Highmark Medicare Services received the following comments to our draft Local Coverage Determinations (LCDs). Highmark Medicare Services would like to thank those who shared their knowledgeable comments with us. The comments received were invaluable in revising the draft policies to their present form. Following are our responses to the comments we received.

G-37H, Dysphagia: Selected Evaluation and Treatment Services

Comment #1:  One commenter wrote in support of the draft policy, as written.

Comment #2:  One commenter opined that a better title for the LCD would be “Upper Dysphagia” or “Oral Pharyngeal Dysphagia,” since “Dysphagia” is too broad and excludes everything done in GI.  Another commenter suggested that we entitle the LCD “Primary Dysphagia” and “Secondary Dysphagia.”

Response:  The title has been changed.

Comment #3:  One commenter asked if the removal of ICD-9 530.85 (Barrett’s esophagus) was correct.

Response:  This code and a few others were inadvertently left off the draft when aligning the three sets of codes and adding many new codes.

Comment #4:  One individual provided the following comments regarding the bedside clinical evaluation:  “this can involve someone simply observing at the bedside, or a more formal instrument-based assessment.  The outcome may determine that further procedures are needed to evaluate swallowing in certain situations (like head and neck cancer patients after surgery or radiation).  There is some cognitive assessment required, and someone has to document this and order the test.”  This commenter posed the following question and statement:  “Will this be the family doctor or the specialist?  I agree that this full decision must rest on the doctor, not the speech pathologist.” 

Response:  The draft LCD states “An instrumental assessment is not medically necessary in the absence of a specific order from the treating physician.”  The treating physician may be the “family doctor” or the “specialist”.

Comment #5:  One commenter provided the following comments regarding Vital Stim®:  There are a number of clinical circumstances where Vital Stim® may play an important role for Medicare beneficiary patients.  Specifically, these include Alzheimer’s, Parkinson’s disease, atrophic lateral sclerosis and patients who have undergone surgical and radiation therapy for head and neck cancer.  I would ask an exception be placed on patients who have the above neurodegenerative dysfunctional disease, or a history of head and neck cancers, to be eligible for Vital Stim® therapy.  This treatment may offer some help for these conditions for which often times there is no curative therapy.”

Response:  The issue of alternative treatment for “conditions for which often times there is no curative therapy” is very important.  The rules and regulations of the Medicare Program stipulate that for coverage, any such alternative treatment must be considered reasonable and medically necessary.  At this time, based upon review of the current scientific and clinical literature, the clinical efficacy and clinical utility of this service remains unproven; thus the treatment is not considered reasonable and medically necessary.  Further, recent studies with the use of this surface electrical stimulation treatment show a lowering of the hyoid bone during swallowing, which may actually be harmful to the patient. This treatment is considered not eligible for coverage.

Comment #6:  A commenter requested that we clarify in the following sentence whether the SLP needs to be supervised during the procedure, especially if it is a FEES study:  "Instrumental assessments used for diagnostic purposes should be performed and interpreted by an otolaryngologist or other physician, authorized through their scope of practice, by the state in which they practice to perform these services, or may be performed by SLPs.”

Comment #7:  The individual commented on the paragraph on page 5 that reads, "A nurse must be available during the procedure (instrumental evaluation) in order to respond immediately to the patient's needs.”  This commenter suggested that this be changed to:  "A nurse or physician must be available during the procedure in order to respond immediately to the patient's needs," since during tests such as a modified Barium swallow, there is always a doctor, and SLP, but not routinely a nurse. 

Comment #8:   A commenter opined that on pages 5 and 6 there are “specific guidelines regarding FEEST regarding supervision, but very limited information regarding supervision with FEES.  Do we assume the policy is the same for both?  Maybe this should be clarified.”

Response to #6 - #8:  With multiple inquiries about supervision, we reviewed again the guidance given by CMS for evaluation and treatment of dysphagia.  After review of the most current guidance, the decision was made to limit the LCD to the coverage limitation for treatment of dysphagia with VitalStim^®, because coverage guidance is available in the CMS Manuals, including the NCD 170.3.  Please see the following CMS Manuals for guidance regarding the evaluation and treatment of dysphagia: Medicare Benefit Policy Manual, IOM 100-02, Chapter 15, Sections 220 and 230.3; Medicare National Coverage Determinations Manual, IOM 100-03, Chapter 1, Section 170.3; and Medicare Claims Processing Manual, IOM 100-04.

Comment #9:    The commenter suggested an addition to page four in the paragraph that reads, "..... therapeutic (behavioral) interventions such as compensatory swallowing techniques and/or postures, dietary recommendations including food and/or fluid texture modification and the safety of continued oral feedings....”  The suggestion was to add "facilitative techniques" after compensatory swallowing techniques and/or postures, because of techniques such as pharyngeal exercises and biofeedback utilized to strengthen and rehabilitate the muscles.

Response:  Comment appreciated; however, please see reply to comments 6-8, above.

I-75, Cancer Chemotherapeutic Agents

Comment #1:  Several commenters were in support of the draft policy, as written.

Comment #2:  One commenter expressed concern regarding the exclusion of “in house publications” and abstracts, and the use of FDA unlabeled uses.  This commenter opined that “the list of peer reviewed journals does not include every journal and seems arbitrary,” and requested that the following journals be added:  Am J Hematology, Leukemia and Lymphoma, Bone Marrow Transplantation, Biology of Blood and Marrow Transplantation, and Experimental Hematology.

Response:  The peer reviewed medical literature that can be used is specified by the CMS Internet-Only Manual (IOM) Publication 100-2, Medicare Benefit Policy Manual, Chapter 15, Section 50.4.5.  At this time no changes have been made to this list.  However, the new LCD I-75, does effectively increase the list of  peer reviewed journals as described, “Peer reviewed medical literature in journals other than those journal cited above (i.e. those listed in IOM 100-2, Medicare Benefit Policy Manual) also can be used to establish a community level standard of care.  Again this literature includes scientific, medical, and pharmaceutical publications in which original manuscripts are published, only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased independent experts. This does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts).  Furthermore, the level of evidence in each article must be determined.”                                        

Comment #3:  One commenter provided the following comments regarding the draft policy:

“I think the point of the policy is well intentioned but the approach seems more appropriate for community oncologists than the academic referral setting.  In particular, the policy seems to presume that our faculty lacks the ability to critically interpret the literature.  This expert and widely encompassing knowledge of published AND developing literature is one reason we choose to practice in an academic center like [our facility].  In particular, I think it is a disservice to our patients to exclude treatment justification culled from meeting abstracts.  Similarly I would not limit evidence based review to particular journals.” 

“While FDA approval is an easy and reasonable way to justify therapy, the absence of FDA approval is insufficient to be used to deny insurance coverage of therapy.  This means that we are left to justify our daily subsistence as standard of care or not based upon literature or clinical guidelines/community standard.  And really, there are VERY few FDA approved therapies in oncology.  As a single example, no drugs are FDA approved at transplant doses, so all BMT is off label.  What constitutes a reasonable defense of clinical decision making is the heart of what I have problems with on the I-75. 

