White Collar Criminal Defense

Criminal investigations and prosecutions are the most serious and potentially life-changing matters we handle at Garfunkel Wild.  Simply receiving a grand jury subpoena or an inquiry from law enforcement immediately brings with it a flood of concerns about where the investigation is headed, and who might be in legal jeopardy.  Garfunkel Wild’s White Collar Criminal Defense Practice Group is comprised of attorneys with extraordinary levels of experience on the government side of these matters, who can aggressively defend our clients to the exclusion of all other concerns.

Investigations and prosecutions of members of the health care community are different from other criminal prosecutions in many ways.  Garfunkel Wild’s attorneys are a far better option for individuals in need of a strong criminal defense than standard criminal defense lawyers because:

  • We understand that, in terms of collateral consequences alone, no other profession is at the same risk of investigation and prosecution as the health care community
  • The laws governing the health care industry are a complex and arcane web of statutes, regulations, manuals, alerts and “guidance,” making the risks even higher.   Garfunkel Wild’s well-earned reputation as a preeminent health care firm, and our mastery of these laws, is an asset that no standard criminal defense practitioners can offer
  • Our team is steeped in the world of health care, giving us a deep understanding of our clients’ businesses and a unique appreciation of the differences and difficulties these cases present
  • Most importantly, we are able to combine our expertise and experience in the general area of criminal practice with our command of health care law and compliance to be effective in the only way that matters:  getting to the right result for the client

Garfunkel Wild  has represented Doctors, Dentists, Nurses, Hospital Executives, Pharmacists, Physical Therapists, Physician Assistants, Businesspeople and others in federal and state investigations and prosecutions brought by the Department of Justice, the Attorney General, and local District Attorneys.  Regardless of who the client is or what the allegation is, our mission is always the same: do what needs to be done to protect our clients from harm, while remaining acutely aware that we are often all that stands between them and an outcome that can destroy their lives.

Practice Group Contacts

Featured Image

John G. Martin

Of Counsel
516-393-2214

Team

Featured Image

Andrew L. Zwerling

Partner/Director
516-393-2581
Featured Image

Steven D. Gorelick

Partner
201-518-3404
Featured Image

Robert A. Del Giorno

Partner/Director
516-393-2505
Featured Image

James H. Knapp

Partner
516-393-2574

September 16, 2025|Alerts

OIG Scrutinizes Remote Patient Monitoring

As remote patient monitoring (RPM) continues to grow in popularity, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) is keeping close watch on how providers are billing, coding, and documenting these services.

September 9, 2025|Alerts

2026 Proposed Fee Schedule Changes

Each year, the Centers for Medicare & Medicaid Services’ issuance of its proposed rule for the Medicare Physician Fee Schedule creates potentially significant changes to PFS payments and Part B in particular. The impact of these proposed changes can be widespread and complex, and it is important to understand how these changes may affect you or your practice.

August 19, 2025|Alerts

OIG Approves Physician Ownership of Device Company

In an increasingly competitive environment, many physicians seek creative ways to grow their personal brands, their practices, and their revenue. One common vehicle for achieving these goals involves physician-owned entities that derive revenue from selling, or arranging for the sale of, medical devices that the physician-owners order and use in procedures they perform at hospitals. Although OIG has long-standing concerns about such arrangements, OIG recently issued a favorable advisory opinion (25-09) regarding a proposed arrangement involving physicians with an ownership interest in a medical device company.

August 11, 2025|Publications

Forming the Right Skin Substitute Team

As a successful podiatrist treating complex wounds with skin substitutes, your growing reputation also brings increased risk of audits, investigations, and costly claw backs from Medicare, Medicaid, and insurers. With billions spent annually on these treatments, government scrutiny is intensifying. Protect your practice by building the right team—experienced health care attorneys, top medical experts, and skilled billing and documentation specialists—before issues arise. Garfunkel Wild focuses exclusively on health care law and offers the resources to safeguard your practice, reputation, and livelihood.

August 6, 2025|Alerts

Health Care Providers Sued Over Web Tracking Tools

Health care providers and other entities are increasingly facing class action lawsuits over the use of tracking technologies on their websites—particularly pixels that transmit user data to platforms like Meta and Google. One such case recently settled for $6.75 million. These lawsuits often catch providers off guard, as they stem from routine, widely used website configurations.

