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

December 13, 2023

A recent investigation by CBS News has exposed the dark side of private equity health care buyouts, and in so doing has stirred the attention of the White House and both parties in a powerful Senate subcommittee, which have launched a wide-ranging probe into health care consolidation trends.

The emotional story of a mother facing a medical crisis who was denied care at a private equity-owned hospital in Pennsylvania because its ED had shut down highlights the worst aspects of private equity consolidations: In pursuit of the almighty dollar, such firms often eliminate vital patient services deemed not profitable enough, including maternity wards, operating rooms, I.C.U.s, and even emergency departments.

Sens. Chuck Grassley (R-Iowa) and Sheldon Whitehouse (D-R.I.), who head the Senate Budget Committee, said "the American people deserve to understand the role that PE [private equity] firms play — and any potential resulting negative financial or patient care impacts — in the delivery of their health care," CBS News says. See also: NBC News.

Stat quotes Sen. Whitehouse: "As private equity has moved into health care, we have become increasingly concerned about the associated negative outcomes for patients. From facility closures to compromised care, it's now a familiar story: private equity buys out a hospital, saddles it with debt, and then reduces operating costs by cutting services and staff — all while investors pocket millions. Before the dust settles, the private equity firm sells and leaves town, leaving communities to pick up the pieces."

Meanwhile, the Biden administration announced interagency efforts "to scrutinize anti-competitive practices that keep healthcare prices high for families, including collecting information from the public on how some corporations are putting profits ahead of patients," MedPageToday reports. "The Department of Justice (DOJ), Federal Trade Commission (FTC), and HHS will jointly gather data on private equity's increasing control of the healthcare market and its impact on patients in order to inform future regulation and help to prioritize enforcement activities." The agencies will also "begin to share data to help antitrust enforcers identify potentially anticompetitive transactions," including acquisitions too small to meet agency reporting thresholds.

UPDATE: Cigna-Humana Talks Called Off

Following the highly publicized revelation last week that Cigna and Humana were engaged in merger discussions that could have created a $140 billion health insurance giant, The Wall Street Journal reported Sunday that Cigna has called off the talks due to a disagreement on financial terms of the deal.

IN RELATED NEWS: Humana has been sued for using an AI algorithm that systematically denies seniors rehabilitation care recommended by their doctors: Axios.

It may be the dawn of a new age in American medical history: On Friday, the FDA announced its approval of two milestone gene therapies designed to treat the scourge of sickle cell disease, one of which, Casgevy, is the first officially OKed to use novel CRISPR genome-editing technology. The announcement follows the UK's world-first approval announcement of Casgevy nearly a month ago.

Exagamglogene autotemcel (Casgevy) and lovotibeglogene autotemcel (Lyfgenia) are both approved for patients 12 years of age and older. The former utilizes CRISPR/Cas9 technology, while the latter uses a lentiviral vector for genetic modification. "Both treatments are administered as one-time infusions," MedPageToday says. "They are made from the patients' own blood stem cells, which are modified and returned to the patient in a hematopoietic stem cell transplant."

"These approvals represent an important medical advance with the use of innovative cell-based gene therapies to target potentially devastating diseases and improve public health," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research (CBER). Nicole Verdun, MD, also at FDA's CBER, said they "hold the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited."

Despite those optimistic remarks, some observers question whether the treatments will be of much benefit to most patients, including this piece from The New York Times, as the price tag for exa-cell (Casgevy) could reach $2.2 million per treatment, per CNBC and the Dallas Weekly. The other therapy, Lyfgenia, will cost $3.1 million (Axios).

IN RELATED NEWS... More patients with severe sickle cell disease may be eligible for potentially curative bone marrow transplants using a new approach that is far less toxic than older methods and allows for more relatives to become donors: Reuters.

Access Now still has over $4,500 in Virginia tax credits available through the Neighborhood Assistance Program (NAP). Generous donors wishing to help Access Now's critical mission of health care access for Central Virginia's uninsured are eligible to claim tax credits for donations $1,000 and up.

A generous donation of $6,964.27 would secure all the remaining credits. Credits are available first-come, first-served. Please note: Donations must be made by December 31, 2023.

We'd like for RAM members to have the opportunity to support a worthy cause and save on their taxes as well. Please contact Sue Speese, RAM COO, if you have any questions: [email protected].

In the ongoing clash between the Biden administration and Big Pharma over high drug prices, the word of the week was "patent."

