CMS NCDs October 2012 Medicare Part B - Noridian LCDs. Easy Policy Access Click Bookmark Tab on left side of page. Click on Individual LCD/NCD

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1 MEDICARE NATIONAL & LOCAL COVERAGE DETERMINATIONS REFERENCE MANUAL CMS NCDs October 2012 Medicare Part B - Noridian LCDs Easy Policy Access Click Bookmark Tab on left side of page. Click on Individual LCD/NCD

2 Quick Reference: Lab Testing Covered Under NCD or LCD (South Dakota Part B November 2011) NCD (Black) or LCD (Blue) Name Common Name or Abbrev. CPT CPT Descriptor Alpha-fetoprotein AFP Alpha-fetoprotein; serum Blood Counts Blood smear exam Blood count; blood smear, microscopic examination with manual differential WBC count Blood Counts Blood smear exam Blood count; blood smear, microscopic examination without manual differential WBC count Blood Counts CBC (without diff) Blood count, complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet ) Blood Counts CBC with diff Blood count, complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) and automated differential WBC count Blood Counts Hematocrit/ HCT Blood count, hematocrit (Hct) Blood Counts Hemoglobing/ HGB Blood count, Hemoglobin Blood Counts Manual cell counts Blood count; manual cell count (erythrocyte, leukocyte, or platelet) each Blood Counts Platelet Blood count; platelet, automated Blood Counts Spun microhematocrit Blood count, Spun microhematocrit Blood Counts WBC Blood count, leukocyte (WBC), automated Blood Counts WBC differential Blood count, automated differential white blood cell (WBC) count BNP BNP Natiuretic Peptide CA 125 Tumor Antigen CA Immunoassay for tumor antigen, quantitative, CA 125 CA 15-3 & CA Tumor Antigens CA 15-3 & CA Immunoassay for tumor antigen, quantitative; CA 15-3 CA CA 19-9 Tumor Antigen CA Immunoassay for tumor antigen, quantitative; CA 19-9 Carcinoembryonic Antigen CEA Carcinoembryonic antigen (CEA) Collagen Crosslinks Collagen crosslinks Collagen cross links, any method Cytogenetics Testing - LDC Cytogenetics / Chromosome studies Multiple 88272/88273/88274/88275 Cytogentics multiple 3-300; Chromosome karyotyping; Chromosome banding; Chromosome count additional; Chromosome study additional; Cyto/molecular report; Cytogenetic study Digoxin Digoxin Digoxin (Therapeutic Drug Assay) Fecal Occult Blood Occult Blood Blood, occult, by peroxidase activity (eg, guaiac), qualitative; feces, single specimen (eg, from digital rectal exam) Fecal Occult Blood Occult Blood G0394 Blood occult test (e.g., guaiac), feces, for single determination for colorectal neoplasm (e.g., patient provided 3 cards or 1 triple card for consecutive collection) Gamma Glutamyl Transferase GGT Glutamyltransferase, gamma (GGT) Genetic Testing - LCD Molecular Testing Multiple Types Examples : Factor V Leiden, Hemachromatosis, Factor 2, Prothrom Nuc, PCR Methods Multiple Molecular diag isolation/extraction; Molecular diag isolation/extraction of purify. Nuc. Acid; Molecular diag enzymatic digestion; Molecular diag DOT/BLOT production; Molecular diag separation by gel electrophoresis; Molecular diag amplification; Molecular diag mutation identification; Molecular diag interp and report Glucose Testing Glucose Glucose; quantitative, blood (except reagent strip) Glucose Testing Glucose Home Device Glucose, blood by glucose monitoring device(s) FDA specifically for home use. Glucose Testing Glucose POC Glucose; blood, reagent strip Glycated Hemoglobin/ Glycated Protein Glycated Protein Glycated protein Glycated Hemoglobin/ Glycated Protein Hemoglobin A1c / Hgb A1c Hemoglobin; glycated Hepatitis Panel/Acute Hepatitis Panel Hepatitis Panel Acute Hepatitis Panel