Our faculty typically review abstracts for selection to national meetings, attend such meetings, and interact directly with the researchers to discuss the data.  As such, it seems reasonable that we can recognize the limitations of these abstracts' data and judge which ones are trustworthy enough for incorporation into clinical practice.  Prominent abstracts from national meetings frequently alter standard of care well in advance of their publication, so excluding them outright is a flawed approach.  Other abstracts will never be published for various reasons, not always related to data quality.

Regarding journals for evidence based review when a community standard isn't obvious, we all recognize that there are journals of varying quality of peer review.  But it doesn't make much sense to arbitrarily exclude all content not published in a chosen list of journals on the basis of "quality control."  Data on rare diseases or conditions simply don't make it into the prominent journals.  At referral centers like [ours], unusual or otherwise complicated cases are our bread and butter.  As such, we have to make decisions based on all available data, not that from cherry picked journals.

If a list of journals is still requested, all the journals that [the previous commenter] mentioned and many more could be included (Clinical Cancer Research, European Journal of Hematology, Cancer Biology and Therapy, Lancet Oncology to name but a few in our field alone).  But the pattern of omissions is more surprising than deciding whether "Leukemia & Lymphoma" meets the NEJM's rigorous editorial standards.  By this I refer to the omission of specialty journals outside of oncology.  There are no pediatric oncology journals to guide chemotherapy choice or dosing in adolescents & younger adults, no obstetric journals to help with pregnant patients with cancer, no renal journals to review studies of chemotherapy safety and dosing in renal disease or on dialysis, no GI journals to assess its safety and dosing in hepatic dysfunction, no solid organ transplant journals for PTLD, no critical care journals for chemotherapy safety in critically ill patients, etc., etc.  It is finally curious that all "approved" published data is in English.  Our faculty includes native speakers of Greek, French, Hindi, and Spanish among others--should articles published in these and other languages be ignored altogether? 

Unfortunately, the academic referral hospital is a place where "evidence based medicine asterisks" are bound to occur with frequency.  This is due to the highly specialized nature of our practices and our position to serve as expert opinion for challenging cases of common disorders and rare diseases alike.  Therefore, policies that could easily guide coverage for typical cases essentially identify the cases that should be (and typically are) referred to places like [ours].  So we have pre-screened for all the cases where insurance denial is most likely due to the lack of FDA-approved indications or a community standard.  And this is likely to engender conflict with insurance companies as to whether we are acting in the best interests of our patients. 

Interestingly, these patients often have one reason or another that would have made them ineligible for the original studies used to create FDA indications.  So since no safety or efficacy testing in comparable populations has ever been done, FDA approved drugs may not have been appropriately tested to guide therapy in many of our patients.  This underscores the need to take into consideration ALL available evidence that therapies could help and are safe to administer.

It's perfectly reasonable for Highmark to query a physician to justify unusual drug indications based upon literature.  I'm not asking for a rubber approval stamp that "[our oncology department] can treat patients with any therapy that they see fit."  If Highmark wants to do its own review using its chosen sources and then query physicians thereafter, fine.  But to say that, in the absence of a community standard, our responses to justify therapies should be limited to a small number of chosen sources is misguided and not in patients' best interests.”

Additional commenters provided the following opinions regarding the guidelines for off-label uses of these drugs: 

• “Why is it that every time we take care of patients, we have to testify there is an article out there that it works?  I think just having it in the office records is sufficient.”
• “Pharmaceutical companies go for one indication.  If they went for ten, the drug would never go on the market with the FDA log jam.  Rituxan® is a perfect example since it has gone through about 20 iterations of indications.  However, in the practical world, the fact that the oncologist wants to use this drug for a certain indication means that he has already reviewed most of the articles and is going to have them handy.”

Response:  LCD I-75 has been revised to require the citation of the article or a copy of the specific information  in the medical record.  This citation or a copy of the specifically required material and the medical record should be available for review on request.

Comment #4:  One commenter provide the following statements:  “Please remember that once a drug is approved by FDA and on the market, the pharmaceutical company may have little reason to get approval for another indication.  In testicular cancer, first line salvage therapy as documented in the National Comprehensive Cancer Network guidelines includes Taxol based upon a tremendous wealth of evidence.  Taxol is not approved for this indication, but is the standard of care.  Why would a company want to invest all the resources to get an indication for such a rare disease?  This is one of countless examples that we confront every day as oncologists.”

Response:  The use of established guidelines such as those available from the National Comprehensive Cancer Network, American Society of Clinical Oncology, are acceptable pieces of evidence to support the use of non-approved FDA use of a chemotherapeutic agent.  A copy of this information or the reference to the information should be retained in patient’s medicl record.

Comment #5:  Several commenters suggested that Highmark Medicare Services require the citation only in the medical records, not the entire journal article.

Response:  LCD I-75 has been revised to require the citation of the article or a copy of the specific information in the medical record.  This citation or a copy of the specifically required material and the medical record should be available for review on request.

Comment #6:  One commenter inquired if it is the intention of this policy to deal with cancer chemotherapeutic agents used in situations where there is no cancer; e.g. Avastin® for macular degeneration.

Response:  LCD I-75 only addresses the use of Cancer Chemotherapeutic Agents. 

Comment #7:  One commenter inquired if there will be a repository of approved off-label uses of specific drugs; i.e., if a physician submits a claim with Compendium information and two peer-reviewed articles, will he have to submit the same information for the second patient.

Response:  When submitting a claim with the KX modifier, the clinician is required to retain a copy of the reference material or a citation to that reference material in the patient’s record.  Submission of this information is required only if it is requested by Highmark Medicare Services. 

L-72, Blood Glucose Monitoring in a Skilled Nursing Facility (SNF)

Comment #1:  One commenter asked: “Would blood glucose testing be approved for patients that are physically or verbally incapacitated (ie., trach or CVA) and/or lack the ability to communicate effectively in notifying the nurse/healthcare worker that they are experiencing symptoms associated with hypoglycemia or hyperglycemia.”

Response:  The frequency of monitoring blood glucose values is to be determined by the patient’s physician on an individual basis, while considering and documenting any of the following factors that affect glycemic control:

• Variations and degree of glycemic control as documented by Hgb AIC levels,
• Treatment with insulin vs oral agents,
• Frequency of signs/symptoms of hypoglycemia,
• Frequency of prior therapy adjustments,
• Motivation or ability for self-care and the presence of limitations, such as language barriers or mental illness/capacity, or
• Presence of diabetic complications.

However, Sections 42 CFT 410.32 and 411.15 specify that for a laboratory service to be reasonable and necessary, it must not only be ordered by a physician, but the ordering physician must also use the result in the management of the patient’s medical problem.

S-14E, Cataract Surgery

Comment #1:    One commenter observed that the draft policy does not contain guidelines regarding separate documentation for the second eye after the first surgery has stabilized.

Response:  The requirements for treatment of the second eye are the same as for the first.

