Midweek update

Telehealth

Midweek update

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Federal employment benefits, Government Contracting, Mental health care, OPM, Patient safety, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Capitol Hill, the Wall Street Journal reports

Senate Democrats celebrated their win in Georgia giving them 51 seats next year, a result that enhances their power by allowing them to more easily advance President Biden’s nominees while also providing slightly more flexibility on legislation.

Sen. Raphael Warnock’s win in a runoff election over GOP challenger Herschel Walker comes after two years in which Vice President Kamala Harris provided a tiebreaking vote in the 50-50 Senate. * * *

Since early 2021, the two parties have been operating under a power-sharing agreement with evenly divided committees, which has prevented Democrats from issuing subpoenas to witnesses without GOP support. When nominees have tied in a committee vote, Democrats have been forced to hold an extra procedural vote to finalize their nomination. The Warnock victory will give Democrats a narrow majority on each panel.

“It’ll be easier for Democrats to move forward with some of their nominees, particularly in the judiciary, and that makes it more difficult for us,” said Sen. Mitt Romney (R., Utah). 

Roll Call informs us

The newly minted defense authorization bill for fiscal 2023 [NDAA], made public Tuesday night, provides a shot in the arm to the U.S. defense budget but bars the military from discharging any more troops who refuse COVID-19 vaccine shots in their arms. * * *

[This bill has been approved by a House-Senate conference committee.] The House is expected to vote on the NDAA as soon as Thursday and the Senate to soon follow suit, perhaps next week.  

The bill would authorize a 4.6 percent across the board pay increase for military personnel and civilians. However, House and Senate negotiators removed a House-passed “inflation bonus” of an additional 2.4 percent for troops and Defense Department civilians making less than $45,000 a year. * * *

Also of note, the bill would ban contractors across the government from using Chinese-made semiconductors, after a lengthy phase-in period, an aide with knowledge of the provision said Tuesday. Many federal contractors and other businesses say they are unclear how they will comply.

 Govexec offers two more insights on the NDAA

Congressional negotiators on Tuesday night finally revealed a compromise version of the annual defense policy bill with the aim of passing it through both the House and Senate this week. But to some lawmakers, federal employee groups and good government experts’ chagrin, the measure did not include [Insight link] a provision aimed at blocking Republican-led efforts to strip potentially tens of thousands of federal employees of their civil service protections.

and

The authorization bill compromise text contains provisions [Insight link] that seek to increase transparency and accountability of investigations into Inspectors Generals [IG] and operations of the Council of Inspectors General on Integrity Efficiency (and its integrity committee, specifically); ensure IGs are only removed for justiciable and compelling reasons (and Congress is notified); and limit who can serve as acting IGs. There are also stipulations for notifying Congress when an agency doesn’t provide requested information or assistance to an IG and providing more training opportunities for IGs. 

In an effort to address persistent watchdog job vacancies, the bill’s text states: “If the president fails to make a formal nomination for a vacant inspector general position that requires a formal nomination by the president to be filled within the period beginning on the later of the date on which the vacancy occurred or on which a nomination is rejected, withdrawn, or returned, and ending on the day that is 210 days after that date, the president shall communicate, within 30 days after the end of such period and not later than June 1 of each year thereafter, to the appropriate congressional committees.” 

From the federal employee benefits front —

FedWeek gives us last minute guidance on the Federal Employee Benefits Open Season that ends next Monday December 12.

The Wall Street Journal offers ideas for use of flexible spending account dollars. The article make a point that was not on the FEHBlog’s radar screen:

This year’s December FSA spending crunch could be worse than usual. While you’re meant to empty your FSA every year, during the pandemic the government relented on this rule, allowing FSA savers to roll over what they saved in 2020 and 2021, with some accounts swelling to more than $7,000. 

That special treatment is set to end in 2022, meaning if you have been accumulating money in your FSA, you may need to empty our account by Dec. 31 or you risk losing it all. “Some people might be in for a rude surprise,” says Spiegel.

Employers are permitted to give workers a little wiggle room—but not much. Some plans include a rollover provision that allows account holders to carry forward a small portion of their savings, although this amount is limited to $570 for 2022. Other plans may allow a spending grace period of up to 10 weeks.  

From the infectious disease front —

  • The Wall Street Journal brings us up to date on Omicron treatments.
  • The Hill reports on the state of the flu and RSV surges. “Dr. Andrew Pekosz, a virologist and professor at Johns Hopkins Bloomberg School of Public Health, believes the U.S. is still in the “early stages” of a surge in influenza cases, he told Nexstar. * * * “With RSV we seem to be hitting a plateau,” said Pekosz. “Case numbers have not increased significantly for a couple of weeks, but they’re still at a very high level. So the burden of RSV is still great, but we may be closer to the peak there than we are with flu.”
  • Forbes relates, “A newly discovered immune response inside the nose could explain why respiratory illnesses like RSV, Covid, the common cold and flu thrive in winter, according to research published Tuesday in The Journal of Allergy and Clinical Immunology, a finding that challenges the conventional wisdom that infections spread because people are stuck indoors and signposts ways to develop new treatments.”

From the Rx development and coverage front

  • MPR informs us “The Food and Drug Administration (FDA) has granted Fast Track designation to PH10 for the treatment of major depressive disorder (MDD). * * * Results showed that treatment with PH10 significantly reduced depressive symptoms as early as 1 week based on the 17-item Hamilton Depression Scale (HAM-D-17) scores compared with placebo (P =.022). The intranasal spray was found to be well tolerated, with no serious adverse events reported.”

Touted by celebrities, raved about by TikTok users, and advertised by med spas, a new class of drugs for treating diabetes and obesity has exploded in popularity for its weight-loss effects, leading to rippling shortages across several of the medications.

Amid the surge in demand, Eli Lilly and pharmacies have started to tighten access to the latest of this type of drug, tirzepatide, focusing on giving it to people with type 2 diabetes, the only population it’s authorized for so far. But that’s left another set of patients scrambling — people with clinical obesity who turned to the medication as one of their few options for treatment. * *

There’s much overlap between the two conditions, said Beverly Tchang, an endocrinologist and assistant professor of clinical medicine at Weill Cornell Medicine. “Obesity can lead to diabetes, diabetes can lead to obesity,” she said. “They’re very much intertwined, and to treat one but not the other seems inequitable.” Tchang treats both types of patients and feels the drug shouldn’t be conserved for one group at the expense of the other.

From the telehealth front, mHealth Intelligence explains

FAIR Health’s Monthly Telehealth Regional tracker reported no change in telehealth usage in September compared with August and noted that COVID-19 fell in its rankings on top telehealth diagnoses lists in all regions and at the national level.

The FAIR Health Monthly Telehealth Regional tracker is a complimentary service that analyzes how telehealth activity and use change monthly by tracking various factors such as claim lines, procedure codes, and diagnostic categories. It represents the privately insured population, including Medicare Advantage but excluding Medicare Fee-for-Service and Medicaid beneficiaries.

From the public health front —

  • MedPage Today informs us “Drug overdose deaths in pregnancy or the postpartum period increased sharply in the U.S. in recent years, with the rise most pronounced at the start of the COVID-19 pandemic in 2020, researchers reported. * * * Jacob S. Ballon, MD, MPH, of Stanford University in California, noted that the study authors did not provide explanations for why the overdose-related death rate rose sharper among the pregnant and postpartum group during the study period, but said it will likely be the basis for further research. “[It’s] an interesting signal,” said Ballon, who was not involved with the study. “But now what do we do with that to explain it or make some sense of it?”
  • Healthcare Dive tells us
  • Increased delays in discharging patients who require additional care after a hospital stay could slow their recovery, potentially harming health outcomes and quality of life, the American Hospital Association cautioned in a report released Tuesday.
  • The inability to discharge patients is putting additional strain on hospitals operating with thin workforces, and health systems are bearing the cost of care for patients who stay excess days without appropriate reimbursement, the AHA said.
  • The association has urged Congress to help offset the costs of care for patients’ additional days in the hospital by creating a temporary per diem Medicare payment targeted to acute, long-term care, rehabilitation and psychiatric facilities.