3 NCD (Black) or LCD (Blue) Name Common Name or Abbrev. CPT CPT Descriptor HIV Testing Diagnosis HIV Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-1 HIV Testing Diagnosis HIV Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; HIV-1 HIV Testing Diagnosis HIV 1& 2 / HIV Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-1 and HIV-2, single assay HIV Testing Diagnosis HIV Qualitative or semiquantitative immunoassays performed by multiple step methods; HIV-2 HIV Testing Diagnosis HIV Infectious agent antigen detection by enzyme immunoassay technique, qualitative or semiquantitative, multiple step method; HIV-2 HIV Testing Diagnosis HIV by PCR Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, direct probe HIV Testing Diagnosis HIV Western Blot Qualitative or semiquantitative immunoassays performed by multiple step methods; HTLV or HIV antibody, confirmatory test (for example, Western Blot) HIV Testing Prognosis/Monitoring HIV viral load or quantification Infectious agent detection by nucleic acid (DNA or RNA); HIV-1, quantification HIV Testing Prognosis/Monitoring HIV viral load/ HIV quantification Infectious agent detection by nucleic acid (DNA or RNA); HIV-2, quantification Human Chorionic Gonadotropin HCG, Quantitative Gonadotropin, chorionic (hcg); quantitative Iron Studies Ferritin Ferritin Iron Studies Iron Iron Iron Studies Iron Binding Capacity / IBC Iron Binding capacity Iron Studies Transferrin Transferrin Lipid Testing Cholesterol Cholesterol, serum or whole blood, total Lipid Testing HDL Cholesterol Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol) Lipid Testing LDL Cholesterol Direct Lipoprotein, direct measurement, LDL cholesterol Lipid Testing Lipid Panel Lipid panel Lipid Testing Lipoprotein electrophoresis Lipoprotein, blood; electrophoretic separation and quantitation Lipid Testing Lipoprotein High Resolution Lipoprotein blood; high resol. fractionation and quantitation of lipoproteins including lipoprotein subclasses when performed (eg, electrophoresis, ultracentrifugation) Lipid Testing Lipoprotein subclasses Lipoprotein blood; quant. of lipoprotein particle #s & lipoprotein particles subclasses Lipid Testing Triglycerides Triglycerides Partial Thromboplastin Time PTT / APTT Thromboplastin time, partial (PTT); plasma or whole blood Prostate Specific Antigen PSA Prostate Specific Antigen (PSA), total Prothrombin Time Protime / PT Prothrombin Time Thyroid Testing T3 Uptake/ THBR Thyroid hormone (T3 or T4) uptake or thyroid hormone binding ratio (THBR) Thyroid Testing T Thyroxine (T4); total Thyroid Testing T4, Free Thyroxine (T4); free Thyroid Testing TSH Thyroid stimulating hormone (TSH) Urine Culture, Bacterial Kirby Bauer Sensitivity Susceptibility studies, antimicrobial agent; disk method, per plate (12 or< agents). Urine Culture, Bacterial MIC Susceptibility studies, antimicrobial agent; microdilution or agar dilution (minimum inhibitory concentration (MIC) or breakpoint), each multi-antimicrobial, per plate. Urine Culture, Bacterial Urine Colony Count Culture, bacterial; quantitative, colony count, urine. Urine Culture, Bacterial Urine Culture / C&S Culture, bacterial; with isolation & presumptive identification of each isolates, urine. Vitamin D Vitamin D Vitamin D; 25 Hydroxy Vitamin D Vitamin D 1, Vitamin D; 1,25 Dihydroxy

4 R QUICK REFERENCE INFORMATION: Preventive Services Official CMS Information for Medicare Fee-For-Service Providers This educational tool provides information on Medicare preventive services. Information provided includes Healthcare Common Procedure Coding System (HCPCS)/Current Procedural Terminology (CPT) codes; International Classification of Diseases, 9 th Revision, Clinical Modification (ICD-9-CM) diagnosis codes; coverage requirements; frequency requirements; and beneficiary liability for each Medicare preventive service. SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS Initial Preventive Physical Examination (IPPE) Also known as the Welcome to Medicare Preventive Visit G0402 IPPE G0403 EKG for IPPE G0404 EKG tracing for IPPE G0405 EKG interpret & report for IPPE No specific diagnosis code Contact the local Medicare Contractor for guidance All Medicare beneficiaries whose first Part B coverage began on or after 01/01/05 Important The screening EKG is an optional service that may be performed as a result of a referral from an IPPE Once in a lifetime Must furnish no later than 12 months after the effective date of the first Medicare Part B coverage G0402: Copayment/coinsurance waived Deductible waived G0403, G0404, and G0405: Copayment/coinsurance applies Deductible applies Annual Wellness Visit (AWV) G0438 Initial visit G0439 Subsequent visit No specific diagnosis code Contact the local Medicare Contractor for guidance All Medicare beneficiaries who are no longer within 12 months after the effective date of their first Medicare Part B coverage period and who have not received an IPPE or AWV within the past 12 months Once in a lifetime for G0438 Annually for G0439 Copayment/coinsurance waived Deductible waived Ultrasound Screening for Abdominal Aortic Aneurysm (AAA) G0389 Ultrasound exam AAA screening No specific diagnosis code Contact the local Medicare Contractor for guidance Medicare beneficiaries with certain risk factors for AAA Important Eligible beneficiaries must receive a referral for an ultrasound screening for AAA as a result of an IPPE Once in a lifetime Copayment/coinsurance waived Deductible waived Cardiovascular Screening Blood Tests Lipid panel Cholesterol Lipoprotein Triglycerides Report one or more of the following codes: V81.0, V81.1, V81.2 All Medicare beneficiaries without apparent signs or symptoms of cardiovascular disease Every 5 years Copayment/coinsurance waived Deductible waived Diabetes Screening Tests Glucose; quantitative, blood (except reagent strip) Glucose; post-glucose dose (includes glucose) Glucose; tolerance test (GTT), 3 specimens (includes glucose) V77.1 Medicare beneficiaries with certain risk factors for diabetes or diagnosed with pre-diabetes Beneficiaries previously diagnosed with diabetes are not eligible for this benefit Two screening tests per year for beneficiaries diagnosed with pre-diabetes One screening per year if previously tested, but not diagnosed with pre-diabetes, or if never tested Copayment/coinsurance waived Deductible waived Diabetes Self-Management Training (DSMT) G0108 DSMT, individual, per 30 minutes G0109 DSMT, group (2 or more), per 30 minutes No specific diagnosis code Contact the local Medicare Contractor for guidance Medicare beneficiaries diagnosed with diabetes Physician or qualified non-physician practitioner treating the beneficiary s diabetes must order DSMT Up to 10 hours of initial training within a continuous 12-month period Subsequent years: Up to 2 hours of follow-up training each year after the initial year Copayment/coinsurance applies Deductible applies ICN May 2012 CPT only copyright 2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS\DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 1

