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.

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.

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.

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

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

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.

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 . Accessed 11/13/2019

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

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:

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

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:

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

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.

    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.

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).

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

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

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.

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

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

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

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

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)

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.

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.

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.

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

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

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.

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 . Accessed 11/13/2019

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

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:

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

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:

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

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.

    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.

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).

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

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

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.

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

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

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

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

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)