From the U.S. healthcare business front —

Imagine going into your doctor’s office and facing not a staff of overworked doctors and nurses, but an inviting conversation. A talk with a healthcare professional who has plenty of time, isn’t in a hurry and is ready to listen to a recital of the different aches and pains of your life. Someone with expertise in medications dedicated to making your life easier and healthier. A professional who makes and then hands you a cup of coffee before you even start talking.

With that conversation–easy, low stress–you can begin a level of trust with your doctor’s office that you might not have had before. And the person listening may, in conjunction with the doctors and nurses, find some better paths to helping you get healthier, even if you suffer from a chronic disease.

That’s the vision that Fergus Hoban has for the American healthcare system. His company, UpStream, provides integrated services for primary care physicians, both independently and as part of networks or bigger healthcare systems. Centered around a prescribing pharmacist, a team of nurses and other professionals work with doctors to provide better care for Medicare patients while at the same time lowering costs.

LHC Group and UnitedHealth Group have extended their merger agreement as the feds take a deeper look at the deal.

The agreement was extended until March 28, 2023, and the two companies now expect the merger to close in the first quarter of 2023, according to a filing with the Securities and Exchange Commission.

That the insurance giant intended to acquire LHC, a home health provider, was announced in March, and the deal is valued at about $5.4 billion. UnitedHealth said it plans to fold LHC into its Optum subsidiary as part of its provider arm, Optum Health, which is one of the country’s largest employers of physicians.

LHC Group would add 30,000 employees who provide more than 12 million home health services annually.

  • Health Payer Intelligence also tells us about positive provider and payer reactions to the CMS proposed rule to promote widespread use of electronic prior authorizations. As noted here yesterday, “[t]he proposed rule would require the implementation of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard Application Programming Interface (API) and mandates that payers have to explain the specific reason behind a prior authorization denial. Expedited prior authorizations will have to occur within 72 hours and non-urgent prior authorizations will have to be turned around in seven calendar days.”

Tuesday’s Tidbits

David Ermer–CMS, Electronic health records, FDA, Medicare, Mental health care, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the Federal employee benefits front, Fedweek offers year-end benefits and tax guidance to federal and postal employees and annuitants.

From the medical research and development front,

STAT News reports, “A consensus may be emerging about how to prescribe the new Alzheimer’s drug lecanemab, according to remarks made by both a critic of other Alzheimer’s medicines and the CEO of the company that developed it.”

The National Institutes of Health announced

The protein apolipoprotein E (APOE) plays a key role throughout the body. It helps to transport cholesterol and other fatty molecules, or lipids. The gene that produces APOE comes in a few different varieties. The most common is called APOE3.

The most notorious is APOE4, which has long been linked to an increased risk of dementia in Alzheimer’s disease. People who inherit one copy of the APOE4 gene have up to a fourfold greater risk of developing Alzheimer’s disease dementia. Inheriting two copies of APOE4 elevates the risk up to twelvefold. But despite years of study, scientists have little understanding of how APOE4 affects the human brain and boosts dementia risk. * * *

[NIH] Researchers found evidence that the Alzheimer’s-related gene APOE4 disrupts cholesterol management in the brain and weakens insulation around nerve fibers.

A drug that affects cholesterol led to improved learning and memory in mice with the gene, pointing to a potential new approach for treating dementia in Alzheimer’s disease.

The Wall Street Journal reports

New research has bolstered a once-gutsy idea: Bugs in the digestive system may play a role in depression.

Two studies published Tuesday in the journal Nature Communications found a link between several types of bacteria in the gut and depressive symptoms. Trillions of microorganisms including bacteria, fungi and yeast live in the digestive tract. Research exploring whether they might affect an array of diseases has increased in recent years.

The new studies, conducted among thousands of people in two cities in the Netherlands, are among the largest to date demonstrating potential associations between gut microbiota and mental health.

“Ten years ago if you’d said there was something linking depression and the microbiome, you’d be carried out with a straitjacket,” said Jos Bosch, an associate professor of psychology at the University of Amsterdam who co-wrote both studies. “Now absolutely, it’s very clear there’s a link.”

. . . Researchers who conducted the studies in the Netherlands called their findings a preliminary step toward identifying biological indicators and therapies for depression. The precise relationship between depression and microbes in the gut couldn’t be determined, they said. Depression can cause a person to eat less healthily, Dr. Bosch pointed out, which can lead to changes in the composition of microorganisms in the gut.

“Causality is a bit up in the air,” he said. 

From the mental healthcare front, Fierce Healthcare tells us

While mental health and substance abuse issues have only grown thanks to the pandemic, a bright spot may be forming: The number of providers available to treat these concerns is increasing, a new study shows.

The United Health Foundation, the philanthropic arm of insurance giant UnitedHealth Group, released its annual “America’s Health Rankings” report and in the analysis found that between 2020 and 2021, the number of people who reported that their mental health was poor in 14 of the last 30 days increased by 11%.

In 2020, 13.2% reported frequent mental distress, and that rose to 14.7% in 2021, according to the report.

At the same time, drug-related deaths spiked. The report found that deaths increased by 20% nationwide between 2019 and 2020, reaching 27.9 deaths per 100,000. This is the largest year-over-year increase in more than a decade, according to the report.

The report also found that disparities within drug deaths increased in tandem. Such deaths increased by 45% among multiracial populations and by 43% among Black populations. Drug-related deaths were highest among American Indian/Alaskan Native populations, occurring at a rate nine times higher than the lowest group, Asian patients.

However, the analysis found that the supply of mental health providers reached its highest levels since the report was first published in 2017. The number of mental health providers per 100,000 increased by 7% between 2021 and 2022 and has increased by 40% since the 2017 report.

There are now 305 mental health providers per 100,000, according to the report.

Health Payer Intelligence adds

Having one or more outpatient behavioral health treatment (OPBHT) visits was associated with lower healthcare costs among patients with newly diagnosed behavioral health conditions, a JAMA Network Open study found.

Adults with a behavioral health condition incur 2.8 to 6.2 times greater medical costs than those without one, and nearly a quarter of adults had a behavioral health condition as of 2018. However, behavioral health condition diagnoses are often delayed, and most individuals receive little or no treatment each year.

From the Rx coverage front, STAT News tells us

During 2021, drugmakers substantially raised prices on seven widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $805 million last year, according to a new report.

The drug for which spending increased the most due to a price increase was Xifaxan, which is used to treat both irritable bowel syndrome and a complication of cirrhosis. Salix Pharmaceuticals, a unit of Bausch Health, raised the wholesale price by 7.9%. The net price — after rebates and discounts — rose by 12%, most likely because the company offered fewer concessions than previously.

Consequently, spending for this drug climbed by $174.7 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost effectiveness of medicines. The report noted that the manufacturer disputed the net price and budget impact, which was provided by the SSR Health market research firm, but did not provide corrected estimates.

Of course, PBM formularies are designed to correct these issues.

The Wall Street Journal adds

Emergent BioSolutions Inc., maker of Narcan, a nasal-spray form of naloxone, said Tuesday that the U.S. Food and Drug Administration fast-tracked an application it submitted for an over-the-counter version of its widely used opioid-reversal nasal spray.

The company said it had been working on the application for several months. Emergent said the FDA’s priority review gives the drug an expected approval date of March 29, 2023, putting it first in line for approval ahead of competitors that have announced their planned foray into the market. 

The FDA has encouraged pharmaceutical companies to apply for approval for over-the-counter versions of overdose-reversal medications such as Narcan to help confront a swelling overdose crisis from bootleg versions of the powerful opioid fentanyl.

