Draft LCD Comments with Contractor Responses: February 2008

Click a link below to drop to the area of the document containing comments and responses on that policy.

February 2008 Draft LCDs

I-6J - Approved Drugs and Biologicals
I-7V - Erythropoiesis Stimulating Agents (ESAs)
M-62F - Scanning Computerized Ophthalmic Diagnostic Imaging
R-13 - Radiation Therapy Services
Z-56G - Trigger Point Injections
Z-61B - Paravertebral Facet Joint Nerve Block and Sacroiliac Joint Injection

J12 MAC LCDs

J12-D1 - Approved Drugs and Biologicals
J12-D2 - Blepharoplasty/Blepharoptosis
J12-D3 - Blood Glucose Monitoring in a Skilled Nursing Facility (SNF)
J12-D4 - Botulinum Toxin Type A and B
J12-D5 - Cancer Chemotherapeutic Agents
J12-D6 - Cardiovascular Stress Testing
J12-D7 - Cataract Surgery
J12-D8 - Chiropractic Services
J12-D9 - Co-Management of Surgical Procedures
J12-D10 - Complex Cataract Extraction
J12-D11 - Computed Tomographic Angiography of the Chest
J12-D12 - Consultations
J12-D13 - Coverage of Services and Procedures in Nursing Facilities
J12-D14 - Routine Foot Care
J12-D15 - Debridement of Mycotic Nails
J12-D16 - Diagnostic Laryngoscopy
J12-D17 - Monitored Anesthesia Care (MAC)
J12-D18 - Electrocardiography
J12-D19 - End - Diastolic Pneumatic Compression Therapy
J12-D20 - Erythropoiesis Stimulating Agents (ESAs)
J12-D21 - Evaluation and Management Services in a Nursing Facility
J12-D22 - Fluorescein and Indocyanine Green Angiography
J12-D23 - Fundus Photography
J12-D24 - Intraoperative Neurophysiological Testing
J12-D25 - Luteinizing Hormone-Releasing Hormone (LHRH) Analogs
J12-D26 - Magnetic Pelvic Floor Stimulation (MPFS)
J12-D27 - Magnetic Resonance Imaging (MRI) of the Breast
J12-D28 - Moh's Micrographic Surgery
J12-D29 - Non-Invasive Cerebrovascular Arterial Studies
J12-D30 - Non-Invasive Peripheral Venous Studies
J12-D31 - Ophthalmic A and B Scans
J12-D32 - Ophthalmic Biometry for Intraocular Lens (IOL) Power Calculation
J12-D33 - Extended Ophthalmoscopy
J12-D34 - Parathormone (Parathyroid Hormone)
J12-D35 - Paravertebral Facet Joint Nerve Block and Sacroiliac Joint Injection
J12-D36 - Physical Medicine and Rehabilitation Services, PT and OT
J12-D37 - Psychiatric Therapeutic Procedures
J12-D38 - Radiation Therapy Services
J12-D39 - Radiologic Examination of the Chest (CXR)
J12-D40 - Real-Time, Outpatient Cardiac Monitoring
J12-D41 - Removal of Benign or Premalignant Skin Lesions
J12-D42 - Removal of Impacted Cerumen
J12-D43 - Scanning Computerized Ophthalmic Diagnostic Imaging
J12-D44 - Sleep Disorders Testing
J12-D45 - Speech-Language Pathology (SLP) Services
J12-D46 - Surgical Treatment of Nails
J12-D47 - Surveillance of Implantable Cardioverter-Defibrillator (ICD), Office, Internet or Non-Internet Based
J12-D48 - Thermotherapies (Minimally Invasive Surgical Techniques [MISTs] for Benign Prostatic Hyperplasia (BPH))
J12-D49 - Transesophageal Echocardiography (TEE)
J12-D50 - Transthoracic Echocardiography (TTE)
J12-D51 - Treatment of Dysphagia (Swallowing Disorders), General; Includes VitalStim® Therapy
J12-D52 - Treatment of Varicose Veins of the Lower Extremities
J12-D53 - Trigger Point Injections
J12-D54 - Visual Fields
J12-D55 - Wound Care
J12-D56 - Acute Care: Inpatient, Observation, and Treatment Room Services Comment Period Closed
J12-D57 - Human Skin Equivalents (HSE) - Use in the Treatment of Chronic Cutaneous Ulcer Wounds

I-6J Approved Drugs and Biologicals

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

Comment 2: One commenter quoted the Medicare Claims Processing Manual (100-04), Chapter 12, Section 30.5.F, and opined that the following statements under the "Indications and Limitations of Coverage and/or Medical Necessity" section may not be correctly stated.

"Note: Payment for the administration of an injection is included in the payment for the office visit or any other service performed on that day. However, the administration may be paid when performed independently."

Response: The LCD has been rewritten to be in compliance with IOM 100-4, Chapter 12, Section 30.5.F and other directives (such as the one stated above) from CMS.

Payment for the administration of a nonchemotherapy injection or infusion may be paid when provided on the same day as an E&M service, other than 99211, if the E&M service represents a separate and significantly identifiable service. Modifier 25 must be used. A different diagnosis code is not required.

Comment 3: One individual inquired if we do not pay for off-label uses that are generally accepted.

Response: Off-label use of drugs must comply with the national Medicare guidelines as stated in the IOM 100-4 (Medicare Benefit Policy Manual), Chapter 15, Section 50.4.2.

Comment 4: One individual inquired how we handle biologicals or other drugs available in multiple dose form; i.e., where one is eligible under Part B and another under Part D.

Response: Each contractor is required to submit a list of self-administered drugs and biologicals. Self-administered drugs are reimbursable under Part D. Drugs that are no self-administered are reimbursed under Part B.

Comment 5: One individual asked if we have abandoned the lists of eligible or ineligible conditions for individual drugs and biologicals.

Response: Many drug-related policies have been retired over the past several months. Therefore, the LCD, Approved Drugs and Biologicals, provides the direction for use of these drugs. The LCD I-6J, Approved Drugs and Biologicals, provides direction for the use of these drugs. The LCD I-75, Cancer Chemotherapeutic Agents, provides direction for the use of anti-cancer drugs.

Comment 6: One commenter suggested that we add a 2-3 line statement on our website advising why there are no longer lists of covered or non-covered conditions for the individual drugs and biologicals.

Response: The listing of retired LCD’s has been posted to the Highmark Medicare Website.

Comment 7: One commenter inquired if there is a pre-approval process.

Response: Currently there is no pre-approval process for any drug, procedure, or service.

Comment 8: One individual inquired, how does Highmark Medicare Services handle drugs that can be dually administered? On this subject, another commenter suggested two J codes for a single product, one for each type of administration.

Response: J codes are not established by this contractor. We understand that the coding system is not perfect and may require continuous modification. However, until changes are enacted we must use the codes that currently are available. Therefore, when submitting claims, one must adhere to correct coding guidelines and use the codes that most accurately describe the service provided.

* These comments were considered; the corresponding J12 MAC LCD draft is J12-D1.*

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J12-D1 (l27473) Approved Drugs and Biologicals

Comment 1: One commenter requested approval for the following injectable drugs: Lucentis, Macugen, and Avastin (as prepared by a compounding pharmacy) for the diagnosis of Wet AMD (362.52) and other diagnoses related to other retinal vascular diseases; i.e., diabetic retinopathy, retinal vein occlusion, robeosis, and other neovascular and vascular disorders of the eye.

Response: Drugs that are reasonable and necessary for the diagnosis and/or treatment of a condition, are not usually self administered and are provided incident to a physician’s service will be covered if they meet the level of evidence required by the policy for coverage in the absence of FDA labeled indications, provided such use is not contraindicated by the FDA labeling.

Comment 2: One commenter inquired if we will pay for Avastin (J9035) for macular degeneration (362.52).

Response: See the previous response.

Comment 3: One commenter recommended that the policy be changed to indicate that physicians do not need to be in the room for the administration of pharmacological agents or biologicals; rather, be present in the suite.

Response: Currently, the CMS On-line Manual Pub. 100-2, Chapter 15, Section 50.3 states the requirements that must be met to bill drugs incident to the physician’s service. It states what has been stated in the policy, “Must be furnished by a physician; and

Must be administered by the physician, or by auxiliary personnel employed by the physician and under the physician’s personal supervision.”

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I-7V Erythropoiesis Stimulating Agents (ESAs)

Comments regarding use of ESAs in cancer patients receiving chemotherapy:

Comment 1: Several commenters addressed anemia due to the treatment of cancer with chemotherapy drugs:

"The National CMS guidelines reimburse for ESAs when used to treat anemia due to chemotherapy. I did not see any mention of this in this draft."
“The National Coverage Determination 110.21 published with CR 5818 on January 14, 2008 does cover ESAs for patients with chemotherapy induced anemia. Although the recent FDA changes (March 9, 2008) further limits the use the ESAs in patients with curable disease and with breast and head and neck cancer, there still appears to be possible coverage under the NCD for patients with non-curable cancer and chemotherapy induced cancer not related to breast or head or neck cancer. Could you please clarify Highmark's position?"
“Where are the guidelines provided for ESA usage for anemia due to chronic disease of cancer, chemotherapy related, and radiation therapy related?”

Response: As noted, CMS has published an updated National Coverage Determination that addresses ESA use in the treatment of anemia in cancer patients. Because NCDs take precedence over LCDs, please follow the direction given by the CMS NCD. The references and a note explaining this are found in our LCD, and reprinted in part, below.

“1. There is an updated NCD for use of Erythropoiesis Stimulating Agents, ESAs, in Cancer and Related Neoplastic Conditions. These uses are not addressed in this LCD. Please see Change Request (CR) 5818 (details in CMS National Coverage Policy section, above) and MLN Matters article number MM5818 for specific instructions on these uses of ESAs. This CR is retroactive to July 30, 2007.

2. One area of the NCD discussed in CR 5818 does not have specific ICD-9-CM codes. Please see this contractor’s Billing and Coding article for further instructions (to follow).

3. The CR 5699 (details in CMS National Coverage Policy section, above) and MLN Matters article number MM5699 give specific instructions on the reporting of hematocrit or hemoglobin levels with use of ESAs, as well as other anti-anemia drug use. They further describe the modifiers required. This CR is retroactive to January 1, 2008.”

