Minimally Invasive Intradiscal/ Annular Pain Management Procedure codes

Minimally Invasive Intradiscal/ Annular Pain Management Procedure codes

Overview

Management of back pain that is persistent and disabling despite the use of recommended conservative treatment is challenging. Numerous diagnostic and therapeutic injections and other interventional and surgicaltreatments have therefore been proposed for the treatment back pain. This Coverage Policy addresses minimally  invasive spine procedures, injection therapy and other intradiscal and/or annular procedures for treatment of back pain conditions.

Coverage Policy

INJECTION THERAPY: TRIGGER POINT

Diagnostic/Stabilization Phase

Medical Coverage Policy: 0139

Trigger-point injection(s) of anesthetic and/or corticosteroid (CPT codes 20552, 20553) for diagnosis/stabilization of subacute or chronic back, or neck pain, or subacute or chronic myofascial pain syndrome is considered medically necessary when pain has persisted despite appropriate conservative treatment, including pharmacological therapy, physical therapy, and/or a home exercise program.

A maximum of four injection sessions for diagnosis and stabilization may be performed at minimum intervals of one week when provided to determine whether injections provide therapeutic benefit.

Therapeutic Phase

Therapeutic trigger-point injections of anesthetic and/or corticosteroid (CPT codes 20552, 20553) are considered medically necessary when prior diagnostic/stabilization injections resulted in a beneficial

clinical response (e.g., improvement in pain, functioning, activity tolerance) and BOTH of the following criteria are met:

• subacute or chronic back pain, neck pain, or myofascial pain syndrome persists

• injections are provided in conjunction with an active treatment program, which may include pain management, physical therapy, and/or a home exercise program

A maximum of six treatment sessions for injection of the same muscle may be performed at a minimum interval of two months, if the preceding therapeutic injection resulted in more than 50% relief for at least six weeks.

Long-term repeated or maintenance therapeutic trigger point injections for any indication are considered

experimental, investigational or unproven. Repeat therapeutic trigger point injections provided for 12 months or longer may result in medical necessity review.

When performed for any indication each of the following is considered experimental, investigational, or unproven:

• dry needling of trigger points (CPT code 64999)

• ultrasound guidance (CPT code 76942) for trigger point injections

INJECTION THERAPY: INTRADISCAL STEROID INJECTION

Intradiscal steroid injection for the treatment of acute, subacute, or chronic back or neck pain is considered experimental, investigational, or unproven.

ENDOSCOPIC DISC/NERVE ROOT DECOMPRESSION of the CERVICAL, THORACIC OR LUMBAR SPINE

Single level lumbar endoscopic disc and/or nerve root decompression (CPT code 62380) for treatment of disc herniation or spinal stenosis and unremitting radiculopathy is considered medically necessary when ALL of the following criteria are met:

• physical examination findings and imaging studies correlate with the level being treated

• clinically significant functional impairment (e.g., inability to perform household chores or prolonged standing, interference with essential job functions)

• in the absence of progressive neurological compromise, failure of at least six weeks of conservative medical management

Please note: As noted below, when endoscopic decompression is combined with procedures such as annuloplasty, ablation, and/or laser the procedure is considered experimental, investigational or unproven.

Medical Coverage Policy: 0139

Each of the following lumbar endoscopic decompression spinal procedures is considered experimental,

investigational or unproven:

• Yeung endoscopic spinal system (YESS)/ selective endoscopic discectomy (SED) when combined with ablation, laser or other thermal methods utilized for disc removal (CPT code 62380)

• endoscopic disc decompression ablation, or annular modulation using the DiscFX™ System (CPT codes 22899, 62380, 64999)

• multilevel endoscopic disc/nerve root decompression of the lumbar spine (CPT codes 22899, 64999)

Cervical and/or thoracic endoscopic disc/nerve root decompression, including ANY of the following

procedures, is considered experimental, investigational or unproven.

• cervical endoscopic decompression with microforaminotomy (e.g., Jho procedure) (CPT codes 22899, 64999)

• endoscopic, anterior cervical disc decompression (e.g., Cervical Deuk Laser Disc Repair) (CPT codes 22899, 64999)

PERCUTANEOUS LAMINECTOMY AND DISC DECOMPRESSION PROCEDURES of the CERVICAL, THORACIC, OR LUMBAR SPINE

Each of the following minimally invasive percutaneous spine procedures is considered experimental, investigational or unproven:

• automated percutaneous lumbar discectomy (APLD)/automated percutaneous nucleotomy (CPT code

62287, HCPCS code C2614)

• percutaneous diskectomy (PELD (CPT code 64999)

• percutaneous laminotomy/laminectomy, percutaneous spinal decompression (e.g., mild® procedure)

(CPT codes 0274T, 0275T)

• percutaneous laser discectomy /decompression, laser-assisted disc decompression (LADD) (CPT code 62287), targeted percutaneous laser disc decompression (targeted PLDD) (CPT code 62287)

THERMAL INTRADISCAL PROCEDURES

Each of the following procedures is considered experimental, investigational or unproven:

• intervertebral disc biacuplasty (CPT code 22899)

• intradiscal electrothermal annuloplasty (e.g., intradiscal electrothermal therapy [IDET™]) (CPT codes

22526, 22527)

• percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), intradiscal radiofrequency thermomodulation or percutaneous radiofrequency thermomodulation (CPT code 22899, HCPCS code S2348)

• Coblation® Nucleoplasty™, disc nucleoplasty, decompression nucleoplasty plasma disc decompression,

radiofrequency thermocoagulation nucleoplasty (RFTC) (CPT code 62287)

• targeted disc decompression (CPT code 22899)

OTHER PROCEDURES

The following procedures are each considered experimental, investigational or unproven:

• devices for annular repair (e.g., Inclose™ Surgical Mesh System, Xclose™ Tissue Repair System[(Anulex Technologies, Inc., Minnetonka, MN], Barricaid® [Intrinsic Therapeutics, Woburn, MA])

• epiduroscopy, epidural myeloscopy, epidural spinal endoscopy (CPT code 64999)

• intradiscal injections (e.g., methylene blue, platelet rich plasma, mesenchymal stem cells, tumor necrosis factor [TNF] alpha) and/or paravertebral oxygen/ozone injection

• spinal decompression using Baxano iO-Flex® System (e.g., Baxano Device)

Medical Coverage Policy: 0139

• intraosseous radiofrequency nerve ablation of basivertebral nerve (e.g., INTRACEPT® Intraosseous

Nerve Ablation System) (CPT codes 64999, C9752, C9753)

  

 

Coding/Billing Information

Note: 1) This list of codes may not be all-inclusive.

