The Leg.Up

Local, state and national news of interest to the physician community

September 18, 2024

NIGHTMARE ON THE OR TABLE

Donor Groups Accused of Attempted Organ Procurement from Live Patients; UNOS Alleges Defamation

Last Wednesday, a House subcommittee held a hearing on the rollout of the Securing the U.S. Organ Procurement and Transplantation Network Act signed into law last year, which broke Richmond-based UNOS' monopoly over the system and was designed in hopes of fixing systemic problems. Allegations of "rampant Medicare and Medicaid fraud" and lost kidneys and pancreases abounded. But, according to MedPage Today and WSJ, it was far more troubling testimony that prompted one lawmaker to describe the situation as "absolutely terrifying."

Greg Sagal, the founder of transplant patient advocacy group Organize, shared a whistleblower's claims that "he was instructed to recover organs from someone who was mouthing the words, 'Help me.' He decided not to proceed, and the person ended up surviving." The Richmond Times-Dispatch reports that a former employee of the Kentucky Organ Donor Affiliates "said a man who was incorrectly listed as brain dead woke up in a Kentucky hospital. But the group...wanted to proceed with the operation anyway."

One transplant surgeon testified that "transplant teams have poor training and a poor standard of practice." Also alleged were threats by executives to "cremate alive" whistleblowers.

A representative for UNOS, which oversees the process, told the Times-Dispatch that it was "unaware of the allegation until it was referenced at [the] Congressional hearing" and called the remarks "serious and unfounded." Two days later, the organization reacted in stronger terms, saying the criticisms "malign and defame UNOS," RTD reports.

IN RELATED NEWS... A new HHS proposed rule would remove clinical research and institutional review board (IRB) requirements for transplanting kidneys and livers from donors with HIV to recipients who also have the virus. (MedPage Today)

Exec. Dir. Sally Graham Retires from GoochlandCares After 25 Years

Associate RAM member Sally K. Graham has held a steady hand for a quarter-century as the executive director of the free clinic GoochlandCares. Now, she's handing over the reins to a new generation of leadership, the Richmond Times-Dispatch reports.

A former nurse practitioner, Graham moved from Atlanta to Goochland in 1998, when she became involved with the now 72-year-old grassroots nonprofit organization. Eventually assuming the role of executive director, Graham has overseen organizational mergers and capital campaigns to help grow this vital health care program.

Congratulations to Sally for her years of devotion and her well-earned retirement, as well as to the new CEO of GoochlandCares, Andrea Ahonen!

UVA Management Strikes Back Against No-Confidence Letter

UVA Health's leadership team is pushing back against the no-confidence letter signed by 128 physician faculty demanding the removal of that system's CEO and Dean of Medical School.

"It is unfortunate, in my view, that these faculty have taken this route. They have besmirched the reputations of not just [Dean] Melina [Kibbe, MD] and [CEO] Craig [Kent, MD]. Instead, through some of their allegations, they have unfairly—and I trust unwittingly—cast a shadow over the great work of the entire health system and medical school," UVA President Jim Ryan wrote in a letter to faculty.

President Ryan says the 9% of faculty who signed the letter "is about in line with medical school faculty dissatisfaction rates nationally," Fierce Healthcare reports, and that his experiences with the two accused officers do not align with the picture painted by the letter.

Various university leaders have countered the letter by citing "quality scores, staffing levels, capacity expansion, financial performance and other internal feedback," and President Ryan claims "his inbox has been 'overflowing' with notes of support from other faculty." CBS 15 reports how the CEO and Dean have responded to the letter.

PBMs: Prescription Benefit MONOPOLIES

The four largest pharmacy benefit managers (PBMs) in the U.S. possess a 70% share of the national market and have carved out their own "highly concentrated" regional zones, data from the American Medical Association (AMA) finds.

"The study dived into 2022 data on commercial and Medicare Part D plans," Fierce Healthcare says. Here's what it found:

Market Share Percentages

1. CVS Health's Caremark = 21.3%
2. UnitedHealth Group's Optum Rx = 20.8%
3. Cigna's Express Scripts = 17.1%
4. Prime Therapeutics = 10.3%

"Eighty-two percent of region-level PBM markets would be considered highly concentrated based on federal guidelines," Fierce Healthcare says, meaning low competition and thus potentially higher health care costs. Also, "payers that are vertically integrated with a PBM covered 72% of people across both commercial plans and Part D."

