“Keeping Our Client Informed” Questions or Comments Call 651-232-3500

HML UPDATE Summer 2016

Inside: Panel Changes ...................................... 1-4

Ordering Estradiol ...................................... 4

Change in Lead Ref. Range ....................... 5

Change in PHV Coding & Billing ............... 5

Medical Necessity Reminder ...................... 5

Drawing Sites ............................................. 6

HML Lab Order Requisition Policy ............. 7

New Layout for HML Invoice ...................... 8

2016 Reference Manual ............................. 9

Mayo Price Increase ............................. 9-10

Tick Borne Disease Recommend. ............ 11

Consultant’s Corner ............................ 11-12

Education ................................................. 12

Panel Changes Effective 4/25/16, Calprotectin became an orderable panel. Calprotectin is a stool (fecal) test that is used to detect inflammation in the intestines. Intestinal inflammation is associated with, for example, some bacterial infections and, in people with inflammatory bowel disease (IBD); it is associated with disease activity and severity. The calprotectin test is not diagnostic but may be used to distinguish between IBD and non-inflammatory disorders and to monitor IBD disease activity. (Effective 6/15/16, the panel code will be changing from FCALP to CALPR) Panel Name: Calprotectin Panel Code: LAB3062 (CALPR) CPT Code: 83993 Collect: Screw-Top Container Submit: 5 g random stool in a separate screw-top container FROZEN. Test Performed at: Mayo Medical Laboratories List Price: $223.00

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Panel Changes Con’t.

Effective 4/4/16, Histoplasma capsulatum Antibody Screen (LAB795) became non-orderable due to unavailability of assay reagent. Recommended alternative test is as follows: Panel Name: Histoplasma Antibody Panel Code: LAB927 CPT Code: 86698x3 Collect: Red Top Tube Submit: 1 mL serum REFRIGERATED. Unacceptable: Markedly hemolyzed or lipemic specimen. Test Performed at: Mayo Medical Laboratories List Price: $35.56 --------------------------------------------------------------------------------------------------------- Effective 4/4/16, Thiopurine Methyltransferase, RBC panel (LAB2216) became non-orderable due to assay performance issues at Mayo Medical Laboratories. Recommended alternative test is as follows: Panel Name: Thiopurine Methyltransferase, RBC Panel Code: LAB3058 CPT Code: 82657 Collect: Lavender (EDTA) Top Tube Submit: 5 mL whole blood in original tube REFRIGERATED. Unacceptable: Markedly hemolyzed specimen. Note: Green Top (Sodium or Lithium Heparin) whole bloods are acceptable specimen types. Test Performed at: Mayo Medical Laboratories List Price: $307.40 --------------------------------------------------------------------------------------------------------- Effective 4/25/16, NMR LipoProfile w/IR Markers became orderable at HealthEast Medical Laboratories. Panel Name: NMR LipoProfile w/IR Markers Panel Code: LAB3060 (FNMR2) CPT Code: 80061, 83704 Collect: Lavender Top Submit: 2 mL plasma REFRIGERATED. Unacceptable: Patient not fasting, markedly hemolyzed specimen. Gel top tube is unacceptable. Note: Patient fasting 12-14 hours. Serum is also an acceptable specimen-draw using plain red-top tube. Test Performed at: Mayo Medical Laboratories List Price: $50.00

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Panel Changes Con’t. Effective 4/25/16, Trazodone is no longer being performed by Mayo Medical Laboratories due to low volumes. Thus, Trazodone testing is being referred to Medtox Laboratories. Panel Name: Trazodone Panel Code: LAB2221 (TZR) CPT Code: 80338 Collect: Plain Red Top Submit: 1 mL serum REFRIGERATED. Unacceptable: Specimen collected in an SST tube. Note: Recommended collection is 12 hours post dose (trough) following a minimum of 5 days on Trazodone. Reference Range: 800-1600 ng/mL Test Performed at: Medtox Laboratories List Price: $47.75 --------------------------------------------------------------------------------------------------------- Effective 4/26/16, Mayo Medical Laboratories testing of Topiramate will undergo a testing platform change resulting in new reference values and specimen stability. Current reference ranges were 2.0-20.0 mg/mL. New Reference Ranges will be 2.0-8.0 mcg/mL. Panel Name: Topiramate Panel Code: LAB498 (TOPI) CPT Code: 80201 Collect: Plain Red Top Submit: 1 mL serum REFRIGERATED. Centrifuge and aliquot within 2 hours of collection. Unacceptable: Specimen collected in an SST tube, markedly hemolyzed, lipemic or icteric specimen. Note: Peak concentration is achieved 2-3 hours after dosing. Trough should be drawn 30 minutes before dose. Test Performed at: Mayo Medical Laboratories

