Tuesday’s Tidbits

Medicare

Tuesday’s Tidbits

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medicare, NIH, Rx coverage, U.S. Healthcare–

Happy Pi Day!

Photo by Patrick Fore on Unsplash

From the Omicron and siblings front —

  • The Wall Street Journal reports
    • In the three years since Covid-19 surfaced in the U.S., most Americans have been infected and are largely back to their prepandemic routines and workaday lives. 
    • Scientists, still in the dark about what the virus will do in the long term, warn it is too early to sound the all clear. Despite the success of a global effort to decode the SARS-CoV-2 virus and create vaccines and treatments to combat it, there remains uncertainty about how the virus will behave, the path of its mutations and Covid-19’s long-term effects. 
    • Covid-19 vaccines are widely available, but researchers don’t yet know enough about how the virus might change or how long immunity lasts to be certain who should get future boosters or how often. The unknowns could have public-health consequences in the years ahead, virus experts said.
    •  “A big question is how will that play out over time?” Bronwyn MacInnis said of the virus’s mutations. She is director of pathogen genomic surveillance at the Broad Institute of MIT and Harvard, a biomedical research center in Cambridge, Mass. “Are there other tricks we have yet to see?” she said. * * *
    • “Any time someone talks about Covid, I think it’s good to start with a lot of humility,” Moderna Chief Executive Officer Stéphane Bancel said. “It’s still a new virus. So we don’t know everything.”
  • The Food and Drug Administration (FDA) announced amending “the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.”
  • Yesterday, The FDA took the following steps concerning the Johnson and Johnson (Jannsen) vaccine.
    • The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to include a Warning conveying that reports of adverse events following use of the vaccine under emergency use authorization suggest increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following vaccination. The Fact Sheet for Recipients and Caregivers was also revised to include information about myocarditis and pericarditis following the administration of the Janssen COVID‑19 Vaccine. An additional revision to the Fact Sheets was made to include that facial paralysis (including Bell’s Palsy) has been reported during post-authorization use. Also, the scope of authorization for a booster dose of the Janssen COVID-19 Vaccine has been revised to reflect that the vaccine may be administered as a first booster dose at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. The FDA reissued the letter of authorization for the Janssen COVID-19 Vaccine to revise the scope of authorization related to the administration of a booster dose and the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Janssen Biotech, Inc. to include myocarditis and pericarditis.  
    • The Janssen COVID-19 Vaccine is authorized for emergency use for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The letter of authorization and revised fact sheets are available on the FDA’s website.

From the Rx coverage front —

  • Fierce Healthcare offers its insights into why the Veterans Administration decided to offer the new Alzheimer’s Disease drug Leqembi to its patients who are eligible for the drug under the FDA’s guidance. Fierce Healthcare does not expect to CMS to follow this approach later this year. Currently, Medicare covers the drug when offered in a clinical trial, while the FDA’s approach is much broader.
  • The Wall Street Journal reports,

    • Novo Nordisk A/S is set to cut the U.S. list prices for several insulin drugs by up to 75%, the latest big drugmaker to make steep price reductions amid pressure to curb diabetes treatment costs.

    • Novo, one of the biggest sellers of insulin in the U.S. and around the world, said Tuesday it would cut the list price of its NovoLog insulin by 75% and the prices for Novolin and Levemir by 65% starting in January 2024. 

    • In addition, Novo plans to cut prices for its unbranded insulin products to match the reduced price of Novo’s corresponding brands.

  • The Centers for Disease Control issued a Vital Signs report titled “Progress Toward Eliminating HIV as a Global Public Health Threat Through Scale-Up of Antiretroviral Therapy and Health System” over the period 2004 through 2022.
    • What is already known about this topic?
    • The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) began providing HIV antiretroviral therapy (ART) worldwide in 2004. [At that time, George W. Bush was President.} Through viral load suppression, effective ART improves health outcomes and prevents transmission.
    • What is added by this report?
    • By 2022, approximately 20 million persons with HIV infection in 54 countries received PEPFAR-supported ART (62% CDC-supported); this number represents an increase of 300-fold from 66,6550 in 2004. During 2015–2022, viral load suppression rates increased from 80% to 95% among those who received testing.
    • What are the implications for public health practice?
    • To eliminate HIV as a global public health threat, achievements must be sustained and expanded to reach all subpopulations. PEPFAR remains committed to tackling HIV while strengthening public health systems and global health security.

In recognition of Patient Safety Awareness Week, Beckers Hospital Review highlights

Healthgrades recognized 864 hospitals with its 2023 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 83 of those hospitals received both awards. 

The dual recipients spanned 28 states. Texas had the most dual recipients with 12 honorees — including three Baylor Scott and White Health hospitals. 

