Podcast appearances and mentions of Stark Law

Send us a textWhat's the difference between following ethical codes and living ethical principles? In this thought-provoking conversation, Dr. Douglas Beck sits down with Dr. Michael Page, lead ethicist and author, to explore the complex ethical terrain healthcare professionals navigate daily.Dr. Page draws a crucial distinction that transforms how we approach ethics: "If we live the principles of ethics, the codes of ethics just automatically fall underneath that." Rather than seeking the outer boundaries of permissible behavior, principled practitioners focus on making decisions that uphold trust and serve patients' best interests.Through personal stories and practical examples, the conversation illuminates ethical gray areas we all face. When should you accept industry incentives? How do you maintain professional boundaries with patients? What happens when your role blurs between clinician and sales representative? These questions have no simple answers, but Dr. Page offers a thoughtful framework: consider whether actions are illegal, unethical according to codes, or simply immoral according to your principles.The discussion delves into regulations like the Stark Law, Anti-Kickback Statute, and Physician Payment Sunshine Act, revealing how transparency shapes ethical practice. As healthcare becomes increasingly commercialized, understanding these guidelines becomes essential for maintaining professional integrity.Perhaps most powerful is Dr. Page's assertion that "if we're not being honest with ourselves, there's no possibility of ethical practice with anyone else." This reminder that ethical practice begins within ourselves provides a compass for navigating the increasingly complex relationships between practitioners, patients, and industry partners.Ready to deepen your understanding of professional ethics? Listen now to gain insights that will strengthen your practice and your relationships with those you serve. While we know all hearing aids amplify sounds to help you hear them, Starkey Genesis AI uses cutting-edge technology designed to help you understand them, too.Click here to find a provider near you and test drive Starkey Genesis AI! Connect with the Hearing Matters Podcast TeamEmail: hearingmatterspodcast@gmail.com Instagram: @hearing_matters_podcast Twitter: @hearing_mattasFacebook: Hearing Matters Podcast

Send us a textWhat's a referral under the Stark Law and Anti-Kickback Statute (AKS)? In this episode, Captain Integrity Bob Wade dives into the definition. Hear what defines a referral, the 3 specialties that don't refer, why a referral under the AKS is much broader in comparison with the Stark Law, the history of a famous saying, and the value of a memorable slogan. Learn more at CaptainIntegrity.com 

Send us a textIn Fiscal Year 2024, the federal government collected $2.9 billion in False Claims Act settlements (FCA). In this episode, Captain Integrity Bob Wade explains what happened. Hear how the qui tam bar is still active, why Stark Law and Fair Market Value issues (FMV) are still very big issues for compliance, how the Department of Justice (DOJ) gives you credit for cooperation & self-reporting, a deep dive into the numbers from 2024, and some fun facts about the settlements. Learn more at CaptainIntegrity.com 

Send us a textIn the case of Ambulatory Surgery Centers (ASCs), the Stark Law does not apply. In this episode, Captain Integrity Bob Wade kicks off his breakdown of ASCs. Hear the pros & cons of ASCs from a patient's perspective, why the Stark Law does not apply, why ASCs need to be billed under the composite rate, how block booking works for physicians, and the story of Bob's daughter's ACL. Learn more at CaptainIntegrity.com 

Selling or acquiring a healthcare practice is no small feat. Regulatory compliance challenges, from Stark Law violations to billing audits, can derail even the best-planned transactions. In this insightful episode of Compliance Conversations, CJ Wolf interviews Ericka Adler, a leading healthcare attorney and Shareholder at Roetzel & Andress, to uncover: - The most common compliance pitfalls in healthcare transactions - Strategies for preparing your practice for sale to ensure a smoother process - Key steps buyers must take to mitigate compliance risks during due diligence - Tune in to the episode and gain actionable strategies from an expert with over 28 years of experience in healthcare law. About Ericka Adler: Ericka has over 25 years representing individual providers, physician groups, and other health care entities, such as home health care agencies, DME companies, hospices, MRI facilities, and surgery centers. She focuses her practice on regulatory and transactional health care law, in compliance counseling, structuring, and implementing complex joint ventures to comply with state and federal laws and regulations. Ericka spends a significant amount of time helping physicians to negotiate their employment agreements with various types of physician employers. She handles mergers, sales and acquisitions of healthcare entities and has extensive experience in completing transactions with private equity, hospitals and other third parties. Ericka also has deep experience dealing with Stark, Anti-Kickback Statute, fee-splitting concerns, the corporate practice of medicine, and other challenges facing healthcare providers. Ericka works closely with her clients on their day-to-day legal health care needs and strives to be available so that her clients always feel like they are her top priority. She serves as general counsel to her practice clients. Ericka keeps clients up-to-date on her weekly podcast, “Roetzel HealthLaw HotSpot®. The podcasts have addressed timely topics, including private equity acquisitions, Stark Law compliance, employment and HR issues, and other matters of importance and interest to her clients. In addition, Ericka contributes to the Law & Malpractice section of the online magazine Physicians Practice and to the Business section of the online blog site Medscape, where she addresses legal and management issues facing independent physician practices. She devotes a large part of her practice to advising professionals and practices on their employment agreements, helping them to negotiate their contractual arrangements, and assisting her clients in acquiring and selling health care entities. She also works with providers in HIPAA, fraud and abuse, billing audits, government investigations, licensure matters, and contract disputes. Ericka can be reached via email at EAdler@ralaw.com.

