Blue Cross Blue Shield of MA: Authorize two-level artificial disc replacement surgery - What will they deny when you need help?

The Issue

My name is Cheryl Marfleet and I am seeking your support in response to an authorization denial for a neck surgery I am in great need of.  Currently suffering from two herniated discs that are putting pressure on my nerves, excruciating pain envelops my left side entirely from shoulder to hand.  The only way I can get through the day is to take strong narcotics.  I am generally opposed to relying so heavily on drugs in order to deal with the pain, and there are many side effects, including dizziness and drowsiness.  My physical condition makes it impossible to work. I have been on medical leave from my teaching job since January 6, 2015.  There are only 49.5 days in my sick bank and I fear running out and not getting paid.  I also fear losing my job if I am unable to return soon.  The denial is detrimental to my health and casts a shadow on my future as a teacher. The longer the surgery is put off, the higher my chances are of having permanent damage to the nerves in my arm.  I expected to have had my surgery by now and be on the road to recovery.  Instead, I have been denied coverage for my surgery because the technology my doctor wants to use is considered “investigational.” 

In September of 2013, I was having excruciating pain in my left shoulder, arm and my neck.  I had several medical consultations and no one was able to assist me.  I saw a Spine Specialist named Dr. Richard Ozuna at Sports Medicine North in Peabody, MA. I had an MRI and it showed I had two herniated discs in my neck, C5-6 and C6-7.  We discussed my options and decided to take the conservative route.  He directed me to a Pain Management Specialist who gave me a total of two cortisone shots to relieve my symptoms; however, I experienced horrible side effects after the second shot.  I was afraid to use my left arm for anything and went to physical therapy to gain back some of the strength I had lost. By September of 2014 I felt a lot better.

Things changed this past December two days after a light workout.  I woke up in excruciating pain and eventually found myself in the emergency room. I saw Dr. Ozuna shortly thereafter and he said it was time for surgery because my MRI showed the pressure of the herniated discs had increased.  He recommended using an implant called a Mobi-C Cervical Disc.  We discussed how I am a perfect candidate for this procedure and how it is far better than having a fusion because it provides more mobility and long-term stability. A surgery date could not be set until my insurance passed authorization.  It took Blue Cross Blue Shield almost five weeks to inform me they would be denying authorization. On February 10, 2015, my doctor had a peer-to-peer conference with one of their employees, who was not a spine specialist, to try to convince them as to why they should allow me to have this surgery.  On February 11, 2015, I found out the authorization was denied, and they would only cover me for one implant. I need two implants because I have two herniated discs. Why, according to BCBS Massachusetts, can one implant be approved while two implants are considered “investigational”? Having a two-level implant has been approved by the FDA and has been happening for years in Europe, India, California and Texas. If I am not willing to have one implant only, BCBS recommends having a fusion.  I did my research on both procedures and decided I did not want to risk my neck’s mobility by having a fusion. 

Fusion, Anterior Cervical Discectomy and Fusion (ACDF), has been around since the 1950s.  Doctors basically remove the herniated disc, replace it with a bone graft that should fuse with the bones above and below the disc space and then close it up with a metal plate and screws.  It could take several months or years to fuse properly, and there is a risk of getting bone spurs. Recovery time is much longer for a fusion. Once you have a fusion, you cannot go back and have the disc replaced with an implant. The percentage of patients that need to go back and have a second fusion is far too high. A fusion can also cause damage to the vertebrae above and below it because they are taking on a bigger load. I am only 44 and do not want to worry about the other discs in my neck being worn out over time because of the fusion.

A Mobi-C Cervical Disc is an artificial load-bearing disc composed of plastic and metal. It takes the place of two damaged cervical discs next to each other and helps keep motion at the disc space, which leaves a person with a better range of motion. It does not require screws or plates to hold it in place.  It also does not have the potential complications associated with a fusion.   Recovery time is quick. There is no need for a bone graft, and it does not have any impact on the adjacent discs, which can cause disc degeneration, resulting in the need for further surgery. Using Mobi-C reduces the overall risk of needing a second surgery as compared to a fusion. (Please see attached table.) Both one-level and two-level Mobi-C Cervical Discs are FDA approved.

“Two years after surgery, 154 out of 221 Mobi-C patients (69.7%) achieved overall study success, compared to 37 out of 99 ACDF patients (37.4%). This shows that Mobi-C achieved superior outcomes to ACDF.” (Mobi-C Cervical Disc Two Contiguous Levels Patient Education Manual)

On February 12, 2015, I filed an appeal with BCBS to cover the second implant. In the meantime, I have had contact with a doctor in California who says he will help me, but I would have to pay for the second implant on my own because of my insurance. Why should I have to pay approximately $15,000 for a second implant I desperately need just because BCBS policies are not in keeping with current technology? Also, the appeal process could take 15-30 days, still with the risk of a second denial. As far as a cost difference between the two procedures, I discovered there really isn't a difference and in some cases artificial disc replacement is less expensive than a fusion.