5 SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS Medical Nutrition Therapy (MNT) MNT; initial assessment, individual, each 15 minutes MNT; re-assessment, individual, each 15 minutes MNT; group (2 or more), each 30 minutes G0270 MNT reassessment and subsequent intervention(s) for change in diagnosis, individual, each 15 minutes G0271 MNT reassessment and subsequent intervention(s) for change in diagnosis, group (2 or more), each 30 minutes No specific diagnosis code Contact the local Medicare Contractor for guidance Certain Medicare beneficiaries diagnosed with diabetes, renal disease, or who have received a kidney transplant within the last 3 years A registered dietitian or nutrition professional must provide the services First year: 3 hours of one-on-one counseling Subsequent years: 2 hours Copayment/coinsurance waived Deductible waived Screening Pap Tests G0123, G0124, G0141, G0143, G0144, G0145, G0147, G0148 Screening cytopathology, cervical or vaginal P3000 Screening Pap smear by technician under physician supervision P3001 Screening Pap smear requiring interpretation by physician Q0091 Screening Pap smear; obtaining, preparing and conveyance to lab Report one of the following codes: Low Risk V72.31, V76.2, V76.47, V76.49 High Risk V15.89 All female Medicare beneficiaries Annually if at high risk for developing cervical or vaginal cancer, or childbearing age with abnormal Pap test within past 3 years Every 24 months for all other women Copayment/coinsurance waived Deductible waived Screening Pelvic Examinations G0101 Cervical or vaginal cancer screening; pelvic and clinical breast examination Report one of the following codes: Low Risk V72.31, V76.2, V76.47, V76.49 High Risk V15.89 All female Medicare beneficiaries Annually if at high risk for developing cervical or vaginal cancer, or childbearing age with abnormal Pap test within past 3 years Every 24 months for all other women Copayment/coinsurance waived Deductible waived Screening Mammography Computer-aided detection; screening mammography Screening mammography, bilateral G0202 Screening mammography, digital Report one of the following codes: V76.11 or V76.12 All female Medicare beneficiaries aged 35 and older Aged 35 through 39: One baseline Aged 40 and older: Annually Copayment/coinsurance waived Deductible waived 2 CPT only copyright 2011 American Medical Association. All rights reserved.

6 SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS Bone Mass Measurements Ultrasound bone density measurement and interpretation; peripheral site(s), any method Computed tomography, bone mineral density study, 1 or more sites; axial skeleton Computed tomography, bone mineral density study, 1 or more sites; appendicular skeleton (peripheral) (e.g., radius, wrist, heel) Dual-energy X-ray absorptiometry (DXA), bone density study, 1 or more sites; axial skeleton DXA, bone density study, 1 or more sites; appendicular skeleton Radiographic absorptiometry (e.g., photodensitometry, radiogrammetry), 1 or more sites G0130 Single energy X-ray study No specific diagnosis code Contact the local Medicare Contractor for guidance Certain Medicare beneficiaries that fall into at least one of the following categories: Women determined by their physician or qualified non-physician practitioner to be estrogen deficient and at clinical risk for osteoporosis; Individuals with vertebral abnormalities; Individuals receiving (or expecting to receive) glucocorticoid therapy for more than 3 months; Individuals with primary hyperparathyroidism; or Individuals being monitored to assess response to FDA-approved osteoporosis drug therapy Every 24 months More frequently if medically necessary Copayment/coinsurance waived Deductible waived Colorectal Cancer Screening G0104 Flexible Sigmoidoscopy G0105 Colonoscopy (high risk) G0106 Barium Enema (alternative to G0104) G0120 Barium Enema (alternative to G0105) G0121 Colonoscopy (not high risk) G0328 Fecal Occult Blood Test (FOBT), immunoassay, 1-3 simultaneous FOBT (blood, occult, by peroxidase activity (e.g., guaiac), qualitative; feces, consecutive collected specimens with single determination, for colorectal neoplasm screening (i.e., patient was provided 3 cards or single triple card for consecutive collection) No specific diagnosis code Contact the local Medicare Contractor for guidance All Medicare beneficiaries aged 50 and older who are: At normal risk of developing colorectal cancer; or At high risk of developing colorectal cancer High risk for developing colorectal cancer is defined in 42 CFR (a)(3) Refer to title42-vol2/pdf/CFR-2011-title42-vol2- sec pdf on the Internet FOBT every year Flexible Sigmoidoscopy once every 4 years, or 120 months after a previous Screening Colonoscopy for people not at high risk Screening Colonoscopy every 10 years (every 24 months for high risk), or 48 months after a previous Flexible Sigmoidoscopy Barium Enema (as an alternative to a covered Flexible Sigmoidoscopy) every 48 months, and every 24 months for high risk G0104, G0105, G0121, G0328, and 82270: Copayment/coinsurance waived Deductible waived G0106 and G0120: Copayment/coinsurance applies Deductible waived No deductible for all surgical procedures (CPT code range of to 69999) furnished on the same date and in the same encounter as a Colonoscopy, Flexible Sigmoidoscopy, or Barium Enema that were initiated as colorectal cancer screening services Modifier -PT should be appended to at least one CPT code in the surgical range of to on a claim for services furnished in this scenario CPT only copyright 2011 American Medical Association. All rights reserved. 3

