National Government Services, Inc. Medicare Monthly Review Part A and B
A Combined Part A and Part B Newsletter

MMR-2007- 10AB, October 2007

New and Revised Local Coverage Determinations (LCD)

The following new and revised Local Coverage Determinations (LCDs) are effective 12/01/2007 for the following contracts.

These Local Coverage Determinations consolidate and replace all previous policies and publications on this subject by the carrier and fiscal intermediary predecessors of National Government Services (AdminaStar Federal, Anthem Health Plans of New Hampshire, Associated Hospital Service, Empire Medicare Services, and United Government Services).

In addition, each LCD is linked to a Supplemental Instructions Article (SIA) that gives specific coding instructions. All National Government Services providers are advised that claims for dates of service on or after 12/01/2007 for services described in these LCDs may be subject to edits according to the medical necessity provisions described in the policy.

All LCDs and articles may be viewed on the CMS database at http://www.cms.hhs.gov/mcd/search.asp or on the National Government Services Web site at http://www.NGSMedicare.com.

You may also request copies via Fax-on-Demand by calling 866-709-1905, toll-free.

LCD Summaries

TITLE: Acid Phosphatase
LCD Database ID Number: L25879
SIA Database ID Number: A44949

LCD Summary
Acid phosphatase is present in highest concentrations in the prostate and in metastases to bone. It has also been detected in tissue of heart, muscle, liver, testicles, spleen, skin, and hemopoietic cells. Prostatic acid phosphatase increases with advanced prostate cancer and is consistent with extracapsular disease or metastases.

Since the introduction of prostate specific antigen (PSA), the use of prostatic acid phosphatase has declined for screening or staging of prostate cancer as it seldom provides additional useful information. Under the indications and limitations defined in this LCD, prostatic acid phosphatase (CPT code 84066) will be denied for all indications, including for patients with prostate cancer.

The prostatic acid phosphatase is mostly a tartrate sensitive isomer, whereas the isomer associated with Gaucher’s disease and other entities is tartrate resistant. In patients suspected of having Gaucher’s disease the correct test to perform is total acid phosphatase.

Under this LCD, total acid phosphatase (84060) is covered for diagnoses of Gaucher’s disease, myeloid leukemias, and hyperparathyroidism.

LCD Summary
The purpose of this LCD is to create a fast track way to coverage for biologic products for wound treatment and/or surgical interventions without requiring the time demanded by the LCD process. This LCD describes the Medicare coverage determination on the use of biologic products for wound treatment and/or as part of a surgical intervention as limited to coverage approved by the Food and Drug Administration. The article also describes the process of submitting a product specific request for coverage of uses that have not yet received FDA approval.

TITLE: Cardiac Computed Tomography (CCT) and Coronary Computed Tomography Angiography (CCTA)
LCD Database ID Number: L25907
SIA Database ID Number: A45020

LCD Summary
This LCD defines the covered indications and limitations for CCT and CCTA. The indications are:

• Patients presenting with chest pain syndrome.
• Facilitation of management decision in patients with an equivocal stress test.
• When the recurrence of symptoms in patients with known coronary artery disease may be related to progression/exacerbation of underlying disease.
• When patients with prior bypass surgery or intracoronary artery stent placement present with chest pain or dyspnea.
• Suspected congenital anomalies of the coronary circulation.
• The assessment of coronary or pulmonary venous anatomy.
• The patient undergoing non-coronary artery cardiac surgery.
• Assessment of patients presenting with complaints consistent with cardiac ischemia, but without diagnostic electrocardiography (ECG) or enzymes.
• Assessment of patients who are status post revascularization procedures and who present with recurrent symptoms not clearly identifiable as ischemic.

The Limitations section addresses medical necessity issues, noncoverage of screening procedures, recommended levels of competence, as well as other issues.