Last week, FDA Commissioner Robert Califf said naloxone—which binds to opioid receptors to reverse the effects of opioids—should be as ubiquitous as defibrillators.

From the fraud, waste, and abuse front, mHealth Intelligence reports

As telehealth use exploded across healthcare programs provided by federal agencies, a report by a watchdog committee shows several program integrity risks linked to telehealth billing, including duplicate billing and ordering unnecessary durable medical equipment or laboratory tests.

They found that approximately 37 million individuals used telehealth services from March 2020 through February 2021 in the selected programs administered by the six federal agencies. This represents a massive increase from the 3 million individuals in these programs who used telehealth services the year prior.  

In most programs, telehealth was used primarily to access office visits with a primary care provider or specialist and for behavioral health services, like individual and group therapy and substance use disorder treatment.

Overall, the agencies spent more than $6.2 billion on telehealth services, with Medicare accounting for the highest expenditure at $5.1 billion, followed by TRICARE and the Federal Employees Health Benefits Program, which together spent $1 billion.

But the OIGs found several similar program integrity risks associated with billing for telehealth services across multiple programs. These included “upcoding” telehealth visits by billing for visits longer than they lasted, duplicate billing for the same service, ordering unnecessary durable medical equipment, supplies, or laboratory tests, and billing for services inappropriate or ineligible for telehealth.

From the plan design front, Fierce Healthcare relates

The Biden administration released a proposal which, if finalized, would mandate Medicare Advantage (MA), Medicaid managed care, Affordable Care Act (ACA) plans and state Medicaid agencies implement electronic prior authorization systems by 2026. 

The proposed rule, released Tuesday by the Centers for Medicare & Medicaid Services (CMS), will require payers and states to streamline prior authorization processes and improve the electronic exchange of health data by 2026. It also contains incentives for hospitals and physicians to adopt electronic prior authorization.

“The prior authorization and interoperability proposals we are announcing today would streamline the prior authorization process and promote healthcare data sharing to improve the care experience across providers, patients and caregivers,” CMS Administrator Chiquita Brooks-LaSure said in a statement. 

It is the revised version of a Trump administration rule originally finalized in late 2020 but withdrawn after concerns about costs and a short deadline. That rule only applied to Medicaid managed care, the Children’s Health Insurance Program and ACA plans, while the new version would apply also to MA plans. 

Monday Roundup

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

From Capitol Hill, Roll Call reports the FY 2023 National Defense Authorization Act is expected to rescind the Defense Secretary’s 2021 Covid vaccine mandate for U.S. service members. “Congressional leaders are aiming to introduce the final compromise NDAA version as soon as Tuesday, with House floor action possible later in the week.”

From the infectious disease front —

  • Bloomberg Prognosis tells about a study confirming the Paxlovid rebounds have been blown out of proportion.
  • Pfizer has asked the Food and Drug Administration for an emergency use authorization applicable to its bivalent Omicron vaccine designed for children at least six months old and not over four years old.
  • The Health and Human Services Secretary has confirmed reported plans to end the mpox public health emergency when the current declaration expires at the end of January 2023. “But we won’t take our foot off the gas – we will continue to monitor the case trends closely and encourage all at-risk individuals to get a free vaccine.”
  • MedPage Today interviews Demetre Daskalakis, MD, MPH, the deputy coordinator of the White House Monkeypox Response Team, about the course of the illness since it erupted in the summer

Influenza hospitalizations this early in the season are higher than they have been in a decade, according to the CDC, with 14 pediatric deaths reported so far.

“Since October 1, there have already been at least 8.7 million illnesses, 78,000 hospitalizations, and 4,500 deaths from flu,” said CDC Director Rochelle Walensky, MD, MPH, on a call with reporters on Monday, held in part to kick off National Influenza Vaccination Week. * * *

This year, influenza vaccines are “well matched to the viruses currently circulating,” she added. The flu shots contain protection for two influenza A and two influenza B virus strains. Of influenza A viruses detected and subtyped this season, 79% have been A(H3N2) and 21% have been A(H1N1).

The CDC recommends influenza vaccination particularly for children, immunocompromised individuals, pregnant women, and people 65 and over.

It was not clear if the pediatric deaths reported so far this season involved unvaccinated children, but Fryhofer noted that previous data showed about 80% of influenza deaths occur in unvaccinated persons.

Pregnant women who get the flu shot also protect their newborns, who are not eligible for vaccination before they are 6 months of age, Fryhofer said. “If you’re not doing it for you, do it for your baby.”

  • For context, here are the flu case and death statistics from the last flu season before Covid struck, October 2019 through March 2020.
2019 – 2020 Winter CDC Fluview  3/28/20
Flu Deaths                  24,000 
Flu Cases             39,000,000 

The flu is a highly contagious, dangerous disease.

  • NPR Shots offers consumer advice should they counter pharmacy shelves with a low or no supply of anti-fever drugs.

From the telehealth front, Health Leaders Media tells us

According to a survey commissioned by America’s Health Insurance Plans, almost 70% used telehealth in the past year because it’s more convenient than in-person care, and almost 80% say telehealth makes it easier to seek out care.

Almost 50% used telehealth because they were unable to make an in-person appointment, while 24% said they wanted to save money.

Some 36% used telehealth just once over the past year, while 53% used it between two and five times.

From the mental healthcare front, Health Payer Intelligence reports

 CareFirst BlueCross BlueShield (CareFirst) is providing community-based organizations with nearly $8 million in grants to help improve behavioral healthcare access and quality for underserved youth.

The COVID-19 pandemic exacerbated the mental and behavioral health crisis among children, adolescents, and families. In response, CareFirst is investing in 19 community-based organizations in Maryland, Washington, DC, and Northern Virginia.

“CareFirst recognizes that behavioral health is an essential part of overall health, which includes a continuum of conditions ranging from severe mental health disorders to the emotional, psychological, and social factors that affect a person’s overall wellbeing,” Destiny-Simone Ramjohn, PhD, vice president of community health and social impact at CareFirst, said in the press release.

Kudos

From the Rx coverage front, Fierce Healthcare informs us

Express Scripts, which is part of Cigna’s Evernorth subsidiary, said Monday that it will add biosimilars for Humira to its largest formularies as preferred products available for patients with inflammatory conditions. Like other major PBMs, Express Scripts sees significant potential in biosimilars to help address the massive costs associated with specialty drugs.

Specialty drugs account for just 2% of prescriptions but drive half of drug spending.

In October 2021, Express Scripts announced that it would put Semglee, the first Food and Drug Administration-approved interchangeable insulin biosimilar, on its National Preferred Formulary for 2022. The company estimates that this move generated $20 million in savings in the first year.

From the federal government employee benefits front, Federal News Network relates

The Office of Personnel Management plans to suspend applications for the Federal Long Term Care Insurance Program for two years beginning Dec. 19, in anticipation of a sizeable rate hike.

OPM announced the unusual measure last month in the Federal Register, and noted that federal workers who submit their applications by the deadline will still be considered for enrollment. FLTCIP was created in 2002 and assists with health care costs for participants who need help with daily personal functions, or who have a severe cognitive illness, and covers home care, nursing home or assisted living benefits.

“OPM is suspending applications for coverage in FLTCIP to allow OPM and the FLTCIP carrier to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency wrote.

The program will continue to operate normally for current enrollees, although they will not be able to apply to increase their coverage. There are currently around 267,000 federal workers and retirees participating in the insurance plan, and OPM typically receives only a few thousand applications to enroll per year.

The decision to suspend applications for the program came after John Hancock Life and Health Insurance Co., the contractor that administers the program, informed OPM that it is likely that there will a premium increase sometime next year.

Finally, the Wall Street Journal offers an interesting article about medical research that is “uncovering links between your ‘subjective age’ [as opposed to your chronological age] and your future health and longevity.”

