July 16, 2015
James Corcoran, MD, Medical Director
Fred Polsky, MD; Medical Director
First Coast Service Options
532 Riverside Ave
ROC 19T
Jacksonville, FL 32202
Re: Draft Local coverage Determination: Special Histochemical Stains and Immunohistochemical Stains (DL36324)
Dear Dr Corcoran and Dr. Polsky,
The Florida Society of Pathologists (FSP), representing more than 350 pathologists in the state of Florida, appreciates this opportunity to comment on the draft Local Coverage Determination: Special Histochemical Stains and Immunohistochemical Stains (DL36324).
While we agree with the general principals of medical necessity and proper communication and documentation of results with use of special stains, we strongly believe that this dLCD as written will restrain pathologists’ diagnostic abilities in multiple key areas including areas with national guidelines changing rapidly, and thus will negatively impact patient care by preventing use of all available tools to achieve correct and definitive diagnosis. If put in practice, these guidelines will adversely affect not only the efficiency with which care is delivered, but also diagnosis, clinical decisions, and treatment options. It is only the pathologist reading the biopsy that can correlate all the clinical, histologic, and practice related factors to provide an accurate and timely diagnosis for our patients.
We in general reiterate the well supported key points made by Dr. Shuan Li in his comments to FCSO from the MAC meeting in June, and agree that there is not medical necessity for use of many of the special stains listed on page 5 as a standard procedure in every case. There are 3 key areas that we feel need to be revised.
- Stains for H. pylori
The standard of care is that gastric biopsies exhibiting pathologic changes be evaluated for H. pylori for proper diagnosis, follow-up and treatment. Special stains are critical in recognizing these organisms, especially today with widespread treatment with antibiotics and medications such as PPIs that result in very few organisms being present, thus necessitating use of special stains for accurate diagnosis. Dictating how and when these important stains are ordered, will delay patient diagnosis and appropriate care, and we strongly believe this decision on when to order should be left to the pathologist who is diagnosing the case.
- Stains for infection in GE junction and esophageal biopsies
As with other organisms in our patients who are often immunocompromised and may have limited inflammatory response, the use of special stains to identify fungal esophagitis for proper diagnosis and treatment is very important. Dictating how and when these important stains are ordered, will delay patient diagnosis and appropriate care, and we strongly believe this decision on when to order should be left to the pathologist who is diagnosing the case.
- MSI and MSR staining
The standards for diagnosis, follow-up and treatment of patients with Lynch syndrome are rapidly changing. Several societies recommend testing for all newly diagnosed CRC. It is known that the Amsterdam and Bethesda criteria are insensitive for the detection of Lynch Syndrome. Furthermore, we often do not have access to family history as pathologists. Not only is the detection of Lynch Syndrome critical to patients and their family members, it is also important to detect sporadic microsatellite instability (up to 15% of CRC) for prognostic and therapeutic purposes. This dLCD prematurely limits use of important diagnositic testing as the national standard is still being established.
In closing, for the issues raised and for optimal care for patients in our state of Florida, the Florida Society of Pathologists requests your consideration of our comments to revise this dLCD.
Should you have questions or need additional information, please contact Margaret Neal, MD at amhneal@yahoo.com.
Sincerely,
The Board of the Florida Society of Pathologists
Margaret Neal, MD, President
Brett Cantrell, MD, Immediate Past President
Antonio Martinez, MD, President-elect
Janice McCall, MD, Treasurer, Past President
Qihui Zhai, MD, Secretary
Luis Rey-Martinez, MD, Past President
Ross Wheeler, MD, Past President
Robert Allan, MD,
Marilyn Bui, MD
Lizardo Cerazo, MD
Diana Molate, MD
Morton Levitt, MD
Shuan C. Li, MD
Curtis McCarty, MD
Jason Savell, MD
David Stewart, MD
Steven Vernon, MD
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- Genta RM, Lash RH. Helicobacter pylori-negative gastritis: seek, yet ye shall not always find. Am J Surg Pathol 2010;34:e25-e34.
- Hartman DJ, Owens SR. Are routine ancillary stains required to diagnose Helicobacter infection in gastric biopsy specimens? An institutional quality assurance review. Am J Clin Pathol 2012;137:255-260.
- Batts KP, Ketover S, Kakar S, Krasinskas AM, Mitchell KA, Wilcox R, et al. Appropriate use of special stains for identifying Helicobacter pylori: Recommendations from the Rodger C. Haggitt Gastrointestinal Pathology Society. The American journal of surgical pathology. 2013;37(11):e12-22. Epub 2013/10/22.
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