05/04/2023
|
R28
|
Under CMS National Coverage Policy deleted regulation Pub 100-08 PIM, Ch. 13, Sec 13.1.3, Program Integrity Manual, and added CMS Internet-Only Manual, Pub. 100-8, Medicare Program Integrity Manual, Chapter 13, §13.5.4 Reasonable and Necessary Provisions in LCDs. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout the LCD.
|
- Provider Education/Guidance
|
12/12/2019
|
R27
|
This LCD is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual. There has been no change in coverage with this LCD revision. Under CMS National Coverage Policy added regulation 45 CFR §162.1002 (a)(5). Under Coverage Indications, Limitations and/or Medical Necessity changed the third bullet to read, “defines the payment rules applied to covered tests that are not reported with specific codes from a code set recognized in 45 CFR §162.1002 (a)(5), and termed “HIPAA compliant code sets” throughout the remainder of this LCD”. Under Applicable Tests/Assays subheading changed verbiage under the third bullet to read, “All tests/assays billed with more than one code from a HIPAA compliant code set to identify the service, including combinations of method-based, serology-based, and anatomic pathology codes”. Under Unique Test Identifier Requirement subheading changed verbiage in the first two sentences to read, “Because the available language in the current HIPAA compliant code sets used to describe the pathology and laboratory categories and the tests included in those categories are not specific to the actual test results provided, all MDT services must include an identifier as additional claim documentation. Test providers must receive an identifier specific to the applicable test and submit the test assigned identifier with the claim for reimbursement” and deleted the verbiage, “Laboratory providers who bill MDT services must register test services on the DEX Diagnostics Exchange”. Under Covered Tests subheading deleted the verbiage, “To obtain a unique identifier for a test and, to submit information for a technical assessment go to DEX Diagnostics Exchange https://app.dexzcodes.com/login”.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
|
- Provider Education/Guidance
|
10/24/2019
|
R26
|
This LCD is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A56853 article.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
|
- Provider Education/Guidance
|
08/15/2019
|
R25
|
All coding located in the Coding Information section has been moved into the related Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A56853 article and removed from the LCD.
Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted where appropriate throughout the LCD.
At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
|
- Provider Education/Guidance
|
01/01/2019
|
R24
|
Either the short and/or long code description was changed for the following codes: 0008U descriptor was changed in Group 1, 0011M descriptor was changed in Group 1. This change is due to the CPT/HCPCS 2019 Q1 update and is effective 1/1/2019.
|
- Revisions Due To CPT/HCPCS Code Changes
|
01/01/2019
|
R23
|
CPT descriptions updated
|
- Revisions Due To CPT/HCPCS Code Changes
|
01/01/2019
|
R22
|
2019 CPT/HCPCS Annual Updates.
Under CPT/HCPCS Codes Group1: The following CPT/HCPCS codes were added to these code ranges: 81163, 81164, 81165, 81166, 81167, 81171, 81172, 81173, 81174,81177, 81178, 81179, 81180, 81181, 81182, 81183, 81184, 81185, 81186, 81187, 81188, 81189, 81190, 81204, 81233, 81234, 81236, 81237, 81239, 81271, 81274, 81284, 81285, 81286, 81289, 81305, 81306, 81312, 81320, 81329, 81333, 81336, 81337, 81343, 81344, 81345, 81443, 81518, 81596
Either the short and/or long code description was changed for the following code(s). Please Note: Depending on which descriptor was used, there may not be any changes to the code display in this document: 0006U, 0012M, 0031U, 0032U, 81109, 81162, 81212, 81215, 81216, 81217, 81244, 81287, 81327, 81334.
The following CPT/HCPCS codes were deleted from Group1: 0001M, 81211, 81213, 81214
We removed bill type 032X, which was selected in error.
|
- Revisions Due To CPT/HCPCS Code Changes
|
10/01/2018
|
R21
|
2018 4th quarter CPT/HCPCS Updates: Either the short and/or long code description was changed for the following code(s): 0001M descriptor was changed in Group 1. The following CPT/HCPCS codes were deleted: 0020U was deleted from Group 1, 0028U was deleted from Group 1. These revisions are effective 10/01/2018.
|
- Revisions Due To CPT/HCPCS Code Changes
|
07/26/2018
|
R20
|
Either the short and/or long code description was changed for the following code(s). Please Note: Depending on which descriptor was used, there may not be any changes to the code display in this document: 0006U descriptor was changed in Group 1. This change was due to the 03Q18 Quarterly CPT/HCPCS Code Update.
|
- Revisions Due To CPT/HCPCS Code Changes
|
06/21/2018
|
R19
|
Made revisions to the CPT/HCPCS Codes section. Removed: 88399, 89398, 87999, 88199, 88299 from the LCD. Added: 0001U, 0002U, 0003U, 0005U, 0006U, 0007U, 0008U, 0009U, 0010U, 0011U, 0012U, 0013U, 0014U, 0016U, 0017U, 0018U, 0019U, 0020U, 0021U, 0022U, 0023U, 0024U, 0025U, 0026U, 0027U, 0028U, 0029U, 0030U, 0031U, 0032U, 0033U, 0034U, 0035U, 0036U, 0037U, 0038U, 0039U, 0040U, 0041U, 0042U, 0043U, 0044U, 0011M, 0012M, 0013M, 81105-81112, 81120-81121, 86152-86153, 88120-88121
|
- Revisions Due To CPT/HCPCS Code Changes
|
04/05/2018
|
R18
|
The following CPT/HCPCS codes were deleted: 0008M was deleted from Group 1. This deletion was effective 1/25/2018 as part of the 2018 Q1 Update. The DEX web address was updated to: https://app.dexzcodes.com/login. Removed G0452, 88380, 88381 from CPT/HCPCS Group 1 because they do not require Z-Codes. The removal of CPT/HCPCS codes G0452, 88380, 88381 is effective 1/1/2018.
