Multi-Carrier System (MCS) Guidelines

Payment under the fee schedule for ambulance services:

• Includes a base rate payment plus a payment for mileage;

• Covers both the transport of the beneficiary to the nearest appropriate facility and all items and services associated with such transport; and

• Precludes a separate payment for items and services furnished under the ambulance benefit.

Payment for items and services is included in the fee schedule payment. Such items and services include but are not limited to oxygen, drugs, extra attendants, and EKG testing - but only when such items and services are both medically necessary and covered by Medicare under the ambulance benefit.

30.1.1 - MCS Coding Requirements for Suppliers


The ambulance fee schedule contains the following HCPCS coding logic:

• Seven categories of ground ambulance services;

• Two categories of air ambulance services;

• Payment based on the condition of the beneficiary, not on the type of vehicle used;

• Payment is determined by the point of pickup (as reported by the 5-digit ZIP Code);

• Increased payment for rural services; and

• Services and supplies included in base rate.

Benefit Level for Non-Emergency Ambulance:

The applicable benefit for eligible non-Emergency ambulance transportation depends on the patient pick-up location (origin) as follows:

1. If the patient is inpatient and is transported from a hospital to another hospital or inpatient facility, coverage levels for these ambulance services may vary. Please refer to the enrollee’s specific plan document to determine benefits. The following are UHIC examples for inpatient ambulance transfer:


a. UHIC 2001 COC: The Hospital Inpatient Stay section of the COC

b. UHIC 2007 and 2011 COC: the Ambulance Services section of the COC


2. If the patient is in a sub-acute setting and is transported to an outpatient facility and back (outpatient hospital, outpatient facility, or physician’s office), these ambulance services are covered under the benefits that apply to that sub-acute setting. For example, if the patient is at a Skilled Nursing Facility, the ambulance transport to an outpatient facility (dialysis facility, or radiation whether or not it is attached to a hospital) and back is covered under the Skilled Nursing Facility/Inpatient Rehabilitation Facility Services section of the COC.


Enrollee Pre-Service Notification Requirements for Non-Emergency Ambulance:

• If UHIC initiates the non-Emergency ambulance transportation, enrollee notification is not required.

• If UHIC does not initiate the non-Emergency ambulance transportation certain plans may require the enrollee or the provider to call in for notification. Please see the enrollee-specific plan documents for details on the notification requirements.


Additional Information:

• Provider notification requirements are not addressed by this document.

• Ambulance transportation that is done for convenience of the patient is not covered. Please see the Coverage Limitations and Exclusions section below for more information on non-covered ambulance transportation.

Benefit Level for Non-Network Ambulance (Emergency):

If the ambulance transportation is covered, non-network Emergency ambulance (ground, water, or air), is covered at the network level of deductible and coinsurance.

Additional Information:

• For UHIC Choice, Choice+, and Options PPO plans: Non-network Emergency ambulance is covered at a negotiated rate, or, at billed charges if a negotiated rate is not reached.

• For UHIC Non-Differential PPO plans: The benefits for network and non-network are the same level but these plans do not require billed charges to be paid on non-network ambulance.

• For UHIC Plans without a Network (eg, Managed Indemnity): These plans do not have network benefit levels. These plans do not require billed charges to be paid on ambulance services.

Coverage Limitations and Exclusions

The following services are not eligible for coverage:

1. Ambulance services from providers that are not properly licensed to be performing the ambulance services rendered.

2. Air ambulance that does not meet the covered indications in the Air Ambulance criteria listed above.

3. Non-ambulance transportation. Non-ambulance transportation is not covered even if rendered in an Emergency situation. Examples include but are not limited to commercial or private airline or helicopter, a police car ride to a hospital, medi-van transportation, wheel-chair van, taxi ride, bus ride, etc.

4. Ambulance transportation when other mode of transportation is appropriate. Except as indicated under the Indications for Coverage section of this policy, ambulance services when transportation by other means would not endanger the enrollee’s health, are not covered.

5. Ambulance transportation to a home, residential, domiciliary or custodial facility is not covered.

6. Ambulance transportation that violates the notification criteria listed in the Indications for Coverage section above.

7. Ambulance transportation for patient convenience or other miscellaneous reasons for patient and/or family. Examples include but are not limited to:

a. Patient wants to be at a certain hospital or facility for personal/preference reasons;

b. Patient is in foreign country, or out of state, wants to come home to for a surgical procedure or treatment (this includes those recently discharged from inpatient care);

c. Patient is going to a routine service and is medically able to use another mode of transportation but can’t find it;

d. Patient is deceased (ie, transportation to the coroner’s office or mortuary)

8. Ambulance transportation deemed not appropriate. Examples include but are not limited to:


a. Hospital to home

b. Home to physician’s office

c. Home (eg. residence, nursing home, domiciliary or custodial facility) to a hospital for a scheduled service


Additional Information:

• If the patient is at a Skilled Nursing Facility/Inpatient Rehabilitation Facility and has met the annual day/visit limit on Skilled Nursing Facility/Inpatient Rehabilitation Facility Services, ambulance transports (during the non-covered days) are not eligible.

DEFINITIONS

Emergency - A serious medical condition or symptom resulting from Injury, Sickness or [1Mental Illness][2mental illness] which is both of the following:

• Arises suddenly

• In the judgment of a reasonable person, requires immediate care and treatment, generally received within 24 hours of onset, to avoid jeopardy to life or health

Medically Necessary (UHIC 2011 COC) - health care services provided for the purpose of preventing, evaluating, diagnosing or treating a Sickness, Injury, [Mental Illness,] [mental illness,] substance use disorder, condition, disease or its symptoms, that are all of the following as determined by us or our designee, within our sole discretion.

• In accordance with Generally Accepted Standards of Medical Practice

• Clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for your Sickness, Injury, [Mental Illness,] [mental illness,] substance use disorder, disease or its symptoms

• Not mainly for your convenience or that of your doctor or other health care providerNot more costly than an alternative drug, service(s) or supply that is at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of your Sickness, Injury, disease or symptoms


Generally Accepted Standards of Medical Practice are standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, relying primarily on controlled clinical trials, or, if not available, observational studies from more than one institution that suggest a causal relationship between the service or treatment and health outcomes.

If no credible scientific evidence is available, then standards that are based on Physician specialty society recommendations or professional standards of care may be considered. We reserve the right to consult expert opinion in determining whether health care services are Medically Necessary. The decision to apply Physician specialty society recommendations, the choice of expert and the determination of when to use any such expert opinion, shall be within our sole discretion.


We develop and maintain clinical policies that describe the Generally Accepted Standards of Medical Practice scientific evidence, prevailing medical standards and clinical guidelines supporting our determinations regarding specific services. These clinical policies (as developed by us and revised from time to time), are available to Covered Persons on [myuhc.com] or by calling Customer Care at the telephone number on your ID card, and to Physicians and other health care professionals on UnitedHealthcareOnline.

Jurisdiction of the claim is based on whether only one ambulance vehicle or multiple vehicles were used.

A. One Ambulance Vehicle Used

If only one vehicle is used to transport the patient from the point of initial pickup to the final destination, jurisdiction is with the carrier serving the point of origin, i.e., home station of the vehicle. This carrier has qualification information on the ambulance supplier and in most cases all other pertinent details necessary to adjudicate a claim.

EXAMPLE: A patient is picked up at the Johns Hopkins Hospital in Baltimore, Maryland and transported to his home in West Virginia by an ambulance dispatched from the area of the patient’s home. The carrier serving the point of origin of the ambulance, Nationwide Mutual Insurance Company, Part B carrier for the State of West Virginia, has jurisdiction of any claim filed. In this case Nationwide should have all the data necessary to make proper payment, i.e., certification of the ambulance company, price information and data pertaining to the nearest appropriate company, price information and data pertaining to the nearest appropriate facility. Had an ambulance whose home station was in Baltimore been used, the carrier servicing Baltimore, Maryland would have had jurisdiction. The Baltimore carrier would then have had
to obtain data concerning the nearest appropriate facility to the patient’s home from Nationwide


B. More Than One Vehicle Used

If more than one vehicle is used in transporting the patient to their destination, jurisdiction of the claim lies with:

• The carrier serving the home base of the ambulance taking the patient on the first leg of the trip, on a trip to a distant institution more remote than the nearest appropriate facility; or

• The carrier serving the home base of the ambulance taking the patient on the final leg of the trip home, on a trip from an institution more remote than the nearest appropriate facility.

• If there is no claim for the final leg of the trip, the carrier serving the patient’s home area handles any resulting claims or disallowance actions.

EXAMPLE: A patient is transported by ambulance from a hospital in Miami Beach, Florida to Miami International Airport and from there by air ambulance to LaGuardia Airport in Queens, New York City. At the airport he is picked up by an ambulance (based in Yonkers, New York) and taken to his home in Yonkers, New York. The carrier that handles the adjudication is the carrier whose area of responsibility includes Yonkers, New York, since partial reimbursement is based upon the nearest appropriate facility to his residence when he is being returned home from a distant institution.

In rules A and B above, the principle followed is that the carrier having the information to determine the “nearest appropriate facility” is the one to adjudicate the claim. In any event, before any partial reimbursement can be made, the carriers as designated in rules A and B, must have all the information concerning the patient’s transportation, from initial pickup to final destination.

CMS will provide each contractor with two files: a national ZIP Code file and a national Ambulance FS file.

A. The national ZIP5 Code file is a file of 5-digit USPS ZIP Codes that will map each ZIP Code to the appropriate FS locality. Every 2 months, CMS obtains an updated listing of ZIP Codes from the USPS. On the basis of the updated USPS file, CMS updates the Medicare ZIP Code file and makes it available to contractors.


The following is a record layout of the ZIP5 file effective January 1, 2009


ZIP5 CODE to LOCALITY RECORD LAYOUT


Field Name           Position         Format         COBOL Description

State                 1-2               X(02)        Alpha State Code

ZIP Code             3-7          X(05)                 Postal ZIP Code

Carrier                     8-12          X(05)           Medicare Part B Carrier Number

Pricing Locality       13-14             X(02)              Pricing Locality

Rural Indicator             15               X(01)                  Effective 1/1/07 Blank = urban,                                                                                                                                         R =rural, B=super rural

Beneficiary Lab CB Locality         16-17             X(02)                 Lab competitive bid locality;
                          Z1= CBA1
                                    Z2= CBA2
                 Z9= Not a demonstration locality

Rural Indicator 2        18                   X(01)               What was effective 12/1/06 Blank=urban, R=rural,                                                                                                                                    B =super rural

Filler                19-20              X(02)

Plus Four Flag                  21              X(01)              0 = no +4 extension
                                                                 1 = +4 extension

Filler                22-75           X(54)      

Year/Quarter              76-80           X(05)                YYYYQ



NOTE: Effective October 1, 2007, claims for ambulance services will continue to be submitted and priced using 5-digit ZIP Codes. Contractors will not need to make use of the ZIP9 file for ambulance claims.


Beginning in 2009, contractors shall maintain separate ZIP Code files for each year which will be updated on a quarterly basis. Claims shall be processed using the correct ZIP Code file based on the date of service submitted on the claim.


A ZIP Code located in a rural area will be identified with either a letter “R” or a letter “B.” Some ZIP Codes will be designated as rural due to the Rural Urban Commuting Area (RUCA) Score even though the ZIP Code may be located, in whole or in part, within an MSA or Core Based Statistical Area (CBSA).

A“B” designation indicates that the ZIP Code is in a rural county (or RUCA area) that is comprised by the lowest quartile by population of all such rural areas arrayed by population density. Effective for claims with dates of service between July 1, 2004 and December 31, 2010, contractors must apply a bonus amount to be determined by CMS to the base rate portion of the payment under the FS for ground ambulance services with a POP “B” ZIP Code. This amount is in addition to the rural bonus amount applied to ground mileage for ground transports originating in a rural POP ZIP Code.

Each calendar quarter beginning October 2007, CMS will upload updated ZIP5 and ZIP9 ZIP Code files to the Direct Connect (formerly the Network Data Mover). Contractors shall make use of the ZIP5 file for ambulance claims and the ZIP9 file as appropriate per IOM Pub. 100-04, Medicare Claims Processing Manual, chapter 1 –General Billing Requirements , section 10.1.1.1 - Payment Jurisdiction Among Local Carriers for Services Paid Under the Physician Fee Schedule and Anesthesia Services and the additional information found in Transmittal 1193, Change Request 5208, issued March 9, 2007. The updated files will be available for downloading on approximately November 15th for the January 1 release, approximately February 15th for the April 1 release, approximately May 15th for the July 1 release, and approximately August 15th for the October 1 release.



1. Upon quarterly Change Requests communicating the availability of updated ZIP Code files, go to the Direct Connect and search for the files. Confirm that the release number (last 5 digits) corresponds to the upcoming calendar quarter. If the release number (last 5 digits) does not correspond to the upcoming calendar quarter, notify CMS.

2. After confirming that the ZIP Code files on the Direct Connect corresponds to the next calendar quarter, download the files and incorporate the files into your testing regime for the upcoming model release.

The names of the files will be in the following format: MU00.AAA2390.ZIP5.LOCALITY.Vyyyyr and MU00.AAA2390.ZIP9.LOCALITY.Vyyyyr where “yyyy” equals the calendar year and “r” equals the release number with January =1, April =2, July =3, and October =4. So, for example, the names of the file updates for October 2007 are MU00.AAA2390.ZIP5.LOCALITY.V20074 and MU00.AAA2390.ZIP9.LOCALITY.V20074. The release number for this file is 20074, release 4 for the year 2007.

When the updated files are loaded to the Direct Connect, they will overlay the previous ZIP Code files.

Bill Type Codes for Ambulance Service (Ground Ambulance)

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

11xHospital Inpatient (Including Medicare Part A)
12xHospital Inpatient (Medicare Part B only)
13xHospital Outpatient
22xSkilled Nursing - Inpatient (Medicare Part B only)
23xSkilled Nursing - Outpatient
83xAmbulatory Surgery Center
85xCritical Access Hospital

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

Note: The contractor has identified the Bill Type and Revenue Codes applicable for use with the CPT/HCPCS codes included in this LCD. Providers are reminded that not all CPT/HCPCS codes listed can be billed with all Bill Type and/or Revenue Codes listed. CPT/HCPCS codes are required to be billed with specific Bill Type and Revenue Codes. Providers are encouraged to refer to the CMS Internet-Only Manual (IOM), Publication 100-04, Claims Processing Manual, for further guidance.

0540Ambulance - General Classification
0541Ambulance - Supplies
0542Ambulance - Medical Transport
0543Ambulance - Heart Mobile
0544Ambulance - Oxygen
0545Ambulance - Air Ambulance
0546Ambulance - Neonatal Ambulance Services
0547Ambulance - Pharmacy
0548Ambulance - EKG Transmission
0549Ambulance - Other Ambulance

CPT/HCPCS Codes


Group 1 Paragraph

Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book.


A0425Ground mileage

A0426Als 1

A0427ALS1-emergency

A0428bls

A0429BLS-emergency

A0433als 2

A0434Specialty care transport

A0999Unlisted ambulance service


A0888Noncovered ambulance mileage
ICD-9 Codes that Support Medical Necessity


Group 1 Paragraph : Note: Providers should continue to submit ICD-9-CM diagnosis codes without decimals on their claim forms and electronic claims.

Medical necessity and coverage of ambulance services are not based solely on the presence of a specific diagnosis. Medicare payment for ambulance transportation may be made only for those patients whose condition at the time of transport is such that ambulance transportation is necessary. For example, it is insufficient that a patient merely has a diagnosis such as pneumonia, stroke or fracture to justify ambulance transportation. In each of those instances, the condition of the patient must be such that transportation by any other means is medically contraindicated. In the case of ambulance transportation, the condition necessitating transportation is often that an accident or injury has occurred giving rise to a clinical suspicion that a specific condition exists (for instance, fractures may be strongly suspected based on clinical examination and history of a specific injury).

It is the provider’s responsibility to supply the contractor with information describing the condition of the patient that necessitated ambulance transportation. Medicare recognizes limitations of usual ambulance personnel for establishing a diagnosis and recognizes, therefore, that diagnosis coding of a patient’s condition using ICD-9-CM codes when reporting ambulance services may be less specific than for services reported by other professional providers. Providers who submit diagnosis codes should choose the code that best describes the patient’s condition at the time of transport. As a reminder to providers of ambulance services, “rule out” or “suspected” diagnoses should not be reported using specific codes. In such instances where a diagnosis is not confirmed, it is more correct to use a symptom, finding or injury code.

Reporting ambulance services using a code from the list below certifies to Medicare that the ambulance provider believes the code description reasonably reflects the condition of the patient at the time of transport and that the patient’s condition was consistent with the requirements of the Medicare ambulance transportation benefit.

The contractor recognizes that ambulance suppliers are currently not required to submit diagnosis codes on their claims if filing on a 1500 claim form or utilizing an electronic version other than the 5010 version of the 837P, though their doing so facilitates timely claim adjudication. The CPT/HCPCS codes included in this LCD will be subjected to “procedure to diagnosis” editing. Claims without a diagnosis code from below will be adjudicated manually utilizing the information contained in the claim’s narrative field and/or medical records (the trip report and any other records supplied to Medicare by the provider upon our request). Ambulance suppliers utilizing the 5010 version of the 837P are required to submit diagnosis code(s).

Due to the large number of possible covered diagnosis codes, the Contractor is not providing a comprehensive list of covered diagnosis codes for HCPCS codes A0425, A0426, A0427, A0428, A0429, A0433 and A0434.

