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January 2020 Local Coverage Determination (LCD)/Coverage Article Updates

Last updated Dec 23 2019
Jurisdictions:

WPS GHA policy staff review and revise Local Coverage Determinations (LCDs) and Coverage Articles to ensure accuracy. When we create, retire, or revise LCDs and coverage articles, we summarize the changes and publish them on our website.

Please note: Our LCDs and coverage articles will reflect these changes on December 26, 2019.

New Policies/Articles

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
Billing and Coding: MolDX: HLA for Transplant Histocompatibility A57851 NA 12/26/2019
Billing and Coding: MolDX: MolDX: Testing of Multiple Genes A57880 NA 12/26/2019
Billing and Coding: MolDX: Next-Generation Sequencing for Solid Tumors A57858 NA 02/09/2020
Billing and Coding: MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies A57878 NA 02/09/2020
MolDX: Clarification on Primary Cancer Designation in Metastatic, Progressive, or Recurrent Disease for Molecular Diagnostic Testing A57852 NA 12/26/2019
MolDX: Next-Generation Sequencing for Solid Tumors L38158 MolDX-061 02/09/2020
MolDX: Next-Generation Sequencing Lab Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies L38176 MolDX-060 02/09/2020

 

Retired Policies/Articles – We retired no Policies/Articles for January 2020

Revised Policies/Articles

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
2020 CPT/HCPCS Code Updates PDF Icon NA NA 01/01/2020
Billing and Coding: Botulinum Toxin Type A & Type B A57474 NA 12/26/2019
The following sentence was removed from Coding Guidelines: “It is acceptable for the provider to bill for the discarded drug on the last patient of the day when more than one patient is treated with one single use vial of Botulinum toxin.” 
Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) A56795 NA 01/01/2020

CR 11244: Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS). Effective 01/01/2020.

CPT/HCPCS Modifiers removed:

ED HEMATOCRIT LEVEL HAS EXCEEDED 39% (OR HEMOGLOBIN LEVEL HAS EXCEEDED 13.0 G/DL) FOR 3 OR MORE CONSECUTIVE BILLING CYCLES IMMEDIATELY PRIOR TO AND INCLUDING THE CURRENT CYCLE

EE HEMATOCRIT LEVEL HAS NOT EXCEEDED 39% (OR HEMOGLOBIN LEVEL HAS NOT EXCEEDED 13.0 G/DL) FOR 3 OR MORE CONSECUTIVE BILLING CYCLES IMMEDIATELY PRIOR TO AND INCLUDING THE CURRENT CYCLE

GS DOSAGE OF ERYTHROPOIETIN STIMULATING AGENT HAS BEEN REDUCED AND MAINTAINED IN RESPONSE TO HEMATOCRIT OR HEMOGLOBIN LEVEL

CPT/HCPCS annual update: Description change noted:
Q5105 Injection, epoetin alfa-epbx, biosimilar (retacrit) (for ESRD on dialysis) 100 units
Q5106 Injection, epoetin alfa-epbx, biosimilar (retacrit) (for non-ESRD use) 1000 units

Group 8 Paragraph: Anemia of chronic disease
Dual Diagnosis Necessary for J0881 or J0885
Added Q5106.

Removed the following information from the Article:
CMS Pub 100-04 Medicare Claim Processing Manual, Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.1 – ESA Claims Monitoring Policy (Rev. 2582, Issued:
11-02-12, Effective: 04-01-13, Implementation: 04-01-13) from CMS National Coverage Policy and referenced content from Article Text.

Added Utilization Guidelines to the Article text:

Utilization Guidelines
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 -Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1 – ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Epogen® is reduced to 400,000 units from 500,000.
Maximum Allowable Administrations The maximum number of administrations of EPO for a billing cycle is 13 times in 30 days and 14 times in 31 days.

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 - Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1- ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Aranesp® is reduced to 1200 mcg from 1500 mcg.
Darbepoetin alfa is given not more than once per week according to its Food and Drug Administration approved labeling. Maximum Allowable Administrations The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30 / 31 days.

Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) A56795 NA 02/09/2020

Content updated related to reconsideration request.

ICD-10 Codes that Support Medical Necessity:
Added Group 11 Paragraph: Myelofibrosis for J0881, J0885 and Q5106, and Group 11 Codes
C94.40  Acute panmyelosis with myelofibrosis not having achieved remission
C94.41  Acute panmyelosis with myelofibrosis, in remission
C94.42  Acute panmyelosis with myelofibrosis, in relapse
D47.1   Chronic myeloproliferative disease
D47.4   Osteomyelofibrosis and D75.81 Myelofibrosis .

ICD-10 Codes that DO NOT Support Medical Necessity:
Added Group 1 Paragraph: Myelofibrosis for J0881 or J0885 and Q5106 and Group 1 Codes:
D61.82 Myelophthisis.

Please see content of LCD updated related to reconsideration request/effective 02/09/2020: Coverage Indications, Limitations, and/or Medical Necessity: Added to Group C: Indications other than Renal Disease, 8. Myelofibrosis. Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.

Billing and Coding: Lab: Bladder/Urothelial Tumor Markers A56332 NA 12/26/2019

The title of this article has changed from “MolDX: Bladder Tumor Marker FISH Billing and Coding Guidelines Update” to “Billing and Coding: Lab: Bladder/Urothelial Tumor Markers”. Under Article Text added billing information.

Added TC modifier to the modifier table.

TC TECHNICAL COMPONENT

The following codes were added to CPT/HCPCS Group 1 codes:

86294 IMMUNOASSAY FOR TUMOR ANTIGEN, QUALITATIVE OR SEMIQUANTITATIVE (EG, BLADDER TUMOR ANTIGEN)
86316 IMMUNOASSAY FOR TUMOR ANTIGEN, OTHER ANTIGEN, QUANTITATIVE (EG, CA 50, 72-4, 549), EACH
86386 NUCLEAR MATRIX PROTEIN 22 (NMP22), QUALITATIVE

The following codes were added to ICD-10 Codes that Support Medical Necessity Group 1:

C67.0-C67.9 Malignant neoplasm of trigone of bladder- Malignant neoplasm of bladder, unspecified
C7A.00 Malignant carcinoid tumor of unspecified site
C7A.010-C7A.012 Malignant carcinoid tumor of the duodenum- Malignant carcinoid tumor of the ileum
C7A.019-C7A.026 Malignant carcinoid tumor of the small intestine- Malignant carcinoid tumor of the appendix, large intestine, and rectum
C7A.029 Malignant carcinoid tumor of the large intestine, unspecified portion
C7A.090-C7A.096 Malignant carcinoid tumor of the bronchus and lung- Malignant carcinoid tumor of the hindgut, unspecified
C7A.098 Malignant carcinoid tumors of other sites
C7A.8 Other malignant neuroendocrine tumors
C7B.00-C7B.04 Secondary carcinoid tumors, unspecified site- Secondary carcinoid tumors of peritoneum
C7B.09 Secondary carcinoid tumors of other sites
C7B.8 Other secondary neuroendocrine tumors
C78.00 Secondary malignant neoplasm of unspecified lung
D09.0 Carcinoma in situ of bladder
D41.4 Neoplasm of uncertain behavior of bladder
D49.4 Neoplasm of unspecified behavior of bladder
E34.0 Carcinoid syndrome
R31.0 Gross hematuria
R31.1 Benign essential microscopic hematuria
R31.21* Asymptomatic microscopic hematuria
R31.29* Other microscopic hematuria
R31.9 Hematuria, unspecified
Z78.9*  Other specified health status
Z85.51 Personal history of malignant neoplasm of bladder

Under Group 1 table the following verbiage was added:
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: R31.2 (before October 1, 2016) and R31.21 or R31.29 (effective October 1, 2016) are to be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis. Z78.9 To be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis.

Billing and Coding: MolDX: clonoSEQ® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies A56277 NA 12/26/2019

Coverage for chronic lymphocytic leukemia has been added to this article.

The following updates were made to this article:
Clinical practice guidelines in a number of hematological malignancies recommend MRD testing and recognize MRD status as a reliable indicator of clinical outcome and response to therapy, which is currently recommended in the course of treatment of patients with acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL).1,2,3

The clonoSEQ® Assay has received State of New York Clinical Laboratory Evaluation Program (CLEP) approval for B-cell malignancies.

ICD-10 Codes that that Support Medical Necessity
Group 1 Paragraph:
Group 1 Codes
C91.10 Chronic lymphoblastic leukemia not having achieved remission
C91.11 Chronic lymphoblastic leukemia, in remission
C91.12 Chronic lymphoblastic leukemia, in relapse

References
4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology 
(NCCN Guidelines®). Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (Version 2.2020).
https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf PDF Icon. Accessed 11/13/2019

Billing and Coding: MolDX: Genetic Testing for Lynch Syndrome A55135 NA 12/26/2019

Due to Fourth Quarter CPT/HCPCS code updates; added 0130U & 0134U to Group 2 effective
10/01/2019:

CPT/HCPCS Codes
Group 2 Paragraph: NA
Group 2 Codes

0130U HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS), TARGETED MRNA SEQUENCE ANALYSIS PANEL (APC, CDH1, CHEK2, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, AND TP53) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0134U HEREDITARY PAN CANCER (EG, HEREDITARY BREAST AND OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER, HEREDITARY COLORECTAL CANCER), TARGETED MRNA SEQUENCE ANALYSIS PANEL (18 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

Added CPT 81436 and moved CPT 81301, 81403 & 81435 from CPT/HCPCS Group 1 to CPT/HCPCS Group 3:

CPT/HCPCS Codes
Group 3 Paragraph: CPT Codes that are also referenced in other articles
Group 3 Codes:

81301 MICROSATELLITE INSTABILITY ANALYSIS (EG, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER, LYNCH SYNDROME) OF MARKERS FOR MISMATCH REPAIR DEFICIENCY (EG, BAT25, BAT26), INCLUDES COMPARISON OF NEOPLASTIC AND NORMAL TISSUE, IF PERFORMED
81403 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 4 (EG, ANALYSIS OF SINGLE EXON BY DNA SEQUENCE ANALYSIS, ANALYSIS OF >10 AMPLICONS USING MULTIPLEX PCR IN 2 OR MORE INDEPENDENT REACTIONS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 2-5 EXONS)
81435 HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS); GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE SEQUENCING OF AT LEAST 10 GENES, INCLUDING APC, BMPR1A, CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4, AND STK11
81436 HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS); DUPLICATION/DELETION ANALYSIS PANEL, MUST INCLUDE ANALYSIS OF AT LEAST 5 GENES, INCLUDING MLH1, MSH2, EPCAM, SMAD4, AND STK11
Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57772 NA 01/01/2020

Multiple code changes were made to this article to be consistent with the MolDX Program Contractor’s Billing and Coding Article.

Added CPT codes 0084U-0103U due to 2nd quarter 2019 CPT/HCPCs code updates. They are effective 07/01/2019:

CPT/HCPCS Codes
Group 1 Paragraph: NA
Group 1 Codes

0084U Rbc dna gnotyp 10 bld groups
0087U-0092U Crd hrt trnspl mrna 1283 gen - Onc lng 3 prtn bmrk plsm alg
0094U Genome rapid sequence alys
0101U - 0103U Hered colon ca do 15 genes - Hered ova ca pnl 24 genes

These CPT codes were moved from Group 1 paragraph to Group 2:

Group 2 Paragraph: CPT codes that are also referenced in other articles
Group 2 Codes:

81401 Mopath procedure level 2
81403 Mopath procedure level 4
81406 Mopath procedure level 7
81407 Mopath procedure level 8
81412 Ashkenazi jewish assoc dis

The following code additions and deletions were made so the only CPT/HCPCs codes that apply to the MolDX Program are listed.

The following codes were added under CPT/HCPCS Codes Group 1: Codes added CPT® codes

87999 Microbiology procedure
0045U-0050U Onc brst dux carc is 12 gene - Trgt gen seq dna 194 genes
0053U-0060U Onc prst8 ca fish alys 4 gen - Twn zyg gen seq alys chrms2
0062U Ai sle igg&igm alys 80 bmrk
0067U Onc brst imhchem prfl 4 bmrk
0068U Candida species pnl amp prb
0070U-0076U Cyp2d6 gen com&slct rar vrnt - Cyp2d6 3' gene dup/mlt
0078U-0080U Pain mgt opi use gnotyp pnl - Onc lng 5 clin rsk factr alg
0083U Onc rspse chemo cntrst tomog
0105U Neph ckd mult eclia tum nec
0107U C diff tox ag detcj ia stool
0108U Gi barrett esoph 9 prtn bmrk
0111U Onc colon ca kras&nras alys
0113U Onc prst8 pca3&tmprss2-erg
0114U Gi barretts esoph vim&ccna1
0118U Trnsplj don-drv cll-fr dna
0120U Onc b cll lymphm mrna 58 gen
0129U-0132U Hered brst ca rltd do panel - Hered ova ca rltd do pnl 17
0134U-0138U Hered pan ca mrna pnl 18 gen - Brca1 brca2 mrna seq alys

The following codes were removed:
CPT® codes 81370-81383, 81596, 88120, 88121, 0002M, 0003M, 0002U, 0006U-0008U, 0010U, 0011U, 0025U, 0035U, 0038U, 0041U-0044U, 0086U, 0093U, 0095U-0100U

See CPT/HCPCs 2020 Code updates table.

Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels A57579 NA 12/26/2019


    Under Article Text added the third bullet point verbiage “For dates of service on or after 10/01/2019, laboratories billing for services using GenMark® ePlex Respiratory Pathogen (RP) Panel should report 0115U. While this panel is able to report results for a specific number of pathogens, this contractor will interpret the use of 0115U to represent the use of a specific testing platform regardless of the number of pathogens reported by the laboratory”. 

Under CPT/HCPCS Codes Group 1 Codes: added 0115U.

0115U RESPIRATORY INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA AND RNA), 18 VIRAL TYPES AND SUBTYPES AND 2 BACTERIAL TARGETS, AMPLIFIED PROBE TECHNIQUE, INCLUDING MULTIPLEX REVERSE TRANSCRIPTION FOR RNA TARGETS, EACH ANALYTE REPORTED AS DETECTED OR NOT DETECTED

Under ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: added the verbiage “and 0115U”. “These are the diagnosis codes corresponding to coverage of 87631, 0098U, 0099U, 0100U, and 0115U.”

This revision is retroactive effective for dates of service on or after 10/01/2019 (CR 11406).

Billing and Coding: Wound Care A55909 NA 02/09/2020

This article’s revision is related to the reconsideration process and medical literature submitted during the comment period 09/26/2019-11/10/2019. 

The following ICD-10 Codes have been added to Group One:
L89.012   Pressure ulcer of right elbow, stage 2
L89.022   Pressure ulcer of left elbow, stage 2
L89.112   Pressure ulcer of right upper back, stage 2
L89.122   Pressure ulcer of left upper back, stage 2
L89.132   Pressure ulcer of right lower back, stage 2
L89.142   Pressure ulcer of left lower back, stage 2
L89.152   Pressure ulcer of sacral region, stage 2
L89.212   Pressure ulcer of right hip, stage 2
L89.222   Pressure ulcer of left hip, stage 2
L89.312   Pressure ulcer of right buttock, stage 2
L89.322   Pressure ulcer of left buttock, stage 2
L89.42     Pressure ulcer of contiguous site of back, buttock and hip, stage 2
L89.512   Pressure ulcer of right ankle, stage 2
L89.522   Pressure ulcer of left ankle, stage 2
L89.612   Pressure ulcer of right heel, stage 2
L89.622   Pressure ulcer of left heel, stage 2
L89.812   Pressure ulcer of head, stage 2
L89.892   Pressure ulcer of other site, stage 2
L97.111   Non-pressure chronic ulcer of right thigh limited to breakdown of skin
L97.121   Non-pressure chronic ulcer of left thigh limited to breakdown of skin
L97.211   Non-pressure chronic ulcer of right calf limited to breakdown of skin
L97.221   Non-pressure chronic ulcer of left calf limited to breakdown of skin
L97.311   Non-pressure chronic ulcer of right calf limited to breakdown of skin
L97.321   Non-pressure chronic ulcer of left ankle limited to breakdown of skin
L97.411   Non-pressure chonic ulcer of right heel and midfoot limited to breakdown of skin
L97.421   Non-pressure chronic ulcer of unspecified part of left lower leg limited to breakdown of skin
L97.511   Non-pressure chronic ulcer of other part of right foot limited to breakdown of skin
L97.521   Non-pressure chronic ulcer of other part of left foot limited to breakdown of skin
L97.811   Non-pressure chronic ulcer of other part of right lower leg limited to skin breakdown
L97.821   Non-pressure chronic ulcer of other part of left lower leg limited to skin breakdown
L98.411   Non-pressure chronic ulcer of buttock limited to breakdown of skin
L98.421   Non-pressure chronic ulcer of back limited to breakdown of skin
L98.491   Non-pressure chronic ulcer of skin of other sites limited to breakdown of skin
L98.496   Non-pressure chronic ulcer of skin other sites with bone involvement without evidence of necrosis
L98.498   Non-pressure chronic ulcer of skin other sites with  other specified severity

The following ICD-10 codes have been removed from Group One due to more specific codes available: 
L97.912  Non-pressure chronic ulcer of unspecified part of right lower leg with fat layer exposed 
L97.913  Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of muscle 
L97.914  Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of bone 
L97.915  Non-pressure chronic ulcer of unspecified part of right lower leg with muscle involvement without evidence of necrosis 
L97.916  Non-pressure chronic ulcer of unspecified part of right lower leg with bone involvement without evidence of necrosis 
L97.918  Non-pressure chronic ulcer of unspecified part of right lower leg with other specified severity 
L97.922  Non-pressure chronic ulcer of unspecified part of left lower leg with fat layer exposed 
L97.923  Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of muscle 
L97.924  Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of bone 
L97.925  Non-pressure chronic ulcer of unspecified part of left lower leg with muscle involvement without evidence of necrosis 
L97.926  Non-pressure chronic ulcer of unspecified part of left lower leg with bone involvement without evidence of necrosis 
L97.928  Non-pressure chronic ulcer of unspecified part of left lower leg with other specified severity

Category III Codes L35490 PHYS-084 02/09/2020

Content updated related to reconsideration request for: 

CPT code 0254T: Endovascular repair of iliac artery bifurcation (e.g., aneurysm, pseudoaneurysm, arteriovenous malformation, trauma, dissection) using bifurcated endograft from the common iliac artery into both the external and internal iliac artery, including all selective and/or nonselective catheterization(s) required for device placement and all associated radiological supervision and interpretation, unilateral.

Analysis of Evidence CPT code 0254T:
The reconsideration request asserts, “the evidence supporting the use of the Gore® Excluder® IBE (with Gore® Excluder® AAA Endoprosthesis) is sufficiently robust to support that it is ‘reasonable and necessary’ under the Statute and the LCD.”  Wisconsin Physicians Service Government Health Administrators (WPS GHA) does not agree. The literature submitted for review is mostly retrospective studies with limitations well outlined by the respective authors. WPS GHA believes that the authors caution is warranted. Coverage is denied at this time.

CPT code 0355T: Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report.

Analysis of Evidence CPT code 0355T:
The reconsideration request asserts “ current published evidence and FDA approval support PillCam COLON 2 as a safe, effective and clinically meaningful diagnostic option in patients after an incomplete colonoscopy or for patients with evidence of a lower GI bleed with major risks for colonoscopy or moderate sedation.” Wisconsin Physicians Service Government Health Administrators (WPS GHA) does not agree. The literature submitted for review is mostly preliminary studies with an unjustified sample size with limitations well outlined by the respective authors. As well as the associated editorials. WPS GHA believes that the authors caution is warranted. Coverage is denied at this time.

Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.

Effective 01/01/2020 CPT/HCPCS Annual Update: deleted CPT 0254T. Providers are responsible for determining the correct diagnostic and procedural coding for the services they furnish to Medicare beneficiaries

Erythropoiesis Stimulating Agents (ESAs) L34633 INJ-023 02/09/2020

Content updated related to reconsideration request.

Coverage Indications, Limitations, and/or Medical Necessity: 
Added to Group C: Indications other than Renal Disease
8. Myelofibrosis. 

Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.  

Please refer to A56975 Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) 
Group 11 Paragraph Myelofibrosis
Group 11 Codes that support Medical Necessity and 
ICD-10 Codes that DO NOT Support Medical Necessity. 

Change Request References updated: added CR 11244 Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS)  Effective 01/01/2020.

MolDX: myPath Melanoma Assay L37923 MolDX-053 12/26/2019

Added 0090U due to 3rd Quarter CPT/HCPCS code updates; effective 07/01/2019. 

CPT/HCPCS Codes
Group 1 Paragraph: NA
Group 1 Codes

0009U ONCOLOGY (CUTANEOUS MELANOMA), MRNA GENE EXPRESSION PROFILING BY RT-PCR OF 23 GENES (14 CONTENT AND 9 HOUSEKEEPING), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS A CATEGORICAL RESULT (IE, BENIGN, INDETERMINATE, MALIGNANT)

All of the coding in the LCD has been moved to the associated Billing and Coding article.

Wound Care L37228 G-SURG-056 02/09/2020

Added the following to CMS National Coverage Policy:
CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.
Change Request 10901, Local Coverage Determinations (LCDs)
42 Code of Federal Regulations (CFR) § 410.20 - Physicians' services

Added the following to Coverage Guidance:
Active wound care procedures are performed to remove necrotic tissue and/or devitalized tissue to promote healing.  Providers are responsible to determine medical necessity and use the appropriate current CPT/HCPCS code for service provided. Please consult the current AMA CPT book for the complete code description of the procedures being performed to submit claims.

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for additional wound care. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for additional wound care sessions and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies are provided under CMS National Coverage Policy section.

Debridement section added: 

  • Pressure Injury
  • Stage II
  • Diabetic Foot Ulcer(s)

Should deep tissue pressure injury or Stage II injury progress to Unstageable, Stage III or Stage IV requiring debridement then documentation supporting this must be included in the medical record.

 Evaluation and Management Section has been revised and the following has been removed:  
The following services may be done during wound care services and can be medically necessary, but they are not considered wound debridement services and wound debridement CPT codes should not be used. 

  • Removal of necrotic tissue by cleansing, scraping (other than by a scalpel or a curette), chemical application, or dry-to-dry or wet-to dry dressing.  Generally, dressing changes are not considered a skilled service. The prior dressings are different and distinct from wet-to-moist dressings that are used for removal of devitalized tissue from wound(s) for non-selective debridement.
  • Washing bacterial or fungal debris from lesions.
  • Removal of secretions and coagulation serum from normal skin surrounding an ulcer.
  • Dressing of small or superficial lesions.
  • Removal of fibrinous material from the margin of an ulcer.
  • Paring or cutting of corns or non-plantar calluses. Skin breakdown under a dorsal corn that begins to heal when the corn is removed, and shoe pressure eliminated is not considered an ulcer that requires debridement unless there is extension into the subcutaneous tissue.
  • Incision and drainage of abscess including paronychia, trimming or debridement of mycotic nails, avulsion of nail plates, acne surgery, or destruction of warts. 
  • Removal of non-tissue integrated fibrin exudates, crusts, biofilms or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such.
  • While mechanical debridement is a valuable technique for healing ulcers, it does not qualify as a surgical wound debridement service, and therefore should not be coded as such. 
  • Scraping the base of the wound bed to induce bleeding, following the removal of devitalized tissue, is not considered to be a separately billable service.
  • Removing a collar of callus (hyperkeratotic tissue) around an ulcer is not debridement of skin or necrotic tissue and should not be billed as debridement unless additional partial full skin thickness tissue directly deep to the callus is removed as well.
  • Infrared, ultrasound thermal and phototherapy-ultraviolet modalities are not considered debridement services.

Negative Pressure Wound Therapy  has been revised and the following has been removed
For disposable NPWT (dNPWT) devices, this contractor recommends following manufacturer’s instructions but, generally be limited to a maximum of 4 applications per 30 days.  

NPWT services should not exceed a 120-day period. It is expected a licensed medical professional must directly assess the wound(s) being treated with NPWT and supervise or directly perform the NPWT dressing changes. It is expected there will be an evaluation with documentation of the wound’s dimensions and characteristics conducted every 30 days. 

NWPT coverage would end, and the pump and/or supplies will be denied as not reasonable and necessary with any of the following, whichever occurs earliest.

  1. In the judgment of the treating physician, adequate wound healing has occurred to the degree that NPWT may be discontinued, 
  2. Any measurable degree of wound healing has failed to occur over the prior month. Wound healing is defined as improvement occurring in either surface area (length times width) or depth of the wound.
  3. One hundred twenty (120) days (including the time NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using NPWT in the treatment of the most recent wound. 

Documentation Section revision completed
When wound care is provided by the Physical Therapist, for both in and out patient wound care, the medical record is required to have the following documentation: 

Physician order(s) for therapy /wound care services and signed plan of treatment (also known as a plan of care) detailing treatment modalities for therapy/wound care services must be established as soon as possible or within 30 days.

Every 10 days progress notes to include current wound status, measurements (including size and depth), and the treatment provided.

Utilization Guidelines has been revised and the following  two statements have been removed:
For disposable NPWT (dNPWT) devices, this contractor recommends following manufacturer’s instructions but, generally be limited to a maximum of 4 applications per 30 days.  

