those from Pfizer Inc. and partner BioNTech SE or Johnson & Johnson, new research indicates.

In a study published by the Centers for Disease Control and Prevention on Friday, researchers studied more than 3,600 adults who were hospitalized in the U.S. between March and August of 2021. They looked at people who were admitted to 21 hospitals who had at least one Covid-19 symptom and a positive PCR or antigen test, as well as patients who were admitted to a hospital who tested negative for Covid-19. They then compared their vaccination status and which vaccine they received.

The researchers found that the Moderna vaccine’s effectiveness against hospitalization was 93%, compared with 88% for Pfizer-BioNTech’s and 71% for J&J’s. The effectiveness of the Moderna and Pfizer-BioNTech vaccines also seemed to stand up better over time than that of J&J’s vaccine. The Moderna vaccine’s effectiveness against hospitalization dropped to 92% after 120 days, while Pfizer-BioNTech’s dropped to 77%. After just 28 days, the J&J vaccine’s effectiveness fell to 68%.

And the administrative suspense is over, STAT News tells us

An advisory panel to the Food and Drug Administration on Friday recommended against a booster dose of a Covid-19 vaccine for most Americans at this time — a major rebuke to the Biden administration — but voted unanimously to recommend one to Americans who are 65 or older.

The FDA is not required to follow the recommendation of its advisory committees but generally does. If the recommendation is adopted by the FDA and Centers for Disease Control and Prevention, it would put the U.S. policy on a par with countries like the United Kingdom.

After seven hours of deliberation, members of the Vaccines and Related Biological Products Advisory Committee voted 16 to 2 against a proposal to administer a third dose of the vaccine developed by Pfizer and BioNTech to individuals 16 years and older. The vote to recommend a booster to people 65 years and older — as well as people who are at risk of severe Covid — was 18 to 0.

It was not immediately clear who would qualify as high risk; fleshing that out will likely fall to the CDC’s advisory committee, the Advisory Committee on Immunization Practices.

You will be able to knock the FEHBlog down with a feather if acting FDA Commissioner Janet Woodcock overrules the advisory committee given the Aduhelm debacle earlier this year. Also the outcome strikes the FEHBlog as a reasonable Goldilocks solution to the thorny problem.

Speaking of the expensive Alzheimer’s Disease drug Aduhelm, Fierce Pharma reports that

Data collected from a survey of 74 neurologists collected at the start of the month found that at least two thirds of respondents anticipate having at least some patients on Aduhelm by March 2022, according to Spherix Global Insights’ newly launched drug report released on Thursday. That could result in “an estimated brand share substantially higher than that projected back in August,” the report found. 

he results indicate increased signs of optimism, according to Spherix, with small increases in the prescriber base and number of new patients compared to the stagnant trends found in the first few months following Aduhelm’s June FDA nod. In Spherix’s mid-July report, only about one fourth (27%) of responding physicians had planned to prescribe Aduhelm in the next few months.

Biogen’s prospects should improve in the coming weeks, Spherix estimates. According to the report, the prescriber base will likely grow by nearly 50% within that time, which could lead to twice the number of new patient initiations when compared with August.

Despite the maelstrom of negative press Biogen’s accelerated FDA nod has garnered, one in seven newly diagnosed patients with the memory-robbing disease are considered potential Aduhelm candidates, Spherix said. 

Therefore, Aduhelm’s long-term success “does not appear to be markedly limited by physician willingness to prescribe” the treatment or “clinical determination of patient eligibility.” 

