From Washington DC

• Healthcare Dive informs us,
  • “The CMS rolled out several flexibilities on Tuesday that aim to help providers’ mounting financial challenges in the wake of the cyberattack against Change Healthcare.
  • “The agency instructed Medicare administrative contractors, who process claims for the government, to expedite provider requests to switch to new clearinghouses to get around the Change outage. CMS is also encouraging Medicare Advantage plans, Part D sponsors, and Medicaid and Children’s Health Insurance Program managed care plans to relax prior authorization requirements or offer advance funding. 
  • “The agency said providers can submit requests for accelerated payment to their Medicare administrative contractors for individual consideration.”

• Fierce Healthcare adds,
  • “Availity, another clearinghouse, is used by Humana and Elevance Health. Humana CEO Bruce Broussard said a lot of business is shifting from Change to Availity.
  • “Elevance Executive Vice President and CFO Mark Kaye noted they’ve noticed providers have been able to adapt in the days after the cyberattack.
  • “Today, we’re about down to a 10% reduction relative to normal daily volumes,” said Kaye. “Some providers are now submitting claims directly to Availity, while others have switched their clearinghouse.”

• Axios tells us that in the wake of the CDC’s recent decision to treat Covid like other respiratory illnesses,
  • “The HHS’s free COVID test program was suspended because of the lowering case rates after the winter respiratory season, though the agency may resume it in the future as needed.
  • “Orders for free tests placed on or before Friday will be delivered, per HHS.” 

• Per an HHS press release,
  • “The Justice Department’s Antitrust Division, Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.
  • “Private equity firms and other corporate owners are increasingly involved in health care system transactions and, at times, those transactions may lead to a maximizing of profits at the expense of quality care. The cross-government inquiry seeks to understand how certain health care market transactions may increase consolidation and generate profits for firms while threatening patients’ health, workers’ safety, quality of care and affordable health care for patients and taxpayers.
  • “The agencies issued a Request for Information – PDF (RFI) requesting public comment on deals conducted by health systems, private payers, private equity funds and other alternative asset managers that involve health care providers, facilities or ancillary products or services. The RFI also requests information on transactions that would not be reported to the Justice Department or FTC for antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act.”

• The Food and Drug Administration announced,
  • “Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “

• The Congressional Research Service issued an In Focus report about the Federal Employee Paid Parental Leave Benefit.

• The U.S. Office of Personnel Management announced,
  • Today, the National Aeronautics and Space Administration (NASA) and the U.S. Office of Personnel Management (OPM) welcomed its new class of next generation Artemis astronauts in a ceremony at the agency’s Johnson Space Center on Tuesday. The ten astronaut graduates are now eligible for flight assignments. The agencies also announced the opening for the next round of NASA astronaut applications.  

From the public health and medical research front,

• The Washington Post reports,
  • “The mortality rate for U.S. women with breast cancer fell an estimated 58 percent from 1975 to 2019, according to research published in JAMA that credits the decline to advances in screening and treatments.
  • “Nearly half (47 percent) of the reduction was attributed to earlier and more effective treatment of those with Stage 1, 2 or 3 breast cancer. (With staging, generally the lower the number, the less the cancer has spread.)
  • “In addition, about 25 percent of the drop was attributed to improved mammography screening and about 29 percent to better treatment of metastatic breast cancer, meaning cancer that has spread.”

• The Wall Street Journal points out,
  • “Novo Nordisk’s blockbuster weight-loss drug cuts the risk of kidney disease-related events in diabetic patients by 24%, according to a new clinical trial conducted by the Danish pharmaceutical company.
  • “Headline results from a five-year study of Semaglutide, which is marketed as Ozempic to treat diabetes, show that diabetic patients with chronic kidney disease saw a statistically significant and superior reduction in kidney disease progression, major adverse cardiovascular events and death, it added.
  • “The announcement follows October’s decision to stop the trial, known as FLOW, early thanks to successful results.
  • “Last year, a separate trial of Novo Nordisk’s obesity drug Wegovy showed that it cuts the risk of heart attacks and strokes.”

• The National Institutes of Health adds,
  • “A weekly injection of semaglutide was safe and reduced the amount of fat in the liver by 31% in people with HIV and metabolic dysfunction-associated steatotic liver disease (MASLD), according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. This is the first clinical trial of semaglutide for MASLD in people with HIV. The research was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted in the United States and Brazil by ACTG, a global clinical trials network focused on HIV and other infectious diseases. ACTG is funded by NIAID and collaborating NIH institutes. McGovern Medical School at UTHealth Houston also contributed funding for this study.
  • “Previously known as nonalcoholic fatty liver disease, MASLD is characterized by the accumulation of excess fat in the liver that is not caused by alcohol consumption or viral hepatitis. Over time, fat deposits may cause inflammation and cellular damage, and can result in cardiovascular and liver disease. MASLD also is associated with obesity, type 2 diabetes, and other metabolic disorders. It is the most common cause of chronic liver disease in the United States, and a leading reason for liver transplantation. An estimated 30-40% of people with HIV experience MASLD, slightly higher than the average among people without HIV.Semaglutide is an antidiabetic medication approved for use for the treatment of type 2 diabetes and an anti-obesity medication used for long-term weight management.”

