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Jeff Weinstein
Senior Counsel
FDA Regulatory, Healthcare, and Consumer Products
Washington, D.C.

D202-973-8952

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Jeff Weinstein is senior counsel in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where he helps health care companies and investors manage regulatory and liability risk. His practice areas include fraud and abuse laws (anti-kickback, physician self-referral, and conflicts-of-interest), cost-effective compliance strategies, and e-health and data privacy.

Examples of Jeff’s work include counseling compliant private equity investment in care management service arrangements; helping a national specialty care chain rebut health care fraud allegations in False Claims Act litigation; drafting a medical software licensing terms compliant with HIPAA and fraud and abuse law; performing regulatory due diligence for corporate acquisition of medical facilities; and helping health services provider remediate a data security incident under HIPAA and California privacy and security law.

Jeff served for more than 12 years as senior counsel with the Industry Guidance Branch in the Office of Inspector General for the U.S. Department of Health & Human Services. There, Jeff’s responsibilities included applying fraud and abuse laws to commercial and charitable arrangements; advising government investigations and prosecutions; writing advisory opinions and other agency guidance; overseeing provider vetting processes; and preparing and delivering compliance training.

Jeff’s law enforcement background also informs his practice counseling clients on e-health law and privacy and data security compliance. He holds HealthCare Information Security and Privacy Practitioner certification from (ISC)2, the leading information security professional organization; he has also been recognized as a Certified Information Privacy Professional/U.S. by the International Association of Privacy Professionals.

Prior to entering government service, Jeff was an associate in FDA, life sciences and consumer products practice at Arent Fox LLP.

Experience

Jeff Weinstein is senior counsel in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where he helps health care companies and investors manage regulatory and liability risk. His practice areas include fraud and abuse laws (anti-kickback, physician self-referral, and conflicts-of-interest), cost-effective compliance strategies, and e-health and data privacy.

Examples of Jeff’s work include counseling compliant private equity investment in care management service arrangements; helping a national specialty care chain rebut health care fraud allegations in False Claims Act litigation; drafting a medical software licensing terms compliant with HIPAA and fraud and abuse law; performing regulatory due diligence for corporate acquisition of medical facilities; and helping health services provider remediate a data security incident under HIPAA and California privacy and security law.

Jeff served for more than 12 years as senior counsel with the Industry Guidance Branch in the Office of Inspector General for the U.S. Department of Health & Human Services. There, Jeff’s responsibilities included applying fraud and abuse laws to commercial and charitable arrangements; advising government investigations and prosecutions; writing advisory opinions and other agency guidance; overseeing provider vetting processes; and preparing and delivering compliance training.

Jeff’s law enforcement background also informs his practice counseling clients on e-health law and privacy and data security compliance. He holds HealthCare Information Security and Privacy Practitioner certification from (ISC)2, the leading information security professional organization; he has also been recognized as a Certified Information Privacy Professional/U.S. by the International Association of Privacy Professionals.

Prior to entering government service, Jeff was an associate in FDA, life sciences and consumer products practice at Arent Fox LLP.

Focus Areas
Recent Insights
Alerts
OIG Tackles New Issues in Its General Compliance Program Guidance: What Companies Need to Know
On November 6, 2023, U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a General Compliance Program Guidance (GCPG) as part of its plan to renovate its library of compliance program guidance documents (CPGs). As we previously reported, the OIG announced in April its plans to issue the GCPG, and to deliver new “industry-specific” (ICPGs) that—like the older CPGs—will each address a different subsector of the healthcare industry or ancillary related fields. The OIG stated that the ICPGs—which the OIG expects to begin publishing in 2024—will address subsectors that have emerged in recent years; the OIG announced that new guidance would first issue for Medicare Advantage organizations and nursing facilities. The OIG stated that it intends to update its CPG library periodically, integrating new risk areas and compliance measures.
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Alerts
HHS Names the First 10 Drugs for Medicare Price Negotiation
In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the provisions of the Inflation Reduction Act of 2022 (IRA).1 This is an update to two previously published Alerts providing a detailed overview of the IRA: “Prescription Drug Provisions in the Inflation Reduction Act of 2022” and “CMS Proceeds Full Steam Ahead with Medicare Drug Price Negotiation Program.”
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