Thursday Miscellany

David Ermer–ACA, CMS, COVID-19, FDA, Federal employment benefits, Medicare, No Surprises Act, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From the Federal Employees Benefit Open Season front, Tammy Flanagan, writing in Govexec, explains the relationship between FEHB and Medicare coverage for the benefit of annuitants over age 65.

From the OPM front, Govexec and Federal News Network discuss an OPM management report released yesterday that includes more details on OPM’s 2022 Federal Employee Viewpoint Survey.

From Capitol Hill, Medpage Today informs us that “Telehealth, Mental Health Likely Topics for the New Congress in 2023, Experts Say.” In this regard, today the bipartisan leadership of the Senate Finance Committee “released a [fifth and final mental health parity] discussion draft including policies aimed at improving mental health parity in Medicare and Medicaid and helping to put access to mental health and substance use disorder (SUD) services on par with physical health care. Mental health parity includes a set of laws aimed at ensuring mental and physical health care are covered equally by health insurance. * * * The full text of the discussion draft is available here. A summary of all provisions released by the committee as a part of the bipartisan mental health effort, including mental health parity, is available here.”

From the Omicron and siblings front —

Beckers Hospital Review reports

COVID-19 hospitalizations have ticked up nationwide in recent weeks amid concerns of a potential winter surge, according to data tracked by The New York Times.

As of Nov. 29, the nation’s daily hospitalization average was 31,125, up 12 percent over the last 14 days. This figure is still down significantly from the more than 800,000 daily hospitalizations recorded during the peak of last winter’s omicron surge. 

MedPage Today informs us

People with acute respiratory illness during the pandemic suffered similar levels of poor well-being in the months afterward whether they tested positive for SARS-CoV-2 or not, a registry study showed.

In a cohort of people who all had initial symptoms suggestive of COVID-19, those who had moderate to severe scores at 3 months on the pain, mood, and other quality-of-life measures on the Patient-Reported Outcomes Measurement Information System (PROMIS) scale were actually less likely to have tested positive for the coronavirus as to have had other causes of illness (39.6% vs 53.5%, P<0.001).

From the public health front —

MedPage Today explains how patients can try to distinguish among different respiratory illnesses, including RSV and the flu because at home testing is unavailable.

Politico Pulse reports

The Biden administration looks to end its public health emergency declaration for mpox — the virus formerly known as monkeypox until recently — a sign that officials believe they’ve brought the unprecedented outbreak under control, POLITICO’s Adam Cancryn reports.

Health officials are likely to issue a 60-day notice later this week for winding down the declaration, two people with knowledge of the matter told POLITICO, putting it on track to expire by Jan. 31. The decision isn’t yet final and could still change, the people cautioned. * * *

Some administration officials see the potential unwinding of the mpox emergency declaration as a test run for eventually ending the yearslong Covid emergency — a more complex challenge — that Biden aides expect to happen at some point next year.

From the Affordable Care Act and No Surprises Act front

The American Hospital Association (“AHA”) informs us

The Centers for Medicare & Medicaid Services seeks public input on topics related to essential health benefits — items and services that all non-grandfathered health plans in the individual and small group markets must cover under the Affordable Care Act. The agency is requesting feedback on how essential health benefits may need to be updated to reflect changes in medical evidence and scientific advancement, address gaps in coverage and health equity, or remove barriers to accessing services. In particular, CMS seeks feedback on essential health benefits related to maternal health, behavioral health and prescription drug coverage. The agency will publish the request for information in the Dec. 2 Federal Register, with comments accepted for 60 days. 

and

AHA today urged the Centers for Medicare & Medicaid Services not to establish a national directory of health care providers and services (NDH) at this time.

“The AHA shares CMS’ goals to improve patient access to provider information and to facilitate health information exchange and data reporting,” the association wrote. “We appreciate the commitment CMS has invested in striving to meet these objectives. However, we are concerned that adding one more provider directory requirement will not support patients in accessing the information they need about their care providers. In fact, adding an additional data source without sufficiently addressing how or why it differs from the myriad provider directories already in existence could further complicate patients’ ability to access accurate information. Meanwhile, such a requirement would add considerable, duplicative burden on providers. Additionally, we have significant reservations about the current state of readiness of the essential technology needed for a centralized data hub such as the NDH.”

Mercer Consulting offers insights on the prescription drug and healthcare spending reports that health plans must submit to the federal government by December 27. Jingle bells.

Healthcare Dive reports that the Texas Medical Association has filed another lawsuit challenging different aspect of the independent dispute resolution rule. Haven’t the TMA lawyers heard about the opportunity available under the Federal Rules of Civil Procedure to amend their existing complaint?

From the Rx coverage front —

STAT News relates

The Food and Drug Administration approved the first therapy using bacteria from stool samples to treat a bowel disorder on Wednesday, paving the way for several similar treatments in development.

The drug, called Rebyota, is given as a one-dose treatment for Clostridium difficile infections, commonly known as C. diff., in which the toxin-producing bacteria disrupts the normal balance in a person’s digestive system. Rebyota is designed to restore balance by introducing good bacteria taken from donor stool samples. 

“We are delighted that FDA has approved the first fecal microbiome restoration therapy for recurrent C. diff. This is an enormous step forward for the nearly 200,000 people who battle rCDI each year,” ​​said Christian John Lillis, the executive director of the C. diff advocacy organization the Peggy Lillis Foundation. 

and

Amgen released detailed data on Thursday suggesting an early-stage drug can induce significant weight loss in patients with obesity, with less frequent dosing than current treatments but a safety profile that remains unclear.

The results for the molecule, codenamed AMG133, throw Amgen in a long-gestating race with other major drugmakers that burst into the popular press this year.

Eli Lilly and the diabetes giant Novo Nordisk both market drugs that were recentlyshown to lower body weight by around 15% to 20% after a little over a year. (Lilly’s is currently approved only for diabetes, but it plans to submit for obesity next year.) The injectables have been highly sought after by both obesity specialist physicians, who have long searched in vain for something safe and effective to offer their patients, and celebrities hoping to look svelte in their next appearance.

From the miscellany department —

Beckers Hospital Review interviews a Kaiser Permanente expert about their successful use of remotely monitoring patients with diabetes and high blood pressure. The monitors deliver their results to Kaiser Permanente’s electronic health records for 40,000 members. Kudos.

Beckers also lets us know about large hospital systems that are having a profitable 2022.

STAT News reports

Elon Musk’s brain-machine interface company Neuralink aims to put its first implant in a human subject in the next six months, he said during an event Wednesday.

Musk said the company has been “working hard to be ready for our first human,” and has submitted most of the required paperwork to the Food and Drug Administration to launch a study in humans. The company — which is designing a device to translate the brain’s signals into actions — also announced it will first focus specifically on two applications: restoring human vision, and helping people who can’t move their muscles to control devices like smartphones or even return the ability to move to people with severed spinal cords, Musk said.

Though it’s starting with certain parts of the brain, Musk said Neuralink’s long-term goal is to create a system that can translate impulses from the entire brain into actions.

Monday Roundup

David Ermer–CDC, COVID-19, Federal employment benefits, HIPAA Privacy and Security Rules, NIH, OPM, Telehealth, U.S. Healthcare–
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.

and

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, (superagersstudy.org) 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.

Friday Stats and More

David Ermer–ACA, CDC, COVID-19, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

The Wall Street Journal again warns us about an impending tripledemic of Covid, the flu, and RSV.

The New York Times adds

As it gets colder and more people move their activities indoors, the recent decline in Covid-19 cases across the United States has started to level off. Coronavirus-related hospitalizations are ticking up in a number of states, including Arizona, Indiana, Illinois, Nevada, Nebraska, Oklahoma, South Dakota and Wisconsin. And there have been a variety of unnerving headlines about the immune evasion and increased transmissibility of the next round of coronavirus subvariants.

