Court Opinion

ID: 6942484
Source: CourtListenerOpinion
Date Created: 2022-07-24 01:09:56.597141+00
Date Added: 2024-06-11T16:07:45.384742
License: Public Domain

ESCHBACH, Circuit Judge,
dissenting.
The majority informs us that Erin Smith has received the HDC/ASCR and the majority is “pleased to report that she is alive and no longer undergoing treatment.” Ante at 954 n. 5. The majority then goes on to hold that CHAMPUS properly interpreted its regulations and that CHAMPUS properly found that HDC/ASCR does not meet “the generally accepted standards of the usual professional medical practice in the general medical community.” 32 C.F.R. § 199.2(b). This decision places this court squarely in conflict with the Fourth Circuit. The result of the decision is a lack of national uniformity — CHAMPUS, a national health benefits program that provides medical benefits for dependents of active-duty and retired members of the United States Military, must cover HDC/ ASCR treatment in one part of the country but is free to refuse to cover the *962treatment in another part of the country. This decision has broader, though no less significant, ramifications because it has implications for coverage decisions regarding other innovative treatments. For the following reasons, I respectfully dissent.
I.
CHAMPUS’s regulations provided that it would pay for medically necessary services, subject to the limitations and exclusions specified in the regulations. 32 C.F.R. § 199.4(a)(1). The regulations listed seventy-four separate exclusions and limitations, but the regulations did not exclude high dose chemotherapy with peripheral stem cell rescue. See 32 C.F.R. § 199.4(g). The regulations did contain an exclusion of coverage for experimental or investigational procedures. 32 C.F.R. § 199.4(g)(15). The term “experimental” is defined in the regulations as:
Medical care that essentially is investigatory or an unproven procedure or treatment regimen (usually performed under controlled medicolegal conditions) that does not meet the generally accepted standards of the usual professional medical practice in the general medical community.
32 C.F.R. § 199.2. This case turns on CHAMPUS’s interpretations of its own regulations. We give substantial deference to an agency’s interpretation of its own regulations and “the agency’s interpretation must be given controlling weight unless it is plainly erroneous or inconsistent with the regulation.” Thomas Jefferson University v. Shalala, 512 U.S. 504, -, 114 S.Ct. 2381, 2386, 129 L.Ed.2d 405 (1994) (internal quotation marks omitted).
CHAMPUS must determine whether a procedure is “experimental” by looking to the “generally accepted standards” of the “general medical community.” Essentially, the definition of “experimental” requires CHAM-PUS to look outside the agency itself, CHAMPUS must look to the general medical community for guidance. CHAMPUS did not do this. CHAMPUS interpreted its regulations as requiring publicized results of Phase III clinical trials in order to establish that a particular treatment was not experimental. This interpretation is inconsistent with CHAMPUS’s own regulation and CHAMPUS’s decision to deny coverage based on its interpretation of its regulations was arbitrary and capricious.
Requiring publicized results of Phase III clinical trials to establish that a procedure is not “experimental” is inconsistent with CHAMPUS’s own regulations, which require only that the procedure meet the generally accepted standards of the general medical community. Medical treatments may become generally accepted without first passing Phase III clinical trials. For example, the Fourth Circuit noted that home run treatments are those treatments that “prove themselves so significantly that Phase III trials are not necessary.” Wilson v. CHAMPUS, 65 F.3d 361, 365 (4th Cir.1995). As the Fourth Circuit points out, a therapy may become standard practice in the medical community before it has been proven more effective than traditional treatments through Phase III studies. Id. (citing Pirozzi v. Blue Cross-Blue Shield, 741 F.Supp. 586, 593 (E.D.Va.1990) (“Many treatments become accepted without phase III studies_”)). The record in the instant appeal contains similar evidence. Martha Maxey, CHAM-PUS’s Health Benefits Program Analyst, stated in her affidavit that clinical trials are not completed if a particular treatment essentially hits a home run. Appellant’s Appendix at 37 (“To resolve the void in published outcome-based research, the National Cancer Institute (NCI) in 1991 approved four multicenter randomized trials to evaluate high dose chemotherapy with ABMT for the treatment of breast cancer. It was anticipated that these studies would be completed within three to five years. However, these studies are structured such that if sufficient evidence becomes available during the trial that a treatment is clearly superior, the trial is to be ended.”).