Send us a textHear Captain Integrity Bob Wade read his original Stark Law holiday poems, “‘Twas the Night before the Subpoena,” “Rudy the Seasoned Compliance Officer,” “Jolly OIG Agent,” and “The 12 Days of Compliance.” Share the poems with your team and learn more at CaptainIntegrity.com

Negotiating Physician Recruitment Agreements to Limit Risk Host Ericka Adler welcomes healthcare attorney Laura Lauth Andrews from Lauth O'Neill, LLC. In this thought-provoking discussion, Ericka and Laura dive into the often-overlooked topic of physician recruitment agreements. Laura sheds light on what a recruitment agreement is and the requirements under the Stark Law that impact the agreement structure and whether a recruitment agreement may be legally offered. Together, they explore the various elements of recruitment agreements between hospitals, physicians and practices, and the type of support provided, such as compensation, bonuses, relocation expenses, and start-up funds. They also talk about the burden on physicians to remain in the community for the forgiveness period or to bear the burden of repayment, and how groups often shift this liability entirely to the physician while benefiting from the finances of the arrangement. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

Welcome to Health-e Law, Sheppard Mullin's podcast exploring the fascinating health tech topics and trends of the day. In this episode, Danielle Vrabie and Amanda Zablocki, partners at Sheppard Mullin and Co-Chairs of the firm's Women in Healthcare Leadership Collaborative (WHLC), join Sara Shanti to talk about the importance of elevating women to leadership roles in healthcare.   What We Discussed in this Episode: Women make up about 75% of entry-level positions in healthcare. Women make up about 32% of executive-level positions in healthcare and less than 5% are women of color. What inspired the founding of WHLC six years ago? What is WHLC's mission? What does the growth of WHLC indicate for the evolving industry? What was the focus of WHLC's First Annual Leadership Summit held last month? Why are women's voices so important in terms of healthcare industry leadership? How might promoting people with frontline healthcare experience help mitigate litigation risks facing the industry? Why is it important to promote women leaders in sectors that intersect with healthcare? What will 2025 look like for WHLC?   About Danielle Vrabie Danielle Vrabie is a partner in the Litigation Practice Group in Sheppard Mullin's New York office and a member of the firm's Healthcare and Life Sciences Teams. Danielle represents corporate clients and individuals in complex commercial litigation and government investigations throughout the country. A substantial portion of her practice is dedicated to serving healthcare and life sciences clients, including hospitals and health systems, physician and specialty practice groups, managed care organizations, pharmaceutical companies, long-term care providers, and medical device companies. She has experience representing these clients in a variety of contexts, including commercial disputes and litigation, enforcement actions, and government investigations. She also has significant experience defending against investigations and litigation involving allegations under the False Claims Act, Stark Law, Anti-Kickback Statute, and similar anti-fraud statutes.  In this context, she also assists companies in conducting internal investigations regarding allegations of fraud, employee misconduct, and whistleblower complaints and developing cost-effective and practical compliance and risk management programs. Danielle also helped establish and serves as Co-Chair of WHLC, which seeks to promote the advancement of women in the healthcare industry by bringing them together in a supportive community and providing them with targeted education focused on complex legal issues, healthcare innovation, and other critical issues.      About Amanda Zablocki A partner in Sheppard Mullin's New York office, Amanda Zablocki is a trusted legal and strategic advisor to healthcare organizations across the country, helping them achieve their goals while navigating a dynamic regulatory landscape.  Amanda leads complex healthcare deals, including mergers and acquisitions, joint ventures and strategic partnerships, corporate reorganizations, and value-based care arrangements. She routinely advises on a range of healthcare and nonprofit regulatory matters, including fraud, waste, and abuse, the corporate practice of medicine, nonprofit law, tax exemption, corporate governance, and compliance matters. Her clients conclude health plans and health insurers, hospitals, academic medical centers, digital health and healthcare technology companies, integrated healthcare delivery systems, pharmaceutical and life sciences companies, rare disease organizations, independent practice associations, physician practices, management services organizations, value-based enterprises, care management organizations, and 501(c)(3) organizations. In addition to helping found and serving as Co-Chair of WHLC, Amanda has devoted substantial time to supporting the recruitment, retention, and advancement of women in the legal industry.  She served as Co-Chair of the New York Women Lawyers' Group (WLG) for several years before joining the firm's WLG National Leadership Council. In her role as Chair of Sheppard Mullin's New York Recruiting Committee, Amanda cultivates the next generation of attorneys through the firm's highly ranked summer associate program.   About Sara Shanti A partner in the Corporate Practice Group in the Sheppard Mullin's Chicago office and co-lead of its Digital Health Team, Sara Shanti's practice sits at the forefront of healthcare technology by providing practical counsel on novel innovation and complex data privacy matters. Using her medical research background and HHS experience, Sara advises providers, payors, start-ups, technology companies, and their investors and stakeholders on digital healthcare and regulatory compliance matters, including artificial intelligence (AI), augmented and virtual reality (AR/VR), gamification, implantable and wearable devices, and telehealth. At the cutting edge of advising on "data as an asset" programming, Sara's practice supports investment in innovation and access to care initiatives, including mergers and acquisitions involving crucial, high-stakes and sensitive data, medical and wellness devices, and web-based applications and care. Contact Info Sara Shanti Danielle Vrabie Amanda Zablocki   Resources WHLC 2024 WHLC Leadership Summit   Thank you for listening! Don't forget to SUBSCRIBE to the show to receive new episodes delivered straight to your podcast player every month. If you enjoyed this episode, please help us get the word out about this podcast. Rate and Review this show on Apple Podcasts, Amazon Music, or Spotify. It helps other listeners find this show. This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.

