ACIP Ratifies FDA Approach to COVID-19 Boosters

Congress

ACIP Ratifies FDA Approach to COVID-19 Boosters

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

In an audible triggered by yesterday’s decision, the CDC’s Advisory Committee on Immunization Practices considered at today’s meeting the FDA’s approach to COVID-19 boosters. AHIP informs us that

ACIP voted today to recommend a Pfizer-BioNTech COVID-19 vaccine booster dose for:

persons aged 65 and older and long-term care facility residents;

persons aged 50 to 64 with underlying medical conditions; and

persons based on individual benefit and risk who are aged 18 to 49 years with underlying medical conditions.

Following robust discussion about the risks and benefits of each option, ACIP ultimately voted to recommend a Pfizer vaccine booster dose, at least 6 months after the primary series, for persons aged 65 and older and long-term care facility residents (by a vote of 15-0), persons aged 50 to 64 with underlying medical conditions (13-2), and persons based on individual benefit and risk who are aged 18 to 49 years with underlying medical conditions (9-6).  

The Committee voted 9-7 against recommending a single Pfizer-BioNTech COVID-19 vaccine booster dose based on individual benefit and risk for persons aged 18-64 years who are in an occupational or institutional setting where the burden of COVID-19 infection and risk of transmission are high based on safety concerns and patient selection. 

ACIP only voted on boosters for individuals in each group who had previously received the initial series of the Pfizer vaccine; FDA indicated in its Emergency Use Authorization (EUA) that there was insufficient evidence to consider using a Pfizer booster in patients who received another vaccine in the initial series and thus it was not considered in the ACIP recommendations.

The next step in the health plan coverage process is for the CDC to ratify the ACIP decision. 15 days thereafter federal law requires health plans to cover the Pfizer-BioNTech booster in these scenarios with no member cost sharing in or out of network.

In additional news from that meeting, AHIP tells us that

ACIP also evaluated data on the COVID-19 vaccine in pregnant people and adverse outcomes associated with COVID-19 infection in this population. Data showed there is no indication that vaccines are associated with spontaneous abortion, birth defects, or stillbirths, but that pregnant people who were infected with COVID-19 exhibited increased risk of preeclampsia, preterm birth, NICU admission, and death. 

In related news, Bloomberg reports that

Pregnant women who get mRNA vaccines pass high levels of antibodies to their babies, according to a study published in American Journal of Obstetrics & Gynecology – Maternal Fetal Medicine on Wednesday.

The study — one of the first to measure antibody levels in umbilical cord blood to distinguish whether immunity is from infection or vaccines — found that 36 newborns tested at birth all had antibodies to protect against Covid-19 after their mothers were vaccinated with shots from Pfizer Inc.–BioNTech SE or Moderna Inc. 

“We didn’t anticipate that. We expected to see more variability,” said Ashley Roman, an obstetrician at NYU Langone Health System and co-author of the study.

That is certainly good news.

From the health equity front —

  • The Government Accountability Office issued a health care capsule on this topic. GAO’s “2-page “capsule” draws from several GAO reports to provide examples of these health disparities, such as COVID-19, maternal mortality, chronic health conditions, as well as disparities among veterans. We also offer policy considerations to help the federal government better understand health disparities and promote health equity.”

Healthcare Dive reports that

Only 75 of the 3,000 hospitals ranked by the Lown Institute Hospitals Index scored top marks across all the metrics meant to evaluate social responsibility: equity, value and outcomes, according to a report out Tuesday.

None of the top 20 hospitals from the U.S. News & World Report rankings made the cut to the honor roll, largely because of low grades in equity, Lown Institute said.

The report also ranked states by which had the most socially responsible hospitals. Topping the list were Hawaii, Delaware, Washington D.C., Oregon and Colorado while at the bottom were Kentucky, Kansas, Alabama, Mississippi and Arkansas.

From the human resources front

  • InsuranceNewsNet informs us that “Almost one in seven Americans has absolutely no plan for their future financial and health care needs, new research suggests. A recent study of 2,000 employed Americans found that only 26% have a one- to four-year plan in place. * * * Conducted by OnePoll on behalf of Bend Financial, the study also discovered * * * more than half felt overwhelmed by the mountain of paperwork surrounding their benefit options.”
  • To that end, OPM is seeking to improve the FEHB enrollment process, and FedSmith offers the first article of 2021 on the upcoming federal benefits open season. The 2022 government contribution should be released soon according to an OPM benefits administration letter.

