Florida Healthcare Law Firm Announces Shareholder Promotion

Delray Beach, FL – The Florida Healthcare Law Firm, established in 2008 by Florida Board Certified Health Law Attorney Jeff Cohen, is proud to announce the promotion of Carlos H. Arce to shareholder. This significant milestone marks a new chapter in the firm’s growth, reinforcing its commitment to excellence, leadership, and long-term succession planning.

With a strong foundation built on specialized expertise in healthcare law, the Florida Healthcare Law Firm has become a trusted name for healthcare professionals and healthcare businesses seeking legal strategy and guidance. The addition of shareholder Carlos H. Arce, Esq. further solidifies the firm’s leadership and ensures its continuity in providing exceptional service to clients.

Founder Jeff Cohen shared his confidence in the firm’s future, stating, “I wanted to be able to show and say that I’m confident in the firm’s succession from this point on. This promotion highlights the strength of our team and the bright path Carlos has ahead of him.”

Mr. Arce has been integral to the firm’s success, bringing unique expertise, dedication, and a client-first approach to his work. His advancement to shareholder not only reflects his professional excellence but also his commitment to upholding the firm’s values and vision.

The Florida Healthcare Law Firm looks forward to continuing its tradition of delivering unparalleled legal support to clients across the healthcare industry, now with an even stronger leadership team.

Regen Consent if FL Law Passes

Credit: Caitlin A. Koppenhaver

A significant legal change in Florida is on the horizon that could directly impact providers and practices offer stem cell therapies. Beginning July 1, 2025, Florida’s House Bill 1617 (2025) goes into effect, allowing certain licensed healthcare professionals to administer stem cell treatments, but only under strict conditions. With these new allowances come clear responsibilities, especially when it comes to patient notification and informed consent. Now is the time to ensure your documentation and protocols are up to date to stay compliant and protect your practice.

House Bill 1617 (2025) authorizes certain licensed physicians in Florida (Specifically Chapters 458 and 459, therefore this includes Ch.458- MD’s, and Ch. 459, DO’s) to perform stem cell therapies that have not been approved by the United States Food and Drug Administration (FDA), but only under limited and defined circumstances. These therapies may only be administered when they fall within the provider’s scope of practice and are specifically related to orthopedics, wound care, or pain management. The legislation imposes clear limitations on the types of stem cells permitted, expressly excluding fetal-derived cells, embryonic tissue from abortions, and adipose-derived mesenchymal stem cells (stem cells from fat tissue).

All stem cells used under this statute must be manufactured in FDA-certified clean room environments that utilize high-efficiency air filtration systems to reduce the risk of contamination. Additionally, the retrieval, processing, and storage of these stem cells must take place in facilities that are both FDA-registered and accredited by recognized organizations such as the National Marrow Donor Program or the American Association of Tissue Banks, among others that the statute lists.

The bill mandates strict patient notification and informed consent procedures. Health care providers must deliver a written notice to patients, in a specific font and size, and clearly displayed in the provider’s office, advising that the stem cell therapies being offered are not FDA-approved. The bill includes specific verbiage for this notice:

(4) A health care provider who conducts stem cell therapy pursuant to this section shall provide a patient who is being treated with stem cell therapy with the following written notice before performing the therapy: 

“THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This health care practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.”

Important: This notice must also be included in any advertisement for the stem cell therapy. In any form of advertisement, the notice must be clearly legible and in a font size no smaller than the largest font size used in the advertisement.

Prior to the provider performing stem cell therapy, treatment, providers are required to obtain a consent form signed by the patient. The consent form must include: 

1. The nature and character of the proposed treatment, including the treatment’s United States Food and Drug Administration approval status.

2. The anticipated results of the proposed treatment.

3. The recognized possible alternative forms of treatment.

4. The recognized serious possible risks, complications, and anticipated benefits involved in the treatment and in the recognized possible alternative forms of treatment, including nontreatment.

The legislation exempts providers engaged in FDA-approved investigational drug or device trials and those operating under contract with accredited institutions recognized for their expertise in stem cell therapy. Any violation of the statute may result in disciplinary action by the relevant regulatory board or agency. The Department of Health is responsible for adopting rules to implement this law, which takes effect on July 1, 2025.

