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

Filgrastim (G-CSF)(NeupogenA®), I-17 – Draft LCD rescinded.

Pegfilgrastim (Neulasta™, I-45

Comment #1:  One comment advised that the “language requiring use of Pegfilgrastim with first chemotherapy is unclear.”

Response:  The language in the final LCD has been clarified.

Use of Intravenous Immune Globulin (IVIG) in Immunodeficiency Syndromes, I-50

Highmark Medicare Services (HMS) did not receive any comments to its draft Local Coverage Determination (LCD) I-50, Use of Intravenous Immune Globulin (IVIG) in Immunodeficiency Syndromes.

Use of Intravenous Immune Globulin (IVIG) for Idiopathic (Immune) Thrombocytopenic Purpura (ITP), I-51

Comment #1:  One commenter submitted clinical documentation to support the following comments:  “Your current LCD restricts the use of HCPCS code J2792 for uses for which it is not indicated for…J2792 (Rh(D) immune globulin, S/D) should be updated to include the coverage of ITP.”  And, “The product WinRho, is the only Rh(D) immune globulin that has the FDA approval and indication for ITP.”

Response:  The final LCD has been limited to a discussion of intravenous products only.  HCPCS code J2792 has been removed from the final LCD because it is not administered intravenously.

Use of Intravenous Immune Globulin (IVIG) in Neurological and Musculoskeletal Disorders, I-52

Highmark Medicare Services (HMS) did not receive any comments to its draft Local Coverage Determination (LCD) I-52, Use of Intravenous Immune Globulin (IVIG) in Neurological and Musculoskeletal Disorders.

Use of Intravenous Immune Globulin (IVIG) for the Treatment of Autoiummune Mucocutaneous Blistering Diseases, I-53

Comment #1:  Several commenters advised that the policy was fair and appropriate, as written.

Ranibizumab (Lucentis™), I-71

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  Several commenters inquired if we will change C9399 to another NOC code since C codes are not used in Medicare Part B.  One of these commenters noted that our August 7, 2006, “What’s New” article advises that the appropriate code is J3590.

Response:  The correct coding was added to the final LCD.

Comment #3:  Several commenters advised that Lucentis™ has smaller molecules and is more specific for covering all of the VEGF in the eye.  Avastin® has larger fragments, is less specific, and was never made for intraocular use, but was a chemotherapeutic agent; however, both of these drugs are similar in their efficacy.  This commenter further advised that the drugs are administered monthly to every 6 weeks, and that the studies show that it is to be administered for 1-2 years of monthly injections.  Finally, the commenter noted that Lucentis™ at $2000.00/injection (versus $50.00 for Avantis®) is a huge reimbursement difference.

Response:  No change in the final LCD was necessary.

Comment #4:  One commenter advised that it is too soon to tell what the long term effect of monthly Avastin® injections since it is a larger molecular, and will, therefore, will remain in the eye longer.  However, this commenter advised that the clinical literature is sufficient to support the legal argument that Avastin® is a reasonable alternative to Lucentis™.

Response:  Both Avastin and Lucentis are covered by Pennsylvania Medicare for exudative senile macular degeneration.

Comment #5:  One commenter advised that he has had patients treated with Lucentis™ who have left the nursing home and gone back to independent living based on the 3-line eye chart improvement.  

Response:  No change in the final LCD was necessary.

Topotecan Hydrochloride (HycamtinA®), I-72

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  On commenter advised that “Stage IVB recurrent or persistent carcinoma of the cervix,” by definition, is an initial stage indicating eustasis.  This commenter advised that it is more appropriate to say, “Stage IVB, (comma) recurrent or persistent carcinoma of the cervix.”

Response:  The detailed suggestions are appreciated and have been included in the final LCD.

Comment #3:  One commenter made the following two suggestions:

1)  Under Indications and Limitations: Topotecan is indicated for metastatic ovarian carcinoma, Stage IVB recurrent cervical cancer and recurrent or progressive small cell lung cancer.  All of which indicates that the patients will have metastatic disease sites.  Under the ICD-9 codes that support medical necessity only 3 metastatic sites are listed. If patients have a period of time cancer free then develop metastatic disease, use of this drug will not be covered with the current list of ICD-9 codes.  Typically the metastatic sites will be coded with as well as the code for history of malignant neoplasm (V10).

