Policy & Medicine Compliance Update
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JULY 2020
ISSUE SUMMARY:
Monitoring the New Normal
Top 5 Compliance Challenges to Consider in the Changing Digital Workspace
ByManny Tzavlakis, Managing Partner and Louie Karapanogiotides, Manager, Helio Health Group LLC
Summary: While the post-pandemic sales strategy is still out of sight, compliance leaders must act now to ensure their organizations are equipped to handle the systemic changes to monitoring responsibilities caused by the shift to digital field activities. Life science organizations must prepare both their commercial teams as well as their compliance teams to adapt to digital sales interactions in the long-term, equipping them with clear guidance and proper controls in a proactive manner. Amidst the numerous opportunities for change sparked by the COVID-19 crisis, the chance for organizations to rebalance and reorient their Compliance Programs to the digital workspace is one that should not be overlooked.
TAGS: COVID-19, PANDEMIC, Monitoring, Digital, transformation
Drug pricing
The Struggle to Curb Rising Drug Prices
Pay-for-Delay Deals Under a New Microscope
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: The much-maligned pay-for-delay strategy to resolve Hatch-Waxman litigation is going under the microscope. Concerned about potential anticompetitive abuses, various federal and state entities are looking at ways to curb these arrangements.
TAGS: Pay-for-delay, hatch-waxman, reverse payments, anda, ftc, grassley, DRUG PRICING
A Mid-Year Update on Prescription Drug Pricing Policy
New Pandemic Dimensions for an Old Issue
By Gwendolyn A. Ball, Staff Writer
Summary: For now, federal and state legislators have tabled drug price reform to fight the “war” against the COVID-19 pandemic. However, since public support for price reform remains strong, this tabling likely is a temporary hiatus. Furthermore, the need to determine sustainable pricing for future coronavirus vaccines and treatments promises to rekindle reform efforts.
TAGS: DRUG pricing, covid-19, pandemic
Governance & Operations
Proving Effectiveness Remains the Compliance “Holy Grail”
The DOJ Revises Its Evaluation Guidance Again
By Kirt Kraeuter, Staff Writer, Policy & Medicine Compliance Update
Summary: The latest revision to the DOJ’s Evaluation of Corporate Compliance Programs Guidance reemphasizes the importance of ongoing effectiveness. While not as substantial as the April 2019 changes, the revised Guidance contains significant changes that all compliance professionals should review and embrace.
TAGS: DOJ, Effectiveness, compliance Program, Guidance, Oversight
Caught in the Crossfire
HHS OIG Finds Itself in the Battle Over Appropriate Oversight
By Gwendolyn A. Ball, Staff Writer
Summary: The Trump administration has made no secret of its disdain for the oversight provided by Inspectors General. However, recently the OIG has come under fire for its report on how hospitals are responding to the pandemic. The concepts of appropriate oversight and independence are at the heart of this controversy, which should concern all compliance professionals.
TAGS: inspectors general, independence, oig, covid-19, pandemic, Oversight
Preserving Audit Independence
Lessons from the Recent Walmart Non-Prosecution Agreement
By Kirt Kraeuter, Staff Writer
Summary: The recent saga of Walmart de Mexico highlights the need for compliance professionals to support efforts to preserve an internal audit department’s actual independence. The compliance and internal audit functions are natural allies in the struggle to maintain an effective compliance program and culture. Therefore, there are steps compliance can take to strengthen that alliance and protect both internal audit and compliance independence.
tags: walmart, fcpa, audit, independence, npa, Oversight