Program Agenda

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Agenda

Thursday, September 24

11:00 am-12:30 pm EST | Plenary Session

1. Billing and Coding Bootcamp
Michael D. Miscoe
Robert A. Pelaia
Leonta (Lee) Williams

  • The basics of procedural (CPT) and diagnosis (ICD-10) coding
  • General guidance on use of the CPT and ICD-10 coding manuals
  • Common issues associated with coding billing disputes
  • Common legal/compliance issues based on coding
  • The basics of inpatient procedural coding (ICD-10-PCS)
  • The importance of internal facility guidelines

Wednesday, September 30

10:45 am-12:00 pm EST | Plenary Session
2. Fraud and Compliance Year in Review
Robert Homchick

Kristen B. Rosati
As usual, this will be a fast-paced overview of developments over the past year. We’ll kick off the presentation with the significant legal developments resulting from the COVID-19 pandemic, with an emphasis on the Fraud and Compliance issues. We’ll also cover other significant developments in False Claims Act litigation, the Stark law, HIPAA and Health Care Reform.  Time permitting we will cover:

  • The Pandemic: The CARES Act, other COVID-related legislation and regulatory waivers
  • False Claims Act Litigation
  • Fraud and abuse:  The beat goes on
  • HIPAA and HIT developments: Information blocking and interoperability and OCR enforcement
  • Health care reform:  Significant Supreme Court decisions and status of the Affordable Care Act

12:15-1:15 pm EST | Concurrent Sessions

3. Fraud Enforcement in the Digital Arena: Trends and Considerations for EHR
Colin J. Callahan
Edward Crooke
Deborah Farringer
Christopher C. Sabis

  • The history of enforcement actions and relator activity involving EHR systems
  • Possible new areas of increased fraud enforcement activity relating to EHR systems beyond EHR donations and MU certifications
  • Considerations for EHR providers and users when marketing and employing EHR technology
  • Expanded authority for HHS-OIG to investigate information blocking and potential implications for EHR developers and users
4. The Evolving Opioid Enforcement Landscape (Advanced)

Sean Bosack
Gary L. Cantrell
Stacy Gerber Ward
The nationally declared Opioid Crisis has left a deep mark on federal enforcement against the health care industry. Aggressive enforcement by both federal and state authorities continues at a brisk pace against both providers and others involved in the distribution and dispensing of opioids. Two veteran lawyers and a lead investigator with significant experience in these enforcement actions will delve into these evolving trends. This presentation will include:

  • The genesis and evolution of opioid prescribing that is at the root of many current enforcement actions
  • Recent guidance being used as prescribing standards by government enforcement officials
  • Trends in both criminal and civil prosecutions related to opioid prescribing under both the Controlled Substances Act and the False Claims Act
  • Best practices that can help health systems and practice groups to be prepared to respond to inquiries from DOJ and the OIG

 5. The Physician Self-Referral Law’s “Big 3”:  Commercial Reasonableness, the Volume or Value Standard, and Fair Market Value. What Was, What Is and What May Be
Albert Shay
Lisa Ohrin Wilson

  • CMS’s existing treatment of commercial reasonableness, the volume or value standard, and fair market value (FMV) (the “Big 3”)
  • CMS’s current policy on the Big 3 and potential inconsistencies with general perceptions of commercial reasonableness, what it means to take into account the volume or value of referrals or other business generated, and FMV
  • CMS’s proposed revisions to the Big 3 and potential implications of these proposed changes, including relevant stakeholder commentary to the proposed changes, to the Big 3
  • Possible outcome of the rule-making process on commercial reasonableness, the volume or value standard, and FMV
1:30-2:30 pm EST | Concurrent Sessions

6. The Evolving Whistleblower Landscape: Views from the Trenches
Patrick Coffey
Shannon Fox Fraser
Chris Mollet

  • FCA and whistleblower cases, settlements and early trends under COVID-19
  • The triggers for whistleblower complaints and potential for FCA enforcement shifts due to the pandemic
  • The whistleblower dynamic and improving the identification and management of potential claims
  • Handling whistleblower complaints and investigations in the midst of COVID-19
  • Addressing the DOJ and OIG perspective on compliance and risk management
  • Using effective compliance and other tools to impact DOJ enforcement decisions (on intervention and even dismissal)

