August 10, 2010
JAYNEE LAVECCHIA, PETITIONER-APPELLANT,
STATE HEALTH BENEFITS COMMISSION, RESPONDENT-RESPONDENT,
On appeal from the State Health Benefits Commission.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued: May 12, 2010
Before Judges Cuff, C.L. Miniman, and Fasciale.
Petitioner Jaynee LaVecchia and her husband are participants in the State Health Benefits Program. At issue in this appeal is whether respondent properly denied reimbursement for a procedure performed on petitioner's husband to relieve long-standing back pain. Respondent determined the procedure was an experimental or investigational procedure and not a covered expense under the State Health Benefits Plan. We affirm.
In November 2006, petitioner participated in the Traditional Plan (the Plan) of the New Jersey State Health Benefits Program (SHBP). Her husband, Michael Cole, was covered as a dependent under the Plan. The Plan was administered by Horizon Blue Cross Blue Shield of New Jersey (Horizon).
In November or December 2006, Cole requested a predetermination of benefits from Horizon for a procedure on his back, known as Percutaneous Laser Disc Decompression (PLDD). PLDD is a minimally invasive alternative procedure for repair of a herniated disc causing nerve root compression that uses a laser to ablate a portion of the disc nucleus to relieve nerve root compression. The traditional surgical treatment is an open lumbar discectomy or microdiscectomy, both of which entail the physical removal of disc material.
Dr. Daniel Choy, the physician who performed Cole's surgery, wrote a letter of medical necessity on November 22, 2006, to Horizon. Dr. Choy is the pioneer of the PLDD procedure. The letter advised that Cole had suffered lower back pain for six to eight years and previous physical therapy was only moderately helpful. Dr. Choy stated that he believed Cole was a "good candidate" for PLDD and that PLDD was noninvestigational as various articles and studies reported on the procedure. He also informed Horizon that "[a]pproximately 75,000 PLDD's have been performed worldwide[, it] is routinely performed in all of Europe, South and Central America, Japan, India, and the U.S.[,]" and that he had performed over 4000 PLDDs over the prior twenty-one years, "with an average success rate of 89%, and a complication rate of 0.4%."
Horizon's Medical Director concluded that PLDD was not covered under the Plan because it was experimental and/or investigational and so advised petitioner on December 27, 2006. On January 2, 2007, Cole underwent the PLDD procedure at Dr. Choy's facility in New York City.
On February 7, 2007, Cole submitted a "Traditional Plan Claim Form" for $22,080, the cost of the procedure. Horizon denied the claim on April 26, 2007. In its decision, Horizon relied upon its internal policies, Uniform Medical Policy #077, and pages 17 and 18 of the SHBP Traditional Plan Member Handbook (the Handbook). The letter stated that the earlier coverage determination was affirmed because the Medical Director determined "PLDD is considered investigational because there have been insufficient large scale long term studies in comparison to the standard of care for micro diskectomy."
Petitioner requested reconsideration of the denial of benefits. The State Health Benefits Commission (SHBC) responded that, pursuant to the provisions of the Plan, the Division of Pensions and Benefits had requested that Horizon conduct the final review of its administrative denial of the claim. On August 29, 2007, SHBC advised petitioner that Horizon had denied the claim and attached a letter from Horizon to SHBC explaining that it continued to view PLDD as an investigational/experimental procedure.
On October 10, 2007, petitioner appealed the denial of her husband's coverage to the SHBC. Following consideration of the appeal at its November 14, 2007 meeting, the SHBC denied the appeal.
On January 27, 2008, petitioner filed a timely appeal and requested that the matter be transmitted to the Office of Administrative Law (OAL). On February 13, 2008, the SHBC reaffirmed its previous determination to deny coverage and voted to transmit petitioner's appeal to the OAL, and advised petitioner's counsel of its decision in a February 27, 2008 letter.
Administrative Law Judge (ALJ) Joseph A. Paone conducted a hearing on January 28, 2009. After hearing the testimony of Doctor Stanley Harris, the Senior Medical Director at Horizon, and reviewing all of the medical literature admitted in evidence, ALJ Paone held that there "is substantial and sound medical literature that supports Horizon's policy, which is grounded on the notion that RCTs [randomized controlled trials] are needed before PLDD can be validated." In making this determination, he made the following findings of fact: (1) "the prevailing opinion within the spinal-surgery field recognizes PLDD as an effective treatment for relief of a herniated lumbar disc"; (2) the prevailing medical opinion is also that "PLDD needs further evaluation . . . before it is used outside clinical trials or research settings"; and (3) "PLDD is an investigational treatment."
