Page 1 – FINDINGS OF FACT AND CONCLUSIONS OF LAW

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF OREGON

CARLA SAMMONS,

Plaintiff,

Case No. 3:15-cv-01703-SI

v.

FINDINGS OF FACT AND 

CONCLUSIONS OF LAW

REGENCE BLUECROSS BLUESHIELD

OF OREGON; OREGON BAKERS 

UNION TRUST FUND; and BOARD OF 

TRUSTEES, OREGON BAKERS UNION 

TRUST FUND,

Defendants.

Samuel T. Stanke, Attorneys at Law, LLC, 1400 SW Montgomery Street, Portland, OR 97201. 

Of Attorneys for Plaintiff. 

Eric A. Lindenauer, GARVEY SCHUBERT BARER, Eleventh Floor, 121 SW Morrison Street, 

Portland, OR 97204-3141. Of Attorneys for Defendants.

Michael H. Simon, District Judge.

Plaintiff Carla Sammons (“Ms. Sammons”) brings this action to challenge the decision 

made by Defendants Regence BlueCross BlueShield of Oregon (“Regence BCBSO”), Oregon 

Bakers Union Trust Fund, and the Board of Trustees of Oregon Bakers Union Trust Fund (the 

“Board”) (collectively “Defendants”) denying medical benefits under the Oregon Bakers Union 

Health and Welfare Trust Fund Plan 4 (the “Plan”) on the grounds that the requested medical 

procedure was “Investigational.” Ms. Sammons argues: (1) her procedure was not Investigational 

under the Plan; (2) even if the procedure were Investigational, it still should have been covered 

under the “Alternative Benefits” section of the Plan; and (3) by paying a portion of the expenses

Case 3:15-cv-01703-SI Document 23 Filed 03/23/16 Page 1 of 23
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of the procedure, the Plan has waived its right to argue that it may not pay the remainder. 

Defendants respond that Ms. Sammons’s medical procedure was “Investigational,” as defined by 

the Plan, because the scientific evidence has not yet permitted a conclusion regarding the

long-term efficacy and safety of artificial discs, in comparison to recognized alternatives.

Defendants add that the Alternative Benefits provision of the Plan have not been triggered and 

that no waiver has occurred. After a bench trial on an administrative record, the Court concludes

that Ms. Sammons is not entitled to the requested benefits under the Plan.

STANDARDS AND PROCEDURE

The Employee Retirement Income Security Act (“ERISA”) provides that an ERISA plan 

“participant” may bring a civil action in federal court “to recover benefits due to him under the 

terms of his plan, to enforce his rights under the terms of the plan, or to clarify his rights to future 

benefits under the terms of the plan[.]” 29 U.S.C. § 1132(a)(1)(B); Metro. Life Ins. Co. v. Glenn, 

554 U.S. 105, 108 (2008) (“[ERISA] permits a person denied benefits under an employee benefit 

plan to challenge that denial in federal court.”). An ERISA plan that does not contain text 

conferring discretion on the plan administrator is subject to a de novo standard of review. Metro. 

Life Ins., 554 U.S. at 111 (citing Firestone Tire & Rubber Co. v. Bruch, 489 U.S. 101, 115 

(1989)). The Plan at issue in this lawsuit does not confer discretion on the Plan administrator. 

AR00001-00103. Further, the parties have agreed that a de novo standard of review applies in 

this case. Dkts. 14 at 6-7; 17 at 8. The court accepts the parties’ stipulation and thus reviews the 

record de novo. See Rorabaugh v. Cont’l Cas. Co., 321 F. App’x 708, 709 (9th Cir. 2009) (court 

may accept parties stipulation to de novo review).

Under de novo review, the trial court does not give deference to the Plan administrator’s 

rationale or determination. Mongeluzo v. Baxter Travenol Long Term Disability Benefit Plan, 

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46 F.3d 938, 943 (9th Cir. 1995). Instead, the trial court performs an “independent and thorough 

inspection” of the Plan administrator’s decision to determine whether the Plan administrator 

correctly or incorrectly denied benefits. Silver v. Exec. Car Leasing Long-Term Disability Plan, 

466 F.3d 727, 733 (9th Cir. 2006). De novo review permits the trial court to “evaluate the 

persuasiveness of conflicting testimony and decide which is more likely true.” Kearney v. 

Standard Ins. Co., 175 F.3d 1084, 1095 (9th Cir. 1999) (en banc). 

Ms. Sammons has filed a motion for summary judgment. Dkt. 14. Defendants have cross 

moved for judgment based on a bench trial on an administrative record. Dkt. 17, at 8. In 

addition, the parties have filed a stipulated motion to supplement the administrative record 

(Dkt. 13), and the Court has granted that motion. Dkt. 16. The appropriate procedure to resolve 

this dispute is through a bench trial on an administrative record, as supplemented, pursuant to the 

parties’ stipulation. See Rabbat v. Standard Ins. Co., 894 F. Supp. 2d 1311, 1314 (D. Or. 2012); 

see also Casey v. Uddeholm Corp., 32 F.3d 1094, 1099 (7th Cir. 1994) (on de novo review of an 

ERISA benefits claim, the “appropriate proceeding[ ] . . . is a bench trial and not the disposition 

of a summary judgment motion”); Lee v. Kaiser Found. Health Plan Long Term Disability Plan, 

812 F. Supp. 2d 1027, 1032 n.2 (N.D. Cal. 2011) (“De novo review on ERISA benefits claims is 

typically conducted as a bench trial under Rule 52.”); but see Orndorf v. Paul Revere Life Ins. 

