Medicare Advantage Under Fire: Public Criticism and Implications.

Congressional hearings and public reports have drawn attention to problems afflicting Medicare Advantage (MA), the privatized version of Medicare. Private plans became a staple of Medicare through the passage of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA). Congress passed this law during a furor of privatization, when think tanks and powerful financial interests emphasized the power of corporations' profit incentive to improve the efficiency and quality of social enterprise. Yet the surging criticism of MA suggests a misalignment between the financial interest of some MA plans and the well-being of their patient populations. The criticisms range from deceptive marketing, ghost networks, and patient cherry-picking to unethical prior authorization denials and defrauding the government. In total, MA plans cost the federal government 22% more per patient than if these patients in question were enrolled in traditional Medicare. Moreover, it is not clear that this additional funding is producing proportional benefits. These developments raise questions about the presence of a profit incentive in Medicare, and perhaps health care more broadly.

Firearm Policy in the Hospital Setting-Recognizing Health Care as a "Sensitive Place".

Importance: Hospitals are hot zones of the US gun injury epidemic. To shelter these facilities from the dangers of gun violence, state legislatures have enacted laws to reduce the carrying of firearms on hospital premises. However, these efforts currently face serious Second Amendment challenges in federal courts. The ongoing legal battles, which have wide-ranging implications for patient and clinician safety as well as public health generally, are setting the stage for a Supreme Court case that may decide the fate of firearm regulations in US hospitals. A permissible pathway for advancing sensible gun regulation in hospitals is urgently needed. Observations: Since the Supreme Court established a new constitutional test for firearm laws in New York State Rifle & Pistol Association v Bruen (2022), states now face unprecedentedly high barriers to enacting health-protecting legislation regarding firearms. Post-Bruen, the Supreme Court requires that laws be consistent with "this Nation's historical tradition of firearms regulation." This means that states hoping to enact laws barring public carry of firearms in hospitals must demonstrate that hospitals are a "sensitive place" as a historical matter (ie, analogous to a location where firearms were traditionally restricted). By reasoning from analogy, it is clear several historical comparators exist for regulating firearms in hospitals. Although the hospital (as understood today) did not exist in the 1700s, it is sufficiently analogous to asylums and schools, to name a few examples. These settings all share a common denominator with the modern-day hospital: serving vulnerable populations or individuals who may be at heightened risk of misusing firearms. Conclusions and Relevance: The Supreme Court's interpretation of the Second Amendment right to bear arms is threatening democratically enacted laws seeking to shelter hospitals from firearm violence. However, it is clear that hospitals and other health care settings are a sensitive place with compelling historical analogies. Policymakers' strategic deployment of the sensitive places designation, along with its rightful judicial recognition in the hospital setting, are critical to upholding laws that protect health care facilities, patients, and professionals from firearm violence-a conclusion consistent with the US Constitution, history, medical ethics, and common sense.

Perioperative Pharmacologic Prophylaxis of Venous Thromboembolism: A Professional Liability Analysis.

BACKGROUND: Fear of medical liability is a major driver for broad administration of perioperative prophylactic anticoagulation, despite the persistently low rates of clinically symptomatic venous thromboembolism events (VTE) postoperatively. This study was undertaken to evaluate the medicolegal landscape of perioperative VTE and its pharmaceutical prophylaxis. METHODS: The Westlaw legal database was retrospectively searched for verdicts in medical professional liability cases in the United States between 2009 and 2020. One search strategy focused on perioperative VTE, and a second on claims of hemorrhagic complications in patients receiving perioperative anticoagulation. RESULTS: The search for VTE revealed 129 cases, and the search for hemorrhagic complications identified 24 cases. Almost half of the VTE cases were brought following orthopedic surgery (49%), and 29% following general surgery. The most common claims were failure to diagnose and treat during hospital stay or after discharge (74%), and failure to prescribe/administer anticoagulation (46%). Verdict for the health care professional (i.e., the defendant) was reached in 75% of cases. The median payout for patient verdicts was 1,213,644 USD (interquartile range 1,014,100; 150,000-7,700,000). Of hemorrhagic complication cases, 42% occurred in patients receiving VTE prophylaxis. In these cases, 82% resulted in a defendant verdict. CONCLUSIONS: Reasons for in-court medical professional liability claims involving perioperative VTE were mainly failure to diagnose VTE and rescue patients from complications postoperatively. The high rate of defendant verdicts supports the notion that decisions on VTE prophylaxis should not be influenced by fear of liability.

Proximal humeral fracture-dislocations: which patterns can be reduced in the emergency department?