July 30, 2025|Alerts

OIG Rejects Flat Fee Business Arrangement

OIG issued an unfavorable opinion (25-08) in which a medical device company proposed to pay a third-party vendor a yearly flat fee to access Vendor’s electronic billing portal.

July 30, 2025|Alerts

OIG Approves Free Lab Tests

An essential component of patient care hinges on a provider’s ability to accurately and efficiently diagnose diseases and prescribe effective treatments. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-07) facilitates a provider’s ability to do just that.

July 21, 2025|Alerts

New CMS Model Targets Skin Substitutes

Traditionally, the Centers for Medicare & Medicaid Services (CMS) has relied on a “pay and chase” approach to recover monies CMS believes it may have paid to providers erroneously. CMS relies on this approach not only for collecting routine overpayments, but also when it believes evidence of fraud, waste, or abuse exists. More recently, CMS has used this approach to target providers who render medically reasonable and necessary services to patients in certain areas that CMS deems to be vulnerable to fraud such as skin and tissue substitutes, among others.

June 25, 2025|Alerts

OIG Rejects Payments for Exclusion Screenings

OIG recently rejected a medical device company’s (Company) novel proposal to pay a third-party (Screener) to perform exclusion screenings of the Company for the Company’s customers. OIG’s unfavorable Advisory Opinion (25-04) determined that this proposed arrangement (Arrangement) implicates the Federal Anti-Kickback Statute and raises concerns about inappropriate steering and anti-competitiveness.

June 18, 2025|Alerts

OIG Approves Telehealth Arrangement for Leased Employees

The U.S. Department of Health and Human Services, Office of Inspector General (OIG), recently issued a favorable Advisory Opinion (25-03) regarding a proposed arrangement (Arrangement) where a non-clinical management support organization and an affiliated professional corporation wholly owned by physician shareholders (PC) enters into lease agreements with telehealth platforms (Platforms) and providers employed by or contracted with these Platforms (Platform Providers).

June 12, 2025|Alerts

New Regulations for Maryland Assisted Living Programs

The Maryland Department of Health’s (DOH) Office of Health Care Quality (OHCQ) recently announced revisions to the regulations that govern Assisted Living Programs (ALPs).

June 11, 2025|Alerts

OIG Report Identifies Emerging Priorities

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently released its Semiannual Report (SAR) covering the period October 1, 2024 to March 31, 2025. The SAR is a must-read because it identifies a wide array of risk areas, which will undoubtedly help providers modify their own risk assessments and audit work plans to stay ahead of government regulators in the ongoing fight against fraud, waste, and abuse.

June 6, 2025|Alerts

A New Look for DOJ White Collar Enforcement

The U.S. Department of Justice, Criminal Division (DOJ) recently and unexpectedly announced changes to the manner in which it handles criminal investigations and prosecutions of white-collar and corporate cases. These changes are aimed at clarifying DOJ’s criminal enforcement priorities, increasing the efficiency with which cases are investigated and resolved, and emphasizing the benefits of voluntarily self-disclosing potential misconduct. They also signal a more business-friendly approach than in the past, and will be undoubtedly welcomed by corporations and executives alike.

April 17, 2025|Publications

SDNY Judge Levels Playing Field for White Collar Defendants

On March 10, 2025, The Hon. Jed Rakoff of the United States District Court for the Southern District of New York, issued an opinion, U.S. v. Tavberidze, in which he held that the one level reduction under the Guidelines for saving the prosecutor from having to prepare for trial was an unconstitutional trial penalty.

April 9, 2025|Publications

Avoiding Self-Inflicted Wounds: Responding to Government Audits Involving Skin Substitutes

Given the massive increase in Part B expenditures related to skin substitute products, government regulators are auditing Medicare Part B claims and investigating providers right now to identify and claw back millions of dollars of payments at risk for non-compliance with Medicare requirements. Partner with experienced legal counsel in advance of being audited or investigated, after you’ve received a government inquiry, or for help with your Medicare appeal. Don’t go it alone. Have a plan and understand your options.