CHAMPUS’s interpretation of its regulations is inconsistent with the regulations because requiring Phase III trials creates an artificial standard that is not contained in the regulations, and is a higher standard than the regulations provide. Phase III trials involve testing a procedure on a control group in which some patients receive the treatment *963at issue and some patients do not receive the treatment. The purpose of Phase III trials is to compare the effectiveness of a new treatment to the effectiveness of existing treatments. Yet, before Phase III trials are conducted, the procedure already must have proven to be effective in treating the disease through successful completion of Phase II trials.
Phase II establishes the procedure’s effectiveness in treating a disease. Phase III determines whether the procedure is the most effective method of treating a disease. The regulations do not require that the treatment be the most effective treatment.1 The regulations do not even require that the treatment be “scientifically” proven to be effective. In the case of a patient dying from breast cancer, HDC/ASCR is often a treatment of last resort. If the most effective treatment has been tried and failed, then a less effective procedure may be used as a last ditch effort to save human life, as long as the treatment is generally accepted in the general medical community. The Fourth Circuit’s opinion summarizes the issue well:
CHAMPUS relied on an unwritten agency policy mandating Phase III trials before a treatment is provided. In contrast, federal regulations require only that a therapy be generally accepted, see [32 C.F.R.] § 199.2(b), not that it prospectively be proven to have a statistically significant effect in curing a disease. While the two categories overlap to a substantial degree, they are not co-extensive, and CHAMPUS wrongly ignored the distinction between them. Effectively, CHAMPUS imposed a requirement beyond those in the applicable regulations by creating an informal, but nonetheless binding, prerequisite that a treatment pass Phase III trials.
Id. at 366. Because the CFR definition requires CHAMPUS to look to the generally accepted standards of the medical community, CHAMPUS cannot make it a sine qua non that a treatment has passed Phase III trials before it is considered non-experimental.
II.
CHAMPUS’s interpretation of its own regulations as requiring published results of Phase III clinical trials in order to establish that HDC/ASCR is not experimental is inconsistent with the regulation itself. The majority does not disagree with this conclusion directly. The majority finds that CHAMPUS did not require published Phase III trials.
The record does not indicate that CHAM-PUS has created a broad new requirement, much less “an unwritten agency policy,” that every new procedure successfully complete Phase III trials before being approved. Rather, CHAMPUS has determined that given the on-going controversy and absent convincing new evidence, Phase III trials will be necessary to determine whether HDC/ASCR can fairly be said to have moved beyond the experimental to the generally accepted.
Ante at 959. I cannot agree with the majority’s new finding. First, it contradicts the record. Second, it contradicts the admissions made by CHAMPUS to the court. Third, it contradicts the understanding of the matter expressed by this court in its earlier (now vacated) opinion. Fourth, it creates a genuine issue of material fact.
A. The Record In This Case.
The record makes clear that Dr. Bogner interpreted the regulations as requiring the completion of Phase III clinical research trials demonstrating the effectiveness of HDC/ ASCR treatment as compared to conventional breast cancer therapy. In his initial letter denying coverage, Dr. Bogner stated:
CHAMPUS is allowed to consider coverage for those forms of therapy that are not experimental or investigational. CHAM-PUS continuously reviews the current literature for outcomes of Phase III trials *964regarding [HDC/ASCR]. In the case of breast carcinoma, we have been unable to find sufficient evidence of this nature to date. In the absence of published randomized, prospective trials, CHAMPUS must continue to consider this therapy as investigational for the treatment of breast carcinoma.
