Stark Integrity

It’s going to get confusing. In this episode, Captain Integrity Bob Wade talks split/shared billing for Advanced Practice Providers (APPs) with Jodi Nayoski and Andrea Ferrari of Pinnacle Healthcare Consulting. Hear when the new guidelines go into effect, why the documentation must be substantive, how to correctly identify the date of service, the difference between APPs and NPPs, and what this all means for split/shared visits. Learn more at CaptainIntegrity.com

Is the knowledge requirement under the False Claims Act (FCA) objective or subjective? In this episode, Captain Integrity Bob Wade dives into the murky waters. Hear why the fines and penalties if the FCA applies are huge, murky regulations could be a defense under the FCA, why you should continue to operate as if the subjective factors would apply, the highlights from recent FCA cases, and the origin of the FCA. Learn more at CaptainIntegrity.com

Incorporating Advanced Practice Providers (APPs) has many benefits and risks. In this episode, Captain Integrity Bob Wade lays out those compliance risks and safeguards. Hear the 4 components of the quadruple aim, why you need documentation for incident-to and split/shared visits, how to handle credit given to any physician for the wRVUs performed by the APP, who’s considered an APP, and the discussion point in which Bob might be stepping into quicksand. Learn more at CaptainIntegrity.com

The Eliminating Kickbacks in Recovery Act (EKRA) is a huge statute. In this episode, Captain Integrity Bob Wade discusses the similarities and differences between EKRA and the Anti-Kickback Statute (AKS). Hear why EKRA applies to private payers, there are broader applications under EKRA as opposed to the AKS, how EKRA applies generally to clinical laboratories, the origin of EKRA, and “liquid gold” in the recovery world. Learn more at CaptainIntegrity.com

The Tuomey case is a pinnacle case for healthcare regulatory attorneys. In this episode, Captain Integrity Bob Wade continues his Tuomey case discussion with Bart Daniel, Partner at Nelson Mullins. Hear why you need to take complaints from employees seriously, why you shouldn’t seek a 2nd opinion on Fair Market Value (FMV) and Commercial Reasonableness (CR), how to structure a model that is compliant and defensible, why the government used the Tuomey case as a poster child, and what issues to look for as a compliance officer or general counsel. Learn more at CaptainIntegrity.com

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

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

There’s been a fascinating shift to value-based reimbursement arrangements from those based on production. In this episode, Captain Integrity Bob Wade discusses trends and issues in that space with Christine Worthen, Partner at Nelson Mullins. Hear why you should consider your strategic planning for the glide path to risk, look at the regulatory addendum and negotiate it, always have providers at the table, opportunities within deferred compensation, and how you can mitigate the risk of takebacks. Learn more at CaptainIntegrity.com

Creating a tagline, slogan, or logo could be an effective way to market and promote your compliance program. In this episode, Captain Integrity Bob Wade dives into the marketing of your compliance program. Hear how a logo helps promote the identification of your compliance program, why it should be consistently used, why it doesn’t ensure an effective compliance program on its own, the story of Captain Integrity, and some nostalgia around Schoolhouse Rock! Learn more and check out the white paper at CaptainIntegrity.com

Unfortunate statements and emails can trigger a long and expensive journey for an organization. In this episode, Captain Integrity Bob Wade discusses the Greber and Holland cases as they relate to the One Purpose test with Gabe Imperato, longtime friend and Partner at Nelson Mullins. Hear why the U.S. v. Holland case is a significant decision, the court looked for evidence of willful conduct, the decision exposes the shortcomings of the One Purpose Test, when it’s optimal for the government to apply the One Purpose Test, and why educating your organization on these matters is so important. Le...