 2) Deleted codes and codes which are not effective at the time the service is rendered may not be eligible  for reimbursement.

Injection Therapy: Trigger Point

Considered Medically Necessary when criteria in the applicable policy statements listed above are met:

CPT®* Codes Description

20552† Injection(s); single or multiple trigger point(s), 1 or 2 muscle(s)

20553† Injection(s); single or multiple trigger point(s), 3 or more muscle(s)

†Note: Considered Experimental/Investigational/Unproven when used to report dry needling of trigger

points

ICD-10-CM

Diagnosis

Codes

Description

M43.8X9 Other specified deforming dorsopathies, site unspecified

M53.80 Other specified dorsopathies, site unspecified

M53.81 Other specified dorsopathies, occipito-atlanto-axial region

M53.82 Other specified dorsopathies, cervical region

M53.83 Other specified dorsopathies, cervicothoracic region

M53.84 Other specified dorsopathies, thoracic region

M53.85 Other specified dorsopathies, thoracolumbar region

M53.9 Dorsopathy, unspecified

M54.2 Cervicalgia

M54.5 Low back pain

M54.6 Pain in thoracic spine

M54.81 Occipital neuralgia

M54.89 Other dorsalgia

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Medical Coverage Policy: 0139

M54.9 Dorsalgia, unspecified

Considered Experimental/Investigational/Unproven:

ICD-10-CM

Diagnosis

Codes

Description

All other codes

Dry Needling of Trigger Points

Considered Experimental/Investigational/Unproven:

CPT®* Codes Description

64999 Unlisted procedure, nervous system

ICD-10-CM

Diagnosis

Codes

Description

All codes

Ultrasound Guidance for Trigger Point Injections

Considered Experimental/Investigational/Unproven:

CPT®* Codes Description

76942 Ultrasonic guidance for needle placement (eg, biopsy, aspiration, injection, localization device), imaging supervision and interpretation

ICD-10-CM

Diagnosis

Codes

Description

All codes

Injection Therapy: Intradiscal Steroid Injection

Considered Experimental/Investigational/Unproven:

CPT®* Codes Description

22899 Unlisted procedure, spine

64999 Unlisted procedure, nervous system

ICD-10-CM

Diagnosis

Codes

Description

All codes

Endoscopic Disc/Nerve Root Decompression of the Cervical, Thoracic or Lumbar Spine Considered Medically Necessary for single level lumbar endoscopic disc and/or nerve root decompression when criteria in the applicable policy statements listed above are met:

CPT®* Codes Description

Medical Coverage Policy: 0139

62380 Endoscopic decompression of spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar

Considered Experimental/Investigational/Unproven when used to report lumbar endoscopic decompression spinal procedures: Yeung endoscopic spinal system (YESS)/ selective endoscopic discectomy (SED) when combined with ablation, laser or other thermal methods utilized for disc removal; endoscopic disc decompression ablation, or annular modulation using the DiscFX™ System; multilevel endoscopic disc/nerve root decompression of the lumbar spine:

CPT®* Codes Description

22899 Unlisted procedure, spine

62380 Endoscopic decompression of spinal cord, nerve root(s), including laminotomy, partial facetectomy, foraminotomy, discectomy and/or excision of herniated intervertebral disc, 1 interspace, lumbar

64999 Unlisted procedure, nervous system

Considered Experimental/Investigational/Unproven when used to report cervical and/or thoracic endoscopic disc/nerve root decompression procedures: cervical endoscopic decompression with microforaminotomy (e.g., Jho procedure); endoscopic, anterior cervical disc decompression (e.g.,

Cervical Deuk Laser Disc Repair):

CPT®* Codes Description

22899 Unlisted procedure, spine

64999 Unlisted procedure, nervous system

Percutaneous, Laminectomy, and Disc Decompression Procedures of the Cervical, Thoracic, or Lumbar Spine

Considered Experimental/Investigational/Unproven when used to report automated percutaneous lumbar discectomy (APLD)/automated percutaneous nucleotomy; percutaneous Laminotomy/laminectomy,

percutaneous spinal decompression (e.g., mild® procedure); percutaneous laser discectomy /decompression, laser-assisted disc decompression (LADD), targeted percutaneous laser disc decompression (targeted PLDD):

CPT®* Codes Description

62287 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbar

64999 Unlisted procedure, nervous system

0274T Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (eg, fluoroscopic, CT), single or multiple levels, unilateral or bilateral; cervical or thoracic

0275T Percutaneous laminotomy/laminectomy (interlaminar approach) for decompression of neural elements, (with or without ligamentous resection, discectomy, facetectomy and/or foraminotomy), any method, under indirect image guidance (eg, fluoroscopic, CT), single or multiple levels, unilateral or bilateral; lumbar

HCPCS Codes Description

C2614 Probe, percutaneous lumbar discectomy

 

Medical Coverage Policy: 0139

ICD-10-CM

Diagnosis

Codes

Description

All codes

Thermal Intradiscal Procedures

Considered Experimental/Investigational/Unproven when used to report intervertebral disc biacuplasty; intradiscal electrothermal annuloplasty (e.g., intradiscal electrothermal therapy [IDET™]); percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), intradiscal radiofrequency thermomodulation or percutaneous radiofrequency thermomodulation; Coblation® Nucleoplasty™, disc nucleoplasty, decompression nucleoplasty plasma disc decompression, radiofrequency thermocoagulation nucleoplasty (RFTC); targeted disc decompression:

