Schedule

Join us for the presentation of the 2023 Patricia T. Meador Leadership Award in recognition to a member-volunteer who has demonstrated extraordinary commitment and dedication to fraud and compliance education and mentoring.

This jam-packed session will cover key Fraud and Abuse developments over the past year. Highlights include:

• Enforcement trends and recent statistics

• False Claims Act case law and settlements

• Important SCOTUS rulings

• Stark and Anti-kickback developments

• Reimbursement rollercoaster–340B, coding changes, shifts in payment policy

• Post- COVID: The pandemic may be over but related enforcement actions are just starting

• The fundamentals of CPT, HCPCS, and ICD-10-CM coding to include example exercises in the code selection process

• Hospital facility coding (ICD-10-PCS) and the inpatient prospective payment system (IPPS)

• Information detailing the process of resolving coding disputes, which commonly occur due to the lack of universal code selection standards and/or the failure to differentiate code selection from reimbursement rules

• Tips for evaluating weak spots in expert opinions w/ case examples will be provided

• Regulatory and enforcement trends impacting health care due diligence activities

• Designing and implementing effective pre-acquisition due diligence and post-acquisition integration

• Best practices and practical considerations for managing compliance risks and program requirements and workplans in acquisitions

• How to prepare, how to respond, and what possible outcomes to expect in managing compliance investigations post-acquisition integration

• How, if at all, is the Supervalu opinion impacting DOJ’s approach to FCA cases?

• How does the defense bar view Supervalu and the recent legal decisions in the FCA arena?

• How is the EKRA statute being used by DOJ in lab and testing enforcement matters?

• What impact, if any, are DOJ’s renewed calls for self-disclosure having on companies making compliance and disclosure decisions?

• What trends are the whistleblower bar tracking

• The significant recent developments in legal challenges to the improper use of sampling and extrapolating overpayments

• How recent updates to how federal agencies use sampling and extrapolation to support fraud claims

• How recent update to HHS-OIG policy on how IROs calculate net overpayments under CIAs impacts application of those definition by other agencies

• How basic due process challenges have been developing in administrative and court decisions

• Practical applications for designing a credible internal sampling and extrapolation for self-disclosures

This session will provide up to date basic overviews of the Physician Self-Referral Law (Stark Law), the Anti-Kickback Statute and their implementing regulations, including their frameworks, interpretations, compliance considerations and potential areas of enforcement risk. Topics covered will include:

• The Stark Law and Anti-Kickback Frameworks

• Key exceptions and safe harbors

• Definitions and interpretations, including compliance with the "Big 3" (FMV, commercial reasonableness, the volume/value standard)

• The Value-Based Framework

• Auditing, monitoring, and compliance considerations

As CMS, OIG, and DOJ continue to issue evolving positions on Medicare Advantage compliance requirements, common themes regarding patient and program protection echo across these agencies.  This presentation will discuss these agencies’ views of emerging fraud and abuse trends, and describe ways to proactively implement compliance safeguards, including:

• Prior authorization requirements

• Risk adjustment

• Remote risk assessments and telefraud

• "Identifying" an overpayment following regulatory updates

• TPMO and enrollee protections

• Developing DOJ enforcement trends

• Regulatory scrutiny on plan and provider contractors

• The current enforcement landscape and why private equity firms investing in health care entities face increased scrutiny

• Recent case reviews highlighting key factors DOJ considers in holding private equity firms liable

• An emphasis on “causation” and evidence used in assessing whether a private equity firm “caused” a false claim

• How private equity firms can mitigate False Claims Act liability

• Regulatory and enforcement trends impacting health care due diligence activities

• Designing and implementing effective pre-acquisition due diligence and post-acquisition integration

• Best practices and practical considerations for managing compliance risks and program requirements and workplans in acquisitions

• How to prepare, how to respond, and what possible outcomes to expect in managing compliance investigations post-acquisition integration

