Understanding Your Right to Try 2.0: A Patient's Guide
If you're facing a serious illness and exploring all your options, here's a breakdown of how the Right to Try 2.0 law might help you access personalized treatments:
Getting a Clear Diagnosis:
- First, you must be formally diagnosed with a life-threatening or severely debilitating illness by your doctor.
Explore Standard Treatment Options:
- You and your doctor must consider all the treatments already approved by the FDA.
- It's important to document that you and your doctor have investigated and considered these standard options.
Getting Your Doctor's Recommendation:
- If your doctor thinks it's right for you, they can recommend an investigative individualized treatment based on your unique genetic makeup (genomic sequence, DNA, RNA, genes, etc.)
Giving Your Informed Consent:
- You'll need to sign a written, informed consent document from your physician. This document must include:
- An explanation of currently approved treatments.
- An attestation that approved treatments are unlikely to prolong your life.
- An identification of the specific individualized treatment.
- A description of potential best, worst, and likely outcomes utilizing the individualized treatment.
- A statement that your health plan is not obligated to pay.
- A statement that your ability for hospice care may be with drawn while undergoing the individualized treatment.
- A statement that you understand that you are liable for all expenses related to the use of the individualized investigational treatment.
Finding a Place for Treatment:
- You'll need to find an eligible facility or a manufacturer operating within an eligible facility that's officially allowed to provide these treatments under a Federalwide Assurance (FWA) for the Protection of Human Subjects as determined by the Department of Health & Human Services.
- Keep in mind, they don't have to provide the treatment just because you ask.
Asking for the Treatment:
- You'll need to formally request the personalized treatment manufacturer.
- Be prepared to potentially pay the costs of manufacturing the treatment.
Paying for Treatment:
- Your insurance company is not obligated to cover the costs of the treatment.
- You'll be responsible for the direct cost of the treatment, unless you have a special agreement with the manufacturer.
Healthcare Provider Protection:
- Your physician's license and Medicare certification are protected when recommending or providing individualized treatments under this law.
Legal Understanding:
- You can't sue the manufacturer or your doctor for harm from the treatment, as long as they acted in good faith and with reasonable care.
- This law doesn't change any existing insurance coverage for standard clinical trials.
Here’s a letter to get your doctor started on a request.
If you or your doctor have questions about the process and steps required, please contact us here.
Due to the large number of inquiries submitted, we are not always able to respond to each one. If your question pertains to receiving treatment under Right to Try, please understand that we cannot provide specific advice to patients.
Join The Fight For The Right To Try
As science rapidly advances, medical treatments are outpacing regulations. That’s why we need the Right to Try for Individualized Treatments. Sign up to stay informed and to help us make this the law of the land.
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