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January 2019 Local Coverage Determination (LCD)/Coverage Article Updates
Last updated May 09 2019
Jurisdictions:

WPS GHA policy staff review and revise Local Coverage Determinations (LCDs) and Coverage Articles to ensure that all information remains accurate and up-to-date. When new LCDs and coverage articles are created, and when current LCDs and coverage articles are revised or retired, a summary of these updates is made available on our website. 

Please note: These changes will not be reflected in the LCDs and coverage articles until December 27, 2018.


New Policies/Articles

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
Billing and Coding Guidelines for Foot Care A56232 NA 02/16/2019
This article contains the billing and coding guidance that was in our L36404 Foot Care LCD.
Frequency of Hemodialysis L37537 RENAL-001 02/16/2019
MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs) L37766 MolDX-043 02/16/2019
MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) L37915 MolDX-047 02/16/2019
Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
Billing and Coding Guidelines for Foot Care A56232 NA 02/16/2019
This article contains the billing and coding guidance that was in our L36404 Foot Care LCD.
Frequency of Hemodialysis L37537 RENAL-001 02/16/2019
MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs) L37766 MolDX-043 02/16/2019
MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) L37915 MolDX-047 02/16/2019
Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
Billing and Coding Guidelines for Foot Care A56232 NA 02/16/2019
This article contains the billing and coding guidance that was in our L36404 Foot Care LCD.
MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs) L37766 MolDX-043 02/16/2019
MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) L37915 MolDX-047 02/16/2019
Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
Billing and Coding Guidelines for Foot Care A56232 NA 02/16/2019
This article contains the billing and coding guidance that was in our L36404 Foot Care LCD.
MolDX: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification Tests (NAATs) L37766 MolDX-043 02/16/2019
MolDX: Oncotype DX AR-V7 Nucleus Detect for Men with Metastatic Castrate Resistant Prostate Cancer (MCRPC) L37915 MolDX-047 02/16/2019

 

Retired Policies/Articles

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
Foot Care L36404 FT-002 02/15/2019

This LCD is being retired due to Change Request 10901 Local Coverage Determinations (LCDs) which does not allow us to include national policy language in our LCDs. Please see our new coverage article A56232 Billing and Coding Guidelines for Foot Care.

Coverage information can be found in the CMS Internet-Only Manual (IOM) Publication, 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 290 – Foot Care, and in the CMS IOM Publication 100-03, Medicare National Coverage Determination Manual, Section 70.2.1 – Services Provided for the Diagnosis and Treatment of Diabetic Sensory Neuropathy with Loss of Protective Sensation (aka Diabetic Peripheral Neuropathy). For information on the exclusion of payment for routine foot care see: 42 CFR Section 411.15 Particular services excluded from coverage and Title XVIII of the Social Security Act, section 1862 (a)(13)(C).

 

Revised Policies/Articles

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
2019 CPT/HCPCS Code Updates NA NA 01/01/2019
2019 CPT/HCPCS Code Update PDF Icon
Category III Codes L35490 PHYS-084 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Deleted the Group 3 codes for leadless pacemaker.
0387T Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular 
0389T Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report, leadless pacemaker system 
0390T Peri-procedural device evaluation (in person) and programming of device system parameters before or after surgery, procedure or test with analysis, review and report, leadless pacemaker system 
0391T Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system 

Removed the corresponding Group 3 Paragraph.
Group 3 Paragraph: For Part B only. Effective for dates of service on or after January 18, 2017, contractors shall cover leadless pacemakers through CED when procedures are performed in CMS-approved CED studies per NCD 20.8.4.

Removed the corresponding Group 3 Paragraph.
For Part B only. The following ICD-10 Codes are used to support medical necessity with CPT codes 0387T, 0389T, 0390T and 0391T.

Removed the corresponding Group 3 table of ICD-10 diagnosis code.
Z00.6 Examination for examination for normal comparison and control in clinical research program

Removed the following Utilization Guidelines language.
0387T, 0389T, 0390T, and 0391T For Part B only.
The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead which are integral elements of traditional pacing systems. The removal of these elements eliminate an important source of complications associated with traditional pacing systems while providing similar benefits. Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single-chamber ventricular pacemakers. Effective January 18, 2017, the Centers for Medicare & Medicaid Services (CMS) covers leadless pacemakers through Coverage with Evidence Development (CED). CMS covers leadless pacemakers when procedures are performed in Food and Drug Administration (FDA) approved studies. CMS also covers, in prospective longitudinal studies, leadless pacemakers that are used in accordance with the FDA approved label for devices that have either:
-    an associated ongoing FDA approved post-approval study; or
-    completed an FDA post-approval study.
Please see NCD for Leadless Pacemakers (20.8.4) for claims processing instructions (see CR 10117, Transmittal #3815, dated 07/28/2017). 

Removed the Related National Coverage Documents, 20.8.4 Leadless Pacemakers.

(The leadless pacemaker system now has true codes.)

Coding for Hemodialysis Sessions A55703 NA 02/16/2019

Formatting changes made.
 
Changed Plan of Care (POC) to Dialysis Orders in the Article Text.

Added the following statement #4 to the scheme of billing:
4. For medically appropriate and necessary dialysis exceeding 14 treatments per month and outlined in the Dialysis Orders. Some patients due to chronic or long term conditions may require dialysis that exceeds the usually covered 14 treatments per month. The number of additional treatment and the reasoning behind the order needed to be present in the dialysis documentation. The additional treatments will be noted as 90999KX on the claim, and will be considered for additional payment. Omission of the KX modifier will result in the sessions paid as the conventional dialysis at 3 X per week.

Added the following Bill Type Code: 
072X Clinic - Hospital Based or Independent Renal Dialysis Center

Added the following Revenue Codes: 
0821 Hemodialysis - Outpatient or Home-Hemodialysis Composite or Other Rate
0881 Miscellaneous Dialysis - Ultrafiltration.

Added the following CPT code:
 90999 Unlisted dialysis procedure, inpatient or outpatient

Added the following Revision History statement:
The original effective date is posted as 09/15/2018 but should be 02/16/2019 to match the original effective date of the associated LCD Frequency of Hemodialysis, L37537.

Coding Radiopharmaceutical Agents A55052 NA 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Added the following verbiage in Miscellaneous Radiopharmaceuticals section: 
10.  A9513 Lutetium lu 177, dotatate, therapeutic, 1 millicurie
       For the treatment of adult patients with somatostatin receptor-positive 
       gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 
       (CPT 79101) 
             
11.  A9589 Instillation, hexaminolevulinate hydrochloride, 100 mg
       A diagnostic agent instilled into the bladder for detection of carcinoma of the bladder. (CPT 52000, 52204, 52214                   
       - 55240.

Typographical error noted in Section A Line 9 of incorrect listing of CPT code 78652; correction made: CPT code 78650.

Erythropoiesis Stimulating Agents (ESAs) L34633 INJ-023 01/01/2019

CMS National Coverage Policy Section Added: 
CR 10859 Transmittal 2200 Issued 11/02/2018: Tenth Revisions (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2019 

CR 11005 Transmittal 2202 Issued 11/9/2018  International Classification of Diseases, 10th Revision, (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2017.

Group 4 Paragraph:
C. Indications other than Renal Disease
1. Anemias related to therapy with Zidovudine (AZT)

Added to Group 4 Codes: 

D61.1 Drug-induced aplastic anemia 

Group 6 Codes added:
Z79.899*  Other long term (current) drug therapy.

Removed Group 7 Paragraph and Group 7 Codes. 
Group 7 Code Z79.899*  relocated to Group 6  Code table.

Group 10 Paragraph:
Removed: Dual Diagnosis necessary for J0881, J0885, and Q5106 and 
Replaced: Both Diagnoses necessary for J0881, J0885, and Q5106.

Group 10 Codes added:
Z01.818  Encounter for other preprocedural examination
Removed Group 12 Paragraph and Group 12 Codes.
Group 12 Code Z01.818 relocated to Group 10 Code table.

Reformatted numerical order of paragraphs and code tables.

Group C: Indications other than Renal Disease
Anemia associated with cancer and related Neoplastic conditions. 
Added: This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to NCD 110.21 for the use of ESAs in cancer and related neoplastic conditions. 

Group 6 Paragraph
Anemia associated with chemotherapeutic medications when medically necessary for a non-cancer diagnosis or following stem cell transplantation and associated immunosuppression. 
Added: This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to NCD 110.21 for the use of ESAs in cancer and related neoplastic conditions. 
See CMS Publication 100-03 Medicare National Coverage Determinations (NCD) Manual Chapter 1- Coverage Determinations, Part 2 Section 110.21 - Erythropoiesis Stimulating Agents (ESA’s) in Cancer and Related Neoplastic Conditions.

Human Granulocyte/Macrophage Colony Stimulating Factor L34699 INJ-019 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Long description change Q5101: Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram

Group 1 Paragraph removed from free text:
Q5108  Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110  Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram

Group 1 Paragraph added to free text:
C9399/J3490 Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg 

Group 1 Codes added to Table:
C9399    Unclassified Drugs or Biologicals
J3490    Unclassified Drugs
J3590    Unclassified Biologics
Q5108    Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110    Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram


Coverage Indication, Limitations, and/or Medical Necessity created:
J.  Indications for Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg (C9399/J3490).  FDA approval date 11/02/2018. Effective date 11/02/2018.
    
1. Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies   receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

Created Group 10 Paragraph 
C9399/J3490 Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg

Created Group 10 Codes
D61.810    Antineoplastic chemotherapy induced pancytopenia
D70.1        Agranulocytosis secondary to cancer chemotherapy
T45.1X5A  Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D  Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S  Adverse effect of antineoplastic and immunosuppressive drugs, sequela
Z51.11       Encounter for antineoplastic chemotherapy
Z92.21       Personal history of antineoplastic chemotherapy

Added Not Otherwise Classified Drug Billing

Not Otherwise Classified (NOC) codes are used when there is absolutely no existing true code for the service, procedure, drug or biological being provided. Claims utilizing “J”/NOC codes are subject to Medical Review.
When a specific HCPCS code does not exist, list the appropriate “J”/NOC code:
J3490: Unclassified drugs
J3590: Unclassified biologics or
J9999: Not otherwise classified, antineoplastic drugs.

When an NOC code is billed, documentation must identify specifically for what the NOC code is being billed for, supporting the service, procedure, and drug biological being provided.
Coverage for medication is based on the patient’s condition, the appropriateness of the dose and route of administration, based on the clinical condition and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition.

The HCPCS is updated annually to reflect changes in the practice of medicine and provision of health care. CMS posts on its Web site the annual alpha-numeric HCPCS file for the upcoming year, historically, at the end of each October. Providers are encouraged to access CMS web site to see the new, revised, and discontinued alpha-numeric codes for the upcoming year.

Office/Clinic Coding

When using a drug Unclassified/NOC code (J3490, J3590, J9999) list the name of the drug, the amount of the drug that is administered and wasted if applicable, strength of dosage if appropriate; method of administration in the electronic narrative 2400/SV101-7 which is equivalent to line 19 of the CMS 1500 form.  List the units of service as one in 2400/SV1-04 data element of the ANSI 837 5010 or in item 24G of the CMS 1500 form.
    
Occasionally, the strength of the drug will also be needed on NOC claims.  If the NOC ASP pricing file lists the name of the drug with its strength it must also be included on line 19. Example: Sodium Bicarbonate 8.4%.
    
Hospital Outpatient Departments Coding
    
Hospital outpatient departments are allowed to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the FDA on or after January 1, 2004 for which pass-through status has not been approved and a C-code and APC payment have not been assigned using the “unclassified” drug/biological HCPCS code C9399 (Unclassified drugs or biological). Drugs, biologicals, and therapeutic radiopharmaceuticals that are assigned to HCPCS code C9399.

List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed.)

As you may know, pricing for NOC J-codes is determined by the information provided on the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug on the file, this indicates that the drug comes in different strengths. Medicare payment varies depending on the strength given. When billing Medicare for an NOC J-code, you can determine if the drug comes in different strengths by accessing the ASP NOC pricing files on the CMS website.

Please refer to Not Otherwise Classified (NOC) Billing
MolDX: BDX-XL2 /formerly MolDX: Xpresys Lung L37216 MolDX-030 01/01/2019

The title of this LCD has been changed from MolDX: Xpresys Lung to MolDX: BDX-XL2.  All references to Xpresys Lung have been changed to BX-XL2 throughout this document.  

