Author Info for Akerman LLP - Health Law Rx

Beth Alcalde

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

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…more

Department of Health and Human Services (HHS), Dobbs v. Jackson Women’s Health Organization, Employee Benefits, Employer Group Health Plans, Final Rules

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Danya Blair

U.S. Supreme Court Holds Healthcare Entities Not Liable for Emotional Injury Damages Under Certain Anti-Discrimination Statutes

Healthcare facilities and other entities receiving federal financial assistance can breathe a little easier after a U.S. Supreme Court decision issued last week barring the recovery of emotional damages for certain…more

Affordable Care Act, Anti-Discrimination Policies, Cummings v Premier Rehab Keller PLLC, Emotional Injury Claims, Federal Funding

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Karen Buesing

Medicare & Medicaid Facilities Are Put On Notice: Employees Must Be Vaccinated

Medicare and Medicaid certified facilities will be required to ensure that their employees are vaccinated for COVID-19, the Centers for Medicare & Medicaid Services (CMS) announced on September 9, 2021…more

Biden Administration, Centers for Medicare & Medicaid Services (CMS), Coronavirus/COVID-19, Emergency Management Plans, Employer Liability Issues

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Martin Burkett

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

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…more

Compliance Management Systems, Corporate Sales Transactions, Department of Justice (DOJ), Federal Trade Commission (FTC), Fraud and Abuse

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Jeremy Burnette

The Supreme Court Clarifies the Government’s FCA Dismissal Power and Invites Constitutional Challenge to the FCA’s Qui Tam Provision

For the second time this month, the United States Supreme Court addressed a circuit split involving the False Claims Act (FCA, 31 U.S.C. §§ 3729 – 3733). Earlier, in the SuperValu decision (discussed in a recent Health Law Rx…more

Article II, False Claims Act (FCA), FRCP 41, Healthcare, Qui Tam

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James M. Burns

Klobuchar Antitrust Bill Could Have Significant Impact on Healthcare Industry

In early February, Senator Amy Klobuchar, new Chair of the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights, introduced the “Competition and Antitrust Law Enforcement Reform Act of 2021″(S225)…more

Anti-Competitive, Antitrust Provisions, Big Tech, Competition, Health Insurance

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Stacey Callaghan

CMS Expands Reimbursement for Telehealth Services

Despite telehealth’s significant expansion over the past ten years, it has been plagued by a historically unstable regulatory and reimbursement landscape…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Medicaid, Medical Reimbursement, Medicare

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Jordan Cohen

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

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,…more

Cybersecurity, Data Breach, Data Protection, Electronic Protected Health Information (ePHI), Federal Trade Commission (FTC)

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Kirk Davis

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…more

Anti-Kickback Statute, Compliance Management Systems, Cooperative Compliance Regime, Department of Health and Human Services (HHS), Health Care Providers

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Sarah DeFranco

Attention Employers: Action Required Before Having Employees or Contractors Sign Non-Disclosure Agreements

In May, President Obama signed the federal Defend Trade Secrets Act of 2016 into law, the details of which we reported in a recent Akerman Practice Update. The Act allows companies for the first time to bring trade secret theft…more

Asset Seizure, Confidential Information, Defend Trade Secrets Act (DTSA), Employment Contract, Ex Parte

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Martin Dix

The Admera Health Settlement Is a Cautionary Tale for Paying Outside Sales Staff on a Commission Basis

The Office of Inspector General recently announced the more than $5.5 million settlement of a qui tam action brought against Admera Health, LLC (Admera). In addition to the fine incurred, the legal fees typically incurred for…more

Anti-Kickback Statute, Enforcement Actions, False Claims Act (FCA), Health Care Providers, Physicians

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Zarra Elias

Paid Sick Time and FMLA Expansion Law Passes

Employers with fewer than 500 employees will be required to provide paid leave to certain employees impacted by the coronavirus (COVID-19) and will receive a tax credit in return, under a new law approved by the Senate and…more

Coronavirus/COVID-19, Families First Coronavirus Response Act (FFCRA), Family and Medical Leave Act (FMLA), Popular, Sick Leave