As we approach the July 1 effective date, it’s important to take a proactive approach. Updating your informed consent forms, office signage, and any related advertising isn’t just a legal requirement—it’s an opportunity to reinforce patient trust and uphold ethical standards in your care. Making these changes now will help you avoid regulatory issues down the line and ensure you’re ready to responsibly offer these advanced therapies within the scope of the new law.

New Regulations on Retail IV Therapy Clinics in Ohio

Credit: Caitlin Koppenhaver

The State Medical Board of Ohio, the Ohio Board of Pharmacy (BOP), and the Ohio Board of Nursing have issued a joint statement that significantly impacts the operation of retail IV therapy clinics across the state. These new guidelines are designed to ensure safety, proper oversight, and compliance within these clinics, affecting both providers and patients.

Here’s what you need to know about the new regulatory measures:

Who Can Diagnose, Treat, or Prescribe IV Medications in Ohio?

Under the new rules, only the following licensed professionals are authorized to diagnose, treat, or prescribe IV medications in Ohio:

1. Physicians licensed under Chapter 4731 of the Ohio Revised Code.

2. Physician Assistants (PAs) who hold:

o A valid prescriber number issued by the State Medical Board of Ohio.

o Physician-delegated prescriptive authority specific to this purpose.

3. Advanced Practice Registered Nurses (APRNs), including:

o Certified Nurse Practitioners (CNPs)

o Certified Nurse Midwives (CNMs)

o Clinical Nurse Specialists (CNSs)

o Licensed under Chapter 4723 of the Ohio Revised Code.

This restricts the ability of any other healthcare personnel, such as nurses or paramedics, from independently ordering or administering IV therapy without direct authorization from an above-listed prescriber.

Standing Orders Prohibited for IV Therapy Administration

A critical change in these regulations is the explicit prohibition of standing orders (or protocols) for the recommendation, compounding, and administration of IV medications. This means that:

· Nurses, paramedics, or other non-prescribing staff may not use protocols to initiate IV therapy services in retail clinics.

· All IV treatments must be based on an individualized diagnosis and prescription from an authorized prescriber.

Exceptions for Protocol Use

Protocols for drug administration are only allowable under highly specific circumstances, such as:

1. Emergency Situations

For instance, in cases of acute conditions such as heart attacks, overdoses, severe burns, or other emergencies where immediate attention is critical to prevent severe harm or loss of life.

2. Disease Prevention

The administration of vaccines or biologicals to prevent diseases falls under this category, such as administering flu shots.

3. Specific Preventive Treatments

Limited to:

– Vitamin K administration in newborns to prevent vitamin K deficiency bleeding.

– Erythromycin administration for the prevention of ophthalmia neonatorum.

– Influenza antiviral treatments, particularly in institutional facilities.

These scenarios are exceptions rather than the norm and require careful adherence to Ohio’s Administrative Code (OAC 4729).

Why Are These Changes Significant?

These guidelines serve as a response to the growing trend of retail IV therapy clinics offering hydration and wellness treatments, often in non-medical settings. While these services have surged in popularity, the updated rules aim to ensure patient safety and prevent improper or unauthorized care practices.

Key concerns addressed include:

· Medical Oversight

The new rules ensure that IV therapy recommendations and administration are under the supervision of qualified prescribers.

· Patient Safety

Preventing the misuse of protocols minimizes risks associated with emergent or unsupervised medical treatments.

What This Means for Retail IV Therapy Clinics

Clinic operators and staff must review these regulatory requirements and ensure compliance, including:

· Ensuring all IV services are supervised or prescribed by licensed professionals listed in the guidelines.

· Discontinuing any standing orders or protocols currently in use for non-emergency or non-preventive services.

· Reviewing hiring practices to ensure compliance with the new rules regarding authorized prescribers.

Non-compliance may lead to regulatory action, including penalties, licensing issues, or potential closures.

Compounding Medications

The joint statement further emphasizes the definition of “compounding”, which under Ohio law is “the preparation, mixing, assembling, packaging, and labeling of one or more drugs pursuant to a prescription issued by a licensed health professional authorized to prescribe drugs. Compounding may only be performed by a licensed pharmacist or licensed health professional authorized to prescribe drugs. The preparation of IV cocktails as previously described is considered compounding under Ohio law and the clinic is required to obtain a license as a terminal distributor of dangerous drugs (TDDD) from the Ohio Board of Pharmacy.”