In HHS News —

  • Today, the Biden-Harris Administration announced a $2.1 billion investment to improve infection prevention and control activities across the U.S. public health and healthcare sectors. The Biden-Harris Administration, working through the Centers for Disease Control and Prevention (CDC), is investing American Rescue Plan funding to strengthen and equip state, local, and territorial public health departments and other partner organizations with the resources needed to better fight infections in U.S. healthcare facilities, including COVID-19 and other known and emerging infectious diseases.”
  • Also today a record breaking third Affordable Care Act notice of benefit and rate parameters notice for 2022 was finalized. Fierce Healthcare tells us that “For 2022, insurers will face an increase in the federally run marketplace user fee rate to 2.75% of their premiums and the state-run exchanges to 2.25%. That is a change from the user fee finalized on Jan. 19 under the Trump administration, which called for a user fee of 2.25% for the federal marketplace and 1.75% for the state-run exchanges. The rule would also extend the open enrollment period by 30 days for ACA signups, with the new deadline on the federally run exchanges being Jan. 15. Open enrollment for the federal exchanges still starts on Nov. 1. * * * CMS is also creating a new special enrollment period that targets low-income individuals through HealthCare.gov. The goal is to target people who could be eligible for boosted subsidies that were included in the American Rescue Plan Act but expire after the 2022 coverage year. Congress is debating whether to extend those subsidies as part of a $3.5 trillion infrastructure package.”

President names an OPM Inspector General nominee

David Ermer–Congress, COVID-19, Federal employment benefits, HSA, OPM, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

The Washington Post reports that

President Biden on Thursday made a nomination to fill the long-vacant position of inspector general at the Office of Personnel Management, a watchdog office that has at times publicly clashed with top management of the federal agency.

Nominee Krista Boyd is chief counsel for oversight and policy on the House Oversight and Reform Committee, which oversees federal workplace matters. Boyd has worked on Capitol Hill for more than two decades with a focus on issues including whistleblower protection, transparency and strengthening the access to agency information for inspectors general and other watchdogs, an announcement said.

Ms. Boyd’s nomination is subject to Senate confirmation.

On the Delta variant front, Govexec.com informs us that

The Biden administration released new guidance on Thursday about implementing the COVID-19 vaccine mandate for federal employees, which says even those on telework or remote work must get vaccinated. 

The guidance implements an executive order President Biden issued on September 9 requiring federal employees to get vaccinated against the novel coronavirus, unless they request an exemption. The Safer Federal Workforce Task Force said on Monday that November 22 is the deadline for employees to get fully vaccinated or possibly be subject to progressive discipline. * * *

Postal Service employees are not covered by the mandate, but they will be subject to the forthcoming emergency temporary standard from the Occupational Safety and Health Administration (OSHA) that will require vaccines for companies with 100 or more employees, the senior administration official pointed out. That was another coronavirus measure the president unveiled last week. 

“Our workplaces are subject to regulations from the Occupational Safety and Health Administration,” USPS said in a statement on Thursday. “Therefore, we are working closely with our union leadership so that once OSHA’s COVID-19 Vaccination Emergency Temporary Standard is issued we can move quickly to determine its applicability to our employees and how best to implement [it].” * * *

Other topics covered in the update are: who is considered fully vaccinated and the timeline for getting fully vaccinated (depending on which vaccine individuals receive); vaccination dates for those who are starting government service after November 22; what protocols employees should follow before becoming fully vaccinated; and how agencies should collect and maintain documentation of vaccination for employees. Agencies must collection documentation even if employees previously attested to being vaccinated. 

The Society for Human Resource Management discusses what to expect from OSHA on the vaccination screening program it is developing for private employers with more than 100 employees.

In mergers and acquisitions news, the Deseret News reports that

Intermountain Healthcare announced Thursday that the organization is merging with SCL Health, a faith-based, nonprofit health care organization based in Colorado.

The two organizations are located in adjacent areas with no geographic overlap, so together they will employ more than 58,000 caregivers, operate 33 hospitals and run 385 clinics across Utah, Idaho, Nevada, Colorado, Montana and Kansas.

SCL Health is a $2.8 billion health network that provides comprehensive, coordinated care in hospitals, clinics, home health, hospice and mental health services across Colorado, Montana and Kansas. It brings eight hospitals and more than 160 physician clinics into the merger. Their hospitals will retain their names and their Catholic identity, directives and values.

The merger, which is subject to regulatory approval, is expected to close early next year.

From the studies front —

  • The Centers for Disease Control released updated adult obesity prevalence maps for the U.S. yesterday.
  • The Employee Benefits Research Institute is offering an issues brief on trends in health savings account balances, contributions, distributions and investments and the impact of COVID-19 thereon.

