Friday Factoids

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us, “The Office of Personnel Management on Friday proposed new regulations aimed at granting federal agencies greater flexibility in selecting new federal employees during the hiring process.” The public comment deadline is September 19, 2023.
  • Federal News Network offers a table of federal government return-to-office policies.
  • The Society for Human Resource Management informs us,
    • “The U.S. Citizenship and Immigration Services (USCIS) announced Friday a new Form I-9—which has been streamlined and shortened—that employers should use beginning Aug. 1, 2023.
    • “Employers may continue to use the older Form I-9 (Rev. 10/21/19)  through Oct. 31., 2023. After that date, they will be subject to penalties if they use the older form. The new version will not be available for downloading until Aug. 1.  
    • “Additionally, the U.S. Department of Homeland Security (DHS) issued a final rule that allows the agency to create a framework under which employers could implement alternative document examination procedures, such as remote document examination. The new form subsequently has a checkbox to indicate when an employee’s Form I-9 documentation was examined using a DHS-authorized alternative procedure.
    • “At this time, the final rule only allows employers using E-Verify to use alternative verification methods.”
  • Healthcare Dive notes
    • “The Federal Trade Commission and the HHS’ Office for Civil Rights are warning hospitals and telehealth companies about embedding online tracking technologies on their websites or apps, saying the trackers risk exposing consumers’ personal health data to third parties. 
    • “The trackers, like the Meta Pixel or Google Analytics, collect identifiable information about users and could reveal information about health conditions, diagnoses, treatments, frequency of visits and more, the agencies wrote in a letter to about 130 health systems and telehealth providers.
    • “The warning marks the latest move from regulators regarding the healthcare industry’s use of tracking technologies, which monitor user behavior on websites. Sharing consumers’ health data with third parties, like advertisers, has been a recent target of FTC oversight.”

Following up on the tornado that struck a Pfizer factory in Rocky Mount, NC, STAT News reports

  • “Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines.
  • “The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel. As a result, it remains unclear about the extent to which destruction at the facility — which produces nearly 8% of all sterile injectables used in U.S. hospitals — will exacerbate a growing shortage of prescription drugs across the country.”

The Food and Drug Administration also issued a report on the incident.

From the medical malpractice front, STAT News points out

  • “A new study published this week in BMJ, * * * estimates that “371,000 people die every year following a misdiagnosis, and 424,000 are permanently disabled — a total of 800,000 people suffering “serious harm,” said David Newman-Toker, the lead author of the paper and a professor of neurology at Johns Hopkins School of Medicine and director of its Center for Diagnostic Excellence. Settling on an exact number is hard because many cases of misdiagnosis go undetected, he said. It could be fewer than his study identified or more — between half a million and a million — though in any event, it would be the most common cause of death or disability due to medical malpractice. 
  • “He likens the issue of misdiagnosis to an iceberg, saying cases leading to death and disability are but a small fraction of the problem. “We focused here on the serious harms, but the number of diagnostic errors that happen out there in the U.S. each year is probably somewhere on the order of magnitude of 50 to 100 million,” he said. “If you actually look, you see it’s happening all the time.” 
  • “But misdiagnoses typically don’t lead to severe consequences because, most times, people aren’t visiting the doctor with a serious condition. “The risk level just walking through the door in the doctor’s office that something horrible is going to happen to you because of a diagnostic error is actually quite low,” said Newman-Toker.”

In related news “[The American Hospital Association] AHA today released its quarterly Health Care Plan Accountability Update, featuring the latest news on AHA efforts to hold commercial health insurers accountable for policies that can delay care for patients, burden health care providers and add unnecessary costs to the health care system. READ MORE.”

From the factoid front —

  • HealthEquity suggests three ways to drive health savings account plan adoption.
  • Beckers Payer Issues points out how seven payers are using artificial intelligence.
  • MedTech Dive reports, “Intuitive Surgical posted strong robotic volume growth in the second quarter and raised its full-year procedure outlook but said patient interest in new weight-loss drugs is curbing demand for bariatric surgeries.”

Midweek update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From our Nation’s capital —

  • STAT News reports
    • “Senators are slightly delaying their latest legislative push on health care, but as they do, a clearer picture is emerging about what’s in — and out — of the mix.
    • “The Senate health committee was expected to mark up legislation related to generic drugs, pharmacy benefit managers, and some leftovers from the Food and Drug Administration’s user fee agreements next week, but leaders are planning to reschedule the meeting, several sources told STAT.
    • “But 17 health care industry lobbyists and Senate staffers said Democratic leadership is targeting relatively low-hanging fruit that is bipartisan, and already has established history in legislation [i.e., a $35 copay on insulin in the commercial market]”.
  • Beckers Payer Issues tells us that “the Justice Department has decided to seek a stay pending appeal of a Texas federal judge’s ruling that struck down an ACA provision requiring insurance companies to provide coverage for preventive services, CNN reported April 11.”
  • The Department of Health and Human Services proposed a HIPAA privacy rule change “to strengthen its protections by prohibiting the use or disclosure of protected health information (PHI) to investigate, or prosecute patients, providers, and others involved in the provision of legal reproductive health care, including abortion care.” The public comment period will end sixty days after April 17, 2023, the day on which the proposed rule will be published in the Federal Register.

From the public health front —

  • MedPage Today informs us
    • Fentanyl adulterated with xylazine is an “emerging drug threat” in the U.S. and requires immediate action, the Biden administration warned.
    • “This is the first time in a nation’s history that a substance is being designated as an emerging threat by any administration,” said Rahul Gupta, MD, director of the White House Office of National Drug Control Policy (ONDCP), during a phone call with reporters late Tuesday afternoon. “And it couldn’t come at a more critical time.”
  • ABC News reports
    • The number of sexually transmitted infections (STIs) in the United States shows “no signs of slowing,” new federal data shows.
    • A total of 2.53 million cases of chlamydia, gonorrhea and syphilis were recorded in 2021, according to a new report published Tuesday from the Centers for Disease Control and Prevention.
    • That’s a 5.8% increase from the 2.39 million cases reported in 2020 and a 7% increase from five years ago when 2.37 million STIs were recorded in 2017.
    • “I’d like people to understand that this data actually impacts them whether they think it does or not and it’s because STIs happen to everyone, regardless of socioeconomic, religious, political lifestyle,” Dr. Kameelah Phillips, an OBGYN in New York City, told ABC News. “I’d like them to really understand that routine testing at their health care office is super important … gonorrhea doesn’t care who you are.”
    • While certain STIs did not reach pre-pandemic levels, others — such as syphilis — are recording the highest numbers seen in more than 70 years.

