Medicare Coverage Guidebook

Transcription

1 Medicare Coverage Guidebook Using this Guidebook Clinical Laboratories are required by law to inform clients annually about Medicare compliance policies pertaining to the use of laboratory testing for Medicare beneficiaries. This booklet contains a summary of these policies, and the medical necessity requirements for laboratory tests that have National and/or Local Coverage limitations. The responsibility for complying with Medicare when ordering laboratory testing lies with the ordering physician. The coding information contained in this booklet was obtained from the Centers for Medicare & Medicaid Services website, coverage index. This booklet should not be used as a sole or final reference or interpretation of Medicare law. For more complete information, please refer to a current CMS ICD-9-CM Coding Manual or the CMS website resources. Resources The CMS website: The CMS Guide to Medicare Preventative Services: The CMS Laboratory Fee Schedule: The CMS Medicare Coverage database LCD/NCD Index: Medicare Fiscal Intermediary for EMH Reference Laboratory: National Government Services, Inc (00131, FI) The EMH Reference Laboratory website:

2 Table of Contents pg # How to Use the Advanced Beneficiary Notice (ABN) 1 Price Estimates for Medicare Limited Tests on ABN 2 Laws and Regulations Governing Laboratories 4 Medicare Coverage for Laboratory Services 6 Medicare Coding, and Billing for Laboratory Services 7 Medicare Rules for Test Ordering 9 EMHRL Reflexed Tests 10 Acid Phosphatase LCD 11 Allergen Testing LCD 13 Alpha-fetoprotein (AFP) Tumor Marker NCD 15 Beta-Natriuretic Peptide (BNP) LCD 18 CA 125 Tumor Marker NCD 20 CA 15-3 / CA Tumor Markers NCD 22 CA 19-9 Tumor Marker NCD 23 Carcinoembryonic Antigen (CEA) NCD 24 Cell Counts, Blood (CBC) NCD 28 Circulating Tumor Cell Assay (CTC) NON-COVERED TEST 41 Collagen Crosslinks (N-Telopeptide) NCD 42 Digoxin Therapeutic Drug Assay NCD 44 Drug Screen, Qualitative LCD 48 Fecal Occult Blood Test, Diagnostic NCD 54 Fecal Occult Blood Test, Colorectal Cancer Screening Prevention 61 Gamma Glutamyl Transferase (GGT) NCD 64 Galectin-3 NON-COVERED TEST 77 Glucose, Diagnostic NCD 78 Glucose, Diabetes Screening Prevention 95 Glycated Hemoglobin/Glycated Protein NCD 96 Hepatitis Panel/Acute Hepatitis Panel NCD 99 Human Chorionic Gonadotropin (hcg) NCD 103 Human Immunodeficiency Virus (HIV) Diagnostic NCD 106 Human Immunodeficiency Virus (HIV) Prognosis / Monitoring NCD 114 Human Immunodeficiency Virus (HIV) Screening Prevention 116 Initial Preventive Physical Examination (IPPE) Prevention 118 Iron Studies NCD 120 Lipids, Diagnostic NCD 135

3 Table of Contents pg # Lipids, Cardiovascular Screening Prevention 146 Pap Test, Diagnostic NCD/LCD 147 Pap Test, Screening Prevention 159 Prostate Specific Antigen (PSA), Diagnostic NCD 161 Prostate Specific Antigen (PSA) Cancer Screening Prevention 163 Prothrombin Time (PT) NCD 164 Partial Thromboplastin Time (PTT) NCD 182 Thyroid Testing NCD 194 Urine Culture, Bacterial NCD 202 Vitamin D Assay LCD 207 Medicare Preventative Services Screening Tests Cardiovascular Screening page 146 Cervical Cancer Prevention page 159 Colorectal Cancer Screening page 61 Diabetes Screening page 95 HIV Screening page 116 Initial Preventive Physical Examination page 118 Prostate Cancer Screening page 163

4 How to Use Advance Beneficiary Notices (ABNs) For all tests listed in this booklet, you must obtain a signed ABN from the patient before ordering the test for payment by Medicare; these tests may not be covered if medical necessity requirements are not met. The test(s) should not be ordered if the beneficiary is unwilling to sign an ABN. The ABN must contain the specific name of the test, and an estimate of the cost (see following pages for estimated costs). The beneficiary must be given a reason why Medicare may not cover the test, such as frequency limitations or noncovered service. The beneficiary must sign the ABN and receive a copy. A duplicate copy must accompany the specimen and test order to the laboratory. For more information about ABN s, see page 6. NEED AN ABN FORM? EMH Reference Laboratory provides ABN forms to clients at no charge. ABN forms are available in English and Spanish. To request ABN forms, you can go to call , or us at referencelab@emhc.org. Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