The ALJ noted that four of the ten articles relied upon by petitioner were written by Dr. Choy, who is admittedly a pioneer in the field, but also "has a large financial interest in the acceptance of the validity of PLDD." The ALJ also noted that Dr. Choy was the executive editor of Photomedicine and Laser Surgery and its predecessor, Journal of Clinical Laser Medicine and Surgery, in which six of the ten articles were published. The ALJ accorded more weight to the articles submitted by SHBC because of the timeliness of SHBC's articles and the limitations of the studies petitioner cited. He stated:
Except for the Tassi article and Choy's article in Techniques in Regional Anesthesia & Pain Management, the other eight articles relied upon by petitioner were published before the articles written by Boswell, Goupille, and "Windows on Medical Technology," which reviewed the state of the various PLDD studies, and criticized the lack of an RCT.
The Tassi study represents a very strong endorsement of PLDD. But even Tassi suggests caution in the interpretation of his results because the study is too short-term. And the Tassi study remains subject to the same criticism as the others -- it is not an RCT.
ALJ Paone concluded that SHBC correctly determined that petitioner's claim did not fall under the Plan because PLDD was still considered experimental/investigational. The SHBC adopted the Initial Decision on April 17, 2009.
Petitioner argues that SHBC plainly erred in classifying PLDD as "experimental." She contends that a finding that the procedure is effective is inconsistent with a finding that it is experimental or investigative. She further maintains that SHBC erroneously imported an extraneous definition of "experimental and investigational" by requiring RCTs of PLDD before removing the procedure from the "experimental" classification. Additionally, petitioner argues that the ALJ erred in failing to place the burden on SHBC to prove that PLDD should be an excluded procedure.
SHBC counters that the exclusion of PLDD is "a straightforward application of the Plan's terms." It argues that the ALJ applied the plain terms of the Plan and relied "on . . . published reports in authoritative medical literature," which is required in any determination of whether a procedure is experimental. SHBC also maintains that the ALJ properly assigned the burden of proof to petitioner but also emphasizes that the ALJ stated he reached his conclusions on the applicable facts regardless of which party bore the burden of proof.
The role of this court in reviewing an administrative agency's final determination is exceedingly limited. In re Taylor, 158 N.J. 644, 656 (1999).
The scope of review of an administrative decision is the same as that for an appeal in any non-jury case, i.e., whether the findings made could reasonably have been reached on sufficient credible evidence present in the record considering the proofs as a whole, with due regard to the opportunity of the one who heard the witnesses to judge of their credibility. [Ibid. (internal quotations and citations omitted).]
Therefore, this court may only reverse an agency's final decision if "(1) it was arbitrary, capricious, or unreasonable;
(2) it violated express or implied legislative policies; (3) it offended the State or Federal Constitution; or (4) the findings on which it was based were not supported by substantial, credible evidence in the record." Univ. Cottage Club of Princeton, N.J. Corp. v. N.J. Dep't of Envtl. Prot., 191 N.J. 38, 48 (2007) (citing In re Taylor, supra, 158 N.J. at 656).
An appellate court is not permitted to "engage in an independent assessment of the evidence as if it were the court of first instance." In re Taylor, supra, 158 N.J. at 656 (quoting State v. Locurto, 157 N.J. 463, 471 (1999)). If, in reviewing the agency's decision, this court finds sufficient credible evidence in the record and the inferences to be drawn therefrom, it must uphold the agency's decision even if the court feels it would have reached a different result. Campbell v. N.J. Racing Comm'n, 169 N.J. 579, 587 (2001); In re Taylor, supra, 158 N.J. at 657. If, on the other hand, the court finds the agency's decision "'is clearly a mistaken one and so plainly unwarranted that the interests of justice demand intervention and correction, then, and only then, [it may] appraise the record as if it were deciding the matter at inception and make its own findings and conclusions.'" Campbell, supra, 169 N.J. at 587 (quoting Clowes v. Terminix Int'l, Inc., 109 N.J. 575, 588 (1988)).
Finally, an appellate court "may not second-guess those judgments of an administrative agency which fall squarely within the agency's expertise." In re Stream Encroachment Permit, Permit No. 0200-04-0002, 402 N.J. Super. 587, 597 (App. Div. 2008). An appellate court must grant deference to an agency's expertise when such expertise is relevant to the case. Campbell, supra, 169 N.J. at 588. When resolution of a legal question rests upon factual issues within an agency's province, those questions should be resolved in accordance with the agency's fact finding. Ibid.
The SHBC was created to institute a health benefit plan for State employees. N.J.S.A. 52:14-17.27. Any insurance contracts purchased by SHBC are required to have certain basic benefits, but the SHBC has the authority to purchase contracts that are subject to limitations and exclusions. N.J.S.A. 52:14-17.29(A), (D). The SHBC is not permitted to provide benefits beyond those enumerated in the contracts they provide. N.J.S.A. 52:14-17.29 (D). Additionally, the SHBC is statutorily prohibited from providing coverage for experimental or investigative procedures. N.J.S.A. 52:14-17.29(B).