At least half a dozen versions of the virus are competing to become the next dominant strain in the United States, but they are part of the same family tree. “They are all offspring of Omicron,” said Dr. Albert Ko, a physician and epidemiologist at the Yale School of Public Health. Though each subvariant has slightly different mutations, none of them seem to be creating significant waves just yet, the way the Delta and Omicron variants did when they first appeared, Dr. Ko said.

From the Omicron and siblings front, the Center for Disease Control’s weekly interpretation of its Covid statistics tells us

Cases

As of November 2, 2022, the current 7-day average of weekly new cases (39,016) increased 4.7% compared with the previous 7-day average (37,261). A total of 97,604,763 COVID-19 cases have been reported in the United States as of November 2, 2022.

Variant Proportions

CDC Nowcast projections for the week ending November 5, 2022, estimate that the combined national proportion of lineages designated as Omicron will continue to be 100%. 

The Wall Street Journal points out

Two BA.5 offshoots, BQ.1 and BQ.1.1, are gaining ground in the U.S., now accounting for an estimated 35% of cases this past week, CDC data show. Researchers and health officials have flagged both BQ variants and another variant called XBB as strains to watch, in part because they might heighten the risk for reinfection or evade certain treatments.

Hospitalizations

The current 7-day daily average for October 26–November 1, 2022, was 3,272. This is a 1.0% decrease from the prior 7-day average (3,306) from October 19–25, 2022.

Deaths

The current 7-day average of new deaths (358) decreased 3.0% compared with the previous 7-day average (369). As of November 2, 2022, a total of 1,068,667 COVID-19 deaths have been reported in the United States.

Vaccinations

As of November 2, 2022, 640.9 million vaccine doses have been administered in the United States. Overall, about 266.4 million people, or 80.2% of the total U.S. population, have received at least one dose of vaccine. About 227.4 million people, or 68.5% of the total U.S. population, have completed a primary series.

Of those who have completed a primary series, about 112.5 million people have received a booster dose, and more than 26.38 million people have received an updated (bivalent) booster dose. But 49.1% of the total booster-eligible population has not yet received a booster dose. 

STAT News adds

New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday.

The companies said the levels of neutralizing antibodies that target the BA.4 and BA.5 subvariants of the SARS-CoV-2 virus were four-fold higher in people aged 55 and older who received the bivalent booster than in similarly aged people who received a monovalent booster. 

The CDC’s Fluview tells us that for the week ended last Saturday

Early increases in seasonal influenza activity continue nationwide. The southeastern and south-central areas of the country are reporting the highest levels of activity followed by the Mid-Atlantic and the south-central West Coast regions.

CDC estimates that, so far this season, there have been at least 1,600,000 illnesses, 13,000 hospitalizations, and 730 deaths from flu.

The cumulative hospitalization rate in the FluSurv-NET system is higher than the rate observed in week 43 during every previous season since 2010-2011.An annual flu vaccine is the best way to protect against flu.

Vaccination helps prevent infection and can also prevent serious outcomes in people who get vaccinated but still get sick with flu.

CDC recommends that everyone ages 6 months and older get a flu vaccine annually.

There are also prescription flu antiviral drugs that can be used to treat flu illness; those need to be started as early as possible.

Forbes informs us about the availability of an RSV immune agent

While clinical trials are currently underway to provide RSV vaccines to pregnant women in order to protect their soon-to-be newborns from RSV infections, pediatric specialists have been administering an RSV “vaccine” for years. This vaccine, called palivizumab (Synagis) isn’t actually a vaccine. It is a preventative monoclonal antibody injection which has been available to high-risk infants since 1998. 

This therapy is administered as an injectable agent, thus was given the vernacular “vaccine” term, even though it is not a vaccine, nor does it act as one. It is an immune agent, providing antibody protection from severe RSV infections in vulnerable infants. It is given as an injection every month for five consecutive months. It was shown to reduce hospitalization by an average of 50% in two large placebo-controlled double-blind studies which included a total of nearly 3,000 high-risk babies. 

[T]he American Academy of Pediatrics has presented updated guidelines for use of Synagis during any time where a particular region is experiencing a surge of RSV cases:

“With the shift in seasonality noted in 2021 and the current regional variability in interseason RSV cases, the AAP continues to support the use of palivizumab in eligible infants in any region experiencing rates of RSV activity at any time in 2022 similar to a typical fall-winter season. The AAP recommends initiating the standard administration of palivizumab, which consists of 5 consecutive monthly doses.”

From the healthcare cost front, Employee Benefits News reports

The Business Group on Health named cancer as the top driver of employer healthcare costs, a spot previously held by musculoskeletal conditions. In fact, 13% of employers surveyed say they have seen more late-stage cancers impacting their workforce, and 44% predict they will see an increase in cancer diagnoses in the future. 

Again, Kelsay points out that delays in screenings, such as mammograms and prostate exams, left many Americans to unknowingly live with cancer. An estimated 64% of Americans deferred cancer screenings in 2021, according to the American Society of Clinical Oncology. And as a condition that can take months or years to treat, cancer is incredibly costly. The National Cancer Institute estimates the average cost of medical care and drugs is approximately $42,000 in the year following a cancer diagnosis.

“A lot of cancer treatments require immunotherapies, which are very expensive pharmaceuticals, as well as hospital stays and surgeries,” says Kelsay. “Cancer is just a terribly expensive condition to have.”

EBRI offers a detailed report on out of pocket spending in employer sponsored plans.

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

Kaiser Permanente posted a $1.6 billion profit for the third quarter, which is down by nearly half from the $3 billion it generated in the previous quarter.

The 39-hospital system and health plan’s earnings, reported Friday, were affected by a major surge of COVID-19 that caused expenses to increase. Kaiser Permanente’s hospital system and health plan reported total operating revenue of $23.2 billion and expenses of $23 billion.

From the virtual care front, mHelath Intelligence reports

 Recent survey results released by Elevance Health found that most Americans who participated in virtual primary care said their experience was satisfactory and that the service effectively enabled them to manage their health.

Formerly known as Anthem Inc., Elevance Health is a health insurer. Through the survey, Elevance aimed to gather data on virtual primary care, its outcomes, and what patients think. The payer commissioned the Harris Poll to conduct an online survey of more than 5,000 US adults aged 18 and over.

Researchers found that 79 percent of study participants believed virtual primary care allowed them to take charge of their health, and 94 percent were satisfied with their experience. * * *

These survey findings come on the heels of a report released at the end of October, which found that telehealth was highly used among those engaging in primary care and mental health services. It also showed that patient satisfaction with telehealth was high.

From the miscellany department, The New York Times offers advice to insomniacs.

A good night’s sleep can make us more empathetic, more creative, better parents and better partners, according to Aric Prather, a psychologist at the University of California, San Francisco who treats insomnia and is the author of the new book “The Sleep Prescription.” Sleep can help us manage stress; it can make us competent and capable and better able to take on the day. But Dr. Prather says we too often view sleep as an afterthought — until we find ourselves frozen in the middle of the night, our thoughts racing, fumbling for rest or relief.

Thursday Miscellany

David Ermer–CDC, Congress, Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–

From the Federal Employee Benefits Open Season front, we find guidance from FedSmith, FedWeek, and My Federal Retirement.

From the unusual viruses front —

The American Hospital Association reports that

The Department of Health and Human Services today renewed the nation’s monkeypox public health emergency declaration for another 90 days. When the PHE was announced in August, Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., said the declaration would provide access to resources and flexibilities, expedite state data sharing, and provide more detailed data on testing and hospitalizations. CDC yesterday reported over 28,000 U.S. monkeypox cases since the first confirmed case May 18.

For a more current information on monkeypox, check out these articles from the Hill and MedPage Today.

From the Rx coverage front., Bloomberg reports

Hundreds of community pharmacies are having trouble filling prescriptions for amoxicillin, a common antibiotic that’s often used to treat bacterial infections in children.

