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Nearing Sunsets For SCHIP, PDUFA Raise Chance Of Bypassing Formal House/Senate Conferences

This article was originally published in The Pink Sheet Daily

Executive Summary

Legislators could use more informal routes to fashioning final legislation of SCHIP/Medicare and FDA reform to meet Sept. 30 expiration deadline.

Congressional leaders may look to bypass a formal House/Senate conference committee on the State Children's Health Insurance Program reauthorization in order get the legislation to the While House as soon as possible, House Energy and Commerce/Health Subcommittee Chairman Frank Pallone, D-N.J., said Sept. 12.

"Whether there is actually a conference committee or a formal conference, I do not think that's really significant," Pallone said during a Families USA-hosted teleconference. "I think the issue here is that we come to a consensus on a bill. That can be done with or without an actual formal conference." Nonetheless, Pallone said he would prefer a formal conference committee between House and Senate legislators.

The House version of the bill contains a number of prescription drug reimbursement components, including deeper Medicaid "best price" rebates, a statutory codification of Medicare Part D's requirement that drug plans cover "all or substantially all" products in six key therapeutic categories, permission for Part D enrollees to switch plans in response to formulary changes, and a cut in Part B reimbursement to large dialysis facilities for erythropoiesis-stimulating agents (1 (Also see "Medicaid Best Price Rebates Could Get A Little Worse For Pharma In House-Passed CHAMP Bill" - Pink Sheet, 2 Aug, 2007.)).

The Senate version excludes Medicare. Pallone said it did not make sense to strip the Medicare provisions out of the bill and add months of work on a separate Medicare bill.

Authorization of SCHIP, as well as FDA's Prescription Drug User Fee program, expires Sept. 30 and bypassing a conference committee might enhance the possibility that the measures could be completed before that sunset date. Normally, differences between House and Senate legislation are ironed out by a committee drawn from legislators on the committees that drafted the original bill. Under the bypass scenario, a conference report on a compromise bill would be worked out more informally, by staff under legislators' supervision. In either approach, the final conference report would be ratified by both House and Senate.

Several congressional aides have suggested that FDA reform legislation containing PDUFA reauthorizaition also could take the non-conference route, though the committees' official word is that they aim to convene a group of conferees the week of Sept. 17. FDA Commissioner Andrew von Eschenbach has been urging congressional leaders to wrap up a conference bill by Sept. 21, in part to preserve agency staff stability (2 (Also see "Von Eschenbach Holds FDA RIFs At Bay With Reserve Fund, But Staff Stability Remains A Concern" - Pink Sheet, 2 Aug, 2007.)).

- Gregory Twachtman ([email protected]) & Cathy Dombrowski ([email protected])

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