Waiving copays and deductibles has to be performed in a specific manner. In this episode, Captain Integrity Bob Wade details the ins and outs of waiving copays. Hear why the routine waiver of copays and deductibles can be illegal, you can waive them in certain instances, what will cause a claim to be overstated, what exactly a copay waiver is, and examples from recent cases. Learn more at CaptainIntegrity.com

There’s an interesting issue with respect to the amount of the collections in 2022. In this episode, Captain Integrity Bob Wade highlights the learning points from the DOJ (Department of Justice) 2022 False Claims Act (FCA) Settlements and Judgments. Hear why the qui tam bar still represents the largest dollar amount of settlements, individual accountability is still occurring, we’re still seeing classic fraud and abuse issues, the most notable cases and issues, and how the 2022 numbers compare to previous years. Learn more at CaptainIntegrity.com

One of the most effective parts of a compliance program is to have a compliant culture. In this episode, Captain Integrity Bob Wade breaks down how to foster a culture of compliance. Hear why an ethical culture starts at the top, how to understand the culture of an organization, what to do if you believe your organization is making unethical decisions, how to measure the effectiveness of your compliance program, and the infamous examples of Enron and FTX. Learn more at CaptainIntegrity.com

The new rules create new standards that reduce compliance risk. In this episode, Captain Integrity Bob Wade discusses the key issues in value-based arrangements with Kelly Conroy, Principal at Pinnacle Healthcare, and Ed White, Partner at Nelson Mullins. Hear why now is the time to start your value-based care strategy, value-based enterprises can be used as a strategy for providers to leverage their value proposition with payers, it’s time to get a fresh perspective on the healthcare market landscape, where the government will help most, and the “Holy Grail” of arrangements. Learn more at CaptainIntegrity.com

Physicians may believe a test or procedure is medically necessary, but payers make the final determination. In this episode, Captain Integrity Bob Wade details medical necessity and the implications for Stark Law compliance. Hear why payers make the medical necessity determination, patients are in control, we can compensate a physician if the patient desires additional services, what the Medicare payment rules say, and examples from the medical field. Learn more at CaptainIntegrity.com

How do you audit practically? In this episode, Captain Integrity Bob Wade breaks down the Who, What, and How of audit work plan development under the Stark Law. Hear why you shouldn’t do it alone, how to look at the government resources out there, use some type of numerical weighting to assess risks, why auditing isn’t rocket science, and a sausage analogy from Bob. Learn more at CaptainIntegrity.com

Make sure that management fee is in order. In this episode, Captain Integrity Bob Wade talks Corporate Practice of Medicine (CPOM) compliance with Heather Miller, Healthcare Transactional and Regulatory Lawyer at Nelson Mullins. Hear why you need to substantiate the management fee in your paperwork, stick with a flat management fee, check state laws on leasing, how CPOM ties to the Stark Law, and what varies the most by state. Learn more at CaptainIntegrity.com

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

This year has been full of change, and I want to wish you all a great holiday season. In this special holiday episode, Captain Integrity Bob Wade reflects on change in 2022 and reads a custom Stark Law holiday poem, “Rudy the Seasoned Compliance Officer.” Hear the good and bad changes that came about this year, how it feels to attend and speak at in-person conferences again, significant Stark Law changes that took effect this year, the personal and professional life changes Bob is grateful for, and the Stark Law holiday poem you can share with your team. Learn more at C...

Be an expert in your field. In this episode, Captain Integrity Bob Wade talks compliance program development and effectiveness with Steve Sugrue, Chief Compliance Officer of DocGo. Hear why you should hire people smarter than you, always be relentlessly in pursuit of best practices, seriously consider an approach towards ESG (Environmental, Social, and Governance), how big your compliance team should be, and how the delegation process should work. Learn more at CaptainIntegrity.com

Use your superpowers in the field of compliance. In this episode, Captain Integrity Bob Wade talks value creation in the world of compliance with Jerry Shafran, Founder and Chief Executive Officer of YouCompli. Hear how to channel your inner salesperson, simplify, be an instigator of change, what sales and compliance have in common, and the reputation of compliance professionals. YouCompli helps you go from chaos to confidence. Learn more https://hubs.la/Q01rX8Q60

Can we really throw Fair Market Value (FMV) out the window? In this episode, Captain Integrity Bob Wade revisits Value-Based Arrangements with a special focus on mistakes that can be made. Hear why Value-Based Arrangements through the Safe Harbor and the Exception are a beautiful thing, it’s critical the governing body meet regularly and review the criteria, what happens if you don’t meet any of the requirements under the Value-Based Exception under the Stark Law, Bob’s lug nut example, and a bonus 7th Deadly Mistake. Learn more at CaptainIntegrity.com

