Dear Colleague,

As previously communicated, we recently changed chemistry and immunology analyzers. After doing so, it is common practice to re-evaluate reference ranges using acquired normal patient data. We have just completed a normal patient evaluation and have updated the reference ranges on the following chemistry analytes:

^*We have updated the normal fasting glucose reference range based on CDC recommendations.

As always, our goal is transparency and good communication in our interactions with you so together we can provide the best patient care possible. If you have any concerns or questions, please feel free to contact me at 214.237.1670.

Thank you,

Carrie Chenault, MD
Medical Director, ProPath

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Dear valued client,

Great news! To offer you and your patients a quicker turnaround time as well as quality results to which you have become accustomed, ProPath is now performing Alpha-Fetoprotein, Maternal Serum (AFP) Screening in-house. As you know, patient demographic information and especially an accurate estimated gestational age are essential to obtaining the best risk assessment analysis, therefore, we have put together this short guide to aid you in obtaining the required information.

ProPath’s AFP testing is validated for patients from

14 weeks - 24 weeks 6 days gestation.

For best results, please answer all ask at order entry (AOE) questions on your lab order form utilizing the outline below:

1. Gestation age (GA) as listed on sonogram: Answer: (Weeks.Days) (do not correct to current gestational age)

Answer: (Weeks.Days)

• First trimester sonogram is the most accurate measure of gestation age.
• Please provide the GA at SONOGRAM; not at time of collection unless same.
• Answer as N/A if no sonogram or if using LMP only to determine EDD.

2. Date of sonogram:

Answer: (MMDDYYYY)

• Answer as N/A if no sonogram or if using LMP only to determine EDD.

3. Date of LMP (last menstrual period):

Answer: (MMDDYYYY)

4. EDD (Estimated date of delivery):

Answer: (MMDDYYYY)

• If EDD determined by LMP; you may check your answer using the following link: http://www.medcalc.com/pregnancy.html

5. Maternal weight:

Answer: (lbs.ounces)

6. Insulin dependent:

Answer: (Y/N/U)

7. Number of gestations (fetuses):

Answer: (# fetus)

8. Race or ethnicity:

Answer: (Race/Ethnicity or NG [Not given])

9. Smoker:

Answer: (Y/N/U)

10. History of NTD:

Answer: (Y/N/U)

11. Initial sample/Repeat/Unknown:

Answer: (Initial/Repeat/Unknown)

If you have any questions, please contact Amy Doty, clinical specialist, at 214.490.2079.

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Please be aware of updated test code, test name, and collection device, M4 Viral Swab, required for SARS-CoV-2 (COVID-19), RT PCR testing. All updates/changes are in bold below.

Test Code/Test Name: SARS CoV-2/ SARS-CoV-2 (COVID-19), RT PCR

Specimen Container: M4 Viral Media and Swab

Collection requirements: Use swab from M4 Viral Swab packaging provided for any of these collection options: nasopharyngeal (collected by healthcare provider only); oropharyngeal (throat) (provider or self-collection); or nasal mid-turbinate collection (provider or self-collection)

**Please see back for detailed collection instructions for each option.

Once collection is complete, place tip of swab into viral transport media and snap off the applicator stick.

Transport Temperature: Critical Refrigerated

Specimen Stability: 72 hours refrigerated; 1 week frozen (-20 degrees)

Expected Turnaround Time: 4-7 days

Billing: Insurance or Uninsured patient (UNS form required)

CPT Code: 87635

M4 Viral Swab collection Kit

SARS-CoV-2 (COVID-19), RT PCR
Collection Instructions:

Nasopharyngeal: Tilt patient’s head back 70 degrees. Insert swab into nostril parallel to palate. (Swab should reach depth equal to distance from nostrils to outer opening of the ear.) Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it.

Nasal mid-turbinate: Tilt patient’s head back 70 degrees. While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril (until resistance is met at turbinates). Rotate the swab several times against nasal wall and repeat in other nostril using the same swab.

Oropharyngeal (throat): Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums.

Place tip of swab into viral transport media and snap off the applicator stick.

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Dear Colleague,

We would like to thank you for continuing to entrust your patients to ProPath. Our goal is excellence in all aspects of diagnostic testing and patient care. With that in mind, we are updating our chemistry and immunology analyzers. These changes will better position us to provide for growing patient test volumes with continued excellence in quality and turnaround time. These new instruments come with new reference ranges so be sure to check the reference ranges on your reports. I would also like to highlight other important changes:

1. The eGFR calculation for adults has been updated to the 2021 CKD-EPI creatinine equation.
2. The new PSA is traceable to the Stanford Reference Standard/WHO 96/670. Results from this new method may not correlate with previous results from the old method, which was traceable to the Hybritech Standard.
3. The anti-thyroglobulin antibody and anti-TPO antibody ranges and cutoff values have changed significantly, but the interpretations correlate well with the previous method.
4. Thyroxine binding capacity (T-uptake) was indirectly measured on the old instrument but will be directly measured on the new instrument and reported as thyroxine binding index which, in turn, is used to calculate the free thyroxine index (fT4I).
5. The total T3 units of measure have changed from ng/mL to ng/dL.

