In neither the bill itself or Kingdon-Reese’s Viewpoint is there evidence of demonstrable benefit for such testing. Although I would not disagree that benefit is possible, what evidence is there that the benefit is so great that it justifies the anticipated cost?
Although the act says in its “purposes” that the tests are only covered if they are approved under the Food,Drug and Cosmetic Act, there is nothing specific in the bill to mandate such approval. Further, no test is foolproof; there are false positives and false negatives and both of these impact the lives of individual patients. The act should include a provision that test manufacturers/developers must make available to physicians and patients a thorough description of the test (including its rate of false positives and negatives, the positive predictive value and the negative predictive value) as well as a list of the published studies upon which the description relies. Without these safeguards in the bill - i.e. rigorous reviews of test claims and information essential for proper test use - the bill risks adding to Medicare cost, patient harms and fraud without a measurable benefit.
I think that before this bill is voted on, legislators should have real evidence of its likely impact and should require, in the bill, that certain information be available to assist care givers and patients alike in both evaluating whether to have the test(s) at all or in their interpretation.
In neither the bill itself or Kingdon-Reese’s Viewpoint is there evidence of demonstrable benefit for such testing. Although I would not disagree that benefit is possible, what evidence is there that the benefit is so great that it justifies the anticipated cost?
Although the act says in its “purposes” that the tests are only covered if they are approved under the Food,Drug and Cosmetic Act, there is nothing specific in the bill to mandate such approval. Further, no test is foolproof; there are false positives and false negatives and both of these impact the lives of individual patients. The act should include a provision that test manufacturers/developers must make available to physicians and patients a thorough description of the test (including its rate of false positives and negatives, the positive predictive value and the negative predictive value) as well as a list of the published studies upon which the description relies. Without these safeguards in the bill - i.e. rigorous reviews of test claims and information essential for proper test use - the bill risks adding to Medicare cost, patient harms and fraud without a measurable benefit.
I think that before this bill is voted on, legislators should have real evidence of its likely impact and should require, in the bill, that certain information be available to assist care givers and patients alike in both evaluating whether to have the test(s) at all or in their interpretation.