FDA and HCFA: Working Together for High Quality Healthcare

This page describes how the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) (formerly Health Care Financing Administration), agencies within the U.S. Department of Health and Human Services (DHHS), assure that high quality medical products and services are readily available to patients covered under the Medicare insurance programs.

FDA

To promote public health, a major role of FDA is to take appropriate actions on the marketing and use of regulated drugs and medical devices. To accomplish this, FDA requires manufacturers to provide valid scientific information, including the results of clinical research as appropriate, before their products can be sold legally in the United States. In addition, the Mammography Quality Standards Act of 1992 (MQSA) requires that mammography facilities meet certain requirements for personnel, equipment, and recordkeeping. Please visit our page on Selected FDA Activities for more information.

CMS (formerly Health Care Financing Administration)

Among CMS's (responsibilities is the management of the Medicare program, one of the largest health insurance programs in the world. With over 39 million beneficiaries, the program covers various categories of medical products and services, including a limited prescription drug benefit and durable medical equipment. By statute, however, the Medicare program may not make payment for any item or service that is not reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member. Their Medicare Coverage Policy website provides information on the process CMS follows in making Medicare coverage decisions. Their Medicare Coverage Database provides information on National Coverage Determinations, National Coverage Analyses, and Local Medical Review Policies

FDA and CMS Working Together

FDA approval of a marketing application for a human drug or medical device is relevant information that CMS uses in determining whether a drug or device may be covered under the Medicare program. However, FDA approval alone does not necessarily mean that CMS will decide that a drug or medical device should be covered for any particular patient or for all Medicare beneficiaries. For mammography, CMS must determine that a facility is MQSA certified before any mammography exams at that facility will be covered by Medicare. FDA and CMS are working together to make the information needed by their customers more helpful and accessible and to improve the processes by which regulated medical products and services are made available to Medicare beneficiaries.

FDA and CMS: Working Together for High Quality Healthcare

FDA

CMS (formerly Health Care Financing Administration)

FDA and CMS Working Together