--------------------------------------------------------------------------------------------------------- Effective 4/29/16, test Poliovirus Antibody will only report antibody testing to Poliovirus Type 1 and Poliovirus Type 3. Mayo Medical Laboratories refers testing to Focus Diagnostics who have been asked to join in the United States National Poliovirus Containment Program in assuring the eradication of Poliovirus Type 2. Therefore Focus Diagnostics is eliminating testing that utilizes Poliovirus Type 2. Thus CPT code and pricing will be updated. Panel Name: Poliovirus Antibody, Neutralizaton Panel Code: LAB653 (FPOLS) CPT Code: 86382x2 Collect: Red Top Submit: 1 mL serum REFRIGERATED. Unacceptable: Note: This panel is unacceptable for acute disease. Test Performed at: Mayo Medical Laboratories List Price: $132.01

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Panel Changes Con’t. Effective 6/15/16, Fecal Occult Blood, Immunochemical testing will be an orderable test. This test is useful for colorectal cancer screening and screening for gastrointestinal bleeding. Fecal immunochemical tests do not detect upper gastrointestinal (GI) bleeding due to the breakdown of globin during intestinal transit; HemoQuant is the most sensitive test to detect upper and lower GI bleeding. Panel Name: Occult Blood, Qualitative, Immunochemical, Fecal Panel Code: LAB3059 (FOBT) Panel Synonym: FIT CPT Code: 82274 Collect: Fecal Occult Blood Test Kit (supplied by HML) Submit: Collect a random stool specimen. Follow these instructions for collection and submission:

1. Fill in required information on sampling bottle. 2. Place supplied collection paper inside toilet bowl. 3. Defecate to deposit stool sample on top of collection paper. 4. Open green cap of sampling bottle by twisting and lifting. 5. Scrape the surface of the stool with the sample probe. Cover grooved portion of the probe

completely with stool. 6. Insert probe into bottle and snap green cap on tightly. Do not reopen. 7. Wrap bottle in absorbent pad and place in biohazard bag. Put in the mailing envelope provided. 8. Return envelope to laboratory REFRIGERATED (preferred) or Ambient (room temperature).

Unacceptable: Stool specimen contaminated with urine or water from the toilet bowl. Note: Specimen must be collected in specific sample vial within 4 hours of defecation. Test Performed at: Mayo Medical Laboratories List Price: $75.00

Ordering Estradiol Abbott Diagnostics, our immunoassay testing platform and reagent vendor, has confirmed that the drug Fulvestrant (Faslodex) may interfere with the Architect Estradiol assay leading to falsely elevated results. Investigation testing at Abbott Laboratories yielded the following information: an Estradiol result of 29.14 pg/mL in an unaltered specimen increased to a result of 85.80 pg/mL in a sample spiked with a representative circulating dose of 25,100 pg/mL of Fulvestrant. This represents approximately 294% interference in the Estradiol result. When ordering an Estradiol test on any patient taking Fulvestrant, please order a WLD and indicate the test as “Estradiol at Mayo Medical Laboratories”. The methodology used at Mayo Medical Laboratories for testing Estradiol is free from interference by Fluvestrant.

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Change in Lead Reference Range Upon recommendations from Minnesota Department of Health and CDC, HealthEast Medical Laboratories updated the reference range for Lead testing effective 6/1/16. The new reference range is <5.0 ug/dL for ALL ages.

Change in HPV Coding & Billing Effective May 1, 2016, HML changed how HPV is coded and billed. In the past, HML has billed out HPV as 87624. In addition, if it was positive GHV (HPV Genotyping) was performed - it too was billed out as 87624. There is a MUE of 1 for 87624 and our billing team would add a 59 modifier to the second 87624. CMS and many 3rd party payers are no longer accepting this modifier. We are aware many of our clients have struggled with this and due to this ongoing struggle; HML has reviewed our work processes and have come up with a new workflow. HML will bill out one 87624 for the HPV. If it is positive, it will reflex to GHV and you will receive results on the HPV and GHV. HML will be increasing the charge for 87624 slightly to compensate when a positive GHV is performed. Current practice is to bill our clients 87624 x2 at $43.28/each test (non-discountable), or $86.56 for HPV and GHV when performed. The new pricing will be $50.00 x1, which - in the long run -will actually be a cost savings. HML is committed in partnering with our clients to provide the best possible solutions and service.

Annual Medical Necessity Reminder Notice HealthEast Medical Laboratory would like to remind all of our medical staff about the importance of

providing medical necessity documentation for the laboratory procedures performed on patients for whom

we will be billing Medicare or other third party payers.

Please indicate the ICD 10 code for each laboratory test ordered on the HML laboratory

requisition. Please note that this documentation must also be available in your medical

records.

Organ or disease-related profiles will only be reimbursed when all components are medically necessary.