The goal of the State Health Benefits Act is to "provide comprehensive health benefits for eligible public employees and their families at tolerable cost." Heaton v. State Health Benefits Comm'n, 264 N.J. Super. 141, 150 (App. Div. 1993). Although contracts procured by the SHBC are not precisely identical to commercial insurance contracts, the consumers who are subject to each are in positions of equal footing, because both must accept the contracts as presented to them and adjust their medical services in accordance with the same. Micheletti v. State Health Benefits Comm'n, 389 N.J. Super. 510, 525 (App. Div. 2007). As such,
"The reasonable expectations of both the State and the insured public employees are reached in large part after a consideration of the scope of the protections offered by the commercial insurance market. If Program provisions compatible with the statute appear to furnish protection consistent with the offerings of the commercial insurance market, those provisions should be interpreted in a consistent manner. Thus, judicial interpretations of coverage provisions of commercial insurance contracts should guide, if not control, interpretation of Program provisions." [Id. at 524-25 (quoting Heaton, supra, 264 N.J. Super. at 152).]
However, the SHBP is not a commercial insurance company and, therefore, contracts by each should not be construed exactly the same. Heaton, supra, 264 N.J. Super. at 150-51. "Program language following the statute should not automatically be construed against the profferer as a contract of adhesion. Instead, the limitation should be interpreted and applied in accordance with legislative intent and in furtherance of statutory goals." Id. at 151.
The Plan was one of several health benefit programs offered by the SHBP in 2006-07. The Plan was administered by Horizon at all relevant times and was a self-funded "indemnity plan that provide[d] reimbursement of expenses for treatment of illness and injury." The terms of the Plan are set forth in the SHBP Handbook.
The Plan provides that it will only pay for eligible services or supplies, which
[(i)] Are medically needed at the appropriate level of care. . . for the medical condition (When there is a question as to medical need, the decision on whether the treatment is eligible for coverage will be made by [Horizon]);
[(ii)] Are listed in the Eligible Services and Supplies sections of this handbook;
[(iii)] Are ordered by a doctor (as defined by the plan) for treatment or illness or injury;
[(iv)] Were provided while you or your eligible family members were covered by the plan; [and]
[(v)] Are not specifically excluded (listed in the Charges Not Covered by the Plan section beginning on page 48).
The Charges Not Covered by the Plan section specifically excludes from coverage "[e]xperimental or investigational services or supplies and charges in connection with such services or supplies."
The Plan gives the following description, in pertinent part, of "Experimental or Investigational Treatments":
For the purpose of this exclusion, a service or supply will be considered experimental or investigational if the claims administrator determines that one or more of the following is true.
* The service or supply is under study or in a clinical trial to evaluate toxicity, safety, or efficacy for a particular diagnosis or set of indications. Clinical trials include but are not limited to phase I, II, and III clinical trials, with the exception of approved cancer trials.
* The prevailing opinion within the appropriate specialty of the United States medical profession is that the service or supply needs further evaluation for a particular diagnosis or set of indications before it is used outside clinical trials or other research settings. The claims administrator will determine this based on:
* Published reports in authoritative medical literature; and
* Regulations, reports, publications, and evaluations issued by government agencies such as the Agency for Health Care Policy and Research, the National Institutes of Health, and the federal Food and Drug Administration (FDA).
* The service or supply is not recognized by the prevailing opinion within the appropriate medical specialty as an effective treatment for the particular diagnosis or set of indications.
Doctor Harries was the sole witness at the hearing. In its capacity as administrator of the Plan, Horizon refers to its internal policies in addition to the Plan's Handbook for further details when determining if a procedure is covered under the Plan. He also stated that if a member's contract contradicted an internal policy, the contract would prevail.
Horizon has a Uniform Evidence Based Medical Policy Manual (the Manual), which contains its policies. Policy Number 077, on which Horizon relied in denying petitioner's claim, addresses "Decompression of Intervertebral Disc Using Laser (Laser Discectomy) or Radiofrequency Energy (DISC Nucleoplasty)." Policy Number 077 became effective on June 25, 2004, and was last reviewed on June 27, 2006. It states that "[a] variety of minimally invasive techniques have been investigated over the years as a treatment of low back pain related to disc disease." It states that removing or ablating disc material is one category of those techniques and that "disc decompression using laser or radio frequency energy," which refers to PLDD, is included within that category. It advises that
[a] variety of different lasers have been investigated for laser discectomy. . .
Regardless of the type of laser, the procedure involves placement of the laser within the nucleus under fluoroscope guidance and then activated. Due to differences in absorption, the energy requirements and the rate of application differ among lasers. In addition, it is unknown how much disc material must be removed to achieve decompression. Therefore, protocols vary according to the length of treatment, but typically the laser is activated for brief periods only.
Due do that information, Policy Number 077's stated policy is that "[l]aser discectomy and Disc nucleoplasty are considered investigational as techniques of disc decompression and treatment of associated pain." Horizon lists thirty-one different sources as references used to obtain the information it relied on in formulating Policy Number 077.