Negative Pressure Wound Therapy services should not exceed a 120-day period. There should be no more than 4 dressing changes per wound per month for the majority of wounds. With dNPWT, there should be a maximum of 4 new disposable NPWT per month. It is expected there will be an evaluation with documentation for a wound(s) every 30 days. 

Added Summary of Evidence, Analysis of Evidence, and Bibliography related to Comment Period (09/26/2019 – 11/10/2019)

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
2020 CPT/HCPCS Code Updates PDF Icon NA NA 01/01/2020
Billing and Coding: Botulinum Toxin Type A & Type B A57474 NA 12/26/2019
The following sentence was removed from Coding Guidelines: “It is acceptable for the provider to bill for the discarded drug on the last patient of the day when more than one patient is treated with one single use vial of Botulinum toxin.” 
Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) A56795 NA 01/01/2020

CR 11244: Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS). Effective 01/01/2020.

CPT/HCPCS Modifiers removed:

ED HEMATOCRIT LEVEL HAS EXCEEDED 39% (OR HEMOGLOBIN LEVEL HAS EXCEEDED 13.0 G/DL) FOR 3 OR MORE CONSECUTIVE BILLING CYCLES IMMEDIATELY PRIOR TO AND INCLUDING THE CURRENT CYCLE

EE HEMATOCRIT LEVEL HAS NOT EXCEEDED 39% (OR HEMOGLOBIN LEVEL HAS NOT EXCEEDED 13.0 G/DL) FOR 3 OR MORE CONSECUTIVE BILLING CYCLES IMMEDIATELY PRIOR TO AND INCLUDING THE CURRENT CYCLE

GS DOSAGE OF ERYTHROPOIETIN STIMULATING AGENT HAS BEEN REDUCED AND MAINTAINED IN RESPONSE TO HEMATOCRIT OR HEMOGLOBIN LEVEL

CPT/HCPCS annual update: Description change noted:
Q5105 Injection, epoetin alfa-epbx, biosimilar (retacrit) (for ESRD on dialysis) 100 units
Q5106 Injection, epoetin alfa-epbx, biosimilar (retacrit) (for non-ESRD use) 1000 units

Group 8 Paragraph: Anemia of chronic disease
Dual Diagnosis Necessary for J0881 or J0885
Added Q5106.

Removed the following information from the Article:
CMS Pub 100-04 Medicare Claim Processing Manual, Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.1 – ESA Claims Monitoring Policy (Rev. 2582, Issued:
11-02-12, Effective: 04-01-13, Implementation: 04-01-13) from CMS National Coverage Policy and referenced content from Article Text.

Added Utilization Guidelines to the Article text:

Utilization Guidelines
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 -Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1 – ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Epogen® is reduced to 400,000 units from 500,000.
Maximum Allowable Administrations The maximum number of administrations of EPO for a billing cycle is 13 times in 30 days and 14 times in 31 days.

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 - Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1- ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Aranesp® is reduced to 1200 mcg from 1500 mcg.
Darbepoetin alfa is given not more than once per week according to its Food and Drug Administration approved labeling. Maximum Allowable Administrations The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30 / 31 days.

Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) A56795 NA 02/09/2020

Content updated related to reconsideration request.

ICD-10 Codes that Support Medical Necessity:
Added Group 11 Paragraph: Myelofibrosis for J0881, J0885 and Q5106, and Group 11 Codes
C94.40  Acute panmyelosis with myelofibrosis not having achieved remission
C94.41  Acute panmyelosis with myelofibrosis, in remission
C94.42  Acute panmyelosis with myelofibrosis, in relapse
D47.1   Chronic myeloproliferative disease
D47.4   Osteomyelofibrosis and D75.81 Myelofibrosis .

ICD-10 Codes that DO NOT Support Medical Necessity:
Added Group 1 Paragraph: Myelofibrosis for J0881 or J0885 and Q5106 and Group 1 Codes:
D61.82 Myelophthisis.

Please see content of LCD updated related to reconsideration request/effective 02/09/2020: Coverage Indications, Limitations, and/or Medical Necessity: Added to Group C: Indications other than Renal Disease, 8. Myelofibrosis. Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.

Billing and Coding: Lab: Bladder/Urothelial Tumor Markers A56332 NA 12/26/2019

The title of this article has changed from “MolDX: Bladder Tumor Marker FISH Billing and Coding Guidelines Update” to “Billing and Coding: Lab: Bladder/Urothelial Tumor Markers”. Under Article Text added billing information.

Added TC modifier to the modifier table.

TC TECHNICAL COMPONENT

The following codes were added to CPT/HCPCS Group 1 codes:

86294 IMMUNOASSAY FOR TUMOR ANTIGEN, QUALITATIVE OR SEMIQUANTITATIVE (EG, BLADDER TUMOR ANTIGEN)
86316 IMMUNOASSAY FOR TUMOR ANTIGEN, OTHER ANTIGEN, QUANTITATIVE (EG, CA 50, 72-4, 549), EACH
86386 NUCLEAR MATRIX PROTEIN 22 (NMP22), QUALITATIVE

The following codes were added to ICD-10 Codes that Support Medical Necessity Group 1:

C67.0-C67.9 Malignant neoplasm of trigone of bladder- Malignant neoplasm of bladder, unspecified
C7A.00 Malignant carcinoid tumor of unspecified site
C7A.010-C7A.012 Malignant carcinoid tumor of the duodenum- Malignant carcinoid tumor of the ileum
C7A.019-C7A.026 Malignant carcinoid tumor of the small intestine- Malignant carcinoid tumor of the appendix, large intestine, and rectum
C7A.029 Malignant carcinoid tumor of the large intestine, unspecified portion
C7A.090-C7A.096 Malignant carcinoid tumor of the bronchus and lung- Malignant carcinoid tumor of the hindgut, unspecified
C7A.098 Malignant carcinoid tumors of other sites
C7A.8 Other malignant neuroendocrine tumors
C7B.00-C7B.04 Secondary carcinoid tumors, unspecified site- Secondary carcinoid tumors of peritoneum
C7B.09 Secondary carcinoid tumors of other sites
C7B.8 Other secondary neuroendocrine tumors
C78.00 Secondary malignant neoplasm of unspecified lung
D09.0 Carcinoma in situ of bladder
D41.4 Neoplasm of uncertain behavior of bladder
D49.4 Neoplasm of unspecified behavior of bladder
E34.0 Carcinoid syndrome
R31.0 Gross hematuria
R31.1 Benign essential microscopic hematuria
R31.21* Asymptomatic microscopic hematuria
R31.29* Other microscopic hematuria
R31.9 Hematuria, unspecified
Z78.9*  Other specified health status
Z85.51 Personal history of malignant neoplasm of bladder

Under Group 1 table the following verbiage was added:
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: R31.2 (before October 1, 2016) and R31.21 or R31.29 (effective October 1, 2016) are to be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis. Z78.9 To be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis.

Billing and Coding: MolDX: clonoSEQ® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies A56277 NA 12/26/2019

Coverage for chronic lymphocytic leukemia has been added to this article.

The following updates were made to this article:
Clinical practice guidelines in a number of hematological malignancies recommend MRD testing and recognize MRD status as a reliable indicator of clinical outcome and response to therapy, which is currently recommended in the course of treatment of patients with acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL).1,2,3

The clonoSEQ® Assay has received State of New York Clinical Laboratory Evaluation Program (CLEP) approval for B-cell malignancies.

ICD-10 Codes that that Support Medical Necessity
Group 1 Paragraph:
Group 1 Codes
C91.10 Chronic lymphoblastic leukemia not having achieved remission
C91.11 Chronic lymphoblastic leukemia, in remission
C91.12 Chronic lymphoblastic leukemia, in relapse

References
4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology 
(NCCN Guidelines®). Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (Version 2.2020).
https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf PDF Icon. Accessed 11/13/2019

Billing and Coding: MolDX: Genetic Testing for Lynch Syndrome A55135 NA 12/26/2019

Due to Fourth Quarter CPT/HCPCS code updates; added 0130U & 0134U to Group 2 effective
10/01/2019:

CPT/HCPCS Codes
Group 2 Paragraph: NA
Group 2 Codes

0130U HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS), TARGETED MRNA SEQUENCE ANALYSIS PANEL (APC, CDH1, CHEK2, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, AND TP53) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0134U HEREDITARY PAN CANCER (EG, HEREDITARY BREAST AND OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER, HEREDITARY COLORECTAL CANCER), TARGETED MRNA SEQUENCE ANALYSIS PANEL (18 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

Added CPT 81436 and moved CPT 81301, 81403 & 81435 from CPT/HCPCS Group 1 to CPT/HCPCS Group 3:

CPT/HCPCS Codes
Group 3 Paragraph: CPT Codes that are also referenced in other articles
Group 3 Codes:

81301 MICROSATELLITE INSTABILITY ANALYSIS (EG, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER, LYNCH SYNDROME) OF MARKERS FOR MISMATCH REPAIR DEFICIENCY (EG, BAT25, BAT26), INCLUDES COMPARISON OF NEOPLASTIC AND NORMAL TISSUE, IF PERFORMED
81403 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 4 (EG, ANALYSIS OF SINGLE EXON BY DNA SEQUENCE ANALYSIS, ANALYSIS OF >10 AMPLICONS USING MULTIPLEX PCR IN 2 OR MORE INDEPENDENT REACTIONS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 2-5 EXONS)
81435 HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS); GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE SEQUENCING OF AT LEAST 10 GENES, INCLUDING APC, BMPR1A, CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4, AND STK11
81436 HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS); DUPLICATION/DELETION ANALYSIS PANEL, MUST INCLUDE ANALYSIS OF AT LEAST 5 GENES, INCLUDING MLH1, MSH2, EPCAM, SMAD4, AND STK11
Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57772 NA 01/01/2020

Multiple code changes were made to this article to be consistent with the MolDX Program Contractor’s Billing and Coding Article.

Added CPT codes 0084U-0103U due to 2nd quarter 2019 CPT/HCPCs code updates. They are effective 07/01/2019:

CPT/HCPCS Codes
Group 1 Paragraph: NA
Group 1 Codes

0084U Rbc dna gnotyp 10 bld groups
0087U-0092U Crd hrt trnspl mrna 1283 gen - Onc lng 3 prtn bmrk plsm alg
0094U Genome rapid sequence alys
0101U - 0103U Hered colon ca do 15 genes - Hered ova ca pnl 24 genes

These CPT codes were moved from Group 1 paragraph to Group 2:

Group 2 Paragraph: CPT codes that are also referenced in other articles
Group 2 Codes:

81401 Mopath procedure level 2
81403 Mopath procedure level 4
81406 Mopath procedure level 7
81407 Mopath procedure level 8
81412 Ashkenazi jewish assoc dis

The following code additions and deletions were made so the only CPT/HCPCs codes that apply to the MolDX Program are listed.

The following codes were added under CPT/HCPCS Codes Group 1: Codes added CPT® codes

87999 Microbiology procedure
0045U-0050U Onc brst dux carc is 12 gene - Trgt gen seq dna 194 genes
0053U-0060U Onc prst8 ca fish alys 4 gen - Twn zyg gen seq alys chrms2
0062U Ai sle igg&igm alys 80 bmrk
0067U Onc brst imhchem prfl 4 bmrk
0068U Candida species pnl amp prb
0070U-0076U Cyp2d6 gen com&slct rar vrnt - Cyp2d6 3' gene dup/mlt
0078U-0080U Pain mgt opi use gnotyp pnl - Onc lng 5 clin rsk factr alg
0083U Onc rspse chemo cntrst tomog
0105U Neph ckd mult eclia tum nec
0107U C diff tox ag detcj ia stool
0108U Gi barrett esoph 9 prtn bmrk
0111U Onc colon ca kras&nras alys
0113U Onc prst8 pca3&tmprss2-erg
0114U Gi barretts esoph vim&ccna1
0118U Trnsplj don-drv cll-fr dna
0120U Onc b cll lymphm mrna 58 gen
0129U-0132U Hered brst ca rltd do panel - Hered ova ca rltd do pnl 17
0134U-0138U Hered pan ca mrna pnl 18 gen - Brca1 brca2 mrna seq alys

The following codes were removed:
CPT® codes 81370-81383, 81596, 88120, 88121, 0002M, 0003M, 0002U, 0006U-0008U, 0010U, 0011U, 0025U, 0035U, 0038U, 0041U-0044U, 0086U, 0093U, 0095U-0100U

See CPT/HCPCs 2020 Code updates table.

Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels A57579 NA 12/26/2019


    Under Article Text added the third bullet point verbiage “For dates of service on or after 10/01/2019, laboratories billing for services using GenMark® ePlex Respiratory Pathogen (RP) Panel should report 0115U. While this panel is able to report results for a specific number of pathogens, this contractor will interpret the use of 0115U to represent the use of a specific testing platform regardless of the number of pathogens reported by the laboratory”. 

Under CPT/HCPCS Codes Group 1 Codes: added 0115U.

