Wednesday, March 24
11:00 am-12:00 noon EDT | Plenary Session
1. Plenary Session
Amy Hall, Staff Director, Subcommittee on Health, Committee on Ways and Means, U.S. House of Representatives
Stuart Portman, Health Policy Advisor, US Senate Committee on Finance
12:15-1:15 pm EDT | Concurrent Sessions
2. Medicaid Fundamentals
(Session was Pre-Recorded for the Fundamentals of Health Law Program, November 2020)
Caroline L. Farrell, Medicaid Attorney, Office of the General Counsel, CMS Division, United States Department of Health and Human Services
Jeff J. Wurzburg, Norton Rose Fulbright US LLP
- The Medicaid program and its program objectives
- The statutory requirements for Medicaid programs
- Medicaid's critical role in addressing the COVID-19 public health emergency
- Different state approaches to Medicaid and Medicaid eligibility
- The next era of the Medicaid program and reforms including the Healthy Adult Opportunity and work and community engagement requirements
- The future: Ongoing litigation and contemplated reforms
3. Hot Topics in Fraud and Abuse
Robert Kaufman, Office of the General Counsel-CMS Division, US Department of Health and Human Services
Laura F. Laemmle-Weidenfeld, Jones Day
Lisa Re, Assistant Inspector General for Legal Affairs, Office of the Inspector General, US Department of Health and Human Services
Alison B. Rousseau, Senior Counsel for Health Care Fraud, US Department of Justice
- Recent developments in CMS’s program integrity efforts
- Recent priorities and developments in HHS-OIG enforcement efforts
- Recent enforcement activity by the DOJ under the FCA and criminal statutes
4. The 340B Program: Overview, Compliance and Looking Ahead
Eva Johnson, Eyman Associates PC
Barbara Straub Williams, Powers Pyles Sutter & Verville PC
- The 340B drug discount program and key compliance issues
- Patient definition, diversion, GPO prohibition
- Interaction of the 340B program with Medicare and Medicaid
- Duplicate discounts, state initiatives to obtain the benefit of 340B pricing, importance of the Medicare cost report in establishing registered sites, Medicare payment reductions for Status Indicator “K” 340B drugs
- “Hot topics” related to the 340B program
- Alternative dispute resolution regulation, manufacturer actions related to contract pharmacy
- Implications of 340B-related litigation for provider appeals and administrative law more generally
5. The Road Ahead: What Telehealth Looks Like in 2021 and Beyond
Jacob Harper, Morgan Lewis & Bockius LLP
Shira N. Hollander, Senior Associate Director, Policy Development, American Hospital Association
Catherine Wong, Assistant Counsel, Mercy
Emily Yoder, Division of Practitioner Services, Hospital and Ambulatory Policy Group, Centers for Medicare and Medicaid Services
- Impact of the COVID-19 PHE declaration on telehealth
- How physicians, hospitals, and other stakeholders have responded
- Off-ramps for telehealth coverage in 2021
- Legislative and regulatory changes on the horizon
1:30-2:30 pm EDT | Concurrent Sessions
6. Mental Health, EKRA and The Opioid Crisis
Lynn M. Barrett, Barrett Law PA
Kimberly Brandt, Tarplin Downs & Young
Gary L. Cantrell, Deputy Inspector General for Investigations, Office of the Inspector General, US Department of Health and Human Services
- Mental health issues focusing on individuals and entities impacted by the opioid crisis
- What we know (and don’t know) about EKRA
- CMS’s strategy to combat the opioid epidemic, including new Part B benefits for OTPs, Part D initiatives, and key guidance and flexibilities for state Medicaid programs
- Latest trends and enforcement strategies in the fight against prescription opioid diversion and fraud
7. Addressing Social Determinants of Health
Michael McKnight, Senior Vice President of National Programs, Green & Healthy Homes Initiative
8. PRRB Appeals–The View from the Board Chair
Clayton J. Nix, PRRB Chairperson, Office of Hearings, Centers for Medicare and Medicaid Services
- Introduction of Board members
- Board decisions
- Jurisdiction
- Hearings
- Case inventory
- Board initiatives
- Electronic case tracking and filing
- Evaluation of decision process
- Observations from the Board
9. Who CARES how you spent CARES Act funds? The OIG: Be Prepared for CARES Act Audits
Jeffrey S. Cohen, Audit Director, Office of the Inspector General, US Department of Health and Human Services
Joseph Geraci, Husch Blackwell
Julie Sullivan, Greenberg Traurig LLP
The Coronavirus Aid, Relief, and Economic Security (CARES) Act allocated tens of billions of dollars for the Provider Relief Fund (PRF) to support health care providers affected by the COVID-19 pandemic. The HHS-OIG has included various CARES Act audit topics to its Work Plan, and providers should ensure their documentation is in order in anticipation of these audits. In this presentation, we will review the ground rules for the various Provider Relief Act funding distributions, and discuss what auditors may expect to see from various providers to determine that the providers complied with the terms and conditions for reporting and expending PRF funds.