Comment #2:  One commenter advised that he disagreed with the requirement to do both a standardized formal measure of visual function (e.g., VF-14); as well as, and document decreased ability to carry out certain activities of daily living.  The commenter opined that doing the visual function is very time consuming and duplicates some of the documentation required for activities of daily living.

Response:  The requirement for determining functional status of the patient remains in the LCD.  However, the specific tests and methods to make this determination are left to the clinician and are not specified.

Comment #3:  One commenter advised that there is disagreement in the clinical literature regarding what questions in the VF-14 are significant.  Based on the disagreement in the literature provided, the commenter suggested that Indication #1 should be deleted.

Response:  The suggestion to use VF-14 as an evaluation tool is no longer a part of the LCD.

Comment #4:  One commenter stated that often an IOL implant is a part of cataract surgery, and asked, “Are all types of implants covered as part of surgery?  If not, that should be clear in this policy.  Or is it described in another policy.  If latter, then there should be a reference or link to that other policy.”

Response:  Payment for IOL (including astigmatism-correcting and presbyopia-correcting) is outlined in CMS Internet-Only Manual (IOM) Publication 100-4, Medicare Claims Processing, Chapter 32, Section 120.   Additional information about IOL is also found in Chapter 14, Sections 10.2 and 40.3 of the same manual.  In addition NCD 80.12 also discusses this issue.

In Comments #5 through #10 a commenter provided suggestions for additions (underscore) and deletions (strike through) to the policy. 

Comment #5:  Indications, 1st paragraph:  “Medicare coverage for cataract extraction and cataract extraction with intraocular lens implant is based on services that are reasonable and medically necessary for the treatment of beneficiaries who have a cataract, and who meet all of the following criteria:” “We need to get rid of ‘intraocular lens implant.’  Even though this is probably done in 99.9% of the time, it only refers to 2 of those procedure codes.” Response:  Provision has been made for both cataract extraction with and without subsequent IOL implantation. Comment #6:  Indications, Item 1:  “Such testing can be performed with standardized measurement tools, such as the Activities of Daily Vision Scale or the VF-14.” Response:  The suggestion to use the Activities of Daily Vision Scale or the VF-14 as an evaluation tools is no longer a part of the LCD. Comment #7:  Indications, Item 2, Bullet 2:  “Snellen visual acuity of 20/40 or worse or if there is a glare complaint, glare testing which reduces visual acuity to less than 20/40. Special situations might arise where a patient would need better than 20/40 vision to function (pilots, professional drivers, etc.). In these instances additional documentation should be available in the patient’s medical record describing these circumstances. Or other medical indications exist for cataract removal such as: Clinically significant anisometropia in the presence of a cataract. The lens opacity interferes with optimal diagnosis or management of posterior segment conditions. The lens causes inflammation (phacolysis, phacoanaphylaxis). The lens induces angle closure (phacomorphic, phacotopic). ·         Not all patients with visual acuity of 20/40 or worse require cataract surgery because: They are able to satisfactorily carry out their activities of daily living with changes in eyeglasses, lighting or other non-operative means. The operative risk is not commensurate with the potential benefit to the patient. Other eye disease such as macular degeneration or diabetic retinopathy rather than cataract is the limiting factor of visual function. The patient has posterior segment disease requiring surgical or laser intervention, and where the cataract is an impairment to visualization. Generally, patients with visual acuity of 20/40 or better do not require cataract surgery to improve their ability to carry out activities of daily living. However, glare or other environmental factors may adversely affect some patients’ activities of daily living because a cataract is present and significantly diminishes function, even with Snellen acuity of 20/40 or better.” “…for cataract surgery, you also have other indications, such as if the lens opacity interferes with optimal diagnosis or treatment of other ocular conditions.  Or the patient has a retinal detachment and a hazy cataract, yet it is not visually impairing their central vision.  They are not less than 20/40 but our retinal colleagues are not able to do a vitrectomy or further surgery and cannot visualize the retina.  But we need to take the cataract out.” “With clinically significant anisometropia in the presence of a cataract, when you have a patient who has a cataract in one eye and is highly nearsighted or farsighted, you take the cataract out of one eye and then it interferes with their binocular vision.  Even though they have a cataract coming on in their other eye – which does not meet the criteria itself – that anisometropia could significantly interfere with their functional vision and cause problems with depth perception, driving, and activities of daily living.” “There are instances when the lens itself causes problems.  The body can have a reaction to the lens and they get phakolysis where the lens starts breaking apart.  Or, they have phacoanaphylaxis where the eye starts creating inflammation.” “There are instances where the lens itself, due to the size increase over time, can cause angle-closure, phacomorphic, or phactopic, glaucoma.” Another commenter suggested another indication is when there may be another procedure that needs to be done where removing a cataract, even if it is not visually significant, helps accomplish the other procedure. Response:  The additional indications as suggested for cataract extraction were added to the LCD.  However, not all patients who have cataracts may require cataract extraction.  Therefore, the description of these patients was retained. Comment #8:  Indications, Item 4:  The patient has undergone an appropriate preoperative ophthalmologic evaluation, which generally includes a comprehensive ophthalmologic exam and an A-scan ultrasound or partial coherence interferometry and keratometry or corneal topography.  Other ophthalmologic studies should be reserved for special situations, such as: ·         Glare testing for patients with cataracts who complain of glare, yet measure good Snellen acuity when tested in an office circumstance. ·         B-scan for patients with dense cataracts, which preclude visualization of the posterior segment of the eye including the vitreous and/or retina, but not limited to these. ·         Flourescein angiography or Optical coherence tomography of the retina when there is significant retinal pathology.”

“But what was left out was ‘keratometry’ or ‘corneal topography’ which measures the curvature of the front of the eye.  You cannot figure out an accurate lens power without both measuring the axial length and curvature of the cornea.” Response:  Keratometry and corneal topography were added to insure that the most accurate determination of lens power could be made.

Comment #9:  Page 3, “The ophthalmic examination should include the following components:

1) Patient history (including patient’s assessment of functional status).
2) Snellen acuity and refraction, if indicated.
3) Measurement of intraocular pressure.
4) Assessment of pupillary function.
5) Examination of ocular motility.
6) External examination.
7) Undilated and dilated Slit-lamp examination. (unless dilation is contraindicated by the anatomy of the eye).
8) Dilated examination of the fundus (unless contraindicated by the anatomy of the eye).”

Response:  The requirements of a slit lamp examination were simplified.

Comment #10:  Page 3, “The following tests are generally not indicated in the preoperative workup for cataract surgery. If performed, the indications for their use must be documented in the patient’s medical record:

Contrast sensitivity testing.
Potential vision testing.
Formal visual fields.
Fluorescein angiography.
External photography.
Corneal pachymetry/specular microscopy.
Specialized color vision tests.
Electrophysiologic tests.”

Response:  These tests are not routinely done in the evaluation of a patient who potentially requires a cataract extraction.  However, there are occasions when these tests are required to thoroughly evaluate the patient.  When this is the case the medical record must document the need for these tests. 