CPT®* Codes Description

22526 Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level

22527 Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including

fluoroscopic guidance; 1 or more additional levels (List separately in addition to code for primary procedure)

22899 Unlisted procedure, spine

62287 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbar

HCPCS Codes Description

S2348 Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar

ICD-10-CM

Diagnosis

Codes

Description

All codes

Other Procedures

Considered Experimental/Investigational/Unproven when used to report devices for annular repair (e.g., Inclose™ Surgical Mesh System, Xclose™ Tissue Repair System [(Anulex Technologies, Inc., Minnetonka, MN], Barricaid® [Intrinsic Therapeutics, Woburn, MA]); epiduroscopy, epidural myeloscopy, epidural spinal endoscopy; intradiscal injections (e.g., methylene blue, platelet rich plasma, mesenchymal stem cells, tumor necrosis factor [TNF] alpha) and/or paravertebral oxygen/ozone injection; spinal decompression using Baxano iO-Flex® System (e.g., Baxano Device); intraosseous radiofrequency nerve ablation of basivertebral nerve (e.g., INTRACEPT® Intraosseous Nerve Ablation System):

CPT®* Codes Description

22899 Unlisted procedure, spine

64999 Unlisted procedure, nervous system

0232T† Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed)

†Note: Considered Experimental/Investigational/Unproven when used to report platelet rich plasma used in an intradiscal injection.

Medical Coverage Policy: 0139

HCPCS Codes Description

C9752 Destruction of intraosseous basivertebral nerve, first two vertebral bodies, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum

C9753 Destruction of intraosseous basivertebral nerve, each additional vertebral body, including imaging guidance (e.g., fluoroscopy), lumbar/sacrum (list separately in addition to code for primary procedure)

Chemotherapy Administration Coding Guide

Chemotherapy Administration Coding Guide

The CPT® 2019 Professional Edition, page 721 contains the following information and direction for CPT® codes to be used for the Administration of Chemotherapy:

“Chemotherapy administration codes 96401-96549 apply to parenteral administration of non-radionuclide antineoplastic drugs; and also to anti-neoplastic agents provided for treatment of non-cancer diagnoses (e.g., cyclophosphamide for auto-immune conditions) or to substances such as certain monoclonal antibody agents, and other biologic response modifiers. The highly complex infusion of chemotherapy or other drug or biologic agents requires physician or other qualified health care professional work and/or clinical staff monitoring well beyond that of therapeutic drug agents (96360-96379) because the incidence of severe adverse patient reactions are typically greater. These services can be provided by any physician or other qualified health care professional. Chemotherapy services are typically highly complex and require direct supervision for any or all purposes of patient assessment, provision of consent, safety oversight, and intra-service supervision of staff. Typically, such chemotherapy services

require advanced practice training and competency for staff who provide these services; special considerations for preparation, dosage, or disposal; and commonly, these services entail significant patient risk and frequent monitoring. Examples are frequent changes in the infusion rate, prolonged presence of the nurse administering the solution for patient monitoring and infusion adjustments, and frequent conferring with the physician or other qualified health care professional about these issues. When performed to facilitate the infusion or injection, preparation of chemotherapy agent(s), highly complex agent(s), or other highly complex drugs is included in the administration service and is not reported separately. To report infusions that do not require this level of complexity, see 96360-96379. Codes 96401-96402, 96409-96425, 96521-96523 are not intended to be reported by the individual physician or other qualified health care professional in the facility setting.

“The term ‘chemotherapy’ in 96401-96549 includes other highly complex drugs or highly complex biologic agents.”

Medicare has determined under Section 1861(t) that these drugs may be paid when they are administered incident to a physician’s service and determined to be medically reasonable and necessary. Such determination of reasonable and necessary is determined by the Medicare Administrative Contractor. The documentation in the patient’s medical record must support that the drug is medically reasonable and necessary for the specific clinical circumstances.

As stated in the Internet Only Manual, CMS Pub 100-4 Medicare Claims Process Manual (MCPM), Chapter 12 Physicians/Non-physician Practitioners, Section 30.5 - Payments for Codes for Chemotherapy Administration: "...A/B

MACs (B) may provide additional guidance as to which drugs may be considered to be chemotherapy drugs under

Medicare.

The lists below are not all-inclusive and will continue to be revised as new information becomes available.

Intramuscular and subcutaneous injections

The administration of the following drugs in their subcutaneous or intramuscular forms should not be billed using a chemotherapy administration code. Instead, unless listed in Noridian's Self-Administered Drugs article, these should be billed using CPT® code 96372 [therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular]. Effective on or after July 31, 2017, if the administration of these drugs is billed using a chemotherapy administration code, both the drug and the administration will be rejected as incorrect coding.

 

Generic Name Trade Name HCPCS Code

abatacept Orencia® J3590

benralizumab Fasenra™

FDA approved 11/04/2017. J3590 (OPPS: C9399 from 11/04/17 to 12/31/2018 then C9466 effective 01/01/2019)

canakinumab Ilaris® J0638

certolizumab pegol Cimzia®* J0717

denosumab Prolia® / Xgeva® J0897

golimumab Simponi® J3590 (OPPS: C9399)

guselkumab Tremfya™  FDA approved 07/13/2017. J3590 (OPPS: C9029 from 01/01/2018 to 12/31/18) then J1628 effective 01/01/2019 for all providers and facilities.

mepolizumab Nucala® J2182

octreotide

acetate Depot Sandostatin LAR depot® J2353

omalizumab Xolair® J2357

pegfilgrastim** Neulasta®** J2505*

rilonacept Arcalyst® J2793

tocilizumab Actemra® J3262

tildrakizumabasmn Iluilumya™ FDA approved 3/21/2018. J3590 (OPPS: C9399 from 03/21/2018 to 12/31/2018) then J3245 effective 01/01/2019 for all providers and facilities.

ustekinumab Stelara® J3357

*Note: The self-administration formulation of certolizumab pegol (Cimzia® prefilled syringe as a 200 mg/1 ml unit dose) is not a Medicare benefit. Providers and facilities must bill this formulation with the GY modifier as a statutorily excluded service.