Policy Number 019 specifically addresses Percutaneous Lumbar Discectomy Surgery and was also relied upon by Horizon in denying petitioner's claim. It cross-references Policy Number 077 with respect to PLDD.
Additionally, Policy Number 004, effective on January 1, 1993, and last reviewed on July 29, 2008, defines "Investigational/Experimental Procedure." It provides the following definition, in pertinent part:
Any treatment, procedure, equipment, device, supply, or drug (collectively referred to as "technology") which fails to satisfy any one of the following criteria is considered investigational/experimental:
2. There is sufficient evidence published in peer-reviewed scientific literature to assess the effectiveness of treatment.
* The evidence should consist of well-designed and well-documented investigations published in peer-reviewed journals. Each clinical trial or study should be considered based on its individual merits (e.g., length of time involved and follow-up, mortality and morbidity rates, etc.) along with any unique factors.
* When evidence is not sufficient or is questionable, opinion and evaluations from appropriate special advisory committees and/or specialty consultants will be considered.
3. There is measurable improvement (progress toward a normal or functional state of health) in health outcome and the therapeutic benefit outweighs the risk, as shown in scientific studies. . . . .
4. The treatment provided is as safe and effective as any established modality.
Dr. Harris testified that "peer reviewed scientific literature" means "[t]he kind of articles you would see in which there are members of the same profession[,] . . . meaning doctors if they're looking at medical journals[, who] are reviewing the information that is submitted . . . for the article publication" and that "any recognized journal has an editorial review board and staff that will look at the article before it's even accepted for publication." He said that all of the articles presented at trial were peer-reviewed articles. He also said that a "well designed and well documented investigation" would ideally be a randomized controlled clinical trial.
Horizon is a member of the Blue Cross Blue Shield Association (the Association). The Association issues internal policies. The Association's policy on laser discectomies provides that such treatment is investigational and noted the importance of RCTs to evaluate procedures like PLDD. Dr. Harris opined that Horizon will continue to regard the procedure as investigational until PLDD is subject to one or more RCTs.
In an appendix to this opinion, we provide a summary of the articles submitted by petitioner and respondent and reviewed by the ALJ. We, too, have reviewed these articles. Having done so, we are satisfied that the ALJ's assessment is well supported by the record that PLDD may provide immediate and at least short term relief but the long-term effectiveness is unknown and unknowable until independent RCTs have been performed.
Both petitioner and the SHBC submitted authoritative medical reports in support of their respective arguments. The ALJ, however, found that the SHBC's reports were more influential because the majority of them were written more recently than those submitted by petitioner and because the majority of petitioner's articles were written by, or published in a journal edited by Dr. Choy, the pioneer of PLDD, who has a financial stake in its acceptance by the mainstream medical community. There is nothing submitted by either party to suggest that the ALJ's interpretation of the evidence is incorrect or improper.
Petitioner argues that it was unfair for the SHBC to base its decision on the lack of RCTs, because the language of the Plan does not state that RCTs will be considered in determining whether a procedure is experimental or investigational. The language in the Association's internal policies does indicate that RCTs should be considered in determining whether a procedure is experimental and also indicates that PLDD is considered investigational because of a lack of RCTs. Petitioner correctly states that the need for RCTs is not in the Plan, but the policy lists fifteen medical sources that support its classification of PLDD, and Horizon is entitled to rely on these authorities.
The Plan specifically provides that experimental or investigational procedures are not covered and states that procedures are considered experimental or investigational when "the prevailing medical opinion within the appropriate specialty. . . is that the service or supply needs further evaluation for a particular diagnosis . . . before it is used outside clinical trials or other research settings" or when "the service or supply is not recognized by the prevailing opinion with the appropriate medical specialty as an effective treatment for the particular diagnosis or set of indications." The Plan also explicitly states that published reports in authoritative medical literature, among other things, will be used in determining whether a procedure is investigational or experimental.
In the end, the SHBC decided that the greater weight of recent and independent medical authority reported that PLDD required further study to determine if it is indeed an effective treatment for herniated discs and nerve root compression. The state of the record before this agency fully supports this decision.
Finally, petitioner argues that the ALJ improperly placed the burden of proof on her rather than respondent. Here, however, the ALJ expressly found that he would have reached the same result no matter which party bore the burden of proof.
A. Articles Submitted into Evidence by Petitioner
i. Percutaneous Laser Disc Decompression Using the
1.06- and 1.32 μm Nd: YAG Lasers
Dr. Choy wrote this article in January 1993. Dr. Daniel S.
J. Choy, M.D. Percutaneous Laser Disc Decompression Using the
1.06- and 1.32 um Nd: YAG Lasers Surgery, 7:1 SPINE: State of the Art Reviews 41 (1993). Dr. Choy noted that patient selection is crucial to successfully performing PLDD and described the ideal patient profile as:
1. Clinical symptomatology corresponding to MR, CT scan, or mylographic documentation of specific level of disc protrusion or herniation.