Co., 404 F.3d 510, 517 (1st Cir. 2005) (“When there is no dispute over plan interpretation, the 

use of summary judgment . . . is proper regardless of whether our review of the ERISA decision 

maker’s decision is de novo or deferential.”). Further, in a trial on an administrative record:

The district judge will be asking a different question as [the judge]

reads the evidence, not whether there is a genuine issue of material 

fact . . . . In a trial on the record, but not on summary judgment, the 

judge can evaluate the persuasiveness of conflicting testimony and 

decide which is more likely true.

Kearney, 175 F.3d at 1095.

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The Court has reviewed the administrative record, as supplemented by stipulation of the 

parties, and has made factual findings under a preponderance of the evidence standard. Pursuant 

to Rule 52(a), the Court issues the following findings of fact and conclusions of law based on the 

supplemented administrative record and the parties’ arguments.

FINDINGS OF FACT

A. Background

1. Ms. Sammons is approximately 55 years old. She has a history of lower back pain 

and degenerative disc disease in her lumbar spine. AR00202. Degenerative disease is an “illness 

resulting from aging, repetitive injury, or other pathological causes.” Taber’s Cyclopedic 

Medical Dictionary 593 (Donald Venes et al. eds. 2009) [hereinafter Taber’s]. 

2. Ms. Sammons was, at all material times, a beneficiary under the Oregon Bakers 

Union Health and Welfare Trust Fund Plan 4 (the “Plan”) through her spouse’s employment by 

Franz Bakery.

3. On December 13, 2011, a Level 1 Lumbar Discogram revealed a Grade IV 

Fissure in Ms. Sammons’s L5-S1 disc; that the disc was abnormal, severely degenerative, and 

sclerotic;1and that pressurization produced severe concordant pain. AR00213-216. 

Ms. Sammons rated her pain a ten on a scale of one to ten. Id. On March 13, 2013, a lumbar 

spine MRI showed Ms. Sammons’s L5-S1 advanced disc space narrowing, disc bulging, mild 

facet arthrosis,2and spondylosis3encroachment upon the interior foramina4resulting in mild 

 

1

“Sclerotic” is the adjective form of “sclerosis,” which means :[a] hardening or induration of an organ or tissue, esp. 

that due to excessive growth or fibrous tissue.” Taber’s Cyclopedic Medical Dictionary 2085 (Donald Venes et al. 

eds. 2009).

2

“Arthoris” is “[a] joint disorder caused by trophic degeneration.” Taber’s at 193.

3

“Spondylosis” is a vertebral condition. Taber’s at 2183.

4

“Foramina” are “hole[s] in a bone for passage of vessels or nerves.” Taber’s at 894.

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bilateral narrowing. AR00239-243. During a March 25, 2013 office visit with Richard Guyer 

M.D., Ms. Sammons reported lower back pain with bilateral leg pain and numbness and giving 

way of the left leg, which she had suffered from for the last three years. AR00202-207. Based 

upon previous discussions with Dr. Guyer, Ms. Sammons requested total disc arthroplasty, i.e.

artificial disc replacement surgery (the “Surgery”), which was scheduled for June 27, 2013. 

AR00202-207.

4. On June 7, 2013, Ms. Sammons sought pre-authorization from defendant Regence 

for the Surgery by completing and faxing to Regence its “Pre-Authorization Request Form.”

AR00356. Regence denied Ms. Sammons’s pre-authorization request on the grounds that “[t]he 

scientific evidence doesn’t sufficiently conclude that lumbar artificial diskectomy improves 

health outcomes,” AR00191, and therefore the requested Surgery is “Investigational,” as defined 

by the Plan.5 AR00075. Notwithstanding this conclusion, the Plan later paid $1,012.50 to 

Pinnacle Anesthesia Consultant for the anesthesia services that Ms. Sammons received during 

the Surgery. Dkt. 15-1 at 6.

5. Despite Regence’s denial, Ms. Sammons underwent the Surgery as scheduled on 

June 27, 2013. AR00231-32. The Surgery was successful in reducing Ms. Sammons’s lower 

back pain, although she continued to suffer from upper back and left arm pain and numbness. 

AR00254-56. X-rays showed that her disc now was in good position at L5-S1. Id.

6. Ms. Sammons appealed the Plan’s denial four times. She appealed twice to 

Regence BCBSO and once to an independent review organization (“IRO”) selected by the 

Oregon State Insurance Division. Finally, she appealed to the Oregon Bakers Union Trust Board 

of Trustees.

 

5 Regence’s original pre-authorization denial is not in the record. 

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7. “Barbara D.,” from patient financial services at Texas Health Partners, 

Ms. Sammons’s surgical provider, submitted the first appeal of claim denial to Regence on 

August 16, 2013. AR00121. The submission consisted of the provider’s medical records for the 

surgery, but omitted any treatment records before the surgery. At Regence BCBSO, Robert 

Manley, M.D., reviewed the first appeal and determined that the Surgery was an 

“investigational” procedure, under the Regence Medical Policy (“Medical Policy”). AR00186-

189. Regence then informed Ms. Sammons of the denial and her right to appeal further. 

AR00191-193.