5 Medicare Limited Tests - Estimate of Costs if Not Covered CPT TEST NAME $ Est. Bill* Acid Phosphatase, Total Acid Phosphatase, Prostatic Allergen Tests, specific IgE (per allergen) Alpha Fetal Protein (AFP),Tumor Marker Beta Natriuretic Peptide (BNP) Blood Count, CBC Only Blood Count, CBC/Diff Blood Count, Hemoglobin Blood Count, Hematocrit Blood Count, Platelets (automated) Blood Count, WBC (automated) Blood Count, manual Differential CA CA 15-3 (CA 27.29) CA CEA Collagen Crosslinks, NTX (urine) Collagen Crosslinks (N-Telopeptides), serum Digoxin (Lanoxin) G0431 Drug Screen, Qualitative (per drug class) Drug Confirmation (per drug class) Fecal Occult Blood, guaiac diagnostic Fecal Occult Blood, guaiac screen Gamma Glutamyl Transferase (GGT) Glucose, 2-hour post 75gm Glucose Tolerance Test, 2hour Glucose, quantitative blood Glycated hemoglobin (HgbA1c) Glycated protein, fructosamine HCG (Pregnancy), serum quantitative Hepatitis Panel, Acute HIV-1+2 Antibody Confirmation Evaluation (Western Blot) HIV-1+2 Antibody Screen HIV-1, Quantitative by amplified probe Iron Studies, Ferritin Iron Studies, Total Iron Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

6 Medicare Limited Tests - Estimate of Costs if Not Covered CPT TEST NAME $ Est. Bill* Iron studies, Binding Capacity Iron Studies, Transferrin Lipids, Lipid Panel Lipids, Total Cholesterol Lipids, Triglycerides Lipoprotein, direct LDL cholesterol Lipoprotein, HDL cholesterol P3000 Pap test, liquid specimen G P3000 Pap test, conventional smear specimen G Prostate Specific Antigen (PSA) Diagnostic G0103 Prostate Specific Antigen (PSA) Screen PT/INR (Prothrombin time ) PTT (APTT) Thyroid testing, Free T Thyroid testing, Total T Thyroid testing, TSH Urine Culture Vitamin D, 25 Hydroxy *Prices listed here are to be used to estimate costs and may not include all charges actually billed. Prices may change without notice. Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

7 Laws and Regulations Governing Laboratories The Social Security Act Medicare and Medicaid laws, rules and regulations come under this act. Anti-Kickback Laws Federal and state law provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive money or favors for referrals of tests or services that will be paid for by the Medicare or Medicaid programs. This prohibits laboratories from offering inducements to physicians in order to gain their business. To comply with the law, the following rules apply to the offering of laboratory services: Supplies Laboratories may only give supplies to a physician for the drawing, processing, storing or transporting of specimens to the laboratory, and cannot provide supplies for physicians to use for their own purposes. The laboratory must monitor the amount of supplies provided to ensure that it matches the number of tests sent to the laboratory. Discounts, Gifts or Billing Adjustments The lab can give discounts, but the price must be above cost and at "fair market value." The lab cannot give excessive or expensive gifts or entertainment to physicians. The laboratory may write off charges only when laboratory errors in billing or testing occur. Phlebotomy Service Laboratories may place phlebotomists or other employees in a client s office only if all of the following conditions are met: The laboratory employee may only perform laboratory related tasks. There is a written understanding given to the physician about what the employee can and cannot do. Periodic audits are done to ensure the employee is following these policies. Equipment Likewise, laboratories may place printers, computers, fax machines or other equipment or products in client offices as long as they ensure that: The physician understands that the equipment belongs to the laboratory. The equipment is used for laboratory purposes, like receiving reports or ordering tests. Periodic audits are done to ensure that the client is using the equipment only for laboratory related tasks. Office Space Laboratories may only lease space from physicians who refer Medicare patients to them under certain circumstances: There must be a written lease for at least one year. Lease price must be at "fair market value." Couriers The laboratory's couriers may not transport items except those related to the testing services offered by the laboratory. Couriers must follow all OSHA standards for the handling and transport of specimens. Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

8 Laws and Regulations Governing Laboratories Anti-Trust Laws Federal laws prohibit unfair pricing practices. Most laboratories have one fee schedule for customers that must be billed individually (patients, insurance, Medicare) and one for customers billed monthly on an invoice type of statement (client or doctor billing). The difference in price between the two schedules should be a reflection of the financial benefits of direct client billing. Test prices should be determined by means of a financial analysis that include such factors as cost, market value and reasonable profit. Contractually arranged pricing that results from negotiations with insurance and managed care companies should at least cover costs of testing. Laboratories may not work together to fix or set prices in the market place. False Claims Act Provides criminal penalties for knowingly or willingly filing a false claim to a government program. ICD-9 codes can only be supplied by the ordering physician or a representative of that physician. It is against the law for a laboratory to change or supply an ICD-9-CM code to a test order submitted by a physician. Code steering means to steer or direct a physician to supply an ICD-9 code that is payable. Code Steering is illegal. The code must come from the patient's medical record. Missing ICD-9 codes cannot be obtained by copying them from a previous laboratory order. It is against the law to use the wrong ICD-9-CM code for the purpose of causing or increasing payment for a test. Health Insurance Portability and Accountability Act (HIPAA) HIPAA provides protection for the privacy of an individual s health information. When releasing test results by phone, fax and other non-routine methods, the laboratory may only release test results to physicians (or authorized representatives) who are involved in the patient s care, or to a patient who is involved in their own medical treatment as directed by their physician. HIPAA regulations prohibit facsimile transmission of confidential records without documented verification of the fax number transmitted from the authorized recipient s fax machine. For a copy of our Protected Health Information (PHI) policy, please call EMH Reference Laboratory at Federal Self-Referral Laws (STARK) STARK laws apply to financial relationships that have the potential to result in directed referrals to the individuals or entities involved. Prohibits the referral of patients or tests between related entities unless certain conditions are met. Stark safe harbors allow hospitals to support up to 85% of EMR startup and implementation costs, excluding physician office hardware. Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

