Category Archives: Healthcare Law

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MHPAEA Final Rule: Clarity on Mental Health Parity?

The three federal agencies tasked with enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) — the Departments of Labor, Health & Human Services (through CMS), and Treasury (the Departments) — issued their Final Rule to implement the MHPAEA on September 9, 2024, to mixed reviews.  Groups composed of providers, such as the … Continue Reading

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

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 … Continue Reading

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

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 … Continue Reading

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

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 … Continue Reading

Rx for Safety: Workplace Violence Policies in Healthcare Settings

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.… Continue Reading

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

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 … Continue Reading

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

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, … Continue Reading

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

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 … Continue Reading

ACTION REQUIRED TO AVOID FINES! DEADLINE APPROACHING: Florida Pharmacy Benefit Managers Must Be Licensed as a Third-Party Administrator by January 1, 2024

Pharmacy Benefit Managers (PBMs) take note! Under Florida’s new Prescription Drug Reform Act, PBMs must be licensed as an insurance administrator (also known as a third-party administrator, or TPA). Under this new law, any entity that wishes to provide PBM services after January 1, 2024, must be licensed as a TPA.… Continue Reading

THE NO SURPRISES ACT: Hoping for an End to the Surprises

By looking at the events that have transpired since the Consolidated Appropriations Act, 2021, which includes the No Surprises Act (the Act), was signed into law, it is clear that the Departments of Health and Human Services, Labor, and Treasury (collectively, the Departments) have lost their way. The United States District Court for the Eastern … Continue Reading

Surprise… No Surprises Act Arbitration Is Too Expensive

Providers finally obtained court ordered relief to the $350 administrative fee each party was required to pay as part of the Federal Independent Dispute Resolution (IDR) Process under the No Surprises Act. Until the Departments of Health and Human Services, Labor, and the Treasury (collectively, the Departments) set a new administrative fee amount, the administrative … Continue Reading

OCR’s Proposed Rule Finds Fertile Ground for Enhanced Reproductive Privacy Protection

The Department of Health and Human Services Office for Civil Rights (OCR) issued a proposed rule on April 17, 2023, to amend provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to strengthen privacy protections for individuals’ protected health information (PHI) related to reproductive healthcare (the Proposed Rule). The Proposed Rule would … Continue Reading

New Florida Law Will Impose A Third-Party Administrator Licensing Requirement for Pharmacy Benefit Managers

On May 3, 2023, the Florida governor signed a comprehensive law (SB 1550) regarding pharmacy benefit managers (PBMs). This new law imposes significant new requirements on PBMs. This article discusses only one of these new requirements: a PBM must obtain a license, called a certificate of authority, to act as an insurance administrator, which is … Continue Reading

Stop – Go – Stop Again – Now GO… Surprised by the No Surprises Act?

We are not surprised by the continued stop-and-go regarding guidance surrounding the No Surprises Act. Most recently, a Texas court vacated portions of the No Surprises Act’s updated final rule (the final rules were discussed in our most recent blog on the subject). This created a domino effect, leading to the Departments of the Treasury, … Continue Reading

State Attorneys General Flex in a Post-Dobbs world – can complying with federal regulatory guidance constitute racketeering activity?

Are State Attorneys General expanding their reach in this Post-Dobbs world? On February 1, 2023, twenty state Attorneys General signed letters to both CVS and Walgreens warning the giant retail pharmacies against mailing medications that could potentially be used to induce abortions. These letters are most notable for the legal posture they assume. The state … Continue Reading

Finally, More Certainty and Fewer Surprises – Final Rules Issued Under the No Surprises Act

The Departments of the Treasury, Labor, and Health and Human Services (the Departments) issued final rules related to the No Surprises Act on August 26, 2022, to be effective October 25, 2022 (Final Rules).  These Final Rules come after months of uncertainty and legal battles regarding the Federal Independent Dispute Resolution (IDR) process, as we … Continue Reading

Florida Medicaid Providers: Action is Required by October 1, 2022

Check your mailboxes.  AHCA is sending out postcards to existing Florida Medicaid providers (Providers) alerting them to upcoming changes in the Florida Medicaid program.  These changes require Providers to pay certain of their employees a minimum wage of at least $15.00 per hour.  Governor Ron DeSantis’s “Freedom First Budget for Fiscal Year 2022-2023” includes funding … Continue Reading

More Turbulence for the No Surprises Act Thanks to Air Ambulance Providers

Given the trajectory, it is no longer surprising that the No Surprises Act (the Act) continues its turbulent path through implementation. The U.S. District Court for the Eastern District of Texas, on July 26, 2022, again vacated provisions of the Federal Independent Dispute Resolution (IDR) process, this time relating to air ambulance payment disputes. (LifeNet, … Continue Reading

Don’t Just Phone It In – Avoiding Fraud in Telehealth Contracts

To facilitate the provision of care during the pandemic, the federal government and many state governments enacted changes that encouraged physicians and other nonphysician practitioners (collectively, Practitioners) to use telehealth services. While this new flexibility increased access to care, it also increased opportunities for fraud. On July 20, 2022, the U.S. Department of Health and … Continue Reading

Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises

Chapter 2022-60, Laws of Florida (http://laws.flrules.org/2022/60), that went into effect July 1, 2022, allows registered pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.”  These pharmacy technicians will be allowed to administer all of the vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC … Continue Reading

ALERT! Your COVID-19 Policies and Procedures Need a BOOSTER!

Employers who are conducting automatic COVID-19 testing of employees or gathering test results of employees’ families should beware: the Equal Employ­ment Opportunity Commission (“EEOC”) has issued new guidance limiting the former and has penalized a healthcare practice recently for doing the latter.… Continue Reading

Healthcare Cyber Insurance? Fortify Your Defenses

Healthcare breaches, including ransomware attacks, continue to increase. As a result, many healthcare organizations seeking cyber coverage to help defray the costs associated with a ransomware attack or other data incident may find that carriers have increased premiums, reduced coverage, and tightened underwriting requirements. Healthcare organization leaders should understand that implementing reasonable administrative, technical, and … Continue Reading

OCR Releases Guidance on HIPAA Compliance When Providing Audio-Only Telehealth

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) recently released new guidance (the “Guidance”) to help ensure that individuals may continue to benefit from audio-only telehealth services and clarify for health care providers and health plans how they can provide such services while complying with the HIPAA Privacy, Security, … Continue Reading

Biden Administration Signals MHPAEA Enforcement a Priority with Fiscal 2023 Budget

The Biden Administration’s proposed budget for fiscal year 2023 serves as a warning to all plan issuers and administrators that enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) is a top priority for the federal government. The proposed budget reflects a substantial and sustained commitment to ramp up enforcement efforts, with specific … Continue Reading
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