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.
Continue readingFlorida’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
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
- 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.
- Protect Patient Trust
Patients expect their data and safety to be prioritized. A breach or lawsuit erodes confidence and can drive patients to competitors. - Streamline Operations
Compliance plans standardize processes, reducing errors in billing, documentation, and patient care. - 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)
- Coding Errors
- Problem: Upcoding (billing for a higher-paying service than performed).
- Fix: Use AI-powered coding tools like AAPC’s Codify.
- Poor Document Management
- Problem: Losing patient records or failing to secure them.
- Fix: Store files in HIPAA-compliant cloud systems like Dropbox Health.
- Ignoring OSHA
- Problem: Failing to provide hepatitis B vaccines to at-risk staff.
- Fix: Partner with occupational health clinics for compliance.
- 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
A 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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:
- Built a strong brand name over time.
- 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:
- You might lose your investment.
- 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:
- Observational comments to raise awareness.
- Suggestions for changes that could benefit the client.
- 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:
- 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.
- Talk to Existing Franchisees: Gain insights into how their relationships with the franchisor are working.
- 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.

How to Leverage Your Billing & Collection Company for Optimal Success in Your Medical Practice
Running a successful medical practice requires more than just offering top-notch patient care. Effective management of billing and collections is crucial for maintaining financial health. Many practices partner with specialized billing and collection companies to handle these tasks, but fail to recognize that the relationship requires active management to truly unlock its full potential. In this post, we’ll explore how to effectively work with your billing and collection company, the importance of quarterly check in meetings, and how your healthcare legal team can be deployed where needed to ensure maximum revenue for your practice.
Understanding the Role of Billing & Collection Companies
Billing and collection companies specialize in handling the financial transactions of your practice. They manage claims processing, patient billing, and collections, ensuring that your practice gets paid for the services rendered. However, they aren’t always forthcoming about their own limitations. This makes it essential for you, as a practice owner, to take an active role in managing this relationship.
The Importance of Taking the Lead
One common challenge practices face is not knowing what they don’t know. Billing companies may not highlight their own shortcomings, so it’s up to you to lead the relationship to success by asking strategic questions that reveal opportunities for improvement. Here are key areas to focus on:
1. Regular Communication
Establish regular communication channels with your billing company. Schedule quarterly meetings to review performance, address issues, and set goals for the upcoming quarter. These meetings are an excellent opportunity to ask questions and get a clear picture of your financial health.
Questions to Ask During Quarterly Meetings:
- What are our current collection rates, and how do they compare to industry standards?
- How do our collection rates in each age bucket compare to the prior quarter?
- What are the top 3 denial reasons?
- How many zero pays do we have?
- How long is the average time from service rendered to payment received?
- Are there any emerging trends that we should be aware of, such as changes in insurance policies, coding procedures or regulatory requirements with respect to documentation?
- Are there any trends that you’ve observed that you think we need to evaluate to ensure compliance?
2. Performance Metrics
Understand and monitor key performance metrics. Knowing these metrics will help you gauge the effectiveness of your billing company and identify areas for improvement. Important metrics include:
- Days in Accounts Receivable (AR) – The average number of days it takes to collect payments.
- Net Collection Rate – The percentage of eligible payments collected.
- Denial Rate – The percentage of claims denied by payers.
3. Compliance and Legal Considerations
Work closely with your healthcare legal team to ensure compliance with healthcare regulations. Your legal team can help you understand where the billing company’s responsibilities end and where you need to step in. This can prevent potential legal issues and ensure that your practice operates within the bounds of the law.
Questions to Discuss with Your Legal Team:
- Are there any compliance issues we need to address?
- What steps can we take to reduce the risk of audits and penalties?
- How can we ensure that our patient billing practices are fair and transparent?
- Do I have any systemic payment issues that my legal team can assist with?
4. Continuous Improvement
Encourage a culture of continuous improvement within your practice and with your billing partner. Regularly review processes and look for ways to enhance efficiency and effectiveness. This can involve updating technology, training staff, or revising workflows.
5. Leveraging Technology
Investing in the right technology can significantly improve your billing and collections process. Many practices are investing in AI tools to assist physicians and staff with progress notes and charting, ensuring that progress notes support the codes being charged in each claim. Ensure that your practice management software integrates seamlessly with the billing company’s systems and that any direct payments made to your office are reported within both systems. This integration can streamline processes, reduce errors, and provide real-time data for better decision-making.