January 22, 2025|Alerts

Second Circuit Adopts “One Purpose” Test

The United States Court of Appeals for the Second Circuit (Second Circuit or Court), which has Federal jurisdiction in Connecticut, New York, and Vermont, recently issued an important decision regarding health care provider liability under the False Claims Act (FCA) when a whistleblower alleges a violation of the Anti-Kickback Statute (AKS). The Second Circuit explicitly adopted the “one purpose” test for the first time to determine whether a financial arrangement between a provider and a referral source violates the AKS, and thus potentially subjects the parties to substantial fines and penalties under the FCA.

December 11, 2024|Alerts

New DOJ Report: Providers Beware

Last week, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) released its annual, jointly authored Health Care Fraud and Abuse Control Program Report (the Report) for Fiscal Year 2023. 

December 11, 2024|Alerts

New OIG Priorities Emerge in Report

The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 4, 2024.

November 21, 2024|Alerts

OIG Highlights New Concerns

This week, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) fulfilled its annual statutory obligation by releasing its 2024 Top Management and Performance Challenges Report (the “Report”). Historically, the Report has not attracted widespread interest in the provider community because it largely focuses on HHS operational challenges. Importantly for providers and other stakeholders, however, the Report reveals crucial insights about compliance priorities for the year ahead.

June 6, 2024|Alerts

OIG Report Highlights Enforcement Priorities

The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its revamped Semiannual Report (SAR) on June 3, 2024.  The SAR’s new format focuses on the oversight work OIG completed during the reporting period, and emphasizes how this work directly addresses the Top Management Challenges Facing HHS. 

May 20, 2024|Alerts

Telehealth Update: NY Proposes Controlled Substance Prescribing, Waiting on DEA

On May 15, 2024, the New York State Department of Health (DOH) announced a pivotal change in its regulations, as it intends to permit health care providers to use telemedicine to conduct patient evaluations before prescribing controlled substances. Prior to the COVID-19 pandemic, DOH required health care providers to perform an initial in-person physical evaluation of patients before prescribing controlled substances.

May 1, 2024|Events

Be Prepared! NYS OMIG’s 2024 Work Plan Provides an Audit Roadmap for Health Care Providers of All Types

Garfunkel’s Compliance Webinar Series rolls on with an examination of the 2024 Work Plan published by the New York State Office of Medicaid Inspector General (OMIG).  

April 25, 2024|Alerts

FTC Bans Non-Competes Across the Nation

On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).

April 18, 2024|Alerts

OIG Allows Patient Assistance Programs Funded by Drug Manufacturers

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-02) permitting a non-profit organization (Non-Profit) to provide financial support to eligible patients with specific rare diseases through assistance programs (Programs) it operates.

March 26, 2024|Events

American Health Law Association – Telemedicine Series Part II: Enforcement Trends in Telehealth

In this webinar, the John G. Martin will explore current trends in criminal and civil telehealth enforcement to better understand provider risks and mitigation strategies.

March 1, 2024|Alerts

OIG Issues New Resource for Single Audits

The United States Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently posted a new educational resource on its website about Single Audits.  HHS is the largest grant-making agency in the Federal government, and OIG’s new resource is designed to help key stakeholders understand the scope of Single Audits, as well as improve the overall quality of such audits.

January 30, 2024|Alerts

New York OMIG Updates Self-Disclosure Guidance

The New York State Office of the Medicaid Inspector General (OMIG) recently updated its Self-Disclosure Guidance and Frequently Asked Questions (collectively, “Updates”). These Updates give participating providers and entities additional insight into how to report overpayments involving unresponsive Medicaid Managed Care Organizations (MMCOs) or multiple entities, as well as those that are untimely, have adjusted or voided claims, or lost or damaged records. 

January 17, 2024|Alerts

OMIG’s 2024 Work Plan Gives Critical Insights into Program Integrity Initiatives

The New York State Office of the Medicaid Inspector General (OMIG) released its 2024 work plan in furtherance of its mission to coordinate and conduct activities to prevent, detect and investigate medical assistance program fraud, waste and abuse, and to recover improperly expended Medicaid funds.  

January 17, 2024|Alerts

OIG’s Newest Strategic Plan Prioritizes Managed Care Oversight

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently designated oversight of managed care as a “priority area”, and developed a coordinated strategic plan (the Plan) to better align its audits, evaluations, investigations, and enforcement of managed care. 

