Thursday Miscellany

Congress

Thursday Miscellany

David Ermer–Congress, COVID-19 vaccine, FDA, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Capitol Hill, the Wall Street Journal reports

A top Senate Democrat said that his party planned to introduce an omnibus spending bill Monday, aiming to pressure Republicans to accept a deal or risk an alternative that would freeze government spending at current levels for the full year and cut off the ability to reallocate money in military and other programs.

Senate Appropriations Committee Chairman Patrick Leahy (D., Vt.) said that the measure would provide military funding at the level Congress is authorizing in its separate defense policy bill—some $858 billion, or roughly a 10% increase—while also paying for what he called a needed increase to nondefense programs.

“This is a reasonable path forward, and I suggest my Republican friends take it,” Mr. Leahy said. * * *

If no deal is reached as the end of the year approaches, lawmakers have said they might need to fall back to a so-called continuing resolution, which funds the government at current levels. Various lawmakers have floated stretching funding into early 2023 or for the full fiscal year, which ends in September. 

The path forward was unclear, as neither House Speaker Nancy Pelosi (D., Calif.) nor Senate Majority Leader Chuck Schumer (D., N.Y.) announced votes on an omnibus bill for next week.

The Journal adds,

House lawmakers on Thursday passed a defense policy bill [discussed in yesterday’s FEHBlog post] that authorizes U.S. military leaders to purchase new weapons and increase pay for troops, and lifts a requirement for members of the military to get vaccinated against Covid-19. * * * The legislation is expected to pass the Senate by the end of next week before heading to President Biden’s desk for his signature.

STAT News tells us

Key decision makers in Congress are closer than they’ve been in years to revamping the way the government regulates some of the diagnostic tests that patients use to make crucial decisions about their health care [due to the Theranos fiasco].

If the VALID act passes, the FDA wouldn’t regulate every single clinical test, but only tests considered “high risk” to patients, where the risk to patients of an inaccurate result could cause serious or irreversible harm.

One example would be a test for breast cancer that could lead a patient to have a mastectomy, Boiani said. Another would be a genetic test that could determine which cancer treatment patients receive, said Jeff Allen, the president and CEO of Friends of Cancer Research.

From the Federal Employee Benefits Open Season front, Tammy Flanagan writing in Govexec and Drew Friedman writing in Federal News Network offer last minute decision-making tips.

Investment News provides advice on income adjusted Medicare premium issues.

Most Medicare beneficiaries will pay the standard Part B premium of $164.90 per month in 2023, down slightly from this year’s monthly premium of $170.10. Medicare Part B covers doctors’ fees and out-patient services. Coupled with a huge 8.7% cost-of-living adjustment in Social Security benefits next year, most retirees will enjoy larger monthly net Social Security benefits after automatic deductions for their Part B premiums in 2023.

But about 8%, or about 5 million, of the nearly 63 million Medicare beneficiaries will pay more than the standard monthly premium for both Part B and Part D prescription drug plans based on their income. My husband and I are among them.

For 2023, single beneficiaries with incomes of $97,000 or more and married couples with joint incomes of $194,000 or more pay a Medicare premium surcharge, officially known as an income-related monthly adjustment amount, or IRMAA. The thresholds increased from $91,000 and $182,000, respectively, in 2022, meaning some beneficiaries may avoid IRMAA surcharges altogether in 2023 or pay less than this year due to the inflation adjustments of the income tiers that trigger those surcharges.

In other health benefits news, Insurance News Net informs us

The average per-employee cost of employer-sponsored health insurance rose by 3.2% in 2022, according to Mercer’s 2022 National Survey of Employer-Sponsored Health Plans, released today.

US employers expect a sharper increase of 5.4% in 2023 — and faster cost growth in the years ahead seems likely

 For now, most employers are prioritizing enhancing benefits to attract and retain workers over cost-cutting; enhancements range from adding perks to improving healthcare affordability

 Mental health remains a top concern of employers and employees – and virtual mental healthcare is proving key to improving access to services

From the Rx development and coverage front, we have three reports from STAT News —

  • Well, this government action didn’t take long. STAT News relates “The Food and Drug Administration announced Thursday it had amended the emergency use authorizations for the updated Moderna and Pfizer-BioNTech Covid-19 boosters, to allow their use in children aged 6 months and older.”
  • Also according to STAT News, “A year ago, the [Purchaser Business Group on Health] coalition created Emsana Health that, in turn, hatched the EmsanaRx pharmacy benefit manager. [Beginning March 1, 2023,] EmsanaRx will run the technology to ensure prescriptions handled by Cuban Cost Plus Drugs are paid and fulfilled, and report all this information back to the [self-funded] employer. In exchange, EmsanaRx will take a flat 1.5% fee for legal, administrative, and data sharing services, but not charge more than $3 for each insurance claim and will pass along any rebates collected.”
  • Finally from STAT News, “Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program. “I can’t speak to any specifics, but just to say that our door is really open,” Chiquita Brooks-LaSure, administrator for the Centers for Medicare and Medicaid Services, said Thursday at the Milken Institute Future of Health Summit when asked about how the agency will approach lecanemab. “We will look at it as new data comes.”

