April Billing and Compliance. Chemistry. Coagulation. Cytogenetics. Cytology. Flow Cytometry. Help Us Help You. Microbiology.

Transcription

1 April 2017 Billing and Compliance Waivers for Medicare replacement plans Chemistry Vitamin D specimen requirement and stability changes Coagulation Low Molecular Weight Heparin reference range changes Cytogenetics Completion of requisitions Cytology Fine Needle Aspirate (FNA) request forms Flow Cytometry Paroxysmal Nocturnal Hemoglobinuria platform change Help Us Help You Keeping your provider list current Microbiology 2016 Microbiology Susceptibility cards available Referral Testing Positive results for Fentanyl on the Compliance Drug Analysis Arsenic fractionation, urine assay changes Cold agglutinins assay changes Endomysial Antibody IgA assay changes Pneumonitis Hypersensitivity Panel changes New orderable tests Supplies Supply catalog help us help you Blood culture bottle change

2 BILLING AND COMPLIANCE Waivers for Medicare replacement plans Approximately 18 months ago, Allina Health Laboratory shared a communication with our clients indicating that Allina Health would no longer accept Advanced Beneficiary Notices (ABNs) for Medicare replacement plans that follow the Center for Medicare & Medicaid Services (CMS) rules regarding medical necessity. This was because the replacement plans do not accept the standard CMS ABN. At this time, an approved waiver has been created for use with the following Medicare replacement plans; Humana Gold MR, Medica Prime Solutions and UCARE (for Seniors) MR. Beginning April 1, 2017, the Non-covered Services Waiver, an example of which is included with this message, are to be used for patients subscribing to these plans when medical necessity is not met. The waiver is available in a fillable PDF format on both the Forms and Billing pages of the Allina Health Laboratory website and is also available via this link. Included with this newsletter is a ABN/waiver test list, a waiver FAQ document, as well as a waiver example. 2

3 CHEMISTRY Vitamin D specimen requirement and stability changes On April 9th, Allina Health Laboratory transitioned to a new formulation of Vitamin D testing which will allows quantitation of results from 3.4 to 311 ng/ml. There was no change to the reference range, which is based upon recommendations from the Institute of Medicine. At the same time, the acceptable specimens, transport and stability for specimens for this assay were updated. Acceptable specimen, transport and stability Specimen Transport/ stability Previous Li Heparin plasma PST (preferred) Serum (acceptable) Refrigerated 5 days Frozen 1 month NEW Serum Refrigerated 12 days Frozen 1 month Ambient 72 hours COAGULATION Effective April 18, 2017 the reference range, therapeutic ranges and prophylactic range for the Low Molecular Weight Heparin assay (2281) changed. In order to correlate with best practice based on the latest reference literature suggestions, as well as due to clinician requests for dose specific reference ranges, on 04/18/2017, the Low Molecular Weight Heparin therapeutic and prophylactic ranges were modified. The up-dated reference ranges are derived from CHEST guidelines (1,2) and provide therapeutic range information for once daily and twice daily dosing for specimens drawn 4-6 hours after administration (peak dose). Note that there are different preparations of low molecular weight heparin available. Always refer to the drug package insert for specific information regarding dosing and/or monitoring of low molecular weight heparin therapy. 3

4 Previous NEW Reference Range Prophylactic Range Units/mL IU/mL Therapeutic Range Twice Daily Dosing Units/mL IU/mL Therapeutic Range - Once Daily Dosing NONE GIVEN IU/mL Panic/Critical >1.50 Units/mL >2.00 IU/mL Reference: 1. Garcia DA et al, Parenteral Anticoagulants Antithrombotic Therapy and Prevention of Thrombosis 9 th ED ACCP Evidence-Based Clinical Practice Guidelines CHEST 2012; 141 (2)(Suppl): e24s-e43s 2. Wei MY et al, The anti-factor Xa range for low molecular weight heparin thromboprophylaxis Hematology Reports 2015; volume 7:5844 CYTOGENETICS Completion of requisitions In order to provide efficient use our laboratory resources, and to ensure that our clients receive the best service possible, the Allina Health Cytogenetics laboratory is requesting that the cytogenetics requisitions are completed in their entirety prior to submission. The following items are required; ordering provider billing indication (if not preprinted) complete patient demographics (name, DOB, gender, address, phone and insurance if the billing indication is bill patient/insurance) reason for referral testing requested testing priority (STAT or routine) If no priority is marked, the specimen will be processed and report as routine. If STAT is indicated, a contact name and phone number are required for results communication. If no contact information is provided, the lab will process and perform the test STAT, however no 3-day preliminary report will be communicated. 4