From the reminders front, Fedweek explains the “five year rule” for continuing FEHB and FEGLI coverage into a civil service retirement.

As a rule, you can only continue your FEHB and/or FEGLI coverage into retirement if you are 1) currently enrolled, 2) have been enrolled for at least five years or from your earliest opportunity to enroll, and 3) are retiring on an immediate annuity (including disability).

Further, if you are a FERS employee who is retiring on an immediate annuity but postponing its receipt to a later date to reduce or eliminate the 5 percent per year penalty for retiring under the MRA+10 provision (minimum retirement age—currently 57—with at least 10 but less than 30 years of service), you’ll be able to reenroll in the FEHB program when your annuity begins. Note: If you leave government before being eligible to retire and later apply for a deferred annuity when you have the right combination of age and service, you can’t reenroll in either program.

While there is an automatic waiver of the FEHB five-year rule if you are accepting an offer of early retirement from your agency, no waiver is possible for FEGLI. Nor are waivers of the “currently enrolled” or “retiring on an immediate annuity” requirements available under current law for either program.

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

Roll Call discusses the status of the $3.5 trillion budget reconciliation bill as “Senate Democrats begin to tweak the House package.” Federal News Network provides a broader perspective on the varied issues facing Congress this month.

From the Delta variant front

  • The Department of Health and Human Services” (HHS) Vaccination Community Corps has updated its resources list.
  • Yesterday, HHS “transitioned from a direct ordering process to a state/territory-coordinated distribution system * * * for the distribution of monoclonal antibody drugs (“mAbs”) [to treat COVID-19 particularly in unvaccinated people].  State and territorial health departments know best where product is needed in their areas. Transitioning to a state/territory-coordinated distribution system gives health departments maximum flexibility to get these critical drugs where they are needed most.” Makes sense.  
  • Healthcare Dive reports that “Just as patients started returning for care they delayed throughout the COVID-19 pandemic, hospitals are again having to put non-emergency procedures on hold to free up resources for patients hospitalized with the delta variant of the coronavirus. Salt Lake City-based Intermountain Healthcare is the latest system to announce it’s postponing elective procedures starting Wednesday at 13 of its hospitals, and expects the pause to last several weeks, CEO Marc Harrison said during a Friday press conference.”
  • JDSupra offers a useful and in the FEHBlog’s opinion accurate legal analysis of the President’s vaccination programs for federal contractors and private employers. Bloomberg expresses concern that “The U.S. may not have enough tests to keep pace with the Biden administration’s tightened workplace Covid-19 mitigation measures.”

In the tidbits department

  • The Mercer consulting firm announced that ‘[a]s the pandemic continues to unfold, the ability of employers to have a positive impact on employee health and resiliency cannot be understated and is one of the most important findings of the latest Mercer “Health on Demand” survey released today.” Since the onset of COVID-19, when employers stepped up to provide essential support, it made a difference. Employees who say they received good support from their employers are much less likely to view their personal experience of the pandemic as mostly or entirely negative compared to those who received little or no support – 25% vs. 49%. And almost half (45%) of those receiving good support say they are less likely to leave their job as a result.
  • The FEHBlog noticed a Modern Healthcare article discussing how employers are incorporating virtual substance abuse programs in their provider networks. As an example the article pointed to Ria Health which describes itself as an evidence based alcohol additional treatment program.
  • The American Medical Association’s President (appropriately in the FEHBlog’s view) is urging physicians and patients to reengage. “As life takes steps to return to normal, it’s urgent that patients and physicians prioritize health screenings and regular procedures.”

Monday Roundup

David Ermer–COVID-19, COVID-19 vaccine, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

On the OPM front, Govexec informs us that

The Office of Personnel Management on Monday announced that it agrees with the vast majority of recommendations posed by a recent study on the future of the agency and is incorporating much of that report’s findings into its strategic plan and budget requests.

In March, the National Academy of Public Administration released its long-awaited report on how to modernize OPM * * * .