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Noam Fischman

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…more

Abortion, Alliance for Hippocratic Medicine v Food and Drug Administration, Article III, Dobbs v. Jackson Women’s Health Organization, EMTALA

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Lauren Gandle

Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District…more

Anti-Kickback Statute, Co-payments, False Claims Act (FCA), False Statements, Health Insurance

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Michael Gennett

Courts May Now Stop Medicare from Recouping Payments

In recent years, many Medicare providers who have received significant overpayment determinations from Medicare contractors have gone out of business while waiting to be heard before an Administrative Law Judge (ALJ) for a…more

Administrative Law Judge (ALJ), False Claims Act (FCA), Health Care Providers, Medicare, Overpayment

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Stefi George

CARES Act Provider Relief Funds – The Requirements Are Taxing

The Internal Revenue Service (“IRS”) recently clarified that CARES Act Provider Relief Funds (“Relief Funds”) are considered taxable income for for-profit providers, including physician practices. This news comes as a surprise…more

CARES Act, Coronavirus/COVID-19, Health Care Providers, IRS, Paycheck Protection Program and Health Care Enhancement Act

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Ari Gerstin

Medical Marijuana’s Florida Debut: A Process Fraught with Constraints

Florida’s limited medical marijuana program is finally almost ready to go live. For those who have been sitting on the sidelines waiting for the right moment to learn about the program, now is that moment. Recently, the Florida…more

Decriminalization of Marijuana, Health Care Providers, Marijuana, Medical Marijuana, New Legislation

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Danielle Gordet

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

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,…more

Cybersecurity, Data Breach, Data Protection, Electronic Protected Health Information (ePHI), Federal Trade Commission (FTC)

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Steven Grigas

2020 Legislative Session –A Sampling of Health Related Bills Filed

The 2020 Legislative Session will begin its 60-day trek to completion on Tuesday, January 14, 2020. The following is a sample of bills that have been filed. We encourage you to review these bills, and contact us with specific…more

Abortion, Affordable Care Act, Assisted Living Facilities (ALFs), Breastfeeding, Crime Victims

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Marcy Hahn-Saperstein

Fix Your Weak Links in Your Medicaid Claims

Medicaid providers and suppliers have likely discovered this the hard way. A provider’s or supplier’s enrollment in the Medicaid program may be insufficient to assure that their provision of a covered and medically necessary…more

Goods or Services, Health Care Providers, Health Insurance, Healthcare, Insurance Claims

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Christy Hawkins

FTC Warns Health App Vendors: Comply with the Health Breach Notification Rule or Pay the Penalty!

Vendors of health applications (“health apps”) and connected devices that collect or use individuals’ health information, along with their service providers, are now on notice that they must provide timely notice to consumers…more

Breach Notification Rule, Federal Trade Commission (FTC), Health Insurance Portability and Accountability Act (HIPAA), Health Technology, Medical Records

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Elizabeth Hodge

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

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,…more

Cybersecurity, Data Breach, Data Protection, Electronic Protected Health Information (ePHI), Federal Trade Commission (FTC)

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Bill Ide III

A Wake Up Call for Hospital Boards

The Georgia Legislature recently passed House Bill 321 (the Act) adding a new code section (O.C.G.A. §31-7-22), which imposes significant financial and business transparency requirements on certain hospitals in Georgia,…more

Board of Directors, Corporate Governance, Health Care Providers, Hospitals, Legislative Agendas

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Paul Kobak

On-Line Resources Help Nonprofit Organizations Prepare for Cybersecurity Threats

The effects of a data breach can be disastrous for any company, but especially for a nonprofit organization, not only because of the harm to the affected individuals, including those served by the organization, but also the…more

Cyber Threats, Cybersecurity, Data Breach, Data Protection, Data Security

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Amanda Leech

A Wake Up Call for Hospital Boards

The Georgia Legislature recently passed House Bill 321 (the Act) adding a new code section (O.C.G.A. §31-7-22), which imposes significant financial and business transparency requirements on certain hospitals in Georgia,…more

Board of Directors, Corporate Governance, Health Care Providers, Hospitals, Legislative Agendas

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Ildefonso Mas

What does the Escobar Decision Mean for Healthcare Providers?