Comments regarding use of ESAs in kidney disease:

Comment 1: Multiple commenters wrote about the Hb / HCT criteria, providing specialty and other guidelines, community standards of care, and scientific evidence / clinical literature. A few specific comments included:

“The NCD from CMS has been targeted to oncology, not CKD including ESRD. There is data ….that points clearly that HgB below 11 have higher mortality and morbidity. The FDA had reflected that there is a difference between oncology and patients with CKD including ESRD. All data from a quality point of view indicates that sub 11 HgB patients have worse outcomes."
One commenter proposed the following LCD change under the "Indications and Limitations of Coverage and/or Medical Necessity" section B1: "For chronic kidney disease patients NOT on a dialysis, ESA therapy should be initiated to achieve and maintain a Hb level within the range of 10 to 12 g/dL (Hct range of 30% to 36%). The proposed recommendation is consistent with the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines which recommend the selected Hb target should generally be in the range of 11 to 12 g/dL. The 2008 PQRI for ESAs references the NKF KDOQI guidelines stating that ‘in dialysis and nondialysis patients with CKD receiving ESA therapy, the selected Hb target should generally be in the range off 11.0 to 12.0 g/dL.’”
"The current overwhelming data demonstrates that targeting HgB hemoglobin to lower values (10-12 g/dL) increases the number of patients who spend time at sub 10 values less than 10 g/dL. The data indicates the that mortality, hospitalizations and costs increase when patients spend time with hemoglobin concentrations below 10 g/dL. There is no data that there are safety issues associated with Hgb hemoglobin concentrations below 12 g/dL. We want to assure that changes in reimbursement policy do not adversely affect outcomes, recognizing that . Rrestrictive management policies hinder the achievement of targeted goals."
One commenter inquired if patients who are already being treated will be allowed to continue their treatment, or will treatment have to be stopped until they meet the new guidelines; e.g., go below 30 in CKD?

Response: The Hb/HCT criteria for use of ESAs in patients with ESRD on dialysis, and chronic kidney disease not on dialysis, have been revised to: “Treatment with ESAs is given to achieve and maintain a Hb level of 10-12 gm/dL.”

Comment 2: Commenters asked about the frequency of the serum creatinine monitoring; and noted that a serum creatinine equal to or greater than 3 is generally equivalent to a GFR of less than 30. For a GFR or creatinine clearance less than 60, the corresponding creatinine in most patients is 1.5-2.0. This commenter also suggested that we remove the creatinine requirement, noting that "almost all of the labs across the state report the GFR or are mandated to do so and should be within the next 6 months. Literature supports the use of these agents in any patient who has a GRF of less than 60 associated with it."

Response: This has been revised in the final LCD.

Other Comments:

Comment 1: One commenter noted that in the "Documentation Requirements" section it states that the patient's weight must be documented in kilograms; however, it was this commenter's opinion that it is unsafe to require manual conversions into kilograms. The commenter further stated that "many electronic medical records and CPOE systems require the patient's weight be entered in pounds and the system performs automated calculations and dosages conversions in the background. This is a patient safety factor to prevent math/transcription errors during conversions."

Response: This change has been made in the LCD, but the dose of ESAs is calculated per kilogram. It is still expected that the dosing itself will be done with the weight in kilograms.

Comment 2: One commenter provided the following recommendation: "In regards to coverage criteria of the mentioned disease states, a Hb less than 10 mg/dl or HCT less than 30% at initiation of therapy will be covered. Please detail coverage Hbg for maintenance therapy."

Response: This has been clarified in the final LCD.

Comment 3: One commenter recommended that we add ICD-9 238.73 (high grade myelodysplastic syndromes).

Response: This has been added, along with additional codes.

Comment #4: Other indications:

"Our clinicians feel that anemia in cardiac disease and anemia in diabetes may also be appropriate for coverage and request that these be added to the policy as potentially reasonable with supporting documentation reflective of specific clinical situation."
"Would the use of an erythropoiesis stimulating agent not be reasonable in an acute situation such as post transplantation with temporary erythropoiesis failure?"
One commenter suggested that we broaden the list of chronic inflammatory diseases: "Obviously, that list of disorders includes many more even than polyarteritis, temporal arteritis, and the vasculitic syndromes. There are mixed connective tissue diseases such as Shogran’s syndrome, scleroderma, and other inflammatory arthritis disorders that include scoriatic arthritis and arthritis associated with inflammatory bowel disease. That whole group of inflammatory arthritis disorders all cause anemia of chronic disease. It is not restricted to rheumatoid arthritis or systemic lupus. Many of those patients are on immunosuppressive agents which are not considered chemotherapy agents by Medicare’s definition, but still have the same suppressive effects on bone marrow and develop anemia as well. We need to broaden the list of disorders either with or without other immunosuppressive agent therapy."

Response: Individual consideration is available with LCDs. No literature was presented in support of the indications suggested. These issues will be followed and re-evaluated over time; the LCD can be liberalized without comment and notice as per the requirements described in the Medicare Program Integrity Manual (IOM 100-08), Chapter 13.

* These comments were considered; the corresponding J12 MAC LCD draft is J12-D20.*

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J12-D20 (L27492) Erythropoiesis Stimulating Agents (ESAs)

Comment 1: One commenter opined in part: "When one looks at the studies in entirety, the data is clear that the proper usage of these agents is per the prior FDA guidelines. This is completely safe. There is no data that it is unsafe with the proper levels of hemoglobin."

Response: The draft LCD was developed in keeping with the FDA recommendations.

Comment 2: One commenter suggested that we change the surgical coverage from hip and knee to "non-cardiac, non-vascular" surgeries.

Response: No literature was provided in support of the request for expansion of coverage. In review of the question raised, the FDA labeling and the CMS guidance are not identical. The CMS guidance, found in the CMS Medicare Benefit Policy Manual IOM 100-02, Chapter 15, Section 50.5.2.2 – Medicare Coverage of Epoetin Alfa (Procrit) for Preoperative Use, states “hip or knee surgery”.

Comment 3: One commenter requested that the LCD be more specific regarding H&Ps: are they required?; how old can an H&P to be acceptable for the service described in the LCD and how long can it be used for?; and does the H&P have to be from the physician ordering the ESA drug?

Response: The medical record needs to contain documentation that supports the medical necessity for the use of the ESA (details by condition are in the Documentation Requirements section of the LCD). The specifics of the information are dependent on the patient situation.

Comment 4: Several commenters recommended expanding the criteria and the eligible ICD-9-CM codes for the use of ESAs in patients with anemia and myelodysplastic syndrome (MDS), as well as suggesting wording changes. "A recent article, Park et al (Blood 2008 111:574-582), which is attached, specifically states: 'Significantly higher response rates were observed with less than 10% blasts, low and int-1 International Prognostic Scoring System (IPSS),…'" 2) The policy should instruct physicians to report on the claim the patient's bone marrow blast count. 3) "I agree with the American Society of Hematology that the blast % should be increased from 5% to 10%." 4) "Due to inadequacies with the existing ICD-9 definitions and the fact that there are a group of patients in ICD-9 codes 238.73 -238.75 who would benefit from ESA therapy"; requested expansion of ICD-9-CM codes.

Response: The literature supplied supports the requested expansion of coverage. The suggestions for wording changes were adopted when feasible, for clarification and to make the LCD least restrictive.

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M-62F Scanning Computerized Ophthalmic Diagnostic Imaging

Comment 1: One commenter requested that we expand the limitation definition provided in the draft policy for Optical Coherence Tomography (OCT) from the evaluation of retina disease only to include glaucoma and neuro management.

Response: The LCD has been expanded to cover glaucoma with little restriction. Full-text, peer-review literature to substantiate the management of specific neurological conditions and their management was not submitted so this diagnostic area was not expanded.

Comment 2: One commenter "disagreed with the use of rim/disc ratio in the definitions of mild, moderate and advanced damage from glaucoma. Although George Spaeth, MD at Wills Eye espouses the use of the narrowest rim-disc ratio to determine the DDLS (disc damage likelihood scale), only a small minority of PA ophthalmologists employ this technique - most, instead, use the cup to disc ratio in their office notes."

Response: Since this technology is widely used in the evaluation of glaucoma, the restrictions and categorization of glaucoma based on severity was removed from the LCD.

Comment 3: One commenter agreed with the elimination of "intraocular pressure equal to or greater than 22 mm Hg under the 'mild' glaucomatous damage paragraph."

Response: Since this technology is widely used in the evaluation of glaucoma, the restrictions and categorization of glaucoma based on severity was removed from the LCD.

Comment 4: One commenter provided the following comment regarding the Limitations/Glaucoma/Mild Damage/Visual Field section: "Nasal step and defects of the Bjerrum area should be eliminated (and moved to the 'moderate damage' paragraph). One of the advantages of SCODI is its use on patients who do not have classic field defects, or who may have mild reduction in retinal sensitivity or no field defects at all and/or disc asymmetry (which was listed in the original version, but not the draft version); i.e., glaucoma suspects."

Response: Since this technology is widely used in the evaluation of glaucoma, the restrictions and categorization of glaucoma based on severity was removed from the LCD.

Comment 5: One commenter provided the following comment regarding the Limitations/Glaucoma/Mild Damage section: "Nerve fiber layer drop is the earliest detectable sign and is best detected by SCODI. In the individual patient, there is no way to tell from the first SCODI whether the progression will be rapid or slow. Therefore, SCODI at six moth intervals would be more appropriate in many cases.

Many prominent glaucoma specialists feel that four to six visual fields are required to establish an adequate baseline. Most patients will not return for four to six visual fields over a short period. Again, SCODI every six months would be more reliable, being an objective measure, particularly since some patients are never able to do reliable visual fields. Moreover, corroboration of progression is needed when change is suspected only on the optic nerve or the visual field, but not both simultaneously."

Response: The frequency of SCODI was clarified in the policy. If SCODI is used to assess retinal changes, the frequency of exams now allowed is one exam/eye/2 months. If SCODI is used to assess glaucomatous related changes, the frequency of the exams now allowed is two exams/eye/year.

Comment 6: Several commenters provided opinions regarding the frequency for the Limitations/Glaucoma/Moderate Damage section:

It should be made clear that "up to two tests per eye per year should be allowed."

"Two tests are probably adequate but some patients might require more since we are not really dealing with the amount of damage, but rather, the rate of progression. SCODI more than once a year is especially useful for corroboration of progression when change is seen in optic nerve or visual field, but not both at the same time."

Comment 7: One commenter provided the following comment regarding the Limitations/Glaucoma/Moderate Damage/Visual Field section: "I feel that other field defects should be listed, including arcuate defects, nasal step and paracentral scotomas. The temporal wedge is not frequently seen compared with these other field defects."

Response: Since this technology is widely used in the evaluation of glaucoma, the restrictions and categorization of glaucoma based on severity was removed from the LCD.

Comment 8: One commenter disagreed with the Note provided in the Limitations/Glaucoma/Advanced Damage section, and advised: "The newer programs in HRT and GDx are able to quantify this late change and thereby track late progression. Therefore, SCODI is quite useful in advanced glaucoma, especially in those patients who cannot respond well to even 10 degree macular fields or to finding the remaining temporal crescent."

Response: Since this technology is widely used in the evaluation of glaucoma, the restrictions and categorization of glaucoma based on severity was removed from the LCD.

Comment 9: Several commenters disagreed with the frequency guidelines provided in the Limitations/Glaucoma section and advised:

"While not every patient may need SCODI more frequently, most of the time it should be allowed at the discretion of the ophthalmologist at every stage of the disease."

Regarding mild damage: "Some patients do progress quickly and progression software is most accurate after three tests. Waiting three years, as suggested by the current once a year coverage, to receive the most accurate progression data will mean that some patients will experience progression of the disease. Studies have shown progression at rates of 10% over five years for patients diagnoses with ocular hypertension that do not receive treatment. EMGT showed progression in over one half of the 'early patients.'"

