INPATIENT HOSPITAL AUTHORIZATION REQUIREMENTS

The information in this section applies to instate and borderland hospitals. Information regarding out-ofstate hospital authorization requirements can be found in the Out-of-State/Beyond Borderland Providers subsection of this chapter.

All inpatient admissions must be medically necessary and appropriate, and all services must relate to a specific diagnosed condition. In the event that an inpatient stay is deemed medically inappropriate or unnecessary, either through a pre-payment predictive modeling review or a post-payment audit, providers are allowed to submit an outpatient claim for all outpatient services and any inpatient ancillary services performed during the inpatient stay. Elective admissions, readmissions, and transfers for surgical and medical inpatient hospital services must be authorized through the Admissions and Certification Review Contractor (ACRC). The physician/dentist should refer to the Prior Authorization Certification Evaluation Review (PACER) subsection of this chapter for specific requirements.

Medically inappropriate or unnecessary inpatient admissions may be resubmitted as outpatient claims for all outpatient services and any inpatient ancillary services performed during the inpatient stay. When an inpatient claim is deemed medically inappropriate or unnecessary through a pre-payment predictive modeling review or a post-payment audit, hospitals are allowed to submit a hospital outpatient Type of Bill (TOB) 013X for all outpatient services and any inpatient ancillary services performed during the inpatient stay. Examples of services related to medically inappropriate or unnecessary inpatient admission include:

** all elective admissions, readmissions, and transfers that are not authorized through the PACER system;

** admissions or readmissions which have been inappropriately identified as emergent/urgent;

** selected ambulatory surgeries inappropriately performed on an inpatient basis; and

** any other inpatient admission determined to have not been medically necessary. Medicaid does not cover inpatient hospital admissions for the sole purpose of:

** Cosmetic surgery (unless prior authorized)

** Custodial or protective care of abused children

** Diagnostic procedures that can be performed on an outpatient basis

** Laboratory work, electrocardiograms (ECGs), electroencephalograms (EEGs), and diagnostic x-rays

** Observation

** Occupational Therapy (OT)

** Patient education

** Physical Therapy (PT)

** Routine dental care

** Routine physical examinations not related to a specific illness, symptom, complaint, or injury

** Speech pathology

** Weight reduction or weight control (unless prior authorized)

If Medicaid does not cover the services of the physician/dentist or hospital, the physician/dentist or hospital must not bill the beneficiary, a member of the beneficiary's family, or other beneficiary representative.


PRIOR AUTHORIZATION CERTIFICATION EVALUATION REVIEW (PACER)

Elective admissions, all readmissions within 15 days of discharge, continued stays (when appropriate), and all transfers for surgical or medical inpatient hospital services to and from any hospital enrolled in the Medicaid program require authorization through the ACRC. This includes transfers between a medical/surgical unit and an enrolled distinct part rehabilitation unit of the same hospital. All cases are screened using the Medicaid approved Severity of Illness/Intensity of Services (SI/IS) criteria sets and the clinical judgment of the review coordinator. An ACRC physician/dentist makes all adverse decisions. The ACRC performs medical/surgical and rehabilitation admission, readmission, and transfer reviews through the PACER system and assigns PACER numbers.

The attending/admitting physician/dentist or representative is responsible for obtaining the PACER number before admitting, readmitting, or transferring the beneficiary, with exceptions as noted below. (Refer to the Directory Appendix for PACER authorization contact information.) The physician/dentist is responsible for providing the PACER number to the admitting hospital. The PACER number is issued on the day that the admission is approved by the ACRC. This number is valid for the entire medical or surgical admission unless otherwise noted in this section. PACER authorization must be requested prior to the admission of the beneficiary. Physicians/dentists are asked to provide the procedure code(s) when a surgical admission/readmission is requested.

Authorization through the ACRC for the hospital admission does not remove the need for prior authorization (PA) required by Medicaid for specific services. The PA for the service must be obtained before the ACRC authorization is requested.

Approval of an admission only confirms the need for services to be provided on an inpatient hospital basis. Payment for the admission is subject to eligibility requirements, readmission, and third party liability (TPL) reimbursement policy, along with any pre- and post-payment determinations of medical  necessity.

If an admission, readmission, transfer, or continued stay is not approved, MDHHS does not reimburse for services rendered.


