In the 1980s and 1990s, the Washington Post had a television critic named John Carmody who would warn readers at the beginning of his column to “strap yourselves into your breakfast nook” when he had big news. So strap yourselves in, and here goes. (The photo to the right is a rough approximation of a breakfast nook, a concept which has fallen out of style evidently.
Over the next 18 to 24 months, according to the Wall Street Journal, Humana will withdraw from the employer health benefits market to focus on the government health programs market.
Humana, which currently offers many FEHB HMO plans, placed the FEHB Program in the “bye-bye” employer health benefits market even though the employer is the federal government. The FEHBlog, and Congress for that matter, prefer to view the FEHB Program as part of the employer market.
In short, Humana could have justified staying in FEHB but chose not to do so. The decision is worth pondering, particularly if you have a long-term perspective.
In other U.S. healthcare business news —
Healthcare Dive reports on earnings announcements from telehealth vendors Teladoc and Amwell.
“While 80% of respondents said they had used telemedicine, there were only two categories where a majority of people preferred telemedicine over in-person care: prescription refills and minor illnesses. More than 60% of people surveyed preferred in-person visits for mental health and chronic condition care, while more than 70% wanted an in-person annual wellness visit. The starkest divide was on physical therapy: 80% of people preferred in-person visits, while only 20% preferred telemedicine.”
Biopharma Dive reports on Moderna’s earnings announcement.
In other vaccine news, CNN tells us
“The independent vaccine advisers to the US Centers for Disease Control and Prevention voted unanimously Wednesday in favor of the two-dose Jynneos mpox vaccine for adults at risk of catching the disease during an outbreak.”
“If the CDC agrees with the committee’s recommendation, there will be a recommendation in place to give the vaccine to people who are at risk for mpox during future outbreaks.”
“Even as mpox cases continue to fall, the CDC is encouraging people who are at risk to get vaccinated.”
From the preventive services front —
The U.S. Preventive Services Task Force issued for public comment a draft research plan regarding preventive interventions for perinatal depression. The public comment deadline is March 22, 2023.
The Mercer consulting firm offers useful observations on how employers and health plans can optimize their investments in preventive care.
The FEHBlog recalls pointing out a Social Determinants of Health Atlas a few years ago. Check out the CDC’s list of health mapping tools that are now available.
From the Rx coverage front, Beckers Hospital Review tells us that the Centers for Medicare and Medicaid Services will not change its Medicare coverage policy on Aduhelm, an Alzheimer’s Disease treatment, based on the recent FDA approval of Leqembi.
CMS said in April 2022 that it would limit Aduhelm coverage to clinical trials only, which partly blocked the drugmaker’s efforts to sell the drug it once deemed a blockbuster. Leqembi will be subject to the same coverage plan.
“We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable,” CMS said in a Feb. 22 statement. “After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration.”
If “any new evidence” becomes available or an amyloid-targeting Alzheimer’s drug receives traditional approval, CMS said it may reconsider its coverage decision.
As readers know, CMS’s Medicare coverage decision on these drugs effectively controls the market for these drugs.
From the miscellany department
Affordable Care Act FAQ 57 was issued yesterday. This FAQ concerns implementation guidance for the No Surprise Act’s anti-gag clause provision.
FedSmith identifies five milestones toward federal retirement.
Kaiser Family Foundation has created federal and state litigation trackers regarding reproductive rights.
From the Affordable Care Act front, the WTW consulting firm informs us
Group health plans and health insurance issuers will not be required to submit certain information on air ambulance services by March 31, 2023 (the deadline included in an example in the proposed regulations). The Centers for Medicare & Medicaid Services has informally confirmed that since final regulations have not yet been issued, no reporting is required in 2023.
Also following up on recent posts, Healthcare Dive tells us that
Amazon completed its $3.9 billion acquisition of primary care chain One Medical on Wednesday, significantly increasing its healthcare offerings with the addition of physical medical clinics.
UnitedHealth has closed its $5.4 billion acquisition of home health business LHC Group, continuing a trend of payers elbowing into direct care delivery.
In other U.S. healthcare business news, Forbes points out that
Aledade, a startup that helps primary care doctors enter into value-based contracts with insurers, has acquired artificial intelligence software company Curia. The acquisition follows a pilot program, where Aledade used Curia’s predictive algorithms to identify 8,000 patients to get them enrolled in a special end-of-life care program.
In a bit of good regulatory news for the FEHB Program, the CMS has delayed for up to one year final rulemaking on a civil monetary penalty rule for Medicare secondary payer violations. The proposed rule issued in Feburary 2020 treated FEHB plans and other group health plans inequitably as compared to non-group health plans, including trial lawyers. The FEHBlog is glad that CMS is trying to create a fair rule.
In other regulatory news, the Food and Drug Administration announced filing civil monetary penalty complaints against four e-cigarette manufacturers.
From the medical research front, MedPage Today reports
Patients with mild to moderate COVID-19 treated with the oral antiviral ensitrelvir within 5 days of symptom onset saw their symptoms resolve a day earlier, according to data from a phase II/III randomized trial.
Median time to symptom resolution was 24.3 hours earlier for patients treated with 125-mg ensitrelvir compared with those receiving placebo (P=0.04), reported Takeki Uehara, PhD, senior vice president of drug development and regulatory science at Shionogi and Co. in Osaka, Japan, during the Conference on Retroviruses and Opportunistic Infections. * * *
Ensitrelvir is a novel 3C-like protease inhibitor that targets the SARS-CoV-2 virus. “Because of its mode of action, ensitrelvir maintains antiviral activities across various different types of variants, including recently circulating Omicron variants,” Uehara said.
Of note, follow-up of patients continued out to 3 months and 6 months to evaluate the drug’s effectiveness on long COVID.
An important new study came out last week in the New England Journal of Medicine (NEJM), which found that a candidate vaccine against RSV was highly effective in preventing lower respiratory tract (read: lung) disease [in adults]. The study also found the vaccine prevented severe disease.