Send us a textWant to know what you get for The 12 Days of Compliance? In this special holiday episode, Captain Integrity Bob Wade reflects on 2024 and sings his latest custom Stark Law holiday carol, “The 12 Days of Compliance.” Hear the latest from Bob's personal life & Nelson Mullins, his favorite things to do in Nashville, the history of “The Twelve Days of Christmas,” fun facts about the birds in the song, and the Stark Law holiday poem you can share with your team. Learn more at CaptainIntegrity.com

Join host Ericka Adler on this week's episode of the #HealthLawHotSpot as she welcomes healthcare attorney Laura Lauth Andrews from Lauth O'Neill, LLC.  In this thought-provoking discussion, Ericka and Laura dive into the often-overlooked topic of physician recruitment agreements. Laura sheds light on what a recruitment agreement is and the requirements under the Stark Law that impact the agreement structure and whether a recruitment agreement may be legally offered. Together, they explore the various elements of recruitment agreements between hospitals, physicians and practices, and the type of support provided, such as compensation, bonuses, relocation expenses, and start-up funds.   They also talk about the burden on physicians to remain in the community for the forgiveness period or to bear the burden of repayment, and how groups often shift this liability entirely to the physician while benefiting from the finances of the arrangement. Listen in as Ericka and Laura share real-world examples of issues that arise in recruitment agreement situations and how physicians can limit their risk by asking the right questions and working with effective healthcare counsel. This episode serves as a critical resource for any physician considering a recruitment agreement.

Send us a textPhysician space sharing could be a great strategy - if you follow the rules. In this episode, Captain Integrity Bob Wade discusses physician space sharing as it relates to Stark Law compliance with Mike Vetter, Partner at HMS Valuation Partners. Hear why utilizing space sharing arrangements is a very cost-effective strategy for a healthcare system to expand services to other communities, why it starts with communication, why these arrangements are watched by the CMS (Centers for Medicare & Medicaid Services) and the regulatory language set forth, the biggest pitfalls of these types of arrangement, and the hotel room example. Learn more at CaptainIntegrity.com

Send us a textQuality will always matter. In this episode, Captain Integrity Bob Wade discusses quality physician compensation as it relates to the Stark Law with Luis Argueso, Co-Founder & Partner at InHealth Advisors. Hear why quality matters, how to translate that importance of quality into effective incentives for healthcare providers, why there's a lot of opportunity for innovation in this space, how quality relates to Fair Market Value (FMV), and some “stupid dad jokes” from Bob. Learn more at CaptainIntegrity.com

Send us a textThis is a fascinating moment in the history of the world. In this episode, Captain Integrity Bob Wade discusses social media and the online world as it relates to healthcare providers and the Stark Law with Mark Weinstein, Author of “Restoring Our Sanity Online” and Speaker of the hit TEDx talk, “The Rise of Surveillance Capitalism.” Hear why Big Tech is driving us mad and we have to get it fixed in a hurry, key lessons we can apply to other industries from Big Ag, Big Energy, and Big Tech, how web platforms can succeed while rejecting horrible practices, how to navigate AI (Artificial Intelligence) as a healthcare provider, and what the early days of social media were like. Learn more at CaptainIntegrity.com 