BACKGROUND: Shoulder fracture-dislocations can represent a challenging management scenario in the emergency department (ED) because of concern for the presence of occult fractures that may displace during a reduction attempt. The alternative, a closed reduction attempt in the operating room, has the benefit of full paralysis but requires additional resource utilization. There is limited guidance in the literature about the risks of an initial reduction attempt in the ED as a function of fracture pattern to help guide physicians with this decision. METHODS: This was a retrospective case review of adult patients with shoulder dislocations and fracture-dislocations seen in the ED at a level 1 trauma center over a 10-year period. Imaging and medical records were reviewed to evaluate whether the reduction attempt was successful, unsuccessful without worsening, or unsuccessful with worsening alignment of any fractures, as well as the ultimate clinical outcome. RESULTS: We identified 165 patients with fracture-dislocations and 484 patients with simple dislocations during the same period. Of the patients with fracture-dislocations, 103 had greater tuberosity fractures, 12 had nondisplaced surgical neck fractures, and 50 had displaced surgical neck fractures. None of the patients with simple dislocations had displacement during an ED reduction attempt, including 100 patients aged >65 years. Of the 103 patients with greater tuberosity fracture-dislocations, only 1 had displacement of a humeral shaft fracture during ED reduction. Displacement occurred in 6 of 8 patients with nondisplaced neck fractures who underwent an initial ED reduction attempt vs. 1 of 4 patients who underwent the initial reduction attempt in the operating room. ED reduction was attempted in 25 of the 50 displaced humeral neck fracture-dislocations and was successful in 10 of these (40%). CONCLUSIONS: For patients with greater tuberosity fracture-dislocations, there is a low rate of displacement with a reduction attempt in the ED, but an ED reduction attempt in nondisplaced neck fractures is not recommended because of the high rate of displacement. For displaced neck fractures, closed reduction can be successful in select patients. Finally, these data confirm prior reports that closed reduction of simple shoulder dislocations in patients aged >65 years is safe in the ED.

Morbidity and mortality of fragility proximal humerus fractures: a retrospective cohort study of patients presenting to a level one trauma center.

PURPOSE: Fragility fractures are a significant source of morbidity and have high associated mortality. Identifying risk factors for poor outcomes is essential for guiding treatment and for setting expectations for patients and their families. Although fragility hip fractures have been abundantly explored, there is a paucity of information regarding proximal humerus fractures (PHFs). METHODS: We retrospectively review the electronic medical records of 379 patients who presented to a level 1 trauma center with a PHF secondary to a fall. Patient demographics, handedness, comorbidities, treatment, imaging data, follow-up data, and death date (if applicable) were recorded. RESULTS: Our cohort consisted of 279 females and 100 males with an average age of 71.4 years. Distribution of injuries was 178 left, 141 right, and 7 bilateral. Compared with handedness, 179 were ipsilateral, 141 were contralateral, and 59 were unknown. A total of 81.3% of injuries were treated nonoperatively, whereas 18.7% were managed surgically. One-year mortality was 17.4%, and 2-year mortality was 24.0%.Males demonstrated a 2.28 increased risk of 1-year mortality (P = .004). Patients who died within 1 year of fracture had significantly higher Charlson comorbidity index scores (P < .0001) and age (P = .0003). Risk of death was significantly lower in patients who underwent surgery compared with those who were treated nonoperatively (P = .01). Patients who used an assist device before fracture had 4.2 increased risk of 1-year mortality (P < .0001). Patients who presented from nursing homes or assisted living had a 2.1 increased risk of 1-year mortality (P = .02). Patients with severe liver disease had a 5.5 increased risk of 1-year mortality (P < .0001), and those with metastatic cancer had a 13.7 increased risk of 1-year mortality (P < .0001). Bilateral fractures, side of injury in relation to handedness, rehospitalization, Neer classification, and PCP follow-up within 30 days were not associated with increased mortality. CONCLUSIONS: Increased understanding risk factors for mortality after PHF will allow for more informed patient discussions regarding treatment outcomes and risk of death. Our data suggest that mortality at 1 year for fragility PHF is universally high regardless of risk factors. This risk is increased in patients who are older, functionally limited, or who have medical comorbidities. Our data demonstrate the importance of medical optimization of patients with a fragility PHF and underscore the importance of fall prevention in high-risk patients.

Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods.

It has been approximately 10 years since the Government Accountability Office (GAO) published its report to Congress entitled, FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS), which strongly criticized FDA noting that its "oversight process does not help ensure the safety of all new GRAS determinations." Congress requested GAO to undertake this audit as a result of concerns that GRAS substances added to foods did not require FDA approval. Since 2010, FDA has addressed only a few of the criticisms regarding its process for establishing a food substance as GRAS. However, several of the most important GAO recommendations remain unaddressed, and most critically, FDA has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers. In its 2016 final rule Substances Generally Recognized as Safe, FDA did not take the opportunity to include a provision for creation of a master list of all GRAS chemicals used in food, nor did the FDA request the authority to do so from Congress. FDA cannot fulfill its statutory obligation for ensuring the chemical safety of the U.S. food supply if it does not know which substances, in which quantities, have been added to foods.

US Supreme Court Limits on the Power of US Health Agencies.

This Viewpoint describes how the overturning of Chevron deference would shift the ability to make policy decisions about public health and the environment from administrative agencies to the courts.

Including E-Cigarettes in the FDA Rule Limiting Nicotine.

This Viewpoint discusses why the US Food and Drug Administration (FDA) should include e-cigarettes in its proposed cap of the nicotine concentration in combustible cigarettes to address the public health problem of vaping among adolescents.

Court Intrusion Into Science and Medicine-The Mifepristone Decisions.

