Monday Roundup

U.S. Healthcare

Monday Roundup

David Ermer–CDC, COVID-19, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Omicron and unusual viruses front —

STAT News reports

Pfizer and BioNTech said Monday that they have asked the Food and Drug Administration to authorize a new booster shot targeted at the Omicron BA.4/BA.5 strain of the coronavirus that causes Covid-19, the first step in a process that could lead to more effective booster shots.

Notably, in the same press release, the companies said that a clinical study investigating the safety, tolerability, and immunogenicity of the vaccine, which also includes the original Covid strain, is expected to start this month, meaning data would not be available for the FDA to consider.

The application to authorize the vaccine without new clinical trial data is part of a bold and potentially controversial gambit by the U.S. and its advisers to try and get ahead of the fast-mutating coronavirus, SARS-CoV-2. But it’s one that could also have a big payoff.

The Pharmacy Times tells us

Officials with the FDA have granted an expanded Emergency Use Authorization (EUA) to Novavax for its COVID-19 vaccine, adjuvanted for adolescents 12 through 17 years of age, according to a press release. The announcement marks the first protein-based COVID-19 vaccine authorized in the United States for this patient population.

The expanded EUA allows for a 2-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents. Doses are now available and primary series immunizations for adolescents can begin once the CDC releases a policy recommendation.

Will the next Novovax approval from the FDA be for a booster?

Medpage Today points to a study suggesting a connection between myocarditis in children and long Covid.

The Wall Street Journal adds

Officials in New York are urging pediatricians and parents to bring patients up to date on polio shots, as evidence suggests the infectious and potentially debilitating poliovirus was present in the state as early as April. 

Health officials said they have sent alerts to healthcare providers, hung fliers in houses of worship, grocery stores and summer camps, and talked with community leaders to boost polio vaccination rates in the greater New York City area. Some places including Rockland and Orange counties have polio vaccination rates around 60% among eligible children, compared with a national rate of around 93%, according to federal data. 

Polio is particularly insidious, health officials and other public-health experts said, because the majority of cases occur in people who never develop symptoms but can still spread the virus. That silent spread can cause meningitis or paralysis in someone unvaccinated against the disease. 

In other public health news, STAT News informs us

Anthony Fauci, the top U.S. infectious diseases official for decades and a leading researcher on crises from HIV to Covid-19, announced Monday that he would be stepping down from his positions in December.

Fauci, 81, has led the National Institute of Allergy and Infectious Diseases for 38 years, serving a line of presidents from both parties since the Reagan administration. He has also served as President Biden’s chief medical adviser since Biden took office. While Fauci has telegraphed that he was planning on leaving those roles in a matter of months, Monday’s announcement makes it official.

But Fauci, known as a tireless workhorse, said he would not be retiring. “After more than 50 years of government service, I plan to pursue the next phase of my career while I still have so much energy and passion for my field,” he said. “I want to use what I have learned as NIAID Director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats.”

From the U.S. healthcare business front, Bloomberg reports

Signify Health Inc. soared the most since its shares started trading last year as UnitedHealth Group Inc., Amazon.com Inc., CVS Health Corp. and Option Care Health Inc. competed to acquire the home-health technology and services provider, according to people familiar with the matter. 

UnitedHealth has submitted the highest bid in excess of $30 a share, while Amazon’s offer is close behind, the people said, asking not to be identified as the discussions are private. Signify is holding a board meeting Monday to discuss the bids, the people said. * * *

Final bids are expected Sept. 6, but a deal could come earlier if any of the parties preempt the sales process, the people said.  * * *

Through its software and services, Signify aims to help clients — payers like health plans, government programs and employers — shift to value-based payment plans. It’s backed by private equity firm New Mountain Capital, which formed the company in 2017, according to the firm’s website. 

That is quite a big business rumble.

From the No Surprises Act front, Prof. Katie Keith and her colleagues wrote two articles on last Friday’s “final, final” independent dispute resolution rule — one concerns its impact on IDR arbitrations and the other on miscellaneous topics.

From the mental healthcare front, Health Payer Intelligence lets us know that “Payers are working toward achieving broader access to mental healthcare and behavioral healthcare services by reimbursing at higher rates and supporting primary care” according to a recent AHIP survey.

Nearly eight in ten health plans had boosted behavioral healthcare workers’ reimbursement rates (78 percent). Additionally, 83 percent of payers had attracted and retained a diverse population of behavioral healthcare providers.

Substance abuse care is becoming more accessible, the survey found. Specifically, more providers have become eligible to offer medication-assisted therapy (MAT). This population has expended 114 percent over the course of three years.

Nearly three-quarters of health plans (72 percent) support behavioral healthcare training for primary care providers. The same share supported primary care providers by helping them find behavioral healthcare specialist referral partners.

Payers have also offered primary care providers the opportunity to call behavioral healthcare specialists via telehealth or telephone in order to consult them on a patient’s condition. More than half of the health plans (56 percent) provide this option. This method has been used in pediatric psychiatry to solve members’ challenges in connecting with specialists.

Health plans reported a couple of main ways that they try to connect members with mental healthcare services. Many plans do this by supporting patient navigation (83 percent). For example, health plans might connect members with community-based organizations that can address their social determinants of health needs. 

Additionally, more than eight in ten health plans said they help members secure behavioral healthcare visits. Follow-up on inpatient care and emergency room visits is often part of health plans’ efforts to connect members with mental health services as well. Seventy-eight percent of the plans leveraged specialized case managers to perform this function.

From the medical research and development front —

Biopharma Dive informs us

Gilead’s long-acting HIV shot Sunlenca is now cleared for sale in Europe, marking the first marketing authorization for a treatment the California biotechnology company hopes can be used broadly as a standard therapy and preventive regimen.

The decision by the European Commission, announced Monday, authorizes Sunlenca for patients whose current treatment regimen can no longer keep their infection at bay. Sunlenca, previously called lenacapavir, will be added to other antiviral drugs to boost patients’ immune response and reduce levels of virus in the body.

Gilead is still waiting on a regulatory decision in the U.S., where it has been delayed by manufacturing issues. An approval by the Food and Drug Administration’s December deadline could put the drug on track to reach sales that RBC Capital Markets analysts estimate will climb as high as $4 billion a year.

The Wall Street Journal reports

Zapping the brain with weak electrical currents that mimic normal neural activity can boost memory in healthy older adults, at least over the short term, researchers said in a study published Monday in the journal Nature Neuroscience.

Electrical stimulation of the brain as a potential tool for enhancing memory is a growing field of research, with experiments showing that the ability to recall memories depends upon synchronized activity between different brain regions.

The new research, conducted on people over age 65, “adds to the growing evidence that noninvasive stimulation mimicking the rhythmic brain activity that supports cognition can improve memory” in this population, said Joel Voss, a University of Chicago professor of neurology who wasn’t involved in the research.

Weekend update

David Ermer–Congress, COVID-19, No Surprises Act, SDOH, Telehealth, U.S. Healthcare–
Thanks to Aaron Burden for sharing their work on Unsplash.

Congress is on a State / District work break again this week.

The FEHBlog performed his weekly review of the FEHBlog this weekend, and he discovered that last Friday’s post on the new No Surprises Act regulation duplicated the closing paragraph. Lo Siento. The missing paragraph concerned the ACA regulators’ 28-page long ACA FAQ 55 on those new rules.