From the medical research front,

  • NIH researchers compared a new genetic animal model of Down syndrome to the standard model and found the updated version to be more similar to the changes seen in humans. The new mouse model shows milder cognitive traits compared to a previously studied Down syndrome mouse model. The results of this study, published in Biological Psychiatry, may help researchers develop more precise treatments to improve learning and memory in people with Down syndrome.
  • The NIH DIrectors in his blog, explains
    • “The human brain is profoundly complex, consisting of tens of billions of neurons that form trillions of interconnections. This complex neural wiring that allows us to think, feel, move, and act is surrounded by the blood-brain barrier (BBB), a dense sheet of cells and blood vessels. The BBB blocks dangerous toxins and infectious agents from entering the brain, while allowing nutrients and other essential small molecules to pass right through.
    • “This gatekeeping function helps to keep the brain healthy, but not when the barrier prevents potentially life-saving drugs from reaching aggressive, inoperable brain tumors. Now, an NIH-funded team reporting in the journal Nature Materials describes a promising new way to ferry cancer drugs across the BBB and reach disease sites [1]. While the researchers have not yet tried this new approach in people, they have some encouraging evidence from studies in mouse models of medulloblastoma, an aggressive brain cancer that’s diagnosed in hundreds of children each year.” 

Thanks, research mice.

From the healthcare costs front, the New York Times reports, “Most older cancer patients received invasive care in the last month of their lives, a new study finds. That may not be what they wanted.”

The health care system could improve end-of-life care. When palliative care is introduced soon after a diagnosis, patients have a better quality of life and less depression, a study of people with metastatic lung cancer found. Though they were less likely to undergo aggressive treatment, they survived longer.

Palliative care doctors, skilled in discussions of serious illness, are scarce in some parts of the country, however, and in outpatient practices.

Nomi Health announced today that “Diabetes costs U.S. employers approximately $245 billion a year — more than double what the entire American automotive industry is worth. * * *Employers spend more than $175 billion annually on direct medical and pharmacy costs for diabetic members, in addition to nearly $70 billion on indirect costs from employee absenteeism, reduced productivity and diabetes-related disability, the research showed.”

Additional findings from Nomi Health’s Trends in Spend Tracker research include:

  • Cost of care for diabetics is increasing twice as fast as for non-diabetics, and it’s growing at a staggering clip of nearly 20% year over year, reaching more than $20,000 average per member per year (PMPY) for employers in 2020-21.
  • A diabetes diagnosis means higher costs for patients, too, who spend about 240% more annually on medical bills and nearly 450% more on pharmacy expenses than non-diabetics.
  • The high cost of diabetes extends to the chronic conditions associated with the disease, which often cost more than the diabetes itself. Care for diabetics with ketoacidosis or kidney disease in 2020-21 cost employers 252% above the average, or $68,325 average PMPY.

This retrospective cohort analysis was conducted by Artemis — a leading benefits analytics platform acquired by Nomi Health last year

From the post-Dobbs front, Healthcare Dive relates

Senate Democrats are urging the largest retail pharmacies in the U.S. to ensure access to the abortion pill mifepristone amid ongoing confusion over legal access to the pill.

On Monday, 18 Democrats sent letters to seven of the biggest pharmacy chains in the country requesting more information about their plans to provide customers access to mifepristone — currently an open question for some chains as pressure from anti-abortion lawmakers and lawsuits target the legality of medication abortion.

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Medicare, OPM, Rx coverage, SDOH, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From our Nation’s capital, the President presented his Fiscal Year 2024 budget to Congress today. Roll Call informs us

    While spending would increase by $1.9 trillion over a decade, revenue would increase by $4.7 trillion, for over $2.8 trillion in a 10-year deficit reduction. But according to the Office of Management and Budget’s numbers, the budget shortfall would still total more than $17 trillion over the next decade even if Biden’s plans were fully implemented, which seems unlikely.

    The Wall Street Journal adds, “Biden’s budget shows the rising cost of leaving Medicare and Social Security untouched. In the President’s blueprint, the two programs plus interest consume a sharply growing share of economic output.

    and

    The President’s proposed spending and tax increases will face an unfriendly reception among Republicans in Congress, as lawmakers gear up for a fight over the debt ceiling that could come before the Sept. 30 end of the fiscal year. GOP leaders in the House have called for unspecified spending cuts as a condition of raising the federal debt limit. But the president has said he won’t negotiate over raising the debt ceiling.

    Republicans plan to release their own budget proposal in the coming months, though they haven’t agreed on a plan.

    The President will make public more budget details over the next few days. Until then, it’s worth noting that the budget includes the following healthcare proposal

    The budget proposes $11 billion for a five-year effort the White House hopes will eliminate hepatitis C in the U.S., said Dr. Francis Collins, the former National Institutes of Health director who is spearheading the initiative. Drugs to treat the disease have been on the market since 2013, but normally retail for about $24,000 per patient. 

    In related news, the American Hospital Association tells us,

    “The Centers for Disease Control and Prevention [CDC] today recommended screening all U.S. adults at least once in their lifetime for hepatitis B using three laboratory tests. It also expanded risk-based testing recommendations to certain populations and activities with increased risk for the hepatitis B virus.”

    The FEHBlog is unsure how this meshes with the ACA’s preventive services mandate because the current US Preventive Services Task Force recommendation is Grade B for “screening for hepatitis B virus (HBV) infection in adolescents and adults at increased risk for infection.” The CDC’s new recommendation is significantly broader.

    The Office of Personnel Management released on March 7 “a new memorandum today detailing a vision for the future of the workforce: a Federal government with a workforce that is inclusive, agile and engaged, with the right skills to enable mission delivery.”