From the mental healthcare front —

  • Benefits Pro highlights a survey finding that
    • 21% of workers at ‘high mental health risk’ and unaware of available [employer sponsored] counseling.
    • Employees often do not know the range of resources available to them in their benefits packages and are often unaware of counseling included in the company’s employee assistance program, according to a TELUS survey.

Federal agencies and the Postal Service sponsor EAPs, but the FEHBlog is unaware of OPM creating a connection between those programs and the FEHBP.

From the Rx coverage front —

  • Drug Channels offers a report on specialty pharmacies which informs us that “Drug Channels Institute (DCI) estimates that in 2022, retail, mail, long-term care, and specialty pharmacies dispensed about $216 billion in specialty pharmaceuticals prescriptions. That’s an increase of 12% from the 2021 figure.”  
  • The Institute for Clinical and Economic Research released
    • Protocol outlining how we will conduct our third annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies, and
    • Draft Evidence Report assessing the comparative clinical effectiveness and value of exagamglogene autotemcel (“exa-cel”, Vertex Pharmaceuticals and CRISPR Therapeutics) and lovotibeglogene autotemcel (“lovo-cel”, bluebird bio) for sickle cell disease.  The draft report represents the midpoint in ICER’s eight month long review process.

From the medical research developments front

  • STAT News reports, “A Parkinson’s ‘game changer,’ backed by Michael J. Fox, could lead to new diagnostics and, someday, treatments.” It’s a heartening medical research story about Mr. Fox’s productive efforts.
  • Medscape reports
    • Phototherapy is a safe, effective, noninvasive, and inexpensive way of boosting cognition for patients with dementia, new research suggests. It may be “one of the most promising interventions for improving core symptoms” of the disease.
    • A new meta-analysis shows that patients with dementia who received phototherapy experienced significant cognitive improvement compared to those who received usual treatment. However, there were no differences between study groups in terms of improved depression, agitation, or sleep problems.

Friday Stats and More

From the Centers for Disease Control’s Covid data tracker and its weekly interpretative summary of its Covid statistics:

  • New Cases totaled 455.556 this week, down 2.7% from last week.
  • Variants BQ.1.1 and BQ.1 are estimated to represent 78% of Covid / Omicron cases
  • New Hospitalizations averaged 5,010 this week, up 2.3% from last week.
  • New Deaths totaled 2,703, down 13.2% from last week.
  • “As of December 14, 2022, 660.4 million vaccine doses have been administered in the United States. About 228.8 million people, or 68.9% of the U.S. population, have completed a primary series.* More than 44.2 million people, or 14.1% of the U.S. population ages 5 years and older, have received an updated (bivalent) booster dose.”

The CDC reports good news about the efficacy of the bivalent booster here and here.

Pfizer announced the sale $2 billion worth of Paxlovid pills (3.7 million courses) to the federal government and its ongoing research on developing combined mRNA Covid and flu vaccine.

From CDC’s Fluview — “Seasonal influenza activity remains high but appears to be declining in some areas.”

Health Affairs brings us up to date on mpox.

Looking forward, Healthcare Dive reports

  • Leaders at hospitals and health systems across the country are anticipating a potentially turbulent operating environment in the coming year, according to a survey from Deloitte.
  • Among health system leaders, 85% said staffing challenges would have a major impact on their 2023 strategy and 76% said inflation is a significant factor. Other expected headwinds include affordability issues for patients, shrinking margins and continual supply chain disruptions.
  • Deloitte also polled health plan executives and found they face challenges related to inflation and a tight labor market, though are generally in a better financial position than hospitals and health systems.

Speaking of hospitals, Fierce Healthcare informs us

The care given in emergency departments came under fire yesterday with the release of a government study saying that 250,000 Americans die every year due to misdiagnoses.

The findings spurred an immediate response from the president of the American College of Emergency Physicians (ACEP), who questions the study’s veracity and methodology.

Christopher S. Kang, M.D., president of the ACEP, said in a statement that “in addition to making misleading, incomplete and erroneous conclusions from the literature reviewed, the report conveys a tone that inaccurately characterizes and unnecessarily disparages the practice of emergency medicine in the United States.”

One of the authors of the study—David Newman-Toker, M.D., Ph.D., a neurologist at Johns Hopkins University—vehemently defends the methodology and told Fierce Healthcare that “high levels of variation in care (across conditions, across hospitals, across demographic groups) tells us that these errors do not need to be thought of as ‘the price of doing business.’ It tells us that there are already probably ways to get it right.”

The study, conducted by Johns Hopkins for the Agency for Healthcare Research and Quality, states that among 130 million ED visits in the U.S. per year, 7.4 million patients are misdiagnosed. In addition, 2.6 million suffer an adverse event, and about 370,000 suffer serious harm from diagnostic errors.

The teenage daughter of CNN reporter Jake Tapper writes in CNN about her frightening ER experience. The FEHBlog joined his wife at a Dripping Springs TX knitting store holiday event. He mentioned the Alice Tapper story to two nurses who were horrified. In the FEHBlog experience, nurses are the best judge of hospital care across facilities.

In HIPAA news, the American Hospital Association tells us

The Department of Health and Human Services yesterday proposed a standard format for attachments to support electronic health care claims and prior authorization transactions under the Health Insurance Portability and Accountability Act. The standard would apply to all health plans, health care clearinghouses, and providers, who currently lack an efficient and uniform method of sending attachments, which can lead to provider burnout, slow down processing and delay payments or patient care.

“The AHA supports establishing a standard for attachments to reduce the administrative burdens facing clinicians, and we look forward to providing robust commentary after analyzing the rule’s specifics,” said Terrence Cunningham, AHA’s director of administrative simplification policy.