7 SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS G0102: Prostate Cancer Screening G0102 Digital Rectal Exam (DRE) G0103 Prostate Specific Antigen Test (PSA) V76.44 All male Medicare beneficiaries aged 50 and older (coverage begins the day after 50 th birthday) Annually for covered beneficiaries Copayment/coinsurance applies Deductible applies G0103: Copayment/coinsurance waived Deductible waived Glaucoma Screening G0117 By an optometrist or ophthalmologist G0118 Under the direct supervision of an optometrist or ophthalmologist V80.1 Medicare beneficiaries with diabetes mellitus, family history of glaucoma, African-Americans aged 50 and older, or Hispanic-Americans aged 65 and older Annually for covered beneficiaries Copayment/coinsurance applies Deductible applies Seasonal Influenza Virus Vaccine and Administration 90654, 90655, 90656, 90657, 90660, 90662, Q2034 (effective for dates of service on or after 07/01/12, and claims processed on or after 10/01/12), Q2035, Q2036, Q2037, Q2038, Q2039 Influenza Virus Vaccine G0008 Administration Report one of the following codes: V04.81 Influenza V06.6 Pneumococcus and Influenza All Medicare beneficiaries Once per influenza season Medicare may provide additional flu shots if medically necessary Copayment/coinsurance waived Deductible waived Pneumococcal Vaccine and Administration 90669, Pneumococcal Conjugate Vaccine Pneumococcal Polysaccharide Vaccine G0009 Administration Report one of the following codes: V03.82 Pneumococcus V06.6 Pneumococcus and Influenza All Medicare beneficiaries Once in a lifetime Medicare may provide additional vaccinations based on risk and provided that at least 5 years have passed since receipt of a previous dose Copayment/coinsurance waived Deductible waived Hepatitis B (HBV) Vaccine and Administration Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (3 dose schedule) Hepatitis B vaccine, adolescent dosage (2 dose schedule) Hepatitis B vaccine, pediatric/adolescent dosage (3 dose schedule) Hepatitis B vaccine, adult dosage Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (4 dose schedule) G0010 Administration V05.3 Certain Medicare beneficiaries at intermediate or high risk for contracting hepatitis B Medicare beneficiaries that are currently positive for antibodies for hepatitis B are not eligible for this benefit Scheduled dosages required Copayment/coinsurance waived Deductible waived 4 CPT only copyright 2011 American Medical Association. All rights reserved.

8 SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS Counseling to Prevent Tobacco Use for Asymptomatic Beneficiaries G0436 Smoking and tobacco cessation counseling visit for the asymptomatic patient; intermediate, greater than 3 minutes, up to 10 minutes G0437 Smoking and tobacco cessation counseling visit for the asymptomatic patient; intensive, greater than 10 minutes Report one of the following codes: or V15.82 Outpatient and hospitalized beneficiaries who use tobacco, regardless of whether they have signs or symptoms of tobaccorelated disease; who are competent and alert at the time that counseling is provided; and whose counseling is furnished by a qualified physician or other Medicarerecognized practitioner Two cessation attempts per year; each attempt includes a maximum of four intermediate or intensive sessions, up to eight sessions in a 12-month period Copayment/coinsurance waived Deductible waived Human Immunodeficiency Virus (HIV) Screening G0432 Infectious agent antibody detection by enzyme immunoassay (EIA) technique G0433 Infectious agent antibody detection by enzymelinked immunosorbent assay (ELISA) technique G0435 Infectious agent antibody detection by rapid antibody test Report one of the following codes: V73.89 Primary V22.0, V22.1, V69.8, or V23.9 Secondary, as appropriate Beneficiaries who are at increased risk for HIV infection or pregnant Increased risk for HIV infection is defined in Publication , Sections (diagnostic) and (screening) Refer to Downloads/ncd103c1_Part3.pdf and Guidance/Manuals/Downloads/ncd103c1_ Part4.pdf on the CMS website Annually for beneficiaries at increased risk Three times per pregnancy for beneficiaries who are pregnant: First, when a woman is diagnosed with pregnancy; Second, during the third trimester; and Third, at labor, if ordered by the woman s clinician Copayment/coinsurance waived Deductible waived Intensive Behavioral Therapy (IBT) for Cardiovascular Disease This is a new benefit beginning for dates of service on or after 11/08/11 G0446 Intensive behavioral therapy to reduce cardiovascular disease risk, individual, face-toface, bi-annual, 15 minutes No specific diagnosis code Contact the local Medicare Contractor for guidance Men aged 45 through 79 and women aged 55 through 79: Encouraging aspirin use for the primary prevention of cardiovascular disease when the benefits outweigh the risks Adults aged 18 and older: Screening for high blood pressure Adults with hyperlipidemia, hypertension, advancing age, and other known risk factors for cardiovascularand diet-related chronic disease: Intensive behavioral counseling to promote a healthy diet Must be furnished by a qualified primary care physician or other primary care practitioner in a primary care setting Annually for covered beneficiaries Copayment/coinsurance waived Deductible waived Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse This is a new benefit beginning for dates of service on or after 10/14/11 G0442 Annual alcohol misuse screening, 15 minutes G0443 Brief face-to-face behavioral counseling for alcohol misuse, 15 minutes No specific diagnosis code Contact the local Medicare Contractor for guidance All Medicare beneficiaries are eligible for alcohol screening Medicare beneficiaries who misuse alcohol, but whose levels or patterns of alcohol consumption do not meet criteria for alcohol dependence, are eligible for counseling if they are competent and alert at the time that counseling is provided and counseling is furnished by qualified primary care physicians or other primary care practitioners in a primary care setting Annually for G0442 Four times per year for G0443 Copayment/coinsurance waived Deductible waived 5

