Michael Jennifer E

Member

Washington, D.C.

(202) 827-2960

VCARD

Jennifer E. Michael

Member

Washington, D.C.

(202) 827-2960

jennifer.michael@bassberry.com

https://www.bassberry.com/professionals/michael-jennifer-e/

The fraud and abuse laws touch virtually every arrangement in the healthcare sector. Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential fraud and abuse landmines and defend them in fraud and abuse investigations. Jennifer helps her clients structure their arrangements to comply with the federal Anti-Kickback Statute (AKS), the federal Civil Monetary Penalty (CMP) law, and other state and federal fraud and abuse laws and navigate government investigations under the federal False Claims Act (FCA). She also leads internal investigations for healthcare and life sciences companies to identify and quantify potential overpayments from federal healthcare programs; advises on fraud risks of existing and proposed arrangements in connection with pending and proposed transactions; and designs, implements, and evaluates compliance programs.

Jennifer represents clients before the Office of Inspector General on advisory opinion requests, corporate integrity agreement (CIA) negotiations and CIA implementation, and voluntary self-disclosures. During her tenure at OCIG, Jennifer led the Industry Guidance Branch in issuing dozens of advisory opinions; the first-ever rescission of an advisory opinion; and Special Fraud Alerts, policy statements, and other guidance documents. She interpreted federal fraud and abuse statutes for the industry and supervised agency rulemaking and the issuance of waivers of fraud and abuse laws for specified arrangements involving alternative payment models being tested by the Center for Medicare & Medicaid Innovation (CMMI). She also provided technical assistance to congressional committees and other parts of the executive branch, including the U.S. Department of Justice (DOJ) and the Centers for Medicare & Medicaid Services (CMS). Jennifer spoke regularly on behalf of the Office of Counsel to the Inspector General at industry conferences, such as the American Health Law Association Fraud and Compliance Forum.

Before joining HHS-OIG, Jennifer worked for eight years in the health law practice of a national law firm. Prior to attending law school, she worked four years as a certified public accountant for a Big Four accounting firm.

Memberships

American Health Law Association (AHLA) — Payers, Plans and Managed Care Practice Group, Vice Chair of Education (2023-2025)

Memberships

American Health Law Association (AHLA) — Payers, Plans and Managed Care Practice Group, Vice Chair of Education (2023-2025)

Representative Experience

Golden State Medical Supply Acquires WSI PBG, LLC

We represented Golden State Medical Supply, the leading provider of generic pharmaceuticals to the US federal healthcare system, in its...
Guidance and Compliance Advice for National Therapy Provider

Created a value-based enterprise (VBE) and helped craft various value-based arrangements under OIG’s VBE safe harbors for a national therapy provider.
Develop Compliant Patient Engagement and Support Arrangements under OIG’s VBE Safe Harbors for Social Determinants of Health

Develop compliant patient engagement and support arrangements under OIG’s VBE safe harbors for social determinants of health.
Representation of a National ASC Company on Fraud and Abuse and Compliance Matters

Provide healthcare fraud and abuse counseling and compliance policy advice on day-to-day matters to a national ASC company.
Counsel Medical Device Companies, Distributors, and Suppliers on the Anti-Kickback Statute

Counsel medical device companies, distributors, and suppliers on Anti-Kickback Statute compliance for proposed and existing arrangements and assist in developing strategic discount policies and novel business arrangements.
Advice on Fraud and Abuse Matters Related to Large Medical Practices and Entities

We provide healthcare fraud and abuse advice to multiple large medical practices that touches on patient engagement tools, discounts, physician compensation, and interactions with managed care payors.
Counsel Telehealth Companies Regarding Anti-Kickback Statute and Beneficiary Inducement Issues

Counsel telehealth companies regarding anti-kickback statute and beneficiary inducement issues related to remote monitoring.
Assist Healthcare Clients in Developing Compliance Policies

Help healthcare clients develop compliant cost-sharing waiver policies, patient assistance policies, free transportation policies, and referral-source interaction policies.
Counsel DME Program Participants in Navigating Fraud and Abuse Risk Related to Upgrade Programs

Represent manufacturers, wholesalers, and suppliers in navigating fraud and abuse risks related to their participation in DME upgrade programs.
Navigating Proposed HHS Legislation on Behalf of Clients

Drafted comment letters advocating for our clients’ interests in response to proposed legislation.