Comments on the rule are due March 21. 

Monday Roundup

Photo by Sven Read on Unsplash

From the Federal Employee Benefits Open Season front, Federal News Network is offering a free e-book on this timely topic.

Fierce Healthcare adds

When many people are looking to enroll in health benefits, they turn to Google as a source of key information on eligibility, the application process and in-network providers.

In this spirit, the Google Search team has quietly rolled out multiple features for its search engine that aim to make it easier for users to access key information about obtaining Medicaid and Medicare benefits, as well as which doctors locally accept those types of coverage.

The article offers more details on these new Google tools.

From the Omicron and siblings front

  • Beckers Hospital Review informs us “The CDC has begun tracking omicron subvariant XBB, which is now estimated to account for 3.1 percent of U.S. cases”[, somewhat higher in New York, New Jersey and New England states]. * * * Health experts anticipate the U.S. will see an increase in COVID-19 cases in the winter months as a collection of omicron subvariants circulates, though they have remained optimistic it will be less severe than last winter’s omicron surge.”
  • The National Institutes of Health discusses its research on the ability of the human body’s immune system to remember a previous Covid infection or vaccination to help ward off, or minimize symptoms during, a future infection.
  • Fierce Healthcare reports “The U.S. came in dead last compared to 20 other countries when it came to preventing deaths from COVID-19 as well as all-cause deaths, and it appears that relatively low vaccination rates might have played a part in those poor showings, a new study finds. * * * The U.S. continued to experience significantly higher COVID-19 and excess all-cause mortality compared with peer countries during 2021 and early 2022, a difference accounting for 150,000 to 470,000 deaths,” authors of the research letter published in JAMA Network wrote. ‘This difference was muted in the 10 states with highest vaccination coverage; remaining gaps may be explained by greater vaccination uptake in peer countries, better vaccination targeting to older age groups, and differences in health and social infrastructure.’”

From the public health front

  • Axios tells us “The RSV season normally runs from December to April, peaking in February and March, but this year has seen an earlier onset. [Dr.] Fauci noted that both the RSV and flu seasons have arrived earlier than usual this year.  Asked by [Meet the Press host Margaret] Brennan whether the U.S. is “in the worst of it” right now, Fauci replied, “I hope so.”
  • The American Hospital Association relates “The World Health Organization today recommended a new name for monkeypox that is intended to mitigate a rise in related racist and stigmatizing language associated with the ailment. The WHO’s newly recommended preferred term is “mpox.” The organization recommends a one-year transition period to mitigate confusion that could be caused by the change and allow for ICD and publication updates. The Biden administration voiced its support for the change, stating, ‘We welcome the change by the World Health Organization. We must do all we can to break down barriers to public health, and reducing stigma associated with disease is one critical step in our work to end mpox.’” The FEHBlog also will begin to refer to chickenpox as cpox.

From the regulatory front, MedPage Today informs us

In an effort to enhance care coordination for patients with substance use disorder (SUD), HHS, acting through its Office for Civil Rights and in collaboration with the Substance Abuse and Mental Health Services Administration, proposed changes to “Part 2” rules to better align privacy measures with those of HIPAA on Monday.

If implemented, the proposed rule would allow Part 2 programs to use and share patients’ records following a single signed consent by the patient “for all future uses and disclosures for treatment, payment, and healthcare operations.”

The proposal also aims to strengthen protections around disclosure of SUD treatment records to guard against discrimination and stigma.

The changes were initially called for in the CARES Act of 2020, provisions of which required the HHS secretary to better align the 42 CFR part 2 rule, better known as “Part 2,” with HIPAA’s Privacy, Security, Breach Notification, and Enforcement Rules.

“This proposed rule would improve coordination of care for patients receiving treatment while strengthening critical privacy protections to help ensure individuals do not forego life-saving care due to concerns about records disclosure,” said HHS Secretary Xavier Becerra in a press release.

HHS adds

From the medical research front, we learn from STAT News that

A drug developed by Axsome Therapeutics significantly reduced a common side effect of Alzheimer’s disease — agitation — the company announced Monday.

The therapy, AXS-05, met its primary goal of delaying time to relapse and preventing patients from relapsing. Patients taking the drug had a 3.6-fold lower risk of relapse overall, compared to placebo.

People with Alzheimer’s disease can get restless, upset, or even aggressive as the disease gets worse. Axsome’s trial also showed an improvement on a scale commonly used to measure overall agitation.

* * *

The Food and Drug Administration has granted Axsome breakthrough therapy status for AXS-05 in Alzheimer’s agitation, which could help the company secure an accelerated, additional approval. Company officials said they plan to wait to see data from another Phase 3 trial called ADVANCE-2 before filing a drug application, according to a third-quarter earnings call transcript from Sentieo.


Dr. Thomas Perls has for decades studied so-called super agers, people who live deep into their 90s and beyond, essentially unburdened by the typical diseases of old age. He is convinced that the secret to this remarkable longevity is buried in people’s genes and passed down through generations.

But which genes harbor this power? And if researchers pinpoint the right genes amid thousands in a person’s body, could that knowledge be harnessed to develop drugs that mimic those genes and allow more people to enjoy longer, healthier lives?

That’s the premise behind an ambitious new trial, the SuperAgers Family Study, ( that aims to enroll 10,000 people who are 95 years old or older and their children.

From the benefit design front, Beckers Payer Issues offers more insights from a recent AHIP study of prior authorization practices:

Gold-card programs give providers exemptions from certain prior authorization requirements, but providers who have discontinued these programs have found them administratively difficult to implement, according to a Nov. 14 America’s Health Insurance Plans survey.  * * *

Here are the top three reasons insurers said they discontinued gold card programs, according to the report:

1. Administratively difficult to implement: 75 percent

2. Reduced quality/patient safety: 50 percent 

3. Higher costs without improved quality: 25 percent

From the healthcare business front, Healthcare Dive reports

[Telehealth vendor] Amwell is in advanced discussions to acquire online therapy app Talkspace for roughly $200 million, according to a report from Israeli business publication Calcalist.

The telemedicine company is in talks to pay $1.50 per share for Talkspace, Calcalist reported on Sunday. The price tag would represent a 150% premium over Talkspace’s share price at Friday’s close.