Believe it or not, the Stark Law involves charitable contributions by physicians and immediate family members. In this episode, Captain Integrity Bob Wade explains the rules of charitable contributions as they relate to the Stark Law. Hear why remuneration plays a key role, charitable contributions cannot be solicited or offered by a physician who takes into account the volume or value of the referral, the Stark Law does involve supporting organizations, fallout from the different phases of regulations, and key comments in the regulations. Learn more at CaptainIntegrity.com

Legal Independent Review Organizations (IRO) are usually required under Corporate Integrity Agreements when physician financial arrangements are involved in the settlement - but you don’t have to use a LIRO in only Corporate Integrity Agreements. In this episode, Captain Integrity Bob Wade breaks down the world of LIROs when it comes to the Stark Law. Hear why a LIRO has to be independent, it doesn’t have to have an adversarial relationship with the company, LIRO services can be provided outside a Corporate Integrity Agreement, who chooses the LIRO, and what determines the level of detail in a revi...

Thorough documentation can go a long way under the Stark Law. In this episode, Captain Integrity Bob Wade continues to dive into the Medicaid-Stark Law pool - this time with special guest Andy Lenobel, Associate General Counsel at Nationwide Children’s Hospital. Hear why you need to show your work, follow your policy, learn to love the endless nature of compliance, Andy’s view from a hospital’s perspective, and what he hears from clients the most. Learn more at CaptainIntegrity.com

Does the federal Stark law apply to state Medicaid reimbursement? In this episode, Captain Integrity Bob Wade outlines why it doesn’t really matter - as he dives into the Medicaid-Stark Law pool. Hear why there’s still an argument whether hospitals violate the federal Stark Law when they submit Medicaid claims, many states still have their own Stark Law statutes and regulations, Fair Market Value (FMV) and Commercial Reasonableness apply regardless of whether the federal Stark Law applies, examples from Bob’s experience in notable cases, and how the Department of Justice (DOJ) has handled the issue in the pa...

Determining where a physician’s conduct should be reviewed is a challenging subject. In this episode, Captain Integrity Bob Wade continues his breakdown of Peer Review and Compliance in relation to the Stark Law. Hear why quality can be both a Peer Review and a Compliance issue depending on the severity, fraud issues that impact billing are usually the exclusive domain of the Compliance department, someone needs to assess issues and concerns to determine who is responsible for their review, specific examples to help you determine who reviews each case, and some things physicians have done you wouldn’t beli...

Physician activities reviewed through the Peer Review process may pose liability under the False Claims Act - including the Stark Law. In this episode, Captain Integrity Bob Wade details how Peer Review and Compliance can work together. Hear how to train your team on Peer Review and Compliance issues, why Peer Review documents can be reviewed by other appropriate individuals in the hospital, how Peer Review issues can simultaneously be a False Claim, the use of the Midas reporting system, and a thrilling book recommendation from Bob. Learn more at CaptainIntegrity.com

Jury trials under the False Claims Act (FCA) can produce very wild outcomes. In this episode, Captain Integrity Bob Wade breaks down what went down in the recent Eli Lilly/Astellas Pharma case. Hear why jury trials under the FCA are extremely rare, there are large jury verdicts, an effective compliance program can reduce or eliminate the risk of going to court, how big a return the government can receive, and how a mistake could be considered fraud. Learn more at CaptainIntegrity.com

The False Claims Act (FCA) continues to be a huge weapon for the government. In this episode, Captain Integrity Bob Wade details the FCA settlements that have happened so far in 2022. Hear why there are still very large settlements that have occurred under the FCA, the knowledge requirement under the FCA is very broad, Corporate Integrity Agreements (CIAs) and Qui Tam Relators were front and center in many of these settlements, the basics of the FCA, and how much of the penalties are coming from the healthcare sector. Learn more at CaptainIntegrity.com

Accountable Care Organizations (ACOs) are truly unique partnerships with the government. In this episode, Captain Integrity Bob Wade welcomes Kelly Conroy of Pinnacle Healthcare Consulting to chat the ins and outs of ACOs as they relate to the Stark Law. Hear why every primary care physician (PCP) should be in an ACO, almost every big commercial carrier has a shared savings component to it, ACOs are good for society, providers, and patients, how Kelly started the first ACO, and what she does in her job. Learn more at CaptainIntegrity.com