Comment #11:  One commenter advised that he strongly recommends that we remove corneal pachymetry/specular microscopy from out list of tests that are “generally not indicated in the preoperative workup for cataract surgery.”  He reviewed the benefits of each procedure and advised that “it is valuable to the surgeon to know whether the cornea is healthy or on the edge of decompensation prior to performing cataract surgery.  Every cataract surgery reduces the endothelial cell count, and if we know ahead that the count is law and therefore that the patient is at greater risk, we might defer surgery or might want to use balanced salt solution with Glutathione and extra Viscoelastic and vary our technique at the time of surgery to spare the endothelium trauma as much as possible. This is especially important when cataract surgery is performed by phacoemulsification which has a greater potential for reducing the cell count and precipitating corneal decompensation and edema.  Phacoemulsification has now become the procedure of choice for just about all cataract surgery.  In some cases of poor endothelial function, especially with a dense nuclear cataract, we might decide to switch from phacoemulsification to planned extracapsular technique with the knowledge that the corneal endothelium is vulnerable.”

Response:  These tests are not routinely done in the evaluation of a patient who potentially requires a cataract extraction.  However, there are occasions when these tests are required to thoroughly evaluate the patient.  When this is the case the medical record must document the need for these tests.  In the above comment, the need for a specific test is clearly stated.  If indeed this is the clinical situation, the need for the test should be recorded in the patient’s medical record.

Comment #12:  Two commenters objected to any language that might be added to the final policy that would obligate an ophthalmic surgeon to provide post-operative care for their cataract patients since such a requirement would 1) present a hardship to patients due to possible geographic, accessibility and cost considerations; 2) conflict with Federal law and current Highmark Medicare Services policy which allows for co-management of post-surgical cataract care by the patient’s optometrist; and 3) not be a resolution to the occasional referral of post-surgical cataract patients to emergency rooms for their post-surgical care by ophthalmic surgeons.  In addition, they suggested adding the words “or referring optometrist” following “contact the ophthalmologist” to the 2^nd sentence in the last paragraph on page 3.

Response:  It is a given that all operating surgeons should provide postoperative care for their patients independent of the type of operation performed.   If the patient requires co-management, then this should be done in accordance with LCD S-139 Co-Management of Surgical Procedures.    

Comment #13:    Several commenters were concerned with the availability of postoperative care.  One commenter suggested adding:  “It is the operating surgeon’s responsibility to provide the necessary postoperative care, rehabilitation and treatment of any complications, or to ensure that such care is available.” 

Response:   It is a given that all operating surgeons should provide postoperative care for their patients independent of the type of operation performed.  If the patient requires co-management, then this should be done in accordance with LCD S-139 Co-Management of Surgical Procedures.    

Comment #14:  Comments were received regarding the necessity of the pre-operative clearance from a physician other than the surgeon.

Response:  All preoperative patients should be thoroughly evaluated based on their general medical and specific surgical procedure requirements.  The goals of these evaluations are to more precisely manage medical conditions and to insure the best possible postoperative outcomes.

S-144D, Wound Care

Comment #1:  One commenter wrote in support of the draft policy, as written.

Comment #2:  One commenter requested clarification of the language at the top of the draft policy regarding the ability of non-physician providers qualified to provide wound care services to Medicare patients; i.e., does this apply throughout the policy.  “Specifically, the introductory remarks suggest that physician extenders (PAs, NPs, etc.) can safely and effectively provide the care necessary for [patient] treatment.   But language deeper in the LCD suggests that some wound care services (such as debridement) may be reimbursed only when provided by or at the order of a physician.  Does this language exist with the understanding that a physician extender, practicing under Pennsylvania state law guidelines for scope of practice and under the general supervision of a physician can order this service (as suggested in the section discussing surgical debridements), or does it mean that the service should be limited to an MD or DO?”

Response:  Wound care is provided by many different providers in variety of clinical settings.  Wound care when billed using 97597, 97598, 97602, 97605, or 97606 can be performed by therapists and non-therapist when permitted by the scope f practice requirements of each state.   Wound debridement codes 11040-11044 may be billed by physicians as defined by Medicare.

Comment #3:  One commenter noted that “the section of the LCD discussing wound care provided by physical therapists suggests that their services should be furnished under a plan of care developed by a physician.”  This commenter asked:  “Does a plan of care developed by a physician extender apply here?”

Response:  Physical therapists must work under a plan of care that is developed/approved by a physician.  Medicare defines “physician” as an MD, DO, Podiatrist, CRNP, or Physician Assistant, as long as practicing within their scope of practice.

One commenter provided Comment #4 through Comment #20.

Comment #4:  Page 3, 3rd paragraph, under “Such evidence must be documented weekly” - The wound care provided may not require weekly visits, so requiring documentation on wound status weekly may not be medically necessary.

Response:  Documentation of wound should occur each time the patient is seen.

Comment #5:  Page 3, first paragraph under “Wet Dressings,” Sentence reads:  “These dressings are specifically effective for moist, oozing and weeping lesions.” -  “it is important to keep the proper fluid balance in the wound environment. If a wound is draining significantly more absorbent products, not wet dressings, would be indicated.”     

Response:   The intent of this section is to broadly describe the types of dressings that are available for the treatment of wounds.  Indications for the use of these dressings have been removed for this descriptive section.             

Comment #6:  Page 3 Under heading “Dressings” -  “This section should include a statement indicating factors involved in selecting an ideal wound dressing. For example:  Proper dressing selection should include consideration of the wound characteristics including presence of tunneling, amount of exudate, degree of necrotic tissue and evidence of infection. Additionally dressings should consider the goal of therapy and in most cases promote a moist wound environment that is protected from trauma and secondary infections.”

Response:  There are many factors to consider when selecting a wound dressing—the characteristics of the wound itself, the patient’s specific medical problems, mobility requirements, social situation, etc.  Selection of an ideal, best dressing is part of the evaluation and management of a wound.    

Comment #7:  “The title of ‘Occlusive Dressings’ is not correct for all of the products listed in this category. Dressings listed have various degrees of water vapor permeability. It may be better to title this section ‘Advanced Dressings.’”

Response:  Advanced dressings is a better descriptor of this broad category of dressings.

Comment #8:  Page3 under “Dressing” – “Can list nurses or wound care nurses. Enterostomal nurses is an old term. Consider throughout when listing applicable personnel who treat wounds, consider adding nurses or wound care nurses.”           

Response:  References to enterostomal nurse have been replaced with the phrase wound care nurse. 

Comment #9:  Page 3, under “Wound Care Selective,” sentence reads:  “Debridement is indicated whenever necrotic tissue is present.” – “This may not always be the case. An ischemic wound may be managed as a dry wound, pending further evaluation of vascular status on ability to heal. A dry stable pressure ulcer with escar [eshcar] of the heel may also be managed as a dry wound. Additionally patients with a conservative maintenance treatment plan for example a patient on hospice may be managed with a stable dry escar [eshcar] to avoid painful debridements. May be more appropriate to state “Debridement is usually indicated when necrotic tissue is present.” with certain exceptions as noted above.”