The reported transaction reflects a sharp decline in Talkspace’s value since the therapy company went public last summer at a $1.4 billion valuation.

Tuesday’s Tidbits

Photo by Patrick Fore on Unsplash

From the Federal Employee Benefits Open Season front, FedSmith provides advice to federal and postal employees and FedWeek provides guidance to all interested parties.

In the Federal Times, Reg Jones answers a reader’s question about whether an annuitant can suspend their FEHBP coverage.

From the Omicron and flu front –

MedPage Today expresses expert views that developing vaccines that prevent the spread of Covid require human challenge trials in which fully informed, vaccinated people are exposed to Omicron.

[M]any experts agree: we need new vaccines to limit the spread of the virus. The current generation of vaccines offers strong protection against serious illness and death, but their edge has dulled against new variants, and they do not always prevent infection and transmission of the virus.

The White House hosted a summit on the issue in July, showcasing the myriad ways researchers are going about developing new vaccines. There are hundreds of candidates in early stages around the world, but the resources devoted to COVID-19 vaccine research are a fraction of what they were 2 years ago. Human challenge trials can greatly speed the selection of the most promising in this field of candidates, providing scientific and economic benefits over uniform reliance on large field studies.

Time will tell.

The Wall Street Journal provides a background story of this year’s flu that compares the spread of the flu vs. the spread of Covid.

How contagious is flu?

Covid-19 is more contagious than influenza, doctors say. One reason is that most people have had flu multiple times and many have gotten multiple flu shots over the years. 

The most common calculation of a virus’s infectiousness is a measure called the R0 (pronounced “R naught”). This metric estimates how many people one contagious person will infect on average. The R0 of influenza is between one and two. R0 data for Covid-19 isn’t definitive, especially as the virus continues to mutate, but studies indicate the number for many Covid strains is higher than for flu. 

From the tidbits department

  • Healthcare Dive offers “five takeaways from the FDA’s list of AI-enabled medical devices. As the number of devices increases, the agency is looking to adapt its regulatory framework to the new technology, including faster approval of algorithm updates.”
  • The Patient-Centered Outcomes Research Institute (PCORI), which the Affordable Care Act requires health insurers and plans to fund, shares its strategic plan.
  • The Segal Company helpfully reminds cafeteria plan sponsors that “As part of COVID-19 relief, the Consolidated Appropriations Act, 2021 (CAA) permitted plan sponsors to immediately implement certain mid-year changes to their cafeteria plans during the 2020 and/or 2021 plan years without first having to adopt plan amendments. Employers that implemented such relief are required to adopt certain retroactive plan amendments by December 31, 2022.”
  • The Centers for Disease Control calls attention to its U.S. Diabetes Surveillance System website. Check it out.
  • Beckers Hospital Review lists the ten most expensive States for healthcare. The only state with a top 10 population included on Becker’s list is Florida.

Midweek Update

From Capitol Hill, Fierce Healthcare tells us

The House unanimously passed the Improving Seniors’ Timely Access to Care Act on Wednesday via a voice vote. The legislation, which has new transparency requirements for MA plans, now heads to the Senate.

Lawmakers behind the legislation said in a joint statement the bill will “make it easier for seniors to get the care they need by cutting unnecessary red tape in the healthcare system,” said Reps. Suzan DelBene, D-Washington, Mike Kelly, R-Pennsylvania, Ami Bera, M.D., D-California, and Larry Bucshon, M.D., R-Indiana.

It’s worth noting that traditional Medicare has no prior authorization requirements. Beckers Payer Issues adds

Enrollees in Medicare Advantage were less likely to receive low-value care than those enrolled in traditional Medicare, a new study published in JAMA Open Network found

The study, published Sept. 9, found Medicare Advantage enrollees received 9.2 percent fewer low-value services than their counterparts using traditional Medicare. 

Low-value care is services that provide little clinical benefit or cause more harm than benefits for a patient. 

The study’s authors, lead by researchers from Humana and Boston-based Tufts University School of Medicine, compared enrollees in a large, national Medicare Advantage plan to a random sample of 5 percent of traditional Medicare beneficiaries. 

The study found among Medicare Advantage enrollees, those who had HMO plans were less likely to receive low-value care than those with PPO plans.

Read the full study here.

Hopefully, Congress will not throw out the baby with the bath water.

From the federal employee benefits front, FedWeek informs us

OPM has issued a reminder to agencies of their authority to verify that family members being covered under the FEHB actually are eligible, including the process to be used and the documentation required.

The notice calls attention to a revision of the FEHB handbook section on family member eligibility reflecting several instructions of recent years, including one telling agencies to tighten scrutiny of those covered and another laying out procedures for removing those deemed ineligible. That is a response to several inspector general reports warning that ineligible persons are being insured under the program, raising premium costs to the government and to other FEHB enrollees.

That directive, now part of the handbook, lists agency responsibilities to verify eligibility of family members during initial enrollment of newly hired employees and when family members are being added to an existing enrollment due to a “qualifying life event” such as marriage.

In the middle of the last decade, OPM added a standard contract provision to FEHB contract requiring carriers to share the cost of any family member eligibility audit that OPM undertakes. OPM has not yet exercised that provision.

It turns out that for the past two weeks federal employee benefits expert Reg Jones has been writing in Fedweek about federal employee retirement benefits. Today’s he discusses survivor benefits which includes a squib about perhaps the most unique and valuable survivor benefit — FEHB coverage for the survivor’s life with the full government contribution as explained here:

If your spouse receives a survivor annuity and was covered under either the Self Plus One or Self and Family option of your Federal Employees Health Benefits plan when you died, he or she and all eligible children can continue that coverage. If the annuity amount is less than the premiums required, your spouse will be able to make payments directly to OPM to cover the cost.