    From the public health front —

    • The Kaiser Family Foundation notes ten numbers to mark the third anniversary of the Covid pandemic
    • The Dana Farber Cancer Institute highlights a comprehensive article about colon cancer in young adults.
    • The Food and Drug Administration “published updates to the mammography regulations to, among other things, require mammography facilities to notify patients about the density of their breasts, strengthen the FDA’s oversight and enforcement of facilities and help interpreting physicians better categorize and assess mammograms.
    • The New York Times reports, “A review of poisonings among children 5 and younger found that opioids contributed to nearly half of the deaths from 2005 to 2018, largely from accidental overdoses, according to new research. * * * The study, published on Wednesday in the journal Pediatrics, analyzed 731 poisoning-related deaths that occurred from 2005 to 2018 across 40 states.”

    From weight loss drugs front —

    • STAT News continues its reporting on obesity drugs. The latest article concerns “‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments.”
    • Medscape provides the account of a physician who took the new obesity drugs, specifically Ozempic. This article is particularly worth a gander.

    From the SDOH front, Mercer Consulting lays out its latest “Must-Do Strategy: Lean in on Benefits Strategy to Support DEI Goals.”

    From the miscellany department

    • Cigna offers its insights on how to choose among virtual care, urgent care centers, and emergency rooms.
    • Beckers Hospital Review notes
      • “In a March 8 Twitter thread, the FDA acknowledged it’s aware of a potential drug supply disruption after Gurnee, Ill.-based Akorn Operating Co. closed in late February. 
      • “The FDA clarified that the ongoing shortage is of a specific albuterol inhalation solution used in nebulizers, typically in hospitals, for patients having trouble breathing, not in inhalers at the consumer level. The agency said it is working with manufacturers to ease the shortage and “reiterated that outsourcing facilities may compound the specific product.”

    Finally, following up on the FEHBlog’s message to Congress about FEHB prescription drug costs, OPM stated its position against carving out prescription drug coverage from FEHB carrier responsibilities in the agency’s FY 2018 annual financial report on page 123:

    OPM does not concur with OIG’s suggestion that OPM continue to pursue efforts towards a prescription carve-out program. The Federal Employees Health Benefits (FEHB) Program is a market-based program that provides complete health benefits within each FEHB plan. The FEHB Program is not a self-funded plan and its statutory framework does not contemplate it to be the direct payer of benefits. Each FEHB Program plan offers comprehensive medical services including services provided by physicians and other health care professionals, hospital services, surgical services, prescription medications, medical supplies and devices, and mental health services. FEHB Program plans compete to offer all of these benefits in a high quality manner at the most competitive price possible.

    Carving out pharmacy benefits or any of the other services normally covered under an FEHB Program contract and administering the benefit as a separate contract or program, could undermine the fundamental market-based nature ofthe FEHB Program. It would be disruptive and could lead to a reduction in plan participation, and limit the ability of FEHB carriers to focus on comprehensively improving the health of the population. There would likely be less effective

    coordination of medical and pharmacy claims, and potentially less effective, one-size-fits-all pharmacy utilization and disease management programs. OPM is now assessing carrier performance on the basis of clinical quality measures that require tight coordination between medical and pharmacy benefits. A carved out pharmacy benefit is not consistent with or supportive of plan performance assessment, and may impair achievement of OPM’s long-term population health goals. As an example, carriers being held accountable for controlling diabetes and hypertension in the population they serve cannot do so readily if they do not have control over pharmacy benefit design and real time access to adherence data.

    To control the cost of prescription drugs, OPM works with carriers to better manage pharmacy networks, focus on drug utilization techniques, coordinate coverage of specialty drugs between the medical and pharmacy benefit, optimize the prescription drug benefit via formulary design, and implement effective cost comparison tools for members and prospective enrollees. Additionally, OPM notes that the most recent drug trend reported by FEHB carriers showed a significantly slower rate of growth compared with previous years, in line with industry trends.

    This statement continues to warm the FEHBlog’s heart.

    Happy International Women’s Day

    David Ermer–CDC, FDA, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, Rx coverage, SDOH, U.S. Healthcare–
    Photo by Hannah Busing on Unsplash

    The Wall Street Journal reports

    American women are staging a return to the workforce that is helping propel the economy in the face of high inflation and rising interest rates.

    Women have gained more jobs than men for four straight months, including in January’s hiring surge, pushing them to hold more than 49.8% of all nonfarm jobs. Female workers last edged higher than men on U.S. payrolls in late 2019, before the pandemic sent nearly 12 million women out of jobs, compared with 10 million men. 

    The Society for Human Resource Management offers five ways employers can reduce gender disparities at work.