TITLE: Cardiac Output Measurement Thoracic Electrical Bioimpedance
LCD Database ID Number: L25447
SIA Database ID Number: A44455

LCD Summary
Cardiac output determined by thoracic electrical bioimpedance is based upon the resistive changes in the thorax to an applied current. A special device measures electrical impedance during the cardiac cycle after the introduction of a high frequency low amplitude current, by way of surface electrodes placed at the root of the neck and the lower chest.

Under the National Coverage Determination (NCD) for this test, coverage meeting specific criteria includes: differentiation of cardiogenic from pulmonary causes of acute, optimization of atrioventricular (A/V) interval for patients with A/V sequential cardiac pacemakers, monitoring of continuous inotropic therapy for patients with terminal congestive heart failure, evaluation for rejection in patients with a heart transplant as a predetermined alternative to a myocardial biopsy, and optimization of fluid management in patients with congestive heart failure when medical criteria are met.

Limitations from the NCD preclude payment for patients with proven or suspected disease involving severe regurgitation of the aorta, patients with minute ventilation (MV) sensor function pacemakers, testing during cardiac bypass surgery, and the management of all forms of hypertension (with the exception of drug-resistant hypertension).

Coverage for drug-resistant hypertension is left to contractor discretion. Under this local coverage determination (LCD), thoracic electrical bioimpedance for drug resistant hypertension will be denied as not medically necessary. The LCD defines several other conditions for which payment will be denied, including for patients with compensated congestive heart failure (CHF), compensated cardiomyopathy, or hypertension.

TITLE: Category III CPT ® Codes
LCD Database ID Number: L25275
SIA Database ID Number: A44880

LCD Summary
The Local Coverage Determination (LCD) for Category III CPT Codes describes National Government Services policy for the coverage of Category III CPT temporary codes.

The American Medical Association (AMA) develops Current Procedural Terminology ( CPT) Category III codes to allow for data collection concerning the use of “emerging technology, services, and procedures.” The creation of a CPT Category III code by the AMA “neither implies nor endorses clinical efficacy, safety or the applicability to clinical practice.”

Because of the specific purpose these Category III codes serve, National Government Services will consider the item, service, or procedure represented by these codes to be not medically necessary, unless we have published an LCD or coverage article specifically extending coverage to a particular Category III code.

TITLE: Computed Tomographic (CT) Colonography
LCD Database ID Number: L25233
SIA Database ID Number: A44376

LCD Summary
CT colonography utilizes helical computed tomography of the abdomen and pelvis to visualize the colon lumen, along with 3-D reconstruction. The test requires colonic preparation similar to that required for standard colonoscopy (instrument colonoscopy), and air insufflation to achieve colonic distention. CT colonography is indicated in those patients in whom a diagnostic (performed for signs/symptoms of disease) optical colonoscopy of the entire colon is incomplete, can not be safely attempted or for the evaluation of a submucosal abnormality detected on colonoscopy or other imaging study.

TITLE: Drugs and Biologicals, Coverage for Labeled and Off-Labeled Indications 
LCD Database ID Number: L25820
SIA Database ID Number: A44930

LCD Summary
The purpose of this LCD is to create a fast track way to coverage for off-labeled indications for drugs and biologicals without requiring the time demanded by the LCD process. This LCD describes the Medicare coverage determination on the drugs and biologicals as those approved by the FDA and so indicated in the FDA label, or a use supported in the drug compendium American Hospital Formulary Service Drug Information (AHFS); or an off-labeled use described in a coverage article or LCD published by National Government Services. The article also describes the process of submitting a drug use specific request for coverage of off-labeled indications.

TITLE: Endoscopy by Capsule
LCD Database ID Number: L25468
SIA Database ID Number: A44553

LCD Summary
Endoscopy by capsule is carried out by a wireless video capsule that is swallowed and ultimately passed from the rectum. Two capsules are available, one designed for the small bowel and one for the esophagus. The LCD outlines coverage guidelines for conditions involving the small bowel where small bowel capsule use may be helpful for diagnosis. This LCD also defines coverage for the esophageal capsule to identify medium-large esophageal varices in a subgroup of patients with hepatic cirrhosis and portal hypertension who are anticipated to tolerate adequate doses of beta-blockers.