From the public health front —

An outside group [the Reagan Udall Foundation] that was asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency’s structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention. * * *

In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA.

  • The Congressional Research Service issued an “In Focus” report on “Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization.”
  • Health Payer Intelligence tells us

Overall, major health outcomes measures are trending in a negative direction, according to America’s Health Rankings Annual Report for 2022.

The Annual Report examines 23 measures to assess health outcomes trends nationwide, including measures for eight chronic conditions. The data for these measures primarily represented 2021 outcomes, but some measures drew from 2018, 2019, 2020, and 2022.

A Morning Consult online survey conducted in October 2022 informed the results as well as racial and ethnic subpopulation data and a total of 80 national and state measures to assess the state of healthcare in the US.

Based on the findings, the coronavirus pandemic has continued to have ripple effects on healthcare. The top three major trends in health outcomes are:

  • Increased drug deaths
  • Increased non-medical drug use
  • Increased premature death

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.”

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.”

Weekend update

David Ermer–AHRQ, Congress, Federal employment benefits, Medicare, Mental health care, OPM, Rx coverage, Uncategorized–
Thanks to ACK15 for sharing their work on Unsplash.

The House of Representatives and the Senate are in session this week for Committee business and floor voting.

The continuing resolution funding the federal government expires at 11:59 pm on Friday December 16.

The Federal Employee Benefits Open Season ends at 11:59 pm, in the location of the enrollee’s electronic enrollment system, on Monday, December 12, 2022.

The Medicare Open Enrollment period ends this Wednesday, December 7.

From the Rx coverage front, the Wall Street Journal reports on

  • A shortage in the weight loss drug Wegovy, “missing out on hundreds of millions of dollars in sales and squandering a head start before a rival could begin selling a competing product. * * * [Wegovy manufacturer’ Novo lists Wegovy at $1,349 a month. Some commercial insurers cover the drug.” OPM has encouraged FEHB carriers to offer coverage of this drug.
  • A CVS Health effort to improve pharmacy efficiency with “a system [currently being tested] that allows pharmacists to process prescriptions in part remotely, a move it said could improve store working conditions and the experience for customers as the company grapples with a shortage of pharmacists.”

From the mental healthcare front, Health Payer Intelligence tells us

Mental healthcare services utilization and network size have grown significantly since 2019 among Blue Cross Blue Shield of Massachusetts (“Blue Cross”) members, according to data from Blue Cross.

Mental healthcare services utilization grew by 100 percent in the timeframe that Blue Cross examined. At the same time, Blue Cross’s mental healthcare network grew by 46 percent.

“As the need for mental health services continues to grow, access to convenient and affordable care is critical,” said Andrew Dreyfus, president and chief executive officer of Blue Cross. “By expanding and diversifying our mental health network, we’re ensuring that our members are able to find and receive the high-quality care they need, when they need it.”

The mental healthcare provider network swelled to a total of 18,000 clinicians. With the growth in utilization, Blue Cross plans to expand its network further. The payer will do this by working with national mental healthcare provider groups as well as expanding its virtual care mental health groups in 2023. * * *

Blue Cross also shared that the health plan’s reimbursement for telehealth and virtual care services is at parity with in-person services. Receiving reimbursement at parity is not only a controversial issue for telehealth providers but also for mental and behavioral healthcare providers, who do not always receive reimbursement at parity with physical care providers.

Kudos.

Also worth reading is this Journal article about a 24-year-old military wife who went through drug addiction hell and came out a new person with help from her family, the Missouri prison where she was housed, and a fellow inmate. The article illustrates the importance of Blue Cross of Massachusett’s efforts to expand mental health coverage and various efforts to reduce drug addiction and overdose deaths.

From the medical research front, the Wall Street Journal offers an essay about breast cancer written by a medical historian and breast cancer patient Dr. Lindsey Fitzharris. What grabbed the FEHBlog’s eye is the article’s conclusion:

The cofounders of BioNTech recently announced that vaccines targeting cancer may be available before the end of the decade. Researchers at Duke University are already developing a vaccine that targets mutations commonly arising in people with certain types of advanced breast cancer. Using the same mRNA technology deployed against Covid-19, these types of vaccines would not be administered prophylactically but, rather, used as a treatment to trigger a stronger immune response in patients with locally recurrent or metastatic disease. When it comes to conquering breast cancer, future medical historians will have plenty to write about.

From the innovation front, Senior Living explains how to use Apple AirPods as hearing aids. MedTech Dive adds

  • Apple AirPods Pro earbuds have the potential to be a hearing aid for adults with mild to moderate hearing loss, according to a paper published in iScience. 
  • Researchers found the earbuds meet four of the five standards for personal sound amplification products and perform comparably to hearing aids in terms of speech perception in quiet environments.
  • The study suggests that some consumer earbuds can function as hearing aids to potentially further lower the cost and address the stigma associated with the technology.