Final Thoughts

The joint regulatory statement emphasizes patient safety and proper medical oversight in the fast-growing field of retail IV therapy clinics. While these changes may introduce additional operational responsibilities for clinics, they ultimately align with the overarching goal of delivering safe and effective care.

For a deeper understanding of the regulations, be sure to review the full joint statement issued by the State Medical Board of Ohio, Ohio BOP, and Ohio Board of Nursing. It’s critical for clinic operators, healthcare staff, and prescribers to stay informed and adapt to these new requirements.

Navigating Dental Practice Mergers: A Comprehensive Guide for Growth and Success

Dental practice mergers

Dental practice mergers are reshaping the industry, offering dentists a strategic path to growth, efficiency, and retirement planning. By combining resources, practices can reduce costs, expand patient bases, and adopt cutting-edge technologies, achieving profit margins up to 70%. However, success hinges on navigating challenges like due diligence, cultural integration, and regulatory compliance. This guide provides a step-by-step roadmap—from identifying opportunities to transparent communication—empowering dentists to execute seamless mergers and thrive in a competitive market.

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Autonomous Nurses: The Future of Healthcare Delivery

Autonomous nurses

Autonomous nurses, driven by AI and robotics, are transforming healthcare by addressing nursing shortages and improving patient care. This blog explores their capabilities, benefits, challenges, and ethical considerations, envisioning their role in the future of healthcare delivery.

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Florida’s Proposed Law on Stem Cell Treatments for Orthopedic, Wound Care, and Pain Management

Credit: Jeff Cohen

Stem cell treatments have long been a topic of debate within the medical and regulatory fields, balancing potential breakthroughs in medicine with questions of safety, ethics, and oversight. A recent proposal in Florida, brought forth through a Committee Substitute for House Bill 1617, has reignited that debate by challenging existing FDA guidelines and seeking to carve a pathway for expanded use of stem cells in specific medical practices.

The Core Elements of the Proposed Law

If passed, the proposed legislation would authorize the use of stem cells in treatments for orthopedics, wound care, and pain management. While the suggested changes are ambitious, the bill also sets out clear boundaries and regulatory requirements to ensure compliance. Here’s what it entails:

Physician-Only Administration

Under the proposed law, only licensed physicians would be legally permitted to administer stem cells for treatment. This stipulation underscores a commitment to safety, requiring a level of expertise and accountability in the administration process.

Ethically-Sourced Stem Cells

The bill specifically prohibits the use of stem cells derived from embryos or fetuses following abortion. This measure is likely intended to address ethical concerns and align with public sentiment while ensuring that the law focuses on stem cells obtained through acceptable and legally compliant methods.

Stringent Manufacturing Standards

Any stem cells used under the proposed law would need to comply with precise manufacturing standards. While the bill does not describe these standards in detail, one can assume they would mirror or even surpass current regulatory best practices to ensure safety and efficacy.

Patient Notice Requirements

One of the more unique aspects of the bill is its requirement for specific written notice to be provided to patients ahead of any stem cell treatment. Notably, this same disclosure must also appear in advertisements. This transparency-first approach likely aims to inform patients about the experimental nature of the treatments and to clarify that they have not been authorized by the FDA.

What sets this bill apart is its bold acknowledgment that the use of stem cells would be permissible under Florida law even though the FDA does not currently authorize it. Typically, state-level legislation aligns with federal guidelines to avoid potential conflicts, particularly where health and safety regulations are concerned. However, House Bill 1617 represents a significant departure by prioritizing patient choice over federal consent.

This raises important legal questions about the relationship between state and federal oversight in medical treatments. Can (or should) individual states legislate to expand patient access to emerging therapies when federal health authorities have not yet sanctioned their use?

Florida’s proposed law follows a growing trend in the United States to expand patient access to alternative and innovative therapies, particularly in cases where traditional treatment methods have been insufficient. The widely discussed “Right to Try” laws, for example, have given terminally ill patients greater access to experimental drugs not yet approved by the FDA.