As I stated before, I cannot work while in this much pain and on such strong narcotics.  I can’t take care of myself without help. I cannot drive.  My mother has been doing everything for me, from running from Wilmington to Peabody and back to pick up prescriptions, to getting groceries and making sure bills are being paid for my Gloucester condo.  For the past few years my mother has been having difficulties with her heart, experiencing episodes of Atrial fibrillation.  She was scheduled for an ablation on February 13, 2015, but because of my situation she had to postpone her procedure.  I have been almost completely bedridden.  I cannot sit up at the kitchen table to visit with family and friends for more than 10 minutes.  The only time I am comfortable is when I am flat on my back in bed and heavily medicated. My quality of life has greatly declined and I cannot continue to live like this.  I need help and support to be able to have surgery right away so that I can return to work and begin to invite normalcy back into my day-to-day routine. I do not want to be forced to continue to take narcotics just to function.  I do not understand why BCBS is lagging behind when more effective treatments have been available for some time.  Herniated discs are pretty common. Shouldn't we all have access to the best technology available when faced with this problem?

Please help support me by signing my petition. 

Sincerely,

 

Cheryl Marfleet

 

28 Boutwell Street, Wilmington MA. 01887

10 Dalton Avenue #6, Gloucester MA 01930

Chermagnolia2013@gmail.com

 

Please reference the following links for more information:

http://www.cervicaldisc.com/

http://thejns.org/doi/pdf/10.3171/2014.7.SPINE13953

http://www.medicaldesignbriefs.com/component/content/article/1105-mdb/features/18810

http://www.spine-health.com/treatment/artificial-disc-replacement/artificial-disc-cervical-disc-replacement ​;

http://www.mayfieldclinic.com/PE-ACDF.htm#.VFm2Yyj89XV

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm367809.htm

http://www.spine-health.com/treatment/spinal-fusion/potential-risks-and-complications-acdf-surgery

http://us.ldr.com/Portals/1/IDEOVERVIEW2L.pdf

https://www.change.org/p/blue-cross-blue-shield-of-massachusetts-save-alan-s-back-by-approving-a-critical-emergency-surgery-what-will-they-deny-when-you-need-help

This petition had 394 supporters

The Issue

My name is Cheryl Marfleet and I am seeking your support in response to an authorization denial for a neck surgery I am in great need of.  Currently suffering from two herniated discs that are putting pressure on my nerves, excruciating pain envelops my left side entirely from shoulder to hand.  The only way I can get through the day is to take strong narcotics.  I am generally opposed to relying so heavily on drugs in order to deal with the pain, and there are many side effects, including dizziness and drowsiness.  My physical condition makes it impossible to work. I have been on medical leave from my teaching job since January 6, 2015.  There are only 49.5 days in my sick bank and I fear running out and not getting paid.  I also fear losing my job if I am unable to return soon.  The denial is detrimental to my health and casts a shadow on my future as a teacher. The longer the surgery is put off, the higher my chances are of having permanent damage to the nerves in my arm.  I expected to have had my surgery by now and be on the road to recovery.  Instead, I have been denied coverage for my surgery because the technology my doctor wants to use is considered “investigational.” 

In September of 2013, I was having excruciating pain in my left shoulder, arm and my neck.  I had several medical consultations and no one was able to assist me.  I saw a Spine Specialist named Dr. Richard Ozuna at Sports Medicine North in Peabody, MA. I had an MRI and it showed I had two herniated discs in my neck, C5-6 and C6-7.  We discussed my options and decided to take the conservative route.  He directed me to a Pain Management Specialist who gave me a total of two cortisone shots to relieve my symptoms; however, I experienced horrible side effects after the second shot.  I was afraid to use my left arm for anything and went to physical therapy to gain back some of the strength I had lost. By September of 2014 I felt a lot better.

Things changed this past December two days after a light workout.  I woke up in excruciating pain and eventually found myself in the emergency room. I saw Dr. Ozuna shortly thereafter and he said it was time for surgery because my MRI showed the pressure of the herniated discs had increased.  He recommended using an implant called a Mobi-C Cervical Disc.  We discussed how I am a perfect candidate for this procedure and how it is far better than having a fusion because it provides more mobility and long-term stability. A surgery date could not be set until my insurance passed authorization.  It took Blue Cross Blue Shield almost five weeks to inform me they would be denying authorization. On February 10, 2015, my doctor had a peer-to-peer conference with one of their employees, who was not a spine specialist, to try to convince them as to why they should allow me to have this surgery.  On February 11, 2015, I found out the authorization was denied, and they would only cover me for one implant. I need two implants because I have two herniated discs. Why, according to BCBS Massachusetts, can one implant be approved while two implants are considered “investigational”? Having a two-level implant has been approved by the FDA and has been happening for years in Europe, India, California and Texas. If I am not willing to have one implant only, BCBS recommends having a fusion.  I did my research on both procedures and decided I did not want to risk my neck’s mobility by having a fusion. 

