It is critical for employers and plan fiduciaries/administrators to stay informed of HIPAA privacy and security-related legal developments because most employer sponsored group health plans — regardless of the employer’s industry or size — are considered covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Therefore, individually identifiable medical information that group health plans create, use, store, or transmit is “protected health information” (PHI) pursuant to HIPAA. This update narrowly focuses on the enhanced HIPAA rules in the nationwide po ..read more

The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community Pharmacies. Normally the pharmacy and the long-term care (LTC) facility have a written agreement that governs the relationship between them. The pharmacy sends the patients’ prescription medications to the facility for administration, but the facility does not actually pay for pharmacy services itself. Instead, the pharmacy relies on patients/residents and their insurance plans fo ..read more

In just a few days’ time, recently promulgated federal final rules addressing sex-based nondiscrimination in the administration of health care benefits have created a flurry of healthcare industry activity. The angst arises from providers, payers, and certain health plans alike. While the spotlight shines brightest on healthcare providers and health insurers, the focus of this post is on employer group health plans and the evolving definition of sex discrimination. On May 6, 2024, two federal agencies — namely the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare ..read more

On April 23, 2024, the Federal Trade Commission (FTC), through a 3-2 vote, approved a final rule (the Final Rule), banning most forms of non-compete clauses with workers. A non-compete clause generally prevents a worker from getting a different job or starting a new business that competes with the employer after the conclusion of their current employment. The Final Rule was published in the Federal Register on May 7, 2024, and will become effective 120 days later, on September 4, 2024 (the Effective Date), although current and anticipated future litigation could delay or ultimately prevent its ..read more

The Centers for Medicare & Medicaid Services (CMS) has revised certain payment policies under the Medicare physician fee schedule, and updated provider and supplier enrollment regulations. CMS recently published a final rule (the Final Rule) effective January 1, 2024. Technical and typographical errors in the Final Rule were later corrected by a subsequent final rule (the Subsequent Rule), effective February 12, 2024. Of the changes addressed herein, only the new “stay of enrollment” was impacted by the Subsequent Rule. Summary of Major Updates The below outlined changes are described in m ..read more

Hospitals, urgent care clinics, doctors’ offices — these are the places we go when we are sick and want to get better. Doctors, nurses, and other healthcare workers are the people who treat us, help us recover, and even save our lives in medical emergencies. Yet according to the U.S. Bureau of Labor Statistics, healthcare workers are five times more likely to experience workplace violence than workers in all other industries, and this statistic has only increased since the COVID-19 pandemic. Because of this rising concern, the Occupational Safety and Health Administration (OSHA) has identified ..read more

By maintaining a robust compliance program, healthcare companies are better able to identify potential red flags early and to prevent violations of fraud and abuse laws. A failure to maintain an effective compliance program may become particularly problematic for companies with business transactions on the horizon as the government increasingly incentivizes business professionals to give compliance a seat at the deal table. On October 4, 2023, Deputy Attorney General Lisa Monaco announced a new Department of Justice (DOJ) safe harbor policy (the DOJ Announcement), which incentivizes voluntary ..read more

Applicants for a health maintenance organization (HMO) certificate of authority (COA) in Florida must use a new application form effective January 28, 2024. After rule development by the Florida Office of Insurance Regulation, the Florida Department of Financial Services adopted amendments to Rule 69O-C1-942, F.A.C. The amendment incorporates changes to the Florida HMO COA application (Form OIR-C1-942). The prior version of the application includes the revision number “REV 5/22″ below the form number in the lower left corner of the application. The revised version will have revision number “Re ..read more

With a couple of “firsts,” the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) is signaling that it is cracking down on healthcare organizations that fail to identify and address cybersecurity vulnerabilities as required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA Rules). On October 31, 2023, OCR issued its first settlement agreement under the HIPAA Rules related to a ransomware attack (the Ransomware Settlement) and on December 7, 2023, its first settlement under the HIPAA Rules arising from a phishing cyber-attack (the Phishing S ..read more

The Office of Inspector General of the U.S. Department of Health and Human Services (the OIG) recently released an updated General Compliance Program Guidance document (GCPG). The GCPG has been anticipated since the OIG announced on April 25, 2023, that it planned to modernize the accessibility and usability of its publicly available resources, including the OIG’s Compliance Program Guidance (CPG) documents. We recommend that the healthcare compliance community and other healthcare stakeholders review the GCPG carefully, and, in particular, that all healthcare compliance officers ensure they u ..read more