Beyond : Implications for End-of-Life Decision-Making During Pregnancy.

The end of has significant implications for the autonomy of pregnant patients at the end of life. At least thirty states restrict the choice to withhold/withdraw life-sustaining treatments from pregnant patients without decisional capacity, invalidating prior advance directives and prohibiting others from choosing these options for the patient. Many restrictions are based on the framework, applying after "viability" or similar considerations of fetal development or prospect for live birth.

Preventing Egregious Ethical Violations in Medical Practice: Evidence-Informed Recommendations from a Multidisciplinary Working Group.

This article reports the consensus recommendations of a working group that was convened at the end of a 4-year research project funded by the National Institutes of Health that examined 280 cases of egregious ethical violations in medical practice. The group reviewed data from the parent project, as well as other research on sexual abuse of patients, criminal prescribing of controlled substances, and unnecessary invasive procedures that were prosecuted as fraud. The working group embraced the goals of making such violations significantly less frequent and, when they do occur, identifying them sooner and taking necessary steps to ensure they are not repeated.

Real-World Evidence in the Real World: Beyond the FDA.

The 21 Century Cures Act ("Cures Act") relies on the concept of real-world evidence ("RWE") to improve the Food and Drug Administration ("FDA") approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation. In this article, we discuss the understandable appeal of RWE's pragmatic application and its many potential benefits.

Off-label drug promotion and the ephemeral line between marketing and education.

Fueled by massive settlements and concerns about pharmaceutical company influence over medical practice, the fight over off-label promotion has become a rancorous one with little middle ground. For some, off-label restrictions are both bad law and bad medicine, violating the First Amendment while denying physicians access to crucial information. For others, the battle pits the very soul of the FDA against the excesses of a profit-driven marketplace.

Truth, Falsity, and Fraud: Off-Label Drug Settlements and the Future of the Civil False Claims Act.

The pharmaceutical industry may be losing the battle of public opinion, but it has won important victories in the war over First Amendment commercial speech. In December 2012, the Second Circuit held in United States v. Caronia that the misbranding provisions of the Food, Drug, and Cosmetic Act could not prohibit a sales representative’s truthful statements promoting off-label uses of his company’s products.

Kickbacks, self-referrals, and false claims: the hazy boundaries of health-care fraud.

The fraud and abuse laws that govern conduct related to the federal health-care programs, such as Medicare and Medicaid, impose broad and complex limitations on billing practices and financial relationships among providers. Given the potential consequences of engaging in fraudulent behavior, it is crucial that physicians appreciate the types of activities that may run afoul of these laws. This article summarizes the major aspects of the fraud laws that are most likely to have a daily impact on physician practice: the Civil False Claims Act, the Medicare and Medicaid Anti-Kickback Statute, and the so-called Stark Law prohibition on physician self-referrals.

Healthcare fraud and quality of care: a patient-centered approach.

This Article explores the intersection between quality of care and healthcare fraud by examining the extent to which quality-related fraud settlements benefit patients. The author argues that, although the protection of beneficiary health and welfare often is invoked by the federal government as one of the reasons for undertaking anti-fraud efforts, such considerations do not appear to play a large role in many of the settlements that are negotiated. While returning funds to the federal Treasury helps to ensure that the federal healthcare programs remain solvent and continue to serve beneficiaries in the aggregate, it may not adequately address harm to individual patients.