It’s also worth calling attention to the HHS Agency for Healthcare Quality and Research’s Effective Health Care Program’s website.

The Effective Health Care (EHC) Program improves the quality of health care by providing the best available evidence on the outcomes, benefits and harms, and appropriateness of drugs, devices, and health care services and by helping health care professionals, patients, policymakers, and health care systems make informed health care decisions. The EHC Program achieves this goal by partnering with research centers, academic institutions, health professional societies, consumer organizations, and other stakeholders to conduct research, evidence synthesis, evidence translation, dissemination, and implementation of research findings.

Tuesday’s Tidbits

David Ermer–CDC, Congress, COVID-19, FDA, Mental health care, NIH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Capitol Hill, Roll Call reports

Congressional leaders and top appropriators are set to meet as early as Wednesday to work through differences on a potential omnibus spending agreement, Senate Majority Leader Charles E. Schumer said Tuesday.

President Joe Biden and Vice President Kamala Harris, along with a few top White House aides, met with Speaker Nancy Pelosi, House Minority Leader Kevin McCarthy, Senate Minority Leader Mitch McConnell and Schumer earlier Tuesday to discuss the lame-duck agenda.

Schumer said the leaders had a “productive discussion” about funding the government, and said all four leaders aim to come together to pass an omnibus.

“We all agreed that it should be done this year, we all agreed we have to work together and everyone has to give a little bit,” he said. “We also…said we would all work toward getting an omnibus as opposed to a CR.”

The prospects of a lame duck omnibus remain murky as Republicans and Democrats have not reached a topline spending agreement. The current continuing resolution runs out Dec. 16, though lawmakers have discussed a stopgap extension of perhaps a week to buy extra time.

The FEHBlog sees these developments as a good sign.

From the Omicron and siblings front, MedPage Today informs us

What happens to people who get reinfected with SARS-CoV-2, the virus that causes COVID-19? A recent paper in Nature Medicinehas been misinterpreted by some as providing evidence that repeat infections are somehow worse than first-time infections.

Here’s the actual situation: second infections are far less dangerous than first infections, with respect to severe, critical, and fatal COVID-19. This is true regardless of vaccination status.

Health Payer Intelligence offers three interesting survey findings about health insurance in our country

  • “Health insurance coverage disruptions were associated with higher mortality risks for people with private and public insurance, a JAMA Health Forum study found.”
  • “In two-adult families with and without children, the majority of members had the same type of health insurance coverage, whether they had group plans, non-group plans, or Me,dicaid” according to a brief from the Employee Benefit Researcher Institute (EBRI).

From the public health front, the FEHBlog ran across The PCORI Health Care Horizon Scanning System identifies and monitors developing innovations with potential to change health care. This database can be used by patients, care partners, and others to track advancements in care options.

The Wall Street Journal reports

The rate of gun deaths in the U.S. reached a 28-year high in 2021 after sharp increases in homicides of Black men and suicides among white men, an analysis of federal data showed.

A record 48,953 deaths in the U.S., or about 15 fatalities per 100,000 people, were caused by guns last year, said the analysis published Tuesday in the journal JAMA Network Open. Gun deaths declined in the 1990s, but have been rising steadily over the past decade and skyrocketed during the Covid-19 pandemic, said researchers who conducted the analysis.

Gun-related deaths of women and children have risen, the analysis said, but men remain far more likely to die from guns.

“The disparities are so marked,” said Chris Rees, a co-author of the study and an assistant professor of pediatrics and emergency medicine at Emory University School of Medicine.

On a related note, Federal News Network relates

The Pentagon is looking to hire hundreds of clinicians and mental health professionals in the coming months, as part of the initial cohort of its worldwide suicide prevention workforce.

Deputy Defense Secretary Kathleen Hicks, speaking Tuesday at a Washington Post Live event, said DoD is building up a “first of its kind” suicide prevention workforce that will eventually reach an end strength of 2,000 personnel.

Hicks said hiring, onboarding and training the suicide prevention workforce is “at the top of the list” of priorities for Defense Secretary Lloyd Austin. This DoD workforce, she added, is expected to outpace any similar effort led by universities or state governments.

“This prevention workforce will be a first of its kind, and we’re going to do it right here in the United States military, because that’s what we owe our people and their families,” Hicks said.

From the medical research and development front, the Wall Street Journal reports

Researchers released new details from a study of a closely watched drug for Alzheimer’s disease on Tuesday, shedding more light on the drug’s risks and benefits as U.S. health regulators weigh approving it. 

Eisai Co. and Biogen Inc.’s drug, called lecanemab, slowed cognitive decline by 27% compared with a placebo over 18 months in a study of more than 1,700 people with early-stage Alzheimer’s, researchers reported in the New England Journal of Medicine on Tuesday. 

The drug’s effect was moderate, and was associated with swelling and bleeding in the brain, the researchers said. They recommended further, longer study of the drug.

