Danielle C. Gordet

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Danielle Gordet focuses her practice on healthcare, including healthcare compliance, conflicts of interest, scope of practice issues, physician contracting, and regulations. Her ability to identify, investigate, and resolve complex issues in collaboration with healthcare administrators allows her to provide them with effective counsel in developing policies and procedures which reduce the risk of inappropriate conduct and prevent non-compliance. She provides expertise on federal and state healthcare statutory and regulatory issues, including adherence to the Stark Law, the Anti-Kickback Statute, and licensure compliance. In addition, Danielle assists manufacturers of U.S. Food and Drug Administration (FDA) regulated products in obtaining necessary FDA clearances for their devices. Danielle works with healthcare administrators on resolving a variety of legal matters, including issues surrounding hospital bylaws, licensure and credentialing, telemedicine, codes of conduct, and Emergency Medical Treatment and Labor Act. On behalf of healthcare providers, she negotiates and drafts contractual agreements including medical directorships, physician employment, clinical trials, and consulting arrangements.

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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, the FTC published its final rule implementing the HBNR. And so begins a new robust enforcement landscape for health and wellness … 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

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 become particularly problematic for companies with business transactions on the horizon as the government increasingly incentivizes business professionals to give … 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

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

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

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

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

“The No Surprises Act” a/k/a “The Act that Continues Surprising Providers”

The No Surprises Act (the “Act”) continues muddling through its implementation period. We have discussed the Act in prior posts, and most recently on March 8, 2022. The surprises have continued, with new updates coming out almost daily! There has been legal movement as health care providers and facilities (collectively, “Providers”) have brought lawsuits against … Continue Reading

UPDATE: No Surprises Here – Portions of the No Surprises Act Regulations Invalidated

The No Surprises Act (the Act) continues to bump through its initial implementation phase. As we discussed in our prior blog, out-of-network physicians and facilities (OON Providers), and their allies, are pushing back against portions of the recently issued interim final rule with comment period (the Interim Rule). Most recently, they succeeded in doing so … Continue Reading

Healthcare Discrimination Based on Disability – Still Prohibited in the Pandemic!

It may seem as though the pandemic is coming to an end, but while COVID cases are declining,  they have not ceased. As the pandemic continues, the Department of Health and Human Services (HHS) Office for Civil Rights issued new guidance on February 4, 2022 to remind healthcare providers that federal disability laws remain in … Continue Reading

Florida Continues Pursuit of Improved Patient Safety

Florida is continuing its efforts to improve patient safety in hospitals and ambulatory surgical centers (ASCs).  The Florida Legislature previously approved a requirement that hospitals and ambulatory surgical centers (ASCs) conduct patient safety surveys and tasked the Agency for Health Care Administration (AHCA) with implementing a rule specifying the submission process for these surveys.  AHCA’s … Continue Reading

Surprised Providers Seek Changes to Latest Provisions of the No Surprises Act

Effective January 1, 2022, new billing protections went into effect that have the goal of providing greater protections for patients against surprise medical bills. As we discussed in our prior blog, the Departments of Health and Human Services, Labor, and Treasury, and the Office of Personnel Management (collectively, the Departments) implemented these additional protections that … Continue Reading

Providers Get Unpleasant Surprise from Latest Provisions to the No Surprises Act

Efforts to stop surprise medical costs are continuing to evolve. The Departments of Health and Human Services (“HHS”), Labor, and Treasury (collectively, the “Departments”), and the Office of Personnel Management issued an interim final rule (“Interim Rule“) with comment period on September 30, 2021 that implements provisions of the No Surprises Act. The majority of … Continue Reading

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. Healthcare providers with 100 or more employees also may be subject to a forthcoming Emergency Temporary Standard (“ETS”) from the U.S. Department of Labor’s Occupational … Continue Reading

New Florida Laws Focus on Health Care

Before closing its 2021 session, the Florida Legislature passed several bills that impact health care, summarized below. The first bill discussed below regarding civil liability became effective on March 29, 2021. The majority of the other bills became effective on July 1, 2021.… Continue Reading

Pelvic Examination Law – Florida Takes a Second Look

The Florida medical community was left concerned and confused by the passage of the original 2020 pelvic examination law. As we discussed in our past blog, practitioners believed the law was overly burdensome, and they were unsure how to implement it. Senator Lauren Book’s new bill, SB 716, sought to make consent clear through an … Continue Reading
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