The feds' latest move is aimed at pharmaceutical firms that accepted taxpayer dollars to develop drugs. "If drugmakers refuse to make their products 'reasonably' available, then the government is prepared to give other companies license to produce those drugs at a lower cost," The Hill reports. Under the Bayh–Dole Act of 1980, the government reserves "march in" rights to issue licenses for such drugs produced under a private-public partnership, Politico reports.

A national economic adviser said, "We'll make clear that when drug companies won't sell taxpayer funded drugs at reasonable prices, we will be prepared to allow other companies to provide those drugs for less." It would be the first time the federal government has ever used this authority, which the government claims it may invoke not only to lower high drug prices but also to "promote competition in the industry."

One official said, "patent and other laws have been misused to inhibit or delay for years and sometimes even decades competition for generic drugs and biosimilars, which overall denies Americans access to lower-cost drugs." Indeed, as Stat reports, "most drugmakers have so far ignored a looming FTC deadline to withdraw or amend wayward patents." As a result, drugmakers such as AbbVie, AstraZeneca, and GSK may face lawsuits for "dozens of patents that were improperly or inaccurately listed in a government registry," a stratagem that allows drugmakers added patent protections to profit for longer as medical monopolies.

IN RELATED NEWS... Federal drug price negotiations could have saved seniors nearly a quarter of their out-of-pocket expenses in 2021: Axios.

RAM member Arun Sunyal, MD is the world's No. 2 specialist in liver diseases, according to ScholarGPS, which ranks researchers and their publications based on productivity, impact and quality. The director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at VCU School of Medicine has been cited more than 100,000 times, a press release from VCU Health notes. Congratulations, Dr. Sunyal!

A tense legal standoff between a Texas judge and the Texas attorney general over a court-ordered abortion ruling exception left physicians in the Lone Star State facing a legal quandary this week. Regardless of your stance on the topic of abortion, the notion that a physician could be imprisoned for performing a procedure backed by a court order is a testament to the uncertainties physicians can face when standing at the edge of the political morass.

Texas resident Kate Cox is 20 weeks pregnant with a fetus afflicted with trisomy 18, a genetic condition that all but guarantees the unborn child's death at birth or soon thereafter. Having visited an ER multiple times because of pain and discharge, she was advised that "under Texas law, she had to continue her pregnancy," per The New York Times.

"The state's abortion ban includes only a narrow exception to save the mother's life or prevent substantial impairment of a major bodily function," Reuters says. Fearing the pregnancy could threaten her health and future fertility, Cox took her case to the Travis County District Court, where her lawsuit stated that "although her doctors believed abortion was medically necessary for her, they were unwilling to perform one without a court order in the face of potential penalties, including life in prison and loss of their licenses."

A judge granted Cox's request last Thursday for "a temporary restraining order that could allow her doctor to perform an abortion without facing civil or criminal penalties." It was the first court-approved individual abortion exception since the overturn of Roe v. Wade by the U.S. Supreme Court in 2022.

IN RELATED BREAKING NEWS: U.S. Supreme Court to hear mifepristone case: NYT.

Hours later, Texas Attorney General Ken Paxton "threatened to prosecute any doctors involved in providing an emergency abortion," saying the District Court order "will not insulate hospitals, doctors, or anyone else, from civil and criminal liability for violating Texas' abortion laws," Reuters reports. Paxton argued that Cox had not shown she qualified for the medical exception. A letter was sent to "three hospitals where Damla Karsan, the doctor who said she would provide the abortion to Cox, has admitting privileges."

Whatever limbo may have arisen from Thursday's conflicting legal moves was suspended Friday, when the Texas Supreme Court said it was "temporarily staying Thursday's ruling 'without regard to the merits'" shortly after AG Paxton requested a block. The high court's order effectively stalled the District Court order, AP reported.

On Monday, it was announced that Kate Cox would be going out-of-state for an abortion rather than awaiting a Texas Supreme Court ruling; several hours later, that ruling was announced against her, overruling the district court order, Reuters reports. "The court agreed with the state, finding that the 'good faith' standard had been applied by the lower court in error and that the correct standard, under the law, is a 'reasonable medical judgment.' It asked the Texas Medical Board 'to provide guidance in response to any confusion that currently prevails,'" per The New York Times. The Texas Medical Association has thus far not issued any releases pertaining to the case.