Response:  The word “usually” was inserted in the sentence, “Debridement is usually indicated when necrotic tissue is present.” with certain exceptions as noted above.”

Comment #10:  Page 4 – “Add curettes to list of instruments used for sharp debridement.”

Response:  Currettes were listed to the list of instruments used for sharp debridement

Comment #11:  Page 4, No. 2a – “Eliminate word enterostomal add nurse or wound care nurse.”

Response:  References to enterostomal nurse have been replaced with the phrase wound care nurse. 

Comment #12:  Page 4, No. 2d – “Wet to dry dressings are not recommended in most case. Please refer to journal article: Hanging Wet to Dry Dressings Out to Dry? Advances in Skin and wound Care, 2002 Mar-Apr 15(2 part1): 79-86 (21 ref).”

Response:  The paragraphs in the section describe the broad types of debridement available to clinicians.  The use of wet-to-dry dressings is just one of many options and should be used cautiously as stated.

Comment #13:  Page 4, 2d – “It may be more appropriate to indicate that wet-to-dry dressings may dry the wound out, interfering with the goal of moist wound healing.  Additionally wounds with significant necrotic tissue wound be very slow to heal utilizing wet-to-dry method and better managed with enzymes or sharp debridement.”

Response:  Management of wounds is patient specific.  Clinicians should select and use the best method (there are many to select from) that will bring about wound closure the quickest.

Comment #14:  Page 4, 2e - How is this distinguished from c. under Selective Debridement which describes lavage as a water jet and classifies it as selective debridement.   Suggest taking the words ‘jet hydrotherapy’ out of this title and just using ‘Wound Irrigation.”’

Response:   Jet hydrotherapy can also be used in selective wound debridement. 

Comment #15:  Page 5 – “HCPCS codes 97597, 97598, 97605 and 97606 have been previously identified as “Sometimes therapy codes.”  Nurses trained in selective sharp debridement (97597, 97598) are permitted to perform based on the nurse practice acts of the states.  Nurses commonly perform Negative Pressure Wound Therapy 97605, 97606. A statement should be included that nurses working under a physician plan of care can perform these procedures as is a common practice in Maryland wound centers.”

Response:   HCPCS codes 97597, 97598, 97605 and 97606 have been identified as “Sometimes therapy codes.”  These codes can be used by non therapists in conjunction with a non therapy revenue code. 

Comment #16:  Page 5, No. 3, 2nd paragraph, sentence reads:  “A wound that shows no improvement after 14 days may require a new approach…” – “If this is specific to PT plan of care then this should be stated here. A contradictory statement appears on page 3 of this document indicating that after 30 days a new approach is required.”

Response:   If a wound fails to improve after 30 days, a new approach to wound care should be pursued.  Changes were made to make this requirement consistent throughout the LCD.

Comment #17:  Pages 5 and 6, Surgical Debridements 11,000 series – “This section states that these are physician only codes.  The Maryland Clinic Task Force has advised all clinics in Maryland to report debridements using the 10,000 series codes and not to use selective debridement codes 97597, 97598.  Caregivers authorized to perform sharp debridement including nurses and physical therapists working under a physician plan of care have been instructed to use the 11,000 series codes by the clinic Task Force in MD clinics despite the fact that selective sharp debridement more aptly describes the services provided by these caregivers.”

Response:   All procedures should be correctly coded; e.g., debridements (11000 series).  The Maryland Clinic Task Force does not have jurisdiction over claims submitted to Medicare.

Comment #18:  Pages 5 and 6, “Additionally these codes represent extensive ….times.” – “This statement seems to imply that these charges should be only be used in an OR setting. Please see above, MD clinics have been advised to use these codes for all debridements. Also the MD clinic task force stated that time studies could be performed to estimate the average time for each procedure and that start and stop times would not be needed if time study was performed.”

Response:   All procedures should be correctly coded.  The Maryland Clinic Task Force does not have jurisdiction over claims submitted to Medicare.

Comment #19:  CPT/HCPCS Codes – “If this is meant to be a complete list of diagnosis codes eligible for wound care the following codes should be added: 

Response:   This LCD does not address the care of burn wounds, so the burn codes were not added to the list of ICD-9 codes eligible for wound care.  The other two ICD-9 codes—459.33 and 705.83—were added to the list of eligible codes.

Comment #20:  Page 13, bullets #4 - Same comment as above in regarding start and stop times.

Response:   The requirement to submit the stop and start times of a debridement has been eliminated. 

Comment #21:  One commenter inquired if there are limits regarding the depth of a wound that would contraindicate a surgical debridement procedure?  Is a wound debridement performed by a sharp instrument, that is only 1-2 mm in depth, considered necessary and reasonable or should other methods be attempted first with supporting documentation?

Response:  Each wound is unique and must be evaluated and managed on an individual basis.  An initial debridement may be appropriate in some instances.  At all time the documentation submitted should support the medical necessity of the procedure performed.

One individual provided Comment # 22 through Comment #30.

Comment #22:  Pages 2 and 3, “Evaluation of wounds,” paragraph reads:  “Evidence of improvement lists:  drainage, inflammation, swelling, pain and/or tenderness, wound dimensions (surface measurements, depth), granulation tissue, and necrotic tissue/slough.” –  “It is nice to say that you have to have all of these documented, but in many cases a doctor may do a very good examination and if the wound shows granulation tissue that is healthy, he doesn’t have to state about drainage.  It is self-explanatory that gray granulation tissue would mean that there is not really any drainage or inflammation.  Swelling can be mentioned in the fact that you can use hyperemia or hyperthermia rather than the word swelling and tenderness may not be present, especially with a Stage III and IV decubitus and to mention there [is not pain] when it is self explanatory that a deep wound would not have pain in many instances.”

“…does the doctor know what he is doing in the note?  Is doing something for the patient and not go by the numbers.  If he doesn’t have six things written down, we are not going to pay him.  I agree that the patient should be documented on a weekly basis if he is going to an appropriate wound clinic, or if the wound is doing well enough it is up to that doctor that runs the wound clinic to decide to see the patient maybe every two weeks or once a month providing he has visiting nurses coming into the home.  His continued progress notes should insinuate what his plans are.”

Response:  The LCD states that “Evidence of improvement includes measurable changes in at least some of the following…”  Some of the following is the key phrase.  Not all parameters will improve at each evaluation.  The importance is to document improvement/progress in wound healing.  If there is no progress another evaluation and/or change in the wound care plan should be completed. 

Comment #23:  Page 3, Wet dressings, sentence reads:  “These dressings are specifically effective for moist, oozing and weeping lesions.” – “That is not true.  A wet wound would want to be kept dry and that would be a case where you would use a foam sponge dressing, Aquacel type dressing, or collagen dressing that would absorbent taking away the bad fluids and leaving it bathed in its own good fluids.  Keep in mind that there are many different hydrophilic/hydrocolloid dressings on the markets today by many companies.  Again the doctor will change from week to week and month to month the types of materials he will use.  That is why progress notes should be looked at in continuity, rather than at separate times.”