On the business front, Beckers Payer Issues reports on senior management changes at Cigna and its Evernorth subsidiary. Among other changes, “Subsidiary Evernorth President and COO Eric Palmer was promoted to company CEO and president. Mr. Palmer will be taking over Jan. 1, 2022 for outgoing CEO Tim Wentworth, who is retiring.”

From Capitol Hill – –

  • Roll Call reports on Democrat efforts to cobble together the enormous $3.5 trillion budget reconciliation bill so that a House vote on the bill can be held next week. “That ambitious timeframe, if it holds, would line up the multitrillion-dollar reconciliation bill with a vote on a smaller [one trillion] bipartisan infrastructure measure that may otherwise be defeated.”
  • In better news, from the FEHBlog’s standpoint, the Wall Street Journal tells us that “House Speaker Nancy Pelosi said Congress wouldn’t let government funding expire next week, the first hint that Democratic leaders might decouple the government’s funding from a contentious increase in the debt limit, on the same day that the Biden administration began preparing for a possible partial shutdown.”

Tuesday’s Tidbits

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

From Capitol Hill, Roll Call reports that “The House passed a catchall budget package Tuesday [along party lines] that’s intended to avoid a partial government shutdown and debt limit crisis, but it seems likely to come back for a do-over once the Senate works its will.” The Republicans are objecting to combining the debt limit increase with the stop gap measure because “Treasury has said Congress needs to act sometime next month; Wrightson ICAP, a private investment advisory firm, said this week the drop-dead deadline was likely Oct. 25 or 26.”  

Here’s a stunner for you from the Roll Call article:

The bill includes language to temporarily extend how fentanyl — a highly potent opioid — is classified. Fentanyl is responsible for a lion’s share of drug overdose deaths, which have been on the rise during the COVID-19 pandemic. The bill would extend fentanyl’s status as a so-called “Schedule 1” drug until Jan. 28, 2022. Under current law, the drug would lose its status as a drug with a high risk for abuse on Oct. 22. 

From the Delta variant front —

  • According to the American Hospital Association, “Johnson & Johnson today said its phase 3 trial data confirms its vaccine’s durability and provided evidence of a second, booster shot’s effectiveness against COVID-19. The drug maker said that, over the course of its ongoing phase 3 trial, it found no evidence of the vaccine’s reduced effectiveness, which J&J said is 79% for preventing COVID-19-related infections and 81% for preventing COVID-19-related hospitalizations. J&J furthermore found that a booster shot administered 56 days after an initial dose provided 100% protection against severe/critical COVID-19 for at least 14 days post-final vaccination and 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. Additionally, boosters resulted in antibody levels four to six times higher than those netted from a single dose.”
  • David Leonhardt in the New York Times understandably criticized federal agencies for dropping the ball on production of rapid COVID tests. “Other countries are awash in Covid tests. The U.S. is not.”

Stefanie Friedhoff, a professor at Brown University’s School of Public Health, recently returned from a visit to Germany and wrote on Twitter about the many benefits of rapid testing that she had seen. A friend’s husband has Parkinson’s disease, and the friend leaves a batch of tests in her hallway for people to take before they enter the home. The day care center where Friedhoff’s sister works has stayed open throughout the pandemic, because the staff and children take frequent tests.

“Imagine what ubiquitous cheap testing could do in the U.S.,” Friedhoff wrote. “It is incomprehensible how the U.S. has failed on testing.”

  • The FEHBlog recalls writing last year at this time about the importance of a vaccine, rapid testing, and a treatment for recently symptomatic people in order to bring the pandemic to a close. We should be grateful for the vaccines but we wouldn’t be in this much of a fix if we also had rapid testing and earlier treatment options.

The American Hospital Association also reports that

U.S. hospitals will lose an estimated $54 billion in net income this year, even after federal relief funds, as higher labor and other expenses and sicker patients impact their financial health during the ongoing COVID-19 pandemic, according to a report by Kaufman, Hall & Associates released today by the AHA. More than a third of hospitals are expected to end 2021 with negative margins. 

“With cases and hospitalizations at elevated levels again due to the rapid spread of the Delta variant, physicians, nurses and other hospital caregivers and personnel are working tirelessly to care for COVID-19 patients and all others who need care,” said AHA President and CEO Rick Pollack. “At the same time, hospitals are experiencing profound headwinds that will continue throughout the rest of 2021.”