January 17, 2024|Alerts

OIG Issues Toolkit for Medicare Advantage Organizations

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) released a new toolkit to help Medicare Advantage (MA) organizations replicate OIG audit methodologies to detect and correct inaccurate diagnosis codes in their own systems.  

January 17, 2024|Alerts

OIG Approves Use of Gift Cards for Referrals in Certification-Heavy Advisory Opinion

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-15) permitting a consulting company’s (Consultant) proposal to offer gift cards to its current physician practice customers for referring potential new physician practice customers to Consultant.  Notably, OIG determined that the proposed arrangement did not implicate the Anti-Kickback Statute (AKS). 

January 17, 2024|Alerts

OIG Approves Creative Approach to Restructuring Medical Practice Partnerships

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-12) that allows a limited liability partnership (the Partnership) consisting of two classes of physician partners to make a one-time, voluntary redemption offer (offer) to individual partners when they reach age 67.  

January 17, 2024|Alerts

Favorable OIG Advisory Opinion Allows Subsidies for FDA-Approved Clinical Studies

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-11) that allows a medical device manufacturer (Manufacturer) to subsidize Medicare cost-sharing obligations as part of a U.S. Food & Drug Administration (FDA)-approved clinical study involving a Category B Investigational Device Exemption.  

December 21, 2023|Alerts

OIG’s Favorable Advisory Opinions Allow Incentives to Medigap Plan Policyholders

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted two favorable Advisory Opinions (23-09 and 23-10) to allow a licensed offeror of Medicare Supplemental Health Insurance (Medigap Plan) policies and a preferred health organization (PHO) (collectively, “the requestors”) to incentivize Medigap Plan policyholders to seek inpatient care from a hospital within the PHO’s network.  Notably, OIG issued these favorable opinions even though the proposed incentives implicated the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Civil Money Penalty (CMP), and there was no applicable exception or safe harbor.

December 21, 2023|Alerts

More Provider “Nuggets” From OIG’s Year-End Reporting Blitz

Continuing its year-end reporting blitz, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 1, 2023. 

November 30, 2023|Alerts

DOJ/HHS Jointly Release “Highlight Reel” Report

This week, the United States Department of Justice (DOJ) and the United States Department of Health and Human Services (HHS) fulfilled its annual statutory obligation by releasing its jointly-authored Health Care Fraud and Abuse Control Program (HCFAC) Report for Fiscal Year 2022.

November 20, 2023|Alerts

OIG Provides Roadmap to Hot-Button Issues

The OIG fulfilled its annual statutory obligation by releasing its Top Management and Performance Challenges (TMC) document. Providers should take note because the document provides important insight into the specific areas over which HHS (and the OIG) will remain focused.  

November 7, 2023|Alerts

OIG Releases New General Compliance Program Reference Guide

On November 6, 2023, the OIG released its General Compliance Program Guidance, the first in a series of new, non-binding reference guides designed to share information with health care compliance professionals and other health care industry stakeholders

September 18, 2019|Events

Fraud and Abuse – Lessons from Esformes Case

John Martin will present the “Fraud and Abuse – Lessons From Esformes Case” Webinar on September 18, 2019.

September 17, 2019|Events

Nassau County Bar Association (NCBA) Hospital and Health Law Committee CLE – Recent Trends in Health Care Fraud Investigations

John G. Martin and Robert A. Del Giorno will present at the Nassau County Bar Association’s CLE – Recent Trends in Health Care Fraud Investigations on September 17, 2019.

September 13, 2019|Media Mentions

John Martin Quoted In Newsday Article Entitled “Former CFO From LI Pleads Guilty To Stealing From Manhasset Real Estate Firm” On September 10, 2019

John Martin Quoted In Newsday Article Entitled “Former CFO From LI Pleads Guilty To Stealing From Manhasset Real Estate Firm” On September 10, 2019.

January 25, 2019|Media Mentions

John Martin Quoted in New York Law Journal on Appellate Reversal of Charges Against His Client, a Suffolk County Pharmacist, in HIV Drug Scheme

John Martin Quoted in New York Law Journal on Appellate Reversal of Charges Against His Client, A Suffolk County Pharmacist, In HIV Drug Scheme

Criminal investigations and prosecutions are the most serious and potentially life-changing matters we handle at Garfunkel Wild.  Simply receiving a grand jury subpoena or an inquiry from law enforcement immediately brings with it a flood of concerns about where the investigation is headed, and who might be in legal jeopardy.  Garfunkel Wild’s White Collar Criminal Defense Practice Group is comprised of attorneys with extraordinary levels of experience on the government side of these matters, who can aggressively defend our clients to the exclusion of all other concerns.