"Expanding the coverage to allow for more frequent testing for patients with 'mild' glaucoma would help in identifying glaucomatous changes at earlier stages, prompting initiation of treatment to avoid/slow progression of the disease."

Response: Since this technology is widely used in the evaluation of glaucoma, the restrictions and categorization of glaucoma based on severity was removed from the LCD. The frequency of SCODI was clarified in the policy. When SCODI is used to assess glaucomatous related changes, the frequency of the exams now allowed is two exams/eye/year.

Comment 10: One commenter addressed 0187T and provided the following:

"The new code 0187T acknowledges the introduction of anterior segment imaging. This new technology makes possible three-dimensional and cross-sectional images which help in the identification and evaluation of abnormalities in the anterior chamber angle, cornea, iris, and lens which can impact treatment options. We are now able to map corneal thickness, evaluate keratoconus, measure LASIK flaps and stromal bed thickness, gauge anterior chamber angle, measure the dimensions of the anterior chamber and assess the fit of intraocular lens implants, visualize and measure the results of corneal implants and lamellar procedures, and look beyond corneal opacities to see internal eye structures.

Current policy addresses glaucoma and retinal diseases and disorders but fails to address the corneal and anterior segment diagnoses for which the new anterior segment imaging is found to be invaluable."

Based on the above, this commenter requested that the following diagnoses be allowed for 0187T:

371.00-371.05 Corneal Opacity and other disorders of cornea

371.20 to 371.24 Corneal Edema

371.30-371.33 Changes of Corneal Membranes

371.40 - 371.49 Corneal Degenerations

371.50-371.58 Hereditary Corneal Dystrophies

371.60-371.62 Keratoconus

371.70 - 371.73 Other corneal deformities

370.00-370.07 Corneal Ulcers

370.20-370.24 Keratitis without conjunctivitis

370.8 Other forms of keratitis

370.60 - 370.64 Corneal Neovascularization

V42.5 Corneal Transplant status

360.34 Anterior chamber, flat, hypotony

360.51 Anterior chamber, foreign body, old (magnetic)

360.61 Anterior chamber, foreign body, old (nonmagnetic)

743.48 Anterior segment anomalies, multiple

743.49 Anterior segment anomalies, other

996.51 Complication due to corneal graft

996.53 Complication due to ocular lens prosthesis

996.59 Complication due to other implant and internal device, NOS

V45.69 s/p eye surgery

V43.1 pseudophakia

364.60-364.64 Cysts of Iris, ciliary body and anterior chamber

364.70-364.77 Adhesions and disruptions of iris and ciliary body

367.20-367.22 Astigmatism

371.71 Corneal Ectasia

Response: A separate section was created in the LCD to describe anterior SCODI. Specific ICD-9-CM codes were identified that would address specific conditions where this exam would be helpful.

Comment 11: One commenter addressed 92135 and provided the following:

"Scanning computerized ophthalmic diagnostic imaging (SCODI) (92135) covers a wide array of equipment (OCT, HRT, GDx) which provide the most accurate measurement and visualization of retinal nerve fiber layers and ganglion cells. The data gained from this testing has become an invaluable tool to monitor glaucoma and retinal diseases as acknowledged by current policy. The information leads to earlier detection and more thorough monitoring of diseases allowing treatment to begin sooner thus making it possible to slow or halt the disease progression.

This testing is proving to be just as valuable a resource to neuro-ophthalmologists and oculo-plastic specialists. It is increasingly useful for monitoring optic nerve disorders caused by brain neoplasms and systemic diseases with ocular manifestations. Neuro-ophthalmologists are frequently sent patients with vague, subjective visual disturbances that may not have any clinical findings during the typical ophthalmological exam. For many patients the first manifestation of a systemic disease or a brain neoplasm is a visual complaint. Visual field testing is not as sensitive in detecting subtle changes and other neurological (MRI, CT) imaging may not pick up ocular manifestations as early as ocular imaging.

Researchers at the University of Pennsylvania are using the optical coherence tomography's RNFL measurements as a biological marker for neuronal and axonal loss. OCT is also being utilized in studies of neuroprotective therapies for MS and optic neurititis. Dr. Laura J. Balcer, MD, MSCE (University of Pennsylvania, Philadelphia) experience with MS patient indicates that Snellen visual acuity measurement does not capture subtle vision dysfunction. Dr. Peter Calabresi (Johns Hopkins University, Baltimore), Dr. Balcer, and colleagues published an article in Ophthalmology 2006 Feb; 113(2):324-32) reporting on their OCT study of 90 subject with multiple sclerosis and 30 subjects without MS. They found that subjects with MS had more reduction in retinal nerve fiber layer thickness than in controls without MS. Another article published in NEUROLOGY 2007; 69:1603-1609 suggest that optical coherence tomography (OCT) quantification of RNFL provides concurrent information about MRI brain abnormality in MS associated with brain parenchymal fraction and CSF volume.

Testing such as OCT, HRT, and GDx along with visual field testing and/or retinal photography allows more objectivity that can detect and quantify subtle changes in the eyes that may not present clinically during the exam. The improving technology allows the ophthalmologist to pick up changes in the RNFL before visual field loss occurs and begin treatment earlier."

Based on the above, this commenter requested that the following diagnoses be allowed:

Ophthalmic Conditions

377.10 - 377.16 Optic Atrophy (377.14 and 377.15 are on current LCD)

377.21-377.24 Other disorders of optic disc

377.30-377.39 Optic Neuritis

377.41- 377.49 Other disorders of optic nerve

377.51- 377.54 Disorders of optic chiasm

377.62 - 377.63 Disorders of Visual Pathways

377.71- 377.75 Disorders of Visual Cortex

950.9 Injury to optic nerve and pathways, NOS / Traumatic Optic Neuropathy

446.5 Giant Cell Arteritis/ Temporal Arteritis

368.46-368.47 Visual Field Defects (current LCD includes 368.40 through 368.45 but leaves out 368.46 and 368.47)

376.21 Thyrotoxic exophthalmos

Symptoms:

368.2 Diplopia

368.10-368.16 Subjective Visual Disturbances

368.8 Other specified visual disturbance

369.9 Unspecified visual disturbance

784.0 Headache

Systemic Disease

340 Multiple Sclerosis

710.0 Lupus SLE

710.8 Other Connective tissue disease

332 Parkinson's Disease

438.7 Late Effect CVA, disturbance of Vision

V58.65 - V58.69 Long term (current) use drug use

V58.83 Encounter for therapeutic drug monitoring

341.0 Neuromyelitis optica

Neoplasms, Brain

225.0 Brain Neoplasm, NEC Benign

237.5 Brain Neoplasm, uncertain behavior

239.6 Brain Neoplasm, unspecified

227.4 Pineal Neoplasm, benign

237.1 Pineal Neoplasm, uncertain behavior

239.7 Pineal Neoplasm, unspecified

227.3 Pituitary Neoplasm, benign

237.0 Pituitary Neoplasm, uncertain behavior

239.7 Pituitary Neoplasm, unspecified

Response: Full-text, peer-review literature to substantiate the management of specific neurological conditions was not submitted, so these diagnoses were not added to the list of ICD-9-CM codes.

Comment 12: One individual provided the following comments regarding 0187T: "I would not say it is experimental since it is being more widely used, but it could theoretically be used investigation ally for certain diagnose. I would be hard pressed to say why you are using that vs. established technologies. Is it the community standard of care, absolutely. What I would question is the reason this is being done is so that would be viable to bill for an anterior segment SCODI on the same day as a posterior segment."

This commenter concluded: "The guidelines are perfect and I do not see a problem there. Retinals, you are covering them more than once a year with use of individual injections for macular degeneration, so you are seeing an upsurge in usage and that is still evolving. There is no real agreement on frequency of injection at this point."

Response: A separate section was created in the LCD to describe anterior SCODI. Specific ICD-9-CM codes were identified that would address specific conditions where this exam would be helpful. In addition the frequency of SCODI was clarified in the policy. If SCODI is used to assess retinal changes, the frequency of exams now allowed is one exam/eye/2 months. If SCODI is used to assess glaucomatous related changes, the frequency of the exams now allowed is two exams/eye/year.

Comment 13: One commenter wrote specific to CPT 0187T. This commenter recommended that we apply the same coverage guidelines and payment policies for anterior segment OCT as anterior segment imaging (as found in LCD X-7F, Ophthalmic Echography and Biometry), and advised:

"Ultrasound and OCT, a more recent non-contact imaging technology, are both used to visualize the anterior segment of the eye and manage a number of ophthalmic conditions. Current literature has compared and highlighted the similarities between the two technologies, as well as independently validated the use of OCT to manage pathologies, including narrow angle glaucoma and corneal infections."

Finally, the commenter provided the following list of recommended indications for anterior segment imaging with OCT:

190.0 - Malignant neoplasm of eyeball except conjunctiva cornea retina and choroid

190.8 - Malignant neoplasm of other specified sites of eye

224.8 - Benign neoplasm of other specified parts of eye

360.50 - Foreign body magnetic intraocular unspecified

364.05 - Hypopyon

364.41 - Hyphema of iris and ciliary body

366.17 - Total or mature cataract

366.18 - Hypermature cataract

366.19 - Other and combined forms of senile cataract

366.22 - Total traumatic cataract

366.23 - Partially resolved traumatic cataract

366.32 - Cataract in inflammatory ocular disorders

366.33 - Cataract with ocular neovascularization

743.30 - Congenital cataract unspecified

921.3 - Contusion of eyeball

365.20 - 365.24 - Primary angle-closure glaucoma

365.41 - Glaucoma associated with chamber angle anomalies

365.42 - Glaucoma associated with anomalies of iris

365.43 - Glaucoma associated with anterior segment anomalies

365.51 - Phacolytic glaucoma

365.52 - Pseudoexfoliation glaucoma

365.53 - Glaucoma associated with other lens disorders

365.61 - Glaucoma associated with pupillary block

365.62 - Glaucoma associated with ocular inflammations

365.64 - Glaucoma associated with tumor or cysts

365.65 - Glaucoma associated with ocular trauma

365.83 - Aqueous misdirection

190.4 - Malignant neoplasm of cornea

224.8 - Benign neoplasm of other specified parts of eye

370.00 - 370.9 - Keratitis

371.00 - 371.9 - Corneal opacity and other disorders of cornea

743.41 - 743.49 - Congenital anomalies of corneal size and shape - other congenital anomalies of anterior segment

918.1 - Superficial injury of cornea

930.0 - Corneal foreign body

Response: A separate section was created in the LCD to describe anterior SCODI. Specific ICD-9-CM codes were identified that would address specific conditions where this exam would be helpful.

* These comments were considered; the corresponding J12 MAC LCD draft is J12-D43.*

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J12-D43 (L27529) Scanning Computerized Ophthalmic Diagnostic Imaging

Comment 1: One commenter wrote in agreement with the policy, as written.

Comments #2 through #7: Several commenters addressed the frequency of one exam/eye/3 months.

Comment 2: The frequency should be waived when the diagnosis is wet AMD (362.52) due to injection therapy being given every month with the need for guidance by laser-scanning diagnostic imagery.