From the Rx front

  • Medcity News reports that “The FDA has approved the first biosimilar that references the blockbuster Roche drug Lucentis. The Biogen and Samsung BioLogics joint venture that developed the biologic product have approval to treat three eye conditions that lead to vision loss.” Bravo.

From the tidbits department

Infants who seemed headed for autism spectrum disorder (ASD) had milder symptoms as toddlers if their caregivers were subject to a social communication intervention when infants were just 1 year of age, a randomized clinical trial found.

Infants whose families participated in the intervention exhibited significantly milder ASD symptoms 12 months later compared to those in the control group. They also had lower odds of being diagnosed with ASD by an independent clinician at age 3 years (6.7% vs 20.5%, OR 0.18, 95% CI 0.00-0.68), according to the study group led by Andrew Whitehouse, PhD, of the University of Western Australia.

Non-career employees at the U.S. Postal Service are significantly more likely to get injured on the job and leave their positions than employees with a permanent status, according to a Sept. 16 Government Accountability Office report.

Employees without permanent status at USPS receive lower pay and fewer benefits than their career counterparts, often under the assumption that they will have a path to a career position in the future. But according to GAO, those non-career employees, of which there are more than 200,000 across the U.S., had 50 percent higher rates of injury than career positions and reported the incidents to the Federal Employees’ Compensation Program 43 percent more often.

  • Fierce Healthcare tells us that

Humana leads the industry on customer experience scores and is the only major national payer to land above the industry average, according to a new report from analysts at Forrester.

Forrester polled members of 17 of the largest health plans in the country and found an industry average score of 70.2 on a 100-point scale, which the organization categorizes as an “OK” rating. In 2020, payers averaged 67.5 points, according to the report.

At the top of the list, Humana earned a 74.8 score, dethroning 2020’s top health plan, Florida Blue, which fell to fourth place with a 71.9. Kaiser Permanente’s health plan landed in the second-place slot with a 73.8 score, and Highmark placed third, earning a 72.9.

Rounding out the top five is Blue Cross Blue Shield of Michigan, which rose from a 10th-place ranking in 2020’s report, Forrester found.

Congrats, Humana and the other high scorers.

Monday Roundup

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

The Hill provides us with the latest on everything that is currently on Congress’s full plate of issues.

From the Delta variant front, the New York Times reports that

The Pfizer-BioNTech coronavirus vaccine has been shown to be safe and highly effective in young children aged 5 to 11 years, the companies announced early Monday morning.

Pfizer and BioNTech plan to apply to the Food and Drug Administration by the end of September for authorization to use the vaccine in these children. If the regulatory review goes as smoothly as it did for older children and adults — it took roughly a month — millions of elementary school students could begin to receive shots around Halloween.

Trial results for children younger than 5 are not expected till the fourth quarter of this year at the earliest, according to Dr. Bill Gruber, a senior vice president at Pfizer and a pediatrician. Results from Moderna’s vaccine trials in children under 12 are also expected around that time, said Dr. Paul Burton, the company’s chief medical officer.

From the M&A front, HCA Healthcare, one of the largest healthcare systems in the U.S., announced this evening that

the signing of a definitive agreement for HCA Healthcare to acquire the operations of Steward Health Care’s five Utah hospitals. HCA Healthcare also entered into an agreement to lease the related real estate from its owner following the expected closing. The hospitals will become part of HCA Healthcare’s Mountain Division, which includes 11 hospitals in Utah, Idaho and Alaska. * * *

Steward Health Care also operates hospitals in Arizona, Texas, Arkansas, Louisiana, Florida, Ohio, Pennsylvania, and Massachusetts. The sale of these facilities to HCA Healthcare will enhance Steward Health Care’s ability to continue growing and reinvesting in other states and locations served by the health system.

Evidently HCA plans to give Intermountain some competition in Utah.

Employee Benefit News offers expert opinions on the pros and cons of healthcare savings account which can only be funded when the individual is enrolled in a high deductible health plan.

From the human resources front

  • The Federal Times informs us that “‘The Office of Personnel Management will temporarily drop several geographic restrictions associated with special hiring authorities for military spouses, according to a regulation published in the Federal Register Sept. 20. * * * ‘It removes limitations — such as a relocation requirement, geographic restrictions, and arbitrary quotas — which caused this authority to be underused until now,’ wrote Rob Shriver, associate director of employee services at OPM, in a Medium blog post. ‘As a result, this new regulation means more military spouses can find their place in the federal workforce, and federal agencies have a larger talent pool of highly-qualified people to hire from.'” The FEHBlog was not aware that OPM has a Medium website.
  • HR Dive reports on the recent Society for Human Resources Management annual conference. The article focuses on a give and take between EEOC commissioners and attendees about vaccination mandates and EEO-1 reporting among other issues.