House Bill 1617 represents an extension of this broader movement by addressing treatments with stem cells for specific conditions. However, the legislation also comes with inherent risks. Without FDA authorization, there may be questions about the long-term safety and efficacy of these treatments, as well as the quality control of stem cell manufacturing.

Florida has an interesting history when it comes to regulating stem cell use in medicine. It wasn’t so long ago—in 2013, to be exact—that the Florida Board of Medicine took the significant step of revoking the licenses of two physicians who were involved in using stem cells for patient treatments outside established regulations. This history demonstrates the fine line lawmakers must walk in balancing innovation with regulatory oversight to protect patient welfare.

If passed, House Bill 1617 would represent a major shift not only for Florida but potentially for the wider conversation on stem cell treatment in the United States. By directly challenging FDA policy and expanding patient access to stem cell therapies within a regulated framework, it could set a precedent for other states to follow suit. However, the bill must first withstand significant legislative and legal hurdles before it can become law.

Florida’s proposed stem cell law has the potential to open new doors for medical treatments, giving patients more choices while pushing regulatory boundaries. Despite its ambition, though, the bill’s complexity and conflict with federal guidelines mean there’s a long road ahead. The key to its success—or failure—will likely lie in its ability to balance the innovative use of stem cells with a strong commitment to safety, ethics, and long-term outcomes.

For now, it remains a waiting game. But the implications of this proposal, both for Florida and for the broader field of medical innovation, are impossible to ignore.

Medical Practice Compliance Plan: A Step-by-Step Guide to Avoiding Penalties and Protecting Patients

Medical practice compliance plan

In today’s complex healthcare landscape, medical practices face ever-evolving regulations. From HIPAA to OSHA, Medicare billing rules to anti-kickback laws, compliance is no longer optional—it’s a necessity. A medical practice compliance plan isn’t just about avoiding fines; it’s about fostering trust, improving patient care, and safeguarding your practice’s reputation.

This guide will break down what a compliance plan entails, why it matters, and how to create one tailored to your practice. Whether you’re a small clinic or a multi-specialty group, these actionable steps will help you stay on the right side of the law.


Why Your Medical Practice Needs a Compliance Plan

  1. Avoid Costly Penalties
    Non-compliance can lead to staggering fines. For example:
    • HIPAA violations range from 100 to 50,000 per record breached.
    • Medicare fraud penalties can exceed $10,000 per claim.
    • OSHA fines for workplace safety issues often exceed $15,000 per violation.
  2. Protect Patient Trust
    Patients expect their data and safety to be prioritized. A breach or lawsuit erodes confidence and can drive patients to competitors.
  3. Streamline Operations
    Compliance plans standardize processes, reducing errors in billing, documentation, and patient care.
  4. Meet Legal Requirements
    The Affordable Care Act (ACA) mandates compliance programs for Medicare/Medicaid providers. Even if not required, having one demonstrates “due diligence” in audits.

7 Key Components of an Effective Medical Practice Compliance Plan

The Office of Inspector General (OIG) outlines seven core elements for compliance programs. Let’s simplify them:

1. Written Policies and Procedures

  • What to Include:
    • HIPAA privacy and security protocols.
    • Billing and coding guidelines (e.g., CPT, ICD-10 accuracy).
    • OSHA safety standards (e.g., handling hazardous materials).
    • Anti-fraud policies (e.g., Stark Law, Anti-Kickback Statute).
  • Tip: Update policies annually or when laws change.

2. Compliance Officer and Committee

  • Compliance Officer Role:
    • Oversee program implementation.
    • Investigate suspected violations.
    • Train staff on regulations.
  • Committee Members: Include physicians, administrators, and IT/HR reps.

3. Staff Training and Education

  • Mandatory Topics:
    • HIPAA (e.g., phishing scams, password security).
    • Proper documentation (avoiding “upcoding”).
    • Sexual harassment prevention.
  • Frequency: Train new hires and conduct annual refreshers.

4. Open Communication Channels

  • Whistleblower Protections: Ensure staff can report issues anonymously without retaliation.
  • Example: Set up a hotline or encrypted email for concerns.