Comment 3: "each time a patient is treated the pattern can change. For instance the mean macular thickness changes each month following monthly ranibizumab. Thus we propose that an OCT also be allowed an additional time after any treatment as permissible under the prior LCD from Trailblazers Healthcare."

Comment 4: "My concern is for those patients who are "under active" treatment, usually involving the injection of pharmaceutical agents inside the eye at intervals between four and six weeks. The primary drugs used are Lucentis and Avastin. These range in price from $2000 per dose to about $100 per dose. The medical community is still working on a way to reduce the frequency of intraocular injections. One of the techniques in widespread use is "extend and inject." This involves a series of three or four injections four weeks apart, at which point the intervals increase to six weeks for three injections, and then to eight weeks. This reduces the frequency of injections from 13 to 14 to ten injections per year. The difficulty is that when we get into "extended mode," the decision whether to continue in the extended mode ore revert to a Q four week interval is in large part based on the OCT."

Comment 5: Instead of "one exam per eye per three month interval," four scans per eye per calendar year were suggested because it "would still limit the total number of scans per year but would provide some flexibility in scheduling."

Comment 6: Add: "In those patients undergoing active treatment protocols, it is difficult to determine a frequency for examination with SCODI technologies. No frequency restrictions are in force for those patients under active treatment. These patients are those that are having intraocular injections or laser treatments on an ongoing basis. Documentation in the patients chart would be expected to justify the frequency of testing." And, change the frequency to the frequency to read: "It is expected that no more than four scans per eye per calendar year would be required to manage the patient whose primary ophthalmological condition is related to a retinal disease not under active treatment."

Comment 7: "…these limitations are appropriate for a majority of retinal conditions. However, for exudative AMD specifically, the use of monthly anti-VEGF intraocular injections (e.g., Lucentis, Avastin) often warrants more frequent use of the technology." "In light of this information, we are requesting that Highmark adopt frequency similar to the following:

'It is expected that no more than four (4) tests per year would be appropriate with the exception of patient with macular degeneration. These patients may require up to (1) one test, per eye, per month. If the condition is other than exudative macular degeneration or diabetic maculopathy, documentation may be requested on services after the second test.'"

Response: After review of all the comments submitted, the frequency of SCODI examinations to evaluate retinal disorders was increased from one exam/eye/3 months to one exam/eye/2 months.

Comment 8: Several commenters inquired if under Highmark Medicare Services' LCD would follow the same guidelines as TrailBlazer's LCD; i.e., in monitoring of retinal disease more than 8 time/calendar year/eye is not considered medically necessary and will not be covered.

Response: Highmark Medicare Services guidelines now state that the frequency of SCODI examinations to evaluate retinal disorders was increased from one exam/eye/3 months to one exam/eye/2 months. If the patient has glaucoma or is a glaucoma suspect the frequency of exam is two exams/eye/year.

Comment 9: One commenter agreed with the addition of 0187T.

Comment 10: One commenter inquired if there is a yearly limit for 0187T for the covered anterior segment disorders (non E/I).

Response: Currently the number of exams required to study anterior segment disorders is not specified. However, the medical record must document the medical necessity of the exam when it is performed.

Comment 11: One commenter noted that the draft LCD does not include the number of times 92135 can be reported by a retinal specialist.

Response: The frequency of SCODI exams is determined by the type of pathology being evaluated in the eye and not by specialty category of the evaluating physician.

Comments #12 and #13: Several commenters provided an opinion on the sentence that reads: "Since Fluorescein angiography, inodcyanine green and SCODI provided similar information; only one test/eye/clinical encounter will be authorized."

Comment 12: It "is not universally true that these tests provide similar information; fundus photographs measure the level of retinopathy (e.g., mild or moderate or severe nonproliferative diabetic retinopathy) or location of lipid relative to the fovia, but do not provide accurate thickness of diabetic macular edema or vitreomascular interface abnormalities." "OCT does not facilitate identification of micraneurysms or telangiectasis or capillary nonperfusion as is detected on fluorescein angiography (see Highmark's own fluorescein angiography summary) to assist with focal/grid Photocoagulation."

Comment 13: This commenter suggested this verbiage: "Since IVFA/ICG/SCODI provides similar but complimentary information, only one test/eye/clinical evaluation would be expected unless the disease process (exudative AMD, Macular Edema) warrants the use of both tests and the reasoning is documented in the patient record."

Response: After review of these comments the phrase was replace with: Since fluorescein angiography, indocyanine green angiography, and SCODI provide similar but complimentary information, only one test/eye/clinical evaluation would be expected unless the disease process (e.g., exudative age related macular degeneration, macular edema) warrants the use of both tests and the reasoning is documented in the patient’s medical record.

Comment 14: One commenter requested that we add 190.3 (Malignant neoplasm of the conjunctiva) and 190.5 (Malignant neoplasm of the retinal) as covered indications.

Response: These codes were added to the final policy.

Comment 15: One commenter recommended that we add 368.14 (metamorphopsia) and 368.11 (sudden vision loss) as covered indications.

Response: These codes were added to the final policy.

Comment 16: One commenter recommended adding the following in the section on Retinal Disorders: "In those patients undergoing active treatment” as they require more frequent exams than one exam/eye/3 months.

Response: In order to address this concern, the frequency of SCODI examinations to evaluate retinal disorders was increased from one exam/eye/3 months to one exam/eye/2 months.

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R-13 Radiation Therapy Services

Comment 1: One commenter wrote in agreement with the draft LCD, as written.

Comment 2: One individual provided the following comments:

"The draft policy as written represents a significant expansion of indications. Outside of its application in prostate cancer and CNS/head & neck cancers, there tends to be a relatively low level of evidence regarding the safety and efficacy of IMRT for the other indications proposed for coverage (e.g., pancreas, bladder, lung). The limited amount of data from well designed comparative trials or the non-existence of comparative or control groups makes it difficult to determine whether IMRT improves clinical outcomes over the use of conventional external beam radiation or 3D conformal radiotherapy for these indications.

It is unclear why the Intermediary supports expanded indications without the benefit of a demonstration of improved outcomes for these cancers. The quality of the currently available evidence appears to be insufficient to determine whether IMRT is superior to conventional radiation therapy for the expanded list of indications, or which patient population would benefit most from this treatment.

The available evidence suggests that IMRT permits the delivery of higher doses of radiation to the target with limited toxicity to surrounding tissues, and some evidence exists to show that higher radiation doses may result in improved local tumor control and biochemical responses. Less radiation exposure is a clinically sound goal, however there is a difference between exposure and meaningful toxicity. IMRT is purported to significantly reduce radiation side effects by reducing the toxic exposure of healthy tissue adjacent to tumors. However, with IMRT, healthy tissue may be exposed too much higher doses of low-level radiation. Presently, the effect of this increased low-level radiation on healthy tissue is not completely understood.

More than 50 clinical trials investigating IMRT are currently underway. The majority of the ongoing trials are evaluating IMRT for the treatment of head and neck or prostate cancer. The remainder of the trials are evaluating IMRT for gynecologic cancers or cancer of the lung, bladder, breast, bone, colon, and thyroid. To date, very few randomized controlled trials have been published comparing IMRT to other radiation treatments for cancer. Until such trials are conducted, the relative clinical utility of IMRT compared to external beam radiation or 3D conformal radiation modalities can only be theorized. Broadening of the indications before clinical trials have demonstrated a benefit would make it less likely that clinical trials would be conducted.

Relatively rapid diffusion of IMRT has been supported despite a lack of evidence to establish that it is superior to other forms of radiation therapy intended to reduce toxicity to healthy tissue. This perceived benefit is based on the assumption that an improvement in the distribution of the radiation dose is absolutely beneficial. To date, data to show that when compared to other forms of radiation therapy, improved dose distribution correlates with improved clinical outcome, improved side effect profile, or improvements in quality of life is very limited. IMRT should be tested head to head with conventional radiotherapy techniques and the expansion of indications beyond those for which sufficient evidence exists, should be limited to those that can be based on quantitative differences not theoretical ones."

Response: The American Society for Therapeutic Radiation and Oncology (ASTRO)/American College of Radiology (ACR) Guide to Radiation Oncology Coding and the ASTRO Model Policy on IMRT was utilized extensively in the creation of the final LCD with the intent of mirroring their recommendations.

Comment 3: One commenter requested the addition of the following conditions for IMRT:

"We believe that breast cancer should be added to the verbiage of covered indications to match up with the covered diagnoses listed in the ICD-9 section. Additionally, while rare, we believe the following diagnoses should be covered and added to the IMRT paragraph and covered IMRT ICD-9 diagnoses section. (Parathyroid-194.1,adrenal mets-178.7, medistium mets 197.1, lung mets 197.0, stomach 151, gyn malignancies-179,180.x,182.x,184.x, and lymphomas-200.xx,201.xx,202.xx). The location of these tumors and their proximity to normal critical structures may warrant complex treatment planning to reduce morbidity to normal surrounding structures. Additionally, in cases of metastatic spread if prior radiation therapy was given, IMRT will be necessary in order to give adequate palliative doses to the tumor without damaging previously irradiated tissues. In theory, that could be any physical location of the metastatic site. Therefore, we believe any metastatic location, should be included for coverage with IMRT technique along with the diagnosis code of V15.3 (Personal history of irradiation) and documentation in the medical record to indicate the clinical rationale."

Comment 4: One commenter advised that everything "except mandible" does not make sense in the first listing of covered indications under 170.0-176.9.

Response: The ICD-9 codes are "ranged" where appropriate. In addition, the "short descriptors" must also be utilized in defining ICD-9, CPT, and HCPCS codes, where applicable.

Comment 5: The following recommendations/observations were provided and echoed by two separate commenters. One commenter provided a copy of the draft LCD with extensive track changes to include the following comments. The other commenter provided a copy of the ASTRO Model Policy on IMRT and External Beam of which paragraphs and sections were suggested be utilized, as stated in the comments below.