9 Medicare Coverage for Laboratory Services Part B of title XVIII of the Social Security Act provides for Supplementary Medical Insurance for certain Medicare Beneficiaries, specifying what health care items or services will be covered by the Medicare Part B program. Diagnostic laboratory tests are generally covered by Part B under the following rules: Medical Necessity According to the statute, testing must be reasonable and necessary for the diagnosis or treatment of an illness or injury in order to be covered. Tests performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicitly authorized by statute. These include exams required by insurance companies, business establishments, government agencies, or other third parties. National and Local Coverage Limitations A National Coverage Determination (NCD) for a diagnostic laboratory test is a document stating CMS policy with respect to the circumstances under which the test will be considered reasonable and necessary for Medicare to cover it. Such a policy applies nationwide. It is neither a practice parameter nor a statement of the accepted standard of medical practice. Claims for tests for which there is a national coverage policy will be denied if submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy, unless documentation justifying the necessity is submitted with the claim. Local Medicare contractors are authorized by CMS to develop coverage policies for laboratory tests as necessary for their respective regions. These policies are referred to as Local Coverage Determinations (LCD). Claims for a test for which an LCD exists that does not fulfill the coverage requirements described may be denied. Denied claims may be given individual consideration based on a review of all pertinent medical information. Local contractors may also develop an LCD to clarify or supplement, but not conflict with, and NCD. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Advanced Beneficiary Notice (ABN) A test may be considered medically appropriate, but nonetheless be excluded from Medicare coverage by statute. The provider must notify the beneficiary in writing if the provider is aware that Medicare may not cover the test, item or procedure. All the tests included in this booklet have limited coverage based on an existing NCD, LCD, or both. If the patient s diagnosis is not supported by the ICD-9-CM codes listed, or if frequency limitations are exceeded, an ABN must be signed before ordering the test (see page 1). The test order should not be placed if the patient is unwilling to sign the ABN. However, if the physician feels obligated to order the test, the ABN may be submitted by a third party witness, documenting the beneficiary s refusal to sign the ABN. Required Documentation Failure to provide documentation of the medical necessity of tests may result in denial of claims. The patient s medical record must contain documentation that fully supports the medical necessity for the test as Medicare covers it. This documentation includes, but is not limited to, relevant medical history, physical examination, results of pertinent diagnostic tests or procedures, and signed copies of any Advanced Beneficiary Notices. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysical practitioner) through documentation in the physician s office may result in denial. Qualified Practitioners Tests that are not ordered by a treating physician or other qualified treating non-physician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. A treating physician or practitioner is defined as someone who is fully knowledgeable about the beneficiary s medical condition, and who would be responsible for using the results of any examination performed in the overall management of the beneficiary s specific medical problem. Qualified Laboratories Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate for the testing performed will result in denial of claims. Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

10 Medicare Coding and Billing for Laboratory Services HCPCS and CPT Codes CPT (Current Procedural Terminology) codes are used to describe specific tests or services. The amount of payment for a test is dependent on the CPT code. It is against the law to use the wrong CPT code for a test for the purpose of causing or increasing payment for a test. CPT or HCPCS (HICFA Common Procedure Coding System) descriptors are used in this booklet. CPT codes and their descriptors are developed and copyrighted by the American Medical Association (AMA). If a descriptor does not accurately or fully describe the test, a more complete description may be included elsewhere in the policy, such as in the Indications section. ICD-9-CM Codes ICD-9-CM (International Classification of Disease, 9th Edition, Clinical Modification) codes are used to classify diseases and conditions, and describe signs, symptoms and medical circumstances. ICD-9-CM codes are submitted to indicate the medical necessity of a particular test, and determine when coverage is allowed. The correct use of an ICD-9-CM code does not assure coverage of a service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in coverage determinations. For all tests listed in this booklet, an appropriate ICD-9-CM code (or equivalent verbiage) must be given to the laboratory at the time it is ordered. The Balanced Budget Act of 1997 made it illegal for physicians to order limited coverage tests without supplying an ICD-9-CM code with the order. It is the responsibility of the provider to code to the highest level specified in the 2012 ICD-9-CM Coding Manual (e.g., to the fourth or fifth digit). A three-digit ICD-9-CM code is to be used only if it is not further subdivided. Where fourth-digit and/or fifth-digit sub-classifications are provided, they must be assigned. A code is invalid if it has not been coded to the full number of digits required for that code. Diagnostic vs. Screening Tests Screening is the testing for disease or disease precursors so that early detection and treatment can be provided for those who test positive for the disease. Screening tests are performed when no specific sign, symptom or diagnosis is present and the patient has not been exposed to a disease. Screening tests are not covered by Medicare except those provided under specific statutes. Diagnostic tests are performed to rule out or confirm a suspected diagnosis when a patient has signs and/or symptoms related to the suspected diagnosis. Unconfirmed or Underlying Conditions Codes that describe symptoms and signs, as opposed to diagnosis, should be provided for reporting purposes when the physician has not established a diagnosis. Diagnoses documented as probable, suspected, questionable, rule-out, or working diagnosis should not be coded as though they exist. Rather, code the condition(s) to the highest degree of certainty for that encounter/visit, such as signs, symptoms, abnormal test results, or other reasons for the visit. The ICD-9 code submitted for the underlying sign, symptom, or condition must be related to the indications for the test. When the reason for performing the test is because the patient has been exposed to a communicable disease, the appropriate code from category V01 Contact with or exposure to communicable diseases, should be assigned, not a screening code; however, the test may still be considered screening and not covered by Medicare. A diagnostic statement that is listed as a manifestation of an underlying condition in ICD-9-CM must be expanded to include the underlying disease in order to accurately code the condition. Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