Conclusion
Effective billing and collections are vital for the financial health of your medical practice. By taking an active role in managing your relationship with your billing and collection company, scheduling regular check in meetings, and leveraging the expertise of your healthcare legal team, you can uncover opportunities for success and ensure that your practice thrives.
Ready to take your billing and collections to the next level? Schedule a consultation with our expert team today and discover how we can help you streamline your operations and maximize your revenue.
Credit: Sinead
Peptides Gone Wild: Why Is This So Hard To Pin Down?
Peptides are short chain amino acids (40 or less amino acids) that are fast becoming one of the underpinnings of the “wellness movement.” When we’re young and healthy, our bodies make plenty of them. When we’re older or stressed or sick, the story goes, their production falls off and our physical (and mental quality) of life is undermined. Because they’re essentially the same chemicals made by our bodies, it makes sense that we ought to be able to augment their decline by injection or ingesting them, right? Kinda of like bioidentical hormones. Not so fast Charlie!
The biggest stumbling block re peptides is this: the Food and Drug Administration (FDA) regulates them as drugs. More specifically, the FDA has been clear that they can be compounded at compound pharmacies but not made by pharmaceutical companies, because they aren’t “approved” by the FDA. Moreover, since they are essentially what’s found in nature, they are not subject to the usual intellectual property (IP) protections that allows a company that creates them to “own” them and monetize them in the same way that pharmaceutical companies can. And unless and until Pharma changes the molecular structure of a peptide, no IP can be obtained and it cannot be FDA approved.
All that said, the FDA is clearly concerned about the growth of peptide use. Which explains why in February, 2024 (updated in May), the FDA expanded the 503A Category 2 list (bulk drugs items raising “significant safety risks”) to include peptides like BPC-157, Kisspeptin, MOTs-C, ipamorelin, thymosin A and B and many other that were the cornerstone of the peptide wellness movement. In many instances, the FDA commented about the peptides on the expanded Category 2 list that there was insufficient data to show efficacy or harm, so they’re “suspect.” Even more “interesting” is the current Category 1 list (“under evaluation) that includes items like aloe vera, CoQ10, curcumin, glutathione, L-Theanine, NAD, pregnenolone, quercetin, resveratrol, tea tree oil and many others that clinicians and patients count on as part of their regular wellness regimen.
The “why” of all this is confounding to clinicians in the wellness space and the patients who want the right to be proactive about their wellness. One narrative is how it’s a Big Brother driven issue, that Big Money (i.e., Pharma) is behind it all and just wants to prevent people from driving their wellness regimen and instead turn each of us into drone like consumers of pharmaceutical products that have unwanted side effects. I don’t know! But I do know this: if you don’t know how law is made and if you don’t have a “seat at the table,” your unique point of view will be completely missing from all the laws and regulatory activity downstreamed to us consumers. Pharma knows the system and has a hand in designing it. Those businesses understand how policy is created and enforced. And they pay a ton of money each year to (1) validate their products, and (2) lobby both legislators and regulators to promote their products and invalidate products they didn’t create and which don’t meet the standards (they help design and implement).
So then…where is all the research on peptides? Why don’t compound pharmacies or providers that rely on peptides for wellness solutions spend millions of dollars a year on double blind studies to validate peptides? Maybe…because there is no IP protection for such products. And if there’s no IP protection, how can any company justify the investment? They’ll never be repaid. And if they did make the investment, all their competitors would reap the benefit, since there is no IP protection for wellness solutions found in nature. Until stakeholders in the wellness industry either (1) invest in changing the regulatory/legislative game and (2) play a very active role in that process, they will just bugle victim and fairness stories. They’ll sound like a bunch of sore losers. There is no winning the game without playing it.
So where does that leave peptide providers and consumers right now? Are they illegal? Nope. Can you go to jail if you prescribe or use them? Nope. That said, given the fact that the latest FDA directives are aimed at compound pharmacies, the pharmacy space is where we see the most scrambling and confusion. Because if the FDA takes issue with them, their licensure is on the line. The net effect for the moment is (i) fear among prescribing professionals and (ii) contraction of peptide availability. That contraction in the compound pharmacy space has spurred new companies that label peptides “for research use only” or “not for human consumption.” The trouble is that these new “research companies” are not subject to any quality related regulations.