Reconsiderations The attending physician/dentist or the hospital may request reconsideration of the adverse determination of the ACRC regarding the need for admission, readmission, transfer, or continued stay. This reconsideration right applies regardless of the current hospitalization status of the beneficiary. Reconsiderations must be requested within three business days of the adverse determination. (Refer to the Directory Appendix for ACRC contact information.) If requested by the ACRC, the provider must provide written documentation. The provider is notified of the reconsideration decision within one business day of receipt of the request or the date of receipt of written documentation. If the initial adverse determination is overturned, the adverse determination is considered null and void. If the initial adverse determination is upheld or is modified in such a manner that some portion of the hospital care is not authorized, the hospital is liable for the cost of care provided from the date of the initial determination, unless this determination is overturned in the Medicaid appeals
process.

Technical Denials If the provider fails to request a PACER number on a timely basis, the provider should make this request as soon as the omission is noted. When the provider contacts the ACRC by telephone with an untimely request, the review coordinator sends the provider a form to complete, explaining the circumstances of the untimely request. If upon review of this written documentation the untimeliness is waived, the case is reviewed for medical necessity and the appropriateness of the admission, readmission, or transfer. If approved, the ACRC gives the provider a PACER number. If the untimeliness issue is not approved, the attending physician/dentist and the hospital are notified in writing within 24 hours of the decision. The physician/dentist or hospital may request further review of the ACRC decision by Medicaid relative to timeliness.


If the ACRC does not authorize the admission or the continued stay for an admission and the beneficiary remains in the hospital for one or more days after Medicaid payment is not authorized, the hospital is at risk of Medicaid nonpayment for those days. The provider may request post-discharge review by the ACRC, regardless of whether reconsideration was requested on the case, in writing within 30 calendar days of the discharge from the hospital. A copy of the medical record must accompany the post-discharge review request.

Post-discharge review is conducted for only those days that were not authorized during the telephone review. The ACRC informs the provider, in writing, of the ACRC decision within 14 calendar days of the receipt of the request and documentation. If some or all of the previously nonauthorized days are approved, a new PACER number is issued and included in the notification of the decision. If the initial adverse determination is upheld, the notification includes the previously issued PACER number. If the provider is dissatisfied with the decision of the ACRC, the decision may be appealed.

The hospital may bill Medicaid only for the days authorized by the ACRC. If the ACRC has made an adverse determination and issued a final PACER number, the hospital  may submit a claim with this PACER number for only the authorized days while the
case is in the reconsideration, post-discharge review, or formal appeals process. Submission of such a claim does not imply acceptance of the ACRC determination.


A. ADMISSIONS/READMISSIONS/TRANSFERS THAT REQUIRE A PACER NUMBER

The following require a PACER number:

** All elective admissions.

** All readmissions within 15 days of discharge (including newborns). [NOTE: If a beneficiary is readmitted to the same hospital within 15 days for a related (required as a consequence of the original admission) condition, Medicaid considers the admission and the related readmission as one episode for payment purposes. The related admissions must be combined on a single claim. No PACER number is issued for continuation of care.]

** All transfers for medical/surgical services to and from any hospital enrolled in the Medicaid program (including newborns).

** Transfers between a medical/surgical unit and an enrolled distinct part rehabilitation unit of the same hospital.

** Authorization of continued stays in freestanding and distinct part rehabilitation units.



B. ADMISSIONS/READMISSIONS/TRANSFERS THAT DO NOT REQUIRE A PACER NUMBER

The following do not require a PACER number:

** Emergent/urgent inpatient hospital admissions. (All transfers and 15-day readmissions to the same or a different hospital do require PACER through the ACRC.)

** All admissions and transfers to distinct-part psychiatric units or freestanding psychiatric hospitals and all continued stays in a psychiatric unit/hospital. (Authorization must be obtained through the local Prepaid Inpatient Health Plan (PIHP)/Community Mental Health Services Program (CMHSP).)

** Obstetrical patients admitted for any delivery.

** Newborns admitted following delivery.

** Admissions of beneficiaries who are eligible for CSHCS only.
** Medicaid beneficiaries enrolled in a Medicaid Health Plan (MHP). (Authorization must be obtained through the MHP.)

** When a beneficiary is admitted to a hospital that is not enrolled with the Michigan Medicaid Program.

** When a beneficiary becomes Medicaid eligible after the admission, readmission, transfer, or certification review period. (When Medicaid eligibility is determined retroactively, "Retroactive Eligibility" must be entered in the Remarks section of the inpatient hospital claim.)