From the Omicron and siblings front, we have two thoughtful pieces from MedPage Today

In other virus news, the American Hospital Association reports

The recent paralytic polio case in an unvaccinated adult in Rockland County, N.Y. and wastewater samples from communities near the patient’s residence meet the World Health Organization’s criteria for circulating vaccine-derived poliovirus, the Centers for Disease Control and Prevention announced yesterday. Genetic sequences from the virus in the patient and wastewater specimens have been linked to wastewater samples in Jerusalem and London, indicating community transmission, CDC said.
Thirty other countries have circulating vaccine-derived poliovirus, which is not caused by the polio vaccine but occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine. Oral polio vaccine has not been used or licensed in the U.S. since 2000 but continues to be used in some countries. N.Y. Governor Kathy Hochul last week declared a state of emergency to help expand vaccination efforts and surveillance. 
“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” said Dr. José R. Romero, director of CDC’s National Center for Immunization and Respiratory Diseases. “We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”

From the No Suprises Act front, Beckers Hospital CFO Report relates

The No Surprises Act, which prevents patients from receiving surprise bills from out-of-network providers at emergency rooms, could lead to an increase in emergency department visits, a new study from the Agency for Healthcare Research and Quality found

The study, published Sept. 12 in The American Journal of Medical Care, compared emergency department visits rates in 15 states that implemented bans on balance billing between 2007 and 2018 to rates in 16 states where these bills were not banned. 

The study’s authors found that state-level bans reduced spending per emergency room visit by 14 percent but increased emergency room visits by 3 percentage points. These visits were 9 percent less urgent than before the balance billing ban, according to an emergency department severity index. 

Based on the state-level analysis, the study’s authors, led by AHRQ researcher William Encinosa, PhD, conclude that the No Surprises Act, which took effect this year, could result in 3.5 million more emergency room visits annually. 

“Because individuals will no longer have the fear of a possible catastrophic surprise ED bill not covered by their insurer, they may be more inclined to go to the ED in marginal, less severe cases,” the authors wrote. 

Read the full study here.

In the FEHBlog’s opinion, the No Surprises Act is working well, and he does not foresee a surge in ER visits because going to the emergency room is no picnic.

In preventive services news, MedPage Today reports

The jury is still out on whether asymptomatic children and adolescents should be screened for diabetes, the U.S. Preventive Services Task Force (USPSTF) said.

In a new recommendation statement published in JAMA, the task force concluded that there is insufficient evidence to weigh the benefits and harms of screening for type 2 diabetes in this pediatric population, despite rising rates of disease.

“[T]here is inadequate evidence that screening and early intervention lead to improvements in health outcomes such as renal impairment, cardiovascular morbidity, mortality, and quality of life,” wrote Carol M. Mangione, MD, MSPH, of the University of California Los Angeles, and colleagues.

From the miscellany department —

  • The Department of Health and Human Services announced that today HHS “Secretary Xavier Becerra formally swore in Melanie Fontes Rainer as Director of the Office for Civil Rights (OCR). Director Fontes Rainer previously served as the Acting Director and was officially appointed to the role last month.  OCR is responsible for enforcing federal civil rights; conscience protections; the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules; and the Patient Safety and Quality Improvement Act and Patient Safety Rule – which together protect individuals’ fundamental civil rights and medical privacy.”
  • The Justice Department announced “the establishment of three Strike Force teams created to enhance the Department’s existing efforts to combat and prevent COVID-19 related fraud. “These Strike Force teams will build on the Department’s historic enforcement efforts to deter, detect, and disrupt pandemic fraud wherever it occurs,” said Attorney General Merrick B. Garland. “Since the start of this pandemic, the Justice Department has seized over $1.2 billion in relief funds that criminals were attempting to steal, and charged over 1,500 defendants with crimes in federal districts across the country, but our work is far from over. The Department will continue to work relentlessly to combat pandemic fraud and hold accountable those who perpetrate it.” The Strike Force teams will operate out of U.S. Attorney’s Offices in the Southern District of Florida, the District of Maryland, and a joint effort between the Central and Eastern Districts of California.”

The good news is there’s a cure for hepatitis C. The bad news is how hard it is to bring that miracle cure to the people who need it. For years experts assumed the drug’s astronomical price was the biggest barrier. So in 2019, Louisiana and Washington state adopted the “Netflix model,” as in paying a lower price for abundant access to the drug. Just last week the White House jumped on board for a national version.

But STAT’s Nicholas Florko has found that neither state is near its goal. In Washington, the treatment rate for Medicaid patients is now lower than before the initiative began, even with a lower price. “The further you get out in the population … the more you start to hit this population that is harder — harder to identify, more costly to convert to treatment,” Rena Conti of Boston University told Nick. Read his investigation here.

  • The National Institute of Health’s HEAL Program offers ways to build opioid use disorder prevention into everyday life.
  • Govexec discusses OPM’s efforts to “highlight ways federal employees can contribute to the White House’s fight against hunger and to improve Americans’ health and nutrition, including through an event later this month.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front, the Wall Street Journal reports

The Biden administration has completed plans for a fall Covid-19 booster campaign that would launch in September with 175 million updated vaccine doses provided to states, pharmacies and other vaccination sites.

The administration is procuring the doses, which drugmakers are updating to target the newest versions of the virus. The administration has also informed states, pharmacies and other entities they can begin preordering now through the end of August, according to the administration’s fall vaccination planning guide.

Vaccines would be shipped immediately following an expected authorization by federal drug regulators, who still must review and sign off on the shots, and recommendations from the Centers for Disease Control and Prevention, which still must review the data and sign off on administering the shots. 

Administration officials have expressed hope that the boosters would help head off a wave of serious illnesses and deaths in the fall and winter, when cases often increase as more people gather indoors.

Due to the 2021-22 Delta and original Omicron variants, I gave up on expecting herd immunity from Covid. However, MedPage Today points out that those perilous Covid surges combined with vaccinations and treatments like Paxlovid create herd safety from hospitalizations and deaths. We should build up vaccination levels, but the vaccination marketing campaign should be built on a sensible theory like herd safety and not on 2020-like hysteria.

From the No Surprises Act front, Fierce Healthcare offers provider and payer opinions on the final independent dispute resolution rule. Last Spring, CMS dethroned the Qualifying Payment Amount from its commanding position in the baseball arbitration process. That aspect of the final rule is not a change in current practice. The FEHBlog senses that the No Surprises Act is working well.

Today, the Office of Personnel Management posted its first FAQs on the Postal Service Health Benefits Program which will launch in January 2025.

