Here's What You Need To Know About the 21st Century Cures Act
Update: On Tuesday, December 13, President Obama signed the 21st Century Cures Act.
On Wednesday, the U.S. Senate passed the 21st Century Cures Act – a landmark piece of legislation designed to speed up drug approvals, fund research and help people living with mental illnesses. The Cures Act breezed through both the House of Representative and Senate, and has been praised by both Republican and Democratic lawmakers. The bill is expected to be signed into law by President Obama before the end of his term in January.
Despite both parties’ eagerness to pass the bill, the 21st Century Cures Act is not without its downsides. Here’s what you need to know.
Several research endeavors are about to get more funding, but how or when they’ll get that money is not guaranteed. The Cures Act sets aside $4.8 billion over the next 10 years to fund the Obama administration’s cancer moonshot, Precision Medicine Initiative and BRAIN initiative. These research programs, set to accelerate cancer research, personalized medicine and take a more detailed look the human brain, have the potential to improve the medical community’s understanding of cancer, rare diseases and neurological conditions like Alzheimer’s disease.
However, these programs are only set to receive about half the amount of funding originally granted by the 2015 version of the Cures Act, spread out over twice the amount of time. And, funding isn’t guaranteed for all 10 years. “Most of the money won’t really be there unless future Congresses pass future bills in future years to spend those dollars,” Sen. Elizabeth Warren (D-MA) said, speaking against the bill on the Senate floor.
The Cures Act will also commit $1 billon to prevent and treat opioid addition, by cutting $3.5 billion from the Prevention and Public Health Fund set up by Obamacare. These funds will be delivered over the course of two years, and must also be approved by a later Congress.
The Cures Act will make it easier, and quicker, for the Food and Drug Administration (FDA) to approve drugs and devices, but it won’t bring down the cost of prescription drugs. The mandates set for the FDA are perhaps the most exciting, and controversial, part of the Cures Act. Under the bill, the FDA will have the power to approve drugs and devices based on new guidelines, allowing the department to consider less rigorous and timely studies. This could mean anything from shorter clinical trials for antibiotics to new FDA approvals of off-label uses for prescription medications. While many patient advocates, especially those in the rare disease community, look forward to faster approvals, others are afraid lowering the requirements will lower the quality of the drugs making it to market.
While the bill addresses how long it takes for prescription drugs to make their way to market, it does nothing to lower the cost of these drugs, which many say helps pharmaceutical companies more than it does patients. “At a time when Americans pay, by far, the highest prices in the world for prescription drugs, this bill provides absolutely no relief for soaring drug prices,” said Sen. Bernie Sanders (D-VT) in a statement. “The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer. Further, this bill cuts Medicare and Medicaid by $1 billion, while not even guaranteeing funding for medical research or substance abuse treatment.”
Another issue is implementation. Many of the new provisions lack a date for when they need to be put in place, meaning it could be years before the FDA changes how it approves drugs and devices.
The bill also includes parts of the Helping Families in Mental Health Crisis Act, making it the first major mental health reform since the Mental Health Parity and Addiction Equity Act in 2008. The Cures Act will strengthen laws enforcing mental health parity, create an assistant secretary of Mental Health and Substance Abuse and provide grants to increase the number of practicing psychologists and psychiatrists.
The bill, which was passed by Congress with help from Rep. Tim Murphy (R-PA), will also prevent federal agencies, like the Substance Abuse and Mental Health Services Administration (SAMHSA), from funding mental health programs that are not evidence-based. “No more of – quite frankly – goofy feel-good programs like how to make a fruit smoothie if you’re stressed… Those aren’t good approaches. It doesn’t deal with the severe mental illness” Murphy, who is also a trained psychologist, told WJLA.
As part of the bill, hospitals will receive more Medicaid funding for psychiatric care. Previously, Medicaid funding was limited to hospitals with less than 16 beds for psychiatric care. The government will also set aside $5 million in grants for assertive community treatment – a 24 hour treatment program designed for people with severe mental illnesses – as well as expand a grant program providing court-ordered mental health care, known as assisted outpatient treatment, for those with serious mental illnesses. States will also be required to use 10 percent of their mental health grants on coordinated specialty care, an early intervention for psychosis which provides psychotherapy, medication and support to people and their families following the first episode of psychosis. Like the grants given to the Obama administration’s research programs, future Congresses will have to approve funding for all Cares Act grants.
The bill will also affect doctor-patient confidentiality. The Health Insurance Portability and Accountability Act, more commonly known as HIPAA, prohibits doctors from sharing a patient’s medical information with their family, making it difficult for families supporting a loved one to coordinate their care, should they be unable to advocate for themselves. Now, the secretary of the Department of Health and Human Services will decide what information doctors can share with caregivers.
Since many of the bills provisions address improving access and care for low-income families, some lawmakers fear the bill will be less effective should Obamacare be repealed. “[L]et’s be clear, the benefits of the mental health bill will be far outweighed by the catastrophic harm caused to individuals with mental illness if the Republicans move forward with their radical plans to repeal the Affordable Care Act, block grant Medicaid and cut benefits for low income individuals,” Rep. Frank Pallone, Jr. (D-NJ) said.
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