LIGHT AT THE END OF THE TUNNEL?

October 27, 2003

With only three of the 13 appropriations bills signed into law-Defense, Homeland Security and the Legislative branch-it seems highly unlikely that Congress will make its November 7 target adjournment date. Add to the remaining workload the GOP leadership's goal of finishing work on a Medicare prescription drug bill, and Thanksgiving looks like a more realistic date for wrapping up this year's legislative business.

Key appropriations issues remain unresolved

This will be a pivotal week in the appropriations process, with the current continuing resolution due to expire October 31. By that time a second CR, this one extending through November 7, will have passed. In the meantime, House and Senate negotiators will attempt to complete work on as many as three conference reports: Interior, Energy & Water and the $87 billion spending bill for Iraq and Afghanistan. Meanwhile, hope is running out that the Senate will be able to complete work on five spending bills that have yet to be passed in that chamber, including the Commerce-Justice-State appropriations bill. It seems likely that all or most of those bills will be folded into omnibus spending legislation.

The $470 billion Labor-HHS-Education bill, which has been the subject of informal negotiations for the past few weeks, has still not been resolved. Among other things, House negotiators are attempting to soften a Senate-approved provision that blocks the Bush administration from implementing new overtime pay rules. That task was made more difficult when a dozen or so House Republicans joined ranks with Democrats in calling for a delay in implementing the rules.

Also at issue is an unprecedented move by House GOP leaders to withhold any "special projects" funding for Democrats who voted against the bill when it last came before the House. At issue are millions of dollars that would otherwise be allotted to Democrats for earmarked projects in their congressional districts. Rep. David Obey, senior Democrat on the Appropriations committee countered that Democrats voted against the bill because it under-funded critical education programs. He suggested that all lawmakers, Republican and Democrat alike, forgo special projects this year, and instead put the roughly $1 billion set-aside into No Child Left Behind and special education programs.

Medicare drug bill plods on

Although House and Senate negotiators say they hope to reach agreement this week on a new Medicare prescription drug benefit, reports are circulating that some contentious issues still remain to be resolved. These include provisions that require Medicare to compete directly against private health plans-something that Senate Democrats vehemently oppose. Also still on the negotiating table is whether Congress should allow the re-importation of U.S.-made prescription drugs from other countries, where prices usually are lower.

If and when an agreement is reached, the costs must be scored by the Congressional Budget Office and drafted into legislative language, a process that could take nearly two weeks.

Also at issue in this legislation are some provisions aimed at physicians and hospitals, including a temporary fix for the physician payment update, geographic disparities in physician payments and the inpatient hospital payment rate.

Generic drug issue resolved

Conferees apparently have reached agreement on new generic drug provisions, amending the 1984 Hatch-Waxman Act to speed the availability of cheaper generic drugs.

The path to agreement on Hatch-Waxman provisions appeared to be clearing as conferees late last week looked toward amending language contained in the Senate bill regarding "declaratory judgment." The change is intended to allay concerns that the Bush administration has about the constitutionality of the Senate language.

Both the House-and Senate-passed Medicare bills would allow a generic drug maker to request a declaratory judgment regarding the validity of a drug patent if the brand-name company does not file an infringement suit within 45 days of the generic company's filing of a new drug application. But earlier this year, Bush administration officials said the Senate measure goes further than the House bill by providing that that if the brand-name drug maker fails to file a lawsuit within 45 days it "shall establish an actual controversy between the [generic] applicant and the patent owner sufficient to confer subject matter jurisdiction in the courts of the United States" to hear an action brought under the Declaratory Judgment Act. Justice Department officials said that this language raised constitutionality problems.

The compromise that was struck by House-Senate conferees late last week states that the failure of a drug patent owner to bring a lawsuit alleging patent infringement before the expiration of 45 days shall, "to the extent consistent with the Constitution, establish an actual controversy" between the generic applicant and the patent owner sufficient to confer subject matter jurisdiction in federal court in any lawsuit brought by the generic applicant "for a declaratory judgment that any patent that is the subject of the certification is invalid or not infringed."