If you disagree with this CHAMPUS benefit determination, we invite you to submit pertinent documentation to support the position that [HDC/ASCR] treatment of breast carcinoma does, in fact, meet the generally accepted standards of usual professional medical practice in the general medical community. While personal opinions are valued, we must give the greatest weight to well-designed, Phase III, outcome based studies which have been published in refereed medical journals.
Bogner Letter of August 2, 1991, at 1-2 (emphasis added). The majority posits that Dr. Bogner’s invitation to submit pertinent documentation and his statement that “personal opinions are valued” but Phase III studies are given the “greatest weight” “does not indicate that CHAMPUS has created a broad new requirement, much less ‘an unwritten agency policy,’ that every new procedure successfully complete Phase III trials before being approved.” Ante at 959.
The majority’s position is contradicted by the record. Smith did submit new materials in response to Dr. Bogner’s invitation, including: (1) the affidavits of three oncologists stating that HDC/ASCR is not new, investigational, or experimental and is a generally accepted treatment that is considered standard care by oncologists; (2) several Federal District Court rulings that CHAMPUS’s decision to deny coverage for HDC/ASCR was arbitrary and capricious; and, (3) a study published in the New England Journal of Medicine that indicated that the majority of requests to insurance companies for coverage of high-dose chemotherapy are granted. Dr. Bogner’s response to this new information indicated that published Phase III trials are a sine qua non for coverage.
As discussed in our 2 August 1994 benefit interpretation letter, CHAMPUS bases its policies upon outcomes of Phase III clinical trials as published in the refereed medical literature. You assert that CHAMPUS has no requirement in statute or regulation for this standard.... The APA does not require that CHAMPUS publish the internal process by which such coverage determinations are made. Further, we believe that our reliance upon the unbiased reporting of these Phase III studies in the refereed medical literature provides the most objective basis upon which we can build new coverage benefits. Consequently, CHAMPUS has chosen to continue the use of this Phase III clinical trial standard, in spite of the injunctive relief decisions provided at the federal district court level.
If CHAMPUS is to adopt a benefit for HDC/ASCR in the treatment of breast carcinoma, it will do so based upon outcomes of Phase III clinical trials as published in the refereed medical literature, or upon formal technology assessments which cite Phase III outcomes as their recommended basis.
Bogner Letter of September 14, 1994., at 1-2 (emphases added). Clearly, CHAM-PUS’s use of a “Phase III clinical trial standard” created a requirement that every new procedure successfully complete Phase III trials before being approved. Dr. Bogner’s reference to the internal process by which such coverage determinations were made is a reference to “an unwritten agency policy.” The majority’s analysis ignores the facts of the case.
Dr. Bogner’s statements are confirmed by CHAMPUS’s Health Care Program Analyst, Martha Maxey.
Although [HDC/ASCR] for breast cancer has gained acceptance among many oncologists, CHAMPUS has not found that the advantages over conventional therapy have been scientifically established. Our coverage position is based upon the fact that neither technology assessments, scientifically controlled studies, or current medical literature have yet shown that *965[HDC/ASCR] for the treatment of breast cancer is safe, effective and superior to existing therapies. In order for CHAM-PUS to adopt a new benefit, these elements must be demonstrated.
Affidavit of Martha M. Maxey, at 4 (emphasis added). Maxey’s statements indicate that CHAMPUS rejected the acceptance of HDC/ASCR among many oncologists (which sounds a lot like it meets the “general accepted standards” of the “general medical community”) because HDC/ASCR’s “advantages over conventional therapy have not been scientifically established.”2 These “elements” lack a statutory or regulatory basis and go beyond establishing that a treatment is generally accepted in the general medical community. These “elements” are, however, consistent with CHAMPUS’s requirement that new procedures complete Phase III trials before being approved. See ante at 953 n. 3 (noting that Phase III trials “assess the efficacy of the experimental treatment as compared with conventional treatments”).