Send us a textWhat do The Addams Family, 1960s, OIG Agents, Medicare, and Halloween have in common? In this special Halloween episode, Captain Integrity Bob Wade explains the connection as it relates to the Stark Law. Hear all the ‘60s nostalgia you can handle, the history of The Addams Family and creator Charles Addams, the potential for a Captain Integrity TV show, the history of Medicare, and Bob's special Halloween poem (sung to the tune of The Addams Family), “The Halloween OIG Agents.” Email Bob to get a printed copy of the poem and learn more at CaptainIntegrity.com

Send us a textIs there such a thing as a free lunch in healthcare? In this episode, Captain Integrity Bob Wade gives you the rules, regulations, and requirements as it relates to the Stark Law. Hear why there's no such thing as a free lunch, what you can do when there are service deficiencies, how to approach providing technology, recent cases that involve free lunches, and the history of free lunches. Learn more at CaptainIntegrity.com

The False Claims Act—alongside the Anti-Kickback Statute and Stark Law—represents one of the five core fraud, waste, and abuse laws identified by the HHS Office of the Inspector General. Out of the billions of dollars reclaimed through False Claims Act recoveries in 2023, the majority was attributed to the healthcare industry. This concerning trend highlights the importance of maintaining robust compliance programs and prioritizing education surrounding these regulations. In this episode of 1st Talk Compliance, Rachel Rose, JD, MBA discusses recent key developments in the False Claims Act landscape and shares tips on how healthcare providers can enhance their compliance strategies and mitigate regulatory risks. Tune in to gain a comprehensive understanding of the False Claims Act and its role in the healthcare sector, hear updates on several recent significant fraud, waste, and abuse cases, and receive actionable insights into bolstering your organization's compliance initiatives.

A referral by a physician of a Designated Health Service (DHS) is the key to opening up the Stark Law City. In this episode, Captain Integrity Bob Wade explains what a DHS is and how they're categorized. Hear why you should add the CMS (Centers for Medicare & Medicaid Services) website page about the Stark Law to your Favorites, which Stark Law categories are defined by the CPT/HCPCS code, the scenarios where the Stark Law doesn't apply, what defines a DHS, and the time Captain Integrity got the Key to the City. Learn more at CaptainIntegrity.com and email Bob to get the slide

The Faculty of Law holds an annual Open Day for undergraduate students, at which members of the Faculty discuss the Faculty, the Cambridge admissions system, and the benefits studying Law at Cambridge, The Open Day gives potential students, and their parents and teachers, a chance to look around the Faculty and the Squire Law Library, meet members of Faculty staff, and ask any questions they might have.In this lecture on 3 July 2024, Professor Findlay Stark gives an interactive lecture on the law of criminal damage.You can download the slides from this presentation from:https://resources.law.cam.ac.uk/documents/open_day/open_day_2024_without_lawful_excuse.pdfThe general talks given at this Open Day are available to listen to in this podcast, or can be watched on YouTube.The Open Day programme:Welcome to the Faculty: Professor Mark ElliottLaw at Cambridge: Dr Christina AngelopoulosWithout Lawful Excuse: Professor Findlay StarkLegal Problems: Professor Janet O'Sullivan & Professor Graham VirgoApplying to Cambridge Law: Dr Tom Hawker-DawsonFor more information about the Undergraduate BA Law Tripos Degree please refer to:http://ba.law.cam.ac.uk

What was the Correlation Theory under the Stark Law? In this episode, Captain Integrity Bob Wade explains what it was and how it differs from the Volume or Value Varying Standard and Volume or Value Determination Standard. Hear why the Correlation Theory is dead, when it can still be a valid theory, what to focus on when it comes to Volume or Value, what happened in the Bookwalter case, and some of the most common conspiracy theories and math theories. Learn more at CaptainIntegrity.com

Are percentage-based compensation arrangements permitted under the Stark Law? In this episode, Captain Integrity Bob Wade explores the answer. Hear the circumstances where percentage-based compensation arrangements are permissible, why they're prohibited when it comes to office space or equipment rentals, the difference between percentages and percentage points, the most common exceptions where percentage-based compensation arrangements are used, and a poem read by Captain Integrity himself. Learn more at CaptainIntegrity.com

To per-click or not to per-click? That is the question. In this episode, Captain Integrity Bob Wade breaks down all things per-click arrangements under the Stark Law. Hear why per-click arrangements are permissible under limited circumstances, how it works with lessors and lessees, what you can bundle together, the most common misconceptions about per-click arrangements, and everything from Shakespeare to Sesame Street. Learn more at CaptainIntegrity.com