0115U RESPIRATORY INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA AND RNA), 18 VIRAL TYPES AND SUBTYPES AND 2 BACTERIAL TARGETS, AMPLIFIED PROBE TECHNIQUE, INCLUDING MULTIPLEX REVERSE TRANSCRIPTION FOR RNA TARGETS, EACH ANALYTE REPORTED AS DETECTED OR NOT DETECTED

Under ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: added the verbiage “and 0115U”. “These are the diagnosis codes corresponding to coverage of 87631, 0098U, 0099U, 0100U, and 0115U.”

This revision is retroactive effective for dates of service on or after 10/01/2019 (CR 11406).

Billing and Coding: Wound Care A55909 NA 02/09/2020

This article’s revision is related to the reconsideration process and medical literature submitted during the comment period 09/26/2019-11/10/2019. 

The following ICD-10 Codes have been added to Group One:
L89.012   Pressure ulcer of right elbow, stage 2
L89.022   Pressure ulcer of left elbow, stage 2
L89.112   Pressure ulcer of right upper back, stage 2
L89.122   Pressure ulcer of left upper back, stage 2
L89.132   Pressure ulcer of right lower back, stage 2
L89.142   Pressure ulcer of left lower back, stage 2
L89.152   Pressure ulcer of sacral region, stage 2
L89.212   Pressure ulcer of right hip, stage 2
L89.222   Pressure ulcer of left hip, stage 2
L89.312   Pressure ulcer of right buttock, stage 2
L89.322   Pressure ulcer of left buttock, stage 2
L89.42     Pressure ulcer of contiguous site of back, buttock and hip, stage 2
L89.512   Pressure ulcer of right ankle, stage 2
L89.522   Pressure ulcer of left ankle, stage 2
L89.612   Pressure ulcer of right heel, stage 2
L89.622   Pressure ulcer of left heel, stage 2
L89.812   Pressure ulcer of head, stage 2
L89.892   Pressure ulcer of other site, stage 2
L97.111   Non-pressure chronic ulcer of right thigh limited to breakdown of skin
L97.121   Non-pressure chronic ulcer of left thigh limited to breakdown of skin
L97.211   Non-pressure chronic ulcer of right calf limited to breakdown of skin
L97.221   Non-pressure chronic ulcer of left calf limited to breakdown of skin
L97.311   Non-pressure chronic ulcer of right calf limited to breakdown of skin
L97.321   Non-pressure chronic ulcer of left ankle limited to breakdown of skin
L97.411   Non-pressure chonic ulcer of right heel and midfoot limited to breakdown of skin
L97.421   Non-pressure chronic ulcer of unspecified part of left lower leg limited to breakdown of skin
L97.511   Non-pressure chronic ulcer of other part of right foot limited to breakdown of skin
L97.521   Non-pressure chronic ulcer of other part of left foot limited to breakdown of skin
L97.811   Non-pressure chronic ulcer of other part of right lower leg limited to skin breakdown
L97.821   Non-pressure chronic ulcer of other part of left lower leg limited to skin breakdown
L98.411   Non-pressure chronic ulcer of buttock limited to breakdown of skin
L98.421   Non-pressure chronic ulcer of back limited to breakdown of skin
L98.491   Non-pressure chronic ulcer of skin of other sites limited to breakdown of skin
L98.496   Non-pressure chronic ulcer of skin other sites with bone involvement without evidence of necrosis
L98.498   Non-pressure chronic ulcer of skin other sites with  other specified severity

The following ICD-10 codes have been removed from Group One due to more specific codes available: 
L97.912  Non-pressure chronic ulcer of unspecified part of right lower leg with fat layer exposed 
L97.913  Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of muscle 
L97.914  Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of bone 
L97.915  Non-pressure chronic ulcer of unspecified part of right lower leg with muscle involvement without evidence of necrosis 
L97.916  Non-pressure chronic ulcer of unspecified part of right lower leg with bone involvement without evidence of necrosis 
L97.918  Non-pressure chronic ulcer of unspecified part of right lower leg with other specified severity 
L97.922  Non-pressure chronic ulcer of unspecified part of left lower leg with fat layer exposed 
L97.923  Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of muscle 
L97.924  Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of bone 
L97.925  Non-pressure chronic ulcer of unspecified part of left lower leg with muscle involvement without evidence of necrosis 
L97.926  Non-pressure chronic ulcer of unspecified part of left lower leg with bone involvement without evidence of necrosis 
L97.928  Non-pressure chronic ulcer of unspecified part of left lower leg with other specified severity

Category III Codes L35490 PHYS-084 02/09/2020

Content updated related to reconsideration request for: 

CPT code 0254T: Endovascular repair of iliac artery bifurcation (e.g., aneurysm, pseudoaneurysm, arteriovenous malformation, trauma, dissection) using bifurcated endograft from the common iliac artery into both the external and internal iliac artery, including all selective and/or nonselective catheterization(s) required for device placement and all associated radiological supervision and interpretation, unilateral.

Analysis of Evidence CPT code 0254T:
The reconsideration request asserts, “the evidence supporting the use of the Gore® Excluder® IBE (with Gore® Excluder® AAA Endoprosthesis) is sufficiently robust to support that it is ‘reasonable and necessary’ under the Statute and the LCD.”  Wisconsin Physicians Service Government Health Administrators (WPS GHA) does not agree. The literature submitted for review is mostly retrospective studies with limitations well outlined by the respective authors. WPS GHA believes that the authors caution is warranted. Coverage is denied at this time.

CPT code 0355T: Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report.

Analysis of Evidence CPT code 0355T:
The reconsideration request asserts “ current published evidence and FDA approval support PillCam COLON 2 as a safe, effective and clinically meaningful diagnostic option in patients after an incomplete colonoscopy or for patients with evidence of a lower GI bleed with major risks for colonoscopy or moderate sedation.” Wisconsin Physicians Service Government Health Administrators (WPS GHA) does not agree. The literature submitted for review is mostly preliminary studies with an unjustified sample size with limitations well outlined by the respective authors. As well as the associated editorials. WPS GHA believes that the authors caution is warranted. Coverage is denied at this time.

Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.

Effective 01/01/2020 CPT/HCPCS Annual Update: deleted CPT 0254T. Providers are responsible for determining the correct diagnostic and procedural coding for the services they furnish to Medicare beneficiaries

Erythropoiesis Stimulating Agents (ESAs) L34633 INJ-023 02/09/2020

Content updated related to reconsideration request.

Coverage Indications, Limitations, and/or Medical Necessity: 
Added to Group C: Indications other than Renal Disease
8. Myelofibrosis. 

Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.  

Please refer to A56975 Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) 
Group 11 Paragraph Myelofibrosis
Group 11 Codes that support Medical Necessity and 
ICD-10 Codes that DO NOT Support Medical Necessity. 

Change Request References updated: added CR 11244 Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS)  Effective 01/01/2020.

MolDX: myPath Melanoma Assay L37923 MolDX-053 12/26/2019

Added 0090U due to 3rd Quarter CPT/HCPCS code updates; effective 07/01/2019. 

CPT/HCPCS Codes
Group 1 Paragraph: NA
Group 1 Codes

0009U ONCOLOGY (CUTANEOUS MELANOMA), MRNA GENE EXPRESSION PROFILING BY RT-PCR OF 23 GENES (14 CONTENT AND 9 HOUSEKEEPING), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS A CATEGORICAL RESULT (IE, BENIGN, INDETERMINATE, MALIGNANT)

All of the coding in the LCD has been moved to the associated Billing and Coding article.

Wound Care L37228 G-SURG-056 02/09/2020

Added the following to CMS National Coverage Policy:
CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.
Change Request 10901, Local Coverage Determinations (LCDs)
42 Code of Federal Regulations (CFR) § 410.20 - Physicians' services

Added the following to Coverage Guidance:
Active wound care procedures are performed to remove necrotic tissue and/or devitalized tissue to promote healing.  Providers are responsible to determine medical necessity and use the appropriate current CPT/HCPCS code for service provided. Please consult the current AMA CPT book for the complete code description of the procedures being performed to submit claims.

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for additional wound care. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for additional wound care sessions and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies are provided under CMS National Coverage Policy section.

Debridement section added: 

  • Pressure Injury
  • Stage II
  • Diabetic Foot Ulcer(s)

Should deep tissue pressure injury or Stage II injury progress to Unstageable, Stage III or Stage IV requiring debridement then documentation supporting this must be included in the medical record.

 Evaluation and Management Section has been revised and the following has been removed:  
The following services may be done during wound care services and can be medically necessary, but they are not considered wound debridement services and wound debridement CPT codes should not be used. 

  • Removal of necrotic tissue by cleansing, scraping (other than by a scalpel or a curette), chemical application, or dry-to-dry or wet-to dry dressing.  Generally, dressing changes are not considered a skilled service. The prior dressings are different and distinct from wet-to-moist dressings that are used for removal of devitalized tissue from wound(s) for non-selective debridement.
  • Washing bacterial or fungal debris from lesions.
  • Removal of secretions and coagulation serum from normal skin surrounding an ulcer.
  • Dressing of small or superficial lesions.
  • Removal of fibrinous material from the margin of an ulcer.
  • Paring or cutting of corns or non-plantar calluses. Skin breakdown under a dorsal corn that begins to heal when the corn is removed, and shoe pressure eliminated is not considered an ulcer that requires debridement unless there is extension into the subcutaneous tissue.
  • Incision and drainage of abscess including paronychia, trimming or debridement of mycotic nails, avulsion of nail plates, acne surgery, or destruction of warts. 
  • Removal of non-tissue integrated fibrin exudates, crusts, biofilms or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such.
  • While mechanical debridement is a valuable technique for healing ulcers, it does not qualify as a surgical wound debridement service, and therefore should not be coded as such. 
  • Scraping the base of the wound bed to induce bleeding, following the removal of devitalized tissue, is not considered to be a separately billable service.
  • Removing a collar of callus (hyperkeratotic tissue) around an ulcer is not debridement of skin or necrotic tissue and should not be billed as debridement unless additional partial full skin thickness tissue directly deep to the callus is removed as well.
  • Infrared, ultrasound thermal and phototherapy-ultraviolet modalities are not considered debridement services.

Negative Pressure Wound Therapy  has been revised and the following has been removed
For disposable NPWT (dNPWT) devices, this contractor recommends following manufacturer’s instructions but, generally be limited to a maximum of 4 applications per 30 days.  

NPWT services should not exceed a 120-day period. It is expected a licensed medical professional must directly assess the wound(s) being treated with NPWT and supervise or directly perform the NPWT dressing changes. It is expected there will be an evaluation with documentation of the wound’s dimensions and characteristics conducted every 30 days. 

NWPT coverage would end, and the pump and/or supplies will be denied as not reasonable and necessary with any of the following, whichever occurs earliest.

  1. In the judgment of the treating physician, adequate wound healing has occurred to the degree that NPWT may be discontinued, 
  2. Any measurable degree of wound healing has failed to occur over the prior month. Wound healing is defined as improvement occurring in either surface area (length times width) or depth of the wound.
  3. One hundred twenty (120) days (including the time NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using NPWT in the treatment of the most recent wound. 

Documentation Section revision completed
When wound care is provided by the Physical Therapist, for both in and out patient wound care, the medical record is required to have the following documentation: 

Physician order(s) for therapy /wound care services and signed plan of treatment (also known as a plan of care) detailing treatment modalities for therapy/wound care services must be established as soon as possible or within 30 days.

Every 10 days progress notes to include current wound status, measurements (including size and depth), and the treatment provided.

Utilization Guidelines has been revised and the following  two statements have been removed:
For disposable NPWT (dNPWT) devices, this contractor recommends following manufacturer’s instructions but, generally be limited to a maximum of 4 applications per 30 days.  

Negative Pressure Wound Therapy services should not exceed a 120-day period. There should be no more than 4 dressing changes per wound per month for the majority of wounds. With dNPWT, there should be a maximum of 4 new disposable NPWT per month. It is expected there will be an evaluation with documentation for a wound(s) every 30 days. 

Added Summary of Evidence, Analysis of Evidence, and Bibliography related to Comment Period (09/26/2019 – 11/10/2019)

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
2020 CPT/HCPCS Code Updates PDF Icon NA NA 01/01/2020
Billing and Coding: Botulinum Toxin Type A & Type B A57474 NA 12/26/2019
The following sentence was removed from Coding Guidelines: “It is acceptable for the provider to bill for the discarded drug on the last patient of the day when more than one patient is treated with one single use vial of Botulinum toxin.” 
Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) A56795 NA 01/01/2020

CR 11244: Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS). Effective 01/01/2020.

