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Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients he treated – reused plastic needle guides meant for single-use to conduct prostate biopsies on his patients over a period of several months.

Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People with Chronic and Complex Health Conditions report.  Key elements of the proposed scheme included:

CMS’s annual report demonstrates that the government is becoming increasingly effective at ferreting out fraud and abuse from the healthcare system. With a 12-to-1 return on investment, the government will likely continue to make fighting healthcare fraud a priority.

The Texas Supreme Court has temporarily blocked the Texas Health and Human Services Commission’s planned rate reductions for Medicaid home health services for severely disabled children, holding that a temporary injunction issued by a trial court enjoining the rate cuts from taking effect remains binding pending the issuance of a mandate by the Texas Third Court of Appeals reversing the trial court decision or further review by the Texas Supreme Court.

On Wednesday, the Justice Department announced that it had brought criminal and civil charges against 301 healthcare professionals as part of the largest national healthcare fraud “takedown” in history. A nationwide investigation spearheaded by the Medicare Fraud Strike Force revealed claims amounting to $900 million in the form of alleged kickbacks, money laundering, and other false billings.

On June 13, 2016, the American Medical Association (AMA) at its annual meeting approved new ethical guidelines for physicians providing telemedicine services, which will be incorporated in the full publication of the AMA Code of Medical Ethics this fall. Although the ethical guidelines do not place legal limitations on the provision of telemedicine for any individual physician or State, they are designed to guide a physician in his or her practice. Allegations of any violations of the Code of Medical Ethics, after a disciplinary hearing, could ultimately result in suspension or revocation of a physician’s AMA membership. Individual State agencies are responsible for issuing licenses and enforcing State law governing the practice of medicine, including ramifications of unethical behavior.

On May 5, 2016, the United States Patent and Trademark Office issued six new examples that provide guidance to Examiners and patent applicants prosecuting claims directed to life sciences subject matter (Subject Matter Eligibility Examples: Life Sciences).  These examples analyze claims that are directed to several of the most contentious areas of patentable subject matter under 35 U.S.C. § 101, including vaccines, methods for diagnosing and treating, nature-based products including mixtures, methods for genetic screening, and machines and processes that are alleged to be founded on a natural law. 

The Texas Health and Human Services Commission (“HHSC”) has been actively trying to reach an agreement with the Centers for Medicare and Medicaid Services (“CMS”) to extend or renew the Texas 1115 Transformation Waiver (the “Waiver”)since March 2015, when HHSC submitted its first iteration of a transition plan focused on a 5-year renewal. The result was released yesterday, May 2, through publication of CMS’ approval of a 15-month extension at current funding levels. CMS’ approval letter clearly states that if an agreement is not reached between HHSC and CMS, the Waiver will not be renewed beyond December 31, 2017. CMS’ letter further indicates that, absent an agreement, funding for uncompensated care in Texas and funding for Waiver-related projects will be drastically reduced beginning January 1, 2018.

In a report released on February 26, 2016, the federal government announced that it recovered $2.4 billion through its Health Care Fraud and Abuse Control Program (HCFAC) during FY 2015.  The $2.4 billion is almost $1 billion lower than the recovery of $3.3 billion in FY 2014.  Over the last three years, the return on investment (ROI) for the HCFAC program is $6.10 returned for every $1.00 expended. Qui tam litigation accounted for $452 million of the recovery by the federal government.