Response:  Wound dressings are selected by clinicians based on the status of the wound at a specific point in time.  The intent of this section is to describe the broad categories of dressings available and or the indications for the use of each specific dressing type.

Comment #24:  Page 3 regarding dressing changes – “…the dressings we are using today are very expensive from the different companies, and in many cases when we are dealing with grafts, the first dressing removals are done by the physician who does the graft to the tissue so that he can actually take the dressing off himself or if a wound is vascular, in many cases the doctor will remove dressings himself and not assign it to a non-physician.  This goes for podiatrists and dentists as well.  I think you have to read the progress note to see if the doctor is doing for a specific reason, and if so he should be reimbursed appropriately for his time and consideration in a very difficult wound.”  “It is important that [the physician sees] what is underneath the dressings, especially with very deep wounds or graft material.” 

Response:  Physicians, podiatrists, and dentists should perform and oversee post operative care. 

Comment #25:  Page 4a, Conservative sharp debridement – “Many times when you have a deep wound in the sacral or hip area on a elderly debilitated patient in a nursing home or at an extended care facility, you can do extensive sharp debridement at the bedside without anesthesia.  Normally …. I prep the area and excise by sharp knife dissection the tissue and usually these are Status III and IV decubiti and I do this all the way down into the muscle and sometimes down to bone at the bedside.  So location as to whether it is done at a hospital, in an emergency room or at an extended care facility or nursing home has nothing to do with the process that is being done.  It can be bleeding and many times I do suture ligation or silver nitrate stick application at the bedside.”

Response:  Anesthesia should be used if and when it is required.  This should be clearly documented in the medical record.  The absolute requirement for anesthesia to debride a wound has been eliminated.

Comment #26:  Page 5, Item 3, paragraph 2 on wound assessment – The commenter advised that the recommendation for a new approach here differs from 3 (page 3 states no improvement after 30 days requires a new approach, while page 5 states no improvement after 14 days requires a new approach). “It is better to have continuity with physical therapy, nutritionists and the doctors rather than have different set goals that may contradict each other.  Pick 14 or 30, it makes no difference as long as you have a set goal.”

Response:  If a wound fails to improve after 30 days, a new approach to wound care should be pursued.  Changes were made to make this requirement consistent throughout the LCD.

Comment #27:  Page 6, 3^rd bullet, sentence reads:  “The patient can be requested to pay for the investigational treatment under waiver of liability provisions of Medicare law, …” – “I think before something is considered investigational the doctor should be contacted before payment is negated or disallowed, so that you find out if it is really investigational or have things changed within a six month to a year period of time, or from the time that these recommendations have been written that some investigations studies may be actually current therapy.  It also will prevent aggravation between physicians, physical therapists, podiatrists, dentists and other doctors in their working relationship with Medicare.”

Response:  Currently Medicare does not have a predetermination process for investigational services.

Comment #28:  Pages 11 and 12, Documentation Requirements for Active Wound Care – “The twelve items that are suppose to be documented in the note, some of which to a treating physician mean very little and others that aren’t even mentioned would be mentioned by the doctor.  I think the care given by a physician has to have a well documented note, but I hate to see a point system where if you don’t meet ten out of twelve points you don’t get paid when a physician may be giving very good care and may be stressing other points that are more important than whether of not he states when the start of care was occurring and the date on which it was done.  Staging, depth of wound, character of the wound, anticipated plan of therapy, and prognosis are all important aspects in evaluation by a wound doctor, but a good wound doctor will do all of those and a note.  If not the first note, then by the second or third time he sees the patient you will see a whole picture if you evaluate the weekly evaluation of the doctor.

Also on the last five dots at the bottom, I really don’t consider start and stop of a procedure to be very important.  There are much more important things that need to be documented in a physician’s note and that is evaluating a wound that he is debriding rather than when I start the procedure and when I stop it.”

Response:  The requirement to submit the stop and start times of a debridement has been eliminated.

Comment #29:  “I think outcome based medicine is probably the best way to evaluate payment to doctors.  If after a period of two to three months taking care of a very significant wound progress is not noted, and if the doctor has not changed his methods or sought second opinions, I think Medicare has to worry about that individual taking care of the patient further.  However, there are extenuating circumstances, such as patients that are not adequately cared for by either the family or themselves.  Are they on proper nutrition?  If they are negative nitrogen balance, no matter what the doctor does he is only going to be slowing down the process of debilitation.  That doesn’t mean we don’t give care to the patient.  It means that our outcome is [not] going to be that of healing, but of slowing down or keeping the status quo of a wound.  At that point, your other services have to be looked at.  If the patient is not able to eat and we are doing all of these heroic methods of treatment, is there a point where Hospice should be involved and we should cut back on the expensive procedures to keep a wound clean and in a stable steady state while the patient has some dignity in dying.  I noticed that these were not addressed in the pages that I reviewed.”

Response:  All of the clinical information and evaluation that has been suggested should be part of the care of a patient who has a difficult wound.  All of these things should be considered when the wound has failed to make progress after 30 days.  Unfortunately, in some cases the underlying disease (PVD, cancer, diabetes) is so severe or far advanced that even “status quo” is unattainable.  All of the things suggested should be considered as extensions of or additions to the wound care treatment plan.     

Comment #30:  “I would like to see representatives from Medicare talk more with the doctors and their offices to get a better idea, not in an adversarial approach, but in a joint approach similar to what visiting nurses do when they are evaluating patients at home and are having questions they call on the telephone to get some guidance from us and sometimes I get guidance from them.  I think the same thing can happen with Medicare if they would clarify a case over the telephone as we are treating it rather than months or years later.  I think being proactive will conserve money.”

Response:   Representatives from Medicare are available by email, telephone, or traditional mail.  We are always willing to hear your questions/concerns and are willing to work on a resolution.

Comment #31:  One commenter suggested that we add the following three codes to the list of “ICD-9 Codes that Support Medical Necessity” – 608.83, 998.83, and 709.8.

Response:  These codes were added to the list of eligible ICD-9 codes

One commenter provided Comment #32 through Comment #36 regarding the “Surgical Debridement – HCPCS 11000-11001 and 11040-11044” section:

Comment #32:  The following comment is specific to start and stop times:

“There is no clinical practice guideline that requires documentation of start and stop times in connection with the treatment of the type wounds that generally present to a podiatric physician.  The concept time in treatment has no application.” 

Response:  The requirement to submit the stop and start times of a debridement has been eliminated.

Comment #33:  The following comments are specific to the anesthesia requirement.

“…while any of the codes may be correctly characterized as ‘extensive,’ and may indeed require anesthesia, this decision should be made at the discretion of the physician.”

“A significant percentage of the wounds/ulcerations seen in a podiatric practice are attributable to diabetic peripheral neuropathy.  These wounds rarely require any use of anesthesia during debridement, as the patient’s feet are already insensate.  In fact, the use of anesthesia can reduce the blood flow to an area that already exhibits vascular compromise.  In a case where the patient is medically compromised, the use of general anesthesia can result in increased morbidity and possible mortality in addition to the accompanying unnecessary increase in cost to the healthcare system.”

