April 2009 Dear Valued Health Care Provider, This is your annual notification of laboratory compliance issues, as required by the Office of Inspector General (OIG). Please carefully review this summary of billing policies and Medicare and Medicaid rules for clinical laboratory testing. This notice will review coverage decisions and policies now in effect. Providence Laboratory Billing Policy: All tests that are both ordered and performed are billed to the appropriate payer under the guidelines provided by the payer and in accordance with all federal, state, and local laws and regulations. Orders: Our laboratory can only perform tests when properly ordered. Orders must include the patient's full legal name, date of birth, reason for the test ordered, date and time of collection, source when applicable, and licensed ordering practitioner's name. Orders submitted under the office MA’s name only are not acceptable. Reoccurring orders must include both the frequency and duration for the order, not to exceed 1 year. Please provide authentication of verbal orders upon request. Specimen Integrity: In order to assure patient safety and provide accurate results on the correct patient, our laboratory requires that all samples be labeled with two patient identifiers. Please make sure that all samples collected in your office are labeled at the time of collection, in the presence of the patient. Use the patient’s first and last name as the primary identifier, and then you may use the patient’s date of birth, chart number, or requisition number as the second identifier. In addition, please include the actual date and time of specimen collection. Having the date and time of collection helps you better interpret the results and it helps us monitor specimen quality. Diagnosis Codes: The ordering practitioner is obligated to provide the signs and symptoms, ICD9 code or descriptive diagnosis that best describes the patient’s condition and that documents your reason for ordering the test. As you know, providing evidence of medical necessity for each order is a requirement for your participation as a Medicare provider. Remember that new ICD9 codes became effective October 1, 2008, and many former codes now require additional digits for specific conditions. National Coverage Decisions (NCDs) and Medical Necessity: As part of the federal government effort to balance the budget, the Center for Medicare and Medicaid Services (CMS) developed 23 coverage policies to assure appropriate laboratory utilization. Please see http://www.cms.hhs.gov/CoverageGenInfo/04_LabNCDs.asp#TopOfPage to select the most current on-line version of the Medicare Coverage Manual. To help you recognize all limited coverage tests, we have marked them with an asterisk (*) on our Providence Health and Services Laboratory Requisition. When the ICD9 code you provide does not meet medical necessity requirements, Medicare patients must be advised in advance. Use the CMS approved Advance Beneficiary Notice of Non-Coverage (ABN) to document your discussion. This gives you the opportunity to review the need for the test with the patient, notifies them that they may be responsible for the charges, and provides the patient the option to not have their test(s) or service(s) performed. As of March 1, 2009, ABNs must include a
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cost estimate for the tests ordered. A price list for tests with coverage policies is posted on our laboratory intranet web site at: http://phsnet.phsor.org/laboratory/Compliance/compliance.htm. Give one completed copy to the patient and send the original to our laboratory with your orders when requesting tests with applicable limited coverage rules. Non-Covered Service: Our laboratory has seen an increase in requests for testing that Medicare considers ‘non-covered.’ These include genetic markers, BRAC analysis, and Prometheus kit tests, many of which are performed by non-FDA approved methods. Compliant billing requires that the performing laboratory directly bill the patient for all non-covered services. These orders often require pre-authorization, your signature as the ordering provider, and a signed patient consent. You are also responsible for completing all paper work required by the testing laboratory. Our laboratory may hold specimens for you until the orders are complete. We can assist you in collecting these samples and in getting them to the performing laboratory requested, but we cannot handle the billing or track the results. Testing that is requested for referral to laboratories not approved by PNMC, the laboratory will assist in collecting these samples and in getting them to the performing laboratory requested, but we cannot handle the billing or track the results. Referral Tests: When tests ordered are not available for analysis within