The study has many of the features you want to see from a well-conducted study: the vaccine was compared to placebo and the study was blinded, meaning that participants and the scientists carrying out the analysis were not aware of who got what. The study had nearly 25,000 participants and was carried out across 17 nations.
The vaccine was found to be over 80% effective against lower respiratory tract disease (the main outcome the study was designed to measure) and 94% effective against severe disease. This is great news.
.From the Rx coverage front —
Bloomberg relates “Eli Lilly & Co said on Tuesday that all doses of its new diabetes drug Mounjaro are now available after social-media enthusiasm about the drug’s weight-loss benefits sparked a two-month-long shortage.”
Drugs like Ozempic have become so popular among people seeking to lose weight that they are now in short supply for patients with diabetes who depend on the medicines.
Diabetes patients said they are spending hourstrying to find nearby pharmacies that have their prescriptions in stock. If they don’t, some patients have had to reduce dosing of Ozempic and similar drugs to stretch out their supplies, or switch to alternative drugs.
The shortfalls are making it harder for people with diabetes to keep their blood-sugar levels low and limit their risk of complications like kidney disease and damage to blood vessels, doctors said. * * *
Novo Nordisk A/S, which sells Ozempic, has been moving to expand production capacity. People may still experience periodic shortages, however, Chief Executive Lars Fruergaard Jorgensen said, because the work hasn’t been finished while demand may remain high.
By and large, doctors appear to be comfortable prescribing biosimilar drugs, the copycat version of biologic medicines like inflammatory disease drug Humira or eye treatment Lucentis. But they aren’t yet sure the discounts offered are enough to justify switching patients who are stable on the brand-name products, according to an annual report from healthcare distributor Cardinal Health released Wednesday. * * *
[A] majority of physicians from the three Humira-prescribing specialties [rheumatology, gastroenterology and dermatology] said they were “very” or “somewhat” comfortable prescribing biosimilars, including 100% of gastroenterologists. Among the ophthalmologists, 48% said they were “uncomfortable from a clinical standpoint” among their primary concerns prescribing biosimilars.
When asked which patients they are most likely to prescribe a biosimilar, the most common response among the Humira-prescribing specialists was “existing patients for whom payers have mandated a biosimilar,” suggesting that insurers’ policies will drive uptake. However, 40% of rheumatologists said “new patients” would be the most likely people to get a biosimilar prescription.
Drug Channels offers its annual update on copay assistance accumulator and maximizer programs.
From the miscellany department –
The Milbank Memorial Fund issued a Baseline Scorecard Tracking Support for High Quality Primary Care. The baseline leaves a lot of room for improvement.
Fierce Healthcare informs us that CMS recently has issued price transparency warnings to hospitals, 300 of which have been satisfactorily resolved.
While Medicare Advantage enrollment has increased by 1.5 million beneficiaries in 2023, this marks a slower growth compared to the last three years, according to data from Chartis.
The analysis reflects Medicare Advantage enrollment, plan, and pricing data from January 2019 to January 2023.
The CDC’s Covid Data Tracker shows all news cases, hospitalizations and deaths statistics trending down.
Health Day informs us, “Natural immunity from a COVID infection confers protection on par with that from mRNA vaccines, but patients run the risk of hospitalization and death during their initial infection.”
“The vaccines and boosters are still the safest way to acquire immunity, mainly for those who are in high-risk populations,” said study co-author Caroline Stein, a postdoctoral researcher at the University of Washington’s Institute for Health Metrics and Evaluation.
In fact, the best protection now appears to come from “hybrid immunity,” the combination of an actual infection and vaccination, said Dr. William Schaffner, medical director of the Bethesda, Md.-based National Foundation for Infectious Diseases.
From the public health front —
The CDC’s weekly Fluview reports, “Seasonal influenza activity is low nationally.”
The Fluview also discusses the risk that avian flu H5N1 poses to humans.
“The current public health threat to people from the H5N1 virus is low. The current H5N1 outbreak in poultry and birds continues to be mostly an animal health issue. However, people should avoid direct and close contact with sick or dead wild birds, poultry, and wild animals. People should not consume uncooked or undercooked poultry or poultry products, including raw eggs. Consuming properly cooked poultry, poultry products, and eggs is safe. Other preventive measures are available at Bird Flu: Current Situation Summary “
Health Day tells us, based on a recent CDC study, that “Far too many young kids aren’t eating enough fruits and vegetables, even as they consume plenty of sugary sodas.” No bueno.
The Wall Street Journal considers “How Common is Depression After a Stroke? Sen. John Fetterman’s Treatment Prompts Question. Depression can often follow a major medical issue or chronic illness. Here’s what to know.”
“Overall, between 20% and 30% of people with a chronic illness experience depression, says Karina Davidson, a clinical psychologist and dean of academic affairs at Northwell Health’s Feinstein Institutes for Medical Research.”
The Mercer consulting firm explains how new approaches are filling gaps created by obstetric unit closings.
“As the access to obstetrics care dwindles, employers can and should be looking for additional solutions to help keep their pregnant members and their newborns healthy. Whether that’s exploring new digital tools [such as Pregnascan and HeraMED] coming to market or just expanding coverage on their health plans to include doulas, community doulas, midwives, and birthing centers, any effort will be an important step forward in the fight to reduce maternal mortality and poor health outcomes in the US.”
From the No Surprises Act front, a colleague reminded the FEHBlog today that the deadline for health plans and air ambulance providers to submit their first NSA air ambulance report, March 31, 2023, is closing in. While the federal government has made available draft information on preparing this report, no sign of an official submission portal has appeared online. The clock continues clicking.
From the Miscellany Department —
Medscape offers an excellent article on the cost of gene therapies. Remember to click pages.
Mercer also delves into the abortion pill coverage quandary. (While FEHB plans must cover contraceptive pills, including the Plan B pill, abortion pills are excluded from coverage unless the mother’s life would be endangered if the fetus were carried to term or when the pregnancy is the result of an act of rape or incest.”
The American Hospital Association puts a favorable spin on a recent CMS report on health system compliance with the federal government’s hospital pricing transparency rule.
