Thermal Intradiscal Procedures

Highlights of CMS Proposed Decision Memo for Thermal Intradiscal Procedures (ASIPP and ISIS public statements)

Smith & Nephew strongly urges you to adopt a positive coverage determination for intradiscal electrothermal (IDET) procedures. This request is supported by the scientific and clinical literature as well as the specialty societies and physicians who have submitted comments and are most familiar with furnishing IDET to patients. To date, at least 27 clinical reports and scientific papers document the effectiveness of IDET.

We recognize the challenges of gathering and reviewing scientific literature and perhaps that is one reason that the initial Proposed National Coverage Decision for Thermal Intradiscal Procedures seemed to focus on a very limited selection of the published evidence and cited evidence from only a small portion of the published studies of IDET.

We expect that the additional information provided to CMS during the comment period as well as insight and comments from the specialty societies have been informative and will enable CMS to develop a national coverage decision that preserves access for the patient groups who will benefit most from the IDET procedure.

As noted above, the experts are in agreement that the large majority of published evidence clearly indicates that IDET is an effective treatment for specific indications. These indications were described in detail during our recent meetings at CMS and an earlier meeting with the Coverage Analysis Group on February 13, 2008. In addition, comments CMS received from clinical specialty societies described essentially the same indications.

For example, the North American Spine Society wrote

–“Based upon our literature review, a highly selected group of patients whosuffer from discogenic LBP may benefit from IDET.”

The International Spine Intervention Society stated in its letter that the society

– “recommends that IDET continue to be covered by CMS” subject to certain patient selection criteria.

The American Academy of Pain Medicine commented

–“Intradiscal thermal lesioning utilizing a resistance-coil heating element placed along or within the posterior disc anulus affords a likelihood of high-grade relief of chronic low back pain in well-selected patients with discogenic low back pain.”

The clinical specialty societies also agree that it is a mistake to group all thermal spine therapies under one coverage policies for ‘TIPs’. The comments noted the differences in the level and amount of evidence supporting IDET as compared to other types of thermal intradiscal procedures and recommended that the agency not treat all techniques and technologies the same. In addition, IDET is the only technology the AMA deemed to have sufficient evidence to warrant a separate CPT code.

The overwhelming amount of “positive” evidence in favor of IDET with emphasis on patient selection criteria should persuade CMS to develop a positive coverage policy for IDET.

However, if CMS continues to have concerns about the adequacy of the clinical evidence Coverage with Appropriateness Determination and/or Coverage with Evidence Development is an option that should be considered. Specifically, we recommend Coverage with Appropriateness Determination where additional information would be provided on the claim to insure that patients receiving IDET meet the published patient indications. We would be happy to meet to further discuss the criteria, coding and other implementation details. We believe this is the most appropriate method given the small number of Medicare IDET candidates.

In closing, we are requesting Medicare coverage for IDET for a well-defined patient population that an objective and informed analysis of the clinical evidence indicates is effective for treatment of discogenic pain. IDET has improved the lives of numerous patients who suffered from debilitating back pain. We strongly believe Medicare beneficiaries should have access to it.

Sincerely yours,

Barbara Rohan
Vice President,Government Affairs

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Dear Dr. Phurrough:

I am writing to express our surprise and our disagreement with CMS’ recently published Proposed Decision Memo on “Thermal Intradiscal Procedures.” I respectfully disagree with CMS’ decision because, as noted in the evidence-based practice guidelines that were published by ASIPP and which were submitted to CMS in January, there is substantial clinical evidence supporting the continued coverage of these procedures, particularly coverage of Intradiscal Electrothermal Therapy (IDET). We were surprised by the Proposed Decision Memo because CMS received overwhelmingly positive comments on IDET but apparently disregarded the opinion of physicians and researchers most familiar with the procedure in order to reach a different conclusion. As an interventional pain management physician, I strongly believe that the clinical evidence as well physicians’ own experiences, justifies Medicare coverage.CMS’ decision places undue emphasis on older studies, which did not employ the current patient selection criteria. Furthermore, the agency lumped together all forms of thermal intradiscal therapy without considering important clinical differences. The current clinical literature and practice guidelines reflect a more sophisticated, stratified approach, rather than a one-size-fits-all analysis. I urge CMS to reconsider its Proposed Decision Memo. Medicare beneficiaries who suffer from discogenic pain should not lose access to IDET, an effective and safe minimally invasive treatment option. At the very least, if CMS needs additional information about the accuracy of the patient selection criteria, the agency should authorize “coverage with evidence development” so that additional studies can be conducted while Medicare beneficiaries continue to have access to this procedure.Thank you for your careful attention to this important issue. I am confident that if you reexamine the clinical literature and the views of the medical community, you will see that IDET is an important treatment option that should not be removed as a treatment option.

Sincerely,

Daniel S. Heller, MD

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Comment on: Thermal Intradiscal Therapy and CAG#: CAG-00387N

I am a physician with extensive experience with both IDET and Biacuplasty devices in clinical practice and in research settings and am very familiar with the pertinent literature. I wish to protest the establishment of a non-approval recommendation for IDET as inappropriately flawed and for Biacuplasty as premature, and without specific basis or relevant supporting data. As you know, CMS non-coverage decisions are broadly adopted by other insurers and such a flawed decision has substantial adverse consequences for patients with discogenic pain who do not require spinal fusion surgery or the non-covered total disc arthoplasty devices.

Several critical randomized trial results for IDET were based on inadequate diagnostic criteria and undoubtedly treated many patients without true discogenic pain. These papers did not require diagnostic discography to be performed using well-accepted criteria developed by either ISIS (International Spine Injection Society) or IASP (International Association for the Study of Pain), making the selection of IDET for treatment entirely questionable and the outcomes analysis meaningless. Furthermore, the Freeman paper includes an MRI illustration of a collapsed degenerated disc which fails to meet criteria for use specified by the IDET manufacturer. No rational physician would today choose IDET for the illustrated disc, yet the publishing spine surgeons managed to get this erroneous, but adverse paper into print. If inadequate diagnosis or erroneous clinical patient selection leads to poor treatment outcomes, it is unreasonable to fault the IDET device. Surely CMS reviewers are sophisticated enough to recognize this fallacy.

Biacuplasty is not equivalent to IDET: Biacuplasty heats a much larger volume of posterior annular disc tissue than IDET and in my published research, appears to be safer than IDET. The Biacuplasty device is not identical to nor should it be considered as substantially similar to IDET. Biacuplasty uses volume tissue heating with radiofrequency energy and active probe tip cooling as opposed to the IDET’s simple heated nichrome coil technology (found in the average toaster). Kapural’s published clinical series show biacuplasty outcomes at 6 months to be superior to those previously reported for IDET. In my as yet unpublished clinical series of 10 worst-case patients (All with motor vehicle accidents or workman’s compensation claims), patients were able to participate in rehabilitative physical therapy much earlier than reported with IDET and several have already returned to work. While these data suggesting superiority of biacuplasty outcomes are preliminary, biacuplasty is a newer technique and sufficient time must be provided to the physician community for completion of clinical outcomes trials and publication. A CMS decision to not approve biacuplasty is therefore premature. It is inappropriate to condemn biacuplasty based upon the IDET literature. I respectfully suggest that any decision on biacuplasty be postponed for at least 18-24 months in order to allow completion of rigorous clinical trials which will better define the appropriateness of biacuplasty.

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Dear Dr. Phurrough & Staff:

We respectfully disagree with the Proposed Decision Memorandum on Thermal Intradiscal Procedures (CAG-00387N) by the Centers for Medicare and Medicaid Services ('CMS'), as it unfairly and incorrectly includes lasers in its Proposed Non-Coverage Determination.

Indeed, lumping lasers with radio frequency energy (RFE) and electrothermal energy (ETE) devices assumes apples and oranges are the same. They are not. Pulsed Holmium Lasers and RFE and ETE devices operate by different mechanisms of action, cause different tissue effects and produce different clinical outcomes.

Let me explain why pulsed Holmium Laser energy produces different tissue effects and clinical outcomes than continuous wave ('CW') RFE and ETE devices, as well as how it produces different tissue effects and clinical outcomes than CW lasers, such as Nd:YAG, KTP or Diode Lasers.

Trimedyne, Inc. ('Trimedyne', 'we' or 'our') manufactures Holmium:YAG lasers (Holmium Lasers) whose energy is pulsed. Continuous wave (CW) energy sources, such as Neodymium:YAG ('Nd:YAG') lasers, KTP lasers, RFE devices and ETE devices, produce a constant level of energy and simply heat, coagulate, char and scar tissue.

Pulsed Holmium Lasers, such as our 80 watt Holmium Laser, produce pulses within a duration of only a few hundred microseconds at up to a maximum of 60 pulses per second. At this pulse repetition rate, our Holmium Laser emits energy for 10 thousandths of a second and, during the remaining 990 thousandths of a second, the tissue cools. In other words, our Holmium Laser at this pulse repetition rate emits laser energy for about 1% of the time, allowing about 99% of the time for the tissue to cool between pulses.

Our Holmium Laser emits energy at 2100 nanometers (nm), a wavelength that is highly absorbed by water. Attached is a paper which contains a chart detailing the absorption of various wavelengths of light in water (Hashishin Y and Kubo U, Development of Laser Endoscope for Coagulation and Incision, Lasers in the Musculosketal System, 2001:81-84, Springer-Verlag Berlin). Water makes up about 75% of most body tissues, except bone. For example, when Holmium Laser energy of 10 to 40 watts is emitted, at a repetition rate of 15 pulses per second, the peak power is 2,900 to 7,100 watts per pulse, respectively. When this amount of Holmium Laser energy contacts tissue, it is rapidly absorbed by the water in the cells, which is almost instantly turned to steam, vaporizing (ablating) the tissue.

Nd:YAG and KTP lasers emit continuous wave (CW) light energy at wavelengths of 1064 and 532 nm, respectively. As you will note in the chart in the paper by Hashishin Y, et al, Nd:YAG and KTP wavelengths of laser energy are poorly absorbed by water. As a result, the energy of Nd:YAG and KTP lasers at commonly used power is more slowly absorbed by water in cells, and the tissue is coagulated, rather than vaporized. As the tissue is being coagulated, heat accumulates and is conducted deeper into the tissue.

Also, at low power per pulse or a low pulse repetition rate (delivering fewer pulses per second reduces the total amount of laser energy applied), our Holmium Laser can denature, shrink or coagulate disc tissue. As described in the papers by Sherk HH et al, Casper GD, et al, Chiu JC et al, Knight MTN et al and Tsou & Yeung AT, which are cited later in this response and attached hereto, the shrinkage effect of pulsed Holmium Laser energy is extremely useful in intradiscal procedures to shrink nucleus tissue and, after the laser device is withdrawn at the end of the intradiscal procedure, to shrink and reduce, at least partially, the opening in the annulus, as the annulus, which is virtually avascular, does not heal.

In addition, the light extinction or penetration depth of our Holmium Laser in tissue is about 0.4 millimeters (mm), so all of its energy is absorbed in a relatively shallow layer of tissue. The light extinction or penetration depth of Nd:YAG and KTP continuous wave (CW) lasers in most tissues is about 2 to 4 mm, affecting tissue to a depth 5 to 10 times greater than pulsed Holmium Laser energy.

In a paper by Sherk HH et al and other papers we cite later in this response, tissue effects of pulsed holmium lasers are described in detail.

Each pulse of energy from our Holmium Laser vaporizes virtually all of the tissue it touches. Between pulses, the adjoining tissue cools and is largely unaffected by the laser energy. However, heat from steam and hot gasses arising from the vaporization of tissue can cause some conduction of heat through the remaining tissue. As explained below, we found a way to minimize this.

When we introduced our earliest Holmium Laser in the orthopedic field, following its FDA clearance for sale under 510(k) No. K905708 on March 28, 1991, our Holmium Lasers were initially used in arthroscopic procedures to vaporize, trim, cut and smooth tissue in the knee, elbow, shoulder, hip, wrist and ankle. This 510(k) also included optical fibers encased in cannulas of medical grade stainless steel from which energy was emitted straight ahead from the distal end face of the optical fiber. Some of the devices were made with cannulas encasing the optical fiber with a bend at their distal end at angles of 10, 20, 30 or 60¨ to enable the surgeon to better direct the laser energy to the target tissue.

Arthroscopy is typically performed with our pulsed Holmium Laser in joints while infusing saline as an irrigation fluid to cool the tissue and carry away debris. The irrigation fluid significantly increases cooling of the tissue between the laser pulses, particularly if the bag of irrigation fluid is refrigerated prior to use. The irrigation fluid also carries away the heat from steam and hot gasses arising from the laser's vaporization of tissue, minimizing conduction of heat into adjoining tissue. In arthroscopy, our Holmium Lasers are often referred to as 'cold' lasers, as there is typically no charring or damage to nearby tissues.

Optical fibers of the size commonly used in surgery cannot be bent at a very sharp angle in a small space. However, we found a way to increase the angle at which pulsed Holmium Laser energy could be directed from an optical fiber device to enable the surgeon to treat tissues lying alongside the laser cannula. We introduced the first side firing optical fiber devices for use with Holmium Lasers following their FDA clearance for sale under 510(k) No. K915223 on January 23, 1992. Emitting pulsed Holmium Laser energy to the side at 3 or 9 o'clock, rather than upward at 12 o'clock or downward at 6 o'clock, is particularly desirable in discectomy or nucleectomy (removal of nucleus tissue). If laser energy is emitted at 6 or 12 o'clock, it could damage the upper and lower surfaces of the disc and the endplates of the vertebra above and below the disc, through which the disc tissue absorbs oxygen, water and nourishment, as the nucleus of the disc is virtually avascular.

To further cool tissues between pulses of energy from our Holmium Laser, we incorporated an irrigation channel in our side firing laser needles to allow an irrigation fluid, such as sterile saline, to be infused through the channel to cool the tissue between pulses of laser energy and enable higher laser powers to be used by the surgeon to accelerate the vaporization of tissue. The channel also permits the surgeon to apply suction through the laser needle, if desired.

We introduced the first side firing needles with a fluid infusion or suction channel for use with our Holmium Laser, following their FDA clearance for sale under 510(k) No. K992230 on July 12, 1999.

More recently, to enable steam and hot gasses from the vaporization of tissue to escape and further minimize thermal conduction into the surrounding tissue, we developed the only side firing laser needle with an external vent sheath, which was cleared for sale by the FDA under 510(k) No. K022655 on November 7, 2002, and was cleared for use with our Holmium Lasers by the FDA under 510(k) No. K041660 on September 8, 2004. This device is described in detail in U.S. Patents No. 6,802,838 B2 and 7,306,588 B2, which were issued on October 12, 2004 and December 11, 2007, respectively. The vent sheath allows the surgeon to apply up to 40 watts of Holmium Laser energy through the laser needle at a peak power of 6,000 watts per pulse, for faster vaporization of tissue and vaporization of denser tissue, if encountered. Since optical fibers for arthroscopic and intradiscal use are commercially available with core diameters of 200 to 550 micrometers (microns), they can be used to access tissues difficult to reach with RFE or ETE devices, nucleotomes, burrs, shavers or graspers.

The reference to mechanical tools in the proceeding sentence leads me to a question. At the bottom of the third paragraph from the end of the 'Background' Section of CMS' Proposed Decision Memorandum (near the end of the fourth full paragraph on Page 4 of the Memorandum from CMS' website), CMS states, 'Disc decompensation or nucleoplasty procedures that involve the physical removal of disc tissue without the use of a thermal energy source (such as the disc decompressor procedure) as opposed to the vaporization of disc tissue, are not within the scope of this NCA.'