**Note: Effective 01/01/2018 providers are instructed to use 96377 for the on-body application injector for Neulasta

® Onpro Kit.

The intralesional administration of talimogene laherparepvec (Imlygic™) should be billed using HCPCS code J9325 with 96405 or 96406, as appropriate.

When gonadotropin releasing hormone (GnRH) and analogs (including but not limited to J9217 or J3490 [OPPS C9016] for Triptodur™) are used in the treatment of cancer, the drugs may be billed only with 96402.

When non-hormonal anti-neoplastic agents [including but not limited to rituximab and hyaluronidase (Rituxan Hycela™) J9999 [OPPS: C9467 from 04/01/2018 to 12/31/2018 and then J9311 effective 01/01/2019 for all providers and facilities] or sargramostim (Leukine®) J2820 are used as a subcutaneous or intramuscular injection in the treatment of cancer, the drugs may be billed only with 96401.

To avoid unnecessary rejections, claims for these types of drugs and their non-chemotherapy administration should be billed as a pair on a separated claim from any chemotherapy.

 

Infusions Non-Chemotherapy

Noridian has been questioned about the use of a chemotherapy administration code for an infusion (or push) of the following drugs. Approved chemotherapy drugs are listed under Infusions Chemotherapy. Effective on or after July 31, 2017, if the administration of any drug that is not approved as a chemotherapy including the following drugs, is billed using a chemotherapy administration code, both the drug and the administration code will be rejected as incorrect coding. The below should not be billed using a chemotherapy administration code. Instead, these should be billed with CPT® codes in the series 96365-96368 or 96373-96375 (Therapeutic Prophylactic, and Diagnostic Injections and Infusions).

To avoid unnecessary rejections; claims for chemotherapy drugs and their chemotherapy administration should be billed as a pair on a separate claim. In this circumstance, the Medicare Claims Processing System will still allow the add-on codes 96367 and 96368 if billed appropriately on a separate claim from the initial claim for the chemotherapy drug and administration codes with the same date of service.

Generic

Name Trade Name HCPCS Code

abatacept Orencia® J0129

bezlotoxumab Zinplava™ J0565 effective 01/01/2018 for all providers and facilities.

decitabine Dacogen® J0894

eculizumab Soliris® J1300

edaravone Radicava™ J3490 (OPPS: C9493 from 10/01/2017 to 12/31/2018) then J1301 effective 01/01/2019 for all providers and facilities.

golimumab Simponi Aria® J1602

natalizumab Tysabri® J2323

patisiran Onpattro™ FDA approved 08/10/2018. J3590 (OPPS: C9399 from 08/10/2018 to 12/31/2018 then C9036 effective 01/01/2019-09/28/2019) then J0222 effective 10/01/2019 for all providers and facilities.

reslizumab Cinqair® J2786

tocilizumab Actemra® J3262

vedolizumab Entyvio® J3380

ustekinumab* Stelara®* (OPPS: Q9989) J3358 effective 01/01/2018

*Effective September 23, 2016, IV ustekinumab (Stelara®) should be billed with HCPCS J3590 (OPPS: C9399 for dates of service (DOS) before 04/01/2017 and C9487 for DOS from 04/01/2017 to 06/30/2017. Q9989 should be used for DOS 07/01/2017-12/31/2017. Effective 01/01/2018, IV ustekinumab (Stelara®) must be billed with HCPCS J3358. The initial IV dose of Stelara® is only FDA approved for Crohn’s disease and must be billed using a therapeutic or diagnostic IV administration code. Each subsequent subcutaneous dose must be billed with 96372 as noted in the Intramuscular and subcutaneous injections section above. On and after July 31, 2017, both the drug and administration should be billed on the same claim with no other drugs or administration to prevent inappropriate claim rejection.

Infusions Chemotherapy

The HCPCS Level II establishes “Chemotherapy Drugs” as those in the range of codes J9000-J9999. Infusions of drugs with assigned HCPCS codes in this range are accepted as appropriately billed using the chemotherapy administration codes. Additionally, because of the documented increased infusion reactions and/or other reasons necessitating increased administration practice expense as indicated in the quotation from CPT at the beginning of this article or because of unmistakable use just as a chemotherapy drug, Noridian agrees with the use of an appropriate chemotherapy administration code for an infusion (or IV push) of the following drugs as described in the drug FDA label.

Note: if an Intravenous (IV) code is used, and it is infused for less than 15 minutes as per the FDA label, providers must bill the IV push infusion codes 96409 or 96411 as appropriate per CPT®.