5. Internal Monitoring and Auditing

  • Conduct Regular Audits:
    • Review 5-10% of Medicare/Medicaid claims monthly.
    • Check EHR access logs for unauthorized entries.
    • Inspect OSHA compliance (e.g., fire exits, PPE supplies).
  • Use Audit Tools: CMS’s Risk Assessment Toolkit or third-party software.

6. Enforcement and Discipline

  • Consistent Penalties: Apply fair consequences for violations (e.g., retraining, suspension).
  • Document Actions: Prove accountability in case of audits.

7. Corrective Action Plans

  • Respond to Issues: If a breach occurs, act swiftly to:
    • Mitigate harm (e.g., notify patients of data breaches within 60 days).
    • Update policies to prevent recurrence.

Step-by-Step Guide to Building Your Compliance Plan

Step 1: Conduct a Risk Assessment

  • Identify vulnerabilities (e.g., outdated software, untrained staff).
  • Prioritize high-risk areas like billing and data security.

Step 2: Draft Policies

  • Use OIG or CMS templates to save time.
  • Customize for your specialty (e.g., mental health vs. surgery).

Step 3: Train Your Team

  • Host interactive workshops with quizzes.
  • Use real-world examples (e.g., “Is this email a HIPAA violation?”).

Step 4: Implement Monitoring Tools

  • Use software like HIPAA Secure Now for automated audits.
  • Schedule quarterly walkthroughs for OSHA compliance.

Step 5: Review and Revise

  • Analyze audit results and update policies.
  • Stay informed about regulatory changes via HHS or CMS newsletters.

Also Read: Licensed for Care, not Commerce: Ethical Excellence in Healthcare


Common Compliance Pitfalls (and How to Avoid Them)

  1. Coding Errors
    • Problem: Upcoding (billing for a higher-paying service than performed).
    • Fix: Use AI-powered coding tools like AAPC’s Codify.
  2. Poor Document Management
    • Problem: Losing patient records or failing to secure them.
    • Fix: Store files in HIPAA-compliant cloud systems like Dropbox Health.
  3. Ignoring OSHA
    • Problem: Failing to provide hepatitis B vaccines to at-risk staff.
    • Fix: Partner with occupational health clinics for compliance.
  4. Inadequate Training
    • Problem: Assuming staff “know the rules.”
    • Fix: Require signed training acknowledgments.

FAQs About Medical Practice Compliance Plans

Q: How much does a compliance plan cost?

  • A: Costs vary. Small practices spend 2,000−2,000−5,000 annually on software/training.

Q: Can I use a template?

  • A: Yes! CMS offers free templates, but customize them for your practice.

Q: What’s the #1 mistake practices make?

  • A: Failing to document compliance efforts. If it’s not written down, it didn’t happen.

Conclusion

medical practice compliance plan isn’t a luxury—it’s a lifeline. By investing in clear policies, ongoing training, and proactive monitoring, you protect your practice from legal nightmares while delivering safer, higher-quality care. Start small: appoint a compliance officer, conduct a risk assessment, and build from there.

Need Help? Consult healthcare attorneys or compliance firms like Compliancy Group to ensure your plan meets all federal and state requirements.

Also Read: Healthcare Marketing Update for Sellers of Weight Loss Medications

Navigating the Complexities of Amniotic Tissue and Skin Substitute Compliance 

By Sinead Baldwin

The healthcare industry’s use of amniotic tissue and skin substitute products has surged over recent years. However, regulatory (and payer) scrutiny is being applied at an increasing rate, with potential exposure to administrative reviews, civil penalties, or even criminal liability. Understanding the risks and compliance expectations is critical for organizations and practitioners navigating this space. This blog post provides a comprehensive breakdown of emerging trends, enforcement actions, and key compliance challenges surrounding amniotic tissue and skin substitute products.  The two most robust sources of enforcement are the FDA and payers.  

FDA Warning Letters to Suppliers 

The FDA is at the forefront of regulating amniotic tissue and related wound care products. Whenever the agency identifies possible statutory or regulatory violations under the Federal Food, Drug, and Cosmetic Act (FD&C Act), it issues a “Warning Letter.” This formal communication outlines the FDA’s concerns and provides the recipient with a limited timeframe to address those issues. 