Since pulsed Holmium lasers vaporize tissue with minimal thermal effect, why did CMS insert, 'as opposed to vaporization of disc tissue?' Vaporization is tantamount to removal. Using small diameter optical fibers, laser vaporization of the nucleus of the disc can be performed through smaller incisions than nucleotomes, graspers, burrs or shavers, reducing bleeding and the risk of infections. We manufacture optical fibers inside cannulas of medical grade stainless steel, which fire straight ahead, with outside diameters of 1.5 mm (about 1/16th of an inch). We manufacture side firing optical fibers inside cannulas of medical grade stainless steel with an outside diameter of 2.0 mm (about 1/12th of an inch).

The area of a circle with a diameter of 1.5 mm (pi x r2) is about 1.3 mm2. The area of a circle with a diameter of 2.0 mm is about 3.1 mm2. The area of a circle with a diameter of 5 mm, to accommodate a cannula through which a nucleotome, burr, shaver or grasper is inserted, is about 19.6 mm2. As a result, the incision and, more importantly, the opening in the annulus to accommodate a nucleotome, burr, shaver or grasper is 15 to 6.3 times larger than that of a 1.5 mm laser cannula or a 2.0 mm side firing laser needle. If surgeons insert nucleotomes, burrs, shavers and graspers through a larger diameter cannula, the above mentioned differences in area and damage to the annulus would be magnified by 3.1416 times the square of the radius of the cannula.

Why would CMS limit removal of disc tissue to larger, more traumatic, mechanical devices, and deny Medicare beneficiaries the benefits of pulsed holmium laser energy through an optical fiber to remove the tissue? The question of whether to cover the removal of tissue by a mechanical device, such as a nucleotome, burr, shaver or grasper, or laser energy, is easy to answer. Holmium Laser energy reduces the risk of infection from a larger incision and potential damage to the annulus of the disc from a larger opening required to admit a mechanical device, and it reduces recovery time due to its smaller incision.

While the use of mechanical devices with our Side Firing Laser Needle is described in many of the papers we cite herein, which reflect clinical studies performed some years ago, due to the improvements in our Side Firing Needles described above, surgeons can now apply greater amounts of laser energy to vaporize a larger volume of tissue, reducing their need to use mechanical tools and the damage from mechanical tools to structures which do not heal well.

Weakening the annulus by the larger opening can lead to the extrusion of nucleus tissue and the rupture of the annulus, possibly requiring surgery and causing a significant increase in cost to Medicare. If a rupture of the annulus occurs in Medicare beneficiaries for whom surgery is contraindicated, due to anti-coagulant use or co-morbidities, and intradiscal laser vaporization of nucleus tissue with less damage to the annulus, is denied by CMS, it would condemn them to unrelenting pain and a diminished quality of life on opiates for the rest of their lives.

The exclusion of vaporization (i.e. laser energy) from the physical removal of disc tissue should be reversed by CMS because, as amply demonstrated by the papers we cite herein, it would be a disservice to Medicare beneficiaries to deny them this safe and effective method of tissue removal.

We are attaching a published paper (Sherk HH, Black JD, Prodoel JA and Cummings RS. Lasers in Orthopedic Surgery LASER DISCECTOMY, Orthopedics, May 1993; 16, (5):573-576) which describes the tissue effects of pulsed holmium laser energy in detail. Instead of our summarizing the information contained in this paper, we are attaching a copy for your perusal. You will also see the tissue effects of our Holmium Laser described in the below cited papers by Tsou P & Yeung AT, Casper GD et al, Chiu JC et al, and Knight MTN et al, copies of which are attached. The tissue effect of pulsed Holmium Laser energy, as described herein, is not comparable to the manner in which energy is delivered by RFE or ETE devices or their tissue effect, as explained below, and as described in detail in the RFE and ETE papers cited by CMS, NASS and CTAF.

Since damaged cartilage typically does not regenerate, the ability of pulsed Holmium Laser energy to vaporize cartilaginous tissue with minimal thermal damage to nearby tissue is particularly useful in discectomy. Unlike RFE and ETE devices, our side firing laser needles allow laser energy to be directed in whatever direction the surgeon wishes.

In the use of RFE and ETE devices, CW lasers and other sources of CW thermal energy, there is little or no time for cooling of the tissue between pulses, and thermal conduction of heat beyond the primary area of thermal effect of such devices can be widespread. Even if RFE devices are pulsed at hundreds of thousands or more pulses per second to minimize damage to nerves, their tissue effect remains essentially CW and thermal.

Monopolar RFE moves from the negative electrode in the RFE device into the tissue and is largely absorbed in a few millimeters of tissue. If RFE is emitted for more than a few seconds or miniutes, the tissue near the device is heated and heat is conducted deeper into the tissue. Any remaining RFE proceeds to the positive electrode, usually on the patient's back. However, the course of Monopolar RFE can be affected by the higher electrical conductivity of blood, due to its salinity, so the movement of RFE through the body and its tissue effects can be erratic, and burns sometimes occur on the skin under the positive electrode and, potentially, can occur elsewhere within the body.

Bipolar RF energy also moves directly from the negative electrode to the positive electrode by the shortest possible path, a straight line, causing a highly local thermal effect and, if such energy is emitted over more than a few seconds or minutes, widespread thermal diffusion can occur.

In CMS' Preliminary Decision of July 15, 2008, CMS cited a paper by Tsou PM, (Tsou PM, Yeung TA and Yeung CA. Posterolateral transforaminal selective endoscopic discectomy and thermal annuloplasty for chronic lumbar discogenic pain: a minimal access visualized intradiscal surgical procedure, The Spine J, 2004;4:564-573).

In this retrospective paper, our pulsed Holmium Laser was used in the intradiscal vaporization of nucleus tissue to treat low back pain arising from a herniated lumbar disc. However, CMS failed to mention that 219 discs in 219 patients were consecutively treated, the age range of the patients was 17 to 71 and the good and excellent success rate was 88% by physician assessment, using modified McNab criteria, over an average follow-up period of 20 months, and the good and excellent success rate was 91.2% in 193 patients who completed a self-administered questionnaire. The complication rate was 2.7% and the missed fragment rate was 0.9%. A copy of this paper is attached.

We respectfully call your attention to seven other published papers on laser discectomy performed with our Holmium Laser, the highlights of which are briefly summarized below. Much other valuable information can be found by a more exhaustive review of these papers, a copy of each of which is attached hereto.

In a published paper (Casper GD, Mullins LL and Hartman VL, Laser-Assisted Disc Decompression: A Clinical Trial of the Holmium:YAG Laser with Side-Firing Fiber, J Clin Laser Med & Surg, 1995;13(1): 27-32), our Holmium Laser was used in the intradiscal vaporization of nucleus tissue to treat 252 discs in 223 consecutive patients with low back pain from a herniated lumbar disc, and the data was retrospectively analyzed. The age range of the patients was 13 to 81, and the good and excellent success rate over a follow-up period of one year was 84.2%, determined by telephone interviews by an independent party, using modified McNab criteria. With 23 patients having a second laser procedure, 52% at a different level and 48% at the index level, at six months after these procedures, the success rate was 92.3%. 1.8% of the patients had discitis or other adverse effects, and 4.5% had a subsequent laminectomy. The authors compared the estimated cost of the $6,000 laser procedure to the estimated cost of $30,000 for a single level disc excision and concluded that, in addition to a shorter recovery period and the aforementioned higher success rates than surgery and other percutaneous procedures (i.e. automated discectomy and Nd:YAG laser discectomy), the laser intradiscal procedure is most cost-effective than alternative treatment modalities.

In a subsequent paper by the same orthopedic surgeon (Casper GD, Hartman VL and Mullins LL. Results of a Clinical Trial of the Holmium:YAG Laser in Disc Decompression Utilizing a Side-Firing Fiber: A Two-Year Follow-up. Lasers in Surg and Med 1996; 19:90-96) our Holmium Laser was used in the intradiscal vaporization of nucleus tissue to treat 110 discs in 100 patients with low back pain from a herniated lumbar disc (100 patients from the above 223 patient paper), and the data was retrospectively analyzed. The age range of the patients was 18 to 75, and the good and excellent success rate over a follow-up period of two years was 86.9%, determined by the telephone interviews by an independent party using modified McNab criteria. 4% of the patients had a subsequent laminectomy, and 10% had a second laser procedure on the same or a different level. There were no intraoperative or postoperative complications. The authors comment that these results contrast with the results of other researchers (using Nd:YAG lasers or KTP lasers), who achieved less positive results and higher complication rates.

In another published paper by the same surgeon (Casper GD, Hartman VL and Mullins LL. Laser Assisted Disc Decompression: an Alternative Treatment Mobility in the Medicare Population, January 1996, J Okla State Med Assoc; 89:11-15), our Holmium Laser was used in the intradiscal vaporization of nucleus tissue to treat 46 discs in 31 patients of Medicare ages with auricular leg pain from a herniated lumbar disc (a subset of patients from the above 223 patient paper), and the data was retrospectively analyzed.

The age of the patients was 65 and older, and the good and excellent success rate over a follow-up period of one year was 80%, determined by telephone interviews by an independent reviewer, using modified McNab criteria. All of the procedures were performed on an outpatient basis under local anesthesia. There were no complications. Four of the patients required a second laser procedure at the same level and two required open laminectomies, which were considered failures. The authors comment that Holmium laser intradiscal procedures offer the elderly a shorter recovery period and a faster return to normal activities at a cost of about one-third of a single level lumbar disc excision.

In another published paper (Chiu, JC, Clifford T, Negron F, Greenspan M and Princethal RA, Microdecompressive Percutaneous Endoscopy: Spinal Discectomy with New Laser Thermodiskoplasty for Non-Extruded Herniated Nucleus Pulposus, Surg Technol Intl VIII:343-351), our Holmium Laser was used in the intradiscal vaporization of nucleus tissue to serially treat 720 discs in 400 patients with low back, leg, neck and shoulder pain from herniated lumbar (n = 376 discs), thoracic (n = 48 discs) or cervical discs (n = 296 discs), and the data was retrospectively analyzed. The age range of the patients was 22 to 78, and the good and excellent success rate over an average follow-up period of 24 months was 95.2%, determined by using a visual analogue pain scale (VAS), MacNab, ODI, patient satisfaction scoring, pain diagram and/or patient target achievement score (PTA) (private communication). There were no significant complications other than residual pain in 7.89% of the patients. Postoperatively, 4.5% continued to have mild spine pain, 4.5% continued analgesics, 4% continued to have muscle weakness, 2% continued to have muscle spasms, and 3.5% continued to have persistent numbness. The authors comment that the Holmium:YAG laser has the advantage of greater safety compared to the Nd:YAG laser, which has been shown to penetrate into the abdomen and injure the disc endplates.

In the above paper, in addition to the reference on laser vaporization of disc tissue at higher power, please note the (a) the photographs of the procedure, (b) the description of our Holmium Laser's ability at a lower power level to shrink disc tissue by 25-30%, (c) the reduction in the herniation by MRI after the pulsed Holmium Laser discectomy procedure and (d) the computerized scans of the disc before and after the pulsed Holmium Laser discectomy procedure.

In another published paper by the same surgeon (Chiu, JC, Clifford TJ, Greenspan M, Richley RC, Lohman G, and Sison, RB. Percutaneous Microdecompressive Endoscopic Cervical Discectomy with Laser Thermodiscoplasty, Mt. Sinai J of Med 2000; 67 (4):278-282), our pulsed Holmium Laser was used in the intradiscal vaporization and shrinkage of nucleus tissue to serially treat 360 discs in 200 persons with neck and shoulder pain from a herniated cervical disc (including the cervical disc patients of the above paper), and the data was retrospectively analyzed. The age range was 26 to 72, and the good and excellent success rate over an average follow-up period of 25 months was 94.5%, determined by the ODI and 5.5% of the patients remained symptomatic and required analgesic medication. There were no significant postoperative complications. 4% had decreased pain and touch sensation, 4% had numbness and tingling and 3% had occasional diminished feeling, without objective findings on examination. The authors reported less morbidity, more rapid recovery and significant economic savings.

In another, paper by same surgeon (Chiu JC, Clifford T, Princenthal R, and Shaw S, Junctional Disc Herniated Syndrome in Post Spinal Fusion Treated With Endoscopic Spine Surgery, Surg Technol Intl, XIV:305-315), our Holmium Laser and Side Firing Laser Needles were used with mechanical instruments in minimally invasive, outpatient procedures, with only local anesthesia, to treat 241 discs in 160 patients with this condition, which can occur in 15% to 52% of post-spinal fusion patients (private communication). The age of the patients were 38 to 77 and the good and excellent success rate, determined by using a visual analogue pain scale (VAS), MacNab, ODI, patient satisfaction scoring, pain diagram and/or patient target achievement score (PTA), was 91.4% over an average follow-up period of 28 months (private communication). In addition to complete descriptions and images of the procedure, the authors present two detailed case studies. Morbidity was less than 1%, blood loss was minimal, there was no incidence of infections, no significant dissection of muscle, bone, ligament or manipulation of dural sac or nerve root was required, there was no promotion of instability, exercise could be commenced on the same day as the surgery, and earlier return to usual activities, including work, was achieved, and the cost was lower than lumbar surgery. The authors conclude that (i.e. with the laser procedure) the risk of a 'domino-like' progression further up and down the spine, junctional disc recurrence is reduced significantly.'

In a prospective study (Knight MTN, Goswami A and Patko JT. Endoscopic laser Foraminoplasty: A Prospective Study on 250 Consecutive Patients with Independent Evaluation, J Clin Laser Med & Surg. 2001;(9)2:73-81), our Holmium Laser and side firing laser needles with an irrigation channel were used in endoscopic intradiscal procedures through a foraminal approach to treat 281 discs causing back pain in 250 consecutive patients, who were followed for an average of 30 months and evaluated by an external, independent assessor.

The ages of the patients were 21 to 86 years. A clinically relevant change in pain and disability of ¡Ã 20% in the ODI score was seen in 82% of the patients, 73% of the patients had a ¡Ã 50% change in ODI score, and 60% of the patients exceeded the ¡Ã 50% ODI score. 95% of the patients needed no further surgical intervention. One patient suffered a neurologic deficit which resolved over 2 years, and one patient had aseptic discitis.

If the results of the 10 papers cited above, after elimination of duplicate groups of patients, were pooled, our Holmium Lasers were used to treat 1,152 patients and other holmium lasers were used to treat 74 patients. These papers would represent, as a group, a total of 1,226 patients treated with holmium lasers in intradiscal laser procedures with an average good or excellent success rate of 88.1% over an average follow-up period of 20.3 months, with minimal adverse effects, a low incidence of subsequent procedures, and a considerable savings to Medicare by avoiding the much higher cost of an open surgical procedure.

You will also note in the papers cited above, many of the subjects were treated on more than one level, as the total number of discs treated in these papers exceeds the number of patients (1,509 discs versus 1,226 patients).

We believe the large number of patients in the papers we cited herein and the length of the follow-up is significantly more convincing than the conflicting results of the two, small randomized, controlled studies of RFE devices and the small numbers of subjects and short follow-up periods of most of the papers cited by CMS in which RFE and ETE devices were used in thermal intradiscal procedures.

Trimedyne did not financially support any of the studies in which our Holmium Lasers were used, and Trimedyne does not presently and has not in the past compensated any of the physicians participating in any of these studies.

Except for the prospective study by Knight MTN et al, all of the other nine papers described above on the use of our Holmium Lasers or other holmium lasers in intradiscal procedures are retrospective analyses of patient data. We recognize the benefit of randomized, controlled clinical trials to rule out bias and any placebo effect. We attempted, several times, to obtain participation in a randomized, controlled clinical trial of our Holmium Laser in the intradiscal laser treatment of herniated discs by the users of our Holmium Lasers. However, having witnessed the relief from pain realized by their patients, the absence of bleeding and damage to the annulus and the superior patient outcomes, these physicians were unwilling to consign their patients to being randomized to a control group and facing the pain and effects of pain killers during an extended watchful waiting period or, for those amenable to a surgical procedure, the risks, poor outcomes and the need to spend the rest of their lives on opiates if the surgical procedure fails and other therapies are unable to adequately treat their pain.