    Following up on recent posts —

    • The Wall Street Journal brings us up to date on Lilly’s decision to offer its insulin products on the commercial market with a $35 copayment.
      • “Lilly comes out the winner of this saga, for now. It dealt PBMs a blow, avoided paying Medicaid rebates that were going to rise next year if its insulin products remained highly-priced, and received plaudits from President Biden. The move also complicates matters for upstarts such as Civica. But Allan Coukell, Civica’s senior vice president of public policy, says plans to introduce low-cost insulin as soon as next year are unchanged.”
    • Bloomberg offers an article on biological age testing that mentions Elysium Health, whose CEO spoke at the WSJ Health Forum on Monday.
    • Beckers Hospital Review tells us that the Amoxicillin shortage is continuing. Because Amoxicillin is one of several drug shortages, Pharma News Intelligence offers short-term and long-term management strategies to deal with them.
    • STAT News reports
      • Last week, the Food and Drug Administration issued an emergency authorization for the first at-home Covid-19 and flu combination test. The news came just days after the test’s maker, Lucira, filed for bankruptcy, blaming the FDA’s “protracted” approval process for its financial problems.
      • “Now the FDA has released a rare comment clarifying what happened during its authorization process. The new details are raising hopes among other home-test manufacturers that the FDA is becoming more flexible about its requirements for approving at-home flu test kits.”
    • Beckers Payer Issues informs us,” Providers join payers in urging CMS to halt proposed 2024 Medicare Advantage rates.” Good news for AHIP. Healthcare Dive reviews insurer and trade association comments to CMS on this topic.
    • The Wall Street Journal highlights the growing backlog of No Surprises Act arbitrations. The silver lining in this cloud is that the litigation-related backup does not impact the law’s Open Negotiation Process. Providers and payers should work to resolve qualifying payment disputes through that effective process.

    In other news

    • JAMA points out a recent CDC report documenting disparities in mental health-related emergency department care.
    • The Drug Channels blog lists the 15 largest U.S. pharmacies. (Trigger warning the link is principally a sales pitch for Drug Channels, but the information is useful.)
    • MedTech Dive informs us
      • “Abbott received U.S. Food and Drug Administration clearance for what it said will be the first commercially available laboratory blood test to help evaluate traumatic brain injury (TBI), also known as concussion.
      • “The test offers a result in 18 minutes, allowing clinicians to quickly assess patients with concussion and triage them, the company said Tuesday. A negative test result can rule out the need for a CT scan, eliminating wait time at the hospital.
      • “The test runs on Abbott’s Alinity i laboratory instrument, making it widely available to U.S. hospitals, the Chicago area-based company said.”
    • NPR discusses efforts to right various healthcare debt collection wrongs:
      • “Dozens of advocates for patients and consumers, citing widespread harm caused by medical debt, are pushing the Biden administration to take more aggressive steps to protect Americans from medical bills and debt collectors.
      • “In letters to the IRS and the Consumer Financial Protection Bureau, the groups call for new federal rules that, among other things, would prohibit debt for medically necessary care from appearing on consumer credit reports.
      • “Advocates also want the federal government to bar nonprofit hospitals from selling patient debt or denying medical care to people with past-due bills, practices that remain widespread across the U.S., KHN found.
      • “And the groups are pressing the IRS to crack down on nonprofit hospital systems that withhold financial assistance from low-income patients or make getting aid cumbersome, another common obstacle KHN documented.”

    FEHBlog message to Congress

    • FEDWeek reports
      • The House Oversight and Accountability Committee has started an investigation into the role of “pharmacy benefit managers” (PBMs), which act as a middleman between insurance carriers and pharmaceutical companies in healthcare programs, including the FEHB.
      • “Greater transparency in the PBM industry is vital to determine the impact PBM tactics are having on patients and the pharmaceutical market,” chairman Rep. James Comer, R-Ky., wrote to OPM. He asked for copies of the PBM contracts in the program and information on how they are carried out, as well as for information on the rebates, fees, or other similar charges received by PBMs and any efforts the agency has made to recoup overpayments to them.”
      • “The use of pharmacy benefit managers has been a long-running issue in the FEHB, with prior proposals—mainly sponsored by Democrats, unsuccessfully—to limit their role or even have OPM negotiate with pharmaceutical companies directly on a program-wide basis.
      • “The inspector general’s office at OPM also has raised that issue, in a recent report saying that “the discounts and other financial terms differed significantly among carriers, with those that have higher enrollments receiving the best deals, reducing the likelihood that the FEHB is maximizing prescription drug savings.” 
      • “That report recommended that OPM conduct a study on options to hold down prescription drug costs, which account for a quarter of all spending in the FEHB. OPM agreed in principle, although it said it does not have the needed funds to conduct such a study.”
    • OPM should inform Rep. Comer that
      • The FEHB Program’s experience-rated carriers, who cover 80% of the FEHB enrollment, are subject to the country’s strictest PBM price transparency arrangement, as far as the FEHBlog knows. Congress should evaluate that system to help the legislative body decide whether transparency should be expanded to ERISA and ACA marketplace plans.
      • In the late 2010s, OPM announced in a management report that the agency agreed with carriers that the FEHB Program saves money by allowing carriers to manage medical and pharmacy benefits under OPM’s oversight. FEHB plan carrier HealthPartners offers a useful examination of carve-in vs. carve-out Rx program management topics.
      • OPM has authorized FEHB carriers to offer prescription drug plans integrated with Medicare Part D beginning in 2024. This change will rapidly reduce the FEHB Program’s prescription drug spend to commercial plan levels. It’s not magic.
      • In sum, the FEHB Program remains a model employer-sponsored health program.