How do you respond to a Civil Investigative Demand (CID) issued by the Department of Justice (DOJ)? In this episode, Captain Integrity Bob Wade details what to do and why you shouldn’t freak out. Hear why you should take the CID seriously and cooperate with the DOJ, involve competent outside legal counsel, review the documents prior to producing them to the DOJ, the types of documents the government demands, and Bob’s poem, “How to Respond to a CID.” Learn more at CaptainIntegrity.com

The Office of Inspector General (OIG) has a Self-Disclosure Protocol (SDP) as well, but it’s different than the Centers for Medicare and Medicaid Services Self-Referral Disclosure Protocol (CMS SRDP). In this episode, Captain Integrity Bob Wade shares how to disclose AKS, False Claims and potentially Stark Law violations through the OIG. Hear why the OIG SDP should not be used for strict Stark Law violations, what it can be used for, the multiplier they’ll target, differences vs. the CMS SRDP, and how long the statute of limitations applies. Learn more at CaptainIntegrity.com

If you discover a Stark Law violation, you can self-report it to the Centers for Medicare and Medicaid Services (CMS) through the Self-Referral Disclosure Protocol (SRDP). In this episode, Captain Integrity Bob Wade breaks down what to do when you find out there’s been a Stark Law violation. Hear why you should do your legal research before using the SRDP, reasonable settlements can be negotiated, you should use competent Stark Law legal counsel to assist you, what happens if you lay low and hope no one discovers the Stark Law violation, and possible resolutions outside of the SRDP. Le...

Continuing Medical Education (CME) is needed, but you need to be careful how you hold these events. In this episode, Captain Integrity Bob Wade shares the positives and watchouts of CME under the Stark Law. Hear why CME is deemed to be remuneration and therefore must comply with the Anti-Kickback Statute (AKS) and Stark Law, Fair Market Value (FMV) for CME can be made by looking at overall expenses and dividing by the number of anticipated attendees, the best way to provide CME is under the Non-Monetary Compensation Exception or avail yourself of the Medical Staff Incidental Benefit Exception...

Compliance experts and monitors can be valuable tools and resources in the world of the Stark Law. In this episode, Captain Integrity Bob Wade breaks down the duties and responsibilities of compliance experts and why they can be valuable for organizations. Hear who compliance monitors are generally appointed by, who pays for their services and expenses, why it’s a valuable effort for an organization to voluntarily engage their services, what life is like as a compliance expert, and an analogy to embedded journalists. Learn more at CaptainIntegrity.com

Being a compliance officer can be very challenging and rewarding. In this episode, Captain Integrity Bob Wade answers the questions he gets most often about compliance officers and the Stark Law. Hear why you need a compliance officer, what a compliance officer does, who should be a compliance officer, Bob’s experience as a compliance officer, and a fun analogy from Toy Story. Learn more at CaptainIntegrity.com

Time reports are important for compliance, Fair Market Value, commercial reasonableness, and cost reporting for physician administrative services. In this episode, Captain Integrity Bob Wade details why time reporting is so essential to Stark Law compliance. Hear why time studies are required for cost reporting purposes, to meet commercial reasonableness and Fair Market Value standards, how to follow the defensibility spectrum, when to get written documentation, and some fun time examples from the music world. Learn more at CaptainIntegrity.com

Compensation pools are commercially reasonable but must be carefully assessed. In this episode, Captain Integrity Bob Wade shares a Stark Law analogy perfect for the summer pool season. Hear why the funding of pooled compensation must come from a defensible source, you cannot use pooled compensation to reward for referrals, attorney and compliance officer “lifeguards” should monitor and audit the division of the pool, the different types of compensation pools, and swimmers with the greatest proficiency. Learn more at CaptainIntegrity.com

K.I.S.S. applies to the Stark Law as well. In this episode, Captain Integrity Bob Wade explains how to “Keep it Simple, Stupid” when considering the Stark Law with your team and clients. Hear how to know your audience, understand what type of complexity you’re dealing with, make your analysis value-based, the impact of attorneys, and how to bring value to your client. Learn more at CaptainIntegrity.com