TITLE: Erythrocyte Sedimentation Rate (ESR) 
LCD Database ID Number: L25639
SIA Database ID Number: A44691

LCD Summary
Erythrocyte sedimentation rate (ESR) is the rate at which red blood cells settle in a capillary tube of venous blood. This test is based on the fact that inflammatory and necrotic processes cause alteration in plasma proteins, resulting in aggregation of erythrocytes. It is a nonspecific test (not considered diagnostic for any particular organ, disease, or injury). It is most often used to monitor the progress of infectious, autoimmune, or connective tissue diseases.

Medicare will consider an ESR medically necessary when it is performed for the evaluation of any of the following conditions:

• Aiding in the diagnosis of temporal arteritis (giant cell arteritis) and polymyalgia rheumatica;
• Monitoring disease activity in temporal arteritis and polymyalgia rheumatica for the principal indication of adjusting the dosage of corticosteroids;
• Monitoring patients with treated Hodgkin’ s disease;
• Monitoring patients with autoimmune diseases, inflammatory disorders caused by infection or connective tissue diseases.

TITLE: Erythropoietin Stimulating Agents (ESA)
LCD Database ID Number: L25211
SIA Database ID Number: A44399

LCD Summary
An erythropoietin stimulating agent (ESA) is an analog of erythropoietin. ESAs are biologically engineered hormones produced by recombinant DNA technology. Erythropoietin analogs contain the identical amino acid sequence as naturally occurring erythropoietin, and have the same biological effect. Primarily, the kidneys produce erythropoietin in response to hypoxia. Both erythropoietin and ESAs stimulate the bone marrow to form new red blood cells. They are used to treat anemia by elevating or maintaining the red blood cell level (as demonstrated by the hematocrit (HCT) and/or hemoglobin (Hb) levels), therefore decreasing anemia and the need for transfusions. Darbepoetin alfa (brand name Aranesp), an erythropoietin analog, differs from recombinant human erythropoietin alfa (brand name Epogen or Procrit) in having 2 additional N-glycosylation sites, which slows its clearance and makes its half-life 2-3 times longer, allowing less frequent injections. This policy will apply to new ESAs as they are approved.

Since darbepoetin alfa and epoetin alfa have a similar mode of action and their structures differ only by the number of N-linked oligosaccharides on the protein, this policy does not distinguish differences for on- or off-label indications and contraindications, except for pretreatment of selective surgery where blood loss is anticipated. Several off-label uses are well-accepted clinically, as indicated by inclusion in various compendia. However, a contraindication for either ESA is binding on both. In March 2007, the FDA issued new warnings against target HCT levels about 12 g/dL (36% Hct) “for all patients.” The FDA also issued specific warnings against off-label use in cancer patients whose anemia is not directly linked to chemotherapy. The FDA also reminded physicians that the main endpoint in studies for on-label indications has been avoidance or reduction in transfusions. The LCD contains descriptions of specific coverage guidelines and documentation that supports medical necessity for individual patients. Coding guidelines may be found in the supplemental instructions article (A44399) which is linked to this LCD.

TITLE: Homocysteine Level, Serum
LCD Database ID Number: L25650
SIA Database ID Number: A44688

LCD Summary
Elevated serum levels of the amino acid homocysteine are associated with increased risk of cardiovascular and cerebrovascular disease events as well as an increased risk of osteoporosis. Treatment of the elevated homocysteine level in the absence of an established causal relationship between hyperhomocysteinemia and these entities has been empiric supplementation with vitamin B-6, B-12, and folic acid. Hyperhomocysteinemia may also be present with Vitamin B12 and folate deficiencies associated with anemia. In these instances the elevated homocysteine confirms the vitamin deficiency as the source of anemia.

Homocysteine levels will be covered by Medicare to confirm Vitamin B12 or folate deficiency.