9 SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS Screening for Depression This is a new benefit beginning for dates of service on or after 10/14/11 G0444 Annual depression screening, 15 minutes No specific diagnosis code Contact the local Medicare Contractor for guidance All Medicare beneficiaries Must be furnished by a qualified primary care physician or other primary care practitioner in a primary care setting that has staff-assisted depression care supports in place to assure accurate diagnosis, effective treatment, and follow-up Annually Copayment/coinsurance waived Deductible waived Sexually Transmitted Infections (STIs) Screening and High Intensity Behavioral Counseling (HIBC) to Prevent STIs This is a new benefit beginning for dates of service on or after 11/08/ , 86632, 87110, 87270, 87320, 87490, 87491, Chlamydia 87590, 87591, Gonorrhea Combined chlamydia and gonorrhea testing 86592, 86593, Syphilis 87340, Hepatitis B (hepatitis B surface antigen) G0445 High intensity behavioral counseling to prevent sexually transmitted infection; face-to-face, individual, includes: education, skills training and guidance on how to change sexual behavior; performed semi-annually, 30 minutes For screening for chlamydia, gonorrhea, and syphilis in women at increased risk who are not pregnant report V74.5 and V69.8 For screening for syphilis in men at increased risk report V74.5 and V69.8 For screening for chlamydia and gonorrhea in pregnant women at increased risk for STIs report: V74.5 and V69.8, and V22.0, V22.1, or V23.9 For screening for syphilis in pregnant women report V74.5 and V22.0, V22.1, or V23.9 For screening for syphilis in pregnant women at increased risk for STIs report: V74.5 and V69.8, and V22.0, V22.1, or V23.9 For screening for hepatitis B in pregnant women report V73.89 and V22.0, V22.1, or V23.9 For screening for hepatitis B in pregnant women at increased risk for STIs report: Sexually active adolescents and adults at increased risk for STIs: HIBC consisting of individual, 20 to 30 minute, face-to-face counseling sessions, if referred for this service by a primary care provider and provided by a Medicare eligible primary care provider in a primary care setting Increased risk for STIs is defined in Publication , Section Refer to Downloads/R141NCD.pdf on the CMS website One annual occurrence of screening for chlamydia, gonorrhea, and syphilis in women at increased risk who are not pregnant One annual occurrence of screening for syphilis in men at increased risk Up to two occurrences per pregnancy of screening for chlamydia and gonorrhea in pregnant women who are at increased risk for STIs and continued increased risk for the second screening One occurrence per pregnancy of screening for syphilis in pregnant women; up to two additional occurrences per pregnancy if at continued increased risk for STIs One occurrence per pregnancy of screening for hepatitis B in pregnant women; one additional occurrence per pregnancy if at continued increased risk for STIs Up to two HIBC counseling sessions annually Copayment/coinsurance waived Deductible waived V73.89 and V69.8, and V22.0, V22.1, or V CPT only copyright 2011 American Medical Association. All rights reserved.

10 SERVICE HCPCS/CPT CODES ICD-9-CM CODES WHO IS COVERED FREQUENCY BENEFICIARY PAYS Intensive Behavioral Therapy (IBT) for Obesity This is a new benefit beginning for dates of service on or after 11/29/11 G0447 Face-to-face behavioral counseling for obesity, 15 minutes Report one of the following codes: V85.30 V85.39, V85.41 V85.45 Medicare beneficiaries with obesity (BMI 30 kg/m 2 ) who are competent and alert at the time that counseling is provided and whose counseling is furnished by a qualified primary care physician or other primary care practitioner in a primary care setting One visit every week for the first month; One visit every other week for months 2 6; and One visit every month for months 7 12 At the 6-month visit, a reassessment of obesity and a determination of the amount of weight loss must be performed To be eligible for additional face-to-face visits occurring once a month for an additional 6 months, beneficiaries must have lost at least 3kg For beneficiaries who do not achieve a weight loss of at least 3kg during the first 6 months, a reassessment of their readiness to change and BMI is appropriate after an additional 6-month period Copayment/coinsurance waived Deductible waived Frequently Asked Questions Why is CMS adding new preventive services as Medicare benefits? Under Section 4105 of the Affordable Care Act, CMS may add coverage of additional preventive services through the National Coverage Determination (NCD) process if the service meets all of the following criteria. They must be: 1) reasonable and necessary for the prevention or early detection of illness or disability, 2) recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF), and 3) appropriate for individuals entitled to benefits under Part A or enrolled under Part B of the Medicare Program. For more information on USPSTF recommendations, visit on the Internet. Watch for announcements of additional new preventive benefits and educational materials at Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/PreventiveServices.html on the CMS website, or refer to MLN/MLNProducts/Downloads/MLNProducts_listserv.pdf to sign up to receive news of new Medicare Learning Network (MLN) products by . For the latest information on Medicare preventive services, visit html on the CMS website. Some services must be performed in a primary care setting. What is that? A primary care setting is one in which there is provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. We do not consider Ambulatory Surgical Centers (ASCs), emergency departments, hospices, independent diagnostic testing facilities, inpatient hospital settings, Inpatient Rehabilitation Facilities (IRFs), and Skilled Nursing Facilities (SNFs) to be primary care settings under this definition. How do I determine the last date a beneficiary received a preventive service, so that I know the beneficiary is eligible to receive the next service and the service will not be denied due to frequency edits? Your options for accessing eligibility information depend on the Medicare Administrative Contractor (MAC) jurisdiction in which your practice or facility is located. For example, MACs who have Internet portals provide the information through the eligibility screens of the portals. You may also be able to access the information through the HIPAA Eligibility Transaction System (HETS), as well as HETS User Interface, through the provider call center Interactive Voice Responses (IVRs). CMS suggests that providers check with their MAC to see what options are available to check eligibility. My patients do not follow up on routine preventive care. How can I help them remember when they are due for their next preventive service? Medicare.gov provides a Preventive Screening Checklist that you can give to your patients. They can use the checklist to track their preventive services. For the checklist, visit navigation/manage-your-health/preventive-services/preventive-service-checklist.aspx on the Internet. 7