All ambulance transports require dual diagnosis codes as described below.

Providers should report the most appropriate ICD-9-CM code that adequately describes the patient's medical condition (for example: stroke, coma, trauma, etc.) at the time of transport as the primary diagnosis. In addition, a secondary diagnosis, from the list below, must be reported.

Additionally, the KX modifier must be reported on the claim for the service to be considered for coverage. Reporting of the KX modifier is an attestation from the provider that the services are reasonable and necessary and that there is documentation of medical necessity in the patient's record. The KX modifier should not be reported if the patient's condition does not require an ambul

Group 1 Codes

V46.11DEPENDENCE ON RESPIRATOR, STATUS
V46.9*UNSPECIFIED MACHINE DEPENDENCE
V49.84BED CONFINEMENT STATUS
V49.87*PHYSICAL RESTRAINTS STATUS
V71.9*OBSERVATION FOR UNSPECIFIED SUSPECTED CONDITION

Note: Use code V46.11 to denote ventilator dependency transport ONLY.

Note: Use code V46.9 to denote the need for continuous IV fluids, 'active airway management' or the need for multiple machine devices.

Note: Use code V49.87 to denote patient safety: danger to self and others - monitoring other and unspecified reactive psychosis.

Note: Use code V71.9 to denote the need for continuous clinical assessment throughout the transport.
ICD-9 Codes that DO NOT Support Medical Necessity
Note: V68.61 should be reported for those patients who were transported by ambulance but did NOT require the services of an ambulance crew.

V68.81REFERRAL OF PATIENT WITHOUT EXAMINATION OR TREATMENT

Beginning January 1, 2008, the I/OCE began editing for the presence of a radiolabeled product when a separately payable nuclear medicine procedure is present on a claim.

Hospitals should include radiolabeled product HCPCS codes on the same claim as a nuclear medicine procedure beginning on January 1, 2008.

Hospitals are required to submit the HCPCS code for the radiolabeled product on the same claim as the HCPCS code for the nuclear medicine procedure. Hospitals are also instructed to submit the claim so that the services on the claim each reflect the date the particular service was provided. Therefore, if the nuclear medicine procedure is provided on a different date of service from the radiolabeled product, the claim will contain more than one date of service. More information regarding these edits is available on the OPPS Web site at http://www.cms.hhs.gov/HospitalOutpatientPPS/.

Hospitals are instructed to use HCPCS code C9898 (Radiolabeled product provided during a hospital inpatient stay) on outpatient claims for nuclear medicine procedures to indicate that a radiolabeled product that provides the radioactivity necessary for the reported diagnostic nuclear medicine procedure was provided during a hospital inpatient stay. This HCPCS code is assigned status indicator “N” because no separate payment is made for the code under the OPPS. The effective date of the code is January 1, 2008, the date the nuclear medicine procedure-to-radiolabeled product edits were initially implemented. Because the Medicare claims processing system requires that there be a charge for each HCPCS code reported on the claim, hospitals should always report a token charge of less than $1.01 for HCPCS code C9898. The date of service reported on the claim for HCPCS code C9898 should be the same as the date of service for the nuclear medicine procedure HCPCS code, which should always accompany the reporting of HCPCS code C9898. HCPCS code C9898 should never be reported on a claim without a diagnostic nuclear medicine procedure that is subject to the nuclear medicine procedure-to-radiolabeled product edits.

More information regarding these edits is available on the OPPS Web site at http://www.cms.hhs.gov/HospitalOutpatientPPS
Future updates to this section will be communicated in a Recurring Update Notification.

Medically necessary ambulance services furnished for dates of service on or after December 21, 2000 and prior to January 1, 2004, by a CAH or by an entity that is owned and operated by the CAH are paid based on 100 percent of the reasonable costs if the 35 mile rule for reasonable cost-based payment is met.

For dates of service on or after January 1, 2004, medically necessary ambulance services furnished by a CAH or by an entity that is owned and operated by the CAH are paid based on 101 percent of the reasonable costs if the 35 mile rule for reasonable cost-based payment is met.

For dates of service on or after December 21, 2000 and prior to October 1, 2011, in order for the 35 mile rule to be met, the CAH or the entity that is owned and operated by the CAH, must be the only provider or supplier of ambulance services located within a 35 mile drive of the CAH or the entity.

For dates of service on or after October 1, 2011, in order for the 35 mile rule to be met, the CAH or the entity that is owned and operated by the CAH, must be the only provider or supplier of ambulance services located within a 35 mile drive of the CAH. Additionally, if there is no provider or supplier of ambulance services located within a 35 mile drive of the CAH but there is an entity owned and operated by the CAH located more than a 35 mile drive from the CAH, that CAH-owned and operated entity can only be paid 101 percent of reasonable costs for its ambulance services if it is the closest provider or supplier of ambulance services to the CAH.

Section 205 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act (BIPA) of 2000 exempts certain CAHs from the current Medicare ambulance cost per trip payment limit as well as from the ambulance fee schedule. Section 205(a) of BIPA states:

The Secretary shall pay the reasonable costs incurred in furnishing ambulance services if such services are furnished (A) by a CAH (as defined in §1861(mm)(1)), or (B) by an entity that is owned and operated by a CAH, but only if the CAH or entity is the only provider or supplier of ambulance services that is located within a 35-mile drive of such CAH.

Those CAHs and CAH-owned and operated entities that meet the 35 mile rule for reasonable cost-based payment shall report condition code B2 (CAH ambulance attestation) on their bills.

When the 35 mile rule for reasonable cost-based payment is not met, the CAH ambulance service or the ambulance service furnished by the entity that is owned and operated by the CAH, is paid based on the ambulance fee schedule.

Procedure Codes and Description

G0477DRUG TEST(S), PRESUMPTIVE, ANY NUMBER OF DRUG CLASSES; ANY NUMBER OF DEVICES OR PROCEDURES, (E.G., IMMUNOASSAY) CAPABLE OF BEING READ BY DIRECT OPTICAL OBSERVATION ONLY (E.G., DIPSTICKS, CUPS, CARDS, CARTRIDGES), INCLUDES SAMPLE VALIDATION WHEN PERFORMED, PER DATE OF SERVICE

G0478DRUG TEST(S), PRESUMPTIVE, ANY NUMBER OF DRUG CLASSES; ANY NUMBER OF DEVICES OR PROCEDURES, (E.G., IMMUNOASSAY) READ BY INSTRUMENT-ASSISTED DIRECT OPTICAL OBSERVATION (E.G., DIPSTICKS, CUPS, CARDS, CARTRIDGES), INCLUDES SAMPLE VALIDATION WHEN PERFORMED, PER DATE OF SERVICE

G0479DRUG TEST(S), PRESUMPTIVE, ANY NUMBER OF DRUG CLASSES; ANY NUMBER OF DEVICES OR PROCEDURES BY INSTRUMENTED CHEMISTRY ANALYZERS UTILIZING IMMUNOASSAY, ENZYME ASSAY, TOF, MALDI, LDTD, DESI, DART, GHPC, GC MASS SPECTROMETRY), INCLUDES SAMPLE VALIDATION WHEN PERFORMED, PER DATE OF SERVICE

G0480DRUG TEST(S), DEFINITIVE, UTILIZING DRUG IDENTIFICATION METHODS ABLE TO IDENTIFY INDIVIDUAL DRUGS AND DISTINGUISH BETWEEN STRUCTURAL ISOMERS (BUT NOT NECESSARILY STEREOISOMERS), INCLUDING, BUT NOT LIMITED TO GC/MS (ANY TYPE, SINGLE OR TANDEM) AND LC/MS (ANY TYPE, SINGLE OR TANDEM AND EXCLUDING IMMUNOASSAYS (E.G., IA, EIA, ELISA, EMIT, FPIA) AND ENZYMATIC METHODS (E.G., ALCOHOL DEHYDROGENASE)); QUALITATIVE OR QUANTITATIVE, ALL SOURCES(S), INCLUDES SPECIMEN VALIDITY TESTING, PER DAY, 1-7 DRUG CLASS(ES), INCLUDING METABOLITE(S) IF PERFORMED

G0481DRUG TEST(S), DEFINITIVE, UTILIZING DRUG IDENTIFICATION METHODS ABLE TO IDENTIFY INDIVIDUAL DRUGS AND DISTINGUISH BETWEEN STRUCTURAL ISOMERS (BUT NOT NECESSARILY STEREOISOMERS), INCLUDING, BUT NOT LIMITED TO GC/MS (ANY TYPE, SINGLE OR TANDEM) AND LC/MS (ANY TYPE, SINGLE OR TANDEM AND EXCLUDING IMMUNOASSAYS (E.G., IA, EIA, ELISA, EMIT, FPIA) AND ENZYMATIC METHODS (E.G., ALCOHOL DEHYDROGENASE)); QUALITATIVE OR QUANTITATIVE, ALL SOURCES(S), INCLUDES SPECIMEN VALIDITY TESTING, PER DAY, 8-14 DRUG CLASS(ES), INCLUDING METABOLITE(S) IF PERFORMED

G0482DRUG TEST(S), DEFINITIVE, UTILIZING DRUG IDENTIFICATION METHODS ABLE TO IDENTIFY INDIVIDUAL DRUGS AND DISTINGUISH BETWEEN STRUCTURAL ISOMERS (BUT NOT NECESSARILY STEREOISOMERS), INCLUDING, BUT NOT LIMITED TO GC/MS (ANY TYPE, SINGLE OR TANDEM) AND LC/MS (ANY TYPE, SINGLE OR TANDEM AND EXCLUDING IMMUNOASSAYS (E.G., IA, EIA, ELISA, EMIT, FPIA) AND ENZYMATIC METHODS (E.G., ALCOHOL DEHYDROGENASE)); QUALITATIVE OR QUANTITATIVE, ALL SOURCES(S), INCLUDES SPECIMEN VALIDITY TESTING, PER DAY, 15-21 DRUG CLASS(ES), INCLUDING METABOLITE(S) IF PERFORMED

G0483DRUG TEST(S), DEFINITIVE, UTILIZING DRUG IDENTIFICATION METHODS ABLE TO IDENTIFY INDIVIDUAL DRUGS AND DISTINGUISH BETWEEN STRUCTURAL ISOMERS (BUT NOT NECESSARILY STEREOISOMERS), INCLUDING, BUT NOT LIMITED TO GC/MS (ANY TYPE, SINGLE OR TANDEM) AND LC/MS (ANY TYPE, SINGLE OR TANDEM AND EXCLUDING IMMUNOASSAYS (E.G., IA, EIA, ELISA, EMIT, FPIA) AND ENZYMATIC METHODS (E.G., ALCOHOL DEHYDROGENASE)); QUALITATIVE OR QUANTITATIVE, ALL SOURCES(S), INCLUDES SPECIMEN VALIDITY TESTING, PER DAY, 22 OR MORE DRUG CLASS(ES), INCLUDING METABOLITE(S) IF PERFORMED


Coverage Indications, Limitations, and/or Medical Necessity

Purpose

Urine drug testing (UDT) provides objective information to assist clinicians in identifying the presence or absence of drugs or drug classes in the body and making treatment decisions.

This policy details:
The appropriate indications and expected frequency of testing for safe medication management of prescribed substances in risk stratified pain management patients and/or in identifying and treating substance use disorders.
Designates documentation, by the clinician caring for the beneficiary in the beneficiary’s medical record, of medical necessity for, and testing ordered on an individual patient basis;
Provides an overview of presumptive urine drug testing (UDT) and definitive UDT testing by various methodologies.

This policy addresses UDT for Medicare patients only.

Definitions

As used in this document, the following terminology relates to the basic forms of UDT:

Presumptive/Qualitative Drug Testing (hereafter called "presumptive" UDT) - Used when medically necessary to determine the presence or absence of drugs or drug classes in a urine sample; results expressed as negative or positive or as a numerical result; includes competitive immunoassays (IA) and thin layer chromatography.

Definitive/Quantitative/Confirmation (hereafter called “definitive” UDT) - Used when medically necessary to identify specific medications, illicit substances and metabolites; reports the results of analytes absent or present typically in concentrations such as ng/mL; definitive methods include, but are not limited to GC-MS and LC-MS/MS testing methods.

Specimen Validity Testing - Urine specimen testing to ensure that it is consistent with normal human urine and has not been adulterated or substituted, may include, but is not limited to pH, specific gravity, oxidants and creatinine.

Immunoassay (IA) - Ordered by clinicians primarily to identify the presence or absence of drug classes and some specific drugs; biochemical tests that measure the presence above a cutoff level of a substance (drug) with the use of an antibody; read by photometric technology.

Point of Care Testing (POCT) - Used when medically necessary by clinicians caring for the beneficiary for immediate test results for the immediate management of the beneficiary; available when the beneficiary and physician are in the same location; IA test method that primarily identifies drug classes and a few specific drugs; platform consists of cups, dipsticks, cassettes, or strips; read by the human eye, or read by instrument assisted direct optical observation.

Standing Orders - Test request for a specific patient representing repetitive testing to monitor a condition or disease for a limited number of sequential visits; individualized orders for certain patients for pre-determined tests based on historical use, risk and community trend patient profiles; clinician can alter the standing order.

Note: A “profile” differs from a “panel” in that a profile responds to the clinical risks of a particular patient, whereas a panel may encourage unnecessary or excessive testing when no clinical cause exists for many of the tests.

Blanket Orders - Test request that is not for a specific patient; rather, it is an identical order for all patients in a clinician’s practice without individualized decision making at every visit.

Reflex Testing - Laboratory testing that is performed "reflexively" after initial test results to identify further diagnostic information essential to patient care. This testing is not based on a specific physician's order. Testing performed as a step necessary to complete a physician’s order is not considered reflex testing.

Drug Test Methods

The Clinical Laboratory Improvement Amendments (CLIA) regulates laboratory testing and requires clinical labs to be certified by their State as well as the CMS before they can accept human samples for diagnostic testing. Multiple types of CLIA certificates may be obtained based on the complexity of testing a lab conducts. CLIA levels of complexity (CLIA-waived, moderate complexity and high complexity) are addressed only as they relate to the HCPCS code description and the coding/billing guidance to be attached to this document.

A. Presumptive Testing Methods:
Presumptive UDT:

Presumptive UDT consist of various platforms including cards, dipsticks, cassettes and cups based on qualitative competitive immunoassay methodology with one or more analytes in the test. A presumptive IA test detects the presence of the amount of drug/substance present in urine above a predetermined “cut-off” value, and may be read by direct optical observation or by instrument assisted direct optical observation.

A positive test result is reported when the concentration of drug is above the cutoff; a negative is reported when the concentration of drug is below the cut-off. Positive test results are presumptive but not necessarily definitive due to sensitivity and cross-reactivity limitations. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen. The accuracy of the results of a presumptive UDT will depend on the testing environment, type of test, and training of the individual conducting the test.

This type of test should only be used when results are needed immediately.


Presumptive UDT by Instrumented Chemistry Analyzers:

Chemistry analyzers with IA UDT technology can be used in an office or clinical laboratory setting. This test may be used when less immediate test results are required. At no time is IA technology by chemistry analyzer analysis considered confirmatory (definitive) testing.

A presumptive positive IA test detects the presence of a drug/substance in urine at or above the “cut-off” value. If the concentration of the drug is below the cut-off, the result will be negative. Presumptive positive tests are not always true positives due to sensitivity, specificity, and cross-reactivity limitations. Negative test results do not necessarily indicate the absence of a drug or substance in the urine specimen.


FDA approved/cleared test platforms are available in the marketplace as well as, laboratory developed tests (LDTs) such as modified FDA approved/ cleared and non-FDA approved/cleared platforms and/or reagents. LDTs generally have been modified to test at a lower cutoff in order to detect substances that would have been missed at a higher cutoff. For example, a FDA labeled cutoff may be 300 ng/mL and the LDT cutoff for the same drug may be a 100 ng/mL.

Presumptive UDT can be carried out at any validated cut-off concentration. Lowering of the cut-off concentration provides more stringent cutoffs for illicit drugs. LDTs may include non-FDA cleared tests not available in CLIA-waived or moderate complexity tests (e.g. tramadol, tapentadol, carisoprodol, fentanyl, zolpidem). Lowering the cutoff increases the possibility of detecting a drug when the test has been modified from the recipe of the manufacturer.

Limitations of Presumptive UDT:

Presumptive UDT testing is limited due to:

Primarily screens for drug classes rather than specific drugs, and therefore, the practitioner may not be able to determine if a different drug within the same class is causing the positive result;

Produces erroneous results due to cross-reactivity with other compounds or does not detect all drugs within a drug class;

Given that not all prescription medications or synthetic/analog drugs are detectable and/or have assays available, it is unclear as to whether other drugs are present when some tests are reported as positive;

Cut-off may be too high to detect presence of a drug

This information could cause a practitioner to make an erroneous assumption or clinical decision.

An IA involves an antibody that reacts best with the stimulating drug, and reacts to a lesser extent (cross-reactive) or not at all with other drugs in the drug class. While presumptive tests vary in their ability to detect illicit drugs such as tetrahydrocannabinol (THC), cocaine, 3,4-methylenedioxy-N-methylamphetamine (MDMA; “ecstasy”), and phencyclidine (PCP), they may not be optimal tests for many prescription drugs, such as: opiates, barbiturates, benzodiazepines and opioids.

