Podcasts about anti kickback statute

On this episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar look at what happens when an OIG Advisory Opinion on pharmaceutical subsidies turns into a court battle over the language of the Anti-Kickback Statute.  Listen now to this episode of The Kickback Chronicles to see what you can learn from the misfortune of others.

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

In this episode, our guest is Arielle Miliambro, a Partner specializing in regulatory and transactional law within the Healthcare & Life Sciences departments. She assists clients with legal issues related to telehealth, data privacy, value-based care, and fraud compliance. She offers counsel on regulations like the Anti-Kickback Statute and prepares requests for OIG Advisory Opinions.Arielle also guides stakeholders in telehealth and digital health models on fraud, corporate practice, and virtual care requirements. Additionally, she advises clients on data security and privacy issues, including HIPAA compliance and data breach response. She works with providers to develop value-based care and alternative payment models.Her expertise extends to pharmacy clients, whom she advises on remote prescription processing, compliance, and licensing board matters. She also assists practitioners with in-office dispensing and scope of practice concerns. Furthermore, Arielle supports clients with corporate transactional matters, drafting various legal agreements and documents.Telehealth Topics for PodcastWhat is the difference between telehealth and telepharmacyPharmacy role in bigger picture of telehealth modelsConsiderations for kickbacks/fee splitting in telehealth models depending on pharmacy's reimbursementPharmacists duty to validate script prior to dispensingTelehealth “red flags”Where does the line get drawn as to pharmacist's obligations with respect to the actual patient encounter between prescriber/patientCovid changesStateLicensing flexibility for prescribersScope of practice of pharmacistsFederalTelehealth reimbursementDEA prescribingHistory / status of new rules related to CDS prescribingTelehealth vs Telepharmacy DifferencesBrief overview distinguishing the definitions of each:Telehealth: Remote provision of clinical careTelepharmacy: Remote provision of pharmacy services (e.g., offsite pharmacist doing DUR, offering patient counseling)Changes in Telehealth During CovidFederal and State WaiversDEA waivers (current through 2025)Physician licensing waivers by state (expired)Modality flexibilities (mostly expired; some extended/made permanent depending on payor)Pharmacist Obligations in Validating Telehealth PrescriptionsPharmacist obligations/dutiesBOP audits/investigations originating from BMEMaintaining Out-of-State Licenses for Telehealth PatientsDEA Updates with Proposed/New Final RulesGuest - Arielle MiliambroLinkedIn: Frier Levitt | LinkedInInstagram: N/AWebsite: Frier Levitt | LinkedInYouTube: Frier Levitt - YouTubeTwitter/X: (2) Frier Levitt (@FrierLevitt) / X (twitter.com)Host - Hillary Blackburn, PharmD, MBAwww.hillaryblackburn.com  https://www.linkedin.com/in/hillary-blackburn-67a92421/ @talktoyourpharmacist for Instagram and Facebook ★ Support this podcast on Patreon ★

Send us a textWhen is the violation of the Anti-Kickback Statute a False Claims Act liability? In this episode, Captain Integrity Bob Wade explains the scenario given a recent district court decision. Hear how the “But For” Causation Standard works under the False Claims Act (FCA) and Anti-Kickback Statute (AKS), how the language has changed under the Anti-Kickback Statute, why the issues brought forward were bifurcated, how sales reps played into the decision, and an analogy involving roller coasters & Cedar Point. 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.

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.

Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickbacks and engaging in a money laundering conspiracy. This case has significant implications for promotional compliance within the pharmacy industry, and we're here to explore them in detail.In a landmark case, the Department of Justice sentenced Richard Hall, a 53-year-old pharmacy owner from Fort Worth, to several years in prison. The charges? Hall paid illegal kickbacks to patient recruiters and physicians, leading to unnecessary prescriptions and defrauding federal healthcare programs. Court documents and trial evidence revealed that Hall, along with others, created and marketed expensive compounded medications. These medications, meant to be custom-tailored to individual patient needs, became the focal point of the fraud. Hall paid marketers to recruit doctors to write prescriptions for these costly compounded medications, offering "investment opportunities" that allowed the doctors to profit from the pharmacy operations. Furthermore, Hall engaged in a conspiracy to launder the unlawful proceeds of this scheme.The Anti-Kickback Statute is explicit – financial incentives should never influence healthcare decisions. Yet, Hall crossed this line, resulting in severe legal consequences. This case was not just about kickbacks; it also involved money laundering to conceal the origins of the illicit funds. Such actions undermine the integrity of the healthcare system and highlight the critical need for strict compliance with legal and ethical standards.This scandal emphasizes the importance of ensuring that: Every prescription dispensed is medically necessary and appropriately documented. As pharmacists and pharmacy marketers, it is our duty to prioritize patient care and uphold the highest ethical standards. The ramifications of failing to do so can be devastating, both legally and professionally.So, what steps can you take to avoid similar pitfalls? First, steer clear of any financial incentives that could be construed as kickbacks. Second, ensure that every prescription is justified by medical necessity. Third, closely monitor financial transactions to ensure they comply with all legal requirements.Support the Show.

Denver-based DaVita Inc. has agreed to pay slightly more than $34 million to resolve allegations that it violated the False Claims Act (FCA).The U.S. Department of Justice (DOJ) reported in a news release that DaVita paid kickbacks to induce referrals to DaVita Rx, a former subsidiary that provided pharmacy services for dialysis patients, directing the payments to nephrologists and vascular access physicians.During the next live edition of Monitor Mondays, famed whistleblower attorney Mary Inman will report the details on this amazing story, focusing on the provisions of the Anti-Kickback Statute that prohibit anyone to induce referrals of patients or items for services covered by Medicare, Medicaid, and other federally funded programs.Other broadcast segments will include these instantly recognizable features:• Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds.• The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors.• Legislative Update: Kate Choe, an undergraduate student at Brown University who is also interning at Zelis, will report on current healthcare legislation.• Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.

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.

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

Join Ropes & Gray's attorneys for a three-part podcast series exploring recent regulatory, compliance, and enforcement developments in the fraud, waste, and abuse space and the potential implications for health care and life science companies in 2024. In this first installment, health care partners Devin Cohen and Michael Lampert discuss key considerations for understanding recent advisory opinions published by the U.S. Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”), as well as their scope and implications. With particular focus on advisory opinions concerning beneficiary inducements to patients, this episode examines Anti-Kickback Statute and Civil Monetary Penalties Law concerns with such arrangements, as well as factors OIG has deemed to alleviate such concerns in the advisory opinions it issued in the past year. 

Hear from leading prosecutors in the Boston U.S. Attorney's Office about recent enforcement trends in the life sciences industry involving the False Claims Act, Anti-Kickback Statute and fraud and abuse regulations, as well as the DOJ's latest approach to self-disclosure and cooperation in civil and criminal investigations. How would you counsel your client about the self-disclosure process or cooperating with a government investigation? You will also learn key strategies from a seasoned member of the life sciences litigation Bar about the nuances to consider when advising your client, communicating with law enforcement, and designing a compliance plan.   Questions? Inquiries about program materials? Contact Trenon Browne at tbrowne@bostonbar.org

This Day in Legal History: The Raven is PublishedOn January 29, 1845, a significant event in literary history indirectly influenced the development of copyright law. Edgar Allan Poe's iconic poem, "The Raven," was published in the New York Evening Mirror. This moment, while primarily literary, holds substantial relevance in the context of copyright law and the protection of creative works."The Raven" quickly became a sensational hit, illustrating the immense commercial potential of literary works. However, Poe's financial gains from the poem were minimal, highlighting the inadequacies in the copyright system of the time. Poe's struggles with securing fair compensation for his works, including "The Raven," underscored the need for stronger legal protections for authors.During Poe's era, copyright laws were still in their infancy, particularly in the United States. The lack of robust international copyright agreements meant that Poe's works were often republished abroad without his consent and without any royalties paid to him. This was a common plight for many authors of the time, leading to widespread calls for reform."The Raven's" popularity, coupled with Poe's public struggles for rightful earnings, played a role in stirring public and legislative awareness about the rights of authors. It highlighted the importance of legal frameworks that balance the interests of creators, publishers, and the public.The plight of authors like Poe eventually contributed to the strengthening of copyright laws, both domestically and internationally. In the following decades, laws evolved to offer more comprehensive protection for intellectual property, ensuring that creators could reap the benefits of their work.Significantly, Poe's experience foreshadowed the complexities of copyright in the age of mass reproduction and distribution. His challenges anticipated the modern dilemmas faced in a digital era where replication and dissemination of works are effortless and widespread.In sum, while "The Raven" is primarily remembered as a masterpiece of poetry, its impact extends into the realm of legal history. Edgar Allan Poe's experiences with this poem contributed to the discourse on copyright law and the need for effective legal protections for intellectual property. His legacy, therefore, is not just literary, but also legal, underscoring the crucial relationship between creative works and the laws that safeguard them.The U.S. Department of Justice (DOJ) is investigating the healthcare industry's use of AI in patient records, which influences doctors' treatment recommendations. This scrutiny arises from concerns about AI's role in potential anti-kickback and false claims violations. Investigators are probing pharmaceutical and digital health companies, examining the impact of AI on healthcare decisions. These investigations are still in early stages, with DOJ attorneys seeking information about AI algorithms and their effects on medical care.The background of these probes can be traced to the 2020 criminal settlements with Purdue Pharma and Practice Fusion. They were penalized for creating AI-based alerts in electronic medical records (EMRs) that encouraged prescriptions of addictive painkillers. This case highlighted the risks of AI in healthcare, particularly when used unethically.Current AI tools in healthcare can both improve diagnoses and be exploited for profit. DOJ's challenge lies in applying laws like the Anti-Kickback Statute and False Claims Act to AI's complex, automated nature. Prosecutors are exploring civil and criminal avenues, considering evidence like internal communications and the AI's impact on prescriptions. These investigations signal a growing focus on the legal responsibilities of companies using AI in healthcare.DOJ's Healthcare Probes of AI Tools Rooted in Purdue Pharma CaseElite UK law firms, known as the Magic Circle, are losing the salary battle to US firms in London. These UK firms pay junior lawyers 35-40% less than the Cravath scale used by top US firms. UK firms' lower profits, due to increased competition and post-Brexit currency changes, hinder their ability to match US salaries. Since 2015, US firms have aggressively entered the UK market, especially in private equity work, often outbidding UK firms for talent. Kirkland & Ellis and Paul, Weiss are notable for hiring several partners in London.This competition has led to about 370 associates leaving Magic Circle firms in the last year, with US firms benefiting. UK firms have responded by increasing associate salaries and introducing bonus schemes. However, they still struggle to close the pay gap with US firms. The Cravath scale, adopted by US firms in London, offers significantly higher salaries, with first-year associates earning around $225,000. The salary disparity and market conditions raise concerns about the sustainability of high associate salaries.Elite UK Firms Are Losing London Salary Battle to US InvadersInvestors are concerned about Exxon Mobil's lawsuit against two shareholders for proposing a resolution on greenhouse gas emissions reduction, bypassing the U.S. Securities and Exchange Commission (SEC). Under Biden's SEC, it's become harder for companies to block shareholder resolutions, leading to a rise in such proposals. Exxon's lawsuit, which claims the resolution aims to diminish its fossil fuels business rather than increase shareholder value, is seen as potentially chilling for small investors. This action deviates from the norm where companies historically viewed the SEC as a fair arbiter for shareholder proposals.The Exxon case is significant as it challenges the recent SEC policy change that makes it difficult for companies to argue against resolutions on the grounds of micromanagement. The number of shareholder resolutions has increased, with 889 proposals filed during the 2023 proxy season. If Exxon succeeds in court, it might encourage other companies to follow suit, bypassing the SEC.This lawsuit comes amidst broader debates over the SEC's authority in enforcing shareholder proposals, with conservative courts possibly playing a role in the outcome. Exxon's approach is a departure from the standard practice of engaging with the SEC on such matters, and its success could reshape the landscape of shareholder activism, particularly in environmental and social governance issues.Activist investors fret over Exxon Mobil's lawsuit bypassing US regulator | ReutersReddit Inc. is considering a valuation of at least $5 billion for its initial public offering (IPO), based on early feedback from potential investors. However, this figure is still tentative and dependent on the recovering IPO market. The social media company, known for its significant role in the meme-stock era, is potentially aiming for a listing as early as March. Despite these ambitions, private trades of Reddit's unlisted shares currently suggest a lower valuation, between $4.5 billion and $4.8 billion. These private share valuations, which are often lower due to their illiquidity, contrast with Reddit's peak valuation of $10 billion in 2021.The fluctuating valuation reflects the broader downturn in the tech sector, where companies are valued lower in public markets compared to their peak private funding valuations. For instance, Instacart, once valued at $39 billion, debuted with a valuation of $9.9 billion and has since dropped to around $7.1 billion. Reddit's situation and potential IPO come at a time when tech IPOs are less lucrative than during the private funding boom of 2021. The company's decision and valuation are subject to ongoing deliberations and market conditions.Reddit Advised to Target at Least $5 Billion Value in IPO (1) Get full access to Minimum Competence - Daily Legal News Podcast at www.minimumcomp.com/subscribe