Several of the FAQs reiterate information from the interim final rules issued in July and October 2021. (Reiteration can a helpful teaching tool.) The FAQs which caught the FEHBlog’s eye were FAQs 5, 8, 10, 13, 14, 15, 17, and 19 (quite important). The last two FAQs 23 and 23 concern the transparency in coverage rule. All of these FAQs are relevant to FEHB plans.

Here’s a link to a Fierce Healthcare article on the new rules.

From the omicron and unusual viruses front —

The Wall Street Journal reports

The U.K. last week became the first country to clear a modified Covid-19 vaccine targeting the Omicron variant, and other countries including Canada and Australia might soon follow.

But in the U.S., modified Covid-19 booster shots are unlikely to be cleared for several more weeks because health authorities decided in late June they wanted modified vaccines to target different Omicron subvariants than those rolling out in other countries.

As a result, the makers of the leading Covid-19 vaccines—Moderna Inc. and Pfizer Inc. with its partner BioNTech SE—got a later start producing the new shots that are planned for the U.S. 

This posed logistical challenges because companies needed to secure different starter material and switch over production lines. Now they are racing to manufacture tens of millions of retooled vaccines that could be used in a fall booster campaign, one that could start in September or October.

The modified vaccines could become available by mid-September, Ashish Jha, the White House Covid-19 response coordinator, said Thursday during an online presentation hosted by the U.S. Chamber of Commerce. 

The effort is a new test of the plug-and-play potential of the gene-based, messenger RNA technology used in the shots from Pfizer and Moderna.

Fingers crossed.

On Friday, the U.S. Office of Personnel Management distributed this FEHB Carrier Letter about long Covid. Today, MedPage Today offers an expert medical interview about the immune signature of that disease.

NPR Shots and Wall Street Journal columnist Allysia Finley discuss the Biden Administration’s problems in dealing with the monkeypox virus. Ms. Finley notes

Monkeypox, first identified in lab animals in 1958, is a close relative of smallpox, though it is less lethal and contagious. Periodic outbreaks have occurred in Central and West Africa, where the virus is endemic and spreads among wild animals. Humans can catch it through direct contact with the skin lesions of an infected animal or person.

A small U.S. outbreak in 2003 was linked to rodents imported from Ghana by an exotic pet dealer. The virus infected 71 Americans but was quickly contained with the help of the smallpox vaccine. No one died.

The outbreak, coupled with growing concerns about bioterrorism, prompted Washington to seek a safer, more effective vaccine against smallpox and monkeypox. 

The federal government reserved over 1 million frozen doses of the preferred smallpox vaccine stored in Denmark but the manufacturer could not start delivering them until after the Food and Drug Administration finished a review of the Danish facility in late July. That delay resulted in the problem discussed in NPR Shots.

The Wall Street Journal offers articles on “What to Know About Polio Symptoms, Vaccines and the Virus’s Spread in New York” and “Am I Protected Against Polio? Here’s What to Know About the Vaccine.”

From the Rx coverage front, BioPharma Dive reports

The Food and Drug Administration on Friday approved a new depression drug from Axsome Therapeutics, one year after putting the treatment in regulatory limbo.

The regulator cleared Axsome’s treatment, an oral drug to be sold as Auvelity, for adults with major depressive disorder. Axsome expects to begin selling the drug in the U.S. in the fourth quarter.

Auvelity consists of bupropion, the active ingredient in GSK’s depression drug Wellbutrin, and dextromethorphan, which is best known for its use as a cough medicine. The dextromethorphan acts on a neurotransmitter, NMDA, that controls mood, while bupropion boosts the amount of dextromethorphan available in the body.

Together, the two components are meant to produce an antidepressant effect faster than standard treatments, which can take weeks or months to show an impact.

STAT News adds

Auvelity * * * is the first pill of its kind approved for major depressive disorder. Spravato, a nasal spray marketed by Johnson & Johnson and approved in 2019, works similarly.

Axsome did not immediately disclose how much Auvelity will cost, saying on a conference call with analysts that it expects to announce a price in the coming weeks. The company will set a price “that ensures broad access for patients and that takes into account the value supported by the innovation Auvelity brings to patients with MDD,” Axsome Executive Vice President Lori Englebert said.

From the U.S. healthcare business front, the Wall Street Journal reports

Amazon.com Inc. is among the bidders for healthcare company Signify Health Inc., joining other heavy hitters vying in an auction for the home-health services provider, according to people familiar with the matter.

Signify is for sale in an auction that could value it at more than $8 billion, the people said. Bids are due around Labor Day, according to people, but it is always possible an eager bidder could strike a deal before then.

CVS Health Corp. is also among the suitors, The Wall Street Journal previously reported, as the drugstore and insurance giant looks to expand in home-health services. UnitedHealth Group Inc. and another corporate buyer are also circling the company, according to the people.

There is no guarantee any of them will reach a deal for Signify, which has been exploring strategic alternatives. The healthcare company has a market value of roughly $5 billion, boosted since the Journal first reported on the possibility of a deal early this month.

From the miscellany front

  • Fortune Well informs us “A global study published this week in The Lancet assessed 34 risk factors for cancer, and found that “modifiable risk factors” accounted for 44.4% of all cancer deaths in 2019—and 42% of disability-adjusted life years (DALYS), defined as the combination of years lost from disability and from premature mortality, according to the World Health Organization.  The highest risk factors globally were largely behavioral, including smoking, followed by alcohol use, then high body-mass-index (BMI). Risk factors varied by region, and for areas with a low socio-demographic index (SDI) alcohol, unsafe sex, and smoking were the most common risk factors attributed to cancer DALYS.”
  • Health Payer Intelligence points out that “Elevance Health, Aetna, and Cigna health plans have launched various social determinants of health initiatives to improve members’ quality of care.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, NIH, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, Federal News Network identifies five federal workforce items on Congress’s to-do list.

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

The Biden administration is planning for an end to its practice of paying for Covid-19 shots and treatments, shifting more control of pricing and coverage to the healthcare industry in ways that could generate sales for companies—and costs for consumers—for years to come. * * *

Shifting payments for Covid-19 drugs and vaccines to the commercial market is expected to take months, an HHS spokesman said.  * * *

Switching vaccine purchasing to the commercial market would mean that each insurer and pharmacy benefit manager would be negotiating with drug manufacturers and prices would likely be higher than what the federal government has paid, said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. Insurers would have to start paying for the vaccines, he said, likely raising premiums.

MedPage Today informs us

More than 2 years after patients started reporting long-lasting symptoms after acute SARS-CoV-2 infection, the U.S. announced its national long COVID plan.

The National Research Action Plan on Long COVID aims to improve prevention, diagnosis, and treatment for long COVID, which currently affects up to 23 million people in the U.S., about 1 million of whom may be out of the workforce at any given time because of the condition, according to Admiral Rachel Levine, MD, HHS assistant secretary for health. * * *

Long COVID advocates expressed mixed opinions. Hannah Davis, co-founder of the Patient-Led Research Collaborative, noted the fact that “there’s going to be an [Office of Long COVID Research and Practice] is pretty amazing.”

