Boldon v. Humana Ins. Co.
| Citation | 466 F.Supp.2d 1199 |
| Decision Date | 13 December 2006 |
| Docket Number | No. CV06-02818 PHXNVW.,CV06-02818 PHXNVW. |
| Parties | Michael J. BOLDON, Plaintiff v. HUMANA INSURANCE COMPANY; Cutter Aviation Group Medical Plan Administrator, Defendants. |
| Court | U.S. District Court — District of Arizona |
Randolph G. Bachrach, Law Office of Randolph G. Bachrach, Phoenix, AZ, for Plaintiff.
Andrew Mark Federhar, Fennemore Craig PC, Phoenix, AZ, for Defendants.
FINDINGS OF FACT AND CONCLUSIONS OF LAW IN SUPPORT OF PRELIMINARY INJUNCTION
This order addresses whether the plaintiffs insurance carrier should be preliminarily enjoined to provide coverage for the plaintiffs prescribed medical treatment under the Employee Retirement Income Security Act ("ERISA"). The court makes the following findings of fact and conclusions of law:
I. Findings of Fact
Plaintiff Michael J. Boldon ("Boldon") is a 54-year old employee of Cutter Aviation, Inc. Since January 1, 2005, Boldon has been enrolled in the Cutter Aviation Group Medical Plan ("Plan"), a participating provider option plan ("PPO") that provides medical benefits to Cutter Aviation employees. Defendant Humana Insurance Company ("Humana") is the administrator, insurer, and payer of benefits under the Plan.
In May 2006, Boldon was diagnosed with advanced unresectable hepatocellular carcinoma ("HCC"), a rare form of terminal liver cancer with four stages of progressing severity. HCC is considered an "orphan disease" because only approximately 16,000 patients are diagnosed with HCC in the United States each year. Patients who do not receive treatment for HCC survive anywhere from three months to four years following diagnosis. Boldon also has hepatitis-C and is HIV positive.
Due to the size of his tumor and his HIV status, Boldon was advised in July 2006 that he is not eligible for liver transplantation at the Banner Good Samaritan Liver Disease Center ("Banner") in Phoenix, Arizona. In August 2006, the Liver Transplant Clinic at the University of California at San Francisco Medical Center ("UCSF") similarly declined to offer the procedure in light of Boldon's use of narcotics and cigarettes, his tumor's size, and evidence from a CT scan performed on August 23 "consistent with" the conclusion that his HCC had metastasized. Doc. # 38, Exhibit 3 at 6.
Contrary to the UCSF CT scan's indication of possible metastasis, the report from a CT scan subsequently performed at Banner on September 11, 2006, did not mention any signs of metastasis. Additional blood and imaging tests conducted at Banner on December 12, 2006, also showed no signs of metastasis.
In September 2006, Boldon's physician at Banner, Kevin S. Hirsch, M.D. ("Dr. Hirsch"), a board-certified interventional radiologist, recommended treating Boldon's advanced HCC' with yttrium-90 radioembolization using TheraSphere Y-90. TheraSphere treatment involves the intraarterial delivery of glass microspheres of the radioactive element yttrium-90 to the site of a patient's liver tumor and is performed at Banner on an outpatient basis. An initial administration of TheraSphere generally costs over $100,000. Subsequent administrations cost approximately $20,000 each.
TheraSphere was recommended to Boldon for the purpose of prolonging and improving the quality of his life. His only alternative is chemoembolization, a form of treatment that is less likely to extend his life expectancy and more likely to produce adverse side effects. If Boldon does not receive TheraSphere treatment in the near future, it is probable that he will lose his life relatively prematurely.
D. The Status of the. Treatment
In March 2000, the Center for Devices and Radiological Health of the United States Food' and Drug Administration ("FDA") approved TheraSphere for commercial distribution under the FDA's humanitarian device exemption. This exemption permits a company to distribute a medical device commercially without a scientifically rigorous demonstration of effectiveness when the number of patients expected to benefit from the device is fewer than 4,000 per year. The FDA's approval notice permits TheraSphere to be used "for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters." Joint Exhibit # 16 at 3-4. The FDA's approval was
based on the results of a randomized, controlled clinical trial involving 70 persons with colorectal cancer metastatic to the liver, 34 of whom received [floxuridine] chemotherapy (control group), and 36 of whom received [floxuridine] plus [microspheres]. Two of the patients receiving [floxuridine] plus [microspheres] had a complete response, and 16 had a partial response. By comparison, one patient receiving [floxuridine] alone achieved a complete response and seven had a partial response. There is a statistically significant delay of time to progression of the disease in the group treated with [floxuridine] plus [micro spheres], when compared with the group treated with [floxuricline] only. Joint Exhibit # 19 at 1.
