Billing News Jul 2019



Frequently Asked Questions: Technical Assessments for Next Generation Sequencing (NGS) Tests

  • July 8, 2019

Updated 6/27/2019 Question: Do we need to submit a TA for each single gene assay or sub-panel that is done as part of a larger hotspot panel, but with masking of the other genes? Answer: The TA must show that the test for which a claim is being submitted was validated. If the test was validated as part of the validation of a larger...

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AMP and CAP Comment on Palmetto Proposed Guidelines for NGS Testing of Myeloid Disorders

  • July 8, 2019

The Association for Molecular Pathology and College of American Pathologists released a letter commenting on Medicare administrative contractor Palmetto GBA's proposed coverage policy for MOLDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies. The organizations provided a list of genes...

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PIK3CA Gene Tests Coding and Billing Guidelines A53558 A/B MAC Article was Revised

  • July 8, 2019

PIK3CA was previously not covered. The FDA approved a new drug for breast cancer that requires PIK3CA testing. This change is effective 5/24/19.

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HLA-B 15:02 Genetic Testing LCD - R1 – L36145

  • July 8, 2019

Effective: February 26, 2018 Summary of Changes: Added ICD-10-CM code B20, Human immunodeficiency virus [HIV] disease.

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FDA Issues Draft Recommendations for Biotin Interference Testing

  • July 8, 2019

The US Food and Drug Administration has issued draft guidance that provides recommendations on testing for biotin interference with in vitro diagnostic devices. Today's draft guidance, building on a safety communication that the agency issued in 2017, provides additional recommendations to IVD manufacturers about testing for biotin...

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Pathology Group Sets Expectations for DTC Genetic Tests

  • July 8, 2019

The Association for Molecular Pathology released an updated position statement with an expanded set of standards the group said should be met by providers of genetic tests marketed directly to consumers. Health-related claims must have well-established clinical validity, test providers must comply with CMS' Clinical Laboratory Improvement...

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No Surprise, Congress Focuses on Surprise Billing and Network Matching, Benchmarking Remain Major Sticking Points to Surprise Billing Solutions

  • July 8, 2019

Employee Benefits & Executive Compensation and Health Care Legislative & Public Policy groups compare three bills Congress may consider to solve the problem, all with their own solutions. Criticism from all sides of the political spectrum The White House takes a position Legislative action in Congress As political pressure to...

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Re-implementation of the AMCC Lab Panel Claims Payment System Logic

  • July 8, 2019

Implementation Date: October 7, 2019, Effective date January 1, 2019 This prior logic of using ATPs and rolling up payment amounts to not exceed the panel rate, no longer exists under PAMA guidelines. HCPCS codes include those from the AMA CPT Manual, that are in the category of Organ or Disease Oriented panels, which are panels that consist of...

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