B. CHAMPUS Admitted That It Required PHASE III Trials.
The majority’s finding that CHAMPUS does not require published Phase III trials is contradicted by CHAMPUS’s own statements. In its brief in opposition to petition for rehearing, CHAMPUS states: “CHAM-PUS Medical Director, Dr. David Bogner, denied plaintiff’s request for [HDC/ASCR] coverage on the basis that no published, randomized, Phase III clinical trials have demonstrated the medical acceptance of [HDC/ASCR].” CHAMPUS’s Opposition To Petition for Rehearing With Suggestion for Rehearing En Banc, at 3. If there is any ambiguity regarding whether this is Cham-pus’s interpretation of the regulations at issue, CHAMPUS clears up the ambiguity. “CHAMPUS Medical Director, Dr. Bogner, has interpreted [32 C.F.R. §§ 199.2(b) and 199.4(g)(15) ] in this context as requiring the completion of Phase III clinical research trials demonstrating the effectiveness of [HDC/ASCR] treatment as compared to conventional breast cancer therapy, in order to provide an ‘unbiased’ and ‘objective’ standard to evaluate this new procedure.” Id. at 6; see also id. at 9 (“CHAMPUS ultimately chose the Phase III standard because the unbiased reporting of these Phase III studies in the refereed medical literature provides the most objective basis upon which we can build new coverage benefits.”).
In its brief on rehearing, CHAMPUS has changed its tack slightly. CHAMPUS now proposes that it required that HDC/ASCR be “safe, effective, and superior to existing therapies.” This new “standard” is problematic for two reasons. First, a requirement that a new procedure be “superior to existing therapies” is without statutory or regulatory basis and goes beyond the pale of general acceptance in the general medical community. Second, this new “standard” is simply a derivative of CHAMPUS’s still existing litmus test that a new treatment must have passed Phase III trials.
CHAMPUS’ requirement that HDC/ PSCR be “safe, effective and superior to existing therapies” derives directly from the nature of scientific research on the new therapies for cancer treatment. As Dr. Bogner explained, before a new cancer therapy can be scientifically accepted, it must be evaluated in Phase I, Phase II and Phase III clinical trials. If a new therapy has been proven in Phase III clinical trials, its safety, efficacy and superiority to existing treatments has been scientifically established. Further, because these requirements are inherent in the nature of scientific research on new cancer thera*966pies, CHAMPUS has chosen to adopt them in evaluating whether HDC/PSCR meets “generally accepted standards” and, therefore, cannot be viewed as “investigational” or “experimental” within its regulations.
Appellant’s Brief at 30 (internal citations omitted).
C. The Majority’s Position.
The majority’s “finding” that CHAMPUS did not require that every new procedure successfully complete Phase III trials before being approved is surprising given this court’s earlier opinion. In that opinion, the court stated:
There appear to be two issues in this case. The first is whether CHAMPUS properly interpreted its regulations as requiring publicized results of Phase III clinical trials in order to determine whether HDC/ PSCR for the treatment of breast cancer met “accepted professional medical standards,” and thus was no longer “experimental” under the CHAMPUS regulations. If so, then the second issue is simply whether, employing that interpretation, CHAMPUS’ decision to deny benefits for Smith’s breast cancer treatment was arbitrary and capricious.
Smith v. CHAMPUS, 66 F.3d 905 (7th Cir.1995), rehearing granted and opinion vacated (Dec. 15, 1995). The court answered these questions: yes and no. Whether CHAMPUS had a policy that required Phase III trials was never an issue. The court acknowledged that CHAMPUS had such a policy and the issue was whether CHAM-PUS’s policy was a proper interpretation of the regulations. With respect to the first issue, whether CHAMPUS properly interpreted its regulations as requiring publicized results of Phase III clinical trials, we stated:
CHAMPUS could have provided that whether a procedure is experimental is to be decided on a ease-by-case basis, following the agency’s review of expert testimony on one side claiming that it is, and the other side’s equally qualified expert testimony claiming it isn’t. But CHAMPUS did not adopt such an interpretation. Instead, CHAMPUS decided that the proper criteria for making this determination should be the publicized results of Phase III trials. This interpretation of the regulation sets forth an objective and efficient method of making the required determination. We find nothing erroneous in this interpretation, nor do we find it inconsistent with the regulation.