CPT/HCPCS Modifiers removed:

ED HEMATOCRIT LEVEL HAS EXCEEDED 39% (OR HEMOGLOBIN LEVEL HAS EXCEEDED 13.0 G/DL) FOR 3 OR MORE CONSECUTIVE BILLING CYCLES IMMEDIATELY PRIOR TO AND INCLUDING THE CURRENT CYCLE

EE HEMATOCRIT LEVEL HAS NOT EXCEEDED 39% (OR HEMOGLOBIN LEVEL HAS NOT EXCEEDED 13.0 G/DL) FOR 3 OR MORE CONSECUTIVE BILLING CYCLES IMMEDIATELY PRIOR TO AND INCLUDING THE CURRENT CYCLE

GS DOSAGE OF ERYTHROPOIETIN STIMULATING AGENT HAS BEEN REDUCED AND MAINTAINED IN RESPONSE TO HEMATOCRIT OR HEMOGLOBIN LEVEL

CPT/HCPCS annual update: Description change noted:
Q5105 Injection, epoetin alfa-epbx, biosimilar (retacrit) (for ESRD on dialysis) 100 units
Q5106 Injection, epoetin alfa-epbx, biosimilar (retacrit) (for non-ESRD use) 1000 units

Group 8 Paragraph: Anemia of chronic disease
Dual Diagnosis Necessary for J0881 or J0885
Added Q5106.

Removed the following information from the Article:
CMS Pub 100-04 Medicare Claim Processing Manual, Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.1 – ESA Claims Monitoring Policy (Rev. 2582, Issued:
11-02-12, Effective: 04-01-13, Implementation: 04-01-13) from CMS National Coverage Policy and referenced content from Article Text.

Added Utilization Guidelines to the Article text:

Utilization Guidelines
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 -Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1 – ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Epogen® is reduced to 400,000 units from 500,000.
Maximum Allowable Administrations The maximum number of administrations of EPO for a billing cycle is 13 times in 30 days and 14 times in 31 days.

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 - Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1- ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Aranesp® is reduced to 1200 mcg from 1500 mcg.
Darbepoetin alfa is given not more than once per week according to its Food and Drug Administration approved labeling. Maximum Allowable Administrations The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30 / 31 days.

Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) A56795 NA 02/09/2020

Content updated related to reconsideration request.

ICD-10 Codes that Support Medical Necessity:
Added Group 11 Paragraph: Myelofibrosis for J0881, J0885 and Q5106, and Group 11 Codes
C94.40  Acute panmyelosis with myelofibrosis not having achieved remission
C94.41  Acute panmyelosis with myelofibrosis, in remission
C94.42  Acute panmyelosis with myelofibrosis, in relapse
D47.1   Chronic myeloproliferative disease
D47.4   Osteomyelofibrosis and D75.81 Myelofibrosis .

ICD-10 Codes that DO NOT Support Medical Necessity:
Added Group 1 Paragraph: Myelofibrosis for J0881 or J0885 and Q5106 and Group 1 Codes:
D61.82 Myelophthisis.

Please see content of LCD updated related to reconsideration request/effective 02/09/2020: Coverage Indications, Limitations, and/or Medical Necessity: Added to Group C: Indications other than Renal Disease, 8. Myelofibrosis. Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.

Billing and Coding: Lab: Bladder/Urothelial Tumor Markers A56332 NA 12/26/2019

The title of this article has changed from “MolDX: Bladder Tumor Marker FISH Billing and Coding Guidelines Update” to “Billing and Coding: Lab: Bladder/Urothelial Tumor Markers”. Under Article Text added billing information.

Added TC modifier to the modifier table.

TC TECHNICAL COMPONENT

The following codes were added to CPT/HCPCS Group 1 codes:

86294 IMMUNOASSAY FOR TUMOR ANTIGEN, QUALITATIVE OR SEMIQUANTITATIVE (EG, BLADDER TUMOR ANTIGEN)
86316 IMMUNOASSAY FOR TUMOR ANTIGEN, OTHER ANTIGEN, QUANTITATIVE (EG, CA 50, 72-4, 549), EACH
86386 NUCLEAR MATRIX PROTEIN 22 (NMP22), QUALITATIVE

The following codes were added to ICD-10 Codes that Support Medical Necessity Group 1:

C67.0-C67.9 Malignant neoplasm of trigone of bladder- Malignant neoplasm of bladder, unspecified
C7A.00 Malignant carcinoid tumor of unspecified site
C7A.010-C7A.012 Malignant carcinoid tumor of the duodenum- Malignant carcinoid tumor of the ileum
C7A.019-C7A.026 Malignant carcinoid tumor of the small intestine- Malignant carcinoid tumor of the appendix, large intestine, and rectum
C7A.029 Malignant carcinoid tumor of the large intestine, unspecified portion
C7A.090-C7A.096 Malignant carcinoid tumor of the bronchus and lung- Malignant carcinoid tumor of the hindgut, unspecified
C7A.098 Malignant carcinoid tumors of other sites
C7A.8 Other malignant neuroendocrine tumors
C7B.00-C7B.04 Secondary carcinoid tumors, unspecified site- Secondary carcinoid tumors of peritoneum
C7B.09 Secondary carcinoid tumors of other sites
C7B.8 Other secondary neuroendocrine tumors
C78.00 Secondary malignant neoplasm of unspecified lung
D09.0 Carcinoma in situ of bladder
D41.4 Neoplasm of uncertain behavior of bladder
D49.4 Neoplasm of unspecified behavior of bladder
E34.0 Carcinoid syndrome
R31.0 Gross hematuria
R31.1 Benign essential microscopic hematuria
R31.21* Asymptomatic microscopic hematuria
R31.29* Other microscopic hematuria
R31.9 Hematuria, unspecified
Z78.9*  Other specified health status
Z85.51 Personal history of malignant neoplasm of bladder

Under Group 1 table the following verbiage was added:
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: R31.2 (before October 1, 2016) and R31.21 or R31.29 (effective October 1, 2016) are to be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis. Z78.9 To be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis.

Billing and Coding: MolDX: clonoSEQ® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies A56277 NA 12/26/2019

Coverage for chronic lymphocytic leukemia has been added to this article.

The following updates were made to this article:
Clinical practice guidelines in a number of hematological malignancies recommend MRD testing and recognize MRD status as a reliable indicator of clinical outcome and response to therapy, which is currently recommended in the course of treatment of patients with acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL).1,2,3

The clonoSEQ® Assay has received State of New York Clinical Laboratory Evaluation Program (CLEP) approval for B-cell malignancies.

ICD-10 Codes that that Support Medical Necessity
Group 1 Paragraph:
Group 1 Codes
C91.10 Chronic lymphoblastic leukemia not having achieved remission
C91.11 Chronic lymphoblastic leukemia, in remission
C91.12 Chronic lymphoblastic leukemia, in relapse

References
4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology 
(NCCN Guidelines®). Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (Version 2.2020).
https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf PDF Icon. Accessed 11/13/2019

Billing and Coding: MolDX: Genetic Testing for Lynch Syndrome A55135 NA 12/26/2019

Due to Fourth Quarter CPT/HCPCS code updates; added 0130U & 0134U to Group 2 effective
10/01/2019:

CPT/HCPCS Codes
Group 2 Paragraph: NA
Group 2 Codes

0130U HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS), TARGETED MRNA SEQUENCE ANALYSIS PANEL (APC, CDH1, CHEK2, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, AND TP53) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0134U HEREDITARY PAN CANCER (EG, HEREDITARY BREAST AND OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER, HEREDITARY COLORECTAL CANCER), TARGETED MRNA SEQUENCE ANALYSIS PANEL (18 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

Added CPT 81436 and moved CPT 81301, 81403 & 81435 from CPT/HCPCS Group 1 to CPT/HCPCS Group 3:

CPT/HCPCS Codes
Group 3 Paragraph: CPT Codes that are also referenced in other articles
Group 3 Codes:

81301 MICROSATELLITE INSTABILITY ANALYSIS (EG, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER, LYNCH SYNDROME) OF MARKERS FOR MISMATCH REPAIR DEFICIENCY (EG, BAT25, BAT26), INCLUDES COMPARISON OF NEOPLASTIC AND NORMAL TISSUE, IF PERFORMED
81403 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 4 (EG, ANALYSIS OF SINGLE EXON BY DNA SEQUENCE ANALYSIS, ANALYSIS OF >10 AMPLICONS USING MULTIPLEX PCR IN 2 OR MORE INDEPENDENT REACTIONS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 2-5 EXONS)
81435 HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS); GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE SEQUENCING OF AT LEAST 10 GENES, INCLUDING APC, BMPR1A, CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4, AND STK11
81436 HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS); DUPLICATION/DELETION ANALYSIS PANEL, MUST INCLUDE ANALYSIS OF AT LEAST 5 GENES, INCLUDING MLH1, MSH2, EPCAM, SMAD4, AND STK11
Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57772 NA 01/01/2020

Multiple code changes were made to this article to be consistent with the MolDX Program Contractor’s Billing and Coding Article.

Added CPT codes 0084U-0103U due to 2nd quarter 2019 CPT/HCPCs code updates. They are effective 07/01/2019:

CPT/HCPCS Codes
Group 1 Paragraph: NA
Group 1 Codes

0084U Rbc dna gnotyp 10 bld groups
0087U-0092U Crd hrt trnspl mrna 1283 gen - Onc lng 3 prtn bmrk plsm alg
0094U Genome rapid sequence alys
0101U - 0103U Hered colon ca do 15 genes - Hered ova ca pnl 24 genes

These CPT codes were moved from Group 1 paragraph to Group 2:

Group 2 Paragraph: CPT codes that are also referenced in other articles
Group 2 Codes:

81401 Mopath procedure level 2
81403 Mopath procedure level 4
81406 Mopath procedure level 7
81407 Mopath procedure level 8
81412 Ashkenazi jewish assoc dis

The following code additions and deletions were made so the only CPT/HCPCs codes that apply to the MolDX Program are listed.

The following codes were added under CPT/HCPCS Codes Group 1: Codes added CPT® codes

87999 Microbiology procedure
0045U-0050U Onc brst dux carc is 12 gene - Trgt gen seq dna 194 genes
0053U-0060U Onc prst8 ca fish alys 4 gen - Twn zyg gen seq alys chrms2
0062U Ai sle igg&igm alys 80 bmrk
0067U Onc brst imhchem prfl 4 bmrk
0068U Candida species pnl amp prb
0070U-0076U Cyp2d6 gen com&slct rar vrnt - Cyp2d6 3' gene dup/mlt
0078U-0080U Pain mgt opi use gnotyp pnl - Onc lng 5 clin rsk factr alg
0083U Onc rspse chemo cntrst tomog
0105U Neph ckd mult eclia tum nec
0107U C diff tox ag detcj ia stool
0108U Gi barrett esoph 9 prtn bmrk
0111U Onc colon ca kras&nras alys
0113U Onc prst8 pca3&tmprss2-erg
0114U Gi barretts esoph vim&ccna1
0118U Trnsplj don-drv cll-fr dna
0120U Onc b cll lymphm mrna 58 gen
0129U-0132U Hered brst ca rltd do panel - Hered ova ca rltd do pnl 17
0134U-0138U Hered pan ca mrna pnl 18 gen - Brca1 brca2 mrna seq alys

The following codes were removed:
CPT® codes 81370-81383, 81596, 88120, 88121, 0002M, 0003M, 0002U, 0006U-0008U, 0010U, 0011U, 0025U, 0035U, 0038U, 0041U-0044U, 0086U, 0093U, 0095U-0100U

See CPT/HCPCs 2020 Code updates table.

Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels A57579 NA 12/26/2019


    Under Article Text added the third bullet point verbiage “For dates of service on or after 10/01/2019, laboratories billing for services using GenMark® ePlex Respiratory Pathogen (RP) Panel should report 0115U. While this panel is able to report results for a specific number of pathogens, this contractor will interpret the use of 0115U to represent the use of a specific testing platform regardless of the number of pathogens reported by the laboratory”. 

Under CPT/HCPCS Codes Group 1 Codes: added 0115U.

0115U RESPIRATORY INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA AND RNA), 18 VIRAL TYPES AND SUBTYPES AND 2 BACTERIAL TARGETS, AMPLIFIED PROBE TECHNIQUE, INCLUDING MULTIPLEX REVERSE TRANSCRIPTION FOR RNA TARGETS, EACH ANALYTE REPORTED AS DETECTED OR NOT DETECTED

Under ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: added the verbiage “and 0115U”. “These are the diagnosis codes corresponding to coverage of 87631, 0098U, 0099U, 0100U, and 0115U.”

This revision is retroactive effective for dates of service on or after 10/01/2019 (CR 11406).

Billing and Coding: Wound Care A55909 NA 02/09/2020

This article’s revision is related to the reconsideration process and medical literature submitted during the comment period 09/26/2019-11/10/2019. 