From the medical research front, BioPharma Dive reports

Over the last decade, drugs based on multiple RNA technologies, known as RNA interference and antisense oligonucleotides, have made it to market. Yet, it took a historic pandemic to thrust RNA into the global spotlight. Equipped with new tools, scientists are now exploring how other types can be used to make therapies that last longer and treat, as well as prevent, more diseases.

At least 10 biotechnology startups are developing next-generation RNA drugs. Though years of research lie ahead, these companies have already raised hundreds of millions of dollars from venture capitalists, large pharmaceutical firms and other investment groups.

If their work pans out, it could provide new treatments for cancer, rare diseases, and chronic illnesses that affect organs, the nervous system and the immune system.

The article provides an overview of these RNA drug development efforts.

From the tidbits department —

  • MedPage Today reports that “For higher-risk adults without prior cardiovascular disease (CVD) events, the U.S. Preventive Services Task Force (USPSTF) continues to broadly recommend statins for primary prevention while differing from other American guidelines in certain key aspects. * * * Despite being consistent with the USPSTF’s 2016 recommendations on the subject, the latest update takes away language about the preferred low-to-moderate dosing of statins in people with no history of CVD. This could be attributed to a lack of data, as a review of the literature showed most statin trials tested a moderate-intensity statin.”
  • Axios reports “Life expectancy in the U.S. fell in all 50 states and the District of Columbia from 2019 to 2020 and fell nationally by 1.8 years, according to new Centers for Disease Control and Prevention data published Tuesday. The big picture: The decline nationally and in states was mostly due to the COVID-19 pandemic and increases in unintentional injuries, specifically drug overdose deaths.
  • The National Institutes of Health announced that “Poverty, combined with other types of adversity in early childhood, is associated with greater chances of premature death in adulthood, compared to other adverse childhood experiences, according to a study of more than 46,000 people by researchers at the National Institutes of Health.”
  • The NIH Director’s Blog features a fascinating description of the inside of the “amazing” human brain.
  • The HHS Office of Civil Rights reached a settlement with dermatology practice over an alleged HIPAA Privacy Rule violation for improper disposal of protected health information.

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports that the Senate majority’s leadership is rallying the caucus to pass the Schumer – Manchin compromise reconciliation bill that would address climate and healthcare concerns while raising taxes. The goal is for the Senate to pass the bill next week which immediately precedes the Senate’s August recess.

The Hill adds that

A day after Sen. Joe Manchin (D-W.Va.) stunned Washington by endorsing hundreds of billions of dollars for President Biden’s domestic agenda, House Democrats are rallying behind the nascent package as a crucial — if incomplete — strategy for tackling the climate crisis and easing working class economic strains.

Both articles discuss the flies remain in the reconciliation ointment.

Govexec informs us

The odds that Congress would increase the average 4.6% pay raise planned for federal employees in 2023 got a little longer Thursday, after Senate appropriators revealed that they would effectively endorse President Biden’s pay increase proposal.” The Senate Appropriations Committee on Thursday revealed all of their initial versions of fiscal 2023 spending bills, including the package governing financial services and general government, which is the vehicle by which Congress weighs in on federal employee compensation. That bill makes no mention of changes to career federal employees’ pay, effectively endorsing the pay raise plan offered by Biden in his fiscal 2023 budget proposal.

Here is a link to the Senate Appropriations Committee’s press release unveiling those bills. What caught the FEHBlog’s eye is the statement in the press release that the Senate appropriations bills, like the House appropriations bills, do not include the Hyde amendments limiting federal funding of abortions to cases of rape, incest, or endangerment of the mother’s life. That tectonic change would draw the FEHBP into the post-Dobbs controversy.

From the Affordable Care Act front, Prof. Katie Keith does her usual outstanding job breaking down the proposed ACA Section 1557 individual non-discrimination rule in Health Affairs Forefront. In the FEHBlog’s view, the rule is unnecessarily complicated. It is the FEHBlog’s understanding that this HHS rule would not apply to FEHBP and that HHS would refer Section 1557 complaints involving FEHB plans to OPM. As the preamble points out, Section 1557 is a law that doesn’t need an implementing rule. Nevertheless, HHS recommends that other agencies with programs covered by Section 1557 adopt their own implementing rule using the HHS rule as a template.

The ACA regulators issued a 13-page long ACA FAQ 54 describing in detail the ACA rule requirements under which health plans must cover contraceptive drugs and services for women without cost sharing.

On a related note, Healthcare Dive tells us

Melanie Fontes Rainer is now acting director of HHS’ Office of Civil Rights. Fontes Rainer will replace Lisa Pino, who oversaw rulemaking related to patient safety, reproductive rights and other healthcare issues and issued policy regarding health equity, long COVID and firearm injury and death prevention, the agency said in an emailed statement.

From the federal employee benefits front, Fedweek explains the circumstances under which survivors of federal employees (as opposed to federal annuitants) are eligible for federal survivor benefits.

If you are an employee who was married when you die and you had at least 18 months of creditable civilian service, your spouse will be entitled to a survivor annuity.  * * * f you were enrolled in either the self plus one or self and family options of the Federal Employees Health Benefits program when you died, the person(s) on your enrollment could continue that coverage. If you weren’t enrolled in the program (or were enrolled but in the self only option), any otherwise eligible survivors would be out of luck.

From the Omicron and siblings front, the American Medical Association offers a helpful Q&A on Covid boosters.

From the monkeypox front, Reuters makes two reports

  • The United States has the capacity to conduct 60,000-80,000 tests for monkeypox virus per week, Health and Human Services Secretary Xavier Becerra said on Thursday. When the monkeypox outbreak began, the U.S. was able to conduct only 6,000 tests per week, Becerra told reporters during a telephone briefing.
  • The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday it plans to make the rapidly spreading monkeypox disease a nationally notifiable condition. The designation, which is set to take effect on Aug. 1, updates criteria for reporting of data on cases by states to the agency and would allow the agency to monitor and respond to monkeypox even after the current outbreak recedes, the CDC said.

From the U.S. healthcare business front —

The American Hospital Association issued a report attacking the commercial health insurance industry, which in the FEHBlog’s view is akin to strangling the golden goose.

