ACL laboratories Compliance Guidance to Providers - 2013 Annual Compliance Notice to Providers 2013 The Medicare and Medicaid Programs look to clinical laboratories to provide education to physician clients 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 800-877-7016 ext. 7916, if you have any questions or concerns. Lab Ordering Documentation Physicians and non-physician providers authorized to order clinical laboratory testing must provide to ACL written or electronic orders that include sufficient information to identify the ordering provider’s National Provider Identifier (NPI). In addition, the ordering provider must maintain documentation of the order for 7 years from the date of service. Medical Record documentation may be written or electronic, must be signed or electronically authorized, and support the specific services ordered for the patient’s date of service. Requirements for Diagnostic Information Physicians and non-physician providers ordering laboratory testing must provide diagnostic information in the form of ICD-9 codes specific to the ordered test(s) at the time of order. When testing is ordered to determine or confirm a diagnosis, ICD-9 codes describing signs, symptoms or chief complaints should be provided. Tests ordered in the absence of confirmed diagnoses, signs, symptoms or complaints are considered screening. Medicare does not generally pay for tests when ordered as screening, unless the test(s) are eligible for preventive services coverage. Screening tests not covered by Medicare are the financial responsibility of the patient. Medical Necessity Medicare will only pay for laboratory testing that meets Medicare policy guidelines and is reasonable and necessary to treat or diagnose an individual patient. Even if a service is medically determined to be "reasonable and necessary," individual patient coverage may be limited if the service is provided more frequently than allowed under Medicare coverage policies. Click here to see a complete list of tests subject to 2013 Medicare coverage policies. 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. Only order testing necessary for diagnosis or treatment. Note that all individual components of a panel or profile must be necessary for the panel/profile to qualify for Medicare reimbursement. 2. Provide a diagnosis, sign, symptom or complaint specific to each test ordered. 3. Document the necessity of testing in the patient’s medical record. 4. Inform the patient via an ABN when testing does not meet Medicare coverage policies, or is being ordered more frequently than allowed by policy. Page |1 ACL laboratories Compliance Guidance to Providers - 2013 Preventive Services Medicare provides reimbursement for specific laboratory tests when all of the following criteria are met: 1. The test is reasonable and necessary for the prevention or early detection of illness, 2. It is recommended by the US Preventive Services Task Force (USPSTF) with a grade of A or B, and 3. It is appropriate for individuals entitled to benefits of the Medicare Program. Click here to see a complete list of tests covered by the Preventive Services program. In many cases, specific screening ICD-9 codes must be provided with the test order for benefits to apply. Tests with Preventive Services coverage are subject to frequency edits. Patients should be informed via an ABN when tests are ordered more frequently than benefits allow. Advanced Beneficiary Notice of Noncoverage (ABN) ABN Form CMS-R-131 is to be used to notify a Medicare Fee for Service beneficiary of testing we believe Medicare will not reimburse. A similar Notice of Noncoverage form is available from ACL for use when notifying a Medicare Advantage patient of testing we believe will not be reimbursed based on Medicare coverage policy. Reasons Medicare and Medicare Advantage Plans may not pay for testing include: 1. The test is subject to a Medicare coverage policy and the diagnosis provided is not included in the policy (Medicare does not pay for this test for your condition). 2. The test has Preventive Services coverage, or other coverage limitations and is being ordered more frequently than allowed (Medicare does not pay for this test as often as this). 