Following the success of last year’s event, the Foundation partnered with the Medical Imaging & Technology Alliance (MITA) to host a second “fly-in” event on Capitol Hill in Washington, DC. On March 10, a passionate group of focused ultrasound patients and physicians joined representatives from the Foundation, MITA, and industry to educate policymakers on the innovative technology.
The group of patients represented two of the conditions for which focused ultrasound is approved by the US Food and Drug Administration (FDA) – essential tremor and prostate cancer.* Their goal was twofold: (1) to clearly define a problem plaguing newly approved medical devices – that is, the lack of a clear and efficient path from FDA approval to reimbursement by the Centers for Medicare and Medicaid Services (CMS) for these treatments – and (2) to introduce a plan forward.
The fly-in participants advocated for four steps that would modify and modernize coverage pathways:
Expand the Parallel Review Program
Allow device manufacturers to concurrently obtain FDA clearance or approval and either national or local coverage determinations (LCDs) for CMS reimbursement. Currently, parallel review only allows national decisions, which is a much greater risk to innovative device manufacturers than LCD.
Amend the Breakthrough Device Program
As part of breakthrough designation, include fast tracking of these devices through both the FDA and CMS processes. If a device warrants priority review at FDA, the same should follow at CMS so innovative technologies are accessible to patients faster.
Improve Application Data Transparency
Device manufacturers need a more user-friendly and transparent platform to view CMS application processing times. This would enable producers to make more informed decisions regarding their path to reimbursement.
Pass the NOVEL Act of 2019
The Newer Opportunities for Value that Extend Lives (NOVEL) Act of 2019 (S.2326) would provide expedited coding and establish provisional coverage for novel medical products after FDA approval. This legislation would ensure Medicare patients have access to breakthrough technologies and for innovative manufacturers to garner data to achieve appropriate payment.
“We had a great day,” said the Foundation’s Chief Scientific Officer, Jessica Foley, PhD. “I think the patients’ powerful stories went a long way toward demonstrating the need for policy changes that will provide more widespread access to life-saving and life-changing technologies like focused ultrasound.”
In April 2018, the Foundation and MITA formed a working group with the goal of raising awareness of focused ultrasound technology among policymakers, payors, and medical specialty societies. They hosted the first fly-in event in February 2019.
Patient and physician advocates join MITA in urging lawmakers to support the NOVEL Act | DOTmed HealthCareBusinessNews
Photos (Left to Right):
- U.S. Senator Martha McSally of Arizona with prostate cancer patients, Reggie and Victor, as well as Hugo Embert of EDAP TMS and Victor’s daughter.
- From left: SonaCare Medical’s CEO Mark Carol, MD; prostate cancer patient Thomas; Karen Cornett from SonaCare; Alex Davidson (a staffer from the office of Senator Elizabeth Warren of Massachusetts); and Karun Sharma, MD, of Children’s National Medical Center.
- Essential tremor patient Beverly with Congressman Greg Gianforte of Montana.
- Essential tremor patients Bob and Beverly pictured with Dee Kolanek of Insightec (center).
*Focused ultrasound is approved for the ablation of prostate tissue, which could be used to treat conditions like prostate cancer and benign prostatic hyperplasia (BPH).