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.”

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.”

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.

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.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Congress, COVID-19, COVID-19 vaccine, Patient safety, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Delta variant front —

Medscape reports on yesterday’s CDC Advisory Committee on Immunization Practices meeting:

“Vaccines remain effective in preventing hospitalization and severe disease but might be less effective in preventing infection or milder symptomatic illness,” Sara Oliver, MD, the CDC scientist who presented the information [about the mRNA vaccines], told the committee.

In a new data analysis released by the CDC on Sunday, unvaccinated adults were 17 times more likely to be hospitalized than vaccinated adults. Hospitalization rates were higher for unvaccinated people in all age groups.

Among the fully vaccinated, people who were hospitalized were much older, more likely to be nursing home residents and more likely to have three or more underlying medical conditions. Nearly a third had immunosuppressive conditions.

Healthcare Dive tells us that

The U.S. government will resume distribution of Eli Lilly’s COVID-19 antibody drug combination in a number of states, HHS said Friday, as cases and hospitalizations in the U.S. are driven higher by the spread of the delta variant.The decision comes roughly two months after administration of Lilly’s therapy was halted by U.S. officials due to concerns of reduced efficacy against coronavirus infections stemming from the beta and gamma variants. Those are now much less prevalent compared with delta, which laboratory testing has shown remains susceptible to treatment with the dual-antibody therapy, HHS said.

Fierce Pharma reports that

Last week’s FDA approval of Pfizer’s Comirnaty vaccine boosted consumer confidence among both vaccinated and unvaccinated people.

A Harris Poll survey over the weekend found that 80% of Americans who were aware of the approval now have more confidence in it. Even more encouraging? Almost half (49%) of unvaccinated people who heard about the approval said they will “probably” or “definitely” get vaccinated.

Overall awareness of the Pfizer approval was high—79% of those surveyed by The Harris Poll were aware of the FDA thumbs-up.

From the telehealth front, Kaiser Health News discusses re-emerging state law barriers to telehealth. “’The whole challenge is to ensure maximum access to health while assuring quality,’said Barak Richman, a Duke University law professor, who said laws and policies haven’t been updated to reflect new technological realities partly because state boards want to hang onto their authority.” The article provides an overview of options available to doctors and state boards.

From the miscellany front

  • Beckers Hospital Review unveils six big ideas in health innovation. For example, Jason Joseph. Senior Vice President and Chief Digital and Information Officer at Spectrum Health (Grand Rapids, Mich.). As we innovate, we are forcing hidden barriers into the light via experimentation. We saw so many of these barriers uncovered within health care, such as lack of connectivity, digital competency, and the need for comprehensive managed workflow. We have shined a spotlight on how much of healthcare relies on people and inconsistent manual processes to get through the system. That needs to change, and that also requires changing a leader’s traditional mindset.
  • The Agency for Healthcare Quality and Research is offering a toolkit to help healthcare providers and possible health plans get patients and members engaged with the diagnosis process.

The toolkit contains two strategies, Be The Expert On You and 60 Seconds To Improve Diagnostic Safety. When paired together, these strategies enhance communication and information sharing within the patient-provider encounter to improve diagnostic safety. Each strategy contains practical materials to support adoption of the strategy within office-based practices.

Be The Expert On You is a patient-facing strategy that prepares patients and their families to tell their personal health stories in a clear, concise way. Research suggests that 79 percent of diagnostic errors are related to the patient-clinician encounter and up to 56 percent of these errors are related to miscommunication during the encounter. Environmental scan findings show that inviting patients to share their entire health story, uninterrupted, and in a way that gives clinicians the information they need can reduce diagnostic errors.

60 Seconds To Improve Diagnostic Safety prepares providers to practice deep and reflective listening for one minute at the start of a patient-encounter. Research suggests that patients are interrupted by their providers in the first 11 to 18 seconds of telling their diagnostic story. Diagnostic safety can be improved when a provider allows a patient to tell his or her health story without interruption for one minute, and then asks questions to deepen understanding.