CMS is pleased “to provide you with the recording (password: 4%2M!3c?) and slides of the February 9, 2023, virtual education session hosted by the CMS Office of Burden Reduction and Health Informatics on the Advancing Interoperability and Improving Prior Authorization Processes proposed rule.
As a reminder, we welcome your feedback on the proposed policies introduced in the CMS Advancing Interoperability and Improving Prior Authorization Processes proposed rule (CMS-0057-P). Comments must be received within the 90-day comment period, which closes on March 13, 2023. When commenting, please refer to file code: CMS-0057-P.”
Beckers Hospital Review reports, “The Federal Trade Commission has welcomed the State University of New York Upstate Medical University and Crouse Health System’s decision to abandon their proposed merger, which it said would have left Syracuse with just two hospital systems — Upstate and St. Joseph’s Health — and given the combined entity a 67 percent share of commercially insured inpatient services in Onondaga County.”
The federal government will run out of cash to pay all its bills sometime between July and September unless the statutory debt limit is lifted, the Congressional Budget Office [CBO] warned Wednesday.
The report by the nonpartisan budget scorekeeper could put pressure on a divided Congress to reach a deal to increase, or at least suspend, the debt limit before adjourning for the annual August recess.
[A] separate CBO report issued Wednesday underscores the challenges for both parties in making the math add up. Deficits over the next decade are now projected to grow by $3.1 trillion, or 20 percent, during the next decade from the agency’s forecast last May.
STAT News “sat down with AMA President Jack Resneck on the sidelines of the [AMA’s Washington., D.C.] conference to talk about legislative reforms, physician burnout, and where the doctors’ lobby goes from here.” The Q&A made the FEHBlog crack up
There’s a lot about the way those [HHS] rules were first written that went way outside of congressional intent. They put major thumbs on the scale of basically moving towards the insurers’ notion of what that value should be.
There’s so many things about those rules that basically would encourage insurers to either just say “Oh, I can pay so much less through this arbitration system that I’m just going to purposely not contract with any physicians” … or just unilaterally, dramatically lower payment rates in a way that threatens practices.
What nonsense!
Medical Economics shares a letter to Congress from a group of medical associations on the topic of value-based care.
The National Academies issued a report on “Achieving Whole Health.”
Whole health is physical, behavioral, spiritual, and socioeconomic well-being as defined by individuals, families, and communities. Whole health care is an interprofessional, team-based approach anchored in trusted relationships to promote well-being, prevent disease, and restore health. It aligns with a person’s life mission, aspiration, and purpose. It shifts the focus from a reactive disease-oriented medical care system to one that prioritizes disease prevention, health, and well-being. It changes the health care conversation from “What’s wrong with you?” to “What matters to you?”
“Whether you want to cure diseases, protect and preserve our national parks, combat climate change, or embark on missions to discover new galaxies, the Federal government is full of opportunity for the best and brightest to serve our country,” said OPM Director Kiran Ahuja. “In order to recruit and sustain the best talent, we must ensure every service-minded individual feels welcome and supported in contributing their talents to the Federal workforce. This inaugural report highlights progress made to advance diversity, equity, inclusion, and accessibility in the workplace, and we look forward to continuing the work to break down barriers to serve and help build a Federal government that draws from the strength and diversity of its people.”
Tomorrow, February 16, at 10 am ET, the Senate Commerce, Science, and Transportation Committee will hold a hearing titled “Bringing Transparency and Accountability to Pharmacy Benefit Managers.”
This hearing will address how the “Pharmacy Benefit Manager Transparency Act” will bring transparency into PBM business practices and prohibit unfair or deceptive PBM conduct that drives up costs for consumers. The bipartisan S. 127, Pharmacy Benefit Manager Transparency Act of 2023, was introduced by Chair Cantwell and Sen. Chuck Grassley (R-Iowa), on January 27, 2023.
In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution.
The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage. For those lacking sufficient insurance, the company will tap a patient assistance program. “Everyone in the U.S. will have access to Moderna’s Covid-19 vaccine regardless of their ability to pay,” the company said.
The about-face came on the same day that Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor, and Pensions, accused the company of “corporate greed” and scheduled a hearing next month to examine the initial decision to charge Americans for its Covid-19 shot. Moderna Chief Executive Officer Stéphane Bancel is among those expected to testify. * * *
A spokesman for America’s Health Insurance Plans, an industry trade group, suggested that health insurers will still get a bill. He sent a note saying the Advisory Committee on Immunization Practices (which advises the CDC) recently updated its list of recommended Covid vaccines and that, while beneficiaries pay nothing in cost sharing after commercialization, health plans are picking up the full cost.
No doubt about the validity of AHIP’s point.
Medscape notes, “The increased risk for diabetes following COVID-19 infection has persisted into the Omicron era, but vaccination against SARS-CoV-2 appears to diminish that likelihood, new data suggest.”
“the Consumer Financial Protection Bureau (CFPB) released a new report that shows that the number of Americans with medical debt on their credit reports fell by 8.2 million from the first quarter of 2020 to the first quarter of 2022. Today’s report is consistent with a recent report from the Centers for Disease Control and Prevention (CDC) that found that the number of Americans who are part of families having trouble paying their medical bills declined by 5.5 million between 2020 and 2021. One driver of these declines is the significant increase in the number of insured Americans over this period, a result of the President’s strategy of protecting and strengthening the Affordable Care Act (ACA) and lowering health care costs. The decline also reflects continued actions by the CFPB to highlight problems with inaccurate reporting of debt in collections and put the industry on notice to correct their behavior.”
The Wall Street Journal reports “More older women with low-risk breast cancer could forgo radiation after surgery to avoid further side effects and costs, research showed,as some doctors work to limit tough treatments without hurting survival.” STAT News also offers an article on this topic.
The National Cancer Institute posts on a variety of cancer topics. For example
“The Food and Drug Administration (FDA) approved tucatinib (Tukysa) with trastuzumab (Herceptin) to treat HER2-positive advanced colorectal cancer. The approval was based on the MOUNTAINEER trial, in which nearly 40% of participants’ tumors shrank after receiving the drugs.”