Some 17.3% of patients taking lecanemab had signs of brain bleeding, compared with 9% in the placebo group. Brain swelling occurred in 12.6% of people getting the drug, versus 1.7% who got placebos. 

The study data have been eagerly anticipated by Alzheimer’s researchers since Eisai disclosed high-level results in September, raising the hopes of doctors and patients that a new treatment proven to help Alzheimer’s patients is on the horizon.

The companies have asked the U.S. Food and Drug Administration to conditionally approve lecanemab based on an earlier study showing that the drug reduced levels of a protein in the brain called amyloid associated with Alzheimer’s. The agency is expected to make a decision by Jan. 6. 

Eisai, which is leading the development of lecanemab, has said it plans to seek full approval using the new study data. 

The NIH DIrector’s Blog tells us about the NIH clinical center doctors who are testing 3D-printed miniature, single-use ventilators. Cool.

Healthcare Dive informs us

Google’s health division has inked its first commercial agreement to use its mammography AI research model in real-world clinical practice, with the goal of improving breast cancer screening, Google Health announced Monday.

Google Health has partnered with cancer detection and therapy medtech iCAD on the 5-year deal. Under the agreement, iCAD will work to validate and incorporate Google’s mammography AI — which Google has been building and testing for several years — into its products for use in clinical practices.

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

Apoorva Mehta, a co-founder of Instacart Inc., is working on his next act after saying earlier this year that he would step down as executive chairman from the startup he built into a grocery delivery giant once it goes public.

Mr. Mehta earlier this month raised $30 million for Cloud Health Systems, a new healthcare startup aiming to offer consumers medical consultations and other health-related services, according to people familiar with the matter. 

Good luck.

Thanksgiving Weekend Update

David Ermer–Congress, COVID-19, COVID-19 testing, Federal employment benefits, Government Contracting, No Surprises Act, OPM, U.S. Healthcare–
Thanks to ACK15 for sharing their work on Unsplash.

The House of Representatives and the Senate return to Capitol Hill for Committee business and floor voting this week.

The Wall Street Journal adds

Lawmakers return to work this week with a to-do list that includes passing a critical government-funding bill, solidifying access to same-sex marriage and setting priorities for the U.S. military before the start of the new Congress next year.

Other issues emphasized by Democrats, including passing a ban on the sale of assault-style weapons, are a long-shot given their narrow majority in the Senate. Most legislation requires 60 votes to advance in the Senate. In addition, lawmakers are discussing raising the federal debt ceiling, which limits how much the government can borrow.

Congress faces a Dec. 16 deadline to pass legislation that would continue funding the federal government; failure to do so could result in a partial shutdown. Lawmakers must decide whether to approve a short-term bill or reach a deal on more-detailed legislation that would fund the government for the full fiscal year.

The Senate also will be considering the National Defense Authorization Act, which typically includes government procurement law changes.

Tomorrow, the Federal Employee Benefits Open Season will reach its clubhouse turn with two weeks left to go. Although not a part of the Open Season, Federal News Network reports an important development concerning the Federal Employees Long Term Care Insurance Program (FLTCIP.

Those looking to enroll in the FLTCIP will soon have to wait a couple of years before applying.

The Office of Personnel Management said it will suspend all new applications to the program starting on Dec. 19. The suspension will last for the next two years, but those who apply ahead of the start date may still see their applications go through. During that time, current FLTCIP enrollees cannot apply to increase their coverage. The suspension will otherwise not affect the coverage of current enrollees.

* * *

The contract for the insurance program, with John Hancock Life and Health Insurance Company, typically lasts seven years before getting a renewal. The program normally gets a premium hike each time the contract turns over. During the open period for new contract proposals earlier this year, only the current underwriter John Hancock submitted a bid. The current FLTCIP contract will expire on April 30, 2023.

The upcoming suspension on applications will allow OPM “to assess the benefit offerings and establish sustainable premium rates that reasonably and equitably reflect the cost of the benefits provided,” the agency said in a Nov. 18 notice. OPM added that it will only suspend applications when it is in the best interest of the program.

Many are eligible to apply for FLTCIP coverage, including federal employees, U.S. Postal Service employees and annuitants, as well as active and retired members of the uniformed services, and qualified relatives of feds. John Hancock has historically sponsored the program, and Long Term Care Partners, LLC, has administered it.

From the Omnicron and siblings front, the National Institutes of Health announced

Reporting a positive or negative test result just became easier through a new website from the National Institutes of Health. MakeMyTestCount.org, developed through NIH’s Rapid Acceleration of Diagnostics (RADx®) Tech program, allows users to anonymously report the results of any brand of at-home COVID-19 test.

COVID-19 testing remains an essential tool as the United States heads into the holiday season and people navigate respiratory viruses. While taking a rapid COVID-19 test has become commonplace, test results are not often reported. COVID-19 test results provide valuable data that public health departments can use to assess the needs and modify the responses in the local community, the state or the nation.

