Smith v. Newport News Shipbuilding Health Plan
| Decision Date | 18 June 2001 |
| Docket Number | No. CIV. A. 4:01CV47.,CIV. A. 4:01CV47. |
| Citation | 148 F.Supp.2d 637 |
| Court | U.S. District Court — Eastern District of Virginia |
| Parties | Valerie SMITH, Plaintiff, v. NEWPORT NEWS SHIPBUILDING HEALTH PLAN, INC., Defendant. |
Richard D. Carter, David S. Panzer, Carter & Coleman, Alexandria, VA, for Plaintiff.
Hill B. Wellford, Jr., Edwin F. Farren, IV, Hunton & Williams, Richmond, VA, for Defendant.
On May 30, 2001, the Court heard oral argument regarding Plaintiff Valerie Smith's Motion for Preliminary Injunction or in the Alternative for Expedited Trial. Plaintiff suffers from Stage II breast cancer which has not yet metastasized. She has requested that Defendant Newport News Shipbuilding Health Plan, Inc. (the "Plan") provide a certification of insurance coverage so that she can receive High Dose Chemotherapy ("HDCT") with Peripheral Stem Cell Support ("PSCS") or Autologuos Hematopoietic Support ("AHS") treatment for her cancer. The Plan's claim administrator, Connecticut General Life Insurance Company and its related companies ("CIGNA"), has denied Plaintiff's requests for pre-authorization of coverage for this treatment, which CIGNA has deemed excluded from the Plan as experimental, investigatory, and not medically necessary. Plaintiff seeks an order enjoining Defendant to issue the certification of insurance coverage necessary for her doctors to go forward with HDCT treatment. In accordance with the Court's directive, the parties filed supplementary briefs concerning Plaintiff's motion on June 4, 2001. For the reasons set forth below, Plaintiff's request for a preliminary injunction hereby is GRANTED.
Ms. Smith is a 42 year-old employee of Newport News Shipbuilding, Inc. ("NNSI"). She is a participant in the Plan, which is self funded through contributions by NNSI and its current and former employees. Gettas Decl., Ex. 2, at General Information 11. In June 2000, Ms. Smith presented a palpable lump in her right breast, and subsequently was diagnosed with Stage II breast cancer.1 She underwent a mastectomy and began adjuvant standard dose chemotherapy ("SDCT") which has resulted in the complete remission of her breast cancer. The Plan has paid for the medical expenses associated with her mastectomy and SDCT.
Although her cancer currently is in remission, it appears that Plaintiff is at high risk for relapse due to her age, multiple node involvement, and other negative prognosis factors. Plaintiff's primary concern is that without aggressive therapy the cancer will metastasize. Vredenburgh Decl., at ¶ 5. According to Plaintiff's oncologist, metastatic breast cancer is almost categorically incurable, with a median survival rate of approximately one year. Id. Plaintiff claims that HDCT offers her the best chance for progression free survival. She was scheduled to be admitted to the Duke University Medical Center ("Duke") in January 2001 for HDCT treatment, but Duke could not admit her until she provided the hospital with a pre-certification from the Plan that the treatment will be covered by insurance. Thus far, the Plan, as administered by CIGNA, has refused to pre-certify coverage for HDCT treatment for Ms. Smith.
The Plan provides that for an expense to be covered, it must, inter alia, be "Necessary for the treatment of an injury or sickness." Gettas Decl, Ex. 2, p. 14 (Summary Plan Description ("SPD")). Services that are not medically necessary are not covered. Id., at 21. The Plan defines "Necessary" as follows:
A service or supply is Necessary if it is for the diagnosis, care or treatment of a physical or mental condition and widely accepted professionally in the U.S. as effective, appropriate, and essential, based upon recognized standards of the health care specialty involved.
Id., at 40. CIGNA argues, and the Plaintiff appears to concede, that experimental/investigative procedures are not Necessary and, therefore, are excluded from coverage. The Plan defines "Experimental/Investigative Procedures" as follows:
[A]ny service or supply which is determined to be experimental or investigative at [CIGNA's] sole discretion. The following four criteria in exercising its discretion will apply:
1. Any supply or drug must have received final approval to market by the United States Food and Drug Administration;
2. There must be sufficient information in the peer reviewed medical and scientific literature to enable [CIGNA] to make conclusions about safety and efficacy;
3. The available scientific evidence must demonstrate a beneficial effect on health outcomes outside a research setting; and
4. The service or supply must be as safe and effective outside a research setting as existing diagnostic or therapeutic alternatives.
