Welcome to the Health Policy WARroom

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 ever changing ecosystem.

Photo by National Cancer Institute on Unsplash

The healthcare industry is constantly changing, and nowhere is that more evident than in the Medicare program. By staying on top of changes to Medicare legislation (like the Affordable Care Act or the Protecting Access to Medicare Act and even the CARES and Families First Acts), regulations (including the annual updates to the Physician Fee Schedule, Outpatient Prospective Payment System and Inpatient Prospective System), to CMS Administrator Rulings, Medicare Transmittals, and National Coverage Decisions, stakeholders can develop effective strategies and plans for developing and commercializing new and innovative technologies.

Having a solid understanding of Medicare Administrative Contractors, their local policy processes and reimbursement requirements can also help stakeholders to position themselves and their products for the most favorable outcomes possible.

In this blog, we will explore some of these changes and highlight some of the benefits and the challenges of this continually evolving landscape

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Innovative Models for Lowering Drug Spending

Recently, much has been written about the escalating costs of drug prices in the US. Increasing drug prices are present challenges to those who struggle with affordability and access to their medications. The Inflation Reduction Act brought changes to the way the Medicare program reimburses for prescription drugs. Last year, President Biden challenged the Center for Medicare and Medicaid Innovation (CMMI) to develop and test new payment models that can support value-based payments and promote high-quality healthcare. CMMI has recently proposed three models intended to improve affordability and access to drugs as well as measuring the feasibility of implementation. 1. The Medicare High-Value Drug List Model Under this model, Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans that participate in the Model wi

Bridging the Gap: The Long Road from FDA Approval to Medicare Coverage

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

FDA Pilot Program for Certain In Vitro Diagnostic Tests

The U.S. Food and Drug Administration (FDA) has announced a pilot program designed to improve oncology patient care by establishing minimum performance standards for in vitro diagnostic tests (IVDTs) used with a limited number of oncology drug products. An IVDT is a device that provides critical information for the safe and effective use of a therapeutic product. The FDA typically requires a companion diagnostic to receive marketing authorization concurrently with the approval of the corresponding therapeutic product. However, in cases where no satisfactory alternative treatment exists for a serious or life-threatening condition, the FDA may approve a therapeutic product even without a companion IVDT. Currently, laboratory developed tests (LDTs) are being used in such cases, and the FDA exercises enforcement discretion regarding these tests. The pilot program aims to improve drug selection and patient care by establishing minimum performance characteristics for certain LDTs used in id

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