For example, opiate reagents are formulated from morphine. Consequently, the cross-reactivity for other opioids and opiates varies based on the manufacturer and lot number. The semisynthetic opioids, hydromorphone and hydrocodone, may contribute to a positive presumptive result, while the semisynthetic opioids, oxycodone and oxymorphone, will not typically be detected even at 300 ng/mL cutoff. Synthetic opioids, such as fentanyl, meperidine and methadone, will not be detected by current opiate IA testing. Consequently, a positive opiate result by IA normally necessitates more specific identification of the substance(s) that account for the positive result, and a negative result does not rule out the presence of opiates or opioids.

Presumptive UDT reagents for benzodiazepine are typically formulated for oxazepam, a metabolite of diazepam (Valium®) and chlordiazepoxide (Librium®), the main benzodiazepines prescribed twenty years ago. However, many of the more than 10 benzodiazepines that are currently available do not cross-react with IA benzodiazepine reagents. In particular, clonazepam and lorazepam give false negative results with presumptive IA tests and may necessitate more specific identification to account for the negative result. Similarly, a positive screening test result may require definitive UDT to identify the specific drug(s).

Synthetic/analog or “designer” drugs manufactured to elude law enforcement require definitive testing for detection. Most commercially available IA reagents fail to detect designer drugs, such as psychedelic phenethylamines even at very high concentrations.

In summary, presumptive IA UDT is often unable to identify specific drugs within many drug classes, particularly within the amphetamine, barbiturate, benzodiazepine, tricyclic antidepressants, and opiate/opioid drug classes. Drugs such as buprenorphine, amphetamines, benzodiazepines, and cocaine/heroin yield false negative IA results due to low cross-reactivity or non-reactivity and drugs such as fentanyl, carisoprodol, tramadol, tapentadol and synthetic designer drugs cannot be detected by presumptive IA. Therefore, it may be medically necessary for clinicians to utilize definitive UDT when the presumptive tests for these drugs are negative.

B. Definitive UDT:

Gas Chromatography coupled with Mass Spectrometry (GC-MS) and Liquid Chromatography coupled with Mass Spectrometry (LC-MS/MS) are complex technologies that use the separation capabilities of gaseous or liquid chromatography with the analytical capabilities of mass spectrometry. These methodologies require the competency of on-site highly trained experts in this technology and interpretation of results. While these tests require different sample preparation and analytical runs, they identify specific drugs, metabolites, and most illicit substances and report the results as absent or present typically in concentrations of ng/mL.

Quantification should not be used to determine adherence with a specific dosage or time of dose of a pain medication or illicit drug for clinical purposes. Rather, the use of quantitative drug data may be important for many reasons such as in a differential patient assessment. For example, when several opioids are present in the urine of a patient prescribed a single opioid, quantification may help the clinician decide whether the presence of the other opioids is consistent with metabolism of the prescribed opioid, opioid contamination during manufacturing, or if more than one drug within a class is being used.

Quantification may also provide information in the setting of illicit drug use. Serial creatinine-corrected quantitative values may assist in the differential assessment of ongoing drug use or cessation of drug use with continued drug excretion.
GC-MS
GC-MS can only be performed on molecules that are volatile. If the test drug is not volatile in its own right, it must be modified or derivatized to a volatile form. To derivatize, the test drug must be extracted from the urine, eluted from the extraction device, concentrated, and then reacted with a chemical reagent to make a volatile product. Each drug class may require a different derivatizing agent. For patients on multiple classes of medications, laboratories using GC procedures must make different volatile derivatives in order to perform comprehensive testing. Since a GC column may not be able to separate more than one class of compounds, multiple chromatographic runs on different column types may be required to monitor multiple drug classes. Newer GC-MS instruments often use tandem systems. GC-MS methodology allows for the testing of multiple substances but differs in ease of run.


LC-MS/MS
LC-MS/MS is roughly 100 times more sensitive and selective, involves less human steps, provides quicker turn-around time, uses less specimen volume and can test for a larger number of substances simultaneously when compared to GC-MS. After sample preparation, it is injected into the LC-MS/MS. The sample has to undergo hydrolysis to break the glucuronide bond that frees the drug and drug metabolites. Hydrolysis is followed by multiple additional steps including protein precipitation, centrifugation and purification. Deuterium-labeled isotopic internal standards are added to quantify the drugs and drug metabolites.

The sample is injected when the mobile phase is flowing through the chromatographic column. Each drug and drug metabolite interacts with the mobile phase and stationary phase differently and moves at different speeds depending on their chemical properties. In other words, each analyte elutes at different times. Specific drugs and metabolites are identified by their retention time and quantified against isotopic internal standards for each drug and metabolite. Each drug peak has to be compared to drug standards (calibrators) in order to ensure identification.

CLIA-Certified Laboratories 

CLIA specifies quality standards for proficiency testing, facility administration, general laboratory systems, pre-analytic, analytic and post-analytic systems, onsite supervision requirements, personnel qualifications and responsibilities, quality control, and quality assessment.

High complexity laboratories must ensure that testing is carried out by onsite qualified, trained personnel using validated reliable methods compliant with regulatory procedures (42 CFR Part 493). Both GC-MS and LC-MS/MS require a quality program to monitor the quality and audit the competency of the staff. LC-MS/MS instrument maintenance must be performed daily as well as the validation of instrument performance prior to patient specimens. Final review and approval of GC-MS and LC-MS/MS results must be performed by a qualified clinical laboratory scientist as defined in 42 CFR Part 493.1489 (Testing Personnel Qualifications). A GC-MS or LC-MS/MS laboratory must have a qualified laboratory director, qualified physician, or qualified clinical laboratory scientist, as provided in 42 CFR 493.1443 (Laboratory Director Qualifications).

Assay validation must be consistent with FDA guidelines. Laboratories that use “application notes” from vendors to establish drug validation do not comply with federal standards, and put patients and providers at risk by potentially reporting inaccurate test results. Only FDA 510K cleared test methods may be distributed by vendors.

Purpose of UDT:

Presumptive UDT may be ordered by the clinician caring for a beneficiary when it is necessary to rapidly obtain and/or integrate results into clinical assessment and treatment decisions.

Definitive UDT is reasonable and necessary for the following circumstances:

Identify a specific substance or metabolite that is inadequately detected by a presumptive UDT;

Definitively identify specific drugs in a large family of drugs;

Identify a specific substance or metabolite that is not detected by presumptive UDT such as fentanyl, meperidine, synthetic cannabinoids and other synthetic/analog drugs;

Identify drugs when a definitive concentration of a drug is needed to guide management (e.g., discontinuation of THC use according to a treatment plan);

Identify a negative, or confirm a positive, presumptive UDT result that is inconsistent with a patient’s self-report, presentation, medical history, or current prescribed pain medication plan;

Rule out an error as the cause of a presumptive UDT result;

Identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; and

Use in a differential assessment of medication efficacy, side effects, or drug-drug interactions.

Definitive UDT may be reasonable and necessary based on patient specific indications, including historical use, medication response, and clinical assessment, when accurate results are necessary to make clinical decisions. The clinician’s rationale for the definitive UDT and the tests ordered must be documented in the patient’s medical record.

Drug Testing Panels
Presumptive UDT Panels

Presumptive UDT testing typically involves testing for multiple analytes based on the beneficiary's clinical history and risk assessment, and must be documented in the medical record.


Definitive UDT Panels

Physician-directed definitive profile testing is reasonable and necessary when ordered for a particular patient based upon historical use and community trends. However, the same physician-defined profile is not reasonable and necessary for every patient in a physician’s practice. Definitive UDT orders should be individualized based on clinical history and risk assessment, and must be documented in the medical record.

Specimen Type

Urine or oral fluid is the preferred biologic specimen for testing because of the ease of collection, storage, and cost-effectiveness. UDT cannot detect the dosage of drug ingested/used, the time of use, or the means of delivery (intravenous vs. oral vs. inhaled). Detection time of a substance in urine is typically 1-3 days depending on the drug, rate of metabolism, and rate of excretion. Lipid-soluble drugs, such as marijuana, may remain in body fat and be detected upwards of a week or more.

Parent Drugs and Metabolite

The following chart illustrates parent drugs and their metabolites but may not be totally inclusive of all drugs and metabolites.

Note: Ethanol is a significant drug of abuse. Alcohol metabolites of ethyl glucuronide and ethyl sulfate are typically detected by definitive (GC-MS or LC-MS/MS) UDT, and should only be performed based on clinician’s documentation of medical necessity.


Parent Drugs and Metabolite Chart

Drug Class/DrugsCommon NamesGeneral Monitoring Possibilities Subject to Medical Necessity
Alcohol/Alcohol Metabolites

Ethyl Glucuronide

Ethyl Sulfate
Alcohol
Ethyl Glucuronide

Ethyl Sulfate
Barbiturates

Amobarbital

Butabarbital

Butalbital

Pentobarbital

Phenobarbital

Secobarbital
Amytal Sodium®

Butisol Sodium®, Butibel

Fiorinal®, Fioricet®

Nembutal®

Belladona, Luminal®

Seconal®
Amobarbital

Butabarbital

Butalbital

Pentobarbital

Phenobarbital

Secobarbital
Benzodiazepines

Alprazolam

Chlordiazepoxide

Clonazepam

Clorazepate

Diazepam

Lorazepam

Oxazepam

Temazepam
Xanax®, Niravam®, Xanor

Librax®, Libritabs

Klonopin®

Tranxene®

Valium®

Ativan®, Lorax

Adumbran, Alepam, Murelax, Serax, Serepax

Restoril®, Tenox, Euhypnos
Alprazolam, Alpha-hydroxyalprazolam

Nordiazepam, Oxazepam

7-Aminoclonazepam

Nordiazepam, Oxazepam

Diazepam, Nordiazepam, Temazepam, Oxazepam

Lorazepam

Oxazepam

Temazepam, Oxazepam
Illicit Drugs

Cocaine

Heroin

Marijuana

MDA

MDMA

Methamphetamine

Phencylclidine (PCP)
Blow, Coke, Crack, Snow

Black Tar, Brown Sugar, Dragon, H, Horse, Tar

Marinol, Pot, Reefer, Weed

Ecstasy, X

Ecstasy, X

Crank, Crystal Meth, Didrex®, Eldepryl®, Ice

Angel Dust
Benzoylecgonine

6-MAM, Morphine

THC-COOH

Methylenedioxyamphetamine

Methylenedioxymethamphetamine, Methylenedioxyamphetamine

Methamphetamine, Amphetamine

Phencyclidine
Synthetic Cannabinoids"K2"/"Spice"

Cathinones"Bath Salts"

Kratom
General Anesthetic

Ketamine
Ketamine

Norketamine
Muscle Relaxants

Carisoprodol

Meprobamate
Soma®, Soprodoal

Equinal, Miltown®, Meprospan
Carisoprodol, Meprobamate

Meprobamate
Neuroleptics

Gabapentin

Pregabalin
Neurontin®

Lyrica®
Opiates

Codeine

Hydrocodone

Hydromorphone

Morphine

Oxycodone

Oxymorphone
Tylenol® 3

Hycodan®, Lorcet®, Lortab®, Norco® Vicodin®, Vicoprofen®

Dilaudid®, Exalgo®, Hymorphan

Avinza®, Kadian®, MS Contin®, MSER, MSIR, Roxanol

OxyContin®, OxyIR®, Percocet®, Percodan®, Roxicodone®, Tylox®

Numorphan®, Opana® ER, Opana®
Codeine, Morphine

Hydrocodone, Hydromorphone, Norhydrocodone

Hydromorphone

Morphine

Oxycodone, Oxymorphone, Noroxycodone

Oxymorphone
Opioids

Buprenorphine

Fentanyl

Meperidine

Methadone

Propoxyphene

Tapentadol

Tramadol
Buprenex®, Butrans®, Suboxone®, Subutex®

Actiq®, Duragesic®, Fentora®, Onsolis® Sublimaze

Demerol®, Mepergan®

Dolophine®, Methadose®

Darvocet®, Darvon®

Nucynta®

Ryzolt®, Ultracet®, Ultram®, Tramadol
Buprenorphine, Norbuprenorphine

Fentanyl, Norfentanyl

Meperidine, Normeperidine

Methadone, EDDP

Propoxyphene, Norpropoxyphene

Tapentadol, N-Desmethyltapentadol

Tramadol, O-Desmethyltramadol
Stimulants

Amphetamine

Methylphenidate

Nicotine
Adderall®, Benzedrine, Dexedrine®, Vyvanse®

Concerta®, Focalin®, Methylin®, Ritalin®

Nicoderm®, Nicorette®
Amphetamine

Methylphenidate, Ritalinic Acid

Cotinine


Covered Indications for UDT

Group A – Symptomatic patients, Multiple drug ingestion and/or Patients with unreliable history

A patient who presents in a variety of medical settings with signs or symptoms of substance use toxicity will be treated presumptively to stabilize the patient while awaiting rapid, then definitive testing to determine the cause(s) of the presentation. The need for definitive UDT is based upon rapid test findings, responses to medical interventions, and treatment plan.

A presumptive UDT should be performed as part of the evaluation and management of a patient who presents in an urgent care setting with any one of the following:

Coma

Altered mental status in the absence of a clinically defined toxic syndrome or toxidrome

Severe or unexplained cardiovascular instability (cardiotoxicity)

Unexplained metabolic or respiratory acidosis in the absence of a clinically defined toxic syndrome or toxidrome

Seizures with an undetermined history

To provide antagonist to specific drug


The presumptive findings, definitive drug tests ordered and reasons for the testing must be documented in the patient's medical record.

Group B - Diagnosis and treatment for substance abuse or dependence

A patient in active treatment for substance use disorder (SUD) or monitoring across different phases of recovery may undergo medical management for a variety of medical conditions. A physician who is writing prescriptions for medications to treat either the SUD or other conditions may need to know if the patient is taking substances which can interact with prescribed medications or taking prescribed medications as expected. The risk of drug-drug interactions is inherent to the patient, and may be compounded by prescribed medications.

UDT is a medically necessary and useful component of chemical dependency diagnosis and treatment. The UDT result influences treatment and level of care decisions. Ordered tests and testing methods (presumptive and/or definitive) must match the stage of screening, treatment, or recovery; the documented history; and Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis.

For patients with no known indicators of risk for SUDs, the clinician may screen for a broad range of commonly abused drugs using presumptive UDT. For patients with known indicators of risk for SUDs, the clinician may screen for a broad range of commonly abused drugs using definitive UDT.

For patients with a diagnosed SUD, the clinician should perform random UDT, at random intervals in order to properly monitor the patient. Testing profiles must be determined by the clinician based on the following medical necessity guidance criteria:

Patient history, physical examination, and previous laboratory findings

Stage of treatment or recovery;

Suspected abused substance;

Substances that may present high risk for additive or synergistic interactions with prescribed medication (e.g., benzodiazepines, alcohol).

The patient’s medical record must include an appropriate testing frequency based on the stage of screening, treatment, or recovery; the rationale for the drugs/drug classes ordered; and the results must be documented in the medical record and used to direct care.

Frequency of Presumptive UDT for SUD:


The testing frequency must meet medical necessity and be documented in the clinician’s medical record.

For patients with 0 to 30 consecutive days of abstinence, presumptive UDT is expected at a frequency of 1 to 3 presumptive UDT per week. More than 3 presumptive panels in one week is not reasonable and necessary and is not covered by Medicare.

For patients with 31 to 90 consecutive days of abstinence, presumptive UDT is expected at a frequency of 1 to 3 UDT per week. More than 3 presumptive UDT in one week is not reasonable and necessary and is not be covered by Medicare.

For patients with > 90 consecutive days of abstinence, presumptive UDT is expected at a frequency of 1 to 3 UDT in one month. More than 3 physician-directed UDT in one month is not reasonable and necessary and is not covered by Medicare.

Frequency of Definitive UDT for SUD:


Depending on the patient’s specific substance use history, definitive UDT to accurately determine the specific drugs in the patient’s system may be necessary. Definitive testing may be ordered when accurate and reliable results are necessary to integrate treatment decisions and clinical assessment. The frequency and the rational for definitive UDT must be documented in the patient’s medical record.

For patients with 0 to 30 consecutive days of abstinence, definitive UDT is expected at a frequency not to exceed 1 physician-directed testing profile in one week. More than 1 physician-directed testing profile in one week is not reasonable and necessary and is not covered by Medicare.

For patients with 31 to 90 consecutive days of abstinence, definitive UDT is expected at a frequency of 1-3 physician-directed testing profiles in one month. More than 3 UDT in one month is not reasonable and necessary and is not covered by Medicare.

For patients with > 90 day of consecutive abstinence, definitive UDT is expected at a frequency of 1-3 physician-directed testing profiles in three months. More than 3 definitive UDT in 3 months is not reasonable and necessary and is not covered by Medicare.

Group C - Treatment for patients on chronic opioid therapy (COT).

A physician who is writing prescriptions for medications to treat chronic pain can manage a patient better if the physician knows whether the patient is consuming another medication or substance, which could suggest the possibility of SUD or lead to drug-drug interactions. Additionally, UDT may help the physician monitor for medication adherence, diversion, efficacy, side effects, and patient safety in general.

COT UDT Testing Objectives:


Identifies absence of prescribed medication and potential for abuse, misuse, and diversion;

Identifies undisclosed substances, such as alcohol, unsanctioned prescription medication, or illicit substances;

Identifies substances that contribute to adverse events or drug-drug interactions;

Provides objectivity to the treatment plan;

Reinforces therapeutic compliance with the patient;

Provides additional documentation demonstrating compliance with patient evaluation and monitoring;

Provide diagnostic information to help assess individual patient response to medications (e.g., metabolism, side effects, drug-drug interaction, etc.) over time for ongoing management of prescribed medications.