Forward IMRT planning should be addressed in the policy.
It is recommended that the paragraphs provided be substituted for the information in the policy regarding IMRT, IMRT Treatment Planning, and IMRT Treatment Delivery.
It is noted that a minimal amount of information is provided regarding the use of different image guided radiation therapy (IGRT) modalities, and the commenters suggested text.
In the section "77295 Therapeutic radiology simulation-aided field setting; 3-dimensional" it is recommended that the "or" be changed to an "and" in the following sentence: "CPT 77295 includes those activities necessary to perform a three-dimensional treatment plan, including digitally reconstructed radiographs of the beam's eye view, and either cross-sectional reconstructions of the dose distributions in three dimensions, or a review of the dose-volume histograms of the resultant treatment."
In the section "Basic Radiation Dosimetry Calculation (77300)" it is noted that the LCD does not address the medically necessary indications for calculations associated with IMRT planning and stereotactic radiosurgery planning. It is also noted that the typical quantity of "between 1 and 6 calculations" in a course of treatment is not representative of complex external beam treatment, some IMRT and some stereotactic radiosurgery courses. Therefore, the recommendation is a limit of ten calculations, with supporting documentation required for more than 10 calculations.
In the section "Special Teletherapy Port Plan (77321), it is noted that the section is not consistent as understood by the radiation oncology community and it is missing medically necessary indications, such as the use of electrons in total skin irradiation, photons for total body or hemibody irradiation, and proton or neutron beam planning.
It is recommend that the following section be eliminated since it "will be burdensome" to monitor it on an ongoing basis: "ICD-9-CM Codes that Support Medical Necessity for CPT codes 77261, 77262, 77263, 77280, 77285, 77290, 77295, 77300, 77305, 77310, 77315, 77321, 77331, 77332, 77333, 77334, 77336, 77370, 77401, 77402, 77403, 77404, 77406, 77407, 77408, 77409, 77411, 77412, 77413, 77414, 77416, 77417, 77422, 77423, 77427, 77431, 77470, 77520, 77522, 77523 and 77525."
It is noted that the section "ICD-9-CM codes that Support Medical Necessity for IMRT CPT codes" is incomplete and the following list of codes is recommended;

140.0 – 140.9	Malignant neoplasm of lip
141.0 – 141.9	Malignant neoplasm of tongue
142.0 – 142.9	Malignant neoplasm of major salivary glands
143.0 – 143.9	Malignant neoplasm of gum
144.0 – 144.9	Malignant neoplasm of floor of mouth
145.0 – 145.9	Malignant neoplasm of other and unspecified parts of mouth
146.0 – 146.9	Malignant neoplasm of oropharynx
147.0 – 147.9	Malignant neoplasm of nasopharynx
148.0 – 148.9	Malignant neoplasm of hypopharynx
149.0 – 149.9	Malignant neoplasm of other and ill-defined sites within the lip, oral cavity, and pharynx
150.0 – 150.9	Malignant neoplasm of esophagus
151.0 – 151.9	Malignant neoplasm of stomach
152.0 – 152.9	Malignant neoplasm of small intestine, including duodenum
153.0 – 153.9	Malignant neoplasm of colon
154.0 – 154.9	Malignant neoplasm of rectum, rectosigmoid junction, and anus
155.0 – 155.9	Malignant neoplasm of liver and intrahepatic bile ducts
156.0 – 156.9	Malignant neoplasm of gallbladder and extrahepatic bile ducts
157.0 – 157.9	Malignant neoplasm of pancreas
158.0 – 158.9	Malignant neoplasm of retroperitoneum and peritoneum
159.0 – 159.9	Malignant neoplasm of other and ill-defined sites within the digestive organs and peritoneum
160.0 – 160.9	Malignant neoplasm of nasal cavities, middle ear, and accessory sinuses
161.0 – 161.9	Malignant neoplasm of larynx
162.0 – 162.9	Malignant neoplasm of trachea, bronchus and lung
163.0 – 163.9	Malignant neoplasm of pleura
164.0 – 164.9	Malignant neoplasm of thymus, heart, and mediastinum
165.0 – 165.9	Malignant neoplasm of other and ill-defined sites within the respiratory system and intrathoracic organs
171.0 – 171.9	Malignant neoplasm of connective and other soft tissue
172.0 – 172.9	Malignant neoplasm of skin
173.0 – 173.9	Other malignant neoplasm of skin
174.0 – 174.9	Malignant neoplasm of female breast
175.0 – 175.9	Malignant neoplasm of male breast
176.0 – 176.9	Kaposi’s sarcoma
179 – 184.9	Malignant neoplasm of genitourinary organs
185	Malignant neoplasm of prostate
186.0 – 186.9	Malignant neoplasm of testis
187.1 – 187.9	Malignant neoplasm of penis and other male genital organs
188.0 – 188.9	Malignant neoplasm of bladder
189.0 – 189.9	Malignant neoplasm of kidney and other and unspecified urinary organs
190.0 – 190.9	Malignant neoplasm of eye
191.0 – 191.9	Malignant neoplasm of brain
192.0 – 192.9	Malignant neoplasm of other and unspecified parts of nervous system
193	Malignant neoplasm of thyroid gland
194.0 – 194.9	Malignant neoplasm of other endocrine glands and related structures
195.0 – 195.8	Malignant neoplasm of other and ill-defined sites
196.0 – 196.9	Secondary and unspecified malignant neoplasm of lymph nodes
197.0 – 197.3	Secondary malignant neoplasm of lung, mediastinum, pleura, and other respiratory organs
198.0 – 198.89	Secondary malignant neoplasm of other specified sites
199.0 – 199.1	Malignant neoplasm without specification of site
200.00 – 200.88	Lymphosarcoma and retriculosarcoma
201.00 – 201.98	Hodgkin’s disease
202.00 – 202.98	Other malignant neoplasms of lymphoid and histiocytic tissue
203.00 – 203.81	Multiple myeloma and immunoproliferative neoplasms
208.8	Other leukemia of unspecified cell type
213.0 – 213.9	Benign neoplasm of bone and cartilage
225.0 – 225.9	Benign neoplasm of brain and other parts of nervous system
227.3	Benign neoplasm of pituitary gland and craniopharyngeal duct (pouch)
227.4	Benign neoplasm of pineal gland
227.6	Benign neoplasm of aortic body and other paranglia
228.0	Hemangioma, any site
228.1	Lymphangioma, any site
233.0	Carcinoma in situ of breast
237.0	Neoplasm of uncertain behavior of pituitary gland and craniopharyngeal duct
237.1	Neoplasm of uncertain behavior of pineal gland
237.2	Neoplasm of uncertain behavior of adrenal gland
237.5	Neoplasm of uncertain behavior of brain and spinal cord
237.6	Neoplasm of uncertain behavior of meninges
336.9	Unspecified disease of the spinal cord
459.2	Compression of vein/vena cava syndrome (inferior) (superior)
747.81	Other specified anomalies of cerebrovascular system (congenital anomalies of cerebral vessels)

* These comments were considered; the corresponding J12 MAC LCD draft is J12-D38.*

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J12-D38 (L27515) Radiation Therapy Services

Comment 1: "The inclusion of treatment devices in the simulation process typically increases the complexity. Simulation without the inclusion of devices or with any pre-made devices (e.g., blocks, immobilization) is considered simple. Custom blocks or custom immobilization devices for palliative ports do not increase complexity except when supported by written patient-specific documentation. Custom devices for curative intent elevate complexity when clinically appropriate.

Levels of simulations should not be decreased in complexity due to the fact the patient is being treated for palliation. In many cases, these palliative cases are time consuming and complex due to added difficulty with patient immobilization as a direct result of increased pain, previous treatment to same or adjacent area, or additional volumes of interest. These specific situations render immobilization and custom blocks a necessary component for appropriate patient care and treatment delivery regardless of the intent of the course of treatment."

Response: Final LCD updated appropriately in keeping with this helpful comment.

Comment 2: "The addition of custom immobilization devices at the time of simulation should be an indicator for a complex level of simulation. The construction and use of complex immobilization devices greatly increases the amount of time and effort for the staff and physician as part of the simulation process. The use of these devices increases the complexity of daily reproducibility and reference or isocenter placement which is highly important at the time of simulation. The staff and physician must evaluate each patient individually for appropriate use and construction of custom immobilization versus the use of premade immobilization devices to ensure patient reproducibility for daily treatments and accurate delivery of the prescribed treatment course."

Response: Final LCD updated to reflect information and examples of comment.

Comment 3: "The use of tangential ports is typically a more complex simulation regardless of the number of devices which are used for the daily treatment. The use and determination of tangential ports increases the complexity of the simulation due to the increase in time and effort involved with establishing the appropriate gantry angles as well as any associated devices used during the treatment planning. The evaluation of the gantry angles is necessary to ensure the decrease in treatment beam divergence which directly impacts the amount of dose delivered to critical structures regardless of the number of treatment devices utilized in the treatment planning. An example of this is the use of tangential ports for the treatment of breast cancer in order to decrease the amount of dose to the adjacent lung or heart volume."

Response: Final LCD updated to reflect information and examples of comment.

Comment 4: "The use of premade wedges and special bolus are typically considered complex treatment devices. The premade wedges are not constructed per patient specifics; however the use and design of fields utilizing these devices is specific to the patient anatomy, tumor volume, and critical structures. In many cases, the use of the devices is necessary to ensure appropriate coverage or avoidance of structures in the path of the radiation beam, as well as the combination of multiple premade wedges in order to provide a more custom beam attenuation effect."

Response: No change was made to final LCD. Treatment devices, especially complex treatment devices have been an area of concern. Quite frankly, an update in both the definitions, and payment of treatment devices is needed as technology has surpassed the original definitions, and resources necessary for treatment devices, especially complex treatment devices.

Comment 5: "Special bolus should be considered a complex device due to the additional time and effort necessary to provide adjustments to dose distribution. In many cases, the use of custom bolus is required due to abnormal or surgically altered patient anatomy which directly affects the deliver and distribution of the radiation beam. The construction of this special bolus is applied at the time of simulation, and it is taken into account for treatment planning to ensure appropriate dose coverage to the prescribed volume of interest."

Comment 6: "Restraining devices and beam modification devices may be billed separately for the same port, but only one restraining device may be billed for each volume of interest treated.

The term restraining devices was not provided in the glossary of terms, so it is not clear on the use of this term in radiation oncology. Typically patient restraints are not billed in radiation oncology due to the fact they are not customized for the specific patient; however billing of custom immobilization devices is expected. If this is referring to custom immobilization devices, then multiple custom devices are sometimes necessary. An example of this would be in the use of a custom immobilization mask and bite block utilized for the treatment of head and neck tumors. Additional immobilization of the mouth and tongue are necessary due to the close proximity of critical structures to the tumor volume as well as the difficulty in complete immobilization of the treatment field necessary for treatment delivery."

Response: Although not addressed in the LCD "glossary," examples have been included in the final LCD.

Comment 7: "It is expected that the Dose Volume Histogram (DVH) would illustrate at least three (3) critical structures protected by the use of IMRT.

It would be unfortunate if a number of critical structures are necessary in order to provide IMRT treatment. In many cases, a patient may meet the requirement for IMRT due to proximity of critical structures, previous irradiated treatment area, or the increased risk of radiation toxicity; however the treatment field may not specifically encompass three crucial structures. In these instances, the use of IMRT may not be available, which would directly impact the outcome of the delivered treatment course by not providing the best dose distribution or elevated dosing necessary to provide the appropriate patient care."

Response: The LCD statement of "it is expected that the Dose Volume Histogram (DVH) would illustrate at least three (3) critical structures protected by use of IMRT is a reasonable expectation and has been supported (and was recommended) by experts in the field.

Comment 8: This commenter also suggest the following be added to under A Glossary of Terms for Radiation Therapy/Radiation Therapist: "In the United States, a radiation therapist is the personnel responsible for the actual treatment delivery on the linear accelerator or treatment unit. The radiation therapist works directly with and under the supervision of the radiation oncologist or therapeutic radiologist. The radiation oncologist is a physician with specific training in therapeutic radiology; however the radiation therapist is a staff member with specific training on the use of the linear accelerator, simulator, CT scanner, treatment planning computer, etc. They are responsible for providing and documenting daily treatments as prescribed by the physician, as well as other necessary functions for patient positioning, simulation, and imaging."

