By a 392 to 26 vote, the U.S. House of Representatives has passed the omnibus healthcare legislation called the 21st Century Cures Act, bringing new funding for top Obama administration health priorities a big step closer to the outgoing president’s signature.
While critics of the bill questioned whether that funding would actually materialize in coming years, the administration signaled its support Tuesday, citing last-minute changes that eased some concerns. The bill now moves to the Senate, where the Republican leadership has promised a swift vote.
After two years and many delays, Congressional committees released the final draft, nearly 1,000 pages, over the Thanksgiving weekend. One major change since then is the removal of a provision to allow more secrecy around the payments that drug and device companies give to doctors under the description of “continuing medical education.” Sen. Charles Grassley (R-IA) had threatened to put a hold on the legislation in the Senate if the provision—“a loophole that would let companies mask their payments to doctors,” Grassley said—was not taken out. He said the Cures Act would “gut the spirit and the letter” of the Physician Payments Sunshine Act, which he cosponsored. It became law as part of the Affordable Care Act in 2010.
There remain other sticking points for critics such as Sen. Elizabeth Warren (D-MA), who vowed Monday night to oppose the bill. But the Obama administration gave its support to the Cures Act Tuesday, praising the more than $6 billion in funding to address the opioid crisis, to back the FDA, and to continue the Precision Medicine Initiative, the so-called “cancer moonshot” program, and neuroscience research—all championed by Obama. The White House also praised the bill’s attention to mental health services and treatment.
The administration’s letter of support cited problems with the legislation but said that some provisions, such as the potential relaxation of rules governing off-label marketing of medical products, have been modified “to address concerns.”
To pay for the dizzying list of projects and changes in the Cures Act, more than $1 billion would come from selling oil from the country’s Strategic Petroleum Reserve. But a much larger chunk—$3.5 billion, according to the Congressional Budget Office—would come from the Affordable Care Act’s prevention and public health fund. It is unclear if that funding would continue if the ACA were repealed, as President-elect Donald Trump and Congressional Republicans have vowed to do as quickly as possible.
The ACA prevention fund was established to bolster immunizations, anti-tobacco education, and other public health programs. It handed out more than $900 million in grants in 2016.
One of the few dissenters in the House, Rep. Jim McDermott (D-WA), worried that the money promised will never materialize in a Republican-controlled Congress. “The money is subject to appropriations,” McDermott said on the House floor before the vote. “Everybody says, ‘Oh, well there’s commitments made.’ Anybody who believes in the tooth fairy will believe that money is going to go to the NIH.”
In the Senate, critics like Bernie Sanders (I-VT) and Warren have vowed to fight what they see as the bill’s unacceptable loosening of FDA standards, or promises of faster reviews, to benefit drug and device makers.
The bill promises to give patients more voice in the regulatory process and directs the FDA to include real-world data—from daily medical practice, not just from clinical trials—as part of its evaluation of products. The FDA has spoken cautiously about making those changes in the past. At a meeting in June, Commissioner Rob Califf told the audience that higher quality real-world data could one day be used to bolster clinical evidence. Drug approvals will always be driven by the quality of the science behind the R&D, he said, but “as the data environment changes, the regulatory environment will change.”
The Cures Act attracted the official attention of 1,455 lobbyists on all sides, making it one of the most lobbied bills of the 114th Congress, according to analysis of disclosure records by Kaiser Health News.
Photo of the U.S. Capitol courtesy of Kevin Dooley via Creative Commons.