Generic Name Trade Name HCPCS Code

alemtuzumab 1 mg Lemtrada™ J0202

atezolizumab Tecentriq™ J9022 Effective 01/01/2018

avelumab Bavencio® FDA approved 03/23/2017. J9023 effective 01/01/2018 for all providers and facilities.

axicabtagene

ciloleucel Yescarta™ Q2041 Effective 04/01/2018

bevacizumab-awwb, 10 mg MVASI™ FDA approved 04/01/2019. J9999 (OPPS: C9399) effective from 04/01/2019-07/17/2019 then Q5107 effective 07/18/2019 for all providers and facilities.

bevacizumab-bvzr, 10 mg Zirabev™ FDA approved 06/27/2019. J9999 (OPPS: C9399) effective from 06/27/2019-09/30/2019 then Q5118 effective 10/01/2019 for all providers and facilities.

cemiplimab-rwlc Libtayo® FDA approved 09/28/2018. J9999 (OPPS: C9399 until 03/31/2019 then C9044 effective 04/01/2019-09/30/2019) then J9119 effective 10/01/2019 for all providers and facilities.

copanlisib Aliqopa™ FDA approved 09/14/2017. J9999 (OPPS: C9030 from 07/01/2017 to 12/31/2018)  then J9057 effective 01/01/2019 for all providers and facilities.

durvalumab Imfinzi™ FDA approved 05/01/2017. J9999 (OPPS: C9492 from 10/01/2017 to 12/31/2018) then J9173 effective 01/01/2019 for all providers and facilities.

inotuzumab

ozogamicin Besponsa™ J9999 (OPPS: C9028 from 01/01/2018 to 12/31/2018) then J9229 effective 01/01/2019 for all providers and facilities.

Generic Name Trade Name HCPCS Code

leucovorin calcium** J0640

levoleucovorin Khapzory™ FDA approved 10/19/2018. J3490 (OPPS: C9399 until 03/31/2019 then C9043 effective 04/01/2019-09/30/2019) then J0642 effective 10/01/2019 for all providers and facilities.

moxetumomab

pasudotox-tdfk Lumoxiti™ FDA approved 09/13/2018. J9999 (OPPS: C9399 until 03/21/2019 then C9045 effective 04/01/2019-09/30/2019) then J9313 effective 10/01/2019 for all providers and facilities.

mogamulizumab-kpkc Poteligeo® FDA approved 08/08/2018. J3590 (J9999) (OPPS: C9399 from  9/28/2018-12/31/2018 then C9038 effective 01/01/2019-09/30/2019) then J9204 effective 10/01/2019 for all providers and facilities.

ocrelizumab Ocrevus™

FDA approved 03/28/2017. J2350 effective 01/01/2018 for all providers and facilities.

olaratumab Lartruvo™ J9285 effective 01/01/2018 for all providers and facilities.

rasburicase Elitek® J2783

infliximab-dyyb,

biosimilar 10 mg Inflectra®* Q5103 Effective 04/01/2018

infliximab-abda,

biosimilar 10 mg Renflexis™* Q5104 Effective 04/01/2018

infliximab-qbtx Ixifi™ FDA approved 12/13/17. Q5109 Effective 01/01/2019 for all providers and facilities.

infliximab, 10mg Remicade® J1745

sargramostim Leukine® J2820

tagraxofusp-erzs) Elzonris™ FDA approved 12/21/2018. J9999 (OPPS: C9399 from 12/21/2018 to 06/30/2019 then C9049 effective 07/01/2019-09/30/2019) then J9269 effective 10/01/2019 for all providers and facilities.

teniposide, 50mg Vumon® Q2017

tisagenlecleucel Kymriah®

Q2040 until 12/31/2018 then Q2042 effective 01/01/2019 (OPPS only under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS)

doxorubicin

hydrochloride,

liposomal, imported

Lipodox, 10mg

Lipodox®Lipodox 50 ® Q2049

doxorubicin

hydrochloride,

liposomal, NOS

Doxil® Q2050

 

Generic Name Trade Name HCPCS Code

daunorubicin and

cytarabine Vyxeos™ J9999 (OPPS: C9024 from 01/01/2018 to 12/31/2018) then J9153 effective 01/01/2019 for all providers and facilities.

trastuzumab-anns, 10 mg

Kanjinti™ FDA approved 06/13/2019. J9999 (OPPS: C9399) effective from 06/13/2019-09/30/2019

then Q5117 effective 10/01/2019 for all providers and facilities.

trastuzumab-dttb,

biosimilar Ontruzant® FDA approved 01/18/2019. J9999 (OPPS: C9399) from 01/18/2019 to 06/30/2019 then Q5112 effective 07/01/2019 for all providers and facilities.

trastuzumab-pkrb,

biosimilar Herzuma® FDA approved 12/14/2018. J9999 (OPPS: C9399) from 12/14/2018 to 06/30/2019 then Q5113 effective 07/01/2019 for all providers and facilities.

trastuzumab-dkst,

biosimilar Ogivri™ FDA approved 12/01/2017. J9999 (OPPS: C9399) from 12/01/2017 to 06/30/2019 then Q5114 effective 07/01/2019 for all providers and facilities.

*Note: Per CR 10454 and CR 10515, CMS has instructed Medicare contractors to discontinue HCPCS code Q5102 and modifiers ZB and ZC beginning April 1, 2018. Q5102 with ZB modifier and Q5102 with ZC modifier should be used to bill injections for infliximab biosimilar for Inflectra® or Renflexis™ respectively only through March 31, 2018.

Effective April 1, 2018, Q5103 should be billed for injection, infliximab-dyyb, biosimilar, (Inflectra®), 10mg or Q5104 injection, infliximab-abda, biosimilar, (Renflexis™), 10mg.

When chemotherapy is given as part of embolization procedure (37243), such as TACE, additional chemotherapy administration intra-arterial push or infusion codes (96420, 96422, 96423 or 96425) may separately be billed.

Noridian also reminds providers that when a patient has to return for a significant, separately identifiable infusion or injection on the same day or requires two IV lines per protocol, these circumstances are to be billed using the -59 modifier per Internet Only Manual (IOM) instruction.

Prolonged Drug and Biological Infusions Using an External Pump

Medicare pays for drugs and biologicals, which are not usually self-administered by the patient and are furnished

“incident to” physicians’ services rendered to patients while in the physician’s office or the hospital outpatient department. In some situations, a hospital outpatient department or physician office may:

• purchase a drug for a medically reasonable and necessary prolonged drug infusion,

• begin the drug infusion in the care setting using an external pump,

• send the patient home for a portion of the infusion, and

• have the patient return at the end of the infusion period.

In this case, bill your A/B MAC for the drug or biological, the administration, and the external infusion pump.

