The algorithm that reflexes HPV testing off the PAP Test (LAB1230097) when the “HPV Reflex” option is selected during PAP ordering will no longer include pregnancy status as a criterion for reflexing on LSIL patients. Prior to this update, if HPV Reflex was selected, a PAP Diagnosis of LSIL on patients 25 and older would only reflex HPV testing if the patient was non-pregnant. Starting 11/6/2024, if HPV Reflex was selected, a PAP Diagnosis of LSIL on patients 25 and older will reflex HPV testing regardless of pregnancy status. This update aligns with current ASCCP Risk-Based Management Consensus guidelines.
Laboratory Services
With the August changes to STI testing Corewell Health Reference Laboratory West has seen an influx of incorrect orders. As a reminder, not all STI testing can be performed off of a Thin Prep® specimen. The STI Panel includes four different tests: Gonorrhea PCR, Chlamydia PCR, Trichomonas PCR and Mycoplasma Geniltalium PCR (Mgen). Unlike the other testing, Mgen cannot be added on to the Thin Prep® container.
If an STI Panel is ordered and the only specimen that is collected is a Thin Prep®, laboratory staff will independently cancel the STI panel and reorder the three tests that are able to be completed off of the specimen that is submitted. If an Mgen test is still needed, please submit a separate urine or swabbed collection using the Alinity -M collection kit.
The following information was updated in the Lab Catalog.
All changes are for Corewell Health West Laboratories. For East and South locations, please visit: corewellhealth.org/labcatalog
Lipid & Vitamin D policy for Medicare patients
Traditional Medicare insured patients who have a Lipid Panel or Vitamin D 25 ordered more than once per 12 months are not covered due to medical necessity.*
If testing is indicated, you will need to provide an appropriately executed Advance Beneficiary Notice (ABN) for Corewell Health Southeast Laboratories and Advance Beneficiary Notice for Corewell Health Southwest and West Laboratories signed by the patient indicating they would like testing and understand they may be financially responsible for payment (ABN: Option 1). ABN must be submitted with specimen.
For testing ordered inside this frequency range without an ABN, Corewell Health will implement an automatic cancellation.
Effective Monday, September 16, 2024 all Corewell Health ambulatory offices will see an increase in Frequency Advance Beneficiary Notices (ABN) when ordering Lipids. This ensures compliance with Medicare requirements. ABNs serve as an indication to ordering physicians and APPs that the order has a stipulation for coverage and that Medicare may not reimburse for services; the patient will need to acknowledge potential financial responsibility. Having this completed ABN on file allows Corewell Health to provide and bill for services.
Specific to lipid frequency ABNs:
• Screening: Medicare covers testing once every 5 years. Per CMS, lipid testing in asymptomatic individuals is considered screening regardless of the presence of other risk factors such as family history, tobacco use, etc.
• Monitoring: Medicare covers testing once annually for monitoring the lifestyle and/or pharmaceutical treatment of lipid disorders. If more frequent testing is medically necessary after initiation of therapy, Medicare will cover up to six total cholesterol or LDL labs in the first year of therapy.
Lab will collect any ABNs needed if not collected prior to patient collection at our Patient Service Centers. If collection occurs in the office, be sure to follow the process: Ambulatory Clinical – Completing the Advance Beneficiary Notice (ABN) from the Epic Education Team SharePoint page. Any Medicare patient specimen submitted for lipid panel testing without an ABN will NOT be tested by the laboratory.
For more information on the CMS requirements for lipid testing, please review the NCD – Lipid Testing (190.23) (cms.gov)
The following information was updated in the Lab Catalog.
All changes are for Corewell Health West Laboratories. For East and South locations, please visit: corewellhealth.org/labcatalog
An equipment issue resulted in artificially high parathyroid hormone results for some patients from July 31- August 17, 2024. We have repeated testing on the potentially affected samples, corrections were made as necessary, and providers for the impacted patients have been notified.
Review of quality indicator data suggested that issue affecting the results began July 31. Not all patient values were affected, but those that were had artificially high values. The laboratory repeated all PTH testing from this instrument for which remaining sample was available, corrected results, and contacted providers via epic inbox message for CHW providers and other appropriate means for CHW affiliates and external providers whose lab work is performed at CHW in Grand Rapids. Providers of potentially impacted patients whose samples could not be repeated have also been notified.
Beginning August 26, 2024, Corewell Health Laboratories (West and South) will begin updating instrumentation for STI and HPV testing. Aptima collection devices will no longer be available except for pediatric patients under 14 years old.
To order the new swabs:
- Corewell Health and CHMG, please order via Workday ITM-1190747 as you run out of Aptima devices until the cutover date. (August 26th for West, late September for South)
- Independent Offices or other non-Corewell Health Sites, please use the Supply Form and continue to order STD multi-collection kit or ThinPrep Pap Container.
Please use for pediatric patients or discard any unused APTIMA kits. Please review the link below for images:
Supply Change Alinity Aptima
New Test: HPV High Risk Screen with HPV Genotype Reflex
Effective August 26, 2024, Corewell Health Laboratories West will be updating their High-Risk HPV testing. The new assay will be performed on the Abbott Alinity m at Corewell Health Reference Laboratory West, Grand Rapids. Testing will now automatically include HPV Genotype results whenever HPV is detected. There will no longer be a separate charge to the patient for HPV Genotype testing.
There will also be an expanded number of High-Risk HPV Genotypes reported:
- HPV Genotype 16
- HPV Genotype 18
- HPV Genotype 45
- HPV Genotype 31/33/52/58
- HPV Genotype 35/39/51/56/59/66/68
The new assay is FDA approved for Primary screening in addition to co-testing.
Post hysterectomy vaginal specimens will still be a send out test (LAB1230722).