Several cases in recent years highlight the growing regulatory focus in this area:

Case Studies of FDA Warning Letters

  • Arizona (August 2024): 

A Warning Letter was issued to a company marketing creams and other products alleged to be “unapproved new drugs.” The FDA also flagged them as “misbranded drugs,” emphasizing violations of labeling and marketing regulations. Some of these products were marketed as aiding in wound healing, intensifying regulatory concerns. 

  • Florida: 

This year, the FDA flagged a supplier manufacturing products derived from human amniotic fluid and umbilical cord material. Allegations centered on the unauthorized marketing of these products, which were distributed to third-party medical centers, pain clinics, wellness facilities, and physicians. 

These examples serve as cautionary tales. While FDA Warning Letters begin as administrative actions, unresolved issues or serious violations often escalate to civil or criminal enforcement involving the Department of Justice (DOJ). Penalties may include substantial fines, injunctive relief, or even imprisonment.

CMS Contractor Audits and Claim Denials 

The Centers for Medicare & Medicaid Services (CMS) contractors — including Medicare Administrative Contractors (MACs), Unified Program Integrity Contractors (UPICs), and the Supplemental Medical Review Contractor (SMRC) — are actively conducting audits of amniotic tissue and skin substitute claims, as are many commercial payers, which can be expected to activate their Special Investigative Units (SIUs) to squeeze utilization and launch clawbacks.  These audits often result in coverage denials and (even worse) clawbacks, with contractors citing medical necessity concerns or documentation deficiencies.  This can be especially punishing for providers who actually pay in advance for the grafts!  

Common Reasons for CMS Denials:

  1. Not Aligning with LCD Guidelines: 

When Local Coverage Determinations (LCDs) outline coverage criteria for specific products, claims failing to meet required documentation standards are quickly denied. 

  1. Homologous Use Misapplication: 

The FDA approves some amniotic tissue products for homologous use, meaning their function matches their effect on the body. However, using these products for wound healing beyond their approved purpose is classified as non-homologous use and warrants further FDA approval, including evidence of safety and efficacy. 

  1. Insufficient Evidence: 

Some applications of amniotic tissue products are considered investigational and fall short of CMS’ “reasonable and necessary” standard for coverage. Without peer-reviewed evidence validating their use for wound healing, claims are deemed unsubstantiated. 

  1. Document Cloning & Lack of Individualization: 

Claims suggesting cloned documentation or failing to reflect patient-specific treatment plans are frequently flagged as insufficient or non-compliant. 

  1. Failure to Explore Alternatives: 

When providers fail to justify why conventional wound care methods, such as sutures, dressings, or skin flaps, were not viable, coverage denials often follow.  

  1. Insufficient Documentation of Product Use: 

Providers must document the precise amount of amniotic material administered and account for any waste. Failure to provide these details frequently leads to CMS rejecting claims. 

Best Practices for CMS Compliance 

Healthcare providers must ensure thorough, individualized documentation and remain updated on LCD and FDA guidelines to minimize risk during CMS audits. Rigorous attention to detail in patient records and proper documentation protocols are crucial to avoiding payment denials.  Even better, having a set of policies and procedures in place that are designed to anticipate the regulatory pushback will help with audits and clawbacks!

Even more predictable is the Medicare coverage limitations in 2025 that will only allow use of a few manufacturers’ skin grafts (ones that are FDA approved).  Further, Medicare is more and more requiring photo documentation.  

DOJ Actions Against Non-Compliance 

Non-compliance with FDA or CMS requirements has also triggered numerous investigations and enforcement actions by the DOJ. These actions range from civil False Claims Act cases to criminal prosecutions, with steep penalties for providers and suppliers found guilty of wrongdoing.

Civil False Claims Act Investigations 

Medicare contractors are required to escalate cases involving potential fraud to the DOJ. Violators can face treble damages and additional penalties for each fraudulent claim submitted. Many investigations begin with the DOJ issuing a Civil Investigative Demand (CID), a request for documentation and testimonies. Providers must take immediate action and seek legal counsel when faced with a CID, as these investigations frequently result in both civil and criminal liabilities.

Criminal Enforcement 

Criminal cases often arise from egregious violations, with examples highlighting the risks of misrepresentation in amniotic tissue marketing and usage. 