Response: Glossary updated.

Comment 9: One commenter compared this draft LCD with LCD R-4P and requested that we list the devices as we had in LCD R-4P: "In the previous version of this LCD (R-4P Radiation Therapeutic Services); customized single use bolus such as wax molds conformed to a particular patient body part was listed as a complex treatment device (77334). Special multi use bolus was considered intermediate (77333). In Draft J12-D38, fabricated single patient use special bolus is listed as an intermediate treatment device. Preparing a customized wax mold specifically for treatment of the head/face requires the skill of a physicist as the thickness needs to be accurate within a millimeter as the facial features are contoured. This process can take up to an hour to simply create the wax mold."

Response: Treatment devices specified to include examples provided.

Comments 10 - 12: One commenter provided the following comments/questions:

Comment 10: Regarding the statements describing the complex planning and coding of 77263 under Tumor Mapping and Clinical Treatment Planning (77261-77263): "Does this exclude brachytherapy (used as the only treatment modality) as a medically reasonable basis for coding 77263?"

Response: No.

Comment 11: Regarding custom blocks under 77280: "The use of custom immobilization in an initial simulation should elevate the complexity of the simulation to complex as indicated in the first part of the simulation directions. The current factors for simple simulation include custom immobilization devices. This should be changed to indicate custom immobilization for palliative patients when the physician has not documented them as medically necessary and custom immobilization should be added to the factors for complex simulation."

Response: Final LCD updated appropriately in keeping with this helpful comment.

Comment 12: Regarding simple treatment devices (77332): "It might be useful to add the application devices used in Brachytherapy such as tandem and ovoids, cylinders and template grids used in prostate seed implants."

Response: Incorporated into the final LCD.

Comment 13: One commenter referenced sections from Highmark Medicare Services' retired Pennsylvania Part B LCD R-10E, "Intensity Modulated Radiation Therapy (IMRT)," noting that this reimbursement information for the professional provider of IMRT services is not provided in this draft LCD. Based on this observation, the commenter inquired: 1) Are these guidelines still in affect, 2) How will the professional provider be reimbursed for IMRT services, and 3) Are there scenarios when the provider can bill and be reimbursed for services that would be typically be bundled by the CCI edits?

Response: Professional services of IMRT are eligible for reimbursement; however, all CCI editing will continue to be implemented by the contractor.

Comment 14: One commenter requested that we include the customized single use bolus as a complex treatment device (77334), and provided the following rationale: "Patients receiving radiation therapy for cancers of the skin of the face require the isocenter to be close to the surface of the skin. In order to achieve this, a wax mold of the patient’s face is created. The depth of the wax as it conforms to the patient’s face needs to be consistent and within a millimeter of the desired depth. This can become very complicated when treating the nose or ears. A physicist can spend 30 to 60 minutes with the patient creating this mold. Considering the time and level of skill required in the creation of the wax mold, we believe this should be a complex device."

Response: Treatment devices specified to include examples provided.

Comment 15: One commenter recommended that are tangential ports should be included under code 77290.

Response: Incorporated in the final LCD.

Comment 16: One commenter recommended that we increase the limits for 77300, 77332, 77333, and 77334 to up to 10 per course of treatment before documentation may be required because "many of our current treatment algorithms are relatively complex and these limits are arbitrary and frequently exceeded."

Response: Final LCD updated to reflect such. However, LCD notes that record documentation of medical necessity would be requested for greater than 10 per course of treatment.

Comment 17: One commenter disagreed with the frequency statement for 77280; i.e., "no more than one simulation should be reported on any given day."

Response: No change to LCD.

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Z-56G Trigger Point Injections

Comment 1: Several commenters provided their opinions regarding the codes listed under the "ICD-9 Codes that Support Medical Necessity" section:

"Many of the codes for epicondylitis, Archilles bursitis, and tendonitis, are codes that would indicate the procedure, which is injection of tendon insertion. They are not specifically trigger points. Why those codes are there attached to this particular procedure code does not make sense. If someone were injecting those areas, they would presumably use the tendon insertion injection procedure code."

"The nonspecific codes for unspecific musculoskeletal disorders referable to neck, unspecific bursitis/tendonitis in the shoulder region, myalgia and myositis unspecified, are all codes that would be appropriately used in that setting."

Removal of code for sprain/strain: "Even if you were to talk about removing the enthesopathy or tendonitis, what you are really looking at is that you can have a person who may have one of these diagnoses, but if you are going to do a trigger point injection, you must identify within your physical exam that there is an actual trigger point. It cannot just be ‘spasm of muscle’ because you can get spasms for a number of acute types of sprains/strains, or even chronic type of problems where you have involuntary muscles guarding in the form of spasm.

The key is having the 729.1 code for Myalgia and Myositis Unspecified, which is, unfortunately, the only code you can use if you have an identified trigger point. If you have a cervical sprain or strain with a secondary myofascial pain problem involving the trapezius or rhomboid muscles, that is the code you end up having to use."

Response: Diagnoses codes were inadvertently pasted from a previous policy. The Contractor agrees with the commenters and has retained myalgia and myositis and added diagnoses codes to represent regional pain syndromes.

Comment 2: One commenter provided the following:

"Trigger point injections for the treatment of myofascial pain disorders should be preceded by appropriate physical therapy including isometric therapy which is often successful when supported with a short course of muscle relaxants and anti-inflammatory drugs. While this treatment can be supported with concurrent trigger point injections, the accumulative injury created by multiple injections can be counterproductive in the management of myofascial pain disorders.

In some patients, botulism toxin has been used effectively, however this use is more restrictive to muscle spasm producing muscle shortening i.e. Torticollis. In most cases of true myofascial pain disorders, the pathology is related to irritability at the motor end plate and the specific muscle fibers related. Botox for treatment of motor end plate irritability is not proven to be effective for such cases of myofascial pain disorders. Thus, routine trigger point with Botox is not likely to be effective for management of myofascial pain disorders in the absence of muscle spasm and attendant muscle shortening.

In either case, appropriate diagnosis of a myofascial pain disorder with attendant pathophysiology is critical to the success of treatment."

Response: Botulinum Toxin A and B has its own LCD coverage policy. The presumed frequency of injections has been changed in the policy to reflect concerns for the injury that could be caused by multiple injections.

Comment 3: One commenter advised that the draft LCD lacked clarity; e.g., does this mean that trigger point injections are not indicated if medical management has not been provided? If yes, this commenter advised: "One or two trigger injections can be very therapeutic for localized myofascial pain. The procedure is low cost and low risk and should be limited to 1 or 2 injections in a three month period. However, I believe that the requirement that noninvasive medical management be unsuccessful prior to the trigger injections should re reconsidered. Ultrasound, physical therapy, ROM exercises may be no more therapeutic than a localized trigger injection, can take much longer for an effect, require much more patient time (as well as family member time if the patient doesn't drive), and are much more expensive than a trigger injection. I agree that multiple and frequently administered trigger injections need to be limited and can be abused. However the limitation for two trigger injections in a three month period would control the excessive utilization, as well as provide the patients with a simple, inexpensive and frequently rapid acting therapeutic management of localized myofascial pain."

Response: The Contractor agrees that trigger point injection may be done in a number of scenarios, not just as a last resort. It may be done, for instance, to control localized pain enough to start physical therapy or to allow time for an oral medication to work while controlling some degree of pain. The policy has been changed to reflect differing approaches to pain management.

* These comments were considered; the corresponding J12 MAC LCD draft is J12-D53.*

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J12-D53 (L27540) Trigger Point Injections

Comment 1: One commenter wrote: "Trigger point injections can be performed in conjunction with medications, not after establishment of failure of conservative therapy. A patient with ongoing myofascial pain can receive multiple trigger point injections in conjunction with physical therapy including joint manipulation, range of motion exercises, ultrasound and stretching exercises. Agree with documentation of results and indication for follow up injections."

Comment 2: One commenter suggested that we look at the previous guidelines, advised that the policy does not include enough diagnoses codes, and concluded, "many of the codes are for 20550 and 20551 which are for tendon and tendon sheath injections."

Comment 3: One commenter wrote about the utilization guidelines: "limiting it to one treatment per month does not make therapeutic sense if you are treating someone for a condition that needs multiple treatments to get better. In one month all the benefit can be lost. Suggest 2 visits per month per region. Also, why does it matter how many regions are done in one session for a therapeutic treatment if the practitioner is getting reimbursed the same no matter how many injections he does. I would just remove that sentence. Also, it should be clear that we should be able to give a treatment up to 2 times per month."

Response: The limitation on three areas per session has been removed as restrictions on the total number of regions billed on any given day are inherent in the CPT codes for this procedure. In addition, the wording of the frequency parameters has been changed to “three in three months” rather than “once per month” to reflect those clinical situations in which a repeated set of injections is needed sooner to break the pain cycle. This frequency also keeps in mind other comments regarding the potential for injury from too many injections.

Comment 4: One commenter suggested adding 728.85, spasm of muscle, to the list of covered ICD-9 codes.

Response: Due to the non-specific nature of this diagnosis code, the Contractor declines to add ICD9-728.85.

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Z-61B Paravertebral Facet Joint Nerve Block and Sacroiliac Joint Injection

Comment 1: Several commenters advised that the draft LCD implies that SI joint injections can be performed without fluoroscopy in some cases. One commenter advised that this should be corrected since there is substantial anatomic variability from patient to patient, and it is "absurd to even attempt needle localization without fluoroscopic guidance at this site." And, one of the commenters also advised that the SI joint injection can be performed using ultrasound for guidance.

Response: We agree that SI joint injection requires some form of radiological guidance. While not stated in the LCD it is assumed that this would occur with each injection.

Comment 2: Several commenters advised that the policy is inconsistent regarding the relief of pain requirement; i.e., uses both > 50% and 50% pain relief. One commenter further advised that patients tend to go to round numbers; therefore, a patient with 50% pain relief technically does not meet the greater than 50% requirement.

Response: The LCD was revised to require >50% pain relief, as recommended by the ASIP guidelines.

Comment 3: Several commenters provided opinions regarding the number of facet injections per year.

One commenter advised that the ASIP guidelines state 4-6 per year, no more than 4 per year/per level, and leave open the possibility of doing up to 2 procedures in a row. The reason the ASIP guidelines say 4-6/year is that for many it takes 2 to make them better and lasts 3-4 months; you do 3x/year and this is why you hit 6.

This commenter further advised that the average age for which the ASIP guidelines were established were much younger than the Medicare population.

Therefore this commenter advised that restricting injections to 1-2 level facets may work for the younger patients, but the older patients with complete lumbar spine facet degeneration, scoliosis, spondylosis, and spondylolisthesis multiple levels doesn't work; i.e., "which 2 do I pick?"

One commenter recommended 4-6 injections per year.

This commenter provided further commented on 2 levels: "If you look at the anatomy and physiology, there is a lot of cross-innervations at the facet level. If you pick the l-4 and L-5 facet joint, there is cross innervations coming from the level above and the level below. Often when you are trying to decide diagnostically what you need to do, you need to make sure you are hitting all aspects of the area that the facet is actually being supplied by." "Rather than 2 levels, it is 3 levels, at least from a diagnostic standpoint."

