Coverage of Cancer Clinical Trials

The major political question for the cancer community this fall is whether the House follows the Senate’s lead and includes a “clinical trials” amendment in its managed care bill. One of the competing House bills (H.R. 2723), sponsored by Reps. John Dingell (D-MI) and Jim Greenwood (R-Pa.), includes coverage of patient care costs in clinical trials for all serious illnesses and for all people covered by a private plan. But the Republican House leadership supports a bill sponsored by Reps. Tom Coburn (R-Okla.) and John Shadegg (R-Ariz.). That bill had no cancer clinical trials amendment in it as it made its way to the House floor. Rep. Matt Salmon (R-AZ) intends to push the Republican leadership to include such an amendment. Deborah Kamin, director of public policy for ASCO, says that the presumed cost of that amendment—health plans say their costs would rise dramatically—has discouraged the Republican leadership from adopting it. But Shadegg calls that argument “a red herring.” He wants to include the Salmon amendment in his Coburn/Shadegg bill.

The Salmon amendment is patterned after the amendment Sen. Connie Mack (R-Fla.) added to the Senate managed care bill. That amendment applied only to about one-third of those covered by private US health plans (the Salmon amendment would apply to all health plans) and ruled out participants in trials run by pharmaceutical companies as part of the FDA approval process. Only trials conducted under the aegis of the National Institutes of Health, Department of Defense, or Department of Veterans Affairs would be eligible. A House vote on managed care will probably come in September. Even if the House does not adopt the Salmon amendment, a clinical trials provision could make it into a final managed care bill because the Mack amendment is in the Senate version. On the other hand, the House and Senate may have a hard time reconciling the many differences in their bills. So no managed care bill may ultimately pass Congress.