The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) continues to offer valuable insights to the healthcare industry as to how best to approach increasingly complex healthcare fraud and abuse issues. Bass, Berry & Sims is pleased to share this HHS-OIG Year In Review (HHS-OIG YIR) that highlights key guidance OIG issued in 2022, as well as other items of import involving the agency.

Our intention is not to exhaustively cover every bit of guidance OIG published last year. Rather, we have used our decades of collective experience inside and outside OIG to focus on the items we think are of the greatest importance to the healthcare industry.

In this HHS-OIG YIR, we discuss the following topics:

  • Significant changes to the advisory opinion process as well as several noteworthy advisory opinions.
  • OIG’s Special Fraud Alert warning against the dangers of fraudulent telehealth arrangements.
  • Provisions of legislation through which Congress established a new exception for physician wellness programs and directed OIG to study contingency management interventions.
  • Implications of some process updates to OIG’s self-disclosure protocol (SDP) and some noteworthy SDP settlements.
  • Pfizer’s efforts to obtain a favorable advisory opinion and its subsequent attempts to convince federal courts to overturn OIG’s unfavorable advisory opinion.
  • Key personnel changes at OIG.
  • Although it occurred in early 2023, we mention OIG’s expanded informal FAQ guidance process for questions related to the AKS and other authorities.

We hope that this HHS-OIG YIR will assist you in understanding and determining how best to navigate fraud and abuse issues in an increasingly complex environment.

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Photo of Kristin Bohl Kristin Bohl

Kristin Bohl blends her experience as a healthcare attorney in private practice and government service with first-hand knowledge of care delivery as a registered nurse. Kristin advises hospitals, health systems and other provider organizations on compliance and regulatory issues and fraud and abuse…

Kristin Bohl blends her experience as a healthcare attorney in private practice and government service with first-hand knowledge of care delivery as a registered nurse. Kristin advises hospitals, health systems and other provider organizations on compliance and regulatory issues and fraud and abuse matters, with a focus on the wide range of Medicare payment models. Before she entered private practice, Kristin was the Technical Advisor in the Division of Technical Payment Policy at the Centers for Medicare & Medicaid Services (CMS), where she concentrated on Stark Law matters. She was part of a team that developed the CMS Voluntary Self-Referral Disclosure Protocol and provided technical assistance in the creation of Stark Law waivers for Accountable Care Organization (ACO) models and other payment initiatives of the Center for Medicare and Medicaid Innovation within CMS.

Photo of Justin Brown Justin Brown

Justin Brown focuses on healthcare fraud and abuse matters, particularly those involving the federal physician self-referral law (Stark Law), the federal Anti-Kickback Statute, and state analogs. He represents hospitals and health systems, ambulatory surgery centers, post-acute care providers, and physician practices, along with…

Justin Brown focuses on healthcare fraud and abuse matters, particularly those involving the federal physician self-referral law (Stark Law), the federal Anti-Kickback Statute, and state analogs. He represents hospitals and health systems, ambulatory surgery centers, post-acute care providers, and physician practices, along with their strategic and financial sponsors, regularly serving as healthcare regulatory counsel for transactions, enforcement actions, and internal investigations, and advising on day-to-day operations. Before entering private practice, Justin was a trial attorney in the Massachusetts public defender’s office.

*Justin Brown is admitted to practice in Alabama and Massachusetts; Tennessee bar application pending

Photo of Anna Grizzle Anna Grizzle

With over 20 years of experience, Anna helps healthcare clients address enforcement and compliance issues and respond to legal and regulatory violations. With significant experience in defending against statistical sampling and extrapolation and claims denials in Medicare and Medicaid claims audits, Anna also…

With over 20 years of experience, Anna helps healthcare clients address enforcement and compliance issues and respond to legal and regulatory violations. With significant experience in defending against statistical sampling and extrapolation and claims denials in Medicare and Medicaid claims audits, Anna also has saved healthcare companies tens of millions of dollars in potential overpayment demands.