2. No response to at least 3 months of adequate conservative treatment.
3. No extruded or sequestered disc fragment.
4. No spinal stenosis, significant spondylolisthesis,*fn1 facet joint pathology, tumor, fracture, osteophytic*fn2 narrowing of neural foraminae.*fn3
5. No previous surgery to the disc in question.
6. No "litigation back." In special instances, when, in the judgment of the clinician, the patient has a genuine desire to get well despite negative financial ramifications, exceptions can be made.
7. Absence of hysteria.
8. A second opinion from an independent neurologist or neurosurgeon approving the patient for PLDD.
[Id. at 42.]
He stated that poor patient selection may have been a factor in PLDD's 20% overall failure rate. Id. at 46.
Dr. Choy opined that PLDD "is a safe and effective new modality for the treatment of herniated intervertebral disc disease, provided patients are selected carefully. Its chief advantages are safety, simplicity, speed, use in an outpatient setting, no general anesthesia, lack of scarring, no late spinal instability, and possible repetitive use." Id. at 47. In discussing the advantages of PLDD, he specifically noted
PLDD offers a less invasive method of treating herniated lumbar discs than automated discectomy. . . and it takes less time. . . . PLDD does not have the side effects of anaphylaxis and leakage of chymopapain.*fn4 Compared to open discectomy, PLDD has almost no morbidity and does not require hospitalization. Questions of future spinal instability do not arise with PLDD since the amount of nucleus pulposus*fn5 vaporized is so small. If PLDD fails, subsequent open surgery is not precluded.
Patients who are poor surgical risks. . . can be treated with PLDD since only a local anesthetic is used. [Id. at 46.]
ii. Results of a Clinical Trial of Holmium: YAG Laser in Disc Decompression Utilizing a Side-Firing Fiber: A Two-Year Follow-Up.
An article was published in 1996, which reported the results of a study of PLDD patients postoperatively at one week, three months, six months, one year, and two years. G. Davis Casper, M.D., et al., Results of a Clinical Trial of Holmium: YAG Laser in Disc Decompression Utilizing a Side-Firing Fiber: A Two-Year Follow-Up, 19 Lasers in Surgery and Medicine 90 (1996). The results yielded an 86.9% success rate after two years and an 80% success rate after six months for those patients who required an additional PLDD procedure. Ibid. The authors concluded that PLDD is a "viable treatment modality for symptomatic, nonsequestered lumbar disc herniation recalcitrant to conservative treatment" and that it "may represent a more cost-effective and safer alternative to traditional surgical procedures." Ibid. They did note, however, that the study was "limited by the lack of a matched control group and relatively limited follow-up period." Id. at 95.
iii. Percutaneous Laser Disk Decompression under CT and Fluoroscopic Guidance: Indications, Technique, and Clinical Experience
Petitioner relied upon an additional article published in 1996, which studied 119 patients presenting with lumbar disk herniation who were treated with PLDD under CT and fluoroscopic guidance. Afshin Gangi, M.D., et al., Percutaneous Laser Disk Decompression under CT and Fluoroscopic Guidance: Indications, Technique, and Clinical Experience, 16:1 Radiographics 89 (1996). The study had a 76.5% success rate and the authors ultimately concluded PLDD is a treatment option for patients with a contained lumbar disk herniation. It has many benefits for the operator and the patient, including reduced procedure time [;] . . . optimal decompression of the nucleus; reduced need for instrument changes, streamlining percutaneous needle placement and minimizing trauma; reduced risk of complications; performance with local anesthesia on an outpatient basis; reduced recovery time; reduced soft tissue and bone injury; no scar formation in the perispinal tissues; possibility of repeated use. . . [Id. at 96.]
They qualified their conclusion, however, by stating that despite the encouraging results of PLDD studies, "the long-term efficacy of this technique needs to be proved with a long-term follow-up." Ibid.
iv. Percutaneous Laser Disc Decompression (PLDD): Twelve Years' Experience with 752 Procedures in 518 Patients
Dr. Choy wrote another article in 1998 that conveyed the results of his non-randomized, non-blinded study of 518 patients over a twelve-year period who were only treated with PLDD. Choy, Percutaneous Laser Disc Decompression (PLDD): Twelve Years' Experience with 752 Procedures in 518 Patients, 16:6 J. Clinical Laser Med. and Surgery 325 (1998). The overall success rate was 75%, but it had risen to 89% in the three years prior to the article's publication. Id. at 328. There was a 1% complication rate. Id. at 329. v. Image-Guided Percutaneous Laser Disk Decompression for Herniated Lumbar Disks: a 4-Year Follow-Up in 200 Patients.