11 Medicare Coding and Billing for Laboratory Services Elmhurst Memorial Reference Laboratory - Medicare Billing Billing department employees must ensure that complete records and documentation exist for all Medicare billing transactions. It is unlawful for anyone other than the licensed ordering physician to change or add any information on a physician s signed order for medical services. When a client assigns Medicare billing to EMRL, tests will be billed using the CPT codes given in the Elmhurst Memorial Reference Laboratory electronic test menu ( or the Client User s Manual. When the licensed ordering physician provides all required information on the service requisition at the time of service, Elmhurst Memorial Reference Laboratory will accept assignment for laboratory services rendered to your patients with Medicare insurance, and bill the appropriate contractor. Payment received from this contractor will be accepted as payment in full for the laboratory services billed. The required information to be provided with the test order includes: 1. Patient name, date of birth, and complete address 2. Medicare/Medicaid number (or a copy of card) 3. Primary or Secondary Payer information 4. Diagnosis (ICD-9 Codes) 5. Physicians name, signature, UPIN, and NPI# (if not on file with us) 6. Copy of ABN (if indicated for the test ordered) Top Five Reasons for Denial of Claims 1. Diagnosis does not support medical necessity or a covered service 2. Service may be covered by a Primary or Secondary Payer 3. Duplicate claims 4. Patient not identified as a Medicare recipient 5. Expenses were incurred after coverage was terminated Top Tests Denied Payment due to Inappropriate ICD-9-CM Codes 1. Vitamin D, 25 hydroxy 2. Lipid Panel 3. Prothrombin Time (PT) 4. TSH Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

12 Medicare Rules for Test Ordering Date of Service During the clinical diagnostic laboratory services negotiated rulemaking, CMS learned that there was considerable variability regarding the date of service on laboratory claims. In order to promote uniformity, the committee recommended a national policy related to the date of service on laboratory claims. CMS published the rule final on November 23, 2001 (66 FR 58788). The final rule states: The date of service for laboratory tests that is reported on the claim is to be the date the tested specimen was collected; and The person obtaining the specimen must furnish the date of collection of the specimen to the entity billing Medicare. Physicians or their staff who draw specimens for testing must report the date of collection of the specimen on orders for laboratory tests. Laboratories may refuse to perform tests on orders for laboratory tests that do not include the information they need in order to seek payment for services performed, i.e., the date of collection of the specimen. Ambiguous or Unclear Test Orders By law, the laboratory cannot perform and bill for tests that are not specifically ordered by the treating physician. When the orders for a test are not absolutely clear, laboratory personnel may not use their own judgment or information supplied by the patient to change or clarify the test order; they must contact the ordering physician. Custom Panels A custom panel is a test grouping that is created by the physician for the physician s ordering convenience. This does not include common practice panels. Our requisitions are designed so that all tests included in custom panels are listed, to facilitate individual test ordering if necessary. However, if you use a paper requisition containing a custom panel that does not indicate individual test components due to space limitations, Medicare requires that you sign a Physician Acknowledgement form annually, indicating that you are aware of any reimbursement limitations your profile or reflex test may have for beneficiaries. Physicians may choose not to use their custom panel for Medicare patients, but instead order individual tests when clinically indicated. If the physician feels that the patient will benefit from tests not covered by Medicare, the patient must be asked to sign an Advance Beneficiary Notice (ABN), advising them that they will be financially responsible for services not covered by Medicare. Reflexed Tests A reflexed test is a secondary test performed after an initial test result is outside of established parameters. These secondary reflex tests further enhance the clinical picture or confirm the initial results, facilitating patient care. Types of reflex testing; Automatic Reflex Considered common laboratory practice, the secondary test is performed and billed automatically, if appropriate,without additional orders from a physician (Table 1). Ordered Reflex The secondary test is not performed automatically. The physician must choose the reflex alternative of the primary test on the test order, or specify the secondary test and reflex criteria on the test order (Table 2). A physician acknowledgement is not needed. Custom Reflex -Reflex tests not available as described above may be created for the individual physician upon request. A physician acknowledgement form must be signed annually in order for the physician to use a custom reflex test for Medicare patients. Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

