                   United States Court of Appeals
                         FOR THE EIGHTH CIRCUIT
                                 ___________

                                 No. 04-1383
                                 ___________

Jo Ortlieb,                             *
                                        *
             Appellant,                 *
                                        * Appeal from the United States
       vs.                              * District Court for the
                                        * District of Nebraska.
United HealthCare Choice Plans,         *
c/o United HealthCare of the            *
Midlands, Inc.; United HealthCare       *
of the Midlands, Inc., as Administrator *
Fiduciary of the Plan; United           *
HealthCare Insurance Company,           *
                                        *
              Appellees.                *
                                   ___________

                            Submitted: August 26, 2004
                               Filed: October 28, 2004
                                ___________

Before BYE, LAY, and RILEY, Circuit Judges.
                             ___________

RILEY, Circuit Judge.

      Jo Ortlieb (Ortlieb) was insured under a United HealthCare Choice Plus Plan
(Plan) when she became seriously ill. Her treating physician prescribed Total
Parenteral Nutrition (TPN).1 Ortlieb requested coverage for TPN, but the defendants
(collectively United HealthCare) denied coverage.           After exhausting her
administrative remedies, Ortlieb filed an action under the Employees Retirement
Income Securities Act of 1974 (ERISA) to recover unpaid health care benefits. The
district court2 granted summary judgment in favor of United HealthCare. Ortlieb
appeals. We affirm.

I.     BACKGROUND
       While working for her husband’s business, Ortlieb enrolled for healthcare
benefits under the group Plan issued by United HealthCare. The Plan provided that
United HealthCare “has sole and exclusive discretion in interpreting the benefits
Covered under the Policy and the other terms, conditions, limitations and exclusions
set out in the Policy and in making factual determinations related to the Policy and
its benefits.” The Plan excluded certain healthcare services, including experimental,
investigational, or unproven services. However, the Plan contained an express life-
threatening condition exception to the experimental, investigational, or unproven
service exclusion. The exception provided:

             The PLAN, in its judgment, may deem an Experimental,
      Investigational or Unproven Service a Covered Health Service for
      treating a life threatening Sickness or condition if it is determined by the


      1
       Total Parenteral Nutrition describes the delivery of nutrients for assimilation
and utilization of nutrients via solutions administered to patients intravenously,
subcutaneously, or by some other non-alimentary route. Protein hydrolysates or free
amino acid mixtures, monosaccharides, and electrolytes are the basic components of
TPN solutions, which are selected for their ability to reverse catabolism, promote
anabolism, and build structural proteins. See http://www.online-medical-
dictionary.org.
      2
       The Honorable Thomas M. Shanahan, United States District Judge for the
District of Nebraska.

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      PLAN that the Experimental, Investigational or Unproven Service at the
      time of the determination:

      A. Is safe with promising efficacy; and
      B. Is provided in a clinically controlled research setting; and
      C. Uses a specific research protocol that meets standards equivalent
         to those defined by the National Institutes of Health.

      When Ortlieb became seriously ill, she initially received medical treatment in
Lincoln, Nebraska, and later at the Mayo Clinic in Rochester, Minnesota. As her
health continued to fail, she sought treatment at the Environmental Health Center
(EHC) in Dallas, Texas, under the medical supervision of Dr. William J. Rea (Dr.
Rea). Dr. Rea diagnosed Ortlieb with a myriad of illnesses, including toxic
encephalopathy, malnutrition, malabsorption, irritable bowel syndrome, allergic food
gastroenteritis, toxic effect petrochemicals and solvents, and fatigue. Dr. Rea
prescribed Ortlieb various treatments, including TPN therapy, which she began in late
October 1999.

      The pharmacy supplying Ortlieb’s TPN services submitted a coverage request
to United HealthCare for TPN and TPN-related services. Based on an internal
medical review conducted by Dr. Debra Esser (Dr. Esser), United HealthCare denied
the coverage request finding that TPN, as it related to malnutrition, fell within the
Plan’s experimental, investigational, or unproven service exclusion. In December
1999, United HealthCare notified Ortlieb of its decision to deny coverage.