  • Missouri Case: 

A physician assistant falsely marketed an amniotic fluid product as containing stem cells when it did not. Despite being informed of the product’s acellular state, the defendant continued promoting it as containing mesenchymal stem cells, resulting in a six-year prison sentence. 

  • Texas Case: 

A Texas-based physician assistant was found guilty of conspiracy to commit healthcare fraud, alongside 12 counts of healthcare fraud, for administering unapproved amniotic fluid treatments. 

Navigating the Path Forward 

The regulatory landscape for amniotic tissue and skin substitute products is increasingly complex. Non-compliance—whether intentional or due to oversight—carries substantial risks, including financial penalties, reputational damage, or criminal charges. Healthcare providers and suppliers must remain diligent in their adherence to FDA and CMS requirements, maintain meticulous documentation, and stay informed of evolving guidelines.  

For those facing regulatory audits, DOJ investigations, or FDA Warning Letters, consulting experienced healthcare law professionals is essential. Proactive legal and compliance strategies can help mitigate liability and ensure ongoing adherence to industry standards.  Having policies and procedures in place that anticipate the clear prosecutorial paths chosen by regulators can be game changing.  

Navigating these challenges is no easy task, but with careful planning and a commitment to regulatory excellence, healthcare providers can balance innovation with compliance, ensuring both patient safety and business resilience.

How to Audit Billing and Collection Company

In the complex world of healthcare, accurate billing and efficient collections are critical to ensuring the financial health of your practice. Florida Healthcare Law Firm specializes in providing comprehensive legal support to healthcare providers and businesses, offering unparalleled expertise in navigating audits and related challenges. This blog will guide you on how to audit billing and collection companies, ensuring compliance, minimizing risks, and optimizing revenue cycles.

Understanding the Importance of Audits

Auditing billing and collection companies isn’t just a regulatory requirement; it’s a strategic step to protect your practice’s financial integrity. Whether it’s a third-party payor audit or internal review, identifying discrepancies early can prevent costly errors, penalties, and reputational damage. Our team at Florida Healthcare Law Firm has vast experience assisting healthcare providers in conducting thorough and effective audits.

Steps to Audit Billing and Collection Companies

  1. Define the Scope of the Audit Start by identifying the objectives of your audit. Are you reviewing compliance with third-party payor requirements, ensuring adherence to contracts, or identifying inefficiencies in collections? Defining the scope ensures a focused and effective audit process.
  2. Review Contracts and Agreements Analyze agreements with the billing and collection company to ensure all terms are being met. Pay particular attention to clauses related to collections, reporting, and fee structures.
  3. Examine Billing Practices Evaluate the billing company’s adherence to coding standards and billing regulations. Our expertise in handling retro review audit attorney cases enables us to provide actionable insights to ensure accuracy and compliance.
  4. Analyze Collections Data Assess the company’s performance by reviewing collection rates, aging reports, and payment trends. Benchmark their results against industry standards to identify potential red flags.
  5. Conduct a Compliance Check Ensure the billing and collection company complies with HIPAA, CMS regulations, and state-specific healthcare laws. For Florida providers, staying prepared for a Florida ZPIC audit is essential to avoid severe penalties.
  6. Implement Corrective Actions After identifying areas for improvement, collaborate with your billing and collection company to address issues. Establish clear timelines and monitoring processes to ensure corrective actions are effective.

Preparing for Third-Party Payor and ZPIC Audits

Healthcare providers often face third-party payor audits and Florida ZPIC audits, which can be challenging without the right legal support. Florida Healthcare Law Firm specializes in defending healthcare businesses during audits, ensuring compliance and mitigating risks. Our proactive approach includes:

  • Conducting pre-audit assessments to identify vulnerabilities.
  • Guiding documentation reviews to ensure readiness.
  • Providing representation during audit proceedings.

Benefits of Partnering with Florida Healthcare Law Firm

When it comes to navigating audits and ensuring compliance, the Florida Healthcare Law Firm stands out as a trusted partner. Our deep industry experience allows us to provide tailored legal strategies to healthcare providers, billing companies, and collection firms. Clients who work with us benefit from:

  • Specialized expertise in healthcare law.
  • Proactive risk management strategies.
  • Comprehensive support for audits, contracts, and compliance.