Medical Necessity Guidance:


Criteria to establish medical necessity for drug testing must be based on patient-specific elements identified during the clinical assessment, and documented by the clinician in the patient’s medical record and minimally include the following elements:

Patient history, physical examination and previous laboratory findings;

Current treatment plan;

Prescribed medication(s)

Risk assessment plan

National pain organizations, physician societies, and the Federation of State Medical Boards recommend a practical approach to definitive UDT for COT. Frequency of testing beyond the baseline presumptive UDT must be based on individual patient needs substantiated by documentation in the patient’s medical record. Recommendations for the ordering of presumptive and definitive UDT for patients on COT are as follows:

COT Baseline Testing:


Initial presumptive and/or definitive COT patient testing may include amphetamine/ methamphetamine, barbiturates, benzodiazepines, cocaine, methadone, oxycodone, tricyclic antidepressants, tetrahydrocannabinol, opioids, opiates, heroin, and synthetic/analog or “designer” drugs.

COT Monitoring Testing:


Ongoing testing may be medically reasonable and necessary based on the patient history, clinical assessment, including medication side effects or inefficacy, suspicious behaviors, self-escalation of dose, doctor-shopping, indications/symptoms of illegal drug use, evidence of diversion, or other clinician documented change in affect or behavioral pattern. The frequency of testing must be based on a complete clinical assessment of the individual’s risk potential for abuse and diversion using a validated risk assessment interview or questionnaire and should include the patient’s response to prescribed medications and the side effects of medications.

The clinician should perform random UDT at random intervals, in order to properly monitor a patient. UDT testing does not have to be associated with an office visit.

Patients with specific symptoms of medication aberrant behavior or misuse may be tested in accordance with this document’s guidance for monitoring patient adherence and compliance during active treatment (<90 days) for substance use or dependence.

UDT Frequency Based on Validated Risk Assessment and Stratification*:


Testing must be based on clinician’s documented medical necessity and reviewed by the clinician in the management of prescribing/renewing a controlled substance for every risk group outlined below.



Risk GroupBaselineFrequency of Testing
Low RiskPrior to
Initiation of
COTRandom testing 1-2 times every 12 months for prescribed medications, non-prescribed medications that may pose a safety risk if taken with prescribed medications, and illicit substances based on patient history, clinical presentation, and/or community usage.
Moderate RiskPrior to
Initiation of
COTRandom testing 1-2 times every 6 months for prescription medications, non-prescribed medication that may pose a safety risk if taken with prescribed medications, and illicit substances, based on patient history, clinical presentation, and/or community usage.
High RiskPrior to Initiation of COTRandom testing performed 1-3 times every 3 months for prescribed medications, non-prescribed medications that may pose a safety risk if mixed with prescribed and illicit substances based on patient history, clinical presentation and/or community usage.


*Note: Any additional definitive UDT beyond recommendations above must be justified by the clinician in the medical record in situations in which changes in prescribed medications may be needed, such as:

Patient response to prescribed medication suddenly changes

Patient side effect profile changes

To assess for possible drug-drug interactions

Sudden change in patient’s medical condition

Patient admits to use of illicit or non-prescribed controlled substance.


Other Covered Services

Reflex Testing by Reference Laboratories – since reference laboratories do not have access to patient-specific data, reflex testing under the following circumstances is reasonable and necessary:
To verify a presumptive positive UDT using definitive methods that include, but are not limited to GC-MS or LC-MS/MS before reporting the presumptive finding to the ordering clinician and without an additional order from the clinician; or
To confirm the absence of prescribed medications when a negative result is obtained by presumptive UDT in the laboratory for a prescribed medication listed by the ordering clinician.

Direct to definitive UDT without a presumptive UDT is reasonable and necessary, when individualized for a particular patient.

Definitive testing to confirm a negative presumptive UDT result, upon the order of the clinician, is reasonable and necessary in the following circumstances:
The result is inconsistent with a patient’s self-report, presentation, medical history, or current prescribed medication plan (should be present in the sample);
Following a review of clinical findings, the clinician suspects use of a substance that is inadequately detected or not detected by a presumptive UDT; or
To rule out an error as the cause of a negative presumptive UDT result.

Definitive testing to confirm a presumptive UDT positive result, upon the order of the clinician, is reasonable and necessary when the result is inconsistent with the expected result, a patient’s self-report, presentation, medical history, or current prescribed medication plan.


Non-Covered Services

Blanket Orders

Reflex definitive UDT is not reasonable and necessary when presumptive testing is performed at point of care because the clinician may have sufficient information to manage the patient. If the clinician is not satisfied, he/she must determine the clinical appropriateness of and order specific subsequent definitive testing (e.g., the patient admits to using a particular drug, or the IA cut-off is set at such a point that is sufficiently low that the physician is satisfied with the presumptive test result).

Routine standing orders for all patients in a physician’s practice are not reasonable and necessary.

It is not reasonable and necessary for a physician to perform presumptive POCT and order presumptive IA testing from a reference laboratory. In other words, Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.

It is not reasonable and necessary for a physician to perform presumptive IA testing and order presumptive IA testing from a reference laboratory with or without reflex testing. Medicare will only pay for one presumptive test result per patient per date of service regardless of the number of billing providers.

It is not reasonable and necessary for a reference laboratory to perform and bill IA presumptive UDT prior to definitive testing without a specific physician’s order for the presumptive testing.

IA testing, regardless of whether it is qualitative or semi-quantitative (numerical), may not be used to “confirm” or definitively identify a presumptive test result obtained by cups, dipsticks, cards, cassettes or other IA testing methods. Definitive UDT provides specific identification and/or quantification typically by GC-MS or LC-MS/MS.

Drug testing of two different specimen types from the same patient on the same date of service for the same drugs/metabolites/analytes.

UDT for medico-legal and/or employment purposes or to protect a physician from drug diversion charges.

Specimen validity testing including, but not limited to, pH, specific gravity, oxidants, creatinine.



Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
N/A

Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A

ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

E87.2Acidosis
F10.20Alcohol dependence, uncomplicated
F11.20Opioid dependence, uncomplicated
F11.220Opioid dependence with intoxication, uncomplicated
F11.221Opioid dependence with intoxication delirium
F11.222Opioid dependence with intoxication with perceptual disturbance
F11.229Opioid dependence with intoxication, unspecified
F11.23Opioid dependence with withdrawal
F11.24Opioid dependence with opioid-induced mood disorder
F11.250Opioid dependence with opioid-induced psychotic disorder with delusions
F11.251Opioid dependence with opioid-induced psychotic disorder with hallucinations
F11.259Opioid dependence with opioid-induced psychotic disorder, unspecified
F11.281Opioid dependence with opioid-induced sexual dysfunction
F11.282Opioid dependence with opioid-induced sleep disorder
F11.288Opioid dependence with other opioid-induced disorder
F11.29Opioid dependence with unspecified opioid-induced disorder
F18.10Inhalant abuse, uncomplicated
F18.120Inhalant abuse with intoxication, uncomplicated
F18.90Inhalant use, unspecified, uncomplicated
F19.20Other psychoactive substance dependence, uncomplicated
F20.0Paranoid schizophrenia
F20.1Disorganized schizophrenia
F20.2Catatonic schizophrenia
F20.89Other schizophrenia
F55.0Abuse of antacids
F55.1Abuse of herbal or folk remedies
F55.2Abuse of laxatives
F55.3Abuse of steroids or hormones
F55.4Abuse of vitamins
F55.8Abuse of other non-psychoactive substances
G40.301Generalized idiopathic epilepsy and epileptic syndromes, not intractable, with status epilepticus
G40.309Generalized idiopathic epilepsy and epileptic syndromes, not intractable, without status epilepticus
G40.311Generalized idiopathic epilepsy and epileptic syndromes, intractable, with status epilepticus
G40.319Generalized idiopathic epilepsy and epileptic syndromes, intractable, without status epilepticus
G40.401Other generalized epilepsy and epileptic syndromes, not intractable, with status epilepticus
G40.409Other generalized epilepsy and epileptic syndromes, not intractable, without status epilepticus
G40.411Other generalized epilepsy and epileptic syndromes, intractable, with status epilepticus
G40.419Other generalized epilepsy and epileptic syndromes, intractable, without status epilepticus
G40.901Epilepsy, unspecified, not intractable, with status epilepticus
G40.909Epilepsy, unspecified, not intractable, without status epilepticus
G40.911Epilepsy, unspecified, intractable, with status epilepticus
G40.919Epilepsy, unspecified, intractable, without status epilepticus
G89.29Other chronic pain
G89.4Chronic pain syndrome
I44.0Atrioventricular block, first degree
I44.1Atrioventricular block, second degree
I44.30Unspecified atrioventricular block
I45.81Long QT syndrome
I47.0Re-entry ventricular arrhythmia
I47.1Supraventricular tachycardia
I47.2Ventricular tachycardia
I49.2Junctional premature depolarization
M25.50Pain in unspecified joint
M47.21Other spondylosis with radiculopathy, occipito-atlanto-axial region
M47.22Other spondylosis with radiculopathy, cervical region
M47.23Other spondylosis with radiculopathy, cervicothoracic region
M47.26Other spondylosis with radiculopathy, lumbar region
M47.27Other spondylosis with radiculopathy, lumbosacral region
M47.28Other spondylosis with radiculopathy, sacral and sacrococcygeal region
M47.811Spondylosis without myelopathy or radiculopathy, occipito-atlanto-axial region
M47.812Spondylosis without myelopathy or radiculopathy, cervical region
M47.813Spondylosis without myelopathy or radiculopathy, cervicothoracic region
M47.816Spondylosis without myelopathy or radiculopathy, lumbar region
M47.817Spondylosis without myelopathy or radiculopathy, lumbosacral region
M47.818Spondylosis without myelopathy or radiculopathy, sacral and sacrococcygeal region
M47.891Other spondylosis, occipito-atlanto-axial region
M47.892Other spondylosis, cervical region
M47.893Other spondylosis, cervicothoracic region
M47.896Other spondylosis, lumbar region
M47.897Other spondylosis, lumbosacral region
M47.898Other spondylosis, sacral and sacrococcygeal region
M51.14Intervertebral disc disorders with radiculopathy, thoracic region
M51.15Intervertebral disc disorders with radiculopathy, thoracolumbar region
M51.16Intervertebral disc disorders with radiculopathy, lumbar region
M51.17Intervertebral disc disorders with radiculopathy, lumbosacral region
M51.36Other intervertebral disc degeneration, lumbar region
M51.37Other intervertebral disc degeneration, lumbosacral region
M54.10Radiculopathy, site unspecified
M54.14Radiculopathy, thoracic region
M54.15Radiculopathy, thoracolumbar region
M54.16Radiculopathy, lumbar region
M54.17Radiculopathy, lumbosacral region
M54.18Radiculopathy, sacral and sacrococcygeal region
M54.2Cervicalgia
M54.5Low back pain
M60.811Other myositis, right shoulder
M60.812Other myositis, left shoulder
M60.821Other myositis, right upper arm
M60.822Other myositis, left upper arm
M60.831Other myositis, right forearm
M60.832Other myositis, left forearm
M60.841Other myositis, right hand
M60.842Other myositis, left hand
M60.851Other myositis, right thigh
M60.852Other myositis, left thigh
M60.861Other myositis, right lower leg
M60.862Other myositis, left lower leg
M60.871Other myositis, right ankle and foot
M60.872Other myositis, left ankle and foot
M60.88Other myositis, other site

Coverage Indications, Limitations, and/or Medical Necessity

Overview:

Allergy testing is performed to determine a patient's immunologic sensitivity or reaction to particular allergens for the purpose of identifying the cause of the allergic state. It is based on findings during a complete medical and immunologic history, and appropriate physical exam obtained by face-to-face contact with the patient.

Indications:

Allergy skin testing is a clinical procedure that is used to evaluate an immunologic response to allergenic material. It would not be expected that all patients would receive the same tests or the same number of sensitivity tests. The number and type of antigens used for testing must be chosen judiciously given the patient’s presentation, history, physical findings, and clinical judgment.

To be covered by Medicare, the antigens must meet all of the following criteria:

Skin testing must be performed based on a complete history and physical exam,

Proven efficacy as demonstrated through scientifically valid peer reviewed published medical studies, and

Exist in the patient’s environment with a reasonable probability of exposure

Allergy testing can be broadly subdivided into two methodologies:

In vivo testing (skin tests): this testing correlates the performance and evaluation of selective cutaneous and mucous membrane tests with the patient’s history, physician examination, and other observations.
Percutaneous Testing (scratch, puncture, prick) and is used to evaluate immunoglobulin E (IgE) mediated hypersensitivity. Percutaneous tests require medical supervision, since there is a small but significant risk of anaphylaxis. Overall, skin testing is quick, safe, and cost-effective. It remains the test of choice in most clinical situations where immediate hypersensitivity reactions are suspected.

Percutaneous testing is the usual preferred method for allergy testing. Medicare covers percutaneous (scratch, prick or puncture) testing when IgE-mediated reactions occur with any of the following:


Inhalants.

Foods. (Patients present with signs and symptoms such as urticarial, angioedema, or anaphylaxis after ingestion of specific foods. Testing for food allergies in patients who present with wheezing is occasionally required.)

Hymenoptera (stinging insects).

Specific drugs (penicillins, macromolecular agents, enzymes, and egg-containing vaccines). Skin testing is unreliable with other drugs.

Intracutaneous/Intradermal Tests are usually performed when increased sensitivity is the main goal such as when percutaneous tests are negative and there is a strong suspicion of allergen sensitivity. Intradermal tests are injections of small amounts of antigen into the superficial layers of the skin. The usual testing program may include 2 concentrations of an extract: a weaker concentration and a stronger concentration. It would not be expected that 3 or more concentrations of one extract would be medically necessary. Medicare covers intradermal (intracutaneous) testing when IgE-mediated reactions occur to any of the following:


Inhalants.

Hymenoptera (stinging insects).

Specific drugs (penicillins and macromolecular agents).

Patch Testing is the gold standard method of identifying the cause of allergic contact dermatitis. This testing is indicated to evaluate a nonspecific dermatitis, pruritus, to differentiate allergic contact dermatitis (ACD) and irritant contact dermatitis (ICD) and determine the causative antigen. It is a diagnostic test reserved for patients with skin eruptions for which a contact allergy source is likely.

The patch test procedure can induce an eczematous reaction in miniature by applying suspect allergens to normal skin, allowing the physician to determine a specific patient allergy. Patch tests are applied to the skin on the patient’s back and left in place for 48 hours. The test is interpreted after 48 hours, and typically once again at 72 or 96 hours, and the reactions are systematically scored and recorded. The patient is then informed and educated regarding specific allergies and avoidance of exposure. Avoidance of the identified allergen(s) is critical to patient improvement and resolution of the dermatitis.

Allergy patch testing is a covered procedure only when used to diagnose allergic contact dermatitis after the following exposures: dermatitis due to detergents, oils and greases, solvents, drugs and medicines in contact with skin, other chemical products, food in contact with skin, plants (except food), cosmetics, metals, rubber additives, other and unspecified. Patch tests may also be used and may be helpful when a distribution and persistence of dermatitis suggests a possible contact allergy, but the exact etiology of the dermatitis is unknown. These allergens are part of a useful, but limited series of 36 allergens. While this series of 36 allergens represents some of the most common contact allergies, there are a significant number of patients who suffer intractable contact dermatitis for which the 36 allergens are inadequate to diagnose their problem. A supplemental series of allergens in this case can enhance accurate diagnosis, patient education, and treatment. This supplemental series is particularly critical in the diagnosis of occupationally induced dermatitis. If another supplemental series of allergens are clinical indicated for an accurate diagnosis, the documentation must support the medically reasonable and necessary use of the additional allergens.

Photo Patch Testing uses two patches, with one of them being irradiated with ultraviolet light half way through the occlusive period. It is indicated to evaluate unique allergies resulting from light exposure. Some chemicals or medications produce an allergic reaction only when exposed to light (usually ultraviolet type A, UVA). Patients who are over-sensitive to light and those with a rash that appears on parts of the body normally exposed to light but that does not appear in areas shielded from the light should have a photo-patch test.

Photo Tests is skin irradiation with a specific range of ultraviolet light. Photo tests are performed for the evaluation of photosensitivity disorders.

Skin Endpoint Titration (SET) Testing or Intradermal Dilutional Testing (IDT) analyzes the highest dilution of a substance that produces a reaction, and may be used to determine the starting dose(s) of allergen immunotherapy.

Delayed Hypersensitivity Skin Testing has been commonly used in three ways: anergy testing, testing for infection with intracellular pathogens, and testing for sensitivity to contact allergens. Accurate testing for contact allergy requires careful attention to technique, and limitation of testing to the specific allergens known to be associated with a contact reaction.

Ophthalmic Mucous Membrane Tests and Direct Nasal Mucous Membrane Tests are rarely indicated. They are allowed when skin testing cannot test allergens.

Ophthalmic mucous membrane tests and direct nasal mucous membrane tests are approved if levels of allergic mediators (such as histamine and tryptase) are measured and a placebo control is performed. This is usually performed in allergy research laboratories. It is also approved in the office setting if the physician is there to observe objective measurement of reactions which might include redness of the eyes, tearing and sneezing.

Inhalation Bronchial Challenge Testing involves the inhalation of agents that can trigger respiratory responses and are often used to evaluate new allergens and/or substantiate the role of allergens in patients with significant symptoms. Results of these tests are ordinarily evaluated by objective measures of pulmonary function and occasionally by characterization of bronchoalveolar lavage samples.
Inhalation bronchial challenge tests should be performed as dose-response assays where in provocation concentration thresholds can be determined on the basis of allergen concentration required to cause a significant decrease in measured pulmonary function.

