Healthcare industry leaders are celebrating the passage Tuesday of a sweeping package of biomedical innovation and mental health reform bills in the first step of a major legislative accomplishment in the lame duck session.
The House passed the 21st Century Cures Act 392-26 after months of negotiations and nearly three years after it was first introduced. The legislation aims to expedite federal approval of new drugs but included a bevy of Easter eggs for nearly all sectors of the healthcare industry, which lobbied heavily for the bill.
Senate leaders have said they will vote on the Cures Act early next week and the White House has said President Barack Obama would sign the long-delayed act into law. The bill would be one of the few episodes of cooperation between the GOP-run 114th Congress.
All but six House Democrats voted for the 996-page bill despite some reservations. Twenty House Republicans voted against the bill, which envisions spending $6.3 billion over the next decade.
The $4.8 billion of funding for the National Institutes of Health included in the act is not mandatory and must still be appropriated every year. Republicans pledged to do so in discussion of the bill Monday night. The NIH spends about $32 billion every year.
The funding would go toward Democratic priorities such as Obama's precision medicine initiative and Vice President Joe Biden's cancer “moonshot” research project. In a tweet Tuesday evening, Biden urged the Senate to pass the bill so it could reach the President's desk.
The final Cures Act included several provisions from Sen. Chris Murphy's (D-Conn.) Mental Health Reform Act, including new administrative positions at the Substance Abuse and Mental Health Services Administration and state funding to fight the opioid epidemic.
It also contains efforts to improve electronic health record interoperability, and changes affecting Medicaid and Medicare.
Patient advocacy groups generally support the Cures Act, although some have said the changes to allow easier federal approval of certain drugs and devices are dangerous.
The Food and Drug Administration would get $500 million to hire more staff to expedite approval processes.
Rep. Frank Pallone (D-NJ) said during floor debate he had some concerns with the bill but was still supporting it because the benefits outweigh those concerns.
“I'm disappointed that this final bill does not contain guaranteed funding,” he said. “Instead, we must ensure each year that the Appropriations Committee, and the Republican Majority, lives up to the promises being made today. We will hold them to these promises.”
Although the Act is expected to pass the Senate, a few senators have vowed to oppose it. Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) have said the Act includes too many concessions to the pharmaceutical industry.
In a fiery speech Monday condemning the bill, Warren said said the bill had been hijacked by special interest.
"It is time for Democrats - Democrats and Republicans who should be ashamed by this kind of corruption -to make it clear who exactly they work for," she said. "Does the Senate work for big pharma that hires the lobbyists and makes the campaign contributions or does the Senate work for American people who actually sent us here?"
The bill was amended this week to remove some exemptions to the Sunshine Act that requires the disclosure of drug and device company payments to doctors.
The Cures Act first passed the House in July 2015 but it was stalled in the Senate over funding disagreements. It was divided into multiple bills that all passed committee but never got a full vote. As the lame duck session began, leaders of both parties worked together to come to an agreement. The act ballooned to include other bipartisan provisions, such as the mental health legislation.
Hospital leaders said they were pleased the act also included a change to take into account patient socioeconomic status in the Medicare Hospital Readmissions Reduction Program.
