CPT codes for FISH in 2015

FISH (fluorescent in situ hybridization) methodology is a cytogenetic technique, but this website receives inquiries about changes in CPT coding in 2015 related to this technique. The recent article “CAP proposals on IHC, PQRS accepted for Medicare in ’15” by Charles Fiegl in CAP TODAY November 2014 (page 80) issue includes interesting materials on in situ hybridization services, but is not informative enough for laboratory practitioners.

CPR codes for In Situ Hybridization (FISH) in 2015.

88365 – In situ hybridization (e.g. FISH), per specimen; initial single probe stain procedure. The previous per probe is eliminated.

88364 – Each additional single probe stain procedure (List separately in addition to code for primary procedure.)

88366- Each multiplex probe stain procedure.

Codes 88365, 88364, and 88366 are for qualitative FISH procedure.

The unit of service is per specimen, not per block. Multiplex (88366) refers to two or more probes, including dual and triple color probe tests. Single presumes only one probe.

Although ISH CPT codes for quantitative and semi-quantitative analysis is rarely the object of interests by visitors of this website, just for completeness on the subject. They are represented by

 88367 – Morphometric analysis, in situ hybridization (quantitative or semi-quantitative), using computer-assisted technology, per specimen: initial single probe stain procedure

 88373 – each additional single probe stain procedure (List separately in addition for primary procedure)

 88374 – each multiplex probe stain procedure

By the way, the article in CAP TODAY is listing codes 88368, 88369, and 88377, which do not exist now, but 88367 is not mentioned. This is confusing.

CMS reimbursement “allawables” are beyond the scope of this website. The general tendency is decrease for ISH with increase for IHC.  

  

 

 

CPT changes in 2015 for surgical pathology

Immunohistochemistry (IHC) code changes –official language

88342 Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure

88341 … each additional single antibody stain procedure (List separately in addition to code for primary procedure)

88344 …each multiple antibody stain procedure

Codes 88342, 88341 & 88344 pertain to qualitative IHC staining

Comments

For 88342. Each separately identifiable antibody per block, cytologic preparation, or hematologic smear specimen; first separately identifiable initial single antibody per slide stain procedure. The main point is that the words block and slide are eliminated.

88343 each additional separately identifiable antibody per slide (List separately in addition to code per primary procedure) is eliminated and replaced by 88341.

Center for Medicare & Medicaid Services (CMS) adapted the new American Medical Association (AMA) way of coding IHC. AMA agreed to replace per block for per specimen. CMS is abandoning the IHC HCPCS-II codes G0461 and G0462 after Jan. 1, 2015.

 Starting on Jan. 1, 2015, code 88342 is for the initial single IHC antibody stain for a specimen, with code 88341 being for each additional single IHC antibody stain for that same specimen. A single IHC antibody stain is like S100, CD20 or PAX-5.

 Code 88344 is for a multiplex IHC antibody stain, like PIN-4.

 On a personal note, I have some satisfaction that my call on the websites and in my letter in CAP TODAY “IHC coding changes” on February 2014, page 6 for a compromise on the clinical diagnostic ground has been adopted.

I am also glad that my point that G codes are a contamination of CPT coding principles has been adapted. They should be used as an extraordinary exception. CPT is time proven rational coding system. See the posts G0461/G0462 damage to CPT coding on Surgical Pathology CPT coding Cookbook website (www. surgepathcode.com) and   88343 vs. G0462 on this website’s blog section.

I am not foolish to think that my voice had been heard. At least, I have thought in the right direction.

The most reliable information and comments can be found in Dennis Padget’s Pathology Service Coding Handbook (American Pathology Foundation) www. PathConsulting.org.

 

 

 

Ebola highlights work place safety

Ebola is on everyone’s minds due to the media frenzy and political implications, which are somewhere between hysteria and paranoia. Ebola is definitely a medical problem in vulnerable countries. Developed countries must help those in inflicted countries contain the disease using a well-established infection epidemiology methodology without contaminating the issue with political correctness.

I want to touch on the nurses’ infection issue because it is related to the topic of this website, safety in surgical pathology grossing. The Dallas nurses’ infections highlighted the lack of attention to details in the use of protective equipment. As I understand it, the nurses may have been contaminated when they took off their protective equipment, which might had been soiled by infectious material near the neck skin that potentially had invisible lacerations. Or there may also have been something wrong in the protective gear, namely the mask. One nurse complained on TV that the nurses’ necks were exposed, so the nurses “resourcefully” taped their necks.  