The following information was removed from the Coverage Summary section:

  • The test is ordered by a physician certified in the XL2 Certification and Training Registry (CTR), and
  • The following information is recorded: all clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors; PET result (if used), physician pre-test risk assessment, physician post-test lung nodule management recommendation, any subsequent procedures (non-invasive or invasive), and clinical diagnosis based on those procedures (i.e., benign or malignant)

The Strength of the evidence has been changed from limited to Moderate:
Analysis of Evidence
(Rationale for Determination)
Level of evidence
Quality-Moderate
Strength- Moderate
Weight – Limited

The following information has been added to the policy:
Data collected by Biodesix through ongoing studies will support utility including:

  • All clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors;
  • PET result (if used),
  • Physician-assessed pre-test cancer risk assessment,
  • Physician post-test lung nodule management recommendation,
  • Any subsequent procedures (non-invasive or invasive), and
  • Clinical diagnosis based on those procedures (i.e., benign or malignant).
MolDX: BRCA1 and BRCA2 Genetic Testing L36813 MolDX-007 01/01/2019

The section on Multigene Panels has been updated.  It now reads as follows:

Multigene Panels***

The indications and limitations of coverage listed in National Coverage Determination (NCD) 90.2 (Next Generation Sequencing- NGS) apply to genetic testing for susceptibility to breast or ovarian cancer. While the NGS NCD Section 90.2 B describes specific coverage criteria for nationally covered tests, Section 90.2D permits coverage of other NGS as a diagnostic laboratory test for patients with cancer when performed and ordered according to the requirements described by the NCD. According to Section D of the NGS NCD AB Medicare Administrative Contractors (AB MACs) may cover next generation sequencing tests in patients with cancer. As such, genetic testing for susceptibility to breast or ovarian cancer with multi¬-gene NGS panels (not otherwise covered under NCD 90.2 Section B) may be covered by this AB MAC as reasonable and necessary when ALL of the NCD criteria are met in addition to the following:

  • Pre¬test genetic counseling by a cancer genetics professional has been performed and post¬test genetic counseling by a cancer genetics professional meeting NCCN accreditation criteria is planned;
  • All genes in the panel are relevant to the personal and family history for the individual being tested (panels with genes that are not relevant to the individual’s personal and family history are not reasonable and necessary);
  • Criteria listed under "Personal History of Female Breast Cancer" and/or "Personal History of Other Cancer" are met.
  • Individual also meets criteria for at least ONE hereditary cancer syndrome for which NCCN guidelines provide clear testing criteria and management recommendations, including but not limited to HBOC, Li¬Fraumeni Syndrome, Cowden Syndrome, or Lynch Syndrome.

CMS National Coverage Policy
National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS), which describes the criteria under which contractors may cover NGS laboratory tests for patients with cancer.

MolDX: CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing L36398 MolDX-002 01/01/2019
The title of this LCD has been changed from MolDX: Genetic Testing for CYP2C19, CYP2D6, CYP2C9, and VKORC1 to MolDX: CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing.
MolDX: Molecular Diagnostic Tests (MDT) L36807 MolDX-004 01/01/2019

G0452 has been removed from this LCD effective 09/28/2017:
G0452 Molecular pathology procedure: physician interpretation and report.

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Not Otherwise Classified Chemotherapy Agents (NOC) Billing and Coding Guidelines A55640 NA 01/01/2019

The title of this Article has been changed from Not Otherwise Classified Chemotherapy Agents (NOC) to Not Otherwise Classified Chemotherapy Agents (NOC) Billing and Coding Guidelines.

CPT/HCPCS Code annual update 
Group 1 Paragraph: 
Removed J9999/C9467 Rituximab and hyaluronidase human/Rituxin Hycela.
True code assigned: J9311

Please refer to LCD L37205 Chemotherapy Drugs and their Adjuncts for Coverage Indications, Limitations, and/or Medical Necessity.

Removed: 
When an NOC code is billed, two separate documents will be required to support the claim:

  • The document which supports the service, procedure, drug biological being provided. 
  • A separate document which identifies specifically for what the NOC code is being billed.

Replaced with:
When an NOC code is billed, documentation must identify specifically for what the NOC code is being billed, supporting the service, procedure, and drug biological being provided.

Added supporting Not Otherwise Classified (NOC) Billing guidance to Article Text: 

 List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed.)

Pricing for NOC J-codes is determined by the information provided on the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug, this indicates that the drug comes in different strengths. Medicare payment varies depending on the strength given. When billing Medicare for an NOC J-code, please access the ASP NOC pricing files on the CMS website to determine the different strengths. 

Please refer to Not Otherwise Classified (NOC) Billing

Psychological and Neuropsychological Testing & Billing and Coding Guidelines L34646 PSYCH-017 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Removed the following statement from the Coverage Guidelines section entitled Psycological testing: CPT codes 96101, 96102, 96103, 96105, 96111.

Removed the following statement from the Coverage Guidelines section entitled Neuropsychological Testing: CPT codes 96116, and 96118, 96119 and 96120.

Removed the following statement from 5. Feedback session: This service is usually billed with CPT coode 96118. 

Added the following statement to the Billing and Coding Guideline:
*Please note this section of the IOM was last updated effective 01/01/2006 and codes 96101, 96102, 96103, 96111, 96118, 96119 and 96120 are deleted effective 12/31/2018.

Removed the following italicized IOM quoted language in the Billing and Coding Guideline because it refers to deleted codes:
Medicare Part B coverage of psychological tests and neuropsychological tests is authorized under section 1861(s)(3) of the Social Security Act. Payment for psychological and neuropsychological tests is authorized under section 1842(b)(2)(A) of the Social Security Act. The payment amounts for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are effective January 1, 2006, and are billed for tests administered by a technician or a computer reflect a site of service payment differential for the facility and non-facility settings. Additionally, there is no authorization for payment for diagnostic tests when performed on an “incident to” basis. 

Under the diagnostic tests provision, all diagnostic tests are assigned a certain level of supervision. Generally, regulations governing the diagnostic tests provision require that only physicians can provide the assigned level of supervision for diagnostic tests. However, there is a regulatory exception to the supervision requirement for diagnostic psychological and neuropsychological tests in terms of who can provide the supervision. That is, regulations allow a clinical psychologist (CP) or a physician to perform the general supervision assigned to diagnostic psychological and neuropsychological tests.
 
In addition, nonphysician practitioners such as nurse practitioners (NPs), clinical nurse specialists (CNSs) and physician assistants (PAs) who personally perform diagnostic psychological and neuropsychological tests are excluded from having to perform these tests under the general supervision of a physician or a CP. Rather, NPs and CNSs must perform such tests under the requirements of their respective benefit instead of the requirements for diagnostic psychological and neuropsychological tests. Accordingly, NPs and CNSs must perform tests in collaboration (as defined under Medicare law at section 1861(aa)(6) of the Act) with a physician. PAs perform tests under the general supervision of a physician as required for services furnished under the PA benefit. 

Furthermore, physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill three test codes as “sometimes therapy” codes. Specifically, CPT codes 96105, and 96111 may be performed by these therapists. However, when PTs, OTs and SLPs perform these three tests, they must be performed under the general supervision of a physician or a CP.

Who May Bill for Diagnostic Psychological and Neuropsychological Tests 

  • CPs – see qualifications under chapter 15, section 160 of the Benefits Policy Manual, Pub. 100-02. 
  • NPs –to the extent authorized under State scope of practice. See qualifications under chapter 15, section 200 of the Benefits Policy Manual, Pub. 100-02. 
  • CNSs –to the extent authorized under State scope of practice. See qualifications under chapter 15, section 210 of the Benefits Policy Manual, Pub. 100-02. 
  • PAs – to the extent authorized under State scope of practice. See qualifications under chapter 15, section 190 of the Benefits Policy Manual, Pub. 100-02. 
  • Independently Practicing Psychologists (IPPs)
  • PTs, OTs and SLPs – see qualifications under chapter 15, sections 220-230.6 of the Benefits Policy Manual, Pub. 100-02. 

Psychological and neuropsychological tests performed by a psychologist (who is not a CP) practicing independently of an institution, agency, or physician’s office are covered when a physician orders such tests. An IPP is any psychologist who is licensed or certified to practice psychology in the State or jurisdiction where furnishing services or, if the jurisdiction does not issue licenses, if provided by any practicing psychologist. (It is CMS’ understanding that all States, the District of Columbia, and Puerto Rico license psychologists, but that some trust territories do not. Examples of psychologists, other than CPs, whose psychological and neuropsychological tests are covered under the diagnostic tests provision include, but are not limited to, educational psychologists and counseling psychologists.) 

The A/B MAC (B) must secure from the appropriate State agency a current listing of psychologists holding the required credentials to determine whether the tests of a particular IPP are covered under Part B in States that have statutory licensure or certification. In States or territories that lack statutory licensing or certification, the A/B MAC (B) checks individual qualifications before provider numbers are issued. Possible reference sources are the national directory of membership of the American Psychological Association, which provides data about the educational background of individuals and indicates which members are board-certified, the records and directories of the State or territorial psychological association, and the National Register of Health Service Providers. If qualification is dependent on a doctoral degree from a currently accredited program, the A/B MAC (B) verifies the date of accreditation of the school involved, since such accreditation is not retroactive. If the listed reference sources do not provide enough information (e.g., the psychologist is not a member of one of these sources), the A/B MAC (B) contacts the psychologist personally for the required information. Generally, A/B MACs (B) maintain a continuing list of psychologists whose qualifications have been verified. 

NOTE: When diagnostic psychological tests are performed by a psychologist who is not practicing independently, but is on the staff of an institution, agency, or clinic, that entity bills for the psychological tests. 

The A/B MAC (B) considers psychologists as practicing independently when: 
1. They render services on their own responsibility, free of the administrative and professional control of an employer such as a physician, institution or agency;
2. The persons they treat are their own patients; and 
3. They have the right to bill directly, collect and retain the fee for their services. 

A psychologist practicing in an office located in an institution may be considered an independently practicing psychologist when both of the following conditions exist:

1. The office is confined to a separately-identified part of the facility which is used solely as the psychologist’s office and cannot be construed as extending throughout the entire institution; and
2. The psychologist conducts a private practice, i.e., services are rendered to patients from outside the institution as well as to institutional patients. 

Payment for Diagnostic Psychological and Neuropsychological Tests 
Expenses for diagnostic psychological and neuropsychological tests are not subject to the outpatient mental health treatment limitation, that is, the payment limitation on treatment services for mental, psychoneurotic and personality disorders as authorized under Section 1833(c) of the Act. The payment amount for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are billed for tests performed by a technician or a computer reflect a site of service payment differential for the facility and non-facility settings. CPs, NPs, CNSs and PAs are required by law to accept assigned payment for psychological and neuropsychological tests. However, while IPPs are not required by law to accept assigned payment for these tests, they must report the name and address of the physician who ordered the test on the claim form when billing for tests. 

CPT Codes for Diagnostic Psychological and Neuropsychological Tests 
The range of CPT codes used to report psychological and neuropsychological tests is 96101-96120. CPT codes 96101, 96102, 96103, 96105, and 96111 are appropriate for use when billing for psychological tests. CPT codes 96116, 96118, 96119 and 96120 are appropriate for use when billing for neuropsychological tests. 

All of the tests under this CPT code range 96101-96120 are indicated as active codes under the physician fee schedule database and are covered if medically necessary. 

Payment and Billing Guidelines for Psychological and Neuropsychological Tests 
The technician and computer CPT codes for psychological and neuropsychological tests include practice expense, malpractice expense and professional work relative value units. Accordingly, CPT psychological test code 96101 should not be paid when billed for the same tests or services performed under psychological test codes 96102 or 96103. CPT neuropsychological test code 96118 should not be paid when billed for the same tests or services performed under neuropsychological test codes 96119 or 96120. However, CPT codes 96101 and 96118 can be paid separately on the rare occasion when billed on the same date of service for different and separate tests from 96102, 96103, 96119 and 96120. 

Under the physician fee schedule, there is no payment for services performed by students or trainees. Accordingly, Medicare does not pay for services represented by CPT codes 
96102 and 96119 when performed by a student or a trainee. However, the presence of a student or a trainee while the test is being administered does not prevent a physician, CP, IPP, NP, CNS or PA from performing and being paid for the psychological test under 96102 or the neuropsychological test under 96119. 

Removed the following Coding Guideline statements in the Billing and Coding Guideline:
Services 96101, 96116, 96118 and 96125 report time as (a) face–to-face with the patent and (b) time spent interpreting and preparing the report. 

CPT code 96119 is reported for tests administration by a technician who is hired, trained, and directly supervised by a practitioner licensed by the State to provide neuropsychological testing. During testing, the qualified health professional frequently checks with the technician to monitor the patient’s performance and make any necessary modifications to the test battery or assessment plan. When all tests have been administered, the qualified health professional meets with the patient again to answer any questions (AMA CPT Assistant, November 2006). The time spent reviewing the results of these tests and writing the report is also reported using the same CPT code 96119.

Code 96120 is reported for computer-administered neuropsychological testing, with subsequent interpretation and report of the specific tests by the physician, psychologist, or other qualified health care professional. 