On this day in legal history, October 5, 1941, Supreme Court Justice Louis Brandeis died at the age of 84. Louis Brandeis was born on November 13, 1856, in Louisville, Kentucky. He graduated from Harvard Law School at the age of 20 with the highest grade point average in the school's history. In 1890, he gained recognition for developing the "right to privacy" concept through an article in the Harvard Law Review. Brandeis was a prominent figure in the antitrust movement and was known for his resistance to monopolies, particularly in the New England railroad sector. He also advised Woodrow Wilson and was critical of large banks and powerful corporations in his writings.Brandeis became active in the Zionist movement, viewing it as a solution to antisemitism in Europe and Russia. He was often referred to as the "People's Lawyer" and took cases without pay to focus on broader issues. He set a new precedent in evidence presentation with the "Brandeis brief," which utilized expert testimony from various professions. In 1916, President Woodrow Wilson nominated him to the U.S. Supreme Court, making him the first Jewish member. His nomination was met with significant opposition but was eventually confirmed by the Senate.During his tenure on the Supreme Court from 1916 to 1939, Brandeis became one of the most influential justices in history. He was known for his strong defenses of freedom of speech and the right to privacy. However, he has been criticized for not addressing issues related to African-Americans and for supporting racial segregation in some cases. Brandeis retired from the Supreme Court on February 13, 1939, and passed away on October 5, 1941, in Washington, D.C.The U.S. Court of Appeals for the Ninth Circuit is set to hear a case concerning Meta Platforms Inc., the parent company of Facebook, and its alleged preference for hiring workers on H-1B visas. The case, brought by appellant Purushothaman Rajaram, questions whether U.S. citizens are a protected class under Section 1981 of the 1866 Civil Rights Act. A federal district court previously dismissed the case, stating that the act does not cover "reverse discrimination" claims. Rajaram's lawyers argue that Section 1981 should be broadly interpreted to include U.S. citizens, while Meta contends that the law has traditionally been applied narrowly to race or alien status.The case also brings into focus Meta's hiring practices. The company was one of the top H-1B employers in fiscal year 2022, with over 1,500 approved petitions for new workers. Rajaram, a naturalized U.S. citizen, claims that Meta's hiring policies favor workers on H-1B visas over equally or more qualified U.S. citizens. If Rajaram wins, it could discourage companies from prioritizing H-1B workers over U.S. citizens.The Department of Justice and the Department of Labor have previously scrutinized Meta's H-1B hiring practices. The company settled those claims by paying over $14 million in civil penalties without admitting any wrongdoing. Rajaram's lawsuit aims to address citizenship discrimination in hiring more broadly, not just positions earmarked for visa workers.Experts note that the structure of the H-1B program itself may contribute to competition between visa holders and U.S. workers. Companies have little incentive to pay H-1B workers more than the prevailing wage, leading them to file as many petitions as possible for minimally qualified candidates. The case began with oral arguments yesterday. Meta's H-1B Hiring Spurs Ninth Circuit Look at Citizenship BiasA federal judge has ordered the Centers for Medicare & Medicaid Services (CMS) to withdraw a Trump-era rule concerning copay assistance programs. The rule had been challenged by patient advocacy groups, including the HIV+Hepatitis Policy Institute and the Diabetes Leadership Council, who claimed it allowed health plans to increase out-of-pocket prescription drug costs. Judge John D. Bates stated that the rule conflicted with the Affordable Care Act's definition of "cost-sharing" and must be set aside.The 2020 rule had stated that pharmacy benefit managers (PBMs), who manage prescription drug benefits for insurers, were not required to count drugmaker copay assistance toward patients' out-of-pocket costs. The patient groups argued that this allowed PBMs and health plans to collect funds from both patients and drugmakers without using the money to ease the financial burden on patients.The ruling is seen as a victory for these patient advocacy groups, who filed the lawsuit in August 2022. Carl Schmid, the executive director of the HIV+Hepatitis Policy Institute, expressed satisfaction with the court's decision and called on the Biden administration to enforce it immediately.The advocacy groups are backed by pharmaceutical companies like Pfizer, Johnson & Johnson, Abbott Laboratories, Eli Lilly & Co., and Merck & Co. While these companies can offer assistance to patients in commercial plans, such programs are prohibited in government-funded health insurance due to the Anti-Kickback Statute.The Department of Health and Human Services (HHS) had previously argued that manufacturer coupons could add long-term costs to the healthcare system, outweighing the short-term benefits. Both the Department of Justice, representing CMS and HHS, and a CMS spokesperson declined to comment on the ruling. The case is titled HIV & Hepatitis Policy Inst. v. Dep't of Health & Human Servs. and was filed on September 29, 2023.Judge Strikes Down Trump-Era Medicare Copay Assistance Rule (1)The trial of Sam Bankman-Fried, founder of the collapsed FTX cryptocurrency exchange, has begun with both sides presenting differing views on the reasons behind the company's failure. Bankman-Fried is accused of using FTX customer funds to support his hedge fund, Alameda Research, as well as for personal expenditures like luxury real estate and political donations. He has pleaded not guilty to these charges. His defense lawyer, Mark Cohen, portrayed him as a "math nerd" from MIT who may have overlooked risk management but did not engage in theft.Prosecutor Thane Rehn, however, argued that Bankman-Fried took more than $10 billion from FTX customers and used the funds to build his empire through fraudulent means. Rehn stated that the defendant "doubled down" on risky investments when Alameda began losing money. The prosecution plans to call three former associates of Bankman-Fried, all of whom have pleaded guilty and agreed to cooperate, to testify against him.The defense suggested that these witnesses might retrospectively portray Bankman-Fried's decisions as deceitful, even though they had agreed with those decisions at the time. The jury for the trial includes a diverse group of individuals, including a retired investment banker, a school librarian, and a train conductor. Bankman-Fried has been in detention since August 11 for likely tampering with witnesses.The trial comes nearly a year after the collapse of FTX, which had a significant impact on financial markets and damaged Bankman-Fried's reputation. It promises to offer an inside look into the operations of a cryptocurrency exchange and the legal boundaries within which such businesses operate.Sam Bankman-Fried trial jurors hear competing explanations for FTX collapse | ReutersJudge Arthur Engoron, overseeing Donald Trump's civil fraud trial in New York, expressed frustration with Trump's legal team for what he termed as "ridiculous" and redundant questioning of a witness. The trial is centered on allegations by the New York attorney general's office that Trump inflated his net worth by billions to secure better loan and insurance terms. Engoron, who is the sole decider of the case's outcome, has already disciplined Trump's lawyers for making "frivolous" arguments.Earlier, Engoron had imposed a gag order on public comments about court staff after Trump criticized the judge's top law clerk on social media. Trump, who has been present in court, has consistently attacked both the judge and New York Attorney General Letitia James, labeling them as "corrupt" and the case as a "sham."Last week, Engoron ruled that Trump, his two adult sons, and 10 of his companies had committed fraud. He revoked the business certificates for key assets, including Trump Tower and 40 Wall Street, and said he would appoint receivers for their dissolution. Trump's lawyers have appealed this decision.The trial mainly concerns the assessment of damages, with James seeking at least $250 million in fines and various bans against Trump and his sons from conducting business in New York. The trial is expected to continue until mid-December. Trump also faces other legal challenges, including four criminal indictments and a civil damages trial scheduled for January. He has denied wrongdoing in all cases.Judge chides Donald Trump lawyer's 'ridiculous' questioning in civil fraud trial | Reuters Get full access to Minimum Competence - Daily Legal News Podcast at www.minimumcomp.com/subscribe

The value-based Anti-Kickback Statute safe harbors and Physician Self-Referral exceptions are some of the most significant rulemaking related to these laws in years. Jennifer Michael, Member, Bass Berry & Sims, and Tony Maida, Partner, McDermott Will & Emery, discuss the background behind the rulemaking and some of the issues they are seeing around value-based arrangements. Jennifer and Michael are speaking at AHLA's upcoming 2023 Fraud and Compliance Forum in Baltimore, MD.To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

This was an epic episode that you do not want to miss. Scott, Terry, Stephanie and Christine joined Sean to discuss the False Claims Act, Anti-Kickback Statute, Template issues, and so much more!

In the Congressional Appropriations Act passed in December 2022, Congress adopted a new Stark exception and Anti-Kickback safe harbor for wellness programs for physicians and other clinicians. Specifically, the new law provides that counseling, mental health services, suicide and substance abuse prevention programs offered by hospitals and other providers with a formal medical staff will not violate the Stark law or Anti-Kickback Statute so long as the are set out in a board-approved policy that meets five specific elements described in the statute.Join HortySpringer Partners Henry Casale and Dan Mulholland on this new Health Law Expressions podcast episode as they explain the new law and what you should do to take advantage of it.  