AMA President Bruce A. Scott, MD remarked, "The findings from the new AMA analysis warrant attention as Congress and the administration continue their work to protect patients and ensure prescription drugs remain affordable and accessible."

IN RELATED NEWS... Despite threats of fines or jail time if they do not revise allegedly perjurious comments they made before the House, executives from the biggest three PBMs informed Congress that they refuse to change their testimony (Healthcare Dive)... Cigna's Express Scripts goes on the offensive, suing the FTC and demanding the withdrawal of the agency's recent report condemning PBMs. (Healthcare Dive)

See Where the Magic Happens:

Food, Drinks, Mingling & Tours @ M4ALL

Thursday, October 3, 2024, 6:00-8:00 P.M.

4th Floor, M4ALL Institute, Biotech Building 8

As a follow-up to last night's September 10th General Membership Meeting, come join the Academy as we tour Medicines for All Institute (M4ALL) at Virginia Commonwealth University’s College of Engineering for our Member Social.

See firsthand how Dr. Frank Gupton and his team practice the art of disrupting the world of Big Pharma while keeping them coming back for more. 

BRING YOUR SPOUSE OR COLLEAGUE:

There is NO COST for

RAM members AND their guest!

Invasion of the Body Snatchers, Medical Edition

An NBC News investigation has unearthed a ghastly enterprise at the University of North Texas Health Science Center, sparking outrage and provoking the suspension of a program which profited off the bodies of homeless individuals without their consent and without notifying survivors.

The Center procured the unclaimed bodies of around 2,350 people under agreements with Dallas and Tarrant Counties. Some bodies were dissected to teach medical students, while others were leased whole or in pieces to entities ranging from medical education and technology companies to the U.S. Army.

"Disproportionately Black, male, mentally ill and homeless," the subjects in many cases were actively being sought after by their families, or their families were unaware of their demise. Medical ethicists are decrying the indignity shown to the deceased as well as the trauma caused to loved ones by denying them a grieving process.

After initially defending its actions, the Center recently announced it had fired the officials who led the program and has hired a consulting firm to investigate.

RAM Family Fall Day at Lloyd Family Farms

Sunday, October 6, 2024, 2:00-5:00 P.M.

12204 Pinhook Road, Rockville, VA 23146

RAM Members and their families are invited to join us at RAM's annual Fall Family Event at Lloyd Family Farms from 2-5 p.m. on Sunday, October 6th!

The family ticket price of $25 gets your immediate family admission to the farm and pumpkin vouchers for the kids. Stop by the barn to pick up your pumpkin vouchers, mingle with your fellow Academy members, and enjoy grab-and-go snacks and drinks.

A pumpkin voucher must be presented at checkout to receive your free child-sized pumpkin. Vouchers are valued at $5 which covers the cost of a pumpkin weighing 3-6 lbs. or $5 toward the cost of a larger pumpkin. 1 voucher/child. Not redeemable for cash. Check in with RAM at the barn to get your voucher.

Tickets are non-refundable and non-transferable.

Down the Drain: Steward's $800 Million Private Equity Payout

The Stewart Health Care bankruptcy saga is a real-time lesson in the tragic consequences that can follow vampiric private equity takeovers. The Wall Street Journal recently published an exclusive which reveals just how outrageous the road to Steward's demise was.

Although the national hospital chain sustained a $300 million net loss in 2016, it was still able to scrape together a $719 million dividend to appease investors in its private-equity owner Cerberus Capital Management, doing so through real estate deals with Medical Properties Trust (MPT).

Cerberus touts itself as "your partner to improve performance and drive value" on its website. However, when Steward requested $750 million in investments four years after that dividend, Cerberus sold it within a month to a physician group led by Steward's CEO Dr. Ralph de la Torre. De la Torre and his management team had received a $71 million payout during the 2016 dividend extravaganza, which all total had sapped $790 million from the hospital chain and greatly decreased its equity and liquidity.