Lab tests have a well-established technology system for sharing test results. RADx Tech has been working on a system to standardize test reporting for at-home tests in a secure manner. The MakeMyTestCount.org website is built on this system for logging test results.

The Wall Street Journal tells us

U.S. life insurers paid a record $100 billion in 2021 in death benefits, fueled by another year of Covid-19 deaths, an industry trade group said.

Payouts rose 11% in 2021 to $100.19 billion, most likely due to the pandemic, according to the American Council of Life Insurers. The increase was on the heels of a 15% year-over-year rise in 2020, when death-benefit payments totaled $90.43 billion.

The ACLI compiles data from annual filings by insurers to state insurance departments. Given limitations in the filings, the group can’t break down causes of death, but it is reasonable to attribute the bulk of the increases to the pandemic, said Andrew Melnyk, ACLI vice president of research and chief economist.

The year-over-year increases are among the largest since the 1918 flu pandemic, when payments surged 41%. They are far above the 4.9% average from 2011 to 2021, the ACLI said.

From the No Surprises Act front, Healthcare Dive reports

House lawmakers expressed their discontent with a final rule on surprise billing and urged federal regulators to make changes.

House Ways and Means Committee Chairman Richard Neal, D-Ma., and ranking member Kevin Brady, R-Texas, sent a letter to HHS Secretary Xavier Becerra and other department heads again expressing disappointment with a much-contested section of the surprise billing ban.

The lawmakers “are severely disappointed to find that the August 2022 final rule violates the No Surprises Act in the same ways as before,” Neal and Brady said in a letter last week.

For Heaven’s sake, Congress should give the revised rule a chance before joining the medical associations in condemning it.

From the public health front, Health Payer Intelligence tells us

The number of Americans with a usual source of care has dropped 10 percent in the last 18 years, with only about three-quarters of people saying they have a regular primary care provider or at least a facility where they know they can access care, according to the Primary Care Collaborative (PCC) and AAFP Graham Center.

The analysis also revealed some health disparities, with folks who are Hispanic, have less than a high school education, are uninsured, and are younger being less likely to have a usual source of care than their counterparts. * * *

“Employers have a very important role to play to ensure that all their employees and their families have ready, convenient access to a usual source of affordable primary care,” said Asaf Bitton, MD, the executive director of Ariadne Labs – Harvard T.H. Chan School of Public Health.

“We applaud those employers who are providing highly accessible virtual and in-person primary care options, and working with preferred provider organizations and health systems to support patients in establishing and maintaining these crucial primary care relationships.”

Amen to that sentiment.

STAT New reports

Cardiovascular disease is responsible for about one in five deaths in women in the U.S., more than any other cause — including all forms of cancer combined. Black women like Shields are particularly vulnerable: In the U.S., Black adults are substantially more likely to die from heart disease than their white, Hispanic, or Asian or Pacific Islander counterparts.

To try to reduce deaths from heart disease, health professionals typically use basic risk calculators, which take about a dozen standard data points to predict a person’s likelihood of having a major event, such as a heart attack or stroke, in the next 10 years.

Regardless of their other risk factors, for the most part, patients who are young and female have a very low chance of having a cardiovascular event in the next 10 years, so they are unlikely to get recommendations for serious lifestyle interventions or medication. But they may still be heading down a path to a fatal event later in life.

Some 10 to 15% of pregnancies have at least one complication that is linked to later heart disease. In addition to preeclampsia, these include other forms of gestational hypertension; gestational diabetes; preterm delivery; low birth weight; and placental abruption. People who experience miscarriages and stillbirths are also at greater risk of heart disease. Additional reproductive health conditions — including the early arrival of periods, polycystic ovary syndrome, infertility, and early menopause — have also been linked to increased risk.

These data, however, are all missing from standard cardiovascular disease risk calculators. Some pregnancy complications are listed as part of the comprehensive American Heart Association screening guidelines. But a large national 2014 survey revealed that only 16% of primary care physicians and 22% of cardiologists were using these full guidelines. The failure of health-care providers to screen for these sorts of early warning signs is in keeping with the long-standing pattern in which women’s risk for heart disease is chronically underestimated by medical professionals — as well as by women themselves.

That’s a big bowl of wrong.

From the plan design front, Beckers Payer Issues relates

Providers using EHRs that aren’t enabled for electronic prior authorization and the cost to upgrade to those EHRs are the main barriers preventing automated PA, according to a Nov. 14 America’s Health Insurance Plans survey. 

The health insurance trade group conducted an industrywide survey on “prior authorization practices and gold carding experience of commercial plans” between February and April, according to the report. AHIP received responses from 26 plans, covering a total of 122 million commercial enrollees.

Top barriers to automated prior authorization:

  1. Provider does not use EHR enabled for electronic PA: 71 percent
  2. Costly/burdensome for providers to buy/upgrade EHR for electronic PA: 71 percent
  3. Lack of interoperability between EHR vendors: 62 percent
  4. Costly for payers to enable PA rules and information to be delivered electronically: 43 percent
  5. Lack of electronic PA solutions on market: 19 percent

This is a surprising outcome considering how vociferously providers object to prior authorization.