Inhalation bronchial challenge tests with occupational allergens need to be carefully controlled with respect to dose and duration of exposure. When industrial small molecular weight agents are assessed, tests should be performed under conditions of continuous monitoring of the specific chemical being assessed so as not to exceed the threshold limit level permitted in the workplace.

Ingestion (Oral) Challenge Test involves the administration of sequentially or incrementally larger doses of the test item. The test items may include food or antibiotics. The service is allowed once per patient encounter, regardless of the number of items tested, and includes evaluation of the patient's response to the test items.

Challenge ingestion food testing is a safe and effective technique in the diagnosis of food allergies. This procedure is covered when it is used on an outpatient basis if it is reasonable and necessary for the individual patient. (CMS Pub. 100-03 Medicare National Coverage Determination (NCD)Manual, Chapter 1- Coverage Determinations, Part 2 Section 110.12- Challenge Ingestion Food Testing).

Challenge ingestion food testing is covered for the following indications:
Food allergy, dermatitis

Anaphylactic shock due to adverse food reaction

Allergy to medicinal agents

Allergy to foods

Challenge ingestion food testing has not been proven to be effective in the diagnosis of rheumatoid arthritis, depression, or respiratory disorders. Accordingly, its use in the diagnosis of these conditions is not reasonable and necessary within the meaning of section 1862(a) (1) of the Medicare law, and no program payment is made for this procedure when it is so used. (CMS Pub. 100-03 Medicare National Coverage Determination (NCD)Manual, Chapter 1- Coverage Determinations, Part 2 Section 110.12- Challenge Ingestion Food Testing).

Intracutaneous testing, delayed reaction - more than 6 tests, may be covered but requires additional justification and case-by-case review for the number of tests performed and the medical necessity except when the skin test is used:

Prior to collagen implant therapy, a skin test for collagen sensitivity must be administered and evaluated over a 4 week period. CMS Pub 100-03 Medicare National Coverage Determinations (NCD) Manual, Chapter 1 – Coverage Determinations, Part 4, Section 230.10 – Incontinence Control Devices.

Organ challenge test materials may be applied to the mucosae of the conjunctivae, nares, GI tract, or bronchi. Considerable experience with these methods is required for proper interpretation and analysis. All organ challenge tests should be preceded by a control test with diluent and, if possible, the procedure should be performed on a double blind or at least single-blind basis.

In vitro testing (blood serum analysis): immediate hypersensitivity testing by measurement of allergen-specific serum IgE in the blood serum. They are useful when testing for inhalant allergens (pollens, molds, dust mites, animal danders), foods, insect stings, and other allergens such as drugs or latex, when direct skin testing is impossible due to extensive dermatitis, marked dermatographism, or in children younger than four years of age.

In vitro testing is covered when skin testing is not possible or would be unreliable; or in vitro testing is medically reasonable and necessary as determined by the physician. When in vitro testing is ordered or performed, the medical record must clearly document the indication and why it is being used instead of skin testing.

It is not covered when done in addition to a skin test for the same antigen, except in the case of suspected latex sensitivity, hymenoptera, or nut/peanut sensitivity where both the skin test and the in-vitro test may be performed. The number of tests done, choice of antigens, frequency of repetition and other coverages issues are the same as skin testing.

Testing must be based on a careful history/physical examination which suggests IgE medicated disease. Total Serum IgE is not appropriate in most general allergy testing. Instead, individual IgE tests are performed against a specific antigen.

Special clinical situations in which specific IgE immunoassays are performed against a specific antigen may be appropriate in the following situations:
Patients with extensive dermatitis, severe dermatographism, ichthyosis or generalized eczema that will not make direct skin testing possible.

Patients needing continued use of H-1 blockers (antihistamines), or in the rare patient with persistent unexplained negative histamine control.

Patients who cannot be safely withdrawn from medications that interfere with skin testing, such as long-acting antihistamines, tricyclic antidepressants, beta-blockers, or medications that may put the patient at undue risk if they are discontinued long enough to perform skin tests.

Uncooperative patients with mental or physical impairments.

For evaluation of cross-reactivity between insect venoms (e.g., fire ant, bee, wasp, yellow jacket, hornet).

As adjunctive laboratory testing for disease activity of allergic bronchopulmonary aspergillosis and certain parasitic disease.

To diagnose atopy in small children.

Patients at increased risk for anaphylactic response from skin testing based on clinical history (e.g., when an unusual allergen is not available as a licensed skin test extract), or who have a history of a previous systemic reaction to skin testing.

Patients in who skin testing were equivocal/inconclusive and in vitro testing is required as a confirmatory test.

Total IgE is reasonable and necessary for follow-up of ABPA and to diagnosis atopy in children.

Retesting with the same antigen(s) should rarely be necessary within a three-year period. Exceptions include young children with negative skin tests, or older children and adults with negative skin tests in the face of persistent symptoms. Routine repetition of skin tests is not indicated (i.e., annually) and not covered.

Limitations:

The following tests are considered not medically reasonable and necessary:
Ingestion (Oral) Challenge Food Testing performed by the patient in the home, and not in the office setting, will not be covered.

Provocative Testing for which there is limited or no evidence of validity include the cytotoxic test, the provocation-neutralization procedure, electrodermal diagnosis, applied kinesiology, the "reaginic" pulse test, and chemical analysis of body tissues. Controlled studies for the cytotoxic and provocation-neutralization tests demonstrated that the results are not reproducible and do not correlate with clinical evidence of allergy. Electrodermal diagnosis and applied kinesiology have not been evaluated for efficacy. Similarly, the "reaginic" pulse test and chemical analysis of body tissues for various exogenous chemicals have not been substantiated as valid tests for allergy.

Provocative and neutralization testing and neutralization therapy (Rinkel test) of food allergies (sublingual, intracutaneous and subcutaneous) are excluded from Medicare coverage because available evidence does not show these tests and therapies are effective.

IgG and IgG Subclass Antibody Tests measure allergen-specific IgG and IgG subclasses by using immunoabsorption assays and IgG and IgG subclass antibody tests for food allergy/delayed food allergic symptoms or intolerance to specific foods. These tests are considered experimental and investigational since there is insufficient evidence in the published peer-reviewed scientific literature to support the diagnostic value of these tests.

Antigens for which no clinical efficacy is documented in peer reviewed literature include the following: newsprint, tobacco smoke and leaf, dandelion, orris root, phenol, alcohol, sugar, yeast, grain mill dust, soybean dust (except when the patient has a known exposure to soybean dust such as a food processing plant), honeysuckle, marigold, goldenrod, fiberglass, wool, green tea, or chalk.

Radioallergosorbent test (RAST), fluoroallergosorbent test (FAST), and multiple antigen simultaneous test (MAST) are in vitro techniques for determining whether a patient's serum contains IgE antibodies against specific allergens of clinical importance. As with any allergy testing, the need for such tests is based on the findings during a complete history and physical examination of the patient. These tests are not appropriate in most general allergy testing. Instead, individual IgE tests should be performed against a specific antigen.

ELISA (enzyme-linked immunoaorbent assay) test is another in vitro method of allergy testing for specific IgE antibodies against allergens. It is used to determine in vitro reaction to various foods and relies on lymphocyte blastogenesis in response to certain food antigens.

Quantitative multi-allergen screen is a non-specific screen that does not identify a specific antigen. It is does not have sufficient literature demonstrating clear cut clinical implication. It is a screening tool and therefore not covered by Medicare.

Effective August 5, 1985, cytotoxic leukocyte tests for food allergies are excluded from Medicare coverage because available evidence does not show that these tests are safe and effective. (CMS Pub. 100-03 Medicare National Coverage Determination (NCD) Manual, Chapter 1- Coverage Determinations, Part 2 Section 110.13-Cytotoxic Food Tests).

Effective October 31, 1988, sublingual intracutaneous and subcutaneous provocative and neutralization testing and neutralization therapy for food allergies are excluded from Medicare coverage because available evidence does not show that these tests and therapies are effective. (CMS Pub 100-03 Medicare National Coverage Determinations Manual, Chapter 1- Coverage Determinations, Part 2, Section 110.11 – Food Allergy Testing and Treatment).

The following tests are considered experimental and investigational for allergy testing as these have not been proven to be effective or appropriate for the evaluation and/or management of IgE-mediated allergic reactions. This list is not all inclusive:
Antigen leukocyte cellular antibody (ALCAT) automated food allergy testing

Applied kinesiology or Nambudripad’s allergy elimination test (NAET (i.e., muscle strength testing or measurement after allergen ingestion)

Anti-Fc epsilon receptor antibodies testing

Anti-IgE receptor antibody testing

Blood, urine, or stool micro-nutrient assessments

Candidiasis test

Chemical analysis of body tissues (e.g., hair)

Chlorinated pesticides (serum)

Chronic urticarial index testing

Clifford materials reactivity testing

Complement (total or components)

Complement antigen testing

C-reactive protein

Cytokine and cytokine receptor assay

Cytotoxic testing for environmental or clinical ecological allergy testing (Bryans Test, ACT)

Electrodermal testing or electro-acupuncture

Electromagnetic sensitivity syndrome/disorder (allergy to electricity, electro-sensitivity, electrohypersensitivity, and hypersensitivity to electricity).

Environmental cultures and chemicals

Eosinophil cationic protein (ECP) test

Food immune complex assay (FICA) or food allergenic extract immunotherapy

General immune system assessments

Immune complex assay

Immunoglobulin G (IgG) testing for allergy

Iridology

Leukocyte antibodies testing

Leukocyte histamine release test (LHRT)/basophil histamine release test

Lymphocytes (B or T subsets)

Lymphocyte function assay

Mediator release test (MRT) or the LEAP program

Metabolic assessments

Multiple chemical sensitivity syndrome (a.k.a., idiopathic environmental intolerance (IEI), clinical ecological illness, clinical ecology, environmental illness, chemical AIDS, environmental/chemical hypersensitivity disease, total allergy syndrome, cerebral allergy, 20th century disease)

Prausnitz-Kustner or P-K testing - passive cutaneous transfer test

Pulse response test

Qualification of nutritional assessments

Rebuck skin window test

Secretory IgA (salvia)

Sage Complement Antigen Test

Specific Immunoglobulin (IgG) (e.g., by Radioallergosorbent (RAST) or Enzyme-linked immunosorbent assay (ELISA)

Sublingual provocative neutralization testing and treatment with hormones.

Total serum IgG, immunoglobulin A (IgA) and immunoglobulin M (IgM)

Venom blocking antibodies

Volatile chemical panels (blood testing for chemicals)

Live Cell Analysis

Passive Transfer

Cytotoxic Food Testing

Routine allergy re-testing does not meet the definition of medically necessity according to the practice parameters and recommendations from the American College of Allergy, Asthma, and Immunology (ACAAI), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the Joint Council of Allergy, Asthma, and Immunology (JCAAI).


CPT/HCPCS Codes

Group 1 Paragraph: Allergy Testing - Covered

Group 1 Codes:

82785Assay of ige

86003Allergen specific ige

95004Percut allergy skin tests

95017Perq & icut allg test venoms

95018Perq&ic allg test drugs/biol

95024Icut allergy test drug/bug

95027Icut allergy titrate-airborn

95028Icut allergy test-delayed

95044Allergy patch tests

95052Photo patch test

95056Photosensitivity tests

95060Eye allergy tests

95065Nose allergy test

95070Bronchial allergy tests

95071Bronchial allergy tests

95076Ingest challenge ini 120 min

95079Ingest challenge addl 60 min



Group 2 Paragraph: Allergy Testing Non-covered


Group 2 Codes:

86001Allergen specific igg

86005Allergen specific ige

ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph: Note: Diagnosis codes must be coded to the highest level of specificity.

Allergy Testing 95004, 95017, 95018, 95024, 95027

For codes in the table below that requires a 7th character: letter A initial encounter, D subsequent encounter or S sequela may be used.


Group 1Codes



ICD-10 CODEDESCRIPTION

B44.81Allergic bronchopulmonary aspergillosis

H10.11Acute atopic conjunctivitis, right eye

H10.12Acute atopic conjunctivitis, left eye

H10.13Acute atopic conjunctivitis, bilateral

H10.31Unspecified acute conjunctivitis, right eye

H10.32Unspecified acute conjunctivitis, left eye

H10.33Unspecified acute conjunctivitis, bilateral

H10.411Chronic giant papillary conjunctivitis, right eye

H10.412Chronic giant papillary conjunctivitis, left eye

H10.413Chronic giant papillary conjunctivitis, bilateral

H10.44Vernal conjunctivitis

H10.45Other chronic allergic conjunctivitis

H16.261Vernal keratoconjunctivitis, with limbar and corneal involvement, right eye

H16.262Vernal keratoconjunctivitis, with limbar and corneal involvement, left eye

H16.263Vernal keratoconjunctivitis, with limbar and corneal involvement, bilateral

H65.01Acute serous otitis media, right ear

H65.02Acute serous otitis media, left ear

H65.03Acute serous otitis media, bilateral

H65.04Acute serous otitis media, recurrent, right ear

H65.05Acute serous otitis media, recurrent, left ear

H65.06Acute serous otitis media, recurrent, bilateral

H65.21Chronic serous otitis media, right ear

H65.22Chronic serous otitis media, left ear

H65.23Chronic serous otitis media, bilateral

H65.411Chronic allergic otitis media, right ear

H65.412Chronic allergic otitis media, left ear

H65.413Chronic allergic otitis media, bilateral

H65.491Other chronic nonsuppurative otitis media, right ear

H65.492Other chronic nonsuppurative otitis media, left ear

H65.493Other chronic nonsuppurative otitis media, bilateral

H66.91Otitis media, unspecified, right ear

H66.92Otitis media, unspecified, left ear

H66.93Otitis media, unspecified, bilateral

J01.00Acute maxillary sinusitis, unspecified

J01.01Acute recurrent maxillary sinusitis

J01.10Acute frontal sinusitis, unspecified

J01.11Acute recurrent frontal sinusitis

J01.20Acute ethmoidal sinusitis, unspecified

J01.21Acute recurrent ethmoidal sinusitis

J01.30Acute sphenoidal sinusitis, unspecified

J01.31Acute recurrent sphenoidal sinusitis

J01.40Acute pansinusitis, unspecified

J01.41Acute recurrent pansinusitis

J01.80Other acute sinusitis

J01.81Other acute recurrent sinusitis

J01.90Acute sinusitis, unspecified

J01.91Acute recurrent sinusitis, unspecified

J04.0Acute laryngitis

J04.30Supraglottitis, unspecified, without obstruction

J04.31Supraglottitis, unspecified, with obstruction

J05.0Acute obstructive laryngitis [croup]

J30.0Vasomotor rhinitis

J30.1Allergic rhinitis due to pollen

J30.2Other seasonal allergic rhinitis

J30.5Allergic rhinitis due to food

J30.81Allergic rhinitis due to animal (cat) (dog) hair and dander

J30.89Other allergic rhinitis

J31.0Chronic rhinitis

J31.1Chronic nasopharyngitis

J31.2Chronic pharyngitis

J32.0Chronic maxillary sinusitis

J32.1Chronic frontal sinusitis

J32.2Chronic ethmoidal sinusitis

J32.3Chronic sphenoidal sinusitis

J33.0Polyp of nasal cavity

J33.8Other polyp of sinus

J34.3Hypertrophy of nasal turbinates

J34.81Nasal mucositis (ulcerative)

J34.89Other specified disorders of nose and nasal sinuses

J35.01Chronic tonsillitis

J35.02Chronic adenoiditis

J35.03Chronic tonsillitis and adenoiditis

J35.1Hypertrophy of tonsils

J35.2Hypertrophy of adenoids

J35.3Hypertrophy of tonsils with hypertrophy of adenoids

J45.20Mild intermittent asthma, uncomplicated

J45.21Mild intermittent asthma with (acute) exacerbation

J45.22Mild intermittent asthma with status asthmaticus

J45.30Mild persistent asthma, uncomplicated

J45.31Mild persistent asthma with (acute) exacerbation

J45.32Mild persistent asthma with status asthmaticus

J45.40Moderate persistent asthma, uncomplicated

J45.41Moderate persistent asthma with (acute) exacerbation

J45.42Moderate persistent asthma with status asthmaticus

J45.50Severe persistent asthma, uncomplicated

J45.51Severe persistent asthma with (acute) exacerbation

J45.52Severe persistent asthma with status asthmaticus

J45.901Unspecified asthma with (acute) exacerbation

J45.902Unspecified asthma with status asthmaticus

J45.909Unspecified asthma, uncomplicated

J45.991Cough variant asthma

J45.998Other asthma

K29.30Chronic superficial gastritis without bleeding

K29.60Other gastritis without bleeding

L20.0Besnier's prurigo

L20.81Atopic neurodermatitis

L20.82Flexural eczema

L20.84Intrinsic (allergic) eczema

L20.89Other atopic dermatitis

L23.9Allergic contact dermatitis, unspecified cause

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

The autonomic nervous system (ANS) regulates physiologic processes, such as blood pressure, heart rate, body temperature, digestion, metabolism, fluid and electrolyte balance, sweating, urination, defecation, sexual response, and other processes. Regulation occurs without conscious control, i.e., autonomously. The ANS has two major divisions: the sympathetic and parasympathetic systems. ANS testing measures alterations in the R-R interval of the electrocardiogram (ECG) in response to parasympathetic and sympathetic system stimulation. The aim of such testing is to correlate signs and symptoms of possible autonomic dysfunction with objective measurement in a way that is clinically useful. Many organs are controlled primarily by either the sympathetic or parasympathetic system, although they may receive input from both; occasionally, functions are reciprocal (e.g., sympathetic input increases heart rate; parasympathetic decreases it).

