The House on Wednesday voted 392-26 to approve the 21st Century Cures Act, legislation that aims to accelerate the development and regulatory approval of medical innovations.
The legislation 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 Health, Education, Labor, and Pensions Committee's 19-bill legislative package.
Senate Democrat and Republican leaders expect the 21st Century Cures Act to pass the chamber early next week, despite objections from Sens. Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.) that the bill could erode patient safety standards.
The White House in a statement of administration policy said the president "strongly supports" the bill. White House spokesperson Josh Earnest acknowledged the bill "is not perfect" but contains "advances in health that far outweigh these concerns."
Provisions specific to hospitals
The measure includes several provisions specific to hospitals. For instance, it would:
- Require CMS to take patient socioeconomic status into account in the Medicare readmissions reduction program;
- Exempt hospital outpatient departments that were under construction before Nov. 5, 2015, from scheduled Medicare reimbursement cuts under CMS' site-neutral payment rule; and
- For long-term acute care hospitals, delay from July 1 to Oct. 1 a rule penalizing hospitals that receive one-fourth or more of their referrals from a single source.
In total, the Cures Act would authorize $6.3 billion in funding over the next decade.
Of those allocations, the bill sets aside $1 billion over two years for opioid misuse prevention efforts. It also allocates $4.8 billion for NIH over the next 10 years to help fund biomedical research, including:
- $1.4 billion for All of Us Research Program, formerly known as the precision medicine initiative;
- $1.6 billion for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative; and
- $1.8 billion for the cancer "moonshot" initiative.
In addition, the legislation includes $500 million over the next 10 years for FDA to accelerate its drug and medical device approval processes. Specifically, 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.
Bill aims to bolster mental health efforts
The bill also includes provisions intended to improve mental health efforts, such as creating new administrative positions at the Substance Abuse and Mental Health Services Administration to help coordinate mental health initiatives.
While the bill would not authorize new funding for mental health efforts, it would provide financial incentives for increasing the number of mental health professionals in the United States and better integrating mental health and primary care services.
Further, the bill would allow Medicare to cover short-term hospitalizations for patients with severe mental illnesses and bolsters oversight of mental health parity rules.
Additional provisions, changes
The legislation also includes several provisions related to Medicare, Medicaid, and health IT. For instance, the bill would:
- Allow documentation by scribes to qualify under electronic health record documentation requirements;
- Crack down on Medicaid fraud by requiring HHS to create and maintain a centralized database of terminated Medicaid providers;
- Create centralized enrollment standards for doctors to participate in Medicaid; and
- Seek to improve interoperability of EHRs.
The Cures Act would use the Affordable Care Act's health care prevention fund, as well as money generated by the Strategic Petroleum Reserves, to offset the allocations. The funding allocated under the bill is not mandatory, despite objections from Democratic lawmakers, and instead will be subject to an appropriations process each year.
Lawmakers and patient advocacy groups who supported the bill celebrated the House's passage.
Rep. Fred Upton (R-Mich.) said, "We are on the cusp of something special—a once-in-a-generation opportunity to transform how we treat disease."
Rep. Joe Courtney (D-Conn.) praised the funding to combat substance misuse. "What this bill demonstrates is that Congress is finally ready to put its money where its mouth is and provide our communities with the support they need to turn the tide on drug addiction," Courtney said.
However, some Democrats and consumer groups criticized provisions to streamline FDA's approval processes to make it easier for drug and medical device manufacturers to gain approval for breakthrough products.
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According to Vox, FDA's approval process is already the fastest in the world.
Rep. Rosa DeLauro (D-Conn.) said the bill would reduce "the already weak regulations on medical devices, allows drugs to be approved with only limited evidence of the drug's safety and efficacy, and rushes the use of new and unproven antibiotics."
Aaron Kesselheim, an associate professor at Harvard University's T.H. Chan School of Public Health said, "There's no evidence the FDA blocks innovation or makes innovation harder or makes it more costly." He added, "The goal in drug development isn't merely innovation—it is innovation that works to help patients" (Steinhauer/Tavernise, New York Times, 11/30; Mukherjee, Fortune, 11/30; Kaplan, STAT News, 11/30; Rondinone, "Capitol Watch," Hartford Courant, 11/30; AP/NBC News, 11/30; Johnson, "Wonkblog," Washington Post, 11/30; Norman/Ehley, Politico Pro, 11/30 [subscription required]; Muchmore, Modern Healthcare, 11/30; Muchmore, Modern Healthcare, 11/30; Dickson, Modern Healthcare, 11/30; Belluzs, Vox, 11/30; Conn, Modern Healthcare, 11/30; Shesgreen, USA Today, 11/30).
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