David M. Traskey
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David Traskey, co-head of the Firm’s Washington, DC Office, advises individuals and entities involved in government investigations, guides clients on corporate compliance and governance matters, and litigates civil and white-collar health care fraud cases. Prior to joining Garfunkel Wild, David served as Senior Counsel with the United States Department of Health and Human Services (HHS), Office of Inspector General (OIG).
David’s unique expertise in health care enforcement and compliance provides clients with specialized insight into federal investigations and enforcement actions based on his knowledge of the government’s case identification strategies, its legal theories, and its interpretation of the applicable laws, rules, and regulations. His HHS-OIG experience also allows him to share critical information with clients about the government’s corporate governance expectations and compliance best practices.
David routinely provides advice to clients on fraud and abuse issues, including matters arising under the False Claims Act, the Anti-Kickback Statute, the physician self-referral law (Stark Law), federal health care reimbursement, and other regulations promulgated by the Centers for Medicare & Medicaid Services, the Food and Drug Administration, and HHS-OIG. He also counsels clients about risk mitigation strategies, implementing compliance safeguards, responding to investigations or audits, identifying and returning overpayments, and submitting OIG self-disclosures.
In his role at HHS-OIG, David represented HHS-OIG in litigation and settlements under the Civil Monetary Penalties Law and False Claims Act, collaboratively recovering over $118 million. He litigated appeals of provider exclusions before HHS’s Departmental Appeals Board and served as an advisor in subsequent appeals to U.S. District Court. He expanded OIG’s use of data analytics, and served as Litigation Hold Coordinator and the Affirmative Litigation Branch Component Liaison, where he provided related guidance and training to all OIG components on a variety of topics.
David’s government service roles span nearly two decades including time served as an attorney with the United States Department of Veterans Affairs (VA), OIG. There, he represented VAOIG before the Merit Systems Protection Board and Equal Employment Opportunity Commission, advised management on employee relations and human resources issues, and prepared referrals to VA’s suspension and debarment committee. David also served as an Acting Veterans Law Judge at VA’s Board of Veterans’ Appeals where he supervised a team of attorneys, conducted administrative hearings with veterans, and adjudicated veterans’ benefits appeals. Upon law school graduation, David clerked for Hon. Cheryl Johnson of the Court of Criminal Appeals of Texas, the court of last resort for all criminal matters in the state.
David is a Certified Fraud Examiner (CFE), certified by the Association of Certified Fraud Examiners (ACFE).
- Reviewed and resolved OIG self-disclosures
- Reviewed referrals from DOJ, OIG components, and Medicare contractors and made recommendations to OIG leaders about legal theories and case projects
- Issued document subpoenas, took testimonial subpoenas, and consulted with DOJ on civil investigative demands
- Initiated and resolved health care or grant fraud cases brought under the Civil Monetary Penalties Law (CMPL)
- Represented OIG in provider exclusion appeals before HHS administrative law judges and served as advisor to DOJ in subsequent U.S. District Court appeals
- Represented OIG in settlements with DOJ of civil False Claims Act (FCA) cases
- Negotiated and monitored provider integrity agreements arising from FCA or CMPL settlements
- Provided guidance on the Anti-Kickback Statute, Stark Law, and rules and regulations from CMS, the U.S. Food and Drug Administration, the Drug Enforcement Agency, and the U.S. Treasury Department
- Collaborated/coordinated activity with OIG’s Office of Investigations, Office of Audit Services (OAS), Office of Evaluation and Inspections (OEI), Medicaid Fraud Control Units, State Offices of Inspector General, and CMS’s Office of General Counsel and Center for Program Integrity, as well as Medicare contractors and fiscal intermediaries (e.g., MACs, RACs, UPICs, ZPICs, etc.)
- Expanded OIG’s use of data analytics and leveraged reports from OIG’s OAS and OEI to identify and pursue targets for potential CMPL violations
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Hospital Pays $10M in FCA Settlement, Data-Only Whistleblower Focused on MCCs, Short Stays", in the Report on Medicare Compliance (Volume 33, Number 45) published by the Health Care Compliance Association (HCCA).
David Traskey was quoted in a Politico Pro article discussing a Supreme Court decision that could significantly affect the federal health agencies' authority to impose fines.
David Traskey was quoted in the article, "Baptist Health Settles FCA Case Over Copay Waivers, Benefited From DOJ Cooperation Credit", in the Report on Medicare Compliance published by the Health Care Compliance Association (HCCA).