Routine chemistry profiles are considered screening tests and are therefore not reimbursable. The Office of

Inspector General (OIG) takes the position that physicians who knowingly order medically unnecessary tests

for which Medicare reimbursement is requested may be subject to civil, criminal and administrative penalties

and sanctions.

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Drawing Site Locations and Hours

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HML Lab Order Requisition Policy Requisitions submitted to HealthEast Medical Laboratory are REQUIRED to have the following information for each patient lab request:

FIRST NAME, LAST NAME,

DATE OF BIRTH (DOB), GENDER (MALE/FEMALE),

ROOM NUMBER, ORDERING PHYSICIAN (Last Name, First Name- One provider name on requisition only)

ICD10 –DX CODE Requisitions received at HealthEast Medical Laboratory not submitted according to the guidelines set above, WILL BE REJECTED. As a temporary courtesy HML will fax back incomplete lab requests to the fax number listed on the order form. A fax cover sheet (example below) will accompany the rejected lab request identifying the missing information needed to schedule a lab draw. Please promptly add the required information and refax to 651-326-8043 to prevent any disruption in lab services. If you have questions, please contact our Customer Service at 651-232-3500, option 5.

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New Layout of HML Invoices Thank you for your ongoing partnership. We value you as a client and appreciate you choosing HML as your laboratory partner. As you may or may not be aware, June 1, 2014, HealthEast Medical Laboratory (HML) changed over to a NEW billing system. Since the changeover to our new billing system, we have received several suggestions on how we could improve our invoices. We have been listening and taking notes from your suggestions. Beginning July 1, 2016, you will see changes in the layout of your HML invoices. We believe the invoices are easier to read and provide a better snapshot of your account. Over the next few months, we will also offer opportunities as to how you can receive your invoices and direct the delivery method of your payments. Features You Will See On Our New Invoices: Previous Account Balance What You Have Paid Since Last Statement Account Level Adjustments Since Last Statement Your New Activity (charges/credits) Your Current Account Balance Total Amount You Owe Payment Stub/Voucher for Payment Charge Detail (Itemized)

Please call our HML Billing Office 651-232-1122 with questions or concerns.

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2016 Reference Manual HealthEast Medical Laboratory strives to provide the most complete and accurate information for our clients. In years past, we have furnished our clients with a hard copy “paper” reference manual. This paper manual is shipped at the beginning of each year which lists our tests, processes and procedures and several documents to use as references. No sooner than the reference manual is printed, it becomes obsolete. New tests are constantly being added, and work flow processes are changed. We try to communicate with you through announcements and newsletters, but we understand that information doesn’t always get to the right individuals. HML is making the transition from a “paper copy” of the HML Reference Manual to “paperless”. In transitioning from a paper reference manual to our online reference manual, many of our clients requested the information be provided via a “jump drive”. However, recently due to heightened security with many of our client’s IT systems, the files on the “jump drives” are not allowed to be opened or accessed. Based on this feedback and ongoing security concerns - HML will no longer distribute “jump drives” with HML Reference Manual information. All HML Reference Manual information must be obtain via the web link given below. Our On-Line reference manual is updated at the minimum monthly and will give you the most current information. That link is: www.healtheast.org/hml or http://www.healtheast.org/laboratory/he-med-lab/reference-manual.html If you have questions regarding this transition, please contact HML Customer Service at 651-232-3500, Option #5. Should you experience a downtime and you do not have access to your internet, please contact our customer service and they can walk you through any needed specimen requirements.

2016 Mayo Price Increase Effective April 1st, Mayo changed the pricing of the following tests:

CPT Test Name New Charge Old Charge 80356 6-MONOACETYLMORPH,UR (6MAMU) $182.10 $168.30 86603 ADENOVIRUS ABY (FADV) $90.43 $86.80 82164 ANGIOTENSIN CONV EN ,CSF(FACEC) $64.70 $102.13

87186 ANTIMICROBIAL SUSCEPTABILITY PANEL, YEAST $153.32 $239.27

82239 BILE ACIDS, TOTAL (BILEA) $68.30 $63.60 87081 CULTURE, THR, DIPTHERIA (CDIP) $128.10 $53.95 86698 COXSACKIE A ANTIBODY (COXA) $108.83 $104.00

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86698 COXSACKIE B ANTIBODY (COXB) $108.83 $104.00 81225 CYTOCHROME P450 2C19 (2C19B) $773.20 $711.90 81227 CYTOCHROME P450 2C9 (2C9B) $773.20 $711.90 81226 CYTOCHROME P450 2D6 (2D6CB) $545.10 $502.10 86656 ECHOVIRUS ANTIBODIES (ECHO) $98.81 $94.08