Investigations and prosecutions of members of the health care community are different from other criminal prosecutions in many ways.  Garfunkel Wild’s attorneys are a far better option for individuals in need of a strong criminal defense than standard criminal defense lawyers because:

  • We understand that, in terms of collateral consequences alone, no other profession is at the same risk of investigation and prosecution as the health care community
  • The laws governing the health care industry are a complex and arcane web of statutes, regulations, manuals, alerts and “guidance,” making the risks even higher.   Garfunkel Wild’s well-earned reputation as a preeminent health care firm, and our mastery of these laws, is an asset that no standard criminal defense practitioners can offer
  • Our team is steeped in the world of health care, giving us a deep understanding of our clients’ businesses and a unique appreciation of the differences and difficulties these cases present
  • Most importantly, we are able to combine our expertise and experience in the general area of criminal practice with our command of health care law and compliance to be effective in the only way that matters:  getting to the right result for the client

Garfunkel Wild  has represented Doctors, Dentists, Nurses, Hospital Executives, Pharmacists, Physical Therapists, Physician Assistants, Businesspeople and others in federal and state investigations and prosecutions brought by the Department of Justice, the Attorney General, and local District Attorneys.  Regardless of who the client is or what the allegation is, our mission is always the same: do what needs to be done to protect our clients from harm, while remaining acutely aware that we are often all that stands between them and an outcome that can destroy their lives.

Practice Group Contacts

Featured Image

John G. Martin

Of Counsel
516-393-2214

Team

Featured Image

Andrew L. Zwerling

Partner/Director
516-393-2581
Featured Image

Steven D. Gorelick

Partner
201-518-3404
Featured Image

Robert A. Del Giorno

Partner/Director
516-393-2505
Featured Image

James H. Knapp

Partner
516-393-2574

September 16, 2025|Alerts

OIG Scrutinizes Remote Patient Monitoring

As remote patient monitoring (RPM) continues to grow in popularity, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) is keeping close watch on how providers are billing, coding, and documenting these services.

September 9, 2025|Alerts

2026 Proposed Fee Schedule Changes

Each year, the Centers for Medicare & Medicaid Services’ issuance of its proposed rule for the Medicare Physician Fee Schedule creates potentially significant changes to PFS payments and Part B in particular. The impact of these proposed changes can be widespread and complex, and it is important to understand how these changes may affect you or your practice.

August 19, 2025|Alerts

OIG Approves Physician Ownership of Device Company

In an increasingly competitive environment, many physicians seek creative ways to grow their personal brands, their practices, and their revenue. One common vehicle for achieving these goals involves physician-owned entities that derive revenue from selling, or arranging for the sale of, medical devices that the physician-owners order and use in procedures they perform at hospitals. Although OIG has long-standing concerns about such arrangements, OIG recently issued a favorable advisory opinion (25-09) regarding a proposed arrangement involving physicians with an ownership interest in a medical device company.

August 11, 2025|Publications

Forming the Right Skin Substitute Team

As a successful podiatrist treating complex wounds with skin substitutes, your growing reputation also brings increased risk of audits, investigations, and costly claw backs from Medicare, Medicaid, and insurers. With billions spent annually on these treatments, government scrutiny is intensifying. Protect your practice by building the right team—experienced health care attorneys, top medical experts, and skilled billing and documentation specialists—before issues arise. Garfunkel Wild focuses exclusively on health care law and offers the resources to safeguard your practice, reputation, and livelihood.

August 6, 2025|Alerts

Health Care Providers Sued Over Web Tracking Tools

Health care providers and other entities are increasingly facing class action lawsuits over the use of tracking technologies on their websites—particularly pixels that transmit user data to platforms like Meta and Google. One such case recently settled for $6.75 million. These lawsuits often catch providers off guard, as they stem from routine, widely used website configurations.