The current protective gear was not designed for work in a medical ward. The nurses work under conditions in which they might experience technical difficulties while they perform the necessary medical procedures on critically ill patient. The initially demonstrated attire could be used for Hazmat cleaning or … for a Halloween party. If workers are uncomfortable in their protective equipment, they may cut corners with regard to safety during extreme situations.

 This brings the discussion to safety in surgical pathology. This isn’t about Ebola. I placed several articles on this website many years ago about a different way to wear protective mask. I proposed it especially for those who are involved in using a power saw for bone cutting, but wearing a mask in this manner may also apply to other situations for protection from any blood- born infection, including when specimens, such as sinus contents, placentas, etc., are processed in the fresh state.Kimberly Clark mask upsdown

The Upside-down Kimberly-Clark FLUIDSHIELD Mask

“Bloody” Specimens as Safety Concern

Prevention of Infection Exposure in the Surgical Pathology Laboratory

Over a decade ago, I sent the Kimberly-Clark Company a proposal for a mask redesign, which provides protection to the neck area, but for some reason, I have not received a response. I’ve forgotten about it, but maybe it makes sense to design a special protective mask for grossing in surgical pathology. Infection disease wards need also a different protective mask.

Before a real vaccine against the disease is developed and implemented, “Ebola scare vaccine” might be beneficial for work place safety, including in the surgical pathology gross room.  

 

CAP TODAY letter IHC Coding Changes

CAP TODAY magazine (http://www.captodayonline.com) published my letter IHC coding changes in the February, 2014 issue. The editor combined very skillfully my original letter to the magazine with the proposal part of my post  88342 code debacle http://surgpathcode.com/?p=352 on my Surgical Pathology Coding CookBook website’s blog http://surgpathcode.com/, although the latter contained more details. I would appreciate your responses directly in the website’s comment section.

The copy of the CAP TODAY’s letter is below:

Letters

IHC coding changes

The January 2014 article “Advocacy pays off, though 2014 CMS cuts will sting” is a report of the impact on pathologists of the 2014 Medicare physician fee schedule and the CAP’s strategy to prevent CMS cuts on the supposedly overvalued 88342 high-volume code. It seems that a compromise still can be reached between the AMA/CAP88342/88343 per block/slide position and the CMS G0461/G0462 per specimen position. Three surgical pathology practice issues can be addressed:

Diagnostic. The definition of a specimen as a unit of service is the cornerstone of CPT coding in surgical pathology. The vast majority of coded cases are specimens. In this regard, the CMS is right. However, the AMA/CAP have a point in pursuing the block approach to IHC coding. In surgical pathology practice, there are diagnostic situations in which different blocks of the same specimen can have different recognizable antigens by antibody stain or their absence, which can have diagnostic value. These occasions, though rare and more common in   oncology, can be     coded separately or covered by a modifier. A pilot study can show how important the need to code per block can be.

Histotechnological. Although peroxidase chromogen is a stain, it only makes the presence of a specific antigen visible through an immunological reaction with a monoclonal antibody. This technology requires equipment, specific reagents, and certain skills. Due to variations in sensitivity and specificity in immunological reactions, interpretation can have subjective variations. On the other hand, the Orwellian paraphrase “All antibodies are equal, but   some antibodies are less equal” is technologically correct because working time, except reagents, is not equal. They cannot be coded for reimbursement equally.

The sticking point is that multiplex antibodies (double, three stain) can occur on the same slide. This can be addressed by a G code for this particular cocktail. A G code as an addition to the main CPT code might be a necessity because of histotechnological peculiarities.

CPT structure. In general, G codes are a sign of weakness of CPT-4 coding (the standard 88000 code system can’t be applied). The goal is to avoid a coding solution that erodes a well-established and generally satisfactory working   system. A G code can be applied only as an extraordinary coding solution. When the CMS replaced 88342 CPT codes with G0461/2 codes, it meant that CPT coding had been disregarded. However, an additional G code as a methodological adjustment is acceptable because in this situation a G code does not erode the CPT coding fabric.

The CMS’ decision regarding IHC coding and reimbursement cuts is ill-advised because it is damaging to surgical pathology as a specialty, for which dramatic cuts in pathologist fees are only part of the main problem. The solution to the problem should consider the interest of the specialty.

