Coalition for 21st Century Medicine Commends CMS for Modernization of Billing Rules for Precision Medicine Tests

On November 1, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year 2018 Hospital Outpatient Prospective Payment System Final Rule, establishing a new policy for determining the billing rules (commonly referred to as the “date of service”) for precision medicine laboratory tests. The new policy will take effect January 1, 2018 and will enable laboratories to bill Medicare directly for many precision diagnostic tests performed on specimens collected from hospital outpatients. Current Medicare regulations frequently require hospitals to bill Medicare for tests that are performed separately by independent laboratories, creating unnecessary complexity and delayed patient access to test results and treatments.

Hannah Murphy Joins the Coalition for 21st Century Medicine as Executive Director

The Coalition for 21st Century Medicine (C21) is pleased to announce that it has engaged Ms. Hannah Murphy as its inaugural executive director. “We are excited to have Hannah lead the expansion of our capabilities to serve our industry and patient health,” says Kim Popovits, President and CEO, Genomic Health and member of the C21 Steering Committee, “The rapid developments and expanding impact of personalized medicine creates tremendous opportunities for C21 and the new Executive Director position will help us best capitalize on these opportunities and respond to these challenges.”

Coalition for 21st Century Medicine Commends CMS for Issuing 2018 Preliminary Private Payor Rate-Based Payment Amounts for Clinical Diagnostic Laboratory Tests as Part of PAMA Implementation

On September 22, the Centers for Medicare & Medicaid Services (CMS) released its 2018 preliminary private payor rate-based payment amounts for clinical diagnostic laboratory tests. The preliminary rates are based on private payor rates reported by laboratories and are part of the market-based payment reforms enacted in Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA).

Coalition for 21st Century Medicine Applauds FDA Decision to Wait to Publish Final LDT Guidance

Coalition of innovative diagnostic test manufacturers agrees that major implementation challenges with proposed regulatory policies should be resolved prior to implementation to avoid disruption of patient services Washington, D.C. – On November 18, 2016, officials from the U.S. Food & Drug Administration (FDA) communicated informally with key stakeholders, including the Coalition for 21st Century Medicine, … Continued

Coalition for 21st Century Medicine Seeks Reconsideration of Drastic Gapfill Cuts to Innovative Advanced Diagnostic Laboratory Tests

Final rates inconsistent with extensive pricing information submitted to MACs, and contrary to the goals of PAMA and the promotion of precision medicine Washington, D.C. – Today, the Centers for Medicare & Medicaid Services (CMS) released the 2016 Final Gapfill Payment Determinations for new CPT codes for a number of well-established, Medicare covered advanced diagnostic … Continued