8. Ms. Sammons submitted her second appeal to Regence on February 12, 2014. 

AR00195-196. This submission consisted of the L5-S1 Operative Report, discogram, MRI,

surgical documentation, letter of medical necessity from Dr. Guyer, Ms. Sammons’s complete 

medical records from the Texas Back Institute, and selected articles on artificial discs. AR00194-

00327. Kim Sloan, M.D., an outside reviewer and orthopedic surgeon with a special expertise in 

spine surgery, was engaged by Regence to review the second appeal. AR00335. Dr. Sloan also 

determined the artificial disc implant fell within the investigational exclusion. Id. She further 

stated that the current peer-reviewed literature “has not shown significant advantage of artificial 

disc replacement compared to the standard of care, which is fusion. While the artificial disc may 

have increased motion, the reoperation rate is higher [1, 2].” AR00334. Dr. Sloan then cited to 

the Regence Medical Policy Manual and additional published medical literature. AR00335.

Based upon this review, Regence BCBSO denied Ms. Sammons’s appeal and informed her of 

her right to initiate an “external review” of the denial by making a request to either Regence 

BCBSO or to the Oregon Department of Consumer and Business, Insurance Division (“DCBS”).

AR00342-345.

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9. On August 25, 2014, Ms. Sammons submitted a request for external review. 

AR00348. This submission consisted of medical records and the same articles submitted in the 

second appeal. AR00348-443. On August 28, 2014, DCBS notified Regence BCBSO that DCBS 

had selected IPRO in Lake Success, New York, as the external reviewer. AR00447-448. The 

IPRO external review was performed by a physician in active practice, board certified in 

orthopedic surgery, and with a fellowship in spine surgery. AR00453. On September 24, 2014, 

IPRO issued a decision upholding the Regence BCBSO denial. AR00453-456. In a summary 

“Analysis and Rationale,” the IPRO Medical Director, Monty M. Bodenheimer, M.D., explained 

that the “use of artificial discs looks promising for future treatment of lumbar disc pathology; 

however, the treatment is still considered investigative. The short-term outcome of TDR is at 

least equivalent to fusion surgery. Long-term efficacy and safety of the devices has yet to be 

established.” AR00455.

10. On February 23, 2015, Ms. Sammons submitted her fourth and final appeal to the 

Board of Trustees of the Oregon Bakers Trust Fund (the “Board”). AR00467-468. On March 17, 

2015, the Board denied the final appeal, finding that both Regence and the Independent Review 

Organization reasonably concluded that the Surgery was investigational. AR00464-466.

11. The Plan does not provide coverage for “investigational” services. AR00035-36. 

“Investigational” is defined as:

A Health Intervention that We have classified as Investigational. 

We will review Scientific Evidence from well-designed clinical 

studies found in peer-reviewed medical literature, if available, and 

information obtained from the treating Physician or Practitioner 

regarding the Health Intervention to determine if it is 

Investigational. A Health Intervention not meeting all of the 

following criteria, is, in Our judgment, Investigational:

[1] If a medication or device, the Health Intervention must have 

final approval from the U. S. Food and Drug Administration as 

being safe and efficacious for general marketing. . . . 

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[2] The Scientific Evidence must permit conclusions concerning 

the effect of the Health Intervention on Health Outcomes, which 

include the disease process, Injury or Illness, length of life, ability 

to function and quality of life. 

[3] The Health Intervention must improve net Health Outcome. 

[4] The Scientific Evidence must show that the Health Intervention 

is as beneficial as any established alternatives.

[5] The improvement must be attainable outside the laboratory or 

clinical research setting.

AR00075.

12. The Plan also provides for payment of “Alternative Benefits” as follows: 

Alternative benefits means benefits for services or supplies that are 

not otherwise covered under the Contract, but for which We may 

approve coverage after case management evaluation and analysis. 

We may cover alternative benefits through case management if We 

determine, in our sole discretion, that alternative benefits are 

Medically Necessary and will result in overall reduced covered 

costs and improved quality of care. Before coverage of alternative 

benefits and before the processing of claims for alternative 

benefits, We, You or Your legal representative and, if required by 

Us (in Our sole discretion), Your Physician or other Provider must 

agree in writing to the specific terms and conditions for payment. 

Alternative benefits are approved on a case-specific basis only.

AR00041.

13. The Plan defines “Medically Necessary” as follows: 

[H]ealth care services or supplies that a Physician or other health 

care Provider, exercising prudent clinical judgment, would provide 

to a patient for the purpose of preventing, evaluating, diagnosing or 

treating an illness, injury, disease, or its symptoms, and that are: 

[1] in accordance with generally accepted standards of medical 

practice; [2] clinically appropriate, in terms of type, frequency, 

extent, site and duration, and considered effective for the patient’s 

illness, injury or disease; and [3] not primarily for the convenience 

of the patient, Physician or other health care Provider, and not 

more costly than an alternative service or sequence of services or 

supply at least as likely to produce equivalent therapeutic or 

diagnostic results as to the diagnosis or treatment of that patient’s 

illness, injury or disease. For these purposes, “generally accepted 

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standards of medical practice” means standards that are based on 

credible Scientific Evidence published in Peer-Reviewed Medical 

Literature generally recognized by the relevant medical 

community, Physician Specialty Society recommendations and the 

views of Physicians and other health care Providers practicing in 

relevant clinical areas and any other relevant factors.

AR00076. 

14. The Plan defines “Scientific Evidence” as:

scientific studies published in or accepted for publication by 

medical journals that meet nationally recognized requirements for 

scientific manuscripts and that submit most of their published 

articles for review by experts who are not part of the editorial staff; 

or findings, studies or research conducted by or under the auspices 

of federal government agencies and nationally recognized federal 

research institutes. However, Scientific Evidence shall not include 

published peer-reviewed literature sponsored to a significant extent 

by a pharmaceutical manufacturing company or medical device 

manufacturer or a single study without other supportable studies.