In a 2003 report regarding patients who underwent PLDD from 1991 to 1997, the authors reported that traditional surgery to treat disk herniation has been problematic because of "considerable soft-tissue injury and long recovery times." D.H.W. Gronemeyer, M.D., et al., Image-Guided Percutaneous Laser Disk Decompression for Herniated Lumbar Disks: a 4-Year Follow-Up in 200 Patients, 21:3 J. Clinical Laser Med. & Surgery 131, 136 (2003). They also discussed the frequent complications that arise from traditional surgery as supporting the development of minimally invasive procedures like PLDD. Ibid. The study ultimately concluded that image-guided PLDD. . . is an effective secure method to treat contained herniated lumbar disks. Advantages include the minimally invasive approach on outpatient basis and the low complication rate. The use of local anesthesia only, clearly reduces the patient's load, compared to open surgery. The reduction of the amount of pain medication and sick days is also encouraging. [Id. at 137.]
Dr. Harris testified that this study was also a positive review of PLDD. He said, however, that it focused upon image-guided PLDD, which is a different type of PLDD than that discussed in the other articles in evidence.
vi. Photomedicine and Laser Surgery-Special Issue dedicated to PLDD
In October 2004, the Journal of Photomedicine and Laser Surgery, published an entire issue on PLDD. The editorial to this issue stated that PLDD has an international success rate of 80% and could, therefore, "spare many intervertebral disc patients open surgery." 22:5 J. Med. & Laser Surgery (Special Issue) 391, 391 (October 2004).
Dr. Choy also wrote an article in this issue entitled Percutaneous Laser Disc Decompression: A 17-Year Experience, 22:5 J. Med. & Laser Surgery at 407-10. He analyzed a new approach to PLDD, which used a Neodymium: YAG Laser ("Nd: YAG laser") to introduce energy into a disc under fluoroscopic control and local anesthesia and reviewed the overall success rate of PLDD since its introduction. Id. at 407. He concluded that PLDD is a "minimally invasive, outpatient, effective, and relatively safe procedure for the non-surgical treatment of herniated disc disease in the lumbar, thoracic, and cervical spine, [and] has established itself worldwide." Id. at 409. He also noted that it generally provides immediate relief of back and sciatic pain and allows patients to return work approximately five to six days after the procedure. Id. at 407.
Another article petitioner highlighted from this issue is written by J. Hellinger, M.D. and entitled Complications of Nonendoscopic Percutaneous Laser Disc Decompression and Nucleotomy with the Neodymium: YAG Laser 1065 nm., 22:5 J. Med. & Laser Surgery at 418-22. Hellinger focused on the complication rate in performing PLDD with a Nd: YAG Laser, because complication rate is an important factor in evaluating success. Id. at 418. He found that Nd: YAG Laser PLDD yielded a relatively low complication rate; it is generally evaluated with a complication rate of 0.5% and a 1.0% complication rate when performed in the cervical spine area. Ibid. He concluded that the 1% complication rate is significantly lower than the 3.7% rate attained by other instrumental percutaneous intradiscal methods. In comparison to other more recent complication figures of up to 14% in open disc surgery (up to 30% complications resulting from fusional surgery), this particular complication rate is exceptionally low. [Id. at 421.]
In another article within the issue, Percutaneous Laser Disc Decompression for the Treatment of Discogenic Lumbar Pain and Sciatica: A Preliminary Report with 3-Month Follow-Up in a General Pain Clinic Population, the authors evaluated the short term efficacy of PLDD for the treatment of lumbar discogenic pain and sciatica. Marion McMillan, M.D., et al., 22:5 J. Med. & Laser Surgery at 434-38. The authors concluded that "PLDD with the [Nd: YAG] laser is a safe and effective treatment for discogenic lumbar pain and sciatica during a preliminary 3-month follow-up period in a general pain management practice setting." Ibid. The authors did note, however, that "[t]he development or worsening of mechanical low back pain symptoms following PLDD was unexpected and needs to be explored further," id. at 437, but ultimately concluded that mechanical lower back pain is common and easily treated, id. at 434.
The study was relatively small, consisting of only thirty-two patients and relatively short. Id. at 435. The authors made the following comments with respect to these limitations:
Our preliminary results from a small group of patients treated and followed for 3 months are in agreement with [the] previous results, and support the continued use of this minimally invasive treatment modality for the treatment of appropriately selected patients with chronic discogenic pain and sciatica refractory to conservative management. Small sample size, limited follow-up periods, and the lack of appropriate control groups are problems shared by many of the studies currently reported in the literature as well as our own, and our results must be viewed as preliminary. Despite these methodologic limitations, we believe our initial experience with PLDD in a population of patients with discogenic spinal pain and sciatica attending an interventional pain management clinic is encouraging and deserves further study in well-designed clinical trials. [Id. at 437.]