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Health System, Cardiologist Settle Related FCA Cases Over Cath Procedures, Admissions".
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Exagen Settles FCA Case for Restitution, Paid Physicians Specimen Fees Despite OIG Alert".
Garfunkel Wild Chairman Andrew Blustein and Partners David Traskey and David Morrissy, are quoted in the Law360 article, “Health Care Firm Garfunkel Wild Opens DC Office.”
Garfunkel Wild’s new Washington, DC office was featured in the Washington Business Journal.
Garfunkel Wild, P.C. is pleased to announce the opening of an office in Washington, D.C., and to welcome two D.C.-based partners, David Morrissy and David Traskey, to co-head the expansion. The D.C. location marks the firm's sixth office in the United States and the second opened in the past two years.
In the article, David gives an OIG insider’s view of the self-disclosure protocol (SDP).
Garfunkel Wild Chairman Andrew Blustein and Partners David Traskey and Robert A. Del Giorno, are quoted in a Law360 article, “Longtime Gov't Health Care Atty Joins Garfunkel Wild,” regarding David joining the firm.
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "Hospital Settles CMP Case Over Inpatient Admissions; Another OIG Short-Stay Audit Looms", in Report on Medicare Compliance (Volume 33, Number 31) published by the Health Care Compliance Association (HCCA).
Garfunkel Wild is pleased to announce that David Traskey, former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), has joined the firm as Partner in its Investigations, Audits, and Regulatory Compliance Practice Group.
Garfunkel Wild’s David Traskey, Partner and former Senior Counsel with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) was quoted in the article, "OIG Urges Action on 'Massive' Increases in Skin Substitute Spending", in the Report on Medicare Compliance (Volume 34, Number 33) published by the Health Care Compliance Association (HCCA). David gives an OIG insider's perspective on the matter of skin substitutes.
After considerable legal and legislative wrangling over the past year, the U.S. Department of Health & Human Services (HHS) announced on December 2, 2025 that it repealed the minimum staffing standards for long-term care facilities participating in Medicare and Medicaid programs due to its burdensome impact on facilities, “especially those serving rural and Tribal communities”, and concerns over patient access to care.
Access to and the cost of health care for children with complex medical needs is a significant burden for many families. Grants can serve as an important lifeline that allows families to obtain and afford medically necessary and appropriate care for their children. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-10) is another positive step towards ensuring that children with special medical needs receive timely and affordable care.
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.
Garfunkel Wild's David M. Traskey will present "Compliance Trends in Assisted Living/Skilled Nursing and an Inside Look at HHS-OIG" at the LifeSpan Network Conference and Expo on September 17, 2025.
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.
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.
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.
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.
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.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) approved a medical device manufacturer’s proposed arrangement to reimburse pharmacies, hospitals, clinics, and laboratories up to $2,500 for the actual costs of certain services related to needlestick injuries. OIG’s favorable Advisory Opinion (25-05) found that the Arrangement implicates the Federal Anti-Kickback Statute, but that it is protected by the regulatory safe harbor for warranties.
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.
Garfunkel Wild's Susan L. St. John and David M. Traskey will be presenting "Are You Ready For Your Survey? Overview of What’s New from CMS for Nursing Facilities" at the Florida Health Care Association's (FHCA) Annual Conference and Trade Show, on Wednesday, July 16, 2025, at 2:15 pm.
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.
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).
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).
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.
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.
In this podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s D.C. office, to talk about what makes for an effective compliance program. In the fourth of seven episodes exploring this topic, we discuss the importance of having effective lines of communication, and how having these lines can create a sense of ally-ship between an organization and its compliance team.
In this podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s DC Office, to talk about what makes for an effective compliance program. In the third of seven episodes exploring this topic, we discuss the pivotal role that compliance training and education have within an organization as well as key considerations when formulating such training and education programs.
Garfunkel Wild's Applied Behavioral Analysis and Medical and Education Services (BAMES) Practice Group Members Steven R. Antico (Practice Group Chair), David Traskey, and Julia Belton will present "ABA Therapy Practice Audit and Compliance Issues and Recent Developments" on May 20, 2025, from 12:00 PM to 1:00 PM.
