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Thursday, December 8, 2022

AMA, WisMed oppose ivermectin as a court ordered treatment for COVID

 In a case before the Wisconsin Supreme Court that seeks to force physicians to provide substandard care, the American Medical Association (AMA) and Wisconsin Medical Society (WisMed) today filed an amicus brief (PDF) arguing against ivermectin as a court ordered intervention for COVID-19 as the drug has not proven effective against the disease.

The amicus brief in Gahl v. Aurora Health notes that ivermectin is not within the standard of care for the treatment of COVID-19 and warned against the court compelling the use of a drug that medical consensus finds is unsupported by available medical evidence and discouraged by federal agencies and health authorities.

The U.S. Centers for Disease Control & Prevention and the Food & Drug Administration have issued advisories indicating that ivermectin is not authorized or approved for the prevention or treatment of COVID-19. While the National Institutes of HealthWorld Health Organization, and Merck—the manufacturer of ivermectin—all state there is insufficient evidence to support the use of ivermectin to treat COVID-19.

The AMA and WisMed stated in the brief, “The overwhelming majority of studies investigating ivermectin have not found it to be an effective COVID-19 treatment. The few dissenting studies that exist have ‘substantially evaporated under close scrutiny’ and even ivermectin’s manufacturer ‘do[es] not believe that the data available support the safety and efficacy of ivermectin for preventing or treating COVID-19. Thus, the consensus view of reasonable medical providers is that, apart from clinical trials, ivermectin should not be administered to treat COVID-19.”

https://www.ama-assn.org/press-center/press-releases/ama-wismed-oppose-ivermectin-court-ordered-treatment-covid

Oncopeptides provides update on Pepaxto US marketing authorization

 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration, FDA, has requested a withdrawal of the US marketing authorization for Pepaxto® (melphalan flufenamide, also called melflufen). The request is based on the outcome of the confirmatory phase 3 OCEAN study, which demonstrated an ITT overall survival HR of 1.1, but with significant survival result differences for both melflufen and the comparator drug pomalidomide for large relevant patient groups.

“We respect FDA´s accelerated approval regulations,” says Jakob Lindberg, CEO of Oncopeptides. “Multiple myeloma remains an incurable disease, and the treatment options for patients with triple class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for non-transplanted elderly patients where the unmet medical need remains very high.”

Pepaxto was granted accelerated approval in the U.S., on February 26, 2021, and is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. At the FDA’s request, Oncopeptides stopped marketing Pepaxto in the US on October 22, 2021, and Pepaxto is currently not commercially available for US patients.

The commercialization of Pepaxti® in Europe is ongoing. Pepaxti has a full approval from the European Medicines Agency, EMA, since August 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the UK on November 11, 2022. Both approvals take the large OCEAN study overall survival differences across relevant patient groups into account. Pepaxti is indicated in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

The Company is developing its preclinical pipeline, including the next generation of drug candidates from the PDC platform, as well as an NK-cell engager, built on the technology platform of “Small Polypeptide based Killer Engagers”, SPiKEs.

https://www.oncopeptides.com/en/media/press-releases/oncopeptides-provides-update-on-pepaxto-us-marketing-authorization

MyChart message fees live on unstable ground

 When Cleveland Clinic said it would begin billing for certain Epic MyChart messages this November, it set off a fiery debate across the healthcare industry around hospital finances, patient access and physician burnout.

Now at least seven other health systems nationwide have also started billing patients for some types of messages sent over patient portals, including those about new symptoms, prescription issues, and those that require extensive time from a clinician to review a patient's medical history.

"Hospitals have every incentive to be creative in generating any cash they can," Ge Bai, PhD, professor of accounting and health policy at Johns Hopkins University, told Becker's. "In general, systems are going to find every single opportunity to charge more. It's like milking the cow."

But what's more uncertain is how long Medicare will cover these charges and whether most commercial insurers will end up reimbursing for them at all.