Therefore, this commenter recommended that we “add the ICD-9 codes for the typical metastatic sites for these primary cancers.  Small cell lung cancer can metastatize to neck and thoracic lymph nodes (196.0, 196.1); pleural (197.2); mediastinium (197.3) and the liver (197.7).  Ovarian and cervical cancer can metastatize to the retroperitonium (197.6); abdominal and pelvic lymph nodes (196.2, 196.5, 196.6) and soft tissue in the pelvic area (198.89).  Add the history of malignant neoplasm codes for ovary (V10.43) and cervix (V10.41).  Usually patients with small cell lung cancer are never disease free and would not be coded as h/o.”

2)  “According to the compendia-based Drug Bulletin of the Association of Community Cancer Centers, Topotecan is also indicated for use with Chronic Myelomonocytic Leukemia (205.1X), Non-Small Cell Lung Cancer (162.x), and Myelodysplastic Syndrome (238.7x). With both CML and MDS, Topotecan is also recognized in the USP DI Thompson Micromedex. Both the USP DI and the AHFS Drug Information, American Society of Health Systems Pharmacists, Inc., recognize Topotecan for use in NSCLC.

Recommendation - Add the following codes for the above conditions:

     238.7X Myelodyplastic Syndrome

     205.1X Chronic Myelomonocytic Leukemia   

     Add Non-Small Cell Lung Cancer to the list of Indications and Limitatiions.”

Response:  At this point, these detailed suggestions are appreciated and have been included in the final LCD.

Comment #4:  One commenter made the following suggestions and comments:

1. Various mechanisms are being investigated to restore sensitivity of certain cancer cells previously noted to be resistant to agents such as Topotecan by a variety of ingenious maneuvers, one of which involves the use of Gefinit which does just this with Topotecan.  The efflux of Topotecan was inhibited and thus the concentration of this agent increased in cancer cells when combined with Gefinit treatment.  These new techniques would, perhaps, rapidly expand the utility of Topotecan in situations where, previously, its use would be prohibited by resistance.  Based on these facts, this commenter suggested that a code be put in place that said, “Topotecan can be used against primary cancer cell subtypes (best perhaps to leave this not further defined) where modulating agents allow for activity of the agent where previously the drug was inactive on a case-by-case basis, Topotecan can be used when documentation is provided that substantive activity can be achieved in this circumstance.”
2. Cancers of the lung:  The commenter advised agreement with the codes and indications listed on the draft LCD.
3. G.U. malignancies:  The commenter advised agreement with the codes and indications listed on the draft LCD.  However, the suggestion was made to include peritoneal malignancy since this tumor, as a rule, responds to all chemotherapeutics that also are effective in treating cancer of the ovary.
4. Additional indications to be considered: 

• Topotecan could be considered as therapy for any patient suffering from leptomeningeal malignant spread or metastatic spread to the brain in selected patients since Topotecan has the ability to penetrate the blood/brain barrier.
• Topotecan has been shown to have efficacy in the treatment of sarcomas and related neoplasms in children.
• Topotecan has been shown to have efficacy in the treatment of lymphomas, especially in the advanced state, when associated lymphoproliferative disease such as myeloma dn particularly primary or metastatic lymphoma to the brain given its previously noted penetrance into the brain and leptomeningeal tissues.
• Topotecan has had low response in the treatment of breast cancer.  It could be considered as a second or third line therapy in patients with breast cancer given its relatively low toxicity profile. 

Response:  At this point, these additional uses will not be added to the LCD, but will be reviewed under individual consideration.

Transesophageal Echocardiography (TEE), M-51I

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Sentinel Lymph Node Biopsy, S-124

Highmark Medicare Services (HMS) did not receive any comments to its draft Local Coverage Determination (LCD) S-124, Sentinel Lymph Node Biopsy.

Diagnostic Upper Gastrointestinal Endoscopy/Esophagogastroduodenoscopy, S-158

Comment #1:  Several commenters advised that the policy was accurate as written.

Comment #2:  One commenter provided the following observations/suggestions:

• Second paragraph of the Indications section – “Rarely if ever is jejunum seen on EUD – seen on small bowel enteroscopy.”
• Coverage Limitations #3 – “I would argue that patients with chronic reflux should have EGD.”