As always, our goal is transparency and good communication in our interactions with you so together we can provide the best patient care possible. If you have any concerns or questions, please feel free to contact me at 214.237.1670.

Thank you,

Carrie Chenault, MD
Medical Director, ProPath

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In an ongoing effort to provide you and our shared patients with the best possible lab results, please share this communication with your laboratory specimen collection and processing staff.

Please follow these guidelines when processing blood specimens:

1. Fill all blood tubes completely.
2. After collection, mix all blood tubes with gentle inversion 4-5 times.
3. Allow serum separator tubes (SST) to sit and clot for at least 30 minutes before placing in a centrifuge. Do not let serum tubes go unspun for more than 2 hours.
   i. Utilize a secondary aliquot container when indicated, such as from red top tube collection or frozen serum.
   ii. Record on any secondary aliquot container what has been aliquoted i.e serum, EDTA plasma, citrate plasma, etc. and 2 patient identifiers (full name, DOB)
4. For outside lockboxes
   a. Include 1-2 cold packs (green zipper pouch) during the hot summer months. Do not place any blood specimens directly on the cold packs.
   b. Place frozen specimens INSIDE blue zipper pouch with copy of the requisition.

For specimen collection requirements, stability, and turnaround time, please refer to the ProPath test menu at https://propath.com/for-healthcare-providers/test-menu/

Please contact your sales or service representative or Amy Doty, clinical specialist at 214-490-2789 with any questions.

We appreciate your assistance in yielding the best results for our patients.

Thank you.

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We would like to thank you for continuing to entrust your patients to ProPath. Our goal is excellence in all aspects of diagnostic testing and patient care. With that in mind, we are notifying you that effective May 15, 2023, we have updated our hematology instrumentation and established new reference ranges for Complete Blood Count with and without Differential (CBC) and Reticulocyte (Retic) Count.

CBC with or without differential

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Date: 05/19/2023

To: ProPath Client

From: Compliance Department

Re: 2023 Annual Notice to Physicians

ProPath is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. ProPath is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements:

CMS Medical Necessity Policy

Medicare will only pay for tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, which does not meet the Medicare definition of medical necessity. All diagnosis and clinical relevance for patient treatment should be noted in the patient’s chart.

The OIG takes the position that an individual who knowingly causes a false claim to be submitted may be subject to sanctions or remedies available under civil, criminal and administrative law.

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.

CMS Signature Requirements

According to CMS’ guidance on laboratory services documentation requirements, unsigned requisitions alone do not support physician intent to order. Physicians should sign all orders for diagnostic services to avoid potential denials. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/LabServices-ICN909221-Text-Only.pdf

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs)

Coverage determination policies define medical conditions through the inclusion on a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD codes to be present on each claim filed. These codes must also be documented in the patient’s medical record.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.novitas-solutions.com/webcenter/portal/NovitasSolutions

Novitas Solutions Medicare Jurisdiction H

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests that are included in NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, diagnosis codes, coverage requirements, and frequency limitations. https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels

The AMA panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf Section 90.2 – Organ or Disease Oriented Panels

In the case of custom test panels, all individual tests must meet medical necessity guidelines.

Reflex Testing

Reflex testing occurs when initial test results indicate that a second related test is medically appropriate or required by state, regulatory, or accreditation standards. Most tests can be ordered without a reflex. Find details at https://www.sonichealthcareusa.com/ap/testing-solutions/test-menu/.

Advance Beneficiary Notice of Non-Coverage (ABN)

• Limited Coverage – An ABN is required if the diagnosis is not covered
• Frequency Limit - An ABN is required at each encounter for frequency limited tests
• Non-Coverage – An ABN is required for experimental or research use tests or tests designated by Medicare as non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html

Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections

Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN)

Medicare Clinical Laboratory Fee Schedule (CLFS)

Medicare reimbursement for laboratory CPT/HCPCS codes is located at.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files

Additional details can be found at PAMA regulations. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html

Medicaid reimbursement amount will be equal to, or less than, the amount of Medicare reimbursement.

Medicare Part B National Correct Coding Initiative (NCCI) Edits

The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment. https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html

Contact Information

The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call 214.638.2000 for assistance. You may also contact our Compliance Department at APCompliance@sonichealthcareusa.com.

Please review this notice with all appropriate staff.

Thank you for supporting ProPath.

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