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a favorable Advisory Opinion (25-02) regarding a federally qualified health center’s (FQHC) proposal to offer to schedule primary care physician appointments for certain individuals who are already receiving non-medical help from the FQHC.
The Centers for Medicare & Medicaid Services (CMS) extended the previous deadline of May 1, 2025 to August 1, 2025, for skilled nursing facilities (SNFs) to provide ownership and management information as well as information about other parties with which the SNFs are associated and the ownership structures of those parties.
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.
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.
In this week’s podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s DC Office, to talk about what makes for an effective compliance program. In the second of seven episodes exploring this topic, we discuss the importance of compliance leadership and oversight, and the key functions of the Compliance Officer, the Compliance Committee, and the Board of Directors. We also share some tips for small to medium-sized entities.
In the first of seven episodes exploring what makes for an effective compliance program, we discuss the importance of having compliance policies and procedures, and how those policies and procedures serve as the foundation upon which effective compliance programs are built.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (25-01) allowing a Pharmaceutical Company (Company) to provide free access to its U.S. Food and Drug Administration (FDA)-approved product (Product) for eligible patients with mild cognitive impairment or disease-related dementia and related symptoms.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-13) allowing a pharmaceutical manufacturer (Manufacturer) to provide transportation, lodging, meal vouchers, and other authorized expenses to eligible patients receiving Manufacturer’s one-time, potentially curative treatment product (Product).
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-12) allowing a pharmaceutical manufacturer (Manufacturer) to sponsor a genetic testing, genetic counseling, and disease-state awareness education program for certain eligible patients with an “ultra-rare” genetic condition that causes kidney stones.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), posted a favorable Advisory Opinion (24-11) allowing a pharmaceutical manufacturer (Manufacturer) to provide free meningococcal vaccinations to eligible patients, including Federal health care program enrollees who receive Manufacturer’s U.S. Food and Drug Administration (FDA)-approved products that treat rare disorders.
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-10) allowing the expansion of an existing loyalty program offered by a medical and dental supply distributor (Company) to its member customers (Customers), while cautioning that “discount” programs are typically high risk.
On December 11, 2024, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) published a Special Fraud Alert in response to the uptick in abusive marketing practices between Medicare Advantage Organizations (MAOs), health care providers, and ancillary participants (such as agents and brokers).
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.
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.
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.
Garfunkel Wild’s Robert Del Giorno, David Traskey, and Colleen Pierson will present the webinar “Navigating HHS-OIG’s New Compliance Guidance for Nursing Facilities: Key Risks, Mitigation Strategies, and Evaluation Considerations” on December 17, 2024, from 12:00 PM – 1:00 PM ET.
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.
The U.S. Department of Health and Human Services, Office of Inspector General (the “OIG”) posted an unfavorable Advisory Opinion (24-08) prohibiting a Corporation offering Medicare Advantage (“MA”), MA-Prescription Drug (“PD”), and MA/MA-PD Employer Group Waiver Plans (“EGWPs”) from sharing a percentage of its savings with its covered groups via a gainshare payment (“Payment”).
Garfunkel Wild's David Traskey will present "Hospice Compliance Trends and an Inside Look at HHS-OIG" at the Hospice & Palliative Care Network of Maryland Annual Conference.
OIG posted a partially favorable Advisory Opinion (24-05) permitting a biotechnology company to provide transportation, lodging, and payment of associated expenses for certain patients receiving gene therapy treatments for two severe genetic diseases. In the same Advisory Opinion, however, OIG responded unfavorably to the Company’s proposal to subsidize some or all costs related to fertility preservation and storage procedures for these same patients.
The OIG's trend of ensuring access to care in compelling circumstances continued with a recent opinion allowing a pharmaceutical affiliate to refund, waive, or delay payment for a drug treating a rare, fatal pediatric immunodeficiency disorder.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-03) permitting a pharmaceutical manufacturer (Manufacturer) to provide financial assistance to qualified patients undergoing its gene therapy treatment for two severe genetic conditions.
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.
Planning for end-of-life medical care and estate planning can be daunting, but failing to put your affairs in order can leave your family with difficult decisions, increased expenses, and outcomes you didn’t intend. Join our webinar as Garfunkel Wild attorneys explain the legal documents every person should have
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.