Two-thirds of 333 pharmacy owners and managers who responded at the end of October to a National Community Pharmacists Association survey about drug shortages said they were having difficulty getting the antibiotic. The liquid form of the drug has been in limited supply in the US since October, according to the Food and Drug Administration, and it’s also in shortage in other countries

 

Another Bloomberg article attributes the shortage to demand due the RSV epidemic and school age children illnesses plus the generic drug’s low price.

“A lot of that risk is driven by market factors, particularly price,” explained Matt Christian, USP’s director of supply chain insights. In general, antibiotics are generic drugs that have existed for years and tend to be cheaper and have lower margins than newer drugs. That means drug companies have a lot less incentive to set up robust, resilient supply chains  and may be caught short if something goes wrong at a competing supplier.

“Lower priced drugs have a higher risk of shortage,” Christian said. “No margin, no inventory.”

An analysis by the FDA found a similar correlation: Drugs in short supply typically cost less than other medicines. * * *

“If you run out of an antibiotic as ubiquitous as amoxicillin, there is a concern that unnecessarily moving [to a more aggressive antibiotic] can further cause antimicrobial resistance,” Christian said.

Why doesn’t the federal government manufacture amoxicillin?

In other medical development news —

MedPage Today tells us

Hard thresholds for pain medication doses and duration are no longer promoted through the CDC’s new Clinical Practice Guideline for Prescribing Opioids for Pain.

The new guidance — which covers acute, subacute, and chronic pain for primary care and other clinicians — updates and replaces the controversial 2016 CDC opioid guideline for chronic pain. The 2016 guideline was interpreted as imposing strict opioid dose and duration limits and was misapplied by some organizations, leading the guideline authors to clarify their recommendations in 2019.

The 2022 recommendations are voluntary and give clinicians and patients flexibility to support individual care, said Christopher Jones, PharmD, DrPH, MPH, acting director of CDC’s National Center for Injury Prevention and Control in a CDC press briefing. They should not be used as an inflexible, one-size-fits-all policy or law, or applied as a rigid standard of care, or replace clinical judgement about personalized treatment, he emphasized.

More details can be found in the STAT News article.

Bloomberg informs us

In just 15 minutes, a small, handheld blood test can tell doctors whether a patient has likely suffered a concussion or traumatic brain injury — no brain scan required.    

After more than a decade of research, the Abbott Laboratories test is being used for the first time in a real-world setting to evaluate patients at Tampa General Hospital in Florida. Doctors using the test say it’s better at evaluating concussions than the brain scans that have been widely used for the last 30 years.  * * *

[Abbott Labs’] test, called the i-STAT TBI Plasma test, was greenlit by the Food and Drug Administration in 2021 to rule out the need for a CT scan when evaluating mild traumatic brain injuries. * * *

Though Abbott’s test is not yet ready to be used on the sidelines of sporting events, the ultimate goal for Abbott is for every hospital, urgent care clinic, ambulance, school and sporting event to have a portable test available. The company is also working on research that will help doctors know the severity of a concussion or brain injury, for both adults and kids, to aid in diagnoses.

Abbott worked with the Department of Defense to develop the test, which supported development with millions of dollars in funding. More than 450,000 US service members were diagnosed with a traumatic brain injury from 2000 to 2021, according to the CDC. It’s an area the DOD is “very concerned about,” said Beth McQuiston, a neurologist and chief medical officer for Abbott’s diagnostic business.  

Bravo.

From the U.S. healthcare business front

Beckers Payer Issues reports

Cigna raised its annual earnings outlook and reported a 70 percent boost in third quarter profits compared to the same period last year, according to the company’s earnings report published Nov. 3.

“We built on our momentum from the first half of 2022 with strong execution in the third quarter across our businesses and a continued focus on serving customers and clients with our differentiated health and well-being solutions,” CEO David Cordani said.

Healthcare Dive offers an M&A perspective on the Cigna announcement.

The Wall Street Journal reports

Moderna Inc.’s third-quarter revenue fell by nearly a third and the pharmaceutical company cut its outlook, saying as part of its earnings report that supply constraints for its Covid-19 vaccines might sap as much as $3 billion in sales this year.

The Cambridge, Mass.-based company said Thursday that higher costs and a decline in demand for its original Covid-19 vaccine also hit its performance.

Moderna, which three months ago said it projected $21 billion in product sales of its Spikevax vaccine for anticipated delivery this year, now expects between $18 billion and $19 billion. The company said short-term supply constraints will delay some sales into 2023.

Beckers Hospital Review cautions

The third quarter brought little relief to hospitals in what is shaping up to be one of their worst financial years.  

Kaufman Hall’s October National Hospital Flash Report — based on data from more than 900 hospitals — found slightly lower hospital expenses in September did not outweigh lower revenue across the board, with decreases in discharges, inpatient minutes and operating minutes.

The median year-to-date operating margin index for hospitals was -0.1 percent in September, marking a ninth straight month of negative operating margins and a dimmer outlook for their climb back into the black by year’s end. 

Kaufman Hall noted that expense pressures and volume and revenue declines could force hospitals to make “difficult decisions” about service reductions and cuts. 

Meanwhile according to MedCity News, the American Medical Association “blasted the Centers for Medicare and Medicaid Services Tuesday for its 2023 Physician Fee Schedule final rule, which would cut the Medicare payment rate to physicians by nearly 4.5%.” The AMA is demanding that Congress prevent the cut from occuring January 1, 2023.

The article adds

[O]ther organizations applauded it for areas that reflected their respective priorities. For instance, the National Association of ACOs (NAACOS) praised changes to the Medicare Shared Savings Program for 2023 that included providing more time to Accountable Care Organizations before they have to assume financial risk. The final rule also gave advance shared savings payments to ACOs that care for underserved communities. CMS said it expects these changes to increase participation in rural and underserved areas. * * *

[T]he final rule made changes to policies related to telehealth. This includes extending several telehealth services that were temporarily made available during the public health emergency through at least 2023. This will “allow additional time for the collection of data that may support their inclusion as permanent additions to the Medicare Telehealth Services List,” CMS said. The change is in line with comments CMS Administrator Chiquita Brooks-LaSure made at a recent conference. 

The Telehealth Access for America (TAFA), which includes the American Hospital Association, applauded the changes to telehealth, though the group called on Congress to make permanent actions.

In other telehealth news, Healthcare Dive reports

  • COVID-19 diagnoses fell by about 1% to 2% as a share of telehealth claims nationally in August, according to Fair Health’s monthly tracker data out Thursday.
  • In the South and West, COVID-19 fell from the second top diagnosis to the third from July to August. It remained in second place in the Midwest and Northeast.
  • Mental health conditions stayed as the top telehealth diagnoses nationally and in every region, and one hour of psychotherapy remained the top telehealth procedure code.

Midweek update

David Ermer–CDC, FDA, Rx coverage, Telehealth, U.S. Healthcare–

From the alcohol abuse front, MedPage Today tells us

One out of every eight deaths in Americans ages 20 to 64 resulted from drinking too much alcohol, according to a U.S. population-based study.

Nationally, 12.9% of total deaths per year among adults in this age group were attributed to excessive alcohol consumption from 2015 to 2019, and that number rose to 20.3% of total deaths per year when restricted to people ages 20 to 49, reported Marissa Esser, PhD, MPH, of the CDC in Atlanta, and colleagues.

Alcohol-attributed deaths ranged from 9.3% in Mississippi to 21.7% in New Mexico and were more common among men than women (15% vs 9.4%), the authors wrote in JAMA Network Open.

That is startling.

From the unusual viruses front, Beckers Hospital Review explains

Wastewater testing has found polioviruses genetically tied to a case that left an unvaccinated Rockland County, N.Y., resident paralyzed this summer in at least five of the state’s counties, according to a new CDC report. 