But Davis voiced concerns about the scarcity of prevention efforts addressed by the plan. “I think there’s still a feeling like we can get through this without minimizing cases, but we really need to be focused on prevention as well,” she said.

Diana Berrent, founder of Survivor Corps, told MedPage Today that the administration “nailed the institutional challenge of long COVID” but also thought the plan was insufficient.

“Millions of Americans, young and old, are suffering the aftermath of COVID and need immediate relief from their pain,” Berrent said. “An established office in HHS is a welcome step but nothing short of actual treatments and therapeutics will do the trick.”

From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of monkeypox cases, and MedPage Today reports

The Biden administration is making an additional 1.8 million doses of the Jynneos monkeypox vaccine available beginning Monday, and will be targeting certain large events — such as gay pride marches that attract many LGBTQIA participants — as sites for monkeypox vaccination and outreach, administration officials said Thursday.

From the healthcare costs front, Healthcare Dive reports

U.S. employers will pay 6.5% more on average for employee healthcare coverage in 2023 compared to this year, according to an Aon report out Thursday.

The latest predicted rise, while a jump from the 3.7% growth in employer costs between 2021 and 2022, is still far below the 9.1% Consumer Price Index, a figure reflecting inflation. 

Inflation typically hits healthcare costs later than other goods and services due to the multi-year nature of contracts between providers and insurers, but impacts will become more prevalent over the year, according to the report.

Speaking of higher costs, Fierce Healthcare discusses Moody’s report on how an economic downturn would impact health plans.

From the post-Dobbs front, the FEHBlog ran across this Congressional Research Service FAQs on Federal Resources for Reproductive Health.

From the No Surprises Act front, the American Hospital Association informs us “The Centers for Medicare & Medicaid Services has launched a new webpage with resources and guidance related to the dispute resolution process under the No Surprises Act, including guidance for disputing parties and a walkthrough of the federal portal. CMS also has added functionality to the portal for initiating disputes, including a button to upload supporting documents at initiation.”

From the miscellany department —

  • Fierce Healthcare discusses J.D. Powers’ annual study of Medicare Advantage plans. “[T]he analysts found members’ general satisfaction is up from 2021 and is higher than satisfaction reported by people in employer-sponsored plans. However, while members said they’re happy with access to preventive and routine care, coverage of mental health and substance abuse treatment is lacking.”
  • STAT News calls our attention to “a new Pew-funded report, by researchers at George Washington University, the federal government can expand methadone access without approval from Congress.” According to the article, “When it comes to fighting opioid addiction, there’s no tool more effective than methadone. Doctors have been prescribing the drug since the 1960s, and patients who use it are far less likely to experience an overdose.”

Midweek update

David Ermer–CDC, Government Contracting, Rx coverage, U.S. Healthcare–

From inside the Beltway, Roll Call tells us

Centers for Disease Control and Prevention Director Rochelle Walensky is looking to reorganize the agency in the wake of an external review of the CDC’s COVID-19 response. * * *

“For 75 years, CDC and public health have been preparing for COVID-19,” Walensky said, “and in our big moment, our performance did not reliably meet expectations.” 

The plan aims to achieve a “more cohesive and customer centric structure,” by implementing new programs and procedures to work more quickly and ensure more accountability. Walensky plans to establish an executive council to oversee the CDC’s progress on specific goals, consolidate various points of access for external stakeholders and establish a new equity office.

STAT News adds

Outside experts expressed enthusiasm — though some of it tempered — for the changes Walensky is proposing.

Jay Varma, who spent 20 years at CDC before becoming director of the Cornell Center for Pandemic Prevention and Response at Weill Cornell Medicine, applauded many of the points Walensky stressed, particularly her promise to reform the culture of the agency and build up the capacity of its staff to respond to emergencies. Over the past two decades or so, Varma told STAT, public health agencies like the CDC have become increasingly bureaucratic.

“If your culture is not aligned entirely with what your mission is, it doesn’t matter how good the strategy is. It doesn’t matter what your org charts are. It is all about the workforce culture,” he said.

But Varma warned effecting change in the agency’s culture will be challenging.

Speaking of change, Fierce Healthcare informs us

A dramatic pickup in the pace of change for payers in the last year has created new priorities for health plan leaders, a new survey has found. 

The survey, conducted by payment integrity solution HealthEdge, reached more than 300 health plan leaders. Common themes, per a report of the survey results, included the move to newer systems amid a digital transformation, rising demand for real-time data access and the promise of interoperability. 

Some of the biggest threats facing health plans are new regulations, growing consumer expectations, competition and the transition to value-based payment strategies. The top two challenges are managing costs and driving operational efficiencies, which were lower on the list of priorities just last year. Tied in third place are member satisfaction and alignment of IT and business needs. 

There are several drivers of these hurdles. Post-pandemic, there are notably more claims. Long delays in care have also led to rising costs, and outdated systems have required significant investment to keep up with demand. Having a solid digital baseline can help payers eliminate manual, repetitive processes, the report suggested. Payers also believe increasing interoperability and improving claims accuracy helps alleviate administrative costs. 

From the Rx coverage front, BioPharma Dive reports

The Food and Drug Administration on Wednesday approved a powerful new treatment for people with an inherited blood condition called beta thalassemia, clearing a personalized gene therapy developed by the biotechnology company Bluebird bio. * * *

Its approval is a milestone in a number of other respects, too. Beta thalassemia, a disease that in severe cases requires regular blood transfusions for life, has for years been marked as a target for gene therapy. Bluebird’s treatment, which will be sold as Zynteglo, is the first of several in development to reach market in the U.S., giving patients an option that could free them from those transfusions and their associated side effects.

STAT News adds

Bluebird has set the price of Zynteglo at $2.8 million per patient, making it one of the most expensive medicines ever sold in the U.S. And that price tag doesn’t include the cost of the lengthy hospitalization for patients getting the therapy.

A person with beta thalassemia incurs total health care costs that average $6.5 million over their lifetime, or 23 times higher than the general population, said Obenshain, making the case for Zynteglo’s cost effectiveness. Earlier this year, the Institute for Clinical and Economic Review, an independent drug-pricing analysis group, said Zynteglo would be cost effective up to a price of $3 million.

Bluebird will be asking insurers to pay for Zynteglo entirely up front, but the company will also return up to 80% of the cost if patients need to restart blood transfusions before two years.

“All the commercial insurers we’ve engaged with have expressed a really strong interest in this,” said [Bluebird CEO Andrew] Obenshain, of Bluebird’s outcome-based payment proposal.