This Health Care Compliance webinar session will review HHS-OIG’s recently issued strategic plan for oversight of Medicare Managed Care and discuss the impact these initiatives could have on providers who participate in Medicare Advantage plans.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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
On October 25, 2023, the OIG posted Advisory Opinion 23-08, an unfavorable opinion regarding a cochlear implant manufacturer’s proposal to offer and provide a free compatible hearing aid to eligible patients.
On October 13, 2023, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) posted Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain outpatient surgical procedures the employed physicians perform at the employer’s two planned ambulatory surgery centers (ASCs).
Join Garfunkel Wild’s Robert A. Del Giorno and David Traskey, former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) updated its Self-Disclosure Program to provide a new pathway for all Medicaid-program entities and providers to report, return, and explain overpayments.
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
On June 27, 2023, and in response to the 21st Century Cures Act (Cures Act), the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG) posted a final rule that amended its Civil Money Penalty (CMP) regulations to authorize penalties of up to $1 million per violation.
Additional speaking & writing
Speeches and Events
- Co-Panelist, Hot Topics in Fraud and Abuse, American Health Lawyers Association, Institute on Medicare and Medicaid Payment Issues (2017)
Publications
- Maximizing VA Benefits for Survivors of Military Sexual Trauma: A Practical Guide for Survivors and Their Advocates (co-authored), 26 Columbia J. Gender & L. 2 (2014)
David Traskey, co-head of the Firm’s Washington, DC Office, advises individuals and entities involved in government investigations, guides clients on corporate compliance and governance matters, and litigates civil and white-collar health care fraud cases. Prior to joining Garfunkel Wild, David served as Senior Counsel with the United States Department of Health and Human Services (HHS), Office of Inspector General (OIG).
David’s unique expertise in health care enforcement and compliance provides clients with specialized insight into federal investigations and enforcement actions based on his knowledge of the government’s case identification strategies, its legal theories, and its interpretation of the applicable laws, rules, and regulations. His HHS-OIG experience also allows him to share critical information with clients about the government’s corporate governance expectations and compliance best practices.
David routinely provides advice to clients on fraud and abuse issues, including matters arising under the False Claims Act, the Anti-Kickback Statute, the physician self-referral law (Stark Law), federal health care reimbursement, and other regulations promulgated by the Centers for Medicare & Medicaid Services, the Food and Drug Administration, and HHS-OIG. He also counsels clients about risk mitigation strategies, implementing compliance safeguards, responding to investigations or audits, identifying and returning overpayments, and submitting OIG self-disclosures.
In his role at HHS-OIG, David represented HHS-OIG in litigation and settlements under the Civil Monetary Penalties Law and False Claims Act, collaboratively recovering over $118 million. He litigated appeals of provider exclusions before HHS’s Departmental Appeals Board and served as an advisor in subsequent appeals to U.S. District Court. He expanded OIG’s use of data analytics, and served as Litigation Hold Coordinator and the Affirmative Litigation Branch Component Liaison, where he provided related guidance and training to all OIG components on a variety of topics.
David’s government service roles span nearly two decades including time served as an attorney with the United States Department of Veterans Affairs (VA), OIG. There, he represented VAOIG before the Merit Systems Protection Board and Equal Employment Opportunity Commission, advised management on employee relations and human resources issues, and prepared referrals to VA’s suspension and debarment committee. David also served as an Acting Veterans Law Judge at VA’s Board of Veterans’ Appeals where he supervised a team of attorneys, conducted administrative hearings with veterans, and adjudicated veterans’ benefits appeals. Upon law school graduation, David clerked for Hon. Cheryl Johnson of the Court of Criminal Appeals of Texas, the court of last resort for all criminal matters in the state.
David is a Certified Fraud Examiner (CFE), certified by the Association of Certified Fraud Examiners (ACFE).
- Reviewed and resolved OIG self-disclosures
- Reviewed referrals from DOJ, OIG components, and Medicare contractors and made recommendations to OIG leaders about legal theories and case projects
- Issued document subpoenas, took testimonial subpoenas, and consulted with DOJ on civil investigative demands
- Initiated and resolved health care or grant fraud cases brought under the Civil Monetary Penalties Law (CMPL)
- Represented OIG in provider exclusion appeals before HHS administrative law judges and served as advisor to DOJ in subsequent U.S. District Court appeals
- Represented OIG in settlements with DOJ of civil False Claims Act (FCA) cases
- Negotiated and monitored provider integrity agreements arising from FCA or CMPL settlements
- Provided guidance on the Anti-Kickback Statute, Stark Law, and rules and regulations from CMS, the U.S. Food and Drug Administration, the Drug Enforcement Agency, and the U.S. Treasury Department
- Collaborated/coordinated activity with OIG’s Office of Investigations, Office of Audit Services (OAS), Office of Evaluation and Inspections (OEI), Medicaid Fraud Control Units, State Offices of Inspector General, and CMS’s Office of General Counsel and Center for Program Integrity, as well as Medicare contractors and fiscal intermediaries (e.g., MACs, RACs, UPICs, ZPICs, etc.)