Diagnostic block: A commenter advised "if it is 1 week or 2 weeks apart, the diagnostic block is determined the first 20 minutes after the block since all you are using is an anesthetic agent and not steroids. You are going to know your answer after the first 20 minutes. Often you want them back a week later to potentially get a repeat diagnostic block, or an actual therapeutic block, and you need that information to determine whether or not you are going to go forward with a radiofrequency neurotomy. Often, if you have done your facet injection, you are not sure whether or not the patient did or did not benefit. If you do a diagnostic block, oftentimes you need a confirmatory diagnostic block before you would go forward with the radiofrequency neurotomy. That is part of the guideline for determining if a patient is a good candidate for the radiofrequency neurotomy."
A commenter advised that there are actually two separate techniques. "One is a facet joint injection and the other is a nerve block to the medial branch that innervates the joint." "To deinnervate 2 joints, you need to basically block 3 nerves."

Response: The LCD allows for two diagnostic blocks and 4 therapeutic blocks per year; this is in accordance with the ASIP guidelines. It is felt that injections at two levels per session should be adequate to treat most patients.

Comment 4: Several commenters recommended that the LCD clarify the last paragraph under "Sacroiliac Injections." The draft policy advises that the physician should first address the non-sacroiliac joint pain generators first; however, it is the recommendation of these commenters that it advise that a therapeutic SI joint injection is done first, but that it is reasonable to consider a diagnostic SI joint injection prior to the treatment of the lumbar condition.

Response: If one cannot determine the precise source of the pain, all sources of pain should be ruled out before the SI joint is injected. However, if the pain is definitely attributed to the SI joint, then this joint may be injected initially.

Comment 5: One commenter advised that "Sources of Information and Basis for Decision" section of the draft policy lists the Boswell article on "Interventional Techniques in the Management of Chronic Spinal Pain: Evidence-Based Practice Guidelines." This article was updated in 2007 in January with Volume X (1), pp 7-111; however, the draft LCD lists the 2005 edition.

Response: The LCD was amended to reflect this update in the reference.

Comment 6: One commenter provided the following regarding the frequency of the SI joint injections (1 every 2-3 months): "It should be 1-2 and if you want to maximize it, 4-6 per year is fairly reasonable. There are many patients where you do 1 injection and people are better, and a second one makes them much better. When I have a patient with a joint problem, I schedule them up to 2 but if we can get away with 1, I will only do 1. We are looking for a 50-70% relief, which is reasonable with an arthritic joint. If someone is better 40% after 1 shot, it is hard not to continue with the second to see if we can get more relief."

Response: The LCD allows for two diagnostic blocks and 4 therapeutic blocks per year; this is in accordance with the ASIP guidelines.

* These comments were considered; the corresponding J12 MAC LCD draft is J12-D35.*

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J12-D35 (L27512) Paravertebral Facet Joint Nerve Block and Sacroiliac Joint Injections

Comment 1: One commenter provided the following: "In patients with pain due to facet syndrome, to expect that pain relief will only last for the duration of the anesthetic after anesthetic blocks of the medial branch nerves is a myth and to require such an effect to proceed with therapy is a mistake. Granted, it is an appealing (THEORETICALLY intuitive) concept, but it is an oversimplification of the pain mechanisms at play. In fact, >50% of patients experience more prolonged decrease in their level of pain (DESPITE the presence of a facet syndrome) than the predicted duration of the local anesthetic effect. There is extensive documentation of this in the literature. Some specialists think that more prolonged relief than the duration of the local anesthetic effect reflects interruption of pain centralization achieved by breaking the cycle of chronic pain. Others think that more prolonged effects/relief (beyond the duration of the anesthetic) may also reflect the anti-inflammatory properties of local anesthetics (please refer to the large amount of peer-reviewed literature on this point)."

Response: This comment provides additional information regarding the use of diagnostic blocks, their effectiveness, and methods of action. It does not change the need for diagnostic blocks.

Comments #2 through #6: One commenter provided the following recommendations:

Comment 2: Indications that an injection can only be done if a person has chronic pain more than 3 months is overly restrictive.

Response: The division of blocks into diagnostic and therapeutic as well as the frequency and maximum number of each block was based upon current national guidelines.

Comment 3: Requiring physical therapy first is often not practical if the person has no one to take them or they have used up their benefits or they are in too much pain to be able to interact in the therapy program.

Response: Participation in physical therapy is not an absolute requirement prior to embarking upon a course of blocks.

Comment 4: Mandating that you must treat the Facet joint first if both an SI joint and Facet joint condition exists takes the physicians judgment out of the equation. If the physician can document the patient has more SI pain than Facet pain he should be able to treat the first if he can properly document shy. This LCD will force the physician to treat another area first which might not be medically necessary and could cost Medicare more in extra procedures.

Response: The rationale for treating the non-SI joint first is that often times treatment of these areas will resolve the pain and the SI joint then does not require treatment.

Comment 5: Requiring a greater than 6 week therapeutic response of over 50% is unrealistic. I suggest just limit the number you can do at 4 procedures per level and leave it at that and let the physician decide what is appropriate.

Response: The division of blocks into diagnostic and therapeutic as well as the frequency and maximum number of each block was based upon current national guidelines.

Comment 6: Limiting it to 4 injections/level/year is too low if you count doing a bilateral L4-5 as two. Withthis rational you will only be able to treat the patient twice per year. If you count it as 4 injections/level/side than it would be acceptable and reasonable therapeutically.

Response: The division of blocks into diagnostic and therapeutic as well as the frequency and maximum number of each block was based upon current national guidelines.

Comments #7 through #10: Several commenters provided the following comments/questions:

Comment 7: These commenters disagreed with the frequency statement at the top of page 3: "Patients may have acute exacerbations of their lumbar facet arthropathy or lumbar spondylosis and prefer not to be on medications. They may have had paravertebral injections in the past which helped. There is no reason a patient should wait three months before they can receive facet injections. They need to consider time away from work, disability payments, etc."

Response: In this specific situation you have described an acute exacerbation of a chronic condition. If the medical record provides documentation of this fact, it may be appropriate to proceed with therapeutic blocks.

Comment 8: Are 2 diagnostic blocks 2 weeks apart a requirement or a suggestion of usual and customary practice? What happens if one is positive and the other is equivocal? A third one?

Response: The division of blocks into diagnostic and therapeutic as well as the frequency and maximum number of each block was based upon current national guidelines.

Comment 9: Regarding the statement at the bottom of page 3 regarding "performing >2 levels bilaterally will be denied." "With soaring prices of gas, patients may prefer to get bilateral 4 level blocks on the same visit."

Response: Treatment that is medically necessary and reasonable should guide clinical judgment and care.

Comment 10: Regarding the frequency criteria for SI joints: "Injections may be performed in conjunction with physical therapy (for SI joint manipulation). Patient cannot wait 2-3 months for SI injection. Need to consider dorsal column stimulation for patients who fail SI joint injection therapy x2 since they probably have no better options. I am not sure I know of any surgical options that work well with sacroilitis."

Response: The time frames provided in the policy are based on national guidelines. The provider must make a decision to continue or to abandon a course of therapy based on the patient’s response to a specific course of treatment and other available options. The provider should always do what is in the best interests of the patient.

Comment 11: One commenter inquired if the facet diagnostic blocks are repeated, is there a need to repeat the history and physical since the patient will return back in 2 weeks?

Response: The medical record should always contain the information—history and physical examination findings--that substantiates the medical decision making and treatment rendered.

Comment 12: One commenter inquired if a patient is on anticoagulants, can we perform the diagnostic and therapeutic procedures within a short frame of time?

Response: The time frames provided in the policy are based on national guidelines.

Comment 13: One commenter inquired if SI joint injections can be performed under fluoroscopy without the use of contrast?

Response: It is expected that some form of imaging will be required to assure that the injection is performed correctly. The specifics of the imaging technique are not specified but the documentation in the medical record should indicate the procedure used and the findings.

Draft LCDs Presented for Comment

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J12-D1 (L27472) Approved Drugs and Biologicals

Please see above.

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J12-D2 (L27474) Blepharoplasty / Blepharoptosis

Comment 1: One commenter stated; “In nearly all cases of Dermatochalasis, the determination of visual field impairment confirmed by Goldman Field Examination by an ophthalmologist or comparable is recommended to determine that visual loss is 15% or greater prior to reimbursement for upper lid blepharoplasty by Medicare.”

Response: Both photographs and visual field assessment will be used to determine the medical necessity of blepahroplasty. The photographs should include one view of the patient in primary position, one view looking up and one view looking down and should demonstrate one or more of the following:

The upper eyelid margin within 2.5 mm (1/4 of the diameter of the visible iris) of the corneal light reflex (MRD< 2.5 mm), with patient in primary gaze
The upper eyelid skin rests on the eyelashes
The upper eyelid indicates the presence of dermatitis
The upper eyelid position contributes to difficulty tolerating a prosthesis in an anophthalmic socket
The brow position is below the superior orbital rim

The results of the taped and untaped Automated Visual Field studies must be submitted with the claim and must demonstrate one or more of the following:

The upper visual field must improve by at least eight degrees or twenty percent with the eyelid taped up as compared to the visual field obtained without taping (two sets of visual fields are required).
Visual field obstruction by the eyelid must limit the upper visual field to within thirty degrees of fixation.

Comment 2: One commenter asked that the condition in which excessive skin weighs down, and the weight of it lowers the position of the upper lid, be added to the draft. Subsequently, this commenter wanted to make sure that the procedure could be billed and performed in a physician’s office.

Response: A definition of psuedoptosis was provided in the LCD. Two examples of this condition were provided. These are only examples of some situations and this list is not complete or exhaustive. Blepahorplasty is a procedure that is usually done in the operating room of the hospital or in an ambulatory surgical center; the office setting is not appropriate for this procedure.

Comment 3: One commenter requested that a discussion of the ABN issue, as well as how to submit photographic documentation, be included in the draft.

Response: Information, rules and regulations regarding ABN (Advance Beneficiary Notice) can be found In the Medicare Claims Processing Manual (IOM 100-04) Chapter 30, Section 40.3. Submission of visual field examinations will not be required for reimbursement. However, the visual field examinations that substantiate the need for the procedure must be retained in the medical record and can be requested at any time.

Comment 4: One commenter questioned whether visual field exam codes 92081, 92082, and 92083 for glaucoma would be paid, or denied if they were for another diagnosis.

Response: A new LCD has been created to address Visual Field examinations. Please see LCD J12-D54.

Comment 5: One commenter requested that in number 6, that “submitted with the claim” be replaced with “documented in the patient record.”

Response: The entire section as designated by number 6 in the Documentation Requirement section was removed. Submission of visual field examinations will not be required for reimbursement. However, the visual field examinations that substantiate the need for the procedure must be retained in the medical record and can be requested at any time.