Weekend update

David Ermer–CDC, Congress, COVID-19, Federal employment benefits, OPM, U.S. Healthcare–

As we barrel toward Thanksgiving, the House of Representatives and the Senate will be on a District / State work break this week.

Concerning Thanksgiving, Bloomberg Prognosis tackles a burning question.

Does turkey actually make you sleepy? It feels like everyone always says that because turkey contains tryptophan it makes you tired, but is that actually true? Madison, New York, New York

The answer to this question is somewhat counterintuitive: Tryptophan can indeed make you sleepy, but the desire for a post-Thanksgiving dinner nap probably isn’t caused by the bird.

The more likely culprit is the very large meal, says Kat Lederle, a sleep therapist in the UK. * * *

[T]he best way to avoid the post-dinner food coma is to pace yourself at the table. Just be sure to save room for dessert. 

From the Federal Employee Benefits Open Season front —

From the Omicron and siblings front, the New York Times reports

As winter looms and Americans increasingly gather indoors without masks or social distancing, a medley of new coronavirus variants is seeding a rise in cases and hospitalizations in counties across the nation.

The Biden administration’s plan for preventing a national surge depends heavily on persuading Americans to get updated booster shots of the Pfizer-BioNTech and Moderna vaccines. Now some scientists are raising doubts about this strategy.

Older adults, immunocompromised people and pregnant women should get the booster shots, because they offer extra protection against severe disease and death, said John Moore, a virologist at Weill Cornell Medicine in New York.

But the picture is less clear for healthy Americans who are middle-aged and younger. They are rarely at risk of severe illness or death from Covid, and at this point most have built immunity through multiple vaccine doses, infections or both.

The newer variants, called BQ.1 and BQ.1.1, are spreading quickly, and boosters seem to do little to prevent infections with these viruses, as they are excellent evaders of immunity.

The Centers for Disease Control reported on Friday

CDC Nowcast projections* for the week ending November 19, 2022, estimate the proportion of ten lineages designated as Omicron with estimates above 1%: BA.5—and five of its sublineages (BQ.1, BQ.1.1, BF.7, BA.5.2.6, and BF.11)—BA.4.6, BA.2, and BA.2.75.

The predominant Omicron lineage is BQ.1, projected to be 25.5% (95% PI 22.1-29.1%). Additionally, other variants represent 3.1% of circulating viruses, largely composed of the Omicron-derived XBB lineage.

The New York Times adds

Diminishing returns from tinkering with the Pfizer-BioNTech and Moderna vaccines call for a new approach to protecting Americans altogether, Dr. Moore and other experts said. A universal vaccine that targets parts of the coronavirus that do not mutate would be ideal, for example. A nasal vaccine might be better at preventing infections than an injected one.

“Chasing variants by tweaking the mRNA vaccines is not a sustainable strategy,” Dr. Moore said. “There’s a need for better vaccine designs, but that needs a change of attitude at the government level.”

NPR Shots discusses the available treatment options for the predominant variants, which include Paxlovid.

Healthcare Dive informs us

A group of 22 states led by Montana Attorney General Austin Knudsen filed a petition Thursday calling on the CMS to repeal its COVID-19 vaccination mandate for healthcare workers, according to a release.

The states argued the requirement has led to worsening staff shortages in the sector, particularly in rural areas.

The federal vaccine mandate covering healthcare workers has faced a flurry of legal challenges since it was first announced last year.

Unfortunately, the government continues to fight last year’s pre-Paxlovid battle in court.

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

Centene has agreed to sell Magellan Specialty Health to Evolent Health, the latest move in its broad value creation plan.

The government insurer said in an announcement that it expects to bank $750 million in the aggregate from the deal. Centene added Magellan Specialty Health, a leading specialty benefit management company, as part of its acquisition of Magellen Health, which closed in January.

Magellan Specialty Health provides utilization management tools to insurers, including for radiology, musculoskeletal, physical medicine and genetic testing. When the transaction closes, Centene and Evolent will enter a multiyear partnership that enables the insurer to extend and build on its work with Magellan Specialty.

“This transaction is another significant milestone in our ongoing portfolio review and value creation plan,” said Sarah London, CEO of Centene, in the release.

Thursday Miscellany

David Ermer–CDC, Congress, FDA, Federal employment benefits, Mental health care, OPM, Rx coverage–
Photo by Josh Mills on Unsplash

Today, November 17, is National Rural Health Day.