From the research and studies front —

  • “Infectious disease expert Dave Wessner reports for Forbes from the 24th International AIDS Conference, where researchers shared ways that Covid vaccine development might help the development of a vaccine for AIDS.”
  • The National Institutes of Health announced “Scientists funded by the National Institutes of Health have developed a same-day test to identify abnormal fetal chromosomes. The Short-read Transpore Rapid Karyotyping (STORK) test can detect extra or missing chromosomes (i.e., aneuploidy) using samples collected from prenatal tests, such as amniocentesis and chorionic villus sampling, as well as tissue obtained from miscarriage and biopsies from pre-implantation embryos produced using in vitro fertilization (IVF). * * * Overall, the study shows that STORK is comparable to standard clinical tests and has many advantages. STORK is faster, providing results within hours versus several days. It is also cheaper, with the study team estimating STORK to cost less than $50 per sample, if 10 samples are run at the same time, or up to $200 if a sample is run on its own. STORK can also be done at the point-of-care for a patient, eliminating the need to ship a sample to a clinical laboratory.  According to the study authors, STORK may be particularly useful in identifying genetic causes of miscarriage. Currently, professional societies only recommend genetic testing if a person has had multiple miscarriages, but an easy, cost-effective test like STORK can potentially be offered after the first miscarriage. STORK can also be used to streamline the IVF process. Currently, embryos must be frozen while genetic tests are run and analyzed before implantation. STORK’s ability to provide results within hours can presumably eliminate this freezing step, which saves time and cost. More work is needed to validate STORK, but if results continue to show promise, STORK could improve the quality of reproductive healthcare.”
  • The National Cancer Institute announced “For people with advanced cancer, severe side effects from treatment often force them to the hospital or the emergency room. Although these time-consuming and, quite often, expensive hospital trips potentially could be prevented by better communication about symptoms between patients and their doctors, the reality is that such discussions don’t typically happen as frequently as they should.   Now, a new study shows that community health workers (CHWs) may help bridge this communication gap in cancer care. In the study, having a CHW directly consult with people newly diagnosed with advanced cancer or cancer recurrence, including assessing their symptoms and helping them with advance care planning, substantially decreased hospitalizations and emergency room visits.”
  • Fierce Healthcare reports “Musculoskeletal conditions are a massive source of health spending—accounting for $420 billion in 2018—and a new report from [Cigna’s] Evernorth aims to pinpoint where health plans could cut down on costs.”
  • Health IT Analytics tells us “New research published in JAMA Internal Medicine shows that an artificial intelligence (AI)-based cognitive behavioral therapy intervention for chronic pain (AI-CBT-CP) had similar outcomes to standard CBT-CP, which could result in increased access and reduced costs.”

From the government contract front, Federal News Network reports that

As the travel industry — and prices — recover from COVID-19, the General Services Administration is giving federal employees a little more leeway on hotel costs for official travel.

The base daily traveling allowances will rise slightly from $155 per day in 2021 to $157 per day in 2022. Per diem lodging rates will account for that rise, increasing from $96 per night to $98. Meals and incidental expenses will not change from their current range of $59-$79 per day.

For feds who already have an idea of their travel plans for fiscal 2023, GSA included a new calculator tool that will allow them to search by city, state, zip code or a map to determine the exact amount of their per diem.

Experience-rated FEHB plan carriers must subject employee lodging and miscellaneous expenses to the GSA’s per diem caps when seeking government contract reimburses for those expenses.

Tuesday Tidbits

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

The FEHBlog is back inside the Capital Beltway this week so let’s kick it off with a link to the President’s remarks at his signing of the budget reconciliation act (H.R. 5376) into law.

Because the new law’s drug pricing changes will impact the FEHB Program most, here is a link to STAT New’s article unpacking those provisions.

From the omicron and siblings front, Federal News Network reports that the Safer Federal Workforce Task Force is following the CDC’s lead by easing restrictions to stop the Covid spread.

From the monkeypox front, check out Fierce Healthcare’s monkeypox news tracker.

MedPage Today offers a fascinating article in which a Johns Hopkins epidemiologist assesses the current case of polio paralysis in New York through a historical lens.

Polio is a fecal-oral pathogen and the Sabin vaccine, as an oral vaccine, more naturally mimicked the natural route of infection and therefore triggers different and more potent immune responses than the injectable Salk vaccine. Also, because it is a “live” vaccine, the vaccine virus is shed and can passively immunize close contacts of vaccinated individuals. For these reasons, the Sabin vaccine eventually came to be a more dominant and preferred vaccine than the [original, injected] Salk version.

However, as polio receded as a public health threat, rare complications elicited by the Sabin vaccine became intolerable in many Western countries. The “live” nature of Sabin’s vaccine, in rare instances, could lead to vaccine-associated paralytic polio. In even rarer circumstances, the virus could mutate or recombine with other viruses to become a circulating vaccine-derived poliovirus (cVDPV) that could be capable of infecting others, and in some cases, causing paralysis. This is why 2 decades ago — with polio no longer an issue domestically — the U.S. switched to an all-Salk injectable polio vaccine regimen for children, away from a combination that used the Sabin oral polio vaccine (OPV) and the injectable polio vaccine. But many countries, especially those in which wild polio still circulates, still use OPV. * * *

In response, [U.S.] healthcare professionals and policymakers need to encourage widespread immunization in areas in which cVDPVs have been found. It is not surprising that this problem has been detected in the same locales in which a very large measles outbreak recently occurred. I suspect other areas likely have cVDPVs circulating as well, and broader wastewater surveillance coupled with targeted catch up immunization will be critical. I can’t stress this point enough: high vaccination rates are required for resiliency. 

In related virus news, the Centers for Disease Control released a report titled “Hepatitis C Treatment Among Insured Adults — the United States, 2019–2020.”

What is already known about this topic?

Direct-acting antiviral (DAA) treatment is recommended for nearly all persons with hepatitis C and cures ≥95% of cases. Treatment saves lives, prevents transmission, and is cost saving.

What is added by this report?

Treatment rates are low overall and vary by age and insurance payor. DAA treatment is lowest among young adults aged 18–29 years and Medicaid recipients, and within Medicaid, among persons reporting Black or other race and persons in states with treatment restrictions.

What are the implications for public health practice?

Timely initiation of DAA treatment, regardless of insurance type, is critical to reducing viral hepatitis–related mortality, disparities, and transmission.

Also of note,

Across insurance types, ≥75% of persons treated initiated treatment within 180 days after diagnosis. The smaller percentage of persons treated within 180 days after diagnosis might indicate lack of access to a hepatitis C treatment provider, insurance denial, or loss to follow-up. Treatment coverage can be increased by providing integrated care, patient navigation, and care coordination (15). The introduction of simplified hepatitis C treatment algorithms reducing the number of laboratory tests and in-person visits can facilitate patient-centered treatment (20).

From the U.S. Healthcare business front

  • The Food and Drug Administration issued “a final rule to improve access to hearing aids which may, in turn, lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without needing a medical exam, prescription or a fitting adjustment by an audiologist.” The rule will take effect in 60 days / mid-October.
  • STAT News reports Merck has cut a deal to enter the mRNA market.

On Tuesday, the company announced a deal to develop mRNA-based vaccines and therapies with Orna Therapeutics, a Cambridge-based startup that launchedduring the pandemic with a slightly different take on mRNA technology. Merck will pay Orna a $150 million upfront fee, invest $100 million in a new funding round for the company, and offer $3.5 billion in longer-term milestones.

  • The American Hospital Association tells us.

Hospital patients are sicker and more medically complex than they were before the COVID-19 pandemic, driving up hospital costs for labor, drugs and supplies, according to a new AHA report.

“Combined with rapidly rising economy-wide inflation and reimbursement shortfalls, these mounting costs are threatening the financial stability of hospitals around the country,” the report notes.