In the paper by Sherk HH et al, mentioned above (Sherk HH, Black JD, Prodoel JA and Cummings RS, Lasers in Orthopedic Surgery LASER DISCECTOMY, Orthopedics, May 1993; Vol 16, No. 5:573-576), 48 patients were treated using a holmium laser manufactured by the Coherent Medical Group (subsequently acquired by Lumenis, Ltd.). 85% of the patients experienced a greater than 20% improvement in subjective pain responses on a pain questionnaire. Even better results were seen from objective evaluation by the treating surgeons of dorsal-lumbar spine motion, responses to straight leg raising and testing for weakness, loss of sensation and knee and ankle jerk reflexes. A copy of this paper is attached hereto.

In another paper (Tonami H, Yokota H, Nakagawa T, Higashi K, Okimura T, Yamamoto T and Nishijima Y. Percutaneous laser discectomy, Clin Radiol, 1997 Dec; 52 (12):938-44) 26 patients were treated with a holmium laser by an unnamed manufacturer for a contained lumbar disc herniation. The results were quantitatively measured by MR by area changes of the herniated mass on axial T1-weighted images and intradiscal signal changes by sagittal T2-weighted images, and clinical outcomes and recovery rates were measured by the Japanese Orthopedic Association (JOA) score immediately and 1 year after the treatment. Recovery was 53.1% immediately after and 64.5% one year after treatment. The abstract of this paper is attached, as the full paper could not be obtained in time to submit our response.

The comment submitted by the North American Spine Society (NASS) to CMS' Proposed Decision Memorandum made no mention of the use of lasers in thermal intradiscal procedures and draws no conclusion on their use. However, while one of the papers we cited above specifically addressed a small group of Medicare age beneficiaries and other papers we cited included patients over age 65, NASS stated in Section 3 of their Summary Comments. 'However, physiological age may be a much more important metric than chronologic age. The absence of evidence in this population (i.e. Medicare beneficiaries) should not be viewed as evidence of a lack of efficacy'.

The California Technology Assessment Forum (CTAF), in its 2008 Technology Assessment of Percutaneous Laser Disc Decompression, addressed laser use in such procedures dating back to the 1980s. However, CTAF lumped pulsed holmium lasers with CW (non-pulsed) Nd:YAG, KTP and Diode lasers, which are no longer in use in orthopedics (arthroscopy or discectomy) due to poor clinical outcomes, and CTAF concluded the entire laser group's results did not meet four of CTAF's five criteria.

CTAF's criteria, briefly stated, are (1) Approval of applicable regulatory bodies; (2) Evidence of effectiveness; (3) Improved patient outcomes; (4) Equal outcomes to therapies and (5) Available in a non-investigative setting.

Of the 26 published papers in CTAF's 2008 survey, only 5 related to the use of holmium lasers, with three relating to the use of our Holmium Lasers (Casper, Casper and Casper) and the other two papers being the Sherk HH and Tonami H papers on the use of other pulsed holmium lasers described above.

Had CTAF separated the results of the pulsed holmium laser papers from the papers on other types of lasers, and pooled the results of the holmium laser papers, the number of patients treated would be 297 (eliminating duplicate patient groups) and the average success rate would be 80% over a follow-up period of two years, with minimal adverse effects and a low subsequent procedure rate, which would likely satisfy CTAF's criteria.

As mentioned above, the North American Spine Society (NASS), the National Institute for Clinical Excellence (NICE), the Institute for Clinical Systems Improvement (ICSI), the Danish Centre for Evaluation and Health Technology Assessment (DCEHTA), the Cochrane Review, the Agence d' Evaluation Technologies et des Modes d'Intervention in Sante (AETMIS), ECRI, the American Society for Interventional Pain Physicians (ASIPP), the American Academy of Pain Medicine (AAPM) and the International Spine Intervention Society (ISIS), all of whom were cited by CMS in its Proposed Decision Memorandum, either did not mention the use of lasers in thermal intradiscal procedures and drew no conclusion on their use or mentioned lasers in intradiscal procedures but drew no conclusion on their use. Their conclusion bears on the use of RFE and ETE devices in intradiscal procedures, but certainly gives no support to CMS' excluding the use of lasers from coverage in intradiscal procedures. We hope our explanation of the difference between the use of pulsed Holmium Lasers and the use of RFE and ETE devices and CW (non-pulsed) lasers in intradiscal procedures and the papers we cited will enable CMS to properly differentiate between the mechanisms of action, tissue effects and clinical outcomes of these three types of energy.

Medicare beneficiaries suffering from a herniated disc should not be denied the benefit of pulsed holmium lasers in intradiscal procedures. The papers cited herein amply demonstrate that the use of pulsed holmium lasers to vaporize tissue in intradiscal and other procedures is safe and effective, and their use in intradiscal procedures is reasonable and necessary, and should be covered by Medicare.

We disagree with CMS' inclusion of lasers, particularly pulsed holmium lasers, in the proposed National Non-Coverage Decision on the use of TIPs, for the above mentioned reasons.

If CMS ultimately issues a National Non-Coverage Decision regarding TIPs, we trust CMS will recognize the difference in tissue effect and patient outcomes between pulsed holmium lasers and RFE, ETE, CW lasers and other sources of thermal energy, and will clearly state that the use of pulsed holmium lasers in the removal of disc tissue by vaporization is not within the scope of the Non-Coverage Decision.

If CMS does not ultimately issue a National Non-coverage Decision regarding TIPS, we respectively request the description of the code number for TIPs be revised to 'mechanical, pulsed holmium laser and thermal intradiscal procedures'.

We understand CMS wishes to make its procedure code descriptions as generic as possible. However, to avoid Medicare's wasting precious funds paying for the use of Nd:YAG lasers, KTP lasers, Diode lasers and other CW lasers that can also be rapidly pulsed at thousands of pulses per second, whose effect is effectively CW, thermal and have not been shown in published studies to produce comparable results to those of pulsed holmium lasers (See papers on the use of Nd:YAG, KTP and Diode lasers cited by CTAF), we hope CMS will include 'pulsed holmium' in the description of the procedure code we suggested in the above paragraph.

If CMS issues no National Decision on TIPs, we hope CMS will relay this response and the attached papers to its intermediaries, many of whom have refused to cover pulsed holmium laser intradiscal procedures, without having the benefit of the detailed information provided herein and in the papers attached to this submission. A list of the FDA clearances and papers we cited herein is appended hereto. Copies of the above are also attached.

We hereby authorize the publication of our response to CMS' Preliminary Decision Memorandum of July 15, 2008 on Thermal Intradiscal Procedures (GAC-00387N) and the attachments to our response.

Sincerely,
TRIMEDYNE, INC.

Glenn D. Yeik, President
Dated: August 13, 2008

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I believe the basis for the necessary availability of intradiscal theramal treatments has been thoroughly researched and documented in the current comments. I am writing just to say that I have personally had excellent results in patients properly selected, with IDET and Biaccuplasty procedures. Recall that this is a treatment for a subset of patients that really has debilitating axial low back pain that will not respond to any other treatment other than fusion or disc replacement, and as we all know the results of these extremely invasive treatments can be devastating. I believe the problem in outcomes from intradiscal procedures stems entirely from the patient selection criteria adherance which is ignored by money seeking unethical physicians that are looking for work.

Maybe we should have an outcome tracking criteria that determines which physicians can perform which procedures, and that would force the physicians to only choose appropriate candidates for various procedures.

Mark me down for being IN FAVOR of intradiscal thermal treatment procedures being approved and reimbursed for appropriately selected patients.

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To: Center for Medicare and Medicaid Services

Regarding: NCD for Thermal Intradiscal Therapy (CAG-00387N)

From: American Academy of Pain Medicine (AAPM)
Kenneth A. Follett, MD, PhD, President
Rollin M. Gallagher, MD, MPH, President-elect
American Academy of Physical Medicine and Rehabilitation (AAPMR)
David Cifu, MD, President
American Society of Interventional Pain Physicians (ASIPP)
David Kloth, MD, Director-at-large
American Society of Anesthesiologists (ASA)
Jeffrey L. Apfelbaum, MD, President
American Society of Spine Radiology (ASSR)
Georgy Bassem, MD, President
International Spine Intervention Society (ISIS)
Paul Dreyfuss, MD, President
Way Yin, MD, Vice President
Nikolai Bogduk, MD
The North American Spine Society (NASS)
Tom Faciszewski, MD, President
Ray Baker, MD, Second Vice President
Physiatric Association of Spine, Sports, Occupational, and Rehabilitation Physicians (PASSOR)
Sheila Dugan, MD, President

The North American Spine Society (NASS), American Society of Anesthesiologists (ASA), the American Society of Spine Radiology (ASSR), the American Academy of Pain Medicine (AAPM), the Physiatric Association of Spine, Sports, Occupational, and Rehabilitation Physicians (PASSOR), the American Academy of Physical Medicine and Rehabilitation (AAPMR), the American Society of Interventional Pain Physicians (ASIPP), and the International Spine Intervention Society (ISIS), collectively representing over 65,000 physician members participating in the care of Medicare beneficiaries, appreciate the opportunity to respond to the proposed national coverage determination on IDET conducted by the CMS.

In its determination, the CMS concluded that:

“…there is insufficient evidence to conclude that TIPs will improve health outcomes in the Medicare population with low back pain.”

Inasmuch as the majority of Medicare patients are individuals over the age of 65, we agree with CMS that there is no evidence that TIPs (thermal intradiscal procedures) are effective in such individuals, for no studies have been conducted explicitly in this age group.

However, NASS, ASA, ASSR, AAPM, PASSOR, AAPMR, ASIPP, and ISIS believe that the determination as currently drafted has disconcerting implications that reach beyond the funding of care for the elderly.

There is a propensity for insurers and others to adopt coverage determinations of CMS. While CMS coverage determinations apply to the Medicare population, such determinations have often been applied by other insurers inappropriately and without qualification to non-Medicare patients.

In evaluating IDET, CMS has raised the standard of evidence required to an unprecedented high level that, historically, has not been applied in other NCDs for spine care. That is, only evaluating randomized controlled trials. Moreover, these randomized controlled trials should be performed in the Medicare age-group. If this standard were to then be applied to other spinal interventions (both surgical and non-surgical), no current treatment for Medicare beneficiaries with chronic low back pain would meet coverage criteria. This would have far greater negative consequences than any decision regarding IDET or other thermal intradiscal procedures (TIPs).

The societies and their membership represented by this letter seek the cooperation of CMS in addressing these primary concerns.

TIPs are not a singular modality. In previous comments to the CMS we have pointed out that the procedures grouped under this rubric differ in their rationale and execution, and in their effectiveness. They are distinguished not only by the mechanism of heat generation, but also by where the electrodes or heating elements are placed within the disc. IDET specifically targets the anulus fibrosus, where it has the potential to affect fissures and the nerve endings of the disc, provided the heating element is accurately placed (1). Placing an electrode in the nucleus has no thermal influence on the anulus (2). For this reason, neither the study of Barendse, et al (3) nor that of Ercelen, et al (4) are relevant to the assessment of IDET.

In their appraisal of the evidence, the original societal respondents to the proposed NCD followed Sackett’s principles that evidence-based medicine is: “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients” and “not restricted to randomised trials and meta-analysis” (5).

For IDET, ten observational reports (6-15) have demonstrated a mean reduction of pain by at least 30 points (which satisfies the minimal important change of 15 required by the CMS for therapeutic interventions); the proportion of patients who achieve greater than 50% relief has ranged from 50% (8,9,16) to 70% (6,7), and up to 20% of patients achieve complete relief (8.9); and outcomes are maintained for two years (9,13,15). A controlled trial has shown that these outcomes cannot be wholly attributed to placebo effects (17). These outcomes apply provided patients are carefully selected. With that provision, investigators (18) and reviewers (19) have argued that IDET can be a valid alternative to surgery.

Appropriate selection criteria guard against abuse of the procedure. NASS, ASA, ASSR, AAPM, PASSOR, AAPMR, ASIPP, and ISIS believe that few patients over the age of 65 would satisfy the indications for IDET, for which reason there is little room, epidemiologically, for abuse of the procedure in this population. However, in that regard, it should be the selection criteria pertaining to the physiologic characteristics of a painful disc, not simply the age or Medicare status of patients that determine the use of IDET. There are some patients covered by Medicare who are not elderly, and who exhaust conventional care. For these patients IDET may be appropriate.

While the treatment effect of IDET is small, the level of evidence is one that unfortunately is not met by many commonly accepted and utilized therapies in medicine or surgery. For this reason, we believe that IDET is a valid option if practised in a disciplined manner according to the recommended criteria.

Accordingly as CMS reviews its proposed determination, we seek any limitations to the coverage of IDET for Medicare patients be based not by demographic classification, but by the application of recommended selection criteria. We further urge CMS to consider Sackett’s principles in the application of evidence-based medical criteria in their final determination and recognize that should the proposed standard applied to IDET be fairly applied for future NCDs, no currently covered surgical or non-surgical treatment for chronic low back pain would meet coverage criteria.

REFERENCES
1. Bogduk N, Lau P, Govind J, Karasek M. Intradiscal electrothermal therapy. Tech Reg Anesth Pain Manag 2005; 9:25-34.
2. Troussier B, Lebas JF, Chirossel JP et al. Percutaneous intradiscal radiofrequency theromocoagulation: a cadaveric study. Spine 1995; 20:1713-1718.
3. Barendse GAM, van der Berg S, Kessels AHF et al. Randomised controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic pain. Spine; 26:287-292.
4. Ercelen Ö, Bulutcu E, Öktenolu T et al. Radiofrequency lesioning using two different time modalities for the treatment of lumbar discogenic pain: a randomised trail. Spine 2003; 28:1922-1927.
5. Sackett DL, Rosenberg WMC, Gray JAM, Haynes RB, Richardson WS. Evidence-based medicine: What it is and what it isn’t. BMJ 1996; 312:71-72.
6. Kapural L, Makhail N, Korunda Z, Basali A. Intradiscal thermal annuloplasty for the treatment of lumbar discogenic pain in patients with multilevel degenerative disc disease. Anesth Analg 2004; 99:472-476.
7. Kapural L, Hayek S, Malak O, Arrigain S, Mekhail N. Intradiscal thermal annuloplasty versus intradiscal radiofrequency ablation for the treatment of discogenic pain: a prospective matched control trial. Pain Medicine 2005; 6:425-431.
8. Karasek M, Bogduk N. Twelve-month follow-up of a controlled trial of intradiscal thermal anuloplasty for back pain due to internal disc disruption. Spine 2000; 25:2601-2607.
9. Bogduk N, Karasek M. Two-year follow-up of a controlled trial of intradiscal electrothermal anuloplasty for chronic low back pain resulting from internal disc disruption. The Spine Journal 2002; 2:343-350.
10. Lutz C, Lutz GE, Cooke PM. Treatment of chronic lumbar diskogenic pain with intradiskal electrothermal therapy: a prospective outcome study. Arch Phys Med Rehabil 2003; 84:23-28.
11. Maurer P, Block JE, Squillante D. Intradiscal electrothermal therapy (IDET) provides effective symptom relief in patients with discogenic low back pain. J Spinal Disord Tech 2008; 21:55-62.
12. Nunley PD, Jawahar A, Brandao SM, Wilkinson KM. Intradiscal electrothermal therapy (IDET) for low back pain in worker’s compensation patients. J Spinal Disord Tech 2008; 21:11-18.
13. Lee MS, Cooper G, Lutz GE, Lutz C, Hong HM. Intradiscal electrothermal therapy (IDET) for treatment of chronic lumbar discogenic pain: a minimum 2-year clinical outcome study. Pain Physician 2003; 6:443-448.
14. Saal JA, Saal JS. Intradiscal electrothermal treatment for chronic discogenic low back pain. A prospective outcome study with minimum 1-year follow-up. Spine 2000; 25:2622-2627.
15. Saal JA, Saal JS. Intradiscal electrothermal treatment for chronic discogenic low back pain. Prospective outcome study with a minimum 2-year follow-up. Spine 2002; 27:966-974.
16. Cohen SP, Larkin T, Abdi S, Chang A, Stojanovic M. Risk factors for failure and complications of intradiscal electrothermal therapy: a pilot study. Spine 2003; 28:1142-1147.
17. Pauza KJ, Howell S, Dreyfuss P, et al. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J 2004;4:27-35.
18. Freedman BA, Cohen SP, Kuklo TR, Lehman RA, Larkin P, Giuliani JR. Intradiscal electrothermal therapy (IDET) for chronic low back pain in active-duty soldiers: 2-year follow-up. The Spine Journal 2003; 3:502-509.
19. Anderson GB, Mekhail NA, Block JE. Treatment of intractable discogenic low back pain. A systematic review of spinal fusion and intradiscal electrothermal therapy (IDET). Pain Physician 2006; 9:237-248.