July 30, 2025|Alerts

OIG Rejects Flat Fee Business Arrangement

OIG issued an unfavorable opinion (25-08) in which a medical device company proposed to pay a third-party vendor a yearly flat fee to access Vendor’s electronic billing portal.

July 30, 2025|Alerts

OIG Approves Free Lab Tests

An essential component of patient care hinges on a provider’s ability to accurately and efficiently diagnose diseases and prescribe effective treatments. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-07) facilitates a provider’s ability to do just that.

July 21, 2025|Alerts

New CMS Model Targets Skin Substitutes

Traditionally, the Centers for Medicare & Medicaid Services (CMS) has relied on a “pay and chase” approach to recover monies CMS believes it may have paid to providers erroneously. CMS relies on this approach not only for collecting routine overpayments, but also when it believes evidence of fraud, waste, or abuse exists. More recently, CMS has used this approach to target providers who render medically reasonable and necessary services to patients in certain areas that CMS deems to be vulnerable to fraud such as skin and tissue substitutes, among others.

June 25, 2025|Alerts

OIG Rejects Payments for Exclusion Screenings

OIG recently rejected a medical device company’s (Company) novel proposal to pay a third-party (Screener) to perform exclusion screenings of the Company for the Company’s customers. OIG’s unfavorable Advisory Opinion (25-04) determined that this proposed arrangement (Arrangement) implicates the Federal Anti-Kickback Statute and raises concerns about inappropriate steering and anti-competitiveness.

June 18, 2025|Alerts

OIG Approves Telehealth Arrangement for Leased Employees

The U.S. Department of Health and Human Services, Office of Inspector General (OIG), recently issued a favorable Advisory Opinion (25-03) regarding a proposed arrangement (Arrangement) where a non-clinical management support organization and an affiliated professional corporation wholly owned by physician shareholders (PC) enters into lease agreements with telehealth platforms (Platforms) and providers employed by or contracted with these Platforms (Platform Providers).

June 12, 2025|Alerts

New Regulations for Maryland Assisted Living Programs

The Maryland Department of Health’s (DOH) Office of Health Care Quality (OHCQ) recently announced revisions to the regulations that govern Assisted Living Programs (ALPs).

June 11, 2025|Alerts

OIG Report Identifies Emerging Priorities

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently released its Semiannual Report (SAR) covering the period October 1, 2024 to March 31, 2025. The SAR is a must-read because it identifies a wide array of risk areas, which will undoubtedly help providers modify their own risk assessments and audit work plans to stay ahead of government regulators in the ongoing fight against fraud, waste, and abuse.

June 6, 2025|Alerts

A New Look for DOJ White Collar Enforcement

The U.S. Department of Justice, Criminal Division (DOJ) recently and unexpectedly announced changes to the manner in which it handles criminal investigations and prosecutions of white-collar and corporate cases. These changes are aimed at clarifying DOJ’s criminal enforcement priorities, increasing the efficiency with which cases are investigated and resolved, and emphasizing the benefits of voluntarily self-disclosing potential misconduct. They also signal a more business-friendly approach than in the past, and will be undoubtedly welcomed by corporations and executives alike.

April 17, 2025|Publications

SDNY Judge Levels Playing Field for White Collar Defendants

On March 10, 2025, The Hon. Jed Rakoff of the United States District Court for the Southern District of New York, issued an opinion, U.S. v. Tavberidze, in which he held that the one level reduction under the Guidelines for saving the prosecutor from having to prepare for trial was an unconstitutional trial penalty.

April 9, 2025|Publications

Avoiding Self-Inflicted Wounds: Responding to Government Audits Involving Skin Substitutes

Given the massive increase in Part B expenditures related to skin substitute products, government regulators are auditing Medicare Part B claims and investigating providers right now to identify and claw back millions of dollars of payments at risk for non-compliance with Medicare requirements. Partner with experienced legal counsel in advance of being audited or investigated, after you’ve received a government inquiry, or for help with your Medicare appeal. Don’t go it alone. Have a plan and understand your options.