Since obtaining FDA approval, Thera-Sphere has become a common, if not standard, treatment-for HCC. TheraSphere is available in 29 cancer treatment centers across the United States. Since 2004, the National Comprehensive Cancer Network has included TheraSphere treatment in its clinical guidelines for unresectable primary liver cancer. TheraSphere is also fully reimbursable under. Medicare and Medicaid, and is covered by insurance plans provided by Aetna, CIGNA, and several Blue Cross/Blue Shield companies. Dr. Hirsch has personally treated approximately 30 HCC patients with, TheraSphere since April 2005.
In total, thirteen Phase I and Phase II clinical studies have been conducted on TheraSphere. Phase I studies tested the proper administration and dosage for the treatment. Phase II studies, in contrast, tested whether TheraSphere is effective against HCC. One randomized, controlled trial specifically compared the efficacy of TheraSphere and the common chemother apy drug floxuridine among 70 cancer patients. All of these studies were discussed in peer-reviewed medical journals, and all of them concluded that TheraSphere is a relatively safe and effective treatment for advanced-stage unresectable HCC. Due in large part to the rarity of HCC, Phase III trials have not been conducted to compare TheraSphere to alternative treatments among large populations of patients.
E. The Scope of Boldon's Coverage
The Cutter Aviation Group Medical Plan covers the "services of a radiologist." Joint. Exhibit # 1 at 35. However, the Plan does not cover the provision of "[a]ny drug, biological product, device, medical treatment, or procedure which is experimental, or investigational or for research purposes." Id. at 52. In the Plan's Glossary, "experimental or investigational of for research purposes" is defined as
a drug, biological product, device, treatment or procedure that meets any one of the following criteria, as determined by us:
• Cannot be lawfully marketed without the final approval of the United States Food and Drug Administration (FDA) and which lacks such final FDA approval for the use or proposed use, unless (a) found to be accepted for that use in the most recently published edition of the United States Pharmacopeia-Drug Information for Healthcare Professional (USP-DI) or in the most recently published edition of the American Hospital Formulary Service (AHFS) Drug Information, or (b) identified as safe, widely used and generally accepted as effective for that use as reported in nationally recognized peer reviewed medical literature published in the English language as of the date of service; or (c) is mandated by state law;
• Is a device required to receive Premarket Approval (PMA) or 510K approval by the FDA but has not received a PMA or 510K approval;
• Is not identified as safe, widely used and generally accepted as effective for the proposed use as reported in nationally recognized peer reviewed medical literature published in the English language as of the date of service;
• Is the subject of a National Cancer Institute (NCI) Phase I, II or III trial or a treatment protocol comparable to a NCI Phase I, II or III trial, or any trial not recognized by NCI regardless of phase; or • Is identified as not covered by the Centers for Medicare and Medicaid Services (CMS) Medicare Coverage Issues Manual, a CMS Operational Policy Letter or a CMS National Coverage Decision, except as required by state or federal law. Joint Exhibit # 1 at 94.
The Plan concludes with the following language:
DISCRETIONARY AUTHORITY
With respect to paying claims for benefits or determining eligibility for coverage under a policy issued by Humana, Humana as administrator for claims determinations and as. ERISA claims review fiduciary, shall have full and exclusive discretionary authority to: 1) interpret plan provisions, 2) make decisions regarding eligibility, for coverage and benefits, and 3) resolve factual questions relating to coverage and benefits. Joint Exhibit # 1, Notices at 2.
F. The Denial of Coverage
In September 2006, Dr. Sankara Atman Sidat-Singh ("DrSidat-Singh"), a former family practitioner now employed as the medical director for Humana's Commercial Segment in Arizona and Colorado, reviewed Dr. Hirsch's recommendation of TheraSphere treatment for Boldon. Following an internal Humana guideline that describes TheraSphere as "experimental/investigational," Dr. Sidat-Singh denied coverage. The guideline on which Dr. Sidat-Singh relied states:
Humana members would NOT be eligible under the Plan for intrahepatic yttrium-90 microsphere therapy. This technology is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as...
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