Hospital patient acuity as measured by average length of stay (ALOS) rose almost 10% between 2019 and 2021, including a 6% increase for non-COVID-19 Medicare patients as the pandemic contributed to delayed and avoided care, the report notes. For example, ALOS rose 89% for patients with rheumatoid arthritis and 65% for patients with neuroblastoma and adrenal cancer. In 2022, patient acuity as reflected in the case mix index rose 11.1% for mastectomy patients, 15% for appendectomy patients and 7% for hysterectomy patients.

These increases have occurred at a time of significant financial challenges for hospitals and health systems, which have still not received support to address the delta and omicron surges that have comprised the majority of all COVID-19 admissions. As a result, AHA is asking Congress to halt its Medicare payment cuts to hospitals and other providers; extend or make permanent certain waivers that improve efficiency and access to care; extend expiring health insurance subsidies for millions of patients; and hold commercial insurers accountable for improper and burdensome business practices.

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the federal policy front, Fierce Health tells us about four healthcare policy changes beyond government negotiation of a subset of Medicare-covered drugs and extension of ACA subsidies found in the budget reconciliation bill that Congress approved last week. The President is scheduled to sign the bill into law tomorrow.

Here are four other health policy changes to look for in the bill:

  • First, expands eligibility for the full amount of low-income Part D subsidies from 135% of the federal poverty line to 150% of the FPL.
  • Gets rid of the cost-sharing for adult vaccines for Medicare Part D. The FEHBlog has personal experience with this one. In 2020 he received the new Shingrix vaccine under Medicare Part D. The vaccine was eligible for no cost sharing when administered in-network under the Affordable Care Act. However, under Part D, the FEHBlog was charged $200 for each of the two doses. This big bowl of wrong will be remedied in 2023.
  • Delays the controversial Part D rebate rule, again. “The Trump-era rule would eliminate the safe harbor for Part D rebates, leaving them open to prosecution under federal anti-kickback laws. The rule passed at the tail end of Trump’s term but has never gone into effect. The law would delay the rule from going into effect again into 2032.”
  • Limits the premium growth on Medicare Part D to no more than six percent a year from 2024 through 2029. “The cap on premium growth is intended to mitigate the impact of other changes to Part D, said Ryan Urgo, managing director of the policy practice at consulting firm Avalere Health. The legislation includes a $2,000 out-of-pocket cost cap on Part D drugs, spread out in installments for the beneficiary over a calendar year. Part D plans will also have to pick up more of the costs for spending in the catastrophic coverage phase, which a beneficiary reaches when their drug costs reach a certain level.”

From the Omicron and siblings front, BioPharma Dive informs us

British drug regulators on Monday approved a two-pronged vaccine from Moderna that’s designed to fight both the original version of the coronavirus and the omicron variant.

The decision makes the U.K. the first country to clear a COVID-19 booster that’s been specifically tailored to a newer form of the virus. While the original shots, like Moderna’s Spikevax, remain strongly effective at preventing hospitalization and death, they’ve had a harder time warding off infections from omicron and its subvariants. * * *

Speaking to a [U.S.] advisory committee in June, executives from Moderna and Pfizer said dual-acting boosters with a BA.4 or BA.5 could be available in large volumes in October and November, although they would first need to undergo regulatory review before they could be administered.

Separately, Novavax on Monday asked the FDA to authorize its COVID-19 vaccine as a booster shot in people 18 and older. The shot is only available as a primary series to those who haven’t yet been vaccinated.

The Centers for Disease Control released updated guidance on what to do if exposed to Covid.

The Wall Street Journal reports on assessing Covid-19 risks after easing CDC guidelines, which began last week. The headline notes, “More decision-making is shifting to individuals, and here is what doctors recommend.”

From the monkeypox front, the Journal discusses “What to Know About Symptoms, Vaccines and How It Spreads,” and Beckers Hospital Review offers five monkeypox updates, including a complete explanation of how the World Health Organization is going about changing the disease’s name.

From the mental healthcare front, about ten years ago, the FEHB Program under OPM’s leadership was the first large employer-sponsored program to cover a form of autism therapy called “applied behavior analysis” (ABA). A STAT News investigation discloses

ABA has long been viewed as the gold standard for kids with autism, so much so that every state mandates insurance coverage. For some families, it is the only option that insurance will cover at all. 

But like other pockets of the health care industry, this one has been transformed over the past decade by a flood of investments from private equity firms, drawn by the promise of insurance reimbursement and the rising rate of autism in children across the U.S., now estimated at 1 in 44 kids. 

Families and clinicians who once believed fully in the promise of ABA say the financial investors’ fixation on profit has degraded the quality of services kids receive, turning it into the equivalent of fast food therapy. They’ve grown disillusioned with the industry, they told STAT.

The HHS Inspector General is auditing Medicaid claims for ABA. The final audit report is expected later this year.

From the Rx coverage front, the Drug Channel blog discloses

Here’s a summer surprise for fans of the 340B Drug Pricing Program: Drug Channels has just obtained the 2021 figures from the Health Resources and Services Administration (HRSA)! Even better, my Freedom of Information Act (FOIA) request was able to pry out detailed purchases by covered entity type. 

The data tell a familiar story. For 2021, discounted purchases under the 340B program reached a record $43.9 billion—an astonishing $5.9 billion (+15.6%) higher than its 2020 counterpart. Hospitals accounted for 87% of these skyrocketing 340B purchases.

What’s more, the difference between list prices and discounted 340B purchases also grew, to $49.7 billion (+$7.0 billion). This figure approximates the money collected by 340B covered entities.

340B advocates have been screaming that “drug companies are cutting 340B,” but the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut. 

From the U.S. healthcare business front, Beckers Payer Issues provides an interview with “Kyu Rhee, MD, a senior vice president at CVS Health and chief medical officer at Aetna. He sat down with Becker’s to discuss ongoing trends across the healthcare industry and how he is working to create a “values-based” care system through opportunities offered by a global pandemic.”

Weekend update

David Ermer–Congress, COVID-19, Mental health care, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

Congress is on a State / District work break until after Labor Day.

The Change Healthcare antitrust trial is ongoing. The judge Hon. Carl J. Nichols will be deciding the case without a jury. He was heard evidence for ten days already. The case is U.S. v UnitedHealth Group et al., 22-cv-481, U.S. District Court for the District of Columbia.

From the Omicron and siblings front, Bloomberg Prognosis informs us

Scientists fear that the omicron shots coming this fall won’t be all that much better at keeping people from getting Covid than the shots we already have. That’s pushing drugmakers to start working on next-generation vaccines that don’t have to be updated that often, if at all, writes Bloomberg’s Madison Muller, Riley Griffin and Fiona Rutherford. 

“Even with the highly flexible platform of mRNA, which is more flexible than virtually anything we’ve had before, it’s going to be very difficult to keep up with the pace of newly evolving variants,” Anthony Fauci, President Joe Biden’s chief medical adviser told Bloomberg. “Which gets us to the question: What about a pan-coronavirus vaccine?”

Aim high.

From the monkeypox front, the World Health Organization has renamed the disease that is quite bland.

Consensus was reached to now refer to the former Congo Basin (Central African) clade as Clade one (I) and the former West African clade as Clade two (II). Additionally, it was agreed that the Clade II consists of two subclades. 

A clade means “a group of organisms believed to have evolved from a common ancestor, according to the principles of cladistics, e.g., “the great ape and human clade.” How will WHO distinguish between the monkeypox clade and the chickenpox clade? Time will tell.