• Medscape relates,
  • “A new and deceptively simple advance in chronic stroke treatment could be a vibrating glove.
  • “Researchers at Stanford University and Georgia Tech have developed a wearable device that straps around the wrist and hand, delivering subtle vibrations (akin to a vibrating cellphone) that may relieve spasticity as well as or better than the standard Botox injections.
  • “The vibro-tactile stimulation can be used at home, and we’re hoping it can be relatively low cost,” said senior study author Allison Okamura, PhD, a mechanical engineer at Stanford University, Stanford, California.
  • “For now, the device is available only to clinical trial patients. But the researchers hope to get the glove into — or rather onto — more patients’ hands within a few years. A recent grant from the National Science Foundation’s Convergence Accelerator program could help pave the way to a commercial product. The team also hopes to expand access in the meantime through larger clinical trials with patients in additional locations.”

• The New York Times reports,
  • “Determining whether someone has Alzheimer’s disease usually requires an extended diagnostic process. A doctor takes a patient’s medical history, discusses symptoms, administers verbal and visual cognitive tests.
  • “The patient may undergo a PET scan, an M.R.I. or a spinal tap — tests that detect the presence of two proteins in the brain, amyloid plaques and tau tangles, both associated with Alzheimer’s.
  • “All of that could change dramatically if new criteria proposed by an Alzheimer’s Association working group are widely adopted.
  • “Its final recommendations, expected later this year, will accelerate a shift that is already underway: from defining the disease by symptoms and behavior to defining it purely biologically — with biomarkers, substances in the body that indicate disease.
  • “The draft guidelines, Revised Criteria for Diagnosis and Staging of Alzheimer’s Disease, call for a simpler approach. That could mean a blood test to indicate the presence of amyloid. Such tests are already available in some clinics and doctors’ offices.”
  • “Someone who has biomarker evidence of amyloid in the brain has the disease, whether they’re symptomatic or not,” said Dr. Clifford R. Jack Jr., the chair of the working group and an Alzheimer’s researcher at the Mayo Clinic.
  • “The pathology exists for years before symptom onset,” he added. “That’s the science. It’s irrefutable.”

From the U.S. healthcare business front,

• Becker’s Hospital Review lets us know,
  • “Danville, Pa.-based Geisinger appointed Terry Gilliland, MD, as the next president and CEO of Geisinger Health.
  • “Dr. Gilliland will succeed Jaewon Ryu, MD, JD, after he transitions to CEO of Risant Health, a nonprofit organization created by Kaiser Foundation Hospitals. Oakland, Calf.-based Kaiser Permanente agreed to acquire Geisinger last year as the first health system to join Risant, and the deal is waiting on regulatory approval.
  • “Geisinger’s board conducted an extensive search for Dr. Ryu’s successor.
  • “The role of leading Geisinger is unique,” said Heather Acker, chair of the Geisinger board of directors, in a news release. “It requires passion for our mission–to make better health easier for our patients and members across Pennsylvania; a drive to innovate care delivery; and a commitment to educating future caregivers. We are confident that Dr. Gilliland is the right person to lead Geisinger on our path forward.”

• According to Fierce Healthcare,
  • “Insurance network coverage dramatically impacts whether a person remains in treatment for opioid use disorder, according to results shared by treatment provider Ophelia.
  • “A new study finds that nearly three-quarters (72.3%) of patients receiving opioid treatment through network insurance stayed in treatment for at least six months. Patients received telehealth treatment from Ophelia.”

• Bloomberg reports,
  • “The US Department of Labor’s new worker classification rule is facing at least four lawsuits alleging the regulation is illegal, with less than a week before the new policy is set to go into effect.
  • “Freelance writers, a trucking company, and groups representing construction, financial services, and tech companies have filed four separate legal challenges in federal district court in Texas, Georgia, Tennessee, and Louisiana contending the new standard, which will make it harder for businesses to use independent contractors, violates the Administrative Procedure Act and departs from the text of the Fair Labor Standards Act. 
  • “The growing pile of lawsuits threatens to disrupt the Biden administration’s implementation of the new rule due to take effect March 11. The DOL says the regulatory update will better protect workers from misclassification, but the business community warns it could have major consequences for industries that rely on independent contractors to operate their services—like Uber Technologies Inc. and Lyft Inc., as well as the trucking, construction, and other sectors. 
  • “And the multi-district nature of the litigation also could lead to splits among the district and appellate courts, inviting potential US Supreme Court review.”