The report, published Oct. 28, is based on wastewater testing from samples collected from March 9 through Oct. 11 from 28 sewersheds serving parts of Rockland County and 12 other counties. Eighty-nine samples, or 8.3 percent of 1,076 samples collected, tested positive for poliovirus type 2. Of those, 82 were linked to the virus isolated from the Rockland County patient who was left paralyzed 

“Although most persons in the United States are sufficiently immunized, unvaccinated or undervaccinated persons living or working in Kings, Orange, Queens, Rockland, or Sullivan counties, New York should complete the polio vaccination series to prevent additional paralytic cases and curtail transmission,” the CDC report said. 

CDC officials recently told CNBC they are considering the use of a novel oral polio vaccine not used in 20 years to halt the outbreak. 

From the opioid epidemic front, Healthcare Dive informs us

CVS Health agreed on Wednesday to pay $5 billion to settle almost all opioid-related lawsuits and claims the company been battling over the past decade that alleged it mishandled prescriptions of the painkillers.

If the deal is finalized, CVS will pay $4.9 billion to states and political entities such as counties and cities, and $130 million to U.S. tribes.

The payments, which depend partially on the number of government entities that agree to join the settlement, will be spread out over the next 10 years beginning in 2023.

Cities, counties and states have filed more than 3,000 lawsuits against drugmakers, distributors and pharmacies for their role in perpetrating the opioid epidemic in the U.S. According to government data, three-fourths of the 92,000 drug overdose deaths in 2020 involved an opioid.

Walgreens and Walmart also have reached deals to settle opioid-related claims, Reuters reported, citing people familiar with the matter. Walgreens will pay $5.7 billion over 15 years and Walmart will pay $3.1 billion, mostly up front, according to the report.

If the settlements from the three companies, which are the largest retail pharmacies in the U.S., become final, it may end much of the yearslong litigation over opioids. Cases still are pending against smaller pharmacies such as Rite Aid.

The deals follow some victories for plaintiffs against the chains. 

In related healthcare business news, Beckers Hospital Review reports

CVS Health raised its annual earnings outlook after beating investor expectations in the third quarter, but the company reported $3.4 billion in losses after agreeing to pay into a global opioid lawsuit settlement starting next year.

The $5 billion settlement will be paid out over 10 years and “substantially resolve all opioid lawsuits and claims against the company by states, political subdivisions, such as counties and cities, and tribes in the United States,” the company said in its Nov. 2 earnings report.

The company’s third quarter EPS is $2.09 and $6.71 for 2022. It also raised its full year guidance and expects adjusted EPS to rise from a range of $8.40-$8.60 to $8.55-$8.65.

“We delivered another outstanding quarter, and have raised full-year guidance as a result. We continue to execute on our strategy with a focus on expanding capabilities in health care delivery, and the announced acquisition of Signify Health will further strengthen our engagement with consumers,” President and CEO Karen Lynch said.

and

Humana reported $1.2 billion in profits during the third quarter and is expecting major increases in Medicare Advantage membership, according to the company’s Nov. 2 earnings report.

The company reported $22.8 billion in third quarter revenues, increasing 10.2 percent from $20.7 billion year over year. Total revenues in 2022 are $70.4 billion

The company expects an annual adjusted EPS guidance of $25 and raised its 2022 earnings outlook to $91.6 billion – $93.2 billion.

Healthcare Dive adds

Los Angeles-based Heal, a provider of primary care through house calls, telemedicine visits and remote patient monitoring, said it has partnered with Cigna Medicare Advantage plans in four states as it continues its national expansion.

The organization is now an in-network provider for Cigna MA enrollees in Illinois, North Carolina, South Carolina and Georgia, effective immediately, it said. Its markets also include Louisiana, New Jersey, New York and Washington.

Heal works with Humana, WellCare, Aetna and UnitedHealthcare insurance plans, according to its website.

Fierce Healthcare relates

Nearly 334,000 physicians, nurse practitioners, physician assistants and other clinicians left the workforce in 2021 due to retirement, burnout and pandemic-related stressors, according to new data [found in the Definitive Healthcare report]. * * *

Hospitals and health systems are spending more money to hire and retain healthcare workers, the report found. These facilities are increasing salaries, offering sign-on bonuses, and expanding benefits to lure in new workers. Hospitals nationwide spent a total of about $97.3 million on employees and physician salaries in 2020, compared with $82.7 million in 2016, according to data from the October 2021 Medicare Cost Report.

From the medical devices front, STAT News tells us

A Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices. The widely used instruments monitor blood oxygen levels and have been shown to work less well on patients with darker skin, possibly exacerbating health disparities in many racial and ethnic groups. 

Healthcare Dive points out

Optical sensor solution in fingertip monitors gives medical-grade accuracy of oxygen level measurement across skin tones and while in motion.

A patented SpO2 sensor chipset, integrated processing and reference design capability has uses in other wearable devices, according to BioIntelliSense.

The inability of many fingertip monitors to accurately read blood oxygen levels has caused people with darker skin to wait hours for supplemental oxygen and in some cases has caused deaths.

That’s good news for you.

Moreover, Health IT Analytics reports

A team of Yale University researchers has developed a machine learning (ML)-based clinical decision support tool to personalize recommendations for pursuing intensive or standard blood pressure treatment goals among individuals with and without diabetes.

The tool, described in a study published earlier this week in The Lancet Digital Health, is designed to facilitate shared decision-making between providers and patients with hypertension through a data-driven approach. Hypertension is defined as a sustained blood pressure greater than 140/90 mm Hg and is a leading cause of heart disease and mortality.

From the Rx coverage front, STAT News tells us

A blockbuster weight-loss medicine led to dramatic effects for adolescents diagnosed with obesity, a result that will likely widen the use of an in-demand drug — and fan a debate over whether someone’s body weight should be treated as a disease.

The drug, a weekly injection called semaglutide, led to a 17% reduction in body mass index compared to placebo in a study of about 200 people between the ages of 12 and 18. On average, adolescents treated with semaglutide lost 34 pounds, or 15% of their body weight, over the course of the 68-week study, which was published in the New England Journal of Medicine on Wednesday. Those on placebo gained an average of five pounds, or 3% of their baseline weight.

The trial’s relatively small size and short duration leave outstanding questions about whether semaglutide’s side effects, which include nausea and rare cases of gallstones, will lead to long-term problems, said Julie Ingelfinger, a pediatric nephrologist at Massachusetts General Hospital who was not involved in the study. But the results suggest semaglutide, sold by the Danish drug company Novo Nordisk, could be a powerful tool for adolescents unable to lose weight through diet and exercise.

From the post Dobbs front, the New York Times surveys the landscape and finds increasing use of telemedicine services, such as Aid Access, to obtain abortion pills.

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Monday Roundup

David Ermer–COVID-19, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Kaiser Health News announced the winner of their fourth annual Halloween haiku contest.

Covid, Ebola,
Monkeypox, seasonal flu —
Who needs Halloween?

— Paul Hughes-Cromwick

The Department of Health and Human Services reminds us that the federal healthcare / Obamacare marketplace will be open for business tomorrow. Professor Katie Keith, writing in Health Affairs Forefront, provides all the details.

The U.S. Office of Personnnel Management issued a press release today with a list of senior staff transitions and additional key staff appointments.

From the Omicron and siblings front, Medscape reports

The U.S. National Institutes of Health’s $1 billion RECOVER Initiative has picked Pfizer Inc’s antiviral drug Paxlovid as the first treatment it will study in patients with long COVID, organizers of the study said on Thursday.

The complex medical condition involves more than 200 symptoms ranging from exhaustion and cognitive impairment to pain, fever and heart palpitations that can last for months and even years following a COVID-19 infection.

According to details of the study, posted on Clinicaltrials.gov, the randomized, placebo-controlled trial will test Pfizer’s treatment or a placebo in 1,700 volunteers aged 18 and older.

The Duke Clinical Research Institute is supervising the study, which is scheduled to start on Jan. 1.