Fusion, Anterior Cervical Discectomy and Fusion (ACDF), has been around since the 1950s.  Doctors basically remove the herniated disc, replace it with a bone graft that should fuse with the bones above and below the disc space and then close it up with a metal plate and screws.  It could take several months or years to fuse properly, and there is a risk of getting bone spurs. Recovery time is much longer for a fusion. Once you have a fusion, you cannot go back and have the disc replaced with an implant. The percentage of patients that need to go back and have a second fusion is far too high. A fusion can also cause damage to the vertebrae above and below it because they are taking on a bigger load. I am only 44 and do not want to worry about the other discs in my neck being worn out over time because of the fusion.

A Mobi-C Cervical Disc is an artificial load-bearing disc composed of plastic and metal. It takes the place of two damaged cervical discs next to each other and helps keep motion at the disc space, which leaves a person with a better range of motion. It does not require screws or plates to hold it in place.  It also does not have the potential complications associated with a fusion.   Recovery time is quick. There is no need for a bone graft, and it does not have any impact on the adjacent discs, which can cause disc degeneration, resulting in the need for further surgery. Using Mobi-C reduces the overall risk of needing a second surgery as compared to a fusion. (Please see attached table.) Both one-level and two-level Mobi-C Cervical Discs are FDA approved.

“Two years after surgery, 154 out of 221 Mobi-C patients (69.7%) achieved overall study success, compared to 37 out of 99 ACDF patients (37.4%). This shows that Mobi-C achieved superior outcomes to ACDF.” (Mobi-C Cervical Disc Two Contiguous Levels Patient Education Manual)

On February 12, 2015, I filed an appeal with BCBS to cover the second implant. In the meantime, I have had contact with a doctor in California who says he will help me, but I would have to pay for the second implant on my own because of my insurance. Why should I have to pay approximately $15,000 for a second implant I desperately need just because BCBS policies are not in keeping with current technology? Also, the appeal process could take 15-30 days, still with the risk of a second denial. As far as a cost difference between the two procedures, I discovered there really isn't a difference and in some cases artificial disc replacement is less expensive than a fusion.

As I stated before, I cannot work while in this much pain and on such strong narcotics.  I can’t take care of myself without help. I cannot drive.  My mother has been doing everything for me, from running from Wilmington to Peabody and back to pick up prescriptions, to getting groceries and making sure bills are being paid for my Gloucester condo.  For the past few years my mother has been having difficulties with her heart, experiencing episodes of Atrial fibrillation.  She was scheduled for an ablation on February 13, 2015, but because of my situation she had to postpone her procedure.  I have been almost completely bedridden.  I cannot sit up at the kitchen table to visit with family and friends for more than 10 minutes.  The only time I am comfortable is when I am flat on my back in bed and heavily medicated. My quality of life has greatly declined and I cannot continue to live like this.  I need help and support to be able to have surgery right away so that I can return to work and begin to invite normalcy back into my day-to-day routine. I do not want to be forced to continue to take narcotics just to function.  I do not understand why BCBS is lagging behind when more effective treatments have been available for some time.  Herniated discs are pretty common. Shouldn't we all have access to the best technology available when faced with this problem?

Please help support me by signing my petition. 

Sincerely,

 

Cheryl Marfleet

 

28 Boutwell Street, Wilmington MA. 01887

10 Dalton Avenue #6, Gloucester MA 01930

Chermagnolia2013@gmail.com

 

Please reference the following links for more information:

http://www.cervicaldisc.com/

http://thejns.org/doi/pdf/10.3171/2014.7.SPINE13953

http://www.medicaldesignbriefs.com/component/content/article/1105-mdb/features/18810

http://www.spine-health.com/treatment/artificial-disc-replacement/artificial-disc-cervical-disc-replacement ​;

http://www.mayfieldclinic.com/PE-ACDF.htm#.VFm2Yyj89XV

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm367809.htm

http://www.spine-health.com/treatment/spinal-fusion/potential-risks-and-complications-acdf-surgery

http://us.ldr.com/Portals/1/IDEOVERVIEW2L.pdf

https://www.change.org/p/blue-cross-blue-shield-of-massachusetts-save-alan-s-back-by-approving-a-critical-emergency-surgery-what-will-they-deny-when-you-need-help

The Decision Makers

Seth Moulton
U.S. House of Representatives - Massachusetts 6th Congressional District
James Miceli
Former State House of Representatives - Massachusetts-78
Charlie Baker
Governor of Massachusetts

Petition Updates