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Scientific Deception
Regulators are increasingly becoming concerned about pharmaceutical companies that offer financial and other incentives to physician-researchers, reasoning that the incentives may affect the physicians' judgment when they make treatment decisions for beneficiaries of health care programs. They think that this can result in increased costs being passed on to the federal government. In the worst-case scenario, such incentives could cause medically unnecessary items and services to be provided, and patients to be harmed.
Because the health care industry is so highly regulated, many health care transactions may draw government scrutiny. Clinical research is not immune from such scrutiny, particularly with the ever-increasing amounts of money, both public and private, being funneled into these activities. The main federal laws addressing financial arrangements between physicians and potential referral sources are the Ethics in Patient Referrals Act, more commonly called the Stark Law (42 U.S.C. ' 1395nn), the Medicare and Medicaid Antikickback Statute (42 U.S.C. ' 1320a-7b) and the False Claims Act (the civil False Claims Act is codified at 31 U.S.C. ' 3729, while the criminal False Claims Act is codified at 18 U.S. C. ' 387). The first two of these laws require physicians who enter into financial arrangements with potential referral sources for which claims for items or services may be presented to federal health benefit programs to try to structure their affairs to fall within one of the narrow statutory or regulatory exceptions or safe harbors the False Claims Act provisions essentially require persons who cause claims to be submitted to the federal government for reimbursement to do so in an honest manner.
Federal Oversight of Fraud and Abuse Laws Affecting Clinical Researchers
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?