The April 2020 sale to CEO de la Torre corresponded with the start of the COVID-19 pandemic. That year, Steward recorded a $408 million loss. That $790 million dividend handed out four years earlier "could have come in handy," WSJ notes.

As for Medical Properties Trust, it continued to pump cash into the dying chain, including $1.2 billion during the 2016 dividend transaction and another $400 million when Cerberus sold it to de la Torre. But don't feel too sorry for it: The 2016 payout landed it five of Steward's Massachusetts hospitals and mortgage loans on four others (which it would later buy), all of which it then leased back to Steward at exorbitant rates. And it has an extensive portfolio of such deals with healthcare entities across the country, which net it hefty profits and fuel private equity's continued push into the field.

A Brighter Future?

Steward inked a deal to exit bankruptcy last Wednesday, forgiven of $7.5 billion in debt to MPT in exchange for not pursuing legal actions against that real estate investment trust. Steward will sell a Florida hospital for $395 million and use the proceeds to pay off creditors and lenders while keeping the majority of its hospitals open, Healthcare Dive says.

CEO Dr. Ralph de la Torre, true to his word was absent from last Thursday's Congressional hearing on Steward's bankruptcy. He is expected to be held in contempt, CBS reports.

General Membership Recap: M4ALL

It works in our backyard every day, accomplishing astounding feats of efficiency to lower both the costs and environmental impacts of medicinal production. Medicines for All Institute's existence ensures critical drugs and their components, overlooked by Big Pharma, are available to those who need them most.

Nearly 130 RAM members and their guests enjoyed a presentation of great optimism delivered by Dr. B. Frank Gupton, who has worked with large pharmaceutical corporations and the government alike on this mission to better the health care world, one drug at a time. Many thanks to all who attended!

Ghost Networks Give Illusion of Health Care Access

HEALTH CARE un-covered's Wendell Potter recently pulled back the veil on one of insurers' dirty secrets, ghost networks, and he provided patients and providers advice for dealing with them.

"Many of the providers listed in their insurer's directory simply don't exist or aren't accepting patients," Potter says. In instances of behavioral health care, these ghost networks serve to satisfy federal parity requirements, creating the "illusion of a robust, well-functioning network" without actually benefitting the beneficiary.

"After all, if fewer people can access care, fewer claims are filed. For insurers, that's a win," Potter says. Unfortunately (and you can bet by the insurers' design), patients are ultimately driven to seek out-of-network care, paying most or all of the bill out of their own pockets.

"Being a squeaky wheel" is crucial to overcoming denials, delays, and other insurer roadblocks, Potter says. "Fighting back includes informing yourself about your case; filing an appeal with your health insurer; and (in my opinion, most importantly) raising hell," he says.

LAST CHANGE TO REGISTER: EVENT FRIDAY!

Consumer Concern: Lead-Contaminated Cinnamon

Last year, a rash of lead poisonings among 500 children were traced by the FDA to consumer goods containing cinnamon, initiating an agency warning against 17 products containing dangerous levels of the element. A year later, Consumer Reports has conducted its own study, and the findings are still highly concerning.

Overall, the lead levels discovered were far lower than those reported by the FDA last year. However, "12 of the 36 products measured above 1 part per million of lead—the threshold that triggers a recall in New York, the only state in the U.S. that regulates heavy metals in spices," Consumer Reports writes.

Such levels are "1,000 times as high as the levels that concern lead-exposure experts who focus on children's health," The New York Times says. Children in particular are susceptible to lead's harmful effects.

Consumer advocacy groups aim to raise public awareness of the issue and are urging Congress to empower the FDA to enact lead testing requirements and strict limits. Currently the agency has no authority in those matters, a spokesperson told The New York Times.

See the Consumer Reports study linked above to see which cinnamon products you and your patients should toss.

Medi¢: The Business of Medicine

Wait, a Health Worker Surplus?!

"A surprising new report by the Mercer consulting firm projects that the American healthcare workforce will face a small shortfall in 2028 — a shortage of less than 1% of all employees. The report even projects a surplus of tens of thousands of registered nurses and home health aides — and even a small surplus of physicians in some states. Mercer report's projections are rosier than federal workforce projections, which paint a grimmer picture of impending shortages." Click here to read more from MedScape.