Employer-sponsored plans pay much higher rates for physician-administered drugs than Medicare, a research letter published Feb. 10 in JAMA Health Forum found.
Researchers at the Healthcare Cost Institute compared per-unit prices for the 10 most expensive and 10 most common physician-administered drugs from 2016 to 2020.
For the most commonly used drugs, employer-sponsored plans paid prices up to 3,350 percent higher than Medicare. For midazolam, employer-sponsored plans paid 30 times more than Medicare for the same drug, and they paid 20 times more for ondansetron.
For the most expensive drugs, employer-sponsored plans did not pay as extreme markups, the researchers found. Markups were 54 percent more than Medicare at the high end, and employer-sponsored plans paid similar prices to Medicare rates for some drugs.
Thank heavens OPM is allowing FEHB plans to offer Medicare Part D EGWPs for the Medicare prime members next year.
Health Payer Intelligence informs us “Out-of-pocket costs for buprenorphine prescriptions for opioid use disorder treatment decreased between 2015 and 2020, but costs varied by payer, according to a study published in JAMA Network Open.”
The nation’s largest payers have filed their fourth quarter earnings reports, revealing which have the most U.S. commercial members. Commercial includes fully- and self-insured members
After more than two decades together, CommonSpirit Health and AdventHealth are dissolving their joint venturemanaging hospital operations in Colorado and western Kansas.
The management company, Centura, operates one of the largest hospital networks in the region, with 20 hospitals and a network of outpatient practices.
In a release on Tuesday, the systems said the partnership had reached its “natural maturity.” CommonSpirit and AdventHealth didn’t lay out a timeline for the transition.
The acquisition builds off the Indianapolis-based insurer’s promise to acquire companies around its health services business, with Elevance CEO Gail Boudreaux announcing at a November industry conference that the insurer planned to grow “very aggressively” into adjacent care services.
Walgreens has agreed to buy the assets of defunct digital pharmacy Medly for $19.35 million, according to a bankruptcy court filing.
Medly declared bankruptcy in December, months after its founder stepped down and it laid off more than half its staff. A judge approved the acquisition of Medly’s assets, including its files, inventory and intellectual property, Feb. 7 in U.S. Bankruptcy Court for the District of Delaware.
From our Nation’s capital, Federal News Network informs us
The Office of Management and Budget filled a key personnel and performance leadership role with a familiar name.
Federal News Networks has confirmed that Loren DeJonge Schulman is starting as the new associate director for performance and personnel management today.
She replaces Pam Coleman, who left in August after 20 months in that role.
DeJonge Schulman joins OMB from the Partnership for Public Service where she was vice president of research, evaluation and modernizing government for the last two-plus years. In that role, she helped lead the Best Places to Work in Government rankings and focused on issues around improving federal workforce management.
The U.S. Office of Personnel Management (OPM) has announced the Finalists for this year’s Presidential Management Fellows (PMF) Program. Of the more than 10,000 individuals from around the world who applied for the program, 850 Finalists were chosen. The large number of applications to this competitive program marks a record number of applications over the past ten years.
“Presidential Management Fellows are the next generation of government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2023 PMF finalists. We cannot wait to see what you will accomplish in public service.” * * *
PMFs are appointed to a two-year, full-time Federal position with salary and benefits, where they apply their skills while engaging in leadership development training that includes experiential learning, cohort-based interactive training, and optional rotational experiences.
In Omicron and siblings news, BioPharma Dive informs us
The U.S. has agreed to buy 1.5 million additional doses of Novavax’s COVID-19 vaccine as part of preparations for the government’s planned transition from bulk purchases to private market sales.
The agreement, announced Monday by Novavax, will support development of an updated version of the company’s shot in line with the Food and Drug Administration’s plan to annually match COVID vaccines to the most prevalent virus variants. It will also aid the company in developing smaller dose vials, which are less logistically challenging.
Novavax did not disclose the cost of the purchases, which are funded under an existing $1.6 billion contract with the government. Its shot uses a vaccine technology that has long been a mainstay and that the company claims remains an important option for those who cannot or will not take the messenger RNA-based shots from Pfizer and Moderna.
From the public health front —
The Washington Post discusses a horrifying CDC report on the mental health of high school students.
“Teen girls across the United States are ‘engulfed in a growing wave of violence and trauma,’ according to federal researchers who released data Monday showing increases in rape and sexual violence, as well as record levels of feeling sad or hopeless.”
In its report, the CDC steered attention to the nation’s schools, saying activities there can make a profound difference in the lives of teens. It recommended improved access to mental health services, more classroom management training for teachers, school clubs that foster gay-straight alliances, high-quality health education and enforcement of anti-harassment policies. Ideally, schools would take on multiple initiatives.”
NBC News reports “A handful of factors, such as education, income and job type, may increase the likelihood that people in their mid-50s will still be mentally sharp, a new study finds.”
From the No Surprises Act front, Healthcare Dive adds
STAT News delves into the ground ambulance billing issue today. It’s worth noting at the risk of belaboring the obvious that air ambulances are considerably more expensive than ground ambulances.
The FEHBlog was surprised to read about the number of arbitration requests in January given the Texas Medical Association’s contention that the new $350 per party arbitration fee would suppress the numbers of arbitrations. In the FEHBlog’s view, providers should place more focus on the open negotiation phase of the process.
From the electronic health records front, HealthITBuzz alerts us
A little over a year ago, we announced the completion of a critical 21st Century Cures Act requirement by publishing the Trusted Exchange Framework and Common Agreement (TEFCA). This milestone established a clear infrastructure model and governing approach for nationwide health information exchange.