From the U.S. healthcare business front, Fierce Healthcare tells us

Humana will acquire a Wisconsin managed care plan in a bid to bulk up its Medicaid services, the insurer announced Friday.

Inclusa, Inc. offers long-term care coverage as well as supporting 16,600 older adults and adults with disabilities in Wisconsin’s Family Care program. The managed care organization has worked with local providers and community resources for more than 20 years to connect members with necessary support and services.

Inclusa partners with more than 6,000 service providers across about 40 service categories, as well as contracts with the state to provide family care services in 68 of Wisconsin’s 72 counties, according to the announcement.

The Wall Street Journal offers two expert interviews on mental health issues:

Check them out.

Speaking of eating, Forbes offers the five best diets for people with diabetes in 2022.

NPR reports on initial experience with the 988 lifelines.

The 988 hotline is the nation’s most comprehensive mental health crisis service and can provide crucial help to those in emotional distress. If you’re thinking about suicide but not taking steps to act on it, 988 is unlikely to call law enforcement without your consent. Instead, 988 counselors can provide resources, referrals and a kind ear. However, if you’re at imminent risk and could act on a plan to kill yourself, police may be called, and you could be taken to a hospital involuntarily.

Sonyia Richardson, a licensed clinical social worker who owns a counseling agency that serves mostly Black and brown clients in Charlotte, N.C., said she didn’t immediately tell her clients about 988 when it launched. Even though she’s a member of her state’s 988 planning committee, she said she needed time to develop trust in the service herself. When she learned at a recent committee meeting that fewer than 5% of 988 calls in North Carolina led to a law enforcement response, she felt reassured.


Friday Stats and More

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

Based on the Centers for Disease Control Covid Data Tracker and using Thursday as the first day of the week, here is the FEHBlog latest weekly chart of new Covid cases:

Note: the massive surge on the left is the original Omicron surge, but the label didn’t carry over from the spreadsheet to the FEHBlog.

The CDC’s weekly review of its Covid statistics tells us

As of August 10, 2022, the current 7-day moving average of daily new cases (103,614) decreased 13.8% compared with the previous 7-day moving average (120,151). * * *

CDC Nowcast projections* for the week ending August 13, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100% with the predominant Omicron lineage being BA.5, projected at 88.8% (95% PI 87.5-90.0%). The national proportion of BA.4 is projected to be 5.3% (95% PI 4.9-5.7%), BA.4.6 is projected to be 5.1% (95% PI 4.1-6.4%), and BA.2.12.1 is projected to be 0.8% (95% PI 0.7-0.9%).

Here’s the CDC’s Daily Trends in Number of New COVID-19 Hospital Admission chart from its weekly review.

The CDC’s weekly review adds, “The current 7-day daily average for August 3–9, 2022, was 6,003. This is a 2.6% decrease from the prior 7-day average (6,163) from July 27–August 2, 2022.”

Here’s the FEHBlog latest daily chart of new Covid deaths for 2022:

Unfortunately, both labels fell off this chart. The missing label under the horizontal axis 3 -5 reads Omicron, and the missing label over weeks 14 – 17 reads Omicron’s siblings. The CDC’s weekly review adds, “The current 7-day moving average of new deaths (400) has decreased 6.7% compared with the previous 7-day moving average (429).”

New cases, new admissions and new deaths have plateaued and are trending down.

Here’s the FEHBlog’s weekly chart of Covid vaccinations distributed and administered from the first week of the Covid vaccination era in December 2020 to this week.

Administered vaccines jumped back up to over 2 million this week. The CDC’s weekly review adds.

Overall, about 262.0 million people, or 78.9% of the total U.S. population, have received at least one dose of vaccine. About 223.5 million people, or 67.3% of the total U.S. population, have been fully vaccinated.* Of those fully vaccinated, about 107.9 million people have received a booster dose,** but 50.0% of the total booster-eligible population has not yet received a booster dose.

MedPage Today informs us

COVID-19 mRNA vaccines have been safe for pregnant women, according to observational data from a large Canadian study.

In fact, the pregnant women reported fewer serious health events than non-pregnant women in the 7 days following vaccination and a similar number of events as a control group of unvaccinated pregnant respondents, as researchers led by Manish Sadarangani, DPhil, of the BC Children’s Hospital Research Institute in Vancouver, reported in The Lancet Infectious Diseases.

The Wall Street Journal reflects on yesterday’s CDC easing Covid restrictions intended to shut down the disease, a state which will not happen anytime soon.

Federal health officials’ move this week to relax pandemic precautions gave business leaders the momentum many have been looking for to return to pre-Covid behaviors.

The new guidelines, issued Thursday by the Centers for Disease Control and Prevention, generally bring the federal guidance in line with policies that had already shifted at companies, schools and public transportation, among other settings. The agency said it no longer recommends that people quarantine after being exposed to the virus, as long as they don’t feel sick, get tested after five days and wear a high-quality mask around others for 10 days.

Many executives and city leaders who had been struggling to break pandemic work-from-home habits see this as a boost to their halting efforts to bring people back into the workplace. They say that previous CDC recommendations made it difficult to enforce their policies, since one exposure could send an entire team home.

It’s worth noting that the CDC issued the revised guidance even though its Spring 2022 innovation based on community levels of the Covid is blinking red.

Overall, 51 out of 52 jurisdictions* had high- or medium-level counties this week. Nevada is the only jurisdiction to have all counties at low Community Levels.

To check your COVID-19 Community Level, visit COVID Data Tracker. To learn which prevention measures are recommended based on your COVID-19 Community Level, visit COVID-19 Community Level and COVID-19 Prevention.

The American Hospital Association calls our attention to another aspect of the Administration’s revised guidance:

The Food and Drug Administration yesterday advised people who get a negative result from an at-home COVID-19 antigen test to test themselves again after 48 hours to reduce the risk of missing an infection and spreading the virus to others.

“Today’s recommendations are based on the latest study results from people with likely omicron infection showing that repeat testing after a negative at-home COVID-19 antigen test result increases the chance of an accurate result,” the agency said

Govexec brings us up to date on the ongoing litigation against the federal government’s Covid vaccination mandate

Remember the vaccine mandate for federal contractors that President Biden issued last September? 

Well, several legal challenges are ongoing: there have been six injunctions issued, one of which was national, and the federal government has appealed them all, as outlined in a post from the law firm Bradley Arant Boult Cummings LLP last week. 

Ambika Biggs, a partner at the law firm Hirschler who specializes in government contracting, told Government Executive earlier this week the matter is likely to be appealed to the Supreme Court, especially if there is a circuit split on decisions.

These cases really “come down to the interpretation of the Federal Property and Administrative Services Act, which is just called the Procurement Act” and “whether President Biden had authority under that act to issue the executive order that put the federal contractor mandate in place,” said Biggs. The main argument she’s seen in the pleadings is that “there wasn’t a close enough nexus between wanting an economical and efficient system for procurement and the actual vaccine mandate,” and the mandate was more about public health, which is usually under states’ jurisdiction. 

The FEHBlog does not expect this issue to get to the Supreme Court.

From the monkeypox front, Beckers Payer Issues recounts seven payer reactions to the announcement of a public health emergency.