Assessments may include testing by a technician and a computer with interpretation and report by the physician, psychologist or qualified health professional. Therefore, it is appropriate in such cases to report all 3 codes 96118-96120. (AMA CPT Assistant, November 2006; CMS Medline, June 2008). However, when this is done each code must represent separately identifiable documented services.  The time spent for the interpretation of a test cannot be combined into the time spent on another service.

Removed the following Billing Guidelines statements:
1) A technician employed and supervised by the primary qualified health care profession who interpretation tests, may perform Central Nervous System Assessments /Tests CPT codes 96102 or 96119. Central Nervous System Assessments/Tests CPT codes 96103 or 96120 may be performed by a computer supervised by the primary provider. 
2) CPT codes 96102 and 96119 describe tests administered by a technician and the provider’s time for the interpretation and the report of each individual test and the report of each individual test result. The integration of all the test data determines the cognitive profile.  The provider’s time for interpretation of the test is billed under CPT code used to bill the test. 
3) CPT codes 96103 and 96120 describe computer tests and the provider’s time for the interpretation and the report. No time is billed for these codes.  
4) Per Medicare regulations Central Nervous System Assessments/Tests CPT codes 96101-96125 may not be reimbursed to clinical social workers. 
5) Physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill CPT codes 96105, 96110 and 96111 as “sometimes therapy” services, services that follow the rules for Physical/Occupational/speech language pathologists. However, when PTs, OTs and SLPs administer these tests, they must be under the general supervision of a physician or clinical psychologists. 
6) CPT code 96125 has been established to report tests performed by speech-language pathologists and occupational therapists. When the test is performed by other Medicare providers, they should not use CPT code 96125 but rather, the appropriate CPT codes 96101-96103 or 96118-96120 should be used. 

Added the following Billing Guidelines statements:
1) For assessment of aphasia and cognitive performance testing use code 96105. 
2) For developmental/behavioral screening and testing use codes 96110, 96112, 96113, and 96127.
3) For neurobehavioral status examinations for psychological/neuropsychological testing use codes 96116 and 96121.
4) For testing evaluation services for psychological/neuropsychological testing use codes 96130, 96131, 96132, and 96133.
5) For test administration and scoring for psychological/neuropsychological testing use codes 96136, 96137, 96138 and 96139.
6) For automated testing and results for psychological/neuropsychological testing use code 96146.

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
2019 CPT/HCPCS Code Updates NA NA 01/01/2019
2019 CPT/HCPCS Code Update PDF Icon
Category III Codes L35490 PHYS-084 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Deleted the Group 3 codes for leadless pacemaker.
0387T Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular 
0389T Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report, leadless pacemaker system 
0390T Peri-procedural device evaluation (in person) and programming of device system parameters before or after surgery, procedure or test with analysis, review and report, leadless pacemaker system 
0391T Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system 

Removed the corresponding Group 3 Paragraph.
Group 3 Paragraph: For Part B only. Effective for dates of service on or after January 18, 2017, contractors shall cover leadless pacemakers through CED when procedures are performed in CMS-approved CED studies per NCD 20.8.4.

Removed the corresponding Group 3 Paragraph.
For Part B only. The following ICD-10 Codes are used to support medical necessity with CPT codes 0387T, 0389T, 0390T and 0391T.

Removed the corresponding Group 3 table of ICD-10 diagnosis code.
Z00.6 Examination for examination for normal comparison and control in clinical research program

Removed the following Utilization Guidelines language.
0387T, 0389T, 0390T, and 0391T For Part B only.
The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead which are integral elements of traditional pacing systems. The removal of these elements eliminate an important source of complications associated with traditional pacing systems while providing similar benefits. Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single-chamber ventricular pacemakers. Effective January 18, 2017, the Centers for Medicare & Medicaid Services (CMS) covers leadless pacemakers through Coverage with Evidence Development (CED). CMS covers leadless pacemakers when procedures are performed in Food and Drug Administration (FDA) approved studies. CMS also covers, in prospective longitudinal studies, leadless pacemakers that are used in accordance with the FDA approved label for devices that have either:
-    an associated ongoing FDA approved post-approval study; or
-    completed an FDA post-approval study.
Please see NCD for Leadless Pacemakers (20.8.4) for claims processing instructions (see CR 10117, Transmittal #3815, dated 07/28/2017). 

Removed the Related National Coverage Documents, 20.8.4 Leadless Pacemakers.

(The leadless pacemaker system now has true codes.)

Coding for Hemodialysis Sessions A55703 NA 02/16/2019

Formatting changes made.
 
Changed Plan of Care (POC) to Dialysis Orders in the Article Text.

Added the following statement #4 to the scheme of billing:
4. For medically appropriate and necessary dialysis exceeding 14 treatments per month and outlined in the Dialysis Orders. Some patients due to chronic or long term conditions may require dialysis that exceeds the usually covered 14 treatments per month. The number of additional treatment and the reasoning behind the order needed to be present in the dialysis documentation. The additional treatments will be noted as 90999KX on the claim, and will be considered for additional payment. Omission of the KX modifier will result in the sessions paid as the conventional dialysis at 3 X per week.

Added the following Bill Type Code: 
072X Clinic - Hospital Based or Independent Renal Dialysis Center

Added the following Revenue Codes: 
0821 Hemodialysis - Outpatient or Home-Hemodialysis Composite or Other Rate
0881 Miscellaneous Dialysis - Ultrafiltration.

Added the following CPT code:
 90999 Unlisted dialysis procedure, inpatient or outpatient

Added the following Revision History statement:
The original effective date is posted as 09/15/2018 but should be 02/16/2019 to match the original effective date of the associated LCD Frequency of Hemodialysis, L37537.

Coding Radiopharmaceutical Agents A55052 NA 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Added the following verbiage in Miscellaneous Radiopharmaceuticals section: 
10.  A9513 Lutetium lu 177, dotatate, therapeutic, 1 millicurie
       For the treatment of adult patients with somatostatin receptor-positive 
       gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 
       (CPT 79101) 
             
11.  A9589 Instillation, hexaminolevulinate hydrochloride, 100 mg
       A diagnostic agent instilled into the bladder for detection of carcinoma of the bladder. (CPT 52000, 52204, 52214                   
       - 55240.

Typographical error noted in Section A Line 9 of incorrect listing of CPT code 78652; correction made: CPT code 78650.

Erythropoiesis Stimulating Agents (ESAs) L34633 INJ-023 01/01/2019

CMS National Coverage Policy Section Added: 
CR 10859 Transmittal 2200 Issued 11/02/2018: Tenth Revisions (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2019 

CR 11005 Transmittal 2202 Issued 11/9/2018  International Classification of Diseases, 10th Revision, (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2017.

Group 4 Paragraph:
C. Indications other than Renal Disease
1. Anemias related to therapy with Zidovudine (AZT)

Added to Group 4 Codes: 

D61.1 Drug-induced aplastic anemia 

Group 6 Codes added:
Z79.899*  Other long term (current) drug therapy.

Removed Group 7 Paragraph and Group 7 Codes. 
Group 7 Code Z79.899*  relocated to Group 6  Code table.

Group 10 Paragraph:
Removed: Dual Diagnosis necessary for J0881, J0885, and Q5106 and 
Replaced: Both Diagnoses necessary for J0881, J0885, and Q5106.

Group 10 Codes added:
Z01.818  Encounter for other preprocedural examination
Removed Group 12 Paragraph and Group 12 Codes.
Group 12 Code Z01.818 relocated to Group 10 Code table.

Reformatted numerical order of paragraphs and code tables.

Group C: Indications other than Renal Disease
Anemia associated with cancer and related Neoplastic conditions. 
Added: This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to NCD 110.21 for the use of ESAs in cancer and related neoplastic conditions. 

Group 6 Paragraph
Anemia associated with chemotherapeutic medications when medically necessary for a non-cancer diagnosis or following stem cell transplantation and associated immunosuppression. 
Added: This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to NCD 110.21 for the use of ESAs in cancer and related neoplastic conditions. 
See CMS Publication 100-03 Medicare National Coverage Determinations (NCD) Manual Chapter 1- Coverage Determinations, Part 2 Section 110.21 - Erythropoiesis Stimulating Agents (ESA’s) in Cancer and Related Neoplastic Conditions.

Human Granulocyte/Macrophage Colony Stimulating Factor L34699 INJ-019 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Long description change Q5101: Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram

Group 1 Paragraph removed from free text:
Q5108  Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110  Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram

Group 1 Paragraph added to free text:
C9399/J3490 Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg 

Group 1 Codes added to Table:
C9399    Unclassified Drugs or Biologicals
J3490    Unclassified Drugs
J3590    Unclassified Biologics
Q5108    Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110    Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram


Coverage Indication, Limitations, and/or Medical Necessity created:
J.  Indications for Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg (C9399/J3490).  FDA approval date 11/02/2018. Effective date 11/02/2018.
    
1. Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies   receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

Created Group 10 Paragraph 
C9399/J3490 Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg

Created Group 10 Codes
D61.810    Antineoplastic chemotherapy induced pancytopenia
D70.1        Agranulocytosis secondary to cancer chemotherapy
T45.1X5A  Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D  Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S  Adverse effect of antineoplastic and immunosuppressive drugs, sequela
Z51.11       Encounter for antineoplastic chemotherapy
Z92.21       Personal history of antineoplastic chemotherapy

Added Not Otherwise Classified Drug Billing

Not Otherwise Classified (NOC) codes are used when there is absolutely no existing true code for the service, procedure, drug or biological being provided. Claims utilizing “J”/NOC codes are subject to Medical Review.
When a specific HCPCS code does not exist, list the appropriate “J”/NOC code:
J3490: Unclassified drugs
J3590: Unclassified biologics or
J9999: Not otherwise classified, antineoplastic drugs.

When an NOC code is billed, documentation must identify specifically for what the NOC code is being billed for, supporting the service, procedure, and drug biological being provided.
Coverage for medication is based on the patient’s condition, the appropriateness of the dose and route of administration, based on the clinical condition and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition.

The HCPCS is updated annually to reflect changes in the practice of medicine and provision of health care. CMS posts on its Web site the annual alpha-numeric HCPCS file for the upcoming year, historically, at the end of each October. Providers are encouraged to access CMS web site to see the new, revised, and discontinued alpha-numeric codes for the upcoming year.

Office/Clinic Coding

When using a drug Unclassified/NOC code (J3490, J3590, J9999) list the name of the drug, the amount of the drug that is administered and wasted if applicable, strength of dosage if appropriate; method of administration in the electronic narrative 2400/SV101-7 which is equivalent to line 19 of the CMS 1500 form.  List the units of service as one in 2400/SV1-04 data element of the ANSI 837 5010 or in item 24G of the CMS 1500 form.
    
Occasionally, the strength of the drug will also be needed on NOC claims.  If the NOC ASP pricing file lists the name of the drug with its strength it must also be included on line 19. Example: Sodium Bicarbonate 8.4%.
    
Hospital Outpatient Departments Coding
    
Hospital outpatient departments are allowed to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the FDA on or after January 1, 2004 for which pass-through status has not been approved and a C-code and APC payment have not been assigned using the “unclassified” drug/biological HCPCS code C9399 (Unclassified drugs or biological). Drugs, biologicals, and therapeutic radiopharmaceuticals that are assigned to HCPCS code C9399.

List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed.)

As you may know, pricing for NOC J-codes is determined by the information provided on the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug on the file, this indicates that the drug comes in different strengths. Medicare payment varies depending on the strength given. When billing Medicare for an NOC J-code, you can determine if the drug comes in different strengths by accessing the ASP NOC pricing files on the CMS website.

Please refer to Not Otherwise Classified (NOC) Billing
MolDX: BDX-XL2 /formerly MolDX: Xpresys Lung L37216 MolDX-030 01/01/2019

The title of this LCD has been changed from MolDX: Xpresys Lung to MolDX: BDX-XL2.  All references to Xpresys Lung have been changed to BX-XL2 throughout this document.  

