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Policy & Medicine Compliance Update
As we begin the new year, we start by continuing our examination of compliance outcomes in 2022 and predictions for 2023. This article is the second of a two-part series.
Next, we look at the latest U.S. Supreme Court case involving the government’s right to intervene to dismiss whistleblower cases. Although here is a split among the U.S. Circuit Courts of Appeals, this decision is anticipated to establish a uniform standard. We also take a detailed look at the 340B issue resolved in 2022 and those that persist in 2023.
Shifting gears, we examine the results from Helio Health Group’s sixth annual Patient Services Compliance survey. Government scrutiny has resulted in an increased compliance focus juxtaposed with lingering uncertainty about the risks inherent in PAP programs.
Finally, at the recent PCF conference there was an extensive discussion on the appropriate role of the Board of Directors. Here we discuss the ever-increasing emphasis on effectiveness, and the renewed emphasis on the role of the Board.
Articles
FEATURE
Forecasting Winds and Weather (Part 2)
Examining the Compliance Outcomes in 2022 & Predictions for 2023
By Dr. Seth B. Whitelaw and Katherine Norris
Summary: This article is the second in a two-part series reflecting on industry and enforcement trends impacting life sciences compliance professionals in 2022, with a look ahead to priorities for 2023 and predictions of where enforcement trends might lean.
Tags: HHS, OIG, DOJ, Supreme Court, Opioids, 340B, Transparency, Italy, EFPIA, Public Nuisance, Native Americans, Individual Accountability, Patient Support, Advisory Opinions, Privacy, Agency Authority, FCPA, Instituto Mexican del Seguro Social, Olympus, Stryker, Zimmer, Stericycle, Stem Cells, FDA, Fortress Biotech, Copays, Charitable Foundations, Pill Mills, State Department
LITGATION & Enforcement
The Limits of Dismissal
U.S. Supreme Court to Address the Issue in FCA Whistleblower Cases
By Robert N. Wilkey, Esq., Senior Staff Writer, and Dr. Seth B. Whitelaw, Editor
Summary: In December 2022, the U.S. Supreme Court heard oral arguments in a case with far-reaching implications for FCA litigation. Before the Court is the question of whether the government can dismiss a whistleblower’s qui tam lawsuit later after initially declining to intervene. There is a split among the U.S. Circuit Courts of Appeals, and this decision is anticipated to establish a uniform standard.
Tags: False Claims, Whistleblowers, Dismissal, Intervention, Circuit Court Split, Supreme Court, Polansky, WLF
A Messy Business
Stretching Scarce Federal Resources Under the 340B Program
By Gwendolyn A. Ball, J.D., Ph.D., Staff Writer
Summary: Although some of the ongoing 340B issues were resolved in 2022, several outstanding and unaddressed issues will persist into 2023. Consequently, 2023 looks to be another busy year in the world of 340B discount drugs.
Tags: 340B, HHS, HRSA, Hospitals, Kickbacks, American Hospital Association, Supreme Court, Reimbursement, Contract Pharmacies, Alternative Dispute Resolution
Patient Services
The Sixth Annual Patient Services Compliance Survey
The Journey Continued in 2022
By Minna Bak, Clara McKinley, and Kuba Mijakowski
Summary: The landscape of Patient Support Services and Patient Assistance Programs continues to evolve as 2022 marks the 6th year of Helio Health Group’s annual Patient Services Compliance survey that captures these changing trends. Results of the survey show that intensified prosecutorial scrutiny in this area has brought improvements to the organization of Patient Support Programs while also increasing the uncertainty and legal risks associated with critical functions.
Tags: Patient Support Services, Patient Assistance Programs, Charitable Foundations, Copays, Survey, Kickbacks, Beneficiary Inducement Statute, Supreme Court, Copay Charities, HHS, OIG, Advisory Opinions, Pfizer, Regeneron, Decommercialization, Monitoring
Governance & Operations
Getting the Board on Board with Compliance
Evaluating Compliance Culture Effectiveness
By Steven Klimberg J.D., Dr. Saul B. Helman, and Dr. Seth B. Whitelaw
Summary: At the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, a panel of experts focused on the importance of the Board of Directors. With the ever-increasing emphasis on effectiveness, there is renewed emphasis on the role of the Board.
Tags: PCF, Board of Directors, Caremark, HHS, OIG, DOJ, Oversight, Culture, Fiduciary Responsibility, Assessments, Effectiveness
Happy New Year from all of us here (virtually) at Policy & Medicine Compliance Update. We hope all our readers and their families are safe and healthy. And as always, thank you for subscribing and for your continuing support in making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor