Posts Tagged ‘21st Century Cures Initiative’
By: Fatima Chowdhry, MD
In the last 50 years, the U.S. has seen a migration in which individuals diagnosed with a mental illness, defined by the Diagnostic and Statistical Manual of Mental Disorders as “a syndrome characterized by clinically significant disturbance in an individual’s cognition, emotion regulation, or behavior”, are treated not in a mental health institution but rather in prisons, nursing homes, and outpatient facilities. To understand the implications of this trend, it’s important to frame this issue as a cascade of events. For example, we can start with a member of law enforcement, not adequately trained to recognize someone in the throes of a manic phase or a schizophrenic not on their medication, arresting an individual with a mental illness. We then find that this individual, upon release, did not receive treatment and now has trouble reintegrating into their community and is unable to find gainful employment. The combination of a lack of treatment, stable community, and employment leads them to continuous run-ins with the law, restarting a vicious cycle that had led us to a prison population in which the majority has a mental illness.
The move to deinstitutionalize people with mental illness from mental institutions began in the 1960’s and accelerated with the passage of the Community Mental Health Act of 1963. This bill was an important step forward to improve the delivery of mental health care because it provided grants to states to set up community health centers. In 1981, President Ronald Reagan signed the Omnibus Budget Reconciliation Act, which sent block grants to states in order for them to provide mental health services. Aside from these two bills, and the Mental Health Parity Act of 1996, which ensured insurance coverage parity of mental health care with other types of health care, there has been little in the way of significant mental health legislation. Mental health was put on the backburner and the result is a mental health infrastructure in tatters.
During the Great Recession, states cut billions in funding dedicated to mental health. A vivid example of how decreased state funding affects mental health services can be seen in the state of Iowa. The current Governor has been put in the difficult position of balancing fiscal responsibility with maintaining access to mental health care. At one point, there were four state mental health hospitals that provided care to each corner of the state. The Governor closed down two of the facilities to save the state money. While they were old facilities built in the 19th century and cost millions to maintain, many people in Iowa felt that he moved too quickly before alternative services were in place. In addition to closing these mental health facilities, the governor obtained a waiver from the federal government to modernize the state’s Medicaid program and move from fee-for-service to managed care. Under fee-for-service, health care providers are paid for each service provided to a Medicaid enrollee. Under managed care, Medicaid enrollees get their services through a vendor under contract with the state. Since the 1990s, the share of Medicaid enrollees covered by managed care has increased, with about 72% of Medicaid enrollees covered by managed care as of July 1, 2013. The move can be difficult because hospital networks and providers have to contract with a vendor and Medicaid beneficiaries may have to switch providers. Needless to say, it can be an administrative nightmare. The transition in Iowa, to say the least, has been rocky with the vendors threatening to pull out because of tens of millions of dollars in losses. The vendors and the providers might not get paid as much as they want but the people getting the short end of the stick are people on Medicaid, which includes individuals with mental health illnesses.
Given the patchwork of mental health care across the country and the lack of funding, what can be done? According to NAMI, 43.8 million Americans experience a mental illness in a year. Many don’t receive the treatment they need. It’s a multi-faceted problem facing families, employers, health care providers and community leaders. At the federal level, lawmakers have introduced several bills to address mental health. In the United States Senate, a bipartisan group of four Senators introduced S. 2680, the Mental Health Reform Act of 2016. This bill encouraged evidence-based programs for the treatment of mental illness, provided federal dollars to states to deliver mental health services for adults and children, and created programs to develop a mental health workforce.
It was encouraging to see that many components of S.2680 were included in H.R 34, the 21st Century Cures Act, which was signed into law on December 13th, 2016. H.R 34 faces some headwinds because some of the funding portions are subject to Congressional appropriations, and if Congress is feeling austere, they can tighten the purse strings. Moving forward, a major issue of concern for mental health is the future of the Affordable Care Act. Under the Affordable Care Act, states were initially mandated to expand their Medicaid rolls. A Supreme Court decision, however, made the decision to expand optional. So far 32 states, including Washington D.C., have expanded. Some red states, like Iowa, Arkansas and Indiana have utilized the waiver process of the ACA to expand their program. If the ACA is repealed, policymakers will have to contend with the effects on the private insurance market as well as Medicaid.
Right now, the crystal ball is murky. Only time will tell.
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By: Danielle Friend, PhD
One year in the making, with several hearings, roundtable discussions, and white papers released, the 21st Century Cures Initiative is nearing completion. The bill has been spearheaded by the conservative Representative, Fred Upton (R-Mich.) and the more liberal Representative Diana DeGette (D-Colo.), both of whom are members of the Energy and Commerce Committee. While biomedical research has advanced at what seems like lightning speed, unfortunately the translation of research into treatments and cures has been slow and costly. This revolutionary new bill aims to update the regulatory processes and to keep legislation readily informed of new developments in the biomedical sciences so that patients see treatments faster.
During the early phases of the 21st Century Cures initiative, the Health Subcommittee Chairman Joe Pitts (R-P.) organized hearings, roundtable discussions, and white papers to collect feedback on the bill from health care stakeholders, patients, manufacturers, medical associations and research institutions. “While increasing accountability, this legislation would invest in the basic research so critical to equipping our nation’s best and brightest with the tools they need to discover the underpinnings of disease”, he stated. The most updated version of the bill was released on April 28, 2015 and following the release, the Heath Subcommittee held a legislative hearing to receive testimony regarding the new bill. Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the National Institutes of Health (NIH), Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), and Dr. Jeff Shuren, Director of the FDA Center for Devices and Radiological Health all testified in support of the bill. On May 6, 2015 the committee also hosted a meeting of biomedical leaders, including NIH Director Francis Collins, in the first public discussion regarding the state of biomedical innovation in the United States.