From the Ingles Studios this is your news minute on the award winning Cherokee Tribune Ledger Podcast, presented by Dayco Systems. Today is Friday June 16th, and I'm Brian GiffinDr. James Ellner, his practice Georgia Pain Management, P.C., and the Samson Pain Center, P.C. in Woodstock have agreed to pay $625,000 to settle allegations of violating the False Claims Act. They were accused of submitting improper claims to Medicare and TRICARE for evaluation and management services and medically unnecessary urine drug screening tests. The U.S. Attorney's Office emphasized the importance of proper billing and holding healthcare providers accountable for overbilling federal healthcare programs. The allegations spanned from May 2015 to December 2019. The settlement also addressed an arrangement that violated the Anti-Kickback Statute, where a laboratory paid the salary of an individual in exchange for urine drug test referrals. A whistleblower will receive $118,000 from the settlement, and no determination of liability has been made.For more news about our community, visit tribune ledger news.com. For the tribune ledger podcast, I'm Brian Giffinwww.ingles-markets.com www.daycosystems.com www.henssler.comSee omnystudio.com/listener for privacy information.

In this episode Sean takes on the routine waiver of copayments and/or deductibles and why it's a really bad idea... There are many Administrative, Civil, and/or Criminal issues/penalties one faces for violating the False Claims Act, Health Care Fraud Statute, and/or the Anti-Kickback Statute(s) (Federal and State)... Charity of the Month: The Tafida Raqeeb Foundation https://tr-foundation.org/ Around 6000 children are diagnosed with serious brain injury in the UK every year which result in devastating effects on the child and their family. Children rarely receive the rehabilitation they require, predominantly due to the lack of available support. There is a limited number of specialist rehabilitation beds for children and young people in the UK. Acceptance to relevant services come with strict pre-requisites and waiting times can be lengthy. Private treatment is very expensive. All in all, many children have little access to rehabilitation and do not reach their full potential. Delivering support for these children and their families is the sole aim of the foundation.

Our colleague Erica Barnes joins hosts Heather and Lauren for a conversation on the Anti-Kickback Statute. We dive into critical information for health care providers across the spectrum when navigating the Anti-Kickback Statute as well as recent enforcement trends. Tune in to episode 142 now!

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."

Expert presenter, Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at Law, P.L.L.C., Houston, TX guides us through current trends and tips. With its roots stemming back to 1863, the False Claims Act continues to be the U.S. Department of Justice's primary enforcement tool for returning money to the Federal Treasury. It is also considered one of five fundamental fraud, waste, and abuse laws, which potentially impact a provider every time a claim is submitted to Medicare, Medicaid, and other government programs because of the attestation language. The purpose of this webinar is to provide a synopsis of the False Claims Act and the current landscape in relation to coverage determinations and the federal Anti-Kickback Statute.

Expert presenter, Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at Law, P.L.L.C., Houston, TX guides us through current trends and tips. With its roots stemming back to 1863, the False Claims Act continues to be the U.S. Department of Justice's primary enforcement tool for returning money to the Federal Treasury. It is also considered one of five fundamental fraud, waste, and abuse laws, which potentially impact a provider every time a claim is submitted to Medicare, Medicaid, and other government programs because of the attestation language. The purpose of this webinar is to provide a synopsis of the False Claims Act and the current landscape in relation to coverage determinations and the federal Anti-Kickback Statute.

In this episode, Norman Acker, Nora Becerra, and Katherine Rippey discuss the False Claims Act as it relates to Stark Law and the Anti-Kickback Statute. They analyze the Wheeling Hospital case and the Catholic Medical Center case and discuss key takeaways from the cases as they relate to the False Claims Act.  

Stuart Oberman is the President of Oberman Law Firm, providing strategic guidance to clients in healthcare law, corporate transactions, mergers & acquisitions, intellectual property and joint ventures. Mr. Oberman graduated from Urbana University and received his law degree from John Marshall Law School. Mr. Oberman has been practicing law for over 28 years. Before going into private practice, Mr. Oberman was in-house counsel for a Fortune 500 Company. Mr. Oberman is highly regarded on a national basis in the area of healthcare law, which includes DSO/MSO formation, corporate business structures, mergers and acquisitions, regulatory compliance, advertising regulations, HIPAA, Compliance, and employment law. Mr. Oberman's expertise in the healthcare industry includes advising clients in the complex regulatory landscape as it relates to telehealth and telemedicine, including compliance of corporate structures, third-party reimbursement, contract negotiations, technology, healthcare fraud, and abuse law (Anti-Kickback Statute and the State Law), professional liability risk management, federal and state regulations. https://obermanlaw.com Chelsea Myers, host, is the founder and CEO of Dental Life Coach (www.DentalLife.Coach). Dental Life Coach works with C-Suite, doctors, and teams to create scalable culture and increased profitability in some of the most successful dental support organizations. Dental Life Coach tools and resources are making a marked improvement in the way that goals are achieved and leaders are developed. To learn more about Dental Life Coach, executive coaching for dentists, increasing case acceptance rates, talent retention, and creating scalable culture visit www.DentalLife.Coach Dental Life Coach tools and resources are making a marked improvement in the way that goals are achieved and leaders are developed. To learn more about Dental Life Coach, executive coaching for dentists, increasing case acceptance rates, talent retention, and creating scalable culture visit www.DentalLife.Coach. //WATCH NEXT: ⏭️ //COME SAY HI!

Biogen has agreed to pay $900 million to resolve allegations that it violated federal law by paying kickbacks to doctors to persuade them to prescribe its multiple sclerosis drugs, federal prosecutors said. The agreement settled a whistleblower lawsuit brought by former Biogen employee Michael Bawduniak, according to a statement from the office of U.S. attorney for Massachusetts, Rachael Rollins. Under the terms of the settlement, Biogen will pay more than $843 million to the federal government and more than $56 million to 15 states for overbilling Medicare and Medicaid insurance programs. Bawduniak will receive a portion of the federal recovery. The Cambridge, Massachusetts-based pharmaceutical company in a statement said it settled so it can focus on “our patients and strategic priorities” and said the settlement does not include an admission of liability. “Biogen believes its intent and conduct was at all times lawful and appropriate and Biogen denies all allegations raised in this case,” the company's statement said. The lawsuit alleged that from January 2009 through March 2014, Biogen paid physicians speaking fees, consulting fees and bought them meals that were actually kickbacks, to get them to prescribe Avonex, Tysabri and Tecfidera in violation of the Anti-Kickback Statute. “We thank Mr. Bawduniak for uncovering this behavior and bringing it to light,” Rollins said. “This matter is an important example of the vital role that whistleblowers and their attorneys can play in protecting our nation's public health care programs.” This article was provided by The Associated Press.

I saw a Tweet from Farzad Mostashari, MD, the other day; and I'm gonna rewrite it in the context of today's show: This is why we can't have nice things! As soon as someone comes up with something that might accomplish some good things when done in moderation and with good intent, it gets exploited for revenue maximization. I have to admit, this conversation with Aaron Mitchell, MD, MPH, and actually the one with Mark Miller, PhD (EP380), from two episodes ago were both kind of painful for me—and let me tell you why. It's the same reason I find conversations painful about hospitals or leading cancer centers or even some self-insured employers and EBCs (employee benefit consultants): It hurts my heart when some percentage of healthcare industry peeps who have the opportunity to produce so much good in the world instead choose to do stuff that is financially or otherwise toxic. But let me get to the point of today's show. Dr. Aaron Mitchell and I are talking about conflicts of interest (COI), and we're talking about COI in the payments that are made from Pharma to physicians. COI might mean when physicians are paid in a way that skews their clinical decision-making. Nobody wants to be the patient of a physician with skewed decision-making, after all. That's the “why” of this whole discourse. Now, let's get into two important points re: skewed decision-making. Any payment that skews decision-making is, in fact, considered no bueno by the current writing of the AKS, the anti-kickback statute. Second, almost any payment, direct or indirect, turns out, skews physician decision-making. It's not just getting paid the big bucks to make a speech or consult or whatever. Getting a modest free lunch can also have the same effect. Prescribing is affected. That's what the data show and what the recent paper that Dr. Aaron Mitchell and his colleagues published in the Journal of Health Politics, Policy and Law articulates. Their paper is titled “Industry Payments to Physicians Are Kickbacks: How Should Stakeholders Respond?” So, hmmm. Much to cogitate upon in what I just said, which is what the conversation with Dr. Aaron Mitchell that follows is all about. But let me offer up a few spoilers and maybe some additional thoughts. First of all, some “Are payments COI and kickbacks?” contemplations are pretty black and white. We start out the conversation in this healthcare podcast talking about the recent Biogen incident, I guess I'll call it, which is sadly not an outlier. Biogen never admitted any wrongdoing here. But if what they are accused of doing is true, this could be considered not a gray area. This is black-and-white COI—unquestionably should not happen. But where things get a little bit more open to interpretation and require some consideration and thoughtfulness is if we're trying to weigh the gray in the middle between black and white. Here, what needs to be thought through is the aggregate good versus the aggregate bad of Pharma paying physicians to do stuff or buying things for them. If Pharma needs help during its clinical trials to figure out a breakthrough therapy and they want to talk to leading experts in a specialty, that's maybe a good thing so that they can get a drug that actually works well for patients. So is—and this is me talking, not Dr. Mitchell—but I could see that Pharma helping to figure out ways to educate clinicians about the best ways to help patients suffering with real diseases that nobody else is making any effort to do anything about at a national scale … it could help humans live better lives if Pharma takes the advice of the right thought leaders and helps to disseminate their teachings. Maybe physician societies could fill this role, but a lot of times, who needs educated are not the actual doctors in the society in question. It's other doctors the patient is seeing who don't realize the root cause is a GI problem or CKD (chronic kidney disease) until the patient needs a liver transplant or “crashes” into dialysis in the ER. But irrespective of the validity of my musings here, the point is to quantify the in-aggregate “good” that might happen as a result of Pharma paying appropriate clinical experts appropriate amounts. Contrast that aggregate good against some not so good. Study findings that Pharma can drive up not only Rx's (prescriptions) for its own drugs but also drugs in general when they buy stuff for doctors or pay doctors. Patient populations get overmedicated when compared to a baseline as a result. Too many patients get diagnosed and treated for some condition that they may not actually have. Too many expensive me-too drugs get prescribed at big unnecessary costs to patients, taxpayers, and employers. When I say costs to patients, by the way, I also might be implying a clinical overtone here as much as a financial one, because there's almost no drug that comes without side effects. So, what are some solutions that Dr. Aaron Mitchell mentions in this episode, or I that bring up, if we are trying to steer physician payments into the aggregate good zone and out of the bad COI zone? Here we go, and these are not necessarily in the order in which they are discussed: Keep an eye on practice patterns and overall costs. This might make physicians aware when their clinical decision-making is getting swayed, so to speak. Get payers involved. Listen to this whole episode for the “how” and “why” here, but if anyone has a visceral reaction to this, here's one possible positive from a physician standpoint: It could be a way to get rid of a lot of PAs (prior auths). If a doc's practice pattern is average, on trend, and/or they do not take industry dollars, then they get what amounts to a PA gold card. With that carrot, a doc may have less inclination to let their prescribing decisions sway and/or take pharma dollars. The federal government can get involved in a few ways that Dr. Mitchell talks about. One of them is a direct ban on all payments. Or maybe they could just clarify what is okay and what is not okay, since what is listed as COI in the current AKS is also currently considered an industry norm. Asking providers themselves to pay attention and self-regulate and to, for example, not accept speaking gigs where they are paid to talk to an empty room or “consult” on topics that really they should know they're not thought leaders in. You can learn more at Dr. Mitchell's personal profile on the Memorial Sloan Kettering Cancer Center Web site. You can also connect with Dr. Mitchell on Twitter at @TheWonkologist. Aaron Mitchell, MD, MPH, is a practicing medical oncologist and health services researcher. He is an assistant attending at Memorial Sloan Kettering Cancer Center in the department of epidemiology and biostatistics. His research focuses on understanding how the financial incentives in the healthcare system affect physician practice patterns and care delivery to cancer patients. He cares for patients with prostate and bladder cancer. 07:32 How does the recent whistleblower case serve as a good example of what shouldn't be permissible in Pharma? 11:23 “There's a little bit of a disconnect between what the law currently says and maybe the ideal world that we would want.” 11:56 Dr. Aaron Mitchell's paper in the Journal of Health Politics, Policy and Law, titled “Industry Payments to Physicians Are Kickbacks: How Should Stakeholders Respond?” 14:37 How should stakeholders react to this new legislation? 17:56 What is the aggregate benefit versus risk of these payments to doctors? 19:53 BMJ paper by Tyler Greenway and Joseph Ross. 23:51 What should providers and the federal government be doing in light of this new legislation? 29:07 “It's just always so much harder to get to the outcomes because there's so much more that happens in between the clinical decision and then what the patient's outcome is down the road.” 30:42 Will innovation be stifled with this new crackdown on kickbacks? You can learn more at Dr. Mitchell's personal profile on the Memorial Sloan Kettering Cancer Center Web site. You can also connect with Dr. Mitchell on Twitter at @TheWonkologist. @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth How does the recent whistleblower case serve as a good example of what shouldn't be permissible in Pharma? @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth “There's a little bit of a disconnect between what the law currently says and maybe the ideal world that we would want.” @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth Dr. Aaron Mitchell's paper in the Journal of Health Politics, Policy and Law, titled “Industry Payments to Physicians Are Kickbacks: How Should Stakeholders Respond?” @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth How should stakeholders react to this new legislation? @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth What is the aggregate benefit versus risk of these payments to doctors? @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth What should providers and the federal government be doing in light of this new legislation? @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth “It's just always so much harder to get to the outcomes because there's so much more that happens in between the clinical decision and then what the patient's outcome is down the road.” @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth Will innovation be stifled with this new crackdown on kickbacks? @TheWonkologist discusses #pharma conflicts and kickbacks on our #healthcarepodcast. #healthcare #podcast #digitalhealth Recent past interviews: Click a guest's name for their latest RHV episode! Karen Root, Mark Miller, AJ Loiacono, Josh LaRosa, Stacey Richter (INBW35), Rebecca Etz (Encore! EP295), Olivia Webb (Encore! EP337), Mike Baldzicki, Lisa Bari, Betsy Seals (EP375), Dave Chase, Cora Opsahl (EP373), Cora Opsahl (EP372), Dr Mark Fendrick (Encore! EP308), Erik Davis and Autumn Yongchu (EP371), Erik Davis and Autumn Yongchu (EP370), Keith Hartman, Dr Aaron Mitchell (Encore! EP282), Stacey Richter (INBW34), Ashleigh Gunter, Doug Hetherington, Dr Kevin Schulman, Scott Haas, David Muhlestein, David Scheinker, Ali Ucar, Dr Carly Eckert, Jeb Dunkelberger (EP360)