** Medicare Part A beneficiaries.

** Commercial insurance coverage for admissions, readmissions, transfers, or continued stays.



PACER READMISSIONS

To be separately reimbursable, all readmissions (whether to the same or a different hospital) for hospital services must be prior authorized through the ACRC. The request for a PACER number for an elective readmission, whether to the same or a different hospital, must be made prior to readmission. The request for a PACER number for an emergent/urgent readmission to the same hospital must be made by the next business day following the readmission. The request for a PACER number for an emergent/urgent readmission to a different hospital must be made prior to the beneficiary's discharge from a transferring hospital. Medicaid defines readmission, for purposes of review, as any admission/hospitalization of a beneficiary within 15 days of a previous discharge, whether the readmission is to the same or a different hospital.

If the hospital intends to combine an admission and a readmission into a single episode for DRG payment purposes, the ACRC should not be contacted for a separate PACER number for the readmission.

Before contacting the ACRC, the provider should assemble as much information as possible regarding the medical condition of the beneficiary upon the first discharge and at the time of the readmission. When contacted for a PACER number, the ACRC either:

** Agrees that the original admission and the readmission are unrelated, as well as medically necessary, and issues a PACER number so that the stays may be billed and paid separately by the same hospital;

** Authorizes a readmission to a different hospital as medically necessary and issues a PACER number;

** Asks the caller to obtain additional information and call back no later than the next business day; or

** Questions the relatedness of two stays at the same hospital or the medical necessity for the readmission and refers the call to a physician/dentist advisor who may issue or deny a PACER number.

If a PACER number is not provided for a readmission due to relatedness (required as a consequence of the original admission), the hospital must combine the two stays into a single episode for DRG payment purposes (using the Leave of Absence revenue code 0180 for the time between discharge and readmission), or request reconsideration of the ACRC physician/dentist advisor's decision within three business days. If the initial admission has already been billed, the hospital must submit a claim
replacement to combine the two stays.

If it is determined a readmission is medically unnecessary, the hospital may only bill for the first admission.


PACER TRANSFERS

If a beneficiary needs to be transferred, authorization for the transfer must be obtained through the ACRC. Authorization for a transfer is granted only if the transfer is medically necessary and the care or treatment is not available at the transferring hospital. Transfers for convenience are not considered.

Transfers include the following situations:

** Transfer from one inpatient hospital to another.

** Transfer from one unit of an inpatient hospital to another unit of the same hospital (i.e., distinctpart rehabilitation unit).

The following describes the appropriate requestor and timeframes for transfer authorization:

** Elective transfers – the transferring physician/dentist or designee must obtain authorization prior to transfer.

** Emergent/urgent transfers – the authorization must be obtained by the transferring physician/dentist no later than the next business day, or by the receiving physician/dentist or hospital before discharge.

If the transfer is approved, a PACER number is issued. The receiving hospital must use this PACER number when billing. The transferring hospital continues to use the original PACER number if a PACER number was required for the admission.