The following ICD-10 Codes have been added to Group One:
L89.012   Pressure ulcer of right elbow, stage 2
L89.022   Pressure ulcer of left elbow, stage 2
L89.112   Pressure ulcer of right upper back, stage 2
L89.122   Pressure ulcer of left upper back, stage 2
L89.132   Pressure ulcer of right lower back, stage 2
L89.142   Pressure ulcer of left lower back, stage 2
L89.152   Pressure ulcer of sacral region, stage 2
L89.212   Pressure ulcer of right hip, stage 2
L89.222   Pressure ulcer of left hip, stage 2
L89.312   Pressure ulcer of right buttock, stage 2
L89.322   Pressure ulcer of left buttock, stage 2
L89.42     Pressure ulcer of contiguous site of back, buttock and hip, stage 2
L89.512   Pressure ulcer of right ankle, stage 2
L89.522   Pressure ulcer of left ankle, stage 2
L89.612   Pressure ulcer of right heel, stage 2
L89.622   Pressure ulcer of left heel, stage 2
L89.812   Pressure ulcer of head, stage 2
L89.892   Pressure ulcer of other site, stage 2
L97.111   Non-pressure chronic ulcer of right thigh limited to breakdown of skin
L97.121   Non-pressure chronic ulcer of left thigh limited to breakdown of skin
L97.211   Non-pressure chronic ulcer of right calf limited to breakdown of skin
L97.221   Non-pressure chronic ulcer of left calf limited to breakdown of skin
L97.311   Non-pressure chronic ulcer of right calf limited to breakdown of skin
L97.321   Non-pressure chronic ulcer of left ankle limited to breakdown of skin
L97.411   Non-pressure chonic ulcer of right heel and midfoot limited to breakdown of skin
L97.421   Non-pressure chronic ulcer of unspecified part of left lower leg limited to breakdown of skin
L97.511   Non-pressure chronic ulcer of other part of right foot limited to breakdown of skin
L97.521   Non-pressure chronic ulcer of other part of left foot limited to breakdown of skin
L97.811   Non-pressure chronic ulcer of other part of right lower leg limited to skin breakdown
L97.821   Non-pressure chronic ulcer of other part of left lower leg limited to skin breakdown
L98.411   Non-pressure chronic ulcer of buttock limited to breakdown of skin
L98.421   Non-pressure chronic ulcer of back limited to breakdown of skin
L98.491   Non-pressure chronic ulcer of skin of other sites limited to breakdown of skin
L98.496   Non-pressure chronic ulcer of skin other sites with bone involvement without evidence of necrosis
L98.498   Non-pressure chronic ulcer of skin other sites with  other specified severity

The following ICD-10 codes have been removed from Group One due to more specific codes available: 
L97.912  Non-pressure chronic ulcer of unspecified part of right lower leg with fat layer exposed 
L97.913  Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of muscle 
L97.914  Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of bone 
L97.915  Non-pressure chronic ulcer of unspecified part of right lower leg with muscle involvement without evidence of necrosis 
L97.916  Non-pressure chronic ulcer of unspecified part of right lower leg with bone involvement without evidence of necrosis 
L97.918  Non-pressure chronic ulcer of unspecified part of right lower leg with other specified severity 
L97.922  Non-pressure chronic ulcer of unspecified part of left lower leg with fat layer exposed 
L97.923  Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of muscle 
L97.924  Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of bone 
L97.925  Non-pressure chronic ulcer of unspecified part of left lower leg with muscle involvement without evidence of necrosis 
L97.926  Non-pressure chronic ulcer of unspecified part of left lower leg with bone involvement without evidence of necrosis 
L97.928  Non-pressure chronic ulcer of unspecified part of left lower leg with other specified severity

Category III Codes L35490 PHYS-084 02/09/2020

Content updated related to reconsideration request for: 

CPT code 0254T: Endovascular repair of iliac artery bifurcation (e.g., aneurysm, pseudoaneurysm, arteriovenous malformation, trauma, dissection) using bifurcated endograft from the common iliac artery into both the external and internal iliac artery, including all selective and/or nonselective catheterization(s) required for device placement and all associated radiological supervision and interpretation, unilateral.

Analysis of Evidence CPT code 0254T:
The reconsideration request asserts, “the evidence supporting the use of the Gore® Excluder® IBE (with Gore® Excluder® AAA Endoprosthesis) is sufficiently robust to support that it is ‘reasonable and necessary’ under the Statute and the LCD.”  Wisconsin Physicians Service Government Health Administrators (WPS GHA) does not agree. The literature submitted for review is mostly retrospective studies with limitations well outlined by the respective authors. WPS GHA believes that the authors caution is warranted. Coverage is denied at this time.

CPT code 0355T: Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report.

Analysis of Evidence CPT code 0355T:
The reconsideration request asserts “ current published evidence and FDA approval support PillCam COLON 2 as a safe, effective and clinically meaningful diagnostic option in patients after an incomplete colonoscopy or for patients with evidence of a lower GI bleed with major risks for colonoscopy or moderate sedation.” Wisconsin Physicians Service Government Health Administrators (WPS GHA) does not agree. The literature submitted for review is mostly preliminary studies with an unjustified sample size with limitations well outlined by the respective authors. As well as the associated editorials. WPS GHA believes that the authors caution is warranted. Coverage is denied at this time.

Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.

Effective 01/01/2020 CPT/HCPCS Annual Update: deleted CPT 0254T. Providers are responsible for determining the correct diagnostic and procedural coding for the services they furnish to Medicare beneficiaries

Erythropoiesis Stimulating Agents (ESAs) L34633 INJ-023 02/09/2020

Content updated related to reconsideration request.

Coverage Indications, Limitations, and/or Medical Necessity: 
Added to Group C: Indications other than Renal Disease
8. Myelofibrosis. 

Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.  

Please refer to A56975 Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) 
Group 11 Paragraph Myelofibrosis
Group 11 Codes that support Medical Necessity and 
ICD-10 Codes that DO NOT Support Medical Necessity. 

Change Request References updated: added CR 11244 Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS)  Effective 01/01/2020.

Independent Diagnostic Testing Facilities- Physician Supervision and Technician Requirements A54943 NA 01/01/2020

Please see the 2020 CPT/HCPCS code update table for description changes, deleted and added codes.

Request for Coverage by an IDTF: 
Added CPT code 27369: 
Long Description: Injection of contrast for imaging of knee joint
Short Description: Njx cntrst kne arthg/ct/mri 
    
Supervising Physician Qualification Requirements: Radiologist or Orthopedic Surgeon
Technician Qualification: Physician Only Service

MolDX: myPath Melanoma Assay L37923 MolDX-053 12/26/2019

Added 0090U due to 3rd Quarter CPT/HCPCS code updates; effective 07/01/2019. 

CPT/HCPCS Codes
Group 1 Paragraph: NA
Group 1 Codes

0009U ONCOLOGY (CUTANEOUS MELANOMA), MRNA GENE EXPRESSION PROFILING BY RT-PCR OF 23 GENES (14 CONTENT AND 9 HOUSEKEEPING), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS A CATEGORICAL RESULT (IE, BENIGN, INDETERMINATE, MALIGNANT)

All of the coding in the LCD has been moved to the associated Billing and Coding article.

Wound Care L37228 G-SURG-056 02/09/2020

Added the following to CMS National Coverage Policy:
CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.
Change Request 10901, Local Coverage Determinations (LCDs)
42 Code of Federal Regulations (CFR) § 410.20 - Physicians' services

Added the following to Coverage Guidance:
Active wound care procedures are performed to remove necrotic tissue and/or devitalized tissue to promote healing.  Providers are responsible to determine medical necessity and use the appropriate current CPT/HCPCS code for service provided. Please consult the current AMA CPT book for the complete code description of the procedures being performed to submit claims.

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for additional wound care. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for additional wound care sessions and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies are provided under CMS National Coverage Policy section.

Debridement section added: 

  • Pressure Injury
  • Stage II
  • Diabetic Foot Ulcer(s)

Should deep tissue pressure injury or Stage II injury progress to Unstageable, Stage III or Stage IV requiring debridement then documentation supporting this must be included in the medical record.

 Evaluation and Management Section has been revised and the following has been removed:  
The following services may be done during wound care services and can be medically necessary, but they are not considered wound debridement services and wound debridement CPT codes should not be used. 

  • Removal of necrotic tissue by cleansing, scraping (other than by a scalpel or a curette), chemical application, or dry-to-dry or wet-to dry dressing.  Generally, dressing changes are not considered a skilled service. The prior dressings are different and distinct from wet-to-moist dressings that are used for removal of devitalized tissue from wound(s) for non-selective debridement.
  • Washing bacterial or fungal debris from lesions.
  • Removal of secretions and coagulation serum from normal skin surrounding an ulcer.
  • Dressing of small or superficial lesions.
  • Removal of fibrinous material from the margin of an ulcer.
  • Paring or cutting of corns or non-plantar calluses. Skin breakdown under a dorsal corn that begins to heal when the corn is removed, and shoe pressure eliminated is not considered an ulcer that requires debridement unless there is extension into the subcutaneous tissue.
  • Incision and drainage of abscess including paronychia, trimming or debridement of mycotic nails, avulsion of nail plates, acne surgery, or destruction of warts. 
  • Removal of non-tissue integrated fibrin exudates, crusts, biofilms or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such.
  • While mechanical debridement is a valuable technique for healing ulcers, it does not qualify as a surgical wound debridement service, and therefore should not be coded as such. 
  • Scraping the base of the wound bed to induce bleeding, following the removal of devitalized tissue, is not considered to be a separately billable service.
  • Removing a collar of callus (hyperkeratotic tissue) around an ulcer is not debridement of skin or necrotic tissue and should not be billed as debridement unless additional partial full skin thickness tissue directly deep to the callus is removed as well.
  • Infrared, ultrasound thermal and phototherapy-ultraviolet modalities are not considered debridement services.

Negative Pressure Wound Therapy  has been revised and the following has been removed
For disposable NPWT (dNPWT) devices, this contractor recommends following manufacturer’s instructions but, generally be limited to a maximum of 4 applications per 30 days.  

NPWT services should not exceed a 120-day period. It is expected a licensed medical professional must directly assess the wound(s) being treated with NPWT and supervise or directly perform the NPWT dressing changes. It is expected there will be an evaluation with documentation of the wound’s dimensions and characteristics conducted every 30 days. 

NWPT coverage would end, and the pump and/or supplies will be denied as not reasonable and necessary with any of the following, whichever occurs earliest.

  1. In the judgment of the treating physician, adequate wound healing has occurred to the degree that NPWT may be discontinued, 
  2. Any measurable degree of wound healing has failed to occur over the prior month. Wound healing is defined as improvement occurring in either surface area (length times width) or depth of the wound.
  3. One hundred twenty (120) days (including the time NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using NPWT in the treatment of the most recent wound. 

Documentation Section revision completed
When wound care is provided by the Physical Therapist, for both in and out patient wound care, the medical record is required to have the following documentation: 

Physician order(s) for therapy /wound care services and signed plan of treatment (also known as a plan of care) detailing treatment modalities for therapy/wound care services must be established as soon as possible or within 30 days.

Every 10 days progress notes to include current wound status, measurements (including size and depth), and the treatment provided.

Utilization Guidelines has been revised and the following  two statements have been removed:
For disposable NPWT (dNPWT) devices, this contractor recommends following manufacturer’s instructions but, generally be limited to a maximum of 4 applications per 30 days.  

Negative Pressure Wound Therapy services should not exceed a 120-day period. There should be no more than 4 dressing changes per wound per month for the majority of wounds. With dNPWT, there should be a maximum of 4 new disposable NPWT per month. It is expected there will be an evaluation with documentation for a wound(s) every 30 days. 

Added Summary of Evidence, Analysis of Evidence, and Bibliography related to Comment Period (09/26/2019 – 11/10/2019)

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
2020 CPT/HCPCS Code Updates PDF Icon NA NA 01/01/2020
Billing and Coding: Botulinum Toxin Type A & Type B A57474 NA 12/26/2019
The following sentence was removed from Coding Guidelines: “It is acceptable for the provider to bill for the discarded drug on the last patient of the day when more than one patient is treated with one single use vial of Botulinum toxin.” 
Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) A56795 NA 01/01/2020

CR 11244: Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS). Effective 01/01/2020.

CPT/HCPCS Modifiers removed:

ED HEMATOCRIT LEVEL HAS EXCEEDED 39% (OR HEMOGLOBIN LEVEL HAS EXCEEDED 13.0 G/DL) FOR 3 OR MORE CONSECUTIVE BILLING CYCLES IMMEDIATELY PRIOR TO AND INCLUDING THE CURRENT CYCLE

EE HEMATOCRIT LEVEL HAS NOT EXCEEDED 39% (OR HEMOGLOBIN LEVEL HAS NOT EXCEEDED 13.0 G/DL) FOR 3 OR MORE CONSECUTIVE BILLING CYCLES IMMEDIATELY PRIOR TO AND INCLUDING THE CURRENT CYCLE

GS DOSAGE OF ERYTHROPOIETIN STIMULATING AGENT HAS BEEN REDUCED AND MAINTAINED IN RESPONSE TO HEMATOCRIT OR HEMOGLOBIN LEVEL

CPT/HCPCS annual update: Description change noted:
Q5105 Injection, epoetin alfa-epbx, biosimilar (retacrit) (for ESRD on dialysis) 100 units
Q5106 Injection, epoetin alfa-epbx, biosimilar (retacrit) (for non-ESRD use) 1000 units

Group 8 Paragraph: Anemia of chronic disease
Dual Diagnosis Necessary for J0881 or J0885
Added Q5106.