- The Coronavirus Aid, Relief, and Economic Security (CARES) Act allocated tens of billions of dollars for the Provider Relief Fund (PRF) to support health care providers affected by the COVID-19 pandemic. The HHS-OIG has included various CARES Act audit topics to its Work Plan, and providers should ensure their documentation is in order in anticipation of these audits.
- What are the likely areas of focus for the OIG (and other federal auditors).
- In light of the often confusing and changing sub-regulatory guidance provided by HHS, what factors will the OIG take into consideration when deciding on penalties.
- How will the OIG audits differ from a Single Audit?
- What are best practices for preparing for an audit?
2:45-3:45 pm EDT | Concurrent Sessions
10. Medicare Graduate Medical Education Reimbursement: Overview and Recent Policy Changes
Tim Johnson, Senior Vice President, Greater New York Hospital Association
Lori K. Mihalich-Levin, Dentons US LLP
- Medicare payment for graduate medical education (GME)
- The Hahnemann fallout and new program closure rules: Displaced Resident Status and Closed Hospital slot redistribution
- Medicare rules regarding newly-accredited residency and fellowship programs
- Medicare GME legislative changes included in Consolidated Appropriations Act, 2021ac
11. Legal Ethics: The Grey Zone–Ethical Issues In Between Compliance and Legal
Dawn R. Crumel, Managing Counsel, Legal Operations and Administration, Vanderbilt University Medical Center
Stella Ghattas, Children's National Health System
Kim Harvey Looney, K & L Gates LLP
- Intersection of compliance and legal in protecting the organization
- Communication and coordination issues when compliance and legal aren’t on the same page
- The role of Rules of Professional Conduct in these situations
- Reality of compliance making independent reports to the board
- Hypothetical situations
12. Medicare Appeals: Soup to Nuts
Hon. McArthur Allen, Chief Administrative Law Judge, Office of Medicare Hearings and Appeals, US Department of Health and Human Services
Andrew B. Wachler, Wachler & Associates PC
- In-depth explanation of the appeals process, what triggers the process, and what to expect at each stage
- Strategic approaches and practical tips to consider and implement when appealing overpayment demands and claim denials through the changing Medicare appeals process
- Overview and updates from OMHA’s new Chief Administrative Law Judge, including practical tips from OMHA ALJs
- The interplay between audits, provider enrollment, and False Claims Act liability in today’s legal landscape
- Significant reforms to the Medicare appeals process, including HHS rulemaking aimed at reducing the backlog of pending appeals and encouraging resolution of cases earlier in the appeals process
13. Current Issues in Medicaid Supplemental Payments and Financing
Barbara D. A. Eyman, Eyman Associates PC
Charles A. Luband, Dentons US LLP
- Medicaid disproportionate share hospital (DSH) and other Medicaid non-DSH supplemental payments
- Medicaid managed care directed payments
- Medicaid waiver payments, including uncompensated care payments and delivery system reform incentive program payments
- Medicaid financing (IGTs, CPEs, provider taxes, and the Medicaid Fiscal Accountability Rule (MFAR))
3:45-4:30 pm EDT
Interactive Networking and Engagement
Interact with your colleagues face to face in our facilitated small group discussions. (Pre-registration required)
Thursday, March 25
10:00-10:45 am EDT
Coffee and Conversations
Start the day by connecting with your colleagues over coffee (or tea). Attendees can choose between two Zoom Breakout Rooms: GME - Deeper Dive or Telehealth - Deeper Dive. Attendance is limited in each room, so sign up early!
