Annual Notice to Providers (2014)

8901 West Lincoln Avenue, West Allis, WI 53227 5400 Pearl, Rosemont, IL 60018 Annual Notice to Providers (2014) May 2014 Dear Physician/Client: The Medicare Program encourages clinical laboratories to educate physicians regarding medical necessity and laboratory billing compliance. This annual notice specifies current Medicare requirements and ACL Laboratories policies. Please review the information contained in this notice and contact Kathy Lindgren, ACL Compliance Officer, at 1.800.877.7016 extension 7916 if you have any questions or concerns. Authorized Ordering Providers Laboratory testing must be ordered by a licensed physician or other individuals authorized by law. If your license has been revoked or suspended, you may no longer order or refer laboratory testing. Written and electronic orders must identify the ordering provider s National Provider Identifier (NPI). Effective January 5, 2014, providers must be enrolled in Medicare and Medicaid programs and of a provider type that is eligible to order testing for Medicare and Medicaid patients. Requirements for Diagnostic Information The Balanced Budget Act of 1997 specifies that the physician or practitioner ordering laboratory testing provide diagnostic information in the form of ICD-9 codes specific to the ordered test(s) at the time of the order. Please provide an ICD-9 code specific for a condition, disease, sign, symptom or complaint for each test ordered. When testing is ordered to determine or confirm a diagnosis, ICD-9 codes describing the signs, symptoms or chief complaints should be provided. It is the responsibility of the authorized ordering provider to also document the diagnosis information in the patient s medical record. Requirements for Signatures Although the signature of the ordering provider is not required on laboratory requisitions, if signed, the requisition will serve as acceptable documentation of a physician order for the testing. In the absence of a signed requisition, documentation of your intent to order the laboratory tests billed must be included in the patient s medical record and made available to ACL Billing, as needed. Documentation must accurately describe the individual tests ordered. It is not sufficient to state labs ordered. Laboratory orders may also be authorized or verified by electronic signature of the ordering provider. Medical Necessity Medicare will pay only for tests that meet Medicare coverage criteria and are reasonable and necessary to treat or diagnose an individual patient. Tests ordered to diagnose or treat patient signs, symptoms or complaints are subject to Medicare guidelines for medical necessity. Tests ordered in the absence of signs, symptoms or complaints are considered screening and are subject to Medicare Preventive Services benefits. Routine screening tests that have no preventive service coverage are the financial responsibility of the beneficiary. Medicare Preventive Services Medicare will pay for some laboratory tests when screening for disease. The CMS Quick Reference Information: Preventive Services Guide lists the services covered along with applicable ICD-9 codes and frequency limitations. 2014 Annual Notice to Providers Addendum 1

Molecular Pathology Procedures Many molecular pathology procedures are not considered covered services when ordered to assess disease risk or to screen for carrier status. Molecular tests may be eligible for coverage when results of the testing directly impacts treatment or management of a condition. Molecular tests may be subject to preauthorization and post payment medical record review. Advance Beneficiary Notices (ABN) Medicare can deny reimbursement for tests based upon absence of medical necessity, tests specified for investigational use only, tests ordered for routine screening (including tests ordered only as pre-operative screening), and when preventive services are ordered more frequently than screening benefits cover. Patients must be allowed to make an informed consumer decision as to whether to have testing performed when asked to assume financial responsibility of the cost of testing. A signed ABN is required by ACL Laboratories whenever a test is requested that does not meet Medicare s Medical Necessity requirements, is being performed more frequently than screening benefits cover, or is considered experimental or research use only. It is the responsibility of the ordering provider to obtain a properly completed ABN when the Medicare beneficiary is serviced in his/her office. Profiles Although profiles and test combinations offer convenience in ordering, they may result in the routine ordering of more tests than needed to diagnose and treat patients. Therefore, ACL limits the offering of profiles to those approved by the American Medical Association (AMA) and those that are approved by the laboratory s Pathology Medical Directors. Please know what tests are in each panel you order and do not order individual tests that might duplicate tests in the panel. Also, please order individual tests rather than a panel when all tests contained in the panel are not required for diagnosis or treatment purposes. The ACL Directory of Services identifies the individual tests included in a panel under Components. Visit ACL s website at acllaboratories.com/test-catalog/ for additional information. Reflex Testing Reflex testing occurs when initial test results are positive or outside normal parameters and general medical practice indicates a second related test is medically appropriate to confirm or validate the initial test results. Unless confirmatory reflex testing is required by law, tests may be ordered with or without reflex criteria. When ordering tests that include reflex criteria, it is also necessary to document the reflex order in the patient s medical record. E.g., CBC w/ diff, Lipid Panel w/ LDL reflex, UA w/ microscopic exam. The ACL Directory of Services lists reflex and/or confirmation criteria under Test Performance. Visit ACL s website at acllaboratories.com/test-catalog/ for additional information. When indicated, ACL will bill for reflex tests along with the initial test. Clinical Consultant ACL is affiliated with 90 board-certified Pathologists in a variety of specialties that are available to provide technical or consultative services regarding appropriate test use and ordering. Please call the ACL Client Service department at 1.800.877.7016 to request test assistance. 2014 Annual Notice to Providers Addendum 2