From Capitol Hill, the American Hospital Administration reports

The House today voted 220-207 [along party lines] to pass the Senate’s [budget reconciliation bill] (H.R. 5376), sending it to President Biden for his signature. Passed by the Senate Sunday, the roughly $700 billion social spending package would extend for three years the American Rescue Plan Act’s expanded subsidies for coverage purchased through the Health Insurance Marketplaces; allow Medicare to negotiate prices for insulin and certain other drugs; implement tax changes and spending subsidies to address climate change; and reduce the deficit, among other provisions.

The International Foundation of Employee Benefit Plans offers six aspects of the legislation that are relevant to employers and health plan sponsors.

While the prescription drug provisions of the law are tied only to Medicare Parts B and D, employers and plan sponsors that provide retiree health care benefits, especially through employer group waiver plans (EGWPs), will want to be familiar with this legislation and its impact. They may wish to discuss changes with their advisors to see how their plans may be affected.  

That’s good advice.

From the U.S. healthcare costs front, the benefits consulting firm Mercer announced

US employers expect health benefit cost per employee to rise 5.6% on average in 2023, according to early results from Mercer’s National Survey of Employer-Sponsored Health Plans 2022, which launched June 22 this year and remains open. 

While significantly higher than the increase of 4.4% projected for 2022, the 2023 increase lags overall inflation, which is currently running at about 9% (see Figure 1). According to Sunit Patel, Mercer’s Chief Actuary for Health and Benefits, “Because health plans typically have multi-year contracts with health care providers, we haven’t felt the full effect of price inflation in health plan cost increases yet. Rather it will be phased in over the next few years as contracts come up for renewal and providers negotiate higher reimbursement levels. Employers have a small window to get out in front of sharper increases coming in 2024 from the cumulative effect of current inflationary pressures.” 

From the U.S. healthcare business front, Becker’s Payer Issues reports

Humana has completed the sale of a 60 percent stake in its subsidiary Kindred at Home’s hospice and personal care business to the private equity firm Clayton, Dubilier & Rice. The divisions have been restructured into a standalone company, according to an Aug. 11 Humana news release.  The $2.8 billion deal was first announced in April.  “Humana will continue to support the long-term success of these operations through our minority ownership and ongoing strategic partnership,” CFO Susan Diamond said in the news release.

and

Health Care Service Corp. has signed an agreement to purchase Trustmark Health Benefits from employee benefits firm Trustmark for an undisclosed amount. HCSC, the parent company of BCBS Illinois, Montana, New Mexico, Oklahoma and Texas, said in an Aug. 11 news release the acquisition would allow the company to serve more members that desire more customizable health benefits. Trustmark Health Benefits provides voluntary benefits, fitness management products and small group plan administration. The Lake Forest, Ill.-based company said no changes to benefits for existing members will occur when the deal is expected to close later this year.

Fierce Healthcare adds

UnitedHealthcare is rebranding one of its fastest-growing health plan designs. Surest plans, first launched in 2016 as Bind, are available nationwide for self-funded employers and in 11 states for fully insured plans. UHC said it plans to make Surest available as an option for fully insured customers in five more states by the end of the year. Surest plans have the fastest growth rate among its employer-sponsored plan designs, the insurance giant said Thursday.

Midweek update

David Ermer–Congress, COVID-19, COVID-19 testing, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the Capitol Hill front, Health Affairs Forefront offers articles from

  • Prof. Katie Keith on the Affordable Care Act provisions in the budget reconciliation bill (H.R. 5376) that the House of Representatives will take up on Friday, and
  • Prof. Rachel Sachs on the Democrats’ drug pricing proposal in that bill.

The FEHBlog found information in Prof. Sachs’ article about the proposed $35 cap on insulin copayments.

[T]he IRA was drafted to include a $35 out-of-pocket cap on insulin not only for Medicare beneficiaries, but also for privately insured patients. The parliamentarian ruled that the application of this out-of-pocket cap to privately insured patients did not comply with the reconciliation rules. Rather than unilaterally remove this provision (as the Democrats did with the inflationary rebate provision), Democrats chose to advance the bill with the provision included. Republican Senators then chose to challenge its inclusion, and 43 Republicans voted to strip the $35 out-of-pocket cap for privately insured patients from the bill, enough to result in its removal. (Although seven Republicans voted with all 50 Democrats to keep the cap, the provision needed 60 votes to remain in the bill.)

The Hill adds “Senate Majority Leader Charles Schumer (D-N.Y.) said Monday night that he is going to bring a $35 cap on [non-Medicare] patients’ insulin costs back up for a vote this fall after Republicans blocked it over the weekend.”

Roll Call discusses the cost shifting between Medicare and other insurance programs, including the FEHBP, once the law is enacted and takes effect. Medicare does not negotiate prices with providers; it sets them.

Govexec informs us

President Biden announced on Wednesday his intent to appoint a prominent surgeon and professor who has been at the vanguard of advances in cancer treatment to lead the federal government’s main agency for cancer research and training. 

The president will appoint Dr. Monica Bertagnolli to be director of the National Cancer Institute, part of the National Institutes of Health, which has about 4,300 employees and had a $6.35 billion budget in fiscal 2021. She is currently the Richard E. Wilson professor of surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer and Sarcoma Disease Centers at Dana-Farber Cancer Institute, a top cancer hospital. Bertagnolli will be the first woman to hold this position.

“Throughout her career, Dr. Bertagnolli has been at the forefront of the field of clinical oncology, advancing, in particular, current understanding of the gene that promotes gastrointestinal cancer development,” said an announcement from the White House. “As a physician-scientist, she led gastrointestinal science initiatives from 1994 to 2011 within the [National Cancer Institute]-funded Cancer Cooperative Groups.” She also served as the chief of the division of Surgical Oncology for the Dana-Farber Brigham Cancer Center from 2007 to 2018. 

Good luck, Dr. Bertagnolli.

From the omicron and siblings front, Forbes reports

Pfizer and BioNTech have completed clinical trials for vaccines that include specific protection against the original omicron variant. Now the two companies have begun testing for vaccines specific to the BA.4 and BA.5 Omicron subvariants, which are the fastest spreading variants of Covid-19 in the United States. Manufacturing for the new vaccines has already begun, and could be rolled out as early as October pending regulatory approvals. That’s good news as we approach the fall and winter, which have been the times of year where Covid spread is at its highest. Competitor Moderna has also begun testing an omicron-specific booster, but the FDA has not yet authorized any Omicron-specific vaccines.   

and

Researchers have identified monkey antibodies that are effective against numerous Covid variants and other coronaviruses, a discovery that could help scientists develop better vaccines and prepare for future pandemics as pharma firms race to update their shots.

If the monkey antibodies research is successful, then the WHO definitely should change monkeypox’s name.

From the medical research front, STAT News tells us

With the tumultuous rollout of Aduhelm behind them, partners Biogen and Eisai have the rare opportunity for a do-over, with all-important data on their next Alzheimer’s disease therapy expected next month.

By the end of September, the world will learn whether lecanemab, another treatment aimed at toxic brain plaques called amyloid, can significantly slow the cognitive decline that characterizes Alzheimer’s.

