On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain hospital covered entities participating in the 340B Drug Pricing Program (340B Program). The new rule is available on HRSA’s website, and will be announced in the Federal Register on July 23, 2014. The rule is effective immediately. Continue reading this entry
Not-for-profit health care providers that have borrowed on a tax-exempt basis within the last five years should be aware of the Securities and Exchange Commission’s (SEC) Municipalities Continuing Disclosure Cooperation (“MCDC”) Initiative. The MCDC Initiative applies to municipal issuers and obligated persons, such as tax-exempt hospital borrowers, that provided materially misleading disclosure in Official Statements issued within the past five years regarding compliance with their continuing disclosure obligations under SEC Rule 15c2-12. The SEC is offering to enter into settlements pursuant to which such borrowers neither admit nor deny wrongdoing, but agree to a cease and desist order against future misleading disclosure and agree to certain undertakings, such as remedying all past disclosure failures, cooperating with subsequent SEC investigations, disclosing the settlement terms for five years in Official Statements, and establishing training programs regarding continuing disclosure obligations. However, the MCDC Initiative expires on September 10, 2014. After that date, the SEC has indicated that penalties for such misleading disclosure are likely to be more severe and may include fines. Continue reading this entry
Operators Should Keep an Eye on Regulations and Regulatory Developments
The provision of home health care services within independent living facilities (ILFs) is becoming more commonplace in some areas, allowing some ILF communities (which in most states are unregulated) to provide services to residents that includes care similar to the care provided in a typical assisted living community (which are licensed and regulated). This may include coordinating the provision of such home health care services through truly independent third-party agencies or, in some instances, though affiliates of the facility operator or owner. That said, what may feel to some ILF operators as a useful and typical optional service made available to ILF residents comes with regulatory concerns that must be monitored. Continue reading this entry
What do a moving company and a hospital association have in common? The False Claims Act (FCA).
The American Hospital Association along with the United States Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America recently submitted an amici curiae brief in support of petitioners, Gosselin World Wide Moving, urging the Supreme Court to bar excessive FCA penalties. Large penalties under the FCA are of concern to business that contract with the government as well as entities that participate in Federal Health Care Programs. Continue reading this entry
Healthcare is an incredibly broad, diverse and dynamic industry. Because of the breadth in the field, providers are surrounded by a wide array of legal issues relating to: employment contracts, taxes, business structure, medical malpractice, nonprofit organization, insurance, and reimbursement to name a few. However, although the field is riddled with potential legal issues, there are several key healthcare laws that every provider should know. Continue reading this entry