Patients Win with 21st Century Cures
The 21st Century Cures Act has been three years in the making, and on December 13, 2016, it was finally signed into law. Over the years, Rep. Bilirakis has met with local patients, doctors, and advocates from Florida to discuss how to get new treatments and cures to market faster. Proudly, much of their input is reflected in the final law.
Overall, Cures provides the National Institutes of Health (NIH) with a fully offset $4.8 billion to help advance the Precision Medicine Initiative, bolster the “Cancer Moonshot,” and invest in the BRAIN initiative.
Bilirakis has 11 provisions and initiatives in 21st Century Cures. Please see below for the full list.
- The National Neurological Conditions Surveillance System: Bilirakis was a lead cosponsor on this provision to create a national data collection system for neurological diseases, like Parkinson’s and Alzheimer’s, which would help develop better treatments.
- Helping Families in Mental Health Crisis Act: This provision, also cosponsored by Bilirakis, would reform the nation’s mental health system by improving federal mental health programs and expanding access to treatment.
- Clarifying Food and Drug Administration Emergency Use Authorization: Bilirakis worked closely on this provision granting the FDA emergency use of animal drug products to fight public health emergencies such as Zika or new strains of animal-based pandemic flu.
- Combination Product Innovation: Bilirakis introduced this provision that streamlines FDA regulation of “combination products,” or products that have elements of a medical device and drug such as inhalers or insulin injectors. This will help get these products to market faster for the patients who need them most.
- Medicare Site-of-Service Price Transparency: Bilirakis introduced this provision to provide seniors with transparency in Medicare Parts A and B by helping them better identify the out-of-pocket costs they might face for certain outpatient procedures and find the care that is right for their budget.
- Prevent Interruptions in Physical Therapy Act: This provision, introduced by Bilirakis, allows physical therapists to enter locum tenens arrangements, meaning they can hire a substitute so they can take maternity leave or sick time without having to turn away patients, helping patients receive their treatment without interruption.
- End-Stage Renal Disease Choice Act: Bilirakis was a co-lead sponsor of this provision to allow end-stage renal disease patients to choose a Medicare Advantage plan, ensuring those with ESRD have access to coverage regardless of their pre-existing condition.
- The Advancing Hope Act: This provision, which Bilirakis cosponsored, encourages finding treatments for childhood cancers by authorizing Priority Review Vouchers for companies that develop drugs for rare pediatric diseases.
- Clarifying Medical Software Regulation: Bilirakis cosponsored this initiative that would define medical software and clarify FDA’s regulatory power over software. This ensures that not all software used in medicine, like a hospital computer system, is regulated the same as a medical device.
- The Strengthening Public Health Emergency Response Act: This provision, cosponsored by Bilirakis, boosts the planning and coordination of stockpiling countermeasures in the case of a public health emergency.
- The Medicare Advantage Coverage Transparency Act: This initiative, which Bilirakis cosponsored, requires CMS to report Medicare enrollment data by congressional district, providing more transparent information to the public, to policymakers, and the health care community.