Let’s follow up on two posts from this week:

  • On Tuesday, the FEHBlog mentioned that the Internal Revenue Service issued Notice 2022-59 which adjusts the PCORI fee for years “that end on or after October 1, 2022, and before October 1, 2023.” The FEHBlog referenced an adjusted PCORI fee of $2.79 per covered life. Whoops. The FEHBlog referenced the current PCORI fee. The adjusted PCORI fee is $3.00 per covered life. Lo siento.
  • Yesterday, the FEHBlog called to readers’ attention a Congressional Research Service report on federal healthcare laws enacted in the current Congress that expire at the end of 2022. The FEHBlog thought “I should go back and read that report.” Today an email from the Wagner Law firm identified one of these expiring laws, to wit

During the pandemic, Congress allowed telehealth services to be provided to HSA-eligible individuals without cost-sharing and without regard to whether they had met their deductibles under their High Deductible Health Plans. That authorization expired December 31, 2021. Congress then again allowed deductible-free telehealth services to resume from April 1, 2022, through December 31, 2022. Unless this authorization is extended again, plans covering HSA-eligible individuals will have to require that telehealth services be provided to those individuals on the same terms as in-person care, i.e., the deductible must be met before telehealth can be provided without further charge to the patient. [The American Benefits Council has asked Congress to extend this consumer protection.]

From Capitol Hill, Politico brings us up to date on medical association efforts to block or at least reduce a 4.5% cut in Medicare Part B payments to physicians.

From the federal employee benefits front, Tammy Flanagan writing in Govexec discusses the health benefit options available to federal employees who are veterans.

“From the public health front —

  • The Labor Department’s Department’s Occupational Safety and Health Administration offers guidance to employers on controlling seasonal flu outbreaks in the office or plant.
  • The New York Times examines anti-depressant drugs. “The most commonly prescribed medications for depression are somewhat effective — but not because they correct a “chemical imbalance.”

Hospitals have made progress in reducing preventable errors, accidents and injuries over the past decade, according to the Leapfrog Group’s fall 2022 hospital safety grades released Wednesday.

Incidents of falls and trauma and of objects unintentionally left in a body after surgery decreased by about 25% since 2012, according to Leapfrog.

In this year’s fall rankings, 30% of hospitals earned an A grade, 28% earned a B, 36% earned a C, 6% earned a D and 1% earned an F.

From the Rx coverage front,

Today the U.S. Food and Drug Administration approved [Provention Bio’s] Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. 

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.” 

“From the plan design front, MedCity News tells us “Historically having worked with Medicaid and Medicare Advantage populations, Uber Health is now expanding its services to self-insured employers. The company made the announcement at the HLTH conference in Las Vegas.”

Midweek update

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Electronic health records, NCQA, NIH, No Surprises Act, OPM, U.S. Healthcare–

From Capitol Hill, the Wall Street Journal reports

Republicans won a majority of seats in the House of Representatives with a victory in California, the Associated Press said late Wednesday, bolstering their ability to steer the agenda on Capitol Hill after two years of Democratic control of both chambers of Congress and the White House.

The Congressional Research Service released a report on health care provisions expiring at the end of this 117th Congress.

Healthcare Dive adds

With midterm elections resulting in a narrowly divided Congress, the HHS will be free to focus on longstanding priorities for the health department, such as implementing drug negotiation policy within Medicare, HHS Secretary Xavier Becerra said at the HLTH conference in Las Vegas on Tuesday.

“In a way, we’re now going to be able to concentrate on the work we have to still execute on,” Becerra said,

Under the Inflation Reduction Act passed earlier this year, Congress granted Medicare the power to negotiate how much it pays for certain prescription drugs starting in 2026, and to receive rebates from pharmaceutical manufacturers that hike drug costs above the rate of inflation starting in 2023.

Of course, HHS and its partners have a lot of work on implementing the No Surprises Act. Health Payer Intelligence discusses the good faith estimate and advance explanation of benefits comments that an ERISA plan trade association, ERIC, submitted to the NSA regulators yesterday.

In other HLTH 2022 conference news,

  • Healthcare Dive tells us about Google’s plans for offering personal health records and Maven Clinic‘s efforts to build a maternal health business by, e.g., recently landing a $90 million Series E amid increasing investor focus on women’s health.
  • MedCity News informs us, “Cell and gene therapies are offering patients potentially curative treatments for a growing scope of diseases. Insurance companies are trying to figure out how to pay for them. Industry consultants speaking at the HLTH conference offered some strategies they see payers taking to these new therapies.”

From the federal employee benefits front,

  • Govexec collected all of its current Open Season articles for convenient access.
  • Reg Jones, writing in Fedweek, recommends that federal employees contemplating retirement should retire on December 31, 2022.
  • Govexec reports that the Postal Service is headed into its busy season with far fewer employees than past years.

From the Affordable Care Act front —

  • The FEHBlog ran across this updated reference chart on minimum essential coverage under the ACA.
  • The U.S. Preventive Services Task Force issued its 12th Annual Report to Congress which is titled “High-Priority Evidence Gaps for Clinical Preventive Services.”