    Thursday Miscellany

    David Ermer–Congress, Medicare, NCQA, Rx coverage, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From Capitol Hill, the Wall Street Journal reports that “Sen. Joe Manchin, who has been a crucial vote in shaping major pieces of President Biden’s agenda, urged Democratic colleagues to hold talks with Republicans on cutting federal spending, ahead of a summer deadline to reach a deal on raising the country’s debt ceiling.”

    From the public health front —

    The Wall Street Journal informs us

    A larger share of people are being diagnosed with colorectal cancer at a younger age and at a more dangerous stage of the disease, a report showed. Doctors aren’t sure why.

    The American Cancer Society said Wednesday that about 20% of new colorectal cancer diagnoses were in patients under 55 in 2019, compared with 11% in 1995. Some 60% of new colorectal cancers in 2019 were diagnosed at advanced stages, the research and advocacy group said, compared with 52% in the mid-2000s and 57% in 1995, before screening was widespread.   

    Cases and death rates for colorectal cancer have continued a decadeslong decline overall thanks to screening, better treatments and reductions in risk factors such as smoking, the ACS report’s authors said. But the shift of the burden toward younger people and diagnoses at more advanced stages has oncologists on alert. 

    “The improvements have slowed, and they’ve slowed because of this opposite trend we’re seeing in young people,” said Kimmie Ng, director of the Young-Onset Colorectal Cancer Center at Dana-Farber Cancer Institute in Boston. “More and more are getting diagnosed with cancer that might not be curable.” 

    The U.S. Preventive Serves Task Force is routinely reevaluating its 2018 grade A recommendation to screen pregnant women/persons for syphilis.

    From the medical device front —

    MedTech Dive tells us

    • The number of remote patient monitoring (RPM) reimbursement claims hit a new high in 2022, according to a report by Definitive Healthcare.
    • By November, the volume of claims across the 10 Centers for Medicare & Medicaid Services’ codes for RPM was already 27% above the total for all of 2021, adding to the growth seen since the start of 2019.
    • Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.

    and

    Medicare will cover continuous glucose monitors for a broader group of patients, starting in April, according to an updated policy published by the Centers for Medicare and Medicaid Services. 

    The policy change included broader language and also came earlier than expected, making it a “welcome surprise,” and could double the market for the devices, J.P. Morgan analyst Robbie Marcus wrote in a research note. * * *

    In an earlier draft of coverage guidelines, CMS had suggested covering the devices for people with diabetes who take daily insulin, or who have a history of problematic hypoglycemia. Now, the policy includes people withnon-insulin treated diabetes and a history of recurrent level 2 or at least one level 3 hypoglycemic event.

    From the Rx coverage front, the Congressional Research Service issued an “In Focus” report about “Selected Issues in Pharmaceutical Drug Pricing.”

    From the healthcare quality front, NCQA posted slides and a recording from its latest Future of HEDIS webinar on February 28.

    From the U.S. healthcare business front —

    Healthcare Dive relates

    • The Cleveland Clinic reported a $1.2 billion net loss for 2022 as expenses climbed from the prior year. Expenses ticked up in every key category in 2022, including salaries and wages, supplies and pharmaceuticals, Cleveland Clinic’s latest financial report shows.    
    • Cleveland Clinic grew 2022 revenue roughly 5% to $13 billion from the prior year, but didn’t outpace expenses as costs increased nearly 14% to $12.4 billion before interest, depreciation and amortization.    
    • Investment income helped pull the Midwest provider into the red as non-operating losses totaled $1 billion.  

    and

    Oak Street Health’s losses grew in 2022 to almost $510 million as the value-based primary care company, which is pending an acquisition by CVS Health, continued to aggressively pursue growth.

    In comparison, Oak Street, which operates a network of clinics for seniors on Medicare, reported a loss of $415 million in 2021.

    The company opened 40 new centers over 2022 and ended the year with 169 facilities in 21 states, serving some 224,000 patients.

    STAT News reports

    In what may well be the latest fad in hospital consolidation, two not-for-profit health systems located across the country from one another are seeking to link up — this time, to create a system with roughly $11 billion in revenue.

    UnityPoint Health and Presbyterian Healthcare Services announced Thursday they’ve inked a letter of intent to explore a merger. Hospital mergers often involve partners in the same region so they can gain leverage with insurers, but in this case, UnityPoint is in the Midwest, whereas all nine of Presbyterian’s hospitals are several states away in New Mexico.  

    The deal illustrates not only health systems’ insatiable desire to get bigger in a tough operating environment, but their evolving strategy for doing so. Antitrust regulators have sunk deals involving partners they said would command too much market share in a given region, so hospitals are doing the next-best thing: seeking partners in far-flung states. 

    Healthcare Dive adds

    • Walmart plans to expand its network of medical centers in 2024, including a launch into two new states, as retail health giants race to build out their primary care footprints.
    • The company announced Thursday it plans to open 28 new Walmart Health centers in 2024, bringing its number of total locations to more than 75.
    • Walmart Health will open clinics in Missouri and Arizona for the first time, while deepening its presence in Texas by expanding in the Dallas area and growing into Houston, according to the announcement.

