Colon Capsule Endoscopy And Epidural Procedures For Pain Management Open Public Meeting - August 31, 2021 - JE Part A

Jocelyn Fernandez:
Good afternoon or maybe it's a good morning for those joining on the West Coast or Hawaii. Welcome members of the public to the Open Meeting for two proposed LCDs, Colon Capsule Endoscopy and Epidural Procedures for Pain Management.

The meeting will be recorded. The audio recording and written transcript will be posted on our website following today's meeting. All lines are currently being muted by our system and will remain muted throughout the meeting. Only registered presenters will be allowed to comment during today's meeting.

For our commenter, you are being allotted 10 minutes to make comments. Your line will be opened when it is your turn to speak. Make sure you are not on mute within your system, or we will not be able to hear your comments. You should be prepared to begin your presentation immediately when called upon and will hear the moderator’s voice when one minute remains. By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any personal health information during your presentation. Any comments made today should also be submitted in writing. All comments will be recorded in the Response to Comments article. I will now turn the meeting over to Dr. Ann Marie Sun for comments on the first proposed LCD Colon Capsule Endoscopy. LCD number, DL38824 for Jurisdiction E, and DL38826 for Jurisdiction F. Dr Sun.

Dr. Sun:
Thank you. Next slide, please.

So, the reason for this portion of the Open meeting is in regards to the Colon Capsule Endoscopy LCD. And it is to inform the public of the updates made to the coverage criteria. The addition stems from CMS' recognition of FDA approved blood based biomarker testing for colorectal cancer as a screening option.

Next slide, please.

To be clear, we are not commenting on any criteria, CMS includes in a national coverage determination 210.3, but what we are doing is that we are acknowledging that the colorectal screening test of choice, still needs to meet CMS coverage requirements. But, in addition, we are discussing here, that the inclusion of that CMS recognize testing option in our Colon Capsule Endoscopy LCD, is another change or update that needed to be made.

Next slide, please.

On this slide is an excerpt of the updated LCD to recognize that this type of screening tests may be the screening tool used to indicate the need for diagnostic evaluation. No other changes to the LCD have been made and, otherwise, there are no other comments. We just appreciate that you have given us your time and your attention. Thank you.

Jocelyn Fernandez:
Thank you, Dr. Sun.

We'll move on to the second proposed LCD, Epidural for Pain Management.

LCD number DL39093 for Jurisdiction E and DL39095 for Jurisdiction F. I will now turn this portion of the meeting over to Dr. Art Lurvey for his comments.

Dr. Lurvey:
Got it on mute.

We have a current policy for epidural injections. But there also is a policy, a collaborative policy, by all other MACs working together. And this current Open meeting is to discuss a few changes that were made to be a little bit closer to the collaborative policy. We have one speaker coming to this Open meeting, Dr. Joshua Rittenberg from Kaiser Permanente, Department of Physical Medicine and Rehabilitation. And in his slide deck, he also notes that he is a member of the Spinal Intervention Society. So, I'll ask Dr. Rittenberg to tell us whether he is representing himself, representing Kaiser Permanente, an excellent group in the West Coast or whether he is representing the Spiral Intervention Society, Dr. Rittenberg, the floor is yours and we will change your slides for you.

Jocelyn Fernandez:
Dr. Rittenberg, your line is open.

Dr. Rittenberg, it looks like you’re self-muted. Can you unmute your device, please?

Dr. Lurvey:
Also, Dr. Rittenberg, we would appreciate your sending in your comments in writing to our address. We will, of course, answer, post the answer to your comments as part of the, LCD, on our website, when it is finished, Dr. Rittenberg.

Jocelyn Fernandez:
Dr. Rittenberg, can you hear us?

Dr. Lurvey:
We will certainly wait another 4, 5 minutes. If there is any problem with your system, please let us know.

Jocelyn Fernandez:
OK, let's give him a few more minutes. Let's see if he can try and call back in.

Dr. Lurvey:
We understand that some of the virtual communication that occurs can be problematic. It appears as if everything is working. At least on my site, which is in Los Angeles and in Jocelyn’s site, which is Hawaii, but it's possible for one reason or another there is a problem. So, Dr. Rittenberg….

Dr. Rittenberg:
Can you hear me now? Are you able to hear me?

Dr. Lurvey:
Now we can hear you.

Dr. Rittenberg:
Yeah, you got it. OK, great. Sorry about that yet. For some reason, the system wasn't letting me unmute, so I just called in through the phone instead. So, thanks. Yes, I am representing Spine Intervention Society on this.

Dr. Lurvey:
Thank you.

Dr. Rittenberg:
OK, great. And, yeah, thank you for letting me speak up. You can go to the next slide.

Dr. Lurvey:
Tell us and we’ll change your slides.