OPM said that many of NAPA’s recommendations have already been incorporated into the agency’s fiscal 2022-2026 strategic plan and will be used as the agency develops its fiscal 2023 budget request, which is due to the Office of Management and Budget in October. The new strategic plan will not be public until February 2023, coinciding with the release of President Biden’s fiscal 2023 budget proposal.

In a statement, OPM Director Kiran Ahuja said she will ensure the agency is focused on implementing policies that reaffirmed OPM as a strong and independent leader in governmental human resources.

Good luck with that effort. It seems like yesterday that OPM released its last five year strategic plan.

On the Delta variant front, The Wall Street Journal reports today that

A surge in Covid-19 deaths caused by the highly contagious Delta variant is hitting working-age people hard while highlighting the risks for people who remain unvaccinated.

Federal data show Covid-19 deaths among people under 55 have roughly matched highs near 1,800 a week set during last winter’s surge. These data show weekly tallies for overall Covid-19 deaths, meanwhile, remain well under half of the pandemic peak near 26,000 reached in January. * * *

Older Americans still account for the most Covid-19 deaths, but their higher vaccination rates have helped hold down the numbers. About 54% of the overall U.S. population and 63% of eligible people ages 12 and above are fully vaccinated, while the average among nursing homes is 84% for their residents, federal data show.

On the COVID vaccination front —

  • David Leonhardt in the New York Times offers helpful information for folks who have received the one dose Johnson & Johnson vaccine.
  • Medscape tells us that “Pfizer’s COVID-19 vaccine could be authorized for ages 5-11 by the end of October, according to Reuters.”

On the Biden Administration’s vaccine mandate front —

Federal News Network reports that

Federal employees have until Nov. 22 to be fully vaccinated in accordance with the president’s new mandate, the Biden administration said Monday.

The Safer Federal Workforce Task Force, led by the White  House COVID-19 Response Team, the Office of Personnel Management and General Services Administration, offered up a few more details on what agencies and employees should expect from the president’s new vaccine executive order.

“Federal executive branch employees must be fully vaccinated, except in limited circumstances where an employee is legally entitled to a reasonable accommodation,” the task force said in a series of updated “model safety principles” released Monday. “Agencies must work expeditiously so that their employees are fully vaccinated as quickly as possible and by no later than Nov. 22, 2021.”

The task force said it’s preparing additional guidance on how agencies should implement the president’s new executive order and will issue it “soon.”

Govexec tells us that “The U.S. Postal Service is not committing to implementing any COVID-19 vaccine mandate—full or partial—for its workforce, with an agency spokesman saying officials will first need to see the fine print of new requirements President Biden has issued.”

On the health equity front —

  • Healthcare Finance News reports that seventeen national healthcare organizations sent a letter “urging Department of Health and Human Services Secretary Xavier Becerra to move forward on alternative payment models as part of its strategy to achieve health equity. [T]he groups [letter] underscored how APMs routinely leverage multidisciplinary approaches to care, assess social risk, partner with community organizations to increase access to nonmedical services and leverage data to improve disparities in patient outcomes.”
  • Health IT Analytics discusses the value including social determinants of health data in artificial intelligence applications. “According to New York University researchers, machine learning can accurately predict cardiovascular disease and guide physicians to select treatment options. However, by factoring social determinants of health into the equation, providers can better serve diverse groups.”

In other healthcare news —

  • HHS’s “Substance Abuse and Mental Health Services Administration (SAMHSA) is awarding more than $123 million in funding through six grant programs to provide multifaceted support to communities and health care providers as the Nation continues to combat the overdose epidemic.”

Policymakers have introduced proposals to combat high and rising hospital prices, but focusing on high-concentration markets likely misses the mark.

The majority of high-price hospitals are active in markets that meet federal definitions of low or moderate concentration, according to a recently published commercial claims review.

As such, price regulation policy proposals that specifically target concentrated hospital markets would only impact a minority of hospitals charging the highest prices for their services, Harvard-affiliated researchers wrote in Health Affairs.

Policymakers would instead be more effective if they focused their interventions directly on limiting high provider prices without regard to a hospital’s surrounding market, researchers wrote.