AR00076-77. 

15. The Plan defines “Health Intervention” as:

medication, service or supply provided to prevent, diagnose, 

detect, treat or palliate the following: disease, Illness, Injury, 

genetic or congenital anomaly, pregnancy or biological or 

psychological condition that lies outside the range or normal, ageappropriate human variation; or to maintain or restore functional 

ability. A Health Intervention is defined not only by the 

intervention itself, but also by the medical condition and patient 

indications for which it is being applied. A Health Intervention is 

considered to be new if it is not yet in widespread use for the 

medical condition and the patient indications being considered. 

AR00074-75. 

16. The Plan defines “Health Outcome” as “an outcome that affects health status as 

measured by the length or quality of a person’s life. The Health Intervention’s overall beneficial 

effects on health must outweigh the overall harmful effects on health.” AR00075. 

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B. Whether Artificial Disc Replacement Surgery Is “Investigational”

18. The parties do not dispute the meaning of the Plan’s terms. Under the Plan, a 

medical procedure must satisfy five criteria to avoid classification as “Investigational.” 

AR00075. The Plan requires that all criteria must be satisfied. Thus, a failure to meet even one of 

the criteria will result in a finding that the Health Intervention is investigational. Id.

19. The parties also do not dispute that the first and fifth criteria are satisfied. The 

artificial disc device has final approval from the United States Food and Drug Administration as 

being safe and efficacious for general marketing (the first criterion) and the improvement was 

attainable outside the laboratory or clinical research setting (the fifth criterion). While 

Defendants do not stipulate that the Surgery performed on Ms. Sammons did in fact improve net 

Health Outcome (the third criterion), the parties do not focus on that issue. The parties primarily 

dispute whether there exists (a) scientific evidence permitting conclusions concerning the effect 

of lumbar total disc replacement on health outcomes (the second criterion) and (b) scientific

evidence showing lumbar total disc replacement is as beneficial as any established alternative 

(the fourth criterion). See ¶ 11 (Findings of Fact, Background), supra.

1. Whether the Scientific Evidence permits conclusions regarding the effect of disc 

replacement on net health outcomes (the second criterion)

20. Regence BCBSO reviewed and updated its Medical Policy on artificial discs in 

February 2013, approximately four months before Ms. Sammons’s surgery. AR00104-120. The 

updated Medical Policy concludes that the “Scientific Evidence” was “insufficient to permit 

conclusions about the long-term benefits and safety of total disc replacement with artificial 

intervertebral discs (“TDR”). AR00106. In support of this conclusion, the Policy addresses five 

concerns with the state of the Scientific Evidence. These concerns are: (1) insufficiency of data 

to adequately establish long-term safety and effectiveness of the discs in the treatment of 

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degenerative disc disease; (2) lack of knowledge regarding long-term performance, durability, 

revisability, and complication rates; (3) existence of only one evidence-based clinical practice 

guideline from U.S. neurosurgery or orthopedic professional associations;6(4) each of the 

randomized trials on which the FDA approval was based was limited to two-year outcomes and 

all studies demonstrating the 5-year data were not available at that time; and (5) lack of 

demonstration of potential benefits and uncertainty regarding whether response rates will decline 

over time. Id. The Medical Policy also notes that long-term data is necessary because patterns of 

degenerative changes following TDR or fusion take at least five years to become measurable, the 

benefits of spinal surgery are known to deteriorate over time, and complications of spinal surgery 

tend to increase over time. AR00107. Moreover, the IPRO external review, in upholding the 

Regence BCBSO denial, explained that artificial disc replacement is “comparable to the lumbar 

fusion at two year followup. However, long term efficacy and safety of the devices cannot be 

established.” AR00455. Thus, to permit conclusions concerning the effect of artificial disc 

replacement surgery on health outcomes, the scientific evidence must address outcomes at least 

five years after surgery.

21. Ms. Sammons initially submitted five articles on artificial disc replacement 

treatment in support of her arguments. AR00276-325. Under the “Investigational” exclusion, the 

reviewer is directed to consider scientific evidence from well-designed clinical studies found in 

peer-reviewed medical literature and information obtained from the treating physician.

Specifically, “Scientific Evidence,” as defined above, consists of scientific studies published in 

or accepted for publication by medical journals that meet nationally recognized requirements and 

 

6

“The North American Spine Society (NASS) guidelines for cervical radiculopathy noted that short-term outcomes 

suggested TDR and fusion are comparable . . . but these outcomes must be validated in long-term studies.” 

AR00106.

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are peer-reviewed, and findings conducted by federal government agencies and nationally 

recognized federal research institutes. Scientific Evidence does not include, however, any 

published peer-reviewed literature that are sponsored to a significant degree by a pharmaceutical 

manufacturing company or medical device manufacturer or a single study without other 

supportable studies. AR00076-77.

22. First, Ms. Sammons submits an article discussing the results of the randomized, 

multicenter FDA study comparing ProDisc-L total disc replacement with circumferential fusion, 

the established alternative to artificial disc replacement.

7 AR00278-285. The study treated 286 

patients, evaluating them before and after surgery at 6 weeks and at 3, 6, 12, 18, and 24 months.

