Health Law Section

9:00 a.m. - 9:10 a.m.

Welcome and Introductions

Speaker

Mary Beth Morrissey, PhD, JD, MPH | Health Law Section Chair Yeshiva University New York, NY

Margaret J. Davino | Fox Rothschild LLP New York, NY

Daniel Weinstein | Manatt Phelps & Phillips, LLP New York, NY

9:10 a.m. – 10:00 a.m.

I. Recent Developments in False Claims Act Law

• Causation in Anti-Kickback Statute Cases
• Scienter in Anti-Kickback Statute Cases
• Scienter under the False Claims Act - End of “Objective Reasonableness”
• Damages in Anti-Kickback Statute Cases
• Potential Anti-Kickback Statute Liability for Paying 1099 Sales Reps
• Potential False Claims Act Liability of Private Equity Investors
• Damages in Reimbursement Regimes with Bundled or Capitated Payments
• Trend Away from Finding First-to-File Bar to Be Jurisdictional
• Constitutionality of False Claims Act

Speaker

Gregg Shapiro, Esq. | Gregg Shapiro Law, LLC Boston, MA

1.0 MCLE Credit in Areas of Professional Practice

10:00 a.m. – 10:50 a.m.

II. Medicaid Waivers and SCNs: Overview of the New York Health Equity Reform (NYHER) 1115 Waiver and Novel Legal Issues for the Healthcare Industry.

This session will provide an overview of the NYHER 1115 Waiver, including the innovative ways it is using Medicaid to reimburse providers for the provision of food and nutrition services, housing supports and other social care needs to vulnerable populations in New York. Based on the innovative nature of this waiver, the session will identify the novel and challenging legal issues that stakeholders will face when accessing this new funding, including contracting structures, privacy and data limitations, and tax requirements.

Speaker

Brett R. Friedman, Esq. | Ropes & Gray LLP New York, NY

David Gross, Esq. | Sachs Policy Group New York, NY

1.0 MCLE Credit in Areas of Professional Practice

10:50 a.m. – 11:05 a.m.

Break

11:05 a.m. – 11:55 a.m.

III. Loper Bright’s Impact on Healthcare Law

This panel will opine on how the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), overturning Chevron doctrine, will play out in healthcare litigation in both the federal and state courts.

The panelists will talk about the immediate impacts in federal healthcare jurisprudence, including rulemaking challenges, audits, and adjudicatory disputes, as well as False Claims Act defense, along with the potential spillover impacts on state healthcare jurisprudence in the mirror image categories of SAPA challenges, audits, and adjudicatory disputes and False Claims Act defense. The panel is comprised of the General Counsel of the New York State Department of Health, the chief defense lawyer in the Office of the New York State Attorney General, the Co-Chief of the Civil Frauds Unit of the U.S. Attorney’s Office for the Southern District of New York, and both the Chair and Co-Chair of the Health Care Section’s Litigation Committee.

Speaker

Jacob Bergman | Co-Chief, Civil Fraud Unit Office of the U.S. Attorney for the Southern District of New York

Linda Clark, Esq. | Barclay Damon LLP Albany, NY

Brian Marc Feldman, Esq. | Aurelian Law PLLC Rochester, NY

Beth E. Goldman, Esq. | Chief Deputy Attorney General for State Counsel Office of the New York State Attorney General

Kathy S. Marks, Esq. | General Counsel New York State Department of Health

1.0 MCLE Credit in Areas of Professional Practice

11:55 a.m. – 12:45 p.m.

IV. Legislative Update

Overview of key health-related bills passed and considered during the 2024 NYS legislative session. Includes bills that would increase wrongful death recoveries, regulate hospital closures, and expand scope of practice for certain health care professionals.