       In February 2000, the pharmacy sought reconsideration of the coverage denial,
and attached to its request a letter written by Dr. Rea describing Ortlieb’s medical
condition and Dr. Rea’s course of treatment. Later, in March 2000, Ortlieb appealed
the initial denial of coverage. United HealthCare hired Dr. Robert A. Beer (Dr. Beer),
an outside consulting physician, to review Ortlieb’s medical records and to



                                          3
recommend a benefit determination under the Plan. Dr. Beer recommended United
HealthCare deny coverage, which it did.

       Ortlieb appealed the second coverage denial. Her intermediate appeal was
reviewed by United HealthCare’s Consumer Affairs Committee (CAC), which
included an internal physician member, Dr. Tim Mergens (Dr. Mergens). The CAC
upheld the denial of coverage for TPN and related services. Ortlieb made a final
appeal to the National Appeals Service Center (NASC). NASC is administered by
Edina, an external review company. Edina, in turn, hired Dr. Arnold Flick (Dr.
Flick), an independent, board-certified gastroenterologist to review Ortlieb’s medical
records. Dr. Flick concluded insufficient medical literature existed to support TPN
treatment for any of Ortlieb’s proven medical conditions.

       Thereafter, Ortlieb contested the denial of coverage by filing her case in the
district court. The district court reviewed the benefit determination using an arbitrary
and capricious standard of review. In opposing United HealthCare’s motion for
summary judgment, Ortlieb submitted four technical documents discussing TPN,
none of which were included in the administrative record. The district court declined
to consider the new evidence. Based on the administrative record, the district court
determined United HealthCare reasonably relied on the assessments of multiple
doctors that TPN was an unproven therapy for Ortlieb’s medical conditions. The
district court rejected Ortlieb’s argument that United HealthCare had failed to
consider the “life-threatening condition” exception to the unproven service exclusion.
The court granted summary judgment in favor of United HealthCare. Ortlieb now
appeals.




                                           4
II.    DISCUSSION
       A.    Standards of Review
       We review de novo a district court’s grant of summary judgment, viewing the
record in the light most favorable to the nonmoving party. Butts v. Cont’l Cas. Co.,
357 F.3d 835, 837 (8th Cir. 2004) (citing Woo v. Deluxe Corp., 144 F.3d 1157, 1160
(8th Cir. 1998)). We also review de novo a district court’s determination of the
standard of review of an ERISA benefit plan determination. See Ferrari v. Teachers
Ins. and Annuity Ass’n, 278 F.3d 801, 806 (8th Cir. 2002).

       The Supreme Court has declared a de novo standard of review applies to a
challenge to the denial of benefits, unless the benefit plan grants the plan
administrator discretionary authority to determine eligibility for benefits or to
construe the terms of the plan. Firestone Tire & Rubber Co. v. Bruch, 489 U.S. 101,
115 (1989). When a plan gives discretion to the plan administrator, then a plan
administrator’s decision is reviewed judicially for an abuse of discretion. Id. Under
an abuse of discretion standard of review, a plan administrator’s decision will stand
if reasonable; “i.e., supported by substantial evidence.” Fletcher-Merrit v. Noram
Energy Corp., 250 F.3d 1174, 1179 (8th Cir. 2001) (quoting Donaho v. FMC Corp.,
74 F.3d 894, 899 (8th Cir. 1996)). “Substantial evidence . . . means such relevant
evidence as a reasonable mind might accept as adequate to support a conclusion.” Id.
(quoting Consol. Edison Co. of New York v. NLRB, 305 U.S. 197, 229 (1938)).

      In order for a plan beneficiary to obtain a less deferential standard of review,
she “must present material, probative evidence demonstrating that (1) a palpable
conflict of interest or a serious procedural irregularity existed, which (2) caused a
serious breach of the plan administrator’s fiduciary duty to her.” Woo, 144 F.3d at
1160. To establish the second requirement, a plan beneficiary “must only show that
the conflict or procedural irregularity has ‘some connection to the substantive
decision reached.’” Id. at 1161 (quoting Buttram v. Central States, S.E. & S.W. Areas
Health & Welfare Fund, 76 F.3d 896, 901 (8th Cir. 1996)).

