[Federal Register Volume 67, Number 75 (Thursday, April 18, 2002)]
[Proposed Rules]
[Pages 19138-19140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9468]
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SOCIAL SECURITY ADMINISTRATION
20 CFR Part 404
[Regulation No. 4]
RIN 0960-AD67
Revised Medical Criteria for Evaluating Hematological Disorders
and Malignant Neoplastic Diseases
AGENCY: Social Security Administration.
ACTION: Proposed rules; reopening of comment period.
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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 [email protected]; telefax to (410) 966-2830;
or by letter to the Commissioner of Social Security, P.O. Box 17703,
Baltimore, Maryland 21235-
[[Page 19139]]
7703. 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/.
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.
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
x10\9\/L Trigger for Prophylactic Platelet Transfusions Compared
With the Traditional 20 x 10\9\/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.''
[[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.
Dated: April 4, 2002.
Jo Anne B. Barnhart,
Commissioner of Social Security.
[FR Doc. 02-9468 Filed 4-17-02; 8:45 am]
BILLING CODE 4191-02-P