The Health Policy War Room

The FDA recently granted authorization for the first multi-gene test for assessing hereditary cancer risk, marking a significant advancement in genetic screening capabilities. Developed by Invitae Corporation, the Invitae Common Hereditary Cancers Panel analyzes variants in 47 genes associated with increased cancer risk. Using next-generation sequencing on DNA from blood samples, the test looks at BRCA1 and BRCA2 variants linked to breast and ovarian cancer, as well as other cancer-related genes.  (image source: Adobe Stock Images) The FDA’s approval provides a regulatory framework giving labs a clearer roadmap for developing similar multi-gene panels. With an authorized model in place, labs can proceed more confidently in navigating FDA submissions. Specifically, the de novo classification created for Invitae’s test allows future lab-developed panels to gain regulatory clearance through the expedited 510(k) pathway by demonstrating substantial equivalence. This streamlined validat...

Liquid biopsies are poised to disrupt cancer testing as we know it. These novel blood tests analyze circulating tumor DNA (ctDNA) and other molecules released by cancer cells, providing a non-invasive option for detection, diagnosis, and monitoring. The promise of liquid biopsies has generated tremendous excitement, along with over $1 billion in investments and acquisitions in recent years. But how close are we to realizing their full potential?  A recent review article sounds a note of caution amidst the hype. While liquid biopsies show ability to detect cancer, evidence that they improve patient outcomes is still lacking. Randomized trials with survival endpoints are needed to prove clinical utility. However, this provides the perfect opportunity for innovative diagnostics companies. Rather than dampening enthusiasm, these evidence gaps highlight major growth possibilities if companies can demonstrate real-world value.   We envision liquid biopsies transforming oncology...

Blood tests and clinical lab tests are vital components of medical care, serving a variety of purposes, from prevention and diagnosis to monitoring various medical conditions. In the United States, these tests are the most common healthcare service, with approximately 14 billion tests ordered annually across 260,000 laboratories. However, recent research has uncovered a concerning trend: hospital outpatient departments are billing private insurance three times more for the same lab tests compared to physician offices and independent laboratories. A study conducted by the Health Care Cost Institute (HCCI) utilized a comprehensive commercial claims dataset to compare prices of clinical lab tests between hospital outpatient departments and physician offices/independent labs. The analysis revealed significant markups for lab tests performed in hospital outpatient departments. The median prices for tests such as lipid panels and comprehensive metabolic panels were three to five times highe...

Automated multichannel chemistry (AMCC) tests are a subset of diagnostic tests that are focused on overall well-being. Testing analytes like glucose, cholesterol, potassium, trigylcerides and others is part of almost every doctor's visit. The 23 tests that are generally identified as AMCC tests are relatively simple in nature using basic testing methods and the simple nature of these tests is reflected in the amounts that Medicare pays for these tests. The average Medicare Clinical Laboratory Fee Schedule (CLFS) payment rates for these tests is just over $6.50 per test. Despite the low per-test payment rate, AMCCs are big business, accounting for $194 million in Medicare spending in 2018. Read on for more...  There has been alot said about Medicare payment for AMCC tests since the Protecting Access to Medicare Act (PAMA) reformed the CLFS. Part of the way PAMA was implemented required Medicare to set payment rates and make payments for individual tests as described by their bil...