A similar but more wide-ranging legal challenge has been filed in Kentucky, Axios says, guaranteeing further uncertainties for physicians as abortion advocates test the new legal strategy across the country. See The Hill for more on possible legal ramifications from this case, as well as more details on the doctor's standpoint in all this.

Advances in medicine have transformed health care in countless ways. One many of us have not even considered is the creation of entirely new specialties to fill the needs of pioneering fields and the requirements of new technologies. Longevity specialists are emerging to help patients live healthier for longer. The ever-expanding field of telemedicine has led some medical schools to offer courses to become medical virtualists. And new research has resulted not only in exciting developments in the fight against cancer but also another specialty: Cancer immunologists. Learn about these and three other emerging specialty fields here.

VCU Massey Comprehensive Cancer Center is excited to invite you to its inaugural Director's Distinguished Visiting Scholars Seminar Series on February 9, 2024, for its first visiting speaker, Dr. Elizabeth Jaffee. This series will feature national and international visionaries in the field of science, and during each day-long visit, they will engage in lively discussions on how the latest science advances are influencing new strategic approaches in cancer prevention, diagnosis, treatment, and survivorship. The speakers for this series will give one auditorium-based keynote presentation, largely directed to our medical professionals and scientists, but VCU will also organize smaller, interactive formats throughout the day to engage with students as well as members of our community.

We're keeping an eye on several large bills with big health care impacts making their way through the House and Senate. Two in particular are quite large and far-reaching in scope:

Lower Costs, More Transparency Act: Passed on House floor Monday night with bipartisan support, 320-71. It will head to the Senate for consideration.

According to Stat, "The health care package would equalize payment between hospital outpatient departments and doctors' offices for administering medicines in Medicare, rein in some practices by pharmacy benefit managers (PBMS), and codify health care price transparency rules. It would also stave off pay cuts for safety-net hospitals and fund community health centers."

Proponents "argue the bill will help patients and employers get the­ best deal possible by codifying price transparency protections, allowing consumers to compare health insurers' rates and prices hospitals charge. This means insurers will have to disclose all billing codes and modifiers," Fierce Healthcare reports. However, critics say the bill does not address private equity issues, and hospital groups oppose the "site-neutral payment provision for drugs under Medicare Part B." For more: Chief Healthcare Executive.

SUPPORT Act: The Senate Health, Education, Labor, and Pensions (HELP) Committee marked-up legislation reauthorizing the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Reauthorization Act yesterday. "In response to the opioid epidemic, Congress passed the SUPPORT Act in 2018 – legislation which focused on prevention, treatment, and recovery services for opioid misuse, including fentanyl. While many provisions of the SUPPORT Act expired in September 2023, Congress has continued funding these programs." Will it vote to re-up the legislation?

RAM Events & News

Click here for photos from the event.

RAM hosted a Legislative Reception at Virginia Physicians for Women on Wednesday evening, December 6, where members were able to discuss scope of practice, prior authorization reform, and COPN, among other issues, with legislators. We'd like to thank Senator Ghazala Hashmi, Senators-elect Glen Sturtevant and Schuyler VanValkenburg, Delegate Betsy Carr, and Delegate-elect Mark Earley for joining us.

Thanks to the nearly 50 RAM members for coming out to visit with their legislators and a special thanks to Virginia Physicians for Women for allowing the Academy to host this event at their Koger Center Office.

The upcoming General Assembly session will be another important one with issues likely including COPN and scope of practice. These issues may carry significant consequences for you, your practice, and your patients. We'll also have a number of new legislators in the General Assembly who will need to be educated on our issues.

WE NEED YOU to be a leader on the legislative front! Please continue to help us contribute to the conversation by making plans to join us for one or both of our upcoming Lobby Days (Tuesday, January 23 and Monday, February 19).

Block your calendar from 7:15 – 11:30 a.m. on these lobby days to meet with local legislators. As always, you'll be briefed by MSV lobbyists about what's happening that day at the General Assembly and we'll meet in small groups with legislators. RAM staff will arrange these meetings and provide you with an easy-to-follow personal schedule.

And Don't Forget Your White Coat!!

Medi¢: The Business of Medicine

The average physician makes $352,000, and some earn well into the $500,000s. So, doctors don't have to worry about money, right? You know the answer to that. One thing all physicians have in common about money, says James M. Dahle, MD, FACEP, founder of The White Coat Investor, is that they don't receive any training in business, personal finance, or investing throughout their schooling or careers unless they seek it out. See what advice he and other physician money experts that understand your unique needs offer at Medscape.