vii. Percutaneous Laser Disc Decompression: History and Scientific Rationale
This article was also written by Dr. Choy and its stated purpose is to summarize the basic science experiments leading up to the clinical application of PLDD in human patients. Choy, Percutaneous Laser Disc Decompression: History and Scientific Rationale, 9:1 Techniques in Reg'l Anesthesia & Pain Mgmt. 50-55 (2005). It focuses upon the necessity of PLDD because of the general discectomy's association with complications and its need for general anesthesia and cutting into individuals' backs. Id. at 50-51. He also noted that PLDD is being performed in almost every nation in Western Europe, the United Kingdom, South and Central America, Cuba, Japan, China, India, Korea, and the United States. As of this writing, over 50,000 cases have been treated worldwide; some 12,000 in the United States. Reported success rates. . . from laser spine surgeons around the world average 75% to 85%, with a complication rate of 1%. My figures from a database of some 2500 cases are 89% and 0.4%, respectively. PLDD received Food and Drug Administration (FDA) approved in 1991 and was awarded a Current Procedural Terminology (CPT) code by the American Medical Association in January 2000. It is being reimbursed by third-party payers in the United States. [Id. at 55.]
He, therefore, concluded that "PLDD should supplant the traditional laminectomy/discectomy as the first choice, mainline therapy" for herniated discs. Ibid.
Dr. Harris testified that, although this article says PLDD received FDA approval, it was, in fact, only the laser used in performing PLDD that received the approval, not the procedure itself. He also admitted that the fact that PLDD was given a billing code suggests that the procedure was being used on a "fairly regular basis." He also noted, however, that the code associated with PLDD is for disc decompression generally, and not just laser disc decompression.*fn6
viii. Comparison of Results of 500 Microdiscectomies and 500 Percutaneous Laser Disc Decompression Procedures for Lumbar Disc Herniation.
This article's objective was to analyze the neurosurgical results of 500 patients who had been treated with microdiscectomies and 500 patients who were treated with PLDD. Gian Paolo Tassi, M.D., Comparison of Results of 500 Microdiscectomies and 500 Percutaneous Laser Disc Decompression Procedures for Lumbar Disc Herniation, 24:6 J. Photomedicine and Laser Surgery 694-97 (2006). It compared the results of both surgeries on patients two years after they were performed. Id. at 695. The PLDD surgeries were performed using Dr. Choy's surgical technique. Ibid. The author concluded that the study had not demonstrated that PLDD is better than microdiscectomy or visa versa, but we can conclude that PLDD with its background and the results of 19 years, represents a strong successful, and safe first choice of a minimally invasive technique in the treatment of patients affected by discogenic pain for disc hernia that was not responsive to standard conservative therapies.
[Id. at 696.]
The author did concede, however, that a two year follow-up was "not very long" and the study would require a follow-up, as it is well-known that failed surgery for a disc hernia may only become evidenced five to ten years after surgery. Ibid.
It is not clear when in 2006 this study was conducted. The ALJ found the absence of the exact date of the article to be significant, because the Medical Director ended the database he used to review the claim in April of 2006. Therefore, if the study was conducted after that, it would not have been considered in denying petitioner's claim.
B. Articles Submitted into Evidence by Respondent
i. Current Concepts in Minimally Invasive Discectomy
In a 2002 article, Joseph C. Maroon, M.D., reported results from a review of literature regarding, and his own personal experiences with, various minimally invasive procedures, including PLDD. Maroon, Current Concepts in Minimally Invasive Discectomy, 51 Neurosurgery 137-44 (Supp. 2 2002). He noted that "[t]here have been few controlled trials of the use of laser energy for disc ablation" and, although "[a]necdotal reports note satisfactory results for 60 to 85% of patients" with relatively few complications, "randomized clinical trials have not yet demonstrated superiority over existing surgical techniques." Id. at 141. He further observed that "[d]espite the relative ease of performance in some cases. . . none of [the minimally invasive methods, including PLDD,] has found a place in the hands of the majority of surgeons, because of the paucity of long-term results, the potential and real complication rates, or the learning curve for acquisition of the required technical skills." Id. at 143-44. He ultimately concluded that "microsurgical discectomy remains the procedure of choice for the majority of patients who require surgery and continues to be the standard against which all other procedures must be measured." Id. at 144.
ii. Minimally Invasive Procedures for Disorders of the Lumbar Spine
Respondent also submitted a 2003 article that "chronicle[d] the evolution and status of several minimally invasive spinal procedures," including PLDD. H. Gordon Deen, M.D., et al., Minimally Invasive Procedures for Disorders of the Lumbar Spine, 78 Mayo Clinic Proceedings 1249 (2003). The authors state that, despite encouraging results, "critical assessment of [PLDD] has been hampered because the procedure has never been compared directly with microdiskectomy" and that it has not "gained widespread acceptance." Id. at 1250. They conclude that, although some minimally invasive procedures have shown clinical benefit, "none have been proved superior to open microdiskectomy, which remains the gold standard for surgical treatment of lumbar disk herniation with radiculopathy." Id. at 1255.
iii. Laser Discectomy for the Treatment of Lumbar Discs
In December 2004, ECRI Health Technology Assessment Information Service (HTAIS) published a Windows on Medical Technology report on PLDD. ECRI HTAIS, Laser Discectomy for the Treatment of Lumbar Discs, Windows on Med. Tech., December 2004 at 1. Windows on Medical Technology reports "are short form evidence reports . . . [that] are designed to provide a rapid and accurate overview of a specific medical technology for a specific application." Ibid. According to the Windows on Medical Technology Policy Statement, ECRI is a non-profit health services research center and has been "designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality." Ibid.
