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...

A new study published in JAMA Health Forum reveals that the road to Medicare coverage for novel medical technologies is a long and winding one. Researchers found that only 44% of innovative devices and diagnostics approved by the FDA from 2016-2019 had even “nominal” Medicare coverage by 2022. This data highlights major hurdles in the system that delay patient access to beneficial emerging technologies. About the Research The study examined 281 novel products cleared through the FDA from 2016-2019 via the high-risk premarket approval, de novo, and breakthrough 510(k) pathways. These included things like groundbreaking diagnostic tests, implantable devices, and other innovative treatment technologies. The goal was to measure how long it took to establish national or regional Medicare coverage policies for these newly approved products. This is important because Medicare coverage is required before hospitals, physicians and patients can reliably access new technologies. Key Findings The ...

  Since January 1, 2020, CMS has made separate payment for the treatment of opioid use disorder when furnished by qualified opioid treatment practitioners (OTP). This new Medicare benefit, established by the SUPPORT Act, allows CMS to make bundled payments for weekly episodes of care. Medicare will pay for episodes of care that include drugs, for non-drug episodes of care, for intake and periodic assessments, take-home dosages of methadone and buprenorphine, as well as for additional counseling. Pricing The episodic payment rate includes reimbursement for the drug- and non-drug-components of the encounter. Pricing for the drug component of the bundle is set using the most appropriate pricing mechanism currently in place and varies depending on the drug. Annual updates to the drug component of the bundle are made using the most recently available data from the applicable pricing mechanism. The non-drug portion of the bundle is updated based on the Medicare Economic Index. To reflect...

Photo by Syed F Hashemi on Unsplash Welcome the the Health Policy WARroom, the official blog of Gettysburg Healthcare Consultants. GHC, located in Hanover, Pennsylvania works with health industry clients to obtain appropriate coverage, coding and reimbursement from the federal Medicare program. John Warren is the owner and principal consultant at GHC. He has been in the health insurance industry for nearly 30 years. He spent 22 years at the Centers for Medicare & Medicaid Services and directed the Divisions that developed payment policy and rate setting for the Medicare physician fee schedule, clinical laboratory fee schedule, ambulance fee schedule and the Part B Average Sales Price programs. He has consulted with a wide range of clients in the healthcare sector including pharmaceutical companies, laboratory test developers, medical equipment suppliers, and physician specialty societies. John uses his comprehensive understanding of the Medicare program to navigate the complex and...