January 22, 2025|Alerts

Second Circuit Adopts “One Purpose” Test

The United States Court of Appeals for the Second Circuit (Second Circuit or Court), which has Federal jurisdiction in Connecticut, New York, and Vermont, recently issued an important decision regarding health care provider liability under the False Claims Act (FCA) when a whistleblower alleges a violation of the Anti-Kickback Statute (AKS). The Second Circuit explicitly adopted the “one purpose” test for the first time to determine whether a financial arrangement between a provider and a referral source violates the AKS, and thus potentially subjects the parties to substantial fines and penalties under the FCA.

December 11, 2024|Alerts

New DOJ Report: Providers Beware

Last week, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) released its annual, jointly authored Health Care Fraud and Abuse Control Program Report (the Report) for Fiscal Year 2023. 

December 11, 2024|Alerts

New OIG Priorities Emerge in Report

The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 4, 2024.

November 21, 2024|Alerts

OIG Highlights New Concerns

This week, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) fulfilled its annual statutory obligation by releasing its 2024 Top Management and Performance Challenges Report (the “Report”). Historically, the Report has not attracted widespread interest in the provider community because it largely focuses on HHS operational challenges. Importantly for providers and other stakeholders, however, the Report reveals crucial insights about compliance priorities for the year ahead.

June 6, 2024|Alerts

OIG Report Highlights Enforcement Priorities

The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its revamped Semiannual Report (SAR) on June 3, 2024.  The SAR’s new format focuses on the oversight work OIG completed during the reporting period, and emphasizes how this work directly addresses the Top Management Challenges Facing HHS. 

May 20, 2024|Alerts

Telehealth Update: NY Proposes Controlled Substance Prescribing, Waiting on DEA

On May 15, 2024, the New York State Department of Health (DOH) announced a pivotal change in its regulations, as it intends to permit health care providers to use telemedicine to conduct patient evaluations before prescribing controlled substances. Prior to the COVID-19 pandemic, DOH required health care providers to perform an initial in-person physical evaluation of patients before prescribing controlled substances.

May 1, 2024|Events

Be Prepared! NYS OMIG’s 2024 Work Plan Provides an Audit Roadmap for Health Care Providers of All Types

Garfunkel’s Compliance Webinar Series rolls on with an examination of the 2024 Work Plan published by the New York State Office of Medicaid Inspector General (OMIG).  

April 25, 2024|Alerts

FTC Bans Non-Competes Across the Nation

On Tuesday, April 23, 2024, the Federal Trade Commission (FTC) promulgated a final rule banning most non-compete agreements, in any industry, and is set to become effective 120 days after its publication in the Federal Register (the “Final Rule”).

April 18, 2024|Alerts

OIG Allows Patient Assistance Programs Funded by Drug Manufacturers

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-02) permitting a non-profit organization (Non-Profit) to provide financial support to eligible patients with specific rare diseases through assistance programs (Programs) it operates.

March 26, 2024|Events

American Health Law Association – Telemedicine Series Part II: Enforcement Trends in Telehealth

In this webinar, the John G. Martin will explore current trends in criminal and civil telehealth enforcement to better understand provider risks and mitigation strategies.

March 1, 2024|Alerts

OIG Issues New Resource for Single Audits

The United States Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently posted a new educational resource on its website about Single Audits.  HHS is the largest grant-making agency in the Federal government, and OIG’s new resource is designed to help key stakeholders understand the scope of Single Audits, as well as improve the overall quality of such audits.

January 30, 2024|Alerts

New York OMIG Updates Self-Disclosure Guidance

The New York State Office of the Medicaid Inspector General (OMIG) recently updated its Self-Disclosure Guidance and Frequently Asked Questions (collectively, “Updates”). These Updates give participating providers and entities additional insight into how to report overpayments involving unresponsive Medicaid Managed Care Organizations (MMCOs) or multiple entities, as well as those that are untimely, have adjusted or voided claims, or lost or damaged records. 

January 17, 2024|Alerts

OMIG’s 2024 Work Plan Gives Critical Insights into Program Integrity Initiatives

The New York State Office of the Medicaid Inspector General (OMIG) released its 2024 work plan in furtherance of its mission to coordinate and conduct activities to prevent, detect and investigate medical assistance program fraud, waste and abuse, and to recover improperly expended Medicaid funds.  

January 17, 2024|Alerts

OIG’s Newest Strategic Plan Prioritizes Managed Care Oversight

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently designated oversight of managed care as a “priority area”, and developed a coordinated strategic plan (the Plan) to better align its audits, evaluations, investigations, and enforcement of managed care. 

