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Appendix C
Sample Letter to Request Expedited Review of a Denial of Coverage

(NOTE: This is a SAMPLE letter that should be used as a guide ONLY where emergency action on administrative review of a denial of care is needed. Where time permits, you should notify the administrator of the appeal and request copies of plan documents and the administrative record relied upon in the initial coverage denial.)

12/19/00

COVER LETTER BY FAX TO *
ORIGINAL WITH ALL ENCLOSURES TO FOLLOW BY FEDERAL EXPRESS


Appeals Committee
HardRock Insurance Company
Outer Mellotopia, NY

Employer
(Included since named as Plan Administrator)


Re: EMERGENCY REQUEST FOR EXPEDITED ADMINISTRATIVE REVIEW

Member Name: Sally Patient

Member I.D.: ________________

Date of Denial of Service: 12/10/96

Greetings:

HardRock has denied coverage for an urgently needed procedure involving the use of High Dose Chemotherapy for Sally Patient's ovarian cancer, supported by Peripheral Stem Cell Rescue (HDC/PSCR). Because the treatment must begin immediately, we ask that her administrative appeal be addressed on an expedited basis.

SALLY PATIENT'S MEDICAL CONDITION

Your records show that Sally Patient suffers from Stage IV ovarian cancer involving a high grade tumor. She has undergone a hysterectomy and surgery, followed by rounds of conventional chemotherapy. Ms. Patient's physicians have successfully obtained a period of remission. However, given the severity of her cancer, the remission will not last long. She needs high-dose chemotherapy if she is to live. As you know, however, high dosages of chemotherapy cannot be administered unless supported by peripheral stem cell or bone marrow transplantation. Ms. Patient's physician's therefore have prescribed HDC/PSCR.

If HDC/PSCR is to be effective, treatment must begin immediately, while Ms. Patient is enjoying this narrow window of remission. Stage IV ovarian cancer, particularly involving a high grade tumor, cannot be controlled over time using conventional dosages of chemotherapy. The period of remission that Ms. Patient now is enjoying will be very short. Once there is a recurrence, obtaining remission again will be extremely difficult, if not impossible. It is for this reason that it is so urgent to begin treatment immediately.

Unless HardRock allows pre-certification of coverage for Ms. Patient's treatment, she will not be able to pay the cost. Without treatment, she will die. Your benefits plan calls for four levels of appeal and administrative review before Ms. Patient can file suit under ERISA. There is no practical way for Cynthia Patient to pursue her claim through these four levels of appeal with the time frames established by your plan if she is to live. I therefore ask that you review this matter on an expedited basis. Unless the plan can allow coverage immediately, we will file a civil action, seeking a temporary restraining order to halt further administrative action and a preliminary injunction to allow a court to decide this case.


MERITS OF SALLY PATIENT'S CLAIM

In Sally Patient's case, HDC/PSCR gives her the only true hope of long-term survival. Its efficacy as a treatment regime is well established. Her treating Oncologist, Dr. Really Good, is a highly respected physician who has given you information strongly supporting the use of the HDC/PSCR protocol in Ms. Patient's case. Thus, there is no reasonable medical basis for HardRock to deny coverage. The treatment requested is medically necessary and certainly would not be considered experimental under these conditions. To support Sally Patient's claim, I am enclosing the following documents:

1. Melphalan, Etoposide and Carboplatinum for the Treatment of Resistant Malignancy: A Phase II Trial, by R.A. Brown, J. Mortimer, J. DiPersio, Washington University/Barnes Hospital BMT protocol #94-0077.

2. Combination of Bone Marrow Transplant and High-Dose Chemotherapy Improves Survival in Ovarian Cancer, Research Report presented at the 18th Annual San Antonio Breast Cancer Symposium.

3. Role of Chemotherapy Dose Intensification in the Treatment of Advanced Ovarian Cancer, by David Fennelly, MB, MRCPI, Jeffrey Schneider, MD, Oncology, October 1995.