Procedure Code Description Rate

E1037 TRANSPORT CHAIR, PEDIATRIC SIZE

E1038 TRANSPORT CHAIR, ADULT SIZE, PATIENT WEIGHT CAPACITY UP TO AND INCLUDING 300 POUNDS

E1039 TRANSPORT CHAIR, ADULT SIZE, HEAVY DUTY, PATIENT WEIGHT CAPACITY GREATER THAN 300 POUNDS

E1161 MANUAL ADULT SIZE WHEELCHAIR, INCLUDES TILT IN SPACE

E1229 WHEELCHAIR, PEDIATRIC SIZE, NOT OTHERWISE SPECIFIED

E1231 WHEELCHAIR, PEDIATRIC SIZE, TILT-IN-SPACE, RIGID, ADJUSTABLE, WITH SEATING SYSTEM

E1232 WHEELCHAIR, PEDIATRIC SIZE, TILT-IN-SPACE, FOLDING, ADJUSTABLE, WITH SEATING SYSTEM

E1233 WHEELCHAIR, PEDIATRIC SIZE, TILT-IN-SPACE, RIGID, ADJUSTABLE, WITHOUT SEATING SYSTEM

E1234 WHEELCHAIR, PEDIATRIC SIZE, TILT-IN-SPACE, FOLDING, ADJUSTABLE, WITHOUT SEATING SYSTEM

E1235 WHEELCHAIR, PEDIATRIC SIZE, RIGID, ADJUSTABLE, WITH SEATING SYSTEM

E1236 WHEELCHAIR, PEDIATRIC SIZE, FOLDING, ADJUSTABLE, WITH SEATING SYSTEM

E1237 WHEELCHAIR, PEDIATRIC SIZE, RIGID, ADJUSTABLE, WITHOUT SEATING SYSTEM

E1238 WHEELCHAIR, PEDIATRIC SIZE, FOLDING, ADJUSTABLE, WITHOUT SEATING SYSTEM


K0001 STANDARD WHEELCHAIR $491.58

K0002 STANDARD HEMI (LOW SEAT) WHEELCHAIR $626.04

K0003 LIGHTWEIGHT WHEELCHAIR $685.35

K0004 HIGH-STRENGTH, LIGHTWEIGHT WHEELCHAIR $1,202.76

K0005 ULTRA LIGHTWEIGHT WHEELCHAIR $1,697.86

K0006 HEAVY DUTY WHEELCHAIR $959.40

K0007 EXTRA HEAVY-DUTY WHEELCHAIR $1,365.57

K0008 CUSTOM MANUAL WHEELCHAIR BASE $0.00

K0009 OTHER MANUAL WHEELCHAIR BASE $0.00

K0010 STANDARD-WEIGHT FRAME MOTORIZED, POWER WHEELCHAIR $3,258.81

K0011 STANDARD WEIGHT FRAME MOTORIZED POWER WHEELCHAIR WITH $4,051.80

K0012 LIGHTWEIGHT PORTABLE MOTORIZED POWER WHEELCHAIR $2,485.62

K0013 CUSTOM MOTORIZED POWER WHEELCHAIR $0.00

K0014 OTHER MOTORIZED POWER WHEELCHAIR BASE $0.00

K0015 DETACHABLE NONADJUSTABLE HEIGHT ARMREST ,EACH $143.83

K0017 DETACHABLE, ADJUSTABLE HEIGHT ARMREST , BASE EACH $40.45

K0018 DETACHABLE ADJUSTABLE HEIGHT ARMREST ,UPPER PORTION EACH $22.60

K0019 ARM PAD , EACH $12.94

K0020 FIXED, ADJUSTABLE HEIGHT ARM REST , PAIR $36.78

K0037 HIGH MOUNT FLIP-UP FOOTREST , EACH $38.12

K0038 LEG STRAP, EACH $19.22

K0039 LEG STRAP H-STYLE , EACH $42.65

K0040 ADJUSTABLE ANGLE FOOTPLATE, EACH $59.10

K0041 LARGE SIZE FOOTPLATE , EACH $41.89

K0042 STANDARD SIZE FOOTPLATE , EACH $28.84

K0043 FOOT REST LOWER EXTENSION TUBE , EACH $15.45

K0044 FOOTREST , UPPER HANGER BRACKET , EACH $13.17

K0045 FOOTREST , COMPLETE ASSEMBLY $44.82

K0046 ELEVATING LEGREST LOWER EXTENSION TUBE , EACH $15.45

K0047 ELEVATING LEGREST UPPER HANGAR BRACKET , EACH $60.53

K0050 RATCHET ASSEMBLY $25.73

K0051 CAM RELEASE ASSEMBLY , FOOTREST OR LEGREST , EACH $41.64

K0052 SWING AWAY DETACHABLE FOOTRESTS , EACH $73.18

K0053 ELEVATING FOOTRESTS ARTICULATING (TELESCOPING) , EACH $80.75

K0056 SEAT HEIGHT LESS THAN 17" OR LESS THAN OR EQUAL TO 21" FOR A HIGH STRENGTH LT-WGT OR ULTRA LT-WGT WHEELCHAIR $87.34

