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Proposed Rule

Revised Medical Criteria for Evaluating Hematological Disorders and Malignant Neoplastic Diseases

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Social Security Administration.

ACTION:

Proposed rules; reopening of comment period.

SUMMARY:

We are reopening the comment period for the notice of proposed rulemaking (NPRM) we published in the Federal Register (66 FR 59306) on November 27, 2001. Due to the significant issues raised by the commenters, we have decided to provide an additional 60-day public comment period.

DATES:

The comment date of the NPRM published at 66 FR 59306 is reopened until June 17, 2002.

ADDRESSES:

You may give us your comments by using: our Internet site facility (i.e., Social Security Online) at http://www.ssa.gov/​regulations; e-mail to regulations@ssa.gov; telefax to (410) 966-2830; or by letter to the Commissioner of Social Security, P.O. Box 17703, Baltimore, Maryland 21235-Start Printed Page 191397703. You may also deliver them to the Office of Process and Innovation Management, Social Security Administration, 2109 West Low Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, between 8 a.m. and 4:30 p.m. on regular business days. Comments are posted on our Internet site, or you may inspect them on regular business days by making arrangements with the contact person shown below.

Electronic Version: The electronic file of this document is available on the date of publication in the Federal Register at http://www.access.gpo.gov/​su_​docs/​aces/​aces140.html. It is also available on the Internet site for SSA (i.e., Social Security Online) at http://www.ssa.gov/​regulations/​.

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FOR FURTHER INFORMATION CONTACT:

Suzanne DiMarino, Social Insurance Specialist, Office of Process and Innovation Management, Social Security Administration, 2109 West Low Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, (410) 966-5995 or TTY (410) 966-5609. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet web site, Social Security Online, at www.ssa.gov.

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SUPPLEMENTARY INFORMATION:

On November 27, 2001, we published “Revised Medical Criteria for Evaluating Hematological Disorders and Malignant Neoplastic Diseases” as an NPRM in the Federal Register (66 FR 59306). This NPRM proposed to revise the criteria in the Listing of Impairments (the listings) that we use to evaluate claims involving hematological disorders and malignant neoplastic diseases. In the NPRM, we provided a 60-day comment period that ended January 28, 2002. Most of the comments on the NPRM were received during the end of the comment period. These comments raised significant issues regarding the proposed criteria. In order to allow the public sufficient time to review and comment on these issues, we are providing an additional 60-day comment period. The comments are posted on our Internet site (i.e., Social Security Online) at http://www.ssa.gov/​regulations. We are also providing a list of the medical and other technical sources we consulted when we developed these proposed rules.

References

A list of the sources we consulted when developing the NPRM “Revised Medical Criteria for Evaluating Hematological Disorders and Malignant Neoplastic Diseases” (66 FR 59306) include the following:

Richard Pazdur, ed., et al. Cancer Management: A Multidisciplinary Approach. Third Edition, Melville, N.Y.: PRR Inc., 1999.

G. Richard Lee, ed., et al. Wintrobe's Clinical Hematology. Tenth Edition, 2 Vols. Baltimore: Williams & Wilkins, 1998.

Martin D. Abeloff, ed., et al. Clinical Oncology. New York: Churchill Livingstone, Inc., 1995.

Raymond E. Lenhard, Jr., Robert T Osteen, and Ted Gansler, eds. Clinical Oncology. Atlanta: The American Cancer Society Inc., 2001.

Robert C. Bast, Jr., ed., et al. Cancer Medicine. Fifth Edition, Hamilton, Ontario: B.C. Decker, Inc., 2000.

Phillip A. Pizzo and David G. Poplack. Principles and Practice of Pediatric Oncology. Third Edition, Philadelphia: Lippincott-Raven, 1997.

Anthony S. Fauci, ed., et al. Principles of Internal Medicine. Fourteenth Edition, New York: McGraw Hill, 1998:334-364, 493-747.

Arnold T. Sigler and William H. Zinkham. “Anemia.” Sports and Exercise for Children with Chronic Health Conditions. Barry Goldberg, ed. Champaign: Human Kinetics, 1995:290-299.

Margot S. Kruskall. “The Perils of Platelet Transfusions.” The New England Journal of Medicine, 337(26) 25 December 1997:1914-1915.

James Abbruzzese, et al. “Unknown Primary Carcinoma: Natural History and Prognostic Factors in 657 Consecutive Patients.” Journal of Clinical Oncology, 12(6) June 1994:1272-1280.

Samy El-Sayed and Norma Nelson. “Adjuvant and Adjunctive Chemotherapy in the Management of Squamous Cell Carcinoma of the Head and Neck Region: A Meta-Analysis of Prospective and Randomized Trials.” Journal of Clinical Oncology, 14(3) March 1996:838-847.