Removed the following information from the Article:
CMS Pub 100-04 Medicare Claim Processing Manual, Chapter 8- Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Section 60.4.1 – ESA Claims Monitoring Policy (Rev. 2582, Issued:
11-02-12, Effective: 04-01-13, Implementation: 04-01-13) from CMS National Coverage Policy and referenced content from Article Text.

Added Utilization Guidelines to the Article text:

Utilization Guidelines
CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 -Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1 – ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Epogen® is reduced to 400,000 units from 500,000.
Maximum Allowable Administrations The maximum number of administrations of EPO for a billing cycle is 13 times in 30 days and 14 times in 31 days.

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 8 - Outpatient ESRD Hospital, Independent Facility, and Physician/Supplier Claims, Sections 60.4.1- ESA Claims Monitoring Policy and 60.4.2 – Facility Billing Requirements for ESAs. Medically Unlikely Edits (MUE) For dates of service on and after January 1, 2008, the MUE for claims billing for Aranesp® is reduced to 1200 mcg from 1500 mcg.
Darbepoetin alfa is given not more than once per week according to its Food and Drug Administration approved labeling. Maximum Allowable Administrations The maximum number of administrations of Aranesp for a billing cycle is 5 times in 30 / 31 days.

Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) A56795 NA 02/09/2020

Content updated related to reconsideration request.

ICD-10 Codes that Support Medical Necessity:
Added Group 11 Paragraph: Myelofibrosis for J0881, J0885 and Q5106, and Group 11 Codes
C94.40  Acute panmyelosis with myelofibrosis not having achieved remission
C94.41  Acute panmyelosis with myelofibrosis, in remission
C94.42  Acute panmyelosis with myelofibrosis, in relapse
D47.1   Chronic myeloproliferative disease
D47.4   Osteomyelofibrosis and D75.81 Myelofibrosis .

ICD-10 Codes that DO NOT Support Medical Necessity:
Added Group 1 Paragraph: Myelofibrosis for J0881 or J0885 and Q5106 and Group 1 Codes:
D61.82 Myelophthisis.

Please see content of LCD updated related to reconsideration request/effective 02/09/2020: Coverage Indications, Limitations, and/or Medical Necessity: Added to Group C: Indications other than Renal Disease, 8. Myelofibrosis. Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.

Billing and Coding: Lab: Bladder/Urothelial Tumor Markers A56332 NA 12/26/2019

The title of this article has changed from “MolDX: Bladder Tumor Marker FISH Billing and Coding Guidelines Update” to “Billing and Coding: Lab: Bladder/Urothelial Tumor Markers”. Under Article Text added billing information.

Added TC modifier to the modifier table.

TC TECHNICAL COMPONENT

The following codes were added to CPT/HCPCS Group 1 codes:

86294 IMMUNOASSAY FOR TUMOR ANTIGEN, QUALITATIVE OR SEMIQUANTITATIVE (EG, BLADDER TUMOR ANTIGEN)
86316 IMMUNOASSAY FOR TUMOR ANTIGEN, OTHER ANTIGEN, QUANTITATIVE (EG, CA 50, 72-4, 549), EACH
86386 NUCLEAR MATRIX PROTEIN 22 (NMP22), QUALITATIVE

The following codes were added to ICD-10 Codes that Support Medical Necessity Group 1:

C67.0-C67.9 Malignant neoplasm of trigone of bladder- Malignant neoplasm of bladder, unspecified
C7A.00 Malignant carcinoid tumor of unspecified site
C7A.010-C7A.012 Malignant carcinoid tumor of the duodenum- Malignant carcinoid tumor of the ileum
C7A.019-C7A.026 Malignant carcinoid tumor of the small intestine- Malignant carcinoid tumor of the appendix, large intestine, and rectum
C7A.029 Malignant carcinoid tumor of the large intestine, unspecified portion
C7A.090-C7A.096 Malignant carcinoid tumor of the bronchus and lung- Malignant carcinoid tumor of the hindgut, unspecified
C7A.098 Malignant carcinoid tumors of other sites
C7A.8 Other malignant neuroendocrine tumors
C7B.00-C7B.04 Secondary carcinoid tumors, unspecified site- Secondary carcinoid tumors of peritoneum
C7B.09 Secondary carcinoid tumors of other sites
C7B.8 Other secondary neuroendocrine tumors
C78.00 Secondary malignant neoplasm of unspecified lung
D09.0 Carcinoma in situ of bladder
D41.4 Neoplasm of uncertain behavior of bladder
D49.4 Neoplasm of unspecified behavior of bladder
E34.0 Carcinoid syndrome
R31.0 Gross hematuria
R31.1 Benign essential microscopic hematuria
R31.21* Asymptomatic microscopic hematuria
R31.29* Other microscopic hematuria
R31.9 Hematuria, unspecified
Z78.9*  Other specified health status
Z85.51 Personal history of malignant neoplasm of bladder

Under Group 1 table the following verbiage was added:
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: R31.2 (before October 1, 2016) and R31.21 or R31.29 (effective October 1, 2016) are to be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis. Z78.9 To be used only when repeat testing is believed to be medically reasonable and necessary, and must be listed as secondary with the primary neoplastic diagnosis.

Billing and Coding: MolDX: clonoSEQ® Assay for Assessment of Minimal Residual Disease (MRD) in Patients with Specific Lymphoid Malignancies A56277 NA 12/26/2019

Coverage for chronic lymphocytic leukemia has been added to this article.

The following updates were made to this article:
Clinical practice guidelines in a number of hematological malignancies recommend MRD testing and recognize MRD status as a reliable indicator of clinical outcome and response to therapy, which is currently recommended in the course of treatment of patients with acute lymphoblastic leukemia (ALL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL).1,2,3

The clonoSEQ® Assay has received State of New York Clinical Laboratory Evaluation Program (CLEP) approval for B-cell malignancies.

ICD-10 Codes that that Support Medical Necessity
Group 1 Paragraph:
Group 1 Codes
C91.10 Chronic lymphoblastic leukemia not having achieved remission
C91.11 Chronic lymphoblastic leukemia, in remission
C91.12 Chronic lymphoblastic leukemia, in relapse

References
4. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology 
(NCCN Guidelines®). Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (Version 2.2020).
https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf PDF Icon. Accessed 11/13/2019

Billing and Coding: MolDX: Genetic Testing for Lynch Syndrome A55135 NA 12/26/2019

Due to Fourth Quarter CPT/HCPCS code updates; added 0130U & 0134U to Group 2 effective
10/01/2019:

CPT/HCPCS Codes
Group 2 Paragraph: NA
Group 2 Codes

0130U HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS), TARGETED MRNA SEQUENCE ANALYSIS PANEL (APC, CDH1, CHEK2, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, AND TP53) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0134U HEREDITARY PAN CANCER (EG, HEREDITARY BREAST AND OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER, HEREDITARY COLORECTAL CANCER), TARGETED MRNA SEQUENCE ANALYSIS PANEL (18 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

Added CPT 81436 and moved CPT 81301, 81403 & 81435 from CPT/HCPCS Group 1 to CPT/HCPCS Group 3:

CPT/HCPCS Codes
Group 3 Paragraph: CPT Codes that are also referenced in other articles
Group 3 Codes:

81301 MICROSATELLITE INSTABILITY ANALYSIS (EG, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER, LYNCH SYNDROME) OF MARKERS FOR MISMATCH REPAIR DEFICIENCY (EG, BAT25, BAT26), INCLUDES COMPARISON OF NEOPLASTIC AND NORMAL TISSUE, IF PERFORMED
81403 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 4 (EG, ANALYSIS OF SINGLE EXON BY DNA SEQUENCE ANALYSIS, ANALYSIS OF >10 AMPLICONS USING MULTIPLEX PCR IN 2 OR MORE INDEPENDENT REACTIONS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 2-5 EXONS)
81435 HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS); GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE SEQUENCING OF AT LEAST 10 GENES, INCLUDING APC, BMPR1A, CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4, AND STK11
81436 HEREDITARY COLON CANCER DISORDERS (EG, LYNCH SYNDROME, PTEN HAMARTOMA SYNDROME, COWDEN SYNDROME, FAMILIAL ADENOMATOSIS POLYPOSIS); DUPLICATION/DELETION ANALYSIS PANEL, MUST INCLUDE ANALYSIS OF AT LEAST 5 GENES, INCLUDING MLH1, MSH2, EPCAM, SMAD4, AND STK11
Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) A57772 NA 01/01/2020

Multiple code changes were made to this article to be consistent with the MolDX Program Contractor’s Billing and Coding Article.

Added CPT codes 0084U-0103U due to 2nd quarter 2019 CPT/HCPCs code updates. They are effective 07/01/2019:

CPT/HCPCS Codes
Group 1 Paragraph: NA
Group 1 Codes

0084U Rbc dna gnotyp 10 bld groups
0087U-0092U Crd hrt trnspl mrna 1283 gen - Onc lng 3 prtn bmrk plsm alg
0094U Genome rapid sequence alys
0101U - 0103U Hered colon ca do 15 genes - Hered ova ca pnl 24 genes

These CPT codes were moved from Group 1 paragraph to Group 2:

Group 2 Paragraph: CPT codes that are also referenced in other articles
Group 2 Codes:

81401 Mopath procedure level 2
81403 Mopath procedure level 4
81406 Mopath procedure level 7
81407 Mopath procedure level 8
81412 Ashkenazi jewish assoc dis

The following code additions and deletions were made so the only CPT/HCPCs codes that apply to the MolDX Program are listed.

The following codes were added under CPT/HCPCS Codes Group 1: Codes added CPT® codes

87999 Microbiology procedure
0045U-0050U Onc brst dux carc is 12 gene - Trgt gen seq dna 194 genes
0053U-0060U Onc prst8 ca fish alys 4 gen - Twn zyg gen seq alys chrms2
0062U Ai sle igg&igm alys 80 bmrk
0067U Onc brst imhchem prfl 4 bmrk
0068U Candida species pnl amp prb
0070U-0076U Cyp2d6 gen com&slct rar vrnt - Cyp2d6 3' gene dup/mlt
0078U-0080U Pain mgt opi use gnotyp pnl - Onc lng 5 clin rsk factr alg
0083U Onc rspse chemo cntrst tomog
0105U Neph ckd mult eclia tum nec
0107U C diff tox ag detcj ia stool
0108U Gi barrett esoph 9 prtn bmrk
0111U Onc colon ca kras&nras alys
0113U Onc prst8 pca3&tmprss2-erg
0114U Gi barretts esoph vim&ccna1
0118U Trnsplj don-drv cll-fr dna
0120U Onc b cll lymphm mrna 58 gen
0129U-0132U Hered brst ca rltd do panel - Hered ova ca rltd do pnl 17
0134U-0138U Hered pan ca mrna pnl 18 gen - Brca1 brca2 mrna seq alys

The following codes were removed:
CPT® codes 81370-81383, 81596, 88120, 88121, 0002M, 0003M, 0002U, 0006U-0008U, 0010U, 0011U, 0025U, 0035U, 0038U, 0041U-0044U, 0086U, 0093U, 0095U-0100U

See CPT/HCPCs 2020 Code updates table.

Billing and Coding: MolDX: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels A57579 NA 12/26/2019


    Under Article Text added the third bullet point verbiage “For dates of service on or after 10/01/2019, laboratories billing for services using GenMark® ePlex Respiratory Pathogen (RP) Panel should report 0115U. While this panel is able to report results for a specific number of pathogens, this contractor will interpret the use of 0115U to represent the use of a specific testing platform regardless of the number of pathogens reported by the laboratory”. 

Under CPT/HCPCS Codes Group 1 Codes: added 0115U.

0115U RESPIRATORY INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA AND RNA), 18 VIRAL TYPES AND SUBTYPES AND 2 BACTERIAL TARGETS, AMPLIFIED PROBE TECHNIQUE, INCLUDING MULTIPLEX REVERSE TRANSCRIPTION FOR RNA TARGETS, EACH ANALYTE REPORTED AS DETECTED OR NOT DETECTED

Under ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: added the verbiage “and 0115U”. “These are the diagnosis codes corresponding to coverage of 87631, 0098U, 0099U, 0100U, and 0115U.”

This revision is retroactive effective for dates of service on or after 10/01/2019 (CR 11406).