- Expanded OIG’s use of data analytics and leveraged reports from OIG’s OAS and OEI to identify and pursue targets for potential CMPL violations
The OIG's trend of ensuring access to care in compelling circumstances continued with a recent opinion allowing a pharmaceutical affiliate to refund, waive, or delay payment for a drug treating a rare, fatal pediatric immunodeficiency disorder.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-03) permitting a pharmaceutical manufacturer (Manufacturer) to provide financial assistance to qualified patients undergoing its gene therapy treatment for two severe genetic conditions.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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
On October 25, 2023, the OIG posted Advisory Opinion 23-08, an unfavorable opinion regarding a cochlear implant manufacturer’s proposal to offer and provide a free compatible hearing aid to eligible patients.
On October 13, 2023, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) posted Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain outpatient surgical procedures the employed physicians perform at the employer’s two planned ambulatory surgery centers (ASCs).
On June 27, 2023, and in response to the 21st Century Cures Act (Cures Act), the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG) posted a final rule that amended its Civil Money Penalty (CMP) regulations to authorize penalties of up to $1 million per violation.
Planning for end-of-life medical care and estate planning can be daunting, but failing to put your affairs in order can leave your family with difficult decisions, increased expenses, and outcomes you didn’t intend. Join our webinar as Garfunkel Wild attorneys explain the legal documents every person should have
This Health Care Compliance webinar session will review HHS-OIG’s recently issued strategic plan for oversight of Medicare Managed Care and discuss the impact these initiatives could have on providers who participate in Medicare Advantage plans.
Join Garfunkel Wild’s Robert A. Del Giorno and David Traskey, former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
OIG posted a partially favorable Advisory Opinion (24-05) permitting a biotechnology company to provide transportation, lodging, and payment of associated expenses for certain patients receiving gene therapy treatments for two severe genetic diseases. In the same Advisory Opinion, however, OIG responded unfavorably to the Company’s proposal to subsidize some or all costs related to fertility preservation and storage procedures for these same patients.
On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) updated its Self-Disclosure Program to provide a new pathway for all Medicaid-program entities and providers to report, return, and explain overpayments.
Garfunkel Wild's David Traskey will present "Hospice Compliance Trends and an Inside Look at HHS-OIG" at the Hospice & Palliative Care Network of Maryland Annual Conference.
The U.S. Department of Health and Human Services, Office of Inspector General (the “OIG”) posted an unfavorable Advisory Opinion (24-08) prohibiting a Corporation offering Medicare Advantage (“MA”), MA-Prescription Drug (“PD”), and MA/MA-PD Employer Group Waiver Plans (“EGWPs”) from sharing a percentage of its savings with its covered groups via a gainshare payment (“Payment”).
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.
Garfunkel Wild’s Robert Del Giorno, David Traskey, and Colleen Pierson will present the webinar “Navigating HHS-OIG’s New Compliance Guidance for Nursing Facilities: Key Risks, Mitigation Strategies, and Evaluation Considerations” on December 17, 2024, from 12:00 PM – 1:00 PM ET.
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.
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.
On December 11, 2024, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) published a Special Fraud Alert in response to the uptick in abusive marketing practices between Medicare Advantage Organizations (MAOs), health care providers, and ancillary participants (such as agents and brokers).
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-10) allowing the expansion of an existing loyalty program offered by a medical and dental supply distributor (Company) to its member customers (Customers), while cautioning that “discount” programs are typically high risk.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), posted a favorable Advisory Opinion (24-11) allowing a pharmaceutical manufacturer (Manufacturer) to provide free meningococcal vaccinations to eligible patients, including Federal health care program enrollees who receive Manufacturer’s U.S. Food and Drug Administration (FDA)-approved products that treat rare disorders.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-12) allowing a pharmaceutical manufacturer (Manufacturer) to sponsor a genetic testing, genetic counseling, and disease-state awareness education program for certain eligible patients with an “ultra-rare” genetic condition that causes kidney stones.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-13) allowing a pharmaceutical manufacturer (Manufacturer) to provide transportation, lodging, meal vouchers, and other authorized expenses to eligible patients receiving Manufacturer’s one-time, potentially curative treatment product (Product).