Dr. Rittenberg:
OK, so yeah, no disclosures, go to the next slide.

OK, so starting with history, physical exam, imaging to support radiculopathy or neurogenic claudication are covered indications. So just making the distinction between radicular pain, rather than radiculopathy. So many patients have severe radicular pain without any physical exam abnormalities. So neurologic deficits are not common and they're not necessary to support a diagnosis of radicular pain. Another part of it is physical exam straight leg raise is a specific test for radicular pain, but it is not very sensitive. Thus, it is often not present, especially in patients with spinal stenosis is much more common in people with herniated disk. So most importantly, patients with a radicular pain who do not have a positive, straight leg raise, or neurologic deficits are just as likely to respond to epidural injections than those who do. You can go to the next slide.

So, our suggestion for rewording this is history and/or physical examination, and diagnostic imaging supporting one of the following: lumbar, cervical, or thoracic radicular pain. You can go to the next slide.

Next, under the covered indications is the requirement for four weeks of pain duration. We feel that it is unrealistic to expect a patient with acute, radicular pain from a herniated disk to delay an epidural steroid injection. These are actually the patients most likely to benefit from the procedure. So, we suggest rewording, pain duration of at least four weeks with exception made for severe radicular pain or a four week delay cannot be tolerated, so the patient would otherwise end up in the emergency room or surgery, et cetera. Next slide, please.

Under the covered indications and requirements to use contrast, we fully support the use of contrast except for patients with a documented contrast allergy or who are pregnant. So, we suggest the following wording: The epidural steroid injections must be performed under CT or fluoroscopic guidance with contrast. Unless the patient has a documented contrast allergy or pregnancy. Ultrasound guidance without contrast may be considered in these and similar circumstances. Next slide.

Next is repeat injections. If after an initial injection, the patient's pain returns prior to three months, it is reasonable to attempt to re-instate relief with a repeat injection. So, we feel that if a three month threshold is required after an initial injection, a significant number of patients who’d otherwise obtain relief from a second injection will proceed to surgery. Next slide.

So, we suggest the following wording: Repeat epidural steroid injections are appropriate when 1 to 2 prior epidural steroid injections provided prolonged reduction in radicular pain such as 50% relief for at least three months for the condition being treated. Epidural steroid injections should not be repeated within 14 days. If a patient fails to respond to a single Epidural steroid injection, however, a repeat epidural steroid injection after 14 days can be performed using a different approach and/or different medication with the rationale and medical necessity for the second Epidural steroid injection documented in the medical chart. Next slide.

Epidural steroid injections injectate. If the injections do not include steroid than they are not epidural steroid injections ESI. So, it is just in terms of the wording, so suggest replacing ESI injectate with epidural injectate.

The current wording is confusing and stipulates that anti-inflammatories are required and contrast is not. So, we suggest the following wording: The epidural injectate must include contrast agent unless the patient has a contraindication to contrast. Injectate may also include corticosteroids, local anesthetic, saline, and/or anti-inflammatories. Next slide.

Next number seven is requirements for other conservative treatments. While some patients will certainly benefit from multimodal treatment, others who experience relief from an epidural steroid injection may not require additional conservative treatment. So, we suggest rewording to indicate that epidural steroid injections may be performed in conjunction with conservative treatments. Next slide.

And then under new indication, diagnostic spinal nerve block. We suggest including the following: Diagnostic spinal nerve blocks are performed by injecting anesthetics onto a single spinal nerve to help confirm or rule out a source of a patient's pain, often to assist in surgical planning. These blocks utilize the same CPT codes as transforaminal epidural steroid injections and should be allowed in patients that may have failed a therapeutic epidural steroid injection when the medical necessity is documented in the medical records. Next slide.

There's some limitations. To highlight, number one, injections performed without image guidance or by ultrasound. We suggest allowing for ultrasound guidance in patients with a documented contraindication to contrast media such as allergy or pregnancy. And then number six, under the limit to four epidural steroid injections for 12 months. We suggest considering allowance of three, epidural steroid injections for six months and six epidural steroid injections per 12 months, regardless of the number of levels involved. Next slide.

OK, the next one, the Limitations, Number 11 series of epidural steroid injections. While we do not support a quote, series of three, we do support repeat injections if previous injections were successful in achieving pain relief and functional improvement or only one prior injection was unsuccessful. We suggest rewording as follows: It is not medically reasonable and necessary to prescribe a pre-determined series of epidural steroid injections. Next slide.

Steroid dosing, number 12. The dosages recommended are inaccurate. Data from the studies looking at dosages implemented in transforaminal injections have been inappropriately extrapolated here to interlaminar injections. So, we do suggest rewording as follows to allow for slightly higher dosages consistent with the previous version of the LCD. Steroid dosing should be the lowest effective amount, not to exceed 80 milligrams of triamcinolone, 80 milligrams of methylprednisolone, 12 milligrams of betamethasone, or 15 milligrams of dexamethasone per session. Next slide.