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I am very saddened that CMS is considering non-coverage of IDET type procedures. The literature is well known to CMS, so I will not repeat the point that about half the patients undergoing the procedure have a very good outcome. In my experience at the VA Medical Center in Dallas I had a 28 year old veteran with disabling low back pain who was on track to join the league of low back pain disabled patients on the disability "payroll".

After the IDET he had "his life back", thanked all of us and wrote a letter to the administration, why the procedure was not available any earlier at the VA. He ended up signing up for a racing motor cycle school and lead a productive life. Of course this is just an n=1 but for that patient IDET made all the difference in his life.

The notion that IDET helps about half the patients may sound like proof that "it is not worth it" but the fair comparison would be with spine operations which have either similar outcomes at much higher expenses or worse outcomes with higher expenses. I would urge you to keep the coverage for IDET but set clinical guidelines for coverage. These could be along the line that the patient should be in the category of patients with known better outcomes (maximum 1-2 lumbar disks, no morbid obesity, partially maintained disc height, provocation discography showing concordant pain in 1 or 2 discs). If CMS removes coverage, only rich patients will be able to pay >$2000 out of pocket and afford the procedure.

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Thank you for providing us with the opportunity to comment on this decision. We are also very grateful for your consideration of comments from ASIPP in decision-making.

The proposed decision memo describes in detail the literature review and the process. However, CMS’s final decision that thermal intradiscal procedures are not reasonable and necessary for the treatment of low back pain and the proposal to issue a national non-coverage determination for thermal intradiscal procedures may not be appropriate for patient care. On behalf of the interventional pain management community, we would like to make the following comments with regards to intradiscal electrothermal therapy (IDET) without inclusion of other techniques.

Dear Dr. Phurrough and the Coverage and Analysis Group,

I am shocked and saddened by the agency’s proposed coverage decision (or lack thereof) for CAG-00387N stating that thermal intradiscal procedures do not improve health outcomes and are not reasonable and necessary for the treatment of low back pain. My first point of contention would be that you have lumped all intradiscal procedures together (IDET, biacuplasty, PIRFT) when it has been well demonstrated that these procedures are vastly different when it comes to mechanism of action (IDET-thermal; biacuplasty and PIRFT-radiofrequency), location of treatment (IDET-annular; biacuplasty and PIRFT-nuclear) and body of supporting evidence (IDET- positive RCT, numerous positive observational and comparison studies; biacuplasty and PIRFT-no RCT, very few observational studies). It is obvious that IDET is in a separate category from biacuplasty and PIRFT: a fact that the AMA made quite clear when it separated all other forms of non-thermal annuplasty from IDET and graduated IDET and IDET alone from a Category III CPT code to its’ own Category I CPT code 2 years ago.

If one looks objectively at the “3” randomized controlled studies you have sited in your proposed decision, one would see that there really is only 1 true randomized controlled trial.

The Barendse study should not even be included since this was not a study of IDET, but rather a single point source RF needle placed in the center of a disc nucleus and heated for a short time. This would be no different than comparing how effective it would be to melt the wax on the side of a candle by holding a match directly against the side of the candle for 16 minutes (IDET) vs. lighting the wick for 2 minutes (PIRFT).

The Freeman study was a study of IDET, however, there were major flaws. First and foremost, not only was there no positive outcome in the treatment group, there was NO PLACEBO EFFECT in the control group. This finding is dissonant with the bulk of all IDET observational data, therefore, Freeman must not have been studying what was commonly practiced and achieved. Furthermore, if there are no positive results in the control group, one can not make the statement that IDET is equivalent to placebo since no conclusion can be justified when there is a comparison between zero and zero. Also, CMS states that the observational studies suffer from a large placebo effect, but then also gives an inordinate amount of credence to the Freeman study which has no placebo effect. You can’t have it both ways. Other problems with Freeman’s study was the selection of patients with pain up to 20 years duration, non-standard discography including the injection of a superdose of antibiotics into each disc which has been shown to be toxic to tissues within the disc at a cellular level.

The Pauza study is therefore the only true RCT of IDET showing improvement on several levels at a high confidence level, comparable with the large body of positive evidence both preceding and proceeding this landmark study.

I do not know if biacuplasty has positive effects since there are clearly not enough studies to support it. However, IDET should be split from these other procedures, and my hope is that CMS objectively reevaluates the evidence in support of IDET and gives it a positive coverage decision to give strictly chosen patients a chance for pain relief.

Douglas Fenton, MD
Assistant Professor of Radiology
Mayo Clinic School of Medicine

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Dear Dr. Phurrough and the Coverage and Analysis Group:

I strongly disagree with CMS'' conclusion in their proposed decision memo titled "Thermal Intradiscal Procedures" (CAG-00387N) that "the evidence is adequate to conclude that thermal intradiscal procedures do not improve health outcomes" and that "thermal intradiscal procedures are not reasonable and necessary for the treatment of low back pain…" (p. 1 of 49). This conclusion contradicts not only the large body of peer-reviewed published literature, but also the stated recommendations of a number of physician specialty societies that represent this area of medicine.

In response to CMS'' initial request in February 2008 for public comment on thermal intradiscal procedures (TIPs), a total of 75 comments were posted to their website. Of the 75 comments, 70 addressed/mentioned intradiscal electrothermal therapy (IDET) and 68 of these urged coverage. The majority of comments were from physicians with experience with IDET, and importantly, three comments - all in favor of IDET coverage - were provided by professional societies, and one was from the president of a professional society. Many comments were from internationally-recognized pain physicians and spine experts including Richard Derby, M.D. and Howard An, M.D. In short, the vast majority of comments on IDET were positive and urged coverage. I find it surprising that CMS elected to ignore this outpouring of support for this procedure from physicians and specialty societies. If there was a large coterie of physicians with strong negative views about the effectiveness of IDET, surely they would have voiced their disapproval in this forum. They did not.

There have been two quantitative systematic reviews of the safety and effectiveness of the IDET procedure, Andersson et al¹ and Appleby et al.² As opposed to other review articles, both of these reports were comprehensive in reviewing the entire compendium of peer-reviewed literature available at the time of their publication, and reached a starkly different conclusion than CMS. It should be noted that I was a co-author on the article by Andersson and we have subsequently updated the analysis to include several additional recently-published reports of IDET. To date, there have been 35 published IDET clinical reports; 23 studies reported findings related to back pain symptoms, and 20 of these provided adequate data to compute the median percentage improvement following the IDET procedure. The overall median percentage improvement in pain severity after the IDET procedure was 52% (range: 22% to 81%). Thus, the typical improvement in pain symptoms experienced after IDET is far in excess of the 30% change promulgated recently as a clinically beneficial improvement.3 Moreover, in 8 IDET studies, the median percentage of patients experiencing a 2 unit improvement in pain severity was 68% (range: 58% to 80%). This degree of improvement in back pain represents the minimal clinically important difference in this outcome.^{3, 4}

Of the 35 published clinical reports of the effectiveness of IDET, the authors of 27 (77%) articles concluded that the procedure was effective, ³ (9%) that it was equivocal, and ⁵ (14%) that it was ineffective. Yet, despite this fairly impressive imbalance in favor of IDET, the CMS Coverage and Analysis Group elected to side with the conclusions reached by a small minority of researchers. This not only defies logic, but flies in the face of the basic tenets of clinical trial interpretation acknowledged by many methodologists and clinical trialists.

There have been 2 randomized sham-controlled trials of IDET. In brief, Pauza et al⁵ found IDET to be effective and Freeman et al⁶ found that it was not. CMS chose to base their proposed negative decision, in large part, on the results of Freeman despite legitimate criticisms that have been levied against this study.⁷ In contrast, the criticisms raised against the Pauza study have been mostly predictable and, in some cases, amount to overreach. For example, CMS has indicated that the primary results of Pauza were analyzed per-protocol and not by intention-to-treat (ITT), thereby excluding 12.5% of originally randomized subjects. I conducted an ITT analysis of the Pauza data on pain severity with missing values designated as failures and computed a p=0.06 for the difference between IDET and sham. CMS also indicates that Pauza''s "Success criteria for pain reduction was defined post-hoc" and it was unclear that "the definition of success that the authors used was clinically meaningful." These assertions were based on a review of IDET by Urrutia et al.⁸ Not only have the conclusions of this review been questioned,⁹ but as I indicated previously, the 2 unit improvement chosen by Pauza to demonstrate a clinically significant improvement in pain severity has been well established as the minimal clinically important difference in this outcome.^{3, 4} Ironically, Freeman and coworkers included the exact same pain improvement criteria in their Materials and Methods section, (see p. 2371 of their originally published report, "The mean clinically important difference in primary and secondary outcome measures was set at … 2 points for the VAS for back pain,").⁶

A major flaw of the Freeman trial was that they neglected to report their pain severity findings, despite the fact that this pivotal outcome is clearly stated in their Materials and Methods section as I have described directly above as well as in the following quote from earlier in the same section, "Outcome measures recorded at baseline and 6 months included the Visual Analogue Score for back pain (VAS)" (p. 2371).⁶ In response to a request to correct this data omission in a letter-to-the editor of Spine,7 Freeman and colleagues replied that "The visual analog score was not a primary outcome measure of success and, as such, was not regarded as ''pivotal data.'' Mean improvement in the visual analog score for the IDET group was 0.57 points compared to 0.15 points for the sham group." Their response failed to explain the absence of an important clinical outcome in their published report among patients whose primary complaint is pain, and also failed to provide the pre- and post-treatment mean values for pain VAS. In any case, if we assume a pre-treatment mean pain VAS score of 7.0, the change values they report reflect an approximate improvement of 8% for IDET and 2% for sham. This 8% estimated average change in IDET-treated patients is striking in that it is noticeably lower than the minimum value (22%) of improvement for all other published studies of IDET reporting pain severity scores, as I have noted above. However, this is not the biggest cause for concern.

Rather, what is most remarkable about this study is the absence of a placebo effect after sham treatment (i.e., 2% estimated mean improvement in pain). This puzzling finding is certainly different than the classic placebo response found in the Pauza study and is at odds with the vast body of clinical research demonstrating a placebo effect in trials that involve subjective outcomes, such as pain.¹⁰ Neither Freeman, or any other author supporting the results of Freeman or CMS has provided a reasonable explanation for this finding. I find it contradictory that CMS would place so much emphasis on Freeman''s inexplicable findings at the same time that they disparage all other non-randomized trials of IDET because they are "particularly problematic in the evaluation of low back pain treatment for the following reasons: …. the placebo effect, also known as expectation response, plays an important role in the treatment of pain" (p. 33 of 49) In other words, CMS wants to have it both ways. On one hand, the agency relies disproportionately on the results of Freeman demonstrating no placebo response and, on the other hand, the agency discredits the positive findings from all other studies because they could result from the placebo effect. If CMS believes in placebo, CMS must discount the Freeman results.

The proposed decision memo also suffers from several other problems. First, there is a misdirected emphasis in the Background section on nonspecific chronic low back pain (NCLBP). IDET is a treatment specifically indicated for patients with symptomatic and radiographically-confirmed internal disc disruption, specifically annular tears, not NCLBP. Internal disc disruption is a sub-class of generalized degenerative disc disease and has been classified separately by combined task forces of the North American Spine Society, American Society of Spine Radiology, and American Society of Neuroradiology.¹¹ Second, there is over reliance throughout the Background section on the use of quotations from editorials and commentaries published by individuals with a known bias against invasive back treatments in general^{12, 13} and the value of discography in the confirmation and selection of patients for treatment of discogenic pain.¹⁴ Third, CMS states that "TIPs are proposed as an alternative to spinal fusion" (p. 4 of 49). This is not true. IDET is a minimally-invasive procedure with a far more attractive safety profile than fusion and actually offers an intermediate intervention between conservative care and more invasive surgical procedures, such as fusion or artificial disc arthroplasty. IDET has the advantage of preserving the native disc structure and, thus, undergoing the procedure does not eliminate the possibility of more invasive treatments such as spinal fusion or disc arthroplasty if severe symptoms re-develop or more progressive mechanical changes ensue. Fourth, CMS states that "The scope of this national coverage analysis is TIPs which involve percutaneous intradiscal techniques utilizing devices that employ the use of an energy source, usually RFE" (p. 5 of 49). This also is not true. The vast majority of published literature on disc annuloplasty involves the IDET procedure, which uses an electrothermal energy source. This distinction has been recognized by the AMA CPT coding committee, issuing a Category I CPT code for IDET alone. The unfortunate use of the TIPs nomenclature invariably lumps together not only techniques with different energy sources, but also techniques with distinctly different indications. For example, CMS conjoins devices indicated for treatment of symptomatic annular tears, such as IDET, with devices for treatment of disc herniation with radiculopathy. For these reasons the TIPs acronym should be abandoned.

There also are numerous portions of this memo that appear slanted. For example, there is a suggestion that obtaining marketing clearance from the FDA via the 510(k) process is in some way sinister, when this is a legitimate regulatory pathway that is well monitored and reviewed by FDA. I would like to see a more balanced presentation.

The Bogduk and Karasek study is incorrectly identified as a case control study (p. 19 of 49). This study is a prospective non-randomized controlled trial. A case-control study is most commonly retrospective in design and seeks to identify possible predictors or risk factors of a disease or syndrome. CMS also lumps together all single arm studies, whether prospective or retrospective, as "case series." This is a simplistic classification and discounts the value of prospective single arm studies of patients with refractory pain followed serially via a planned protocol versus patient data retrospectively retrieved from medical records or patient recall. In reality, findings derived from single-arm prospective trials may be more realistic and closer to results achieved in the clinic. Placebo-controlled randomized trials actualize a distinctly abnormal clinical scenario, e.g., a physician would never prescribe a medication for a patient and tell them that they only had a 50/50 chance of getting the real drug when they arrived at the pharmacy to fill their prescription. Clearly, the expectations experienced by patients involved in a randomized controlled trial (RCT) are different than those receiving a treatment in the clinical setting, and this possible "masking bias" associated with RCTs has been postulated.¹⁵

In closing, all of the clinical studies published in 2008 have shown a positive treatment effect for IDET in patients with radiographically-confirmed, symptomatic annular tears.^16-18 The approximate clinical success rate in these studies has been 75% using patient selection criteria similar to those proposed (and accepted for publication) by myself and my co-authors with extensive experience in performing the procedure and/or evaluating treatment options in this area of medicine.¹⁹

Sincerely,

Jon E. Block, Ph.D.