I suggest this compromise: The   AMA/CAP would abandon the block/slide notion of 88343 as a unit of service, but the CMS would take 88343 as each additional stain, including the same stain on a different block of the same specimen if diagnostically warranted. The multiplex stain controversy can be solved with G codes. 88343 and a G code for multiplex stain can have fee adjustments that can satisfy the need to cut costs. The integrity of surgical pathology practice would be honored, and an abuse of the system would be prevented.

Izak B. Dimenstein, MD,

PhD, HT (ASCP)

Grand Rapids, Mich.

—Send ‍letters to srice@cap.org.

 

 

88343 vs. G0462

AMA’s 88343 block vs. CMS’s G0462 specimen

Immunohistochemistry (IHC) has become the dominant methodology in histotechnology. At the 2013 National Society of Histotechnology (NSH) Convention, almost all 22 IHC out of 127 total workshops were sold out. Machinery and reagent suppliers’ vendor booths (Ventana, Dako) were the largest at the Convention’s trade show. Demand and supply are parallel processes. The cost of surgical pathology diagnostic services steadily increases in parallel with IHC methodology implementation.

Starting on January 1th, 2014, the American Medical Association (AMA) presented in the AMA’s CPT-2014 Codebook the set of IHC codes, which are different from the Centers for Medicare & Medicaid Services (CMS) provisions. AMA’ CPT-2014 suggested 88342 code for each separately identifiable antibody per block/cytology/smear and 88343 for each additional separately identifiable antibody per slide. CMS abandoned CPT coding for Medicare claim filing for qualitative immunohistochemistry. Instead CMS suggested two G codes, namely G0461 for immunohistochemistry or immunocytochemistry per specimen and G0462 for each additional single or multiplex antibody stain. See diagram visualization on our “Surgical Pathology CPT Coding CookBook” website blog’s post  “Changes in IHC coding in 2014” (http://surgpathcode.com/?p=242)

The difference between specimen and block is the key issue in the CMS and the AMA approaches. After almost five years of vacillating between specimen vs. block, the AMA created this ambiguity. Before October 1, 2009, both the AMA and the CMS have advised that ‘specimen’ is the appropriate unit of reporting IHC for 88342 code. Between 2009 and 2012, the CMS switched to ‘block’. Who had advised the CMS? Were both coding authorities, the AMA and the CAP, able to be neutral in the CMS’s decision? On January 1, 2012, the CMS returned to ‘specimen’, but now the AMA is suggesting ‘block” as a unit of service for IHC coding. The CAP’s STATLINE (December 5, 2013, Vol. 29, Number 24) has a paragraph in an article “2014 Anatomic Pathology Code Revaluations”, which states: “Moving forward, the CAP will work with the AMA and other groups to pressure CMS to change their G code definitions so that payment is made per slide’ rather than ‘per specimen.” http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=/portlets/contentViewer/show&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=statline/index.html&_state=maximized&_pageLabel=cntvwr .  Is not this a coding mess?

Although the AMA has a point that in some occasions, especially in oncology surgical pathology, ‘block’ reflects the unit of service for IHC coding, the CMS’s adherence to ‘specimen’ is more reasonable in many aspects. First, the main CPT coding principle in surgical pathology is ‘specimen’ as unit of service, although it is explicitly mentioned only for 88300-88309. Second, ‘specimen’ is simpler for account (CPT coding is for billing and only for this purpose). Third, block/slide antibody separate multiplex reporting can generate abuse by some laboratories.

 G- codes expansion in surgical pathology is not a positive trend in coding because it is a deviation from well-established, in general rational, AMA’s CPT coding manual (See the post G0461/G0462 damage to CPT coding on our “Surgical Pathology Coding CooBookhttp://surgpathcode.com/?p=348) . In the case of G prostate biopsies codes the reason might be changes in methodology (saturation); in IHC coding, it is a result of AMA/CAP’s inability to come up with a compromise that would satisfy CMS’s goal to limit health care costs. G codes’ “contamination” erodes the CPT coding numeric system and brings additional problems to the institution’s LIS.

88342 and G0461 are very much similar except per block/per specimen difference. The 88343 code’s “each separately interpretable antibody” descriptor, however, looks as a semantic trick that generates coding ambiguity. Today “multiplex antibody stain” (double stain as the histotechnologists call them) reveals two or three antibodies. Who knows how many multiplex antibodies the technology will offer tomorrow?