Joe Wolfe, Attorney, Hall Render Killian Heath & Lyman PC, speaks with Charles Oppenheim, Partner, Hooper Lundy & Bookman PC, about trends, updates, reforms, and developments related to the Stark Law. They discuss the history of Stark and recent reforms, how both new and experienced lawyers can approach Stark, practical applications of the 2021 changes, and best practices for analyzing financial arrangements and creating compliance processes. Charles is the author of the supplement to the Seventh Edition of AHLA's The Stark Law: Comprehensive Analysis and Practical Guide. From AHLA's Fraud and Abuse Practice Group. Watch the conversation here.To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

How do you identify covert retaliation? In this episode, Captain Integrity Bob Wade reveals 8 categories of covert retaliation as they relate to the Stark Law. Hear the 2 broad categories of retaliation, how the anti-retaliation provisions under the False Claims Act (FCA) are separate causes of action an individual can bring against entity and individuals, why covert retaliation is the most challenging form of retaliation to identify, the origins of retaliation, and how it differs when it comes to government employees. Learn more at CaptainIntegrity.com

In this episode, Clint Davis, Senior Vice President & General Counsel at HealthTronics joins Dr. Silva to discuss the nuances of physician-industry partnerships in urology, focusing on mobile equipment services like shockwave lithotripsy and ureteroscopy. First, they delve into the Stark Law restrictions on physician referrals and the unique legal status of lithotripsy services. The conversation also covers partnership benefits, compliance strategies for different services, the importance of due diligence, and considerations for physicians looking to invest in or maintain ancillary income through such partnerships. Additionally, they explore the impact of the Federal Sunshine Act on partnership reporting obligations, as well as advice for navigating hospital policies and ensuring legal and financial protections when engaging in these partnerships. --- SHOW NOTES 00:00 - Introduction 06:38 - Exploring Physician Partnerships and Investment Models 10:28 - Navigating Legal and Regulatory Aspects of Urology Partnerships 12:43 - Investment Strategies and Compliance for Urologists 21:42 - Addressing Common Concerns and Opportunities in Urology Partnerships 34:53 - Advice on Urology Partnerships --- RESOURCES HealthTronics https://www.healthtronics.com/

Billions of dollars are spent on marketing in the healthcare sector each year. In this episode, Captain Integrity Bob Wade explains why such marketing can cause issues under the Stark Law and Anti-Kickback Statute (AKS). Hear why marketing between referral sources is not illegal, you need to look at the development and placement of the advertisement, Fair Market Value (FMV) is king, the typical amount different medical specialties spend each month on marketing, and the different types of ads you can run. Learn more at CaptainIntegrity.com

Welcome to a very special episode of The Veterinary Roundtable! This week we are joined by the infamous Dr. Evan Levine who has caused quite the stir in recent weeks over his TikToks discussing veterinary medicine. In this episode, we discuss where the ideas for these videos started, if pets are a luxury, defining what affordable pet care means, if the human healthcare model would work in our industry, and more!Do you have a question for The Veterinary Roundtable? Ask us on any social media platform or email harrison@kingmediamarketing.com!Do you have an icebreaker? Ask us on any social media platform or email harrison@kingmediamarketing.com!Episodes of The Veterinary Roundtable are on all podcast services along with video form on YouTube!Instagram: https://tinyurl.com/2h27xnfu TikTok: https://tinyurl.com/m8f62ame TIMESTAMPSIntro 00:00Dr. Levine's Background 01:16Why Dr. Levine Started Posting About Vet Med 05:45The Vet Med Community's Response 12:00Dr. King Doesn't Feel Bad About "Upcharging" 14:42Comparing Stark Law To Vet Med 15:34Pets Are An Optional Expense 18:20The Reasoning Behind "Upcharging" 21:35Defining What Affordable Pet Care Looks Like 28:49Nobody Knows What Anything Costs In Human Healthcare 32:22Dr. Levine's Hypothetical Pet Insurance 34:32Capping A Veterinarian's Profit 40:10Veterinarians Aren't In It For The Money 46:08Dr. Levine Wants Pet Owners To Know About "Upcharging" 51:55Is Pet Care Affordable? 56:32Introducing A Mid-Tier Position Into Vet Med 01:02:31What Happens To Animal Shelters If People Can't Afford Care? 01:05:45Regulation In Veterinary Medicine 01:07:26Would One Corporation Taking Over Vet Med Help? 01:09:23Outro 01:22:40

Does the Stark Law have a de minimis compensation exception? In this episode, Captain Integrity Bob Wade explores whether one exists. Hear what a de minimis compensation exception means, why the compensation must still be Fair Market Value (FMV) and Commercially Reasonable (CR), why you don't need to have a written agreement after the fact, examples from the world of the Stark Law, and a brief history lesson on exceptions. Learn more at CaptainIntegrity.com

