Author Archives: test

In 2014, Las Vegas urologist, Dr. Michael Kaplan, was convicted by a federal jury for reusing single-use plastic needle guides during prostate biopsies. He was convicted of conspiracy to commit adulteration in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 USC Section 331(k) with the intent to defraud or mislead, and sentenced to 4 years in prison. The background of the case began in 2010 when Dr. Kaplan’s office ran out of reusable needle guides for prostate biopsies. The needle guide is a housing that stabilizes the needle throughout the biopsy procedure.  During the procedure, the needle is contaminated with tissue, blood, and fecal material.  Patients take antibiotics to prevent infection. Needle guides come in single-use and reusable forms. Reusable guides are made of stainless steel and can be disinfected after every use.  Single-use guides are made of plastic and are not to be reused. The plastic guides are prone to scratching by the needle, which may create crevices that can trap debris. After Dr. Kaplan needed to purchase a new ultrasound machine, he could no longer use his reusable stainless steel guide as it did not … Continue reading →

The Physician Self-Referral Law, also known as the Stark law, prohibits a physician from referring federal health care program patients for “designated health services” to an entity in which the physician (or an immediate family member) has a financial relationship, unless an exception applies. Financial relationships include both ownership and investment interests, as well as compensation arrangements.  The law also prohibits an entity from billing federal health care programs for services provided pursuant to an impermissible referral.  Although Congress intended the Stark law to provide a bright line test to curb physicians’ self-referrals, it has, over the years, increased in complexity and breadth. In December, 2015, the Senate Committee on Finance and the House Committee on Ways and Means invited a group of Stark law experts and stakeholders to participate in a roundtable discussion on issues related to the Stark law. The discussion resulted in a majority staff report issued on June 30, 2016 from the Senate Finance Committee entitled “Why Stark, Why Now?- suggestions to improve the Stark law to encourage innovative payment models.”  The report was based on 90 comments  from the industry roundtable discussion about the  law. … Continue reading →

For more than thirty years, Arizona law has allowed juries to allocate fault among all who contribute to an injury. On July 18, 2016, the Arizona Supreme Court unanimously re-affirmed Arizona’s commitment to “comparative fault” by reversing a trial court’s decision that attempted to reconcile “full allocation” of fault with a much older doctrine that made the “original” or first in- line tortfeasor legally responsible for all injuries resulting from an occurrence regardless of the fault of subsequent tortfeasors. In Cramer v. Starr, No. CV-15-1317- PR, filed July 18, 2016, the Court held that the “original tortfeasor rule” (“OTR”) was abolished by the Arizona Legislature with the enactment of the Uniform Contribution Among Tortfeasors Act (“UCATA”), ARS §§ 12-2501 to 12-2509, including the comparative fault provision, ARS § 12-2506, which extinguished joint and several liability, subject to three exceptions. http://www.azcourts.gov/opinions/Search-Opinions-Memo-Decs/year/2016/court/999 In Cramer, the plaintiff was injured in a car accident with petitioner-defendant Cramer. Following the accident, plaintiff had spinal fusion surgery performed by a physician to treat her injuries from the car accident. The defendant driver designated the physician as a non-party at fault, alleging that the surgery was unnecessary … Continue reading →

On June 16, 2016, the U.S. Supreme Court in Universal Health Services, Inc. v. United States, ex. rel. Escobar, U.S. No. 15-17, 06/16/2016, ruled unanimously in an opinion written by Justice Thomas that the “implied false certification theory” can be a basis for FCA liability. This theory treats a provider’s payment request as provider’s implied certification of compliance with any statutes, regulations, or contract requirements that are material conditions of payment. This means that a failure to disclose a violation of the material conditions is a misrepresentation that renders the claim false or fraudulent.  By accepting this theory of FCA liability, the Court held that providers can have FCA liability if they bill the government when not in compliance with regulations that are not explicit conditions of payment. The FCA makes it unlawful to knowingly present a false or fraudulent claim to the government for reimbursement. A claim can be false either factually or legally.  A claim is factually false when a provider submits a claim for services that were not provided.  A claim is legally false when a provider falsely certifies compliance with regulations that are a condition of … Continue reading →