 Current Procedural Terminology (CPT) coding provisions follow the basic logic of laboratory procedures. From this standpoint, the understanding dictates a rational notion. If a specimen’s presentation on the block/ cytology preparation/smear by a stain from one vial reveals a single or n+1 antibodies (or zero antibodies-negative), it is one CPT code and subsequently one charge. Would the simultaneous PAS stain of mucin and fungi coded for both 88312 and 88313? To take AMA/CAP logic to the extreme, if a histochemistry procedure (e.g. Gomori’s modification) for pancreas islands reveals countable alpha and beta-cells, there would be two charges. By the way, this procedure is not less  technically sophisticated than the immunoperoxidase stain. What about the latter that is now used for alpha beta cells studies? However, interpretation of the immunological reaction by the pathologist is more subjective and tends to be more variable do to variants in sensitivity and specificity of the reaction. Coding should not to tolerate ambiguity. Procedural considerations – not the results of the procedure- should determine laboratory coding. There should be some compromises, especially in the multiplex stain on the same slide.

The similarity of codes 88342 and G0461 might generate the notion that G0462- each additional single or multiplex antibody stain (rejection of 88343!) is superfluous and can be deactivated. However, the key provision is in the parentheses: “(List separately in addition to code for primary procedure)”. The CMS wants to know what procedure is primary and what is additional in order to lower reimbursement for additional stains.

Actually, CMS keeps the principle of payment for qualitative immunohistochemistry testing the same as it is today, but the actual reimbursement cut is significant. The table below also from the STATLINE article reflects CMS’s intentions.

CPT Code

Modifier

88342 2013 Total Payment

2014 Total Payment

Total % Change from 2013 88342

G0461   $115.34 $88.04 -24%
G0461 TC $73.15 $57.39 -22%
G0461 26 $42.19 $30.65 -27%
G0462   $115.34 $68.08 -41%
G0462 TC $73.15 $55.61 -24%
G0462 26 $42.19 $12.48 -70%

 

Our website tries to avoid the submersion in the payments issues, but coding is about payments. G0462 Modifier 26 -70% cut is impressive. It is doubtful that CMS will abandon this code.

The G0462 code might also diminish the amount of additional antibody stains, which sometimes reach up to five to eight or even more. I’ve read about up to 10-12, even 25 that is doubtful. In most cases, pathologists do not order multiple additional stains simply to drive up costs. The main reason for “just in case” orders is diagnostic insecurity accompanied by the reluctance to answer trial lawyers’ questions about IHC testing that was not done. Tort reform is still a remote project.

All materials about IHC coding changes are presented in full in Dennis Padget‘s Pathology Service Coding Handbook and the Subscriber Special Bulletins. An excerpt from one of them is on the HistoNet discussion group http://lists.utsouthwestern.edu/mailman/listinfo/histonet  on 12/18/13. Dennis Padget’s nuanced approach is invaluable for understanding differences in reimbursement policies of different insurance entities. Many institutions have this publication.

The issue of 88342 vs. G0462 with a suggestion of a compromise is presented in the post 88342 code debacle on our “Surgical Pathology Coding CookBook” website’s blog http://surgpathcode.com/?p=352  . There is a necessity to present IHC coding as a surgical pathology specialty problem. This can lay ground to the CMS’s reconsideration of the reimbursement.

For 2015 unfortunately, the confusion that is feeding numerous interpretations and consultants remains: For non-Medicare it is per block – CPT code 88342. And of course, 88343 for multiple stains on the same slide, when the first is 88342 and additional 88343, for example in prostate triple stain (PIN4 cocktail).
For Medicare – per specimen. G0461 for the first antibody and G0462 for each additional different antibody.

 

Lab Medicine’s New Face

Lab Medicine needed changes. The core of the problem was ambiguity of the content. On one hand, as an American Society for Clinical Pathology (ASCP) publication, it tried to reflect the everyday practice needs of ASCP’s members which are more heterogeneous than in other medical professional groups; on the other hand, there was a temptation to ascend to the level of high science studies. Although commendable by intention, these two trends are inconceivable in real life. ASCP already has a very solid science journal for high level clinical research, the American Journal of Clinical Pathology (AJCP), which has been read over the world for many years. Unlike AJCP, Lab Medicine comes as a part of ASCP membership. In my observation, doctors do not read Lab Medicine. It goes immediately in their recycling bins upon arrival.

This brings us to current changes in Lab Medicine. Its new face is impressive. The cover and the print are attractive. The redesigned website presents archived articles in categories.  Perhaps, quarterly printed and additionally exclusive on-line publication is the right option. The complete replacement of the Board of Editors may have been justified, although the breadth of the Board’s specialties does make one wonder. Isn’t immunohematology a part of immunology and hematology? Isn’t a pathologist’s assistant a laboratory position, in contrast to specialties such as cytology, histology or even laboratory management and administration? Where are anatomical pathology, and its branch – surgical pathology?

