Attention, Group Health Plans: New HIPAA Privacy Rule Governing Reproductive Health Care Information Imposes Obligations, Deadlines

Posted in HIPAA, Privacy, and Data Security

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 politically charged space of “reproductive health information” within group health plans, including attempted access by state law enforcement agencies. 

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When a Gift Becomes a Kickback: Gifts from Florida Pharmacies to Long-Term Care Facilities

Posted in Pharmacy, Drugs, Medical Devices & Equipment

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 for reimbursement.

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On the Basis of Sex…Discrimination in Group Health Plans and What Employers Should Know

Posted in Health Plans

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.

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Don’t Panic! – A Guide for Healthcare Employers to Understand the Potential Impact of FTC’s Non-Compete Ban

Posted in Health Insurers & Managed Care Organizations, Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

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 enforcement. Please refer to Akerman’s HR Defense Blog for an in-depth review of the non-compete ban, including a discussion of current litigation. This blog adds to the information issued by our colleagues by providing specific guidance for healthcare employers regarding how the non-compete ban will impact them if it becomes effective.


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Did You Know Medicare Implemented New Provider and Supplier Enrollment Requirements?  

Posted in Health Insurers & Managed Care Organizations, Healthcare Law, Hospitals & Health Systems, Physicians

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.

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Rx for Safety: Workplace Violence Policies in Healthcare Settings

Posted in Health Care Providers, Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Labor Relations & Employment Law, Physicians

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.

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New Safe Harbor and General Compliance Program Guidance Provides Opportunity for Buyers to Mitigate Litigation and Fraud Risk

Posted in Healthcare Litigation, Healthcare M&A, Joint Ventures, Transactions & Health Ventures

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.

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The Florida Office of Insurance Regulation Amends the Application for Certificate of Authority for Health Maintenance Organizations

Posted in Government Affairs, Licensure & Regulatory, Healthcare Law

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 “Rev.: 07/23.”

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OCR Will Focus on You if You Don’t Focus on Cybersecurity

Posted in Health Insurers & Managed Care Organizations, Healthcare Law, HIPAA, Privacy, and Data Security, Hospitals & Health Systems, Physicians, Technology

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 Settlement). In the press release for its first settlement agreement, OCR made clear that cybersecurity awareness is a top concern for OCR, with hacking accounting for 77 percent of the large breaches reported to OCR in 2023.

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Compliance Officers: Read the New OIG General Compliance Program Guidance!

Posted in Health Insurers & Managed Care Organizations, Healthcare Law, Healthcare Litigation, Hospitals & Health Systems, Physicians

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 use the GCPG as a guidebook going forward.

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