In the 1980s and 1990s, the search for better breast cancer treatments led to increased use of chemotherapy, both in terms of drugs utilized and dosages administered.2 The phrase "high dose chemotherapy" refers to chemotherapy at doses that are so toxic to the patient's bone marrow that the patient could not survive without infusions of stem cells derived from either the bone marrow or peripheral blood. In the AHS procedure, stem cells are withdrawn from the marrow, frozen and then later re-infused into the patient. In the PSCS procedure, medication is used to force stem cells out of the marrow into the peripheral blood stream where they can be retrieved through a blood draw. PSCS has the advantage of sparing the patient an invasive bone marrow aspiration for the initial harvesting of marrow cells.3 Plaintiff alleges that HDCT with PSCS is not only more effective than SDCT in producing complete remissions in breast cancer patients, but HDCT has the added advantage of permitting the patient to be off treatment and without need for additional chemotherapy treatments. The mortality rate related to the toxicity of HDCT, as administered at Duke, currently is between 1% and 3%. Vredenburgh Supp. Decl., at ¶ 8.
Plaintiff's local oncologist, Dr. Elizabeth Harden, recommended HDCT with PSCS as the best treatment available for Ms. Smith's breast cancer. Dr. James J. Vredenburgh, Assistant Professor of Medicine at Duke, then evaluated Ms. Smith. On or about January 5, 2001, Dr. Vredenburgh requested that the Plan pre-authorize coverage to permit Plaintiff to undergo HDCT with PSCS at Duke. Gettas Decl., ¶ 5. On January 11, 2001, Dr. Nicholas Gettas, a Medical Director at CIGNA, responded that CIGNA could not authorize coverage for HDCT because the treatment fails to "meet our standards for medical necessity" for the following reasons: (1) demonstrated literature and past reviews indicate that autologuous stem cell transplants for breast cancer are "investigational and experimental," and (2) experimental and investigative procedures are not covered under the Plan. Gettas Decl., at 4. This letter advised Dr. Vredenburgh of the patient's right to request reconsideration of the denial.
Duke appealed CIGNA's initial denial of pre-authorized coverage. On January 26, 2001, Dr. James Rollins of CIGNA informed Dr. Vredenburgh of his decision to uphold the original denial of benefits. Dr. Rollins reiterated that autologous stem cell bone marrow transplant is experimental/investigative. In this letter, Dr. Rollins advised Plaintiff that her appeal had been forwarded to CIGNA's LIFESOURCE Transplant Program and Clinical Decision Support Inquiry Unit and that an external review of the request was performed. CIGNA refers for external review requests for coverage such as Ms. Smith's to the Medical Care Management Corporation, a company unaffiliated with CIGNA, that administers the Medical Care Ombudsman Program ("MCOP"). MCOP selects medical expert reviewers on a rotating basis from a panel of physicians within particular medical specialties. Gettas Decl., ¶ 6-7.
The independent reviewer who, upon referral from MCOP, first considered Ms. Smith's case was Dr. Christopher E. Desch. Desch Decl., ¶¶ 1-2. Dr. Desch is the Medical Director of the Virginia Cancer Treatment Centers and Director of Clinical Research for the Virginia Cancer Institute. Id., ¶ 1. On January 21, 2001, Dr. Desch completed his review of Plaintiff's request. Id., Ex. 2. It was Dr. Desch's opinion that "there is no convincing evidence that the high-dose chemotherapy with peripheral stem cell support proposed for Ms. Smith will improve her health outcome over what is to be expected from conventional chemotherapy." Id., at ¶ 6. Dr. Desch's report did not accompany CIGNA's January 26, 2001 denial of coverage.
Although Dr. Desch concluded that "the health benefits of [HDCT] are not clear for this treatment for this patient," his report acknowledges that "[h]igh dose chemotherapy has been a promising treatment for high-risk breast cancer." Citing a 1993 study conducted by doctors at Duke, including Plaintiff's oncologist Dr. Vredenburgh, Dr. Desch stated that "[d]ata from Duke show a longer disease free survival in women with more than 10 nodes compared to a non-concurrent group of historical controls."4 Dr. Desch also referred to a 1995 study that showed a high proportion of patients disease free at two years after receiving HDCT.5 Dr. Desch, however, suggested that the benefits of HDCT shown in the Peters Study and Bearman Study may be attributable to selection bias.6 Finally, Dr. Desch acknowledged that a 1998 Dutch study of 885 women who were randomized to receive HDCT versus intermediate doses of chemotherapy produced preliminary findings in the first 284 patients demonstrating a disease-free survival rate of 77% for HDCT patients versus 62% for intermediate dose patients and a significantly greater overall survival rate for women in the high-dose arm of the study.7 Dr. Desch clarified, however, that analysis of all patients in the Dutch Study failed to demonstrate a significantly greater overall...
To continue reading
Request your trial
-
Wade v. Life Ins. Co. of North America
...finds that Defendant's review procedures substantially complied with the relevant regulations. See Smith v. Newport News Shipbuilding Health Plan, 148 F.Supp.2d 637, 649 (E.D.Va.2001) (finding substantial compliance despite alleged failure to produce medical reports where plaintiff was not ......
-
Rli Ins. Co. v. Nexus Servs., Inc.
...through a preliminary injunction as neutral in regards to the public interest. See, e.g., Smith v. Newport News Shipbuilding Health Plan, Inc., 148 F. Supp. 2d 637, 653, 2001 WL 694518 (E.D. Va. 2001). However, Nexus admits its contractual obligation to provide at least some financial recor......