Kim Czubaruk

The quest to discover effective treatments and cures for diseases and conditions is a worthwhile and compelling goal. Scientific research is responsible for innovative breakthroughs that improve quality of life, extend survival, and even prove life-saving. But alongside the potential benefits of scientific research are the potential risks to the people who participate in the journey that makes breakthroughs possible. The Belmont Report identifies basic ethical principles for conducting research that involve human subjects and sets forth guidelines to assure these principles are followed throughout the research process. The Belmont Report is the result of over four years of meetings that began in 1976 and were conducted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Commission). With the Food and Drug Reauthorization Act of 2017’s recent amendment of the term patient experience data to now include both “physical and psychosocial impacts of a disease or condition, or related therapy or clinical investigation,” it is a particularly relevant and important time to revisit the ethical principles established in the Belmont Report.

Approximately 43 million Americans are enrolled in Medicare Part D - a voluntary outpatient benefit provided through private health insurance plans approved by the federal government. These plans assist seniors in affording their prescription medications. However, for people with complex and serious health conditions who depend on high-cost drugs, affording medications under Medicare Part D is becoming more and more difficult. Read our break-down of the different payment phases in Medicare Part D and an explanation of why imposing a cap (limit) on the amount beneficiaries pay out-of-pocket each year for prescription drugs is more important than ever.

Medicare Part D is a voluntary outpatient prescription drug benefit to assist people in affording their prescription medications. Part D benefits are provided through private health insurance plans and approved by the federal government. Participants in Part D are able to choose between supplementing their traditional Medicare with a stand-alone prescription drug plan or a Medicare Advantage prescription drug plan that is part of and includes other aspects of Medicare. In November, 2018 the Centers for Medicare & Medicaid Services (CMS) proposed a new rule for Part D that would have changed the special coverage protections for medications included in the six protected classes.