On this episode, Conrad and Rory dive into the Stark Law and Anti-Kickback Statute basics and recent changes! --- Send in a voice message: https://anchor.fm/rory-bellina6/message Support this podcast: https://anchor.fm/rory-bellina6/support

Meet Mr. Silberman JD from the BENESCH law firm! We talk about the New Hampshire ruling and Nurse Anesthesiologist, Qui Tam lawsuits and anti-trust, The risk of medicare fraud with medical direction and TEFRA, if Extubation is part of emergence as it related to TEFRA based on the Donegan v. Anesthesia Associates of Kansas City, PC, Liability of surgeons with CRNAs in the ACT or independently and MUCH more! A little about Mark:Mark is an experienced trial lawyer, health care attorney and litigator. His practice focuses on helping health care professionals and businesses navigate the complex and changing landscape of health care with an emphasis on achieving governmental and regulatory compliance.Mark concentrates on managing internal and external health care investigations, False Claims Act cases, white collar criminal defense, all forms of health care litigation, and all aspects of the Illinois Certificate of Need program.Mark handles audit, compliance, investigations and enforcement actions involving HHS-OIG, the Medicare/Medicaid programs, the Illinois Department of Public Health, and Illinois Health Facilities and Services Review Board (Certificate of Need). He advises clients regarding managing and avoiding allegations of health care fraud and health care-related criminal conduct, addressing concerns related to the Anti-Kickback Statute, and pharmacy and pharmaceutical related litigation. He provides counsel and litigation services for physicians, facilities and pharmacies engaged with any federal agency, along with handling Medicare/Medicaid reimbursement issues, False Claims Act/Qui Tam defense, and various health care transactional matters. Mark also served as the outside General Counsel to the American Association of Nurse Anesthetists.More about Mark can be found hereStories and Strategies for Public RelationsCommunication is in every facet of our daily business.Listen on: Apple Podcasts Spotify

In this episode of Bona Fide Needs, Arnold & Porter Partner Mike McGill and PubKGroup Managing Editor Bill Olver cover a broad range of recent legal developments affecting government contractors. Our feature this month is Mike's in-depth discussion with Arnold & Porter partner Chuck Blanchard, who previously served as general counsel of the Air Force and earlier the Army. Mike and Chuck discuss a range of topics, including the Defense Production Act, Other Transaction Authority, and Foreign Military Sales. The episode starts with Mike highlighting several key regulatory and policy developments that you may have missed over the summer, including the Department of Labor's proposed rule on non-displacement of service employees, the Office of Personnel Management's proposal to update “ban the box” rules for federal employees and the implications for the upcoming rules applicable to federal contractors, the Department of Defense's guidance to contracting officers related to assessing and enforcing contractor cybersecurity compliance, and the Department of Defense's guidance on economic price adjustments to combat inflation. Next, Bill flags several notable PubK headlines, most involving recent significant developments involving the False Claims Act. Bill provides an overview of the Supreme Court's consideration of cases involving the Rule 9(b) particularity standard and DOJ's authority to dismiss qui tam complaints, as well as other cases involving causation and the Anti-Kickback Statute. This month's headlines also touch on GAO case decisions and two court decisions that impacted regulatory issues, including the Chevron deference.   Show notes 0:25 - Introduction and Overview 01:45 - Mike McGill's summary of regulatory and policy developments 19:00 - Bill Olver's summary of headline developments 33:30 - Mike's discussion with Chuck Blanchard on DPA, OTA, and FMS 1:18:00 - Credits and copyright Music credit: Scratch the Itch by Marc Walloch (Shutterstock) Links Department of Labor Proposal Rule Implementing EO 14055, Nondisplacement of Qualified Workers Under Service Contracts. Office of Personnel Management Proposed Rule Implementing Fair Chance to Compete for Jobs Act of 2019. Department of Defense Memorandum "Contractual Remedies to Ensure Contractor Compliance with Defense Federal Acquisition Regulation Supplement Clause 252.204-7012, for contracts and orders not subject to Clause 252.204-7020; and Additional Considerations Regarding National Institute of Standards and Technology Special Publication 800-171 Department of Defense Assessments." Department of Defense Memorandum “Guidance on Inflation and Economic Price Adjustments.” Arnold & Porter Alert “Expanded Use of the Defense Product Act and Focus on Building the Domestic Supply Chain: What Companies Need to Know.” Arnold & Porter Webinar “Understanding and Leveraging the Defense Production Act.” Arnold & Porter Alert “DoD Ushers in CMMC and NIST SP 800-171 Assessment Methodology With Interim Rule.” Justice Department Sues to Block Booz Allen Hamilton's Proposed Acquisition of EverWatch Booz Allen says Acquisition Aimed at Lockheed, Raytheon, ‘Billions' in Contracts GAO Rejects Agency's Tortured Explanation as to How a Key Person Who Resigned Was Still Technically Available. If a Key Person Leaves After Proposal Submission, When Do They Become “Unavailable”? United States Court of Appeals for the DC Circuit No. 20-5291; the Humane Society of the United States v. United States Department of Agriculture Supreme Court of the United States No. 20-1530; West Virginia, et al., v. Environmental Protection Agency, et al.; Supreme Court restricts the EPA's authority to mandate carbon emissions reductions District Court Adopts Swift Standard of Unfettered Right of DOJ to Dismiss Qui Tam Actions Nothing to See Here: Solicitor General Recommends That SCOTUS Deny Cert. in Eleventh Circuit Case on Rule 9(b) Fraudulent Activity, Without the Submission of False Claims, Insufficient to Support Qui Tam Case Seventh Circuit Reverses Ruling on Knowledge Element, Finding Defendant Had to Know High-Cost Services Were Material to High Capitation Rate Dissent: Materiality Not Shown Where Defendant Failed to Provide One Service Out of Many Possible Services CBO Issues Long-Awaited Analysis of Proposed FCA Amendments Court Split: Sixth Circuit Says FCA Anti-Retaliation Provision Also Applies to Former Employees Eighth Circuit: But-For Causation Required to Show FCA Liability Arising from AKS Violations Eighth Circuit Puts the Teeth Back in the AKS's Causation Requirement, Creating Yet Another FCA Circuit Split Second Circuit: Anti-Kickback Statute Liability Doesn't Require Corrupt Intent  