John M. Kirkwood, et al. “Interferon Alfa-2b Adjuvant Therapy of High-Risk Resected Cutaneous Melanoma: The Eastern Cooperative Oncology Group Trial EST 1684.” Journal of Clinical Oncology, 14(1) January 1996:7-17.

Lauren Abrey, Lisa DeAngelis, and Joachim Yahalom. “Long-Term Survival in Primary CNS Lymphoma.” Journal of Clinical Oncology, 16(3) March 1998:859-863.

Marianne J. Hejermstad, et al. “Health-Related Quality of Life 1 Year After Allogeneic or Autologous Stem-Cell Transplantation: A Prospective Study.” Journal of Clinical Oncology, 17(2) February 1999:706-718.

Katherine K. Matthay. “Stage 4S Neuroblastoma: What Makes It Special?” Journal of Clinical Oncology, 16(6) June 1998:2003-2006.

W. Mendenhall, et al. “Is Radiation Therapy a Preferred Alternative to Surgery for Squamous Cell Carcinoma of the Base of Tongue?” Journal of Clinical Oncology, 18(1) January 2000:35-42.

Saul A. Rosenberg. “Classification of Lymphoid Neoplasms.” Blood, 84(5) 1 September 1994:1359-1360.

Nancy Lee Harris, et al. “A Revised European-American Classification of Lymphoid Neoplasms: A Proposal From the International Lymphoma Study Group.” Blood, 84(5) 1 September 1994:1361-1392.

Hannes Wandt, et al. “Safety and Cost Effectiveness of a 10 x109/L Trigger for Prophylactic Platelet Transfusions Compared With the Traditional 20 x 109/L Trigger: a Prospective Comparative Trial in 105 Patients With Acute Myeloid Leukemia.” Blood, 91(10) 15 May 1998:3601-3606.

Stefan Faderl, et al. “Chronic Myelogenous Leukemia: Biology and Therapy.” Annals of Internal Medicine, 131(3) 3 August 1999:207-219.

David P. Ryan, Carolyn C. Compton, and Robert J. Mayer. “Carcinoma of the Anal Canal.” The New England Journal of Medicine, 342(11) 16 March 2000:792-799.

Mario A. Eissenberger, et al. “Bilateral Orchiectomy With Or Without Flutamide For Metastatic Prostate Cancer.” The New England Journal of Medicine, 339(15) 8 October 1998:1036-1042.

Scott T. Miller, et al. “Prediction of Adverse Outcomes in Children with Sickle Cell Disease.” The New England Journal of Medicine, 342(2) 13 January 2000:83-89.

C. P. Karakousis. “Surgical Treatment of Malignant Melanoma.” Surgical Clinics of North America, 76(6) December 1996:1299-1312.

Martin H. Steinberg. “Sickle Cell Disease: Pathophysiology, Diagnosis, and Treatment.” Federal Practitioner, December 1998:22-47.

Michael D. Prados, Mitchell S. Berger, and Charles B. Wilson. “Primary Central Nervous System Tumors: Advances in Knowledge and Treatment.” CA-A Cancer Journal for Clinicians, 48(6) November/December 1998:331-360.

D. H. Kraus, et al. “Surgical management of squamous cell carcinoma of the base of the tongue.” American Journal of Surgery, 166(4) October 1993:384-388.

David M. Brizel, et al. “Hyperfractionated Irradiation with or without Concurrent Chemotherapy for Locally Advanced Head and Neck Cancer.” New England Journal of Medicine, 338(25) 18 June 1998:1798-1804.

H. J. Lee, et al. “Long-term regional control after radiation therapy and neck dissection for base of tongue carcinoma.” International Journal of Radiation Oncology, Biology and Physics, 38(5) 15 July 1997: 995-1000.

D. P. Derman, et al. “Adjuvant Chemotherapy (CMF) For Stage III Breast Cancer: A Randomized Trial.” International Journal of Radiation Oncology, Biology and Physics, 17(2) August 1989:257-261.

Karen J. Halverson, et al. “Survival Following Locoregional Recurrence Of Breast Cancer: Univariate And Multivariate Analysis.” International Journal of Radiation Oncology, Biology and Physics, 23(2) 1992:285-291.

Benjamin Corn, et al. “Endometrial Cancer With Para-Aortic Adenopathy: Patterns Of Failure And Opportunities For Cure.” International Journal of Radiation Oncology, Biology and Physics, 24(2) 1992:223-227.

L. B. Harrison, et al. “Detailed quality of life assessment in patients treated with primary radiotherapy for squamous cell cancer of the base of the tongue.” Head & Neck, 19(3) May 1997:169-175.

G. J. Moore, J. T. Parsons, and W. M. Mendenhall. “Quality of life outcomes after primary radiotherapy for squamous cell carcinoma of the base of tongue.” Start Printed Page 19140 International Journal of Radiation Oncology, Biology and Physics, 36(2) 1 September 1996:351-354.