3. The test has not been deemed effective by Medicare for diagnosis or treatment (Medicare does not pay for experimental or research use tests) 4. The test does not have Preventive Services coverage and is ordered for routine screening. This is an optional use of the ABN. (Medicare does not pay for tests when ordered as screening) When testing is ordered for reasons Medicare will not reimburse, the patient must be allowed to make an informed consumer decision as to whether to have testing performed and assume financial responsibility of the costs. Click here to see Medicare ABN Form CMS-R-131 Click here to see the Medicare Advantage Notice of Noncoverage Form Profiles Although profiles and test combinations offer convenience in ordering, they may also result in the routine ordering of more tests than necessary to diagnose and treat patients. ACL limits the offering of profiles to those approved by the American Medical Association (AMA) and those approved by the laboratory’s pathology medical directors. Please know what tests are included in the profile you order. To prevent test duplication, do not separately order individual tests already included in the profile. Also, if every test included in the profile is not necessary for diagnosis or treatment, order the individual tests needed rather than the profile. When in doubt as to which tests are included in a profile, please check the ACL Directory of Services at: www.acllaboratories.com Page |2 ACL laboratories Compliance Guidance to Providers - 2013 Reflex and Confirmation 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. The ACL Directory of Services identifies reflex and/or confirmation testing under ‘Test Performance’. When indicated, ACL will bill reflex and confirmation tests as well as the initial test. CPT Coding and Medicare / Medicaid Reimbursement ACL Laboratories maintains a directory of services that lists our clinical test menu, test order codes and CPT codes used to bill third parties. 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. The ACL Directory of Service can be accessed at: www.acllaboratories.com The 2013 Medicare Clinical Laboratory Fee Schedule can be accessed at: http://www.cms.gov/Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/clinlab.html The 2013 Wisconsin Medicaid fee schedule can be accessed at: https://www.forwardhealth.wi.gov/MaxFee/LAB_max_fee_20130302.txt The 2013 Illinois Department of Healthcare and Family Services fee schedule can be accessed at: http://www2.illinois.gov/hfs/MedicalProvider/FeeSchedule/Pages/default.aspx Clinical Consultant ACL Laboratories is affiliated with more than 80 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 800-877-7016 for test assistance. Page |3 ACL laboratories Compliance Guidance to Providers - 2013 Lab Tests with Medicare Specific Diagnosis Coverage Lab Test Description CPT Code(s) NCD (National) LCD (Local) Alpha-fetoprotein (AFP, AFET) 82105 Blood Counts (CBCNO, CBCA, WBC, PLT) 85205, 85207, 85048, 85049 Glucose (GLU, GLUPL) 82947, 82962 CEA (CEA) Collagen Crosslinks Digoxin (DIG) Fecal Occult Blood (IFOB) GGT (GGTP) 82378 82523 80162 82274 82977 NCD NCD NCD NCD NCD NCD Hepatitis Panel (ACUTE) 83036 80074 NCD NCD HCG (HCGQT, HCGTM) HIV Screening (HIVSCR) HIV Quantitative (HIVDNR, HIVQTM) Lipid (LIPPNL, LIPFA, CHOL, TRIG, NMRLIP) PTT (PTT) Prothrombin Time (PTINR) 84702 87389 87535, 87536 80061, 82495, 84778, 83704 85730 85610 NCD NCD NCD 84153 83540, 82728, 84466 84443, 84439, 84436, 84479 86304 86300 86301 87086 NCD Iron Studies (FERR, IRON, IRONP, TRANS) Thyroid Testing (TSH, TSHR, FT4, TT4, FT3, TT3) CA 125 (C125) CA 15-3/CA 27.29 (CAN153, C2729) CA 19-9 (CA199) Urine Culture (URC) Allergy Testing (RAST) 86003, 86001 Glycated Hemoglobin (GLYH) Prostate Specific Antigen (PSA) Circulating Tumor Cell Marker Assays (CFCCT) Cytogenetic Studies PAP Tests Flow Cytometry Heavy Metal Testing: Lead, Lithium Thallium, Zinc, etc. Drug Testing, Qualitative Vitamin D Assays (25VDR, VITD25, 125DR) 86152 88230 – 88275 88164, 88175 88184 Additional Frequency Limitations NCD NCD NCD NCD NCD Yes, once annually Yes, once every 3 months and 1 day Yes, once annually Yes, annual. More often if treatment dictates Yes, once annually NCD NCD NCD NCD NCD NCD LCD LCD LCD LCD LCD 83655, 80178, 84999, 84630 LCD 80100, 80101 LCD 82306, 82652 LCD Yes, 86003 limited to 24 allergens annually Yes, once