Additional information is available in MLN Matters® Special Edition Article # 1609, in the “Downloads” section of the Medicare Part B Drug Average Sales Price webpage (ASP).

One CPT® code that is intended for this purpose is:

96416 Initiation of prolonged chemotherapy infusion (more than 8 hours), requiring use of a portable or

implantable pump.


However, the practice expense for 96416, though inclusive of all other expenses for provision of a prolonged chemotherapy infusion (other than the drug itself), does not include the expense specific for the pump (since 96416 was prepared for the situation where the pump has previously been implanted or is otherwise provided). Therefore, for billing the service to include the expense of the provision of the pump, providers SHOULD NOT SUBMIT THE

CODE 96416, 96379 OR ANOTHER PUMP CODE, but, per CR9749, should instead submit this service using the code:

G0498 - Chemotherapy administration, intravenous infusion technique; initiation of infusion in the office/other outpatient setting using office/other outpatient setting pump/supplies, with continuation of the infusion in the community setting (e.g., home, domiciliary, rest home or assisted living) using a portable pump provided by the office/other outpatient setting, includes follow up office/other outpatient visit at the conclusion of the infusion.


G0498 must only be billed for the use of an external pump where the chemotherapy infusion was initiated in the office/other outpatient setting using office/other outpatient setting pump and supplies, with continuation of the infusion in the community setting. G0498 may be used whether the pump is an item of durable medical equipment (DME) provided by the office, or an equivalent functioning disposable pump. This code is not to be billed to the DME contractor. Billing this code once also includes the follow up office/other outpatient visit at the conclusion of the infusion and the pump and infusion discontinuation. G0498 may be applicable for the prolonged infusions by an external pump of the following drugs:

J9000 Injection, doxorubicin hydrochloride, 10 mg (Adriamycin®, Doxil®, Caelyx®, Myocet® • and others)

• J9041 Injection of bortezomib, 0.1mg (Velcade®)

• J9065 Injection of cladribine, 10mg

• J9100 Injection, cytarabine, 100mg effective 01/01/17

• J9181 Injection, etoposide, 10 mg (Toposar®, Etopophos)

• J9190 Injection, fluorouracil, 500 mg (Efudex, Carac, Fluoroplex)

• J9267 Injection of Paclitaxel, 6mg (Taxol®)

• J9352 Injection, trabectedin Yondelis®

CPT® 96416 should not be billed with G0498 as it is included in the fee for the pump. If a separate service is

performed for procedure code 96416 (or other appropriate chemotherapy administration), this service and the drug to which it relates should be billed as a pair on a separate claim, and not on a claim for G0498.

Patients supplying their own drugs

The Medicare Program provides limited benefits for outpatient drugs. The program covers drugs that are furnished under the “incident to” benefit (section 1861(s)(2)(A) or (B) of the Social Security Act), for an FDA approved drug or biological which is furnished by a physician’s practice or hospital (respectively), provided that the drug is not usually

self-administered by the patient, and is reasonable and necessary for the diagnosis or treatment of the illness or injury according to accepted standards of medical practice. The physician practice or hospital must incur a cost for Created on 10/10/2019. Page 9 of 20

the drug or biological which is then administered by the physician or by auxiliary personnel employed by the practice or hospital and under the physician's personal supervision.

Per the "incident to" guidelines explained above and in the Medicare Benefit Policy Manual, CMS Internet-Only Manual (IOM) Publication 100-02, Chapter 15, Sections 50 and 50.3 MBPM, providers are not allowed to instruct

patients to purchase a drug themselves and bring it to the provider's office for administration. Claims for a chemotherapy administration (codes 96401-96549) require an associated drug. Correspondingly a chemotherapy

drug (listed above) requires a chemotherapy administration code to be billed. When the administration claim is processing, an allowed claim for the drug must be present, either on a prior claim or on the same claim as the administration. For further information on the rare circumstances where it may be appropriate to submit a claim for a drug administration where the provider has not incurred the expense for the drug, see the separate Noridian article

“Patients Supplied Donated or Free-of-Charge Drug" link under the Related Local Coverage Document below.


Cosmetic and Reconstructive Services Coding Policy

Cosmetic and Reconstructive Services Coding Policy

Introduction

There are generally two types of plastic surgery, cosmetic and reconstructive. Cosmetic surgery is performed to improve appearance, not to improve function or ability. The plan does not cover cosmetic surgery. Reconstructive surgery focuses on reconstructing defects of the body or face due to trauma, burns, disease, or birth disorders. Reconstructive surgery is designed to restore or improve function associated with the presence of a defect. This policy outlines when reconstructive surgery may be covered.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria

Procedure Cosmetic

Cosmetic services A procedure is considered cosmetic when the medical necessity criteria in this policy are not met.

A procedure or drug may be considered cosmetic when the primary purpose is to preserve or improve appearance in the absence of a physical functional impairment (defined below).

Procedures

• Procedures that are usually considered cosmetic include but are not limited to the following:

o Abdominoplasty (includes mini or modified abdominoplasty)

o Arm lift (brachioplasty)

o Body or ear piercing

o Breast augmentation (breast implants)

o Breast lift (mastopexy)

o Buttock or thigh lift

o Chin implant (genioplasty)

o Dermabrasion

o Diastasis recti repair

o Electrolysis or laser hair removal

o Excessive/redundant skin removal from limbs and other

areas of the body

o Fat grafts

o Injectable dermal fillers used to sculpt body contours

o Inverted nipple correction

o Labial reduction (labiaplasty)/(aesthetic alteration of the female genitalia)

o Lipectomy (includes belt lipectomy, circumferential lipectomy and others)

o Lower body lift

o Neck tucks

o Penis enhancement surgery

 

Procedure Cosmetic

o Otoplasty for large or protruding ears

o Removal of frown lines

o Rhytidectomy (face lift)

o Tattoo (also see reconstructive services section)

o Tattoo removal

o Torsoplasty

o Treatment for skin wrinkles

o Treatment for spider veins (telangiectasia)