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

A former Assistant United States Attorney, Josh Russ is a principled and relentless advocate.In 2013, after practicing healthcare regulation and litigation at a large corporate law firm, Josh joined the firm of Reese Marketos. During his time as an associate there, Josh tried a jury trial on behalf of a plaintiff financial firm involving debt owed to his client under multiple loan instruments. The case was settled just before closing arguments for more than $2 million. In addition, Josh represented two entrepreneurs in a commercial fraud and breach of contract matter that resulted in a favorable judgment for more than $5 million. The Fifth Court of Appeals in Dallas affirmed the judgment in 2016.In 2015, the United States Attorney's Office for the Eastern District of Texas offered Josh the opportunity to serve the American public as the Eastern District's Affirmative Civil Enforcement (ACE) Coordinator. In that role, Josh oversaw and directed most of the Eastern District's False Claims Act and civil Controlled Substances Act investigations and litigation. In less than five years, Josh's work contributed to the recovery of more than $85 million in settlements, suspensions, and judgments on behalf of American taxpayers, most of which involved enforcement of the Anti-Kickback Statute and the False Claims Act. Josh was also named the Eastern District's Civil Healthcare Fraud Coordinator, where he worked to develop the district's parallel proceedings practices in accordance with Department of Justice policy.For his work, Josh was awarded the Executive Office of United States Attorneys Director's Award for Superior Performance as a Civil Assistant US Attorney. Josh frequently lectured internally for the Department of Justice regarding the False Claims Act, the Controlled Substances Act, and parallel proceedings.In 2018, at the age of 33, Josh was promoted to serve as the Eastern District's Civil Chief. In that position, Josh supervised all civil litigation across the Eastern District's six divisions: Sherman, Texarkana, Marshall, Tyler, Lufkin, and Beaumont. In addition to managing the Eastern District's affirmative False Claims Act and civil Controlled Substances Act dockets, Josh supervised the district's Financial Litigation Unit as well as defensive litigation against the United States, its agencies, and its personnel.Josh's highest priority as Civil Chief became fighting the nation's devastating opioid crisis. He served as the co-chair of a national Prescription Interdiction and Litigation (PIL) Task Force working group.In November 2019, Josh rejoined Reese Marketos as a partner, where he leads the firm's Eastern District office and the firm's False Claims Act practice.Support the show

On this week's episode, HortySpringer attorneys Henry Casale and Hala Mouzaffar look at the recent conviction of the 3 owners of multiple orthotic brace supply companies across Texas. Together they set out to defraud Medicare out of nearly $6.5 million by violating the Anti-Kickback Statute. This case will leave you wondering how you even conceal these payments, and what is the price these owners stand to pay?Listen now to this episode to see what you can learn from the misfortune of others.

It takes two to tango in the Stark Law world. In this episode, Captain Integrity Bob Wade welcomes Marlan Wilbanks, Esq. to chat physician liability and qui tam cases under the Stark Law and Anti-Kickback Statute. Hear why the Fair Market Value (FMV) train runs both ways, you should be very, very wary of how you handle wRVU calculations in your hospital, free employees aren't always free, why the government is historically so focused on the DHS entities over the physicians, and the formula attorneys like Marlan Wilbanks use when assessing potential qui tam cases. Learn more at CaptainIntegrity.com

The parties need to intend to enter into a financial arrangement for a violation under the Stark Law to occur. In this episode, Captain Integrity Bob Wade talks all things “intent” in relation to the Stark Law. Hear why the intent of both parties to enter into an arrangement needs to be made for the Stark Law to be implicated, parties must obtain payment of the value of the remuneration or benefit that has been taken, mere overpayments do not equal a Stark Law violation, Bob's 3 Buckets of Intention, and how the Anti-Kickback Statute ties into things. Learn more at CaptainIntegrity.com

We have a chicken and egg problem. In this episode, Captain Integrity Bob Wade welcomes Anthony Domanico of VMG Health to recap what they learned and discussed at the recent AAPCP Conference (American Association of Provider Compensation Professionals). Hear what makes the AAPCP a great organization, why compensation compliance under the Stark Law and Anti-Kickback Statute covers both the amount and structure of the compensation, 2021 wRVU values have an impact that needs to be carefully analyzed, learnings from surveys at the conference, and what tools you can use to develop compensation metrics. Learn more at CaptainIntegrity.com

Many healthcare entities focus on the initial physician contract development/execution itself, often in a decentralized manner where multiple ‘'owners'' are involved in getting the contract executed and supporting documentation is retained within different departments which can lead to inconsistencies in the documentation collection/retention process. In addition, many healthcare entities lack on-going centralized auditing and monitoring procedures of existing contractual arrangements with independent physicians to ensure there are no potential violations of the Anti-Kickback Statute or non-adherence to contract terms. This podcast will discuss typical compliance risks and key areas organizations should consider when monitoring existing physician arrangements through on-going compliance audits. Host: Andrew Demetriou, Lamb and Kawakami, LLP Guest: Gary Keilty, Regulatory Compliance and Government Investigations Support Consultant If you have an idea for an upcoming episode of Voices in Health Law, you can submit a proposal form at ambar.org/voicesinhealth

There are many lessons to learn from the 2021 False Claims Act settlements. In this episode, Captain Integrity Bob Wade recaps the major settlements under the False Claims Act in 2021 and what actionable insights we can pull from them. Hear why the qui tam weapon is still a large tool for the Department of Justice, healthcare is the largest source of false claims recovery for the government, personal liability continues to rise under the False Claims Act, how much was recovered in 2021, and the most game-changing settlements. Learn more at CaptainIntegrity.com

Ericka Adler is a healthcare attorney, a shareholder at Roetzel in their Chicago office, and the Practice Group Manager of Roetzel's healthcare practice. Ericka has nearly 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 handles mergers, sales and acquisitions of healthcare entities and has extensive experience in completing transactions with private equity, hospitals and other third parties. Ericka has deep experience dealing with Stark, Anti-Kickback Statute, Fee splitting concerns, the corporate practice of medicine, and other challenges facing healthcare providers. She also hosts a weekly podcast, "Roetzel HealthLaw Hotspot®, which has earned the #5 spot on Health Radio Now. In this episode, Carl White and Ericka Adler discuss:The typical situations when it comes to employee theft and employee fraudHow to discover employee theft or mismanagement in your practiceLimiting and managing access to important aspects of your businessDiscovering weak points in your practice where employees can get in when they shouldn't be able to. Key Takeaways: When somebody is stealing, it's often somebody you don't suspect and is probably the person you trust the most. Often times, something changes - in their life for example - that triggers someone to steal. You might even feel guilty for asking that person questions. The best way to discover employee theft or employee fraud is by bringing in somebody from the outside. Do a yearly billing audit. If anyone is reluctant or hostile about the audit, that'll be one of your first red flags.Make sure you have access to your passwords, files, finances, sites, social media and other important documents and properties. If one person should have control over all these things, it has to be the owner or else it has to be managed by a lot of people to ensure accountability and transparency. Look around your business, what are the things that have worried you but you figured you'll get to it when you get to it? These things that worry you may be some of the current weakness points in your practice and it's best to fix the situation before thefts, fraud, or dishonesty even happen.  “The most serious situations that we face typically involve very long term employees. It doesn't mean that you can't have a loyal person working for you for all those years, something typically changes and it can be very difficult to discover.” - Ericka Adler Connect with Ericka Adler:Website: https://www.ralaw.comEmail: eadler@ralaw.comLinkedIn: https://www.linkedin.com/in/ericka-adler-87a2a93/ | https://www.linkedin.com/company/roetzel-&-andress/Twitter: https://twitter.com/modernhealthlaw | https://twitter.com/roetzel_andress Connect with Carl White: Website: www.marketvisorygroup.com  Email:  whitec@marketvisorygroup.comFacebook:  https://www.facebook.com/marketvisorygroupYouTube: https://www.youtube.com/channel/UCD9BLCu_i2ezBj1ktUHVmigLinkedIn: https://www.linkedin.com/in/healthcaremktg/

In this episode of AHLA's monthly series on fraud and abuse issues, Matthew Wetzel, Partner, Goodwin Procter, speaks to Laura Laemmle-Weidenfeld, Partner, Jones Day, about some of the significant changes that have taken place in health law enforcement over the past year. They discuss changes to the Stark Law and Anti-Kickback Statute safe harbor for personal services arrangements, challenges related to telemedicine fraud enforcement, and DOJ's back-and-forth on the use of agency guidance documents in civil enforcement actions. Laura is the author of the recent supplement to the Fifth Edition of AHLA's Legal Issues in Health Care Fraud and Abuse. From AHLA's Fraud and Abuse Practice Group. Sponsored by BRG.

Post By: Adam Turteltaub As if Stark Law and the Anti-Kickback Statute aren't complicated enough, they can also lead to False Claims Act issues, explains Charles Oppenheim, Partner at the law firm of Hopper, Lundy & Bookman and author of the chapter “The Stark Law and Anti-Kickback Statute as FCA Risks” in the new HCCA book False Claims in Healthcare. In the case of Stark Law, where there is strict liability, something as simple as faulty paperwork can be highly problematic. If the documents don't match up, no matter how innocent the mistake, an entity is prohibited from billing for services. And, when it comes to the Anti-Kickback Statute, the law is intent-based. So even if the remuneration is fair market value, corrupt intent can have drastic consequences. To prevent issues from occurring, and effectively remediate them should they occur, he offers several recommendations in this podcast. First, have well-designed policies and procedures when it comes to entering into new relationships, including policies for when not to enter into a relationship. Second, document how fair market value is determined, how you entered into the relationship and alternatives considered. Should a potential violation be identified, bring in experts who understand the subtleties of these very complex laws. And, he notes, don't despair. It is quite possible that the relationship falls into an exception. For example, CMS has proven more flexible of late in its documentation requirements. Should you need to make a disclosure, consider the Self-Referral Disclosure Protocol (SRDP). It can take some time, but the outcomes can be more positive than many think. Finally, he advises healthcare entities to remember that we will one day come to the end of this pandemic emergency. During this crisis CMS issued a narrow waiver on Stark Law that many took advantage of while medical practices were in deep financial troubles. It's important to document what you did and be prepared for the end of the emergency and, quite possibly, the end of the waivers. To learn more, listen in to this podcast, and check out our new publication False Claims in Healthcare.

Post By: Adam Turteltaub As if Stark Law and the Anti-Kickback Statute aren't complicated enough, they can also lead to False Claims Act issues, explains Charles Oppenheim, Partner at the law firm of Hopper, Lundy & Bookman and author of the chapter “The Stark Law and Anti-Kickback Statute as FCA Risks” in the new HCCA book False Claims in Healthcare. In the case of Stark Law, where there is strict liability, something as simple as faulty paperwork can be highly problematic. If the documents don't match up, no matter how innocent the mistake, an entity is prohibited from billing for services. And, when it comes to the Anti-Kickback Statute, the law is intent-based. So even if the remuneration is fair market value, corrupt intent can have drastic consequences. To prevent issues from occurring, and effectively remediate them should they occur, he offers several recommendations in this podcast. First, have well-designed policies and procedures when it comes to entering into new relationships, including policies for when not to enter into a relationship. Second, document how fair market value is determined, how you entered into the relationship and alternatives considered. Should a potential violation be identified, bring in experts who understand the subtleties of these very complex laws. And, he notes, don't despair. It is quite possible that the relationship falls into an exception. For example, CMS has proven more flexible of late in its documentation requirements. Should you need to make a disclosure, consider the Self-Referral Disclosure Protocol (SRDP). It can take some time, but the outcomes can be more positive than many think. Finally, he advises healthcare entities to remember that we will one day come to the end of this pandemic emergency. During this crisis CMS issued a narrow waiver on Stark Law that many took advantage of while medical practices were in deep financial troubles. It's important to document what you did and be prepared for the end of the emergency and, quite possibly, the end of the waivers. To learn more, listen in to this podcast, and check out our new publication False Claims in Healthcare.