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (25-01) allowing a Pharmaceutical Company (Company) to provide free access to its U.S. Food and Drug Administration (FDA)-approved product (Product) for eligible patients with mild cognitive impairment or disease-related dementia and related symptoms.
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.
In the first of seven episodes exploring what makes for an effective compliance program, we discuss the importance of having compliance policies and procedures, and how those policies and procedures serve as the foundation upon which effective compliance programs are built.
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.
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.
In this week’s podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s DC Office, to talk about what makes for an effective compliance program. In the second of seven episodes exploring this topic, we discuss the importance of compliance leadership and oversight, and the key functions of the Compliance Officer, the Compliance Committee, and the Board of Directors. We also share some tips for small to medium-sized entities.
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.
In this podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s DC Office, to talk about what makes for an effective compliance program. In the third of seven episodes exploring this topic, we discuss the pivotal role that compliance training and education have within an organization as well as key considerations when formulating such training and education programs.
Garfunkel Wild's Applied Behavioral Analysis and Medical and Education Services (BAMES) Practice Group Members Steven R. Antico (Practice Group Chair), David Traskey, and Julia Belton will present "ABA Therapy Practice Audit and Compliance Issues and Recent Developments" on May 20, 2025, from 12:00 PM to 1:00 PM.
The Centers for Medicare & Medicaid Services (CMS) extended the previous deadline of May 1, 2025 to August 1, 2025, for skilled nursing facilities (SNFs) to provide ownership and management information as well as information about other parties with which the SNFs are associated and the ownership structures of those parties.
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a favorable Advisory Opinion (25-02) regarding a federally qualified health center’s (FQHC) proposal to offer to schedule primary care physician appointments for certain individuals who are already receiving non-medical help from the FQHC.
In this podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s D.C. office, to talk about what makes for an effective compliance program. In the fourth of seven episodes exploring this topic, we discuss the importance of having effective lines of communication, and how having these lines can create a sense of ally-ship between an organization and its compliance team.
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.
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.
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).
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).
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.
Garfunkel Wild's Susan L. St. John and David M. Traskey will be presenting "Are You Ready For Your Survey? Overview of What’s New from CMS for Nursing Facilities" at the Florida Health Care Association's (FHCA) Annual Conference and Trade Show, on Wednesday, July 16, 2025, at 2:15 pm.
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.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) approved a medical device manufacturer’s proposed arrangement to reimburse pharmacies, hospitals, clinics, and laboratories up to $2,500 for the actual costs of certain services related to needlestick injuries. OIG’s favorable Advisory Opinion (25-05) found that the Arrangement implicates the Federal Anti-Kickback Statute, but that it is protected by the regulatory safe harbor for warranties.
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.
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.
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.
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.
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.
Garfunkel Wild's David M. Traskey will present "Compliance Trends in Assisted Living/Skilled Nursing and an Inside Look at HHS-OIG" at the LifeSpan Network Conference and Expo on September 17, 2025.
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.
Access to and the cost of health care for children with complex medical needs is a significant burden for many families. Grants can serve as an important lifeline that allows families to obtain and afford medically necessary and appropriate care for their children. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-10) is another positive step towards ensuring that children with special medical needs receive timely and affordable care.
After considerable legal and legislative wrangling over the past year, the U.S. Department of Health & Human Services (HHS) announced on December 2, 2025 that it repealed the minimum staffing standards for long-term care facilities participating in Medicare and Medicaid programs due to its burdensome impact on facilities, “especially those serving rural and Tribal communities”, and concerns over patient access to care.
After considerable legal and legislative wrangling over the past year, the U.S. Department of Health & Human Services (HHS) announced on December 2, 2025 that it repealed the minimum staffing standards for long-term care facilities participating in Medicare and Medicaid programs due to its burdensome impact on facilities, “especially those serving rural and Tribal communities”, and concerns over patient access to care.