“Policymakers could start with modest approaches, such as capping the highest prices, tracking outcomes and gradually pushing the caps downward, and monitoring trade-offs between savings and any unintended consequences for access or quality,” they wrote.

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.

Friday Stats and More

David Ermer–ACA, COVID-19, COVID-19 vaccine, OPM, U.S. Healthcare–

Based on the Centers for Disease Control (CDC) constantly improving COVID data tracker website, here are charts of new weekly COVID-19 cases and deaths using Thursday as the first day of the week. As you can see, new cases trended down last week. Per the CDC, “The current 7-day moving average of daily new cases (136,558) decreased 12.7% compared with the previous 7-day moving average (156,341).” Moreover, “The current 7-day moving average of new deaths (1,077) has decreased 11.3% compared with the previous 7-day moving average (1,214).”

Here are links to the COVID hospitalization statistics and the CDC’s weekly interpretation of its COVID data. Per the CDC, “The current 7-day daily average for September 1–September7, 2021, was 11,754 This is a 4.1% decrease from the prior 7-day average (12,251) from August 25–August 31, 2021.”

Here is chart of weekly COVID vaccines distributed and administered from the time administration began last December through the 36th week of this year (ending September 8, 2021):

New vaccinations have levelled out at a rate of roughly 5 million per week for the past two months. Per the CDC, “As of September 9, 2021, 92.6% of people ages 65 years or older have received at least one dose of vaccine and 82.2% are fully vaccinated. Over three-quarters (75.3%) of people ages 18 years or older have received at least one dose of vaccine and 64.5% are fully vaccinated. For people ages 12 years or older, 73.4% have received at least one dose of vaccine and 62.5% are fully vaccinated.”

The Food and Drug Administration today released this bulletin about the status of making available a COVID vaccine for young children.

The FDA is working around the clock to support the process for making COVID-19 vaccines available for children. As outlined above, this process is complex and relies on robust manufacturer trials and data, and while we cannot offer a specific date or timeline for when it may be completed for the various manufacturers’ vaccine candidates, we can assure the public we are working as expeditiously as possible to meet this critical public health need and we very much hope to have pediatric COVID-19 vaccines available in the coming months.

The New York Times reports

Federal health officials released new data showing that unvaccinated Americans are 11 times as likely as vaccinated people to die of Covid-19.

Three large studies, published on Friday by the Centers for Disease Control and Prevention, also highlighted the effectiveness of the shots at preventing infection and hospitalizations with the virus.

The research underscored a deep conviction among scientists that vaccine hesitancy and refusal have prolonged the pandemic. The administration’s new plan should stem the flood of infections and return the country to some semblance of normalcy in the long term, several experts said in interviews.

With respect to the President’s vaccination mandates, Gov Exec tells us that

The U.S. Postal Service is not committing to implementing any COVID-19 vaccine mandate—full or partial—for its workforce, with an agency spokesman saying officials will first need to see the fine print of new requirements President Biden has issued. 

Biden’s executive order mandating the vaccines for the federal workforce took a somewhat narrow definition of agencies that carved out USPS, which employs more than 640,000 people. The president on Thursday also announced the Labor Department would put forward a rule directing all employers with more than 100 workers to require their staff to either be vaccinated or submit to weekly COVID-19 testing. USPS said on Friday it was still determining whether the rule would apply to the agency.

From the No Surprises Act front, HHS has issued its proposed rule implementing the Consolidated Appropriations Act 2021 Division BB provisions on air ambulance reporting, health insurer / plan broker compensation reporting and HHS enforcement of the law. Here is a link to a fact sheet on the proposal. The public comment deadline is October 18.

HHS also announced today that its “Health Resources and Services Administration (HRSA), is making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic. This funding includes $8.5 billion in American Rescue Plan (ARP) resources for providers who serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients, and an additional $17 billion for Provider Relief Fund (PRF) Phase 4 for a broad range of providers who can document revenue loss and expenses associated with the pandemic.” The American Hospital Association was pleased with the news.