On June 16, 2016, the U.S. Supreme Court in Universal Health Servs., Inc. v. United States ex rel Escobar, No. 13-317, — S. Ct. — (June 16, 2016), confirmed that the implied certification theory may serve as a basis for…more

False Claims Act (FCA), False Implied Certification Theory, Federal Contractors, Health Care Providers, Implied Certification

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Jane McCahill

Medicare Fraud Strike Force Strikes Again – in a Big Way

The Medicare Fraud Strike Force initiated its largest ever healthcare enforcement action, charging 412 defendants in July 2017 with approximately $1.3 billion in fraudulent claims. The Strike Force consists of teams that include…more

False Billing, False Claims Act (FCA), Health Care Providers, Healthcare Facilities, Healthcare Fraud

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Amy Jeon McCullough

California Telehealth Updates

California has joined the growing ranks of states, as well as the federal government, in efforts to facilitate the efficient provision of healthcare services during the pandemic…more

Coronavirus/COVID-19, Health Care Providers, Licensing Rules, Medi-Cal, Patient Access

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Carolyn Metnick

Get your Single IRB lined up for Multi-Site Research

Changes to the federal regulations governing the protection of human subjects participating in research (known as the Common Rule) were amended earlier this year. The changes to the Common Rule impact research conducted,…more

Clinical Trials, IRB, Medical Research, National Institute of Health (NIH), Regulatory Oversight

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Martin Monaco Jr.

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the…more

Affordable Care Act, Drug Pricing, Health Care Providers, Health Insurance, Healthcare

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Erin O'Neal

Tread Carefully – DC Federal Judge Weakens Association Health Plan Regulation

A recent ruling by the United States District Court for the District of Columbia calls into question the recently expanded regulations allowing small employers to band together to establish Association Health Plans…more

Affordable Care Act, Association Health Plans, Compensation & Benefits, Department of Labor (DOL), Employee Benefits

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Rachel Perez

Anticipated Changes to Employment-Based Green Card Processing

U.S. employers and foreign workers could soon face significant additional burdens and years-long delays in the employment-based green card process. Last month, the U.S. House of Representatives passed the Fairness for…more

Foreign Workers, Green Cards, Highly-Skilled Workers Visa, Immigrants, Immigration Procedures

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Bruce Platt

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,…more

Certificate of Authority, Florida, Health Care Providers, Healthcare, HMOs

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Henry Raattama Jr.

Enhancements to Florida's Solicitation of Funds Law Now Effective - Charities Now Have Tighter Regulations

In response to the Tampa Bay Times investigative story, "America's Worst Charities," Florida’s Commissioner of Agriculture, Adam Putnam, worked with the Florida Legislature to enact material enhancements to Florida's…more

Charitable Donations, Charitable Organizations, Fundraisers, Nonprofits

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Thomas Range

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,…more

Certificate of Authority, Florida, Health Care Providers, Healthcare, HMOs

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Ayman Rizkalla

SafeCo No More: The Changing Landscape of Scienter under the False Claims Act

Yesterday, the United States Supreme Court held that a False Claims Act (FCA) defendant cannot rely on an objectively reasonable interpretation of a law, regulation, or rule to negate the scienter element of the FCA. In United…more

Drug Pricing, False Claims Act (FCA), Healthcare, Pharmaceutical Industry, Pharmacies

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Amber Roberts

Group Health Plan Sponsors are Getting Serious About Pricing Transparency – Are You Keeping Up?

In early July, the Department of Health and Human Services (HHS), the Department of Labor (Labor), and the Department of the Treasury (Treasury) (collectively, the Departments), along with the Office of Personnel Management…more

Employee Benefits, Employer Group Health Plans, Health Insurance, Price Transparency, Surprise Medical Bills

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Marisa Rodriguez

CMS Postpones Pre-Claim Review Demonstration for Home Health Services

The Centers for Medicare & Medicaid Services (CMS) announced that it would postpone the initiation of the CMS Pre-Claim Review Demonstration for Home Health Services (the “Demonstration”) in Florida, which was scheduled to begin…more

Centers for Medicare & Medicaid Services (CMS), Health Care Providers, Healthcare, Home Health Care, Home Healthcare Workers

