Palmetto Billing Guidance for Chemotherapy Drugs

on Tuesday, 13 November 2018. All News Items | Medicare Coverage

Must Versus Should

A few weeks ago, we ran a Wednesday@One article about changes to Medicare’s Local Coverage Determination (LCD) process. From section 13.1.2 of the Program Integrity Manual, “An LCD… is a determination by a Medicare Administrative Contractor (MAC) respecting whether or not a particular item or service is covered on a contractor–wide basis in accordance with section 1862(a)(1)(A) of the Act.” But did you notice in the revised guidance that it will no longer be appropriate to routinely include CPT or ICD-10-CM codes in the LCD? All codes will be removed from LCDs and placed in billing & coding articles that are linked to the LCD. This constitutes a major change in the way providers have used LCDs and articles. Evidently LCDs will be more similar to the current format of National Coverage Determinations (NCDs) with just the coverage information, and all billing and coding information will be shifted to coverage articles.

This month, Palmetto GBA, released an article for Jurisdictions J and M, concerning Billing and Coding for Chemotherapy effective November 1, 2018. The article provides billing guidance for chemotherapeutic agents that have designated “J” codes. The article clarifies that ICD-10 diagnosis codes that support medical necessity of a chemotherapy drug may be listed in the article but, even if not listed include all FDA approved indications, NCCN 2B and better and Compendia approved indications rated as CAT III or better. Other off-label uses may be identified with the KX modifier when supported by clinical research. Off-label usages will be subject to review at the discretion of Palmetto GBA. Providers should submit full articles, not abstracts, to support off-label uses if the claim is selected for review by Palmetto.

The Palmetto article provides the necessary information to be included in box 19 of the CMS-1500 Claim Form or the electronic equivalent for Part B or in the remarks field (Field Locator 80) of the CMS-1450 (UB-04) Claim Form or the electronic equivalent for Part A. The article lists 37 code groups (usually only one J code), the ICD-10 diagnosis codes supporting medical necessity for some, and the narrative that must appear in the remarks field if necessary.

For example, for J9023, Injection Avelumab, 10 mg, the article includes the following paragraphs and also lists covered diagnosis codes for group 11 codes further down in the article.

“Group 11 Paragraph:
Bavencio® (Avelumab)

Bavencio® is a cancer immunotherapy designed for the treatment of metastatic merkel cell carcinoma, and advanced or metastatic urothelial carcinoma with disease progression during or following platinum containing chemotherapy or progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Narrative must include documentation of the metastatic level of merkel cell carcinoma, or for advanced or metastatic urothelial carcinoma, evidence of prior platinum-containing chemotherapy.” (underlining emphasis added)

Not all drugs include narrative requirements, but for those that do, some paragraphs state “the narrative must include…” while others say “the narrative should include…” It is unknown if this is simply a word difference or an indication of mandatory versus optional requirements. The article does not indicate what will happen if the narrative is not included in the remarks section of the claim – will the claim deny, return to provider, be subject to medical review, or be paid if an appropriate diagnosis code is on the claim? I will try to get additional information from Palmetto concerning these requirements and will share that information with readers if/when I receive it.

In the meantime, I suggest JJ and JM providers read this new coverage article carefully, follow the guidance as best you can, and monitor the status of your chemotherapy claims. Providers may consider installing claim processing edits to hold the affected claims for further internal review to be sure the comment field is completed. Also, billing and medical oncology MUST collaborate in order for this to work since billers will have no way to know this information without input from the department.

Palmetto has already conducted complex medical reviews of several drugs. They have denied claims when dosing and treatment guidelines/protocols consistent with package insert instructions were not ordered and/or followed. For example, Palmetto has denied the drug Rituxan for the treatment of rheumatoid arthritis if the patient is not concurrently taking Methotrexate. If a drug treatment protocol ordered is different than the disease-specific treatment protocol referenced in the package insert, persuasive physician documentation is recommended to explain the circumstances of why an alternate protocol was medically necessary. Off-label usages should also be supported by appropriate medical literature.

Other LCD and coverage article updates from last month are listed in the table below.

