Add-ons ensure Cures Act easy lame-duck passage
It started as a Food and Drug Administration reform bill. But by the time the 21st Century Cures Act cleared the House of Representatives by an overwhelming 392-26 margin last week, the legislation was receiving cheers from virtually every segment of the healthcare industry. The bill appears headed for quick Senate passage and signature into law by President Barack Obama.
The legislation, which initially aimed to expedite federal approval of new drugs and devices, includes a bevy of Easter eggs for nearly all sectors of the healthcare industry, which lobbied heavily for the bill. It will cost $6.3 billion over the next decade.
A centerpiece that helped win broad support was the $4.8 billion increase in funding over 10 years for the National Institutes of Health, whose current budget stands at $33 billion a year. The president’s Precision Medicine Initiative and Vice President Joe Biden’s Cancer Moonshot research project are included in the bill.
But far more significant in the long run may be the provisions drawn from Rep. Tim Murphy’s (R-Pa.) Helping Families in Mental Health Crisis Act (See story, p. 12). They include a revamp of the Substance Abuse and Mental Health Services Administration and funding to fight the opioid epidemic.
The legislation also aims to improve electronic health record interoperability and clarifies that the FDA will not be allowed to regulate a number of consumer-facing applications, including those for “maintaining and encouraging a healthy lifestyle.”
The FDA is slated to receive an additional $500 million a year, subject to congressional authorization, to hire more staff to expedite approval processes for the drug and device industries.
While many disease-focused patient advocacy groups support the Cures Act, safety advocates warn many of the FDA changes in the bill could lead to marketing of drugs and devices that are either dangerous or not effective (See story, p. 11). The issue is likely to come up during the Senate debate.
In a fiery speech last week, Sen. Elizabeth Warren (D-Mass.) said the bill had been hijacked by special interests. “Does the Senate work for big pharma that hires the lobbyists and makes the campaign contributions” she asked, “or does the Senate work for American people who actually sent us here?”
More than 1,400 lobbyists worked on the legislation, according to Senate disclosure records. But they didn’t win on every issue.
One provision included in an earlier version of the bill would have exempted drug and device companies from provisions of the Physician Payment Sunshine Act that require reporting some of the payments they make to physicians who give talks about their products. But when Sen. Chuck Grassley (R-Iowa)— who had worked to include the Sunshine Act in the Affordable Care Act before opposing the latter’s final passage—threatened to oppose the bill, the House architects of the Cures Act stripped that provision.
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.
It also expanded to include sweeteners aimed at winning support from hospitals and other healthcare interests. For instance, it requires the CMS to include a measure of patient socio-economic status when it calculates penalties under the Medicare Hospital Readmissions Reduction Program, and it gives more hospitals inpatient payment rates at their recently built or acquired outpatient facilities.