The study concluded that the ProDisc-L was safe, efficacious, and “superior to circumferential 

fusion by multiple clinical criteria.” AR00278. Specifically, the study demonstrated that at 24 

months, the ProDisc-L patients had 51 percent improvement in visual analog scale (“VAS”)

pain, 46 percent improvement from baseline Oswestry Disability Index (“ODI”), and

significantly higher VAS satisfaction and neurological status than fusion patients. AR00285.

23. Second, Ms. Sammons submits an article entitled “ProDisc Retrospective Clinical 

Study: 7 to 11 Year Follow-Up.” AR00276-277, 286-297, 311-313. This article has not been 

published, or accepted for publication, by any medical journals and thus cannot be considered 

under the Plan’s definition of “Scientific Evidence.” The Court does not consider this article.

24. Third, Ms. Sammons submits an article entitled “Minimally invasive total disc 

replacement: surgical technique and preliminary clinical results,” AR00298-302, which 

considered a nonrandomized study of 34 patients with an average age of 44 years. AR00301. 

Patients were evaluated before and after surgery at 3, 6, 12, and 24 months. Id. The study found

 

7 Circumferential fusion is the surgical standard of care and the established alternative to artificial disc replacement. 

AR00278, 329.

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major advantages to disc replacement such as its standardized, minimally-invasive approach and 

quick recovery time, with patients able to get out of bed the day after surgery. AR00302. The 

article concluded that, “although preliminary, the results suggest, that total disc replacement for 

the indications mentioned above might be a reasonable alternative to lumbar fusion.” Id.

25. Fourth, Ms. Sammons submits an article entitled “Lumbar Total Disc 

Replacement. Seven to Eleven-Year Follow-Up,” AR00303-310, which addresses the same 

study as the unpublished article cited above. The article was co-authored by Dr. Thierry Marnay, 

the inventor of the ProDisc, and published in the Journal of Bone & Joint Surgery in 2005. 

AR00303. Of the 64 patients treated, 55 had sufficient follow-up, with a mean duration of 

follow-up at 8.7 years. AR00304. The results showed that at approximately 8.7 years after 

surgery, 33 had excellent results, 8 had good results, and 14 had poor results. Id. The study 

concluded that ProDisc lumbar total disc replacement appears to be safe and effective in 

treatment yet stressed the need for randomized trials and validation:

The current study had all of the limitations inherent to 

nonrandomized case series. We cannot make any definitive 

statements regarding the outcomes of lumbar total disc 

replacement compared with those of nonoperative treatment or 

arthrodesis [fusion]. The data reflect the results associated with a 

single implant type and may be different for other designs... 

Furthermore, the study would be more useful if validated outcomes 

instruments had been used. Nevertheless, our data indicate that the 

prosthesis is safe, with an acceptably low rate of complications at 

seven to eleven years postoperatively, and that its efficacy appears 

promising and should be tested in a randomized prospective trial.

AR00309.

26. Fifth, Ms. Sammons submits an article entitled “Long-term Results of One-Level 

Lumbar Arthroplasty,” AR00314-319, which describes a study of 108 patients with a mean age 

of 36.4 years. AR00314-315. All patients were seen for a clinical follow-up at 3 and 6 months, 

and at 1, 5, and 10 years. AR00315. Also, 10 patients were followed for 15 years after surgery. 

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Id. The study found that the “[c]linical outcomes and the rate of return to work were excellent 

overall. The rate of adjacent-level disease requiring surgical intervention was considerably lower 

(2.8%) compared with . . . lumbar fusion.”8 AR00319. These results, the study notes, 

demonstrate the safety and efficacy of artificial disc replacement surgery over the long term.

27. Defendants argue that the articles and studies submitted by Ms. Sammons do not 

alter the conclusions in the Medical Policy or made by the reviewers. Of the five studies 

described above, only one is a randomized clinical trial, most note an inability to make definitive

statements regarding outcomes, and all fail to present long-term results based on a randomized 

trial or study. According to Defendants, a post-operative follow-up study of five years is needed 

to assess long-term effects due to the special nature of spinal surgery, with benefits deteriorating 

over time and degenerative changes taking at least five years to manifest. In support of these 

contentions, Defendants cite to the Regence Medical Policy Manual. AR00106-107.

28. The Plan requires that the scientific evidence must permit conclusions concerning 

the effect of the Surgery on “Health Outcomes, which include the disease process, Injury or 

Illness, length of life, ability to function and quality of life.” AR00075. Of the four reviewable

studies cited by Ms. Sammons, only one was a randomized clinical trial. AR00278-285. A 

randomized clinical trial is an “experimental study to assess the effects of a particular variable 

(for example, a drug or treatment) in which subjects are assigned randomly to an experimental, 

placebo, or control group. . . . Members of each group are prevented from knowing whether they 

are receiving the active therapy. The researchers gathering the data are also typically blinded to 

 

8 Additionally, in comparing replacement surgery with fusion procedures, the study notes “[f]or fusion 

procedures . . . ‘complications’ [such as subsequent reoperations at the index-level or the adjacent-level] are rarely 

reported because in most cases the follow-up is limited to 2 years, sometimes less. The rate of complications in this 

series is acceptable in comparison to . . . fusion studies.” AR00318.

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group assignment.” Taber’s at 1969. The use of randomization in research allows clinicians “to 

assign subjects to experimental groups without introducing biases into a study.” Id.

29. The sole randomized study, the FDA comparison of ProDisc-L total disc

replacement with circumferential fusion, reviewed patients with a final follow-up date at 24 

months from the time of surgery. AR00278. Although this study concluded that total disc 

replacement was superior to circumferential fusion at 24 months, it cannot make any conclusions 

regarding success rates, complications, or reoperation rates beyond this period of time. Id.