our Laboratories, we forward them to carefully selected referral laboratories. Reference laboratories must meet our criteria for quality and service, and they must be properly accredited for the testing ordered. Through such arrangements (as we have with ARUP Laboratories in Utah) we are able to enhance connected care with quicker turn-around-times and interfaced electronic result reporting. Testing that is requested for referral to laboratories not approved by PNMC, the laboratory will assist in collecting these samples and in getting them to the performing laboratory requested, but we cannot handle the billing or track the results. Pap Smear Orders: CMS provides very specific direction for assuring coverage of Pap Smears. Medicare covers screening Pap Smear tests only when ordered with one of these four ICD9 codes: V76.2 (screening, cervix), V15.89 (high risk), V76.47 (screening, vaginal), or V76.49 (screening, other sites). These four codes are pre-printed on our laboratory requisition for your convenient selection. Provide a separate ICD9 code (or descriptive signs/symptom) whenever you order diagnostic PAPs. PSA Tests: CMS also provides even more specific coverage rules for PSA testing. Screening PSA’s are covered for Medicare patients only when ordered with ICD9 code V76.44. Medicare patients must always be presented with an ABN when a screening PSA is ordered for any reason other than V76.44. Indicate other appropriate ICD9 codes when ordering diagnostic PSA’s. Panel Tests: Organ or disease related panels are charged and reimbursed only when all test components are medically necessary. All components of panels offered by Providence Laboratories may be ordered individually. Providence Laboratories may not recognize custom panel orders designed by other laboratories. To prevent delays with testing, and to be sure you receive the tests intended, please order using specific test names and numbers as provided in our test catalogue. Medicare Laboratory Fee Schedule: Medicare recently published the reimbursement fee schedule for 2009 on the CMS site, http://www.cms.hhs.gov/ClinicalLabFeeSched/02_clinlab.asp#TopOfPage. The Medicaid reimbursement amount will be equal to or less than the amount of Medicare reimbursement.
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Additional Charges: Some laboratory tests may trigger additional automatic orders and appropriate charges based on laboratory policy. Our test directory provides specific information including criteria that will lead to these charges, and the specific CPT codes we use. The on-line directory is available at: http://www.providence.org/oregon/programs_and_services/lab_services/default.htm Examples include: • Presence of pathological organisms on cultures will reflex to include appropriate organism identification and susceptibility testing. • Complete Blood Counts (CBC’s) meeting our internal criteria will automatically reflex to slide review and/or manual differentials. You do not need to order manual differentials separately. • Body Fluid Cell Counts with WBC’s present will reflex to include a differential WBC count. • Lower respiratory, deep wound, body fluid and CSF cultures include Gram Stains. Reflex Testing: In other cases, defined results will trigger additional testing and charges only when so requested with the initial order. Typically, ‘reflex’ or ‘if’ will be included in the test name. Examples include: • Pap Smear, HPV if ASCUS. • UA, C & S IF, which will add a urine culture based on results of the urinalysis • PSA Reflex, which adds a Free PSA based on results of the PSA Total, Diagnostic. • Rapid Influenza Reflex Panel, which includes both rapid flu direct testing and PCR testing, and then adds a respiratory virus culture when the PCR testing is negative. Supplies: Providence Laboratory Services will provide supplies required for the collection of specimens that are to be sent to our laboratory. Anti-Kickback statutes govern these practices, and our laboratory monitors the volume of supplies provided to your offices. Supply volumes must reasonably match volumes of testing received. Clinical Consultant: Consultation services regarding appropriateness of testing ordered and interpretation of results is available to you. Contact information is listed here: James Durham, M.D., Regional Medical Director of the Providence Portland Service Area; Phone 503.215.6096. James Booth, M.D., Medical Director, PNMC Laboratory; Phone: 503 216-7525 We hope you find this information useful in your practice, and that many of your questions have been answered. Please don’t hesitate to call 503.216.9754 for further information. Nick Cirlincione, MT (ASCP) Manager, Laboratory Quality Assurance & Compliance Providence Laboratory Services, Yamhill Service Area
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