Darshan's LinkedIn: https://www.linkedin.com/in/darshankulkarni/CRIO: http://www.clinicalresearch.ioInato: https://go.inato.com/3VnSro6Join me at my conference! http://www.saveoursites.comText Me: (949) 415-6256My podcast is Random Musings From The Clinical Trials GuruListen on Spotify: https://open.spotify.com/show/7JF6FNvoLnBpfIrLNCcg7aGET THE BOOK! https://www.amazon.com/Comprehensive-Guide-Clinical-Research-Practical/dp/1090349521/ref=sr_1_1?keywords=Dan+Sfera&qid=1691974540&s=audible&sr=1-1-catcorrText "guru" to 855-942-5288 to join VIP list!My blog: http://www.TheClinicalTrialsGuru.comMy CRO and Site Network: http://www.DSCScro.comMy CRA Academy: http://www.TheCRAacademy.comMy CRC Academy: http://www.TheCRCacademy.comLatinos In Clinical Research: http://www.LatinosinClinicalResearch.comThe University Of Clinical Research: https://www.theuniversityofclinicalresearch.com/My TikTok: DanSferaTimestamps:Fraud and investing in the stock market. (0:00)US-China decoupling and Wushi Aptech's impact. (6:27)Vetting sponsors and mitigating risk in clinical trials. (13:22)US-China relations and investing in tech companies. (17:57)Email outreach strategies for startups. (22:44)Protecting intellectual property in clinical trials. (25:43)Legal agreements for clinical trials. (31:17)Site ownership and exclusivity agreements. (37:15)Clinical trial site compliance and Stark Law. (41:25)Compliance and fraud in clinical research. (47:50)Clinical trial site compliance and regulatory issues. (52:07)

The Volume or Value Restriction under the Stark Law is a conundrum. In this episode, Captain Integrity Bob Wade breaks down how to approach compensation under the Stark Law. Hear why aggregate compensation can vary, why you can use the same analysis under the safe harbors under the Anti-Kickback Statute (AKS), why you should keep your compensation determination process separate, how volume and value are determined, and when to use volume or value. Learn more at CaptainIntegrity.com

Under the Stark Law, entities with medical staffs can pay for treatment and promotion of mental health. In this episode, Captain Integrity Bob Wade dives into the tough topics of substance abuse and addiction as they relate to the Stark Law. Hear why we're all addicted to something, the new exception under the Stark Law, why the exception is a good thing, the 5 characteristics of an addiction, and which medical profession has the highest burnout rate. Learn more at CaptainIntegrity.com

Commercial Reasonableness is like a pie. Fair Market Value (FMV) is like a slice of the pie. In this episode, Captain Integrity Bob Wade discusses the latest on FMV under the Stark Law with Tim Smith, Principal at TS Healthcare Consulting. Hear why you need to study the regs, start doing economic analysis, start developing in-house expertise in this area, what you need to say loudly and clearly, and insights from Tim's book, “The Complete Guide to Fair Market Value Under the Stark Regulations.” Learn more at CaptainIntegrity.com

In this podcast episode, Gary interviews Mysty Blagg, a North Carolina attorney with a healthcare and compliance investigation background. Mysty discusses her transition from the medical field to law, seeking a career with more flexibility to balance work and family life. She shares her struggles with stress and the importance of mindfulness and hobbies like gardening and golf for maintaining work-life balance. Mysty also talks about her podcast, "The Zealous Advocate," which offers insights for lawyers on advocacy, mental health, and technology. She emphasizes the value of learning from failure, the importance of listening skills, and the support she receives from her law firm. Listeners can find Mysty's podcast on Spotify and connect with her on LinkedIn or through her law firm, Shipman and Wright LLP. Mysty Blagg helps healthcare professionals and companies achieve their strategic goals through her legal representation. She is a second-career healthcare advocate who brings over twenty years of prior healthcare industry experience into law practice.  Her clients benefit from her unique and valued perspective from her previous careers as a healthcare compliance investigator, Medicaid appeals specialist, and a registered dental hygienist. She leverages her experience as a Medicaid healthcare compliance investigator to assist clients in maintaining an effective compliance program, responding to government investigations and audits, and complying with healthcare fraud and abuse laws such as the False Claims Act, Anti-kickback Statute, and Stark Law.  In addition, Mysty assists clients with various other healthcare transactional matters, including contract drafting and review. Mysty spends time with her three children, husband, and golden retriever playing on the beach in her free time.  She also enjoys playing golf and listening to local bands. Would you like to learn more about Breaking Free or order your copy? https://www.garymiles.net/break-free Some highlights of this episode: Balancing Work and Family (00:01:49) Misty's strategies for maintaining work-life balance with a challenging legal career and a family. Meditation and Stress Management (00:03:36) Misty's approach to stress management and the importance of intentional activities like meditation and golf. Overcoming Mindset Obstacles (00:06:32) Misty's insights on overcoming self-doubt and reframing thoughts in the practice of law. Finding Fulfillment in Legal Practice (00:10:38) Misty's motivations and alignment of her legal career with her values and goals. Problem-Solving Methodology (00:12:25) The importance of being a good listener and making many telephone calls to solve clients' problems. Big Firm vs. Small Firm Experience (00:15:07) Benefits and drawbacks of working in a big firm versus a small firm based on Misty's experiences. Advice for Young Lawyers (00:17:34) Misty's suggestions for young lawyers in navigating their legal careers and prioritizing life goals over money.