• The elements of a False Claims Act violation

• The consequences of a False Claims Act violation

• What governmental agencies are involved in False Claims Act investigations

• How DOJ investigates allegations of False Claims Act Violations

• False Claims Act trends, including industry sectors, recovery statistics and new matter statistics

• Significant FCA cases from the last year

This session will discuss the evolving role of sub-regulatory guidance, such as manual provisions and memorandum, in fraud and compliance actions and reimbursement disputes. The session will include updates on the agency’s latest approach to sub-regulatory guidance, as well as recent relevant court decisions. It’ll specifically address applications of the Supreme Court's 2019 decision in Azar v. Allina expanding the types of Medicare policies that must undergo notice-and-comment rulemaking to become effective. Topics will include:

• What constitutes sub-regulatory guidance?

• When does sub-regulatory guidance create a “substantive legal standard” necessitating notice and comment rulemaking under Allina?

• Can sub-regulatory guidance trigger an “overpayment” and self-reporting obligations?

• Is sub-regulatory guidance binding in False Claims Act litigation?

• Where do local coverage determinations (LCDs) and national coverage determinations (NCDs) fit in?

• Overall, what difference does it make whether a policy is found in nonbinding subregulatory guidance or binding regulations?

• The different types of exclusions that are relevant in health care, with a main focus on OIG exclusions and authorities

• The impacts of exclusion on health care providers or organizations

• Guidance on how to operationalize an effective screening program

• Potential corrective actions in the event you identify an excluded party

• How organizations can use the value-based AKS safe harbors and Stark exceptions

• How to incorporate these issues into your organization's compliance program

• Other common fraud and abuse issues with value-based arrangements

• OCR enforcement activity, is your organization at risk?

• Privacy is more than OCR: DOJ, FTC, OIG and others you should be watching

• Key considerations for state privacy law obligations

• Courts, cases, and other actions

• Third party risks associated with BAs and other business partners

• The nuts and bolts of criminal health care fraud cases from inception through resolution with an emphasis on recent trends and enforcement priorities

• The current practices for initiation of investigations, modern investigative strategies, evidence development, evaluation of criminal versus civil charges, working with experts, joint defense considerations, cooperation and disclosures, resolution, and collateral consequences

• The impact of DOJ’s new corporate criminal enforcement policies and revised guidance on Effective Corporate Compliance Programs on health care fraud investigations and resolutions

• Best practices for effective advocacy to DOJ and OIG

• Why the “Big 3” requirements matter more than ever (most of the time)

• In depth look at what is “commercially reasonable” and what is not, and how to avoid trouble

• How to determine “fair market value” in the current volatile marketplace

• Squaring the new “Volume or Value” Standard with enforcement trends and related concerns, including recent examples

• Checklist for Big 3 compliance–ensuring transactions are defensible and documentation is created that supports defensibility

• Recent enforcement trends under the FCA

• The Supreme Court’s decision in SuperValu and what it means for a defendant to act with “substantial and unjustifiable risk” regarding the falsity of the claim? 

• The Supreme Court’s decision in Polansky and the extent the case may alter, if at all, the government’s relationship with relator and defendant’s relationship with the relator in litigating qui tam actions

• Latest circuit court decisions regarding the extent to which plaintiff must prove that the alleged unlawful remuneration was the cause of referral to bring a successful FCA / AKS lawsuit

• When the FCA requires that companies must remit an overpayment or be held liable under the FCA

Ransomware attacks on U.S. hospitals and health systems are surging. The question is “not if, but when?” Preparation may be the only thing that allows for continuity of care and patient safety. This special lunch panel will provide advice based on real-life experiences about how to: (i) respond a ransomware attack; (ii) remain operational; (iii) negotiate a settlement; and (iv) prepare for an attack based on lessons learned. Finally, the panel will take you inside the dark web to see where PHI and other confidential data is being sold and traded. Please join us.