 7. Emerging Compliance Considerations for Value-Based Care (Advanced)
Priya Bathija
Kelly Conroy
Elizabeth Isbey
Neal Shah

  • Value-based payment (“VBP”) models are increasingly moving to the center of healthcare strategy and decision-making, with some advisory bodies calling for 100% of Medicare payments to be made through VBP models in the next five years
  • The effects of the COVID-19 pandemic have also encouraged additional providers to consider alternatives to fee-for-service reimbursement
  • The payment structures and underlying goals of these models create new challenges and opportunities that may impact the business strategy, financial relationships, and compliance considerations for participants in these models
  • A brief survey of the recent activity in VBP models including a summary of applicable ACO rules, Advanced APM bonuses, quality-based elements in Medicare fee schedules, efforts to engage physicians in VBP models, interventions to address social drivers of health, and implications of the pandemic
  • Current special flexibilities for certain kinds of VBP models (e.g., ACO waivers and proposed Stark and Anti-Kickback Statute rules on value-based care)
  • Practical considerations for health care operations under value-based care models
  • Common operational problems/failures in using the special fraud and abuse flexibilities for ACOs
  • Compliance considerations for risk adjustment models and related compensation models

8. A(nother) Peek Behind the Curtain:  The Interactions of DOJ, OIG, CMS, and the HHS Office of General Counsel
Karen Glassman
Janet Nolan
Laurie Oberembt
Lisa Ohrin Wilson

  • An insider's perspective on how DOJ, OIG, CMS, and HHS Office of General Counsel (HHS OGC) interact during the course of investigations, litigation, review of self-disclosures, and other government work
  • The roles of each of the agencies in enforcing critical fraud and abuse laws, such as the federal Anti-kickback Statute the Physician Self-referral Law, and Medicare/Medicaid rules and regulations
  • Tips for providers during investigations and self-disclosures
 
2:45-3:45 pm EST | Concurrent Sessions

9. OIG/DOJ’s 2020 Health Care Fraud Priorities: What Providers Need to Know; How they Should Prepare and Respond (Advanced)
Ritu Cooper
Allan Medina
Christian Schrank

  • OIG Efforts during the 2020 Pandemic
    • OIG-Office of Investigations’ work
    • OIG COVID-19 Strategic Goals
    • Emerging Fraud Schemes with COVID-19
  • Collaboration between, OIG, DOJ, FBI and other law enforcement partners
  • Emerging Trends in Health Care Fraud Enforcement
    • Education/prevention of health care fraud schemes
  • The Strike Force and Model
  • In-house responses and considerations
    • Internal investigations into potential fraud
    • Marshalling internal assets, gathering data, and response
    • Best practices

 10. Navigating Ethical and Compliance Challenges
Charise R. Frazier
Josephine Nelson Harriott

  • An interactive session that focuses on the latest happenings related to legal ethics and compliance in the health care industry
  • The speakers will present a number of hypotheticals which address common ethical and compliance issues. Attendees will have the opportunity to assist with resolving the challenges presented in the hypotheticals
  • Recent developments in ethics and compliance in health care and address identifying risk, leadership accountability, attorney-client privilege, internal investigations, and ethics in new technologies
  • Best ethical strategies and gain tips for implementing effective ethics and compliance practices
    4:00-4:45 pm EST

    Virtual Networking Reception
    Following the sessions, grab a drink, set up your virtual background, and hop on our Zoom Happy Hour(ish). Relax after a full day of learning and see and talk to your colleagues live! (Pre-registration required).

    Thursday, October 1, 2020

    10:00-10:45 am EST

    Coffee and Conversations: Compliance Best Practices, hosted by the Fraud and Abuse Practice Group
    Start the day by connecting with your colleagues over coffee (or tea). Virtual Zoom Rooms will be open for small group, moderated discussion on Compliance Best Practices. (Pre-registration required)


    11:00-11:30 am EST | Plenary Session

    11. Connecting the Dots: An OIG Update
    Christi Grimm


    11:45 am-12:45 pm EST | Concurrent Sessions

    12. Managing Fraud and Abuse Challenges in Telehealth 
    Laura Laemmle-Weidenfeld
    Terrence M. Lewis
    Andrew VanLandingham