Response:  First bullet:  These comments were appreciated.  Second bullet:  Chronic reflux patients may require and be eligible for EGD as per the indications section.  This limitation in its entirety states:

“EGD is considered not medically reasonable and necessary in patients with uncomplicated heartburn responding to medical therapy. Patients with symptoms of uncomplicated gastroesophageal reflux disease (GERD) or those with mild intermittent dyspepsia may not require endoscopic evaluation. Only when clinical signs and symptoms suggest that reflux is severe (to include hoarseness, laryugeal inflammation or edema) or that other diseases may be present, is endoscopic evaluation warranted.”

No LCD change was necessary.

Extracorporeal Shock Wave Lithotripsy (Lithotripsy), S-159

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  One commenter advised that the Indications section (“ESWL is ideal for kidney stones larger than 0.5cm in diameter and smaller than 2.5cm in diameter.  Stones less than 0.5cm in diameter have a high chance of spontaneous passage.”) does not address stones that are 0.5 cm.  It was this commenter’s opinion that a stone that is 0.5 cm has about a 50% chance of passing and should, therefore, be included in the treatment.

Comment #3:   Several commenters provided opinions regarding the above quoted Indications section.  These included: 

1) “If you have a patient with a history of not passing 2 cm stones, then 4 cm could be a problem.” 

2) Airplane pilots cannot fly with a 2 cm stone. 

3) “Small stones sometimes have to be lithotripsed.  I do agree with an upper limit.” 

4)  “There is a high probability that 2.5 cm stones could need more than 1 treatment.  Even with stents in, where stone fragments are all bunched up in the mid or distal ureter, they need a ureteroscopy to get them out.  So it may warrant more surgery.” 

5)  The following are several comments by one commenter regarding these Indications statements:  “The 0.5 cm size restriction on kidney stones is a bit outdated.”  “Restricting treatment of stones less than 0.5 cm that do not cause blockage, infection, or severe pain/colic is also outdated.”  This commenter felt that the guideline in the draft policy was taken from older references, and that contemporary care is now different because of less invasive and much safer treatments being available to alleviate the patient’s pain.  Finally, this commenter suggested that we delete the word “high” in the Indications section.

6)  “I would recommend that the lower threshold of stone size be changed to 0.4 cm.  Even though these stones have a high rate of eventual stone passage, they can cause considerable pain upon passage.”

Response to #2 and #3:  The final LCD has been revised to state greater than or equal to 0.4 cm for a lower limit.  Use for treatment of renal stones larger than 2.5 cm will be reviewed under individual consideration.

Comment #4:  Several commenters advised that ESWL therapy for gallbladder disease is not the current preferred method of treatment.  One stated:  “Fragments formed by ESWL treatment of stones in the gallbladder, however, do not readily pass from the gallbladder into the cystic duct, and the risk of cystic duct obstruction is high.  Moreover, despite adjunctive ursodiol therapy to hasten fragment dissolution, patients continue to have biliary colic for weeks and there is a high rate of stone recurrence.” “I would recommend eliminating the codes that include calculus of the gallbladder.”

Response:  The final LCD has been revised to eliminate the indication and codes for gallbladder disease treatment.

Comment #5:  Comments advised that ESWL therapy can be helpful in breaking up biliary duct and pancreatic duct stones – making them amenable to further endoscopic removal. 

Response:  These indications have been retained in the final LCD.

Computed Tomographic Angiography of the Chest, X-45B

Comment #1:  Several commenters wrote in agreement with the draft LCD as written.

Comment #2:  One commenter advised that “Coronary CTA is the best and least invasive way to evaluate the coronary arteries. This test accurately determines coronary stenosis, and will replace most cardiac nuclear medicine studies and all diagnostic cardiac catheterizations. Therefore, the indications for this test should be the same as those for nuclear stress testing, notably patients with chest pain.

The indications should also be expanded to include high risk patients with or without chest pain using the criteria established by the Framingham and other studies. CCTA will revolutionize medicine saving countless dollars currently being spent on the high percentage of normal cardiac catheterizations that are being performed.”

Response:  The final LCD includes all indications developed by the ACC and ACR in their model LCD.  Coronary CTA is, however, not covered as a screening test for asymptomatic individuals.