    Strap Yourself In

    David Ermer–FDA, Federal employment benefits, Medicare, No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    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.
      • In related telehealth news, Forbes informs us about a “new survey out from Rock Health.”
        • “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.

    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.

    Midweek Update

    David Ermer–CMS, COVID treatment, FDA, Medicare, No Surprises Act, Rx coverage, U.S. Healthcare–
    Photo by Manasvita S on Unsplash

    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.

    and

    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.

    and

    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.”

    while

    • The Wall Street Journal reports
      • 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 hours trying 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. 
    • Biopharma Dive tells us
      • 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.
    • Health Payer Intelligence reports
      • 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.
      • Between 2019 and 2023, Medicare Advantage enrollment has grown by 2.1 percent. As of January 2023, 46 percent of all Medicare beneficiaries are enrolled in Medicare Advantage, translating to 29.5 million people. * * *

    Tuesday Tidbits

    David Ermer–CDC, CMS, COVID treatment, Electronic health records, FDA, Medicare, Mental health care, NCQA, Rx coverage, Telehealth–
    Photo by Laura Ockel on Unsplash

    From the Omicron and siblings front, HealthDay tells us

    Paxlovid remains a powerful weapon against the Omicron variants BA.4 and BA.5, new research shows

    The antiviral continued to protect against hospitalization and death in patients [including the immunocompromised] who took it

    Research is ongoing to see if Paxlovid also guards against newer Omicron variants such as XBB.1.5 and BQ.1

    From the public health front —

    • Medscape reports that the five-year survival rate in pancreatic cancer is increasing.
    • MedPage Today explains that while there’s no ‘Recipe’ to reduce dementia risk, here’s how to discuss it with patients until more evidence emerges.
    • The U.S. Preventive Services Task Force reaffirmed a Grade D recommendation against routine serologic screening for genital herpes simplex virus infection in asymptomatic adolescents and adults, including pregnant persons.

    From the healthcare quality front

    • Beckers Hospital Review shares Healthgrades’ 2023 list of top hospitals for joint replacement by state.
    • The National Committee for Quality Assurance opened its 2023 HEDIS public comment period yesterday. The comment period closes on March 13.

    From the Medicare front —

    • The Department of Health and Human Services unveiled three models for reducing prescription drug costs charged to Medicare beneficiaries, including two-dollar generic drug prescriptions for Medicare Part D.
      • “Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans participating in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug”.
    • Beckers Payer Issues reports, “Medicare beneficiaries who enroll in a Medicare Advantage plan may need less retirement savings to cover their healthcare costs, an analysis published Feb. 9 by the Employee Benefits Research Institute found.”
    • Fierce Healthcare informs us
      • “Health insurers and the Biden administration are at loggerheads over whether Medicare Advantage (MA) plans will see a pay cut next year, the ramifications of which come amid increased regulatory scrutiny for the popular program.
      • “Insurer groups and some politicians charge that the latest 2024 payment rule will wind up being a 2.27% cut to MA plans after considering risk adjustment changes and other factors. The Centers for Medicare & Medicaid Services (CMS) has pushed back, arguing that isn’t true.”
    • STAT News relates, “Medicare advisers on Tuesday recommended that the program alter its requirements for drugs, diagnostics, and medical devices that face coverage restrictions [such as the Biogen Eisai Alzheimers Disease drugs] to make the process more transparent and better incorporate diversity data.”
      • Speaking of which, USA Today reports
        • One in 10 new drugs was cleared by federal drug regulators in recent years based on studies that didn’t achieve their main goals, a new study shows.
        • The study by Harvard and Yale researchers found that of 210 new therapies approved by the Food and Drug Administration from 2018 through 2021, 21 drugs were based on studies that had one or more goals, or endpoints, that wasn’t achieved. Those 21 drugs were approved to treat cancer, Alzheimer’s and other diseases.
        • Researchers said the findings raise questions about whether the federal agency’s drug approvals lack transparency about some products’ safety and effectiveness. 

    In hospital pricing transparency news —

    • Healthcare Dive discusses a JAMA-published study of available hospital pricing data, which produced head-scratching results.
    • Beckers Hospital Review explains four ways CMS is trying to improve hospital price transparency in 2023. Good luck with that.

    From the HR department

    • The Society for Human Resource Management tells us
      • “Employers need to understand that the timeline for submitting their demographic data to the U.S. Equal Employment Opportunity Commission (EEOC) is somewhat different this year. The agency recently confirmed that EEO-1 reporting for 2022 data is scheduled to begin in mid-July. In recent years, the starting points and deadlines for data collection have varied.”
      • “All private employers with 100 or more employees and federal contractors with 50 or more employees must file EEO-1 reports each year that summarize employee headcount by sex, race/ethnicity, and job category. This component of data collection, called Component 1, does not include pay data.
    • HR Dive explores how the Pregnant Workers Fairness Act protects pregnant workers beginning this June and how do those accommodations stack up to the federal Family and Medical Leave Act? 
    • HR Dive also notes, “Short breaks of fewer than 20 minutes taken by hourly, non-exempt employees who telework or must be counted as compensable time under the Fair Labor Standards Act — as is the case for employers working from an employer’s own location — Jessica Looman, principal deputy administrator of the U.S. Department of Labor’s Wage and Hour Administration, wrote in a Field Assistance Bulletin published Thursday.”