How will payers respond?

On Nov. 15, Cleveland Clinic said most insurers would cover charges for MyChart messages "at little to no cost to the patient," though it's likely that coverage policies will be fragmented across payers.

"The provider gets the money, so the payers are being blindfolded and they have very little skin in the game," Dr. Bai said. "That makes them not very nimble and low response players."

In 2022, she predicts that self-insured employers will mostly pass the cost of portal messages along to employees. A small number of payers could act proactively to prevent charges this year, especially those operating in the most competitive premiums markets. 

Next year, Dr. Bai expects the price tag of patient portal messages for commercially insured patients to become like most other healthcare services — dependent on the health plan and negotiated between payers and providers.

"You pay, but you are not the person who negotiates that," Dr. Bai said. "Even the most sophisticated and well informed consumers have their hands tied."

At Cleveland Clinic, patients with a deductible (over half of private-sector Americans in 2020) and those without insurance (26.4 million people in 2022) face charges of up to $50. A spokesperson for Ohio State University Wexner Medical Center in Columbus told cleveland.com that some patients could face charges of up to $160.

"Many messages sent through MyChart are never billed to insurance," Providence wrote in a MyChart FAQ. "However, those that require time and expertise are a form of virtual care and are treated as such — alongside other types of care.”

Out-of-pocket costs for Medicare members are expected to range from about $3 to $10, depending on the health system.

Commercial payers will also likely wait to see how Medicare policies develop around this issue because they may be shaped by the end of the COVID-19 public health emergency, which won't occur until at least next spring.

Becker's asked UnitedHealthcare, Aetna, Cigna and Health Care Service Corp. (BCBS) how they are developing coverage policies around patient portal messages, but did not receive any responses.

Long-term billing outlook

In 2020, Current Procedural Terminology, or CPT, codes were rolled out to allow for providers to report and bill for patient portal messages.

Under a current rule from CMS, patient portal codes would remain past the PHE expiration date. But according to Terry Fletcher, a healthcare coding and reimbursement consultant, there's been no published final guidance from CMS confirming that the codes won't be rolled back to non-payable status once the PHE has been over for 151 days. Patient portals are not necessarily considered "telehealth," she said, meaning the Advancing Telehealth Beyond COVID-19 Act would not preserve coverage under Medicare either.

"We anticipate this [codes] is going to be rolled back once the PHE ends and at the end of the Consolidated Appropriations Act," Ms. Fletcher told Becker's. "Patients are mostly accessing this, from what I'm hearing, because they can't get an appointment, not because they want the information."

Her Laguna Niguel, Calif.-based consulting firm has advised some of the nation's largest health systems on their coding and billing practices. She's concerned some systems will face audit issues with charging for patient portal messages because of the strict coding rules in place.

"Where there may be a problem reporting this service to payers, is that there are entities that say they can put out "general information" to their patients to the portal, and then charge for it. They can't, and as an auditor myself, I would have a field day with it," she said. "There are specific rules that are attached to EMR portal e-visits, and even though I can see the appeal of capture, there's actually more, in my opinion, that can expose providers to an audit than could help them with revenue if not compliant."

Physicians and other qualified healthcare professionals can bill patients for cumulative work done over a seven-day period that takes a minimum of five minutes or more. If the patient was seen for an office visit within 7-days of the initiation of the online digital visit, the service is included in the face-to-face encounter and cannot be billed. The clock on the seven days starts ticking with the review of the patient's inquiry, and patients must provide consent to be charged for the service.

Ms. Fletcher said there's already scrutiny from CMS around the practice of virtual services, and she expects it to continue.