The following information was removed from the Coverage Summary section:

  • The test is ordered by a physician certified in the XL2 Certification and Training Registry (CTR), and
  • The following information is recorded: all clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors; PET result (if used), physician pre-test risk assessment, physician post-test lung nodule management recommendation, any subsequent procedures (non-invasive or invasive), and clinical diagnosis based on those procedures (i.e., benign or malignant)

The Strength of the evidence has been changed from limited to Moderate:
Analysis of Evidence
(Rationale for Determination)
Level of evidence
Quality-Moderate
Strength- Moderate
Weight – Limited

The following information has been added to the policy:
Data collected by Biodesix through ongoing studies will support utility including:

  • All clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors;
  • PET result (if used),
  • Physician-assessed pre-test cancer risk assessment,
  • Physician post-test lung nodule management recommendation,
  • Any subsequent procedures (non-invasive or invasive), and
  • Clinical diagnosis based on those procedures (i.e., benign or malignant).
MolDX: BRCA1 and BRCA2 Genetic Testing L36813 MolDX-007 01/01/2019

The section on Multigene Panels has been updated.  It now reads as follows:

Multigene Panels***

The indications and limitations of coverage listed in National Coverage Determination (NCD) 90.2 (Next Generation Sequencing- NGS) apply to genetic testing for susceptibility to breast or ovarian cancer. While the NGS NCD Section 90.2 B describes specific coverage criteria for nationally covered tests, Section 90.2D permits coverage of other NGS as a diagnostic laboratory test for patients with cancer when performed and ordered according to the requirements described by the NCD. According to Section D of the NGS NCD AB Medicare Administrative Contractors (AB MACs) may cover next generation sequencing tests in patients with cancer. As such, genetic testing for susceptibility to breast or ovarian cancer with multi¬-gene NGS panels (not otherwise covered under NCD 90.2 Section B) may be covered by this AB MAC as reasonable and necessary when ALL of the NCD criteria are met in addition to the following:

  • Pre¬test genetic counseling by a cancer genetics professional has been performed and post¬test genetic counseling by a cancer genetics professional meeting NCCN accreditation criteria is planned;
  • All genes in the panel are relevant to the personal and family history for the individual being tested (panels with genes that are not relevant to the individual’s personal and family history are not reasonable and necessary);
  • Criteria listed under "Personal History of Female Breast Cancer" and/or "Personal History of Other Cancer" are met.
  • Individual also meets criteria for at least ONE hereditary cancer syndrome for which NCCN guidelines provide clear testing criteria and management recommendations, including but not limited to HBOC, Li¬Fraumeni Syndrome, Cowden Syndrome, or Lynch Syndrome.

CMS National Coverage Policy
National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS), which describes the criteria under which contractors may cover NGS laboratory tests for patients with cancer.

MolDX: CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing L36398 MolDX-002 01/01/2019
The title of this LCD has been changed from MolDX: Genetic Testing for CYP2C19, CYP2D6, CYP2C9, and VKORC1 to MolDX: CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing.
MolDX: Molecular Diagnostic Tests (MDT) L36807 MolDX-004 01/01/2019

G0452 has been removed from this LCD effective 09/28/2017:
G0452 Molecular pathology procedure: physician interpretation and report.

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Not Otherwise Classified Chemotherapy Agents (NOC) Billing and Coding Guidelines A55640 NA 01/01/2019

The title of this Article has been changed from Not Otherwise Classified Chemotherapy Agents (NOC) to Not Otherwise Classified Chemotherapy Agents (NOC) Billing and Coding Guidelines.

CPT/HCPCS Code annual update 
Group 1 Paragraph: 
Removed J9999/C9467 Rituximab and hyaluronidase human/Rituxin Hycela.
True code assigned: J9311

Please refer to LCD L37205 Chemotherapy Drugs and their Adjuncts for Coverage Indications, Limitations, and/or Medical Necessity.

Removed: 
When an NOC code is billed, two separate documents will be required to support the claim:

  • The document which supports the service, procedure, drug biological being provided. 
  • A separate document which identifies specifically for what the NOC code is being billed.

Replaced with:
When an NOC code is billed, documentation must identify specifically for what the NOC code is being billed, supporting the service, procedure, and drug biological being provided.

Added supporting Not Otherwise Classified (NOC) Billing guidance to Article Text: 

 List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed.)

Pricing for NOC J-codes is determined by the information provided on the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug, this indicates that the drug comes in different strengths. Medicare payment varies depending on the strength given. When billing Medicare for an NOC J-code, please access the ASP NOC pricing files on the CMS website to determine the different strengths. 

Please refer to Not Otherwise Classified (NOC) Billing

Psychological and Neuropsychological Testing & Billing and Coding Guidelines L34646 PSYCH-017 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Removed the following statement from the Coverage Guidelines section entitled Psycological testing: CPT codes 96101, 96102, 96103, 96105, 96111.

Removed the following statement from the Coverage Guidelines section entitled Neuropsychological Testing: CPT codes 96116, and 96118, 96119 and 96120.

Removed the following statement from 5. Feedback session: This service is usually billed with CPT coode 96118. 

Added the following statement to the Billing and Coding Guideline:
*Please note this section of the IOM was last updated effective 01/01/2006 and codes 96101, 96102, 96103, 96111, 96118, 96119 and 96120 are deleted effective 12/31/2018.

Removed the following italicized IOM quoted language in the Billing and Coding Guideline because it refers to deleted codes:
Medicare Part B coverage of psychological tests and neuropsychological tests is authorized under section 1861(s)(3) of the Social Security Act. Payment for psychological and neuropsychological tests is authorized under section 1842(b)(2)(A) of the Social Security Act. The payment amounts for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are effective January 1, 2006, and are billed for tests administered by a technician or a computer reflect a site of service payment differential for the facility and non-facility settings. Additionally, there is no authorization for payment for diagnostic tests when performed on an “incident to” basis. 

Under the diagnostic tests provision, all diagnostic tests are assigned a certain level of supervision. Generally, regulations governing the diagnostic tests provision require that only physicians can provide the assigned level of supervision for diagnostic tests. However, there is a regulatory exception to the supervision requirement for diagnostic psychological and neuropsychological tests in terms of who can provide the supervision. That is, regulations allow a clinical psychologist (CP) or a physician to perform the general supervision assigned to diagnostic psychological and neuropsychological tests.
 
In addition, nonphysician practitioners such as nurse practitioners (NPs), clinical nurse specialists (CNSs) and physician assistants (PAs) who personally perform diagnostic psychological and neuropsychological tests are excluded from having to perform these tests under the general supervision of a physician or a CP. Rather, NPs and CNSs must perform such tests under the requirements of their respective benefit instead of the requirements for diagnostic psychological and neuropsychological tests. Accordingly, NPs and CNSs must perform tests in collaboration (as defined under Medicare law at section 1861(aa)(6) of the Act) with a physician. PAs perform tests under the general supervision of a physician as required for services furnished under the PA benefit. 

Furthermore, physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill three test codes as “sometimes therapy” codes. Specifically, CPT codes 96105, and 96111 may be performed by these therapists. However, when PTs, OTs and SLPs perform these three tests, they must be performed under the general supervision of a physician or a CP.

Who May Bill for Diagnostic Psychological and Neuropsychological Tests 

  • CPs – see qualifications under chapter 15, section 160 of the Benefits Policy Manual, Pub. 100-02. 
  • NPs –to the extent authorized under State scope of practice. See qualifications under chapter 15, section 200 of the Benefits Policy Manual, Pub. 100-02. 
  • CNSs –to the extent authorized under State scope of practice. See qualifications under chapter 15, section 210 of the Benefits Policy Manual, Pub. 100-02. 
  • PAs – to the extent authorized under State scope of practice. See qualifications under chapter 15, section 190 of the Benefits Policy Manual, Pub. 100-02. 
  • Independently Practicing Psychologists (IPPs)
  • PTs, OTs and SLPs – see qualifications under chapter 15, sections 220-230.6 of the Benefits Policy Manual, Pub. 100-02. 

Psychological and neuropsychological tests performed by a psychologist (who is not a CP) practicing independently of an institution, agency, or physician’s office are covered when a physician orders such tests. An IPP is any psychologist who is licensed or certified to practice psychology in the State or jurisdiction where furnishing services or, if the jurisdiction does not issue licenses, if provided by any practicing psychologist. (It is CMS’ understanding that all States, the District of Columbia, and Puerto Rico license psychologists, but that some trust territories do not. Examples of psychologists, other than CPs, whose psychological and neuropsychological tests are covered under the diagnostic tests provision include, but are not limited to, educational psychologists and counseling psychologists.) 

The A/B MAC (B) must secure from the appropriate State agency a current listing of psychologists holding the required credentials to determine whether the tests of a particular IPP are covered under Part B in States that have statutory licensure or certification. In States or territories that lack statutory licensing or certification, the A/B MAC (B) checks individual qualifications before provider numbers are issued. Possible reference sources are the national directory of membership of the American Psychological Association, which provides data about the educational background of individuals and indicates which members are board-certified, the records and directories of the State or territorial psychological association, and the National Register of Health Service Providers. If qualification is dependent on a doctoral degree from a currently accredited program, the A/B MAC (B) verifies the date of accreditation of the school involved, since such accreditation is not retroactive. If the listed reference sources do not provide enough information (e.g., the psychologist is not a member of one of these sources), the A/B MAC (B) contacts the psychologist personally for the required information. Generally, A/B MACs (B) maintain a continuing list of psychologists whose qualifications have been verified. 

NOTE: When diagnostic psychological tests are performed by a psychologist who is not practicing independently, but is on the staff of an institution, agency, or clinic, that entity bills for the psychological tests. 

The A/B MAC (B) considers psychologists as practicing independently when: 
1. They render services on their own responsibility, free of the administrative and professional control of an employer such as a physician, institution or agency;
2. The persons they treat are their own patients; and 
3. They have the right to bill directly, collect and retain the fee for their services. 

A psychologist practicing in an office located in an institution may be considered an independently practicing psychologist when both of the following conditions exist:

1. The office is confined to a separately-identified part of the facility which is used solely as the psychologist’s office and cannot be construed as extending throughout the entire institution; and
2. The psychologist conducts a private practice, i.e., services are rendered to patients from outside the institution as well as to institutional patients. 

Payment for Diagnostic Psychological and Neuropsychological Tests 
Expenses for diagnostic psychological and neuropsychological tests are not subject to the outpatient mental health treatment limitation, that is, the payment limitation on treatment services for mental, psychoneurotic and personality disorders as authorized under Section 1833(c) of the Act. The payment amount for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are billed for tests performed by a technician or a computer reflect a site of service payment differential for the facility and non-facility settings. CPs, NPs, CNSs and PAs are required by law to accept assigned payment for psychological and neuropsychological tests. However, while IPPs are not required by law to accept assigned payment for these tests, they must report the name and address of the physician who ordered the test on the claim form when billing for tests. 

CPT Codes for Diagnostic Psychological and Neuropsychological Tests 
The range of CPT codes used to report psychological and neuropsychological tests is 96101-96120. CPT codes 96101, 96102, 96103, 96105, and 96111 are appropriate for use when billing for psychological tests. CPT codes 96116, 96118, 96119 and 96120 are appropriate for use when billing for neuropsychological tests. 

All of the tests under this CPT code range 96101-96120 are indicated as active codes under the physician fee schedule database and are covered if medically necessary. 

Payment and Billing Guidelines for Psychological and Neuropsychological Tests 
The technician and computer CPT codes for psychological and neuropsychological tests include practice expense, malpractice expense and professional work relative value units. Accordingly, CPT psychological test code 96101 should not be paid when billed for the same tests or services performed under psychological test codes 96102 or 96103. CPT neuropsychological test code 96118 should not be paid when billed for the same tests or services performed under neuropsychological test codes 96119 or 96120. However, CPT codes 96101 and 96118 can be paid separately on the rare occasion when billed on the same date of service for different and separate tests from 96102, 96103, 96119 and 96120. 

Under the physician fee schedule, there is no payment for services performed by students or trainees. Accordingly, Medicare does not pay for services represented by CPT codes 
96102 and 96119 when performed by a student or a trainee. However, the presence of a student or a trainee while the test is being administered does not prevent a physician, CP, IPP, NP, CNS or PA from performing and being paid for the psychological test under 96102 or the neuropsychological test under 96119. 

Removed the following Coding Guideline statements in the Billing and Coding Guideline:
Services 96101, 96116, 96118 and 96125 report time as (a) face–to-face with the patent and (b) time spent interpreting and preparing the report. 

CPT code 96119 is reported for tests administration by a technician who is hired, trained, and directly supervised by a practitioner licensed by the State to provide neuropsychological testing. During testing, the qualified health professional frequently checks with the technician to monitor the patient’s performance and make any necessary modifications to the test battery or assessment plan. When all tests have been administered, the qualified health professional meets with the patient again to answer any questions (AMA CPT Assistant, November 2006). The time spent reviewing the results of these tests and writing the report is also reported using the same CPT code 96119.

Code 96120 is reported for computer-administered neuropsychological testing, with subsequent interpretation and report of the specific tests by the physician, psychologist, or other qualified health care professional. 

Assessments may include testing by a technician and a computer with interpretation and report by the physician, psychologist or qualified health professional. Therefore, it is appropriate in such cases to report all 3 codes 96118-96120. (AMA CPT Assistant, November 2006; CMS Medline, June 2008). However, when this is done each code must represent separately identifiable documented services.  The time spent for the interpretation of a test cannot be combined into the time spent on another service.

