July 14, 2008
PATIENT DIRECT ACCESS TO MEDICAL TEST RESULTS
By: John Kasprak, Senior Attorney
You asked us to survey nearby states to determine if they allow patients to directly receive the results of medical laboratory tests.
Connecticut does not allow the direct reporting to patients of medical laboratory test results. But such results may be reported to patients upon the written request of the provider who ordered the testing. (For more information on Connecticut's law and policy see OLR report 2008-R-0046.)
We examined the other New England states as well as New Jersey, New York, and Pennsylvania on this issue. Of these states, only Vermont allows consumers to directly receive their laboratory test results without limitation. Vermont is “silent” on this issue, that is, it has no laws or regulations addressing who is authorized to request testing or receive test results.
Of the other states, Maine, Massachusetts, New Jersey, and New York allow for limited reporting to patients. Generally, direct reporting to patients is allowed for diabetes, pregnancy, and cholesterol-related testing and other health promotion and screening tests. Such testing and reporting is sometimes referred to as direct-to-consumer (DTC) testing.
The remaining states examined, New Hampshire, Pennsylvania, and Rhode Island, do not allow direct reporting to patients.
(The information in this report is taken from a 2007 “Survey of Direct-to-Consumer Testing Statutes and Regulations” produced by the Genetics and Public Policy Center at Johns Hopkins University.)
Maine allows direct reporting to consumers in a limited manner. In general, a medical laboratory must examine specimens only at the request of a licensed physician or other person authorized by law to use the findings of laboratory examinations. But, a medical laboratory may examine specimens without a physician referral for a limited number of laboratory services to be determined by rules adopted by the state health department. These services include tests for (1) glucose for patients who have been previously diagnosed with diabetes, (2) pregnancy, (3) colon cancer, and (4) cholesterol.
(Maine Revised Statutes, Title 22, §§ 2030-2031-A; Code of Maine regulations § 10-144-256(9)).
Massachusetts has limited test reporting to consumers. In general, tests may be ordered only by physicians or other authorized persons listed in statute, and test results may be reported only to the authorized person who requested the test, unless the authorized person requests that the result be sent to the patient. The law provides an exception for tests conducted according to “health promotion screening programs,” for the purpose of “promoting health awareness and education among the general public by early detection of disease and associated risk factors.”
Health promotion screening tests are not used for providing clinical diagnosis or treatment to patients. Such exceptions are limited to eight tests, including those for pregnancy and cholesterol.
(Mass. Gen. Laws, ch. 111D, §§ 4, 8; 105 Mass. Code of Regs. §§ 180.010, 180.043, 180.280, 180.290.)
New Hampshire does not allow direct reporting to patients. State regulations provide that laboratories may perform testing only at the request of a physician, dentist, chiropractor, court of law, or any other person authorized by state statute to order and receive laboratory tests. Patients do have the right to access all their medical records including laboratory test results.
(N.H. Admin. Rules He-P 817.15(a)).
New Jersey has limited direct reporting to patients. In general, tests may be ordered only by a licensed physician, dentist, or other person authorized by law to use the findings of laboratory examinations and must report only to those authorized by law to receive such results. But patients can also request a copy. The only tests that are exempt are original CLIA-waived tests such as dipstick urinalysis, fecal occult, and pregnancy tests. (“CLIA” refers to the federal Clinical Laboratory Improvement Amendments,” passed by Congress in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.)
(N.J. Stats, § 45:9-42.42; N.J. Admin. Code, §§ 8:44-2.2, 8:44-2.7.)
New York has limited direct reporting. In general, tests may be ordered only by licensed physicians or other persons authorized by law to use the findings of laboratory examinations in their practice or the performance of their official duties. (Consumers are not listed among those so authorized.) Test results cannot be sent directly to patients except with the written consent of the physician or authorized person, except blood type and RH factor can be given in writing to the patient without written consent.
DTC testing is allowed for tests that have been approved by the Food and Drug Administration for direct, over-the-counter sale to consumers.
(N.Y. Pub. Health Law §§ 576-b, 577; 10 N.Y. Code (regs) §§ 19.1(j), 58-1.7, 58-1.8, 63.3(e)).
Pennsylvania does not allow direct reporting to patients. Tests may be ordered only by licensed members of the healing arts or other persons authorized by statute and results may be sent only to the person ordering the test.
(28 Pa. Code §§ 5.41, 5.47.)
Rhode Island does not allow direct reporting to patients. Tests may be ordered only by licensed physicians or other authorized personnel, defined as “health professionals” working under the auspices of a physician or licensed health care professional acting within his or her scope of practice.” Patients may only have direct access to their laboratory results with written permission from their physician.
(R.I. Rules and Regulations for Licensing Clinical Laboratories and Stations, R-23-16.2-C and S/Lab. §§ 1-2, 10-2, 13.2.)
Vermont does allow DTC testing. State law is silent on the issue. Vermont has no laws or regulations addressing DTC testing or who is authorized to request testing or receive test results.