“[We} believe that the need for anesthesia during debridement(s) should be determined as medically necessary by the physician or healthcare provider and that documentation in the medical record should support the debridement performed.”

One commenter provided clinical examples of the use and non-use of anesthesia, and concluded by saying, “But to put in the policy that these are so extensive they almost of all of time require anesthesia is probably not true.  The data shows that of all the debridements, 52% of them are diabetic patients, and a very high percentage of them are neuropathic ulcers and the patients cannot feel that well.”

Response:  Anesthesia should be used if and when it is required.  This should be clearly documented in the medical record.  The absolute requirement for anesthesia to debride a wound has been eliminated.

Comment #34:  The following comments apply to both start and stop times and anesthesia:

“There are two requirements for surgical debridements of wounds contained in the LCD which are foreign to the normal course of care, which is also the community standard of care, in connection with wounds.  The LCD appears to uniformly require anesthesia for wound debridement and introduces the concept of ‘timing.’  While these two standards may apply to burn treatment, they are foreign concepts to the treatment of non-burn wounds.”

“There is an abundance of literature demonstrating the effectiveness of frequent debridement of diabetic ulcerations, and none of this literature includes the uniform requirement of anesthesia or ‘time’ computation.”

“To impose a requirement that all wound debridement(s) must be accompanied by anesthesia and ‘time’ management places patients at unnecessary risk.”

“Sometimes, that is required in a surgery center in a hospital, but in an office setting it is almost unprecedented.”

Response:   The requirement to submit the stop and start times of a debridement has been eliminated.  In addition anesthesia should be used if and when it is required.  This should be clearly documented in the medical record.  The absolute requirement for anesthesia to debride a wound has been eliminated.

Comment #35:  The following comments are general comments regarding this section:

“It would appear that the LCD is drafted to apply primarily to burn wounds….”

“While we realize that the draft LCD applies to all wounds and is not limited to either wounds involving the lower extremity or those associated with diabetes, of greatest concern to us in the effect of this policy on the Medicare diabetic patient population requiring debridement of ulcerations.”

Response:  The LCD does not address burn wounds.  Specifically stated in the in the LCD, “The policy addresses the care of wounds, including, but not limited to ulcers, pressure, ulcers, open surgical sites, fistulas, tube sites, and tumor erosion sites…”

Comment #36:  “If the proposed policy changes are a response to Highmark Medicare Services’ (HMS) concern with utilization of the debridement codes, we suggest that the HMS work with all of the local medical societies whose members are subject to the LCD, including the Pennsylvania Podiatric Medical Association, to formulate appropriate clinical guidelines.  If it is determined that provider education about wound care in general and debridement services in particular is warranted, the professional societies and representatives can assist the HMS in addressing that need.”

Response:  Highmark Medicare Services is able to provide education in a variety of venues.

Comment #37:  One commenter provided the following comments regarding the anesthesia guidelines for CPT codes 11040-11044 as found in the “Surgical Debridements” section, and recommended that the anesthesia requirement be removed from the policy:  “Based on our experience, these debridements are usually performed in an outpatient setting with the use of topical and/or injectable anesthesia.  We would never expect this level of anesthesia noted in your LCD would be administered or clinically appropriate in a hospital setting.”

Response:  Anesthesia should be used if and when it is required.  This should be clearly documented in the medical record.  The absolute requirement for anesthesia to debride a wound has been eliminated.

Comment #38:  One commenter provided the following opinion regarding the “stop and start times” requirement, and recommended that the guideline be removed from the policy:  “This is a requirement that one would only expect in the operating room setting.  In an outpatient clinic, it does not seem pertinent or necessary since the patient would not be sedated.”  And, “…the surgical debridement in an outpatient setting is part of an overall visit so it may include other services (i.e., evaluation and management).”

Response:   The requirement to submit the stop and start times of a debridement has been eliminated.

Comment #39:  A commenter advised that the policy does not provide a clear clarification of what a debridement is.  He advised that it is “removal of the vitalized tissue.” 

Response:  Debridement is defined in medical dictionaries and indirectly in CPT coding manuals.   

S-161, Complex Cataract Extraction

Comment #1:  The commenter suggested that there should be 2 additional indications for 66982:  1) miotic pupil which requires pupillary stretching, requiring iris retractors, Bechler expansion device, sector iridectomy, sphincterotomies, and manual techniques; e.g. Frye papillary stretching technique; and 2) mature cataract requiring dye for visualization and performance of capsulorhexis.

Response:  Both of these indications were added to the LCD.

Comment #2:  The commenter advised that the correct spelling is Beehler, not Beechler.  Another commenter noted that there are other devices available (other than the Beehler expansion device), and that the selection of the device should be left to the surgeon’s discretion.

Response:  The requirement for a specific device to dilate the pupil was deleted and a general description “pupil expansion device or technique” will be used.  

Comment #3:  The commenter advised that capsular rings are approved for use by the FDA; however, the draft policy advised that the device is not approved for use by the FDA.

Response:  The LCD was edited to recognize that these devices now have FDA approval.

Comment #4:  The commenter advised that the endocapsular ring is used to stabilize the capsular bag in the presence of weak or partially absent zonules in adult patients undergoing cataract surgery.  It is not used to partially occlude the pupil, as stated on pages 4 and 5 of the draft policy.

Response:  Reference to occlusion of the pupil by an endocapsular ring was removed from the LCD.

Comment #5:  The commenter suggested the addition of “manual papillary stretching” in several of the paragraphs pertaining to the diagnoses requirements.

Response:  Manual papillary stretching is incorporated in the description “pupil expansion device or technique.”

Comment #6:  The commenter suggested that we add to the Indications section the information found under the diagnoses requirements for 366.17; i.e., “if the operative note indicates dye was used to stain the anterior capsule.”

Response:  The Indications section of the LCD was expanded to include the “use of capsular dye to assist in the visualization of the anterior capsule in performing capsulorhexis.”

Comment #7:  One commenter stated that often an IOL implant is a part of cataract surgery, and asked, “Are all types of implants covered as part of surgery?  If not, that should be clear in this policy.  Or is it described in another policy.  If latter, then there should be a reference or link to that other policy.”

Response:  Information about payment for IOL can be found in the Medicare Claims Processing Manual, Chapter 32, Section 120 and in Chapter 14, Sections 10.2 and 40.3.  This is an Internet Only Manual designated as IOM Pub. 100-4.  NCD 80.12 also discusses IOL.

One commenter provided recommendations for additions (underlined) and deletions (strike through) in Comment #8 through Comment #13.    

Comment #8:  Indications, Item #1:  “A miotic pupil which will not dilate sufficiently to allow adequate visualization of the lens in the posterior chamber of the eye and which requires any of the following techniques; the insertion of four (4) iris retractors through four (4) additional incisions, Beechler a pupil expansion device or technique, a sector iridectomy with or without subsequent suture repair of iris sphincter, and sphincterotomies created with scissors.”