Unfortunately, the content of the Science section in both the Winter and Spring issues is a disappointment. For example, I doubt that the readers are interested in hemoglobin and serum iron concentration in menstruating nulliparous women in Jos, Nigeria or serum B12 levels related to weight status among healthy Jordanian students.  These kinds of articles should instead be published in appropriate specialized journals with the adequate peer-review evaluation and an interested readership.

Is it not strange, that all out of 11 science articles in the Winter and six in the Spring issues are from the institutions outside the USA? By the way, the Fall 2012 issue contained only two of ten science articles from the USA. Of the remaining articles, five came from Iran, and one each from China, South Korea, and India. Outsourcing science articles is not the option for a thin manuscript portfolio.

On the other hand, the series of articles devoted to laboratory management issues is interesting and engaging. They breathe real laboratory problems. For example, an excellent article Clinical and Anatomic Pathology Test Volume by Specialty and Subspecialty Among High Complexity CLIA-Certifies Laboratories in 2001 opens perspectives in modern laboratory testing or the article about the concept of shared accountability (the Dyad organizational model). The diverse selection in the Case Studies might be interesting for different specialties.

Wouldn’t it be preferable, if Lab Medicine abandoned the pretense of a scientific publication, and instead became the ASCP’s voice for laboratory bench workers, and leave academic science to the AJCP? Really, Activation of DC-Sign Promoter and Common Signaling Pathways between HIV-1 5’LTP and DC-SIGN is so far even from their educational range of interests.

Laboratory practitioners need a publication that reflects their ‘mundane’ methodological and organizational interests. The sad truth is that despite numerous printed and now on- line publications, there is no place to send an observation, proposal, or methodology study at the practical laboratory level. I encountered this situation while promoting grossing technology in surgical pathology. I had no choice but to develop this “Grossing Technology in Surgical Pathology” website.

These are my friendly remarks as an observer who is not indifferent, but an interested reader and frequent contributor. The journal is in transition. Hopefully, the publication’s new face will mark a serious change in the content.

 

“Heavy-duty” Grossing Station

The speed of processing in surgical pathology laboratories is faster than it was a couple of decades ago, but the average weight of specimens is lighter. However, although surgical pathology laboratories are overwhelmed with biopsies, larger laboratories, especially those in academic institutions, have considerable numbers of “heavy” specimens. Advances in surgery have led to production of voluminous specimens. Examples include the specimens taken during Whipple procedure, transplants, radical resections, and amputations due to tumors. New circumstances involving factors such as TAT pressure, productivity concerns, and stricter laboratory safety requirements dictate the gradual specialization of grossing stations.

Calcified specimens are first in the line for specialized grossing processing.  Bone grossing employs saws, hammers and other attributes that require a literally heavy-duty table. Additional hazards, such as formalin- loaded sharp particles of bone dust, add to the necessity of separating this type of grossing from others in order to provide high quality work under safe conditions. For details, see Bone Grossing Table article. TBJ Inc. has developed and introduced the Bone Grossing Table.www.tbjinc.com/Product.aspx?id=110401.

It is doubtful that there is a waiting list to acquire this piece of equipment. Perhaps, the limited demand can be explained by customer’s filling that they do not need a specially designated bone grossing table when they are grossing only a couple of femoral heads or tibia plateaus per day or even week. With the exception of large laboratories that deal with head and neck surgery or bone oncology surgery, most surgical pathology laboratories can cope without a specially designated bone grossing table. At least, that is what most decision making managers think.

But…

This is a tribute to old ways of work in the surgical pathology laboratory. Separation of biopsies and the rest of the materials, an appropriate working place contributes to laboratory productivity and higher quality of grossing besides bone sampling. There are other substantial details. Let’s take some examples from the surgical pathology laboratory practice.

When a gangrenous odorous small bowel is opened, the laboratory is paralyzed by the intolerable smell. The “heavy –duty” grossing station (i.e., the Bone Grossing Table) with its enhanced ventilation can somewhat alleviate the laboratory stuff suffering. The same can be mentioned when other gangrenous specimens are sampled.

An amputated extremity needs both space and special cumbersome immobilization contrivances. Sampling an extremity specimen can be a time- and efforts- consuming procedure which combines both bone sections and vessels dissection. A “heavy-duty” grossing station is the right place to work with such a specimen.