The outcome is vitally important for millions of patients awaiting a medicine that can meaningfully impact the disease, and success could spell a massive financial windfall for Biogen and Eisai. Failure would damage — though not destroy — the idea that targeting amyloid might ever make for an efficacious treatment.

Fingers crossed for a successful outcome.

From the U.S. healthcare business front, Fierce Healthcare reports

Amazon Care, which currently offers virtual health visits, in-person primary care visits at patients’ homes or offices and prescription delivery, is adding behavioral health care to its slate of services.

Amazon’s health service business plans to team up with teletherapy startup Ginger as an optional add-on to Amazon Care. Through the partnership, Amazon Care users will be connected to Ginger’s on-demand mental health services including behavioral health coaches, licensed therapists and psychiatrists, according to a live website about the service. * * *

The new service hasn’t launched yet, according to people familiar with the matter, Business Insider reported.

As an aside, Smart Brief discusses telemedicine in pediatrics.

Fierce Health also tells us

A company with a long history of providing medical supplies for chronic conditions is expanding its business into monitoring and coaching services for diabetes patients.

CCS, which now includes CCS Medical and CCS Health, aims to provide a more integrated experience for chronic care management, Tony Vahedian, CEO of CCS, said in an interview. * * *

“We believe we’re in the appropriate position to really take that fragmented experience and make it an integrated, seamless experience because not only can we deliver the products at the time, but we also can coach them and provide that clinical care,” the CEO noted. CCS can combine its home-delivered medical supplies business with accredited clinicians supported by proprietary data and technology to simplify the patient experience, he added. 

The company supports more than 200,000 patients living with chronic conditions in the U.S. and delivers more than 1.2 million shipments of medical supplies to patients in their own homes.

From the nudging front, Health Payer Intelligence shares another survey illustrating that participants in employer-sponsored health plans need more help with health plan literacy.

Tuesday Tidbits

David Ermer–AHRQ, COVID-19, HSA, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

The Wall Street Journal reports

A federal judge approved Blue Cross Blue Shield companies’ settlement of a sweeping antitrust suit filed on behalf of their customers, with the insurers agreeing to pay $2.67 billion and change certain practices that allegedly limited competition. * * *

Under the settlement, the Blue insurers would drop a Blue Cross Blue Shield Association rule that limits the share of each company’s total national revenue that can come from business that isn’t under Blue brands.

That change could increase competition among the companies if they choose to expand their non-Blue lines of business in one another’s geographies, insurance experts said.

The settlement would also loosen a rule that had limited the Blue insurers’ ability to compete with one another for the business of large national employers. Under the changes, certain national employers would be able to also request a bid from a second Blue insurer of their choice, setting up competition between the two Blues.

However, the settlement stops short of unwinding the Blues’ licensing setup that grants exclusive geographic branding rights to companies—the main original focus of the litigation. * * *

A spokeswoman for the Blue Cross Blue Shield Association said it was pleased with the approval, and is committed to finalizing and implementing the agreement.

The settlement should be implemented beginning in 30 days. There are limited appeal rights for class members. The Journal adds, “The Blue insurers still face a second, parallel antitrust suit filed on behalf of doctors, hospitals and other healthcare providers.”

From the Omicron and siblings front, the New York Times offers advice on how to manage Omicron BA.5 symptoms, including sore throats, from home.

From the monkeypox front, Becker’s Hospital Review provides a state-by-state breakdown of U.S. monkeypox cases and offers physician perspectives on the monkeypox cases that they are treating. “‘The biggest misconception is that this is always a mild disease,’ Jason Zucker, MD, an infectious diseases specialist at NewYork-Presbyterian/Columbia University Irving Medical Center in New York City, said during an Aug. 5 call with reporters.”

Govexec reports that the FDA implemented its plan to significantly extend the supply of the preferred monkeypox vaccine. Bloomberg Prognosis provides more medical details on this development.

From the Rx coverage front, Fierce Healthcare discusses Optum’s latest drug development pipeline report and STAT News reports

For only the second time, Pfizer is offering a warranty for a medicine that will cover the cost for any patient or health plan if the medication fails to work, a move that expands an effort to appease concerns about high drug costs.

The newest warranty program began last month and covers Panzyga, which was approved last year in the U.S. to treat a rare neurological disorder called chronic inflammatory demyelinating polyneuropathy, or CIPD. Patients can get repaid for four treatments — up to $16,500 each, or a maximum of $50,000 — if use is discontinued for clinical reasons. And insurers can also get reimbursed for their own outlays.

Unlike the first warranty program — which Pfizer began a year ago for its Xalkori lung cancer treatment — this newest warranty is only available to patients who are covered by commercial insurance or pay cash, not government health care programs.  The Xalkori program is available to patients who are covered by commercial insurance or those who pay cash but are also covered by Medicare.

And how about an Rx coverage tidbit? Bayer tells us with understandable pride

This year, acetylsalicylic acid (ASA), the active ingredient that brought Aspirin to fame, celebrates its 125th anniversary. On August 10, 1897, Dr. Felix Hoffmann discovered the ideal formula for acetylsalicylic acid when he synthesized the first chemically pure and stable form of acetylsalicylic acid. * * *

Hoffmann’s breakthrough was entered in the trademark register of the Imperial Patent Office in Berlin in 1899 and received a patent in the USA the following year, and scientists continue to conduct research even to this day on Aspirin, other potential areas of application, and dosage forms. In 1969, the round tablet made its way to the moon with the astronauts in the Apollo 11 capsule.

From the U.S. healthcare business front, MedCity News examines CVS Health’s expansion into the primary and homecare markets.

From the plan design front,

  • AHRQ’s Medical Expenditure Panel released a survey on trends in health insurance at private employers, 2008 – 2021.
  • The International Foundation of Employee Benefit Plans offers four steps for evaluating your plan’s diabetes coverage.
  • The Congressional Research Service updated its health savings account report.

From the telehealth and fraud, waste and abuse fronts

Healthcare Dive informs us

More patients turned to telehealth to see a doctor in May than April, in step with an increase in COVID-19 cases reported to the Centers for Disease Control and Prevention, according to Fair Health’s latest monthly tracker of private insurance claim lines.

Virtual visits rose 10.2% in May, accounting for 5.4% of all medical claim lines in the month, compared to 4.9% in April, Fair Health said Monday. It was the second straight month that telehealth’s share of claims grew.

COVID-19 made the list of top five telehealth diagnoses in every region of the country in May, holding in the No. 2 spot in the Northeast while climbing to second place in the Midwest and West and third place in the South.

STAT News delves into how telehealth fraud concerns could impact the industry’s future.

In Postal Service news, Federal News Network reports that USPS is eyeing mail price increases for January 2023.

USPS Chief Financial Officer Joe Corbett said the agency remains “in a financial hole,” and that more progress under the 10-year reform plan is needed.

“While we have accomplished a tremendous amount executing on the [Delivering for America] plan, we still have a lot of work to do. We need to continue executing the management initiatives in our Delivering for America plan to fill this hole and return to Postal Service to continuous self-sustaining financial health,” Corbett said.

[Postmaster General] DeJoy said USPS contributions to the retirement health care plan for its employees, under Postal Service Reform Act, will resume in 2026, and will grow to about $6.7 billion a year.

“We will not be able to make these payments unless we timely engage and accomplish all our initiatives, and we are trying to do just that,” DeJoy said.