"This is what we call low-hanging fruit because it's not face to face and it has to be patient initiated," she said. "Plus there's the seven-day accumulation, and doctors are not always compliant in documenting time in their records, for time-based codes."

https://www.beckerspayer.com/policy-updates/mychart-message-fees-live-on-unstable-ground.html?utm_medium=email&utm_content=newsletter

Omega Therapeutics started at Buy by Wainwright

 Target $11

https://finviz.com/quote.ashx?t=OMGA&ty=c&ta=1&p=d

Actinium In Research Collaboration with Columbia University to Study Actimab-A in AML

 Collaboration builds on the groundbreaking research of Columbia University oncologist Dr. Siddhartha Mukherjee that uses gene-editing to remove the CD33 surface protein from hematopoietic stem cells

- Actimab-A to be used post-transplant of these engineered stem cells to prevent relapse by selectively targeting residual CD33 positive leukemia cells while sparing the engineered stem cells

- High rates of measurable residual disease negativity demonstrated by Actimab-A + CLAG-M validates merits of Actimab-A's use to prevent disease relapse post gene edited stem cell transplant

- Actimab-A + CLAG-M data to be presented in oral presentation at American Society of Hematology Annual Meeting on Saturday, December 10th highlighting 53% 1-year and 32% 2-year overall survival, 67% Overall Response Rate and 72% MRD negativity in patients with relapsed or refractory acute myeloid leukemia

https://www.biospace.com/article/releases/actinium-pharmaceuticals-inc-announces-research-collaboration-with-columbia-university-to-study-actimab-a-in-aml-patients-following-transplant-of-engineered-hematopoietic-stem-cells-gene-edited-to-be-cd33-negative/

IN8bio cleared for glioblastoma Phase 2

 IN8bio, Inc. today announced that it has received received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy (INB-400) targeting newly diagnosed glioblastoma (GBM).

https://www.biospace.com/article/releases/in8bio-announces-fda-clearance-to-initiate-a-phase-2-clinical-trial-of-inb-400-gamma-delta-t-cells-for-glioblastoma/

'Long Covid is distorting the labor market'

 

  • Long Covid is affecting how Americans work. Some are unable to work at all due to symptoms of the chronic illness.
  • The overall labor impact of long Covid is tough to quantify. Estimates suggest hundreds of thousands to millions may be out of work, at a time when there are historic levels of job openings.
  • It is likely underpinning dynamics contributing to inflation. Meanwhile, lost earnings might translate to reduced household spending, or mean that patients must lean on public assistance programs funded by taxpayer dollars.
  • Weeks after Charlotte Hultquist got Covid-19 in November 2020, she developed a severe pain in her right ear.

    “It felt like someone was sticking a knife in [it],” said Hultquist, a single mother of five who lives in Hartford, Vermont.

    The 41-year-old is one of millions of Americans who have long Covid. The chronic illness carries a host of potentially debilitating symptoms that can last for months or years, making it impossible for some to work.

    For about a year, Hultquist was among those long Covid patients sidelined from the workforce. She would fall constantly, tripping just by stepping over a toy or small object on the floor. She eventually learned that the balance issues and ear pain resulted from a damaged vestibular nerve, a known effect of long Covid. After rigorous testing, a physical therapist told Hultquist she had the “balance of a 1-year-old learning to walk.”

    Her body — which she said felt like it weighed 1,000 pounds — couldn’t regulate its temperature, causing dramatic swings from cold to hot.

    “I couldn’t work when my memory just kept failing,” Hultquist said.

    There remain many unknowns about long Covid, including causes, cures, even how to define it. But this much is clear: The illness is disabling thousands, perhaps millions, of workers to such an extent that they must throttle back hours or leave the workforce altogether.

    In other words, at a time when job openings are near an all-time high, long Covid is reducing the supply of people able to fill those positions. The dynamic may have large and adverse effects on the U.S. economy.

    Long Covid “is certainly wind blowing in the other direction” of economic growth, said Betsey Stevenson, a professor of public policy and economics at the University of Michigan who served as chief economist for the U.S. Department of Labor in the Obama administration.