Federal News Network has interviewed many current and former federal employees about their memories of September 11, 2001. Check it out as the interviews include two OPM officials. Of course, never forget.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, Federal employment benefits, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

On the Delta variant front and acccording to the CDC’s COVID Data Tracker, the United States reached two data points today — the number of COVID cases now exceeds 40 million and the percentage of Americans aged 18 and over who have received at least one dose of a COVID-19 vaccine reached 75%.

At the end of 2020, the number of cases according to the CDC stood at 20 million. In his blog, National Institutes of Health Director Francis Collins discusses a recent Nature study estimating that “the true number of [COVID] infections by the end of 2020 at more than 100 million [1]. That’s equal to just under a third of the U.S. population of 328 million. This revised number shows just how rapidly this novel coronavirus spread through the country last year. It also brings home just how timely the vaccines have been—and continue to be in 2021—to protect our nation’s health in this time of pandemic.” It also suggests to the FEHBlog that we may to closer to effective herd immunity in some areas of the U.S. than generally thought.

Also David Leonhardt in today’s New York Times tells us about another way to look at the situation.

The C.D.C. reported a terrifying fact in July: Vaccinated people with the Delta variant of the Covid virus carried roughly the same viral load in their noses and throats as unvaccinated people.

The news seemed to suggest that even the vaccinated were highly vulnerable to getting infected and passing the virus to others. Sure enough, stories about vaccinated people getting Covid — so-called breakthrough infections — were all around this summer: at a party in Provincetown, Mass.; among the Chicago Cubs; on Capitol Hill. Delta seemed as if it might be changing everything.

In recent weeks, however, more data has become available, and it suggests that the true picture is less alarming. Yes, Delta has increased the chances of getting Covid for almost everyone. But if you’re vaccinated, a Covid infection is still uncommon, and those high viral loads are not as worrisome as they initially sounded.

How small are the chances of the average vaccinated American contracting Covid? Probably about one in 5,000 per day, and even lower for people who take precautions or live in a highly vaccinated community. * * *

I will confess to one bit of hesitation about walking you through the data on breakthrough infections: It’s not clear how much we should be worrying about them. For the vaccinated, Covid resembles the flu and usually a mild one. Society does not grind to a halt over the flu.

In Britain, many people have become comfortable with the current Covid risks. The vaccines make serious illness rare in adults, and the risks to young children are so low that Britain may never recommend that most receive the vaccine. Letting the virus continue to dominate life, on the other hand, has large costs.

“There’s a feeling that finally we can breathe; we can start trying to get back what we’ve lost,” Devi Sridhar, the head of the global public health program at the University of Edinburgh, told The Times.

Well put, Mr. Leonhardt, as usual.

From the federal employee benefits front, OPM posted on the Federal Register website today a notice of changes to Federal Group Life Insurance premium rates for “Employee Basic Insurance, Option A (most age bands), Option B (most age bands), Option C (most age bands), and Post-Retirement Basic Insurance. These rates will be effective the first pay period beginning on or after October 1, 2021.”