13 Table 1. Automatic Reflex Testing (physician order not required for secondary test) Primary Test Includes Reflex Test Reflex Criteria ANA screen by EIA Antinuclear antibodies ANA titer / pattern by IFA Positive/equivocal screen CBC/DIFF Culture, Routine Culture, Blood Chest Pain Panel (CP0, CP2, CP6) Cell counts, indices, automated WBC diff Inoculation of appropriate culture media, interpretation of growth Aerobic and Anaerobic culture set Manual differential and RBC morphology Identification of pathogenic bacteria present, sensitivity to antibiotics if appropriate Second set of blood cultures Abnormal flagging criteria Presence/type of pathogens One set of blood culture ordered Troponin I + CK-MB + CPK Lipid panel, if none 7 days previous Troponin > 0.10 ng/ml Hepatitis A screen Anti- HAV total Anti-HAV IgM Reactive anti-hav total Hepatitis B surface antigen (SAG) SAG screening Confirmatory SAG Reactive screen HIV 1 & 2 by EIA HIV 1 & 2 antibodies Confirmatory HIV Evaluation Positive EIA test Lupus Anticoagulant Protime, PTT, DRVVT Confirmatory platelet neutralization Positive DRVVT Lyme Antibodies Lyme IgG and IgM screen Lyme Disease AB by Western Blot Reactive/equivocal screen Malarial smear Smear, microscopic exam Confirmation and species ID Parasitemia on smear exam Mixing studies Circulating anticoagulants Additional factor assays Pathologist review Rapid RSV Rapid RSV Influenza A, B, and RSV by PCR Negative Rapid RSV Rapid Strep Screen Rapid Strep Screen Beta Strep confirmatory culture* Negative Screen* RPR Syphilis serology RPR charcoal flocculation Confirmatory Treponemal test by EIA at IDPH Reactive RPR Troponin I Troponin I Lipid Panel if none 7 days previous Troponin > 0.10 ng/ml *Only on children under 18 yrs old Table 2. Ordered Reflex Testing (Physician must indicate Reflex Test when ordering) Primary Test Includes Secondary Test Reflex Criteria ANA Reflex Antinuclear antibodies, titer and pattern anti ENA, anti-dna, anti-ssa, anti-ssb Positive ANA screen PAP w HPV Reflex Liquid-based Pap Test High-Risk HPV DNA testing PAP interpretation = ASCUS PSA Free Reflex Total PSA % Free PSA Total PSA = 4-10 ng/ml. Thyroid Function TSH T4, possible T3 (per algorithm) TSH is abnormal Serum Protein Electrophoresis Reflex UA Dip Reflex Urine Drug Screen Reflex Total protein, albumin, alpha, beta & gamma globulin, A/G ratio Urine dipstick chemical analysis Immunofixation Microscopic analysis of urine Abnormal band on SPE Abnormal dipstick results Common drugs of abuse GCMS confirmation testing Positive drug screen Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

14 ACID PHOSPHATASE Acid Phosphatase Local Coverage Determination, National Government Services, Inc. (00131, FI) 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. The enzyme hydrolyzes esters to inorganic phosphate when at an acid ph and can be measured by enzymatic analysis (Roy method) or immunoassay technique. Prostatic acid phosphatase increases with advanced prostate cancer and is consistent with extracapsular disease or metastases. Acid phosphatase has also been clinically relevant in the diagnosis and follow-up of patients with Gaucher s disease. Indications 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. Since the introduction of prostate specific antigen (PSA), the use of prostatic acid phosphatase has declined and is no longer routinely used for screening or staging of prostate cancer as it seldom provides additional useful information. The American Urological Association states that PSA is the best predictor of skeletal metastases found on radionuclide bone scan. Additionally, the standard for defining response to drugs in clinical trials is the change in PSA. New biochemical markers (e.g., IL-6, TGF-β1) are being investigated for the staging of prostate cancer. The clinical accuracy of prostatic acid phosphatase assay is problematic. The assay is not organ specific, and levels measured are influenced by diurnal fluctuations, prostate examinations prior to blood sampling, and enzyme instability (due to ph, temperature and time since blood-drawing) if not handled properly prior to testing. Furthermore, elevated values of radioimmunoassays may not be as interpretable as results when the test is performed by the Roy enzymatic test. Limitations of Coverage Prostatic acid phosphatase (CPT code 84066) is not covered for any indication, and will be denied as not medically necessary for all diagnosis including Gaucher s disease and osteoporosis. Total acid phosphatase (CPT code 84060) will be denied as not medically necessary for a diagnosis of prostate disease or osteoporosis. Total acid phosphatase (84060) will be covered for the ICD-9-CM codes listed below. Covered Tests CPT/HCPCS Codes Phosphatase, Acid Total Descriptor Covered Diagnosis Codes for CPT Phosphatase, Acid Total ICD-9-CM codes Secondary malignant neoplasm of bone and bone marrow Acute myeloid leukemia, without mention of having achieved remission Myeloid leukemia acute in remission Acute myeloid leukemia, in relapse Chronic myeloid leukemia, without mention of having achieved remission Myeloid leukemia chronic in remission Chronic myeloid leukemia, in relapse Subacute myeloid leukemia, without mention of having achieved remission Myeloid leukemia subacute in remission Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