    • Common types of telehealth arrangements
    • Fraud and abuse risks in telehealth versus traditional medicine
    • Impact of COVID-19 on fraud and abuse risks
    • Government enforcement activity in telehealth
    • Strategies for mitigating F&A risks in telehealth

    13. Government Enforcement Considerations for Private Equity
    Evan Panich
    Lisa S. Rivera
    Benjamin S. Schecter
    Phil Watts

    • Government enforcement considerations for private equity
    • Recent government enforcement targeting private equity
    • Questions for private equity and due diligence efforts
    • Best practices and considerations for compliance and control in private equity transactions

    14. Compliance Program Effectiveness: A Map for the Journey Ahead
    Jacqueline C. Baratian
    Felicia Heimer
    Christine Morse

    • Basic compliance program structure and how to get your program to the next level
    • Recent guidance on the role of compliance in specific areas such as managing third party relationships, contributing to due diligence in mergers and acquisitions, and conducting investigations
    • The roles of compliance officers, boards of directors, in-house legal, outside counsel, and other consultants in conducting compliance program effectiveness reviews
    • Common pitfalls and tips to help you remain in a proactive compliance mode

    1:00-2:00 pm EST | Concurrent Sessions

    15. Cutting Edge Issues Regarding False Claims Act, Stark, Kickback Allegations (Advanced)
    David Fuchs
    Robert S. Salcido
    Benjamin Wei

    • Regarding the FCA, understand statutory duty to remit known overpayments and potential pitfalls when making routine overpayments, which could prejudice the company in a subsequent FCA action
    • In FCA litigation, learn emerging theories of liability and developing defenses that maximize the likelihood that defendant will prevail on the FCA’s falsity, knowledge and materiality elements
    • Regarding the AKS, explore developing theories of liability and new defenses related to fair market value and the requirement that plaintiff link remuneration to claims
    • Regarding Stark law, learn the type of activity FCA plaintiffs target such as when providers measure revenue associated with downstream referrals and when physician compensation does not match productivity

    16. Developments in Government Managed Care Fraud Enforcement
    Wayne Gibson
    Amy Hargreaves
    Megan Tinker

    • The trend in case rulings and the trend in enforcement actions against Medicare and Medicaid Managed Care providers and their contactors – what has changed and what is new?
    • What do smaller enforcement actions and trends suggest regarding industry oversight?
    • Are regulations changing or is enforcement increasing? Thoughts on Call Letters and other items
    • Key considerations for Health Plans, Providers, and Third Party Vendors

    17. Administrative Enforcement: Case Study with Perspectives from CMS, OIG and the DAB
    Julie Burns
    Katie Fink
    Joshua Jowers
    Judith Waltz

    • CMS – Revocations of Enrollment, including under the “Affiliates” Rule, and Collateral Consequences
    • OIG – CMP Authorities, Exclusion, and the Role of the Fraud Risk Indicator
    • DAB – Practice tips

    2:15-3:15 pm EST | Concurrent Sessions

    18. Fraud and Compliance Issues Relating to the CARES Act Provider Relief Fund
    Jeffrey Davis
    Brenna Jenny
    Susan Monarez
    Joseph Roach

    • CARES Act Provider Relief Fund distribution process
    • Key Requirements in the terms and conditions and FAQs
    • Reporting requirements
    • Common issues faced by provider recipients
    • Ongoing and potential future oversight

    19. The Proposed Physician Self-Referral (“Stark Law”) Regulations—New Tools to Avoid Technical Non-Compliance and Other Clarifying Updates (Advanced)
    Nicholas F. Alarif
    Matthew Edgar

    • Significant proposed changes to the Stark Law outside of the value-based care exceptions and “the Big 3” definitional changes (i.e., “fair market value,” “commercial reasonableness,” and “volume or value of referrals”)
    • New Stark Law exceptions, changes to existing Stark Law exceptions, definitional changes, and additional regulatory commentary clarifying CMS’s interpretation of the Stark Law. Hypotheticals surrounding the application of:
    • The new limited remuneration exception to the Stark Law
    • New “writing” grace periods
    • Payments by a physician exception “restoration”
    • Remuneration unrelated to DHS “restoration”
    • New period of disallowance (period of non-compliance) commentary from CMS
    • Liberalization of exceptions for leases including use of the fair market value exception and tenant’s ability to share space or equipment without violation of the “exclusivity” requirement
    • Definitional changes to:
      • Isolated financial transactions
      • Inpatient and outpatient designated health services
      • The group practice definition of “overall profits”