ALSO: Find out what physicians say is driving them away from their positions, and how you can entice them to stay, at Fierce Healthcare. And check out photos from last night's Independent Physician Group dinner presentation on staffing on our Facebook page!

Other Medical Business News



• Increased medical service costs and higher use are expected to fuel a 5.8% spike in employer health insurance costs next year. (Reuters)
• UnitedHealth will remove expensive Humira from some of its lists of preferred drugs for reimbursement as of Jan. 1, 2025, and recommend less expensive biosimilars instead. (Reuters)
• By 2031, the weight loss drug market could reach $200 billion and feature up to 16 new drugs. (Reuters)
• Walgreens will pay the U.S. government $106.8 million to settle claims it charged the feds for prescriptions it never filled. (DOJ)
• The feds are facing mounting criticisms for an allegedly inadequate response to cyberattacks in health care. (NPR)
• $220 million loss for Philip Morris as it sells its inhaled-therapeutics unit. (WSJ)
• In an investigation into Catholic hospital charity, KFF Health cites research by the Lown Institute that claims Bon Secours Mercy Health is among the 10 health systems with the greatest "fair share deficits" between community benefits and tax exemptions. Bon Secours responded that the study used "flawed high-level assumptions and incomplete data."

Public Health, Recalls & Shortages

• The FDA flagged the Boar's Head meat processing facility in Jarratt as an "imminent threat" to public health two years ago...But the facility continued to operate with many of the same problems until the current deadly Listeria outbreak (NYT; The Hill). The facility has now been closed "indefinitely." (WWBT)
• You may have noticed a distressing number of recalls related to cardiac devices recently. The FDA is under fire for allowing many unsafe devices to reach the market without rigorous clinical testing, MedPage Today reports.
• That FDA has announced it will conduct an independent review and lab study to evaluate the presence of toxic heavy metals in tampons following a recent study's findings. (Healio)

Get a Clearer Picture of New Intraocular Lens Implants with Lunch on Tuesday!

Tuesday, October 8, 2024, 12:30-1:30 P.M.

Intraocular lens implants are game changers in the treatment of cataracts. Join us at the Westwood Club for lunch and to learn more about the latest research and procedures from Seth Krawitz, MD, Virginia Eye Institute.

COVID Communiqué

The legacy of former New York Gov. Andrew Cuomo (D) is saddled with the deaths of an untold number of New Yorkers who resided in nursing homes during the pandemic. Last Tuesday, he faced scrutiny and criticism from both sides of the political aisle at a Congressional hearing. "The former governor’s opponents allege that directives made by him early in the COVID-19 pandemic led to nursing home exposures resulting in avoidable deaths. Cuomo is further accused of making efforts to obscure the number of deaths among nursing home residents," The Hill reports. Click here to learn what was said and to see where the investigation is headed.

• A new nationwide survey from The Ohio State University Wexner Medical Center determined 37% of respondents have gotten vaccines in the past for COVID and other respiratory viruses but do not plan to this year.
• Two new variants, XEC and MV.1, are on the rise globally, with the former poised to become the next dominant strain. (USA Today)

Quick Bites

Brief Useful & Intriguing Health News of Note:

Global Angle

• Bavarian Nordic mpox vaccine approved by WHO. (The Hill)

Across the Nation

• The Protecting Patients from Deceptive Drug Ads Online Act has been introduced to combat the sale and misleading promotion of prescription drugs by telehealth firms and social media influencers. (The Hill)

Virginia Focus

• A 16% raise, annual $100,000 housing allowance, and four-year contract extension have been granted to VCU President Michael Rao. (RTD)
• RAM member Dr. Danny Avula is now the top fundraiser in the race to be the next Richmond mayor. (Richmonder)
• Pharmacy Technician Training Program to open at VCU later this month to address worker shortages. (WRIC 8)
• Report delivered to the General Assembly Tuesday on the death of Irvin Otieno while in police custody last March offers disturbing details on his final hours. (RTD)
• Fall allergy season has arrived here with a vengeance: Axios Richmond gives us the lowdown.
• Men's health clinic franchise GameDay opens in Innsbrook. (Richmond BizSense)