 

Pharmaceutical Agents

• Treatment with the following pharmaceutical agents is usually considered cosmetic (not an all-     inclusive list):

o Botox Cosmetic® or Juvéderm® (onabotulinum toxin for cosmetic use)

o Egrifta® (tesamorelin)

o Juvederm

o Kybella™ (deoxycholic acid) injection

o Latisse® (bimatoprost)

o Mirvaso® (brimonidine topical gel)

o Promiseb® (multiple ingredients)

o Vaniqa® (eflornithine)

o Rhofade® (oxymetazoline hydrochloride) topical cream

o Any topical agent not containing an FDA-approved legend drug whose primary purpose is other than to preserve or improve appearance in the absence of a physical functional impairment

Procedure Reconstructive / Medical Necessity

Reconstructive services A procedure is considered reconstructive when the primary purpose is to improve or restore function of a physical functional impairment of an abnormal body structure.

The following procedures may be considered medically necessary when criteria are met (see Related Policies):

• Blepharoplasty

• Breast reduction

• Gynecomastia surgery

Procedure Reconstructive / Medical Necessity

• Orthognathic surgery

• Panniculectomy

• Rhinoplasty

• Scar revision when functional impairment symptoms are present

• Skin tag removal when causing irritation and bleeding

• Tattoo when done as part of breast reconstructive surgery after mastectomy

Breast cancer The Women’s Health and Cancer Rights Act of 1998 requires that in patients with breast cancer or a history of breast cancer, all stages of reconstruction of the breast on which a mastectomy was performed, surgery and reconstruction of the other breast to produce symmetrical appearance, prostheses and treatment of physical complications of the mastectomy including lymphedema are considered medically necessary.

 

 

Coding

Code Description

Medically Necessary Services

CPT

17106 Destruction of cutaneous vascular proliferative lesions (eg, laser technique; less than 10 sq cm

17107 Destruction of cutaneous vascular proliferative lesions (eg, laser technique; 10.0 to 50.0 sq cm

17108 Destruction of cutaneous vascular proliferative lesions (eg, laser technique); over 50.0 sq cm

21125 Augmentation, mandibular body or angle; prosthetic material

21127 Augmentation, mandibular body or angle; with bone graft, onlay or interpositional (includes obtaining autograft)

21137 Reduction forehead; contouring only

21138 Reduction forehead; contouring and application of prosthetic material or bone graft (includes obtaining autograft)

 

Code Description

Medically Necessary Services

CPT

21139 Reduction forehead; contouring and setback of anterior frontal sinus wall

65760 Keratomileusis

65765 Keratophakia

65767 Epikeratoplasty

 

Code Description

Cosmetic Services

CPT

11920 Tattooing, intradermal introduction of insoluble opaque pigments to correct color defects of skin, including micropigmentation; 6.0 sq cm or less

11921 Tattooing, intradermal introduction of insoluable opaque pigments to correct color defects of skin, including micropigmentation; 6.1 sq cm to 20.0 sq cm

11922 Tattooing, intradermal introduction of insoluable opaque pigments to correct color defects of skin, including micropigmentation; each additional 20.0 sq cm, or part thereof (List separately in addition to code for primary procedure)

11950 Subcutaneous injection of filling material (eg, collagen); 1cc or less

11951 Subcutaneous injection of filling material (eg, collagen); 1.1 to 5.0 cc

11952 Subcutaneous injection of filling material (eg, collagen); 5.1 to 10.0 cc

11954 Subcutaneous injection of filling material (eg, collagen); over 10.0 cc

11960 Insertion of tissue expander(s) for other than breast, including subsequent expansion

15780 Dermabrasion; total face (eg, for acne scarring, fine wrinkling, rhytids, general keratosis)

15781 Dermabrasion; segmental, face

15782 Dermabrasion; regional, other than face

15783 Dermabrasion; superficial, any site, (eg, tattoo removal)

15786 Abrasion; single lesion (eg keratosis, scar)

15787 Abrasion; each additional four lesions or less (List separately in addition to code for primary procedure)

15819 Cervicoplasty

 

Code Description

Cosmetic Services

15824 Rhytidectomy; forehead

15825 Rhytidectomy; neck with platysmal tightening (platsymal flap, P-flap)

15826 Rhytidectomy; glabellar frown lines

15828 Rhytidectomy; cheek, chin, and neck

15829 Rhytidectomy; superficial musculoapneurotic system SMAS flap

15832 Excision, excessive skin and subcutaneous tissue (includes lipectomy); thigh

15833 Excision, excessive skin and subcutaneous tissue (includes lipectomy); leg

15834 Excision, excessive skin and subcutaneous tissue (includes lipectomy); hip

15835 Excision, excessive skin and subcutaneous tissue (includes lipectomy); buttock

15836 Excision, excessive skin and subcutaneous tissue (includes lipectomy); arm

15837 Excision, excessive skin and subcutaneous tissue (includes lipectomy); forearm or hand

15838 Excision, excessive skin and subcutaneous tissue (includes lipectomy); submental fat pad

15839 Excision excessive skin and subcutaneous tissue (includes lipectomy); other areas

15847 Excision, excessive skin and subcutaneous tissue (includes lipectomy), abdomen (eg, abdominoplasty) (includes umbilical transposition and fascial plication) (List separately in addition to code for primary procedure)

15876 Suction assisted lipectomy; head and neck

15877 Suction assisted lipectomy; trunk

15878 Suction assisted lipectomy; upper extremity

15879 Suction assisted lipectomy; lower extremity

19355 Correction of inverted nipples

21120 Genioplasty; augmentation (autograft, allograft, prosthetic material)

21121 Genioplasty; sliding osteotomy, single piece

21122 Genioplasty; sliding osteotomies, 2 or more osteotomies (eg, wedge excision or bone wedge reversal for asymmetrical chin)