Other Medical Business News:

• Looking Ahead: MedPAC releases proposed 2025 Medicare physician payment proposal: A modest 1.3% increase recommended, not enough to counteract inflationary costs: MedPageToday.
• Nearly 7.3 million Americans have signed up for a 2024 Affordable Care Act Health Insurance Marketplace plan, nearly a quarter of them new to the program: Reuters.
• U.S. employers turn to virtual healthcare providers like Teladoc to oversee and implement weight-loss management programs before covering obesity drugs for employees: Reuters.
• New CMS rules jeopardize Medicare coverage of blood tests used to monitor organ transplant rejections: MedPageToday.
• Insurers tighten restrictions on diabetes drug Ozempic to deter doctors from prescribing it for weight loss; diabetes patients are now having a harder time getting reimbursed: Reuters.
• Price Gouging?: Amidst publicized patient dangers from contaminated applesauce pouches to lead pipes, hospitals face massive price hike for calcium disodium edetate (EDTA) lead poisoning antidote - Jumped from $3,500 to $32,000: CNN.
• Medical records on 500,000 patients and former patients of dialysis group Fresenius Medical Care stolen from a warehouse: Reuters.
• Sacramento's Sutter Center for Psychiatry (Becker's Hospital Review) and four Prime Healthcare facilities in Southern California (Becker's Hospital Review) are the latest health care institutions to face union strikes over working conditions.
• Big Spenders: A week after announcing $10.1 billion Immunogen deal, AbbVie says it will purchase Cerevel Therapeutics for $8.7 billion: Reuters; Reuters. ALSO: Pfizer-Seagen $43 billion deal OK'd: Reuters. AND: AstraZeneca buys respiratory vaccine developer Icosavax in $1.1 billion deal: Reuters.

• Hospitalizations continue to increase across the U.S., especially among the elderly and toddlers: ABC News.
• COVID rapid antigen test sensitivity was improved by including both nasal and throat swab specimens: MedPageToday; CIDRAP.
• Experimental drug SIM01 alters the gut microbiome and relieves multiple symptoms of long COVID: CIDRAP.
• Infants exposed to COVID in utero are at risk of developmental delay, a study says: CIDRAP.
• Forty percent of children are still infectious even after their symptoms resolve; antigen tests unreliable: CIDRAP.

Global Perspective

• Last international effort to devise a near-term HIV vaccine has failed; nothing new expected on that front until the next decade: Stat; Reuters; MedPageToday. ALSO: AIDS relief stalemate in Congress drags into next year: Politico.

National News

• The national Trusted Exchange Framework and Common Agreement (TEFCA) network to exchange patient health information will be operational Q1 2024: Fierce Healthcare; MedPageToday.
• After pushing back plans to ban menthol cigarettes until next March, the Biden administration faces criticisms and worries from lobby groups: ABC News; The Hill.
• Firearm suicides in the U.S. reached an "unprecedented high" in 2022, a CDC report found.
• UPDATE: FDA may have underreported the number of applesauce lead poisonings across U.S.: The Washington Post finds 118 national cases.
• Americans' walking trips have plunged since before the pandemic, according to Axios; annual national average dropped 36%; click link to see how Richmond fares.
• Doctors Groups Clash: Doctors group Do No Harm sues patient medical network Vituity for alleged discriminatory practices for offering a physician program with $100,000 bonus that is open only to Black applicants: Fox News.
• IN MEMORIAM: Dr. William P. Murphy, Jr., designer of the blood bag: NYT.

Virginia Focus

• Amidst low national and local COVID vaccination numbers, Emily Rich, the COVID-19 epidemiologist for the Richmond and Henrico Health Districts, encourages locals to get boosted: Henrico Citizen.
• Seven Amherst County students ingested gummies laced with fentanyl; five hospitalized: WBBT 12.