80354/G0480 FENTANYL CONFIRM, UR (FENTU) $223.20 $162.10 86674 GIARDIA LAMBLIA ABS (FGIAR) $85.67 $81.92 86692 HEPATITIS D VIR ABY,TOT(FHEPD) $128.43 $122.32 86790 HERPESVIRUS 6 (HHV-6)ABS(FHP6) $99.72 $94.93 87385 HISTOPLASMA AG CASC,UR(UHIST) $110.90 $102.80 86334 IMMUNOFIX CRYOGLOB (IMFXC) $157.40 $145.60 83516 MYOSITIS ABY PANEL (FMYO) $285.00 $310.00 86255 NMDA-R AB CSA (NMDCS) $509.20 $469.10 87449 NOROVIRUS DETECTION,STL (FNLV) $136.00 $133.00 82656 PANCREATIC ELASTASE, STL (FPANC) $81.75 $127.58 86382 POLIOVIRUS ABY, NEUT (FPOLS) $180.52 $209.95 86682 SCHISTOSOMA ABY, IGG (FSCHS) $108.49 $94.34 86682 STRONGYLOIDES AB, IGG (STRNG) $70.60 $72.60 83520 TUMOR NECROSIS FTR (FFTUM) $155.38 $147.50 84579 VITAMIN K1(VITK1) $116.50 $107.90

86701/86702 HIV-1 and HIV-2 Aby Differentiation, Serum $195.80 $318.67

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Recommended Laboratory Tests for Tick-Borne Disease Season

Lyme Disease: Lyme Antibody Cascade (Panel: LYC): automatically reflexes the Lyme Disease Antibody Confirmation (Western Blot), if positive. Please note All Positive Lyme Antibody tests should be confirmed by Western Blot.

Rocky Mountain Spotted Fever: Spotted Fever Antibody Group (Panel: SPT) includes IgG and IgM antibodies.

Babesiosis: Babesia microti Antibody, IgG (Panel: BBM) is used for antibody detection. Alternatively, PCR testing is available which would detect the DNA of the parasite. A peripheral blood smear may also be used for pa detection. (Panel: BAB)

Ehrlichia and Anaplasmosis: Ehrlichia Antibodies (Panel: EH) includes IgG antibody testing for Ehr chaffeensis (HME) and Anaplasma phagocytophilum. PCR Testing for Anaplasma is useful in early disease (Panel: EHL). Buffy coat smears useful for acute disease. (Panel EHR)

Powassan Encephalitis: If Powassan is suspected, contact the MDH at 651-201-5414. The specimen to be sent to MDH directly.

For more information, contact HML Customer Service: 651-232-3500 www.healtheast.org/hml

HML provides a wide range of clinical and pathology laboratory service hours a day, seven days a week.

Consultant’s Corner

Spring cleaning in June?!! Yes, spring is almost over, but it seems like there are always more things to clean than we can complete in the spring season. I have a suggestion for this year’s cleanup. Now would be a great time to perform an inventory of all lab testing supplies, not just those in the lab, but ones in the exam rooms and supply closets. Check for expired supplies and get them thrown out!

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Lab personnel, this impacts you! So take a few minutes each day this week, list the exam rooms and supply store rooms, check them off the list as you get a chance to purge expired supplies. Check culturette swabs, saline tubes for wet prep collection, PAP collection vials, fecal occult blood collection cards or vials, and any other lab testing container or device that may be kept in a drawer or cabinet in the exam rooms. Discard any that are expired and restock with fresh supplies. Since many of these supplies have extremely long expiration dates this can lead to a mindset of “these never expire, we always use them up long before they expire.” But there are always one or two items that don’t get rotated, and bingo! You do not want the patient to go through the collection process then have the specimen rejected because it was collected in an expired container. When you are done, give the checklist to your lab consultant. This is an excellent example of a “pre-analytical” QA and they can write up a summary for your QA manual to satisfy annual QA requirements. At one of my consulting visits in May we were discussing fecal occult blood testing, and I suggested they make a quick check of the exam rooms for expired collection cards, and they found nearly a dozen in random rooms! It can happen! Watch for those expiration dates!

Education

Basic Phlebotomy Techniques: The First Step in Quality Patient Results Friday, June 24, 2016 8:00am – 12:00 Noon Woodwinds Health Campus, Auditorium A Friday, August 26, 2016 8:00am – 12:00 Noon Woodwinds Health Campus, Auditorium A Program Summary This seminar / skills training session is designed for health care professionals to provide a basic understanding of clinical laboratory sample requirements, NCCLS Standards regarding venous site selection, proper equipment, sampling methods, specimen handling and transport, and related patient care requirements. The target audience for this class is RN, LPN, CMA, MA, MLT, MT. For questions: Linda Wagener- 651-232-6925 or email ljwagener@healtheast.org or Karen Anderson-651-232-3190 or kkanderson@healtheast.org.