    Friday, October 2, 2020

    10:00-10:45 am EST

    Coffee and Conversations hosted by the Fraud and Abuse Practice Group
    Start the day by connecting with your colleagues over coffee (or tea). Virtual Zoom Rooms will be open for small group, moderated discussion on a topic. (Pre-registration required)


    11:30 am-12:00 pm EST | Plenary Session

    20. CMS Provider Flexibilities in Response to COVID-19 and Other Burden Reduction Efforts
    Kimberly Brandt

    • COVID-19 Flexibilities:  Waivers and Interim Final Rules
    • CMS Burden Reduction Efforts including:  Final Interoperability Rule, Patients Over Paperwork, and Updating the Physician Self-Referral Or “Stark” Law

    12:15-1:15 pm EST | Concurrent Sessions

    21. Digging Deeper in Your Audits: An Investigative Approach to Effective Compliance, the 60-Day Rule, and Identifying Overpayments
    Adam Hepworth
    Lori Laubach

    • Knowing when to audit (and when to refund)
      • Auditing is a core component of an effective compliance program (Sentencing Guidelines/DOJ/HHS-OIG) and is critical for meeting federal obligations under the 60-day rule
    • Structuring the audit, getting it done, and moving forward
      • Early legal assessment is essential to identify the applicable ruleset and guidance. Audit design may be sensitive to eventual refund obligations (e.g., MAC refund vs. OIG self-disclosure vs. Medicaid self-disclosure). Discuss tips for dealing with data, records review, and statistical extrapolation
    • Meeting legal obligations while maximizing legal protections
      • How to identify when there is an overpayment (relevance of Escobar). Importance of transparency in self-disclosures. How to maintain attorney-client privilege

    22. Strategic Considerations for Resolving FCA Matters: Adjusting to Recent DOJ, OIG, and CMS Policy Changes (Advanced)
    Tony Maida (Moderator)
    Jacob T. Elberg
    Susan Gillin
    Alison Rousseau
    The panel will discuss recent changes in DOJ, OIG, and CMS policy which relate to the resolution of FCA matters, and discuss how those changes impact resolution strategy. The panel will include representatives from DOJ, OIG, the defense bar, and a professor who has researched several years of data surrounding FCA resolutions.
    How has DOJ’s May 2019 FCA Resolution Guidance impacted settlement negotiations?

    • What is the impact of OIG’s creation of the “High Risk” List on evaluating and negotiating Corporate Integrity Agreements?
    • How to deal with a CMS Medicare payment suspension during an FCA investigation and settlement negotiation
    • What does data analysis reveal re: FCA resolutions and DOJ policy and what the data can teach parties entering negotiations today?

    1:30-2:30 pm EST | Concurrent Sessions

    23. A New Frontier: DOJ Enforcement Involving Health IT (Advanced)
    R. Joseph Burby, IV
    Aaron M. Danzig
    Lauren Lively
    Adam Schwartz

    • The federal government’s Promoting Interoperability Programs, formerly known as "Meaningful Use," and how the DOJ is pursuing civil and criminal enforcement actions against Health IT companies, particularly EHR vendors, and their provider customers related to their participation in the programs.  Topics covered will include:
    • Promoting Interoperability Programs and related EHR certification program
    • The DOJ’s theories of FCA and AKS liability in this area, and focus on individuals in addition to companies
    • Potential defenses for Health IT companies and providers, litigation strategies, and compliance advice
    • Recent major settlements by eClinicalWorks, Greenway Health and Practice Fusion, as well as other ongoing cases involving Health IT

    24. Leading Compliance Through Difficult Times—Lessons From Successful CIAs
    Laura E. Ellis
    Margaret Hambleton

    • The three buckets of CIA adherence
    • What makes an entity a CIA success
    • What are the keys to CIA success
    • How can lessons apply to new or emerging risks, transitions, and issues