  • Not every innovative idea makes sense to implement though. The President and Democrat leadership in Congress want the Centers for Medicare Services to “negotiate” drug prices for Medicare Part D plans. Regulatory Focus informs us that “A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.”

Tuesday’s Tidbits

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

From Capitol Hill, Roll Call reports that the House Speaker Nancy Pelosi negotiated a Democrat legislative victory when the House narrowly approved a rule adopting the $3.5 trillion budget blueprint and agreeing to hold a floor vote on the Senate’s bipartisan, $1 trillion infrastructure bill no later than September 27, 2021.

Leadership is hoping to have the reconciliation package, which committees have a Sept. 15 deadline to assemble, ready for floor action around the same time as the infrastructure bill with the goal of passing both by the end of September, House Majority Leader Steny H. Hoyer told reporters on a press call Tuesday afternoon.

How soon the reconciliation package is ready “will dictate to some degree the flow of legislation,” the Maryland Democrat said. “We have not got a hard view on sequencing.”

Federal News Network informs us about three items for federal employees to watch in the bipartisan infrastructure bill.

From the Delta variant front, the American Hospital Association tells us

The Centers for Disease Control and Prevention today released research highlighting two important trends emerging from the COVID-19 pandemic regarding vaccines’ current effectiveness. The first, which looked at breakthrough infections among fully vaccinated front-line health care workers, found that, following the emergence of the SARS-CoV-2 delta variant, there has been a moderate reduction in the effectiveness of COVID-19 vaccines in preventing infection in this group. However, the authors note that “this trend should be interpreted with caution because [vaccine efficacy] might also be declining as time since vaccination increases and because of poor precision in estimates due to limited number of weeks of observation and few infections among participants.” Additionally, the CDC notes that even a sustained two-thirds reduction in infection risk underscores COVID-19 vaccinations’ continued importance and benefits in preventing deaths, hospitalizations and the virus’ spread. 

The second study reviewed SARS-CoV-2 infections in Los Angeles County over the course of nearly three months, starting in May 2021. Researchers found that approximately three out of four cases were among unvaccinated individuals. Additionally, infection and hospitalization rates among unvaccinated persons were 4.9 and 29.2 times more likely, respectively, than those in fully vaccinated persons, with little change when the delta variant took root as the nation’s dominant virus strain.

The Society for Human Resource Management discusses what the FDA’s full approval for the Pfizer vaccine means for employer COVID-19 policies.

The Wall Street Journal informs us that

Johnson & Johnson said [over Tuesday night] that a second dose of its [one dose] Covid-19 vaccine was found in a study to generate a strong immune response, justifying a booster shot after eight months. * * * J&J said researchers found antibody levels increased ninefold among people who received a second dose of its vaccine, compared with one month after they received a first dose. * * *

“We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson Covid-19 vaccine, boosting eight months or longer after the primary single-dose vaccination,” [said] Dr. Mathai Mammen, global head of R&D at Janssen Pharmaceutical Cos. of Johnson & Johnson.

The Biden administration said last week that people ages 18 and older who got the Covid-19 vaccines from Pfizer Inc. or Moderna Inc. should get an extra dose eight months later, reflecting heightened concern over the highly contagious Delta variant and data showing initial immunity to Covid-19 diminishes over time. J&J’s suggested timeline would be in sync with that broader strategy.

Currently boosters are only authorized for immunocompromised people who received two-dose messenger-RNA vaccines. The Food and Drug Administration must authorize extra doses before they can be offered more broadly as recommended by the Biden administration to those 18 and older who received two-dose messenger-RNA vaccines, and it is expected to do so before Sept. 20, when health authorities said messenger-RNA boosters would become available

The CDC’s expert advisory panel on vaccines will meet next week to discuss the Biden administration’s plans for booster shots.

According to the CDC’s website, this virtual ACIP meeting will be held on August 30 and 31.

Finally STAT News reports that

The age at which adults who are overweight or obese should be screened for type 2 diabetes is going down while the prevalence of both forms of the disease is going up among children and adolescents — two developments reported Tuesday that signal a growing burden of these chronic health conditions among Americans.

The U.S. Preventive Services Task Force lowered its recommended age to 35 — down from 40 in its 2015 guidance — to test people with above-normal BMIs for elevated glucose levels that could mean prediabetes or diabetes itself. The new evidence review and recommendations, published in the Journal of the American Medical Association, would make more than 40% of adults eligible for screening, and an estimated one-third will likely meet USPSTF criteria to undertake preventive steps.