• Recent industry trends in the area of Behavioral Health

• Effects of COVID on Behavioral Health services

• Key factors for health systems to consider when expanding behavioral health services (e.g., adding to Audit and Compliance Programs)

• DOJ/OIG enforcement actions, areas of focus, and alleged "fraudulent schemes" involving behavioral health, with a particular focus on those involving Hospital systems and physician groups

• Primer on notable issues currently being litigated under the Parity Act and what to watch for going forward, including comparative treatments, licensing requirements, exclusions, wilderness therapy, guidelines, and damages

• Key "things to know" about reimbursement/payer considerations in the behavioral health space (e.g., the Parity Act, common billing errors and billing issues)

• Potential policy developments being discussed in the industry

This program will focus on best practices for communicating with HHS regulators through comment letters and requests for OIG and CMS Advisory Opinions. We will offer insights from a current senior OIG official and two speakers with experience in private practice, in-house, and at OIG. This presentation will cover a range of strategies for these interactions, including:

• How to write effective and persuasive comment letters and common pitfalls to avoid

• What to consider when requesting Advisory Opinions, such as (1) whether to submit a request; (2) how to optimize your submission; and (3) what to expect from the Advisory Opinion process

• We also will provide an overview of the new OIG FAQ process and explore ways that the health care industry may be able to utilize this valuable resource

• Keeping track of Who’s your client—Corporations, individuals, joint engagements

• Upjohn—How to provide warnings and why?

• Deep dive on confidentiality obligations under MRE 1.6 v. Attorney Client Privilege

• Developments in Work Product Case law—surreptitious recordings, use of consultants, and more

• Common Interest Doctrine—What is it, how does it work, and what are the pitfalls?

• Attorney Client Privilege—compliance program e-mails, crime fraud, advice of counsel waiver

The OIG Special Fraud Alert on equity JVs was issued 29 years ago and the OIG Special Advisory Bulletin on Contractual JVs is 20 years old. Much has changed in the health care industry in the intervening decades. How relevant is this OIG guidance today? The OIG and DOJ have investigated a variety of JVs over the years, but they have been reticent to argue that JVs, even between referral sources, are per se illegal. For example, the 2014 DaVita settlement challenged certain practices related to JVs and the valuations that were used, but the settlement and CIA did not challenge the fundamental existence of JVs between the physicians who order dialysis and the companies that operate centers to provide dialysis. Government policy is increasingly focused on improving quality and reducing costs through collaboration. Shouldn’t JVs be a legitimate way to achieve such collaboration? Where should the line be drawn under the F&A laws with respect to JVs in the health care industry?

• Key guidance from the OIG and important cases and settlements that speak to the government’s view of joint ventures

• Suggestions for ways to mitigate risk in developing joint ventures

• Hypotheticals to tease out where the line is between legal and illegal joint ventures

• Medical necessity cases continue to thrive in various audits and investigations, including under the False Claims Act

• Consider the primary legal issues when allegations of lack of medical necessity are made, including recent cases, settlements, and court rulings

• Consider what conduct in medical necessity cases results in the matter being pursued either civilly or criminally, as opposed to just an administrative overpayment recoupment

• What steps an organization can take to remediate risk and reduce potential liability

• Forced labor can be difficult to detect in the operations of large multi-national corporations. It can also be challenging to combat forced labor in supply chains given the complexity of subcontracting and staffing services these companies use to carry out their activities. This is particularly acute in the health care space given the reliance on medical devices and equipment and personal protective equipment made with cotton and rubber

• With the expansion of the Trafficking Victims Protection Act and other novel avenues of potential liability, the legal landscape has been in flux; emerging theories of liability are being leveled at US based companies with increasing frequency and intensity. Depending on the particular facts, a company, and potentially its directors, could be held liable for failure to remedy forced labor in its supply chain if it benefited from that labor and knew or should have known of the issue. This potential risk carries over into the health care space as well

• Companies may leverage a variety of practices to prevent forced labor in their supply chains by exercising oversight over their contractors and suppliers. This can include targeted due diligence procedures implemented prior an acquisition or contract, as well as anti-trafficking policies and codes of conduct applicable to the company’s contractors