This commenter advised that the correct spelling is Beehler who invented a pupil expansion device; however, it is only one of man devices that the surgeon may select.

This commenter also advised that not every sector iridectomy needs to be sewn back together.

This comment regarding the deletion of “four (4)” was repeated by another commenter:  “I cannot see why four should be required if fewer will do the job.  In addition, sometimes more than four are necessary.”

Response:  The proposed changes were all made except the word “multiple” was used in the place of “four (4).”

Comment #9:  Indications, Item #2:  “The presence of a disease state that produces lens support structures that are abnormally weak or absent. This requires the need to support the lens implant with permanent intraocular sutures. Or when a capsular support ring may be is necessary to allow placement of an intraocular lens. At this time capsular support rings have not be approved for use by the FDA.”

This commenter advised that capsular support rings have been approved by the FDA.

Response:  The LCD was edited to recognize that these devices now have FDA approval.

Comment #10:  Indications, Item #4:  Delete:  “Fourth, extraordinary work may occur during the postoperative period. This is the case with pediatric cases mentioned above and very rarely when there is extreme postoperative inflammation and pain.”  Add:  “The use of a capsular dye for the assisted visualization of the anterior capsule in performing capsulorhexis.”

This commenter advised that capsular dye use should be added for the visualization of the anterior capsule for the capsulorhexis.

Response:  The Indications section of the LCD was expanded to include the use of capsular dye as suggested.

Comment #11:  One commenter suggested the following Medicare Part A changes regarding Bill Type Codes and Revenue Codes:

       Bill Type Codes:

MD—A  13X and 83X  and descriptors

PA—A   11X and 13X and 85X and descriptors

PA—B   99X and descriptors

Revenue Codes:

MD—A      036X and 049X and descriptors

PA—A  36X

PA-B  99999

Response:  These were part of the draft LCD for Medicare Part A; they do not apply to Medicare Part B.

Comment #12:  One commenter suggested that we delete all of the guidelines following the list of “ICD-9 Codes That Support Medical Necessity,” and replace it with the following:  “The operative note must support the use of any of the previously noted techniques when billing for a complicated cataract procedure.”

Response:  The detail of the operative technique is required to insure that claims are reviewed accurately.

Comment #13:  One commenter questioned the descriptor used for ICD-9 365.51.

Response:  The proper information for the descriptor of 365.51 will be added to the final LCD.

Comment #14:  One commenter wrote in support of additional compensation to the ambulatory surgical center when capsular dye is used to better define the anterior capsule prior to capsulorhexis at cataract surgery and also when it is determined that the use of BSS+ (Balanced Salt Solution with Glutathione).  The commenter further opined that the use of these materials should be considered a complex cataract.

Response:  The Indications section of the LCD was expanded to include the “use of capsular dye to assist in the visualization of the anterior capsule in performing capsulorhexis.”

Comment #15:  One commenter noted that the Indications section does not include a simple designation of poor dilation as the reason for using mechanical iris dilation at surgery.

Response:  The use of mechanical pupil dilation was added and is described by “pupil expansion device or technique” in the LCD.

Comment #`16:  One commenter provided the following opinion regarding the designation of complex cataract extraction:  “If a superior sector iridectomy is required to gain adequate exposure, the surgeon should be required to subsequently suture the iris sphincter in order for the procedure to be considered complex.  Whether or not the iris is sutured should be left to surgical discretion and in no way affects the fact that the iris had to be cut to obtain better exposure.  An operation complex enough to require capsular dye should also be reimbursed as complex.”

Response:   The requirement to suture the iris sphincter was eliminated and the Indications section of the LCD was expanded to include the “use of capsular dye to assist in the visualization of the anterior capsule in performing capsulorhexis.”

Comment #17:  One commenter found Indication #3 regarding pediatric cataract surgery confusing:  “I am not sure how you know there will be extraordinary work during the postoperative period, unless there has been an intraoperative complication.”

Response:  Extraordinary work after performing a pediatric cataract extraction could be apparent at the time of the operation or determined in the postoperative period.

Comment #18:  One commenter noted the increase in complex cataracts due in large part to the increase use of alpha-agonists, specifically, Flomax®.

Response:  This is an observation that has yet to be documented in the medical literature. 

Comment #19:  One commenter advised that the pre-operative clearance should clearly note the use of Flomax®.

Response:  All pre-operative evaluations should include an evaluation of current medications as well as recent medications that might impact the outcome of any operative procedure.

X-3Q, Computerized Axial Tomography (CT Scans)

Comment #1:  One commenter wrote in support of the draft policy, as written

Comment #2:  One commenter stated concern that the intent of the policy is to give the carrier the right to pre-certify all CTs. 

Response:  Medicare fee-for-service contractors cannot pre-certify services. 

Comment #3:  One commenter advised that the medical decision making for ordering CTs has nothing to do with diagnosis, but has to do with a complex set of clinical indicators; i.e., one headache needs a CT, another does not.  “You cannot computerize that easily so maybe the policy should be dropped.” 

Comment #4:  One commenter opined that the draft policy “is more likely to trip up valid claims than to identify erroneous claims.  It is likely that ICD-9 codes will be missed.”

Comment #5:  One commenter advised that the LCD should be retired.  This would be taken partly from the framework of what is going on in Medicare with pay-for-performance (PQRI). 

Medicare must decide whether to require certain testing for diagnoses for which performance is measured, and retire LCDs that may conflict with the new process.

Comment #6:  One commenter asked whether this broad LCD is useful - how many claims come through that get denied because they do not have an appropriate ICD-9-CM code? 

Response to #3 - #6:  With multiple comments regarding possible retirement of this long-standing LCD, we reviewed our data again, including an assessment of the current effectiveness of this LCD.  This LCD will be retired, and the data followed.  If aberrancies occur, they will be explored.  If the criteria for development of an LCD recur, a new LCD will be developed through the full process.

Comment #7:  One commenter recommended “the inclusion of open/closed fractures of all tarsal/metatarsal bones and Lisfranc’s joint injuries.  Because these bones are superimposed on most radiographs, they are very difficult to observe and diagnose.  The CT scan can be very helpful in getting an accurate diagnosis and planning for adequate care, whether conservative or surgical.”

Comment #7:  A commenter advised that the ICD-9 codes that support medical necessary of CT scans of the maxillofacial area much too limited.  This commenter, therefore, provided the following information with a request to defer finalizing the policy:   “The CT is now recognized as the diagnostic test to measure sinus disease and especially detect Osteal-meatal obstruction. The measures being developed by the Physician Consortium for Performance Improvement by the ENT and Allergy Specialties will spell out the role of CTs of the sinus area in the management of maxillofacial disease and especially sinusitis.  I request that you defer acting on this LCD until this measure is fully developed and vetted thru the AQA.”

Comment #9:  One commenter inquired if there are reasons not to do CTs based on diagnosis codes?  This commenter advised that there are a few missing for autoimmune connective diseases, most of which affect the lungs. 

Response to #7 - #9:   Please see response to comments 3-6, above.