From the tidbits department

  • Federal News Network reports that “The White House is proposing billions of dollars in supplemental funding for disaster relief and other programs, which it’s asking Congress to attach to a short-term continuing resolution that will be critical toward avoiding a government shutdown at the end of the month. ‘With the end of the fiscal year rapidly approaching, it’s clear that Congress will need to pass a short term continuing resolution to provide more time for the fiscal 2022 process to unfold,’ Shalanda Young, the Office of Management and Budget’s acting director, said Tuesday in a blog post.” 
  • Fierce Healthcare informs us that “The American Medical Association [“AMA”] released updates to its medical codes for 2022 with many tied to new technology services and the administration of COVID-19 vaccines. The AMA made 405 changes in the 2022 Current Procedural Terminology code set, including 249 new codes, 63 deletions and 93 revisions. The changes will take effect Jan. 1. ” The CPT is recognized as a HIPAA electronic transaction code set.
  • AP News reports that “Four companies in the drug industry said Saturday that enough states had agreed to a settlement of lawsuits over the opioid crisis for them to move ahead with the $26 billion deal. An announcement from the three largest U.S. drug distribution companies and a confirmation from drugmaker Johnson & Johnson, which had previously announced that it would move ahead, came Saturday. That was the deadline for the companies to decide whether there was enough buy-in to continue the settlement plan. * * * Together, the settlements are likely to represent the biggest piece of a string of settlements between companies in the drug industry and state and local governments over the addiction and overdose epidemic in the U.S.”
  • Healthcare Dive tells us that “The use of telehealth for patient visits seems to have leveled off at 20% or fewer of all appointments, more than a year and a half after COVID-19 first spurred an unprecedented jump in utilization, according to a new survey from KLAS Research and the Center for Connected Medicine.”
  • The AMA discusses “what doctors wish patients knew about a prediabetes diagnosis,” which of course is a fairly common diagnosis in our country.
  • The Wall Street Journal continues its series on the Future of Everything in healthcare with an article about sensor studded smart clothes. “From a prescription bra that signals cardiac arrest to a mosquito-proof textile, startups and scientists are developing garments for healthier living.”

Labor Day Roundup

David Ermer–COVID-19, U.S. Healthcare–
Photo by Sven Read on Unsplash

The Senate remains on a State work break while the House of Representatives will engage in limited Committee business later this week.

The FEHBlog ran across two stories which seek to answer questions which have puzzled him lately.

  • The Wall Street Journal discusses why FDA approval of a COVID-19 vaccine for children “is taking so long.” Of note, “Pfizer-BioNTech trial results for 5- to 12-year-olds could come by the end of this month, which could mean shots aren’t authorized for use until October or November, months after they were cleared for adolescents. Data for younger children could come in October. Moderna Inc. expects to seek emergency use for 6- to 12-year-olds by the end of this year, and early next year for children 6 months to less than 6 years, a company spokeswoman said.”
  • The National Institutes of Health reports on a large genomic study that “illuminates the origins of lung cancer in never-smokers.” “’What we’re seeing is that there are different subtypes of lung cancer in never smokers that have distinct molecular characteristics and evolutionary processes,’ said epidemiologist Maria Teresa Landi, M.D., Ph.D., of the Integrative Tumor Epidemiology Branch in NCI’s Division of Cancer Epidemiology and Genetics, who led the study. * * * A future direction of this research will be to study people of different ethnic backgrounds and geographic locations, and whose exposure history to lung cancer risk factors is well described. “We’re at the beginning of understanding how these tumors evolve,” Dr. Landi said. This analysis shows that there is heterogeneity, or diversity, in lung cancers in never smokers.” Stephen J. Chanock, M.D., director of NCI’s Division of Cancer Epidemiology and Genetics, noted, “We expect this detective-style investigation of genomic tumor characteristics to unlock new avenues of discovery for multiple cancer types.”

The Wall Street Journal continues its series on the future of healthcare with an article about how thanks to the pandemic routine physical exams have gained a remote aspect which will expand over time. “In five to 10 years, says Michael Blum, a cardiologist and chief digital transformation officer at University of California San Francisco, ‘I’ll be able to do the same quality of physical exam out of the office as if you were right in front of me in the office.’” More convenient for the doctor and patient no doubt but will this transition lower costs?

Friday Stats and More

David Ermer–COVID-19, COVID-19 vaccine, OPM, U.S. Healthcare, Uncategorized–

FEHBlog readers, hold onto your hats. The FEHBlog has changed the COVID-19 charts presentations which he had been using since April 11, 2020. He has broken out new weekly COVID-19 cases and deaths into completely separate charts which display only information for 2021. This allows you to appreciate the dramatic vaccination driven plunge in cases and deaths that occurred in the spring of this year and the Delta variant driven surge in cases and to a lesser extent deaths that have occurred since the beginning of July. And hopefully before long we will see a final plunge without another surge.

Here’s the usual chart of vaccinations administered and distributed on a weekly basis since mid-December 2020 through this past Wednesday, September 1.

