Research, regulatory updates and industry perspectives to help you navigate a complex healthcare landscape.

Publications &
White Papers

Manny Tzavlakis 7/15/26 Manny Tzavlakis 7/15/26

2027 Medicare Physician Fee Schedule (PFS) Proposed Rule

The Impact on Drug Manufacturers and ASP

Manny Tzavlakis 7/1/26 Manny Tzavlakis 7/1/26

Documentation Updates Related to the New CMS ASP Reporting Requirements

Manny Tzavlakis 6/10/26 Manny Tzavlakis 6/10/26

A Regulatory, Compliance, and Financial Perspective of CMS’s Bona Fide Service Fee (BFSF) Framework

Manny Tzavlakis 5/13/26 Manny Tzavlakis 5/13/26

Helping to tell your GP Compliance Story

Manny Tzavlakis 5/1/26 Manny Tzavlakis 5/1/26

A Manufacturer-Focused Compliance Perspective and HELIO’s MFP Effectuation & Part B Drug Compliance Support

Manny Tzavlakis 4/15/26 Manny Tzavlakis 4/15/26

A Case Study in Understanding Opportunities and Managing Risks: Will You be Ready on Day 1?

Manny Tzavlakis 4/1/26 Manny Tzavlakis 4/1/26

A Discussion of Recent HELIO Audits of COT Assignments and 340B Validations, and the Various Types of Issues Identified.

Manny Tzavlakis 3/18/26 Manny Tzavlakis 3/18/26

Evaluating your GP Audit Readiness Through Compliance Assessments to Identify Potential Gaps and Improve Documentation.

Manny Tzavlakis 3/2/26 Manny Tzavlakis 3/2/26

An Overview of the 2026 Consolidated Appropriations Act and what the PBM Reforms mean for Pharmaceutical Manufacturers

Manny Tzavlakis 1/14/26 Manny Tzavlakis 1/14/26

CMS Publishes a Holiday Gift with the Promised FAQ