Did you know there are specific rules from the Office of the Inspector General (OIG) regarding giving things of value (i.e. gifts) to solicit potential customers? In this episode of Talking with the Toothcop, Andrea and I talk about some of the specific rules on gifts and kickbacks. This is stuff that you need to be aware of so you don't get hit with penalties and fines for breaking the law.  Outline of This Episode [3:34] The OIG Backpack Rule [11:26] Texas Administrative Code Rule 108.58 [15:25] The anti-kickback statute (42 U.S.C. 1320a-7b) [20:34] Section 259.008 Dental Practice Act [23:03] “But everyone is doing it” [28:08] Dental Compliance Bootcamp 2021 The OIG “Backpack” Rule The OIG released a special bulletin entitled “Offering Gifts and Other Inducements to Beneficiaries.” This advisory from the OIG clarifies how the state interprets and applies the rules and statutes to giving things of value to Medicaid benefit recipients.  While they understand the competitive market and desire of dental practices to differentiate themselves in the mind of potential patients, they must uphold the integrity and fairness of the Texas Medicaid program. Giving gifts may raise concerns among the community and other providers.  The OIG reinforces Texas Administrative Code §371.1669, which prohibits a person “From transferring or offering any remuneration which the person knows or should know is likely to influence the beneficiary's selection of a provider, practitioner or supplier of Medicaid payable items or services.” The state of Texas has announced that they will enforce more stringent rules than the HHS OIG, including: Providers are prohibited from offering items or services to influence health care decisions. The OIG presumes that any items that do not exceed $10 per patient were not provided to influence their decisions. Likewise, anything offered to a patient must be directly related to dentistry (i.e. a toothbrush, toothpaste, floss, etc.). You are NOT allowed to give patients backpacks and school supplies, even if your intentions are good. We get that it's back-to-school time and people like to give out back-to-school supplies. Dental providers cannot do that.  You may never offer patients cash or gift cards.  Is it different for non-Medicaid providers? Non-Medicaid providers still have to adhere to the Texas Occupations Code Section 102: Solicitation of Patients, which includes rules about not giving gifts to patients (though it doesn't explicitly call out backpacks). Can non-Medicaid providers give gifts or do giveaways for current patients? Listen to learn more about Texas Administrative Code Rule 108.58 The anti-kickback rule (42 U.S.C. 1320a-7b) The Anti-Kickback Statute is a criminal law that prohibits the knowing and willful payment to reward patient referrals or the generation of business involving any item or service payable by the Federal healthcare programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients). This includes things like rent, hotel stays, meals, excessive compensation, paying referrals, etc. Physicians or dentists who accept or pay kickbacks will be penalized up to $50,000 per kickback plus three times the amount of the remuneration. Dentists make attractive targets for kickback schemes because you are a source of referrals.  Kickbacks in healthcare can lead to overutilization, increased program costs, corruption of medical decision-making, patient steering, and unfair competition. I hear of offices that offer free or discounted dental care for parents if they bring their children on Medicaid to the practice—which is clearly a violation of Federal law. Taking a kickback can never be justified, even if the service rendered was medically necessary. More of this is coerced in Texas Occupations Code Sec. 259.008 Unprofessional Conduct.  When people say “But everyone is doing it” Some dentists have pointed out to me that there is an unfair advantage because dentists in their community do these things. The temptation to get involved in a scheme like this is high because “everyone is already doing it.” Firstly, don't do something that everyone else is doing. That's not how you grow your business (especially with something illegal).  Instead, find out what's legal in your state (and federally) and then run tests to see what works. It can be as simple as focusing on giving your patients the greatest experience possible. You can make it a memorable and pleasurable experience. How can you take customer experience up a notch? Lastly, if people in your community are doing illegal things, perhaps they aren't aware. If you have the gumption, you can talk to them about it.  We cover a lot in this episode. Listen to the whole thing for all the nitty-gritty details! Resources & People Mentioned Learn more about protectIt dental at https://dentalcompliance.com/drugkit or call them at 888-878-8916 and tell them that the Toothcop sent you! Check out ProEdge Dental at https://proedgedental.com/toothcop!  Offering Gifts and other Inducements to Beneficiaries Texas Occupations Code Section 102: Solicitation of Patients Texas Administrative Code Rule 108.58 42 U.S.C. 1320a-7b - Criminal penalties for acts involving Federal health care programs Texas Occupations Code Sec. 259.008 Unprofessional Conduct Mark your calendar for Dental Compliance Bootcamp 2021 Connect With Duane https://www.dentalcompliance.com/ toothcop(at)dentalcompliance.com On Facebook On Twitter On LinkedIn On Youtube

In the second part of our Medical Alley Association webinar replay on value-based care, our group of panelists explore recent changes to the Stark Law and Anti-Kickback Statute and the opportunities for patients to realize the benefits of value-based care. It also examines further changes to enhance the transformation to value-based care.

On this episode of Health+Tech, please join Ludi founder and CEO Gail Peace and McGuireWoods partner Andrea Lee Linna as they discuss how technology can further healthcare compliance, including: ·   How providers can leverage technology to streamline their physician contracting processes to reduce administrative burdens on physicians and staff ·   How the Anti-Kickback Statute and Stark Law apply to physician contracting and how providers can leverage technology to ensure regulatory compliance ·   How process automation can improve business efficiencies and physician relationships

On this episode of Health Care Beat, we wrap up our special series addressing trends and forecasts related to health law under the Biden Administration. Chris DeMeo, partner in Seyfarth's Corporate department and member of the firm's Health Care, Life Sciences & Pharmaceuticals group, joins host Adam Laughton for a conversation about the Stark Law and Anti-Kickback Statute, and how the government could implement both as part of its overall administration of Medicare and other federal health care programs.

Circulation Bariatric Surgery and Cardiovascular Outcomes in Patients With Obesity and Cardiovascular Disease: A Population-Based Retrospective Cohort Study Circulation 2021 Apr 13;143(15)1468-1480, AG Doumouras, JA Wong, JM Paterson, Y Lee, B Sivapathasundaram, JE Tarride, L Thabane, D Hong, S Yusuf, M Anvari Patients with CVD who underwent bariatric surgery were matched 1:1 with similar CVD patients who did not undergo bariatric surgery. primary outcome was major adverse cardiovascular events (MACE) (first occurrence of all-cause mortality, myocardial infarction, coronary revascularization, cerebrovascular events, and heart failure hospitalization) n follow-up of 4.6 years, the primary outcome was lower in the surgery group compared with the control group occurred in 11.5% (151/1319) of the surgery group and 19.6% (259/1319) of the controls that is roughly a NNT of 12. But enough with the observational trials- do what we want to see or don’t do it. And while observation studies annoy me, sometimes they are necessary evil lead to practice or board changing answers, Girometti N et al. Clinical and serological outcomes in patients treated with oral doxycycline for early neurosyphilis. J Antimicrob Chemother 2021 Mar 30; [e-pub]. (https://doi.org/10.1093/jac/dkab100) The board question is someone comes in with neurosyphilis but is allergic to penicillin- the answer on every test is always who cares give it to them anyways. You go with penicillin desensitation, with is painfully slow and annoying. But in this study retrospectively evaluated 87 patients with early neurosyphilis who either received intramuscular (IM) penicillin with oral probenecid for 14 days (71%), 200 mg oral doxycycline twice daily for 28 days (18%), 2 g IM or intravenous ceftriaxone daily for 14 days (3%), a majority did get the penicillin but . All patients attained seroreversion to a negative rapid plasma regain [RPR] or a fourfold decline in RPR titer. And At 30 days after completion of therapy, 91% of patients receiving parenteral penicillin therapy and 100% of doxycycline recipients achieved symptomatic resolution. But enough of the observation data lets move onto a viewpoint in JAMA Industry-Sponsored Speaker Programs—End of the Line? | Law and Medicine | JAMA | JAMA Network November 16, 2020 for only the 6 times in 20 years the the Office of Inspector General (OIG) for the US Department of Health and Human Services (HHS) issued a Special Fraud Alert on “abuse risks associated with the offer, payment, solicitation, or receipt of remuneration” relating to industry-sponsored speaker programs Now when I was a resident I took a free dinner but I was never invited back because I would ask a bunch of hard questions about the methods of the study that the speaker wasn’t prepared to answer. It was entertainment, education, and a free meal. SINCE becoming an attending I have not been to one and I said that with pride. industry-sponsored speaker programs dates back to the 1950s and they have always been ‘dirty’ with physician kick backs and bias. And off these CME or speaker sponsored programs are “offered under circumstances that are not conducive to learning. ALSO lets be very clear often these drugs are not better than current standard of practice and they are more expensive which is a losing situation for our patients. But why this fraud alert issued?? Well July 1, 2020, During covid peak, Novartis quietly agreed to pay 678$ million dollar settlement for fraud charges of payment to physician and speak programs. And I quote- Novartis “violated the federal False Claims Act and Anti-Kickback Statute by providing doctors with cash payments, recreational outings, lavish meals, and expensive alcohol to induce them to prescribe Novartis cardiovascular and diabetes drugs reimbursed by federal healthcare programs.” From 2017 to 2019, drug and device companies reported paying health care professionals nearly $2 billion in compensation for services other than consulting but I suspect this will be going down significantly in the near future as it is hard to continue to issue kickbacks when you have the attention of the office of the inspector general. SOO if you are a big pharma industry sponsored event attendee that like a free industry sponsored meal, enjoy it while you can because this for the betterment of medicine and the well being of our patients is likely going away. And while we are talking about government lets talk politicians and something they did positive which is usually few and far between but on December 27, 2020, congress passed the Surprises Act — which banned “surprise billing” and in order to talk about how this is a good thing lets quickly make sure we are all on the same page. Lets say a patient gets sick and goes to the ER and then gets admitted to the hospital. Once in the hospital that patient has no control over what doctors they see. IF they see a doctor or two that are out of their network. Since insurance plans aren’t required to pay out-of-network providers their full charges, clinicians may bill the patient for the difference between the insurance payment and their charges. This ends of up being a surprise bill and usually a surprise that is a lot of money. This is terrible. You get sick, you just want to get better, you are at a hospital and you have no control if the pulmonologist or cardiologist is in your insurance plan but yet SURPRISE you get stuck with the bill. BUT BUT BUT Effective January 1, 2022, patients receiving out-of-network emergency services, air-ambulance transportation, or out-of-network nonemergency services at in-network facilities may be billed only the amount they would owe for an in-network provider. Finally lets end with a little game from JAMA internal med. Adverse Events Associated With the Addition of Aspirin to Direct Oral Anticoagulant Therapy Without a Clear Indication | Atrial Fibrillation | JAMA Internal Medicine | JAMA Network ASA and anticoagulation is done wrong all the time so lets play a game The combination of ASA with oral anticoagulation can be indicated for patients with?? The answer is certain devices (eg, left ventricular assist devices) , patients with nonvalvular atrial fibrillation and have acute coronary syndrome (ACS) and undergo percutaneous coronary intervention (PCI). And finally those with venous thromboembolism (VTE) and have acute coronary syndrome (ACS) and undergo percutaneous coronary intervention (PCI). Boom that is it! If you use combination therapy outside this setting then likely more harm than good and in this registry-based cohort study researchers looked at the medical records of almost 3300 patients and matched up Roughly 1000 patients who received a DOAC plus aspirin were matched to 1000 who received a DOAC alone. During a 12month follow-up, patients on combination therapy were more likely to experience a bleeding event and Hospitalization for bleeding. BUT Thrombotic events, did not differ between the groups. So you bleed more but you have the same risk of thrombotic events which sounds like a major losing strategy and something we should all keep in our minds for times when we can do a drugectomy and remove either the ASA or the anticoagulant, which ever is not needed. So I ask you again The combination of ASA with oral anticoagulation can be indicated for patients with?? The answer is certain devices (eg, left ventricular assist devices) patients with nonvalvular atrial fibrillation and have acute coronary syndrome (ACS) and undergo percutaneous coronary intervention (PCI). And finally those with venous thromboembolism (VTE) and have acute coronary syndrome (ACS) and undergo percutaneous coronary intervention (PCI).