References
1. Andersson GB, Mekhail NA, Block JE. Treatment of intractable discogenic low back pain. A systematic review of spinal fusion and intradiscal electrothermal therapy (IDET). Pain Physician. 2006;9(3):237-248.
2. Appleby D, Andersson G, Totta M. Meta-analysis of the efficacy and safety of intradiscal electrothermal therapy (IDET). Pain Med. 2006;7(4):308-316.
3. Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain. Towards international consensus regarding minimal important change. Spine. 2008;33(1):90-94.
4. Hagg O, Fritzell P, Nordwall A. The clinical importance of changes in outcome scores after treatment for chronic low back pain. Eur Spine J. 2003;12(1):12-20.
5. Pauza KJ, Howell S, Dreyfuss P, Peloza JH, Dawson K, Bogduk N. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. 2004;4(1):27-35.
6. Freeman BJ, Fraser RD, Cain CM, Hall DJ, Chapple DC. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine. 2005;30(21):2369-2377.
7. Andersson GB, Mekhail NA, Block JE. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine. 2006;31(14):1637-1638; author reply 1638.
8. Urrutia G, Kovacs F, Nishishinya MB, Olabe J. Percutaneous thermocoagulation intradiscal techniques for discogenic low back pain. Spine. 2007;32(10):1146-1154.
9. Andersson GB, Block JE. Re: Urrutia G, Kovacs F, Nishishinya MB, et al. Percutaneous thermocoagulation intradiscal techniques for discogenic low back pain. Spine 2007;32:1146-54. Spine. 2007;32(25):2927-2928; author reply 2928-2929.
10. Turner JA, Deyo RA, Loeser JD, Von Korff M, Fordyce WE. The importance of placebo effects in pain treatment and research. JAMA. 1994;271(20):1609-1614.
11. Fardon DF, Milette PC. Nomenclature and classification of lumbar disc pathology. Recommendations of the Combined task Forces of the North American Spine Society, American Society of Spine Radiology, and American Society of Neuroradiology. Spine. 2001;26(5):E93-E113.
12. Deyo RA. Back surgerywho needs it? N Engl J Med. 2007;356(22):2239-2243.
13. Carragee E. Surgical treatment of lumbar disk disorders. JAMA. 2006;296(20):2485-2487.
14. Carragee EJ, Lincoln T, Parmar VS, Alamin T. A gold standard evaluation of the "discogenic pain" diagnosis as determined by provocative discography. Spine. 2006;31(18):2115-2123.
15. Kaptchuk TJ. The double-blind, randomized, placebo-controlled trial: gold standard or golden calf? J Clin Epidemiol. 2001;54(6):541-549.
16. Ergun R, Sekerci Z, Bulut H, Dolgun H. Intradiscal electrothermal treatment for chronic discogenic low back pain: a prospective outcome study of 39 patients with the Oswestry disability index at 18 month follow-up. Neurol Res. 2008;30(4):411-416.
17. Maurer P, Block JE, Squillante D. Intradiscal electrothermal therapy (IDET) provides effective symptom relief in patients with discogenic low back pain. J Spinal Disord Tech. 2008;21(1):55-62.
18. Nunley PD, Jawahar A, Brandao SM, Wilkinson KM. Intradiscal electrothermal therapy (IDET) for low back pain in worker''s compensation patients: can it provide a potential answer? Long-term results. J Spinal Disord Tech. 2008;21(1):11-18.
19. Kloth DS, Fenton DS, Andersson G, Block JE. Intradiscal electrothermal therapy (IDET) for the treatment of discogenic low back pain: patient selection and indications for use. Pain Physician. 2008;in press.

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Dear Dr. Phurrough,

My name is Steven Cohen and I am writing this letter in response to CMS’ proposed Decision memorandum (CAG-00387N) passed on the National Coverage Determination of Thermal Intradiscal Procedures (TIPs).

I am currently the Director of Medical Education for the Pain Management Division at John Hopkins School of Medicine and Chief of Pain Research at Walter Reed Army Medical Center. Over the past 10 years, we have performed several hundred Thermal Intradiscal Procedures, and I have authored several manuscripts on IDET. More recently, we have used the TransDiscal System for the treatment of discogenic pain with promising results.

In this Decision memorandum (CAG-00387N) CMS has proposed to issue a national non-coverage determination for all procedures involved with TIPs. This also includes "second generation" procedures such as Disc Biacuplasty using the TransDiscal System. I would like to request CMS to separate disc Biacuplasty from the noncoverage determination and consider holding off the coverage decision until additional procedure-specific evidence is available.

Disc Biacuplasty ablates nociceptors present in the posterior and posterior-lateral aspects of the painful disc. This rational for treatment is in alignment with our current understanding of disc innervation and pathogenesis. There is evidence to suggest that sensitization of free nerve endings of the posterior disc occurs following fissure formation or in response to other unresolved events in the disc degeneration cascade. Coagulation of these nerves is therefore an intuitive modality of treatment.

There are several features which distinguish Disc Biacuplasty from IDET. Electrode placement in the posterior-larteral aspects of the disc is straight forward and repeatable. The use of internal cooling during energy delivery allows for increased power deposition, and the creation of a thermal lesion across the posterior border of the disc. The suitability of the resultant profile to coagulate nervous tissue has been described in the literature (Petersohn 2008, Kapural 2008). The flexible catheter of IDET is more difficult to repeatedly place, and uses a less efficient means of heat transfer to the surrounding tissue.

The evidence required to make claims regarding the efficacy of Disc Biacuplasty is still being developed. This is to be expected given the duration of time that the treatment has been on the market. A prospective pilot study from Kapural et al. has demonstrated encouraging results. More importantly, two randomized placebo controlled trials are in progress.

I would like to request CMS to separate disc Biacuplasty from the noncoverage determination and consider holding off the coverage decision until RCT study results are published.

Sincerely,

Steven Cohen, MD

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August 12, 2008

Re: Thermal Intradiscal Therapy and CAG#: CAG-00387N

Proposed Decision Memorandum Thermal Intradiscal Procedures (TIPs) - National Coverage Determination (NCD) Public Comment Periodon the proposed Decision memorandum (CAG-00387N) passed on the National Coverage Determination of Thermal Intradiscal Procedures (TIPs). proposed to issue a national non-coverage determination for all procedures involved with TIPs.

This is to comment on the proposed non-coverage determination for all procedures involved with TIPs.

1. While there have been some studies that support the scientific basis for IDET, I would agree that the effectiveness to this modality is insufficient to justify its continued support. In fact, I have stopped doing this procedure, even though I have had about 40-50% positive outcomes. i.e. I would support non-coverage of IDET
2. The inadequacy of the IDET procedure, as well as other modalities, however has stimulated research and technical development for a minimally invasive approach which is desperately needed as an alternative to surgical intervention. I would encourage you not to make a blanket non-coverage issuance that would likely impede progress in techniques which are alternatives to the IDET procedure.
3. One such promising development is the Biacuplasty. The technical aspects (cooled radiofrequency) and the procedure compared to the IDET (resistive coil) make much more sense on a conceptual basis.
4. Beyond the conceptual basis is the fact that early results of well designed studies are showing promise as a legitimate tool in the treatment of low back and lower extremity pain. (reference the studies by Dr. Kapural and Dr. Bogduk and others presented at the ISIS conference several weeks ago in Las Vegas)
5. Double blind controlled clinical trials are ongoing for biacuplasty. A non-coverage determination that includes biacuplasty before quality study results are in seems prejudicial and premature and could delay further studies and the availability of a quality technique if the outcome study results are good.

I would encourage you to separate Biacuplasty from this National Coverage Determination.

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Regarding recently published Proposed National Coverage Determination Decision Memo on “Thermal Intradiscal Procedures (TIP)” I am writing to express our surprise and our disagreement with CMS. I respectfully disagree with CMS decision because, as noted in the evidence-based practice guidelines that were published by various societies including ASIPP which were submitted to CMS in January and previously. There is substantial clinical evidence supporting the continued coverage of these procedures including Intradiscal laser thermodiskoplasty and radiofrequency.We were surprised by the Proposed Decision Memo because CMS received overwhelmingly positive comments on laser thermodiskoplasty and radiofrequency thermal intradiscal procedures in the past but apparently disregarded the opinion of physicians and researchers most familiar with the procedures in order to reach a different conclusion. As a minimally invasive spinal surgeon, I strongly believe that the clinical evidence as well physicians’ own experiences, justifies Medicare coverage.CMS’ decision places undue emphasis on older studies, which did not employ the current patient selection criteria. Furthermore, the agency lumped together all forms of thermal intradiscal therapy without considering important clinical differences. The current clinical literature and practice guidelines reflect a more sophisticated, stratified approach, rather than a one-size-fits-all analysis. I urge CMS to reconsider its Proposed Decision Memo. Medicare beneficiaries who suffer from discogenic pain should not lose access to TIP, an effective and safe minimally invasive treatment option on selected patients. At the very least, if CMS needs additional information about the accuracy of the patient selection criteria, the agency should authorize “coverage with evidence development” so that additional studies can be conducted while Medicare beneficiaries continue to have access to this procedure.Thank you for your careful attention to this important issue. I am confident that if you reexamine the clinical literature and the views of the medical community, you will see that TIP procedures are an important treatment option that should not be removed as a treatment option.

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I am a neurosurgeon practicing in Nashville, Tennessee and I have extensive experience with plasma disc decompression.

As noted by others, I, too, would like to express my concern regarding the inclusion of plasma disc decompression (PDD) using Coblation technology in this assessment. The procedures and devices which are the focus of this report are used to treat axial low back pain found with early stage disc degeneration, whereas PDD is used to treat radicular pain associated with focal disc protrusion.

Additionally, the PDD procedure is not comparable to the heat-based intradiscal procedures being evaluated in this assessment. The plasma generated with Coblation is not heat-based and, in fact, generates temperatures in the disc that are much lower than those found in heat-driven procedures. Further, the PDD procedure provides a means of a discectomy with vaporization of nucleus pulposis and consequently a significant reduction in the intradiscal pressure. The IDET procedure does not allow for discectomy or a reduction in intradiscal pressure. Studies to date show greater clinical outcomes with the PDD procedure because of these differences.

It appears that this NCA is focused on procedures that employ heat-based technologies. Therefore, I respectfully request that PDD be removed from the listing of procedures shown in this NCA since it can be distinctly differentiated from the TIPs described in this review. The plasma disc decompression (PDD) procedure should not be included in this analysis.

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I am an Associate Professor of Neurosurgery at the University of Pittsburgh Medical Center and have performed hundreds of plasma disc decompression procedures over the past six years. I have published extensively in peer-reviewed journals and lectured around the world regarding the procedure and am considered somewhat of an “expert” in the technique.

In reviewing the proposed NCA for Thermal Intradiscal Therapy, CMS appears to have incorrectly classified plasma disc decompression (PDD) as a Thermal Intradiscal Procedure (TIP). I am writing this letter in an effort to ensure that the final NCA is clear and accurate regarding the scope of this evaluation.

According to this assessment, CMS defines TIPs as “percutaneous intradiscal techniques utilizing devices that employ the use of an energy source, usually RFE, to apply or create heat within the disc for coagulation and/or decompression of disc material to treat symptomatic patients with annular disruption of contained herniated disc, to seal annular tears or fissures, or destroy nociceptors for the purpose of relieving pain.”

The PDD procedure is performed using Coblation technology, which has unique qualities that differentiate it from technologies used to perform TIPs. It is well documented in the literature that the “plasma” formed by a Coblation device is created by a non-heat driven process. Similar to mechanical devices, Coblation devices remove or debulk soft tissue. It does not rely upon the use heat to destroy nociceptors such as the other techniques listed. Thermal energy is not the mechanism of action by which PDD works. In fact, Coblation devices have supplanted mechanical devices and become the standard of care in a number of surgical procedures involving tissue removal, including arthroscopic procedures such as subacromial decompression or meniscectomy and tonsillectomy.

Because of the very important and highly significant differences between plasma disc decompression (PDD) and TIPs as described in this NCA, PDD should be excluded from this national coverage analysis and removed from the proposed list of non covered services. I would be very happy to discuss this with anyone in more detail if you wish.

Peter C. Gerszten, MD, MPH

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Thomas M. Larkin, M.D.

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop: C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Thermal Intradiscal Procedures (CAG-00387N)

Dear Dr. Phurrough:

I am writing to express our surprise and our disagreement with CMS’ recently published Proposed Decision Memo on “Thermal Intradiscal Procedures.” I respectfully disagree with CMS’ decision because, as noted in the evidence-based practice guidelines that were published by ASIPP and which were submitted to CMS in January, there is substantial clinical evidence supporting the continued coverage of these procedures, particularly coverage of Intradiscal Electrothermal Therapy (IDET). We were surprised by the Proposed Decision Memo because CMS received overwhelmingly positive comments on IDET but apparently disregarded the opinion of physicians and researchers most familiar with the procedure in order to reach a different conclusion. As an interventional pain management, I strongly believe that the clinical evidence as well physicians’ own experiences, justifies Medicare coverage.CMS’ decision places undue emphasis on older studies, which did not employ the current patient selection criteria. Furthermore, the agency lumped together all forms of thermal intradiscal therapy without considering important clinical differences. The current clinical literature and practice guidelines reflect a more sophisticated, stratified approach, rather than a one-size-fits-all analysis. I urge CMS to reconsider its Proposed Decision Memo. Medicare beneficiaries who suffer from discogenic pain should not lose access to IDET, an effective and safe minimally invasive treatment option. At the very least, if CMS needs additional information about the accuracy of the patient selection criteria, the agency should authorize “coverage with evidence development” so that additional studies can be conducted while Medicare beneficiaries continue to have access to this procedure.Thank you for your careful attention to this important issue. I am confident that if you reexamine the clinical literature and the views of the medical community, you will see that IDET is an important treatment option that should not be removed as a treatment option.

Sincerely,
Thomas M. Larkin, M.D.

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Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop: C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Thermal Intradiscal Procedures (CAG-00387N)

Dear Dr. Phurrough:

I am writing to express our surprise and ourdisagreement with CMS’ recently published ProposedDecision Memo on “Thermal Intradiscal Procedures.” I respectfully disagree with CMS’ decisionbecause, as noted in the evidence-based practiceguidelines that were published by ASIPP and whichwere submitted to CMS in January, there issubstantial clinical evidence supporting thecontinued coverage of these procedures,particularly coverage of IntradiscalElectrothermal Therapy (IDET). We were surprised by the Proposed Decision Memobecause CMS received overwhelmingly positivecomments on IDET but apparently disregarded theopinion of physicians and researchers mostfamiliar with the procedure in order to reach adifferent conclusion. As an interventional painmanagement, I strongly believe that the clinicalevidence as well physicians’ own experiences,justifies Medicare coverage.CMS’ decision places undue emphasis on olderstudies, which did not employ the current patientselection criteria. Furthermore, the agency lumpedtogether all forms of thermal intradiscal therapywithout considering important clinicaldifferences. The current clinical literature andpractice guidelines reflect a more sophisticated,stratified approach, rather than aone-size-fits-all analysis. I urge CMS to reconsider its Proposed DecisionMemo. Medicare beneficiaries who suffer fromdiscogenic pain should not lose access to IDET, aneffective and safe minimally invasive treatmentoption. At the very least, if CMS needs additionalinformation about the accuracy of the patientselection criteria, the agency should authorize“coverage with evidence development” so thatadditional studies can be conducted while Medicarebeneficiaries continue to have access to thisprocedure.Thank you for your careful attention to thisimportant issue. I am confident that if youreexamine the clinical literature and the views ofthe medical community, you will see that IDET isan important treatment option that should not beremoved as a treatment option.