every 24 months Yes, up to 4 annually Page |4 ACL laboratories Compliance Guidance to Providers - 2013 Lab Tests that have Screening Coverage through Medicare Preventive Services Lab Test Description HCPCS/CPT Codes Covered ICD-9 Screening Codes Frequency Limitations Lipid Testing: CHOL, TRIG, HDL 80061, 82465 83718, 84478 82947, 82950 82951 P3000, G0147 V81.0 V81.1 V81.2 Once every 5 years V77.1 V77.1 TS Low risk: V72.31 V76.2 V76.47 V76.49 High risk: V15.89 V76.49 One per year Two per year Once every 24 months V76.44 Primary V73.89 Secondary, as appropriate V69.8, V22.0, V22.1, V23.9 Not pregnant V74.5 & V69.8 Pregnant women V74.5 & V69.8 & V22.0, V22.1 or V23.9 Males & Not pregnant V74.5 & V69.8 Pregnant women V74.5 & V22.0, V22.1 or V23.9 Pregnant & at increased risk V74.5 & V69.8 & V22.0, V22.1 or V23.9 Pregnant women V73.89 & V22.0, V22.1 or V23.9 Pregnant & at increased risk V73.89 & V69.8 & V22.0, V22.1 or V23.9 One per year One per year Glucose Testing: GLU, GLUPL, GTT3 PAP Testing Fecal Occult Blood Testing: IFOB, STBLD PSA HIV Chlamydia, Gonorrhea Syphilis Testing Hepatitis B Surface Antigen G0328, 82270 G0103 G0432, G0433 87491, 87591 86592, 86780 87340, 87341 One per year One per year If pregnant, 3 times per pregnancy One per year If pregnant, 2 times per pregnancy One per year One per pregnancy 2 times per pregnancy if at continued increased risk One per pregnancy 2 times per pregnancy if at continued increased risk Page |5 8901 W Lincoln Avenue West Allis, WI 53227 (888) 719-3569 Patient Name: Identification Number: Advance Beneficiary Notice of Noncoverage (ABN) NOTE: If Medicare doesn’t pay for the Laboratory Test(s) below, you may have to pay. Medicare does not pay for everything, even some care that you or your health care provider have good reason to think you need. We expect Medicare may not pay for the Laboratory Test(s) below. Laboratory Test(s): Reason Medicare May Not Pay: Estimated Cost: ☐ Medicare does not pay for these test(s) for your condition $ ☐ Medicare does not pay for these test(s) as often as this (denied as too frequent) ☐ Medicare does not pay for experimental or research use test(s) ☐ Medicare does not pay for these test(s) when ordered as routine screening WHAT YOU NEED TO DO NOW: Read this notice, so you can make an informed decision about your care. Ask us any questions that you may have after you finish reading. Choose an option below about whether to receive the Laboratory Test(s) listed above. Note: If you choose Option 1 or 2, we may help you to use any other insurance that you might have, but Medicare cannot require us to do this. OPTIONS: Check only one box. We cannot choose a box for you. ☐ OPTION 1. I want the Laboratory Test(s) listed above. You may ask to be paid now, but I also want Medicare billed for an official decision on payment, which is sent to me on a Medicare Summary Notice (MSN). I understand that if Medicare doesn’t pay, I am responsible for payment, but I can appeal to Medicare by following the directions on the MSN. If Medicare does pay, you will refund any payments I made to you, less co-pays or deductibles. ☐ OPTION 2. I want the Laboratory Test(s) listed above, but do not bill Medicare. You may ask to be paid now as I am responsible for payment. I cannot appeal if Medicare is not billed. ☐ OPTION 3. I don’t want the Laboratory Test(s) listed above. I understand with this choice I am not responsible for payment, and I cannot appeal to see if Medicare would pay. Additional Information: If you choose Option 3, you should notify your doctor who ordered these Laboratory Test(s) that you did not receive them. This notice gives our opinion, not an official Medicare decision. If you have other questions on this notice or Medicare billing, call 1-800-MEDICARE (1-800-633-4227/TTY: 1-877-486-2048). Signing below means that you have received and understand this notice. You also receive a copy. Signature: Date: According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0566. The time required to complete this information collection is estimated to average 7 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850. Form CMS-R-131 (03/11) Form Approved OMB No. 0938-0566 Aurora Health Care, Milwaukee, Wisconsin Page |6 8901 W Lincoln Avenue West Allis, WI 53227 (888) 719-3569 Page |7