In the absence of evidence that treatment of hyperhomocysteinemia reduces cardiovascular events, this test can only be covered in patients with known vascular disease or risk thereof (based upon abnormal lipid metabolism, high blood pressure, or diabetes mellitus) for the purpose of risk stratification. In this circumstance it will be covered only once per lifetime.

TITLE: Hyperbaric Oxygen Therapy (HBO)
LCD Database ID Number: L25204
SIA Database ID Number: A44555

LCD Summary
For purposes of coverage under Medicare, hyperbaric oxygen (HBO) therapy is a modality in which the entire body is exposed to oxygen under increased atmospheric pressure. T he patient is entirely enclosed in a pressure chamber breathing 100% oxygen (O 2) at greater than one atmosphere (atm) pressure. Either a monoplace chamber pressurized with pure O 2 or a larger multiplace chamber pressurized with compressed air where the patient receives pure O 2 by mask, head tent, or endotracheal tube may be used.

Hyperbaric oxygen therapy serves four primary functions:

• It increases the concentration of dissolved oxygen in the blood, which enhances perfusion;
• It stimulates the formation of a collagen matrix so that new blood vessels may develop;
• It replaces inert gas in the bloodstream with oxygen, which is then metabolized by the body; and
• It works as a bactericide.

Program reimbursement for HBO therapy will be limited to that which is administered in a chamber (including the one-man unit) and is limited to the following conditions :

• Acute carbon monoxide intoxication;
• Decompression illness;
• Gas embolism;
• Gas gangrene;
• Acute traumatic peripheral ischemia;
• Crush injuries and suturing of severed limbs;
• Progressive necrotizing infections (necrotizing fasciitis);
• Acute peripheral arterial insufficiency;
• Preparation and preservation of compromised skin grafts;
• Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management;
• Osteoradionecrosis as an adjunct to conventional treatment;
• Soft tissue radionecrosis as an adjunct to conventional treatment;
• Cyanide poisoning;
• Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment;
• Diabetic wounds of the lower extremities in patients who meet the following three criteria:
• Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes;
• Patient has a wound classified as Wagner grade III or higher; and
• Patient has failed an adequate course of standard wound therapy.

All other indications not listed above are not covered under the Medicare program.

TITLE: Infrared Coagulation (IRC) of Hemorrhoids
LCD Database ID Number: L25178
SIA Database ID Number: A44342

LCD Summary
The local coverage determination (LCD) for Infrared Coagulation (IRC) of Hemorrhoids describes National Government Services policy for the treatment of hemorrhoids with infrared coagulation. Infrared coagulation of hemorrhoids (IRC) is considered reasonable and necessary for patients with symptomatic Grade I or Grade II internal hemorrhoids that have not responded to conservative treatment. The IRC may occasionally be utilized for symptomatic Grade III internal hemorrhoids. Payment will only be made for IRC once per 90-day global period, and only twice per patient in a year.

TITLE: Inpatient Rehabilitation Services Provided in an Inpatient Rehabilitation Facility ( IRF)
LCD Database ID Number: L25714
SIA Database ID Number: A44851

LCD Summary
The Local Coverage Determination (LCD) for Inpatient Rehabilitation Services Provided in an Inpatient Rehabilitation Facility ( IRF) describes National Government Services policy for the coverage of IRF services. This LCD addresses Medicare coverage for rehabilitation services provided in an Inpatient Rehabilitation Facility ( IRF), whether freestanding or an “excluded” unit [as defined in 42 CFR, Section 412.25]. The medical necessity for provision of the rehabilitative services in an inpatient setting is the primary focus. We note a distinction between medical necessity for individual therapy services, which may be reasonable and necessary in a particular case, and the medical necessity of providing coordinated, comprehensive, and interdisciplinary services in an inpatient rehabilitation setting. This LCD describes the relevant factors that differentiate Medicare coverage for rehabilitation in an IRF from coverage for rehabilitation in other settings, such as acute care hospitals, skilled nursing facilities (SNFs), home health care, and outpatient settings.