Today, we marked the next major milestone during an event at the U.S. Department of Health and Human Services (HHS) headquarters, which recognized the first set of networks to be approved to implement TEFCA as prospective Qualified Health Information Networks (QHINs). Once fully onboarded, the organizations will officially be “designated” as QHINs. At this event, HHS Secretary Becerra recognized and congratulated CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2, and KONZA for their willingness to voluntarily step up and meet the rigorous TEFCA eligibility requirements, terms and conditions of TEFCA participation, and commitment to a 12-month go-live timeline. Collectively, the QHIN applicants have networks that cover most U.S. hospitals, tens of thousands of providers, and process billions of annual transactions across all fifty states.
Bravissimo.
From the U.S. healthcare business front —
Cigna announced a rebranding of its businesses: The Cigna Group, the global health company; Cigna Healthcare, the health benefits provider; and Evernorth Health Services, the pharmacy, care and benefits solutions provider.
Politico, upon examining whether a new CMS policy can save rural hospitals, offers us a mixed bag:
The Rural Emergency Hospital designation, aimed at sustaining emergency rooms, outpatient care and clinics, will be a major consideration for a significant number of hospitals, according to a new report from Chartis, a health care consulting group.
The policy changes are among the largest made to the rural health system in years. Through Medicare, hospitals that agree to the program requirements are guaranteed a set amount of money for facilities and a boosted Medicare reimbursement rate.
About 400 hospitals are “most likely” to consider conversion, according to the analysis, with about 80 of those “ideal” candidates for the change — often facilities on the brink of closing without growing revenues.
Several dozen hospitals are expected to move toward the new designation in the next 12 to 18 months “because they’re right on the ropes,” Michael Topchik, national leader of the Chartis Center for Rural Health, told Pulse.
Another group will wait and see how the first group does under the new rules, he said.
Still, most of the nearly 1,600 rural hospitals aren’t interested. The designation requires giving up inpatient care, a key part of many hospitals’ business and a handful of financial incentives offered through other rural health programs.
That doesn’t mean rural hospitals are thriving, though. Closures slowed significantly during the pandemic, likely because of the government’s infusion of resources through the pandemic, but are again ticking up.
Sanford Health and Fairview Health Services have agreed to push back their planned megamerger by two months.
The health systems said in a statement that they jointly determined they should “voluntarily” move the expected closure date for the deal to May 31, according to a report in MPR News. The merger was originally set to close March 31, but Minnesota Attorney General Keith Ellison asked the two providers to delay.
The deal includes 58 hospitals, and, if the two systems are joined, they would employ more than 80,000 people.
New Cases – As of February 8, 2023, the current 7-day average of weekly new cases (40,404) decreased 1.0% compared with the previous 7-day average (40,815).
New Hospitalizations — The current 7-day daily average for February 1–7, 2023, was 3,665. This is an 6.2% decrease from the prior 7-day average (3,907) from January 25–31, 2023.
New Deaths — The current 7-day average of new deaths (453) decreased 9.7% compared with the previous 7-day average (502).
Vaccinations — As of February 8, 2023, 670.3 million vaccine doses have been administered in the United States. Overall, about 229.8 million people, or 69.2% of the total U.S. population, have completed a primary series. About 52.5 million people, or 15.8% of the U.S. population, have received an updated booster dose.
Communities Levels — As of February 9, 2023, there are 91 (2.8%) counties, districts, or territories with a high COVID-19 Community Level, 715 (22.2%) with a medium Community Level, and 2,407 (74.8%) with a low Community Level. Compared with last week, the number of counties, districts, or territories in the high level decreased by 1.2%, in the medium level decreased by 3.2%, and in the low level increased by 4.3%.
The weekly report explains why immunocompromised folks with weakened immune systems should create a Covid action plan.
The CDC’s weekly flu report informs us “Seasonal influenza activity is low nationally.” Nevertheless the CDC adds
CDC reported 9 new flu-related pediatric deaths this week, bringing the total for the season to 106, the highest number of flu deaths in children since the start of the COVID-19 pandemic. Most of these children were not vaccinated. This tragic milestone underscores the importance of vaccinating children against flu. Flu vaccination uptake in children is lower by about 6 percentage points than it was prior to the COVID-19 pandemic. While flu activity has returned to low levels this season, CDC continues to recommend flu vaccination as long as flu viruses are spreading.
During the most recent 10 flu seasons, the number of pediatric flu deaths in a season has ranged from 1 (2020-2021) to 199 (2019-2020). Prior to the pandemic, the record low for pediatric deaths was 37, which was during the 2011-2012 season.
AHIP reports,
The Centers for Disease Control and Prevention (CDC) has added COVID-19 vaccinations for children, adolescents, and adults to its immunization schedule. Adding these vaccines to the schedule formalizes guidance for health care providers and schools.
CDC recommends that healthy children 6 months to 4 years old receive a primary series of two doses of the Moderna or Pfizer-BioNTech monovalent COVID-19 vaccine followed by a third dose of a bivalent vaccine.
CDC recommends that children aged 5 to 12 years receive two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine followed by a bivalent shot.
CDC recommends children ages 12 and older should get either two doses of the Moderna, Pfizer-BioNTech, or Novavax vaccine, followed by a bivalent booster.
Immunocompromised children should receive three doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine as a primary series instead of two shots, and should receive a bivalent booster.
CDC recommends healthy adults receive a primary COVID-19 vaccination of two doses of the Moderna, Pfizer-BioNTech or Novavax vaccine and a bivalent booster, similar to children. Some adults may choose to receive a Novavax booster instead if they would not like the Moderna or Pfizer-BioNTech shot, or if those boosters are not available.
CDC recommends immunocompromised adults receive either two doses of the Novavax vaccine, or three doses of the Pfizer-BioNTech or Moderna vaccine and a bivalent booster.
CDC also recommends that adults who received the one-dose Johnson & Johnson vaccine receive one booster dose, followed by a bivalent booster.
It’s a new year, which means a new ACIP adult immunization schedule — a valuable resource collating ACIP’s most up-to-date vaccination recommendations.