|
- Revisions Due To CPT/HCPCS Code Changes
|
02/26/2018
|
R17
|
The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
|
- Change in Affiliated Contract Numbers
|
01/29/2018
|
R16
|
The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
|
- Change in Affiliated Contract Numbers
|
01/01/2018
|
R15
|
2018 Annual CPT/HCPCS Updates: Description was changed for the following CPT/HCPCS codes, effective 1/1/2018:
81257 descriptor was changed in Group 1 81405 descriptor was changed in Group 1 81432 descriptor was changed in Group 1 81439 descriptor was changed in Group 1 81519 descriptor was changed in Group 1
|
- Revisions Due To CPT/HCPCS Code Changes
|
10/02/2017
|
R14
|
2017 4th quarter CPT/HCPCS Updates: Description was changed for the following CPT/HCPCS codes: 81405 descriptor was changed in Group 1, effective 10/2/2017.
Added Part A contractor numbers.
Replaced McKesson Diagnostics ExchangeTM with DEXTM Diagnostics Exchange and corrected a typo the web address.
|
- Revisions Due To CPT/HCPCS Code Changes
|
04/20/2017
|
R13
|
Annual review, no changes.
DATE (08/21/2017): At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
|
- Other (Annual review, no changes.)
|
01/01/2017
|
R12
|
2017 CPT Code Changes: The following CPT/HCPCS codes were added to these code ranges: 81327 was added to code range 81161 - 81599 in Group 1 81413 was added to code range 81161 - 81599 in Group 1 81414 was added to code range 81161 - 81599 in Group 1 81422 was added to code range 81161 - 81599 in Group 1 81439 was added to code range 81161 - 81599 in Group 1 81539 was added to code range 81161 - 81599 in Group 1
Description was changed for the following CPT/HCPCS codes: 81402 descriptor was changed in Group 1 81407 descriptor was changed in Group 1
CPT/HCPCS codes were deleted: 0010M was deleted from Group 1 81280 was deleted from Group 1 81281 was deleted from Group 1 81282 was deleted from Group 1
|
- Revisions Due To CPT/HCPCS Code Changes
|
06/20/2016
|
R11
|
Typographical error. Under Coverage Guidance Coverage Indications, Limitations and/or Medical Necessity section moved "Technology Assessments (TA) down and removed the following last sentence "Prior to completion of this TA and published coverage determination."
|
|
04/21/2016
|
R10
|
Annual validation completed. Replaced Palmetto GBA reference with MolDX, Under "Unique Test Identifier Requirement" - removed instruction to register services via Z-Code Identifier Application and Palmetto GBA Test Identifier (PTI) Application. Under "Payment Rules" - removed suspension of claims that omit Z-Code IDs. Under "Covered Tests" - updated the point of contact for McKesson and MolDX.
|
- Other (Annual validation completed. Replaced Palmetto GBA reference with MolDX, Under "Unique Test Identifier Requirement" - removed instruction to register services via Z-Code Identifier Application and Palmetto GBA Test Identifier (PTI) Application. Under "Payment Rules" - removed suspension of claims that omit Z-Code IDs. Under "Covered Tests" - updated the point of contact for McKesson and MolDX.)
|
01/01/2016
|
R9
|
2016 CPT code update
|
- Revisions Due To CPT/HCPCS Code Changes
|
10/01/2015
|
R8
|
addition of MolDX to LCD title
|
- Other (per request of MAC's using MolDX service)
|
10/01/2015
|
R7
|
Completed Annual Validation - 4/15/15
|
- Other (Annual Validation)
|
10/01/2015
|
R6
|
To expand and include the MAAA codes.
|
- Revisions Due To CPT/HCPCS Code Changes
|
10/01/2015
|
R5
|
Added new CPT codes:
81500-81599 0001M 0002M 0003M 0004M
|
|
10/01/2015
|
R4
|
Added the following codes due to CR 8975:
81410 81471 81246 81288 61313 0006M 0007M 0008M 81519
For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 81245 descriptor was changed in Group 1 81402 descriptor was changed in Group 1 81405 descriptor was changed in Group 1
|
- Revisions Due To CPT/HCPCS Code Changes
|
10/01/2015
|
R3
|
Added 81161 to HCPCS code list. Removed it from the paragraph section since is has been released in the annual CPT update.
|
- Revisions Due To CPT/HCPCS Code Changes
|
10/01/2015
|
R2
|
Updated policy to remove covered tests table and direct readers to the MolDX program Web site for covered and excluded tests' billing and coding guidelines.
For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document: 81405 descriptor was changed in Group 1
|
- Revisions Due To CPT/HCPCS Code Changes
|
10/01/2015
|
R1
|
On the Covered Tests table, AlloMap (ZB863) CPT code was changed to 81479. ZB798 test developer name was changed to Response Genetics and title changed to ResponseDX: Tissue of Origin. ThxID™ BRAF V600E/K Test by bioMerieux, Inc. (ZBO64) was added as a covered test.
|
- Revisions Due To CPT/HCPCS Code Changes
|