The New York Times offers readers background on the RSV epidemic and related matters.

R.S.V. is a common winter virus that typically causes mild cold-like illness in most people, but can occasionally be very dangerous for young children and older adults, said Emily Martin, an associate professor of epidemiology at the University of Michigan School of Public Health.

“The youngest infants have a high risk of coming into the hospital in what we call their first R.S.V. season,” Dr. Martin said. “If a child is born in the summer and they get exposed for the first time in the winter, they are at risk of having more serious disease. But many infants didn’t experience the first R.S.V. season on the regular schedule that they would have, particularly if they were born in or after 2020.”

In a normal prepandemic year, 1 to 2 percent of babies younger than 6 months with an R.S.V. infection may need to be hospitalized. And virtually all children have gotten an R.S.V. infection by the time they are 2 years old.

But many experts believe masking, social distancing, school closures and other precautions taken during the first year or two of the pandemic protected most children from exposure to the virus and other germs. “As a result, there are still many children who are less than 3 years old who’ve never been exposed to R.S.V.,” said Dr. James Antoon, an assistant professor of pediatrics and pediatric hospitalist at Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville, Tenn. “The virus is now playing catch-up in all these kids.”

No good deed, etc.

From the virtual care front, mHealth Intelligence informs us

In collaboration with Mayo Clinic, Memora Health has launched the first phase of a research program focused on virtual postpartum care.

The program aims to improve communication between patients and providers through the addition of new technology to enhance postpartum care.

Memora Health, which offers digital and automated care programs, is working with Mayo Clinic to implement the virtual care program, which will provide the health system’s maternal care teams access to technology that can help them extend care for postpartum patients in the home and between clinic visits.

From the healthcare cost front, Health Payer Intelligence tells us

Dialysis increased monthly spending for privately-covered members with chronic diseases by approximately 292 percent, according to a study published in JAMA Open Network.

The researchers drew their insights from a sample of nearly 12,400 private insurance enrollees over the course of 309,800 enrollee-months. The data from Health Care Cost Institute spanned 2012 to 2019 and was analyzed from late August 2021 to mid-August 2022. Enrollees had employer-sponsored insurance for a year after starting dialysis.

Most enrollees were in preferred provider organization health plans that were self-funded. * * *

Medicare beneficiaries had much lower costs than their employer-sponsored health plan counterparts. The mean spending for enrollees on Medicare in the year after starting dialysis was $80,509, compared to $238,126 for individuals with private healthcare coverage.

“The large costs borne by private insurers to cover enrollees with kidney failure underscore the importance of Medicare becoming a primary payer after 30 months,” the study indicated. “The differences in spending between enrollees receiving dialysis with private insurance and those with Medicare are especially important given growing concerns about the market power of large dialysis organizations and recent policy proposals.”

The level of spending increase post-dialysis initiation that the researchers discovered in this study was higher than previous studies indicated.

The Wall Street Journal adds

Rival drugmakers are seeking to upend Pfizer Inc.’s dominance of the $7 billion worldwide market for pneumonia vaccines, launching what is shaping up to be one of the industry’s fiercest battles.

Merck & Co. has already introduced a new competitor to Pfizer’s Prevnar vaccine franchise, while GSK PLC and VaxcyteInc. are among companies developing shots that aim to win sales by protecting against even more strains of the pneumonia virus.

The companies are all vying for a piece of a lucrative market that Pfizer has commanded for more than a decade and is forecast to reach more than $10 billion annually by 2028, according to Wall Street analysts.

“It is kind of an all-out battle to see who can get this $10 billion that’s out there on the table,” said Louise Chen, an analyst at Cantor Fitzgerald & Co.

Weekend update

David Ermer–Congress, COVID-19, Mental health care, Telehealth, U.S. Healthcare–

Congress remains on the campaign trail with the November 8 election just nine days away.

The Federal Employees Benefits Open Season starts two weeks from tomorrow.

From the Omicron and siblings front, Fortune Well tells us about the Zoe Health Study, a study of Covid symptoms among five million people.

Getting vaccinated against COVID reduces your risk of severe illness, hospitalization, and death if you do catch the disease—but according to new research, it could also dictate which batch of the milder, more common symptoms of the virus you end up getting. It’s thought that a large proportion of cases are still asymptomatic.

In an update to the ongoing Zoe Health Study, which has collected data from almost 5 million participants since 2020, researchers said they had identified symptoms that had emerged in recent weeks, noting that they appeared to differ depending on vaccination status. 

“Generally, we saw similar symptoms of COVID-19 being reported overall in the app by people who had and hadn’t been vaccinated,” the research team said in its update. “However, fewer symptoms were reported over a shorter period of time by those who had already had a jab, suggesting that they were falling less seriously ill and getting better more quickly.”

Precision Vaccinations informs us

As World Pneumonia Day approaches on November 12th, the ongoing effort to reduce fatalities from infectious diseases has never been more urgent.

Pneumonia is an infection of the lungs that needlessly affects millions worldwide each year. Most of the people affected by pneumonia in the U.S. are adults.

Previous U.S. CDC data indicates 47,000 people died from pneumonia in the U.S. in 2020.

And that negative trend continues today.

According to the National Center for Health Statistics (NCHS) Mortality Surveillance data available on October 27, 2022, 9.2% of infectious disease fatalities that occurred during week #42 were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 2,128 PIC deaths reported last week, 1,164 listed pneumonia as an underlying or contributing cause of death on the death certificate, 949 had COVID-19, and 15 listed influenza.

Pneumonia always has been a killer. The FEHBlog’s Dad referred to the disease as “the old man’s friend.” He was not alone. A 2018 medical editorial explains

The term “old man’s friend” is often used when referring to pneumonia. Searching for it on Google yields 16,400 results in 0.33 s for this combination.

The term is attributed to William Osler, who in the first edition of his book The Principles and Practice of Medicine (1892) wrote:

In children and in healthy adults the outlook is good. In the debilitated, in drunkards and in the aged the chances are against recovery. So fatal is it in the latter class [i.e. the elderly] that it has been termed the natural end of the old man [1].

In the 9th edition, published after Osler himself already died (in 1919 from pneumonia at the age of 70 years [2]), this excerpt was rephrased as “.. . one may say that to die of pneumonia is almost the natural end of old people” [3]. But that was 100 years ago. Fortunately, a lot changed for the better in the century that followed.

Today, pneumonia still affects many ‘old’ men. Medical progress made since William Osler’s time has resulted in survival rate for hospitalized pneumonia that now sits above 90–95%. However, longer-term mortality is high. The reasons for this are still largely unknown. A hypothesis from the editors of Pneumonia? Perhaps chronic inflammation leading to silent progression of cardiac disease is an underlying mechanism.

In mental healthcare news, the Wall Street Journal reports

Mental-health screenings for kids are expanding across the country. But as more children are identified as needing assistance, families can face a tough time getting help from resources that are already stretched thin.

and

Startups [i.e., this site] are prescribing ketamine online to treat serious mental-health conditions, raising concern among psychiatrists about the safety of taking the mind-altering anesthetic without medical supervision, sometimes at high doses that raise risks of side effects.

The first story illustrates an issue for which telehealth is a solution, while the story shows why telehealth cannot replace in-person care.

In U.S. healthcare business news, Bloomberg relates

VillageMD, which is majority owned by Walgreens Boots Alliance Inc., is exploring a deal to merge with Warburg Pincus-backed Summit Health, according to people familiar with the matter. 

The acquisition by primary-care provider VillageMD of Summit, a health-care network and the parent of CityMD, would value the combined entity at between $5 billion to $10 billion, said the people, who asked to not be identified because the matter isn’t public.

An agreement could be reached in the coming weeks, though talks could still fall apart, the people added. Representatives for VillageMD, Walgreens and Warburg Pincus declined to comment, while Summit Health didn’t immediately respond to a request for comment.