Drug, Tech & Vax News

• GLP-1 drugs (Ozempic, Mounjaro, etc.) linked to lower colorectal cancer risk in diabetes patients, particularly the overweight and obese: MedPageToday.
• Symptom improvement by dapagliflozin (Farxiga) may be limited to heart failure patients with reduced ejection fraction: Circulation.
• Novel monoclonal antibody marstacimab reduced the rate of treated bleeds in patients with hemophilia A or B: MedPageToday.
• Baricitinib (Olumiant) helped preserve beta-cell function in people with recent-onset type 1 diabetes: MedPageToday.
• Cheap diabetes drug Metformin lowers odds of developing age-related macular degeneration (AMD) in non-diabetic patients: MedPageToday.
• When combined with immunotherapy, allergy drug dupilumab (Dupixent) may boost anti-cancer immune response in non-small cell lung cancer (NSCLC) patients: MedPageToday.
• Imbruvica plus Venclexta achieved an overall remission rate of 82% for patients with relapsed or hard-to-control mantle cell lymphoma and delayed disease worsening by about 10 months: Reuters.
• 3D printers using sound waves may one day be able to print body parts and medical devices inside of a patient's body: Reuters; Stat.
• RECALLED: Getinge CARDIOHELP Emergency Drive, due to an issue with the hand crank getting stuck: FDA.
• Waste Not, Want Not: Given that TNKase (tenecteplase) is only available in 50-mg vials, it is feasible to thaw previously frozen half-vials for treating stroke in order to reduce waste: Stroke.

FDA Approvals

• Becton Dickinson's BD MiniDraw Collection System, less-invasive finger-prick blood collection device that does not require a vein: Reuters.
• Iptacopan (Fabhalta), first oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH): Novartis; MedPageToday.
• OSSIOfiber bio-integrative fixation implants, for fixing bone fractures in children: OSSIO.
• Mosie Baby Kit, the first FDA-cleared over-the-counter option for at-home artificial intravaginal insemination: USA Today.
• BioPorto’s ProNephro AKI NGAL test, first acute kidney injury biomarker test for patients ages 3 to 21 years.
• Bering's BraveCX, an artificial intelligence (AI)-powered chest x-ray triage solution.
• Cresemba, expanded use for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients: Astellas.

Medical Miscellany

• Healthy wound-healing cells in a tumor can help it resist chemotherapy by slowing the cancer cells' growth: Reuters.
• It may be possible to detect ovarian cancer years in advance of actual symptom onset based on Pap test cell analysis: Science Translational Medicine.
• Breast cancer survivors over 50 may be just fine with mammograms less frequent than yearly, a UK study finds: AP.
• Experts warn increased monitoring for cardiovascular toxicities is needed for breast cancer patients on one of many recently approved drugs for treatment: MedPageToday.
• Older patients with chronic kidney disease (CKD) stages 3 to 4 and no history of atherosclerotic cardiovascular disease (ASCVD) saw lower risk of mortality or major adverse cardiovascular events (MACE) when taking a statin: JAMA.
• Women with pregnancy-related end-stage kidney disease (ESKD) were often overlooked prior to disease onset, had lower access to care compared with those who had other causes of ESKD: MedPageToday. ALSO: Black women report feeling ignored or dismissed by health care workers due to "unconscious biases": NYT.
• Chronic fatigue syndrome may be more common than previously thought, with 3.3 million patients in the U.S.: AP; MedPageToday.
• A newly discovered neural pathway between the brain and heart may explain why a healthy person can faint: NPR.

Pathogen Report

• Salmonella cantaloupe update: Eight deaths - Three in U.S., five in Canada; 238 ill in 38 states with 96 hospitalizations since mid-November: AP; CIDRAP.
• Rocky Mountain spotted fever outbreak in southern California leaves three dead; all five cases linked to travel to Tecate, Mexico: Fox News.
• Whooping cough cases soar 250% in the UK: Fox News.
• CDC issues traveler warning to clinicians and health departments about a deadly, more infectious subtype of mpox circulating in the Democratic Republic of the Congo: Reuters; The Hill. View VDH's mpox updates for Virginia.
• Co-infections of mpox and chicken pox produce more severe symptoms: CIDRAP.
• Anthrax in Africa: 684 cases in Zambia; 4 deaths so far: CIDRAP.

FUN FACT OF THE WEEK

You may have heard of nanobots, tiny robots that could have beneficial applications to medicine in the future. Scientists have created a new type of "living robot" called an anthrobot, which "can move around in a lab dish and may one day be able to help heal wounds or damaged tissue," CNN reports. Unlike nanobots, which are purely machines, these anthrobots defy easy classification: Generated from human tracheal cells, they act on their own but are "not full-fledged organisms because they didn’t have a full life cycle." In a recently released study, the anthrobots moved over damaged neuron regions and "encouraged growth," although the healing mechanism is yet to be understood.

Thanks for reading The Leg.Up!



I strive each week to bring you an informative and (occasionally) entertaining recap of news in the world of medicine and how it affects you. Please be sure to send me any feedback and news tips:

[email protected].

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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