Conclusion

Auditing your billing and collection company is an essential part of maintaining financial and regulatory health. With the support of Florida Healthcare Law Firm, you can confidently navigate the complexities of audits, from third-party payor audits to Florida ZPIC audits, ensuring compliance and success.

If you’re looking for expert legal guidance on how to audit billing and collection companies, contact Florida Healthcare Law Firm today. Our attorneys are dedicated to protecting your practice and helping you thrive in a competitive healthcare landscape.

Navigating the Franchise Maze in the Wellness Industry

Jeff Cohen 

Entering the realm of franchising can be both exhilarating and daunting. For entrepreneurs and investors eyeing the booming wellness sector, which includes hormone replacement therapy (HRT), regenerative medicine, aesthetics (MedSpas), and IV hydration, understanding the intricacies of franchising is crucial. The wellness market presents a myriad of opportunities; however, potential franchisees find themselves overwhelmed by the stack of documents and decisions ahead. Here’s what you need to know to make informed choices and steer your franchise venture toward success.

Why Choose a Franchisor Over Going Solo?

One of the first questions that arise is why not simply start your own business? The answer largely boils down to brand name recognition and effective marketing. While it’s true that setting up the logistics—like sourcing labs, pharmacies, and ensuring compliance with standards such as uniflow hoods and 797 compliance—is challenging, these are hurdles that can be overcome. However, building a brand from scratch takes immense time and resources.

A franchisor offers the benefit of established brand awareness and marketing strategies that have been refined through experience. A successful franchise comes from a franchisor who has:

  1. Built a strong brand name over time.
  2. Invested in marketing strategies, learning what works and what doesn’t.

But remember, even the best brand and marketing can only do so much if the franchisee cannot convert traffic into business. Sales skills and customer engagement are critical components for achieving success in any franchise endeavor.

Deciphering Franchise Documents

Franchise agreements can be intimidating. They often communicate two stark realities:

  1. You might lose your investment.
  2. You may not make a profit.

Why this harsh message? Because franchisors need to protect themselves legally from making false promises. Therefore, well-crafted franchise documents are filled with disclosures, refrain from making guarantees, and push compliance responsibilities onto the franchisee. It’s a way of saying, “It’s your business, your risk.”

The Negotiability of Franchise Agreements

Prospective franchisees often wonder if they can negotiate the terms of their agreements. The key is getting independent legal advice before signing anything. Lawyers typically provide three types of feedback:

  1. Observational comments to raise awareness.
  2. Suggestions for changes that could benefit the client.
  3. Red alert comments if there’s a legal or regulatory concern.

While initial contracts might be more flexible, especially if you’re an early franchisee, established franchisors are less likely to agree to modifications unless necessary due to compliance issues.

Understanding Franchise Fees

Franchise fees can also be perplexing. They come in two types:

  • Upfront Fees: These might include the Unit Franchise fee.
  • Continuing Fees: These ongoing fees, such as royalty fees, branding fees, advertising fees, technology fees, and EMR fees, are where franchisors truly benefit.

The franchisor’s long-term income depends on the success of the franchisees. It’s a precision game, not a numbers game. Franchisors seek well-qualified franchisees with business acumen rather than large numbers of inexperienced ones because their ongoing income relies on the franchisee’s performance.

Building a Successful Franchise Relationship

Franchisor relationships, like well-tuned orchestras, are harmonious and productive when all parties are in sync. To ensure this harmony, consider the following steps:

  1. Engage an Experienced Lawyer: A good lawyer will help you understand the intricate nature of the franchise relationship and identify potential issues in the documents.
  1. Talk to Existing Franchisees: Gain insights into how their relationships with the franchisor are working.
  2. Self-evaluate Your Business Expertise: If you lack business experience, bring in expertise. Learning as you go is costly and time-consuming.

In conclusion, entering a franchise in the wellness sector requires careful consideration and diligence. By understanding the nuances of franchising—such as choosing a reputable franchisor, navigating legal documents, and ensuring you have or develop the necessary business skills—you can position yourself for success. Remember, a harmonious franchisor-franchisee relationship is the key to a thriving business. By taking these steps, you’ll be well-prepared to make your mark in the wellness industry.