Hear Captain Integrity Bob Wade read his original Stark Law holiday poems, “‘Twas the Night before the Subpoena,” “Rudy the Seasoned Compliance Officer,” and “Jolly OIG Agent.” Share the poems with your team and learn more at CaptainIntegrity.com

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Thank you, listeners, for making this 100th episode of Stark Integrity happen. In this special milestone and holiday episode, Captain Integrity Bob Wade reflects on 2023 and reads his latest custom Stark Law holiday poem, “Jolly OIG Agent.” Hear what Bob is grateful for in 2023, his latest thoughts on the Stark Law, the history of a certain controversial holiday poem, what to expect next from Stark Integrity, and the Stark Law holiday poem you can share with your team. Learn more at CaptainIntegrity.com

A chair is more than a chair. In this episode, Captain Integrity Bob Wade dives into fixed asset valuations under the Stark Law with Mike Vetter, Partner at HMS Valuation Partners. Hear why valuations in healthcare have additional regulatory guidelines and laws to follow, the devil is in the details, using a certified appraiser with healthcare experience can help keep you compliant, the weirdest fixed assets Mike has had to value, and what The Wizard of Oz has to do with fixed asset valuations. Learn more at CaptainIntegrity.com

There's going to be more and more competition in the healthcare space. In this episode, Captain Integrity Bob Wade discusses recruitment and the Physician Needs Assessment (PNA) as it relates to the Stark Law with Coker Group VP Stephen Ross and EVP Justin Chamblee. Hear why there will be a continued strain on organizations to provide access to high-quality healthcare, why you need to use and regularly update a PNA in order to confirm Commercial Reasonableness (CR), how the value of the PNA extends to supporting and informing growth of service lines and other health system initiatives, the latest trends in the workforce, and how to successfully recruit physicians while remaining in compliance. Learn more at CaptainIntegrity.com

There are a multitude of compliance issues related to medical directors. In this episode, Captain Integrity Bob Wade explains why there's a struggle, yet they're so important. Hear why you need to evaluate the commercial reasonableness (CR) of the medical director administrative arrangement, how to determine the hourly rate using clinical benchmark data, how to verify the services and hours are reasonable when the time records are available, famous Stark Law cases involving medical directors, and the key questions to ask when considering compensation. Learn more at CaptainIntegrity.com

Why are there timing requirements under the Stark Law? In this episode, Captain Integrity Bob Wade explores the background and details of these limitations. Hear why the 1-year term is a standalone provision under the exception, when the calendar year vs. a rolling period applies, why you should be careful about the multiple use of various exceptions, how timing limitations are determined, and an original poem for this episode. Learn more at CaptainIntegrity.com

There are a ton of considerations when it comes to hospital-based financial arrangements under the Stark Law. In this episode, Captain Integrity Bob Wade goes into the numbers and details with Joe Aguilar, Partner at HMS Valuation Partners. Hear why it's important to include all aspects of revenue when determining Fair Market Value (FMV), why you need to understand the Full-Time Equivalents (FTEs), why you shouldn't be afraid to start considering building the service line in house, why the devil is in the details, and Joe's additional experience as a nurse practitioner. Learn more at CaptainIntegrity.com

A master list reference is sometimes necessary under the Stark Law. In this episode - suggested by a Stark Integrity listener - Captain Integrity Bob Wade explains when and why that's the case. Hear why creating a master list is just good practice, why it's a legal requirement to cross-reference it, why you need to dedicate resources to maintain a master list, some interesting numbers tied to master lists, and what The Sound of Music has to do with them. Learn more at CaptainIntegrity.com

When do you need to enter into the Self-Referral Disclosure Protocol (SRDP)? In this episode, Captain Integrity Bob Wade talks the notable settlements and timing under the SRDP. Hear how the CMS (Centers for Medicare and Medicaid Services) is investing greater resources to review and settle these Stark Law violations, why it can be a long process, why it's advantageous to enter the protocol process, how to do so, and the record-setting numbers tied to the SRDP. Learn more at CaptainIntegrity.com

Hear Captain Integrity Bob Wade perform his original Stark Law Halloween song, “Compliance Mash.” Share the song with your team and learn more at CaptainIntegrity.com