Access to and the cost of health care for children with complex medical needs is a significant burden for many families. Grants can serve as an important lifeline that allows families to obtain and afford medically necessary and appropriate care for their children. The U.S. Department of Health and Human Services, Office of Inspector General’s (OIG) favorable advisory opinion (25-10) is another positive step towards ensuring that children with special medical needs receive timely and affordable care.
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.
Garfunkel Wild's David M. Traskey will present "Compliance Trends in Assisted Living/Skilled Nursing and an Inside Look at HHS-OIG" at the LifeSpan Network Conference and Expo on September 17, 2025.
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.
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.
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.
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.
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.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) approved a medical device manufacturer’s proposed arrangement to reimburse pharmacies, hospitals, clinics, and laboratories up to $2,500 for the actual costs of certain services related to needlestick injuries. OIG’s favorable Advisory Opinion (25-05) found that the Arrangement implicates the Federal Anti-Kickback Statute, but that it is protected by the regulatory safe harbor for warranties.
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.
Garfunkel Wild's Susan L. St. John and David M. Traskey will be presenting "Are You Ready For Your Survey? Overview of What’s New from CMS for Nursing Facilities" at the Florida Health Care Association's (FHCA) Annual Conference and Trade Show, on Wednesday, July 16, 2025, at 2:15 pm.
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.
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).
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).
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.
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.
In this podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s D.C. office, to talk about what makes for an effective compliance program. In the fourth of seven episodes exploring this topic, we discuss the importance of having effective lines of communication, and how having these lines can create a sense of ally-ship between an organization and its compliance team.
In this podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s DC Office, to talk about what makes for an effective compliance program. In the third of seven episodes exploring this topic, we discuss the pivotal role that compliance training and education have within an organization as well as key considerations when formulating such training and education programs.
Garfunkel Wild's Applied Behavioral Analysis and Medical and Education Services (BAMES) Practice Group Members Steven R. Antico (Practice Group Chair), David Traskey, and Julia Belton will present "ABA Therapy Practice Audit and Compliance Issues and Recent Developments" on May 20, 2025, from 12:00 PM to 1:00 PM.
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a favorable Advisory Opinion (25-02) regarding a federally qualified health center’s (FQHC) proposal to offer to schedule primary care physician appointments for certain individuals who are already receiving non-medical help from the FQHC.
The Centers for Medicare & Medicaid Services (CMS) extended the previous deadline of May 1, 2025 to August 1, 2025, for skilled nursing facilities (SNFs) to provide ownership and management information as well as information about other parties with which the SNFs are associated and the ownership structures of those parties.
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.
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.
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.
In this week’s podcast, we sit down with David Traskey, former Senior Counsel at HHS-OIG and current co-head of Garfunkel Wild’s DC Office, to talk about what makes for an effective compliance program. In the second of seven episodes exploring this topic, we discuss the importance of compliance leadership and oversight, and the key functions of the Compliance Officer, the Compliance Committee, and the Board of Directors. We also share some tips for small to medium-sized entities.
In the first of seven episodes exploring what makes for an effective compliance program, we discuss the importance of having compliance policies and procedures, and how those policies and procedures serve as the foundation upon which effective compliance programs are built.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (25-01) allowing a Pharmaceutical Company (Company) to provide free access to its U.S. Food and Drug Administration (FDA)-approved product (Product) for eligible patients with mild cognitive impairment or disease-related dementia and related symptoms.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-13) allowing a pharmaceutical manufacturer (Manufacturer) to provide transportation, lodging, meal vouchers, and other authorized expenses to eligible patients receiving Manufacturer’s one-time, potentially curative treatment product (Product).
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-12) allowing a pharmaceutical manufacturer (Manufacturer) to sponsor a genetic testing, genetic counseling, and disease-state awareness education program for certain eligible patients with an “ultra-rare” genetic condition that causes kidney stones.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), posted a favorable Advisory Opinion (24-11) allowing a pharmaceutical manufacturer (Manufacturer) to provide free meningococcal vaccinations to eligible patients, including Federal health care program enrollees who receive Manufacturer’s U.S. Food and Drug Administration (FDA)-approved products that treat rare disorders.
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-10) allowing the expansion of an existing loyalty program offered by a medical and dental supply distributor (Company) to its member customers (Customers), while cautioning that “discount” programs are typically high risk.
On December 11, 2024, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) published a Special Fraud Alert in response to the uptick in abusive marketing practices between Medicare Advantage Organizations (MAOs), health care providers, and ancillary participants (such as agents and brokers).