Id. (emphasis added). Today, the majority bases its holding on its new finding that CHAMPUS never had a policy in the first place. I cannot accept this. The facts, CHAMPUS’s admissions, and this court’s prior statements on the issue indicate that Champús did have such a policy. We must address whether such a policy was consistent with CHAMPUS’s own regulations. It was not, and CHAMPUS’s decision to deny coverage based on its interpretation of its regulations was arbitrary and capricious.
D. Genuine Issue of Material Fact.
Even assuming that the majority appropriately rejects the weight of the evidence and determines that the record in this case does not conclusively establish that CHAMPUS had a policy that required new procedures to have completed Phase III trials, the majority is simply creating a genuine issue of material fact. It cannot be that CHAMPUS both had a policy that mandated Phase III trials before a treatment is provided and did not have a policy that every new procedure successfully complete Phase III trials before being approved. Cf. Wilson, 65 F.3d at 366 (CHAMPUS had such a policy) with ante at 959-60 (CHAMPUS does not have such a policy).
If this issue is a question of fact susceptible to proof in the normal ways, then clearly Smith has produced enough evidence to defeat summary judgment against her. In such a case, it is improper for this court to remand to the district court to enter an order affirming CHAMPUS’s initial determination denying Smith coverage. At most, this court should remand to the district court for a determination of whether CHAMPUS had such a policy. If this issue is a question of law, then we have created a conflict with the Fourth Circuit’s decision in Wilson and the Fourth Circuit has it right. CHAMPUS’s policy required publicized results of Phase *967III clinical trials in order to establish that a particular treatment was not experimental.
III.
The record in this ease requires us to affirm the lower court’s decision. CHAM-PUS admits that its initial decision to classify HDC/ASCR as investigational “was based on literature and technical assessments dating from the 1988-1990 time-frame-” Affidavit of Dr. David Bogner, at para. 7. The district court appropriately found that it was improper for CHAMPUS to rely on outdated studies in the face of the affidavit testimony presented by plaintiffs oncologist experts. The oncologists’ curricula vitae indicate that their medical expertise is national. Their affidavits indicated that HDC/ASCR is generally accepted in the general medical community. The affidavits were sworn in late August and early September of 1994. In addition, experts in other areas of the country had reached similar conclusions, see Gripkey v. Mail Handlers Benefit Plan, No. 3:94-378-0, 1994 WL 276265 (D.S.C. Feb 14, 1994) (unpublished); Hawkins v. Mail Handlers Benefit Plan, No. 1:94 CV 6, 1994 WL 214262 (W.D.N.C. Jan.28, 1994) (unpublished) and Wheeler v. Dynamic Engineering, Inc., 850 F.Supp. 459 (E.D.Va.1994), aff'd, 62 F.3d 634 (4th Cir.1995), and CHAM-PUS had received notice of the expert opinions in these eases.
The majority recognizes that the status of certain medical treatments is in a state of flux and notes that the medical value of HDC/ASCR is an “ongoing dispute.” Ante at 956; see also id. at 956 (“The pace of medical science is ever quickening; yesterday’s esoteric experiment is today’s miraculous cure.”). In this “ongoing dispute,” the record supports the plaintiffs position that HDC/ASCR is not experimental. The majority, however, seeks to rely on a July 1993 study entitled “Autologous Bone Marrow Transplant and Peripheral Blood Stem Cell Rescue for the Treatment of Breast Cancer” (the “ECRI study”) and news releases published in Health and Technology Trends in June 1994 (the “HTT news release”). Reliance on these sources is misplaced. First, CHAMPUS simply reviewed these more recent studies to determine whether HDC/ ASCR had passed published Phase III clinical trials. Second, a review of these sources indicates that neither source concludes that HDC/ASCR is not generally accepted in the general medical community.
