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August 2023 Issue
August 2023
This month’s focus is on regulatory updates, but before diving into the topic, we begin by assessing the impact of life science ethics & compliance programs after thirty years. The article examines the evidence as the debate continues about whether the programs have resulted in meaningful behavioral change.
Next, we shift to our primary focus and examine regulatory updates in three significant areas. First, we review the recently released Open Payments Data for 2022. After analyzing the data, we look at the apparent lack of interest in the data and suggest some possible solutions.
Second, HHS-OIG recently announced plans to update its now-aging series of Compliance Program Guidance documents. We review the Agency’s changed approach and discuss possible guidance updates.
Finally, CMS recently released its final guidance outlining its process for implementing the Inflation Reduction Act’s drug price negotiation provisions. Although a simple concept, implementation is proving complex and challenging.
Articles
FEATURE
Making an Appreciable Difference
Assessing the Impact of Life Science Ethics & Compliance Programs
By Ann Beasley and Dr. Seth B. Whitelaw
Summary: After thirty years, the debate continues about whether ethics and compliance programs have meaningfully changed behavior in life sciences. However, as this article explores, the evidence suggests otherwise.
Tags: Ethics, Compliance, Federal Sentencing Guidelines, Caremark, Packard Commission, ABPI, Code of Practice, COSO, Turnbill Report, DOJ, HHS-OIG, CCO Certifications, Speaker Programs, Educational Programs, Risk Management
Regulatory Updates
Has the Shine Worn Off?
CMS Releases 2022 Open Payments Data Without Fanfare
By Nicodemo Fiorentino and Dr. Seth B. Whitelaw
Summary: In June 2023, CMS released the Open Payments data for 2022. However, unlike previous years, this recent data release was not accompanied by fanfare and garnered limited attention, suggesting that Open Payments reporting has become mundane. This article explores the 2022 data, some possible reasons for the apparent lack of interest, and suggests possible solutions.
Tags: CMS, Open Payments, Physician Payments Sunshine Act, PY 2022, Physicians, Patients, Medtronic, Novo Nordisk, Meals, Entertainment, CME, General Payments, Research Payments, Ownership or Investment Interests, Grassley, McCaskill, Transparency, Assumptions Document, Enforcement, DOJ
Emerging from the Shadows
HHS-OIG Announces Plans to Revise Compliance Program Guidances
By Dr. Seth B. Whitelaw and Kirt Kraeuter
Summary: The HHS-OIG’s CPGs are vital if somewhat outdated, tools for compliance professionals developing and implementing healthcare compliance programs. In April 2023, the HHS-OIG announced plans to “modernize” the previously issued CPGs and add new ones. This article explores the known details and provides insights about topics that the revisions might include.
Tags: HHS-OIG, DOJ, Compliance Program Guidance, Federal Sentencing Guidelines, HIPAA, Healthcare Fraud & Abuse Control Program, SmithKline Beecham, Modernization, Industry-Specific Guidance, Medicare Advantage, “Add-On” Tests, COVID-19, PBM, Spread Pricing, 21st Century Cures Act, Electronic Health Records, Notice-And-Comment Rulemaking
Anything But Simple
CMS Releases its Final “Guidance” on Drug Price Negotiations
By Gwendolyn A. Ball, Staff Writer
Summary: As CMS continues implementing the IRA’s drug price negotiation provisions, it faces significant challenges threatening the program’s viability. Thus, while the concept is simple, its execution is exceedingly complex, especially under the tight statutory deadlines imposed by the IRA.
Tags: CMS, Inflation Reduction Act, Medicare, Drug Pricing, Negotiations, Guidance, Merck, Johnson & Johnson, Bristol Myers Squibb, Astellas Pharma, U.S. Chamber of Commerce, First Amendment, Fifth Amendment, Timeline, Notice-And-Comment Rulemaking
About THE Authors[1]
Ann Beasley: Ms. Beasley is Senior Vice President and Chief Compliance Officer for Zai Labs.
Gwendolyn A. Ball: Dr. Ball is a policy analyst specializing in innovation and health policy. She holds a Ph.D. in economics and an M.S. in statistics from the University of Illinois (“UIUC”). She also holds a J.D. from George Mason University, where she was a Levy Fellow in Law and Economics and managing editor of the Journal of Law, Economics, and Policy. Dr. Ball is also a staff writer for the Policy & Medicine Compliance Update.
Nicodemo Fiorentino:Mr. Fiorentino is Compliance Counsel with Guerbet LLC and Associate Editor of the Policy & Medicine Compliance Update.
Kirt Kraeuter: Besides being a staff writer for the Policy & Medicine Compliance Update and providing compliance advisory services, Mr. Kraeuter is the former Senior Director, Corporate Compliance at Moderna.
Dr. Seth B. Whitelaw: Dr. Whitelaw is a Senior Fellow and Adjunct Professor, Life Science Compliance at Mitchell Hamline School of Law, President & CEO of Whitelaw Compliance Group, LLC, and the Editor of the Policy & Medicine Compliance Update. He has an S.J.D. in Health Law (Widener University School of Law), an LL.M. in Administrative Law (GWU Law School), and a J.D. (Washington & Lee University School of Law).
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
sbwhitelaw@whitelawcompliance.com