Insiders say lawmakers are no closer to finding common ground on key funding issues that have postponed discussion on the proposed 21st Century Cures Act 21st Century Cures Act (PDF).
The House Energy and Commerce Committee scheduled a markup of the bill on Wednesday morning, but delayed the session until Thursday.
While the majority of committee members took time during opening statements Tuesday evening to praise the bipartisan work involved in drafting the proposed legislation, a number of legislators voiced concern over how to fund its estimated cost of $13 billion.
Rep. Jan Schakowsky (D-Ill.) made an impassioned plea to her colleagues to not offset the bill's gaps in funding with Medicare and Medicaid cuts, which she said would undermine the essence of both programs.
“We simply cannot pay for this legislation by further reducing benefits for Medicare and Medicaid beneficiaries or asking providers to accept further reductions in payments,” Schakowsky said. “Time and time again, healthcare dollars are used to pay for legislation regardless of whether or not it's even related to healthcare.”
Stakeholders monitoring the ongoing discussions say they don't know what specific funding within either Medicare or Medicaid is on the chopping block.
The 21st Century Cures Act has been touted as a much-needed modernization of the approval process for new prescription drugs and medical devices that would provide patients with faster access to lifesaving medications.
Lawmakers have promoted it as a bipartisan effort, with Republican committee Chair Rep. Fred Upton of Michigan and Rep. Diane DeGette (D-Colo.) leading its support. But many Democrats oppose a number of the bill's provisions, including those that would provide drug and device makers several additional years of market exclusivity.
Critics of the bill argue it has the potential to heighten patients' risk of being exposed to inadequately tested and potentially harmful products approved based on less-stringent standards than now in place.
Revised versions of the bill have received more bipartisan support than the original draft after many of the market-exclusivity provisions were removed and billions of funding were added for research and development at the National Institutes of Health.
But some potential additions have faced less support, such as language (PDF) recently released calling for possible changes to the 340B Drug Pricing Program, which requires drugmakers to provide healthcare organizations with discounted drugs for low-income outpatients. The program has come under fire from pharmaceutical companies that contend current eligibility criteria allow hospitals to participate even though they aren't mostly serving the intended patients.
Hospitals have argued that tightening the rules would limit many patients' access to medications they couldn't otherwise afford.
In light of those concerns, 340B Health, a group representing 500 hospitals held a news conference Wednesday urging Congress not to include changes to the program in 21st Century Cures. The group said lawmakers should first consider guidance that the Health Resources and Services Administration recently submitted to the Office of Management and Budget for review before taking unilateral action.
“While we appreciate the committee's interest in the 340B program, we think Congress should first review and consider what HRSA proposes to do before considering any changes to this vital program,” said Ted Slafsky, CEO of 340B Health.