4. The Role of High-dose Chemotherapy in the Management of Advanced Ovarian Cancer, by David Fennelly, MB, FRCPI, Rapid Science Publishers, 1996.

5. Dose Escalation of Paclitaxel with High-Dose Cyclophosphamide, with Analysis of Progenitor-Cel Mobilization and Hematologic Support of Advanced Ovarian Cancer Patients Receiving Rapidly Sequenced High-Dose Carboplatin/Cyclophosphamide Courses, by D. Fennelly, J. Schneider, D. Spriggs, C. Bengala, T. Hakes, L. Reich, R. Barakat, J. Curtin, M.A.S. Moore, W. Hoskins, L. Norton, and J. Crown, Journal of Clinical Oncology, Vol 13, No 5 (May), 1995: pp 1160-1166.

6. Consolidation an Secondary Therapies for Ovarian Cancer, by Mace L. Rothenberg, Division of Medical Oncology, University of Texas Health Science Center, San Antonio, Texas 78284-7884.

7. Chemotherapeutic Dose Intensity in Ovarian Cancer, by Robert F. Ozols, MD, PhD., Advances in Oncology, Vol 11, No 3.

8. High-Dose Chemotherapy and Hematopoietic Progenitor Cell Support for Patients with Epithelial Ovarian Cancer, by Kenneth W. Kotz and Russell J. Schilder, Seminars in Oncology, Vol 22, No 3 (June), 1995: pp 250-262.

9. Chemotherapeutic Dose Intensity in Ovarian Cancer, by Robert F. Ozols, MD, PhD, Advances in Oncology, Vol 11, No 3.

10. Report from GOG #164

11. Report from GOG #9501 , and what additional information is needed to support the appeal.

12. "Office Personnel Management Policy" regarding coverage of HDC/PSCR for ovarian cancer under Federal Employees Health Benefits Programs.

13. State of Florida Policy regarding coverage of HCD for ovarian cancer.

14. High-Dose Chemotherapy with Autologous Hematopoietic Cell Support (AHCS) for the Treatment of Epithelial Ovarian Cancer.

15. Future Strategies for the Treatment of Advanced Epithelial Ovarian Cancer Using High-Dose Chemotherapy and Autologous Bone Marrow Support.

16. High-Doses of Melphalan and Autologous Marrow Rescue in Advanced Common Epithelial Ovarian Carcinomas: A Retrospective Analysis in 35 patients.

17. High-dose Chemotherapy with Autologous Bone Marrow Transplantation in Patients with Refractory Ovarian Cancer.

18. High-Dose Alkylating Agent Chemotherapy with Autologous Bone Marrow Support in Patients with Stage III/IV Epithelial Ovarian Cancer.

19. "Cancer Literature Medical Abstracts"

20. Mary Jo FENIO, Plaintiff, v. MUTUAL OF OMAHA INSURANCE COMPANY, Defendant. No. 94-1040 CIV.

Dr. Good has written to you under separate cover, but an additional copy of his letter is enclosed for your review as well.

ACTION REQUESTED

We genuinely hope that HardRock will allow coverage without the necessity of further action on our part. We want to cooperate with your plan as much as we can in the next few days, but we cannot compromise Ms. Patient's treatment needs in the process. So that we can move forward as quickly as possible, we ask that you do this:

1. If your plan will be retaining counsel, please have your attorney contact me immediately so that we can establish a clear line of communication for a rapid exchange of information.

2. If your plan is not retaining counsel at this point, please give me the name of a responsible party with whom I can communicate, and to whom pleadings can be directed if it becomes necessary to seek an emergency restraining order.

3. Please respond to this letter by the close of business on Monday, December 23. If we do not hear from you by that date, then it may be necessary to seek an emergency restraining order.

Thank you for your attention to this claim. I look forward to hearing from you or your counsel immediately.

Yours sincerely,





Enclosures (with Original Letter)