Here are this year’s five most important changes:
COVID vaccines now front and center
New emphasis on polio vaccination
Inclusion of some nonvaccine products (such as monoclonal antibody products)
Pharmacists group has approved the schedule for the first time
New shared clinical decision-making option for pneumococcal vaccines
From the No Surprises Act front, the American Hospital Association relates
Following a Feb. 6 court decision that vacated nationwide the federal government’s revised independent dispute resolution process for determining payment for out-of-network services under the No Surprises Act, the Centers for Medicare & Medicaid Services today instructed certified IDR entities to hold all payment determinations until the departments of Health and Human Services, Labor, and the Treasury issue further guidance. Certified IDR entities have also been instructed to recall any payment determinations issued after Feb. 6, 2023.
“The Departments are currently reviewing the court’s decision and evaluating current IDR processes, guidance, templates, and systems for updates that will be necessary to comply with the court’s order,” CMS said. “The Departments will provide specific directions to certified IDR entities for resuming the issuance of payment determinations that are consistent with the court’s judgment and order. Certified IDR entities should continue working through other parts of the IDR process, including eligibility determinations, as they wait for additional direction from the Departments.”
The FEHBlog notes that while the court ordered changes to the IDR rule which favor the plaintiffs, the court did not vacate the IDR rule. The FEHBlog does not otherwise doubt the veracity of this report.
From the Rx coverage and research front —
BioPharma Dive reports “Pfizer and partner BioNTech on Friday started the first human trial of a messenger RNA-based vaccine for shingles, believing their shot can be easier to take, and more efficiently produced, than the one available for use [Shingrix].
Medscape alerts us that a new vibrating, drug-free pill to relieve constipation is on the market.
From the healthcare quality front, NCQA puts us on notice that
This year’s HEDIS public comment is open Monday, February 13–Monday, March 13.
We’re seeking advice on:
Revisions to diabetes measures.
Expansion of race and ethnicity stratifications in select HEDIS measures.
Advancing gender-inclusion measurement in two HEDIS measures.
Retirement of several measures.
This year’s public comment will go live at Monday, February 13, 9:00 AM ET.
Kaiser Permanente released its 2022 financial results
Total operating revenues for 2022 were $95.4 billion compared to $93.1 billion in 2021. Total operating expenses were $96.7 billion compared to $92.5 billion in the prior year. There was an operating loss of $1.3 billion for the year compared to operating income of $611 million in 2021. * * *
Strong economic headwinds in the financial markets drove a loss in total other income and expense of $3.2 billion in 2022 compared to a gain of $7.5 billion in 2021. For 2022, there was a net loss of $4.5 billion compared to net income of $8.1 billion in 2021.
Capital spending totaled $3.5 billion, consistent with the $3.5 billion spent the prior year. During 2022, Kaiser Permanente opened 4 new medical offices. Kaiser Permanente now has 737 medical offices, 39 owned hospitals, and 43 retail and employee clinics.
“Clinical staff shortages, COVID-19 care and testing, higher costs of goods and services, and deferred care drove Kaiser Permanente’s expenses beyond revenue,” said chair and chief executive officer Greg A. Adams. “Rather than pull back amid financial pressures, we made the decision to continue our long-term and strategic investments in care and service improvements while carefully managing resources. Our staff and physicians worked hard to meet our members’ needs and I am grateful for their outstanding contributions.”
Major for-profit hospital chain Tenet Healthcare is projecting growth in 2023 thanks to less reliance on contract labor and growth in its surgery subsidiary.
The chain announced in its earnings release that it generated $102 million in profits with $4.9 billion in net revenue for the fourth quarter of 2022. It also released the full year financial guidance for 2023, projecting adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) to be $3.16 to $3.36 billion.
“Our momentum going into 2023 positions us for continued growth as we remain focused on expanding our industry-leading ambulatory business and investing in technology, innovation and talent,” said CEO Saum Sutaria in a statement.
Beckers Hospital Review identifies six considerations related to the fact that 43% of rural hospitals are in the red.
Reuters reports “AstraZeneca (AZN.L) on Thursday said it was poised to grow in 2023 and beyond, banking on its burgeoning line-up of cancer, metabolic and rare disease drugs to pick up the pace from dwindling COVID product sales.”
From Washington, DC, the Society for Human Resource Management tells us that Labor Secretary Marty Walsh will be leaving his position to become head of the National Hockey League (NHL) Players’ Association, according to news reports.
In other regulatory news, Health Payer Intelligence reports
The Alliance of Community Health Plans (ACHP) was among around 50 organizations—including AHIP and Blue Cross Blue Shield Association—to sign a letter to HHS that supported fully aligning the substance use disorder patient data requirements in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) with the Health Insurance Portability and Accountability Act (HIPAA).
The group noted that the proposed rule falls short of this goal.
Also, the Office of National Coordinator of Health IT announced that “On Monday, February 13, HHS will recognize the first set of applicant organizations that are approved for onboarding as Qualified Health Information Networks (QHINs) under TEFCA.” The ongoing launch of TEFCA, which will serve as a backbone for the country’s electronic health record systems, is exciting.
From the Omicron and siblings front —
The Kaiser Family Foundation’s Covid Vaccine Monitor informs us “nearly four in ten households (38%) were affected by this winter’s” tripledemic. The flu affected the largest share of households (27%), followed by Covid (15%) and RSV (10%). “At the same time, almost three years into the COVID-19 pandemic, most of the public says they are “not too” or “not at all” worried about getting seriously ill from the virus (69%), though 31% still say they are worried.”
The Food and Drug Administration offers step-by-step guidance on reporting Covid test results to public health authorities.
From the public health front,
MedPage Today and the New York Times offer opinion pieces on why experts are concerned about the spread of avian flu to humans.
Health Affairs discusses an interesting study finding: “A high prevalence of mental health diagnoses in adults alongside ongoing shortages of mental health specialists and expansion of the patient-centered medical home has increased the involvement of primary care clinicians in treating mental health concerns.”