• Separate and apart from supply chains, it is estimated that 80% of human trafficking victims visit with a medical professional during their trafficking situation. Training of health care professionals–and raising awareness concerning the applicable laws–has the potential to disrupt and mitigate human trafficking as it is occurring

The presentation will cover a several of the more complicated and confused issues under the Physician Self-Referral Law (PSL), including:

• Indirect compensation arrangements–knowing when you have one and when you don't

• Group Practices and the furnishing of DHS

• Is that really remuneration that creates a compensation arrangement?

• … And other nagging issues under the PSL

• The different types of exclusions that are relevant in health care, with a main focus on OIG exclusions and authorities

• The impacts of exclusion on health care providers or organizations

• Guidance on how to operationalize an effective screening program

• Potential corrective actions in the event you identify an excluded party

Representatives from OIG, Baptist Hospital, and its IRO will discuss Baptist’s experience under its CIA and how its compliance program and approach evolved during the CIA and what it took away from the experience. OIG will also proffer advice on the intent by various CIA provisions. The speakers also look forward to answering questions from the audience about CIAs and Baptist’s experience. Topics covered will include:

• Preparing for a CIA

• The compliance officer’s role and the compliance department

• Training and education—and how to achieve 100% medical staff participation

• Internal billing and coding review

• Billing and coding audits, and getting the most from an IRO or external review

• Facilitating communication among stakeholders

• Why the “Big 3” requirements matter more than ever (most of the time)

• In depth look at what is “commercially reasonable” and what is not, and how to avoid trouble

• How to determine “fair market value” in the current volatile marketplace

• Squaring the new “Volume or Value” Standard with enforcement trends and related concerns, including recent examples

• Checklist for Big 3 compliance–ensuring transactions are defensible and documentation is created that supports defensibility

• Recent enforcement trends under the FCA

• The Supreme Court’s decision in SuperValu and what it means for a defendant to act with “substantial and unjustifiable risk” regarding the falsity of the claim? 

• The Supreme Court’s decision in Polansky and the extent the case may alter, if at all, the government’s relationship with relator and defendant’s relationship with the relator in litigating qui tam actions

• Latest circuit court decisions regarding the extent to which plaintiff must prove that the alleged unlawful remuneration was the cause of referral to bring a successful FCA / AKS lawsuit

• When the FCA requires that companies must remit an overpayment or be held liable under the FCA

The OIG Special Fraud Alert on equity JVs was issued 29 years ago and the OIG Special Advisory Bulletin on Contractual JVs is 20 years old. Much has changed in the health care industry in the intervening decades. How relevant is this OIG guidance today? The OIG and DOJ have investigated a variety of JVs over the years, but they have been reticent to argue that JVs, even between referral sources, are per se illegal. For example, the 2014 DaVita settlement challenged certain practices related to JVs and the valuations that were used, but the settlement and CIA did not challenge the fundamental existence of JVs between the physicians who order dialysis and the companies that operate centers to provide dialysis. Government policy is increasingly focused on improving quality and reducing costs through collaboration. Shouldn’t JVs be a legitimate way to achieve such collaboration? Where should the line be drawn under the F&A laws with respect to JVs in the health care industry?

• Key guidance from the OIG and important cases and settlements that speak to the government’s view of joint ventures

• Suggestions for ways to mitigate risk in developing joint ventures

• Hypotheticals to tease out where the line is between legal and illegal joint ventures

• Insights and tips into conducting discovery to prepare for an FCA trial

• Preparing effective pretrial motions, including motions in limine

• Interesting legal and evidentiary issues that could arise at trial

• Dealing with post-trial issues, including damages and penalties

• CMS–Expanded Authorities for Billing Privileges Revocations

• CMS–Credible Allegations of Fraud Suspensions

• CMS–Increased Disclosure of Ownership Requirements

• OIG–Use of the CMP Authorities

• OIG–the Role of the Fraud Risk Indicator

• Non CMS/OIG Consequences Associated with CMS/OIG Actions

• How, if at all, is the Supervalu opinion impacting DOJ’s approach to FCA cases?

