The Health Policy War Room

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...

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...

Access to affordable health care is a persistent challenge for many Americans. However, a recent bill, the Protecting Health Care for All Patients Act (HR 485) , is making its way through the House of Representatives, which could hinder efforts to improve affordability of prescription drugs and other health care services. The bill seeks to block the use of quality-adjusted life-years (QALYs) and similar measures in government health care programs such as Medicare and Medicaid. QALYs are a widely accepted outcome measure used in health economic studies to assess the benefit of a therapy compared to standard care. They combine two critical health outcomes—length of life and health-related quality of life—into a single measure. QALYs are calculated by assigning weights to different health states, ranging from perfect health to death. By using QALYs, policymakers can estimate the average benefits of a treatment for a specific population. The debate over the use and impact of QALY is beyond...

In the ever-evolving landscape of healthcare, the rising costs of prescription drugs continue to be a major concern for patients, providers, and payers alike. Drug spending is a complex issue with many different dynamics at play. While the Medicare program has recently been given authorities to control drug spending, some have expressed concern that these efforts will only shift drug cost pressures to different parts of the healthcare system. The escalating cost of prescription drugs is a significant burden on both patients and payers. As the prices of pharmaceuticals continue to soar, it is crucial to understand the myriad factors behind this trend. Pharmaceutical companies cite research and development costs, regulatory requirements, and the need for profit as justifications for the high prices. The ballooning drug costs have prompted federal interventions aimed at curbing the financial strain on the healthcare system. CMS now has the authority to negotiate the price of some prescri...

The Centers for Medicare & Medicaid Services (CMS) has recently announced a comprehensive plan aimed at ensuring the availability of new Alzheimer's drugs for beneficiaries granted full approval by the FDA. This significant development comes in response to the anticipated full FDA-approval of the first new drug for Alzheimer's disease in nearly two decades, signaling a critical milestone in the fight against this debilitating condition. CMS recognizes the urgent need to make these treatments accessible to patients, and their plan outlines several key measures to support coverage and access. Under the plan, CMS intends to provide Medicare coverage for the newly approved Alzheimer's drugs under the national coverage determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease.  The plan acknowledges the ongoing debate surrounding the efficacy of these drugs, and CMS emphasizes the importance of allowing patients to make informe...