At the end of 2020, the US Department of Health and Human Services Office of Inspector General and Centers for Medicare and Medicaid Services issued final rules modifying and expanding upon the regulatory safe harbors and exceptions to the federal Anti-Kickback Statute and the Stark Law, respectively. In Part 2 of this two-part series, Mintz's Karen Lovitch and Rachel Yount return to examine the changes to the Stark Law regulations, including new defined terms, modifications to existing exceptions, and the government's efforts to ease compliance burdens associated with this strict liability statute.

At the end of 2020, the U.S. Department of Health and Human Services Office of Inspector General and Centers for Medicare and Medicaid Services issued final rules modifying and expanding upon the regulatory safe harbors and exceptions to the federal Anti-Kickback Statute and the Stark Law, respectively. In Part 1 of this two-part series, Mintz's Karen Lovitch and Rachel Yount examine the changes to the Anti-Kickback safe harbors, and how they advance the government's efforts to promote value-based care and reduce the regulatory burdens that impede care coordination.

On this week's episode of the Healthcare Happy Hour, Marcy M. Buckner reviews some regulatory developments that occurred right before the holiday: two major rules regarding prescription drugs. In addition, CMS and OIG just released final rules in an attempt to modernize the Stark Law and Anti-Kickback Statute.

Matthew welcomes Mary Grealy, President of the Healthcare Leadership Council, for a fantastic conversation on how collaboration in the industry can truly usher in a new age in healthcare innovation.  Mary discusses HLC's upcoming Disaster Preparedness and Response Plan, the recently announced Stark Law and Anti-Kickback Statute, and how COVID-19 highlighted (and exacerbated) health disparities and value based care in the U.S.

