Progress in Medical Research: Government Programs and Key Issues

Nima Gustavsson (Editor)

Series: Medical Procedures, Testing and Technology
BISAC: MED106000



Volume 10

Issue 1

Volume 2

Volume 3

Special issue: Resilience in breaking the cycle of children’s environmental health disparities
Edited by I Leslie Rubin, Robert J Geller, Abby Mutic, Benjamin A Gitterman, Nathan Mutic, Wayne Garfinkel, Claire D Coles, Kurt Martinuzzi, and Joav Merrick


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During the 115th Congress, several bipartisan bills were introduced that aimed to expand the number of telehealth services that are covered under Medicare. Telehealth is the electronic delivery of a health care service via a technological method. Health care providers use telehealth to improve patients’ access to and quality of care. Under Medicare, these patients are likely to live in rural areas, be under the age of 65 and be disabled. The first chapter in this book examines legislation as it relates to expanding telehealth services, including the five conditions that a telehealth service must meet to be covered and paid for under Medicare Part B. The second chapter focuses on the background and key issues surrounding biologics and biosimilars.

Biologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes and other unwanted substances. Also, they are usually administered to patients via injection or infused directly into the bloodstream. For these reasons, biologics often are referred to as specialty drugs. The cost of specialty drugs, including biologics, can be extremely high. The next chapter is a two-page report on a recent experiment in the United States using the gene modification tool CRISPR to target a disease gene in human embryos which raised optimism about promising medical advances, generated scientific debate as well as renewed debate about longstanding ethical issues. The fourth chapter provides a brief history of FDA drug regulation, describes FDA’s early risk management programs, and focuses on the agency’s current risk management authorities, specifically risk evaluation and mitigation strategies (REMS).

The chapter also discusses issues that have arisen as a result of REMS, particularly the impact on generic drug competition. The last chapter of this book addresses frequently asked questions about government and private-sector policies that affect drug prices and availability. Among the prescription drug topics covered are federally funded research and development, regulation of direct-to-consumer advertising, legal restrictions on reimportation and federal price negotiation.


Chapter 1. Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet (pp. 1-8)

Chapter 2. Biologics and Biosimilars: Background and Key Issues (pp. 9-64)

Chapter 3. CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate (pp. 65-68)

Chapter 4. FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development (pp. 69-100)

Chapter 5. Frequently Asked Questions About Prescription Drug Pricing and Policy (pp. 101-150)

Index (pp. 151)

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