January 17, 2024|Alerts

OIG Issues Toolkit for Medicare Advantage Organizations

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) released a new toolkit to help Medicare Advantage (MA) organizations replicate OIG audit methodologies to detect and correct inaccurate diagnosis codes in their own systems.  

January 17, 2024|Alerts

OIG Approves Use of Gift Cards for Referrals in Certification-Heavy Advisory Opinion

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-15) permitting a consulting company’s (Consultant) proposal to offer gift cards to its current physician practice customers for referring potential new physician practice customers to Consultant.  Notably, OIG determined that the proposed arrangement did not implicate the Anti-Kickback Statute (AKS). 

January 17, 2024|Alerts

OIG Approves Creative Approach to Restructuring Medical Practice Partnerships

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-12) that allows a limited liability partnership (the Partnership) consisting of two classes of physician partners to make a one-time, voluntary redemption offer (offer) to individual partners when they reach age 67.  

January 17, 2024|Alerts

Favorable OIG Advisory Opinion Allows Subsidies for FDA-Approved Clinical Studies

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-11) that allows a medical device manufacturer (Manufacturer) to subsidize Medicare cost-sharing obligations as part of a U.S. Food & Drug Administration (FDA)-approved clinical study involving a Category B Investigational Device Exemption.  

December 21, 2023|Alerts

OIG’s Favorable Advisory Opinions Allow Incentives to Medigap Plan Policyholders

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted two favorable Advisory Opinions (23-09 and 23-10) to allow a licensed offeror of Medicare Supplemental Health Insurance (Medigap Plan) policies and a preferred health organization (PHO) (collectively, “the requestors”) to incentivize Medigap Plan policyholders to seek inpatient care from a hospital within the PHO’s network.  Notably, OIG issued these favorable opinions even though the proposed incentives implicated the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Civil Money Penalty (CMP), and there was no applicable exception or safe harbor.

December 21, 2023|Alerts

More Provider “Nuggets” From OIG’s Year-End Reporting Blitz

Continuing its year-end reporting blitz, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 1, 2023. 

November 30, 2023|Alerts

DOJ/HHS Jointly Release “Highlight Reel” Report

This week, the United States Department of Justice (DOJ) and the United States Department of Health and Human Services (HHS) fulfilled its annual statutory obligation by releasing its jointly-authored Health Care Fraud and Abuse Control Program (HCFAC) Report for Fiscal Year 2022.

November 20, 2023|Alerts

OIG Provides Roadmap to Hot-Button Issues

The OIG fulfilled its annual statutory obligation by releasing its Top Management and Performance Challenges (TMC) document. Providers should take note because the document provides important insight into the specific areas over which HHS (and the OIG) will remain focused.  

November 7, 2023|Alerts

OIG Releases New General Compliance Program Reference Guide

On November 6, 2023, the OIG released its General Compliance Program Guidance, the first in a series of new, non-binding reference guides designed to share information with health care compliance professionals and other health care industry stakeholders

September 18, 2019|Events

Fraud and Abuse – Lessons from Esformes Case

John Martin will present the “Fraud and Abuse – Lessons From Esformes Case” Webinar on September 18, 2019.

September 17, 2019|Events

Nassau County Bar Association (NCBA) Hospital and Health Law Committee CLE – Recent Trends in Health Care Fraud Investigations

John G. Martin and Robert A. Del Giorno will present at the Nassau County Bar Association’s CLE – Recent Trends in Health Care Fraud Investigations on September 17, 2019.

September 13, 2019 |Media Mentions

John Martin Quoted In Newsday Article Entitled “Former CFO From LI Pleads Guilty To Stealing From Manhasset Real Estate Firm” On September 10, 2019

John Martin Quoted In Newsday Article Entitled “Former CFO From LI Pleads Guilty To Stealing From Manhasset Real Estate Firm” On September 10, 2019.

January 25, 2019 |Media Mentions

John Martin Quoted in New York Law Journal on Appellate Reversal of Charges Against His Client, a Suffolk County Pharmacist, in HIV Drug Scheme

John Martin Quoted in New York Law Journal on Appellate Reversal of Charges Against His Client, A Suffolk County Pharmacist, In HIV Drug Scheme