    From the tidbits department

    • Healio advises “Adolescents and young adults with type 1 diabetes who primarily attend diabetes clinic visits via telehealth have better overall attendance and less diabetes distress compared with those who attend in person, according to study data.”
    • MedCity News states, “Since the start of the Covid-19 pandemic, there has been a 23% increase in alcohol abuse and a 16% increase in drug abuse, and people in self-isolation reported a 26% higher consumption than usual, according to the National Library of Medicine. Some apps are trying to meet this need, including Sober Sidekick and SoberBuddy.”

    Happy Groundhog Day

    David Ermer–ACA, Congress, Federal employment benefits, Medicare, OPM, Telehealth, U.S. Healthcare–

    The Hill reflects on the history of Groundhog Day. By the way, “on Thursday, Punxsutawney Phil predicted six more weeks of winter.”

    Each year on the first Friday in February, [February 3, 2023], the National Heart, Lung, and Blood Institute, The Heart Truth® and others around the country celebrate National Wear Red Day® to bring greater attention to heart disease as a leading cause of death for Americans and steps people can take to protect their heart. Promote Wear Red Day in your community with resources such as printable stickers, posters, and social media graphics, including customizable ones.

    From Capitol Hill, Roll Call tells us that “Senate committees will be able to get to work next week after the Senate adopted resolutions constituting their membership for the 118th Congress before departing Thursday afternoon.”

    STAT News interviews the Chair and Ranking Member of the Senate’s Health, Education, Labor and Pensions Committee, Senators Bernie Sanders and Bill Cassidy respectively.

    Both senators cited addressing the national shortage of nurses as high on the bipartisan to-do list. The chairman also said he thinks expanding community health centers and improving dental coverage could get both parties’ buy-ins, while Cassidy pointed to mental health care legislation and probing the rollout of efforts to eliminate patients’ surprise medical bills.

    Unsurprisingly, however, Sanders’ top priority is slashing drug costs — and he’s banking on voter polling to push GOP members, or at least put them in an uncomfortable spot with constituents. 

    From the Medicare front, Health Payer Intelligence provides an overview of reactions to yesterday’s CMS 2024 Medicare Advantage Advance Notice with changes for Medicare Advantage plans and Medicare Part D.

    The Kaiser Family Foundation offers a detailed study of prior authorization requests for Medicare Advantage enrollees in 2021. Adverse decisions on prior authorization requests. The number of requests varied by Medicare Advantage carrier. Six percent of all prior authorizations were partially or entirely denied. 11% of prior authorization requests were appealed, and 82% of appeals were decided in the Medicare Advantage enrollee’s favor. What an interesting batch of percentages.

    From the U.S. healthcare business front, BioPharma Dive reports

    Sales of Eli Lilly’s new diabetes drug Mounjaro grew strongly in the final quarter of 2022, the company reported Thursday, challenging the market position of competing medicines from rival Novo Nordisk. 

    Fourth quarter sales totaled $279 million, bringing the total for 2022 to $483 million following the drug’s June launch. The fast sales put Mounjaro, approved to improve blood sugar control in people with Type 2 diabetes, on pace to quickly reach blockbuster status. Studies have shown the drug to have a powerful weight-loss effect as well, supporting Lilly’s current efforts to expand the drug’s approval to include obesity treatment.  * * *

    On an earnings call Thursday, Lilly executives said the company is having trouble keeping Mounjaro production high enough to match patient demand. More manufacturing capacity is being added, with a site in North Carolina expected to start production sometime later this year, CFO Anat Ashkenazi said on the call.

    Russ Roberts spoke with Dr. Vinay Prasad on this week’s Econtalk episode. The topic is “Pharmaceuticals, the FDA, and the Death of Duty.” During the episode, Dr. Prasad identified Dr. Bernard Fisher as one of his heroes. Dr. Fisher passed away in 2019 at age 101. I had never heard of Dr. Fisher, but his story should be shared.

    Healthcare Dive informs us.

    Healthcare consumers appear to be increasingly comfortable switching providers when their current one isn’t meeting their needs, according to a report from Accenture. About 30% of patients selected a new provider in 2021 — up from 26% in 2017, the report found. A quarter switched providers in 2021 because they were unhappy with their care — up from 18% in 2017. Switching providers is especially true among younger generations, like Gen Zers and millennials, who were six times more likely to switch providers than older people, according to the report.

    From the miscellany department —

    • Health Affairs Forefront delves into the data produced to date by the government’s payer transparency rules.
    • Fierce Healthcare tells us about a recent expansion of CVS Health’s virtual primary care service.
    • Benefit consultant Tammy Flanagan writing in Govexec, follows the path of a federal employee’s retirement application.

    Midweek update

    David Ermer–ACA, CDC, CMS, Congress, COVID treatment, FDA, Medicare, NIH, No Surprises Act, U.S. Healthcare–

    From our Nation’s capital, HHS Secretary Xavier Becerra made a statement honoring Black History Month which began today.