                                          5
        In this case, the Plan granted United HealthCare, as plan administrator, “sole
and exclusive discretion in interpreting the benefits Covered under the Policy.” We
agree with the district court that the Plan’s “express discretion-granting language” is
sufficient to confer discretionary authority upon United HealthCare. Therefore, the
district court properly reviewed the benefit decision for an abuse of discretion. We
also agree with the district court that Ortlieb failed to present material, probative
evidence demonstrating either a “palpable conflict of interest” or “a serious
procedural irregularity,” which would warrant applying a less deferential standard of
review.

       B.    Reasonableness of Benefit Decision
       Our record review convinces us that United HealthCare’s decision to deny
coverage is supported by substantial evidence and is, therefore, reasonable. The
record indicates that, at the direction of Dr. Rea, Ortlieb commenced TPN treatment
in late October 1999 and then sought coverage from United HealthCare. Upon
receiving a request for TPN coverage, United HealthCare requested additional
medical records, which were received in mid-November 1999. Dr. Esser initially
reviewed Ortlieb’s medical records and consulted with Ortlieb’s primary care
physician and gastroenterologist. Based on her record review and consultations, Dr.
Esser determined TPN services were investigational and were not supported by peer
literature. On December 7, 1999, Dr. Esser wrote Ortlieb explaining United
HealthCare was denying coverage based on the Plan’s exclusion for experimental,
investigational, and unproven services.

        Within weeks of denying coverage, United HealthCare received a request for
reconsideration accompanied by a detailed letter from Dr. Rea. Although Dr. Rea’s
letter declared Ortlieb’s receipt of TPN services was “a medical necessity” and also
stated TPN therapy had been used at the EHC clinic “for over twenty-five years with
more than five thousand patients and . . . no significant long-term effects have been



                                          6
noted,” Dr. Rea’s letter cited no peer-reviewed medical literature indicating TPN
services are a safe and effective treatment for Ortlieb’s medical conditions.

       Because the reconsideration request included a first-time coverage request for
intravenous mineral and antibiotic therapy, United HealthCare requested additional
medical records. In March 2000, Ortlieb formally appealed the initial denial of
coverage, and in April 2000, United HealthCare hired Dr. Beer, an outside physician
consultant, to review Ortlieb’s medical records and to make an independent benefit
determination. Dr. Beer determined (1) the records reflected “insufficient objective
data for cause of malnutrition”; and (2) the requested TPN services were
“investigational” and unsupported by sufficient medical evidence in Ortlieb’s case or
in the literature indicating any clinical improvement. Based on these findings, Dr.
Beer recommended denial of coverage.

      Near the same time, Dr. Esser reviewed the coverage request for Ortlieb’s
supplemental intravenous mineral and antibiotic therapy services. Relying on the
documentation provided, Dr. Esser determined the requested TPN therapy services
were investigational and not a covered benefit. On May 23, 2000, Dr. Esser wrote
two denial-of-coverage letters. One letter notified Ortlieb that United HealthCare was
denying the coverage request for supplemental, intravenous mineral and antibiotic
therapy services. Dr. Esser’s letter explained:

      There is no documentation of positive cultures of an infection that
      would require intravenous antibiotics. It is also documented in your
      records that you are “allergic to all antibiotics,” yet intravenous
      antibiotics were given. Without supporting documentation of an
      infection, use of antibiotics is considered investigational and not a
      covered benefit.

      Dr. Esser’s second letter denied Ortlieb’s request to reconsider the initial denial
of coverage for TPN services. Although the letter did not refer to Dr. Beer by name,
Dr. Esser informed Ortlieb her file “has been carefully reviewed by a physician

                                           7
consultant who was not involved in the initial decision,” which had resulted in an
independent determination that the previous decision should be upheld. Dr. Esser
explained:

      There is also insufficient evidence in your medical records and peer-
      reviewed medical literature that TPN (and especially
      vitamin/mineral/anti-oxidant supplementation) results in clinical
      improvement. Therefore, the use of TPN is considered investigational
      and the TPN, supplies, and skilled nursing visits are not covered under
      your benefit plan.

       Ortlieb then pursued an intermediate appeal to the CAC. United HealthCare
representatives, including physician member Dr. Mergens, reviewed Ortlieb’s file and
upheld the decision to deny coverage. United HealthCare notified Ortlieb of the
CAC’s decision in January 2001, citing, as the basis for denial, the experimental,
investigational, or unproven service exclusion.

