Course Content

Regulatory and Reimbursement: Assessment Questions

Course Overview

Needs and Markets

Intellectual Property

• Regulatory and Reimbursement

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Company Formation

Funding

Financials

Summary

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Answer the following questions regarding the important topics covered in this section of the CD. The correct answers can be accessed through the link at the bottom of the page.

1. The FDA regulates three distinct categories of medical products. Which of these is NOT one of them?
   1. Drugs
   2. Nutritional supplements
   3. Medical devices
   4. Biologic agents
2. Which of the following is NOT regulated as a medical product by the FDA?
   1. A SCUBA tank and regulator advertised for recreational diving
   2. A rowing device advertised to speed healing of cartilage injury
   3. A manufactured splint advertised to facilitate healing of broken bones
   4. A topical cream advertised to reduce itching associated with poison ivy
3. Which of the following most closely matches the FDA's mission with regard to medical products?
   1. To ensure the safety and efficacy of the product, but not its cost-effectiveness
   2. To ensure the safety of the product without regard for efficacy or cost
   3. To ensure the cost-effectiveness of the product without specific regard for safety or efficacy
   4. To ensure the safety, efficacy, and cost-effectiveness of the product
4. In the US, insurers must make coverage decisions based upon the decisions made by which organization or entity?
   1. The first private insurance company to publish a coverage decision
   2. The FDA
   3. Medicare
   4. None of the above; each insurer makes independent coverage decisions
5. Which of the following is a true statement regarding reimbursement?
   1. Reimbursement policies are simple, clear, logical, and consistent
   2. When making coverage decisions, only the direct costs associated with the medical product are considered
   3. Reimbursement codes and procedures depend upon the location where the service is performed (e.g., physician office, hospital, ambulatory surgery center, etc.)
   4. A separate coverage decision is required for every medical product that comes to market