According to the Regence BCBSO Medical Policy, patterns of degenerative changes following 

TDR or fusion take at least five years to become measurable. AR00107. This is due to the special 

nature of spinal surgery, the benefits of which are known to deteriorate over time. Id. The IPRO 

external reviewer, in finding artificial disc replacement to be “Investigational” under the terms of 

the Plan, emphasized the lack of long-term scientific evidence and stated that even though the 

current literature indicates that artificial disc replacement is comparable to fusion at two year 

follow-up, the “long term efficacy and safety of the devices cannot be established.” AR00455.

Moreover, Dr. Sloan, the independent reviewer of Ms. Sammons’s second appeal, explained:

“While the artificial disc may have increased motion, the reoperation rate is higher.” AR00334

(footnotes omitted). Therefore, the only randomized study cited by Ms. Sammons demonstrates a 

time period that is too short to draw conclusions regarding the effect of total disc replacement 

surgery on disease process, injury, length of life, ability to function, and quality of life beyond 

a 24-month period.9 Ms. Sammons encounters a similar problem with respect to article three, 

 

9 On March 15, 2016, Ms. Sammons submitted a supplemental article entitled “Comparison of Artificial Total Disc 

Replacement Versus Fusion for Lumbar Degenerative Disc Disease: A Meta-Analysis of Randomized Controlled 

Trials.” See Dkt. 21-1. The Court may exercise its discretion to consider evidence beyond the administrative record 

“only when circumstances clearly establish that additional evidence is necessary to conduct an adequate de novo 

review of the benefit decision.” Opeta v. Nw. Airlines Pension Plan for Contract Emps., 484 F.3d 1211, 1217 (9th 

Cir. 2007) (emphasis in original) (quotation marks and citation omitted). The Ninth Circuit has also emphasized that 

district courts should not consider additional evidence “merely because someone at a later time comes up with new 

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“Minimally invasive total disc replacement: surgical technique and preliminary clinical results,”

because it is a nonrandomized study with a final follow-up date at 24 months. AR00298-302.

30. In an attempt to display the benefits of total disc replacement surgery beyond 24 

months, Ms. Sammons submits two articles. The first of these, “Lumbar Total Disc Replacement. 

Seven to Eleven-Year Follow-Up,” was a nonrandomized study with a mean postoperative 

follow-up date at 8.7 years. Although the study had approximately a 75 percent success rate, the 

study itself emphasized that the reviewers “cannot make any definitive statements regarding the 

outcomes of lumbar total disc replacement compared with those of nonoperative treatment or 

arthrodesis.” AR00309. Although the Regence BCBSO Medical Policy stated that there are 23 

types of artificial disc either approved or seeking the approval of the FDA, the study considered

only one implant type. AR00104-105, 309. The reviewers themselves conclude that the 

prosthesis “should be tested in a randomized prospective trial.” AR00309. Thus, this study does 

not allow a conclusion to be drawn regarding the effect of the Surgery on net health outcomes. 

31. The second long-term study, “Long-term Results of One-Level Lumbar 

Arthroplasty,” was a nonrandomized study with a final postoperative follow-up date at 10 years, 

with 10 patients being followed for 15 years. AR00314-315. This study also reviewed a single 

type of artificial disc, the Charité Artificial Disc, which was withdrawn from the market and has 

been the subject of several products liability lawsuits. AR00105; see e.g., Miller v. DePuy Spine, 

Inc. 638 F.Supp.2d 1226 (D. Nev. 2009); Carson v. Depuy Spine, Inc. 2007 WL 1839324 (C.D. 

 

evidence.” Id. This article is not new evidence because it was published before Ms. Sammons underwent the 

Surgery. Ms. Sammons could have submitted the article when she submitted the other five articles in the appeal 

process. Moreover, the article does not present new scientific evidence that would affect the outcome of Ms. 

Sammons’s claim determination. This article also repeated the scientific evidence already contained in the 

administrative record. Specifically, the article reiterates that the Surgery has been studied under randomized 

controlled trials with only 24 months follow up and that long-term follow-up in a randomized trial is necessary to 

evaluate the efficacy and safety of the Surgery. Ms. Sammons has not “clearly established” that this article is 

“necessary” to the Court’s de novo review. Thus, the court does not consider this article on de novo review.

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Cal. June 21, 2007). Therefore, the Court finds that the study is not persuasive scientific 

evidence to support Ms. Sammons’s claim against Defendants.

32. Plaintiff also introduces evidence of treating physician Dr. Guyer’s support for 

artificial disc replacement surgery.10 AR00340-341. Defendants argue that this information is 

immaterial to an “Investigational” determination because it does not constitute “Scientific 

Evidence” under the Plan. The Plan’s definition of “Investigational,” however, explicitly states 

that the reviewer “will review Scientific Evidence . . . and information obtained from the treating 

Physician or Practitioner regarding the Health Intervention to determine if it is Investigational.” 

AR00075 (emphasis added). Therefore, Dr. Guyer’s remarks regarding the safety and efficacy of 

artificial disc treatment are appropriate and material. 

33. Dr. Guyer’s letter states, “I feel that arthroplasty with ProDisc is a better choice of 

treatment for my patient than spinal fusion.... and feel that it is medically necessary.” AR00341. 