Billing and Coding: Wound Care A55909 NA 02/09/2020

This article’s revision is related to the reconsideration process and medical literature submitted during the comment period 09/26/2019-11/10/2019. 

The following ICD-10 Codes have been added to Group One:
L89.012   Pressure ulcer of right elbow, stage 2
L89.022   Pressure ulcer of left elbow, stage 2
L89.112   Pressure ulcer of right upper back, stage 2
L89.122   Pressure ulcer of left upper back, stage 2
L89.132   Pressure ulcer of right lower back, stage 2
L89.142   Pressure ulcer of left lower back, stage 2
L89.152   Pressure ulcer of sacral region, stage 2
L89.212   Pressure ulcer of right hip, stage 2
L89.222   Pressure ulcer of left hip, stage 2
L89.312   Pressure ulcer of right buttock, stage 2
L89.322   Pressure ulcer of left buttock, stage 2
L89.42     Pressure ulcer of contiguous site of back, buttock and hip, stage 2
L89.512   Pressure ulcer of right ankle, stage 2
L89.522   Pressure ulcer of left ankle, stage 2
L89.612   Pressure ulcer of right heel, stage 2
L89.622   Pressure ulcer of left heel, stage 2
L89.812   Pressure ulcer of head, stage 2
L89.892   Pressure ulcer of other site, stage 2
L97.111   Non-pressure chronic ulcer of right thigh limited to breakdown of skin
L97.121   Non-pressure chronic ulcer of left thigh limited to breakdown of skin
L97.211   Non-pressure chronic ulcer of right calf limited to breakdown of skin
L97.221   Non-pressure chronic ulcer of left calf limited to breakdown of skin
L97.311   Non-pressure chronic ulcer of right calf limited to breakdown of skin
L97.321   Non-pressure chronic ulcer of left ankle limited to breakdown of skin
L97.411   Non-pressure chonic ulcer of right heel and midfoot limited to breakdown of skin
L97.421   Non-pressure chronic ulcer of unspecified part of left lower leg limited to breakdown of skin
L97.511   Non-pressure chronic ulcer of other part of right foot limited to breakdown of skin
L97.521   Non-pressure chronic ulcer of other part of left foot limited to breakdown of skin
L97.811   Non-pressure chronic ulcer of other part of right lower leg limited to skin breakdown
L97.821   Non-pressure chronic ulcer of other part of left lower leg limited to skin breakdown
L98.411   Non-pressure chronic ulcer of buttock limited to breakdown of skin
L98.421   Non-pressure chronic ulcer of back limited to breakdown of skin
L98.491   Non-pressure chronic ulcer of skin of other sites limited to breakdown of skin
L98.496   Non-pressure chronic ulcer of skin other sites with bone involvement without evidence of necrosis
L98.498   Non-pressure chronic ulcer of skin other sites with  other specified severity

The following ICD-10 codes have been removed from Group One due to more specific codes available: 
L97.912  Non-pressure chronic ulcer of unspecified part of right lower leg with fat layer exposed 
L97.913  Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of muscle 
L97.914  Non-pressure chronic ulcer of unspecified part of right lower leg with necrosis of bone 
L97.915  Non-pressure chronic ulcer of unspecified part of right lower leg with muscle involvement without evidence of necrosis 
L97.916  Non-pressure chronic ulcer of unspecified part of right lower leg with bone involvement without evidence of necrosis 
L97.918  Non-pressure chronic ulcer of unspecified part of right lower leg with other specified severity 
L97.922  Non-pressure chronic ulcer of unspecified part of left lower leg with fat layer exposed 
L97.923  Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of muscle 
L97.924  Non-pressure chronic ulcer of unspecified part of left lower leg with necrosis of bone 
L97.925  Non-pressure chronic ulcer of unspecified part of left lower leg with muscle involvement without evidence of necrosis 
L97.926  Non-pressure chronic ulcer of unspecified part of left lower leg with bone involvement without evidence of necrosis 
L97.928  Non-pressure chronic ulcer of unspecified part of left lower leg with other specified severity

Category III Codes L35490 PHYS-084 02/09/2020

Content updated related to reconsideration request for: 

CPT code 0254T: Endovascular repair of iliac artery bifurcation (e.g., aneurysm, pseudoaneurysm, arteriovenous malformation, trauma, dissection) using bifurcated endograft from the common iliac artery into both the external and internal iliac artery, including all selective and/or nonselective catheterization(s) required for device placement and all associated radiological supervision and interpretation, unilateral.

Analysis of Evidence CPT code 0254T:
The reconsideration request asserts, “the evidence supporting the use of the Gore® Excluder® IBE (with Gore® Excluder® AAA Endoprosthesis) is sufficiently robust to support that it is ‘reasonable and necessary’ under the Statute and the LCD.”  Wisconsin Physicians Service Government Health Administrators (WPS GHA) does not agree. The literature submitted for review is mostly retrospective studies with limitations well outlined by the respective authors. WPS GHA believes that the authors caution is warranted. Coverage is denied at this time.

CPT code 0355T: Gastrointestinal tract imaging, intraluminal (e.g., capsule endoscopy), colon, with interpretation and report.

Analysis of Evidence CPT code 0355T:
The reconsideration request asserts “ current published evidence and FDA approval support PillCam COLON 2 as a safe, effective and clinically meaningful diagnostic option in patients after an incomplete colonoscopy or for patients with evidence of a lower GI bleed with major risks for colonoscopy or moderate sedation.” Wisconsin Physicians Service Government Health Administrators (WPS GHA) does not agree. The literature submitted for review is mostly preliminary studies with an unjustified sample size with limitations well outlined by the respective authors. As well as the associated editorials. WPS GHA believes that the authors caution is warranted. Coverage is denied at this time.

Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.

Effective 01/01/2020 CPT/HCPCS Annual Update: deleted CPT 0254T. Providers are responsible for determining the correct diagnostic and procedural coding for the services they furnish to Medicare beneficiaries

Erythropoiesis Stimulating Agents (ESAs) L34633 INJ-023 02/09/2020

Content updated related to reconsideration request.

Coverage Indications, Limitations, and/or Medical Necessity: 
Added to Group C: Indications other than Renal Disease
8. Myelofibrosis. 

Summary of Evidence, Analysis of Evidence and Bibliography related to reconsideration request included.  

Please refer to A56975 Billing and Coding: Erythropoiesis Stimulating Agents (ESAs) 
Group 11 Paragraph Myelofibrosis
Group 11 Codes that support Medical Necessity and 
ICD-10 Codes that DO NOT Support Medical Necessity. 

Change Request References updated: added CR 11244 Discontinuing the Erythropoietin Stimulating Agent (ESA) Monitoring Policy System Edits under the End Stage Renal Dialysis Prospective Payment System (ESRD PPS)  Effective 01/01/2020.

Independent Diagnostic Testing Facilities- Physician Supervision and Technician Requirements A54943 NA 01/01/2020

Please see the 2020 CPT/HCPCS code update table for description changes, deleted and added codes.

Request for Coverage by an IDTF: 
Added CPT code 27369: 
Long Description: Injection of contrast for imaging of knee joint
Short Description: Njx cntrst kne arthg/ct/mri 
    
Supervising Physician Qualification Requirements: Radiologist or Orthopedic Surgeon
Technician Qualification: Physician Only Service

MolDX: myPath Melanoma Assay L37923 MolDX-053 12/26/2019

Added 0090U due to 3rd Quarter CPT/HCPCS code updates; effective 07/01/2019. 

CPT/HCPCS Codes
Group 1 Paragraph: NA
Group 1 Codes

0009U ONCOLOGY (CUTANEOUS MELANOMA), MRNA GENE EXPRESSION PROFILING BY RT-PCR OF 23 GENES (14 CONTENT AND 9 HOUSEKEEPING), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS A CATEGORICAL RESULT (IE, BENIGN, INDETERMINATE, MALIGNANT)

All of the coding in the LCD has been moved to the associated Billing and Coding article.

Wound Care L37228 G-SURG-056 02/09/2020

Added the following to CMS National Coverage Policy:
CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.
Change Request 10901, Local Coverage Determinations (LCDs)
42 Code of Federal Regulations (CFR) § 410.20 - Physicians' services

Added the following to Coverage Guidance:
Active wound care procedures are performed to remove necrotic tissue and/or devitalized tissue to promote healing.  Providers are responsible to determine medical necessity and use the appropriate current CPT/HCPCS code for service provided. Please consult the current AMA CPT book for the complete code description of the procedures being performed to submit claims.

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for additional wound care. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for additional wound care sessions and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies are provided under CMS National Coverage Policy section.

Debridement section added: 

  • Pressure Injury
  • Stage II
  • Diabetic Foot Ulcer(s)

Should deep tissue pressure injury or Stage II injury progress to Unstageable, Stage III or Stage IV requiring debridement then documentation supporting this must be included in the medical record.

 Evaluation and Management Section has been revised and the following has been removed:  
The following services may be done during wound care services and can be medically necessary, but they are not considered wound debridement services and wound debridement CPT codes should not be used. 

  • Removal of necrotic tissue by cleansing, scraping (other than by a scalpel or a curette), chemical application, or dry-to-dry or wet-to dry dressing.  Generally, dressing changes are not considered a skilled service. The prior dressings are different and distinct from wet-to-moist dressings that are used for removal of devitalized tissue from wound(s) for non-selective debridement.
  • Washing bacterial or fungal debris from lesions.
  • Removal of secretions and coagulation serum from normal skin surrounding an ulcer.
  • Dressing of small or superficial lesions.
  • Removal of fibrinous material from the margin of an ulcer.
  • Paring or cutting of corns or non-plantar calluses. Skin breakdown under a dorsal corn that begins to heal when the corn is removed, and shoe pressure eliminated is not considered an ulcer that requires debridement unless there is extension into the subcutaneous tissue.
  • Incision and drainage of abscess including paronychia, trimming or debridement of mycotic nails, avulsion of nail plates, acne surgery, or destruction of warts. 
  • Removal of non-tissue integrated fibrin exudates, crusts, biofilms or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such.
  • While mechanical debridement is a valuable technique for healing ulcers, it does not qualify as a surgical wound debridement service, and therefore should not be coded as such. 
  • Scraping the base of the wound bed to induce bleeding, following the removal of devitalized tissue, is not considered to be a separately billable service.
  • Removing a collar of callus (hyperkeratotic tissue) around an ulcer is not debridement of skin or necrotic tissue and should not be billed as debridement unless additional partial full skin thickness tissue directly deep to the callus is removed as well.
  • Infrared, ultrasound thermal and phototherapy-ultraviolet modalities are not considered debridement services.

Negative Pressure Wound Therapy  has been revised and the following has been removed
For disposable NPWT (dNPWT) devices, this contractor recommends following manufacturer’s instructions but, generally be limited to a maximum of 4 applications per 30 days.  

NPWT services should not exceed a 120-day period. It is expected a licensed medical professional must directly assess the wound(s) being treated with NPWT and supervise or directly perform the NPWT dressing changes. It is expected there will be an evaluation with documentation of the wound’s dimensions and characteristics conducted every 30 days. 

NWPT coverage would end, and the pump and/or supplies will be denied as not reasonable and necessary with any of the following, whichever occurs earliest.

  1. In the judgment of the treating physician, adequate wound healing has occurred to the degree that NPWT may be discontinued, 
  2. Any measurable degree of wound healing has failed to occur over the prior month. Wound healing is defined as improvement occurring in either surface area (length times width) or depth of the wound.
  3. One hundred twenty (120) days (including the time NPWT was applied in an inpatient setting prior to discharge to the home) have elapsed using NPWT in the treatment of the most recent wound. 

Documentation Section revision completed
When wound care is provided by the Physical Therapist, for both in and out patient wound care, the medical record is required to have the following documentation: 

Physician order(s) for therapy /wound care services and signed plan of treatment (also known as a plan of care) detailing treatment modalities for therapy/wound care services must be established as soon as possible or within 30 days.

Every 10 days progress notes to include current wound status, measurements (including size and depth), and the treatment provided.

Utilization Guidelines has been revised and the following  two statements have been removed:
For disposable NPWT (dNPWT) devices, this contractor recommends following manufacturer’s instructions but, generally be limited to a maximum of 4 applications per 30 days.  

Negative Pressure Wound Therapy services should not exceed a 120-day period. There should be no more than 4 dressing changes per wound per month for the majority of wounds. With dNPWT, there should be a maximum of 4 new disposable NPWT per month. It is expected there will be an evaluation with documentation for a wound(s) every 30 days. 

Added Summary of Evidence, Analysis of Evidence, and Bibliography related to Comment Period (09/26/2019 – 11/10/2019)

 

To access Local Coverage Determinations (LCDs) and Coverage Articles from the WPS GHA website, please visit our Local Coverage Determinations (LCDs) and Coverage Articles web page. You can also access LCDs and Coverage Articles in the CMS Medicare Coverage Database