11 Resources RESOURCE WEBSITE Medicare Preventive Services General Information MLN Guided Pathways to Medicare Resources Preventive Services MLN Page Publications for Your Medicare Beneficiaries The MLN Educational Web Guides MLN Guided Pathways to Medicare Resources help providers gain knowledge on resources and products related to Medicare and the CMS website. For more information about preventive services, refer to the Coverage of Preventive Services section in the MLN Guided Pathways to Medicare Resources Basic Curriculum for Health Care Professionals, Suppliers, and Providers booklet at Downloads/Guided_Pathways_Basic_Booklet.pdf on the CMS website. For all other Guided Pathways resources, visit Learning-Network-MLN/MLNEdWebGuide/Guided_Pathways.html on the CMS website. PreventiveServices.html BenePubFS-ICN pdf R Official CMS Information for Medicare Fee-For-Service Providers This educational tool was current at the time it was published or uploaded onto the web. Medicare policy changes frequently so links to the source documents have been provided within the document for your reference. This educational tool was prepared as a service to the public and is not intended to grant rights or impose obligations. This educational tool may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations, and other interpretive materials for a full and accurate statement of their contents. The International Classification of Diseases, 9 th Revision, Clinical Modification (ICD-9-CM) is published by the United States Government. A CD-ROM, which may be purchased through the Government Printing Office, is the only official Federal government version of the ICD-9-CM. ICD-9-CM is an official Health Insurance Portability and Accountability Act standard. The Medicare Learning Network (MLN), a registered trademark of CMS, is the brand name for official CMS educational products and information for Medicare Fee-For-Service Providers. For additional information, visit the MLN s web page at on the CMS website. Your feedback is important to us and we use your suggestions to help us improve our educational products, services and activities and to develop products, services and activities that better meet your educational needs. To evaluate Medicare Learning Network (MLN) products, services and activities you have participated in, received, or downloaded, please go to MLNProducts and click on the link called MLN Opinion Page in the left-hand menu and follow the instructions. Please send your suggestions related to MLN product topics or formats to MLN@cms.hhs.gov. 8

12 Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report October 2012 Clinical Diagnostic Laboratory Services Health & Human Services Department Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD CMS Point of Contact: TDD Fu Associates, Ltd.

13 Table of Contents NCD Manual Changes... ii Table of Contents... xxiii Introduction... 1 Non-covered ICD-9-CM s for All NCD Edits... 4 Reasons for Denial for All NCD Edits... 6 Coding Guidelines for All NCD Edits... 7 Additional Coding Guidelines Urine Culture, Bacterial Human Immunodeficiency Virus (HIV)Testing (Prognosis Including Monitoring) Human Immunodeficiency Virus (HIV) Testing (Diagnosis) Blood Counts Partial Thromboplastin Time (PTT) Prothrombin Time (PT) Serum Iron Studies Collagen Crosslinks, Any Method Blood Glucose Testing Glycated Hemoglobin/Glycated Protein Thyroid Testing Lipids Testing Digoxin Therapeutic Drug Assay Alpha-fetoprotein Carcinoembryonic Antigen Human Chorionic Gonadotropin Tumor Antigen by Immunoassay CA Tumor Antigen by Immunoassay CA 15-3/CA Tumor Antigen by Immunoassay CA Prostate Specific Antigen Gamma Glutamyl Transferase Hepatitis Panel/Acute Hepatitis Panel Fecal Occult Blood Test Fu Associates, Ltd. xxiii October 2012