Addendum to the 2014 Annual Notice to Providers Table of Contents for References ACL Directory of Services Website... 3 Medicare Fee Schedule for Clinical Laboratory Tests... 3 OIG Notice... 3 Medicare Enrollment Information... 3 Provision of Diagnosis Codes... 3 Signature Requirements... 4 National Coverage Determination Policies... 4 Local Coverage Determination Policies... 4 Lab Tests with Preventive Service Coverage... 5 ABN Requirements... 6 AMA Recognized Panels... 6 Additional Test Information and Website References ACL Laboratories publishes a Directory of Services that lists our clinical test menu, test order code, and CPT code(s) used to bill Medicare. Correct CPT coding can vary by carrier; therefore, the codes referenced are intended as general guidelines and should not be used without confirming their appropriateness with applicable payers. An electronic version of the ACL Directory of Services is available. Visit ACL s website at: acllaboratories.com/test-catalog/. Medicare reimbursement for the laboratory CPT codes may be found on the following web site: http://www.cms.gov/clinicallabfeesched/02_clinlab.asp 2014 Wisconsin Medicaid reimbursement may be found on the following web site: https://www.forwardhealth.wi.gov/wiportal/max%20fee%20home/tabid/77/default.aspx 2014 Illinois Medicaid reimbursement may be located at the following web site: http://www2.illinois.gov/hfs/medicalprovider/medicaidreimbursement/pages/default.aspx OIG Notice Only tests that meet Medicare coverage policies may be submitted for reimbursement. Individuals who knowingly cause a false claim to be submitted to Medicare may be subject to sanctions or remedies available under civil, criminal and administrative law. To avoid false claim submission, be sure to: 1. Order only those tests necessary for diagnosis or treatment. Note: each component of a panel must be necessary for the panel to qualify for Medicare reimbursement. 2. Provide a diagnosis, sign or symptom for each test ordered. 3. Document this information in the patient s medical record. 4. Obtain an ABN from the Medicare patient when tests do not meet medical necessity criteria. Eligible Provider Enrollment (PECOS): MLN Matters SE 1305 http://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/ SE1305.pdf Provision of Diagnostic Information: CMS Transmittal B-03-046 http://www.cms.gov/regulations-and-guidance/guidance/transmittals/downloads/b03046.pdf 2014 Annual Notice to Providers Addendum 3

Signature Requirements: MLN Complying with Medicare Signature Requirements http://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/ Signature_Requirements_Fact_Sheet_ICN905364.pdf Medical Necessity Policies Laboratory Tests: The Center for Medicare and Medicaid Services (CMS) has published 23 National Coverage Determinations (NCD) that specify the medical conditions that will be covered for commonly ordered lab tests. The Laboratory NCDs may be found on the web at: https://www.cms.gov/medicare-coverage-database/indexes/lab-ncd-index. aspx?bc=baaaaaaaaaaa& CMS has authorized National Government Services, the Illinois, Wisconsin and Minnesota Medicare Part B carrier, to develop Local Coverage Determination Policies (LCDs) and Supplemental Instruction Articles (SIAs). These guidelines may supplement or be in addition to NCDs, give direction for medical necessity on selected tests and can be found at: http://www.ngsmedicare.com/ngs/portal/ngsmedicare/mpc National Coverage Policies Alpha-fetoprotein Blood Counts (CBC) CA 125, CA15-3/CA27.29, CA 19-9, CEA Collagen Crosslinks Digoxin Fecal Occult Blood GGTP Glucose Glycated Hemoglobin Hepatitis Panel, Acute hcg HIV Testing, Diagnosis & Prognosis Iron Studies (Iron, Ferritin, Transferrin) Lipid Testing Prostate Specific Antigen (PSA) PTT PT/INR Thyroid Testing (TSH, T4, T3) Urine Culture Local Coverage Policies B-type Natriuretic Peptide (BNP) Circulating Tumor Cell (CTC) Drug Screens, Qualitative Galectin-3 Heavy Metal Testing (Lead, Zinc, Cobalt, etc) Molecular Pathology MRSA (Methicillin Resistant detection by DNA or RNA) Pre-operative Testing (Non-covered Services) OVA1 RAST Allergen Tests (IgE, IgG) Vitamin D Assay 2014 Annual Notice to Providers Addendum 4

