House committee members Thursday voted unanimously to move the proposed 21st Century Cures Act toward consideration by the full body.
The bipartisan support reflected in House Energy and Commerce Committee members' 51-0 vote in favor of the bill came after lawmakers hashed out an agreement on ways to offset its estimated $13 billion cost.
“Every single member here on both sides of the aisle has something in this bill,” committee Chair Rep. Fred Upton (R-Mich.) said during the proceedings.
The bill will provide more than $10 billion in funding over five years to the National Institutes of Health, as well as $550 million in added funds for the Food and Drug Administration.
Concerns expressed by some lawmakers over potential cuts to Medicare and Medicaid to offset the cost of the bill were resolved over the past 24 hours, as committee members negotiated agreements (PDF) on a variety of funding sources that left payments to providers and coverage for beneficiaries intact.
Funding would come from the sale of crude oil from the Strategic Petroleum Reserve, as well as limiting the amount of Medicaid reimbursement states receive for the purchase of certain durable medical equipment to the rate paid by Medicare.
Also included is a provision that would limit Medicare reimbursement for film X-rays as a means of promoting greater use of digital imaging. The amendment would alter the timing of reinsurance payments to prescription drug plan sponsors under Medicare Part D to reduce the amount of interest that can accrue the longer it takes for reimbursement to be sent.
America's Health Insurance Plans, the lobbying group for the insurance industry, released a statement opposing the provision, saying it was “using seniors' Medicare benefits to offset increased federal spending.”
“Taking funds from the component of Medicare that is driving innovation for beneficiaries would contradict our shared goal of improving patient care and health outcomes for individuals with serious medical conditions,” outgoing AHIP President Karen Ignagni said in a letter written to the committee (PDF).
A congressional staffer speaking on background said that a detailed estimate as to the amount each of the offsets will generate was expected in a few weeks and that it would fully fund the bill.
The bill is viewed by supporters as a way to expedite the process by which medications and medical devices are approved in order get new treatments to patients faster. Critics of the bill have argued it heightens the risk for harm to patients by loosening standards for approval.
Some of the key provisions include allowing the FDA to grant market approval of a drug based on its early stage testing for safety and effectiveness. Medical-device makers would be able to apply for “breakthrough designation” pathway for products that treat conditions where no alternative exists, or that significantly improve upon already approved therapies.
Some of the more controversial aspects of the bill, such as extending market exclusivity for newly developed medications by several years, were significantly reduced. Also removed was language to impose tighter controls over the 340B Drug Pricing Program, which allows hospitals to purchase discounted drugs from pharmaceutical firms to provide them for low-income outpatients.
But other provisions that many expected to be removed from the bill remain Thursday, such as requiring the FDA to establish a process for the use of surrogate markers in clinical trials, which would cut the amount of time it takes to get results from drug tests but does not reveal the full potential effects that come with its long-term use.
Another provision would exclude drug and devicemakers from having to report payments made to doctors for continuing education activities, such as lectures or journal articles under the federal Physicians Payments Sunshine Act.