McKinsey and Company offer the following interview: “McKinsey Global Publishing’s Eleni Kostopoulos chats with Alex Jadad and Tamen Jadad-Garcia about their new book, Healthy No Matter What: How Humans Are Hardwired to Adapt (Penguin Random House, January 2023). Dr. Jadad created the widely popular Jadad scale for assessing clinical trials. Now, he’s combining his medical expertise with his daughter’s health entrepreneurship to explore what it truly means to be ‘healthy’.”
From the No Surprises Act front, Becker’s Payer Issues reports on a February 6, 2023, opinion from the Eastern District of Texas striking down certain provisions of the latest independent dispute resolution rule. Judge Kernodle considers those stricken provisions to conflict with the statute by placing too much emphasis on one of six factors that the law allows the arbitrator to consider: the health plan’s qualified payment amount. The FEHBlog doubts that this decision will immediately impact the IDR process, which continues to be quite bogged down. Providers should emphasize resolving billing disputes during the initial open negotiation period. Regardless, the plaintiff Texas Medical Association has two more NSA issues pending before the good Judge.
From the fraud, waste, and abuse front, the Justice Department announced that False Claims Act settlements and judgments exceeded $2 billion in fiscal year 2022. “[H]ealth care fraud remained a leading source of False Claims Act settlements and judgments.”
From the U.S. healthcare business front
Fierce Healthcare tells us that Health insurer Centene announced its fourth-quarter 2022 financial results today.
Medcity Today relates, “The U.S. healthcare system spent $60 billion on administrative tasks last year, which is about $18 billion more than it spent in 2021, according to a new report from the Council for Affordable Quality Healthcare (CAQH).” The report attributed the increase to a labor shortage and greater utilization of healthcare services in 2022.
The Drug Channels blog assesses biosimilar challenges to Humira.
President Biden and House Speaker Kevin McCarthy began face-to-face debt-ceiling discussions [today], with the latter expressing cautious optimism that they can come to a deal to avoid the first-ever default of the country’s debt.
Senate Minority Leader Mitch McConnell (R-Ky.) has pulled Sen. Rick Scott (R-Fla.), who tried to oust him as the Senate’s top Republican in a bruising leadership race, off the powerful Commerce Committee.
McConnell also removed Sen. Mike Lee (R-Utah), who supported Scott’s bid to replace McConnell as leader, from the Commerce panel, which has broad jurisdiction over a swath of federal agencies.
Speaking of federal agencies, Healthcare Dive informs us
The Federal Trade Commission is penalizing GoodRx for sharing users’ sensitive health information with advertisers, in the agency’s first enforcement action under the Health Breach Notification Rule.
The FTC filed an order with the Department of Justice on Wednesday that would prohibit GoodRx from sharing user health data with third parties for advertising purposes, among other guardrails. GoodRx has also agreed to pay a $1.5 million fine, though the company admitted no wrongdoing. The order needs to be approved by a federal court in order to go into effect.
Also, the President issued a Statement of Administration Policy objecting to Republican legislative efforts to end the national and public health emergencies for the Covid pandemic without further delay. The Statement explains why the White House has opted to end those emergencies on May 11.
CMS announced that there will be a special enrollment period on the Affordable Care Act marketplace for individuals who lose their Medicaid coverage due to the public health emergency unwinding.
“Today, CMS is announcing a Marketplace Special Enrollment Period (SEP) for qualified individuals and their families who lose Medicaid or CHIP coverage due to the end of the continuous enrollment condition, also known as ‘unwinding,’” the FAQ sheet explained.
The special enrollment period will stretch from March 31, 2023 to July 31, 2024. In order to be eligible for the special enrollment period, individuals must be eligible for Affordable Care Act marketplace coverage and must have lost their Medicaid, Children’s Health Insurance Program (CHIP), or Basic Health Program (BHP) coverage.
From the Omicron and siblings front, Beckers Hospital Review points out
The FDA altered its emergency use authorizations on Paxlovid and Lagevrio, two COVID-19 treatments, on Feb. 1 to revoke a requirement for a positive COVID-19 test before a provider can prescribe them.
“The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19,” the FDA said in an emailed statement. But, “in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their healthcare provider as having COVID-19” even if they test negative.
From the public health front —
The Commonwealth Fund issued a report titled “U.S. Health Care from a Global Perspective, 2022: Accelerating Spending, Worsening Outcomes.” The FEHBlog’s perception is quite sunny compared to this gloomy report.
The National Institutes of Health is celebrating American Heart Month.
The National Cancer Institute offers an interesting newsletter on its work.
The Wall Street considers dangerous fungi that are infecting people as a result of climate change.
From the No Surprises Act front, according to Healthcare Dive, the Texas Medical Association has filed a fourth lawsuit concerning the law. This time the TMA objects to the regulators’ entirely appropriate decision to increase the arbitration administration fee from $100 split between the parties to $700 similarly split. The arbitration or IDRE process was being bombarded with arbitration requests from providers. The fee increase will focus more provider attention on the open negotiation period that precedes the arbitration. “The suit also challenges the laws’ restrictions on batching claims, which allows arbitration processes only on claims with the same service code, requiring providers to go through a separate payment dispute process for each claim related to an individual’s care episode, according to the suit.” Quelle domage.
From the U.S. healthcare business front
Beckers Payer Issues reports, “Humana posted revenues of nearly $93 billion in 2022 and a net loss of $15 million in the most recent quarter, according to its year-end earnings report published Feb. 1. The company also appointed Steward Health Care President Sanjay Shetty, MD, to lead its healthcare services business, CenterWell, which includes pharmacy dispensing, provider and home health services. Dr. Shetty will start April 1. In addition, the company promoted its Medicare president, George Renaudin, to president of Medicare and Medicaid, effective immediately.”
Beckers Hospital Review examines whether Amazon can disrupt the pharmacy industry.
From the Medicare front, the Centers for Medicare and Medicaid Services released
the Calendar Year (CY) 2024 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies (the Advance Notice). CMS will accept comments on the CY 2024 Advance Notice through Friday, March 3, 2023. CMS will carefully consider timely comments received before publishing the final Rate Announcement by April 3, 2023.