15 ACID PHOSPHATASE Phosphatase, Acid Total ICD-9-CM codes Subacute myeloid leukemia, in relapse Myeloid sarcoma, without mention of having achieved remission Myeloid sarcoma in remission Myeloid sarcoma, in relapse Other myeloid leukemia, without mention of having achieved remission Other myeloid leukemia in remission Other myeloid leukemia, in relapse Unspecified myeloid leukemia, without mention of having achieved remission Unspecified myeloid leukemia in remission Unspecified myeloid leukemia, in relapse Hyperparathyroidism, unspecified Primary hyperparathyroidism Secondary hyperparathyroidism, non-renal Other hyperparathyroidism Lipidoses Osteitis deformans without bone tumor Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

16 Allergen Testing Local Coverage Determination, National Government Services, Inc. (00131,FI) Elmhurst Memorial Reference Laboratory Medicare Notification April of 208 ALLERGEN TESTING Radioallergosorbent test (RAST), fluoroallergosorbent test (FAST), and multiple antigen simultaneous tests are in vitro techniques for determining whether a patient's serum contains IgE antibodies against specific allergens of clinical importance. As with any allergy testing, the need for such tests is based on the findings during a complete history and physical examination of the patient. The multiple antigen simultaneous testing technique is similar to the RAST/FAST techniques in that it depends upon the existence of allergic antibodies in the blood of the patient being tested. With the multiple antigen simultaneous test system, several antigens may be used to test for specific IgE simultaneously. ELISA (enzyme-linked immunosorbent assay) is another in vitro method of allergy testing for specific IgE antibodies against allergens. This method is also a variation of RAST. Limitations It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity. The following tests are considered to be NOT medically necessary and will be denied. ELISA/Act qualitative antibody testing This testing is used to determine in vitro reaction to various foods and relies on lymphocyte blastogenesis in response to certain food antigens. LMRA (Lymphocyte Mitogen Response Assays) by ELISA/Act IgG ELISA, indirect method (CPT code 86001) Qualitative multi-allergen screen (CPT code 86005) This is a non-specific test that does not identify a specific antigen. IgG and IgG subclass antibody tests for food allergy do not have clinical relevance, are not validated, lack sufficient quality control, and should not be performed. Covered Tests CPT/HCPCS Codes Descriptor Allergen specific IGE; quantitative or semi-quantitative, each allergen Covered Diagnosis Codes Allergen Tests ICD-9 Codes Covered The following ICD-9 Codes apply only to CPT code 86003: Allergic rhinitis due to pollen Allergic rhinitis due to food Allergic rhinitis, due to animal (cat) (dog) hair and dander Allergic rhinitis due to other allergen Allergic rhinitis cause unspecified Extrinsic asthma unspecified Extrinsic asthma with status asthmaticus Extrinsic asthma with (acute) exacerbation Cough variant asthma Asthma unspecified

17 ALLERGEN TESTING Allergen Tests ICD-9 Codes Covered Asthma unspecified type with status asthmaticus Asthma unspecified with (acute) exacerbation Other atopic dermatitis and related conditions Allergic urticaria Other specified urticaria Unspecified urticaria Wheezing 989.5* Toxic effect of venom Other anaphylactic reaction Angioneurotic edema not elsewhere classified Unspecified adverse effect of unspecified drug, medicinal and biological substance Unspecified adverse effect of anesthesia Other drug allergy Unspecified adverse effect of other drug, medicinal and biological substance Allergy unspecified not elsewhere classified Anaphylactic reaction due to unspecified food Anaphylactic reaction due to peanuts Anaphylactic reaction due to crustaceans Anaphylactic reaction due to fruits and vegetables Anaphylactic reaction due to tree nuts and seeds Anaphylactic reaction due to fish Anaphylactic reaction due to food additives Anaphylactic reaction due to milk products Anaphylactic reaction due to eggs Anaphylactic reaction due to other specified food V15.09 Personal history of other allergy other than to medicinal agents *ICD-9-CM code should be reported for venom hypersensitivity. Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