Sincerely,

W. Porter McRoberts MD, FABPMR
Section Chief, Pain Medicine, Holy Cross Hospital,
Fort Lauderdale, Florida

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Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop: C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Thermal Intradiscal Procedures (CAG-00387N)

Dear Dr. Phurrough:

I am writing to express our surprise and our disagreement with CMS’ recently published Proposed Decision Memo on “Thermal Intradiscal Procedures.” I respectfully disagree with CMS’ decision because, as noted in the evidence-based practice guidelines that were published by ASIPP and which were submitted to CMS in January, there is substantial clinical evidence supporting the continued coverage of these procedures, particularly coverage of Intradiscal Electrothermal Therapy (IDET). We were surprised by the Proposed Decision Memo because CMS received overwhelmingly positive comments on IDET but apparently disregarded the opinion of physicians and researchers most familiar with the procedure in order to reach a different conclusion. As an interventional pain management, I strongly believe that the clinical evidence as well physicians’ own experiences, justifies Medicare coverage.CMS’ decision places undue emphasis on older studies, which did not employ the current patient selection criteria. Furthermore, the agency lumped together all forms of thermal intradiscal therapy without considering important clinical differences. The current clinical literature and practice guidelines reflect a more sophisticated, stratified approach, rather than a one-size-fits-all analysis. I urge CMS to reconsider its Proposed Decision Memo. Medicare beneficiaries who suffer from discogenic pain should not lose access to IDET, an effective and safe minimally invasive treatment option. At the very least, if CMS needs additional information about the accuracy of the patient selection criteria, the agency should authorize “coverage with evidence development” so that additional studies can be conducted while Medicare beneficiaries continue to have access to this procedure.Thank you for your careful attention to this important issue. I am confident that if you reexamine the clinical literature and the views of the medical community, you will see that IDET is an important treatment option that should not be removed as a treatment option.

Sincerely,
Raj Sureja MD
Interventional Pain Management
Orthopaedic & Spine Center
751 J. Clyde Morris Blvd.
Newport News, Virginia 23601

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Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mailstop: C1-09-06
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Thermal Intradiscal Procedures (CAG-00387N)

Dear Dr. Phurrough:

I am writing to express our surprise and our disagreement with CMS’ recently published Proposed Decision Memo on “Thermal Intradiscal Procedures.” I respectfully disagree with CMS’ decision because, as noted in the evidence-based practice guidelines that were published by ASIPP and which were submitted to CMS in January, there is substantial clinical evidence supporting the continued coverage of these procedures, particularly coverage of Intradiscal Electrothermal Therapy (IDET). We were surprised by the Proposed Decision Memo because CMS received overwhelmingly positive comments on IDET but apparently disregarded the opinion of physicians and researchers most familiar with the procedure in order to reach a different conclusion. As an interventional pain management, I strongly believe that the clinical evidence as well physicians’ own experiences, justifies Medicare coverage.CMS’ decision places undue emphasis on older studies, which did not employ the current patient selection criteria. Furthermore, the agency lumped together all forms of thermal intradiscal therapy without considering important clinical differences. The current clinical literature and practice guidelines reflect a more sophisticated, stratified approach, rather than a one-size-fits-all analysis. I urge CMS to reconsider its Proposed Decision Memo. Medicare beneficiaries who suffer from discogenic pain should not lose access to IDET, an effective and safe minimally invasive treatment option. At the very least, if CMS needs additional information about the accuracy of the patient selection criteria, the agency should authorize “coverage with evidence development” so that additional studies can be conducted while Medicare beneficiaries continue to have access to this procedure.Thank you for your careful attention to this important issue. I am confident that if you reexamine the clinical literature and the views of the medical community, you will see that IDET is an important treatment option that should not be removed as a treatment option.

Sincerely,
Timothy R Lubenow MD
Timothy R. Lubenow MD

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August 1, 2008,
Dear Doctor Phurrough, et al:
I have reviewed CMS' proposed coverage decision memorandum for thermal intradiscal procedures. This memorandum encompasses a number of different procedures or techniques including IDET (Intradiscal Electrothermal Annuloplasty), PIRFT (Percutaneous Intradiscal Radiofrequency Thermocoagulation), and Biaculoplasty.

The evidence on these modalities of treatment and more specifically with IDET is quite extensive and supports coverage of IDET.

While all of the literature does not meet with what CMS considers the highest quality (RCT studies), much of it is of good quality and supports the effectiveness of IDET. In my opinion, the evidence that supports the use of these modalities is not fairly and uniformly presented within this proposed decision memorandum. Instead, CMS seems to focus on only the aspects which support a non-coverage decision. While this may not have been the intention, it gives an appearance that this document was written in a biased format to support an opinion to deny access to these therapies.

As we all know, literature can be interpreted in many different ways. It is very difficult to argue the specifics of literature interpretation, but I will try to do so throughout this letter at pertinent points. I would like to begin by pointing out to CMS that it has never been proven that evidence based medicine provides higher quality of care than clinical decision making by the physician or practitioner. In addition, the difficulties and limitations of performing RCT's studies from an ethical standpoint like it or not complicates the ability to perform such studies and this must be kept in mind when emphasis is to be placed on such literature.

I think the best way to review this decision is in a page by page format following your actual proposed decision. I would note that many quotes in this proposed decision memorandum are in my opinion taken of context and do not represent the author's actual opinion. Hopefully those individuals will provide their own comments to set the record straight.

The proposed decision memorandum begins with a background on back pain in the United States and the contributions of degenerative disc disease towards chronic lower back pain. The memorandum indicates that CMS has concerns with the rapid escalation in procedures and treatments for lower back pain. Martin is quoted in the second paragraph of page 3 as stating, 'There are no improvements over this period in self assessed health status, functional disability, work limitations, or social functioning among respondents with spine problems'. However, this is merely one individual's opinion and is not consistent with the body of literature on pain management treatments over the last 15-20 years. Martin and his colleagues work has been criticized by many including Ratliff and Hilibrand. ¹ While there has been a marked increase in the number and type of procedures performed, which could inherently lead to some confusion and perhaps frustration amongst payers (not necessarily patients or clinicians as you have eluded), this does not mean that we should not be trying to offer indicated, appropriate medical care to Medicare beneficiaries. The increased numbers and types of procedures are consistent with the growth of Interventional Pain Management as a specialty and the expansion of treatments that have been developed to control pain with less invasive techniques than surgical intervention. Haldeman states that, 'We do not know the origin of low back pain in the majority of cases'. While this may be true, this is why it is so important for the clinician to perform a thorough history and physical examination in order to provide an accurate differential diagnosis and direct an appropriate diagnostic workup. Unfortunetly not all clinicians have the same diagnostic acumen. Many of the procedures performed by Interventional Pain Management doctors are not just for therapeutic purposes but also provide diagnostic information (i.e. failure to respond to a lumbar facet block provides evidence against a diagnosis of lumbar facet syndrome). You go on to quote Haldeman on Page 4, 'The question that needs to be answered is whether any treatments should be offered'. This statement by Holderman is taken out of context and I doubt that Medicare beneficiaries who have received help from a pain specialist would agree that they should not be offered care for their chronic lower back pain.

The next paragraph discusses an alleged controversy surrounding discography. Without a doubt discography is the standard of care. I would point out that very few physicians in this country agree with Dr. Carragee's opinion on discography, a subject on which he has been very outspoken. The controversy only exists in small circles and in general this is a well accepted diagnostic tool. For more information on discography, see the review article in Pain Physician by Dr. Rinoo Shah where the literature on discography has been extensively reviewed and Dr. Carragee's criticism of this diagnostic tool critically critiqued.². Most recently (July/August issue of Pain Physician) Wolfer et. al. published a meta analysis looking at the false positive rate of discography based on concerns raised by some physicians such as Caragee. They found a low and very acceptable false positive rate (< 10%) in contrast to the claims of these other physicians.³ Dr. Peng's statements on discography have been taken out of context and Dr. Peng himself supports the use of discography,⁴ as do some of the other physicians that you have quoted as stating that discography is controversial. Many of these physicians believe strongly in discography as a diagnostic tool and their opinions seem to be misrepresented in your proposed decision memorandum.

One of my many concerns stems from the emphasis and weight that CMS places on Dr. Carragee's extreme opinion which is contrary to the thousands of other physicians in this country who disagree with his view. One must also question why Dr. Carragee's opinion carries more weight than the NASS policy position on discography⁵ as well as the thousands of other physicians in this country who disagree with his opinion. Discography is standard of care in this country for the diagnostic workup of discogenic pain. Thus it is unclear why CMS in a proposed decision memorandum feels that it is within their purview to change the standard of care within the United States. The final full sentence of Page 4 states, 'The mechanism of the disorder of nonspecific chronic lower back pain remains uncertain'. By definition if it is nonspecific, the etiology or mechanism is uncertain. Discography can help us understand the cause of pain and is an important and medically indicated and appropriate diagnostic tool.

Page 5 contains Dr. Derby's description of RFE. I would note that when Dr. Derby is talking about coablation he is talking about Nucleoplasty and not Thermal Intradiscal Procedures (TIPs). This shows a lack of understanding of annuloplasty treatments. In the third full paragraph of this page decompression of the disc is discussed and that is not the purpose of TIPs procedures, but rather they are designed to effectuate annular repair and/or denervation. TIP's are typically used to treat annular tears not associated with contained disc herniations. To treat a disc herniation one must decompress the disc through one of the other modalities available today.

At the bottom of Page 5, it becomes very clear why this was brought to the attention of CMS. The North American Spine Society (NASS) was unhappy with the AMA CPT's final ruling on IDET (I was one of the presenters at the AMA CPT meeting on IDET in 2/06) which went against their representatives' opinion at this meeting. I would like to point out that NASS offers courses where they actually teach physicians how to perform IDET treatment. If they have concerns about the efficacy of IDET why are they teaching it? There are also numerous NASS members who perform this treatment on a regular basis. Therefore, NASS' complaints to CMS and public statements on this subject, are at times in direct contradiction to their actual actions. It has been suggested by some that the letter you 'received 12/06' was not the official stance of NASS.

NASS' complaints bring to mind the statement that people who live in glass houses shouldn't throw stones. The failure rate of lumbar fusions in the Medicare population in this country is astounding. The costs of failed back surgery are astronomical when compared to the costs of a failed IDET treatment. A patient who fails IDET will likely go on either to no other treatment or to other conservative modalities of treatment. Patients who fail fusion surgery require spinal cord stimulators, implantable spinal opioid delivery systems, or chronic oral narcotic medications at an extremely high cost to Medicare.

Expertise as it relates to annuloplasty procedures is more in the purview of interventional pain management specialists such as are members of the American Society of Interventional Pain Physicians (ASIPP), The Interventional Spinal Injection Society (ISIS), and the American Academy of Pain Medicine (AAPM). How much weight would CMS place on ASIPP's critique of spinal fusions in the United States? NASS' concluding statement on the top of Page 6 could equally be applied to lumbar fusion surgery, disc arthroplasty, or any number of procedures performed by spinal surgeons in the United States.

I would emphasize that IDET received a level one CPT Code 22527/27 from the AMA in February, 2006. NASS provided strong objections at that time but a committee of nationally recognized physicians who sit on the AMA CPT Committee determined that there was a level of evidence enough to provide a level one CPT Code for IDET. I presented at this meeting on behalf of ASIPP. The final CPT code was written in a specific format as to only include the IDET technique as the committee felt that was the only technique which had adequate literature to support its use at that time. The objections by NASS were heard by this committee and the decision was made that indeed this treatment had merit.

At the AMA RUC Meeting, at which I also presented on behalf of ASIPP, NASS and several other societies raised some objection and ultimately strongly influenced the RVU values provided to this procedure. The reimbursement to a physician for performing IDET is clearly not enticement to do this procedure given the actual work involved ($344.83 for 22526 and $157.62 for 22527). Therefore fears that this will be over-utilized due to excessively high reimbursement are unfounded.

I would also disagree with CMS' decision to lump all types of TIPs into one treatment. While there are similarities between technologies, since the exact mechanisms of these treatments has not been fully delineated, it would be inappropriate for CMS to suggest that they are all identical. In addition the amount of literature that is available on each of these three techniques is vastly different. There are more than 70 articles on IDET treatment, approximately 4 on Biaculoplasty, and only 4 or 5 that I am aware of on PIRFT which includes multiple techniques discTRODE, RF cannula, etc.).

On Page 8 CMS' general methodological principles to the development of an NCD are stated. The document specifically states, 'CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service falling within a benefit category is reasonable and necessary'. I would note the following in terms of IDET: „« There are well over 70 articles in the literature on this treatment modality.„« The vast majority of these articles support IDET and its effectiveness.„« For CMS to suggest that the vast majority of these are of insufficient quality would seem to question the ethics of the entire medical research community.„« As for the final components of this statement, clearly treatment of lower back is necessary or Medicare beneficiaries would not be seeking treatment with pain doctors to improve their ambulatory ability, overall function, and ability to perform activities of daily living.The purpose of Medicare is to provide care to our disabled and elderly. IDET and other TIPs procedures are certainly reasonable; they are not associated with a high risk, the costs are quite nominal, especially when you compare treatment alternatives, which are described in greater detail below. The literature clearly demonstrates that in a certain percentage of well selected patients there are improved health outcomes with IDET, a less invasive approach than our surgical colleagues would prefer to pursue. It seems to me that CMS is applying a double standard to TIPs procedures as compared to fusion surgeries and other covered medical services. CMS must apply the same standards to all treatments in order to have an unbiased approach to care for Medicare beneficiaries. I would argue that nondiscriminatory policies and laws apply equally or even more importantly in CMS rule making.

Evidence:Contrary to your opening sentence, chronic pain is a disease state no different than hypertension, coronary artery disease, or renal failure. Pain is a disease which can require daily treatment in the form of PT, chiropractic, medications and/or intermittent therapeutic interventions which can come in the form of injections, interventional procedures, or open surgical treatment. We treat diabetes with insulin but the disease doesn't go away; we treat chronic low back pain to manage the symptoms not to eliminate the degenerative disc disease that is causing it. Degenerative disc disease is progressive, as are other causes of chronic pain; ongoing treatment should be expected as the disease progresses. To ignore the fact that chronic pain is actually a disease is to have missed the last 20 years of advances that have occurred in pain management.

Measurement of pain levels is difficult, due to the subjective nature of the pain experience. However, most patients try to accurately report their level of pain. Because the natural history of back pain is variable, the causes of back pain can be variable (genetic, environmental, traumatic, etc). The etiology of pain is also multifactorial. In fact many patients will have more than one cause for their pain (facetogenic and discogenic causes simultaneously in the same patient). How is this different than a surgeon who decompresses spinal stenosis for treatment of a radiculopathy or removes a disc herniation for treatment of a radiculopathy, but also fuses an unstable spinal segment together to treat two different pathologies simultaneously in one operative procedure?

CMS demonstrated a clear preference for double blind randomized control trials and while from a theoretical ground many would agree that this represents the best form of scientific research; the ability to perform those types of studies from an ethical standpoint are extraordinarily difficult. The work that Dr. Pauza did in order to accomplish his RCT study has been recognized and marveled at by researchers, practitioners, and scientists as this type of work is extraordinarily difficult to do today.

A heavy emphasis is placed on standardized measuring tools while little evidence is placed on patient satisfaction and I would suggest that both have importance. While a pain level reduction from an 8 to a 5 may not seem like a lot to someone who is not suffering from chronic pain, to others it can be the difference between working and not working or being able to care for ones self versus needing assistance with activities of daily living.

In the California Assessment Forum, October, 2003, on Page 10 it is stated that certain criteria were not met. The statement most striking to me was 'The technology must be as beneficial as any established alternatives'. I would suggest that patients who are receiving IDET have already failed to respond to other more conservative established alternatives. This is not a modality of treatment that we are supporting, recommending, or in any way suggesting should be preformed as primary treatment for lower back pain, but should be reserved for those patients who fail to respond on a sustained basis to other more established alternatives. However it is certainly equally effective, and by some reports more effective, with far lower risks and costs, than surgical alternatives such as fusion or total disc arthroplasty in the age groups that have been studied to date.

Over your next several pages a number of foreign references are provided and it is my understanding that evidence from foreign literature is not to be utilized in CMS reviews either in support or in deference to any treatment modality unless it is published in a peer reviewed American journal.