From the public health front —

  • Forbes reports “Researchers at the University of Houston have developed a vaccine that could block the effects of fentanyl and prevent addiction, according to a new study that could unlock solutions to the opioid epidemic as more than 150 people die every day from overdoses connected to synthetic opioids.”
  • CNN reports “The five-year lung cancer survival rate has increased 21%, from 21% in 2014 to 25% in 2018, making what experts call “remarkable progress” – but it is still the leading cause of cancer death in the United States. However, in communities of color, a person’s odds of surviving five years after diagnosis are much lower, at only 20%, according to the 2022 State of Lung Cancer report, which was published by the American Lung Association on Tuesday.”
  • The National Institutes of Health tells us “COVID-19 Vaccines Are Safe for People Receiving Cancer Immunotherapy, Study Confirms.”

From the miscellany department —

  • Forbes informs us “UnitedHealth Group’s pharmacy benefit manager Optum Rx Tuesday said it will put three less expensive “biosimilar” versions of Abbvie’s pricey rheumatoid arthritis drug Humira ‘in the same position as the brand’ on the PBM’s preferred list of drugs known as a formulary.”
  • MedTech Dive discusses how Labcorp, Abbott, BD, and Siemens plan to expand the home testing market
  • NCQA looks back at its recent Health Innovation Summit.

Monday Roundup

David Ermer–ACA, Congress, Federal employment benefits, Mental health care, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From the Capitol Hill front —

  • Roll Call and Govexec bring us up to date on the lame-duck session’s agenda.
  • The Washington Post tells us about the Administration’s plans to include $10 billion in Covid funding in the omnibus appropriations bill that Congress must pass or extend by December 16.
  • The Wall Street Journal reports “Republicans have won 217 House seats to the Democrats’ 205, according to the Associated Press tally. A party needs 218 for a majority in the chamber, and Republicans were on track for a very narrow margin after they won seats Monday in Arizona, California and New York. ” This development increases the likelihood that Congress will pass an omnibus appropriations bill before year-end.
  • The Congressional Budget Office posted a presentation on its recommended policy approaches to reduce commercial health Insurer payments for hospitals’ and physicians’ services. The presentation is worth a gander because the American Hospital Association, among others, is not pleased with the CBO’s recommendations.

The Federal Employee Benefits Open Season started today, and Govexec offers a checklist to help decision-makers.

From the conferences’ front —

  • The American Medical Association shares developments from its interim meeting which concludes tomorrow.
  • Fierce Healthcare offers a news feed from the HLTH 2022 conference.

From the Affordable Care Act front, the Internal Revenue Service announced the PCORI support fee that health plans must pay for policy years and plan years that end on or after October 1, 2022, and before October 1, 2023. In short, the dollar amount that calendar year plans such as the FEHB plan must pay next July 31 is $3.00 times the average number of covered lives.

From the Alzheimer’s Disease and dementia front, Medscape reports

  • “Dementia prevalence is dropping in the United States, new research shows.”
  • “Of the more than 6 million Alzheimer’s patients in the U.S. age 65 or older, nearly two-thirds are women. A new study may help explain the gender gap — and offer clues to new treatments for helping patients of both sexes fight back.” The FEHBlog has been taking a continuing legal education course on eldercare, and the practicing lawyers teaching the court remarked that 95% of the clients for whom Medicaid nursing home coverage is sought are husbands.
  • “Among older adults who use the US Supplemental Nutrition Assistance Program (SNAP), rates of memory decline appear to be slower than among those who don’t use the program, new research shows.”

The Wall Street Journal informs us

An experimental Alzheimer’s drug from Roche Holding AG failed to significantly slow cognitive decline in long-awaited trials, the latest in a long line of setbacks for a field that has seen little progress in decades.

The drug, called gantenerumab, slightly reduced cognitive decline in people with early Alzheimer’s compared with a placebo across two large and lengthy trials, but the difference wasn’t statistically significant, Roche said Monday. The trials, which lasted more than two years and involved nearly 2,000 participants, compared scores of cognition and function in areas such as memory, orientation and problem-solving. * * *

The news comes just weeks after clinical trial results from a drug developed jointly by Biogen Inc. and Eisai Co. infused fresh hope into a field that has been marked by failure. The Biogen and Eisai drug, called lecanemab, reduced cognitive and functional decline by 27% compared with a placebo. The companies say they plan to provide more detailed study results at an upcoming research conference.

Like lecanemab, Roche’s gantenerumab targets accumulations of beta-amyloid, a protein that is found in the brains of people with Alzheimer’s and is thought to be linked to the disease. Several earlier beta-amyloid-targeting drugs had failed in clinical trials, although each drug acts slightly differently.

Roche Chief Executive Severin Schwan said last month that the Biogen and Eisai results were encouraging, but cautioned that they didn’t shed any light on the likely success of gantenerumab. Roche said Monday that the level of beta-amyloid removal by gantenerumab was lower than expected in the trials.

In other news —

  • Per Fierce Healthcare, Aetna announced a new advanced price care program in cooperation with Crossover Health. The program will launch next January 1 in the Seattle Washington region. “The new hybrid care model is integrated into a health plan and aims to tackle the rising access issues and costs of healthcare with a fixed fee, value-based payment model, executives said.”
  • Milliman offers its thoughts on mental health challenges facing employers.