Treatment exceeding 12 months, in this limitation seems unreasonable and the requirements add a significant documentation burden to explain that a patient does not wish to proceed to surgery. So, we suggest omitting that. Requiring the pain physician to communicate with a primary care provider to discuss whether a patient is eligible for prolonged repeat steroid use, places undue burden on physicians and should not be required. Next slide.

Next one is under provider qualifications. So, we suggest replacing healthcare professionals with physicians.

Physicians have the requisite required training to accurately select patients, safely perform technically demanding procedures, and immediately recognize, evaluate, and address potentially serious, life altering complications. Next slide.

So, we recommend the following language: Patient safety and quality of care mandate that healthcare professionals who perform epidural injection procedures for chronic pain, not surgical anesthesia are appropriately trained by an accredited allopathic or osteopathic medical residency or Fellowship program in an ABMS or an AOA accredited specialty whose core curriculum includes performance and management procedures addressed in the policy. If the practitioner works in a hospital facility, at any time or is credentialed by a hospital for any procedure, the practitioner must be credentialed to perform the same procedure in the outpatient setting. And a minimum training must cover and develop an understanding of anatomy and drug pharmacodynamics and pharmacokinetics as well as proficiency and diagnosis and management of chronic pain related disease, technical performance of the procedure, and utilization of required associated imaging modalities. Next slide.

We’ve got Society Guidance. Just pointing out that the North American Spine Society revised their coverage policy recommendations in 2020, and these should be reviewed and replace the 2013 and 2011 references that are listed on pages 25 and 26. We also, kind of some typos on society names, so American Society of Anesthesiologists, American Association of Neurological Surgeons and Congress of Neurological Surgeons, and, of course, Spine Intervention Society. Next slide.

Yeah, that's it. Ok so thanks again, for giving me the opportunity to present this, and happy to answer any questions, or we have Belinda Duszynski’s contact information listed on this slide as well.

Dr. Lurvey:
Thank you. We would appreciate that you would send us, formerly in writing, these comments, one way or another, so that we can respond to them in writing when the policy gets finalized. I do have one question that comes to mind, and that is, the treatment of epidurals is primarily for patient with chronic back pain and the vast majority of people with acute pain, often acute after trauma or something, tends to get better within four weeks. How would you distinguish between someone with an acute episode that would get better by itself or with physical therapy and various analgesics than someone, you know, who does, who has not, compared to someone with chronic pain since in the original language, it does say, make exceptions for unusual situations.

Dr. Rittenberg:
Yeah, right, right. No. That's a good question. And first of all, Epidurals are not for back pain, this is for radicular pain, so sciatica pain running down the leg. So real common scenarios and acute Herniated disk and those patients can have a significant amount of pain and disability. And those are ones that tend to respond, really the best to epidural steroid injections. The other grouping is more, you know, chronically current, such as, like the spinal stenosis patients who are a little bit older, and they have acute flare ups in the setting of a chronic issue that they have. And so, those would be probably the most common   scenarios where, where these are done. And, in most cases, these patients have tried conservative management first before they've moved on. But then, there are also those scenarios that we alluded to, where patients are severely debilitated from acute pain, such as an acute Herniated disk where they may not be able to tolerate other conservative care, and there may be indications in that patient population to do an epidural sooner.

Dr. Lurvey:
I believe that is in the current policy, but we will look very carefully at that. I think there are exceptions, but we will look at that. Thank you very much for your time, your presentation. And one last reminder, please send the notes in writing in the best form you wish, so that we can respond to them in the final policy. Is there anything you wish to ask us?

Dr. Rittenberg:
No, thanks. Thanks for that reminder. We'll make sure to do that and appreciate the opportunity.

Dr. Lurvey:
Is there anybody, anyone else who is listening on the call, this is an Open meeting, has the ability to send their written comments in to be included in our response to comments portion of the policy, so I remind anybody who is on the line, but not giving a presentation for the ability to have written comments sent in. That is all I have. Jocelyn, do you want to close the meeting?

Jocelyn Fernandez:
Sure. We will now move on to closing and next steps.

In closing, we would like to communicate the next steps in the policy development process. The comment period for the proposed LCDs will remain open until September 18th, 2021.

All comments to be considered by our Medical Directors for the proposed LCDs must be submitted in writing. Written comments can be e-mailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website at noridianmedicare.com. Upon review of the comments, the medical directors will either finalize or retire the proposed LCDs. Please monitor our website or register for listserv notifications to be informed of actions taken on our proposed LCDs. And thank you everyone for attending. This concludes our Open meeting for today. Have a wonderful day.