Removed the following Billing Guidelines statements:
1) A technician employed and supervised by the primary qualified health care profession who interpretation tests, may perform Central Nervous System Assessments /Tests CPT codes 96102 or 96119. Central Nervous System Assessments/Tests CPT codes 96103 or 96120 may be performed by a computer supervised by the primary provider. 
2) CPT codes 96102 and 96119 describe tests administered by a technician and the provider’s time for the interpretation and the report of each individual test and the report of each individual test result. The integration of all the test data determines the cognitive profile.  The provider’s time for interpretation of the test is billed under CPT code used to bill the test. 
3) CPT codes 96103 and 96120 describe computer tests and the provider’s time for the interpretation and the report. No time is billed for these codes.  
4) Per Medicare regulations Central Nervous System Assessments/Tests CPT codes 96101-96125 may not be reimbursed to clinical social workers. 
5) Physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill CPT codes 96105, 96110 and 96111 as “sometimes therapy” services, services that follow the rules for Physical/Occupational/speech language pathologists. However, when PTs, OTs and SLPs administer these tests, they must be under the general supervision of a physician or clinical psychologists. 
6) CPT code 96125 has been established to report tests performed by speech-language pathologists and occupational therapists. When the test is performed by other Medicare providers, they should not use CPT code 96125 but rather, the appropriate CPT codes 96101-96103 or 96118-96120 should be used. 

Added the following Billing Guidelines statements:
1) For assessment of aphasia and cognitive performance testing use code 96105. 
2) For developmental/behavioral screening and testing use codes 96110, 96112, 96113, and 96127.
3) For neurobehavioral status examinations for psychological/neuropsychological testing use codes 96116 and 96121.
4) For testing evaluation services for psychological/neuropsychological testing use codes 96130, 96131, 96132, and 96133.
5) For test administration and scoring for psychological/neuropsychological testing use codes 96136, 96137, 96138 and 96139.
6) For automated testing and results for psychological/neuropsychological testing use code 96146.

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
2019 CPT/HCPCS Code Updates NA NA 01/01/2019
2019 CPT/HCPCS Code Update PDF Icon
Category III Codes L35490 PHYS-084 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Deleted the Group 3 codes for leadless pacemaker.
0387T Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular 
0389T Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report, leadless pacemaker system 
0390T Peri-procedural device evaluation (in person) and programming of device system parameters before or after surgery, procedure or test with analysis, review and report, leadless pacemaker system 
0391T Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system 

Removed the corresponding Group 3 Paragraph.
Group 3 Paragraph: For Part B only. Effective for dates of service on or after January 18, 2017, contractors shall cover leadless pacemakers through CED when procedures are performed in CMS-approved CED studies per NCD 20.8.4.

Removed the corresponding Group 3 Paragraph.
For Part B only. The following ICD-10 Codes are used to support medical necessity with CPT codes 0387T, 0389T, 0390T and 0391T.

Removed the corresponding Group 3 table of ICD-10 diagnosis code.
Z00.6 Examination for examination for normal comparison and control in clinical research program

Removed the following Utilization Guidelines language.
0387T, 0389T, 0390T, and 0391T For Part B only.
The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead which are integral elements of traditional pacing systems. The removal of these elements eliminate an important source of complications associated with traditional pacing systems while providing similar benefits. Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single-chamber ventricular pacemakers. Effective January 18, 2017, the Centers for Medicare & Medicaid Services (CMS) covers leadless pacemakers through Coverage with Evidence Development (CED). CMS covers leadless pacemakers when procedures are performed in Food and Drug Administration (FDA) approved studies. CMS also covers, in prospective longitudinal studies, leadless pacemakers that are used in accordance with the FDA approved label for devices that have either:
-    an associated ongoing FDA approved post-approval study; or
-    completed an FDA post-approval study.
Please see NCD for Leadless Pacemakers (20.8.4) for claims processing instructions (see CR 10117, Transmittal #3815, dated 07/28/2017). 

Removed the Related National Coverage Documents, 20.8.4 Leadless Pacemakers.

(The leadless pacemaker system now has true codes.)

Coding Radiopharmaceutical Agents A55052 NA 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Added the following verbiage in Miscellaneous Radiopharmaceuticals section: 
10.  A9513 Lutetium lu 177, dotatate, therapeutic, 1 millicurie
       For the treatment of adult patients with somatostatin receptor-positive 
       gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 
       (CPT 79101) 
             
11.  A9589 Instillation, hexaminolevulinate hydrochloride, 100 mg
       A diagnostic agent instilled into the bladder for detection of carcinoma of the bladder. (CPT 52000, 52204, 52214                   
       - 55240.

Typographical error noted in Section A Line 9 of incorrect listing of CPT code 78652; correction made: CPT code 78650.

Erythropoiesis Stimulating Agents (ESAs) L34633 INJ-023 01/01/2019

CMS National Coverage Policy Section Added: 
CR 10859 Transmittal 2200 Issued 11/02/2018: Tenth Revisions (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2019 

CR 11005 Transmittal 2202 Issued 11/9/2018  International Classification of Diseases, 10th Revision, (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2017.

Group 4 Paragraph:
C. Indications other than Renal Disease
1. Anemias related to therapy with Zidovudine (AZT)

Added to Group 4 Codes: 

D61.1 Drug-induced aplastic anemia 

Group 6 Codes added:
Z79.899*  Other long term (current) drug therapy.

Removed Group 7 Paragraph and Group 7 Codes. 
Group 7 Code Z79.899*  relocated to Group 6  Code table.

Group 10 Paragraph:
Removed: Dual Diagnosis necessary for J0881, J0885, and Q5106 and 
Replaced: Both Diagnoses necessary for J0881, J0885, and Q5106.

Group 10 Codes added:
Z01.818  Encounter for other preprocedural examination
Removed Group 12 Paragraph and Group 12 Codes.
Group 12 Code Z01.818 relocated to Group 10 Code table.

Reformatted numerical order of paragraphs and code tables.

Group C: Indications other than Renal Disease
Anemia associated with cancer and related Neoplastic conditions. 
Added: This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to NCD 110.21 for the use of ESAs in cancer and related neoplastic conditions. 

Group 6 Paragraph
Anemia associated with chemotherapeutic medications when medically necessary for a non-cancer diagnosis or following stem cell transplantation and associated immunosuppression. 
Added: This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to NCD 110.21 for the use of ESAs in cancer and related neoplastic conditions. 
See CMS Publication 100-03 Medicare National Coverage Determinations (NCD) Manual Chapter 1- Coverage Determinations, Part 2 Section 110.21 - Erythropoiesis Stimulating Agents (ESA’s) in Cancer and Related Neoplastic Conditions.

Human Granulocyte/Macrophage Colony Stimulating Factor L34699 INJ-019 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Long description change Q5101: Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram

Group 1 Paragraph removed from free text:
Q5108  Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110  Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram

Group 1 Paragraph added to free text:
C9399/J3490 Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg 

Group 1 Codes added to Table:
C9399    Unclassified Drugs or Biologicals
J3490    Unclassified Drugs
J3590    Unclassified Biologics
Q5108    Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110    Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram


Coverage Indication, Limitations, and/or Medical Necessity created:
J.  Indications for Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg (C9399/J3490).  FDA approval date 11/02/2018. Effective date 11/02/2018.
    
1. Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies   receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

Created Group 10 Paragraph 
C9399/J3490 Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg

Created Group 10 Codes
D61.810    Antineoplastic chemotherapy induced pancytopenia
D70.1        Agranulocytosis secondary to cancer chemotherapy
T45.1X5A  Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D  Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S  Adverse effect of antineoplastic and immunosuppressive drugs, sequela
Z51.11       Encounter for antineoplastic chemotherapy
Z92.21       Personal history of antineoplastic chemotherapy

Added Not Otherwise Classified Drug Billing

Not Otherwise Classified (NOC) codes are used when there is absolutely no existing true code for the service, procedure, drug or biological being provided. Claims utilizing “J”/NOC codes are subject to Medical Review.
When a specific HCPCS code does not exist, list the appropriate “J”/NOC code:
J3490: Unclassified drugs
J3590: Unclassified biologics or
J9999: Not otherwise classified, antineoplastic drugs.

When an NOC code is billed, documentation must identify specifically for what the NOC code is being billed for, supporting the service, procedure, and drug biological being provided.
Coverage for medication is based on the patient’s condition, the appropriateness of the dose and route of administration, based on the clinical condition and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition.

The HCPCS is updated annually to reflect changes in the practice of medicine and provision of health care. CMS posts on its Web site the annual alpha-numeric HCPCS file for the upcoming year, historically, at the end of each October. Providers are encouraged to access CMS web site to see the new, revised, and discontinued alpha-numeric codes for the upcoming year.

Office/Clinic Coding

When using a drug Unclassified/NOC code (J3490, J3590, J9999) list the name of the drug, the amount of the drug that is administered and wasted if applicable, strength of dosage if appropriate; method of administration in the electronic narrative 2400/SV101-7 which is equivalent to line 19 of the CMS 1500 form.  List the units of service as one in 2400/SV1-04 data element of the ANSI 837 5010 or in item 24G of the CMS 1500 form.
    
Occasionally, the strength of the drug will also be needed on NOC claims.  If the NOC ASP pricing file lists the name of the drug with its strength it must also be included on line 19. Example: Sodium Bicarbonate 8.4%.
    
Hospital Outpatient Departments Coding
    
Hospital outpatient departments are allowed to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the FDA on or after January 1, 2004 for which pass-through status has not been approved and a C-code and APC payment have not been assigned using the “unclassified” drug/biological HCPCS code C9399 (Unclassified drugs or biological). Drugs, biologicals, and therapeutic radiopharmaceuticals that are assigned to HCPCS code C9399.

List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed.)

As you may know, pricing for NOC J-codes is determined by the information provided on the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug on the file, this indicates that the drug comes in different strengths. Medicare payment varies depending on the strength given. When billing Medicare for an NOC J-code, you can determine if the drug comes in different strengths by accessing the ASP NOC pricing files on the CMS website.

Please refer to Not Otherwise Classified (NOC) Billing
Independent Diagnostic Testing Facilities- physician supervision and technician requirements A54953 NA 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Description corrections:
95017  Perq & icut allg test venoms
95018  Perq & ic allg test drugs/biol 
95076  Ingest challenge ini 120 min 
95079  Ingest challenge addl 60 min 
95907  Nvr cndj tst 1-2 studies 
95908  Nvr cndj tst 3-4 studies
95909  Nvr cndj tst 5-6 studies
95910  Nvr cndj tst 7-8 studies
95911  Nvr cndj tst 9-10 studies
95912  Nvr cndj tst 11-12studies
95913  Nvr cndj tst 13/> studies and 
95924  Ans parasymp & symp w/tilt

MolDX: BDX-XL2 /formerly MolDX: Xpresys Lung L37216 MolDX-030 01/01/2019

The title of this LCD has been changed from MolDX: Xpresys Lung to MolDX: BDX-XL2.  All references to Xpresys Lung have been changed to BX-XL2 throughout this document.  

The following information was removed from the Coverage Summary section:

  • The test is ordered by a physician certified in the XL2 Certification and Training Registry (CTR), and
  • The following information is recorded: all clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors; PET result (if used), physician pre-test risk assessment, physician post-test lung nodule management recommendation, any subsequent procedures (non-invasive or invasive), and clinical diagnosis based on those procedures (i.e., benign or malignant)

The Strength of the evidence has been changed from limited to Moderate:
Analysis of Evidence
(Rationale for Determination)
Level of evidence
Quality-Moderate
Strength- Moderate
Weight – Limited

The following information has been added to the policy:
Data collected by Biodesix through ongoing studies will support utility including:

  • All clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors;
  • PET result (if used),
  • Physician-assessed pre-test cancer risk assessment,
  • Physician post-test lung nodule management recommendation,
  • Any subsequent procedures (non-invasive or invasive), and
  • Clinical diagnosis based on those procedures (i.e., benign or malignant).
MolDX: BRCA1 and BRCA2 Genetic Testing L36813 MolDX-007 01/01/2019

The section on Multigene Panels has been updated.  It now reads as follows:

Multigene Panels***

The indications and limitations of coverage listed in National Coverage Determination (NCD) 90.2 (Next Generation Sequencing- NGS) apply to genetic testing for susceptibility to breast or ovarian cancer. While the NGS NCD Section 90.2 B describes specific coverage criteria for nationally covered tests, Section 90.2D permits coverage of other NGS as a diagnostic laboratory test for patients with cancer when performed and ordered according to the requirements described by the NCD. According to Section D of the NGS NCD AB Medicare Administrative Contractors (AB MACs) may cover next generation sequencing tests in patients with cancer. As such, genetic testing for susceptibility to breast or ovarian cancer with multi¬-gene NGS panels (not otherwise covered under NCD 90.2 Section B) may be covered by this AB MAC as reasonable and necessary when ALL of the NCD criteria are met in addition to the following:

  • Pre¬test genetic counseling by a cancer genetics professional has been performed and post¬test genetic counseling by a cancer genetics professional meeting NCCN accreditation criteria is planned;
  • All genes in the panel are relevant to the personal and family history for the individual being tested (panels with genes that are not relevant to the individual’s personal and family history are not reasonable and necessary);
  • Criteria listed under "Personal History of Female Breast Cancer" and/or "Personal History of Other Cancer" are met.
  • Individual also meets criteria for at least ONE hereditary cancer syndrome for which NCCN guidelines provide clear testing criteria and management recommendations, including but not limited to HBOC, Li¬Fraumeni Syndrome, Cowden Syndrome, or Lynch Syndrome.