5 CYTOLOGY Fine Needle Aspirate (FNA) request forms The Allina Health Laboratory FNA request forms, as well as the corresponding completion instructions, have been updated. Clients submitting FNA s to Allina Health Laboratory will be contacted by their account representative to obtain updated forms, as well as a brief introduction to the forms. If you submit FNA s, but have not yet been contacted by your account representative, or if you have any questions about the forms, please reach out for assistance. FLOW CYTOMETRY Paroxysmal Nocturnal Hemoglobinuria changes On May 1, 2017, the Allina Health Flow Cytometry Laboratory will transition to a new platform for Paroxysmal Nocturnal Hemoglobinuria (PNH) testing (2323/Lab2323). The platform currently utilized for PNH testing is based on expression of the GPI-linked proteins, CD55 and CD59, in association with fluorescent aerolysin (FLAER), on granulocytes and monocytes, and CD59 expression on red blood cells. The new platform employs FLAER in combination with CD157, a GPI-linked protein densely expressed on mature granulocytes and monocytes, and CD59 expression on RBCs. Recent data indicates that small PNH clones can be detected in a relatively high percentage of cases of aplastic anemia and myelodysplastic syndromes. While the clinical significance of this finding is still uncertain, it appears that some of these patients may benefit from immunosuppressive therapy. To detect small PNH clonal populations in blood specimens requires the use of high-sensitivity flow cytometry methods. To that end, the new PNH assay combines lineage-specific gating with acquisition of large numbers of events to achieve a high level of analytic sensitivity. Granulocytes, monocytes, and RBCs are selectively gated for GPI-linked marker analysis using CD15, CD64, and CD235a, respectively. By acquiring large numbers of cells (>100,000 granulocytes and >500,000 RBCs), the new assay achieved analytic sensitivities of 0.01% for PNH granulocytes, and 0.01% for PNH III RBCs, in blood samples from two patients with classic, hemolytic PNH. In summary, by collecting more events, using lineage-gating, and employing new monoclonal antibodies, this redesigned PNH test produces a result that is more specific and sensitive while meeting ICCS guidelines. PNH testing is performed Monday through Friday, 8am 3pm. 5

6 Report Format Results are reported as percentage of monocytes or granulocytes deficient in CD157/FLAER, and percentage of RBCs partially (PNH II) or completely (PNH III) deficient in CD59. Patient results are compared to reference intervals, which represent rare background events detectable in normal blood specimens. An interpreted comment in also provided. Specimen requirements There is no change to specimen requirements associated with this platform change. CPT code Because the new platform utilizes 7 probes, as compared to the current 4 probe platform, there will be a change to the CPT codes. CPT Current x 3 New x 6 6

