United States District Court, D. New Jersey
MEMORANDUM AND ORDER
G. SHERIDAN, U.S.D.J.
before the Court are cross-motions for Summary Judgment by
Plaintiff Ellen Whitford and Defendant Horizon Blue Cross
Blue Shield of New Jersey (ECF Nos. 14, 16). For the reasons
discussed herein, BCBS's Motion for Summary Judgment is
case arises from BCBS's refusal to authorize a particular
treatment to Plaintiff, finding the procedure experimental.
Plaintiff is a 64 year old woman, who works as a school nurse
at The Rugby School, which provides a fully insured Horizon
OMNIA plan. ("BCBS's Statement of Undisputed Facts
[SUF]" at ¶¶ 1-2; ECF No. 1-2,
most insurance plans, the Plan here does not provide benefits
for out-of-network services. (Id. at ¶ 3).
Moreover, the Plan requires covered individuals to first
receive BCBS's authorization before receiving particular
services or treatment. (Plan at 100-06). Under this
"utilization review, " a "plan administrator
reviews a procedure before it is performed to determine
whether it is 'medically necessary and appropriate'
for treatment of the member's condition." (SUF at
¶ 8). The Plan also grants BCBS discretion in reviewing
benefits claims. The Plan limits payment for benefits for
"[s]ervices, in [BCBS's] judgment, are at the proper
level of care" and reserves BCBS with "the right to
require that care be rendered in an alternate setting as a
condition of providing payment for benefits, " if it
"determines that a more cost-effective manner
exists." (Id. at 74, 75).
Plan also states that BCBS is to determine what is considered
"medically necessary and appropriate" under the
program. (Plan at 100). Notably, the services deemed to be
"Experimental or Investigational Technology" are
not considered medically necessary and appropriate.
(Id. at 35). Under the Plan, a service is considered
experimental or investigational if it fails to meet any of
the following tests:
a. The Technology must either be: (a) approved by the
appropriate federal regulatory agency and have been in use
for the purpose defined in that approval; or (b) proven to
Horizon BCBSNJ's satisfaction to be the standard of
b. There must be sufficient proof, published in peer-reviewed
scientific literature, that confirms the effectiveness of the
Technology. That proof must consist of well-designed and
well-documented investigations. But, if such proof is not
sufficient or is questionable, Horizon BCBSNJ may consider
opinions about and evaluations of the Technology from
appropriate specialty advisory committees and/or specialty
c. The Technology must result in measurable improvement in
health outcomes, and the therapeutic benefits must outweigh
the risks, as shown in scientific studies.
"Improvement" means progress toward a normal or
functional state of health.
d. The Technology must be as safe and effective as any
established modality. (If an alternative to the Technology is
not available, Horizon BCBSNJ may, to determine the safety
and effectiveness of a Technology, consider opinions about
and evaluations of the Technology from appropriate specialty
advisory committees and/or specialty consultants.)
e. The Technology must demonstrate effectiveness when applied
outside of the investigative research setting.
(Id. at 35). The Plan also provides a three-level
appellate process, for which covered individuals can
challenge Adverse Benefit Determinations. (Id. at
129). This process consists of: (1) "an informal
internal review by Horizon BCBSNJ"; (2) "if the
initial decision is upheld, a formal second level internal
review by Horizon BCBSNJ"; and (3) an external appeal
presided by the Independent Utilization Review Organization
(hereinafter, "IURO"), which is binding on both
parties. (Id. at 130-33). An external appeal is
conditioned on first exhausting the first two internal
reviews. (Id. at 133).
event, on August 6, 2016, Plaintiff suffered an injury to her
left elbow, the pain of which has affected her ability to use
her left hand and perform everyday tasks. (Amended Complaint
at ¶¶ 3, 5). In August and September 2016,
Plaintiff consulted with Dr. J. Saleh, an in-network
provider, who opined that she needed complex elbow
reconstructive surgery and referred her to Dr. Michael
Hausman, who handles such cases. (Id. at ¶ 6).
The following month Dr. Hausman, an out of network provider,
recommended that Plaintiff receive "combined ligament
and radiocapitellar reconstruction" of her left elbow.
(Id. at ¶ 10). The procedure, known as
interposition anthroplasty, also required the use of an
internal joint stabilizer device, which includes a base plate
with three screws, a connecting arm, a locking joint, a boom
arm and an axis pin. (Id. at ¶ 11). Plaintiff
seeks to have this device inserted into her left elbow. This
is a relatively new and innovative device that provides
temporary stabilization of the elbow joint after chronic
elbow dislocation. A surgeon employs an open lateral
approach, to insert the device.
consulting with Plaintiff, on November 10, 2016, Dr. Hausman
wrote to BCBS to receive preauthorization to perform the
described procedure. (SUF at ¶ 19). On December 16,
2016, BCBS denied Dr. Hausman's request, finding the
proposed procedure to be "experimental or
investigational." (ECF No. 9-2, "December 16, 2016
Letter"). Specifically, the letter explained that
"the use of internal joint stabilizer in elbow
reconstruction is considered investigational. . . . There is
insufficient literature to support the use of the requested
device." (Id.). The letter also provided
Plaintiff with two in-network elbow surgeons and noted that
Plaintiff may appeal this determination. (Id.). In