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title: Healthcare Docket, from MedCity News & Above the Law
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 Welcome to the redesigned, reimagined and relaunched Healthcare Docket from your friends at MedCity News and Above the Law.

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| FRIDAY, MARCH 15, 2024 |
| MedCity News and Above the Law offer the latest in litigation, regulation, transactions, and trends for in-house counsel in the healthcare and life sciences industries. |
| Opening Argument       Feds and states move to curb private equity’s takeover of healthcare By Ron Harman King Good old American capitalism is getting a hard look under the healthcare regulatory microscope. And none too soon, in some eyes. For your next doctor’s appointment, odds are nearly 3-to-1 that the physician who sees you is a corporate employee. And regulators and legislators far and wide are saying that this ratio may be harmful to your health. Corporate control of U.S. healthcare has reached such proportions that three federal agencies announced on March 5 a cross-government investigation into the mushrooming role of corporate and private-equity (PE) investment in the industry. States are also getting in on the oversight action. To date, nearly a dozen state legislatures have passed laws or are in the process of enacting regulation heightening oversight of corporate acquisitions and mergers in healthcare. “Private equity firms and other corporate owners are increasingly involved in healthcare system transactions, and, at times, those transactions may lead to a maximizing of profits at the expense of quality care,” said a Federal Trade Commission press release announcing the inquiry. For more than a few healthcare providers, that is an understatement. In a physician survey published in JAMA Internal Medicine on March 11, three out of five respondents (60.8%) said they view private equity involvement negatively, while only 10.5% saw it as positive or somewhat positive. Doctors around the country are stridently blaming corporate takeover of healthcare for escalating physician and nurse burnout since the COVID-19 pandemic and for deteriorating patient care due to increased pressure on clinicians to see more patients in the same or less time. For example, Jonathan Jones, MD, president of the American Academy of Emergency Medicine, said he left his job in a community hospital when a private equity-controlled group took over his department and doubled the patient-to-physician ratio. A JAMA study published December 26, 2023, found that patients receiving care at PE-owned hospitals experienced a higher rate of hospital-acquired adverse events – such as bloodstream infections, falls, and medication errors – than patients at non-PE-owned hospitals. The difference was as much as 25% for Medicare patients. Another study published in the BMJ uncovered a link between private-equity investment and cost increases for payers and patients as high as 32%. Yet another study found PE-owned nursing homes were associated with 20,000 additional deaths over a 12-year period. The disparities are driving Indiana legislators to join those in nine other states in requiring healthcare entities and PE firms to give advance notice to state officials prior to any acquisition or merger. If the legislation passes, the Hoosier State will become the first red state to join its all-blue predecessors in enacting similar mandates: New York, Oregon, California, Massachusetts, Minnesota, Nevada, Connecticut, Illinois, and Washington. Of course, the question arises as to whether the toothpaste can be returned to the tube. For a variety of economic reasons, independent medical practices may be headed toward total extinction. Principally, commercial insurers’ muscle in negotiating provider reimbursements put the declining number of independents at a sizable disadvantage. But will American healthcare go the way of the banking sector’s consolidation into a handful of all-powerful titans? Possibly so. One study found that PE acquisitions of physician practices increased sixfold in a decade. Another reported that in one of eight metropolitan areas nationwide, a single PE firm owns more than half of market share for certain specialties. Alas, the corporately employed doctor will see you now. But only for a few minutes. — Ron Harman King, JD, MS, is CEO of Vanguard Communications, a legal and healthcare practice marketing and management consulting firm. He writes for Breaking Media on the topics of technology and the intersection of law and healthcare. From MedCity News And Above The Law       AstraZeneca Acquisition Brings Drug to Fill a Rare Disease Gap Left by Takeda AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug. Debunked Episode 2(audio): Discussing Unfair Hospital Pricing & How CA is Overseeing Large Transactions Episode 2 of the Debunked (audio) show focuses on how hospitals are inflating prices for outpatient