Comment #3:  One commenter provided the following comments and suggestions:

• Limitations, #3:  “Sometimes you’re looking for a graft patency when the patient is not a good candidate for catherization.  It is a screening, but an appropriate screening that should be included when you’re trying to check for graft patency.”
• Limitations, #5:  “Cardio is in attendance to give the beta block medicine and to monitor the patient, and give other beta blockers.  This should be a reimbursed service.”
• Limitations, #7:   “I assume that means the physician can be in the vicinity, not actually needed in the room.”
• “Concerning coronary CT angiography, if a patient has an acute coronary syndrome or unstable angina with ECG changes or abnormal enzymes, then a cardiac cath and not CT angiography would be the appropriate test since there is a high likelihood that the patient may need an intervention.”

Response:  Again, the final LCD includes all indications developed by the ACC and ACR in their model LCD.  Coronary CTA is, however, not covered as a screening test for asymptomatic individuals.  Drug injections would be a separate covered item.  Attendance is part of professional allowance for the study.  The level of supervision to inject and/or give a beta blocker and monitor the patient accordingly would be “Direct supervision”, which requires the physician/provider in the suite and immediately available to the patient.

Comment #4:  One commenter strongly recommended that the American College of Cardiology (ACC) Scored items 7 to 9 be used as the Indications for these tests.  If not, this commenter suggested the following changes in the Indications section:

• 71275 – “Abnormalities of the pulmonary vasculature” should read “Abnormalities of Extra-Cardiac vasculature.”
• 0146T-0149T – “1) Emergency evaluation of acute chest pain is much too restrictive.  I would suggest the ACC criteria of Intermediate pre-test probability, ECG uninterruptible OR unable to exercise for evaluation of Chest Pain Syndrome and Intermediate pre-test probability of CAD in Acute Chest Pain cases.  2) Cardiac evaluation of patient with chest pain syndrome who is NOT a candidate for cath should be changed to can be used as an alternative to cath.”

This commenter also recommended that the acceptable cardiac indications should not include hypertensive heart disease; chest pain unspecified; and, perhaps, chest pain, other.  “The ACC article would suggest that Chest Pain Syndrome; intermediate probability, Acute Chest Pain, intermediate probability, suspected coronary anomalies, uninterruptible non-invasive studies, and evaluation of complex congenital heart lesions would be the main intra-cardiac indications. I am not at all sure that simply having a history of coronary disease or coronary atherosclerosis should be an indication for one of these tests without non-invasive evidence to suspect an actively ischemic process.”

Response:  The final LCD includes all indications developed by the ACC and ACR in their model LCD.  Hypertensive heart disease was removed from the final LCD based on these comments. 

Comment #5:  Another commenter also recommended that our policy be aligned to the model LCD created by the ACC.  This commenter suggested the following additional Indications (and an ICD-9 list provided):

• Coronary CTA be used as a first test to assess the cause of chest pain.
• Coronary CTA be used as a triage tool to invasive coronary angiography following a stress test that is equivocal or suspected to be inaccurate.
• Coronary CTA be used to evaluate the cause of symptoms in those with known coronary artery disease.
• Coronary CTA be used to evaluate the cause of chest pain or dyspnea in patients with prior bypass surgery of intracoronary artery stent placement.
• CTA be used for the assessment of coronary or pulmonary venous anatomy.
• The use of coronary CTA prior to non-coronary artery surgery.

This commenter also provided the following changes: 

• The Indications section “for noncardiac assessment, the multidector scan may be capable of less than 16 slices per second” be replaced with “the multidector scan may be capable of 16 slices or greater per second.”
• The Indications, Bullet 2 be modified to read, “Abnormalities of the various vascular beds including the pulmonary vasculature [pulmonary artery and veins, pulmonary AV malformations], and aorta [aortic dissection, aortic aneurysm, and other arterial vascular abnormalities/vasculities] excluding the heart.”
• The Indications section, paragraph 2 be changed to reflect that MCT is capable of imaging both left and right subclavian and left and right common carotid arteries, not just the left as stated in the draft LCD.

Response:  The indication from the comments received above, and the ACC-ACR model policy of “first test to assess the cause of chest pain” is the one indication that has been questioned and debated during our development of the final LCD, and in the clinical literature recently.  Our final LCD did incorporate all the information and indications for cardiac CTA that had been developed by the ACC and ACR in their model policy and the recent JACC article(s).  However, cardiac CTA is NOT a replacement for cardiac stress imaging testing at this time.  We feel very strongly that specific guidelines need to be utilized to differentiate those patients at low risk vs moderate risk vs high risk for coronary events and appropriately utilize cardiac CTA vs stress imaging testing as the “first test to assess the cause of chest pain”.