18 ALPHA FETOPROTEIN TUMOR MARKER Alpha Fetoprotein, Tumor Marker National Coverage Determination, Center for Medicare & Medicaid Services Alpha-fetoprotein (AFP) is a polysaccharide found in some carcinomas. It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy. Indications AFP is useful for the diagnosis of hepatocellular carcinoma in high-risk patients (such as alcoholic cirrhosis, cirrhosis of viral etiology, hemochromatosis, and alpha 1-antitrypsin deficiency) and in separating patients with benign hepatocellular neoplasms or metastases from those with hepatocellular carcinoma and, as a non-specific tumor associated antigen, serves in marking germ cell neoplasms of the testis, ovary, retro peritoneum, and mediastinum. Covered Tests CPT/HCPCS Codes Alpha-Fetoprotein; Serum Descriptor Covered Diagnosis Codes Alpha-fetoprotein, Serum ICD-9 Codes Covered Chronic viral hepatitis B with hepatic coma without hepatitis delta Chronic viral hepatitis B with hepatic coma with hepatitis delta Chronic viral hepatitis B without hepatic coma without hepatitis delta Chronic viral hepatitis B without hepatic coma with hepatitis delta Chronic hepatitis C with hepatic coma Chronic hepatitis C without hepatic coma Syphilis of liver Clonorchiasis Fascioliasis Malignant neoplasm of liver primary Malignant neoplasm of intrahepatic bile ducts Malignant neoplasm of liver not specified as primary or secondary Malignant neoplasm of anterior mediastinum Malignant neoplasm of posterior mediastinum Malignant neoplasm of other parts of mediastinum Malignant neoplasm of mediastinum part unspecified Malignant neoplasm of upper respiratory tract part unspecified Malignant neoplasm of other sites within the respiratory system and intrathoracic organs Malignant neoplasm of ill-defined sites within the respiratory system Malignant neoplasm of ovary Malignant neoplasm of undescended testis Malignant neoplasm of other and unspecified testis Secondary malignant neoplasm of mediastinum Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

19 ALPHA FETOPROTEIN TUMOR MARKER Alpha-fetoprotein, Serum ICD-9 Codes Covered Secondary malignant neoplasm of liver Secondary malignant neoplasm of ovary Secondary malignant neoplasm, genital organs Malignant carcinoid tumors of other and unspecified sites Secondary neuroendocrine tumor, unspecified site Secondary neuroendocrine tumor of distant lymph nodes Secondary neuroendocrine tumor of liver Secondary neuroendocrine tumor of bone Secondary neuroendocrine tumor of peritoneum Secondary Merkel cell carcinoma Secondary neuroendocrine tumor of other sites Benign neoplasm of liver and biliary passages Neoplasm of uncertain behavior of liver and biliary passages Mixed hyperlipidemia Alpha-1-antitrypsin deficiency Hereditary hemochromatosis Hemochromatosis due to repeated red blood cell transfusions Other hemochromatosis Other disorders of iron metabolism Disorders of copper metabolism Cystic fibrosis without meconium ileus Cystic fibrosis with gastrointestinal manifestations Other deficiencies of circulating enzymes Sideroblastic anemia Neoplasm related pain, acute or chronic Coronary atherosclerosis due to calcified coronary lesion Saddle embolus of abdominal aorta Other arterial embolism and thrombosis of abdominal aorta Alcoholic cirrhosis of liver Chronic hepatitis unspecified Chronic persistent hepatitis Autoimmune hepatitis Other chronic hepatitis Cirrhosis of liver without alcohol Hepatopulmonary syndrome Other specified disorders of male genital organs Solitary pulmonary nodule Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

20 ALPHA FETOPROTEIN TUMOR MARKER Alpha-fetoprotein, Serum ICD-9 Codes Covered Other nonspecific abnormal finding of lung field Nonspecific abnormal findings of other intrathoracic organs Nonspecific abnormal findings of biliary tract Nonspecific abnormal findings of abdominal area including retroperitoneum Other abnormal tumor markers V10.07 Personal history of malignant neoplasm of liver V10.43 Personal history of malignant neoplasm of ovary V10.47 Personal history of malignant neoplasm of testis V86.0 Estrogen receptor positive status [ER+] V86.1 Estrogen receptor negative status [ER-] Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