The Stark Law has its own exception related to Academic Medical Centers. In this episode, Captain Integrity Bob Wade explores its application and alternatives. Hear the definition of Academic Medical Centers, where there's some leeway, why you might not need to meet the exception, direct vs. indirect compensation arrangements, and how research grants impact things. Learn more at CaptainIntegrity.com

There have been some surprising and some not-so-surprising settlements under the False Claims Act (FCA) so far in 2023. In this episode, Captain Integrity Bob Wade details the most interesting decisions. Hear why the qui tam bar is still extremely active, there appears to be a great focus on the specialty of ophthalmology, Fair Market Value (FMV) and Stark Law issues are still high on the list, the most notable cases, and one that has a shock factor. Learn more at CaptainIntegrity.com

There is a legal storm brewing over the definition of remuneration. In this episode, Captain Integrity Bob Wade breaks down all the factors under the Stark Law. Hear why it needs to meet a safe harbor, it needs to meet Fair Market Value (FMV) and Commercial Reasonableness (CR), why you shouldn't make the connection between the financial arrangement and the inducement for referrals, notable cases to discuss, and how the transfer of value plays into things. Learn more at CaptainIntegrity.com

The Stark Law prohibits physicians from referring patients to entities in which they have a financial interest to prevent financial incentives from driving medical decision-making. The Anti-Kickback Statute prohibits the exchange of anything of value in exchange for referrals for services. Examples of Stark Law violations:A cardiologist refers patients to a diagnostic testing facility in which he has a financial interest. A physician is found to be billing Medicare for services provided by an unlicensed midlevel. Other Exceptions to the Stark Law "In-office ancillary services" allows physicians to refer patients for certain designated health services provided in the same building where the physician's medical practice is located if the service is furnished under the direct supervision of the referring physician or another provider in the same group practice and that the arrangement complies with fair market value (FMV). Healthcare providers to give non-monetary compensation to physicians and their families up to the annual limit. FMV compensation allows providers to enter into financial relationships with other providers if does not take into account the volume or value of referrals.Academic medical centers that meet certain criteria may provide compensation to physicians who are engaged in teaching or research activities.Rural providers  may be able to enter into certain financial relationships that would otherwise be prohibited under the Stark Law provided certain criteria are met. Safe harbor provisions that provide exceptions to the Anti-Kickback Statute :Investments in entities that provide healthcare services if held for one year, and is not be tied to the volume or value of referrals. Office space or equipment rented between providers if the rental amount is consistent with FMV and is for a period of at least one year.Personal services and management contracts between healthcare providers if the compensation paid is at FMV and  not be tied to the volume or value of referrals.The key takeaways—you can't do things that are tied to volume or referrals and any financial arrangement has to be at FMV. I strongly urge you to discuss Stark and AntiKickback with your healthcare attorney so that you know what is required to be in compliance.Earn credits: https://earnc.me/HnuHBDWant to hear more tips on how to start, run and grow your practice and related medical businesses, please sign up for my newsletter at https://www.thepracticebuildingmd.com Join my FB group, The Private Medical Practice Academy.Enroll in How To Start Your Own Practice and get the step-by-step process for opening your practice.Join The Private Medical Practice Academy Membership for live group coaching, expert guest speakers and everything you need to know to start, grow and leverage your private practice. The course, How To Start Your Own Practice is included in the membership, as a bonus.Rate, Review, & Follow on Apple Podcasts"I love Sandy Weitz and The Private Medical Practice Academy Podcast."

There's a lot we can learn from the landmark Tuomey case in the healthcare industry. In this episode, Captain Integrity Bob Wade discusses the Stark Law and legal learnings with someone who was involved firsthand in the case: Bart Daniel, Partner at Nelson Mullins. Hear why you shouldn't dig the hole deeper, why you should take 1 appraisal and stick with it, how to settle a False Claims Act case, why the Tuomey case went down the way it did, and why it ended up being a way bigger case than initially thought. Learn more at CaptainIntegrity.com

Healthcare transactions are different from ordinary transactions. In this episode, Captain Integrity Bob Wade discusses the issues we should be focusing on in the healthcare space. Hear how to ensure the arrangement is Fair Market Value (FMV), why you should purchase assets, when not to assume liability for physicians, the biggest transactional issues in the healthcare space, and when to figure out if the Stark Law applies. Learn more at CaptainIntegrity.com

In this 15 minute episode Sean tackles the issues with routine waiver of copays and/or deductibles, professional courtesy, and the potential implications with the FCA, Health Care Fraud Statute, Anti-Kickback Statute, and Stark Law. Sean addresses the Special Fraud Alert from OIG on why it's illegal for "charged-based" providers, practitioners and suppliers to Routinely Waive Copayment and Deductibles! https://oig.hhs.gov/documents/special-fraud-alerts/876/121994.html