This Viewpoint discusses recent US court decisions on the availability of mifepristone, a drug used to terminate pregnancies, and how these conflicting court decisions affect the scientific process and decision-making of the US Food and Drug Administration.

The Supreme Court's 303 Creative Decision and the Threat to LGBTQ+ Health Care.

This Viewpoint examines the importance of the Supreme Court decision in 303 Creative and its possible effects on legislation safeguarding nondiscriminatory health care.

The FDA Struggle to Withdraw Makena: Problems With the Accelerated Approval Process.

This Viewpoint discusses the controversy surrounding the FDA's efforts to withdraw Makena from the market and the broader implications for the accelerated approval pathway.

The landscape of genetic variation in dilated cardiomyopathy as surveyed by clinical DNA sequencing.

PURPOSE: Dilated cardiomyopathy is characterized by substantial locus, allelic, and clinical heterogeneity that necessitates testing of many genes across clinically overlapping diseases. Few studies have sequenced sufficient individuals; thus, the contributions of individual genes and the pathogenic variant spectrum are still poorly defined. We analyzed 766 dilated cardiomyopathy patients tested over 5 years in our molecular diagnostics laboratory. METHODS: Patients were tested using gene panels of increasing size from 5 to 46 genes, including 121 cases tested with a multiple-cardiomyopathy next-generation panel covering 46 genes. All variants were reassessed using our current clinical-grade scoring system to eliminate false-positive disease associations that afflict many older analyses. RESULTS: Up to 37% of dilated cardiomyopathy cases carry a clinically relevant variant in one of 20 genes, titin (TTN) being the largest contributor (up to 14%). Desmoplakin (DSP), an arrhythmogenic right ventricular cardiomyopathy gene, contributed 2.4%, illustrating the utility of multidisease testing. The clinical sensitivity increased from 10 to 37% as gene panel sizes increased. However, the number of inconclusive cases also increased from 4.6 to 51%. CONCLUSION: Our data illustrate the utility of broad gene panels for genetically and clinically heterogeneous diseases but also highlight challenges as molecular diagnostics moves toward genome-wide testing.

Proximal humeral fractures: prosthetic replacement.

Shoulder arthroplasty has emerged as a reliable treatment for displaced or comminuted fractures of the proximal humerus. The outcomes of humeral head replacement have improved as technology and techniques have evolved. Reverse shoulder arthroplasty has yielded promising results in early investigations. With either type of instrumentation, meticulous surgical technique is critical to achieving a good outcome. Prosthesis height and version and the stable fixation of anatomically reduced tuberosities are essential variables. Shoulder arthroplasty for fracture treatment remains a technically challenging procedure that demands knowledge of shoulder anatomy and implant options.

Proximal humeral fractures: internal fixation.

Fractures of the proximal humerus are common injuries that are increasing in incidence as the population ages. These fractures are often treated nonsurgically; however, surgery is indicated if displacement, concurrent dislocation, or unacceptable alignment is present. Knowledge of the anatomic and physiologic characteristics of the proximal humerus and shoulder joint and familiarity with the available fixation elements will help surgeons make informed and patient-specific decisions regarding treatment. Reduction and internal fixation of proximal humeral fractures has expanding indications in comparison with arthroplasty, in part because of improvements in fixation technology and a better understanding of anatomy and physiology. The outcomes of proximal humeral fractures managed with percutaneous pinning, open reduction and locked-plate fixation, and intramedullary fixation are being actively investigated.

The story of the development of generic lenalidomide: How one company thwarted the Hatch-Waxman Act to generate billions of dollars in revenue.

Lenalidomide (Revlimid®) was originally approved by the Food and Drug Administration (FDA) in 2005, however, a generic version was not available until 2022. In that time, the price of lenalidomide has increased more than 20 times, and in 2021 alone, it accounted for >$5.8 billion dollars in Medicare Part D spending. This was a direct consequence of legal tactics employed by the manufacturer to thwart development of generic formulations of lenalidomide. In this report, we review the clinical development of lenalidomide, provide background on generic drug manufacturing in the United States (US), describe the steps that the manufacturer took to prevent entry of generic lenalidomide into the US market, and advocate for legislative reform of the FDA approval process and patent law protections in the US.

Medicine, structural racism, and systems.

Medicine is having a reckoning with systemic racism. While some continue to believe medicine is apolitical and grounded purely in science, history and research reveal that medicine is inseparable from underlying systems, laws, and policies. Obesity is a useful case study. Weight loss trials have shown the immense difficulty in achieving and sustaining weight loss without addressing overlying systems. Barriers are double for Black, Indigenous, and People of Color (BIPOC) with obesity, who must contend with multiple layers of oppressive systems. Increasingly, illness is not a matter of bad luck, but is a function of oppressive structures. COVID-19 likely originates in a deteriorating environment, we have an increasing global burden of disease from oppressive sales of food, sugar, alcohol, guns, nicotine, and other harmful products, and social inequality and resource hoarding are at a peak. Medicine can and must participate in redefining these systems. In doing so, it must center the experiences of BIPOC and push change that alleviates power disparities.