Representative Experience

Golden State Medical Supply Acquires WSI PBG, LLC

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Guidance and Compliance Advice for National Therapy Provider

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Develop Compliant Patient Engagement and Support Arrangements under OIG’s VBE Safe Harbors for Social Determinants of Health

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Representation of a National ASC Company on Fraud and Abuse and Compliance Matters

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Counsel Medical Device Companies, Distributors, and Suppliers on the Anti-Kickback Statute

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Advice on Fraud and Abuse Matters Related to Large Medical Practices and Entities

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Counsel Telehealth Companies Regarding Anti-Kickback Statute and Beneficiary Inducement Issues

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Assist Healthcare Clients in Developing Compliance Policies

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Counsel DME Program Participants in Navigating Fraud and Abuse Risk Related to Upgrade Programs

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Navigating Proposed HHS Legislation on Behalf of Clients

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Advised Health System on Overpayment Analysis and Options

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United Musculoskeletal Partners Acquires Pinnacle Surgical Orthopedics

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SENTA Partners Acquires Allergy, Asthma & Immunology Associates of South Texas, P.A

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Advanced Dermatology & Cosmetic Surgery Acquires Maragh Dermatology, Surgery and Vein Institute

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Advanced Dermatology and Cosmetic Surgery Acquires Maryland Dermatology Practice

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Advanced Dermatology & Cosmetic Surgery Acquires Greenville Dermatology

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Publications

More Losses than Gains? OIG Declines to Approve Certain Medicare Advantage Gainsharing Arrangements in Advisory Opinion 24-08

September 18, 2024 | Firm Publication

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

June 27, 2024 | Firm Publication

Is Your Compliance House In Order? Tips for Ensuring Private Equity and Portfolio Company Compliance in the Wake of the Recent Request for Information

May 7, 2024 | Firm Publication

Past Events

29th Annual Scientific Session and Exhibition of the American Society of Nuclear Cardiology

September 5-7, 2024 | Austin, Texas
American Society of Nuclear Cardiology
HHS-OIG Year in Review Webinar Replay

April 11, 2024 | Webinar
Bass, Berry & Sims
HHS-OIG Year in Review Webinar

February 27, 2024 | Webinar
Bass, Berry & Sims

Media Mentions & Firm News

Jennifer Michael Provides Insight on Vertex Challenge to HHS-OIG Interpretation of Inducement

July 17, 2024 | Law360

Jennifer Michael Discusses Developments in Value-Based Care and the Value-Based Enterprise Rules on AHLA Podcast

April 1, 2024 | AHLA Speaking of Health Law Podcast

Jennifer Michael Discusses Federal Court Decision Challenging Reach of Anti-Kickback Statute

January 22, 2024 | Law360

Additional News & Insights

Publications

“Are We There Yet? OIG and CMS Issue Long-Awaited Final Rules Aimed at Promoting Innovative Value-Based Care Models and Arrangements,” (co-author) Journal of Health Care Compliance (January–February 2021)
“Legal and Compliance Considerations When Bringing Cellular Therapies to Market,” (co-author) Journal of Commercial Biotechnology (2020, 25(4), 74–7. doi: 10.5912/jcb958)

Media Mentions

“IG Approval of Free Kymriah Might Be Model for Other CAR T Makers,” Inside Health Policy (March 26, 2021)
“Medical Device Makers Get More Flexibility with Value-Based Care in Stark, Anti-Kickback Final Rules,” MedTech Dive (November 24, 2020)
“U.S. Officials Will Let Novartis Pay Expenses for Some Kymriah Patients Who Must Travel for Treatment,” STAT News (January 30, 2020)

Presentations

“Charitable Patient Assistance Programs: Ensuring Compliance. Establishing and Maintaining Arrangements With PAPs, Monitoring and Auditing PAPs,” Strafford Webinar (February 2, 2021)
“Healthcare Providers and Voluntary Disclosures: Evaluating If, When, and How to Report to CMS, DOJ, or OIG,” Strafford Webinar (October 13, 2020)
“Rapid Evolution: Fair Market Value in the COVID Era and Beyond,” AHLA 2020 Virtual Fraud and Compliance Forum (September 2020)