Regulatory Developments

The Maine legislature passed with broad bipartisan approval L.D. 911, An Act to Prohibit Certain Gifts to Health Care Practitioners. The legislation prohibits gifts to practitioners who are licensed to prescribe and administer drugs by manufacturers, wholesalers, or agents of manufacturers or wholesalers of prescription drugs. What’s Excluded? Free samples of prescription drugs for patients…… Continue reading this entry

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air.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

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

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