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J12-D3 (L27475) Blood Glucose Monitoring in a Skilled Nursing Facility (SNF)

Comment 1: One commenter provided anecdotal information regarding the care of several SNF patients, and opined: "For these particular patients the blood sugars still tend to fluctuate and are occasionally above or below the limits for which you suggest the physician needs to be notified. Normally the correct dose of insulin and/or feeding corrects the abnormal value and I see no value in being notified by phone 4 or 5 times a week that the patient's blood sugar is above or below a certain value when the therapy is already prescribed and historically the values continue to stabilize albeit widely variable.

If the patient is on oral agents or stable doses of insulin the blood sugars certainly do not need to be checked so often, and certainly not multiple times a day. To suggest that all patients can be easily controlled and will remain stable is potentially seriously harmful to the small subset of brittle patients whose management remains a significant clinical challenge."

Response: As our LCD notes:

"If the patient is in a skilled nursing facility, routine glucose monitoring (including any tests which are not promptly reported) is a part of routine personal care and is not a separately billed procedure (PM AB-00-108, December 2000)."

"Routine glucose monitoring of diabetics is never covered in a SNF, whether the beneficiary is in a covered Part A stay or not. Glucose monitoring may only be covered when it meets all the conditions of a covered laboratory service including use by the physician in modifying the patient's treatment.

Medicare pays for a blood glucose test only when the service meets all of the conditions of payment for a test payable under the clinical laboratory fee schedule including that the test must be ordered by the physician who is treating the beneficiary and the physician must use the results in the management of the beneficiary’s specific medical condition. For payment to be made for a blood glucose test under Medicare Part B, a physician must certify that each test is medically necessary and that a standing order for many tests over a time period is not sufficient documentation.

Repeated performance of finger-stick blood glucose tests to maintain standing orders for insulin injection or oral hypoglycemic agents does not meet the criteria for Part B payment in a SNF. Payment for nursing care glucose monitoring is encompassed under Medicare Part A and other payment methods."

Comment 2: One commenter asked if this policy could apply to hospital inpatients who have exhausted their Part A benefits but retain Part B benefits? The commenter further stated: "Under this circumstance, glucose monitoring meeting the criteria described in the LCD would be separately billable.

Response: Such a specific example could be a billable Part B service depending on specific patient circumstances. However, this specific LCD is focused on "Blood Glucose Monitoring in a Skilled Nursing Facility."

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J12-D4 (L27476) Botulinum Toxin Type A and B

Comment 1: A commenter requested that the following be incorporated into the policy:

“As a consequence of the chemistry and the clinical pharmacology of each product, botulinum toxins are NOT interchangeable. Each individual botulinum toxin is chemically, pharmacologically, and clinically distinct. Units of biological activity are unique to each botulinum toxin preparation and cannot be compared or converted unto units of another.”
“Dosing units are specific to the preparation of the botulinum toxin and differ substantially among as well as between serotypes. There is no universally applicable safe dose conversion ration. Failure to recognize the unique characteristics of each formulation of botulinum toxin can lead to undesired patient outcomes. Therefore, it is expected that use of these products will be based on each product’s individual dosing, efficacy and safety profiles.”
“Physicians’ individual clinical expertise, judgment, familiarity with the use of botulinum toxins and the incorporation of evidence-based medicine principles should be used as a guide in selecting the appropriate drug and dose regimen for use in each patient and their specific medical condition.”

Response: The LCD does acknowledge the differences between the differed serotypes of botulinum toxin and recommends that individual providers consult compendia, medical literature, and community standards when using these toxins. The Utilization section clearly states that the unit doses of toxins may not be equated.

Comment 2: A commenter requested that the unit of service description be the billing and coding article be updated.

Response: Providers should consult compendia and medical literature to assure that proper doses of each botulinum toxin are used and that the correct units are billed for the type of toxin administered.

Comment 3: A commenter suggested that physicians be informed that billing multiple procedures with 64614 would only be in an unusual circumstance, and supporting documentation or a manual review may be required.

Response: A single unit of service can only be billed for a body area treated per session no matter how many injections were used to treat that body area. In the rare event that multiple body areas are treated in one session, the medical record should thoroughly detail the medical necessity of the treatments rendered. This record is always subject to review.

Comment 4: A commenter suggested those ICD-9-CM codes 341.22 and 344.5 be added; as well as CPT code 95873.

Response: ICD-9-CM code 341.22 and 344.5 were added. CPT code 95873 (electrical stimulation for guidance in conjunction with chemodenervation (List separately in addition to code for primary procedure”)) was not.

Comment 5: Acommenter suggested the allowance of coverage for uses not supported by the compendia for type B. Examples include failure to improve and patient intolerance or hypersensitivity to the other neurotoxin.

Response: The choice to the toxin that will be used to treat a specific patient is chosen by the provider based on the patient’s circumstances, available medical literature and community standards and is not specifically regulated by the LCD.

Comment 6: A commenter requested that 705.22 “Secondary Focal Hyperhidrosis” be an included indication.

Response: After review ICD-9-CM 705.22 Secondary Focal Hyperhidorsis was added to the list of covered diagnostic codes.

Comment 7: A commenter questioned the treatment of strabismus with botulinum unless it is secondary to blepharospasm.

Response: Strabismus has been historically treated with Botulinum Toxin Type A. Accepted indications include the treatment of horizontal strabismus up to 50 diopters, vertical strabismus, and persistent palsy of CN VI that lasts one month or longer, blepharospasm associated with dystonia, including benign essential blepharospasm or CN VII disorders.

Comment 8: A commenter suggested that “the correction of brow ptosis in situations in which the surgical correction would be approved under the blepharoplasty policy, but for which the patient might not be a surgical candidate, either due to disability, use of blood thinners, etc.,” be considered medically necessary. Subsequently, the commenter wanted to verify that this could be administered in a physician’s office.

Response: It is the rare patient who requires correction of brow ptosis and whose medical condition would not allow for an operative procedure. Therefore, if botulinum toxin is required to manage the patient’s brow ptosis, the medical record must clearly demonstrate why an operative procedure is contraindicated. These unique cases will be handled on an individual case-by-case basis.

Comment 9: A commenter asked that the draft state that there may be wasted units that may also be billed for, due to the fact that the drug is purchased in 100 unit increments, it has a short lifespan, and there may not be multiple patients that need it.

Response: The Medicare Claims Processing Manual (IOM 100-04) Chapter 17, Section 40 provides claim submission guidelines for wasted drug units.

Comment 10: A commenter provided the recent FDA “Early Communication about an Ongoing Safety Review Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)” for consideration in finalizing the policy.

Response: This article was reviewed. Providers should consult compendia, medical literature, and information from other sources such as the FDA to assure that they are administering the proper form of the toxin and utilizing the appropriate dose.

Comment 11: A commenter supported the language indicating the non-interchangeability of the two forms of botulinum toxin (Botox vs. Myobloc).

Comment 12: A commenter thought the draft appeared to be reasonable.

Response: Thank you.

Comment 13: A commenter requested that codes 722.83, 723.31, 728.85, and 95874 be added to the draft.

Response: At this time, the clinical efficacy of botulinum toxin in the treatment of the following conditions is not proven for the treatment of postlaminectomy syndrome, cervicobrachial syndrome in the medical literature and therefore, is considered not medically reasonable and necessary. Spasm is an unspecific term so it was not added to the list of covered indications. In the absence of a reference to CPT code 95874 (Needle electromyography for guidance in conjunction with chemodenervation) all services billed to Medicare must be in keeping with the correct coding guidelines and with Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section states, “no payment may be made for any expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of injury or to improve the functioning of a malformed body member.”

Comment 14: A commenter questioned the number of injections allowed, and whether coding of 64614 per contiguous body site would be paid.

Response: In the absence of a reference to CPT code 64614 all services billed to Medicare must be in keeping with the correct coding guidelines and with Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section states, “no payment may be made for any expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of injury or to improve the functioning of a malformed body member.”

If more than one unit CPT code 64614 is billed, the medical record must reflect the medical necessity of the procedure AND that two separate distinct areas of the body were treated, i.e. one arm, one leg.

Comment 15: A commenter asked whether the EMG guidance was to allow only once per encounter, or for each 64614 coded.

Response: Codes used for EMG guidance of chemodenervation must be applied based on the clinical situation and according to correct coding guidelines. In general only one unit of chemodenervation may be reported per body area, per session regardless of the number of injections performed.

Comment 16: A commenter requested that codes 333.80-333.89, 524.6, 729.89, 729.1, 784, 31513, 31570, 31599, 43499, 53899, 64612, 64613, 64614, 64650, 64653, and 67345 be added to the draft.

Response: ICD -9-CM codes 338.81-338.89 are already included in the LCD. ICD-9-CM codes 524.6, 729.89, 729.1 and 784 were not added. At this time, the clinical efficacy of botulinum toxin in the treatment of chronic migraine and intractable headache (e.g., tension) and temporomandibular disorder is not proven in the published medical literature and, therefore, is considered not medically reasonable and necessary so these codes were not added to the list.

CPT codes that reflect the procedure that is required to administer botulimun toxins are not included in the LCD. In the absence of a reference to CPT code all services billed to Medicare must be in keeping with the correct coding guidelines and with Title XVIII of the Social Security Act, Section 1862(a)(1)(A). This section states, “no payment may be made for any expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of injury or to improve the functioning of a malformed body member.”

Comment 17: A commenter asked that coverage for chronic daily headache of migraine and of tension type, and chronic low back pain, be included in the draft.

Response: The use of botulinum toxin to treat chronic headaches and chronic low back pain are off-label uses of the toxin. Therefore, the use of the toxins to treat these conditions was not included in the final version of the LCD.

Comment 18: Multiple commenters stated that a standard conversion of Type A units to Type B units, and vice versa, would not be a safe practice.

Comment 19: A commenter requested that instructions for the use of modifiers also be included.

Response: The use of modifiers and other billing information will be found in a forthcoming Billing and Coding Article.

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J12-D5 (L27477) Cancer Chemotherapeutic Agents

Comment 1: Various commenters requested using the KX modifier only if the drug is not mentioned in the three compendia or by the FDA labeling.

Response: The policy will reflect that the KX modifier will be needed if its use is for other than the FDA Labeling and it is not mentioned in the three compendia.

Comment 2: A commenter requested that Highmark accept the Association of Community Cancer Center Compendia (ACCC) as a valid resource to reference when validating a cancer treatment.

Response: The Association of Community Cancer Center Compendia (ACCC) has been added to the Policy for referencing a valid cancer treatment.

Comment 3: A commenter provided the link to the updated AHFS compendia listing for Vidaza in AML.

Response: The American Hospital Formulary Service is considered a major compendia citation for Potential coverage by the policy.

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J12-D6 (L27478) Cardiovascular Stress Testing

Comment 1: A commenter requested that code V12.53 be added to the list of covered diagnoses.

Response: This diagnosis will not be added to the list of covered diagnoses. It seems likely that another diagnosis would become the primary reason for the test following the successful resuscitation from sudden cardiac death.

Comment 2: One commenter stated that they felt it would be reasonable not to include Hypertension on the list of diagnoses, but it should be standard for all stress testing.

Response: Testing should only be done for what is reasonable and nec

J12 MAC Transition(* = off-site link)

J12 MAC Transition
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