CMS National Coverage Policy
National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS), which describes the criteria under which contractors may cover NGS laboratory tests for patients with cancer.

MolDX: CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing L36398 MolDX-002 01/01/2019
The title of this LCD has been changed from MolDX: Genetic Testing for CYP2C19, CYP2D6, CYP2C9, and VKORC1 to MolDX: CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing.
MolDX: Molecular Diagnostic Tests (MDT) L36807 MolDX-004 01/01/2019

G0452 has been removed from this LCD effective 09/28/2017:
G0452 Molecular pathology procedure: physician interpretation and report.

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Not Otherwise Classified Chemotherapy Agents (NOC) Billing and Coding Guidelines A55640 NA 01/01/2019

The title of this Article has been changed from Not Otherwise Classified Chemotherapy Agents (NOC) to Not Otherwise Classified Chemotherapy Agents (NOC) Billing and Coding Guidelines.

CPT/HCPCS Code annual update 
Group 1 Paragraph: 
Removed J9999/C9467 Rituximab and hyaluronidase human/Rituxin Hycela.
True code assigned: J9311

Please refer to LCD L37205 Chemotherapy Drugs and their Adjuncts for Coverage Indications, Limitations, and/or Medical Necessity.

Removed: 
When an NOC code is billed, two separate documents will be required to support the claim:

  • The document which supports the service, procedure, drug biological being provided. 
  • A separate document which identifies specifically for what the NOC code is being billed.

Replaced with:
When an NOC code is billed, documentation must identify specifically for what the NOC code is being billed, supporting the service, procedure, and drug biological being provided.

Added supporting Not Otherwise Classified (NOC) Billing guidance to Article Text: 

 List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed.)

Pricing for NOC J-codes is determined by the information provided on the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug, this indicates that the drug comes in different strengths. Medicare payment varies depending on the strength given. When billing Medicare for an NOC J-code, please access the ASP NOC pricing files on the CMS website to determine the different strengths. 

Please refer to Not Otherwise Classified (NOC) Billing

Psychological and Neuropsychological Testing & Billing and Coding Guidelines L34646 PSYCH-017 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Removed the following statement from the Coverage Guidelines section entitled Psycological testing: CPT codes 96101, 96102, 96103, 96105, 96111.

Removed the following statement from the Coverage Guidelines section entitled Neuropsychological Testing: CPT codes 96116, and 96118, 96119 and 96120.

Removed the following statement from 5. Feedback session: This service is usually billed with CPT coode 96118. 

Added the following statement to the Billing and Coding Guideline:
*Please note this section of the IOM was last updated effective 01/01/2006 and codes 96101, 96102, 96103, 96111, 96118, 96119 and 96120 are deleted effective 12/31/2018.

Removed the following italicized IOM quoted language in the Billing and Coding Guideline because it refers to deleted codes:
Medicare Part B coverage of psychological tests and neuropsychological tests is authorized under section 1861(s)(3) of the Social Security Act. Payment for psychological and neuropsychological tests is authorized under section 1842(b)(2)(A) of the Social Security Act. The payment amounts for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are effective January 1, 2006, and are billed for tests administered by a technician or a computer reflect a site of service payment differential for the facility and non-facility settings. Additionally, there is no authorization for payment for diagnostic tests when performed on an “incident to” basis. 

Under the diagnostic tests provision, all diagnostic tests are assigned a certain level of supervision. Generally, regulations governing the diagnostic tests provision require that only physicians can provide the assigned level of supervision for diagnostic tests. However, there is a regulatory exception to the supervision requirement for diagnostic psychological and neuropsychological tests in terms of who can provide the supervision. That is, regulations allow a clinical psychologist (CP) or a physician to perform the general supervision assigned to diagnostic psychological and neuropsychological tests.
 
In addition, nonphysician practitioners such as nurse practitioners (NPs), clinical nurse specialists (CNSs) and physician assistants (PAs) who personally perform diagnostic psychological and neuropsychological tests are excluded from having to perform these tests under the general supervision of a physician or a CP. Rather, NPs and CNSs must perform such tests under the requirements of their respective benefit instead of the requirements for diagnostic psychological and neuropsychological tests. Accordingly, NPs and CNSs must perform tests in collaboration (as defined under Medicare law at section 1861(aa)(6) of the Act) with a physician. PAs perform tests under the general supervision of a physician as required for services furnished under the PA benefit. 

Furthermore, physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill three test codes as “sometimes therapy” codes. Specifically, CPT codes 96105, and 96111 may be performed by these therapists. However, when PTs, OTs and SLPs perform these three tests, they must be performed under the general supervision of a physician or a CP.

Who May Bill for Diagnostic Psychological and Neuropsychological Tests 

  • CPs – see qualifications under chapter 15, section 160 of the Benefits Policy Manual, Pub. 100-02. 
  • NPs –to the extent authorized under State scope of practice. See qualifications under chapter 15, section 200 of the Benefits Policy Manual, Pub. 100-02. 
  • CNSs –to the extent authorized under State scope of practice. See qualifications under chapter 15, section 210 of the Benefits Policy Manual, Pub. 100-02. 
  • PAs – to the extent authorized under State scope of practice. See qualifications under chapter 15, section 190 of the Benefits Policy Manual, Pub. 100-02. 
  • Independently Practicing Psychologists (IPPs)
  • PTs, OTs and SLPs – see qualifications under chapter 15, sections 220-230.6 of the Benefits Policy Manual, Pub. 100-02. 

Psychological and neuropsychological tests performed by a psychologist (who is not a CP) practicing independently of an institution, agency, or physician’s office are covered when a physician orders such tests. An IPP is any psychologist who is licensed or certified to practice psychology in the State or jurisdiction where furnishing services or, if the jurisdiction does not issue licenses, if provided by any practicing psychologist. (It is CMS’ understanding that all States, the District of Columbia, and Puerto Rico license psychologists, but that some trust territories do not. Examples of psychologists, other than CPs, whose psychological and neuropsychological tests are covered under the diagnostic tests provision include, but are not limited to, educational psychologists and counseling psychologists.) 

The A/B MAC (B) must secure from the appropriate State agency a current listing of psychologists holding the required credentials to determine whether the tests of a particular IPP are covered under Part B in States that have statutory licensure or certification. In States or territories that lack statutory licensing or certification, the A/B MAC (B) checks individual qualifications before provider numbers are issued. Possible reference sources are the national directory of membership of the American Psychological Association, which provides data about the educational background of individuals and indicates which members are board-certified, the records and directories of the State or territorial psychological association, and the National Register of Health Service Providers. If qualification is dependent on a doctoral degree from a currently accredited program, the A/B MAC (B) verifies the date of accreditation of the school involved, since such accreditation is not retroactive. If the listed reference sources do not provide enough information (e.g., the psychologist is not a member of one of these sources), the A/B MAC (B) contacts the psychologist personally for the required information. Generally, A/B MACs (B) maintain a continuing list of psychologists whose qualifications have been verified. 

NOTE: When diagnostic psychological tests are performed by a psychologist who is not practicing independently, but is on the staff of an institution, agency, or clinic, that entity bills for the psychological tests. 

The A/B MAC (B) considers psychologists as practicing independently when: 
1. They render services on their own responsibility, free of the administrative and professional control of an employer such as a physician, institution or agency;
2. The persons they treat are their own patients; and 
3. They have the right to bill directly, collect and retain the fee for their services. 

A psychologist practicing in an office located in an institution may be considered an independently practicing psychologist when both of the following conditions exist:

1. The office is confined to a separately-identified part of the facility which is used solely as the psychologist’s office and cannot be construed as extending throughout the entire institution; and
2. The psychologist conducts a private practice, i.e., services are rendered to patients from outside the institution as well as to institutional patients. 

Payment for Diagnostic Psychological and Neuropsychological Tests 
Expenses for diagnostic psychological and neuropsychological tests are not subject to the outpatient mental health treatment limitation, that is, the payment limitation on treatment services for mental, psychoneurotic and personality disorders as authorized under Section 1833(c) of the Act. The payment amount for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are billed for tests performed by a technician or a computer reflect a site of service payment differential for the facility and non-facility settings. CPs, NPs, CNSs and PAs are required by law to accept assigned payment for psychological and neuropsychological tests. However, while IPPs are not required by law to accept assigned payment for these tests, they must report the name and address of the physician who ordered the test on the claim form when billing for tests. 

CPT Codes for Diagnostic Psychological and Neuropsychological Tests 
The range of CPT codes used to report psychological and neuropsychological tests is 96101-96120. CPT codes 96101, 96102, 96103, 96105, and 96111 are appropriate for use when billing for psychological tests. CPT codes 96116, 96118, 96119 and 96120 are appropriate for use when billing for neuropsychological tests. 

All of the tests under this CPT code range 96101-96120 are indicated as active codes under the physician fee schedule database and are covered if medically necessary. 

Payment and Billing Guidelines for Psychological and Neuropsychological Tests 
The technician and computer CPT codes for psychological and neuropsychological tests include practice expense, malpractice expense and professional work relative value units. Accordingly, CPT psychological test code 96101 should not be paid when billed for the same tests or services performed under psychological test codes 96102 or 96103. CPT neuropsychological test code 96118 should not be paid when billed for the same tests or services performed under neuropsychological test codes 96119 or 96120. However, CPT codes 96101 and 96118 can be paid separately on the rare occasion when billed on the same date of service for different and separate tests from 96102, 96103, 96119 and 96120. 

Under the physician fee schedule, there is no payment for services performed by students or trainees. Accordingly, Medicare does not pay for services represented by CPT codes 
96102 and 96119 when performed by a student or a trainee. However, the presence of a student or a trainee while the test is being administered does not prevent a physician, CP, IPP, NP, CNS or PA from performing and being paid for the psychological test under 96102 or the neuropsychological test under 96119. 

Removed the following Coding Guideline statements in the Billing and Coding Guideline:
Services 96101, 96116, 96118 and 96125 report time as (a) face–to-face with the patent and (b) time spent interpreting and preparing the report. 

CPT code 96119 is reported for tests administration by a technician who is hired, trained, and directly supervised by a practitioner licensed by the State to provide neuropsychological testing. During testing, the qualified health professional frequently checks with the technician to monitor the patient’s performance and make any necessary modifications to the test battery or assessment plan. When all tests have been administered, the qualified health professional meets with the patient again to answer any questions (AMA CPT Assistant, November 2006). The time spent reviewing the results of these tests and writing the report is also reported using the same CPT code 96119.

Code 96120 is reported for computer-administered neuropsychological testing, with subsequent interpretation and report of the specific tests by the physician, psychologist, or other qualified health care professional. 

Assessments may include testing by a technician and a computer with interpretation and report by the physician, psychologist or qualified health professional. Therefore, it is appropriate in such cases to report all 3 codes 96118-96120. (AMA CPT Assistant, November 2006; CMS Medline, June 2008). However, when this is done each code must represent separately identifiable documented services.  The time spent for the interpretation of a test cannot be combined into the time spent on another service.

Removed the following Billing Guidelines statements:
1) A technician employed and supervised by the primary qualified health care profession who interpretation tests, may perform Central Nervous System Assessments /Tests CPT codes 96102 or 96119. Central Nervous System Assessments/Tests CPT codes 96103 or 96120 may be performed by a computer supervised by the primary provider. 
2) CPT codes 96102 and 96119 describe tests administered by a technician and the provider’s time for the interpretation and the report of each individual test and the report of each individual test result. The integration of all the test data determines the cognitive profile.  The provider’s time for interpretation of the test is billed under CPT code used to bill the test. 
3) CPT codes 96103 and 96120 describe computer tests and the provider’s time for the interpretation and the report. No time is billed for these codes.  
4) Per Medicare regulations Central Nervous System Assessments/Tests CPT codes 96101-96125 may not be reimbursed to clinical social workers. 
5) Physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill CPT codes 96105, 96110 and 96111 as “sometimes therapy” services, services that follow the rules for Physical/Occupational/speech language pathologists. However, when PTs, OTs and SLPs administer these tests, they must be under the general supervision of a physician or clinical psychologists. 
6) CPT code 96125 has been established to report tests performed by speech-language pathologists and occupational therapists. When the test is performed by other Medicare providers, they should not use CPT code 96125 but rather, the appropriate CPT codes 96101-96103 or 96118-96120 should be used. 

