House of Representatives Approves Health Package
st Century Cures Act (“Cures Act”). Many individuals commented that the House of Representatives exhibited “bipartisan spirit” and passed the Cures Act with an overwhelming 392 to 26 vote. The bill is headed to the Senate early next week. The Cures Act contains many provisions that would affect healthcare providers.
Background
The Cures Act has been in existence for quite some time, making its debut in early 2014. While the House of Representatives approved an earlier version of the Cures Act in July of 2015, the Act was not approved by the Senate. Democrats within the Senate refused to endorse the accelerated approval provisions unless funding for the National Institutes of Health (“NIH”) and the Food and Drug Administration (“FDA”) was included. On the contrary, Republicans would not support mandatory funding without first determining the source of that funding. Accordingly, the Cures Act has undergone several revisions since its inception in an effort to satisfy lawmakers.
The revised Cures Act is a $6.3 billion bill that was created to help support healthcare innovation in the 21st century. It is expected that the Cures Act will significantly change the current process used for FDA approval in the U.S.
Accelerated Drug and Device Innovation and Approval
The Cures Act’s mission statement states that it aims to “help modernize and personalize healthcare, encourage greater innovation, support research and streamline the system”. While lawmakers, lobbyists and various patient advocacy groups are generally thrilled that the Cures Act contains provisions which accelerate the approval of prescription drugs and medical devices, many skeptics believe that this could potentially compromise patient safety.
Proponents of the Cures Act feel that the idea of life-saving medicine reaching patients faster is alluring, but critics believe that these provisions will make it easier for pharmaceutical companies to bring substandard and ineffective medical devices and drugs into the market. Representative Rosa DeLauro (D-Conn) believes that the provisions weaken regulations and allow drugs to be approved with limited evidence as to the drugs’ safety and efficacy.
Researchers are concerned that the Cures Act provides pharmaceutical companies with the ability to use “real world evidence” to support the approval and use of drugs approved through an accelerated regulatory process. Under the Cures Act, companies would be permitted to submit safety monitoring data or observational studies as proof of the drugs’ efficacy. Previously, rigorous and thorough clinical trials were required.
Additionally, the Cures Act would permit companies to submit “summary level reviews” for drug approvals rather than raw data which is currently required by the Food and Drug Administration (“FDA”). The FDA would rely on summaries generated by pharmaceutical companies as opposed to having the opportunity to independently analyze the data. Skeptics agree with Joseph Ross, a Yale researcher who stated that relying on summaries rather than raw data “undermines the integrity of the regulatory review process and it limits transparency.”
Increased Funding for Medical Research, Opioid Prevention & the FDA
One of the most appealing provisions within the Cures Act addresses medical research. The bill would increase funding by providing $4.8 billion to the NIH over 10 years to support three signature Obama administration research programs: Cancer Moonshot, the Brain Research through Advancing Innovative Neurotechnologies (“BRAIN”) Initiative and the Precision Medicine Initiative (“PMI”).
The Cancer Moonshot: The Cancer Moonshot was established to help accelerate cancer research. The initiative, led by Vice President Joe Biden, aims to make more therapies available to more patients, while also improving the ability to prevent cancer and detect it at an early stage.
The BRAIN Initiative: The BRAIN Initiative focuses on revolutionizing the understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a revolutionary, new dynamic picture of the brain that will provide unprecedented opportunities for exploring exactly how the brain enables the human body to record, process, utilize, store and retrieve vast quantities of information.
Precision Medicine Initiative: As part of PMI, the NIH is leading the effort to build a national, large-scale research enterprise to extend precision medicine to all diseases. The Research Program will be a participant-engaged, data-driven operation supporting research at the intersection of lifestyle, environment, and genetics to increase knowledge with the goal of developing more effective ways to prolong health and treat disease.
Additionally, the Cures Act includes $1 billion of funding, over two years, to fight the opioid crisis by providing state governments with opioid painkiller abuse prevention and treatment programs. The Cures Act also provides $500 million dollars of additional funding to the FDA.
Mental Health on Campus Improvement Act
Another popular component of the Cures Act is the Mental Health on Campus Improvement Act. This part of the bill would provide colleges and universities access to grants in order to help fund mental health services on campus. Additionally, it would expand Medicaid to children with severe mental illness.
Conclusion
The latest revision of the Cures Act funds the above programs by selling some of the Strategic Petroleum Reserve, an emergency fuel storage of petroleum maintained by the United States Department of Energy. Additionally, the Cures Act would cut $3.5 billion (about 30%) from the Prevention and Public Health Fund established by the Affordable Care Act. This fund was established to promote prevention of Alzheimer disease, hospital acquired infections, chronic illness and other ailments.
As outlined earlier, the Cures Act also contains many other provisions in which healthcare providers would be interested including, but not limited to, modifying the Hospital Readmissions Reductions Program, reducing the fiscal year 2018 Inpatient Payment Prospective System and relief for long-term care hospitals from the 25% rule which is a payment adjustment made when the number of cases which a long-term care hospital admits from a single hospital exceeds a specified threshold; generally 25%.
The controversy of the Cures Act comes as no surprise. Many members of the House of Representatives and Senate have been quite vocal about their feelings regarding the Cures Act. While some agree with Fred Upton (R-Michigan) who believes that “we are at the cusp of something special,” others subscribe to Senators Bernie Sanders and Elizabeth Warren’s notion about “not giving more handouts and standing up to the world’s biggest pharmaceutical companies”. Ultimately, and in spite of the controversy, both Republican and Democratic party leaders expect the bill to pass the Senate.
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The information contained herein is not necessarily all inclusive, does not constitute legal or any other advice, and should not be relied upon without first consulting with appropriate qualified professionals for your individual facts and circumstances.