Quick Reference Information: Preventive Services guide for a list of tests, applicable ICD-9 codes and frequency limits at: http://www.cms.gov/medicare/prevention/prevntiongeninfo/downloads/mps_ QuickReferenceChart_1.pdf Laboratory Service Cardiovascular HCPCs/CPT Codes Applicable ICD-9 Codes Frequency 80081 Lipid Panel Covered when one of 82465 Cholesterol the following are reported: 83718 HDL Cholesterol V81.0, V81.1, V81.2 Every 5 years 84478 Triglycerides Diabetes 82947 Glucose 82950 Glucose; post-glucose 82951 Glucose; tolerance V77.1 1 per year, or 2 per year, if diagnosed with pre-diabetes Covered when one of the following PAP Screens G0123, G0124, G0143, G0147 are reported: V72.31, V76.2, V76.47, V76.49 Low Risk Every 24 months, if Low Risk Annually if High Risk V15.89 High Risk Colorectal Cancer G0328 FOBT, Immunoassay 82270 FOBT, Guaiac Annually Prostate Cancer G0103 PSA V76.44 Annually HIV G0432 EIA technique G0433 ELISA technique V73.89 Primary V22.0, V22.1, V69.8 or V23.9 Secondary, as appropriate Annually Chlamydia, gonorrhea & syphilis in Sexually Transmitted Infections (STIs) 86631, 86632, 87110, 87491 Chlamydia 87591 Gonorrhea 86592, 86593, 86780 Syphilis 87340, 87341 Hepatitis B Surface Antigen women at increased risk who are not pregnant: V74.5 & V69.8 Syphilis in men at increased risk: V74.5 & V69.8 Chlamydia & gonorrhea in pregnant women at increased risk: V74.5 & V69.8 plus either V22.0, V22.1 or V23.9 Syphilis in pregnant women: V74.5 and either V22.0, V22.1 or V23.9 Hepatitis B in pregnant women: V73.89 and either V22.0, V22.1 or V23.9 Hepatitis B in pregnant women at increased risk: V73.89 & V69.8 and either V22.0, V22.1 or V23.9 1 annual screening for chlamydia, gonorrhea and syphilis in women at increate risk who are not pregnant 1 annual screening for syphilis in men at increased risk Up to 2 screenings per pregnancy for chlamydia and gonorrhea if at continued increased risk 1 screening per pregnancy for syphilis; up to 2 additional screenings if at continued increased risk 1 screening per pregnancy for hepatitis B; 1 additional screening if at continued increased risk 2014 Annual Notice to Providers Addendum 5

Advance Beneficiary Notices (ABN) Transfer of financial liability to the patient ABN Form CMS-R-131 is issued by providers (including independent laboratories), physicians, and practitioners to Medicare fee-for-service beneficiaries in situations where Medicare payment is expected to be denied. Patients must have sufficient time to make an informed decision on whether or not to receive the test in question and accept potential financial liability. CMS Form R-131 and instructions for use and completion can be found at: http://www.cms.gov/medicare/medicare-general-information/bni/abn.html AMA Recognized Organ/Disease Panels Panel Order Code BPNL Panel Name & Components Basic Metabolic Panel Calcium Creatinine Comprehensive Metabolic Panel Glucose BUN Panel CPT Code WI Medicare IL Medicare WI Medicaid IL Medicaid 80048 $11.54 $11.54 $11.63 $8.06 CPNL ALT Albumin Alk Phos AST Calcium Bilirubin, Total Creatinine Glucose Protein, Total BUN 80053 $14.41 $14.41 $14.53 $10.08 ELEPNL HACUTE Electrolyte Panel Hepatitis Panel, Acute with Reflexes Hepatitis A Ab, IgM (AIGM) Hepatitis B Surface Ag (HBAG) Hepatitis B Core IgM (HEPCM) Hepatitis C Ab (HCV) Hepatic Function Panel (Liver Panel) 80051 $9.57 $9.57 $9.64 $6.67 80074 $64.99 $64.99 $65.47 $37.44 LIVPNL ALT Albumin Alk Phos AST Bilirubin, Total Bilirubin, Direct Protein, Total 80076 $11.14 $11.14 $11.23 $7.76 LIPDPL LIPPNL not to be ordered for screening RENPNL Lipid Panel (without reflex) Cholesterol Triglyceride HDL LDL, calc. Lipid Panel (with reflex Direct LDL) Cholesterol Triglyceride HDL LDL, calc. When Triglyceride >400, a LDL, Direct will be performed and charged Renal Panel Albumin Calcium Creatinine Glucose Phosphorus BUN 80061 $18.27 $18.27 $18.42 $6.05 80061 18.27 $18.27 $18.42 $6.05 83721 $13.02 $13.02 $13.11 $9.09 80069 $11.85 $11.85 $11.94 $8.29 2014 Annual Notice to Providers Addendum 6