As the majority notes, the ECRI study, addressed metastatic (stage IV) therapies rather than the milder stage III cancer that afflicts plaintiff Smith. In addition the ECRI study, which was over fifteen months older than the affidavits of the three oncologists, noted that HDC with ABMT was not an entirely “experimental” treatment, even at the time of the report. “Although still considered experimental for breast cancer, it is approved for acute leukemia in remission, resistant non-Hodgkins disease, recurrent neuroblastoma, and advanced Hodgkin’s disease if conventional therapy has failed.” Id. § 2.4. Clearly the treatment is considered safe and useful for treatment of other conditions. Thus, it is not clear that the report lends any support to CHAMPUS’s position that HDC/ASCR is experimental for Smith’s stage III cancer.
Furthermore, a review of the report lends support to Smith’s position. The report noted that a number of Phase III studies were in progress at the time the report was completed:
At present, there are three Phase III and five Phase II protocols examining HDC with ABMT or PBSCR. Phase III protocols include randomized studies comparing conventional chemotherapies using HDC with stem cell rescue for metastatic and high-risk (stages II and IIIA) breast cancer. Phase II studies include induction using HDC with PBSCR....
ECRI Report at § 2.4. Phase III trials would not be necessary if HDC/ASCR showed no promise. The remainder of the report indicates that HDC/ASCR did show promise.
The report noted that Phase I and some Phase II studies had been completed. Id. § 2.11. On the basis of these studies, the ECRI report concluded that there was a statistical improvement in patients who received HDC with ABMT.
*968Combination-agent HDC with ABMT has replaced single agent treatment. Overall, in 486 patients, the CRR [Complete Response Rate] was 38%, with the ORR [Objective Response Rate] at 68%. There is a statistical improvement in the CRR and ORR, and the median duration times of combination-agent HDC with ABMT compared to STD combination agents.
Id. at § 4.1.1.4; see also id. at § 8.0 (the Report’s General Summary concludes that “For metastatic breast cancer, ... [c]ombi-nation-agent HDC with ABMT appears to statistically improve the response and duration times over standard combinations and has replaced single-agent HDC with ABMT therapy.”). This statistical improvement translates into quantifiable benefits.3
After five years, 12.9% of HDC with ABMT cases are in complete remission (death rate = 84.2%) compared to 2.5% (death rate = 95.7%) for STD. Statistically, one year after initial therapy, 75 out of every 100 lives are saved by HDC with ABMT as opposed to 63.1 by STD. Both survival rates drop rapidly after three years (HDC with ABMT = 26.6%; STD = 14.0% and five years (HDC with ABMT = 15.8%; STD = 4.3%). In total, HDC with ABMT statistically saves 233.8 years of life (75 lives for one year plus 26.6 for three years plus 15.8 for five years), while STD saves 126.6 years of life (63.1 lives for one year plus 14.0 for three years plus 4.3 for five years).
Id. at § 5.1.41 do not find it unusual for the general medical community to accept a treatment that improves the odds that patients will survive longer and go into complete remission, especially when the treatment has already been accepted by the general medical community as safe and useful for the treatment of similar conditions.
The HTT news release describes HDC/ ASCR as “[a]n experimental — and costly— treatment for advanced breast cancer [that] is diffusing into the healthcare system before there is any clear evidence that the treatment is better than conventional therapies." HTT News Releases. The report does not say that HDC/ASCR is not effective in treating breast cancer. It says that it is not clear that it is more effective than conventional therapies. So what. CHAMPUS’s regulations say nothing about requiring a particular treatment to be statistically proven in published results to be the most effective treatment. The regulations require the treatment to be generally accepted in the general medical community. On this note, the HTT news release relates that HDC with peripheral stem cell rescue is becoming a common procedure.