The sympathetic nervous system is catabolic and activates fight-or-flight responses. Thus, sympathetic output increases heart rate and contractility, bronchodilation, hepatic glycogenolysis and glucose release, BMR (basal metabolism rate), and muscular strength; it also causes sweaty palms. Less immediately-life-preserving functions (e.g., digestion, renal filtration) are decreased.

The parasympathetic nervous system is anabolic; it conserves and restores. Gastrointestinal secretions and motility (including evacuation) are stimulated, heart rate is slowed, and blood pressure decreases.

Disorders of the ANS can affect any system of the body; they can originate in the peripheral or central nervous system and may be primary or secondary to other disorders. Symptoms suggesting autonomic dysfunction include orthostatic hypotension, heat intolerance, nausea, constipation, urinary retention or incontinence, nocturia, impotence, and dry mucous membranes. If a patient has symptoms suggesting autonomic dysfunction, cardiovagal, adrenergic, and sudomotor tests are usually done to help determine severity and distribution of the dysfunction.

ANS testing can be grouped into three general categories:

Cardiovagal innervation - a test that provides a standardized quantitative evaluation of vagal innervation to parasympathetic function of the heart. Responses are based on the interpretation of changes in continuous heart recordings in response to standardized maneuvers and include heart rate response to deep breathing, Valsalva ratio, and 30:15 ratio heart rate responses to standing. A tilt table may be used, but is not required.

Vasomotor adrenergic innervation - evaluates adrenergic innervation of the circulation and of the heart in autonomic failure. The following tests are included: beat-to-beat blood pressure and R-R interval response to Valsalva maneuver, sustained hand grip, and blood pressure and heart rate responses to tilt-up or active standing and must be performed with a tilt table.

Sudomotor - function testing is used to evaluate and document neuropathic disturbances that may be associated with pain. The quantitative sudomotor axon reflex test (QSART), thermoregulatory sweat test (TST), sympathetic skin responses, and silastic sweat imprints are tests of sympathetic cholinergic sudomotor function.

Indications:

Tests are useful in defining the presence of autonomic failure, their natural history, and response to treatment. They can also define patterns of dysautonomia that are useful in helping the clinician diagnose certain autonomic conditions. Selective autonomic failure (which only one system is affected) can be diagnosed by autonomic testing. An example is chronic idiopathic anhidrosis, where only sudomotor function is affected. Among the synucleinopathies, autonomic function tests can distinguish Parkinson’s disease (PD) from multiple system atrophy (MSA). There is a gradation of autonomic failure. PD is characterized by mild autonomic failure and a length-dependent pattern of sudomotor involvement. MSA and pure autonomic failure have severe generalized autonomic failure while Dementia with Lewy Bodies ( DLB) is intermediate.

Limitations:

Syndromes of autonomic dysfunction which require formal autonomic function testing are relatively rare. Generally, only after excluding more common causes of autonomic signs or symptoms (e.g., hypotension, hyperhidrosis, and orthostatic tachycardia) may formal autonomic testing be indicated to exclude or confirm rarer autonomic disorders. Autonomic function testing is covered as reasonable and necessary when used as a diagnostic tool to evaluate symptoms indicative of vasomotor instability and the ANS testing is directed at establishing a more accurate or definitive diagnosis or contributing to clinically useful and relevant medical decision making for one of the following indications:

To diagnose the presence of autonomic neuropathy in a patient with signs or symptoms suggesting a progressive autonomic neuropathy.

To evaluate the severity and distribution of a diagnosed progressive autonomic neuropathy.

To differentiate the diagnosis between certain complicated variants of syncope from other causes of loss of consciousness.

To evaluate inadequate response to beta blockade in vasodepressor syncope.

To evaluate distressing symptoms in a patient with a clinical picture suspicious for distal small fiber neuropathy in order to diagnose the condition.

To differentiate the cause of postural tachycardia syndrome.

To evaluate change in type, distribution or severity of autonomic deficits in patients with autonomic failure.

To evaluate the response to treatment in patients with autonomic failure who demonstrate a change in clinical exam.

To diagnose axonal neuropathy or suspected autonomic neuropathy in the symptomatic patient.

To evaluate and treat patients with recurrent unexplained syncope or demonstrate autonomic failure, after more common causes have been excluded by other standard testing.

The following indications are considered not medically reasonable and necessary and will not be covered:
Screening patients without signs or symptoms of autonomic dysfunction, including patients with diabetes, hepatic or renal disease.

Testing for the sole purpose of monitoring disease intensity or treatment efficacy in diabetes, hepatic or renal disease.

Testing results that are not used in clinical decision-making or patient management.

Testing performed by physicians who do not have evidence of training, and expertise to perform and interpret these tests. (Physicians must have knowledge, training, and expertise to perform and interpret these tests, and to assess and train personnel working with them. This training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program or must reflect extensive continued medical education activities. If these skills have been acquired by way of continued medical education, the courses must be comprehensive, offered, sponsored or endorsed by an academic [institution] in the United States and/or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as category I credit.)

General professional standards with FDA clearance apply for all equipment used in ANS testing.

Testing with ANSAR ANX 3.0 or a similar machine is considered investigational for screening and will not be covered.

Equipment for Autonomic Nervous System Studies 

Equipment with FDA clearance for heart rate variability measurements in response to paced respirations and exercises that tests only heart rate variability does not meet the full range of testing parameters required for the performance of cardiovagal innervation (parasympathetic function) or vasomotor adrenergic innervation (sympathetic adrenergic function), and does not ensure full test requirements, such as blood pressure monitoring and blood oxygen levels; nor do they incorporate proper testing conditions, such as the use of a tilt table. Providers may be asked to supply information on the equipment used to perform autonomic nervous system studies, to ensure that all studies performed meet the requirements of the procedure.




CPT/HCPCS Codes

Group 1 Paragraph: NA

Group 1 Codes:

95921TESTING OF AUTONOMIC NERVOUS SYSTEM FUNCTION; CARDIOVAGAL INNERVATION (PARASYMPATHETIC FUNCTION), INCLUDING 2 OR MORE OF THE FOLLOWING: HEART RATE RESPONSE TO DEEP BREATHING WITH RECORDED R-R INTERVAL, VALSALVA RATIO, AND 30:15 RATIO

95922TESTING OF AUTONOMIC NERVOUS SYSTEM FUNCTION; VASOMOTOR ADRENERGIC INNERVATION (SYMPATHETIC ADRENERGIC FUNCTION), INCLUDING BEAT-TO-BEAT BLOOD PRESSURE AND R-R INTERVAL CHANGES DURING VALSALVA MANEUVER AND AT LEAST 5 MINUTES OF PASSIVE TILT

95923TESTING OF AUTONOMIC NERVOUS SYSTEM FUNCTION; SUDOMOTOR, INCLUDING 1 OR MORE OF THE FOLLOWING: QUANTITATIVE SUDOMOTOR AXON REFLEX TEST (QSART), SILASTIC SWEAT IMPRINT, THERMOREGULATORY SWEAT TEST, AND CHANGES IN SYMPATHETIC SKIN POTENTIAL

95924TESTING OF AUTONOMIC NERVOUS SYSTEM FUNCTION; COMBINED PARASYMPATHETIC AND SYMPATHETIC ADRENERGIC FUNCTION TESTING WITH AT LEAST 5 MINUTES OF PASSIVE TILT

Group 2 Paragraph: CPT code 95943 was not developed and intended to be specific to any brand/manufacturer. If a physician finds that this non-standardized component information of autonomic function testing (AFT) is useful in a patient assessment and clinical decision making given certain patient risks/signs/symptoms, this would be included in the physician’s basic evaluation and management service and not separately covered. In addition, testing patients prior to the development of symptomatic autonomic neuropathy would be screening, and there is no such screening Medicare benefit with the absence of disease.


Group 2 Codes:

95943SIMULTANEOUS, INDEPENDENT, QUANTITATIVE MEASURES OF BOTH PARASYMPATHETIC FUNCTION AND SYMPATHETIC FUNCTION, BASED ON TIME-FREQUENCY ANALYSIS OF HEART RATE VARIABILITY CONCURRENT WITH TIME-FREQUENCY ANALYSIS OF CONTINUOUS RESPIRATORY ACTIVITY, WITH MEAN HEART RATE AND BLOOD PRESSURE MEASURES, DURING REST, PACED (DEEP) BREATHING, VALSALVA MANEUVERS, AND HEAD-UP POSTURAL CHANGE





ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph: Group 1 diagnosis codes apply to codes 95921, 95922, 95923 and 95924


ICD-10 CODEDESCRIPTION

E10.41Type 1 diabetes mellitus with diabetic mononeuropathy

E10.42Type 1 diabetes mellitus with diabetic polyneuropathy

E10.43Type 1 diabetes mellitus with diabetic autonomic (poly)neuropathy

E10.44Type 1 diabetes mellitus with diabetic amyotrophy

E10.49Type 1 diabetes mellitus with other diabetic neurological complication

E10.610Type 1 diabetes mellitus with diabetic neuropathic arthropathy

E11.41Type 2 diabetes mellitus with diabetic mononeuropathy

E11.42Type 2 diabetes mellitus with diabetic polyneuropathy

E11.43Type 2 diabetes mellitus with diabetic autonomic (poly)neuropathy

E11.44Type 2 diabetes mellitus with diabetic amyotrophy

E11.49Type 2 diabetes mellitus with other diabetic neurological complication

E11.610Type 2 diabetes mellitus with diabetic neuropathic arthropathy

E13.41Other specified diabetes mellitus with diabetic mononeuropathy

E13.42Other specified diabetes mellitus with diabetic polyneuropathy

E13.43Other specified diabetes mellitus with diabetic autonomic (poly)neuropathy

E13.44Other specified diabetes mellitus with diabetic amyotrophy

E13.49Other specified diabetes mellitus with other diabetic neurological complication

E13.610Other specified diabetes mellitus with diabetic neuropathic arthropathy

E85.0Non-neuropathic heredofamilial amyloidosis

E85.1Neuropathic heredofamilial amyloidosis

E85.3Secondary systemic amyloidosis

E85.4Organ-limited amyloidosis

E85.8Other amyloidosis


G23.0Hallervorden-Spatz disease

G23.1Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]

G23.2Striatonigral degeneration

G23.8Other specified degenerative diseases of basal ganglia

G60.3Idiopathic progressive neuropathy

G60.8Other hereditary and idiopathic neuropathies

G90.09Other idiopathic peripheral autonomic neuropathy

G90.3Multi-system degeneration of the autonomic nervous system

G90.50Complex regional pain syndrome I, unspecified

G90.511Complex regional pain syndrome I of right upper limb
G90.512Complex regional pain syndrome I of left upper limb

G90.513Complex regional pain syndrome I of upper limb, bilateral

G90.521Complex regional pain syndrome I of right lower limb

G90.522Complex regional pain syndrome I of left lower limb
G90.523Complex regional pain syndrome I of lower limb, bilateral

G90.59Complex regional pain syndrome I of other specified site

I95.1Orthostatic hypotension

R00.0Tachycardia, unspecified
R55Syncope and collapse

R61Generalized hyperhidrosis

CPT/HCPCS Codes

Group 1 Codes:

J1436INJECTION, ETIDRONATE DISODIUM, PER 300 MG

J1740INJECTION, IBANDRONATE SODIUM, 1 MG

J2430INJECTION, PAMIDRONATE DISODIUM, PER 30 MG

J3489INJECTION, ZOLEDRONIC ACID, 1 MG

Coverage Indications, Limitations, and/or Medical Necessity

Bisphosphonate drugs act to inhibit normal and abnormal bone reabsorption. This action is helpful in reducing pain, reversing hypercalcemia, preventing and reducing fractures in a range of diseases that directly or indirectly impact bone modeling and remodeling.

Bisphosphonates are available in both oral and parenteral forms. Coverage is limited to those drugs administered parenterally (IV). Bisphosphonates are indicated parenterally when the patient has failed a trial of the oral drug or has insurmountable issues related to absorption, compliance or dosing posture.

Etidronate disodium IV, Pamidronate disodium IV, and Zoledronic acid IV, are covered for the following indications:
Hypercalcemia associated with malignancy
Osteoclastic hyperactivity resulting in excessive bone resorption is the underlying complication with metastatic bone disease and hypercalcemia associated with malignancy. Most cases of hypercalcemia, associated with malignancy, occurs in patients who have breast cancer, squamous-cell tumors of the lung or head and neck, renal-cell carcinoma, and certain hematologic malignancies (multiple myeloma and some types of lymphomas). Bisphosphonates, in conjunction with hydration, are indicated for moderate or severe hypercalcemia associated with malignancy with or without bone metastases.

Cancer Treatment-Induced Bone Loss (CTIBL) in Breast and Prostate Cancer

Breast Cancer

Cytotoxic chemotherapy: There are 2 mechanisms of cytotoxic chemotherapy inducing bone loss. First, there is a direct negative effect of the cytotoxic therapy on bone cells, predominantly osteoblasts and, second, many women who are premenopausal have cytotoxic therapy effects on ovarian function, which results in gonadal loss. In addition, in premenopausal women, surgery (oophorectomy) or radiation therapy to the ovary results in bone loss. Hormone therapy, tamoxifen in premenopausal women, and the aromatase inhibitors result in bone loss, as well as gonadotropin-releasing hormone (GnRH) antagonists/agonists, which shut off ovarian function. All of these result in estrogen depletion.

Prostate Cancer

In prostate cancer, cytotoxic therapy again has a negative effect not only on testicular function but also on bone. Surgical therapy, hormone therapy, including antiandrogens and GnRH agonists/antagonists, results in androgen depletion. The final common pathway, estrogen and androgen depletion, results in a decrease in bone mineral density.

Bone metastases secondary to solid tumors, breast cancer, and prostate cancer

Multiple Myeloma

Osteolytic lesions due to metastases

Paget’s Disease of bone (osteitis deformans)

Intravenous bisphosphonates are indicated for moderate to severe Paget’s disease of bone.

Prophylaxis and treatment of heterotopic ossification associated with spinal cord injury, traumatic brain injury, hip replacement, and burns
It is indicated parenterally when the patient has failed a trial of the oral drug or has insurmountable issues related to absorption, compliance or dosing posture.

Besides the indication listed above, Pamidronate Sodium is covered for the following indications:
Osteogenesis Imperfecta

Fibrous dysplasia of bone (McCune-Albright syndrome)

Ibandronate sodium, Pamidronate or Zoledronic acid are covered for the following additional indication:
Treatment of osteoporosis when there is no drug classification contraindications. There also needs to exist either one or more of the following:
Demonstrated intolerance or contraindication for FDA approved oral bisphosphonates dosing regimens, or insurmountable issues related to absorption, compliance or dosing posture.

When adequate trials of FDA-approved oral bisphosphonates result in fallen Bone Mass Density and/or failure to suppress bone turnover (e.g. persisting high bone -turnover marker measurements).

Evidence in the medical record should clearly support the need for the intravenous administration of bisphosphonates for the treatment of osteoporosis.

Ibandronate sodium is covered for:
Hypercalcemia associated with malignancy

Bone metastases secondary to solid tumors, breast cancer, prostate cancer

Zoledronic acid - Injection is covered for the treatment of:
Paget's disease of bone in men and women.

Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease, to induce remission (normalization of serum alkaline phosphatase).

This contractor will cover zoledronic acid at most once per year because after a single treatment with zoledronic acid in Paget’s disease, an extended remission period is observed. Re-treatment with zoledronic acid may be considered, after one year in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.


Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
999xNot Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A


ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph: Note: Diagnosis codes must be coded to the highest level of specificity.