Added the following Billing Guidelines statements:
1) For assessment of aphasia and cognitive performance testing use code 96105. 
2) For developmental/behavioral screening and testing use codes 96110, 96112, 96113, and 96127.
3) For neurobehavioral status examinations for psychological/neuropsychological testing use codes 96116 and 96121.
4) For testing evaluation services for psychological/neuropsychological testing use codes 96130, 96131, 96132, and 96133.
5) For test administration and scoring for psychological/neuropsychological testing use codes 96136, 96137, 96138 and 96139.
6) For automated testing and results for psychological/neuropsychological testing use code 96146.

Policy/Article Title MCD Policy/Article # WPS Policy # Effective Date
2019 CPT/HCPCS Code Updates NA NA 01/01/2019
2019 CPT/HCPCS Code Update PDF Icon
Category III Codes L35490 PHYS-084 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Deleted the Group 3 codes for leadless pacemaker.
0387T Transcatheter insertion or replacement of permanent leadless pacemaker, ventricular 
0389T Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report, leadless pacemaker system 
0390T Peri-procedural device evaluation (in person) and programming of device system parameters before or after surgery, procedure or test with analysis, review and report, leadless pacemaker system 
0391T Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter, leadless pacemaker system 

Removed the corresponding Group 3 Paragraph.
Group 3 Paragraph: For Part B only. Effective for dates of service on or after January 18, 2017, contractors shall cover leadless pacemakers through CED when procedures are performed in CMS-approved CED studies per NCD 20.8.4.

Removed the corresponding Group 3 Paragraph.
For Part B only. The following ICD-10 Codes are used to support medical necessity with CPT codes 0387T, 0389T, 0390T and 0391T.

Removed the corresponding Group 3 table of ICD-10 diagnosis code.
Z00.6 Examination for examination for normal comparison and control in clinical research program

Removed the following Utilization Guidelines language.
0387T, 0389T, 0390T, and 0391T For Part B only.
The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing lead which are integral elements of traditional pacing systems. The removal of these elements eliminate an important source of complications associated with traditional pacing systems while providing similar benefits. Leadless pacemakers are delivered via catheter to the heart, and function similarly to other transvenous single-chamber ventricular pacemakers. Effective January 18, 2017, the Centers for Medicare & Medicaid Services (CMS) covers leadless pacemakers through Coverage with Evidence Development (CED). CMS covers leadless pacemakers when procedures are performed in Food and Drug Administration (FDA) approved studies. CMS also covers, in prospective longitudinal studies, leadless pacemakers that are used in accordance with the FDA approved label for devices that have either:
-    an associated ongoing FDA approved post-approval study; or
-    completed an FDA post-approval study.
Please see NCD for Leadless Pacemakers (20.8.4) for claims processing instructions (see CR 10117, Transmittal #3815, dated 07/28/2017). 

Removed the Related National Coverage Documents, 20.8.4 Leadless Pacemakers.

(The leadless pacemaker system now has true codes.)

Coding Radiopharmaceutical Agents A55052 NA 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Added the following verbiage in Miscellaneous Radiopharmaceuticals section: 
10.  A9513 Lutetium lu 177, dotatate, therapeutic, 1 millicurie
       For the treatment of adult patients with somatostatin receptor-positive 
       gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 
       (CPT 79101) 
             
11.  A9589 Instillation, hexaminolevulinate hydrochloride, 100 mg
       A diagnostic agent instilled into the bladder for detection of carcinoma of the bladder. (CPT 52000, 52204, 52214                   
       - 55240.

Typographical error noted in Section A Line 9 of incorrect listing of CPT code 78652; correction made: CPT code 78650.

Erythropoiesis Stimulating Agents (ESAs) L34633 INJ-023 01/01/2019

CMS National Coverage Policy Section Added: 
CR 10859 Transmittal 2200 Issued 11/02/2018: Tenth Revisions (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2019 

CR 11005 Transmittal 2202 Issued 11/9/2018  International Classification of Diseases, 10th Revision, (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) NCD 110.21 Erythropoiesis Stimulating Agents (ESAs in Cancer) effective January 1, 2017.

Group 4 Paragraph:
C. Indications other than Renal Disease
1. Anemias related to therapy with Zidovudine (AZT)

Added to Group 4 Codes: 

D61.1 Drug-induced aplastic anemia 

Group 6 Codes added:
Z79.899*  Other long term (current) drug therapy.

Removed Group 7 Paragraph and Group 7 Codes. 
Group 7 Code Z79.899*  relocated to Group 6  Code table.

Group 10 Paragraph:
Removed: Dual Diagnosis necessary for J0881, J0885, and Q5106 and 
Replaced: Both Diagnoses necessary for J0881, J0885, and Q5106.

Group 10 Codes added:
Z01.818  Encounter for other preprocedural examination
Removed Group 12 Paragraph and Group 12 Codes.
Group 12 Code Z01.818 relocated to Group 10 Code table.

Reformatted numerical order of paragraphs and code tables.

Group C: Indications other than Renal Disease
Anemia associated with cancer and related Neoplastic conditions. 
Added: This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to NCD 110.21 for the use of ESAs in cancer and related neoplastic conditions. 

Group 6 Paragraph
Anemia associated with chemotherapeutic medications when medically necessary for a non-cancer diagnosis or following stem cell transplantation and associated immunosuppression. 
Added: This policy does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) and does not contain specific diagnosis codes related to NCD 110.21 for the use of ESAs in cancer and related neoplastic conditions. 
See CMS Publication 100-03 Medicare National Coverage Determinations (NCD) Manual Chapter 1- Coverage Determinations, Part 2 Section 110.21 - Erythropoiesis Stimulating Agents (ESA’s) in Cancer and Related Neoplastic Conditions.

Human Granulocyte/Macrophage Colony Stimulating Factor L34699 INJ-019 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Long description change Q5101: Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram

Group 1 Paragraph removed from free text:
Q5108  Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110  Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram

Group 1 Paragraph added to free text:
C9399/J3490 Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg 

Group 1 Codes added to Table:
C9399    Unclassified Drugs or Biologicals
J3490    Unclassified Drugs
J3590    Unclassified Biologics
Q5108    Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110    Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram


Coverage Indication, Limitations, and/or Medical Necessity created:
J.  Indications for Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg (C9399/J3490).  FDA approval date 11/02/2018. Effective date 11/02/2018.
    
1. Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies   receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia

Created Group 10 Paragraph 
C9399/J3490 Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg

Created Group 10 Codes
D61.810    Antineoplastic chemotherapy induced pancytopenia
D70.1        Agranulocytosis secondary to cancer chemotherapy
T45.1X5A  Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1X5D  Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1X5S  Adverse effect of antineoplastic and immunosuppressive drugs, sequela
Z51.11       Encounter for antineoplastic chemotherapy
Z92.21       Personal history of antineoplastic chemotherapy

Added Not Otherwise Classified Drug Billing

Not Otherwise Classified (NOC) codes are used when there is absolutely no existing true code for the service, procedure, drug or biological being provided. Claims utilizing “J”/NOC codes are subject to Medical Review.
When a specific HCPCS code does not exist, list the appropriate “J”/NOC code:
J3490: Unclassified drugs
J3590: Unclassified biologics or
J9999: Not otherwise classified, antineoplastic drugs.

When an NOC code is billed, documentation must identify specifically for what the NOC code is being billed for, supporting the service, procedure, and drug biological being provided.
Coverage for medication is based on the patient’s condition, the appropriateness of the dose and route of administration, based on the clinical condition and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition.

The HCPCS is updated annually to reflect changes in the practice of medicine and provision of health care. CMS posts on its Web site the annual alpha-numeric HCPCS file for the upcoming year, historically, at the end of each October. Providers are encouraged to access CMS web site to see the new, revised, and discontinued alpha-numeric codes for the upcoming year.

Office/Clinic Coding

When using a drug Unclassified/NOC code (J3490, J3590, J9999) list the name of the drug, the amount of the drug that is administered and wasted if applicable, strength of dosage if appropriate; method of administration in the electronic narrative 2400/SV101-7 which is equivalent to line 19 of the CMS 1500 form.  List the units of service as one in 2400/SV1-04 data element of the ANSI 837 5010 or in item 24G of the CMS 1500 form.
    
Occasionally, the strength of the drug will also be needed on NOC claims.  If the NOC ASP pricing file lists the name of the drug with its strength it must also be included on line 19. Example: Sodium Bicarbonate 8.4%.
    
Hospital Outpatient Departments Coding
    
Hospital outpatient departments are allowed to bill for new drugs, biologicals, and therapeutic radiopharmaceuticals that are approved by the FDA on or after January 1, 2004 for which pass-through status has not been approved and a C-code and APC payment have not been assigned using the “unclassified” drug/biological HCPCS code C9399 (Unclassified drugs or biological). Drugs, biologicals, and therapeutic radiopharmaceuticals that are assigned to HCPCS code C9399.

List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed.)

As you may know, pricing for NOC J-codes is determined by the information provided on the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug on the file, this indicates that the drug comes in different strengths. Medicare payment varies depending on the strength given. When billing Medicare for an NOC J-code, you can determine if the drug comes in different strengths by accessing the ASP NOC pricing files on the CMS website.

Please refer to Not Otherwise Classified (NOC) Billing
Independent Diagnostic Testing Facilities- physician supervision and technician requirements A54953 NA 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Description corrections:
95017  Perq & icut allg test venoms
95018  Perq & ic allg test drugs/biol 
95076  Ingest challenge ini 120 min 
95079  Ingest challenge addl 60 min 
95907  Nvr cndj tst 1-2 studies 
95908  Nvr cndj tst 3-4 studies
95909  Nvr cndj tst 5-6 studies
95910  Nvr cndj tst 7-8 studies
95911  Nvr cndj tst 9-10 studies
95912  Nvr cndj tst 11-12studies
95913  Nvr cndj tst 13/> studies and 
95924  Ans parasymp & symp w/tilt

MolDX: BDX-XL2 /formerly MolDX: Xpresys Lung L37216 MolDX-030 01/01/2019

The title of this LCD has been changed from MolDX: Xpresys Lung to MolDX: BDX-XL2.  All references to Xpresys Lung have been changed to BX-XL2 throughout this document.  

The following information was removed from the Coverage Summary section:

  • The test is ordered by a physician certified in the XL2 Certification and Training Registry (CTR), and
  • The following information is recorded: all clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors; PET result (if used), physician pre-test risk assessment, physician post-test lung nodule management recommendation, any subsequent procedures (non-invasive or invasive), and clinical diagnosis based on those procedures (i.e., benign or malignant)

The Strength of the evidence has been changed from limited to Moderate:
Analysis of Evidence
(Rationale for Determination)
Level of evidence
Quality-Moderate
Strength- Moderate
Weight – Limited

The following information has been added to the policy:
Data collected by Biodesix through ongoing studies will support utility including:

  • All clinical risk factors to calculate the Mayo, VA, and Brock cancer risk predictors;
  • PET result (if used),
  • Physician-assessed pre-test cancer risk assessment,
  • Physician post-test lung nodule management recommendation,
  • Any subsequent procedures (non-invasive or invasive), and
  • Clinical diagnosis based on those procedures (i.e., benign or malignant).
MolDX: BRCA1 and BRCA2 Genetic Testing L36813 MolDX-007 01/01/2019

The section on Multigene Panels has been updated.  It now reads as follows:

Multigene Panels***

The indications and limitations of coverage listed in National Coverage Determination (NCD) 90.2 (Next Generation Sequencing- NGS) apply to genetic testing for susceptibility to breast or ovarian cancer. While the NGS NCD Section 90.2 B describes specific coverage criteria for nationally covered tests, Section 90.2D permits coverage of other NGS as a diagnostic laboratory test for patients with cancer when performed and ordered according to the requirements described by the NCD. According to Section D of the NGS NCD AB Medicare Administrative Contractors (AB MACs) may cover next generation sequencing tests in patients with cancer. As such, genetic testing for susceptibility to breast or ovarian cancer with multi¬-gene NGS panels (not otherwise covered under NCD 90.2 Section B) may be covered by this AB MAC as reasonable and necessary when ALL of the NCD criteria are met in addition to the following:

  • Pre¬test genetic counseling by a cancer genetics professional has been performed and post¬test genetic counseling by a cancer genetics professional meeting NCCN accreditation criteria is planned;
  • All genes in the panel are relevant to the personal and family history for the individual being tested (panels with genes that are not relevant to the individual’s personal and family history are not reasonable and necessary);
  • Criteria listed under "Personal History of Female Breast Cancer" and/or "Personal History of Other Cancer" are met.
  • Individual also meets criteria for at least ONE hereditary cancer syndrome for which NCCN guidelines provide clear testing criteria and management recommendations, including but not limited to HBOC, Li¬Fraumeni Syndrome, Cowden Syndrome, or Lynch Syndrome.

CMS National Coverage Policy
National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS), which describes the criteria under which contractors may cover NGS laboratory tests for patients with cancer.