14 Background Introduction Section 4554(b)(1) of the Balanced Budget Act of 1997 (BBA), Public Law , mandated the use of a negotiated rulemaking committee to develop national coverage and administrative policies for clinical diagnostic laboratory services payable under Medicare Part B by January 1, This provision requires that these national coverage policies be designed to promote program integrity and national uniformity and simplify administrative requirements with respect to clinical diagnostic laboratory services in connection with the following: Beneficiary information required to be submitted with each claim or order for laboratory services; The medical condition for which a laboratory test is reasonable and necessary (within the meaning of section 1862(a)(1)(A) of the Social Security Act); The appropriate use of procedure codes in billing for a laboratory test, including the unbundling of laboratory services; The medical documentation that is required by a Medicare contractor at the time a claim is submitted for a laboratory test (in accordance with section 1833(e) of the Act); Record keeping requirements in addition to any information required to be submitted with a claim, including physicians obligations regarding these requirements; Procedures for filing claims and for providing remittances by electronic media; and Limitations on frequency of coverage for the same services performed on the same individual. On March 10, 2000, a proposed rule was published in the Federal Register (65 FR 13082) that set forth uniform national coverage and administrative policies for clinical diagnostic laboratory services. These proposed policies reflected the consensus of the Negotiated Rulemaking Committee. The final rule, published in the Federal Register on November 23, 2001 (66 FR 58788), addresses the public comments received on the proposed rule. The final rule established the national coverage and administrative policies for clinical diagnostic laboratory services payable under Medicare Part B. It promotes Medicare program integrity and national uniformity, and simplifies administrative requirements for clinical diagnostic services. There are 23 national coverage determinations included in the final rule listed below: Culture, Bacterial, Urine Human Immunodeficiency Virus Testing (Prognosis including monitoring) Human Immunodeficiency Virus Testing (Diagnosis) Blood Counts Partial Thromboplastin Time Prothrombin Time Serum Iron Studies Collagen Crosslinks, Any Method Blood Glucose Testing Glycated Hemoglobin/Glycated Protein Thyroid Testing Lipids Digoxin Therapeutic Drug Assay Alpha-fetoprotein Fu Associates, Ltd. 1 October 2012

15 Carcinoembryonic Antigen Human Chorionic Gonadotropin Tumor Antigen by Immunoassay - CA125 Tumor Antigen by Immunoassay CA 15-3/CA Tumor Antigen by Immunoassay CA 19-9 Prostate Specific Antigen Gamma Glutamyl Transferase Hepatitis Panel/Acute Hepatitis Panel Fecal Occult Blood What Is a National Coverage Policy? Part B of title XVIII of the Social Security Act (the Act) provides for Supplementary Medical Insurance (SMI) 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 under Part B, unless excluded from coverage by the Act. Services that are excluded from coverage include routine physical examinations and services that are not reasonable and necessary for the diagnosis or treatment of an illness or injury. CMS interprets these provisions to prohibit coverage of screening services, including laboratory tests furnished in the absence of signs, symptoms, or personal history of disease or injury, except as explicitly authorized by statute. A test may be considered medically appropriate, but nonetheless be excluded from Medicare coverage by statute. A national coverage policy for diagnostic laboratory test(s) is a document stating CMS s policy with respect to the circumstances under which the test(s) will be considered reasonable and necessary, and not screening, for Medicare purposes. Such a policy applies nationwide. A national coverage policy is neither a practice parameter nor a statement of the accepted standard of medical practice. Words such as may be indicated or may be considered medically necessary are used for this reason. Where a policy gives a general description and then lists examples (following words like for example or including ), the list of examples is not meant to be all-inclusive but to provide some guidance. What Is the Effect of a National Coverage Policy? A national coverage policy to which this introduction applies is a National Coverage Decision (NCD) under section 1862(a) (1) of the Social Security Act. Regulations on National Coverage Decisions are codified at 42 CFR (b) (d). A Medicare contractor may not develop a local policy that conflicts with a national coverage policy. What Is the Format for These National Coverage Policies? Below are the headings for national coverage policies, developed by the Negotiated Rulemaking Committee on Clinical Diagnostic Laboratory Tests. Other Names/Abbreviations This section identifies other names for the policy. It reflects more colloquial terminology. This section includes a description of the test(s) addressed by the policy and provides a general description of the appropriate uses of the test(s). Fu Associates, Ltd. 2 October 2012

16 HCPCS s The descriptor(s) used in this section is (are) the Current Procedural Terminology (CPT) or other CMS Common Procedure Coding System (HCPCS). The CPT is 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 s Covered by Medicare Program This section includes covered codes those where there is a presumption of medical necessity, but the claim is subject to review to determine whether the test was in fact reasonable and necessary. The diagnosis codes are from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD 9 CM). Where the policy takes an exclusionary approach, as described below, this section states: Any ICD 9 CM code not listed in either of the ICD 9 CM code sections below. Indications This section lists detailed clinical indications for Medicare coverage of the test(s). Limitations This section lists any national frequency expectations, as well as other limitations on Medicare coverage of the specific test(s) addressed in the policy for example, if it would be unnecessary to perform a particular test with a particular combination of diagnoses. ICD 9 CM s That Do Not Support Medical Necessity This section lists/describes generally non-covered codes for which there are only limited exceptions. However, additional documentation could support a determination of medical necessity in certain circumstances. Subject to section 1879 of the Social Security Act (the Act), 42 CFR 411, subpart K, section 7330 of the Medicare Carriers Manual section of the Medicare Fiscal Intermediary Manual and any applicable rulings, it would be appropriate for the ordering physician or the laboratory to obtain an advance beneficiary notice from the beneficiary. Where the policy takes an inclusionary approach, as described below, this section states: Any ICD 9 CM code not listed in either of the ICD 9 CM sections above. Other Comments This section may contain other relevant comments that are not addressed in the sections above. Documentation Requirements This section refers to documentation requirements for clinical diagnostic laboratory tests at 42 CFR (d) and includes any specific documentation requirements related to the test(s) addressed in the policy. Sources of Information Relevant sources of information used in developing the policy are listed in this section. Fu Associates, Ltd. 3 October 2012

