The House on Wednesday is set to vote on the 21st Century Cures Act, legislation that aims to accelerate the development and regulatory approval of medical innovations.
According to Politico's "Pulse," if the House passes the measure, the Senate is then expected to vote on the bill without amendment.
House Energy and Commerce Committee Chair Fred Upton (R-Mich.) and Senate Health, Education, Labor, and Pensions Committee Chair Lamar Alexander (R-Tenn.) on Friday released what they called a "final" version of the 21st Century Cures Act. However, a senior Democratic aide told STAT News that discussions with Senate Democrats are ongoing.
The bill is the culmination of months of negotiations between House and Senate leaders to combine the House-approved 21st Century Cures Act (HR 6) and the Senate HELP committee's 19-bill legislative package.
Overall, the latest version of the Cures Act would authorize $6.3 billion in funding, including $1 billion over two years for opioid misuse prevention efforts.
The legislation's overall funding also includes $4.8 billion for NIH over 10 years to help fund the Obama administration's:
- All of Us Research Program, formerly known as the precision medicine initiative;
- Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative; and
- Cancer "moonshot" initiative.
In addition, the legislation includes $500 million over 10 years for FDA to accelerate its drug and medical device approval processes. For instance, the bill calls for FDA to:
- Accelerate its review processes for breakthrough medical devices;
- Expedite the approval of regenerative advanced therapies, or stem cell therapies;
- Increase patient participation in the drug approval process; and
- Streamline the review process for products that are both a drug and a device.
The bill also includes provisions designed to:
- Bolster information blocking oversight and penalties;
- Facilitate electronic data sharing;
- Improve interoperability among EHRs;
- Increase data sharing among NIH-funded research;
- Protect research participants' privacy; and
- Reduce administrative burden for researchers conducting NIH-funded studies.
Further, the Cures legislation would:
- Establish a HIPAA training program for providers;
- Require the Government Accountability Office to produce a report on patient matching;
- Require HHS to clarify through guidance cases when HIPAA-covered entities can disclose patient information; and
- Require HHS and the Medicare Payment Advisory Commission to report on ways to expand Medicare reimbursement for telemedicine.
Mental health bill to be added to HR 6
Meanwhile, a mental health reform bill (HR 2646) by Rep. Tim Murphy (R-Pa.) is expected to be added to the Cures measure.
Among other provisions, the measure would create a new assistant secretary position at HHS for mental health and substance use disorders. It also would authorize grants for programs intended to make mental health care more effective, as well as suicide prevention programs and initiatives to bolster early intervention for children with mental health conditions.
The bill also includes provisions from a mental health reform measure (S 1945) offered by Sens. Bill Cassidy (R-La.) and Chris Murphy (D-Conn.).
Lawmakers' negotiations had repeatedly stalled over disagreements about how to pay for the Cures Act.
However, according to Politico Pro, Democrats dropped their demand that the legislation's funding be mandatory after President-elect Donald Trump won the election and Republicans maintained control of Congress. Instead, funding for the legislation's programs will be subject to an appropriations process each year.
The bill would use the Affordable Care Act's health care prevention fund, as well as money generated by the Strategic Petroleum Reserves, to offset the funding.
The Cures Act is the second most-lobbied health care bill since 2011, according federal disclosure forms compiled by the Center for Responsive Politics. The forms show more than 1,455 lobbyists representing 400 companies, universities, and other organizations weighed in on the bill this congressional cycle, and media reports show industry reaction to the final bill has been mixed.
The American Association of Medical Colleges praised certain provisions of the legislation, including one that would require CMS to take patient socioeconomic status into account in the Medicare readmissions reduction program and another that would exempt hospital outpatient departments that are under construction from scheduled Medicare reimbursement cuts.
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Jack Mitchell, director of government relations for the National Center for Health Research, said, "While there are positive aspects of this legislation, many provisions would severely weaken the FDA's drug and medical device approval standards and seriously harm rather than help patients." He added, "Congress shouldn't sacrifice the safety and effectiveness of medical products in order to increase research monies." (Zanona/Sullivan, The Hill, 11/25; Muchmore, Modern Healthcare, 11/27; AP/Sacramento Bee, 11/26; Kaplan, STAT News, 11/27; Burton, Wall Street Journal, 11/26; Norman, Politico Pro, 11/25 [subscription required]; Pittman , Politico Pro, 11/25 [subscription required]; Pittman , Politico Pro, 11/25 [subscription required]; Lupkin, "Shots," NPR, 11/25; Diamond, "Pulse," Politico, 11/28)
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