Consumers ought to be wary of these new (non pharmacy) companies. The Alliance for Pharmacy Compounding (APC), for instance, advises that such peptides not be labeled as described above. They advise that any such substances “must be manufactured by an FDA-registered facility.” For similar reasons, clinicians need to be selective about the companies they’re using to fulfill prescriptions for peptides during this dynamic time.
All of that said, some peptides, like semaglutide and tirzepatide, are free flowing, which is confusing to consumers and clinicians. The short reason is there’s an exception for compounding that applies to FDA approved drugs that are “currently in shortage.”
The current state of the law and peptide industry is in flux. That will mean some providers will contract and others will fill the void created by leaving the market. It’s a short-lived situation that is expected to develop further during the next year or so. But if the past is any predictor of the future, the future belongs only to those clinicians and providers (and consumers) that organize and interact with the FDA and legislators to demonstrate both safety and efficacy.
Navigating Increased Scrutiny: What Acupuncturists Need to Know About VA Audit Findings and Legal Risks
By: Sinead Killeen
The regulatory environment for acupuncture providers is becoming increasingly complex as scrutiny and enforcement actions under the False Claims Act intensify. A 2021 audit by the Department of Veterans Affairs (VA) has revealed significant concerns about the handling of payments and authorizations for acupuncture services provided to veterans through non-VA providers. Understanding these findings and their implications is crucial for practitioners to effectively navigate these changes.
Expanding Coverage and Scrutiny
Acupuncture services for veterans have been a part of the VA’s offerings long before traditional Medicare even considered covering these treatments. The Veterans’ Access to Care through Choice, Accountability, and Transparency Act of 2014 (Choice Act) and the VA MISSION Act of 2018 were pivotal in expanding veterans’ access to acupuncture and accelerated referrals to non-VA providers. These acts allowed veterans to access funding to obtain acupuncture treatment from non-VA providers, given that the VA lacked sufficient in-house acupuncturists to meet demand.
During Fiscal Years (FYs) 2018 and 2019, the VA paid approximately $114 million to non-VA community acupuncture providers. However, a December 2021 audit by the VA’s Office of Inspector General (OIG) revealed significant issues with many of these payments. As a result, the number of VA acupuncture audits has increased dramatically. This article will examine the reasons cited for denying acupuncture claims and discuss strategies to reduce audit risks.
Problems Identified in VA Acupuncture Audits
The December 2021 VA OIG audit uncovered several issues with the acupuncture claims that had been paid in 2018 and 2019:
- Lack of Authorization: Approximately 51,200 claims lacked the necessary pre-authorization from the VHA. The VA’s financial services system automatically paid for all claims within a year of authorization leading to overpayments for unauthorized services; including the number of visits in excess of the authorization, dates of service after the allowable dates on the authorization, etc.
- Documentation Deficiencies: About 76% of the claims lacked proper documentation. The OIG found that many claims were not supported by medical documentation meeting VHA requirements, including illegible or incomplete records. The VA requires that claims conform to Medicare’s billing requirements.
- Incorrect Billing for E/M Services: Some Evaluation and Management (E/M) services billed were not fully supported by medical records or illegible, leading to further issues with claims.
- VHA Staff Failed to Follow Reauthorization Guidelines: The VHA failed to evaluate the efficacy of non-VA care prior to reauthorizing additional acupuncture services, thus improper payments were made with faulty authorization.
Lessons Learned from VA OIG’s Acupuncture Audits
- The acupuncturist is responsible for medical necessity and documentation.
- You must adhere to authorization limits – make sure that the services provided are administered by the provider listed on the authorization and limit the services to the amount of treatment and within the time period authorized by the VA.
- Correct Coding: Follow the AMA CPT Codebook for accurate coding of services.
- Maintain Legible Documentation: Ensure all documentation is clear and legible to avoid claim denials based on poor record-keeping.
Current Enforcement Trends
Followingthe VA OIG acupuncture audit report there have been a large number of resulting provider audits and investigations, in an attempt to recoup some of the funds that were paid in 2018 & 2019. The audits are being performed by the VA, third-party administrators and even the U.S. Department of Justice. You may receive a subpoena requesting claims information including progress notes or your entire case file on a group of VA patients as the initial indication of a pending investigation. Following transmission of these documents, you may be informed of several possible results. You may be subject to administrative recoupment which simply requires you to repay improperly paid funds. Common issues include unauthorized services or incomplete/illegible documentation. In more extreme instances the VA or DOJ may pursue you for civil damages pursuant to the False Claims Act. Providers may face significant penalties under the False Claims Act for knowingly submitting false claims. The DOJ often handles these cases, pursuing treble damages and substantial fines. If the investigation finds that your conduct may rise to the level of health care fraud you may be subject to criminal liability.