TITLE: Magnetic Resonance Angiography (MRA)
LCD Database ID Number: L25367
SIA Database ID Number: A44488

LCD Summary
Magnetic resonance angiography (MRA) is a noninvasive diagnostic test that is an application of magnetic resonance imaging (MRI). By analyzing the amount of energy released from tissues exposed to a strong magnetic field, MRA provides images of normal and diseased blood vessels as well as visualization and quantification of blood flow through these vessels.

Medicare will cover MRAs for the following indications only:

• Head and Neck
• Peripheral Arteries of Lower Extremities
• Abdomen and Pelvis
• Chest

While the intent of this LCD is to provide reimbursement for either MRA or CA, CMS is also allowing flexibility for physicians to make appropriate decisions concerning the use of these tests based on the needs of individual patients. CMS anticipates, however, low utilization of the combined use of MRA and CA. As a result, CMS encourages contractors to monitor the use of these tests and, where indicated, requires evidence of the need to perform both MRA and CA.

TITLE: Neuromuscular Junction Testing
LCD Database ID Number: L25563
SIA Database ID Number: A44653

LCD Summary
The local coverage determination (LCD) for Neuromuscular Junction Testing describes National Government Services policy for neuromuscular junction testing. Neuromuscular junction testing by repetitive stimulation may be reasonable and necessary to diagnose patients with fatiguable weakness that is being evaluated for possible disease of the neuromuscular junction. Additional indications for testing would include patients with exposure to certain drugs (occasionally) and patients in intensive care unit (ICU) settings who experience continued weakness after a critical illness which has required being paralyzed for mechanical ventilation. Neuromuscular junction testing must not be billed for any diagnostic test or procedure that does not meet the CPT definition of CPT 95937 (Neuromuscular junction testing [repetitive stimulation, paired stimuli], each nerve, any one method). Examples of tests or procedures not covered under this code of repetitive nerve stimulation include quantitative sensory testing by any means and sensory nerve conduction threshold testing. Tests depending on the patient’s subjective response to single or repetitive stimulation (electrical, vibratory, thermal, or tactile), regardless of whether or not these data are analyzed and presented through electronic or computerized systems, also fail to satisfy the definition of CPT 95937.

TITLE: Ophthalmic Angiography (Fluorescein and Indocyanine Green)
LCD Database ID Number: L25347
SIA Database ID Number: A44526

LCD Summary
Fluorescein angiography is used in the diagnosis and treatment of a wide range of ocular disorders, such as chorioretinal vasculitis, age related macular degeneration, intraocular tumors, visual loss in systemic disease, and acute exudative inflammations. Medical necessity criteria for these indications are defined in this LCD.

Indocyanine green angiography (ICG) is effective in the diagnosis and treatment of ill-defined choroidal neovascularization (e.g., associated with age related macular degeneration). It is also useful in the evaluation of feeder vessels, choroidal leakages in the late phase, and ruptures of the pigment epithelium.

ICG may be a valuable diagnostic adjunct to fluorescein angiography in the evaluation of retinal neovascularization, choroid neovascularization, serous detachment of retinal pigment epithelium, hemorrhagic detachment of retinal pigment epithelium and retinal hemorrhage.

ICG for the evaluation of patients with background diabetic retinopathy is not considered to be a medically necessary service.

Both fluorescein angiography and ICG angiography of an asymptomatic contralateral eye without new abnormalities on ophthalmoscopic exam, in patients with unilateral AMD or other disease, will be denied as not medically necessary. Evidence of medical necessity must be documented in the medical record for each eye.

TITLE: Ophthalmology: Posterior Segment Imaging (Extended Ophthalmoscopy and Fundus Photography)
LCD Database ID Number: L25466
SIA Database ID Number: A44439

LCD Summary
Fundus photography involves the use of a retinal camera to photograph the regions of the vitreous, retina, choroids, and optic nerve. Fundus photography is indicated under this LCD for the diagnosis of conditions such as macular degeneration, retinal neoplasms, choroid disturbances, diabetic retinopathy, glaucoma, multiple sclerosis, or other central nervous system anomalies. This test must include a written interpretation to be covered.

