Health Policy

The FDA has issued a final rule intended to ensure patients are better informed about their breast tissue density when undergoing mammography. The rule updates regulations first issued in the 1990s under the Mammography Quality Standards Act to oversee mammography facilities and improve breast cancer testing.

The Centers for Medicare & Medicaid Services (CMS) has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their physicians without having to travel to a healthcare facility. Clinicians can bill immediately for services starting March 6, 2020.

On July 14, 2010, the Departments of Treasury, Labor, and Health and Human Services issued interim final rules for group health plans and health insurance issuers to provide detail on how those entities are to cover the preventive services required under the Patient Protection and Affordable Care Act (PPACA).

Silver Spring, MD—Risk Evaluation and Mitigation Strategies (REMS) are required from some drug manufacturers as part of a new US Food and Drug Administration (FDA) regulation designed to draw the attention of sponsors, providers, and patients to the likelihood of severe adverse events accompanying certain drugs and biologic agents.

Washington, DC—A panel discussion on health and drug politics took place at the Sixth Annual Conference of the Association for Value-Based Cancer Care. The expert panel included Kavita Patel, MD, Johns Hopkins Medicine, Baltimore; Dan Todd, Principal of Todd Strategy, Washington, DC; and Liz Fowler, Vice President, Global Health Policy, Johnson & Johnson. The panel discussed what is working in healthcare, what is not, and where cancer care fits into it all.

The Individual Patient Expanded Access Application, which is designed to streamline the application procedure for individual patients who apply for expanded access to investigational therapeutics, including expanded access to drugs that are not in clinical trials, was recently updated by the FDA. Form FDA 3926 authorizes expanded access to investigational drugs for patients with serious or life-threatening conditions who have no therapeutic options.

Opposition to proposed changes to the Medicare Part B payment for prescription drugs continues to grow since the Centers for Medicare & Medicaid Services (CMS) announced its plan in March 2016.

A new payment and delivery model introduced by the Center for Medicare & Medicaid Innovation aims to align financial incentives to improve oncology care and outcomes. Expected to begin in July 2016, the program will target patients from the start of their chemotherapy through 6 months of care.

Two related studies have documented significant deficiencies in the way the FDA approves expanded or new indications for drugs, using its expedited approval processes with limited evidence.