procedures and how California is looking at healthcare M&A and trying to address price increases and anti-competitive behavior. How Marketing Fueled the Opioid Overdose Crisis and What We Can Learn From It \[MedCity Influencers\] Given the link established across studies between marketing practices and the opioid overdose crisis, a few strategic steps can form a path forward for clinicians and policymakers. How Law Department Pros Can Get The Resources They Need Join us on March 21 for a CLE-eligible webinar titled 'Winning the Race for Resources: Building a Powerful Business Case for Your Legal Technology Project.' Expanding Your Value As In-House Counsel Consider how you could better develop in-house roles to grow your impact and influence at your company. Story of the Week       Alabama Supreme Court pushes other embryo legal disputes out of spotlight By Ron Harman King If anyone found good news in the current brouhaha over the Alabama Supreme Court’s holding that frozen IVF-created embryos are "unborn children," it would likely be executives at CooperSurgical, Inc. The Connecticut-based subsidiary of CooperCompanies ($3.6 billion in revenues) is a maker of medical devices and fertility and genomic products. Just days before the Alabama ruling, the U.S. Food & Drug Administration (FDA) issued a Class 2 Device Recall for what’s known among fertility specialists as culture media – a carefully designed culture fluid for growing human embryos to blastocyst stage (typically five days or more) for surgical transfer to a woman’s uterus for implantation and gestation. The CooperSurgical recall is the outcome of a swelling number of lawsuits by IVF patients claiming that the fluid destroyed their zygotes and parenting hopes. Collectively, the plaintiffs say they lost more than 100 embryos due to the omission of a key nutrient that halted cellular growth.  The recall is at least the second in barely over a year over allegedly flawed IVF culture fluid. In January 2023, Fujifilm Irvine Scientific recalled four lots of its “Oil for Embryo Culture,” after IVF patients learned their embryos, too, had been destroyed by contact with the oil. According to FDA filings, as many as 20 IVF patients may have been affected. A company announcement indicates the product had been on the market less than a year. Both recalls had generated coast-to-coast press coverage. Then, in the wake of the Alabama Supreme Court decision, IVF-related headlines have all but exclusively focused on the legal and political ramifications of the highly controversial 8-to-1 opinion of that state’s highest court. The frequency of IVF-related lawsuits points to the value would-be parents place on five-day human embryos, which are so microscopically tiny that 10 to 20 would fit into the volume occupied by a peanut. In a twenty-year analysis published in the scientific journal Fertility and Sterility, on average an IVF patient files a malpractice lawsuit somewhere in the United States every few months. The most common issues involve embryology lab processes and genetic testing errors. Nearly half the suits evaluated (45.3%) alleged embryology errors such as lost specimens and incorrect sperm donors. The second most common claim (20.8%) were over children born with genetic illnesses despite preimplantation testing of the embryos. A little more than half of the suits evaluated (54.7%) were decided in favor of the defendant IVF clinics or providers. Plaintiffs won about one-quarter (24.5%) of the time, while the rest involved ongoing proceedings at the time of the analysis. Even with the odds stacked against plaintiffs, the rewards can be tempting for contingency-motivated counsel. The largest award uncovered in the study amounted to a payout of nearly $15 million in a class-action case involving a cryostorage accident. Estimates of the size of the global IVF market are all over the place, ranging from $628 million in 2021 to $25 billion in 2023. Whatever the scale, not only can IVF errors and embryo mix-ups generate national press coverage of couples’ heartbreaks, but it’s a safe bet that certain legal practitioners will continue keeping a close eye out for the next IVF calamity. — Ron Harman King, JD, MS, is CEO of Vanguard Communications, a legal and healthcare practice marketing and management consulting firm. He writes for Breaking Media on the topics of technology and the intersection of law and healthcare. ICYMI       Progressive SF Votes to Drug-Test Welfare Recipients & Expand Cop Surveillance Public Health Crisis of School Shootings Spike, Reaching Highest Numbers Ever Family Dollar Fined $41 Million for Rodent-Infested Warehousing of Drugs & Med Devices FDA Gains Final Commitments to Ban Forever PFAS Substances in Food Packaging $465 Million Settlement Clears Way for Opioid Maker Endo’s End to Bankruptcy If you would like to stop receiving these emails, please click here to update your preferences or unsubscribe. 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