Dr. Guyer summarized the disadvantages of spinal fusion such as its permanent and irreversible 

nature, prolonged recovery time, variable success rates, and loss of motion of the fused spinal 

segment that may result in increased stress and load at adjacent levels. AR00340. Dr. Guyer 

concluded that replacement surgery using the ProDisc is advantageous because it preserves

normal motion of the operative spinal segment, improves segmental stability, restores disc 

height, reestablishes lordotic alignment, reduces discogenic pain, potentially reduces adjacent 

level degeneration, requires a shorter hospital stay, and allows for more rapid rehabilitation and 

return to function and work. Id.

34. Although Dr. Guyer presents a strong argument in support of the merits of 

artificial disc replacement surgery and the ProDisc device, Ms. Sammons’s proffered “Scientific 

 

10 The Record also appears to contain an unsigned copy of an identical letter from Jack Zigler, M.D., another 

co-director at Texas Back Institute. AR00337-338.

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Evidence” fails to support a conclusion regarding the effect of the Surgery on “net health 

outcomes.” As the IPRO Medical Director, Dr. Bodenheimer explained, the “use of artificial 

discs looks promising for future treatment of lumbar disc pathology; however, the treatment is 

still considered investigative. . . . Long-term efficacy and safety of the devices has yet to be 

established.” AR00455. The data put forward by Ms. Sammons does not contain necessary longterm data as of this time and therefore does not permit a conclusion regarding the effects of 

artificial disc replacement surgery on net health outcomes.11

2. Whether the Scientific Evidence shows that disc replacement is as beneficial as 

any established alternative (the fourth criterion)

35. For the same reasons that the scientific evidence submitted does not show the 

required conclusions regarding net health outcomes, that evidence also does not show that the 

Surgery is as beneficial as any established alternative. Ms. Sammons’s scientific evidence 

permits the conclusion that lumbar spine arthroplasty procedures are at least equivalent to 

circumferential fusion in short-term results. AR00278, 285. Long-term results, however, have 

not yet been shown. Because the proffered data does not permit a conclusion regarding the effect 

of the surgery on net health outcomes, it similarly does not permit a conclusion regarding 

whether the surgery is equivalent to fusion. Therefore, the Court cannot state with any reasonable 

degree of confidence that this method is as beneficial as any established alternative. Accordingly, 

the Court finds, by a preponderance of the evidence, that artificial disc replacement surgery is 

not “Investigational” under the terms of the Plan. 

 

11 The evidence submitted to supplement the administrative record consists of documents Ms. Sammons sent to the 

Oregon Bakers Union Health and Welfare Trust. The documents include references to a number of studies not 

otherwise discussed in the parties’ briefing. These studies do not alter the Court’s finding that Ms. Sammons has not 

presented sufficient evidence regarding the effects of artificial replacement surgery on net health outcomes. The 

studies either do not follow up with patients more than 24 months after surgery or contain qualifying statements 

such as “the evidence of efficacy should not be generalized beyond carefully selected patients that match trial and 

FDA indications,” Dkt. 13 at 30, and “the quality (risk of bias) of this trial was ‘poor,’” id. at 44. 

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C. Whether There Is Coverage Under the Plan’s “Alternative Benefits” Provision

36. Ms. Sammons also argues that even if her Surgery is not covered based on the 

investigational exclusion, the Plan should have provided coverage under its “Alternative 

Benefits” provision. Under the alternative benefits provision in the Plan, Regence BCBSO may 

approve coverage “for services or supplies that are not otherwise covered under the Contract.” 

AR00041. This provision states that Regence BCBSO “may approve coverage after case 

management evaluation and analysis.” Id. The provision further states that the Plan “may cover 

alternative benefits through case management if [Regence BCBSO] determine[s], in [its] sole 

discretion, that alternative benefits are Medically Necessary and will result in overall reduced 

covered costs and improved quality of care.” Id. The Plan notes, however, that “[b]efore 

coverage . . . and . . . the processing of claims for alternative benefits,” Regence BCBSO, 

Ms. Sammons or her legal representative, and if required by Regence BCBSO in its sole 

discretion, Ms. Sammons’s physician or other provider, “must agree in writing to the specific 

terms and conditions for payment.” Id. Defendants contend that Ms. Sammons never participated 

in case management and that the parties never came to a written agreement regarding terms and 

conditions for payment. Therefore, according to Defendants, the Surgery could not have been 

covered by the alternative benefits provision. Ms. Sammons argues that the Surgery was 

medically necessary and therefore should have been covered under this provision in the Plan. 

1. Case Management

37. According to Ms. Sammons, Defendants improperly denied Ms. Sammons’s 

pre-authorization request and should have conducted case management. The Plan explains that a 

member of the Plan may request case management or that a case manager may be assigned to a 

particular Plan member and lists a case management phone number. AR00007. The Plan 

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explicitly states that Regence BCBSO has, in its sole discretion, the authority to cover alternative 

benefits only “after case management evaluation and analysis.” 

38. Ms. Sammons asserts that by submitting the Pre-Authorization Form, she initiated 

a request for case management assessment. There is no evidence, however, that submitting a 

Pre-Authorization Form is a proper method to initiate case management. There is also no 

evidence in the record that Ms. Sammons ever called the number listed in the Plan to request a 

case manager. Further, there is no evidence that Regence BCBSO ever exercised its sole 

discretion as part of a case management process in Ms. Sammons’s case. Finally, there is no 

evidence of a written agreement to the specific terms and conditions for payment, which also is

required under the alternative benefits provision in the Plan. 

