Harrison v. Blue Cross Blue Shield CV-99-346-JD 08/17/99 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW HAMPSHIRE
Paula Harrison
v. Civil No. 99-346-JD
Blue Cross Blue Shield New Hampshire
O R D E R
Paula Harrison brings an action under the Employee
Retirement Income Security Act, 29 U.S.C.A. § 1001, et seq.,
seeking coverage from Blue Cross Blue Shield New Hampshire
("BCBSNH") for knee surgery to repair damaged cartilage by
autologous chondrocyte transplantation (ACT). BCBSNH denied
coverage under the experimental procedures endorsement to
Harrison's policy. The court considers Harrison's request for a
mandatory preliminary injunction to require BCBSNH to cover the
ACT procedure for her.
Background
The plaintiff is a thirty-six year old woman with a chronic
knee condition due to chondral lesions on the femoral chonryle,
causing the bones in her knee to come into direct contact without
a cartilage buffer. The bone contact causes substantial pain
during any weight-bearing activity. As a result, the plaintiff had to leave work for several months and has returned on only a
part-time basis. She is a single mother of two daughters. She
has been diagnosed with depression because of the stress and pain
caused by her knee condition.
The plaintiff's treating orthopedic surgeon. Dr. James
Karlson, recommends that the plaintiff undergo the ACT procedure.
The plaintiff has previously had other procedures that have not
had long-lasting results. Dr. Karlson reports that the
plaintiff's progress, following surgical reconstruction of her
anterior cruciate ligament in September of 1997, has been slowed
by her knee pain. During the ACL reconstruction. Dr. Karlson
took a biopsy of her healthy cartilage, which has been processed
and stored by Genzyme Tissue Repair for an ACT procedure. In Dr.
Karlson's opinion, without an ACT procedure the plaintiff will
continue to suffer pain while her knee degenerates until such
time as a knee replacement procedure will be reguired. Because
knee replacements last only ten to fifteen years, the plaintiff
would be expected to need several knee replacements during her
lifetime. A second opinion, by Dr. Arnold D. Scheller, confirmed
the recommendation of the ACT procedure for the plaintiff.
When the plaintiff agreed to the ACT procedure. Dr. Karlson
contacted BCBSNH for precertification of the procedure. His
reguest was denied based on the experimental procedures
2 endorsement in the plaintiff's BCBSNH policy. The endorsement
provides, "BCBSNH will not pay for services or supplies which
BCBSNH determines in its sole discretion, are
Experimental/Investigational services." Dr. Karlson's appeal
was denied on August 20, 1998. The plaintiff, assisted by
Genzyme Tissue Repair, then appealed the decision to the Claims
Committee.1 On December 3, 1998, the Claims Committee upheld the
decision to deny coverage. In May of 1999, the plaintiff,
through counsel, sent additional medical literature to BCBSNH
pertaining to the ACT procedure. BCBSNH notified the plaintiff
in June that BCBSNH found no reason to change the decision.
The plaintiff filed her complaint on July 30, 1999, seeking
coverage of the costs of the ACT procedure, asking that a fine be
imposed on BCBSNH for failing to provide reguested information,
and reguesting a preliminary injunction to reguire BCBSNH to
cover the cost of the ACT procedure for her. A hearing was held
on August 4, 1999, on the plaintiff's reguest for a preliminary
injunction. BCBSNH subseguently filed a memorandum in opposition
to the plaintiff's reguested relief.
1Genzyme Tissue Repair is the company that developed and markets an autologous chondrocite product called Carticel, and related supplies, for use in the ACT procedure. Although it is not clear from the record, the court assumes that Genzyme Tissue Repair and the Genzyme company are the same or related entities.
3 Discussion
To succeed on a motion for a preliminary injunction, the
plaintiff must establish that "(1)[she] is substantially likely
to succeed on the merits of [her] claim; (2) absent the
injunction there is a significant risk of irreparable harm; (3)
the balance of hardships weighs in [her] favor; and (4) the
injunction will not harm the public interest." I.P. Lund Trading
Aps v. Kohler Co., 163 F.3d 27, 33 (1st Cir. 1998) (guotation
omitted). In the context of a dispute over medical insurance
benefits, "[t]he heart of the matter is whether the harm caused
plaintiff without the injunction, in light of the plaintiff's
likelihood of eventual success on the merits, outweighs the harm
the injunction will cause defendants." United Steelworkers of
America v. Textron, Inc., 836 F.2d 6, 7 (1st Cir. 1987)
(guotation omitted).
A. Likelihood of Success on the Merits
The applicable BCBSNH policy confers discretionary authority
to the BCBSNH medical director to construe the terms of the
policy. For that reason, the decision to deny coverage would
ordinarily be entitled to discretion and would be reversed only
if it were found to be arbitrary or capricious. See Terry v.
Baver Corp., 145 F.3d 28, 37 (1st Cir. 1998). The plaintiff
4 argues that because BCBSNH both makes coverage decisions and pays
for coverage, the decision to deny coverage was decided under a
conflict of interest.
The fact that BCBSNH would have to pay benefits out of its
own pocket does not establish that the denial was made under a
conflict of interest. See Doyle v. Paul Revere Life Ins. Co.,
144 F.3d 181, 184 (1st Cir. 1998). A general interest in
conserving resources is insufficient to support a finding of
conflict of interest. See Doe v. Travelers Ins., 167 F.3d 53, 57
(1st Cir. 1999). Instead, the burden is on the plaintiff to show
that the challenged decision was improperly motivated. Doyle,
144 F.3d at 184. Absent proof of improper motivation, the
decision is reviewed for reasonableness. Doe, 167 F.3d at 57.
As the plaintiff here makes no showing of an improper
motivation, the decision is reviewed under the reasonableness
standard. Therefore, BCBSNH's decision will be reviewed in light
of the record before the court to determine "whether [BCBSNH] had
substantial evidentiary grounds for a reasonable decision in its
favor." Doyle, 144 F.3d at 184.
The plaintiff argues that BCBSNH's decision in her case is
unreasonable because BCBSNH approved coverage for an ACT
procedure for another patient, because the Food and Drug
Administration has approved the cartilage product used in the ACT
5 procedure, because ACT coverage is mandated for federal employees
under Blue Cross policies, and because Blue Cross plans in other
states cover the ACT procedure. The plaintiff also contends that
BCBSNH's decision that the ACT procedure is experimental or
investigational is unreasonable because it is not based on
substantial evidence and ignores current medical evidence.
1. Approval for another insured.
In her motion for injunctive relief, the plaintiff argued
that because BCBSNH had approved an ACT procedure for another
insured, its decision to deny her approval was a selective
application of its policy and unreasonable. At the hearing on
August 4, counsel for BCBSNH explained that an ACT procedure was
approved for another BCBSNH insured by mistake but that the
procedure was not in fact done. The decision, therefore, was an
error and did not show selective application by BCBSNH of its
policy against ACT.
The plaintiff also argues that another BCBSNH insured
underwent an ACT procedure in 1996. BCBSNH contends that it did
not provide coverage. Instead, after it denied coverage for the
procedure, the insured's employer paid for the costs of the
surgery.
6 2. FDA approval.
On August 22, 1997, the FDA approved Carticel, an autologous
cultured chondrocyte, marketed by Genzyme Tissue Repair, "for the
repair of clinically significant, symptomatic, cartilaginous
defects of the femoral condyle (medial, lateral or trochlear)
caused by acute or repetitive trauma." FDA Summary Basis of
Approval at 1. The product was judged under the standards for
accelerated approval provided in 21 C.F.R. § 601.41. Id. at 19.
Because of the accelerated approval process, post-approval
studies are reguired, and Genzyme Tissue Repair committed to
further development and testing, "to confirm the long-term
clinical benefit of this product and to assess the contribution
of the autologous cells to observed benefit of the procedure."
Id. at 2 0.
The plaintiff argues that BCBSNH's determination that the
ACT procedure is experimental contravenes the FDA's approval of
Carticel.2 The plaintiff cites language from the FDA rule
defining the scope of the accelerated approval process to show
that FDA approval constitutes a finding that the approved product
2If the plaintiff also intended to argue that BCBSNH violated federal law by denying coverage, the argument fails since the plaintiff has not cited any federal law that reguires BCBSNH to cover all products or procedures that have FDA approval.
7 is safe, effective, and provides benefits to patients over
existing treatments. 21 C.F.R. § 601.40 (1998) ("This subpart
applies to certain biological products that have been studied for
their safety and effectiveness in treating serious or life-
threatening illnesses and that provide meaningful therapeutic
benefits to patients over existing treatments.") That language,
the plaintiff contends, shows that BCBSNH's determination in its
denial letter that medical evidence is insufficient to show
health improvement in ACT patients contradicts FDA approval.
In response, BCBSNH asserts that the bases for the exclusion
of experimental procedures under the policy are different than
the FDA's approval reguirements. BCBSNH notes that its medical
policy on ACT explains that ACT is not covered "because the
scientific evidence is insufficient to show improvement in health
outcomes for patients." BCBSNH/MTHP Medical Policy effective
11/26/97. BCBSNH argues that because the FDA rule applicable to
accelerated approval, 21 C.F.R. § 601.41, applies to treatment
for life-threatening conditions, it does not reguire scientific
proof of health outcomes, as BCBSNH's experimental procedures
exclusion does. See 21 C.F.R. § 601.41 (providing, in pertinent
part, as follows:
FDA may grant marketing approval for a biological product on the basis of adeguate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity.)
BCBSNH also argues that transcripts of the FDA advisory committee
that reviewed the Carticel application show that the FDA approval
process does not reguire the same degree of scientific research
on the effect of a procedure that BCBSNH reguires for coverage
approval.
While the FDA rules suggest that the product must show a
benefit over existing treatment to gain approval, the context of
the benefit may be, as BCBSNH suggests, a strong influence that
is not relevant to the BCBSNH experimental procedures exclusion.
The meaning of the FDA standards for accelerated approval is not
sufficiently clear to compare FDA reguirements with BCBSNH
reguirements based on the record presented.
In addition, FDA approval of Carticel, and by implication
the ACT procedure, is one of the reguirements (Part C of the
experimental procedures endorsement) for approval of an otherwise
experimental procedure under the BCBSNH policy exclusion. If the
BCBSNH experimental procedures endorsement reguirements were
interpreted to be identical to FDA approval reguirements, the
four criteria listed in Part B of the exclusion, which is applicable to the plaintiff's determination, would be mere
surplusage. Common principles of contract interpretation counsel
against construing a contract in such a way as to render parts
meaningless. See Jimenez v. Peninsular & Oriental Steam
Navigation Co., 974 F.2d 221, 223 (1st Cir. 1992); see also
Rodriquez-Abreu v. Chase Manhattan Bank, N.H., 986 F.2d 580, 585
(1st Cir. 1993) (ERISA federal common law based on state law
principles of contract interpretation). Based on the record
presented for a preliminary injunction, the plaintiff has not
shown that FDA approval of Carticel reguires BCBSNH to approve an
3. Coverage of ACT by other plans.
The plaintiff argues that coverage of ACT procedures by
other insurers shows that BCBSNH's decision is unreasonable.3
The plaintiff represents that all health plans participating in
the Federal Employee Health Benefit Program, including BCBSNH,
are reguired to provide coverage for ACT procedures for federal
3The plaintiff says that coverage has been approved for ACT procedures by Blue Cross Blue Shield of Kansas, Minnesota, California, New York, New Jersey, Maine, and Massachusetts, and by other insurers, Fallon Health Plan, Aetna/USHealthcare, PHCS, Allmerica, and Harvard Pilgrim Health Plan. BCBSNH notes that the BCBS entities in different states are licensed to use the trademarks and names but are otherwise independent and unrelated.
10 employees. Because particular medical insurance benefits depend
on the policy and the level of coverage purchased, the fact that
coverage for ACT procedures is offered or mandated in other
policies does not obligate BCBSNH to offer the same coverage
under the plaintiff's policy. Determinations by other insurers
that the ACT procedure is not experimental, however, may be
instructive as to the reasonableness of BCBSNH's determination.
In particular, the plaintiff points to approval of ACT
procedures by Blue Cross Massachusetts ("BCBSMA") to show that
BCBSNH's decision was unreasonable. BCBSMA policies apparently
do not have an endorsement excluding experimental procedures, as
BCBSNH policies do, but instead BCBSMA uses "Medical Technology
Assessment Guidelines" to determine whether to approve particular
procedures based on "whether a technology improves health
outcomes such as length of life, ability to function or guality
of life." BCBSMA Guidelines, 7/96, at 1. The BCBSMA Guidelines
and the BCBSNH experimental procedures endorsement reguire
substantially similar evidence and assurance of the safety and
efficacy of technology.
BCBSNH issued a policy statement on ACT procedures on
November 26, 1997, reviewed on July 7, 1999, based on a review by
the Technology Evaluation Center ("TEC"), saying "We do not cover
autologous chondrocyte transplantation . . . because the
11 scientific evidence is insufficient to show improvements in
health outcomes for patients." Medical Policy, 11/26/97 at 1.
BCBSMA issued a policy statement on ACT procedures in April of
1998 that was reviewed in March of 1999.4 The BCBSMA policy
statement noted that TEC "determined that there is not enough
scientific evidence to make conclusions about health outcomes for
patients" and that "the long-term effects of cartilage harvesting
on knee function and the long-term safety of cartilage
implantation are unknown." BCBSMA policy at 1. Nevertheless,
BCBSMA decided to cover ACT procedures on a case by case basis
for those insureds who are determined to be likely to benefit
from the procedure. Id. Although both BCBSMA and BCBSNH found
insufficient scientific evidence of the patient health outcomes
of ACT procedures, they came to different conclusions about
coverage. BCBSMA did not, however, conclude that the ACT
procedure was not experimental; instead, it exercised its
discretion in favor of approving the procedure in limited
circumstances despite the lack of material scientific evidence.
It does not follow that the limited approval of the procedure by
BCBSMA demonstrates that BCBSNH's decision not to approve ACT
4Ihe BCBSMA policy statement refers to the procedure as autologous chondrocyte implantation ("ACT") rather than transplantation ("ACT"). At least in the present record, there appears to be no difference between ACT and ACT.
12 procedures was unreasonable.
4. Evidence to support BCBSNH's decision.
BCBSNH's experimental procedures endorsement provides
certain guidelines for the medical director to follow in
determining whether a particular treatment is experimental. If
the procedure is approved by the FDA and is not part of a
protocol, informed consent, or an ongoing Phase I or II clinical
trial, the medical director "may reguire that demonstrated
evidence exists, (as reflected in the published Peer Review
Medical Literature)" to satisfy four criteria pertaining to
positive health outcomes. The four criteria are: (1) evidence
that the procedure "has proved a positive health outcome through
well designed investigations that have been reproduced by non
affiliated authoritative sources with measurable results
supported by the positive endorsements of national medical bodies
or panels regarding scientific efficacy and rationale"; (2) "the
beneficial effects [of the procedure] outweigh any harmful net
effects"; (3) the procedure "is more effective in improving net
health outcomes than established technology"; and (4)
"improvement in health outcomes is achievable in standard
conditions of medical practice outside clinical investigatory
settings."
13 BCBSNH denied coverage based on its medical policy on ACT
that states:
Currently there are no well-designed published studies comparing this new procedure to other treatments. The FDA has reguired Genzyme company to do additional human trials to research the role of the Carticel product in the knee repair process, to compare autologous chondrocyte implantation to other knee repair procedures, and to evaluate long-term effects. This trial is expected to be completed after the year 2002. Today, the long-term effect of cartilage harvesting on knee functions and the long-term safety of cartilage implantation are unknown.
BCBSNH Medical Policy, 11/26/97, at 1. BCBSNH's medical policy
on ACT is in turn based on an evaluation of medical literature
between 1985 and January of 1996 by TEC. Id. at 3. According to
the medical policy statement, TEC found "one small Swedish study
of 23 patients," the Brittberg study, that showed "good clinical
results one year out," but no further follow-up. The policy
statement notes "no published study compares ACT to prosthetic
knee arthroplasty" and concludes that the Brittberg study, "while
encouraging, is insufficient to permit determination about
improved health outcome compared to prosthetic knee
arthroplasty." Id. at 3.
The plaintiff does not challenge BCBSNH's four criteria
pertaining to positive health outcomes in the experimental
procedures exclusion. Instead, the plaintiff contends that
BCBSNH's decision is unreasonable because it was based on an out-
14 of-date policy on ACT procedures, failed to consider more recent
medical studies and information about ACT, and imposed an
unreasonable condition that a study compare prosthetic knee
arthroplasty with ACT.
BCBSNH responds that its reliance on TEC assessments for ACT
policy is reasonable because, as TEC describes itself in
promotional literature, "TEC offers a comprehensive and objective
technology assessment program that gives decision makers access
to the largest pool of assessment information, knowledge, and
experience available today." Decision Makers' Guide to TEC at 1.
TEC however is not an independent agency or a public information
source. Instead, TEC is affiliated with the national Blue Cross
Blue Shield Association and apparently is limited to providing
information to BCBS programs: "The Blue Cross Blue Shield
Association provides assessments on selected health technologies
for use by program subscribers only." Id. TEC also cautions,
"TEC Assessments are scientific opinions, provided for
informational purposes only." Id.
BCBSNH argues that TEC's assessment is not out of date. TEC
issued an assessment of ACT in February of 1998 and reviewed its
assessment in December of 1998. In December, TEC's medical
advisory board heard from a panel of four orthopedists, two
designated by the Genzyme company, maker of Carticel used in ACT
15 procedures, and two designated by BCBS Association. In the TEC
Bulletin of April 16, 1999, volume 16, number 3, TEC said that it
was in the process of updating the February 1998 assessment, but
reported that "[t]he Medical Advisory Panel has not changed its
position that ACT does not meet TEC criteria" because "empirical
evidence is necessary to demonstrate the clinical effectiveness
of autologous cultured chondrocytes." Bulletin at 2. The
plaintiff has not addressed the more recent TEC assessments.
Since the determination of whether a procedure is
experimental is defined by the BCBSNH policy, the medical
director's discretion does not extend to ignoring the policy
criteria in favor of different criteria to deny coverage. See,
e.g.. Smith v. CHAMPUS. 97 F.3d 950, 962 (7th Cir. 1996). If
appropriate evidence about the ACT procedure satisfies the stated
policy criteria, the medical director's determination to the
contrary would be unreasonable regardless of what other
information he may have used in making the determination. See,
e.g., Wilson v. CHAMPUS, 65 F.3d 361, 364-66 (4th Cir. 1995).
Therefore, if BCBSNH relied on a negative TEC assessment of ACT
that is based on different grounds than the experimental
procedures endorsement criteria or that is contradicted by other
appropriate information, BCBSNH's reliance may not have been
reasonable. C f . Martin v. Blue Cross & Blue Shield of Virginia,
16 115 F.3d 1201, 1207-08 (4th Cir. 1997) (affirming experimental
determination where Blue Cross extensively reviewed applicable
medical literature and evidence showed procedure did not meet one
of the four experimental criteria).
The plaintiff submitted the following articles and
information to BCBSNH in support of her reguest for approval of
ACT: Mats Brittberg, et al.. Treatment of Deep Cartilage Defects
in the Knee with Autologous Chondrocyte Transplantation, New
England Journal of Medicine, (Oct. 6, 1994); Bert R. Mandelbaum,
et al.. Articular Cartilage Lesions of the Knee, The American
Journal of Sports Medicine, Vol. 26, No. 6 (1998); Cartilage
Repair Registry, Periodic Report, vol. 5 , (Jan. 1999); Scott D.
Gillogly, et al.. Treatment of Articular Cartilage Defects of the
Knee with Autologous Chondrocyte Implantation, Journal of
Orthopedic and Sports Physical Therapy, Vol. 28, No. 4, (Oct.
1998); Press Release by Genzyme Tissue Repair (Feb. 3, 1999); Tom
Minas and Stefan Nehrer, Current Concepts in the Treatment of
Articular Cartilage Defects, Orthopedics, vol. 20, no. 6 (June
1997); Tom Minas, Chrondrocvte Implantation in the Repair of
Chondral Lesions of the Knee: Economics and Quality of Life," The
American Journal of Orthopedics (Nov. 1998); Cartilage Repair
Registry, Summary Report, vol. 5, (Feb. 1999). BCBSNH dismisses
the medical articles and registry information provided by the
17 plaintiff as recent commentaries on old research, the Brittberg
clinical study and the Genzyme registry of ACT patients.
a. The Brittberg study and Genzyme registry.
BCBSNH contends that neither the Brittberg study nor the
Genzyme registry is sufficient to support a conclusion as to the
effect of ACT on patient health outcomes. BCBSNH also criticizes
those studies as "single-arm series with incomplete follow-up and
reporting and no concurrent control group." BCBSNH Medical
Policy, 11/29/97, at 3. The policy statement says that although
the Brittberg study was promising, it was insufficient because of
its small size, lack of follow-up results after a year, and the
lack of a study comparing ACT and prosthetic knee arthroplasty.
The plaintiff argues that it is not reasonable to reguire
comparison between ACT and prosthetic knee arthroplasty (knee
replacement) because the procedures are intended for entirely
different patients. A prosthetic knee, apparently, is expected
to last only ten to fifteen years, and therefore the procedure is
more appropriate in older patients and patients with
osteoarthritis, a condition that is not treatable with ACT. ACT,
apparently, is expected to last longer than a knee prosthesis,
and is therefore appropriate for younger patients until a knee
replacement is necessary. However, absent gualified medical
18 opinion on the efficacy of comparing ACT and knee replacement, in
the context of showing whether ACT is "more effective in
improving net health outcomes than established technology," the
reasonableness of BCBSNH's reguirement cannot be assessed on the
current record.
The plaintiff does not specifically contradict BCBSNH's
conclusion that the Brittberg study and the Genzyme registry are
insufficient evidence that ACT is not experimental in the context
of the experimental procedures endorsement criteria.
B. Additional information.
Even if the Brittberg study and the Genzyme registry
information are insufficient, as BCBSNH contends, at least some
of the plaintiff's articles seem to include more evidence of ACT
health outcomes than BCBSNH has acknowledged. The Mandelbaum
article in The American Journal of Sports Medicine discusses
previous treatments for cartilage lesions, such as debridement,
and explains why those results have not lasted over time, putting
the benefits of ACT in context of other established treatments
for damaged cartilage. The Mandelbaum article also discusses a
reported study by Dr. Lars Peterson with results based on
unpublished data of one hundred patients followed from two to
nine years that shows good to excellent results in 96% of the
19 patients with isolated femoral condyle defects (similar to the
plaintiff's condition) .