(Pre-registration required)
11:00 am-12:00 noon EDT | Plenary Session
14. Plenary Session
Gregory E. Demske, Chief Counsel, Office of the Inspector General, US Department of Health and Human Services
Matt Salo, Executive Director, National Association of Medicaid Directors
12:15-1:15 pm EDT | Concurrent Sessions
15. Original Medicare DSH Payment–An Ongoing Saga
Peter Bryce, Civil Division, US Department of Justice
Serena M. Orloff, Trial Attorney, Civil Division, Federal Programs Branch, US Department of Justice
Stephanie Ann Webster, Ropes & Gray LLP
- DSH payment adjustment
- Legal issues, including:
- Medicare Part C days
- Medicare Part A non-covered days
- Section 1115 waiver days
- Jurisdictional challenges/decisions and implications
16. Medicare Litigation Update
Mimi H. Brouillette, Associate General Counsel, Office of Legal Affairs Westchester Medical Center
Melissa Hart, Office of the General Counsel, US Department of Health and Human Services
- Past year’s significant Medicare reimbursement decisions issued by the federal courts as well as review of the relevant agency decisions at issue
- Litigation topics including: Jurisdiction; scope of the administrative record; substantive and procedural challenges (e.g., notice and opportunity to comment, contrary to law, and arbitrary and capricious); and remedies (e.g., remand orders and injunctions)
- Potential areas of future Medicare litigation implicated by the past year’s developments
- How courts and the agency have addressed the full spectrum of issues that might be applicable in Medicare litigation, thus giving attendees a better understanding of the strengths and weaknesses of ongoing reimbursement issues
17. Medicare Reimbursement for CAR-T and Allogeneic Stem Cell Transplant: Major Wins, Unknown Future Impact
Jugna J. Shah, Nimitt Consulting Inc
Mark Trusheim, Strategic Director, NEWDIGS, Visiting Scientist, Sloan School of Management Massachusetts Institute of Technology; President, Co-Bio Consulting
- The new Medicare cost reimbursement model for donor cell acquisition costs and how hospitals can access it
- Medicare payment methods for new technologies and what happens after they expire
- The latest about Medicare CAR-T coverage, coding, and reimbursement
- Near-term product pipeline and issues on the horizon
- What other payers are doing for new technologies and what can Medicare can learn from them
- Strategies for tackling tomorrow’s reimbursement challenges today
18. The Changing Medicaid Program–A Panel of State Medicaid Directors
Michael Cook, Liles Parker PLLC
Karen Kimsey, Director, Virginia Department of Medical Assistance Services
Lynnette R. Rhodes, Executive Director, Medical Assistance Plans, Department of Community Health
- How the Medicaid program is changing in a particular state and nationally
- Innovative features of the particular state's Medicaid program
- How the COVID pandemic is affecting their various programs including budget and coverage issues
1:30-2:30 pm EDT | Concurrent Sessions
19. How Much Deference Does CMS Get These Days?
Sven Collins, Squire Patton Boggs
Alisa B. Klein, Attorneys, Appellate Staff, Civil Division, US Department of Justice
Recent Supreme Court decisions have altered the deference standards courts apply to agency actions. This session will explore:
- How those deference standards are playing out in the lower courts
- What implications those deference standards have for providers and CMS
- Which types of agency actions and circumstances are getting deference and which are not
- How guidance on policymaking practices has been adapted to the new deference standards
20. What’s Up Doc: Updates to Medicare Physician Fee Schedule and Part B Payments
Cynthia Brown, Vice President, Government Affairs, American Medical Association
Sidney S. Welch, Akerman LLP
- Important updates and Implications from the 2021 Final Physician Fee Schedule
- Trends and considerations for Part B reimbursement
- Looking forward to 2021 and beyond–areas for input and consideration
21. Uncompensated Care Reporting - Audits and Financial Assistance Policies
Fred A. Fisher, Toyon Associates Inc
K. Michael Nichols, PYA
Mark Polston, King & Spalding LLP
This presentation will cover the importance of reporting uncompensated care on worksheet S-10 of Medicare Cost report, and highlight emerging issues including:
- Variations and consistencies from national S-10 audits
- The impact of COVID-19 to Uncompensated Care
- Takeaways from CMS' new proposed S-10 instructions
- Uncompensated Care's relationship to Financial Assistance Policies
- Frankenstein accounts-can an old account be brought back and reported as charity care?
- Out of network as charity care-is this a measurement of low income?
22. The Federal Health Policy Agenda in the Age of Coronavirus and the Biden Administration: A look Ahead
Eric Zimmerman, McDermott Will & Emery LLP
The new President has a long health care policy wish list. Tackling COVID is priority one, but the President and Congress can chew gum and walk at the same time. Expect much more from the new Administration and Congress this year. This session will identify anticipated federal Medicare and Medicaid policy changes in 2021 and beyond, and assess how those changes could affect client strategies, budgets and transactions.
- Telehealth
- Rural
- Surprise billing
- Medicare payment
- Medicaid waivers