The report identified several theoretical advantages of PLDD: (1) it is relatively non-invasive; (2) it takes place in an outpatient setting; (3) the treatment time is short; (4) it requires minimal recovery time; (5) the amount of tissue removal can be precisely controlled; (6) it can be used repetitively; (7) it does not preclude future surgery; (8) it does not cause epidural scars; (9) there is no association with postoperative pain syndromes; and (10) it yields a low complication rate. Id. at 4-5. The report, however, discussed the lack of RCTs for PLDD as being problematic. Id. at 17. It noted that there has only been one RCT and it utilized subjective measures and was of low quality. Id. at 18. The report, therefore concluded that lack of controlled studies comparing [PLDD] to either continued conservative therapy or other operative procedures such as microdiscectomy or open discectomy prevents the construction of any evidence-based conclusions about this technology. Considering that [PLDD] is considered an alternative to open discectomy, the absence of a comparison trial for these two procedures is noteworthy. . . . .
Controlled trials are especially important when evaluating pain-relieving treatments to determine the influence of nonspecific effects and regression to the mean on pain-related outcome measures. Given the natural history of herniated lumbar discs, pain relief may be as likely to occur without invasive treatment as with invasive treatment. A controlled trial is therefore needed to determine the actual extent to which [PLDD] achieves pain relief beyond that of the natural course of the disorder. [Id. at 25.]
The report also noted that Blue Cross/Blue Shield of Massachusetts and Medicare do not cover PLDD, and that Aetna US Healthcare only covers PLDD when certain conditions are met. Id. at 24-25.
iv. Interventional Techniques: Evidence Based-Practice Guidelines in the Management of Chronic Spinal Pain
In a 2007 publication, distributed by Pain Physician Journal, numerous authors attempted to "develop evidence-based clinical practice guidelines for interventional techniques in the diagnosis and treatment of chronic spinal pain. Mark V. Boswell, et al., Interventional Techniques: Evidence Based-Practice Guidelines in the Management of Chronic Spinal Pain, 10 Pain Physician J. 7 (2007). The authors described PLDD as an "alternative to the standard open discectomy treatment." Id. at 59. Relying on a third-party review of PLDD, the authors opined that "there is no acceptable evidence . . . for laser discectomy." Ibid. They also noted that they reviewed fourteen studies and none of them were randomized trials. Ibid.
v. Percutaneous Laser Disc Decompression With a Treatment of Lumbar Disc Herniation
In another 2007 publication, PLDD studies from January 1980 to June 2006 were reviewed. Philippe Goupille, M.D., Percutaneous Laser Disc Decompression With a Treatment of Lumbar Disc Herniation: A Review, 37 Seminars in Arthritis Rheumatism 20 (2007). The authors determined that the quality of information available about PLDD was poor. Id. at 21. They ranked the available evidence at a level of 3 or 4 on a scale of 1 to 4, with 1 being the most evidence-based and 4 being the least evidence-based.*fn7 Ibid. They reasoned that "[n]one of the articles offered high-quality evidence, particularly because of the current lack of controlled, blinded, or randomized trials." Ibid.
The authors ultimately opined that
[a]lthough the concept of laser nucleotomy is tempting for use in treating lumbar herniated disc, many unresolved issues remain regarding equipment,. . . the precise mechanism of action, and possible untoward effects on the intervertebral disc. Therefore, PLDD could be used as an alternative to classical surgery. However, in light of results of the open studies published to date, which involve weak methodology, and the absence of controlled trials, its use as a validated treatment for disc herniation-related radiculopathy resistant to medical treatment is questionable.
[Id. at 28.]
vi. Intervention for Lumbar Disc Prolapse (Review)
Finally, a 2007 review, published in 2008, specifically states that automated percutaneous discectomy and laser assisted discectomy should be regarded as research techniques only. Gibson JNA & Waddell G., Surgical Interventions for Lumbar Disc Prolapse (Review) in The Cochrane Database of Systematic Reviews 2007, Issue 2, at 1 (The Cochrane Collaboration, No. CD001350, 2008). The reviewers assessed "the effects of surgical intervention for the treatments of lumbar disc prolapse" by evaluating trial quality and extracted data from published papers. Id. at 1. They concluded that "there is considerable evidence that surgical discectomy provides effective clinical relief for carefully selected patients," but "[a]t present, unless or until better scientific evidence is available, automated percutaneous discectomy, coblation therapy and laser discectomy should be regarded as research techniques." Id. at 8. They further averred that "[h]igh quality RCTs are necessary to determine if there is any role for [PLDD]." Ibid.