Speaker

Laura M. Alfredo, Esq. | Executive Vice President and General Counsel Legal, Regulatory, and Professional Affairs Greater New York Hospital Association New York, NY

Sandi Jessica Toll. Esq. | Senior Vice President and General Counsel Healthcare Association of New York State Rensselaer, New York

1.0 MCLE Credit in Areas of Professional Practice

12:45 p.m. – 1:45 p.m.

Lunch Break

1:45 p.m. – 2:35 p.m.

V. Hospital Charity Care and Financial Assistance: New Laws, Regulatory Actions, and Compliance Initiatives

• Review of charity care requirements (HFAL amendments effective 10/20/24). Recent state hospital charity care law changes, enforcement actions in other jurisdictions (maps, statutes, guidance documents)
• The Model Financial Assistance Compliance Program from Northwell Health and the NY Attorney General. How to implement an effective hospital system operational process for charity care-designed and developed by the speakers
• IRS Charity care hospital audits. Responding to Congressional demands- 35 in 2024; new guidance in 2025
• Summary of scholarship and advocacy on charity care and medical debt collection

Speaker

James Grahan Sheehan, Esq. | New York Attorney General New York, NY

Paul Kaufman, Esq. | Deputy General Counsel and Vice President Northwell Health Inc. New Hyde Park, NY

1.0 MCLE Credit in Areas of Professional Practice

2:35 p.m. – 3:25 p.m.

VI. HIPAA Issues: Tracking Technologies, New Reproductive Health Regulations, OCR Updates

• Recent activity from the Office for Civil Rights (OCR), including guidance and any updates concerning reproductive health information, if available
• Trends in OCR enforcement activity
• Recent updates in litigation related to the use of tracking technology on websites

Speaker

David A. Carney, Esq. | Baker & Hostetler Cleveland, OH

Puja Khare, Esq. | Greater New York Hospital Association New York, NY

1.5 MCLE Credits in Areas of Professional Practice

3:25 p.m. – 3:35 p.m.

Break

3:35 p.m. – 4:00 p.m.

VII. Health Care Transaction Review Laws: Current State and Emerging Trends

This session will provide a refresher and check-in on New York's material transactions law, which became effective August 1, 2023. In addition, the session will provide a brief overview of similar laws that have taken effect in other states (notably California), why such efforts to regulate health care transactions have failed in certain states, like Oregon, and what is next for this evolving area of the law.

Speaker

Jason S. Madden, Esq. | Proskauer Rose LLP New York, NY

Jonian Rafti, Esq. | Proskauer Rose LLP New York, NY

0.5 MCLE Credit in Areas of Professional Practice

4:00 p.m. – 4:50 p.m.

VIII. Opioid Crisis and New York Issues

This program will discuss how the opioid crisis has hit home for so many people in New York, how New York has dealt with it, and how partnerships between providers and treatment programs can improve outcomes, with financial and quality implications. It will also discuss:
• How telehealth can be used and misused with regards to persons with substance abuse disorder, prosecutors’ actions re telehealth, and compliance guidance for telehealth, and current rules for telehealth when prescribing controlled substances
• The current rules for initiation of medications for opioid use disorder in hospital EDs.
• Opportunities for hospitals to connect patients with community-based addiction treatment programs.
• Factors that may trigger a DEA audit or investigation
• Prosecutors’ evaluation whether conduct by a medical provider in connection with death of a patient may be criminal, and discussion of the People v. Li case
• How Special Narcotics Prosecutors work with DEA, Medicaid and other agencies when alerted to certain practices Involving healthcare providers in education and outreach

Speaker

Bridget G. Brennan | NYC Special Narcotics Prosecutor

Ann-Marie Foster, MPA | FACHE President and Chief Executive Officer Phoenix House New York, NY

Robert A. Kent, Esq. | Kent Strategic Advisors, LLC Leesburg, VA

Frank Tarentino III | Special Agent in Charge Drug Enforcement Administration New York Division

1.0 MCLE Credit in Areas of Professional Practice

4:50 p.m. – 5:00 p.m.

Q&A

5:00 p.m.

Adjourn