Healthcare Dive reports

Teladoc beat Wall Street expectations for revenue in the second quarter, with a topline of $592 million, up 18% year over year. Chronic care membership came in higher than analysts expected, while member utilization improved year over year.

But “all eyes” are on the vendor’s guidance for the rest of the year, which implies a third-quarter miss and a steep ramp-up for earnings in the fourth quarter, SVB Securities analyst Stephanie Davis wrote in a note on the results.

STAT News chimes in

Telehealth giant Teladoc is bracing for disappointing earnings this year as it faces headwinds that could also thwart competitors struggling to turn a profit — including increasingly frugal employers delaying or dropping contracts for virtual care.

“The challenge that we’re seeing is in these times of economic uncertainty, all purchases are just getting a significantly higher level of scrutiny,” CEO Jason Gorevic said in an earnings call Wednesday.

Gorevic also noted that declining yield on advertising suggests that individual patients may start spending less on direct-to-consumer services like BetterHelp, the company’s mental health care offering. Those hurdles aren’t unique to Teladoc. Competitors like Amwell and Talkspace could also have to grapple with cutbacks.

Healthcare Dive also delves into Amazon’s planned acquisition of One Medical. “The deal fast-tracks Amazon’s ambitions in healthcare, while giving One Medical a cushion in today’s tricky economic environment.”

Yesterday, the FEHB wrote about the hospitals receiving five stars from Medicare. Today Becker’s Hospital Review lists the 192 hospitals receiving a single start from that program.

Finally STAT News lists the 41 best books and podcasts on health and science to check out this Summer.

Weekend update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

The House of Representatives and the Senate are in session this week for Committee business and floor voting. This is the House’s last week of scheduled floor voting before the August recess.

The Wall Street Journal reported last Friday evening

President Biden signaled he was prepared to support a narrow bill that lowered prescription drug costs and extended Affordable Care Act subsidies but left out climate provisions, as Senate Democrats grappled with whether to abandon their broader economic agenda after intraparty talks hit an impasse.

Mr. Biden said that if the Senate didn’t move forward with climate legislation, he would turn to executive action, calling clean energy and combating climate change urgent matters. On the prescription drug portion of the agenda, he said the Senate “should move forward, pass it before the August recess, and get it to my desk so I can sign it,” characterizing it as a major victory for American households.

The statement came a day after talks between Sen. Joe Manchin (D., W.Va.) and Senate Majority Leader Chuck Schumer (D., N.Y.) broke down. Mr. Manchin told Mr. Schumer that he would back a prescription-drug proposal but couldn’t yet commit to backing tax increases or climate provisions, citing inflation worries.

From the Omicron and siblings front, NPR tells us

The BA.5 omicron subvariant, which is now the most prevalent coronavirus strain in the United States, is four times more resistant to COVID-19 vaccines, according to a new study.

The strain, which is considered “hypercontagious,” according to the Mayo Clinic, is more defiant against messenger RNA vaccines, which include Pfizer and Moderna.

The BA.5 strain represented 65% of cases from July 3 to 9, according to data from the Centers of Disease Control and Prevention. 

It is contributing to increases in COVID-19 hospitalizations and admissions to intensive care units across the country. 

But vaccines still provide much better protection than going without the safeguards.

Bloomberg Prognosis adds

Bertha Hidalgo, a University of Alabama epidemiologist, was faked out by a variant that never truly got off the launchpad.

“A few weeks ago, I thought BA2.12.1 would drive the summer wave and it would be a small wave, with not too many infections, to be followed by a BA.5 wave when schools reopened,” she says.

Instead, the BA.5 omicron variant decided that the summer of 2022 was its time to shine. The variant is now dominant in the US, according to the Centers for Disease Control and Prevention. Combined with BA.4, it is also powering a surge of the virus in Europe. 

This week, World Health Organization chief Tedros Adhanom Ghebreyesus warned that “new waves of the virus demonstrate again that Covid-19 is nowhere near over.”

The good news is that we now know much more about what strategies are effective for reducing spread of the virus as we go about our lives in these very odd times.

Hidalgo shared her list of best practices:

* Get vaccinated and get all available boosters

* Wear a mask indoors (and outdoors if in crowded spaces)

* Make sure to get a good quality, good fitting mask, like a KN95 

* Use rapid tests before gathering with others, or at the sign of any questionable symptoms

* If gathering indoors, consider improving ventilation through measures like opening windows or running a central HVAC system

“All of these are layers of protection we can take advantage of that are preventive and can help reduce chances of infection and transmission,” she says.

Quite honestly, the FEHBlog relies on vaccines, including boosters, and rapid tests along with common sense.

HR Dive informs us

Employers must now justify mandatory coronavirus testing for workers, the U.S. Equal Employment Opportunity Commission said in a July 12 update to its technical assistance manual.

Until now, the commission took the position that the Americans with Disabilities Act standard for medical examinations always permitted employer worksite COVID-19 testing. 

Going forward, employers will need to assess whether current pandemic circumstances and individual workplace circumstances justify testing to prevent workplace transmission, the agency said. Specifically, an employer must show that testing is job-related and consistent with business necessity, as defined by the ADA.

From the unusual viruses front, Govexec brings us a CDC update on monkeypox. Here are links to

From the U.S. healthcare business front, Fierce Healthcare offers 21st Century advice on improving health plan call centers.

From the mental healthcare front, NPR takes a deep dive into the new 988 suicide and mental health crisis number.

From the HIPAA privacy and security rule enforcement front, HHS’s Office for Civil Rights announced “the resolution of eleven investigations in its Health Insurance Portability and Accountability Act (HIPAA) Right of Access Initiative, bringing the total number of these enforcement actions to thirty-eight since the initiative began.  OCR created this initiative to support individuals’ right to timely access their health records at a reasonable cost under the HIPAA Privacy Rule.” All of the chastised parties were healthcare providers.

This morning the FEHBlog was doing his weekly quality review of the FEHBlog. He noticed that last Thursday, he mentioned a new Kaiser Family Foundation report without providing a topic or a link for his readers. Lo siento. Here is the missing information:

Pregnancy is one of the most common reasons for a hospitalization among non-elderly people. In addition to the cost of the birth itself, pregnancy care also involves costs associated with prenatal visits and often includes care to treat psychological and medical conditions associated with pregnancy, birth, and the post-partum period.