Merck's History of Crimes and Misdemeanors   Richard Gale and Gary Null Progressive Radio Network, June 1, 2020 Which private corporation has likely been responsible for the deaths of more innocent people than any terrorist organization or military regime change in Afghanistan, Iraq, Libya, Syria and elsewhere?  For us, the answer is evident:  Merck and Company. Iatraogenic medicine, or medical error, is now the third leading cause of death in the US after cardiovascular disease and cancer. The majority of these deaths are caused by FDA approved drugs' adverse effects and from patients taking multiple medications without thorough clinical research to determine the safety of their synergistic effects.  Consequently our health agencies' oversight and monitoring of drugs on the market is dismal.    One of the worst corporate deals the US government may have ever made in modern history was to acquire the American subsidiary of the German pharmaceutical firm Merck and Company during the first world war. Later in 1953, Merck acquired a competitive drug maker Sharp and Dohme, thereby establishing itself as America's largest drug developer and manufacturer. Since then this corporate Medusa has ensnared thirteen other drug firms, including Scherring Plough, which it acquired for $41 billion. The two pharmaceutical giants had earned $47 billion in combined sales at the time the merger was finalized in 2009.   Merck's life of criminal behavior was observed back in the 1970s. In 1975, it was busted by the SEC for illegal payments to foreign government officials from "approximately" 36 nations. The scam was orchestrated through personal bank accounts with the sole purpose of advancing drug approvals through foreign nations' regulatory medical agencies.     One of the largest frauds in recent medical history was the company's anti-inflammatory drug Vioxx that resulted in fines above $4.8 billion for causing over a minimum 60,000 deaths from sudden heart attacks and over 120,000 serious medical injuries. At its height, Vioxx was earning over $2 billion in revenues annually and it is estimated that 25 million patients were prescribed the medication. The securities class action suit against the company alone reached $1 billion, placing it in the top 15 securities lawsuits in US corporate history. The centerpiece of the crime was Merck's intentional withholding of scientific data about the drug's adverse cardiovascular side effects.    Years after the settlement, Ron Unz, the publisher of The American Conservative, undertook his own investigation to validate Vioxx's death toll. Analyzing the drug's adverse effects over a longer time period, Unz estimated Merck may have been responsible for nearly half a million premature deaths in elderly patients, the drug's primary target group. That is roughly the same number of total civilian, military and terrorist deaths from the US's military escapades in Afghanistan, Iraq and Pakistan combined.    Merck's settlement of 47,000 pending lawsuits for personal injuries and 265 class action cases was a small pittance for the harm Vioxx left in its wake. Merck executives were never properly punished for willingly concealing the drug's dangers in order to assure FDA approval.    In Australia, Merck's efforts to increase Vioxx profits employed other forms of malfeasance. The Australian government launched a class action suit against the drug maker on charges that employees schemed a fake scientific paper that was ghostwritten for a medical journal in order to put Vioxx into a positive light. Testimonies during the trial stated data was completely based upon "wishful thinking." Merck also founded the peer-reviewed journal Australasian Journal of Bone and Joint Medicine. The journal was a fraud; it was not properly peer-reviewed and its primary purpose was to promote Vioxx on the Australian continent.    Moreover, the class action lawsuit contained Merck emails accessed by Australian officials. The company's internal communications ordered select employees to draft up a hit list of physicians who were critical of Vioxx. According to the documents, these physicians were targeted to be "neutralized" or "discredited." Some, including Dr. James Fries at Sanford University's medical school, were clinical investigators who happened to speak out about the drug's shortcomings. One email said, "We may need to seek them out and destroy them where they live..."     Efforts to target critics for harassment is not limited to Merck. Earlier, Monsanto earned a similar reputation. The Monsanto's parent company Bayer had to release a public apology for the discovery of a Monsanto hit list of 200 French journalists and politicians who opposed glyphosate and its GMO crops. It has acted similarly in other countries including the US, according to veteran journalist Carey Gillam.  The list originated from the multinational public relations firm Fleishman Hillard. Merck has also employed Fleishman Hillard as well as Monsanto's other notorious PR firm Ketchum. One of Merck's Executive Directors, Ian McConnell, earlier served as a vice president at Fleishman. The PR firm's senior adviser on healthcare Dr. Lukas Pfister, was at Merck for 25 years in its government affairs unit. Merck's revolving door is not limited to our federal health agencies, but also fully infiltrates some of the world's most shadowy international PR firms that specialize in whitewashing the public images of executive elites, corporations and in the case of the PR firm Burson-Marsteller even dictators. Following the Vioxx case, Merck had hired B-Marsteller to clean up its public image. MSNBC reported back in 2009, "When evil needs public relations, evil has Burson-Marsteller on speed dial."   But Merck's efforts to conceal the dangers of its products, falsify data about drugs' efficacy and safety and exaggeration of medical claims go back sixty years. In the 1960s, the FDA discovered that the drug maker's arthritis medication Indocin had not been properly tested for efficacy and its adverse effects were being completely ignored.  In the 1970s, Merck's drug dietheylstilbestrol (DES) prescribed for the prevention of miscarriages caused a flurry of vaginal cancer cases and other gynecological disorders. Merck had all along known that DES was carcinogenic based upon its own animal clinical trials. In 2007, its cholesterol drug Zetia was shown to increase liver disease. Again Merck had known about Zetia's liver risks but withheld the clinical trial's damning results.    It would also appear that Merck has managed to hijack US courts as well. This includes an early 2019 ruling by Trump's corporate-friendly US Supreme Court to side with the drug maker and squash hundreds of lawsuits for failing to issue warnings that its osteoporosis drug Fosamax's may contribute to debilitating bone breaks. A federal court in California found that Merck committed perjury for lying in a patent infringement case against Gilead Sciences over the latter's blockbuster Hepatitis C drug Sovaldi. The judge ruled that Merck carried out a "systematic and outrageous deception in conjunction with unethical business practices and litigation misconduct."  It turned out that Merck's patent claims were a sham and orchestrated by its legal division.   Besides pushing through the FDA dangerous medications onto the market, the company has also found itself in the courtroom on many occasions for price-fixing, routinely defrauding and overbilling states' Medicare and Medicaid programs, and violating the Anti-Kickback Statute. In 2006, the IRS went after Merck for owing almost $2 billion in back taxes. According to the Wall Street Journal, Merck partnered with a British bank to create an offshore subsidiary in tax-friendly Bermuda to divert taxable revenue on its bestselling cholesterol drugs Zocor and Mevacor through a patent scheme. The company ran the operation for ten years before the FDA uncovered the racket.    Merck is America's leading vaccine manufacturer. Despite public perception and the ruse that vaccines are somehow safer and more effective than pharmaceutical drugs in general, it is the same industry and corporate culture that manufactures both them. Currently Merck markets vaccines for Haemophilus B, Hepatitis A and Hepatitis B (individually and in combination), human papilomavirus (Gardasil), Measles, Mumps and Rubella (MMR), pneumococcal, rotavirus, varicella (chickenpox) and Zoster virus (for shingles). More recently it has jumped into the coronavirus vaccine race. In 2010, Merck obtained exclusive rights to MassBiologics vaccine portfolio. The consequence is that Merck's Adult Vaccine Portfolio expanded to include 9 of the 10 vaccines on the CDC's adult immunization schedule. The company now holds almost a full monopoly on the government's vaccines    On its website, the FDA assures the public that "Vaccines, as with all products regulated by the FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products."  However, except for Gardasil, not a single one of Merck's vaccines has ever been tested in a scientifically viable double-blinded placebo controlled trial. In each case, the placebo in the control group was not inert, such as the use of sterile saline. Rather Merck only tested the vaccine with the viral component against a faux placebo containing the same ingredients, including aluminum, but minus the virus. Known as a "carrier solution," the standard scientific protocol does not designate it as a proper placebo for measuring the efficacy and disease risks of a drug. And in the case of Gardasil, the trial was statistical trickery to mask Gardasil's adverse effects. Therefore the FDA's claim is patently false. None of Merck's vaccines have ever undergone a "rigorous review" prior to regulatory approval.    Although not completely innocent from internal unfairness and conflicts of interest, the Cochrane Database Collaboration arguably remains the most reliable resource for analysis of drugs, vaccines and medical devices in the evidence-based medical establishment. In its 2016 analysis of Merck's human papillomavirus vaccine Gardasil, the investigators were so alarmed they filed a complaint against the European Medical Agency for failing to adequately assess the vaccine's neurological harms.    As we have recently witnessed with Monsanto's Roundup and Bayer's settlement of $10 billion to cover 80,000 lawsuits, Gardasil may very well become the company's Achilles heel. The Gardasil scandal may very well begin to topple the vaccine regime and raise the public's already increasing awareness and distrust in the official mantra that vaccines are safe and effective. The development, scientific rationale, fraudulent clinical trials and data reporting, and inside negotiations with federal health officials to market the vaccine to pre-teen and teen girls and boys, is a story riddled with misconduct. Today it is Merck's third largest revenue-generating drug after its cancer drug Keytruda and diabetes drug Januvia, earning $3.1 billion in 2018. Its MMR vaccine is fifth having earned $1.8 billion. Gardasil's success has nothing to do with the prevention of an urgent national health need. Instead it was a business strategy through Merck's influence over our nation's regulatory agencies and state politicians whose election campaigns it funds.    In 2018, a French oncologist, Dr. Gerard Delepine, stumbled upon a correlation between the increase of cervical cancer rates with the rising rates of Gardasil vaccinations. Delepine also compared France, which was deliberating on whether to mandate HPV vaccination, with other countries that relied upon pap smears as a preventative measure against cervical cancer. He observed that in all countries that prioritized pap smears, cervical cancer rates were decreasing; whereas, in those countries with higher HPV vaccination compliance, the rates increased. In his letter to the French government in defiance of Merck's lobbying efforts, Delephine stated:   "A compulsory health measure should not be based on faith in vaccination or hidden conflicts of interest, but on proven facts, verifiable by every citizen. However, the facts established by the official records of cancer registries show that HPV vaccination does not protect against invasive cancer of the cervix, but seems rather to maintain its frequency at a high level and sometimes even increase it."   An article published in the French journal Agoravox noted that other national health ministries are coming around to acknowledge that Gardasil is an extremely unsafe vaccine. Japan, Austria and Denmark no longer promote it due to is trail of injuries with fatal consequences. Public demonstrations against Merck's Gardasil have occurred in Japan, Colombia, and Ireland.    Yet none of these efforts to warn the public about Gardasil's risks have reached the American media. Hopefully this may change. Medical researchers at the University of South Alabama presented their paper at the Society of Gynecologic Oncology's annual conference. There is great disparity between HPV vaccine compliance across Alabama counties, which range anywhere between 33 and 66 percent. Yet the epidemiological data suggests there is no evidence that Gardasil lowered cancer rates in counties with higher vaccine uptake. Moreover, there is zero chance of pre-teens and teens getting cervical cancer. The average age for the onset of the cancer is 50 years. Nor has the vaccine been on the market long enough to determine whether it protects a woman when she reaches even close to that age. Its product insert for physicians states the vaccine "may not result in protection in all vaccine recipients" and it "has not been demonstrated to prevent HPV-related CIN 2/3 [abnormal pre-cancerous cervical cells] or worse in women older than 26 years of age." Consequently, there is no scientific rationale for states to mandate the HPV vaccine for schoolchildren let alone even vaccinating them in the first place. In addition, the federal agencies and Merck market the vaccine under a false pretext that HPV infection is the leading cause of cervical cancer; correctly, only a third of cervical cancer cases are caused by the virus.    Robert Kennedy Jr is currently taking steps to sue Merck over the Gardasil deception. Merck's first effort to have the class action suit dismissed was overturned by the court. Kennedy's in-depth investigations through his Children's Health Defense organization has uncovered evidence that the vaccine increases birth defects in children conceived of HPV-vaccinated moms; miscarriages have increased 2000 percent above normal, and girls are experiencing serious reproductive complications, including infertility, at approximately ten-fold above the normal rate. During an interview on the Progressive Radio Network, he noted that there was 10 times greater risk of dying from cervical cancer among Gardasil trial participants compared to the general public. There is a 10-fold increase for ovarian failure, and 1 in 37 girls who receive the vaccine will experience an autoimmune disease after 6 months of receiving the series of injections. When we consider that 1 in 37,000 women have a chance of dying from cervical cancer, it puts HPV vaccines into a completely different light. Sadly, across the nation, politicians from both sides of the aisle in state legislatures, notably Governor Andrew Cuomo in New York, are doing Merck's bidding to mandate Gardasil for all girls and boys upon entering school.    Based upon Kennedy's research and documents received from Freedom of Information Act filings, during Merck's own Gardasil clinical trials, 2.3 percent of girls and women between the ages of 9 through 26 developed a serious autoimmune disease and crippling neurological disorders within seven months of vaccination. Among the 10,700 who received the actual vaccine, 245 (2.3%) had an autoimmune disorder; among the 9,412 who received either an "AAHS Control" -- the aluminum hydrophosphate sulfate adjuvant solution with other ingredients minus the HPV virus vectors, there were 218 (2.3%) life-threatening injuries. The most frequent adverse effects were arthritis and anthropathy, autoimmune thyroiditis, celiac disease, hyperthyroidism and hypothyroidism, inflammatory bowel disease, psoriasis, Raynaud's Phenomenon, rheumatoid arthritis and uveitis. In other words, it was the aluminum adjuvant responsible for this enormous suffering. He stated during the Progressive Radio Network broadcast that according to Merck's own statistics, girls are one hundred times more likely to experience a serious adverse effect from the vaccine than to be protected from cervical cancer.    In a 2012 article published in the Journal of Law and Medical Ethics, researchers at the University of British Columbia wrote that ever since Gardasil was approved in 2006, Merck has engaged in an "overly aggressive marketing strategies and lobbying campaigns aimed at promoting Gardasil as a mandatory vaccine."  One strategy Merck has employed is to take advantage of FDA loopholes to fast track its drugs. In the case of its expanded Gardasil-9 for adults between the ages of 27 to 45, the company applied for fast tracking two days after the Journal of Toxicological and Environmental Health published a study that the HPV vaccine was lowering the probability of pregnancy for women in their 20s.   Unfortunately, the media has indiscriminately colluded with Merck's scam. Drug companies, according to Kennedy, pay $4.5 billion to the major media networks and publications to promote their drugs. And none of the media outlets are willing to sacrifice their profits for advertising drugs on moral and ethical grounds.    Another scandal erupted within Merck's vaccine business in 2010 after two whistleblowers gave testimony that the mumps' component in its Measles-Mumps-Rubella (MMR) vaccine was based on fraudulent data about it's efficacy, and the company knowingly proceeded in order to corner the mumps vaccine market. Merck had been defrauding the US government, which purchases the MMR, for a decade. The government and the two Merck whistleblowers, virologists Stephen Krahling and Joan Wlochowski, filed a lawsuit against Merck for being in violation of the False Claims Act. According to the charges, Merck had "falsified its mumps vaccine test results to hit an efficacy rate of 95 percent. The company achieved this by adding "animal antibodies to a blood sample to give the impression of increased antibodies." This would certainly explain why mumps outbreaks in summer camps and on college campuses are found to occur among those vaccinated.    Merck's has gained enormous political and social influence over the national perception about vaccines.  One example is Merck's behind the scenes aggression against the flim Vaxxed.  When the documentary film was officially selected to screen during the 2016 Tribeca Film Festival in Manhattan, we discovered in an earlier report that Merck left its fingerprints on the film's removal and censorship. The Alfred Sloan Foundation is the festival's largest sponsor; pro-vaccine advocate Bill Gates is also a notable contributor. One of the leading persons on the Foundation's board of trustees was Dr. Peter Kim.  Kim happens to be the former president of Merck's Research Laboratories who was directly responsible for the launch of Gardasil and Merck's other vaccines for the Zoster virus and rotavirus. The film presents a harsh indictment against Dr Julie Gerberding, the former head of the CDC who coordinated the cover up of data that confirmed thimerosal's role in the onset of autism. After managing the agency's operations to mine sweep the data and generate new manipulated studies with public funds to suggest thimerosal's safety, Gerberding accepted her reward from the pharmaceutical industry by becoming the head of Merck's vaccine division. In addition, according to the whistleblowing of a senior CDC scientist, Dr. William Thompson, Gerberding was responsible for destroying the CDC's research that showed African American boys were at a substantially higher risk of becoming autistic from Merck's MMR vaccine. Fortunately, Dr. Thompson, who was present during the order to shred documents, saved copies which he subsequently turned over to Congressman Bill Posy and an independent biologist Prof. Brian Hooker. Since then, Congress has failed to hold hearings.    All told, these examples of Merck's culture of greed, deception, political maneuvering and illegal aggression has collectively injured countless people. Merck is a global corporation. Its products, like Monsanto's glyphoste, are marketed globally. To better understand Merck, the company should be perceived foremost as a cash cow for Wall Street. Its prime directive is selling drugs; its history of misdemeanors and criminal activities should indicate the company holds little integrity in its commitment to prevent and treat disease. The full extent of the casualties from Merck's drugs and vaccines may never be properly calculated. For firms such as Merck and Monsanto, injuries and deaths are the necessary collateral damage of getting poorly tested products on the market and as fast as possible. A black box should be slapped on the Merck logo.    What is important at this moment is that many corporations are fast-tracking, without sufficient long-term animal and human clinical trials, Merck is now aggressively making efforts to beat out its competition with a Covid-19 vaccine.  Do we really want to trust such a company with this reputation with a Covid vaccine? Therefore we recommend people to support the efforts of Bobby Kennedy and the Children's Health Defense in its lawsuit against Merck's Gardasil. A victory may well weaken the entire edifice of vaccine pseudoscience and the public will realize that for decades it has been little more than a house of cards.

Today I'm by joined by Will Brady, the Chief of Staff to the Deputy Secretary and Senior Advisor to the Secretary at the Department of Health and Human Services. It's a long title, but what it means is that Will is at the center of the major policy decisions being made in our nation's Health Department.  Specifically, Will leads the three issues we will discuss today: interoperability of medical information such as medical records, reducing unnecessary and burdensome regulations, and modernization of the Stark Law and Anti-Kickback Statute. Stay tuned to hear Will's insights into HHS's approach to removing regulatory burden in health delivery, as well as details on the new, much-anticipated interoperability rules released just a few weeks ago.  A Second Opinion is brought to you by Change Healthcare. From patient to provider to payer, Change Healthcare is inspiring a better healthcare system at every step of the patient journey with innovative clinical, financial, and engagement solutions that help solve healthcare's biggest challenges. Visit changehealthcare.com/asecondopinion.   Visit A Second Opinion's website here: https://asecondopinionpodcast.com/ Engage with us on social media at: Facebook Twitter Instagram

Hall Render Talks COVID-19: Stark, AKS, CMP Gregg Wallander, Joe Wolfe, and Alyssa James chat about the latest on the Stark Law waivers as well as Anti-Kickback Statute and Civil Monetary Penalties Statute implications on physician and patient relationships in light of COVID-19. Podcast Participants Gregg Wallander President/CEO with Hall Render Joe Wolfe Attorney with Hall Render Alyssa...