    The Wall Street Journal reports

    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.

    The Hill tells us

    • 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.

    In that regard, Health Payer Intelligence notes

    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.

    Monday Roundup

    David Ermer–ACA, CMS, COVID-19, Electronic health records, Medicare, OPM, Patient safety, U.S. Healthcare–
      Photo by Sven Read on Unsplash

      Today was another busy day.

      The biggest surprise is that OPM begun refreshing its website and has revealed its logo.

      U.S. Office of Personnel Management logo
      New OPM Logo

        From the public health front —

        • The Hill reports that the President plans to end the national and public health emergencies for the Covid pandemic on May 11, 2023. Congress took steps to arrange for a soft landing in the Consolidated Appropriations Act 2023, which likely is a factor in reaching this executive decision.
        • Health IT Analytics tells us, “Researchers from New York University (NYU) Grossman School of Medicine and the Robert Wood Johnson Foundation (RWJF) unveiled the Congressional District Health Dashboard (CDHD), an online data tool that provides health data for all 435 US congressional districts and the District of Columbia.” Interesting.
        • The New York Times informs us, “A new report [on maternal health in the U.S.] highlighted the dangers faced by Native American women, who face the greatest risks during and after pregnancy. Native American women were 3.5 times as likely to die during this critical period, compared with white women, the study found.” This rang a bell with the FEHBlog because the FEHB Program included Native American employers who have contracted with OPM for FEHB coverage for their employees. “During and after pregnancy, Black women also faced heightened odds of death that were almost double those of white women, along with a risk of dying specifically from pregnancy complications that was 2.8 times that of white women.” No child should be deprived of a mother due to inadequate healthcare.
        • Yale New Haven Hospital offers insights on heart disease for lay people/patients.
        • Medpage Today discusses recently extended and updated Body Mass Indices (BMIs0 for children and adolescents.
        • LifeSciences Intelligence reports that “In a recent news release, the Emergency Care Research Institute (ECRI) highlighted gaps in communication regarding medical device recalls, noting that these gaps could be a significant threat to patient safety. This commentary was a part of the organization’s Top 10 Health Technology Hazards report.”

        From the Affordable Care Act front, the ACA regulators today promulgated a proposed rule that would create

        a new independent pathway through which individuals enrolled in plans or coverage sponsored or arranged by objecting entities that have not opted for the existing accommodation (including those enrolled in individual health insurance coverage issued by such an objecting entity) could access contraceptive services at no cost. Specifically, these proposed rules would create a mechanism, independent from the employer, group health plan, plan sponsor, institution of higher education, or issuer, through which individuals could obtain contraceptive services at no cost from a willing provider of contraceptive services. This individual contraceptive arrangement would be available to the participant, beneficiary, or enrollee without the objecting entity having to take any action facilitating the coverage to which it objects. Simply put, the action is undertaken by the individual, on behalf of the individual. * * *

        These proposed rules, if finalized, would rescind the moral exemption to covering contraceptive services without cost sharing, while keeping intact the religious exemption and without narrowing its scope or the types of entities or individuals that may claim the religious exemption. These proposed rules would also maintain the optional accommodation for sponsors of group health plans and institutions of higher education arranging student health insurance coverage that qualify for the religious exemption. 

        Here’s a link to the regulator’s fact sheet. This strikes the FEHBlog has a wise solution to this knotty problem.

        From the healthcare business front —

        The American Hospital Association relates

        Last year was the worst financial year for U.S. hospitals and health systems since the start of the COVID-19 pandemic, as growth in expenses outpaced growth in revenues and volumes, according to the latest report on hospital finances from Kaufman Hall. 

        “The increases were driven in part by a competitive labor market, as well as hospitals needing to rely on more expensive contract labor to meet staffing demands,” the report notes. “Increased lengths of stay due to a decline in discharges also negatively affected hospital margins.” 

        Hospitals experienced negative operating margins for most of the year, with approximately half of the nation’s hospitals ending the year in the red. According to the report, hospitals’ expense pressures “are unlikely to recede in 2023.”

        STAT News discusses business focused on improving human longevity.

        Health Payer Intelligence reports

        The US Department of Health and Human Services (HHS) has released a final rule that aims to introduce more oversight into the Medicare Advantage risk adjustment data validation and payment process. * * * Under the finalized rule, CMS will not extrapolate audit findings for payment years 2011 through 2017, the CMS fact sheet stated. CMS will collect non-extrapolated overpayments for plan years 2011 through 2017. Extrapolation will begin with the plan year 2018 risk adjustment data validation audit using any extrapolation technique that is statistically valid. The audits will center on high-risk plans.

        The Wall Street Journal adds “A Centers for Medicare and Medicaid Services official, Deputy Administrator and Center for Program Integrity Director Dara Corrigan, said the estimated recoveries for 2018 would be around $479 million, and the agency projected a total of about $4.7 billion over a decade. The large recoveries wouldn’t actually occur until 2025 and after, however.”

        Will this regulation drive companies out of Medicare Advantage? Time will tell. In the meantime here is a link to HHS’s fact sheet.