netic screening may be warranted, and that will require the development of appropriate reimbursement policy as well. Genetic screening may thus follow the path of certain other screening and preventive services such as mammography or immunization, which are increasingly becoming part of health insurance plans; however, counseling raises another dimension for reimbursement of genetic testing services that differs from these other screening and preventive health services.

Newborn screening is another type of genetic testing for which insurance reimbursement has been limited. In the past, most states paid directly for newborn screening tests, but now more than half the states bill the birth hospital (or more rarely the birth physician or even the parents) for the cost of newborn screening (CORN, 1992). They leave the hospital (or doctor) to collect from whatever third-party coverage the parents may have. Insurance companies, however, have resisted paying for such screening in many states, so the hospitals must somehow absorb the expense (S. Panney, Maryland Department of Health and Mental Hygiene, personal communication, 1993).

There are a few sources of noninsurance funding for genetics services that will reimburse out-of-pocket costs for persons without health insurance or whose insurer will not reimburse for genetic testing and counseling. Some academic laboratories have special research funding, some programs have state grants-in-aid (including funding from the Maternal and Child Health block grant funds to the states), some programs have limited private foundation funding, and some programs receive financial assistance available from genetic support groups. Such alternative sources of funding are not consistently available.

However, much of the complex genetic linkage analysis today is performed in academic research laboratories, and some of these laboratories bill patients for such services. Even if the proband has insurance that would cover individual genetic testing and linkage analysis, his or her insurance company may not pay for genetic testing and linkage analysis for the whole family. Extended family members are likely to have different insurance coverage that may or may not cover such procedures, and if family members are unable or unwilling to pay the costs of their own genetic testing and linkage analysis, the procedures will not produce complete and useful results. Thus, the structure of the insurance system in the United States imposes an additional impediment to genetic testing that requires linkage analysis; patients must often pay out-of-pocket or not have access to such testing.

Another barrier to coverage is the fact that most testing now performed by academic laboratories has not been approved and is therefore "investigational" under the definitions of the Food and Drug Administration. "Investigational" or "experimental" services are almost never reimbursed by third-party payers. However, most of these laboratories have not applied for or received certification under the requirements of the Clinical Laboratory Improvements Amendments of 1988. Requiring these laboratories to comply with existing federal laws (see Chapter 3) will remove some of the genetic testing and counseling these laborato-

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement