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,

, 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.,

(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.,

(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.,

(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.,

(1st Cir. 1998). A general interest in

conserving resources is insufficient to support a finding of

conflict of interest. See Doe v. Travelers Ins.,

(1st Cir. 1999). Instead, the burden is on the plaintiff to show

that the challenged decision was improperly motivated. Doyle,

. Absent proof of improper motivation, the

decision is reviewed for reasonableness. Doe,

.

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,

.

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

.

.

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."

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.

(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,

, applies to treatment

for life-threatening conditions, it does not reguire scientific

proof of health outcomes, as BCBSNH's experimental procedures

exclusion does. See

(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.,

(1st Cir. 1992); see also

Rodriquez-Abreu v. Chase Manhattan Bank, N.H.,

(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

ACT procedure for her.

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.

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.

, 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,

(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

(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,

(8th

Cir. 1993); United Steelworkers of America v. Textron, Inc.,

(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.

23