 

Palmetto JJ and JM Coverage Updates

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37612  MolDX: Corus® CAD Assay  11/5/2018 N/A  N/A  9/14/2018 New
L36143  MolDX: NSCLC, Comprehensive Genomic Profile Testing  10/1/2015 4/12/2018 9/24/2018 9/24/2018 Retired
A56141  Billing and Coding for Chemotherapy  11/1/2018 N/A N/A 10/24/2018 New

CGS J15 Coverage Updates

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
A56175  Low frequency, non-contact, non-thermal ultrasound (CPT code 97610)  11/1/2018 11/1/2018 N/A 10/25/2018 New
ID Title Comment Start Date Comment End Date Final   Status
DL37832  MolDX: Breast Cancer IndexTM (BCI) Gene Expression Test  11/15/2018 12/29/2018 No   Draft
DL37834  MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease  11/15/2018 12/29/2018 No   Draft
DL37905  MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test  11/15/2018 12/29/2018 No   Draft
DL37903  MolDX: Inivata, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer  11/15/2018 12/29/2018 No   Draft
DL37907  MolDX: myPath Melanoma Assay  11/15/2018 12/29/2018 No   Draft
DL37909  MolDX: NeuroIDgenetix® Test for Depression  11/15/2018 12/29/2018 No   Draft
DL37836  MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC)  11/15/2018 12/29/2018 No   Draft

First Coast JN

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L33538  Radiation Therapy for T1 Basal Cell and Squamous Cell Carcinomas of the Skin  10/1/2015 10/1/2018 10/18/2018 10/18/2018 Retired 
L34029  Urinalysis  10/1/2015 5/12/2017 10/16/2018 10/16/2018 Retired 
A56179  Insertion of anterior segment aqueous drainage device – Current Procedural Terminology (CPT®) codes 0191T, 0474T and 0449T  10/31/2018 N/A N/A 10/31/2018 New

National Government Services J6 and JK

No updates this month

Noridian JE

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37649  MolDX: Guardant360® Plasma-Based Comprehensive Genomic Profiling in Non-Small Cell Lung Cancer (NSCLC)  10/20/2018 N/A  N/A  8/21/2018 New
L37373  MRI and CT Scans of the Head and Neck  10/8/2018 10/8/2018 N/A  11/2/2018 New
L34133  Cranial Computerized Tomography (CCT) Scans  10/1/2015 10/1/2017 10/7/2018 10/7/2018 Retired 
L36194  MolDX: NSCLC, Comprehensive Genomic Profile Testing  4/15/2016 1/1/2018 9/24/2018 9/26/2018 Retired 
A56155  Use of Amniotic Membrane Derived Skin Substitutes  11/8/2018 N/A N/A 11/1/2018 New

Noridian JF

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37651  MolDX: Guardant360® Plasma-Based Comprehensive Genomic Profiling in Non-Small Cell Lung Cancer (NSCLC)  10/20/2018 N/A  N/A  8/21/2018 New
L36198  MolDX: NSCLC, Comprehensive Genomic Profile Testing  4/15/2016 1/1/2018 9/24/2018 9/26/2018 Retired 
A56156  Use of Amniotic Membrane Derived Skin Substitutes  11/8/2018 N/A N/A 11/1/2018 New

Novitas JH and JL

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L34999  Transoral Incisionless Fundoplication  10/1/2015 11/9/2017 10/25/2018 10/25/2018 Retired 
L34861  Infrared Photocoagulation (IRC) of Hemorrhoids  10/1/2015 12/30/2015 10/4/2018 10/4/2018 Retired 
L35047  Oral Maxillofacial Prosthesis  10/1/2015 2/8/2018 10/4/2018 10/4/2018 Retired 
L35679  Pharmacokinetic (PK) Testing for Chemotherapy Dosing  10/1/2015 1/1/2018 10/4/2018 10/4/2018 Retired 

WPS J5 and J8

IDTitleEffective DateRevision Effective DateEnd DateLast UpdatedStatus
L37671  MolDX: Guardant360® Plasma-Based Comprehensive Genomic Profiling in Non-Small Cell Lung Cancer (NSCLC)  10/17/2018 10/17/2018 N/A  9/19/2018 New
L36803  MolDX: NSCLC, Comprehensive Genomic Profile Testing  2/16/2017 6/1/2018 11/1/2018 11/1/2018 Retired 
A56157  Intraarticular Knee Injections of Hyaluronan Billing Guidelines  12/1/2018 N/A N/A 10/1/2018 New
A55703  Coding for Hemodialysis Sessions  9/15/2018 N/A N/A 3/16/2018 New

 

Article by Debbie Rubio

Debbie Rubio, BS, MT (ASCP), is the Manager of Regulatory Affairs and Compliance at Medical Management Plus, Inc. Debbie has over twenty-seven years of experience in healthcare including nine years as the Clinical Compliance Coordinator at a large multi-facility health system. In her current position, Debbie monitors, interprets and communicates current and upcoming regulatory and compliance issues as they relate to specific entities concerning Medicare and other payers. You may contact Debbie at This email address is being protected from spambots. You need JavaScript enabled to view it..

This material was compiled to share information. MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.

 

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