On Page 11 you quote the 'Cochrane review'. I would point out that the Cochrane review process has been criticized by numerous authors including Robert Gatchel and Donald McGeary in Spine Journal in 20026.

Evidence Summary: In this section you review begin with three 'randomized control trials'. I would note that two of these relate to IDET treatment, one positive and one negative, and a third to simple radiofrequency lesioning of the disc with a needle. To assume that this latter therapy is identical to the placement of an IDET coil along the posterior annulus ignores the obvious differences in anatomic placement. Therefore one must look at your evidence not in total, lumping all procedures together, but individually for each technique, and then only later lumping these together if appropriate. Otherwise inadequate literature for one modality could have negative consequences for one of the other treatment approaches (1 out of 2 positive RCT's is very different from 1 out of 3).

In the first study you review Dr. Pauza's landmark randomized placebo controlled IDET study. Dr. Pauza used extremely strict selection criteria, one of which was a disc height of at least 80%. This is one of the few studies that has required such a disc height criteria and does not prove or suggest that this treatment modality only works for those with disc heights better than 80%. In fact it is possible that the success rate may be higher when the disc height is lower as the spread of heat through the annular wall may be more ideal when there is less vertical disc height with which to heat. Specifically the IDET coil only heats a several millimeters in each direction effectively, therefore if the coil is placed in a tall disc in a location cephalad or caudad to the tear it could limit the results of the procedure. That would be less likely in a narrow disc based on the number of millimeters that the IDET coil can heat up and down. In fact there are some who have advocated that this works better when there is some loss of disc height (but not more than 50% which would be indicative of advanced disease). The only thing that can be concluded on disc height today is that lass than 50% seems to be a contraindication. What is in fact the ideal disc height has yet to be proven. The purpose of Dr. Pauza's study was not to develop selection criteria, but to determine whether IDET worked better than placebo. His study did show that there was a greater degree of improvement in patients treated with IDET as compared to the placebo control group in several measured categories.

The document goes on to discuss the Freeman Study, another placebo double blind controlled study. This study has been criticized extensively by numerous experts within the field of IPM for reasons such as poor patient selection (advanced disc degeneration, positive neurologic findings, etc.), an inability to even match recognized success rates in previous published reports, and an inability to demonstrate a placebo effect. I have previously pointed out that the most likely explanation for their inability to demonstrate any improvement (and in fact many of their patients experienced increased pain) was the fact that they used an excessive dose of intradiscal antibiotics with each patient receiving 100 mg of intradiscal Ancef. This is more than 10 times the standard dosage used in this country. Studies have shown that high does of intradiscal antibiotic can be potentially irritative to the disc⁷. On the basis of their methodological flaws alone this study must be discarded as the potential harmful effects of such a high dose of intradiscal antibiotics could skew all information that subsequently arises.

The final randomized controlled study you describe is from Barendse. In this study they used a simple radiofrequency needle placed into the center of the disc to provide what would appear to be nuclear and not annular lesioning; anatomically this is not consistent with where IDET delivers its RF energy. This modality of treatment has not been shown to be helpful in a non-randomized controlled trial and is not equivalent to IDET or Biaculoplasty therapies. Certainly it does not provide heat energy directly to the annulus. I would also point out that their patient selection was not based on typical published criteria and also that their study patients did not receive provocative discography but rather analgesic discograms which has not been shown to provide equilavant diagnostic information to a standard provocative discogram.

On Page 20 you begin to look at the systematic reviews of IDET and PIRFT. In the first article by Anderson, et al that you review you discredit the conclusion and its comparison to spinal fusion stating that none of the studies were actually head to head comparative studies. However I would suggest that the author's statements have been misrepresented and in reality what they concluded was that historical success rates with spinal fusion for the treatment of discogenic pain were similar to the success rates achieved with IDET based on their review of the literature suggesting that IDET may be the preferred procedure because the success rates were comparable with a far lower historical incidence of complications. The authors were not trying to suggest that they had compared these two treatments head to head.

In the second review by Urrutia I find one major fault and that is his fairly heavy reliance on Freeman's RCT study which as I have noted above must be discounted based on its severe methodological flaws. When that study is removed I believe the conclusions of this review article may likely be different and certainly cannot be predicted either way.

When discussing the Meta-Analysis you discount it from the outset by stating that it was company sponsored. Whether we like it or not in the world that we live today almost all research into new technology is sponsored by companies or else it would not be done. Medicine has become a business. Physicians cannot afford to perform research pro bono for altruistic reasons. Almost all research on new technology is company sponsored. I don't believe that there is any evidence that these or other authors on TIP's have not stuck to strict ethical guidelines and standards.

In evidence-based guidelines you discuss both ASIPP and ISIS recommendations. I would note that these are the two main interventional pain management societies within the United States of America. Both of these societies of professionals recommend limited coverage of IDET with specific selection criteria. These organizations are led by the brightest, smartest, and most knowledgeable interventional pain management physicians in this country and both organizations have extraordinarily high ethical standards. Is CMS suggesting that these societies are promoting the use of this modality for no reason other than for financial gain of its members? Clearly this is not the case. These societies truly believe that these modalities of treatment are good for patients and can help in properly selected situations.

On Page 23 you quote ISIS 'for which there are no alternative procedures'. I believe that is the perhaps the most important thing to remember when discussing IDET treatment in many situations, there is usually no other viable alternative except aggressive open surgical interventions. I do not believe that any of the physicians who are advocating for this modality think it is a panacea and will 'cure all lower back pain'. We however believe in properly selected patients that this modality of treatment can be highly effective and help treat a limited number of patients. It is also a far better option than the alternative treatments that exist today (fusions, disc arthroplasties, pumps, stimulators, chronic medications, etc). When one analyzes the cost of these other approaches and compares it to the cost of an IDET treatment it is clear from a cost benefit ratio that IDET should be a covered procedure when applied to a strictly selected group of patients. It has clearly been shown to be a safe and effective in a selected group of patients. Even NASS, in their own comments to CMS, which you quote on Page 26 of 47 'If IDET is performed, NASS recommends that strict inclusion criteria be followed', this would suggest that they believe that this modality of treatment has some benefit in carefully selected patients. I would also again point out that since they are teaching IDET at their own cadaver courses that even NASS must see some merit in this procedure.

We would concur that the use of this modality must be tightly controlled to prevent abuse and excessive use. This is why we have strongly recommended to CMS the use of appropriate selection criteria. In addition the incidence or use of this modality should be extremely limited in the Medicare population as the majority of Medicare beneficiaries are 65 and older and at this stage of life most will have advanced degenerative disc disease which would make them poor candidates for TIPs procedures (i.e. they would not fit the selection criteria). In fact the subset of Medicare beneficiaries that would likely be the best candidates for this modality would be the young Medicare beneficiaries with back injuries who have not been able to return to work and have or will be left long term in our Social Security Disability system. If those patients have a successful response to an IDET procedure and thereafter return to work on a long term basis this would save an enormous amount of money for the Social Security system. This treatment would actually pay for itself within 2-3 months of the individual no longer receiving Social Security benefits and having returned to work. A simple cost analysis would demonstrate that a successful outcome in even 50% of patients would long term result in huge savings to Medicare. Even if only half of those returned to gainful employment long term (25% of those treated), the savings would be enormous, not to mention the avoidance of more expensive treatment modalities. These are individuals who would otherwise stay on Social Security Disability for 30-40 years. I believe the decision to not cover this for at least a Medicare beneficiary under the age of 65 is extremely shortsighted. While it is impossible to defend the fact that the majority of studies have been done for patient under 65 this is fairly typical of research that is done in this country on new treatments. However the literature is very clear that this modality of treatment will help a certain subsection of patients under the age of 65.

On Page 27 you begin your analysis. On Page 48 'Most patients will recover over time with supportive care'. That is true. The natural history of low back pain is that the majority of individuals with acute back pain will resolve spontaneously. We recognize that 80+% of patients will do so. IDET is not for those individuals. It is for those individuals who do not respond, who do not get better, who do not improve with physical therapy, chiropractic manipulation, simple injections (ESI's/Facets/etc.) or other conservative modalities of treatment and who have discogenic pathology that is amenable to annuloplasty treatment based on a set of very specific selection criteria.

In the next paragraph you discuss mechanisms of action. You quote Cohen from an article in 2005 in which he states that if IDET worked by nociceptive denervation it would be immediate. I would state that this statement is untrue. Cervical and lumbar facet radiofrequency denervation treatments typically take 6-8 weeks to see a peak effect. Similarly, IDET does not work overnight. In fact IDET may take somewhat longer because the size of the radiofrequency lesion is larger and because a greater degree of physical rehabilitation is required after treatment with IDET therapy than with radiofrequency facet denervation. Therefore I would disagree with Cohen's comments and state that I would not expect IDET to work overnight and that it should take upwards of two months to begin to see the initial effects. This is typically the response that is seen by clinicians who regularly practice this therapy. Later in the paragraph you discuss repeat procedures. In my experience repeat procedures are rarely performed at the same level. It is possible that a patient can re-tear the disc. This however is not common and could be addressed with an appropriate policy to prevent abuse in that regard. Finally, at the end of this paragraph you state that Narvani describes that at six months post-procedure there is no resolution of the HIZ. I think this requires understanding of what the HIZ represents. The High Intensity Zone or a white spot on a T2 weighted image represents fluid; in this case blood (i.e. blood vessels). When a tear occurs in the disc the body responds by growing blood vessels into the area. With this new vasculature also grows nerve endings/receptors. The HIZ is representative of these blood vessels and not the actual nociceptive receptors. After IDET the hypervascularity remains but the nociceptors are denervated. The heat generated with IDET would not cause coagulation of a blood vessel and therefore I would not expect the HIZ to disappear on the MRI following IDET. This does not mean the treatment was ineffective.

On Page 29 you again explain why you have combined these different technologies into one decision memorandum and you state that there is no evidence of significant outcome difference, but I would point out that there is at least one limited study comparing IDET and discTrode and as noted previously, in this study, IDET showed a significantly better outcome⁷. There are no studies comparing Biaculoplasty with any other techniques that have been published at this time.

On Page 29 you also state there is uncertainty in the selection of appropriate patients for these various procedures. I recently co-authored an article accepted for publication in Pain Physician (in press for the Sept. /Oct. issue) to help delineate the appropriate selection criteria for IDET treatment to assist physicians and payers in order to limit this modality to those individuals most likely to respond. In the remainder of this paragraph you describe discography and its shortfalls. I again would point out that you rely far too much on Dr. Carragee who is one of a few voices who has taken this side of the argument. The overwhelming number of physicians in this country (both surgeon and interventional pain management), believe strongly that discography, when performed in a well controlled fashion, and as described by ISIS guidelines, can provide excellent diagnostic information to assist the clinician in planning future treatment.

In the last paragraph on Page 29 of 47 you state 'There are wide and ever growing variety of treatment options that include activity modification, multiple pharmacologic options, various types of massage, manipulations, medication assisted with manipulation, many types of exercise, multiple physical modalities, education and psychological training, many types of injections, lifestyle therapies, and complimenting alternative therapies'. I would point out that a number of these are not covered services by Medicare (massage) or only in part (psychological services equal only 50% covered) and I would further point out that the patients who undergo IDET treatment have typically failed all of these other approaches. Should they just be left to suffer in pain? Should they be forced to have a more aggressive operation such as an interbody fusion which might make them worse if it fails? Surely one of the benefits of IDET treatment is that the likelihood of it making you worse is far less than 1%. The chance of getting worse after a lumbar fusion is greater than 10% and in some studies approaches 20%. Just ask the thousands of patients in our waiting rooms everyday. This paragraph clearly cherry picks quotes, often out of context, to support the decision that you have arrived at rather than providing factual information. This is reminiscent of sound bites on the six o'clock news which may not necessarily represent what the actual individual was trying to state. I would also note that you repeatedly quote Rhyne from an article that he published in 1995. I would point out that article predates the development of TIPs technology and therefore should not be referenced in this proposed memorandum.

On Page 30 of 47 you criticize a number of aspects of the studies that have been performed and I will comment on a few of these. 'It is unclear that the definition of success that the authors used was clinically meaningful'. Perhaps CMS should outline what it believes should be used as the definition of success for all future pain studies so that we can comply in a more effective fashion with studies that will meet your future needs. This issue is a particular topic of discussion in the pain literature and as you are aware it is very difficult to quantitate what are the best measures of outcome success. I believe this point could be argued back and forth for days. It is interesting that you did not find clinical significance in many of the studies despite the fact that the authors of these studies actually did find statistical significance. It appears that CMS chose to pick and choose which pieces of the statistical evidence they wanted to believe and thereby include in this document, to support their final conclusion rather than using the evidence in its entirety.

On Page 31 adverse events are discussed and it is suggested that the incidence of complication is higher than has been reported in the literature. Numerous articles have shown an extremely low complication rate with IDET. The requirement for surgery following TIPs is not an adverse event but a failure of the treatment to provide the anticipated result. This is not analogous to a post-fusion patient developing a nerve injury, but rather a fusion not providing pain relief.

Unfortunately there studies to date have not specifically looked at age population or those over 65 years old specifically for these treatment modalities. However, there are many Medicare beneficiaries who are under the age of 65. This is also the sub-group of Medicare beneficiaries that would most likely be a candidate for this treatment approach if strict selection criteria are followed (this also means that CMS's exposure should be limited for this procedure).

In summary, I believe that CMS should revise its proposed decision memorandum at least as it relates to IDET and provide a positive coverage policy which is the only reasonable conclusion if the evidence is reviewed in its entirety and objectively. This treatment is merely one tool in the interventional pain management physician's doctor's bag to treat low back pain which is clearly a multifactorial problem. The evidence in the literature is overwhelming in support of IDET as a therapeutic intervention. I understand CMS' concerns with the potential for abuse, overuse, and misuse of this treatment modality. I would strongly urge that IDET be approved for coverage with specific selection criteria requirements and that other forms of TIP's procedures receive the same consideration as they develop a body of literature to support their effectiveness.

Sincerely,

David Kloth, M.D.
President and Executive Director
Connecticut Pain Care
President Connecticut Pain Society
Board of Directors ASIPP

Mailing Address: 109 Newtown Road Suite 1
Danbury, CT 06810
Email Address: DKMD@ctpaincare.com
Phone: (203)792-PAIN

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It is unfortunate that CMS published a Proposed Decision Memo for Thermal Intradiscal Procedures, including Intradiscal Electrothermal Therapy (IDET), in which CMS proposes a non-coverage policy.

I believe this decision to be poor and unfounded based on the available literature. I am a physician who performs a handful of these cases annually and it is the only reasonable option for these select patients with discogenic low back pain.

There is recent published evidence that IDET can provide pain relief to carefully selected patients. Relevant clinical specialty societies and the published literature provide detailed descriptions of appropriate patient selection criteria. I believe CMS coverage policy should reflect current clinical evidence and the recommendations of the clinical community.

I believe Medicare patients who suffer from discogenic pain should have access to IDET, which provides an effective and safe minimally invasive alternative to surgery.

Please reverse this decision, and resume an IDET coverage policy. If necessary, make coverage dependent on certain criteria, which have previously described in the literature.

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In understand that CMS is proposing a non-coverage policy for Thermal Intradiscal Procedures, including Intradiscal Electrothermal Therapy (IDET.

During the initial comment period after the National Coverage Analysis for Thermal Intradiscal Procedures was announced, numerous comments were submitted to CMS indicating that in appropriate patients the procedure is efficacious. Recent studies support that conclusion. A blanket non-coverage policy would thus constitute an abuse of discretion.

The American Society of Interventional Pain Physicians (ASIPP) 2007 evidence-based practice guidelines state that the evidence for IDET is moderate for managing chronic discogenic back pain.

The International Spine Intervention Society (ISIS) Practice Guidelines list IDET under its established procedures with specific patient selection criteria.