• How does the defense bar view Supervalu and the recent legal decisions in the FCA arena?

• How is the EKRA statute being used by DOJ in lab and testing enforcement matters?

• What impact, if any, are DOJ’s renewed calls for self-disclosure having on companies making compliance and disclosure decisions?

• What trends are the whistleblower bar tracking?

• The current enforcement landscape and why private equity firms investing in health care entities face increased scrutiny

• Recent case reviews highlighting key factors DOJ considers in holding private equity firms liable

• An emphasis on “causation” and evidence used in assessing whether a private equity firm “caused” a false claim

• How private equity firms can mitigate False Claims Act liability

This session will include a review of recent enforcement actions and trends involving laboratories related to:

• Genetic testing

• COVID-19 testing

• Telehealth

• Marketing (including the use of independent contractors)

• In-office personnel

• Urine drug testing

• Addiction recovery services (including a discussion of EKRA)

• How organizations can use the value-based AKS safe harbors and Stark exceptions

• How to incorporate these issues into your organization's compliance program

• Other common fraud and abuse issues with value-based arrangements

This program will focus on best practices for communicating with HHS regulators through comment letters and requests for OIG and CMS Advisory Opinions. We will offer insights from a current senior OIG official and two speakers with experience in private practice, in-house, and at OIG. This presentation will cover a range of strategies for these interactions, including:

• How to write effective and persuasive comment letters and common pitfalls to avoid

• What to consider when requesting Advisory Opinions, such as (1) whether to submit a request; (2) how to optimize your submission; and (3) what to expect from the Advisory Opinion process

• We also will provide an overview of the new OIG FAQ process and explore ways that the health care industry may be able to utilize this valuable resource

• Keeping track of Who’s your client—Corporations, individuals, joint engagements

• Upjohn—How to provide warnings and why?

• Deep dive on confidentiality obligations under MRE 1.6 v. Attorney Client Privilege

• Developments in Work Product Case law—surreptitious recordings, use of consultants, and more

• Common Interest Doctrine—What is it, how does it work, and what are the pitfalls?

• Attorney Client Privilege—compliance program e-mails, crime fraud, advice of counsel waiver

• The nuts and bolts of criminal health care fraud cases from inception through resolution with an emphasis on recent trends and enforcement priorities

• The current practices for initiation of investigations, modern investigative strategies, evidence development, evaluation of criminal versus civil charges, working with experts, joint defense considerations, cooperation and disclosures, resolution, and collateral consequences

• The impact of DOJ’s new corporate criminal enforcement policies and revised guidance on Effective Corporate Compliance Programs on health care fraud investigations and resolutions

• Best practices for effective advocacy to DOJ and OIG

The presentation will cover a several of the more complicated and confused issues under the Physician Self-Referral Law (PSL), including:

• Indirect compensation arrangements–knowing when you have one and when you don't

• Group Practices and the furnishing of DHS

• Is that really remuneration that creates a compensation arrangement?

• … And other nagging issues under the PSL

• The significant recent developments in legal challenges to the improper use of sampling and extrapolating overpayments

• How recent updates to how federal agencies use sampling and extrapolation to support fraud claims

• How recent update to HHS-OIG policy on how IROs calculate net overpayments under CIAs impacts application of those definition by other agencies

• How basic due process challenges have been developing in administrative and court decisions

• Practical applications for designing a credible internal sampling and extrapolation for self-disclosures

• CMS–Expanded Authorities for Billing Privileges Revocations

• CMS–Credible Allegations of Fraud Suspensions

• CMS–Increased Disclosure of Ownership Requirements

• OIG–Use of the CMP Authorities

• OIG–the Role of the Fraud Risk Indicator

• Non CMS/OIG Consequences Associated with CMS/OIG Actions