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VELEZ v. PRUDENTIAL HEALTH CARE PLAN OF NEW YORK

October 18, 1996

NOEMI VELEZ, Plaintiff, against PRUDENTIAL HEALTH CARE PLAN OF NEW YORK, INC., Defendant.


The opinion of the court was delivered by: PARKER

 BARRINGTON D. PARKER, JR., U.S.D.J.

 Plaintiff Noemi Velez brings this action pursuant to section 502 of the Employee Retirement Income Security Act of 1974 ("ERISA"), 29 U.S.C. ยง 1132 (1995), seeking a determination of her right to coverage under a medical insurance plan issued by defendant Prudential Health Care Plan of New York ("Prudential") through her employer Chemical Bank.

 I. BACKGROUND

 Noemi Velez suffers from stage III multiple myeloma, *fn1" a cancer of the blood that, although frequently fatal, can be ameliorated with chemotherapy and sometimes radiation therapy. But standard out-patient levels of chemotherapy provide only limited success in treating multiple myeloma. With conventional doses of chemotherapy, her life expectancy is approximately 30 months.

 High-dose chemotherapy ("HDC") has advantages over conventional chemotherapy and results in a greater rate of success in the treatment of multiple myeloma. A limitation on HDC, however, is imposed by its side effects. As the dosage increases, so does the toxic effect on bone marrow, thus damaging and ultimately destroying it. This secondary effect, untreated, can be lethal. To avoid this result, some doctors have incorporated into treatment therapy the autologous bone marrow transplant ("ABMT") procedure, whereby bone marrow is removed from the patient before the chemotherapy begins, is frozen for preservation, and is reinfused after treatment. A patient undergoing HDC-ABMT is hospitalized--often in intensive care--for approximately 10 days of treatment and requires full medical attention.

 In December 1995, plaintiff's doctors, Dr. Tauseef Ahmed, Chief of Oncology at New York Medical College and Dr. Ram Kancherla of Westchester County Medical Center ("WCMC"), determined that sequential or "tandem" administration of HDC-ABMT therapy was the best treatment for plaintiff's condition. According to Dr. Ahmed, the likelihood that patients will achieve complete remission almost doubles with tandem as opposed to single HDC-ABMT treatment. In July, Velez received her initial HDC-ABMT treatment, for which Prudential agreed to pay. This litigation arises from Prudential's failure to precertify the second or "tandem" component of Velez's HDC-ABMT treatment. Velez was and continues to be a suitable candidate for the treatment because of her youth (she is 48 years old) and the fact that her disease has been responsive to lower-dose outpatient chemotherapy. Patients like Velez, however, enjoy a limited window of opportunity in which they may receive the HDC-ABMT treatment with succesful results.

 At the time that the HDC-ABMT was suggested by her doctors, Velez, as an employee of Chemical Bank, was insured under Prudential Health Care's New York HMO Plan ("the Plan"). Thus, in March 1996, WCMC, the medical facility that was to administer the tandem HDC-ABMT, requested that Prudential precertify the treatment to guarantee payment for the procedure. On May 10, 1996, Prudential denied coverage for the treatment in writing, asserting -- without any explanation or elaboration -- that the treatment was "medically unnecessary." Prudential did not specify in the letter the grounds for making that determination. Weeks later, Prudential adverted to a provision in plaintiff's policy that defined "medical necessity" as satisfying, among others, the following criteria:

 
(b) The prevailing opinion within the appropriate specialty of the United States medical profession is that [the treatment] is safe and effective for its intended use, and that its omission would adversely affect the person's medical condition.
 
PruCare *fn2" will determine whether these requirements have been met based on:
 
. Regulations, reports, publications or evaluations issued by government agencies such as the Agency for Health Care Policy and Research, the National Institutes of Health, and the Food and Drug Administration (FDA);
 
. Listings in the following drug compendia: The American Medical Association Drug Evaluations, The American Hospital Formulary Service Drug Information and The United States Pharmacopeia Dispensing Information; and
 
. Other authoritative medical sources to the extent that PruCare determines them to be necessary.

 In response to the May 10 letter, WCMC, on behalf of Velez, asked for reconsideration of the benefit denial. In a letter of June 4, 1996, Prudential again denied the request for precertification, but this time advanced a new, different, basis for denial, stating that the procedure was "experimental or investigational" and mentioning nothing of "medical necessity."

 The June 4 denial offered no reasoned explanation or analysis but simply quoted from plan language that excludes experimental or investigational services where

 
PruCare determines that one or more of the following is true:
 
(a) The service or supply is under study or in a clinical trial to evaluate its toxicity, safety and efficacy for a particular diagnosis or set of indications. Clinical trials include but are not limited to phase I, II and III clinical trials.
 
(b) The prevailing opinion within the appropriate specialty of the United States medical professions is that the service or supply needs further evaluation for the particular diagnosis or set of indications before it is ...

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