Photo of Dee Harleston Dee Harleston

Dee Harleston provides healthcare regulatory counsel on mergers, acquisitions, compliance, and operational matters. He also represents healthcare-focused private equity clients and their portfolio companies in buy-side and sell-side mergers and acquisitions. In addition, Dee advises clients related to compliance with federal healthcare laws…

Dee Harleston provides healthcare regulatory counsel on mergers, acquisitions, compliance, and operational matters. He also represents healthcare-focused private equity clients and their portfolio companies in buy-side and sell-side mergers and acquisitions. In addition, Dee advises clients related to compliance with federal healthcare laws such as HIPAA, AKS, Stark Law, and CMP and in matters of medical licensure.

Photo of Stewart Kameen Stewart Kameen

Stewart Kameen advises healthcare clients on all aspects of federal and state healthcare laws and regulations, with a particular emphasis on fraud and abuse regulatory counseling, corporate compliance, internal investigations and government enforcement actions, qui tam litigation, and transactional matters. Stewart is able…

Stewart Kameen advises healthcare clients on all aspects of federal and state healthcare laws and regulations, with a particular emphasis on fraud and abuse regulatory counseling, corporate compliance, internal investigations and government enforcement actions, qui tam litigation, and transactional matters. Stewart is able to counsel providers drawing on his unique perspective informed by his experience working at the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG).

Photo of Travis Lloyd Travis Lloyd

Travis Lloyd focuses on complex healthcare regulatory matters. He represents a broad range of healthcare industry clients, including hospitals and health systems, ambulatory surgery centers, post-acute providers, behavioral health providers, and physician practices, as well as their strategic partners. He has significant experience…

Travis Lloyd focuses on complex healthcare regulatory matters. He represents a broad range of healthcare industry clients, including hospitals and health systems, ambulatory surgery centers, post-acute providers, behavioral health providers, and physician practices, as well as their strategic partners. He has significant experience in the areas of fraud and abuse, reimbursement, and health information privacy and security, as well as in the licensure, certification, and accreditation of healthcare facilities. His work has earned numerous noteworthy plaudits, including selection by Law360 as one of five “Rising Stars” in healthcare across the country in 2018 and selection by Bloomberg Law for its inaugural “They’ve Got Next” series in 2021.

Photo of Bill Mathias Bill Mathias

Bill Mathias advises healthcare companies on complex fraud and abuse and Stark Law issues.  He draws on over two decades of experience to address thorny healthcare regulatory questions.  He regularly assists clients with internal and government investigations and corporate compliance matters.

Photo of Jennifer Michael Jennifer Michael

Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential…

Jennifer Michael draws on her experience as the former Chief of the Industry Guidance Branch at the U.S. Department of Health and Human Services (HHS), Office of Counsel to the Inspector General (OCIG) to help healthcare providers and life science companies avoid potential fraud and abuse landmines and defend them in fraud and abuse investigations. Jennifer helps her clients structure their arrangements to comply with the federal Anti-Kickback Statute (AKS), the federal Civil Monetary Penalty (CMP) law, and other state and federal fraud and abuse laws and navigate government investigations under the federal False Claims Act (FCA).

Photo of Heather Pearson Heather Pearson

Heather Pearson provides healthcare regulatory and transactional counsel as it relates to compliance, operational matters, and mergers and acquisitions. Heather draws on her experience as a public health analyst at RTI International, focusing on program evaluation and health system financing for CMS, and…

Heather Pearson provides healthcare regulatory and transactional counsel as it relates to compliance, operational matters, and mergers and acquisitions. Heather draws on her experience as a public health analyst at RTI International, focusing on program evaluation and health system financing for CMS, and her judicial clerkships in the Minnesota Court of Appeals and the U.S. District Court for the Northern District of Indiana. During law school, she summered at the Center for Health Law & Policy Innovation at Harvard Law School and in the Office of the Chief Counsel at the FDA.

Photo of Angelique Salib Angelique Salib

Angelique Salib is an associate at Bass, Berry & Sims PLC, in their Washington, D.C. office. She provides healthcare regulatory counsel as it relates to compliance, operational and transactional matters through applicable components of the Stark Law, Anti-Kickback Statute (AKS), Medicare reimbursement, managed…

Angelique Salib is an associate at Bass, Berry & Sims PLC, in their Washington, D.C. office. She provides healthcare regulatory counsel as it relates to compliance, operational and transactional matters through applicable components of the Stark Law, Anti-Kickback Statute (AKS), Medicare reimbursement, managed care, in addition to clinical research and life sciences matters. She also works with hospital and health system clients on contractual arrangements and a broad range of compliance matters.