The Biden administration will send its budget for the next fiscal year up to Capitol Hill on March 9, according to a memo from top White House aides.
That’s about a month later than the statutory deadline, which is the first Monday in February, though that target is often missed and there’s no penalty for doing so.
National Econonic Council Director Brian Deese and Office of Management and Budget Director Shalanda Young laid out the timing in a memo to “interested parties” that also discussed agenda topics for Wednesday’s scheduled meeting between President Joe Biden and Speaker Kevin McCarthy, R-Calif.
The memo, first reported by ABC News, said Biden will ask McCarthy to “commit to the bedrock principle that the United States will never default on its financial obligations,” a reference to the upcoming fight over the statutory debt ceiling. Treasury Secretary Janet L. Yellen has warned that the U.S. could be in danger of missed payments by early June if Congress doesn’t act to raise or suspend the $31.4 trillion debt limit.
The memo also says Biden will urge McCarthy and House Republicans to release their own fiscal 2024 budget blueprint that spells out the spending cuts they want to attach to any debt limit deal and how their budget will balance if they plan to extend expiring tax cuts.
Senator Tina Smith (D MN) and a bipartisan group of colleagues sent several large health insurers a letter requesting answers to questions about ghost networks. It turns out the ghost networks are online provider directories with errors. The FEHBlog thinks that the Senators should be pressuring the No Surprises Act regulators to implement the provider directory accuracy provision in that law.
From the Omicron and siblings front, the New York Times explores why Paxlovid, a reliable treatment, is underprescribed by doctors.
Doctors prescribed it in about 45 percent of recorded Covid cases nationwide during the first two weeks of January, according to White House data. In some states, Paxlovid is given in less than 25 or even 20 percent of recorded cases. (Those are likely overestimates because cases are underreported.)
Why is Paxlovid still relatively untapped? Part of the answer lies in a lack of public awareness. Some Covid patients also may decide that they don’t need Paxlovid because they are already vaccinated, have had Covid before or are younger. (My colleagues explained why even mild cases often still warrant a dose of Paxlovid.) * * *
Experts have increasingly pointed to another explanation for Paxlovid’s underuse: Doctors still resist prescribing it. Today’s newsletter will focus on that cause.
Some doctors have concerns that are rooted in real issues with Paxlovid and inform their reluctance to prescribe it. But experts are unconvinced that those fears are enough to avoid prescribing Paxlovid altogether, especially to older and higher-risk patients.
“What I’m doing for a living is weighing the benefits and the risks for everything,” said Dr. Robert Wachter, the chair of the medicine department at the University of California, San Francisco. In deciding whether to prescribe Paxlovid, he said, the benefits significantly outweigh the risks.
Six years after regulators approved Amjevita, a biosimilar to the nation’s most lucrative drug, Humira, Amgen’s drug jumped on the U.S. market Jan. 31 with two list prices.
The biosimilar to AbbVie’s most profitable drug will either cost 5 percent or 55 percent less than Humira’s price, according to Amgen. Humira costs $6,922 for a month’s supply, meaning Amjevita’s price — depending on the buyer — will be $6,576 or $3,115. The higher price is designed to entice pharmacy benefit managers, and the lower one is for payers, according to Bloomberg.
As Humira’s 20-year, $114 billion, 247-patent-strong monopoly ends with the first biosimilar, more copycat versions are set to premiere in the next few months.
STAT News dives deeper into the implications of Amgen’s pricing approach.
AHIP responded yesterday to CMS’s final Medicare Advantage plan audit rule.
“Our view remains unchanged: This rule is unlawful and fatally flawed, and it should have been withdrawn instead of finalized. The rule will hurt seniors, reduce health equity, and discriminate against those who need care the most. Further, the rule would raise prices for seniors and taxpayers, reduce benefits for those who choose MA, and yield fewer plan options in the future.
“We encourage CMS to work with us, continuing our shared public-private partnership for the health and financial stability of the American people. Together, we can identify solutions that are fair, are legally sound, and ensure uninterrupted access to care and benefits for MA enrollees.”
Is the next step the courthouse?
Money Magazine offers a list of hospitals that provide bariatric surgery with Leapfrog safety grades.
From the mental healthcare front, Fierce Healthcare tells us
Parents can now be added alongside providers, health insurers and employers to the list of stakeholders with growing concerns about mental health, according to a study by the Pew Research Center.
The study found that 40% of parents call the fact that their children might be struggling with anxiety and depression their No. 1 concern—something they’re extremely or very worried about—followed by 35% of parents who put the fear that their children are being bullied into that category.
From the tidbits department —
The NY Times lists ten nutrition myths that experts wish would be forgotten.
The NIH Directors blog explains why a “New 3D Atlas of Colorectal Cancer Promises Improved Diagnosis, Treatment.”
The National Association of Plan Advisors points out that “Despite a rebound in out-of-pocket health care spending in 2021, health savings account (HSA) balances increased on average over the course of the year, the Employee Benefit Research Institute (EBRI) recently found. Its analysis of HSA balances, contributions, and distributions also found, “patients sought health care services more frequently in 2021—and spent more out of pocket, as well—than they did in 2020, yet the average end-of-year balance was higher than the average beginning-of-year balance.”
Congress will be in session this week for Committee and floor business.
The No Surprises Act’s RxDC reporting deadline is this Tuesday, January 31, for the 2020 and 2021 reporting years. RxBenefits informs us, “Optum, Caremark, and Express Scripts have finalized their submission files and confirmed that all submissions would be completed before January 31, 2023, if not already filed.”
From the public health front —
NPR Shots explains why your kids are germ vectors, albeit adorable ones.
Fortune Wells reports that “Researchers at the Institute of Psychiatry, Psychology & Neuroscience at King’s College London have developed a blood-based test that can detect Alzheimer’s disease up to 3.5 years before a clinical diagnosis.” This test would help people decide whether they need the new Biogen/Eisai drug assuming Medicare approves it.
Fortune Well also points out how employers can reduce workplace stress.
Kaiser Family Foundation provides us with recent upbeat data on long Covid.
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