7 Example negative test report Paroxysmal Nocturnal Hemoglobinuria (PNH) panel: Interpretation Negative for immunophenotypic abnormalities associated with a paroxysmal nocturnal hemoglobinuria (PNH) clone. A negative result means no deficiency of the GPI-associated markers, CD157, FLAER or CD59. Clinical indication for flow cytometry: Test for phenotypic abnormalities associated with paroxysmal nocturnal hemoglobinuria (PNH). EDTA peripheral blood monocytes and granulocytes are lineage-gated using CD45, CD15 and CD64. WBC GPI-linked antibodies, CD157 and FLAER, are used to identify the PNH clone. Erythrocytes are lineage-gated using CD235a and the GPI-linked antibody CD59 is employed to identify the PNH clone. Viability: ***% Data quality variables Patient Monocytes (SS/CD64+): ***% Granulocytes (SS/CD15+): ***% PNH-associated variables Result Reference WBC - Monocyte CD157/FLAER deficiency: ***% % WBC - Granulocyte CD157/FLAER deficiency: ***% % RBC CD59 deficiency (Type III): ***% % These results and the Flow Cytometry cytograms have been verified by Dr. ***. Allina reference ranges based on 34 normal peripheral blood samples. The lower limit of detection for this assay has been verified as follows: WBC - Granulocyte CD157/FLAER deficiency: 0.01% RBC Type III (complete CD59 deficiency): 0.01% The lower limit of detection was determined based on dilution studies of two PNH positive patients. This test was developed and verified by the Allina Health Flow Cytometry Laboratory. It has not been cleared or approved by the US Food and Drug Administration. FDA does not require this test to undergo premarket FDA review. This test is used for clinical purposes and should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. 7

8 Example positive test report Paroxysmal Nocturnal Hemoglobinuria (PNH) panel: Interpretation Positive for immunophenotypic abnormalities associated with a paroxysmal nocturnal hemoglobinuria (PNH) clone. A positive result means a deficiency of the GPI-associated markers, CD157, FLAER or CD59. The PNH clone is detected among gated red blood cells, and/or granulocytes/monocytes. Clinical indication for flow cytometry: Test for phenotypic abnormalities associated with paroxysmal nocturnal hemoglobinuria (PNH). EDTA peripheral blood monocytes and granulocytes are lineage-gated using CD45, CD15 and CD64. WBC GPI-linked antibodies, CD157 and FLAER, are used to identify the PNH clone. Erythrocytes are lineage-gated using CD235a and the GPI-linked antibody CD59 is employed to identify the PNH clone. Viability: ***% Data quality variables Patient Monocytes (SS/CD64+): ***% Granulocytes (SS/CD15+): ***% PNH-associated variables Result Reference WBC - Monocyte CD157/FLAER deficiency: ***% % WBC - Granulocyte CD157/FLAER deficiency: ***% % RBC Type III (complete CD59 deficiency): ***% % RBC Type II (partial CD59 deficiency): ***% % RBC Type II and Type III deficiency: ***% These results and the Flow Cytometry cytograms have been verified by Dr. ***. Allina reference ranges based on 34 normal peripheral blood samples. The lower limit of detection for this assay has been verified as follows: WBC - Granulocyte CD157/FLAER deficiency: 0.01% RBC Type III (complete CD59 deficiency): 0.01% The lower limit of detection was determined based on dilution studies on two PNH positive patients. This test was developed and verified by the Allina Health Flow Cytometry Laboratory. It has not been cleared or approved by the US Food and Drug Administration. FDA does not require this test to undergo premarket FDA review. This test is used for clinical purposes and should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. 8

9 HELP US HELP YOU Keeping your provider list current To ensure accurate reports, and accurate billing insurance claims, please review your Allina Health Laboratory request forms on a regular basis to make sure that we are maintaining a complete and accurate physician listing for your clinic. If any updates (removals or additions) are needed, please submit a completed Provider Change Request form, available on the billing page of our website, or contact your account representative for assistance. MICROBIOLOGY 2016 Antimicrobial Susceptibility Cards available 2016 Outpatient Antimicrobial Susceptibilities Cards, containing summaries of the major pathogens isolated from outpatients tested at Allina Health Laboratory, are now available. The intent of the card is to provide a preliminary guide to susceptibilities. The information should be used together with the specific susceptibility results of the isolated organism and guidelines from current publications. The outpatient cards, as well as cards containing information regarding pathogens isolated from Abbott Northwestern, Mercy, United, Unity Hospitals and our regional hospitals are available on our website at ww5.allinahealth.org/ahs/allinalabs.nsf/page/microsusceptcard. Pocket sized hard copies of the Outpatient resource are available from your Account Representative. For further information, contact Mary Colson-Burns, Microbiology Technical Specialist, mary.colson-burns@allina.com or Brenda Katz, M.D., Medical Director of the Microbiology laboratories, Brenda.Katz@allina.com. 9