Large specimens obviously require an appropriately larger table space that a standard grossing station can barely provide. Often, the grossing person has to stop the sampling in order to ask questions of the pathologist who is not always immediately available. If the specimen is placed back in the container, many tissue relationships become less clear. Thus, the specimen needs to be left on the table for some time while the grossing person waits for the pathologist. Sometimes clinicians also need to be involved in grossing. They are rarely available immediately. Big, complicated specimens should be sampled on the “heavy-duty” grossing station.

Often, upon request from the pathologist, a big specimen needs to be pulled out after sampling. The specimen is already saturated with formalin. For example, a search for additional mesenteric lymph nodes in colon cancer can take some time when the grossing person inhales formaldehyde in a dose much greater than by OSHA- regulated short- and long- term limits. And often the saturated with formalin specimen is pulled out for observation of a pathologist who for whatever reason cannot arrive immediately, and thus the specimen is left to wait for some time while emanating formaldehyde. A “heavy- duty” grossing station is designated to be the most adequate equipment for these kinds of grossing situations.

Specimens are now very often sampled in the fresh state. Although the previous 1:20 ratio orthodoxy has now, for good reason as unnecessary, been abandoned, the amount of formalin used is substantial. Rivers of formalin flow during fixation. The installation of a formalin- powered dispenser might be reasonable for a “heavy-duty” grossing station (TBJ’s Powered Formalin Dispensing System, MOPEC’s FP250), while its presence in a standard grossing station is questionable because most specimens, biopsies, are in formalin- prefilled containers.

These are features of everyday practice that cannot be dismissed. However, such real- life examples are not often on the minds of decision- making people when they encounter the Bone Grossing Table which should be called the “heavy-duty” grossing station.

There is another reason that a “heavy-duty” grossing station makes an attractive and necessary addition to a surgical pathology practice: the disposal of specimens. Specimen disposal is a serious safety problem. See the post Wet Specimen Disposal in the Surgical Pathology Laboratory.It is an area that is neglected by management and safety officers. When a specimen is separated from formalin, both the saturated- with- formalin specimen and the formalin itself emanate formaldehyde in concentrations much exceeding any monitoring limits. OSHA standard monitoring cannot catch these episodes, in which the formaldehyde is in its most damaging. Everyone who has participated in specimen disposal can remember filling irritation and the sour taste that lingers in the mouth. Of course, PPE- wearing is helpful and obligatory, but the procedure needs an appropriate space and different than a regular grossing station ventilation. The table needs higher vertical panels.

Autopsy specimen disposal would be also a “customer” of “heavy-duty” grossing station because autopsies use large volumes of formalin, and periodic specimen disposal is a real safety problem. Brain washing (literally) after postmortem fixation would be safer to perform on the station’s table. The entire anatomical pathology department would benefit from the presence of this station, which can also be used for postmortem gross sampling.

Disposal of formalin after its separation from the specimen is another problem. Most laboratories neutralize formalin before it is discarded. The hazardous effect for laboratory environment of this procedure is underestimated. The “heavy duty” grossing station can be connected to a special neutralization device for this purpose. A combination of the “heavy-duty” grossing stations with specimens and formalin disposal would be a solution of many problems in the surgical pathology laboratory.

This post has tried to make the case that the “heavy-duty” grossing station with the Bone Grossing Table, as the base design, is not a luxury for a surgical pathology laboratory, but rather a necessity for productive and safe work. Perhaps, the quotation marks will be irrelevant for this equipment in the near future, as it will become a commonly accepted fixture of civilized work in the modern surgical pathology laboratory.

 

CPT Code 88305 TC

Just for fun a song: http://tissuepathology.com/2014/08/28/bye-bye-88305-sung-to-american-pie/#axzz3Bn0mloT9

The Centers for Medicare and Medicaid Services (CMS) has announced a series of changes to the 2013 Fee Schedule. The changes will be effective on January 1, 2013. The most significant change is in the CPT code 88305 Technical Component (TC) which will be lowered by 52%. Although the professional component will be increased by 2%, the global payment for 88305 will decrease by 33%.

 

Code Modifier Percent change 2013
88305 Global

-33%

88305 26

2%

88305 TC

-52%

Although there is also a decrease in 88304, the changes in88305 initiated an outcry predominately among the reference, specialized surgical pathology laboratories, and in-office laboratories for understandable reasons, because 88305 is a biopsy code.

