Kit for the preparation of Technetium Tc 99m

Sulfur Colloid Injection

For Subcutaneous, Intraperitoneal, intravenous and Oral Use
For Diagnostic Use by Prescription Only

Selected Lymph Node Localization with Sulfur Colloid Bibliography.
The references provided are intended to assist health care practitioners with additional information on the use of Sulfur Colloid in lymph node localization studies for Breast Cancer or Malignant Melanoma patients.

BREAST CANCER PROCEDURE STANDARDS

BREAST CANCER REFERENCES

Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP 8-32 randomised phase 3 trial.
Krag ON, Anderson SJ, Julian TB, Brown AM, Harlow SP, Costantino JP, Ashikaga T, Weaver DL, Mamounas EP, Jalovec LM, Frazier TG, Noyes RD, Robidoux A, Scarth HM, Wolmark N. Lancet Oncol. 201O Oct;l1(10):927-933.

Auxiliary reverse mapping: Mapping and preserving arm lymphatics may be important in preventing lymphedema during sentinel lymph node biopsy.
Boneti C, Korourian S, Bland K,Cox K, Adkins LL, Henry-Tillman RS, et al. J Am Coll Surg. 2008;206(5:1) 038-42;discussion 42-4.

Concordance of peritumoral technetium 99m colloid and subareolar blue dye injection in breast cancer sentinel lymph node biopsy.
Kargozaran H, Shah M, Li Y, Beckett L, Gandour-Edwards R, Schneider PD, et al.
J Surg Res. 2007;143(1:)126-9.

lntraoperative subareolar radioisotope injection for immediate sentinel lymph node biopsy.
Layeeque R, Kepple J, Henry-Tillman RS, Adkins L, Kass R, Colvert M, et al.
Ann Surg. 2004;239(6:8) 41-5; discussion 5-8. 

An analysis of filtration and volume of radionucleotide in sentinel lymph node biopsy in breast cancer patients. 
Lloyd LR, Wesen CA, Mccallum S. Am Surg. 2002;68(4:)373-5;discussion 5-6.

MELANOMA PROCEDURE STANDARDS

MALIGNANT MELANOMA REFERENCES

Evolution of sentinel lymph node biopsy for melanoma at a National Cancer Institute-designated caneer center.
Sabel MS, Gibbs JF, Cheney R, McKinley BP, Lee JS, Kraybill WG. Surgery. 2000 Oct;128( 4):556-63.

Localization of Regional Lymph Nodes in Melanomas of the Head and Neck
James C. Alex, MD; David N. Krag, MD; Seth P. Harlow, MD; Sybren Meijer, MD; Brian W. Loggie, MD; Joseph Kuhn, MD; Michele Gadd, MD; Donald L. Weaver, MD Arch Otolaryngol Head Neck Surg. 1998;124(2):135-140

Local recurrence in malignant melanoma: Long-term results of the multiinstitutional randomized surgical trial
Constantine P. Karakousis MD, PhD, Dr. Charles M. Balch MD, Marshall M. UristMD, Merrick M. Ross MD, Thomas J. Smith MD, Alfred A. Bartolucci PhD Ann of Surg One. 1996 Sep 3(5):446-452 

 

*Selected clinical publications from Pharmalucence Sulfur Colloid s-NDA submissions to FDA (Approved 2011 and 2012). 

2017 vs 2018 Final Rule Medicare Reimbursement
(4Q 2017 vs 1Q 2018 Physician Office/IDTF Procedure Allowables)
(4Q 2017 vs 1Q 2018 Hospital Outpatient Procedure Rates

Sentinel Node Imaging Using Technetium Tc 99mSulfur Colloid Injection  

Click here to identify the Medicare Physician payment rate for your specific geographical region, visit the CMS website 

Click herefor more information for Medicare HOPPS Reference  

Click herefor more information for Medicare PFS References  

For calculation of 4Q 2017 rates in the above Table, the conversion factor $35.8887 was used. 

For calculation of 1Q 2018 rates in the above Table, the conversion factor $35.9998 was used. 

For more information including reimbursement guidance, please see the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Practice Management Coding Corner Q & A“Coding Sentinel Node Injection With and Without Imaging.” 