Gillogly and his co-authors discuss the deterioration of
results in current cartilage treatments. They also discuss
Peterson's study with ACT patients. Gillogly reports results of
forty-one of his own patients, treated with ACT, noting that
twenty-nine of the forty-one patients had undergone a total of
fifty previous surgeries that did not alleviate their knee
symptoms. He documents improvement in a variety of evaluation
fields and characterizes the results as promising.
Minas and Nehrer discuss current treatments and outcomes for
cartilage repair and provide more detail about the Peterson study
in their article, saying that Peterson reported on ACT knee
treatment of 246 patients in Sweden. Minas also reported his
experience with fifty patients and that after eighteen months
there was "near complete resolution of pre-treatment pain."
Minas and Nehrer, Orthopedics, vol. 20, no. 6 at 534. Minas's
study of forty-four patients treated with ACT is published in The
American Journal of Orthopedics, where Minas reported that after
twelve months, 72% of the patients improved, while 14% stayed the
same, and 14% had a deterioration in their condition.
BCBSNH ignores updates in the Genzyme registry and the
additional studies and information in the medical articles. The
20 articles and registry information appear to provide some evidence
that the benefits of the ACT procedure outweigh the harms, that
net improvement exists in outcomes compared to other procedures,
and results in medical practice. There appears to be no
evidence, however, that the Brittberg study, the Genzyme
registry, or the additional studies and information meet the
first criteria reguirements of "well designed investigations . .
. reproduced by non-affiliated authoritative sources with
measurable results supported by the positive endorsements of
national medical bodies . . . Although the articles and
information submitted may include sufficient evidence, the
plaintiff has failed to carry her burden to show that the ACT
procedure meets all four of the criteria listed in the
experimental procedures exclusion.5 Therefore, based on the
record presented for preliminary injunctive relief, the plaintiff
has not shown that she is likely to succeed in proving that the
medical director's decision was unreasonable.
B. The Remaining Reguirements for Preliminary Injunctive Relief
Since the plaintiff has not demonstrated that she is likely
to succeed on the merits of her claim for coverage against
51he experimental procedures exclusion also reguires that the evidence exist in peer review medical literature, which is defined in the endorsement.
21 BCBSNH, the remaining preliminary injunction requirements require
little consideration. The plaintiff argues that irreparable harm
is presumed in circumstances when insurance coverage for medical
care is at issue. The cases the plaintiff cites, involving a
loss of coverage for all medical care or coverage for treatment
of a life threatening illness, do not presume irreparable harm in
all circumstances, but instead find harm in the circumstances
presented. See, e.g., Harris v. Blue Cross, 995 F.2d 877 (8th
Cir. 1993); United Steelworkers of America v. Textron, Inc., 836
F.2d 6 (1st Cir. 1987). Irreparable harm cannot be presumed in
this case.
Plaintiff's counsel argued at the hearing that the plaintiff
has a narrow window of opportunity for an ACT procedure before
the plaintiff's lesions become too large. Plaintiff's counsel
did not explain how much time is left for the plaintiff to
undergo a successful ACT procedure. In his affidavit. Dr.
Karlson, the plaintiff's treating orthopedic surgeon, did not
mention a medical urgency in scheduling the procedure although he
discussed the plaintiff's condition and prognosis. As a result,
it is not possible to assess the harm further delay in treatment
may cause.
With an insufficient showing of the plaintiff's likelihood
of success and risk of irreparable harm, it is not necessary to
22 weigh the relative harm to BCBSNH to pay the substantial cost of
the ACT procedure in advance of having the coverage issue
determined.
Conclusion
For the foregoing reasons, the plaintiff's motion for a
preliminary injunction (document no. 2) is denied. The motion
with respect to a permanent injunction is denied, and the issue
of permanent relief will be considered at the time the court acts
on the merits of the plaintiff's ERISA claims.
SO ORDERED.
Joseph A. DiClerico, Jr. District Judge
August 17, 1999
cc: Scott F. Johnson, Esg. Michael A. Pignatelli, Esg.