This analysis examines the health costs associated with pregnancy, childbirth, and post-partum care using a subset of claims from the IBM MarketScan Encounter Database from 2018 through 2020 for enrollees in large employer private health plans. It finds that health costs associated with pregnancy, childbirth, and post-partum care average a total of $18,865 and the average out-of-pocket payments total $2,854. The analysis also examine how pregnancy, childbirth, and post-partum health spending among large group enrollees varies by the type of delivery.

The analysis can be found on the Peterson-KFF Health System Tracker, an information hub dedicated to monitoring and assessing the performance of the U.S. health system.

Childbirth also is one of the required out-of-pocket cost requirements for a health plan’s ACA summary of benefits and coverage template.

Midweek update

Thanks to Alexandr Hovhannisyan for sharing their work on Unsplash.

From the Omicron and siblings front —

The Wall Street Journal reports

The Biden administration has agreed to pay $3.2 billion for 105 million doses of Pfizer Inc.’s Covid-19 vaccine.

The deal would provide supplies for the federal government’s planned fall booster campaign, which administration officials are devising to blunt a potential wave in cases, possibly driven by variants of the Omicron strain now spreading across the U.S.

Under the deal, the federal government would have the option to buy 195 million additional doses, the Health and Human Services Department said Wednesday. Pfizer, which developed and makes the vaccine with partner BioNTech SE, would make whatever type of vaccine federal health regulators decide should be featured in the fall campaign.

The American Hospital Administration informs us

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and Food and Drug Administration this week extended the shelf life for certain refrigerated lots of the COVID-19 combination monoclonal antibody therapies REGEN-COV and Evusheld. They extended the shelf life for REGEN-COV from 24 months to 30 months and the shelf life for Evusheld from 18 months to 24 months. FDA last year authorized the therapies for emergency use to prevent COVID-19 in certain adults and children. REGEN-COV is not currently authorized in any U.S. region because it is unlikely to be effective against the omicron variant and subvariants.

Health IT Analytics tells us “The National Institutes of Health’s (NIH) All of Us Research Program has announced that health data from 20,000 people who have had SARS-CoV-2 is now available to researchers in the US, expanding the program’s dataset to encourage the study of long COVID, social determinants of health (SDOH), and health disparities.”

Also, from the SDOH front, MedPage Today informs us

Maternal mortality rates substantially increased during the COVID-19 pandemic, according to a study using data from the National Center for Health Statistics.

After March 2020, maternal deaths increased by 33.3%, which was higher than the 22% overall excess death estimate expected to result from the pandemic, reported Marie Thoma, PhD, of the University of Maryland in College Park, and Eugene Declercq, PhD, of Boston University.

The rate of maternal deaths before the pandemic was 18.8 per 100,000 live births, which increased to 25.1 per 100,000 live births during the pandemic, the authors noted in a research letter published in JAMA Network Open. * * *

The largest increases were seen in Hispanic and Black women, which was in line with maternal mortality rates before the pandemic. Hispanic women saw a relative change of 74.2% (8.9 deaths per 100,000 live births), and Black women saw a 40.2% relative change (16.8 deaths per 100,000 live births), while white women saw a 17.2% relative change (2.9 deaths per 100,000 live births).

From the monkeypox front, the Department of Health and Human Services announced

an enhanced nationwide vaccination strategy to mitigate the spread of monkeypox.  The strategy will vaccinate and protect those at-risk of monkeypox, prioritize vaccines for areas with the highest numbers of cases, and provide guidance to state, territorial, tribal, and local health officials to aid their planning and response efforts.

Under the strategy, HHS is rapidly expanding access to hundreds of thousands of doses of the JYNNEOS vaccine for prophylactic use against monkeypox in areas with the highest transmission and need, using a tiered allocation system. Jurisdictions can also request shipments of the ACAM2000 vaccine, which is in much greater supply, but due to significant side effects is not recommended for everyone.  * * *

The Advisory Committee on Immunization Practices currently recommends vaccination for those at high risk following a confirmed monkeypox exposure. Given the large number of contacts and difficulty in identifying all contacts during the current outbreak, vaccine will now be provided to individuals with confirmed and presumed monkeypox exposures. This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.

The American Hospital Association adds

CDC yesterday activated its Emergency Operations Center to monitor and coordinate the emergency response to monkeypox and mobilize additional CDC personnel and resources. The agency has expanded testing capacity for the virus since May 18, when the first U.S. case in the global outbreak was confirmed, to include up to 78 state public health laboratories and five commercial laboratory companies. As of June 28, 306 U.S. monkeypox cases have been reported

From the Dobbs case front

  • CNBC reports “CVS is removing its earlier purchase limit on emergency contraceptive pills. The chain said that ‘sales have since returned to normal and we’re in the process of removing the purchase limits.'”
  • HHS’s Office for Civil Rights announced “new guidance to help protect patients seeking reproductive health care, as well as their providers.”

In general, the guidance does two things:

1. addresses how federal law and regulations protect individuals’ private medical information (known as protected health information or PHI) relating to abortion and other sexual and reproductive health care – making it clear that providers are not required to disclose private medical information to third parties; and

2. addresses the extent to which private medical information is protected on personal cell phones and tablets, and provides tips for protecting individuals’ privacy when using period trackers and other health information apps.

According to recent reports, many patients are concerned that period trackers and other health information apps on smartphones may threaten their right to privacy by disclosing geolocation data which may be misused by those seeking to deny care. * * *

The guidance on the HIPAA Privacy Rule and Disclosures of Information Relating to Reproductive Health Care may be found at

The guidance on Protecting the Privacy and Security of Your Health Information When Using Your Personal Cell Phone or Tablet may be found at

From the FDA front, BioPharma Dive identifies five FDA decisions to watch in the third quarter of 2022 which starts on Friday.

From the Affordable Care Act front, the Internal Revenue Service released a draft of the 2022 Form 1095-B which FEHB and other health plans offering minimum essential coverage must make available to their enrollees.