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Sheryl Rosen

Physicians: Beware of FTC Rules for Product Endorsements

It has become increasingly common for physicians and other healthcare professionals to share medical information with the public via video platforms, blogs, and social media sites…more

Disclosure Requirements, Federal Trade Commission (FTC), FTC Endorsement Guidelines, Medical Devices, Online Advertisements

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Christopher John Shin

Tread Carefully – DC Federal Judge Weakens Association Health Plan Regulation

A recent ruling by the United States District Court for the District of Columbia calls into question the recently expanded regulations allowing small employers to band together to establish Association Health Plans…more

Affordable Care Act, Association Health Plans, Compensation & Benefits, Department of Labor (DOL), Employee Benefits

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S. Montaye Sigmon

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…more

Biden Administration, Department of Labor (DOL), Employee Retirement Income Security Act (ERISA), Employer Group Health Plans, Enforcement Actions

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Scott Silverman

Paid Sick Time and FMLA Expansion Law Passes

Employers with fewer than 500 employees will be required to provide paid leave to certain employees impacted by the coronavirus (COVID-19) and will receive a tax credit in return, under a new law approved by the Senate and…more

Coronavirus/COVID-19, Families First Coronavirus Response Act (FFCRA), Family and Medical Leave Act (FMLA), Popular, Sick Leave

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Robert Slavkin

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…more

Competition, Employer Liability Issues, Employment Contract, Federal Labor Laws, Federal Trade Commission (FTC)

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Richard Spees

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the…more

Affordable Care Act, Drug Pricing, Health Care Providers, Health Insurance, Healthcare

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William Spratt Jr.

SCOTUS May Resolve Circuit Split on the Specificity Required of False Claims Act Claims: Relief or More FCA Grief for Providers?

Currently, providers have different risks of potential False Claims Act (“FCA”) liability depending on where they are geographically located due to the difference in the standards required by the U.S. Courts of Appeals regarding…more

Burden of Proof, Criminal Liability, False Claims Act (FCA), Health Care Providers, Healthcare

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Philip Sprinkle, II

Hospitals Take Heed: Gradual Evolution of the IRS’ Position on Tax Exemption

There has been much fanfare, but little discussion, among healthcare experts in the United States regarding the Internal Revenue Service recently published PLR 201731014. The Letter Ruling provides a good opportunity to review…more

Charitable Organizations, Form 990, Health Care Providers, Healthcare Facilities, Hospitals

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Ashlee Tising

The Sun is Rising on COVID Liability Protection for Florida Healthcare Providers

Good news is here for healthcare providers worried about being left out of COVID-19-related liability protections during the 2021 Florida Legislative Session! The Republican-led Legislature, supported by Governor Ron DeSantis,…more

Coronavirus/COVID-19, Florida, Health Care Providers, Immunity, Infectious Diseases

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William Weiner

New York State Enforces Data Breach Notification Law

Earlier this month, New York Attorney General Eric Schneiderman announced his state had entered into a settlement with CoPilot Provider Support Services, Inc. (CoPilot)—a settlement resulting from CoPilot’s violation of the data…more

Breach Notification Rule, Data Breach, Health Care Providers, Health Insurance Portability and Accountability Act (HIPAA), HIPAA Breach

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Sidney Welch

U.S. Department of Justice Withdraws Longstanding Healthcare Antitrust Policy Statements, Causing Uncertainty

It has already been a busy 2023 for the U.S. antitrust enforcement agencies. Right on the heels of the Federal Trade Commission’s announcement of a proposed rule that potentially would ban non-compete agreements nationally, on…more

Antitrust Division, Antitrust Provisions, Competition, Department of Justice (DOJ), Federal Trade Commission (FTC)

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Melissa Zinkil

Paid Sick Time and FMLA Expansion Law Passes

Employers with fewer than 500 employees will be required to provide paid leave to certain employees impacted by the coronavirus (COVID-19) and will receive a tax credit in return, under a new law approved by the Senate and…more

Coronavirus/COVID-19, Families First Coronavirus Response Act (FFCRA), Family and Medical Leave Act (FMLA), Popular, Sick Leave

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James Zirkle

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character limited…more

Advertising, Food and Drug Administration (FDA), Marketing, Medical Devices, Pharmaceutical Industry

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