For additional reference severalSNMMI Practice Guidelinesdescribing the use of Technetium Tc 99m sulfur colloid imaging forGastric Emptying, Small-Bowel and Colon Transit, Liver and Spleen, Hepatic and Splenic, Cystography, Cystography in Children, Lymphatic or Sentinel Node forBreast Canceror forMelanoma, can be found in the Quality and Practice section under Guidance followed by Guidelines of the SNMMI website. 

Sulfur Colloid Injection 
Kit for the Preparation of Technetium Tc 99m 

Choose CPT codes for procedures separately ordered, medically necessary and performed following AMA and Specialty Society coding guidelines. Above rates are national and are not wage adjusted. 

Be aware of Correct Coding Initiative quarterly updates, Title XVIII of the Social Security Act, section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.

Procedure coding is a listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians. Coding should be based upon procedures and supplies provided to the patient that accurately describe the medical, surgical, and diagnostic services provided. Coding and reimbursement information is provided to you for educational purposes only and does not assure coverage in a specific case or setting. Neither Pharmalucence nor Merlino Healthcare Consulting, Inc. makes any guarantee of coverage or reimbursement of fees. Contact your commercial plan representative, local Medicare Administrative Contractor or the Centers for Medicare and Medicaid Services (CMS) for specific information as payment rates listed are National and subject to change. To the extent that you submit cost information to Medicare, Medicaid or any other reimbursement program to support claims for services or items, you are obligated to accurately report the actual price paid for such items, including any subsequent adjustments. Current Procedural Terminology numeric codes, descriptions, and modifiers are trademarks and copyrights of the AMA.

See Package Insert for full prescribing Information. 

Sulfur Colloid Injection

Kit for the preparation of Technetium Tc 99m

SUMMARY SLIDES

Use in Lymph Node Localization Studies (downloadable)

TREE OF MEDICINE

A comprehensive Lymph Node Localization research tool for medical professionals 

This resource is provided to provide the health care practitioner additional information on the use of Sulfur Colloid in lymph node localization studies for Breast Cancer patients. 

Tree of Medicine is a comprehensive web based resource which provides clinicians with a means to access and review the vast compendium of peer reviewed publications and clinical trials related to breast cancer management, including techniques and protocols related to lymph node localization studies. 

Every article. Read and categorized 

Each article within the Tree of Medicine has been fully reviewed and added to an expanding tree of categories by our panel of subject-matter experts. Gain rapid and unprecedented insight into important clinical information or the latest research with only a few simple mouse gestures. No more searching, we’ve done that for you. 

Keep up to date with your medical field 

Take all the guess work out of staying up to date. The Tree of Medicine gives you all the tools you need to keep track of new and existing articles. Never let valuable information slip through the cracks. The Tree of Medicine team is composed of doctors and researchers who all needed something better than what already existed. The Tree of Medicine is that and more. 

To learn more visit: www.treeofmedicine.com 

IMPORTANT SAFETY INFORMATION

Anaphylactic reactions with bronchospasm, hypotension, urticaria and rare fatalities have occurred following intravenously administered Technetium Tc 99m Sulfur Colloid Injection. Have emergency resuscitation equipment and personnel immediately available.

Radiation-emitting products, including Technetium Tc 99m Sulfur Colloid Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

Technetium Tc 99m Sulfur Colloid Injection is physically unstable, and the particles will settle with time or with exposure to polyvalent cations. These larger particles are likely to be trapped by the pulmonary capillary bed following intravenous injection and result in non-uniform distribution of radioactivity. Agitate the vial adequately before administration of sulfur colloid to avoid particle aggregation and non-uniform distribution of radioactivity. Discard unused drug after 6 hours from the time of formulation.

ADVERSE REACTIONS

The most frequently reported adverse reactions, across all categories of use and routes of administration, include rash, allergic reaction, urticaria, anaphylaxis/anaphylactic shock, and hypotension. Less frequently reported adverse reactions are fatal cardiopulmonary arrest, seizures, dyspnea, bronchospasm, abdominal pain, flushing, nausea, vomiting, itching, fever, chills, perspiration, numbness, and dizziness. Local injection site reactions, including burning, blanching, erythema, sclerosis, swelling, eschar, and scarring, have also been reported.

Please See Full Prescribing Information Above

The above information provided in this page is intended for use by professional licensed health care provider only. This information is not intended for Medical advice. Please refer to Package Insert for full Prescribing Information including the adverse reactions with the use. Kit for the preparation of Technetium Tc 99m Sulfur Colloid as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.