10 REFERRAL TESTING Positive results for Fentanyl on the Compliance Drug Analysis Due to a recent reporting change at Hennepin County Medical Center (HCMC), it is possible that some unconfirmed positive urine fentanyl results have been reported in the past few weeks. Allina Health Laboratory is working with HCMC to identify any cases where unconfirmed positive fentanyl results were reported and will be contacting providers as needed. Positive fentanyl results reported after April 1 st are not affected. How to tell if a urine fentanyl result was confirmed: Fentanyl should be listed in the spectrometry section of the result. As a reminder, please page HCMC for clinical consultation whenever urine drug screen results are unexpected. HCMC pager number for clinical consultation: (612) Make sure to enter a direct callback number. What is the explanation for any unconfirmed positive urine fentanyl results that may have been reported? In other clinical settings, such as overdose and heroin use, there is a valid reason to report unconfirmed urine fentanyl results. As reported in a recent Star Tribune article, carfentanil, which is 100x more potent than fentanyl, has recently entered the heroin supply. Carfentanil is used only in large animals such elephants and miniscule amounts of the drug are fatal to humans. Such miniscule amounts by cannot be detected by standard confirmation testing, but can be detected by the fentanyl screening test. The fentanyl screen is used as a surrogate marker for carfentanil in patients with overdose and heroin use, but as with any screening test, false positives can occur. Carfentanil detection is not relevant for pain management compliance drug screening. The prevalence of heroin use in the clinic pain management population is extremely low and because carfentanil is poisonous to humans, exposed patients would not be seen in the clinic. For these reasons, positive results for fentanyl will be reported only if seen by confirmatory mass spectrometry. Arsenic fractionation, urine assay changes Effective 3/24/17, Allina Health Laboratory transitioned the referral of samples for the Arsenic fractionation, urine assay from MedTox Scientific to Mayo Medical Laboratories (MML). All specimens received at Allina Health Laboratory for the Arsenic fractionation, urine assay (3186/LSB3186) will be forwarded to MML for analysis. Making this change allowed us to provide our clients with better turn-around-times for this assay, as well as more favorable pricing. 10

11 Test Name: Test Number: 994 Collect Container: Arsenic fractionation, urine 5 ml Urine Mayo Screw Cap Transfer Vial (T465) Processing: Submit 5mL of random urine, or a 5mL aliquot of a 24 hour urine Transport/Stability: Refrigerated (preferred), ambient or frozen 7 days Alternate Names: Arsenic, Inorganic Forms; Arsenic, Organic Forms; As; MSO; LAB994 Performing Lab: Mayo Medical Labs (ASFRU); R Days Set Up: Mo Fr; 11am Expected TAT: 3 4 days Ref. Ranges: Inorganic Arsenic 0-24 µ/l Collection/ Processing Details: Containers must not have metal caps or glued inserts Patient should not eat seafood for a 48-hour period prior to the start of collection. CPT Cold agglutinins assay changes Effective April 10, 2017, Mayo Medical Laboratories discontinued their Cold Agglutinin assay, Allina Health Laboratory test 3667/LAB3667 (MML CAGG). The suggested replacement test for cold agglutinins is Mayo assay CATTH, Cold Agglutinin Titer. Until our system can be updated to reflect these changes, this test will need to be ordered as a 994, Miscellaneous Sendout. Test Name: Test Number: 994 Collect: Container: Processing: Cold Agglutinin Titer 4.0 ml Serum - Pln red Mayo Screw Cap Transfer Vial Spin and separate Transport/Stability: Refrigerated (preferred) Performing Lab: Days Set Up: Expected TAT: Mayo Medical Labs (CATTH); R-MM Mo - Fr & Su 1-3 days Ref. Ranges: <1:64 Collection/ Collection Instructions: Processing Details: 1. Use a warm pack to keep specimen at 37 C prior to and after collecting. 2. Allow specimen to clot at 37 C. 3. Centrifuge at 37 C and separate serum from red cells immediately after blood clots. 4. Do not refrigerate prior to separation of serum from red cells. CPT Codes:

12 Endomysial Antibody IgA assay changes Effective April 12, 2017, Mayo Medical Laboratories (MML) added a new reflex titer to the Endomysial Antibody IgA assay, at an additional charge, when appropriate. At the same time, the specimen stability was changed. Details regarding the changes are as indicated below. Test Name: Endomysial Antibody, IgA Test Number: 7972 Collect: 2.0 ml serum - SST Container: Mayo Screw Cap Transfer Vial Processing: Spin and separate Transport/Stability: Refrigerated (preferred) - 14 days Frozen - OK Ambient - OK NEW Transport/stability Refrigerated (preferred) - 14 days Ambient - 14 days Frozen - 30 days Performing Lab: Mayo Medical Labs (EMA/9360); R-MM CPT Codes: NEW CPT Codes: Screen Titer (when appropriate) Price: $56.60 Pneumonitis Hypersensitivity Panel changes Effective April 12, 2017, Mayo Medical Laboratories (MML), discontinued their Pneumonitis Hypersensitivity Panel (MML SAL). The suggested replacement test is the MML Hypersensitivity Pneumonitis Panel, IgG (MML HYPS). Test changes, as a result of this, are as detailed below. Test Name: Pneumonitis Hypersensitivity Panel Test Number: 679 Transport/Stability: Refrigerated (preferred) - 7 days Frozen - 90 days NEW Transport/Stability: Refrigerated (preferred) - 21days Frozen - 21 days Performing Lab: Mayo Medical Labs (SAL/8768); R-MM NEW Performing Lab Mayo Medical Labs (HYPS); R-MM There are no other changes, including CPT, associated with this test change. 12

13 New orderable tests Effective 4/4/2017, five referral tests were made orderable with unique test numbers and are no longer be ordered as a 994, Miscellaneous Sendout. With this change, the results for three of these tests (Aspergillus Antigen, BAL, HSV by Rapid PCR (Herpes), CSF and Pneumocystis jioveci PCR) are now interfaced and no longer answered as See Separate Report with the referral lab report faxed separately. The five tests listed below were affected by this changes. Test Name Previous test # NEW test # Aspergillus Antigen, BAL Chlamydia psittaci Culture Fragile X Test (Symptomatic or family history) HSV by Rapid PCR (Herpes), CSF Pneumocystis jiroveci PCR Effective 4/18/2017, four additional referral tests were made orderable with unique test numbers and are no longer ordered as a 994, Miscellaneous Sendout. Test Name Previous test # NEW test # Bile Acids, Total Fondaparinux Level Proteinase 3, IgG Ab Rickettsial Disease Panel The Allina Health Laboratory test catalog has been updated to reflect the new test numbers. 13

14 SUPPLIES Supply catalog Help us help you It has come to our attention that when semicolons (;) are used in the Special Instructions field of our supply catalog, the orders are getting held up. To prevent possible delays in order fulfillment, when using this field, please refrain from using semicolons. Blood culture bottle change Allina Health Laboratory is in the process of converting from our current glass blood culture collection bottles, to new plastic bottles. The new bottles will be used to fulfill orders when our current supply is depleted. Advantages: The plastic bottles are light in weight making them easier to handle The plastic bottles are less likely to break if dropped There is no difference in organism recovery between the glass and plastic bottles The new bottles are slightly smaller in height, but are handled and inoculated in the same manner as the glass bottles. If you have any questions about these new bottles, please contact Client Services or your Allina Health Laboratory Account Representative. Thank you for choosing Allina Health Laboratory - we value your business! 14