    Up to 4 million people are out of work

    Estimating the labor impact of long Covid — also known as long-haul Covid, post-Covid or post-acute Covid syndrome — is a somewhat fraught mathematical exercise; it’s complicated by the nebulous nature of the fledgling illness and a dearth of data tracking how people with long-haul symptoms flow in and out of work.

    Economic models suggest that hundreds of thousands of people and potentially millions are out of work because of long-haul symptoms after a Covid infection.

    “At a minimum, long Covid is adding a lot of uncertainty to an already very uncertain economic picture,” Paige Ouimet, an economist and finance professor at the University of North Carolina, wrote in September.

    The midpoint of her estimate — 3 million workers — accounts for 1.8% of the entire U.S. civilian labor force. The figure may “sound unbelievably high” but is consistent with the impact in other major economies like the United Kingdom, Bach wrote in an August report. The figures are also likely conservative, since they exclude workers over age 65, she said.

    “Mild symptoms, employer accommodations or significant financial need can all keep people with long Covid employed,” Bach said. “But in many cases, long Covid impacts work.”

    Impact akin to extra year of baby boomers retiring

    Other studies have also found a sizable, though more muted, impact.

    Economists Gopi Shah Goda and Evan Soltas estimated 500,000 Americans had left the labor force through this June due to Covid.

    That led the labor force participation rate to fall by 0.2 percentage points — which may sound small but amounts to about the same share as baby boomers retiring each year, according to the duo, respectively of the Stanford Institute for Economic Policy Research and the Massachusetts Institute of Technology.

    Put another way: Long Covid’s labor impact translates to an extra year of population aging, Goda said.

    For the average person, the work absence from long Covid translates to $9,000 in foregone earnings over a 14-month period — representing an 18% reduction in pay during that time, Goda and Soltas said. In aggregate, the lost labor supply amounts to $62 billion a year — equivalent to half the lost earnings attributable to illnesses like cancer or diabetes.

    A separate Brookings paper published in October estimated about 420,000 workers aged 16 to 64 years old had likely left the labor force because of long Covid. The authors — Louise Sheiner and Nasiha Salwati — cite a “reasonable” range of 281,000 to 683,000 people, or 0.2% to 0.4% of the U.S. labor force.

    About 26% of long-haulers said their illness negatively affected employment or work hours, according to a July report published by the Federal Reserve Bank of Minneapolis. Those with long Covid were 10 percentage points less likely to be employed than individuals without a prior Covid infection, and worked 50% fewer hours, on average, according to Dasom Ham, the report’s author.

    Just half of the patients who visit the Mayo Clinic’s Covid Activity Rehabilitation Program can work a full-time schedule, said Dr. Greg Vanichkachorn, the program’s medical director.

    “Because of the brain fog issues in addition to physical symptoms, many patients have had a really frustrating experience trying to get back to work,” Vanichkachorn said.

    Those able to return, even part-time, sometimes face hostility from employers and co-workers, he added.

    For one, many of the hundreds of potential long Covid symptoms are invisible to others, even if disabling for the afflicted. Difficulty meeting a work deadline due to brain fog or extreme fatigue, for example, may not be met kindly by their colleagues.

    Meanwhile, long Covid can put even accommodating employers in a tricky situation. It can take several months for a patient to make progress in treatment and therapy — meaning some businesses may need to make tough retention, hiring and personnel decisions, Vanichkachorn said. Lengthy recovery times mean a patient’s job might be filled in the interim, he said.

    And patients’ symptoms can relapse if they push themselves too rigorously, experts said.

    “You can bring a [long Covid] diagnosis to your employer, but it doesn’t allow you to say, ’I need to be part time for X number of months,” said Alice Burns, associate director of the Program on Medicaid and the Uninsured at health care nonprofit the Henry J. Kaiser Family Foundation. “It may be more months or fewer months; it may mean you can return 10% or 80%.

    “That’s just because long Covid is so different for so many different people.”

    Why the long Covid labor gap matters

    Jerome Powell, chair of the Federal Reserve, mentioned Sheiner and Salwati’s long Covid research in a recent speech about inflation and the labor market.