21 Beta-Natriuretic Peptide (BNP) Local Coverage Determination, National Government Services, Inc. (00131, FI) BETA-NATRIURETIC PEPTIDE B-type natriuretic peptide (BNP) is a cardiac neurohormone produced mainly in the left ventricle. It is secreted in response to ventricular volume expansion and pressure overload, factors often found in congestive heart failure (CHF). Used in conjunction with other clinical information, rapid measurement of BNP is useful in establishing or excluding the diagnosis and assessing the severity of CHF in patients with acute dyspnea so that appropriate and timely treatment can be initiated. This test is also used to predict the long-term risk of cardiac events or death across the spectrum of acute coronary syndromes when measured in the first few days after an acute coronary event. For the purposes of this policy, either total or N-terminal assays are acceptable. Indications BNP measurements may be considered reasonable and necessary when used in combination with other medical data such as medical history, physical examination, laboratory studies, chest x-ray, and electrocardiography: To distinguish cardiac cause of acute dyspnea from pulmonary or other non-cardiac causes. Plasma BNP levels are significantly increased in patients with CHF presenting with acute dyspnea compared with patients presenting with acute dyspnea due to other causes. To distinguish decompensated CHF from exacerbated chronic obstructive pulmonary disease (COPD) in a symptomatic patient with combined chronic CHF and COPD. Plasma BNP levels are significantly increased in patients with CHF with or without concurrent lung disease compared with patients primary lung disease. Limitations BNP measurements must be analyzed in conjunction with standard diagnostic tests, the medical history and clinical findings. The efficacy of BNP measurement as a stand-alone test has not yet been established. Clinicians should be aware that certain conditions such as ischemia, infarction and renal insufficiency, may cause elevation of circulating BNP concentration and require alterations of the interpretation of BNP results. Additional investigation is required to further define the diagnostic value of plasma BNP in monitoring the efficiency of treatment for CHF and in tailoring the therapy for heart failure. Therefore, BNP measurements for monitoring and management of CHF are not a covered service. Although a correlation between serum BNP levels and the clinical severity of HF has been shown in broad populations, it cannot be assumed that BNP levels can be used effectively as targets for adjustment of therapy in individual patients BNP measurement has not been clearly shown to supplement careful clinical assessment. (Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, pgs ). The 2009 Guidelines stated, The value of serial measurements of BNP to guide therapy for patient with HF is not well established. Covered Tests CPT/HCPCS Codes Natriuretic Peptide Descriptor Covered Diagnosis Codes When billed in either an office or outpatient setting. CMS does not support medical necessity for BNP in hospital settings Natriuretic Peptide ICD-9 Codes Covered Malignant hypertensive heart disease with heart failure Benign hypertensive heart disease with heart failure Unspecified hypertensive heart disease with heart failure Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

22 BETA-NATRIURETIC PEPTIDE Natriuretic Peptide ICD-9 Codes Covered Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage V or end stage renal disease Hypertensive heart and chronic kidney disease, benign, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified Hypertensive heart and chronic kidney disease, benign, with heart failure and chronic kidney disease stage V or end stage renal disease Hypertensive heart and chronic kidney disease, unspecified, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified Hypertensive heart and chronic kidney disease, unspecified, with heart failure and chronic kidney disease stage V or end stage renal disease Congestive heart failure unspecified Left heart failure Unspecified systolic heart failure Acute systolic heart failure Chronic systolic heart failure Acute or chronic systolic heart failure Unspecified diastolic heart failure Acute diastolic heart failure Chronic diastolic heart failure Acute or chronic diastolic heart failure Unspecified combined systolic and diastolic heart failure Acute combined systolic and diastolic heart failure Chronic combined systolic and diastolic heart failure Acute or chronic combined systolic and diastolic heart failure Heart failure unspecified Obstructive chronic bronchitis with (acute) exacerbation Obstructive chronic bronchitis with acute bronchitis Chronic obstructive asthma with (acute) exacerbation Asthma unspecified with (acute) exacerbation Acute bronchospasm Respiratory abnormality unspecified Orthopnea Shortness of breath Tachypnea Wheezing Respiratory abnormality, other Elmhurst Memorial Reference Laboratory Medicare Notification April of 208

23 CA 125 National Coverage Determination, Center for Medicare & Medicaid Services CA 125 TUMOR ANTIGEN ASSAY Immunoassay determinations of the serum levels of certain proteins or carbohydrates, such as CA 125, serve as tumor markers. When elevated, serum concentration of these markers may reflect tumor size and grade. Indications CA 125 is a high molecular weight serum tumor marker elevated in 80% of patients who present with epithelial ovarian carcinoma. It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix. An elevated level may also be associated with the presence of a malignant mesothelioma or primary peritoneal carcinoma. A CA 125 level may be obtained as part of the initial pre-operative work-up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of post-operative monitoring. Initial declines in CA125 after initial surgery and/or chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels during the first month post treatment to determine the patient's CA-125 half-life, which has significant prognostic implications. CA 125 levels are again obtained at the completion of chemotherapy as an index of residual disease. Surveillance measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter. CA 125 levels are also an important indicator of a patient's response to therapy in the presence of advanced or recurrent disease. In this setting, CA 125 levels may be obtained prior to each treatment cycle. Limitations These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy. The service may be ordered at times necessary to assess either the presence of recurrent disease or the patient's response to treatment with subsequent treatment cycles. CA 125 is specifically not covered for aiding in the differential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient. In general, a single "tumor marker" will suffice in following a patient with one of these malignancies. Covered Tests CPT/HCPCS Codes Descriptor Immunoassay For Tumor Antigen, Quantitative; CA 125 Covered Diagnosis Codes Immunoassay for Tumor Antigen CA- 125 ICD-9 Codes Covered Malignant neoplasm, specified parts of peritoneum Malignant neoplasm, peritoneum, unspecified Malignant neoplasm, endocervix Malignant neoplasm of corpus uteri, except isthmus Malignant neoplasm, ovary Malignant neoplasm, fallopian tube Malignant neoplasm, other specified sites of uterine adnexa Malignant neoplasm, other specified sites of female genital organs Secondary malignant neoplasm, ovary Secondary malignancy of genital organs Neoplasm of uncertain behavior of uterus Neoplasm of uncertain behavior of placenta Elmhurst Memorial Reference Laboratory Medicare Notification April of 208