What should you know about the bill?
The new draft of the bill comes in at approximately 200 pages (which is, surprisingly, about half the size of the previous draft!). The current draft is divided into three sections: Discovery, Development, and Delivery. Discovery generally focuses on the budget and organization of the NIH. Development focuses on the FDA’s regulation of clinical trials, drug development and precision medicine. Currently, Delivery focuses on changes to the Social Security Act and Medicare, however much of this section is still being drafted. Below are some of the most important highlights and take-home points from the current draft of the bill.
Title 1: Discovery
Title I of the new bill primarily concerns the organization and budget of the NIH. In fact, through the “NIH Innovation Fund”, the new draft increases the NIH budget by $2 billion per year for five years beginning in fiscal year 2016. The current NIH budget is approximately $30 billion a year, and an additional $2 billion each year is a small but significant increase. Although the programs that the “NIH Innovation Fund” will support are not yet defined, they may include precision medicine and programs for young emerging scientists, like those included in the Capstone Award (Section 1061). More details and definitions of the “NIH innovation fund” are surely to come.
The remainder of Title 1 focuses on the organization and administration of the NIH and the ways in which biomedical innovation can be better translated to the clinic. For example:
- Subtitle E, “Promoting Pediatric Research Through the National Institutes of Health” states that the “National Institutes of Health should encourage a global pediatric clinical trial network through the allocation of grants, contracts, or cooperative agreements to supplement the salaries of new and early investigators who participate in the global pediatric clinical trial network,” with the goal of combining resources to combat pediatric diseases and birth defects.
- Subtitle F, “Advancement of National Institutes of Health Research and Data Access” calls for data “generated through NIH-funded research” to be standardized and made available to other researchers.
- Subtitle G, “Facilitating Collaborative Research” calls for the establishment and release of de-identified clinical trial data from “qualified clinical trials,” including trials on drugs and medical devices so that this data can be used for future discovery. Additionally, this section establishes a national neurological diseases surveillance system.
- Subtitle H, “Council for 21st Century Cures” establishes a “nonprofit corporation to be known as Council that consists of a public-private partnership” with “the purpose … to accelerate the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for. ”
Title II: Development
As mentioned above, the overall purpose of the bill is to accelerate the speed with which discovered treatments reach the patient in the clinic. Title II of the new bill focuses on ways in which this may occur through the help of the FDA.
- Subtitle B, “Qualification and Use of Drug Development Tools” aims to establish new biomarkers and other endpoints to accelerate the approval of new treatments. The bill states “The development of biomarkers and other drug development tools can benefit the availability of new medical therapies by helping translate scientific discoveries into clinical applications.” The bill also establishes that the FDA will develop guidelines regarding the use of these biomarkers. The legislation would require FDA and a sponsor to enter into an “accelerated approval development plan” to support the approval of a drug using surrogate endpoints.
- Subtitle C, “Advancement of Precision Medicine” establishes that the FDA will produce guidelines regarding the definition of a “precision drug.” This part of the bill also establishes that the FDA will release guidelines on investigations can be designed to answer specific questions about narrow sub-populations of patients.
- Subtitle D, “Modern Trial Design and Evidence Development” aims to accelerate clinical trials. One way this will occur is through the development of FDA guidelines for clinical data collected outside clinical trials, which may include observational trials, product registries and therapeutic use, according to the bill.
- Section E, “Expediting Patient Access” overhauls “compassionate use”, allowing patients’ easier access to experimental drugs. This policy designates that drug companies company have a point of contact who will process patients’ requests, details of the procedures for making an expanded access request, the criteria for enrolling in a trial and the amount of time the company expects to take to process a request.
- Section G, “Antibiotic Drug Development” creates a “limited population pathway” for antibacterial and antifungal drugs. This will allow sponsors to seek approval for a product intended to treat “a serious or life-threatening disease, condition or indication” that is currently not adequately served by existing therapies. FDA is also required to set up a website to provide recommendations on which bacteria/fungi are susceptible to specific drugs.
- Subtitle K, “Priority Review for Breakthrough Devices”, establishes that medical devices are eligible to receive “breakthrough” designation by FDA and provides priority review for these devices. “Breakthrough devices” are those which represent “breakthrough technologies,” are intended to treat conditions “for which no approved alternative exist,” offer “significant advantages over existing approved or cleared alternative,” and are “otherwise in the best interest of patients.”
- Subtitle L, “Medical Device Regulatory Process Improvements” aims to make the approval process for medical devices faster and easier. For example, in this section, companies would be allowed to make recommendations for the types of expertise FDA should include on an advisory committee panel.
Lastly, much of Title III, Delivery, is currently still being drafted and the Energy and Commerce Committee will be adding sections covering interoperability and telemedicine soon. We’ll look forward to reading the completion of these sections in the near future.
Developing effective treatments and cures for disease is a bipartisan, national priority. However, in order for biomedical discoveries to be translated to the clinic in an efficient and cost effective manner, regulatory processes to facilitate that must keep up to speed. The new 21st Century Cures Initiative aims to do just that. In the developing phases of the bill, Representatives Upton and DeGette explored issues that occur during the discovery of clues to treatments in basic science, during the development of these new treatments, and during the delivery of the identified cures. The current draft of the bill has developed policy to accelerate the regulatory processes involved and to facilitate each of these steps on the road to clinical treatments and cures.