Extended ophthalmoscopy is the detailed examination of the retina with drawing. It is most frequently performed utilizing an indirect lens, although it may be performed using contact lens biomicroscopy. It may use scleral depression.

Extended ophthalmoscopy is indicated when the level of examination requires a complete view of the posterior segment of the eye and documentation is greater than that required for general ophthalmoscopy. It is covered under this LCD for several indications including retinal defects, retinal diseases and disorders, chorioretinitis, chorioretinal scars or choroidal degeneration, dystrophies, hemorrhage and rupture, or detachment, injury to the eye, disorders of the vitreous body, glaucoma, and macular degeneration.

• Extended ophthalmoscopy done without a drawing is not separately payable and will be considered part of a general ophthalmologic exam or E&M service. In addition, extended ophthalmoscopy performed during the global surgery period of an ophthalmologic surgery procedure, by the same provider performing the surgery, will not be separately payable unless unrelated to the condition for which the surgery was performed.

TITLE: Psychiatric Inpatient Hospitalization
LCD Database ID Number: L25507
SIA Database ID Number: A44896

LCD Summary
The Local Coverage Determination (LCD) Psychiatric Inpatient Hospitalization describes National Government Services policy for the coverage criteria and indications (including intensity of service and severity of illness) for psychiatric inpatient hospitalization services.

Inpatient psychiatric hospitalization provides twenty-four (24) hours of daily care in a structured, intensive, and secure setting for patients who cannot be safely and/or adequately managed at a lower level of care. This setting provides daily physician (MD/DO) supervision, twenty-four (24) hour nursing/treatment team evaluation and observation, diagnostic services, and psychotherapeutic and medical interventions.

Inpatient psychiatric care may be delivered in a psychiatric hospital, a psychiatric hospital acute care unit within a Psychiatric Institution, or a psychiatric inpatient unit within a general hospital as defined in CMS Publication 100-01, Medicare General Information, Eligibility, and Entitlement Manual, Chapter 5, Sections 20.3, 20.4, 20.5, 20.6, and 20.7.

TITLE: Surgical Decompression for Peripheral Polyneuropathy
LCD Database ID Number: L25271
SIA Database ID Number: A44493

LCD Summary
The National Government Services local coverage determination (LCD) for Surgical Decompression for Peripheral Polyneuropathy is essentially a noncoverage policy. There are currently no accepted indications for the surgical decompression of diabetic, other metabolic/toxic, or idiopathic polyneuropathy. Neither the procedure nor the anesthesia services for the procedure will be considered medically necessary.

TITLE: Varicose Veins of the Lower Extremity, Treatment of
LCD Database ID Number: L25519
SIA Database ID Number: A44614

LCD Summary
This LCD describes the covered treatment modalities for symptomatic varicose veins of the lower extremity and the indications for which such treatments are covered or noncovered. Treatment modalities specifically addressed in the LCD are: ligation and striping, sclerotherapy, laser ablation, and radio frequency ablation.

The following Local Coverage Determination (LCD) is effective 12/01/2007 only for the following contracts:

TITLE: Hospice – Determining Terminal Status
LCD Database ID Number: L25678
SIA Database ID Number: A45194

LCD Summary
Medicare coverage of hospice depends on a physician’s certification that an individual’s prognosis is a life expectancy of six months or less if the terminal illness runs its normal course. This LCD describes guidelines to be used by National Government Services in reviewing hospice claims and by hospice providers to determine eligibility of beneficiaries for hospice benefits. Although guidelines applicable to certain disease categories are included, this LCD is applicable to all hospice patients. It is intended to be used to identify any Medicare beneficiary whose current clinical status and anticipated progression of disease is more likely than not to result in a life expectancy of six months or less.