J1436 Etidronate disodium



Group 1 Codes:

ICD-10 CODEDESCRIPTION

C79.51*Secondary malignant neoplasm of bone

C79.52*Secondary malignant neoplasm of bone marrow

C90.00Multiple myeloma not having achieved remission
C90.01Multiple myeloma in remission

C90.02Multiple myeloma in relapse

E83.52Hypercalcemia

M61.011Myositis ossificans traumatica, right shoulder

M61.012Myositis ossificans traumatica, left shoulder

M61.021Myositis ossificans traumatica, right upper arm

M61.022Myositis ossificans traumatica, left upper arm

M61.031Myositis ossificans traumatica, right forearm

M61.032Myositis ossificans traumatica, left forearm

M61.041Myositis ossificans traumatica, right hand

M61.042Myositis ossificans traumatica, left hand

M61.051Myositis ossificans traumatica, right thigh

M61.052Myositis ossificans traumatica, left thigh

M61.061Myositis ossificans traumatica, right lower leg

M61.062Myositis ossificans traumatica, left lower leg

M61.071Myositis ossificans traumatica, right ankle and foot

M61.072Myositis ossificans traumatica, left ankle and foot

M61.08Myositis ossificans traumatica, other site

M61.09Myositis ossificans traumatica, multiple sites

M61.111Myositis ossificans progressiva, right shoulder

M61.112Myositis ossificans progressiva, left shoulder

M61.121Myositis ossificans progressiva, right upper arm

M61.122Myositis ossificans progressiva, left upper arm

M61.131Myositis ossificans progressiva, right forearm
M61.132Myositis ossificans progressiva, left forearm

M61.141Myositis ossificans progressiva, right hand

M61.142Myositis ossificans progressiva, left hand

M61.144Myositis ossificans progressiva, right finger(s)

M61.145Myositis ossificans progressiva, left finger(s)

M61.151Myositis ossificans progressiva, right thigh

M61.152Myositis ossificans progressiva, left thigh

M61.161Myositis ossificans progressiva, right lower leg

M61.162Myositis ossificans progressiva, left lower leg

M61.171Myositis ossificans progressiva, right ankle

M61.172Myositis ossificans progressiva, left ankle

M61.174Myositis ossificans progressiva, right foot

M61.175Myositis ossificans progressiva, left foot

M61.177Myositis ossificans progressiva, right toe(s)

M61.178Myositis ossificans progressiva, left toe(s)

M61.18Myositis ossificans progressiva, other site

M61.19Myositis ossificans progressiva, multiple sites

M61.211Paralytic calcification and ossification of muscle, right shoulder

M61.212Paralytic calcification and ossification of muscle, left shoulder

M61.221Paralytic calcification and ossification of muscle, right upper arm

M61.222Paralytic calcification and ossification of muscle, left upper arm

M61.231Paralytic calcification and ossification of muscle, right forearm

M61.232Paralytic calcification and ossification of muscle, left forearm

M61.241Paralytic calcification and ossification of muscle, right hand

M61.242Paralytic calcification and ossification of muscle, left hand

M61.251Paralytic calcification and ossification of muscle, right thigh

M61.252Paralytic calcification and ossification of muscle, left thigh

M61.261Paralytic calcification and ossification of muscle, right lower leg

M61.262Paralytic calcification and ossification of muscle, left lower leg

M61.271Paralytic calcification and ossification of muscle, right ankle and foot

M61.272Paralytic calcification and ossification of muscle, left ankle and foot

M61.28Paralytic calcification and ossification of muscle, other site

M61.29Paralytic calcification and ossification of muscle, multiple sites

M88.0Osteitis deformans of skull

M88.1Osteitis deformans of vertebrae

M88.811Osteitis deformans of right shoulder

M88.812Osteitis deformans of left shoulder

M88.821Osteitis deformans of right upper arm

M88.822Osteitis deformans of left upper arm

M88.831Osteitis deformans of right forearm

M88.832Osteitis deformans of left forearm

M88.841Osteitis deformans of right hand

M88.842Osteitis deformans of left hand

M88.851Osteitis deformans of right thigh

M88.852Osteitis deformans of left thigh

M88.861Osteitis deformans of right lower leg

M88.862Osteitis deformans of left lower leg

M88.871Osteitis deformans of right ankle and foot

M88.872Osteitis deformans of left ankle and foot

M88.88Osteitis deformans of other bones

M88.89Osteitis deformans of multiple sites

M89.9*Disorder of bone, unspecified

M94.9*Disorder of cartilage, unspecified


T79.6XXATraumatic ischemia of muscle, initial encounter
T79.6XXDTraumatic ischemia of muscle, subsequent encounter

T79.6XXSTraumatic ischemia of muscle, sequela

Z79.811*Long term (current) use of aromatase inhibitors

Z79.899*Other long term (current) drug therapy

Z85.3*Personal history of malignant neoplasm of breast

Z85.46*Personal history of malignant neoplasm of prostate

Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: *For C79.51 and C79.52, see Documentation Requirements



*For treatment of bone loss in woman receiving adjuvant aromatase inhibitor therapy for breast cancer, ICD-10 code M89.9 or M94.9 must be reported with Z85.3 and Z79.811.


*For treatment of bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer, ICD-10 M89.9 or M94.9 must be reported with Z85.46 and Z79.899.

CPT/HCPCS Codes

Group 1 Paragraph: The following lists Category III services determined by WPS Medicare to be reasonable and medically necessary. Coverage will only be allowed when the service is delivered in clinical situations meeting medical necessity. For services addressed in a separate LCD all criteria addressed in that LCD must be met

Group 1 Codes:

0075TTRANSCATHETER PLACEMENT OF EXTRACRANIAL VERTEBRAL ARTERY STENT(S), INCLUDING RADIOLOGIC SUPERVISION AND INTERPRETATION, OPEN OR PERCUTANEOUS; INITIAL VESSEL

0076TTRANSCATHETER PLACEMENT OF EXTRACRANIAL VERTEBRAL ARTERY STENT(S), INCLUDING RADIOLOGIC SUPERVISION AND INTERPRETATION, OPEN OR PERCUTANEOUS; EACH ADDITIONAL VESSEL (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

0184TEXCISION OF RECTAL TUMOR, TRANSANAL ENDOSCOPIC MICROSURGICAL APPROACH (IE, TEMS), INCLUDING MUSCULARIS PROPRIA (IE, FULL THICKNESS)

0191TINSERTION OF ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICE, WITHOUT EXTRAOCULAR RESERVOIR, INTERNAL APPROACH, INTO THE TRABECULAR MESHWORK; INITIAL INSERTION

0249TLIGATION, HEMORRHOIDAL VASCULAR BUNDLE(S), INCLUDING ULTRASOUND GUIDANCE

0295TEXTERNAL ELECTROCARDIOGRAPHIC RECORDING FOR MORE THAN 48 HOURS UP TO 21 DAYS BY CONTINUOUS RHYTHM RECORDING AND STORAGE; INCLUDES RECORDING, SCANNING ANALYSIS WITH REPORT, REVIEW AND INTERPRETATION

0296TEXTERNAL ELECTROCARDIOGRAPHIC RECORDING FOR MORE THAN 48 HOURS UP TO 21 DAYS BY CONTINUOUS RHYTHM RECORDING AND STORAGE; RECORDING (INCLUDES CONNECTION AND INITIAL RECORDING)

0297TEXTERNAL ELECTROCARDIOGRAPHIC RECORDING FOR MORE THAN 48 HOURS UP TO 21 DAYS BY CONTINUOUS RHYTHM RECORDING AND STORAGE; SCANNING ANALYSIS WITH REPORT

0298TEXTERNAL ELECTROCARDIOGRAPHIC RECORDING FOR MORE THAN 48 HOURS UP TO 21 DAYS BY CONTINUOUS RHYTHM RECORDING AND STORAGE; REVIEW AND INTERPRETATION

0308TINSERTION OF OCULAR TELESCOPE PROSTHESIS INCLUDING REMOVAL OF CRYSTALLINE LENS OR INTRAOCULAR LENS PROSTHESIS

0376TINSERTION OF ANTERIOR SEGMENT AQUEOUS DRAINAGE DEVICE, WITHOUT EXTRAOCULAR RESERVOIR, INTERNAL APPROACH, INTO THE TRABECULAR MESHWORK; EACH ADDITIONAL DEVICE INSERTION (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

0394THIGH DOSE RATE ELECTRONIC BRACHYTHERAPY, SKIN SURFACE APPLICATION, PER FRACTION, INCLUDES BASIC DOSIMETRY, WHEN PERFORMED

0395THIGH DOSE RATE ELECTRONIC BRACHYTHERAPY, INTERSTITIAL OR INTRACAVITARY TREATMENT, PER FRACTION, INCLUDES BASIC DOSIMETRY, WHEN PERFORMED


Group 2 Paragraph: Coverage for this device will be allowed for FDA approved indications.
Payment for 0171T and 0172T will be an inclusive payment. No additional code for approach or hardware placement should be billed or paid.


Group 2 Codes:

0171TINSERTION OF POSTERIOR SPINOUS PROCESS DISTRACTION DEVICE (INCLUDING NECESSARY REMOVAL OF BONE OR LIGAMENT FOR INSERTION AND IMAGING GUIDANCE), LUMBAR; SINGLE LEVEL

0172TINSERTION OF POSTERIOR SPINOUS PROCESS DISTRACTION DEVICE (INCLUDING NECESSARY REMOVAL OF BONE OR LIGAMENT FOR
INSERTION AND IMAGING GUIDANCE), LUMBAR; EACH ADDITIONAL LEVEL (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

Group 3 Paragraph: For claims with dates of service on or after January 9, 2014, PILD, procedure code 0275T, is a covered service only when billed as part of a clinical trial approved by CMS per NCD-150.13. All Percutaneous Image-Guided Lumbar Decompression for Lumbar Spinal Stenosis (PILD for LSS) claims:
12/31/2014 and earlier should be processed with code 0275T.
01/01/2015 and after use 2 different codes:
- G0276 for clinical trial with Identifier NCT02079038. Is a blinded randomized controlled clinical trial which includes a CMS-approved placebo procedure arm (See CR 8954);
- 0275T for all other clinical trials (See CR 8757).


Group 3 Codes:

0275TPERCUTANEOUS 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), WITH OR WITHOUT THE USE OF AN ENDOSCOPE, SINGLE OR MULTIPLE LEVELS, UNILATERAL OR BILATERAL; LUMBAR

Group 4 Paragraph: The Centers for Medicare & Medicaid Services (CMS) published a final decision memorandum for left atrial appendage closure (LAAC) on February 8, 2016, covering percutaneous LAAC for non-valvular atrial fibrillation through Coverage with Evidence Development under 1862(a)(1)(E) of the Social Security Act per CAG-00445N and NCD 20.34 LAAC.

Group 4 Codes:

0281TPERCUTANEOUS TRANSCATHETER CLOSURE OF THE LEFT ATRIAL APPENDAGE WITH IMPLANT, INCLUDING FLUOROSCOPY, TRANSSEPTAL PUNCTURE, CATHETER PLACEMENT(S), LEFT ATRIAL ANGIOGRAPHY, LEFT ATRIAL APPENDAGE ANGIOGRAPHY, RADIOLOGICAL SUPERVISION AND INTERPRETATION

Coverage Indications, Limitations, and/or Medical Necessity

Indications

This LCD addresses limited coverage for the CellSearch ® Circulating Tumor Cell (CTC) (Veridex, LLC) assay. All other methods for CTC detection, including PCR (RTPCR) assays, are non-covered.

CTCs represent the point in the metastatic process of solid tumors when cells from a primary tumor invade, detach, disseminate, colonize and proliferate in a distant site. Detection of elevated CTCs during therapy is an accurate indication of subsequent rapid disease progression and mortality in breast, colorectal and prostate cancer.

The assay is reported as a numerical result where five or more cells per 7.5 ml of whole blood predicts worse prognosis in patients with known recurrent breast and prostate cancer, and three or more cells are predictive of shorter Progression Free Survival (PFS) and Overall Survival (OS) in metastatic colorectal cancer.

CTC is indicated for an established diagnosis of:
Breast cancer;
Colorectal cancer;
Prostate cancer.

Limitations

All methods for CTC enrichment/detection other than the CellSearch ® CTC assay, including PCR (RT-PCR) assays, are non-covered as they are considered investigational.

CTC testing will be limited to metastatic breast, colorectal and prostate cancer. CTC testing for all other malignant diagnoses will be denied as not reasonable and necessary.

All assays for CTC are non-covered for routine screening or prognosis.

No further CTC testing would be expected after the transition to palliative/hospice care.

Frequency
Baseline – limited to once prior to initiation of tumor-type specific chemotherapy.
During chemotherapy treatment – may be performed once during chemotherapy.
Following chemotherapy treatment – may be repeated at end of chemotherapy.
Surveillance with no chemotherapy treatments - may be repeated each year.


Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
N/A

Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:
86152Cell enumeration & id
86153Cell enumeration phys interp



ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

C18.0 - C21.8 - Opens in a new windowMalignant neoplasm of cecum - Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C50.011 - C50.929 - Opens in a new windowMalignant neoplasm of nipple and areola, right female breast - Malignant neoplasm of unspecified site of unspecified male breast
C61Malignant neoplasm of prostate
Showing 1 to 3 of 3 entries in Group 1
FirstPrevCurrently Selected1NextLast

Coverage Indications, Limitations, and/or Medical Necessity

This policy limits CYP2C19 (CPT 81225) and CYP2D6 (CPT 81226) genetic testing to defined indications. All other testing for CYP2C19 and CYP2D6 is non-covered until definitive clinical utility is established to justify coverage.

This policy non-covers CYP2C9 (CPT 81227) and VKORC1 (CPT 81355) genetic testing medications to defined indications. All other testing for CYP2C9 and VKORC1 is non-covered until definitive clinical utility is established to justify coverage.

CYP2C19 Genotyping

Background on CYP2C19 Testing

The CYP450 gene superfamily is composed of many isoenzymes that are involved in the metabolism of about 75% of commonly prescribed drugs. CYP2C19 metabolizes 15% of all currently used drugs, whereas CYP2D6 enzymes metabolize approximately 20-25%, and CYP2C9 metabolizes approximately 10%.

Genetic alterations or “polymorphisms” are common in these isoenzymes, with more than 30 polymorphisms identified in CYP2C19. These polymorphisms can lead to differences in individual drug response secondary to variation in metabolism.

CYP2C19 phenotypes include poor, intermediate, extensive and ultra-rapid metabolizers. The frequency of the various metabolizers phenotypes has been estimated as follows:

2-15% - poor metabolizers

18-45% - intermediate metabolizers

35-50% - extensive metabolizers

5-30% - ultra-rapid metabolizers


The genotypic rates vary by ethnicity. Approximately 2% of whites, 4% of blacks and 14% of Chinese are poor CYP2C19 metabolizers.

Pharmacogenetic testing has been proposed to predict individual response to a variety of CYP2C19-metabolized drugs including clopidogrel, proton pump inhibitors, and tricyclic antidepressants, among others. In certain scenarios, an individual patient may benefit from genetic testing in determining dosage and likely response to specific medications.

Clopidogrel bisulfate (Plavix) is a widely prescribed medication to/for:

Prevent blood clots in patients with acute coronary syndrome (ACS),

Other cardiovascular (CV) disease-related events,

Undergoing percutaneous coronary intervention


Clopidogrel response varies significantly due to genetic and acquired factors including obesity, smoking and non-compliance. Patients with poor response to clopidogrel may experience recurrent CV event or thrombotic events while taking clopidogrel. They are at greater risk for major adverse CV events such as heart attack, stroke and death. These individuals are typically poor to intermediate metabolizers of clopidogrel due to the presence of the associated CYP2C19 polymorphisms. These individuals should be given an alternate treatment strategy (Plavix PI). As such, the clinical utility of CYP2C19 genotyping has been supported with net benefits on improving health outcomes for individuals with ACS who are undergoing percutaneous coronary interventions (PCI). There is insufficient evidence of clinical utility of CYP2C19 genotyping for individuals considering clopidogrel therapy for other indications, such as medical management of ACS without PCI, stroke, or peripheral artery disease.

With regards to CYP2C19 testing for antidepressant treatment, recent evidence has suggested genetic testing prior to initiating certain tricyclic antidepressants, namely amitriptyline, due to the effects of the genotype on drug efficacy and safety. Use of this information to determine dosing has been proposed to improve clinical outcomes and reduce the failure rate of initial treatment. However, even with genotype information, a suggestion is given to start patients on low dose, gradually increasing to avoid adverse side effects. Consequently, genotyping is not needed with this approach.

Proton pump inhibitors are used to treat several gastric acid-related conditions including duodenal ulcer, gastric ulcer and gastroesophageal reflux disease. Proton pump inhibitors can also be used to treat Helicobactor pylori. Several proton pump inhibitors are metabolized by CYP2C19. However, there is insufficient data to warrant CYP2C19 genotyping to determine health outcomes or adverse drug reactions in treatment with proton pump inhibitors.

With regards to Serotonin reuptake inhibitors, there is insufficient evidence to support CYP2C19 genotyping to determine medical management for the treatment of obsessive compulsive disorder at this time.

Covered Indications

In summary, genetic testing of the CYP2C19 gene is considered medically necessary for patients with ACS undergoing PCI who are initiating or reinitiating Clopidogrel (Plavix) therapy.

Non-covered Indications

There is insufficient evidence to demonstrate that genetic testing for the CYP2C19 gene improves clinical outcomes. Consequently, genetic testing for the CYP2C19 gene outside of the specified covered indications is considered investigational.

CYP2D6 Genotyping

Background on CYP2D6 Testing

Genetic alterations or “polymorphisms” are common in these isoenzymes, with more than 100 polymorphisms identified in CYP2D6. These polymorphisms can lead to differences in individual drug response secondary to variation in metabolism.

CYP2D6 phenotypes include poor, intermediate, extensive and ultra-rapid metabolizers. The frequency of the poor metabolizer phenotype varies by ethnicity with 7-10% in Caucasians, 1.9-7.3% in African- Americans, and = 1% in most Asian populations studied. The extensive metabolizer phenotype, observed in 50% of Caucasians, is the most common in this population. Genetic variation, as well as drug-drug interactions, can influence the classification of CYP2D6 metabolism into one of the above phenotypes. In addition, chronic dosing of a CYP2D6 drug can inhibit its own metabolism over time as the concentration of the drug approaches a steady state.

Pharmacogenetic testing has been proposed to predict individual response to a variety of CYP2D6-metabolized drugs including tamoxifen, antidepressants, opioid analgesics, and tetrabenzine for chorea, among others. In certain scenarios, an individual patient may benefit from this genetic testing in determining dosage and likely response to specific medications.

Tamoxifen

Available evidence fails to support direct evidence of clinical utility for testing of CYP2D6 in treatment with tamoxifen. Tamoxifen metabolism and the causes for resistance are complex rather than the result of a single polymorphism.

Antidepressants

In regards to CYP2D6 testing for antidepressant treatment, there was insufficient evidence in the past to support testing to determine treatment. More recently, evidence has supported the use of genetic testing prior to initiating certain tricyclic antidepressants due to the effects of genotype on drug efficacy and safety. Use of this information to determine dosing can improve clinical outcomes and reduce the failure rate of initial treatment. However, there is insufficient evidence for CYP2D6 genotyping for individuals considering antipsychotic medications or other antidepressants with CYP2D6 as a metabolizing enzyme.

