FTC’s Updated Health Breach Notification Rule Puts Health App Developers on Notice

Posted in Digital Health, HIPAA, Privacy, and Data Security, Technology

The Federal Trade Commission’s (FTC) years-long effort to modernize its Health Breach Notification Rule (HBNR) in the midst of a swiftly changing technological landscape appears to be coming to an end. On Thursday, May 30, 2024, the FTC published its final rule implementing the HBNR. And so begins a new robust enforcement landscape for health and wellness app developers and vendors.

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What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of Mifepristone

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

Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand name: Mifeprex), a drug used to terminate pregnancies through ten weeks gestation. Avoiding a substantive decision on the merits of the plaintiffs’ case, the Court held that the plaintiffs’ legal and moral objections to elective abortion and the FDA’s increasingly relaxed regulation of mifepristone are not sufficient to establish Article III standing to advance this lawsuit. The Court noted that a win for the plaintiffs would have had widespread repercussions, not only to the ability of patients to use mifepristone, but also to the regulatory authority of Executive branch agencies to fulfill their regulatory obligations amidst an increasingly divided American citizenry.

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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.

Overview

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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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