New Challenges: Veteran Interviews and Documentation Issues
Recent developments indicate that the VA is now interviewing veterans to challenge the validity of acupuncture claims. This new approach includes questioning whether treatments were actually received and undermining the claims made by acupuncturists. Notably, progress notes are increasingly being deemed insufficient evidence of treatment completion, particularly where legibility is an issue.
Recommendation: To counteract these challenges, we are advising acupuncture providers to incorporate an attestation form for patients to sign at each appointment. This attestation should confirm that the treatment was received and can serve as additional documentation to support the claim.
What This Means for Acupuncturists
- Increased Scrutiny: Providers with high billing amounts are under heightened scrutiny. The VA’s focus on these cases, combined with DOJ investigations, means that billing discrepancies or errors can lead to severe legal repercussions.
- Potential Penalties: The DOJ’s pursuit of treble damages for improper claims under the False Claims Act can lead to substantial financial penalties, significantly exceeding the original claim amounts.
- Proactive Measures: To mitigate risks, acupuncture providers should review and strengthen their compliance practices. This includes ensuring all treatments are pre-authorized, maintaining comprehensive and accurate documentation, and using additional patient attestations to confirm treatment receipt.
- Seek Professional Advice: Engaging with healthcare compliance specialists or legal advisors is crucial. These professionals can help navigate the complex regulatory landscape and ensure your practice remains compliant.
Conclusion
With the expanding coverage for acupuncture services and the rise in audits by federal, state, and private payors, acupuncturists must be vigilant. Reviewing and updating medical necessity, documentation practices, and billing procedures is crucial. By adhering to regulatory requirements and maintaining thorough records, providers can better manage audit risks and continue to offer valuable care to veterans with confidence.
So, You Want to Open Your Own Veterinary Practice?
As a veterinarian, the dream of owning your own practice often represents the pinnacle of professional achievement. However, venturing into practice ownership is a monumental decision that requires thorough preparation and strategic planning. Here’s a comprehensive guide to help you navigate this exciting journey.
First Things First: New Practice vs. Established Practice
Starting from Scratch – Opening a new veterinary practice means building everything from the ground up. This option provides you with the ultimate level of control over every aspect of your practice, it also involves substantial initial investment and higher risk, as you will need to attract a clientele from scratch and navigate the unpredictable early stages of business growth.
Purchasing an Existing Practice – On the other hand, acquiring an established practice comes with a built-in client base, experienced staff, and an existing revenue stream, which can significantly mitigate initial risks. Many lenders prefer financing acquisitions because they can assess the financial history of the practice to predict future revenue. However, you will inherit the existing business culture and practices, which may require time and effort to align with your vision. Potential downsides include staff turnover and adjustments in business philosophy.
Key Questions to Ask When Purchasing an Existing Practice
Once you decide to take the leap and purchase an existing practice there are a few questions you must ask yourself when evaluating the potential purchase which include:
- How did the seller arrive at the sale price?
- What all is included in the sale?
- Does the sale include any special conditions?
- Why is the owner selling, and what are his or her plans following the sale?
Due Diligence: Ensuring a Smooth Transition
Due diligence is a critical phase in acquiring a veterinary practice, requiring meticulous attention to detail and professional expertise.
- Compliance Documentation: Ensure all regulatory requirements are met. A compliance audit can prevent costly future fines and enhance the practice’s value.
- Non-Disclosure Agreements:
Protect sensitive business information with NDAs to prevent information leaks that could harm the practice’s value or operations. - Non-Compete Agreements
Verify that existing veterinarians have non-compete agreements to safeguard against them taking clients if they leave the practice.
Conclusion
Owning a veterinary practice is a significant milestone, representing either the start of an exciting new venture or the culmination of a dedicated career. Whether you choose to build a practice from scratch or acquire an existing one, being well-prepared and informed is key. By asking the right questions, understanding valuation methods, and ensuring thorough due diligence, you can set the foundation for a successful and fulfilling practice ownership journey.
Clients who work with the Florida Healthcare Law Firm are protected by deep healthcare industry experience and fully served by attorneys aligned with their success. The team here doesn’t dabble in healthcare law, we specialize in full spectrum representation of healthcare providers and nearly every type of healthcare business.