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.
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.
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.
Garfunkel Wild’s Robert Del Giorno, David Traskey, and Colleen Pierson will present the webinar “Navigating HHS-OIG’s New Compliance Guidance for Nursing Facilities: Key Risks, Mitigation Strategies, and Evaluation Considerations” on December 17, 2024, from 12:00 PM – 1:00 PM ET.
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.
The U.S. Department of Health and Human Services, Office of Inspector General (the “OIG”) posted an unfavorable Advisory Opinion (24-08) prohibiting a Corporation offering Medicare Advantage (“MA”), MA-Prescription Drug (“PD”), and MA/MA-PD Employer Group Waiver Plans (“EGWPs”) from sharing a percentage of its savings with its covered groups via a gainshare payment (“Payment”).
Garfunkel Wild's David Traskey will present "Hospice Compliance Trends and an Inside Look at HHS-OIG" at the Hospice & Palliative Care Network of Maryland Annual Conference.
OIG posted a partially favorable Advisory Opinion (24-05) permitting a biotechnology company to provide transportation, lodging, and payment of associated expenses for certain patients receiving gene therapy treatments for two severe genetic diseases. In the same Advisory Opinion, however, OIG responded unfavorably to the Company’s proposal to subsidize some or all costs related to fertility preservation and storage procedures for these same patients.
The OIG's trend of ensuring access to care in compelling circumstances continued with a recent opinion allowing a pharmaceutical affiliate to refund, waive, or delay payment for a drug treating a rare, fatal pediatric immunodeficiency disorder.
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-03) permitting a pharmaceutical manufacturer (Manufacturer) to provide financial assistance to qualified patients undergoing its gene therapy treatment for two severe genetic conditions.
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.
Planning for end-of-life medical care and estate planning can be daunting, but failing to put your affairs in order can leave your family with difficult decisions, increased expenses, and outcomes you didn’t intend. Join our webinar as Garfunkel Wild attorneys explain the legal documents every person should have
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.
This Health Care Compliance webinar session will review HHS-OIG’s recently issued strategic plan for oversight of Medicare Managed Care and discuss the impact these initiatives could have on providers who participate in Medicare Advantage plans.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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
On October 25, 2023, the OIG posted Advisory Opinion 23-08, an unfavorable opinion regarding a cochlear implant manufacturer’s proposal to offer and provide a free compatible hearing aid to eligible patients.
On October 13, 2023, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) posted Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain outpatient surgical procedures the employed physicians perform at the employer’s two planned ambulatory surgery centers (ASCs).
Join Garfunkel Wild’s Robert A. Del Giorno and David Traskey, former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) updated its Self-Disclosure Program to provide a new pathway for all Medicaid-program entities and providers to report, return, and explain overpayments.
Join Garfunkel Wild’s Robert A. Del Giorno and John G. Martin for a discussion with David Traskey, the firm’s newest Partner and former Senior Counsel with the HHS-OIG as they delve into HHS-OIG’s inner workings.
On June 27, 2023, and in response to the 21st Century Cures Act (Cures Act), the U.S. Department of Health and Human Services, Office of the Inspector General (HHS-OIG) posted a final rule that amended its Civil Money Penalty (CMP) regulations to authorize penalties of up to $1 million per violation.
Additional speaking & writing
Speeches and Events
- Co-Panelist, Hot Topics in Fraud and Abuse, American Health Lawyers Association, Institute on Medicare and Medicaid Payment Issues (2017)
Publications
- Maximizing VA Benefits for Survivors of Military Sexual Trauma: A Practical Guide for Survivors and Their Advocates (co-authored), 26 Columbia J. Gender & L. 2 (2014)
Education
- Real Estate and Infrastructure
- Political Science
Court admissions
U.S. District Court: District of Maryland
AWARDS & RANKINGS
HHS-OIG
Inspector General’s Award for Advancing Innovation, Grant Analytics Portal (2019)
Inspector General’s Cooperative Achievement Award, SBIR Grant Team (2018)
Inspector General’s Award for Quality, Safety, and Value, Hospice Team (2017)
VAOIG
Employee of the Year and Special Contribution Award, Office of the Counselor to the Inspector General (2014)
VABVA
Awarded 12 commendations for outstanding writing and/or exceptional productivity, and for exceeding yearly productivity goals by 16% (2007-2013)