IDET is the only technology the AMA deemed to have sufficient evidence to warrant a separate CPT code.

It is clear that the porposed policy of noncoverage does not take into account all studies and the methodology used in each study.

I have used the procedure in the past on very selective patients (i.e., disc height > 50%, failed other therapy, a postive discogram indicating limited disc bulge or annular tear). All of whom have reported more than 50% pain relief. If Medicare decertifies the procedure then other insurance companies will follow suit. The procedure is probably best suited for younger patients. To deny them a proven technique will mean that there will be a substantial increase in unnnecessary back surgeries. Those patients in the long run will do poorly.

In summary, recently published studies indicate that IDET can provide pain relief to carefully selected patients. Relevant clinical specialty societies and the published literature provide detailed descriptions of appropriate patient selection criteria. We believe CMS coverage policy should reflect current clinical evidence and the recommendations of the clinical community.

A blanket decertification would be irresponsible and contrary to the weight of evidence.

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I am writing to urge CMS to maintain coverage of the IDET procedure. My interest in this issue is particularly focused in that I am currently performing a systematic review of intradiscal annuloplasty procedures, including both the IDET and Biaculoplasty procedures. Analysis of the literature is being performed using both AHRQ and Cochrane criteria. While the study will not be published until January 2009 and discussion of findings before publication is inappropriate, I have been impressed by the methodological shortcomings of the literature purporting to document the lack of efficacy of IDET. There are, on the other hand, clearly patient s who do benefit from thermal treatment of the annulus. In addition, intradiscal injection procedures are being developed which will offer great promise. Patients treated with IDET will be candidates for future intradiscal injection therapy. If IDET is not covered and these patients have fusions, they will not have access to future therapy. In addition, my personal experience in my practice, where I maintain large numbers of patients who are failures after fusion, mirrors the literature documenting the risks associated with fusion.In summary, intradiscal heat therapies provide an important intermediate option between conservative therapy and fusion. The evidence supporting IDET is controversial, with significant limitation on the work opposing the procedure. Accordingly, I would urge that this important treatment option continue to be covered.

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Hello,

I reviewed recently your tentative decision not to cover intradiscal procedures. As an interventional pain physician with experience with these procedures, I want to say unequivocally that you are making a grave mistake.

Anatomically, it is absolutely clear that abnormal neuroangiogenesis within the injured disc is associated with severe disc-based painful conditions that have been inadequately treated by various modalities in the past. However, simply because an adeqaute treatment has not been devised is not sufficient reason in my mind to deny coverage for potential treatments for this devastating and crippling painful condition via a balnket edict concerning intradiscal procedures.

I will not hesitate to state that in my personal experience the utility of annuloplasty and IDET are quite limited and the results, even in carefully selected patients are disappointing. I have had, conversely, great success combining nucleoplasty with Dekompressor percutaneous discectomy, with the vast majority of carefully selected patients having very good results.

Reflecting on Thermal Intradiscal Procedures (TIP's) , there is a new procedure, not yet clinically proven (although early results are positive), called Biaculoplasty. It is very different from traditional TIP's in that it utilizes a cooled system to achieve a carefully shaped bipolar heated are (unlike the other TIP's whose monopolar electrical delivery results in small lesions limited by vacuolization and cavitation.

I can't pass judgment on Biaculoplasty yet, not having done enough procedures personally to feel I can give you an informed view. However, what I do want to express to you is that new technology has the potential to provide dramatic pain reduction for a problem that is very diificult to treat but simultaneously virtually ubiquitous. While I agree that older technologies probably do not yield results that justify payment, this does not invalidate the anatomy or the painful condition of discogenic pain. We should keep an open mind and be willing to consider paying for newer tretaments that may be effective.

Please do not hesitate to contact me for whatever reason at 415-509-6123.

Sincerely,

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This is one og the greatest procedure invented for discogenic pain. I have performed more than 200 procedure over 9 years period . I only had 2 failure and more than 200 success. The reason for failure is clearly: not adhering to strict indication which is pure discogenic pain, increased with sitting, better with standing, absent neurologic symptoms and signs, clearly positive discogram in an awake patient with clear reproduction of the same pain, and adequate disc height, and the procedure should be performed technically correct with good placement of the spine cath.

Unfortunatly, many of the physician who performed IDET did not adhere to the rules mainly due to financial reasons, specially during workers comp peak in California 2000-2004. IDET works 100% if done right

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CMS has come to a partially correct conclusionabout intradiscal procedures. However, theconclusion should be amended to say "that thermalintradiscal procedures are not reasonable andnecessary for the treatment of low back pain INMOST PATIENTS." However, IDET is clearly abeneficial treatment in some patients, and itwould be unfortunate if CMS “throws out the babywith the bath water.”

In the medical literature, the randomized,double-blind, placebo controlled trial is the goldstandard study design and is therefore of theutmost importance. Due to the subjective natureof pain, this type of study design is even morepowerful and more important in the interventionalspine literature. IDET is one of the fewtreatments that have been subject to this studydesign not once, but twice. We in the medicalcommunity are fortunate enough to be able to studythe findings from these trials. Hopefully, wewill evaluate them appropriately and draw properconclusions. Other studies with less stringentdesign have some utility, however, when atreatment has undergone 2 RCT’s, we must rely onthe findings from these studies.

Some have suggested that a 3rd RCT exists in theIDET literature – that by Barendse in Spine 2001. This study, however, reported on a very differentprocedure. In this study, 90 second lesions wereperformed at 70 degrees Celsius. The IDETprotocol utilizes heating to 90 degrees Celsiusover a 16.5 minute time period. The studies byErcelen in Spine 2003, and Kapural in PainMedicine 2005, clearly demonstrate a difference inresponse between lesions at different temperaturesfor different time periods. One can reasonablyextrapolate from this data that by increasing thetemperature of the lesioning by 30%, and byincreasing the time of the lesioning by over1000%, that the procedure performed by Barendsecould be expected to have outcomes that aredifferent from the standard IDET protocol. Therefore, it is inappropriate to consider thisstudy to be the 3rd RCT that is equivalent to thestudies by Pauza and Freeman. The two IDET RCT’s (Pauza and Freeman) provide uswith an interesting dilemma – one demonstratesefficacy, and one does not. There is a correctanswer – either IDET has benefit, or it does not. The conclusion reached in the Pauza study – thatIDET does have benefit - is either correct orincorrect. Since this study was prospectivelyrandomized, baseline differences cannot accountfor the different results that were obtainedbetween groups. Therefore, in order for thisstudy to have drawn the incorrect conclusion, itmust be one of the 5% of studies that we as amedical community choose to accept as falselypositive with the universally agreed upon p-valueof 0.05. This is a possibility. A much morelikely possibility (95% chance) is that IDET doeshave benefit.

The conclusion drawn from the Freeman study isthat IDET has no benefit. This conclusion also iseither correct or incorrect. For this conclusionto be correct, since lack of benefit is verydifficult to prove, the study design must havebeen nearly flawless. It was not. The biggestflaw in this study was in patient selection. Surprisingly, approximately 85% of patients whoreceived IDET had an abnormal reflex – the mostobjective physical exam finding. In thispopulation (patients with spine problems with anaverage age of 37), the most likely cause for anabnormal reflex is radiculopathy. Additionally,in order to get an abnormal reflex, theradiculopathy must be quite severe (either severeconduction block or axonopathy.) This brings intoquestion whether IDET was used to treat the wrongdiagnosis in this study. IDET should be used as atreatment of discogenic pain, not radiculopathy.

Another flaw from the Freeman study, againpertaining to patient selection, is the criteriaused to define a positive discography. Discography is not like a pregnancy test (eitherpositive or negative.) Unfortunately, there isnot one standard set of criteria that defines apositive discogram. One thing that is clear fromdiscography is that if it is the discographer’sdesire to call a study positive, he/she almostcertainly can do so. Simply by pushing harder andfaster on the syringe, by not using a severity orconcordancy requirement, and by not requiring anegative control disc, it is quite easy to callthe diagnostic test positive.

The early work on discography showed mixedresults. Many of these studies showed thatdiscography that was done without a strict set ofcriteria to define a positive result is not aworthwhile diagnostic test. However, several morerecent studies, which used pressure-controlleddiscography, severity and concordancyrequirements, and requirements for negativecontrol discs, have demonstrated its utility(Derby, Spine 1999; O’Neill, Spine 2004; Pauza,The Spine J 2004; Oh, Clin J Pain 2004; Derby, TheSpine J 2005; Derby, Pain Medicine 2005; Derby,Arch PM&R 2008). The best example of this islooking at the study by Carragee in Spine 2000. By using the Walsh criteria (no manometry, noconcordancy requirement, no negative control discrequirement), this study demonstrated a 38% falsepositive rate. However, if one were to look atthe raw data and use the more strict requirementsto define a positive study that have been proposedby Derby and O’Neill, the false positive rate inthis study by Carragee would be just 3.8%. Clearly, a diagnostic study with a 3.8% falsepositive rate is much more useful than one with a38% false positive rate, and one would certainlyexpect better treatment outcomes when using theformer diagnostic study for patient selection.

The criteria used in the Freeman study on IDET tocall a discography positive were “one or two-levelsymptomatic disc degeneration with an adjacentasymptomatic control disc.” Manometry was notused. There was not a severity requirement. There was not a concordancy requirement. Onemight expect an unacceptably high false-positiverate of discography when these criteria to definea positive diagnostic study are used. When astudy treats a large percentage of patients whohave been diagnosed with a false positivediagnostic test, negative outcomes can beexpected, and conclusions about the efficacy ofthe treatment are in question.

Given the information listed above, it would beincorrect to conclude from the Freeman study thatIDET is ineffective. A more appropriateconclusion would be that in patients with anabnormal reflex (likely signifying a diagnosis ofradiculopathy) who are selected by the discographycriteria of “one or two-level symptomatic discdegeneration with an adjacent asymptomatic controldisc”, IDET is not effective. However, ageneralized statement about the efficacy of thistreatment for the diagnosis in which it wasintended to be used cannot be made.

Similarly, an appropriate conclusion from thePauza study would be that in patients withdiscogenic pain who are selected by thediscography criteria of “accustomed pain withinsimilar pressure ranges, but provided that no painwas reported when adjacent discs were stimulatedor during sham pressurizations,” IDET is amodestly effective treatment. The viewpoint that“numeric differences between treatment and controlgroups did not appear to be clinicallysignificant” is a flawed way of interpreting thestatistics. What this study demonstrated is thatIDET improves pain from 6.6 to 4.2. The placebogroup improved from 6.5 to 5.4, however, comparingthe 5.4 to 4.2 is not appropriate. Thestatistically significant difference between theimprovement of 6.6 to 4.2 vs. 6.5 to 5.4 simplyshows that a true difference existed, and that itdid not occur by chance alone. Therefore, the 6.6to 4.2 is real. Regarding whether or not thisbenefit is “clinically meaningful”, it isincorrect to say that this is “unclear.” It isperfectly clear. It is widely (and possiblyuniversally?) accepted that an improvement on theVAS of 2 points is clinically significant. Theimprovement in the Pauza study of 2.4 clearlyfalls into this category. From a physiatrist’sperspective, an improvement from themoderately-severe range (6.6) down to the moderaterange (4.2) often translates into less time missedfrom work, better ability to perform physicalactivity, and improved overall function.

Many (including this report by the CMS) criticizethe Pauza study for randomizing only 1.4% of theprospective patients. However, shouldn’t weapplaud this stringent selection criteria? Ibelieve that a reasonable physician should notview an invasive treatment – such as IDET orsurgical fusion – to be an appropriate option formore than 1-2% of low back pain patients. Mostpatients should be treated with exercise,lifestyle changes, coping mechanisms, andreassurance. However, there is a very smallminority of patients who may be appropriatecandidates for invasive treatments, and it wouldbe unfortunate if these treatments were notavailable to this small subset of patients.

Taking the information listed above, we can nowturn to a few more topics: applicability to theMedicare population, long-term results, andalternative treatment. The first two topics arevery easily addressed. There is a clear answer tothe question about whether or not IDET iseffective in the Medicare population. The answerto this question is that it is unknown. It isimportant not to confuse the unknown withinefficacy. Similarly, the long-term benefit isunknown. The Pauza study demonstrated benefit at6 months. Results in a well-done, RCT beyond thistime period are not available, and conclusionscannot be drawn one way or the other.

An argument can be made for CMS to decide that itwould be inappropriate to cover a treatment thathas an unknown long-term outcome in the Medicarepopulation. If CMS decides to do this in regardsto IDET, the next logical step would be toevaluate the alternative treatment – surgicalfusion. One would expect that the same standardswould be held for surgical fusion. Given the muchhigher rates of morbidity (including adjacentsegment disease) and mortality, one might evenexpect that surgical fusion should be held to morestringent standards.

There are three RCT’s in the surgical fusionliterature (Fritzell, Spine 2001; Brox, Spine2003; Fairbank, BMJ 2005.) The Brox and Fairbankstudies demonstrated no benefit of fusion overintense rehabilitation programs. The Fritzellstudy showed benefit at 2 years over continuedfailed physical therapy, however, it has beenreported that the 5-year data was presented at theAnnual meeting of the International Society forthe Study of the Lumbar Spine in Porto, Portugalin 2004, and that this 5-year data no longerdemonstrated benefit over the physical therapygroup. Regarding surgical fusion, 5-year data isof the utmost importance since hardware - andadjacent segment disease – remain present for theremainder of the patient’s life.

Surgical fusion is an enormous business in ourcountry and there is proven benefit from its use. Unfortunately, when one views the highest quality(RCT) literature on the topic, it becomes unclearwhether this benefit is for the patients. One maysuggest that a more important and more appropriatequestion than that asked in this CMS report wouldbe, “Is the evidence sufficient to conclude thatSURGICAL FUSION will improve health outcomes inthe Medicare population with low back pain?” Onewonders if this important question will ever beasked. Yet, it does not stop one from wonderingwhy the treatment that has positive RCT evidence(IDET) is being questioned, yet the more invasivetreatment with no RCT evidence (surgical fusion)continues to be covered by insurance companies.

I believe that just as there is a place for IDETin a very select group of patients, there alsoprobably is a place for surgical fusion (in aneven more select group of patients.) The surgicalRCT’s are flawed, mostly in patient selection(none used discography as standard inclusioncriteria), and this may explain the lack ofefficacy in the RCT’s. What is desperately neededis a randomized, controlled study that includes asurgical fusion group, an intradiscal heatinggroup, and a placebo group. Many people believethat a placebo-controlled surgical study isunethical. I believe that it is unethical not toperform such a study. By not doing so, tens ofthousands of people continue to get majoroperations without any strong RCT evidence tosupport the efficacy of these procedures, yetplenty of evidence of lack of benefit overconservative treatment, morbidity, and evenmortality associated with them.

Lastly, this CMS report mentions plasma discdecompression (PDD) using Coblation technology. This procedure is a completely different procedurefrom the intradiscal heating procedures and shouldnot be viewed as comparable. PDD is a procedurethat is intended to be used to treatradiculopathy. Some practitioners have been usingPDD to treat discogenic pain, and there is a smallbody of literature to support this use as well (ina select group of patients). However, the primaryuse of PDD is in the treatment of radiculopathy,and it should not be included in the current CMSevaluation or conclusions.

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I have been performing Thermal Intradiscal Procedures (TIPs) for years with great success and obviously positive outcomes. The keys to getting good results are proper patient selection, the tecnical skills to do the procedures and to have strict post-op care policies to which the patients must subscribe. If these criteria are met, the treating physician is almost guaranteed good to excellent results. If CMS deems TIPs as not medically necessary, the patient loses because they are left with invasive procedures with significantly higher rates of morbidity and mortality. Invasive procedures also result in longer "down time" for the patient, and when the patient is OW that results in reduced productivity with an increased finacial burden on the patient, the workplace and the ins. cos. TIPs work well when implemented appropriately.

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