Public Comment Period Now Open for Medicare Coverage of Optune
Ends June 24th, 2019
We need your help in ensuring GBM patients have access to Optune under Medicare.
Medicare is considering coverage for Optune in glioblastoma. Currently they don't cover it. We need your help!
Medicare has issued a proposed rule for the coverage of Optune which now allows payment for Optune, but added a bunch of restrictions that we want to try to get removed. There is an open comment period now which ends June 24th as well as a public meeting on June 20th in Baltimore, where we can voice our opinions.
Here's how you can help:
- We need people to send an email to Medicare, and their Senators and Representatives, to provide comments on this policy
- We need people to show up at the meeting in person (or by webinar) on June 20th from 9 to 12 at the BWI Westin in Baltimore. We may be able to help a limited number of people with travel costs if you would like to attend but can't afford it. (Ask me at firstname.lastname@example.org)
Here is what we need you to do:
- Write an email. In your own words ask Medicare to cover Optune for GBM and to remove all restrictions and explain why it is important to you.
- Send that email to 5 places: (Use subject: "Comment on Proposed LCD ID DL34823: Tumor Treating Field Therapy.")
- Medicare: TTFTLCDComments@cgsadmin.com
- Your (2) Senators: find them at Senate.gov
- Your (1) Representative: find at House.gov
- Me (Al Musella): email@example.com
- Register for the meeting. Click HERE for details about the Public Meeting
And Click HERE to register if you would like to go to the meeting or participate via web
- Post your email on your social media accounts and ask your friends to send emails!
Tips: We want to fight all of the restrictions but we do not want all of the emails to be the same so we are not providing a cut and paste version. Write from the heart but be polite. No threats. Explain how important it is to you that Medicare covers this treatment without the proposed restrictions. Pick 1 or 2 of the restrictions from my letter below and write about that. Yours does not have to be this long or detailed.
Sample: Here is the letter that I sent. Do not copy it word for word. Change it to suit your situation as patient, caregiver, friend, doctor, nurse, or whatever.
Subject: I would like to comment on Proposed LCD ID DL34823: Tumor Treating Field Therapy.
I am writing as the president and founder of the Musella Foundation For Brain Tumor Research and Information, Inc, a 501(c)(3) nonprofit public charity dedicated to helping brain tumor patients through emotional and financial support, education, advocacy and raising money for brain tumor research. I have interacted with tens of thousands of brain tumor patients over the last 21 years and went through this battle with 2 relatives who died of Glioblastoma.
I applaud your decision to cover Optune for newly diagnosed Glioblastoma patients. However, I would question the decision to limit coverage with such severe restrictions. Glioblastoma is a horrendous diagnosis and these patients need fast, easy access to the best approved treatments. Optune is FDA approved and has a level 1 recommendation from the NCCN guidelines as one of the standards of care. The decision on using it should be up to the treating team of physicians and the patient. Optune is an important tool in their toolbox and should not be withheld from patients based on insurance guidelines.
I object to all of the restrictions:
- "Must receive care at a NCI designated cancer facility. " My organization encourages all brain tumor patients to be treated at major brain tumors centers (not all of which are designated as such by the NCI). However, it is not always practical. There are issues of travel and expenses. Some of the patients have neurological problems and a propensity for blood clots that interfere with easy travel — some cannot fly, or sit in a car for long periods of time. Most of these patients will never work again so finances become an issue and this restriction will force these patients to pay for frequent travel to faraway places. Adding this large expense to the other expenses these patients have is not fair. If the restriction must stay in place, I would request that Medicare allow payments for travel and hotels to allow these patients to get to these centers.
There are a few states that do not even have a NCI designated cancer center. What are these patients expected to do?
This is a treatment that is done at home by patients and their families. There is no need for these patients to go to the major centers. This restriction makes no sense at all. The majority of patients are not treated at major centers and these centers do not have the capacity to treat all glioblastoma patients.
The majority of neuro-oncologists do not practice at the NCI designated cancer centers. This restriction would prevent all of these doctors from being able to prescribe what is currently the best treatment for Glioblastoma. These doctors would have to refer the patients to major centers, and that may put many of these doctors and many of the smaller centers out of business.
Please remove this restriction.
- "Patients may not have progression as defined by the RANO criteria." The problem with this is twofold:
First: about 50% of patients will show progression based on RANO within 1 month of completion of radiation (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5398984/). About half of these patients will have pseudo progression, which means that they really do not have progression — they only have the appearance of progression on MRI due to treatment effects. So, 25% of patient will be denied treatment under this restriction without really having progression. There is currently no sure way to differentiate true progression from pseudo progression.
Second: even if they have progression at this point (within 7 weeks of the end of radiation), Optune is still the best choice of treatment for most. It has less chance of working, but there is nothing better available now. Please remove this restriction.
- "Must have had maximal debulking surgery, followed by radiation with concomitant Temodar": A recent study https://academic.oup.com/nop/article-abstract/6/1/37/5001149 reports on over 100,000 glioblastoma patients and found that only 50% of Glioblastoma patients received any form of chemotherapy, only 69% received any form of radiation and 73% received any type of surgery. There are situations where patients will not get the "maximal debulking surgery, followed by radiation with concomitant Temodar". A few reasons may be that more than half of Glioblastomas have unmethylated MGMT which makes it less likely to work, elderly patients may not be able to withstand these harsh treatment, and high costs — especially for those who have Medicare without a supplemental policy. Optune is the ideal treatment in this situation — for the elderly, it is much easier to go through than radiation or chemotherapy. No nausea, no problems with blood counts, no interactions with their many other medications. And Optune is not tied to MGMT status. This restriction will cut off half of the eligible population — the half that would benefit the most by using Optune. Please remove this restriction.
- "Must have a Karnofsky score of 70 or above". There is very little physical difference between a 60 and a 70. Once a patient gets to 40 (disabled), it may be difficult for them to use the device, which would be reflected in the compliance rate anyway. So this restriction could be dropped and the intention behind it would be taken up by the compliance restriction.
- "Must use the device 18 hours a day". It is reasonable to discontinue the treatment if the patient is not using the device correctly. However, according to the most recent research, https://link.springer.com/article/10.1007%2Fs11060-018-03057-z, there is benefit when the patients use Optune for at least 12 hours a day. So I would request the restriction be changed to "Must use the device for at least 12 hours a day", and allow exceptions for when there has to be a break in the treatment plan such as to allow a skin irritation to heal. Better yet, remove the restriction and leave the medical decision of when to stop up to the patient and the doctors.
- "Must start within 7 weeks of end of chemo-radiation". As mentioned above, not everyone has chemo-radiation. And for those that do have it, some patients develop complications such as burns on the skin of the head or non-healing head wounds which need to heal before Optune can be used. Some patients might not learn about Optune in time. It is a very chaotic time in these patient's lives and putting an artificial time limit on making such a life changing decision adds stress to what is already the most stressful time in the families' lives. Please eliminate this restriction.
- And finally, the requirement for "benefitting from use between days 60-90" may be early to see the benefits. It has been shown that Optune is slow and steady and that most of the long term responders had an apparent recurrence (Pseudo progression) early on but continued therapy and the tumors shrank. In the EF-14 trial, Optune was used through the first recurrence and stopped at the second recurrence. Since the LCD is pretty much based on this trial, you should follow the trials' guidelines in this respect. Please change the requirement to "benefitting from use by 3-6 months of use", or drop this restriction and allow the patient and doctors to make the decision on when to stop.
Thank you for considering my opinions.
Al Musella, DPM
Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
[ To see a video of me presenting the above statmeent, click HERE! ]