Medical Miscellany



• One in five U.S. adults had obesity in 2023; 23 states had one in three living with obesity. (Healio)
• Prevalence of atrial fibrillation (afib) in U.S. adults is higher than originally thought, at 4.5%, according to new data. (Healio)
• Microplastics have been discovered in human olfactory bulbs, possibly providing a route for the fragments to enter the brain. (MedPage Today)

Drug & Tech News



• FDA Warning: Hormone-free hot flash pill fezolinetant (Veozah) can cause rare but serious liver damage. Liver blood tests should be performed before and during treatment. (MedPage Today)
• GLP-1 receptor agonists have been tied to lower risk of cirrhosis and death in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). (MedPage Today)
• Ozempic predecessor liraglutide has been shown to reduce BMI in children 6 to 11 with obesity, according to a new study - But what would be the long-term side effects of such an early use? (NBC News; MedPage Today)
• Tirzepatide helped women lose nearly a quarter (24.7%) of their body weight, compared to 18.1% in men. (MNT)
• Twice-a-year injection lenacapavir has reduced HIV infections by 96% in new study findings. But once again, experts fear it will be too expensive for most. (NBC News)
• FDA approval of a new manufacturing line for Sanofi and AstraZeneca will enable expanded capacity for production of infant RSV therapy Beyfortus, which was hard to come by last year. (Reuters)

FDA Approvals



• Dupilumab (Dupixent), for chronic rhinosinusitis with nasal polyps to include children ages 12 years and up. (Regeneron; MedPage Today)
• Guselkumab (Tremfya), expanded use to treat adults with ulcerative colitis. (Reuters; MedPage Today)
• Lebrikizumab (Ebglyss), for treating atopic dermatitis in adults and children ages 12 years and up. (Healio; MedPage Today)
• Ocrelizumab (Ocrevus Zunovo), for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis. (MedScape)
• Pembrolizumab (Keytruda) with chemotherapy, for unresectable advanced or metastatic malignant pleural mesothelioma. (FDA)
• Ribociclib (Kisqali), in combination with endocrine therapy as adjuvant treatment for early high-risk breast cancer. (NBC News; MedPage Today)
• Eversense 365, a continuous glucose monitoring system with an implantable sensor that can be worn for up to 1 year for adults aged 18 years and older with type 1 or type 2 diabetes. (Healio)
• First OTC hearing aid software to be used in Apple's AirPods Pro. (Reuters; MedPage Today)
• Apple Watch sleep apnea detection function. (CBS News)

Infectious Disease Report



• Tennessee's first case of measles in five years reported. (CIDRAP)
• Massachusetts West Nile virus cases up to 11. (WJAR)
• Africa recorded 107 mpox deaths and 3,160 new cases in one week. (AP)
• A novel zoonotic poxvirus infected a bat sanctuary worker in Israel. (Healio)
• Enterovirus D68, linked to acute flaccid myelitis (AFM), is on the rise in wastewater samples. (NBC News)
• Drug-resistant bacteria deaths are projected to rise 70% over the next 25 years. (MedPage Today)

FASCINATING FACT OF THE WEEK

The changes in a woman's body arising from pregnancy are well-documented, but a new study has added to our understanding of how pregnancy affects the brain. "Researchers said on Monday they have for the first time mapped the changes that unfold as a woman's brain reorganizes in response to pregnancy, based on scans carried out 26 times starting three weeks before conception, through nine months of pregnancy and then two years postpartum," Reuters reports. Among the key findings were a widespread decrease in the volume of cortical gray matter and an increased in the structural integrity of the white matter, changes which researchers surmise may affect maternal-fetal bonding and other behaviors. The new discovery may also shed light on conditions such as post-partum depression and pre-eclampsia, NYT says.

Thanks for reading The Leg.Up!



Just in time for Halloween season: A pair of ghoulish tales regarding the organ transplant system and unclaimed bodies, a private equity vampire, a spice worthy of a witch's brew, and a spooky ghost network story. You might not want to read this one before bed, folks!

communications@ramdocs.org

Click here for past editions of The Leg.Up.

Scott C. Matthew

RAM Director of Communications

Richmond Academy of Medicine

www.ramdocs.org

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