 

Code Modifier Percent change 2013
88304 Global

-28%

88304 26

3%

88304 TC

-35%

The increase in 88307 TC to 39%, as well as the TC immunohistochemistry to 14% (a significant part of the histology laboratory earnings) has gone unnoticed. However, the biopsy code 88305 TC is literally the bread and butter of most clinical histology laboratories. The entire table pertaining to changes of in CPT coding in the surgical pathology laboratory.

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Reflections on Formaldehyde Carcinogenicity

Formaldehyde carcinogenicity is now a commonly accepted notion in society, as well as in anatomic pathology laboratories. Guilty on arrival. However, the background of this concept is far beyond a reasonable doubt.

There is not now even an echo politically charged dispute of 1980s between U.S. Environment Protection Agency (EPA), Occupational Safety & Health Agency (OSHA), College of American Pathologists (CAP), Formaldehyde Institute, DuPont, and labor unions on the evaluation of formaldehyde occupational exposure risk, which was based on the assessment of formaldehyde as “probable carcinogen” at that time. 1 In 1989, the American Medical Association (AMA) summarized the literature data through 1985 on occupational exposure to formaldehyde. Mentioning that regulatory agencies as OSHA, regarded formaldehyde as a possible human carcinogen, AMA observed that “this is a controversial opinion in the view of many industry and academic scientists.”1

Times have changed. The main organization influencing the assessment of reagents as carcinogenic is the World Health Organization’s (WHO) International Agency for Research on Cancer (IARC) based in Lyon, France. IARC summarizes literature data predominantly epidemiological research, as well as some experimental studies. According to IARC Press Release No 153, 15 June 2004 formaldehyde is placed in Group I – known carcinogens- along with such substances as asbestos and benzene.2 The dispute is over.

However, the Monograph Programme, the IARC’s main document, presents cohort and case-control epidemiological studies predominately manufacturing and garment industries, as well as exposure in mobile homes to formaldehyde- containing materials.3 The main conclusions are based on studies of industrial workers, although there is a group of professionals which included pathologists, anatomists, and funeral homes workers. The data are quite contradictory due to the misclassification and the inadequate methodology of the dose-response relationship. Most data represent epidemiological studies, including cohort analyses which cannot be now repeated due to changes in manufacturing and environment.

There are conflicting literature data on this subject which cast doubt that the IRAC conclusion is balanced and can be accepted as a scientific fact. Despite attempts of scientific objective discussion, there is a trend to leave out some publications and opinions that contradict the group’s conclusion.4-9 Most references reflect data before 80th even if the articles are published after 2000. The long list of references represents limited groups of authors which publish articles in different combinations.

There is a discrepancy between the statistical epidemiological data and minimal clinical evidence from physicians who observed particular or groups of patients. Neither otolaryngology, nor other surgical manuals even mention formaldehyde as a possible ethological or contributing factor of cancer in their clinical observations. The fundamental “Cancer Principles and Practice of Oncology” do not mention formaldehyde either in carcinogenicity or in other clinical chapters (head and neck, lung).10Pathologists haven’t observed higher morbidity or mortality of colleagues and technical staff in contact with formalin. (See details at post “Formaldehyde carcinogenicity as safety concern” at Safety section).

The divide regarding formaldehyde carcinogenicity has a remote analogy with global warming/climate change. Nobody dare to challenge this notion. The deleterious effect of formaldehyde makes carcinogenicity so obvious that it is even impolite to question its credibility.

In practical sense, however, the dispute over formaldehyde carcinogenicity is meaningless at this time. We have to accept the conclusion of IARC until it is proven wrong. Moreover, there is barely a chance that such studies will be conducted in the foreseeable future. The USA regulatory agencies, the EPA and the OSHA assume formaldehyde as a potential occupational carcinogen with appropriate regulations. 1 OSHA mandated the notice in any laboratory or industrial area where formaldehyde mixtures or solutions capable of releasing formaldehyde into the air at concentrations reaching exceeding 0.1 ppm are used:” Danger: Formaldehyde: irritant and potential cancer hazard.”

Manufacturers have accepted regulation and measure improvements in the work place environment, instead of engaging in costly altercations with the EPA and lawyers, as well as sustaining public relation losses with the aggressive coverage on formaldehyde carcinogenicity subject by the mainstream media. The American Conference of Governmental Industrial Hygienists (ACGIH) has more stricter requirements for time weighted average (TWA) short-term-exposure limit (STEL) (0.3 ppm) than OSHA (2 ppm), although the recommended exposure limits do not have a legal application in the USA in opposite to OSHA. It is remarkable that the ACGIH 0.3 ppm limit is set on irritation, not carcinogenicity.