M. Machtay, et al. “Combined surgery and postoperative radiotherapy for carcinoma of the base of the tongue: analysis of treatment outcome and prognostic value of margin status.” Head & Neck, 19(6) September 1997:494-499.

Arlene A. Forastiere, et al. “NCCN Practice Guidelines for Head and Neck Cancer.” Oncology, 14(11A) November 2000:163-194.

William H. Zinkham, Alexander J. Seidler, and Thomas S. Kickler. “Variable degrees of suppression of hemoglobin S synthesis in subjects with hemoglobin SS disease on a long-term transfusion regimen.” Journal of Pediatrics, 124 February 1994:215-219.

Clifton F. Mountain. “Revision in the International System for Staging Lung Cancer.” Chest, 111(6) June 1997:1710-1717.

Clifton F. Mountain and Carolyn M. Dresler. “Regional Lymph Node Classification for Lung Cancer Staging.” Chest, 111(6) June 1997:1718-1723.

James R. Jett. “What's New in Staging of Lung Cancer?” Chest, 111(6) June 1997:1486-1487.

James E. Krook, et al. “A Prospective, Randomized Evaluation of Intensive-Course 5-Fluorouracil Plus Doxorubicin as Surgical Adjuvant Chemotherapy for Resected Gastric Cancer.” Cancer, 67(10) 15 May 1991:2454-2458.

Aman U. Busdar, et al. “Clinical Course of Patients With Breast Cancer With Ten or More Positive Nodes Who Were Treated With Doxorubicin-Containing Adjuvant Therapy.” Cancer, 69(2) 15 January 1992:448-452.

William J. Hoskins. “Surgical Staging and Cytoreductive Surgery of Epithelial Ovarian Cancer.” Cancer Supplement, 71(4) 15 February 1993:1534-1540.

Carlos Perez, et al. “Management of Locally Advanced Carcinoma of the Breast.” Cancer Supplement, 74(1) 1 July 1994:466-476.

Stephen C. Rubin, et al. “Prognostic Factors for Recurrence following Negative Second-Look Laparotomy in Ovarian Cancer Patients Treated with Platinum-Based Chemotherapy 1,2.” Gynecologic Oncology, 42 3 January 1991:137-141.

Naoto T. Ueno, et al. “Combined-modality treatment of inflammatory breast carcinoma: twenty years of experience at M.D. Anderson Cancer Center.” Cancer Chemotherapy and Pharmacology, 40 1997:321-329.

Michael Moore, et al. “Inflammatory Breast Cancer.” Archives of Surgery, 126 March 1991:304-306.

Aman U. Buzdar, et al. “Ten-Year Results of FAC Adjuvant Chemotherapy Trial in Breast Cancer.” American Journal of Clinical Oncology, 12(2) 1989:123-128.

B. A. Leone, et al. “Stage IV Breast Cancer: Clinical Course and Survival of Patients with Osseous Versus Extraosseous Metastases at Initial Diagnosis.” American Journal of Clinical Oncology, 11(6) 1988:618-622.

Michael M. Sherry, et al. “Metastatic Breast Cancer Confined to the Skeletal System.” American Journal of Medicine, 81 September 1986:381-386.

Per-Uno Malmstrom, et al. “Five-Year Followup Of A Prospective Trial Of Radical Cystectomy And Neoadjuvant Chemotherapy: Nordic Cystectomy Trial I.” The Journal of Urology, 55 June 1996:1903-1906.

Mario A. Eisenberger, et al. “Prognostic Factors in Stage D2 Prostate Cancer; Important Implications for Future Trials: Results of a Cooperative Intergroup Study (INT. 0036).” Seminars in Oncology, 21(5) October 1994:613-619.

Charles M. Balch, et al. “A Multifactorial Analysis of Melanoma.” Annals of Surgery, 193(3) March 1981:377-388.

“A Genetic Overview of Thalassemia” available at <http://www.thalassemia.com/​genetics>.

“Psycho-social Aspects” available at <http://www.thalassemia.com/​psych>.

“Thalassemia” available at <http://sickle.bwh.harvard.edu/​thalover.html>.

“Medical Management” available at <http://www.thalassemia.com/​medical/​definition.shtml>.

“Frequently Asked Questions” available at <http://www.thalassemia.com/​faq>.

“Sickle Cell Anemia” available at <http://www.healthanswers.com/​database/​ami/​converted/​000527.html>

“Sickle Cell Anemia” available at <http://www.emory.edu/​PEDS/​SICKLE/​sicklept.htm>

“Anemia” available at <http://www.mayohealth.org/​mayo/​9511/​htm/​anemia.htm>

These references are included in the rulemaking record for these proposed rules and are available for inspection by interested persons by making arrangements with the contact person shown above.

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Dated: April 4, 2002.

Jo Anne B. Barnhart,

Commissioner of Social Security.

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[FR Doc. 02-9468 Filed 4-17-02; 8:45 am]

BILLING CODE 4191-02-P