       Ortlieb filed her final administrative appeal with the NASC, which was
independently processed by Edina, an external review company. Edina retained Dr.
Flick, an independent, board certified, gastroenterology consultant. In August 2002,
Dr. Flick reviewed Ortlieb’s medical records and found no peer-reviewed literature
supporting TPN therapy treatment for any of Ortlieb’s proven diagnoses. Dr. Flick
concluded TPN treatment to be “unproven for [Ortlieb’s] clinical condition(s).”
Edina notified Ortlieb that, based upon an independent external review, TPN was not
a covered service because “TPN treatment is unproven for Ms. Ortlieb’s clinical
condition,” and unproven services are excluded under the Plan.

      This recitation of the record illustrates that Ortlieb’s coverage request for TPN
therapy was reviewed at least four times by four physicians, two of whom were
external, independent physician consultants. Each of the physicians reviewing
Ortlieb’s medical file consistently determined TPN therapy was an unproven therapy
for Ortlieb’s medical conditions. At least three of the four reviewing physicians

                                          8
concluded there was insufficient peer-reviewed literature supporting TPN therapy for
Ortlieb’s medical conditions. All five denial-of-coverage notices explained Ortlieb’s
coverage request for TPN therapy and related services was being denied based on the
Plan’s exclusion for experimental, investigational, or unproven services. All but the
final denial notice, which was issued by Edina, specifically cited to and quoted the
Plan’s exclusion provision. Moreover, Dr. Esser’s May 2000 letter informed Ortlieb
there was “insufficient . . . peer-reviewed medical literature that TPN . . . results in
clinical improvement.” Despite receiving these notices that clearly and consistently
identified the bases for coverage denial–unproven service and insufficient peer-
reviewed medical literature–neither Ortlieb nor her treating physician provided
United HealthCare with clinical evidence or peer-reviewed literature establishing
TPN therapy was a proven therapy for Ortlieb’s medical conditions. For these
reasons, we conclude Ortlieb’s arguments are without merit, and United HealthCare’s
denial of coverage is reasonable.3

      C.     Life-Threatening Condition Exception
      Ortlieb also argues United HealthCare was not entitled to summary judgment,
because a genuine issue of material fact exists as to whether United HealthCare
considered Ortlieb’s medical condition as life threatening, an express exception to the
Plan’s experimental, investigational, or unproven service exclusion. United
HealthCare contends the life-threatening exception does not apply for two reasons:
(1) Ortlieb’s medical records do not establish her medical condition was life

      3
        Ortlieb also argues United HealthCare should be strictly bound to the grounds
for its original denial. After initially denying coverage for TPN therapy, United
HealthCare continued to assess and investigate Ortlieb’s claim, at Ortlieb’s request.
As the administrative process evolved, United HealthCare learned more about
Ortlieb’s claim and the medical field’s recognition of her conditions and TPN
therapy. United HealthCare’s further investigation is commendable and should be
encouraged, not discouraged. On this record, to the extent United HealthCare’s
grounds for denial changed, we see no justification for limiting United HealthCare’s
reasons for denial.

                                           9
threatening, and (2) TPN therapy, as utilized in this case, was not a treatment “safe
with promising efficacy,” part of a clinical study, or performed according to specific
research protocol.

        The district court concluded that, although United HealthCare never expressly
stated it considered and rejected the Plan’s life-threatening condition exception, Dr.
Flick addressed the first required element of the exception by questioning the efficacy
of TPN treatment for Ortlieb’s medical conditions and by identifying several adverse
side effects related to TPN therapy. Moreover, the district court determined the
record contained no evidence that Ortlieb’s TPN therapy at EHC was “provided in a
clinically controlled research setting” and “[used] specific research protocol that
meets standard[s] equivalent to those defined by the National Institutes of Health.”
We agree with the district court’s conclusion that United HealthCare’s independent
medical expert, Dr. Flick, at least implicitly considered and rejected the life-
threatening condition exception, and his decision in doing so was reasonable. If
Ortlieb’s medical condition were life-threatening, which is dubious based on this
record, United HealthCare’s reliance on Dr. Flick’s opinions and on the
administrative record is reasonable, and its decision to deny benefits is supported by
substantial evidence.

III.     CONCLUSION
         For the foregoing reasons, we affirm the well-reasoned judgment of the district
court.
                         ______________________________




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