Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers. What do I Need to Know? 1. What is an HTC/P? Under the Public Health Service Act (PHSA) and implementing regulations, the FDA regulates … Continue reading this entry
Background Health Plans and health care providers are getting into each other’s business. This payor/provider convergence has taken different forms. Health systems have ventured into the health insurance business by acquiring or starting their own health plans and by establishing joint ventures with payors, to jointly own and operate a health plan. Health plans have … Continue reading this entry
Foley recently co-hosted the Florida Hospital Association’s (FHA) 2017 Health Law Summit, which brought together more than 40 in-house attorneys and compliance officers from FHA member hospitals to discuss the current state and future direction of the health care industry. Amid so much economic and political uncertainty, we are diligent about keeping our fingers on … Continue reading this entry
The US Department of Justice (DOJ) Fraud Section has published new guidance for corporate entities on corporate compliance programs. The guidance, titled, “Evaluation of Corporate Compliance Programs” (Compliance Program Evaluation) provides companies – and their compliance teams – with key insights into how government regulators will assess efforts taken to develop, implement and evaluate the … Continue reading this entry
In June 2016, California became the fifth state to enact an aid-in-dying law. California’s End of Life Option Act (the “Act”) authorizes an adult who is suffering from a terminal disease and meets other qualifications to request an aid-in-dying drug that may be prescribed for the purpose of ending his or her life. Cal. Health … Continue reading this entry
The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The guidance was proposed in the Fall of 2015, and would have updated all areas of 340B Program guidance. The guidance would have … Continue reading this entry
“A robust, sustainable blood system is a crucial component of every health care system.” That is how Rand Corporation’s recently issued comprehensive report entitled “Toward a Sustainable Blood Supply in the United States” (the “Report”) begins. Issued as a result of research sponsored by the U.S. Department of Health and Human Services (“HHS”), the Report … Continue reading this entry
On Jan. 12, 2017, the Office of Inspector General of the U.S. Department of Health and Human Services issued the third and final installment of its recent three-part rulemaking effort — a final rule updating its exclusion regulations, 82 Fed. Reg. 4100 (Jan. 12, 2017). This final rule follows two others that were published in December updating the OIG’s civil monetary … Continue reading this entry
New Hampshire is starting 2017 with stepped-up efforts to manage its oft-described opioid epidemic. Though the most recent regulations are directed at individual prescribers, and do not apply to the administration of opioids to patients in a health care setting, now is the time for New Hampshire hospitals, ambulatory surgical centers, urgent care facilities, and … Continue reading this entry
A final rule published on January 18 implements the first major revisions to the federal regulations governing the confidentiality of substance-use disorder patient records (Part 2) since 1987. It finalizes a proposal from last February to modernize the regulations in light of the significant changes in the health care delivery system. On the same day, … Continue reading this entry