MolDX: CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing L36398 MolDX-002 01/01/2019
The title of this LCD has been changed from MolDX: Genetic Testing for CYP2C19, CYP2D6, CYP2C9, and VKORC1 to MolDX: CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing.
MolDX: Molecular Diagnostic Tests (MDT) L36807 MolDX-004 01/01/2019

G0452 has been removed from this LCD effective 09/28/2017:
G0452 Molecular pathology procedure: physician interpretation and report.

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Not Otherwise Classified Chemotherapy Agents (NOC) Billing and Coding Guidelines A55640 NA 01/01/2019

The title of this Article has been changed from Not Otherwise Classified Chemotherapy Agents (NOC) to Not Otherwise Classified Chemotherapy Agents (NOC) Billing and Coding Guidelines.

CPT/HCPCS Code annual update 
Group 1 Paragraph: 
Removed J9999/C9467 Rituximab and hyaluronidase human/Rituxin Hycela.
True code assigned: J9311

Please refer to LCD L37205 Chemotherapy Drugs and their Adjuncts for Coverage Indications, Limitations, and/or Medical Necessity.

Removed: 
When an NOC code is billed, two separate documents will be required to support the claim:

  • The document which supports the service, procedure, drug biological being provided. 
  • A separate document which identifies specifically for what the NOC code is being billed.

Replaced with:
When an NOC code is billed, documentation must identify specifically for what the NOC code is being billed, supporting the service, procedure, and drug biological being provided.

Added supporting Not Otherwise Classified (NOC) Billing guidance to Article Text: 

 List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed.)

Pricing for NOC J-codes is determined by the information provided on the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug, this indicates that the drug comes in different strengths. Medicare payment varies depending on the strength given. When billing Medicare for an NOC J-code, please access the ASP NOC pricing files on the CMS website to determine the different strengths. 

Please refer to Not Otherwise Classified (NOC) Billing

Psychological and Neuropsychological Testing & Billing and Coding Guidelines L34646 PSYCH-017 01/01/2019

See 2019 CPT/HCPCS Code Updates for annual CPT/HCPCS code updates.

Removed the following statement from the Coverage Guidelines section entitled Psycological testing: CPT codes 96101, 96102, 96103, 96105, 96111.

Removed the following statement from the Coverage Guidelines section entitled Neuropsychological Testing: CPT codes 96116, and 96118, 96119 and 96120.

Removed the following statement from 5. Feedback session: This service is usually billed with CPT coode 96118. 

Added the following statement to the Billing and Coding Guideline:
*Please note this section of the IOM was last updated effective 01/01/2006 and codes 96101, 96102, 96103, 96111, 96118, 96119 and 96120 are deleted effective 12/31/2018.

Removed the following italicized IOM quoted language in the Billing and Coding Guideline because it refers to deleted codes:
Medicare Part B coverage of psychological tests and neuropsychological tests is authorized under section 1861(s)(3) of the Social Security Act. Payment for psychological and neuropsychological tests is authorized under section 1842(b)(2)(A) of the Social Security Act. The payment amounts for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are effective January 1, 2006, and are billed for tests administered by a technician or a computer reflect a site of service payment differential for the facility and non-facility settings. Additionally, there is no authorization for payment for diagnostic tests when performed on an “incident to” basis. 

Under the diagnostic tests provision, all diagnostic tests are assigned a certain level of supervision. Generally, regulations governing the diagnostic tests provision require that only physicians can provide the assigned level of supervision for diagnostic tests. However, there is a regulatory exception to the supervision requirement for diagnostic psychological and neuropsychological tests in terms of who can provide the supervision. That is, regulations allow a clinical psychologist (CP) or a physician to perform the general supervision assigned to diagnostic psychological and neuropsychological tests.
 
In addition, nonphysician practitioners such as nurse practitioners (NPs), clinical nurse specialists (CNSs) and physician assistants (PAs) who personally perform diagnostic psychological and neuropsychological tests are excluded from having to perform these tests under the general supervision of a physician or a CP. Rather, NPs and CNSs must perform such tests under the requirements of their respective benefit instead of the requirements for diagnostic psychological and neuropsychological tests. Accordingly, NPs and CNSs must perform tests in collaboration (as defined under Medicare law at section 1861(aa)(6) of the Act) with a physician. PAs perform tests under the general supervision of a physician as required for services furnished under the PA benefit. 

Furthermore, physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill three test codes as “sometimes therapy” codes. Specifically, CPT codes 96105, and 96111 may be performed by these therapists. However, when PTs, OTs and SLPs perform these three tests, they must be performed under the general supervision of a physician or a CP.

Who May Bill for Diagnostic Psychological and Neuropsychological Tests 

  • CPs – see qualifications under chapter 15, section 160 of the Benefits Policy Manual, Pub. 100-02. 
  • NPs –to the extent authorized under State scope of practice. See qualifications under chapter 15, section 200 of the Benefits Policy Manual, Pub. 100-02. 
  • CNSs –to the extent authorized under State scope of practice. See qualifications under chapter 15, section 210 of the Benefits Policy Manual, Pub. 100-02. 
  • PAs – to the extent authorized under State scope of practice. See qualifications under chapter 15, section 190 of the Benefits Policy Manual, Pub. 100-02. 
  • Independently Practicing Psychologists (IPPs)
  • PTs, OTs and SLPs – see qualifications under chapter 15, sections 220-230.6 of the Benefits Policy Manual, Pub. 100-02. 

Psychological and neuropsychological tests performed by a psychologist (who is not a CP) practicing independently of an institution, agency, or physician’s office are covered when a physician orders such tests. An IPP is any psychologist who is licensed or certified to practice psychology in the State or jurisdiction where furnishing services or, if the jurisdiction does not issue licenses, if provided by any practicing psychologist. (It is CMS’ understanding that all States, the District of Columbia, and Puerto Rico license psychologists, but that some trust territories do not. Examples of psychologists, other than CPs, whose psychological and neuropsychological tests are covered under the diagnostic tests provision include, but are not limited to, educational psychologists and counseling psychologists.) 

The A/B MAC (B) must secure from the appropriate State agency a current listing of psychologists holding the required credentials to determine whether the tests of a particular IPP are covered under Part B in States that have statutory licensure or certification. In States or territories that lack statutory licensing or certification, the A/B MAC (B) checks individual qualifications before provider numbers are issued. Possible reference sources are the national directory of membership of the American Psychological Association, which provides data about the educational background of individuals and indicates which members are board-certified, the records and directories of the State or territorial psychological association, and the National Register of Health Service Providers. If qualification is dependent on a doctoral degree from a currently accredited program, the A/B MAC (B) verifies the date of accreditation of the school involved, since such accreditation is not retroactive. If the listed reference sources do not provide enough information (e.g., the psychologist is not a member of one of these sources), the A/B MAC (B) contacts the psychologist personally for the required information. Generally, A/B MACs (B) maintain a continuing list of psychologists whose qualifications have been verified. 

NOTE: When diagnostic psychological tests are performed by a psychologist who is not practicing independently, but is on the staff of an institution, agency, or clinic, that entity bills for the psychological tests. 

The A/B MAC (B) considers psychologists as practicing independently when: 
1. They render services on their own responsibility, free of the administrative and professional control of an employer such as a physician, institution or agency;
2. The persons they treat are their own patients; and 
3. They have the right to bill directly, collect and retain the fee for their services. 

A psychologist practicing in an office located in an institution may be considered an independently practicing psychologist when both of the following conditions exist:

1. The office is confined to a separately-identified part of the facility which is used solely as the psychologist’s office and cannot be construed as extending throughout the entire institution; and
2. The psychologist conducts a private practice, i.e., services are rendered to patients from outside the institution as well as to institutional patients. 

Payment for Diagnostic Psychological and Neuropsychological Tests 
Expenses for diagnostic psychological and neuropsychological tests are not subject to the outpatient mental health treatment limitation, that is, the payment limitation on treatment services for mental, psychoneurotic and personality disorders as authorized under Section 1833(c) of the Act. The payment amount for the new psychological and neuropsychological tests (CPT codes 96102, 96103, 96119 and 96120) that are billed for tests performed by a technician or a computer reflect a site of service payment differential for the facility and non-facility settings. CPs, NPs, CNSs and PAs are required by law to accept assigned payment for psychological and neuropsychological tests. However, while IPPs are not required by law to accept assigned payment for these tests, they must report the name and address of the physician who ordered the test on the claim form when billing for tests. 

CPT Codes for Diagnostic Psychological and Neuropsychological Tests 
The range of CPT codes used to report psychological and neuropsychological tests is 96101-96120. CPT codes 96101, 96102, 96103, 96105, and 96111 are appropriate for use when billing for psychological tests. CPT codes 96116, 96118, 96119 and 96120 are appropriate for use when billing for neuropsychological tests. 

All of the tests under this CPT code range 96101-96120 are indicated as active codes under the physician fee schedule database and are covered if medically necessary. 

Payment and Billing Guidelines for Psychological and Neuropsychological Tests 
The technician and computer CPT codes for psychological and neuropsychological tests include practice expense, malpractice expense and professional work relative value units. Accordingly, CPT psychological test code 96101 should not be paid when billed for the same tests or services performed under psychological test codes 96102 or 96103. CPT neuropsychological test code 96118 should not be paid when billed for the same tests or services performed under neuropsychological test codes 96119 or 96120. However, CPT codes 96101 and 96118 can be paid separately on the rare occasion when billed on the same date of service for different and separate tests from 96102, 96103, 96119 and 96120. 

Under the physician fee schedule, there is no payment for services performed by students or trainees. Accordingly, Medicare does not pay for services represented by CPT codes 
96102 and 96119 when performed by a student or a trainee. However, the presence of a student or a trainee while the test is being administered does not prevent a physician, CP, IPP, NP, CNS or PA from performing and being paid for the psychological test under 96102 or the neuropsychological test under 96119. 

Removed the following Coding Guideline statements in the Billing and Coding Guideline:
Services 96101, 96116, 96118 and 96125 report time as (a) face–to-face with the patent and (b) time spent interpreting and preparing the report. 

CPT code 96119 is reported for tests administration by a technician who is hired, trained, and directly supervised by a practitioner licensed by the State to provide neuropsychological testing. During testing, the qualified health professional frequently checks with the technician to monitor the patient’s performance and make any necessary modifications to the test battery or assessment plan. When all tests have been administered, the qualified health professional meets with the patient again to answer any questions (AMA CPT Assistant, November 2006). The time spent reviewing the results of these tests and writing the report is also reported using the same CPT code 96119.

Code 96120 is reported for computer-administered neuropsychological testing, with subsequent interpretation and report of the specific tests by the physician, psychologist, or other qualified health care professional. 

Assessments may include testing by a technician and a computer with interpretation and report by the physician, psychologist or qualified health professional. Therefore, it is appropriate in such cases to report all 3 codes 96118-96120. (AMA CPT Assistant, November 2006; CMS Medline, June 2008). However, when this is done each code must represent separately identifiable documented services.  The time spent for the interpretation of a test cannot be combined into the time spent on another service.

Removed the following Billing Guidelines statements:
1) A technician employed and supervised by the primary qualified health care profession who interpretation tests, may perform Central Nervous System Assessments /Tests CPT codes 96102 or 96119. Central Nervous System Assessments/Tests CPT codes 96103 or 96120 may be performed by a computer supervised by the primary provider. 
2) CPT codes 96102 and 96119 describe tests administered by a technician and the provider’s time for the interpretation and the report of each individual test and the report of each individual test result. The integration of all the test data determines the cognitive profile.  The provider’s time for interpretation of the test is billed under CPT code used to bill the test. 
3) CPT codes 96103 and 96120 describe computer tests and the provider’s time for the interpretation and the report. No time is billed for these codes.  
4) Per Medicare regulations Central Nervous System Assessments/Tests CPT codes 96101-96125 may not be reimbursed to clinical social workers. 
5) Physical therapists (PTs), occupational therapists (OTs) and speech language pathologists (SLPs) are authorized to bill CPT codes 96105, 96110 and 96111 as “sometimes therapy” services, services that follow the rules for Physical/Occupational/speech language pathologists. However, when PTs, OTs and SLPs administer these tests, they must be under the general supervision of a physician or clinical psychologists. 
6) CPT code 96125 has been established to report tests performed by speech-language pathologists and occupational therapists. When the test is performed by other Medicare providers, they should not use CPT code 96125 but rather, the appropriate CPT codes 96101-96103 or 96118-96120 should be used. 

Added the following Billing Guidelines statements:
1) For assessment of aphasia and cognitive performance testing use code 96105. 
2) For developmental/behavioral screening and testing use codes 96110, 96112, 96113, and 96127.
3) For neurobehavioral status examinations for psychological/neuropsychological testing use codes 96116 and 96121.
4) For testing evaluation services for psychological/neuropsychological testing use codes 96130, 96131, 96132, and 96133.
5) For test administration and scoring for psychological/neuropsychological testing use codes 96136, 96137, 96138 and 96139.
6) For automated testing and results for psychological/neuropsychological testing use code 96146.