Codeine

In addition, the role of CYP2D6 genotyping has been evaluated for use in opioid analgesic drug therapy, specifically codeine analgesia. The efficacy and toxicity, including severe or life- threatening toxicity after normal doses of codeine has been linked to an individual’s CYP2D6 genotype. However, genotyping would indicate avoidance of codeine due to risk of adverse events in only 1-2% of the populations, and there is considerable variation in the degree of severity of adverse events, with most not classified as serious. Furthermore, codeine is widely used without genotyping. At this time, there is insufficient evidence to support clinical utility of genotyping for management of codeine therapy.

Tetrabenazine

The dosing of tetrabenazine is based, in part, on CYP2D6 genotyping. However, a recent study suggests that the necessity to genotype may need to be reconsidered. The Xenazine® manufacturer package insert indicates that poor metabolizers of CYP2D6 should not exceed a maximum does of 50 mg/day.

Drugs for Alzheimer’s Disease

Galantamine is an antidementia drug used in the treatment of Alzheimer’s disease. Studies have been performed that reveal the CYP2D6 genotype significantly influences galantamine concentrations in blood. Still other studies have revealed that urinary assays for CYP2D6 phenotype are technically feasible. At this time, the association between phenotype and drug responsiveness remains unknown. Conformational studies in larger populations are necessary to establish evidence regarding individuals most likely to benefit from galatamine, including information on treatment efficacy and tolerability.

Donepezil (Aricept) is a drugs used to treat an Alzheimer’s disease. Some studies have reported an influence of the CYP2D6 on the response to treatment with this drug. Other studies suggest that therapy based on CYP2D6 genotype is unlikely to be beneficial for treating Alzheimer’s disease patients in routine clinical practice. Additional studies are needed to determine the efficacy and utility of CYP2D6 genotyping in those patients who are treated with donepezil.

Covered Indications

In summary, genetic testing of the CYP2D6 gene is considered medically necessary to guide medical treatment and/or dosing for individuals for whom initial therapy is planned with:

Amitriptyline or nortriptyline for treatment of depressive disorders

Tetrabenazine doses greater than 50 mg/day, or re-initiation of therapy with doses greater than 50 mg/day



Non-covered Indications

There is insufficient evidence to demonstrate that genetic testing for the CYP2D6 gene improves clinical outcomes. Consequently, genetic testing for the CYP2D6 gene outside of the specified covered indications is considered investigational.

CYP2C9 Genotyping

Background on CYP2C9 Testing

CYP2C9 metabolizes approximately 10-15% of all currently used drugs. Genetic alternations or “polymorphisms” are common in these isoenzymes, with 57 polymorphisms identified in CYP2C9, which can lead to differences in individual drug response secondary to variation in metabolism.

Pharmacogenetic testing has been proposed to predict individual response to a variety of CYP2C9-metabolized drugs including celecoxib, fluorbipofen, fluvoxamine and warfarin, among others. In certain scenarios, an individual patient may benefit from this genetic testing in determining dosage and likely response to specific medications. However, there is insufficient evidence to support CYP2C9 genotyping to determine medical management and alter outcomes at this time.

Individuals with low enzyme activity for CYP2C9 substrates are at risk of adverse drug reactions. However, pharmacogenetic testing for individuals being treated with drugs, such as warfarin, may experience little or no benefit from testing. This is, in part, because the CYP2C9 genotype accounts for only part of the variability in drug sensitivity.

Warfarin

While there is extensive literature regarding warfarin and the CYP2C9 genotype, the clinical utility of such testing remains unproven at this time. In fact, pharmacogenetic testing for warfarin treatment has been recommended against by the American College of Medical Genetics and the American College of Chest Physicians. These guidelines suggest that genetic testing for warfarin metabolism is not medically necessary, and evidence of clinical utility remains to be proven. Obstacles for determining clinical utility have been reviewed with suggestions for researchers in this area.

Celecoxib

In addition, limited information is available regarding celecoxib metabolism in individuals with CYP2C9 polymorphisms. More trials are needed to determine clinical utility and appropriateness of pharmacogenetic testing in this population.

Covered Indications

Effective August 3, 2009, the Centers for Medicare & Medicaid Services (CMS) believes that the available evidence supports that coverage with evidence development (CED) under §1862(a)(1)(E) of the Social Security Act (the Act) is appropriate for pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness by any method, and is therefore covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin who:

Have not been previously tested for CYP2C9 or VKORC1 alleles; and

Have received fewer than five days of warfarin in the anticoagulation regimen for which the testing is ordered; and

Are enrolled in a prospective, randomized, controlled clinical study when that study meets the following standards.


Non-covered Indications

All other coverage for genetic testing for the CYP2C9 gene is considered investigational at this time. There is currently no proven clinical utility related to any medication, including but not limited to:

Celecoxib

Fluorbiprofen

Flovoxamine



VKORC1 Genotyping

Background on VKORC1 Testing

The vitamin K epoxide reductase complex subunit 1, encoded by the gene VKORC1, is critical in the vitamin K pathway for coagulation. Warfarin therapy targets VKORC1 to reduce clotting risk.

Variation in response to warfarin therapy has been linked to genetic variations. Retrospective study of European-American patients undergoing long term warfarin therapy identified 5 major haplotypes that were most predictive of approximately 25% of variance in warfarin dose. These are classified into A: low dose haplotype and B: high dose haplotype. This was validated in two European-American populations. Average maintenance dose for A/A haplotypes was approximately 2.7 mg per day; 4.9 mg per day for A/B, and 6.2 mg per day for B/B (p<0.001).

Review by the American College of Medical Genetics (2008) confirmed the analytic validity of testing VKORC1 and confirmed that there is sufficient evidence to support association with final therapeutic dose of warfarin. However, safe warfarin dosing requires careful monitoring and there is insufficient evidence is available to support routine VKORC1 genotyping for determination of final dosing. Further study in prospective clinical trials are needed to determine clinical utility.

Clinical Pharmacogenetics Implementation Consortium guidelines recommend that pharmacogenetic algorithms be used to determine ideal dosing, and recommend including VKORC1 genotyping when available. However the evidence from randomized prospective trials is limited, and impact on clinical outcomes is not yet known, limiting the ability to recommend that genotyping be performed for initial warfarin prescribing.

Meta-analysis of CYP2C9 and VKORC1 genotypes influence the risk of hemorrhagic complications in warfarin treated patients and increase the risk for over-coagulation and hemorrhagic complications with CYP2C9*3 carriers. No significant association was noted between VKORC1 genotypes and hemorrhagic complications in randomized controlled study testing.

Covered Indications

Effective August 3, 2009, the Centers for Medicare & Medicaid Services (CMS) believes that the available evidence supports that coverage with evidence development (CED) under §1862(a)(1)(E) of the Social Security Act (the Act) is appropriate for pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness by any method, and is therefore covered only when provided to Medicare beneficiaries who are candidates for anticoagulation therapy with warfarin who:

Have not been previously tested for CYP2C9 or VKORC1 alleles; and

Have received fewer than five days of warfarin in the anticoagulation regimen for which the testing is ordered; and

Are enrolled in a prospective, randomized, controlled clinical study when that study meets the following standards.


Non-covered Indications

There is insufficient evidence to demonstrate that genetic testing for the VKORC1 gene improves clinical outcomes. Consequently, genetic testing for the VKORC1 gene outside of the specified covered indications is considered investigational.


CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:

81225CYP2C19 (CYTOCHROME P450, FAMILY 2, SUBFAMILY C, POLYPEPTIDE 19) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3, *4, *8, *17)

Group 2 Paragraph: N/A

Group 2 Codes:
81226CYP2D6 (CYTOCHROME P450, FAMILY 2, SUBFAMILY D, POLYPEPTIDE 6) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN)

Group 3 Paragraph: N/A

Group 3 Codes:
81227CYP2C9 (CYTOCHROME P450, FAMILY 2, SUBFAMILY C, POLYPEPTIDE 9) (EG, DRUG METABOLISM), GENE ANALYSIS, COMMON VARIANTS (EG, *2, *3, *5, *6)
81355VKORC1 (VITAMIN K EPOXIDE REDUCTASE COMPLEX, SUBUNIT 1) (EG, WARFARIN METABOLISM), GENE ANALYSIS, COMMON VARIANT(S) (EG, -1639G>A, C.173+1000C>T)




ICD-10 Codes that Support Medical Necessity

ICD-10 CODEDESCRIPTION

I20.0Unstable angina
I20.1Angina pectoris with documented spasm
I20.8Other forms of angina pectoris
I20.9Angina pectoris, unspecified
I21.09ST elevation (STEMI) myocardial infarction involving other coronary artery of anterior wall
I21.11ST elevation (STEMI) myocardial infarction involving right coronary artery
I21.19ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall
I21.29ST elevation (STEMI) myocardial infarction involving other sites
I21.3ST elevation (STEMI) myocardial infarction of unspecified site
I21.4Non-ST elevation (NSTEMI) myocardial infarction
I24.0Acute coronary thrombosis not resulting in myocardial infarction
I24.1Dressler's syndrome
I24.8Other forms of acute ischemic heart disease
I25.110Atherosclerotic heart disease of native coronary artery with unstable angina pectoris
I25.111Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm
I25.118Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris
I25.119Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris
I25.700Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris
I25.701Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm
I25.708Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris
I25.709Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris
I25.710Atherosclerosis of autologous vein coronary artery bypass graft(s) with unstable angina pectoris
I25.711Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with documented spasm
I25.718Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina pectoris
I25.719 - I25.721 - Opens in a new windowAtherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris - Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris with documented spasm
I25.728 - I25.731 - Opens in a new windowAtherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris - Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris with documented spasm
I25.738Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris
I25.739Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina pectoris
I25.750Atherosclerosis of native coronary artery of transplanted heart with unstable angina
I25.751Atherosclerosis of native coronary artery of transplanted heart with angina pectoris with documented spasm
I25.758 - I25.761 - Opens in a new windowAtherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris - Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm
I25.768Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms of angina pectoris
I25.769Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified angina pectoris
I25.790Atherosclerosis of other coronary artery bypass graft(s) with unstable angina pectoris
I25.791Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris with documented spasm
I25.798Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina pectoris
I25.799Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina pectoris
L24.9Irritant contact dermatitis, unspecified cause

CPT/HCPCS Codes


Group 1 Codes:
64493Inj paravert f jnt l/s 1 lev
64494Inj paravert f jnt l/s 2 lev
64495Inj paravert f jnt l/s 3 lev
64635Destroy lumb/sac facet jnt
64636Destroy l/s facet jnt addl

Group 2 Paragraph: The CPT codes listed below will be denied as investigational.


Group 2 Codes:
0216TNjx paravert w/us lumb/sac
0217TNjx paravert w/us lumb/sac
0218TNjx paravert w/us lumb/sac

CPT/HCPCS Codes


Group 1 Codes:

64566Neuroeltrd stim post tibial

Coverage Indications, Limitations, and/or Medical Necessity

Background

Posterior Tibial Nerve Stimulation (PTNS), a minimally invasive procedure, consists of insertion of an acupuncture needle above the medial malleolus into a superficial branch of the posterior tibial nerve. An adjustable low voltage electrical impulse (10mA, 1-10 Hz frequency) travels via the posterior tibial nerve to the sacral nerve plexus to alter pelvic floor function by neuromodulation.

Indications

Studies demonstrate that PTNS is safe with statistically significant improvements in the clinical assessment of overactive bladder (OAB) (urge incontinence) and may be considered a clinically significant alternative to failed pharmacotherapy. Treatment regimens consist of 30-minute weekly sessions for 12 weeks.

Limitations

Patients must report an improvement in urge incontinence within 6 weeks (i.e., 6 sessions) of initiation of PTNS for continued coverage.

Treatment beyond the initial 12 sessions will be allowed at a frequency of 1 every 1 to 2 months for the remainder of one year. Subsequent treatment will not be covered.

Stress and neurogenic incontinence would not be expected to improve with PTNS.

There is currently no data that shows sustained improved urge incontinence after one year.


Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999xNot Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999Not Applicable


ICD-10 Codes that Support Medical Necessity

ICD-10 CODEDESCRIPTION

N39.41Urge incontinence
N39.46Mixed incontinence
R32Unspecified urinary incontinence

OUT OF STATE NONBORDERLAND TRANSPORTS

Except for emergencies, out of state, nonborderland transports require PA. (Refer to the General Information for Providers chapter of this manual for additional information.) The ambulance provider, home health agency (HHA), hospital, NF, physician, or social worker may request this authorization. The ambulance provider must retain documentation of medical necessity (physician's order) in the beneficiary's file to support the need for ambulance transportation. To request
authorization, the requestor must call or write the MDHHS Program Review Division before services are rendered. (Refer to the Directory Appendix for contact information.) The request must include:

* Point of pick-up

* Beneficiary's name and Medicaid ID number

* Diagnosis

* Service to be provided

* Destination point

* Reason why the ambulance transport was medically necessary

* Reason why the beneficiary cannot be transported by any other means

* Name and address of the ambulance provider

* Requestor's name


Based on the authorization requested, MDHHS approves or denies the request. The ambulance provider may render the service upon receipt of verbal approval. A copy of the approval authorization letter is mailed to the ambulance provider following the verbal authorization. The ambulance provider may not bill Medicaid until he has received the authorization letter. The ambulance provider must keep a copy of the authorization letter in the beneficiary's file.

The requestor must notify the MDHHS Program Review Division of any changes to the approved PA (e.g., change in service date or ambulance provider, etc.).

When seeking reimbursement for out of state transports, the PA number must be entered on the claim, except in the case of emergency transports.



AMBULANCE COVERAGE EXCLUSIONS

Circumstances under which Medicaid does not pay for ambulance transportation include, but are not limited to:

* Medi-car, Medi-van, or wheelchair transports.

* Transport to a funeral home.

* Trips made for services, such as drawing blood and catheterization that could have been provided at the beneficiary’s
location.

* Transportation of a beneficiary pronounced dead before the ambulance was called.

* Round trips when a beneficiary is taken from a hospital to another facility and returned to the same hospital. As long as the beneficiary is an inpatient, all ancillary services are the responsibility of the hospital.

* Transport of correctional facility inmates to and from the correctional facility.

* Transports that are not medically necessary.

When Medicaid Is Secondary Payer:

When Medicare and other commercial insurance is involved and if the lab or radiology provider is required to bill Medicare or the commercial insurance directly, the ancillary provider should do so and then bill eMedNY for any balance due. The clinic should not report these ancillaries on their APG claim since they will not be paying the ancillary provider. If Medicare denies payment for the ancillary service because it is not covered by Medicare, the ancillary service provider should bill Medicaid directly.

Exceptions to the APG Ancillary Billing Policy: There are four exceptions to the uniform application of the APG billing policy for ancillary laboratory and radiology services provided on behalf of clinic patients. They include the following:

** Laboratory and radiology tests performed on behalf of Federally Qualified Health Centers that do not participate in the APG payment methodology;

** Procedure codes carved-out of APGs as specified in Section 4.20 (e.g. Coumadin, Clozaril, lead screen, HIV viral load, virtual phenotype, blood factors, etc.);

** Procedure codes which may be carved-out of APGS (optional carve-outs) as specified in Section 4.21 (e.g. pregnancy testing); and

** Laboratory and radiology services associated with specialty clinic rate codes carved-out of APGs as specified in Section 4.22, since these are not “APG” visits. Utilization Thresholds and Laboratory/Radiology Ancillary Services: Utilization threshold limits will not apply to laboratory or radiology services incorporated in APG claims. Note: see section below regarding billing for professional and technical component of radiology services.


RADIOLOGY SERVICES – PROFESSIONAL PHYSICIAN COMPONENT AND TECHNICAL COMPONENT:
The professional component of radiology services is carved-out of the APG payment to the hospital or D&TC clinic and may be billed separately by the radiologist using the Medicaid fee schedule. This applies when a clinic patient receives radiology services from a clinic and the clinic is billing Medicaid under APGs for the patient encounter as well as those situations when a patient has been referred from another hospital outpatient department or freestanding clinic to a clinic and that clinic is billing the referring hospital/free-standing clinic for the radiology service (the referring hospital/free-standing clinic must bill for the radiology procedures on their Medicaid APG claim).

** The radiologist should use the radiology fee schedule (physician component) for radiology procedures provided to patients referred by other hospitals or free-standing clinics.

** The facility that provides the radiology services should bill the referring hospital or free-standing clinic for the technical component.

** The referring hospital or free-standing clinic must include the radiology procedure in the APG claim for the visit in which the radiology procedure was prescribed.

Note: The ancillary vendor may not bill the professional component of the radiology service if the hospital practitioner is planning to read and bill for this professional service. If the hospital plans to bill for the professional component of radiology service, the hospital should tell the ancillary vendor not to bill for the professional component of this service.

INPATIENT-ONLY SERVICES:

Under APG payment rules, certain surgical procedures may only be performed in the hospital inpatient setting. These procedures may not be performed on an ambulatory surgery or clinic outpatient basis. These designated ‘inpatient only’ procedures will not be reimbursed under the APG payment methodology. They will continue to be paid through the Diagnosis Related Groups (DRG) payment methodology. The APG Grouper will automatically reject these procedures for payment. The list of these procedures is available at the Department’s Website at: www.nyhealth.gov/health_care/medicaid/rates/apg/docs/inpatient_only.pdf.