The number of stem cell rescue procedures performed worldwide is increasing. By 1992, some 19,000 transplants had been performed, up from over 2,500 performed as of 1986. And the total number of transplants is expected to reach 251,000 by 1998....
*969Id. The HTT news release certainly makes HDC/ASCR seem like a procedure that has been generally accepted in the general medical community. The authors of the HTT news release simply object to the fact that HDC/ ASCR is expensive and the fact that acceptance of HDC/ ASCR has preceded the publication of Phase III clinical trials.
IV.
CHAMPUS interpreted its own regulations as requiring plaintiff Smith to produce published results of Phase III clinical trials in order to establish that the treatment she needed was not experimental. CHAMPUS’s interpretation is inconsistent with the regulation, which requires that the treatment “meet the generally accepted standards of the usual professional medical practice in the general medical community.”' 32 C.F.R. § 199.2. CHAMPUS’s decision to deny coverage based on its interpretation of the regulations was therefore arbitrary and capricious. Plaintiff Smith presented sufficient evidence to establish that HDC/ASCR was not experimental. CHAMPUS’s evidence, which was all of less recent vintage than plaintiffs evidence, simply pointed out that there were no published results of Phase III clinical trials and pointed out the redundancy that it had not been “scientifically established” that HDC/ASCR was more effective than conventional therapy. CHAMPUS’s evidence did not contradict plaintiffs evidence and in fact supported plaintiffs position to some degree by noting that HDC/ASCR is at least as effective as conventional therapy. I respectfully dissent.

. Such a requirement would change the practice of medicine as we know it. Certainly there are treatments that are generally accepted that are not the single most effective treatment known to the medical communily. A drug that costs one million times less than a drug that is only marginally more effective may be part of a treatment that is generally accepted in the medical community, even though it is not the most effective drug.

. Ms. Maxey's statements conflate the distinction between an innovative treatment whose superior effectiveness over existing treatments has been "scientifically established" and an innovative treatment that qualifies as non-experimental under CHAMPUS’s regulations. As a philosophical question, we may not know the distinction between "experimental” and “scientifically established." But we do know that experimental is defined by looking to the “generally accepted standards of the usual medical profession in the general medical community." 32 C.F.R. § 199.2. Thus, if the medical community accepts a treatment as nonexperimental, it is irrelevant that philosophers (or “scientists”) reserve judgment until published results appear in a refereed scientific journal.

. The majority defines "general acceptance" as “the point at which the medical value of a treatment is no longer generally disputed." Ante at 956-57. The majority does not define "medical value.” From the remainder of the majority’s opinion, however, it appears that the majority equates "medical value" with "effectiveness.” See id. (“[W]e are probably dealing more with a zone of perceived effectiveness than a precise dividing line.”); id. at 958 ("the effectiveness of ABMT was not certain”); id. at 960-61 ("while the medical controversy over the efficacy of HDC/ ASCR rages, CHAMPUS will sit tight until convincing evidence is forthcoming”). Under this definition, the ECRI report supports Smith’s position. Even if HDC/ASCR is only as effective as conventional chemotherapy, it is still effective at treating breast cancer because it is better than doing nothing. CHAMPUS points to no evidence that HDC/ASCR is equivalent to or less effective than doing nothing.

. These projected results are contained in a section discussing the cost-effectiveness of HDC with ABMT. The report concludes that HDC with ABMT is 20 to 25 times more costly than standard chemotherapy. Calculating these additional costs per treatment, "HDC with ABMT saves 107.2 more years of life [for 100 patients] for $11,435,100. The cost of each additional year of life is $106,700. Similarly, it provides an additional 121.6 years of complete remission for an extra $94,000 per year.... The overall projected costs are $51,000 to $144,000 for each additional year of life and $45,000 to $127,000 for each additional year of complete remission." Id. at § 5.1. This may explain why insurers seek to deny coverage.