21123 Genioplasty; sliding, augmentation with interpositional bone grafts (includes obtaining autografts)

 

Code Description

Cosmetic Services

40500 Vermilionectomy (lip shave), with mucosal advancement

56620 Vulvectomy simple; partial

69300 Otoplasty, protruding ear, with or without size reduction

 

HCPCS

Q2026 Injection, Radiesse, 0.1 ml

Q2028 Injection, sculptra, 0.5 mg

Code Description

Cosmetic / Reconstructive

CPT

11970 Replacement of tissue expander with permanent prosthesis

11971 Removal of tissue expander(s) without insertion of prosthesis

19316 Mastopexy

19324 Mammaplasty, augmentation; without prosthetic implant

19325 Mammaplasty, augmentation; with prosthetic implant

19328 Removal of intact mammary implant

19330 Removal of mammary implant material

19340 Immediate insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction

19342 Delayed insertion of breast prosthesis following mastopexy, mastectomy or in reconstruction

19350 Nipple/areola reconstruction

19357 Breast reconstruction, immediate or delayed, with tissue expander, including subsequent expansion

19366 Breast reconstruction with other technique

19370 Open periprosthetic capsulotomy, breast

19371 Periprosthetic capsulectomy, breast

19380 Revision of reconstructed breast

 

Code Description

Cosmetic / Reconstructive

21088 Impression and custom preparation; facial prosthesis

21188 Reconstruction midface, osteotomies (other than LeFort type) and bone grafts (includes obtaining autografts)

21280 Medial canthopexy (separate procedure)

21282 Lateral canthopexy

 

Code Description

Non-covered Services

CPT

17380 Electrolysis epilation, each 30 minutes

69090 Ear piercing

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

 

Related Information

Definition of Terms

When specific definitions are not present in a member’s plan, the following definitions will be applied. Cosmetic: In this policy, cosmetic services are those which are primarily intended to preserve or improve appearance. Cosmetic surgery is performed to reshape normal structures of the body in order to improve the patient’s appearance or self-esteem.

Physical functional impairment: In this policy, physical functional impairment means either limitation from normal physical functioning or baseline level of functioning that may include, but is not limited to, problems with ambulation, mobilization, communication, respiration, eating, swallowing, vision, facial expression, skin integrity, distortion of nearby body part(s) or obstruction of an orifice. The physical functional impairment can be due to structure, congenital  deformity, pain, or other causes. Physical functional impairment excludes social, emotional and psychological impairments or potential impairments.

Reconstructive surgery: In this policy, reconstructive surgery refers to surgeries performed on abnormal structures of the body, caused by congenital defects, developmental abnormalities, trauma, infection, tumors or disease. It is generally performed to improve function.

Determination of Eligibility for Coverage

The final determination of eligibility for coverage should be based on application of the specific contract language based on the etiology of the defect and the presence or absence of documented physical functional impairment.

Administering the Contract Language (also see Benefit Application) The following general principles describe the issues to be determined in properly administering the contract language.

1. The eligibility of a service for coverage may be based on either a specific benefit addressing cosmetic or reconstructive services or on its specific exemption or exclusion for cosmetic or reconstructive services or both.

2. Cosmetic services are usually considered to be those that are primarily to restore appearance and that otherwise do not meet the definition of reconstructive. The definition of reconstructive may be based on two distinct factors:

o Whether the service is primarily indicated to improve or correct a functional impairment or is primarily to improve appearance; and

o The etiology of the defect (eg, congenital anomaly, anatomic variant, result of trauma, post-therapeutic intervention, disease process).

3. The presence or absence of a functional impairment is a critical point in interpreting coverage eligibility. For musculoskeletal conditions, the concept of a functional impairment is straightforward. However, when considering dermatologic conditions, the function of the skin is more difficult to define. Procedures designed to enhance the appearance of the skin are typically considered cosmetic.

Benefit Application

Considerations when reviewing a case: Contract language may vary regarding the definition of reconstructive services for different categories of conditions. Two key considerations are listed below:

• First, it must be determined whether a functional impairment is present that would render its treatment medically necessary and thus eligible for coverage if no other exclusions apply.

• Second, if no functional impairment is present, the etiology of the condition must be determined and the contract language reviewed to see if this etiology is included in the definition of reconstructive services.

Evidence Review

This policy was reviewed by consensus without literature review.

Description

The coverage of medical and surgical therapies to treat musculoskeletal abnormalities and abnormalities of the integumentary system are often based on a determination of whether the abnormality is considered reconstructive or cosmetic in nature.

While reconstructive is often taken to mean that the service “returns the patient to whole” and cosmetic is often interpreted as meaning the restoration of appearance only, the application of these terms must be based on specific contract language that often varies from those in the

Definition of Terms section.

Cosmetic Genital Procedures

Vaginal procedures referred to as “rejuvenation” surgery are generally considered cosmetic as most are performed for aesthetic reasons to enhance appearance. Labia reduction surgery, also known as labiaplasty, removes excess skin or reshapes the labia, or vaginal lips. In the absence of genital mutilation, cancer, or traumatic injury a labiaplasty is cosmetic surgery. According to an American College of Obstetricians and Gynecologists (ACOG) committee opinion statement from 20075

, “these procedures are not medically indicated, and the safety and effectiveness of

these procedures have not been documented.” (See Related Medical Policies for procedures that are under gender reassignment surgery.)

Injectable Dermal Fillers

The FDA has approved a number of injectable dermal fillers and volume-producing agents for treatment localized to the face in order to create a smoother appearance. These include, but are not limited to the following:

• Calcium hydroxylapatite microsphere (Radiesse®)

• Hyaluronic acid (Restylane®, Perlane®, Juvederm® Ultra, Elevess™, Prevelle® Silk,

Teosyal®, Revanesse® Ultra)

• Poly-L-lactic acid (Sculptra®)