For a Congress best known for years of rancor, the extent of cooperation surrounding the he 21st Century Cures Act — coming on the heels of the bipartisan “doc fix” — suggests that Capitol Hill may really be focusing on legislating. Last Thursday’s 51-0 vote to advance the Cures Act to the full U.S. House of Representatives was an important milestone for a fast-evolving bill.
“This really kind of blows your mind considering all the angst and animosity and other kinds of … engagements that we have,” said Rep. Bobby Rush, D-Ill., who labeled Thursday’s hearing a “lovefest.” (Creddit AP).
Moreover, a 49-page amendment approved as part of Thursday’s vote at the Energy & Commerce Committee addressed a key concern by earmarking $550 million over five years to help the U.S. Food and Drug Administration fulfill new duties created by the bill. Those include development of new “biomarkers” to gauge drug effectiveness, enhanced incorporation of patient perspective into approval decisions, and grants to study so-called continuous drug manufacturing that could reduce production costs.
In addition, the amendment would exempt from budget sequestration the user fees paid by drug and device makers to support FDA reviews and inspections. Sequestration only kicks in if spending caps are exceeded, but the Cures bill now provides peace of mind for companies that complained about private money being locked away in 2013 because of political spending fights.
“FDA user fees were never intended, I think, to be part of the sequester,” Rep. Fred Upton, R-Mich., said on Thursday. (Credit AP).
Other substantive provisions were notable for their omission, including possible changes to dial back use of the 340B drug discount program by hospitals and clinics. Any such change could have alienated Democrats and jeopardized bipartisan support, and the provision’s absence won praise.
One provision would delay so-called reinsurance subsidies that go to health insurance plans in Medicare Part D in order to partly offset the costs of unusually expensive policyholders. The proposal stems from a 2013 inspector general’s report that found delays of certain advance payments would allow Medicare to generate more interest income — roughly $110 million in 2009 alone.
The current financial impact of that step is not yet public, but trade group America’s Health Insurance Plans reacted angrily on Thursday, saying that it “strongly opposes” the idea. Elsewhere, a new section starting in 2020 would cap Medicaid reimbursement for durable medical equipment at the amount paid under Medicare’s new competitive bidding program. The section is based on a provision in next year’s budget blueprint for the U.S. Department of Health and Human Services, which predicted $4.3 billion in savings over 10 years.
Nevertheless, Rep. Joe Barton, R-Texas, suggested that the vote was historic against any backdrop, and perhaps unprecedented in his nearly three decades on the Energy & Commerce Committee.
“I don’t think we’ve ever had a major bill — major bill — that didn’t have somebody … that voted no,” Barton said. “This is a real achievement.” (Credit AP).