    Millions of people left the labor force in the early days of the pandemic, due to factors like illness, caregiving and fear of infection. But workers haven’t returned as quickly as imagined, particularly those outside their prime working years, Powell said. About 3.5 million workers are still missing, he said.

    While most of that shortfall is due to “excess” (i.e., early) retirements, “some of the participation gap” is attributable to long Covid, Powell said. Other big contributors to the shortfall include a plunge in net immigration to the U.S. and a surge in deaths during the pandemic, he added.

    “Looking back, we can see that a significant and persistent labor supply shortfall opened up during the pandemic — a shortfall that appears unlikely to fully close anytime soon,” the Fed chair said.

    That shortfall has broad economic repercussions.

    When the U.S. economy started to reopen in early 2021 from its pandemic-era hibernation — around the time Covid vaccines became widely available to Americans — demand for labor catapulted to historic highs.

    Job openings peaked near 12 million in March 2022 and remain well above the pre-pandemic high. There are currently 1.7 job openings per unemployed American — meaning the available jobs are almost double the number of people looking for work, though the ratio has declined in recent months.  

    That demand has led businesses to raise wages to compete for talent, helping fuel the fastest wage growth in 25 years, according to Federal Reserve Bank of Atlanta data.

    A worker shortage — exacerbated by long Covid — is helping underpin dynamics that have fueled fast-rising prices for household goods and services.

    But the labor gap is just the “tip of the iceberg,” said Stevenson at the University of Michigan. There are all sorts of unknowns relative to the economic impact of long Covid, such as effects on worker productivity, the types of jobs they can do, and how long the illness persists, she said.

    “When you’re sick, you’re not productive, and that’s not good for you or for anybody around you,” Stevenson said of the economic impact.

    For example, lost pay might weigh on consumer spending, the lifeblood of the U.S. economy. The sick may need to lean more on public aid programs, like Medicaid, disability insurance or nutrition assistance (i.e., food stamps) funded by taxpayer dollars.

    Economic drag will rise if recovery rates don’t improve

    In all, long Covid is a $3.7 trillion drain on the U.S. economy, an aggregate cost rivaling that of the Great Recession, estimated David Cutler, an economist at Harvard University. Prior to the pandemic, the Great Recession had been the worst economic downturn since the Great Depression. His estimate is conservative, based on known Covid cases at the time of his analysis.

    Americans would forgo $168 billion in lost earnings — about 1% of all U.S. economic output — if 3 million were out of work due to long Covid, said Bach of the Brookings Institution. That burden will continue to rise if long Covid patients don’t start recovering at greater rates, she said.

    “To give a sense of the magnitude: If the long Covid population increases by just 10% each year, in 10 years, the annual cost of lost wages will be half a trillion dollars,” Bach wrote.

    The Vermont resident sometimes had to reduce her typical workweek of about 20 hours, due partly to ongoing health issues, as well as multiple doctor appointments for both her and her daughter, who also has long Covid. Meanwhile, Hultquist nearly emptied her savings.

    Hultquist has benefited from different treatments, including physical therapy to restore muscle strength, therapy to “tone” the vagus nerve (which controls certain involuntary bodily functions) and occupational therapy to help overcome cognitive challenges, she said.

    “All my [health] providers keep saying, ‘We don’t know what the future looks like. We don’t know if you’ll get better like you were before Covid,’” Hultquist said.

    The therapy and adaptations eventually led her to seek full-time employment. She recently accepted a full-time job offer from the New Hampshire Department of Health & Human Services, where she’ll serve as a case aide for economic services.

    “It feels amazing to be recovered enough to work full time,” Hultquist said. “I’m very far from pre-Covid functioning but I found a way to keep moving forward.”



  • https://www.cnbc.com/2022/12/08/long-covid-is-distorting-the-labor-market-hurting-the-us-economy.html