39. The Regence BCBSO Medical Policy also describes the requirements for 

covering alternative benefits. Ms. Sammons did not comply with these requirements and thus 

never triggered Regence BCBSO’s discretion to provide alternative benefits through case 

management evaluation and analysis. Thus, the Surgery never became eligible for coverage 

under the alternative benefits provision. 

2. Medically Necessary

40. Ms. Sammons argues that the Plan covers the Surgery under the Alternative 

Benefits provision because it was medically necessary and would result in reduced costs and 

improved quality of care compared to fusion. Because the Court finds that the Surgery never 

became eligible for coverage through a case management process under the Plan, there is no 

need to assess the medical necessity of the Surgery under the Alternative Benefits provision. 

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D. Whether Regence BCBSO Waived the Plan’s Investigational Exclusion by Paying the

Anesthesiology Bill after the Surgery

41. Ms. Sammons argues that by paying for the anesthesiology bill in connection with 

the Surgery, Defendants have waived nonpayment of the rest of the Surgery bill.12

42. Regence BCBSO Medical Policy, updated several months before Ms. Sammons’s 

Surgery, expressly provides that total disc replacement with artificial intervertebral discs was 

Investigational and therefore is not covered under the Plan. AR00104.

43. The record does not indicate precisely when Ms. Sammons received the decision 

denying her first request for pre-authorization, but Ms. Sammons admits that she knew that her 

pre-authorization request was denied before her Surgery and that she went ahead with the 

Surgery with that knowledge.

44. Regence has consistently maintained, through each denial of coverage and 

through its medical policy, that it had no intention of covering the Surgery because it fell within 

the Plan’s “Investigational” exception. Further, Ms. Sammons does not argue that she relied on 

her receipt of the post-surgery payment for anesthesiology services to support any assumption 

that Regence BCBSO would reverse its intention under its Medical Policy not to cover the 

Surgery or in any other way relied on that payment to her detriment.

CONCLUSIONS OF LAW

1. Based on the Court’s factual findings that Plaintiff’s artificial disc replacement 

Surgery is Investigational under the terms of the Plan, Defendants are not obligated to provide 

coverage for that procedure.13

 

12 Ms. Sammons does not specify whether the alleged waiver was express or implied. Because there is no evidence 

in the record of any express waiver from Regence BCBSO for the Surgery, the Court assumes that Ms. Sammons is 

arguing for the Court to find an implied waiver based on its post-surgery partial payment.

13 The claimant must establish by a preponderance of the evidence that he or she is entitled to benefits under the 

plan. See Muniz, 623 F.3d at 1294; Inciong v. Fort Dearborn Life Ins. Co., 570 F. App’x 724, 725 (9th Cir. 2014). In 

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2. Based on the Court’s factual findings that Plaintiff did not satisfy the 

requirements for receiving coverage under the “Alternative Benefits” provision of the Plan, 

Defendants are not obligated to provide coverage under that provision for Plaintiff’s artificial 

disc replacement Surgery.

3. “To constitute a waiver of a requirement in an insurance policy, there must be . . . 

an actual intention to relinquish it or such conduct as warrants an inference of relinquishment.” 6 

Couch on Insurance § 85:2 (3d ed. 2015). Further, an “insurer will not be barred contrary to its 

actual intention unless the insured has been misled to his . . . prejudice into the honest belief that 

the waiver was intended or consented to, in which case an estoppel arises.” Id. “[E]ven in 

insurance cases where the courts are inclined to grasp any circumstance which indicates an 

election to waive . . . there must be a clear, unequivocal, and decisive act showing a purpose or 

intention to waive, or the acts or conduct relied upon must involve some element of estoppel.” 

Id. Based on the Court’s factual findings that Defendants neither actually intended to waive their 

right to invoke the “Investigational” exclusion and that Ms. Sammons has not been misled to her 

prejudice into the honest belief that a waiver was intended or consented to, Ms. Sammons has 

failed to show that Defendants waived their rights to invoke the Investigational exclusion.

CONCLUSION

The Court construes Plaintiff’s motion for summary judgment, Dkt. 14, and Defendants’

motion for judgment on the record, Dkt. 17, as cross motions for judgment after a bench trial on 

 

the ERISA context, the Ninth Circuit has not yet decided which party bears the burden of proving that a policy 

exclusion applies after the claimant establishes that he or she is entitled to benefits. The Second and Seventh Circuit 

have, however, held that the burden shifts to the insurer to prove exclusions in ERISA cases. See Mario v. P & C 

Food Markets, Inc., 313 F.3d 758, 765 (2d Cir. 2002) (“[A]s a matter of general insurance law, the insured has the 

burden of proving that a benefit is covered, while the insurer has the burden of proving that an exclusion applies.”); 

Santaella v. Metro. Life Ins. Co., 123 F.3d 456, 461 (7th Cir. 1997) (“[A]t trial the plaintiffs would bear the burden 

of proving [the plaintiffs’] entitlement to the benefits of the insurance coverage, and the defendant [insurance 

company] would bear the burden of establishing [the plaintiffs’] lack of entitlement because she falls within the 

‘exclusions’ section of the insurance contract.”). The Court concludes that it need not decide which party bears the 

burden of proving that the relevant exclusion applies because even if BCBSO bears that burden, BCSBO has met it. 

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an administrative record supplemented by stipulation. The Court DENIES Plaintiff’s motion and 

GRANTS Defendants’ motion.

IT IS SO ORDERED.

Dated this 23rd day of March, 2016.

/s/ Michael H. Simon

Michael H. Simon

United States District Judge

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