17 Non-covered ICD-9-CM s for All NCD Edits This section lists codes that are never covered. If a code from this section is given as the reason for the test, the test may be billed to the Medicare beneficiary without billing Medicare first because the service is not covered by statute, in most instances because it is performed for screening purposes and is not within an exception. The beneficiary, however, does have a right to have the claim submitted to Medicare, upon request. The individual ICD-9-CM codes included in code ranges in the table below can be viewed on CMS website under Downloads: Lab List. The link is: Sudden death, cause unknown V15.85 Personal history of contact with and (suspected) exposure to potentially hazardous body fluids V16.1 Family history of malignant neoplasm, trachea, bronchus, and lung V16.2 Family history of malignant neoplasm, other respiratory and intrathoracic organs V16.40 Family history of malignant neoplasm, genital organs V16.50 Family history of malignant neoplasm, urinary organs V16.51 Family history of malignant neoplasm, kidney V16.52 Family history of malignant neoplasm, bladder V16.59 Family history of malignant neoplasm, other V16.6 Family history of malignant neoplasm, leukemia V16.7 Family history of malignant neoplasm, other lymphatic and hematopoietic neoplasms V16.8 Family history of malignant neoplasm, other specified malignant neoplasm V16.9 Family history of malignant neoplasm, unspecified malignant neoplasm V17.0-V17.3 Family history of certain chronic disabling diseases V17.41 Family history of sudden cardiac death (SCD) V17.49 Family history of other cardiovascular diseases V V17.89 Family history of asthma; other chronic respiratory conditions arthritis; other musculoskeletal diseases V18.0 Family history of diabetes mellitus V18.11 Family history of multiple endocrine neoplasia (MEN) syndrome V18.19 Family history of other endocrine and metabolic diseases V18.2-V18.4, V18.51,V18.59, V18.61, V18.69, V18.7-V18.9 V19.0-V19.8 Family history of anemia; other blood disorders; mental retardation; colonic polyps; other digestive disorders; polycystic kidney; other kidney diseases; other genitourinary diseases; infectious and parasitic diseases; genetic disease carrier Family history of other conditions V V20.2 Health supervision of infant or child V20.31 Health supervision for newborn under 8 days old Fu Associates, Ltd. 4 October 2012

18 V20.32 Health supervision for newborn 8 to 28 days old V V28.9 Encounter for antenatal screening of mother V V50.9 Elective surgery for purposes other than remedying health states V53.2 Hearing aid V60.0-V60.6 Lack of housing; inadequate housing; lack of material resources; person living alone; no other household person avle to render care; holiday relief care; and person living in residential institution V60.81 Foster care (status) V60.89 Other specified housing or economic circumstances V60.9 Unspecified housing or economic circumstances V62.0 Unemployment V62.1 Adverse effects of work environment V65.0 Healthy persons accompanying sick persons V65.11 Pediatric pre-birth visit for expectant parent(s) V65.19 Other person consulting on behalf of another person V V68.9 Encounters for administrative purposes V V70.9 General medical examinations V73.0-V73.6 Special screening examinations for viral and chlamydia diseases V73.81 Special screening examinations for Human papillomavirus (HPV) V73.88-V73.89 Other specified chlamydial and viral diseases V73.98-V73.99 Unspecified chlamydial and viral disease V V74.9 Special screening examinations for bacterial and spirochetal diseases V V75.9 Special screening examination for other infectious diseases V76.0 Special screening for malignant neoplasms, respiratory organs V76.3 Special screening for malignant neoplasms, bladder V76.42-V76.43, V V76.47, V76.49, V76.50, V76.52, V76.81, V76.89,V76.9 Special screening for malignant neoplasms,(sites other than breast, cervix, and rectum) V77.0 Special screening for endocrine, nutrition, metabolic, and immunity disorders V77.2-V77.99 Special screening for endocrine, nutrition, metabolic, and immunity disorders V78.0-V78.9 Special screening for disorders of blood and blood-forming organs V79.0-V79.9 Special screening for mental disorders V80.01 Special screening for traumatic brain injury V80.09 Special screening for other neurological conditions V80.1-V80.3 Special screening for glaucoma and other eye conditions; ear diseases V81.3-V81.6 Special screening for cardiovascular, respiratory, and genitourinary diseases V82.0-V82.6, V82.71,V82.79, Special screening for other conditions V82.81, V82.89, V82.9 Fu Associates, Ltd. 5 October 2012

19 Reasons for Denial for All NCD Edits NOTE: This section has not been negotiated by the Negotiated Rulemaking Committee. It includes CMS s interpretation of its longstanding policies and is included for informational purposes. Tests for screening purposes that are 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. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statute. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. 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. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. 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. Fu Associates, Ltd. 6 October 2012