Clinical laboratories and other facilities (anatomical, research) have accepted the OSHA requirement for 8 hours time weighted average Permissible Exposure Limit (PEL) of 0.75 ppm. There is not in public domain 8 hours TWA by the ACGIH. The management of local laboratories accepts this measure without any question. The institution’s authorities would not forgive the laboratory management’s failure to meet these relatively simple requirements because there would be some consequences of accreditation which nobody needs.

This rosy picture, however, obscures very important question. The regularly scheduled monitoring reflects more or less the general environment in the work place but the devil of formaldehyde exposure is in the details of every day work practices– how the splashes and spills are handled, as well as wet specimen disposal; this is when the most overexposure occurs, but nobody monitors and even pays attention. The everyday practice occurrences of overexposure are more important than quite theoretical carcinogenicity.

During overexposure, the workers lose, temporally or permanently due to sensitization, the natural defense of the upper respiratory tract or skin. Given by evolution, both are, especially upper respiratory area (nasal mucosa, paranasal sinuses, conches) with the tiny cilia movement mechanism, very important immunological line of defense not only against pathogenic infection although the latter is the main beneficiary. (See more details in ”Formaldehyde exposure safety rationale” in the Safety section  ).

Toxicity of formaldehyde overexposure is not urban legend. Due to my silly behavior during a cleanup of a formalin spill, I lost once my voice for a week. Of course, it was a chemical injury. However, some “micro burns” occur in practice on a permanent basis. For example, when the working tissue processor is opened for some reasons (add/take out a cassette/s, check something, etc.)in formalin phase a vapor of formaldehyde from the warm formalin goes in the person’s breathing area. Separation of specimens from formalin during specimen disposal is a different example. In my pathology youth, I had many eye injuries by formalin splashes.

Regarding formaldehyde carcinogenicity everyone is entitled to his/her opinion, especially the question is unsolvable at this stage of society’s development.

In my opinion, this is an unproven concept. However, the harmful effect of formaldehyde exposure is indisputable. Efforts should be concentrated as much as possible on the prevention of negative consequences, by improving working conditions, introducing and following safe work practices. It should be made clear to everyone that personal responsibility is matter of paramount importance.

(See also posts “Monitoring formaldehyde exposure ”, “Formalin Spills and Splashes”, as well as the summarized article”Formalin safety in the surgical pathology laboratory” in the Safety section. Although the article is too long for a website, it provides a comprehensive approach to formalin safety topics that are presented in separate website’s posts. It is an “uncensored by reviewers” variant of the article which has been published in LabMedicine in 2009 )

References

1. Council Report. Formaldehyde.  Council on Scientific Affairs. JAMA 1989; 261:1183-1187

2.  IARC Press Release No 153, 15 June 2004

3. World Health Organization International  Agency for Research on Cancer IARC Monographs on the Evaluation Carcinogenic Risks on Humans Volume 88 , 2006 Formaldehyde Monographs Programme  http://monographs.iarc.fr/ENG/Monographs/Vol88/index.php

4.  Collins JJ, Acquavella JF, Esmen NA: An Updated Meta-Analysis of Formaldehyde Exposure and Upper Respiratory Tract JOEM, Vol 39, Number 7, July 1997: 639-651

5.  Gardner MJ, Pannett B., Winter PD, Crudas AM.  A cohort study of workers exposed to formaldehyde in the British chemical industry: an update British Journal of Industrial Medicine 1993; 50: 827-834

6. McLaughlin JK. Formaldehyde cancer: a critical review. Int Arch Occup Environ Health (1994) 66: 295-301

7. Chang ET. Adami HO The enigmatic epidemiology of nasopharyngeal carcinoma. Cancer Epidemiol. Biomarkers Prev, 2006; 15 (10); 1765-1977

8. Hauptman M, Lubin JH, Stewart PA, Hayes RB, Blair A: Mortality from solid cancers among Workers in Formaldehyde Industries. American Journal of Epidemiology, 159; (12): 1117-1130

9. C. Bosetti C, McLaughlin JK, Tarone RE, Pira E and La Vecchia C: Formaldehyde and cancer risk: a quantative review of cohort studies through 2006. Annals of Oncology 2008; 19; (1): 29-43

10. DeVita VT, Hellman S, Rosenberg SA. Cancer: Principles and Practice of Oncology.  Lippincott Williams & Wilkins 7th Ed, 2008