The presentation change was prompted by the David Leonhardt column which the FEHBlog discussed mid-week and this blurb written by John Tozzi that appeared in one of the many Bloomberg emails that show up in the FEHBlog’s email box during the day.

Rewind to mid-March of last year. There was a feeling that a few weeks of sheltering at home, combined with aggressive testing, tracing and isolation, would contain the epidemic in the U.S., much as aggressive actions in China and South Korea had.

That turned out to be wrong, of course. Many experts overestimated Americans’ tolerance for mitigation measures and underestimated the virus’s stealth and persistence. Non-pharmaceutical interventions wouldn’t save us. The only way to end the pandemic was a vaccine.

This spring, with millions of shots administered each day in the U.S., there was hope that the inoculation campaign would put Covid mostly behind us — at least ending the surges that threatened to overwhelm hospitals. But again we were too optimistic about the willingness of Americans to get immunized and failed to account for the resilience of the virus and its variants. * * *

As a nation, the U.S. hasn’t put Covid behind us. The public health emergency formally declared almost 18 months ago remains in place. In its early weeks, it felt like one. Now the state of emergency feels perhaps less urgent but permanent. And that requires a cognitive shift.

But that shouldn’t mean complacency. Most Covid deaths are now preventable, and we should try to prevent them. * * * In places like the U.S., with abundant access to vaccines, we have more power than ever to shape the future course of the pandemic. The question is how we will use it. 

Very well put, Mr. Tozzi.

Also from the Delta variant front, here are a link to the CDC’s COVID-19 hospitalizations chart and a link to the CDC’s COVID Data Tracker Weekly Review which conveniently is issued on Friday afternoons.

Yesterday, the FEHBlog called attention to reports that the Food and Drug Administration wants to scale back the Administration’s COVID vaccination booster campaign set to launch on September 20, contingent upon necessary FDA and CDC approvals. The New York Times today writes at length on this matter. The FEHBlog personally has no problem with the system working.

Federal News Network reports that ‘More details are trickling out from the Biden administration about its vaccine and testing policy for federal employees and contractors. ‘Agencies should not ask federal employees to provide proof of their vaccination status, the Safer Federal Workforce Task Force said in a series of frequently asked questions updated Friday.

Here’s that new FAQ (there were several other new FAQs):

Q: Should agencies request documentation to verify an employee’s vaccination status?

A: Agencies should not request documentation to verify an employee’s vaccination status. If the agency receives a good faith allegation that strongly suggests that an employee made a false statement on the Certification of Vaccination form, the agency may request documentation as part of its investigation into the alleged false statement. If an employee who has attested to being vaccinated exhibits symptoms of COVID-19 illness, the agency should apply its safety protocols, but this is not an appropriate reason to request documentation to verify an employee’s vaccination status.

Federal News Network adds that

The administration’s latest guidance comes as the Government Managers Coalition, a group of five associations that represents federal supervisors, has asked the administration for more guidance and support to implement the new vaccine and testing policy.

“Agencies often interpret OPM guidance in different ways, as each organization views the guidance through different organizational structures and programmatic lenses and lexicons,” the coalition wrote Thursday in a letter to the Safer Federal Workforce Task Force. “This is confusing and problematic for our members who lack central, authoritative guidance.”

The coalition, which includes the Senior Executives Association, Federal Managers Association, Professional Managers Association, Federal Aviation Administration Managers Association and the National Council of Social Security Management Associations, reiterated many of the concerns they expressed to Federal News Network last week.

STAT News informs us that

The Biden administration on Friday unveiled a sweeping new biosecurity plan, outlining a $65 billion proposal to remake the nation’s pandemic preparedness infrastructure in the wake of Covid-19.

The new spending would represent one of the largest investments in public health in American history: During a press briefing, Eric Lander, the White House science adviser, likened the proposal to the Apollo program of the late 1960s.

The immense funding boost would target programs aimed at developing and manufacturing vaccines, treatments, and tests more quickly. It would also provide new money for laboratory capacity, viral detection mechanisms, and early warning systems.

Please Dr. Lander build flexibility and an appreciation of unknown factors in your plans.