Publications & White Papers
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2027 Medicare Physician Fee Schedule (PFS) Proposed Rule
The Impact on Drug Manufacturers and ASP
July 2026
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Once the Dust Settles on Q2 ASP Reporting
Documentation Updates Related to the New CMS ASP Reporting Requirements
July 2026
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The Current Landscape of Service-Fee FMV
A Regulatory, Compliance, and Financial Perspective of CMS’s Bona Fide Service Fee (BFSF) Framework
June 2026
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GP Compliance For Manufacturers in the Third Party Provider (TPP) Managed Services Environment
Helping to tell your GP Compliance Story
May 2026
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Maximum Fair Price (MFP) Effectuation for Part B Drugs
A Manufacturer-Focused Compliance Perspective and HELIO’s MFP Effectuation & Part B Drug Compliance Support
May 2026
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Government Programs Participation for Emerging Pharma and Biotech
A Case Study in Understanding Opportunities and Managing Risks: Will You be Ready on Day 1?
April 2026
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Applying Smart Technology to Class of Trade and 340B Validation
A Discussion of Recent HELIO Audits of COT Assignments and 340B Validations, and the Various Types of Issues Identified.
April 2026
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Government Programs Compliance "Health Check"
Evaluating your GP Audit Readiness Through Compliance Assessments to Identify Potential Gaps and Improve Documentation.
Mar 2026
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Navigating CAA 2026 PBM Reforms: Critical Concerns for Drug Manufacturers
An Overview of the 2026 Consolidated Appropriations Act and what the PBM Reforms mean for Pharmaceutical Manufacturers
Mar 2026
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Update on the CMS ASP Final Rule which goes into Effect Q1 2026
CMS Publishes a Holiday Gift with the Promised FAQ
Jan 2026
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CMS’s Proposed GLOBE and GUARD Models
A Side-By-Side Summary of What Pharmaceutical Manufacturers Need to Know
Dec 2025
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Our Thoughts on Priorities for the New ASP Requirements, Effective Q1 2026
Preparing to Defend your Reasonable Assumptions
Nov 2025
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Summary of the GENEROUS Model Request for Applications (RFA)
A Detailed Look into The CMS Request for Applications from Applicable Manufacturers
Nov 2025
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Most Favored Nation (MFN) pricing through Status Supplemental Rebates
Recent ways CMS is looking to effectuate MFN pricing through Status Supplemental Rebates
Nov 2025
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Shifting Compliance From Detection to Direction
How AI Is Rewriting the Rules of Data-Driven Compliance
Oct 2025
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Government Programs for the Compliance Officer
A HELIO Case Study: GP from the View of a Compliance Officer
Oct 2024
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Mergers & Acquisitions Government Price Reporting, Due Diligence and Avoiding Transition Nightmares
Common Recurring Issues in Life Sciences M&A and How to Address them.
April 2024
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The Guardians of Innovation
Compliance Executives in the Age of the AI-Driven Pharma Enterprise
Mar 2024
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Helio’s Seventh Annual Patient Services Compliance Survey
Surprising Developments in 2023
Mar 2024
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AI in Life Science Enterprise
Real World Ethical, Compliance, and Security Considerations of AI in the Life Science Industry
Feb 2024
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The Ongoing Saga of Patient Definition, or Lack Thereof, in the 340B Program
Patient definition in the 340b program becomes more complicated after recent court decision.
Jan 2024
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Back to Basics: Compliance Oversight of Government Pricing Programs
Where We Are Now and Where We Are Headed
Dec 2023
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Embracing Generative Artificial Intelligence
The Race to Reshape the Life Sciences Industry
May 2023
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6th Annual Patient Services Compliance Survey
The Journey Continued in 2022
Jan 2023
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5th Annual Patient Services Compliance Survey
Patient Support Program Compliance Continues Evolving
DEC 2021
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Looking for Compliance Risks in Oceans of Data
Leveraging machine learning & advanced anomaly detection to address the flood of digital communications data
SEP 2021
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Your Data & You: Who Works for Whom?
The Burning Platform for Compliance Data Analytics
MAY 2021
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Operating in the Gray Zone
Patient Support Programs & the Guardrails to Mitigate Risk
MAY 2021
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4th Annual Patient Services Complaince Survey
Patient Services Program Compliance Continues Evolving
DEC 2020
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Monitoring the New Normal
Top 5 Compliance Challenges to Consider in the Changing Digital Workspace
JUL 2020
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Patient Services Compliance Survey
Trends & Insights into this Highly Scrutinized Area
FEB 2019
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HELIO Patient Services Compliance Survey
The Latest Trends & Lessons Learned
NOV 2019