K0065 SPOKE PROTECTORS, EACH $40.82

K0069 REAR WHEEL ASSEMBLY COMPLETE WITH SOLID TIRES, SPOKES OR MOLDED , EACH $91.77

K0070 REAR WHEEL ASSEMBLY COMPLETE, WITH PNEUMATIC TIRE, SPOKES OR MOLDER, EACH $168.21

K0071 FRONT CASTER ASSEMBLY COMPLETE, WITH PNEUMATIC TIRE, EACH $100.33

K0072 FRONT CASTER ASSEMBLY COMPLETE, WITH SEMI-PNEUMATIC TIRE, EACH $60.40

K0073 CASTER PINLOCK, EACH $31.96

K0077 FRONT CASTER ASSEMBLY COMPLETE, WITH SOLID TIRE,EACH $54.05

K0098 DRIVE BELT FOR POWER WHEELCHAIR $20.91

K0105 IV HANGER, EACH $91.31

K0108 WHEELCHAIR COMPONENT OR ACCESSORY, NOT OTHERWISE SPECIFIED $0.00

K0148 HYDROGEL DRESSING, EACH $4.92

K0195 ELEVATING LEG RESTS, PAIR (FOR USED WITH CAPPED RENTAL WHEELCHAIR BASE) $161.19

K0267 REPLACEMENT BATTERY, ANY TYPE, FOR USE WITH MEDICALLY NECESSARY HOME BLOOD GLUCOSE MONITOR OWNED BY PATIENT, $6.10

K0455 INFUSION PUMP USED FOR UNINTERRUPTED ADMINISTRATION OF EPOPROSTENOL $0.00

K0462 TEMPORARY REPLACEMENT FOR PATIENT OWNED EQUIPMENT BEING REPAIRED, ANY TYPE $0.00

K0552 SUPPLIES FOR EXTERNAL DRUG INFUSION PUMP, SYRINGE TYPE CARTRIDGE, STERILE, EACH $2.44

K0601 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, SILVER OXIDE, 1.5 VOLT, EACH $1.02

K0602 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, SILVER OXIDE, 3 VOLT, EACH $5.84

K0603 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, ALKALINE, 1.5 VOLT, EACH $0.52

K0604 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, LITHIUM, 3.6 VOLT, EACH $5.58

K0605 REPLACEMENT BATTERY FOR EXTERNAL INFUSION PUMP OWNED BY PATIENT, LITHIUM, 4.5 VOLT, EACH $13.41

K0606 AUTOMATIC EXTERNAL DEFIBRILLATOR, WITH INTEGRATED ELECTROCARDIOGRAM ANALYSIS, GARMENT TYPE $0.01

K0607 REPLACEMENT BATTERY FOR AUTOMATED EXTERNAL DEFIBRILLATOR, GARMENT TYPE ONLY, EACH $178.38

K0608 REPLACEMENT GARMENT FOR AUTOMATED EXTERNAL DEFIBRILLATOR, EACH $111.31

K0609 REPLACEMENT ELECTRODES FOR USE WITH AUTOMATED EXTERNAL DEFIBRILLATOR, GARMENT TYPE ONLY, EACH $740.29

K0669 WHEELCHAIR SEAT OR BACK CUSHION, NO WRITTEN CODING VERIFICATION FROM SADMERC $0.00

K0730 CONTROLLED DOSE INHALATION DRUG DELIVERY SYSTEM $1,583.30

K0733 POWER WHEELCHAIR ACCESSORY, 12 TO 24 AMP HOUR SEALED LEAD ACID BATTERY, EACH (E.G. GEL CELL, ABSORBED GLASS $23.91

K0734 SKIN PROTECTION WHEELCHAIR SEAT CUSHSION, ADJUSTABLE, WIDTH LESS THAN 22 INCHES, ANY DEPTH $284.98

K0735 SKIN PROTECTION WHEELCHAIR SEAT CUSHION, ADJUSTABLE, WIDTH 22 INCHES OR GREATER, ANY DEPTH $362.62

K0736 SKIN PROTECTION AND POSITIONING WHEELCHAIR SEAT CUSHION, ADJUSTABLE, WIDTH LESS THAN 22 INCHES, ANY DEPTH $287.32

K0737 SKIN PROTECTION AND POSITIONING WHEELCHAIR SEAT CUSHION, ADJUSTABLE, WIDTH 22 INCHES OR GREATER, ANY DEPTH $363.73

K0738 PORTABLE GASEOUS OXYGEN SYSTEM, RENTAL; HOME COMPRESSOR USED TO FILL PORTABLE OXYGEN CLYLINDERS; $464.67

K0739 REPAIR OR NONROUTINE SERVICE FOR DURABLE MEDICAL EQUIPMENT OTHER THAN OXYGEN EQUIPMENT REQUIRING THE SKILL OF $13.56

K0800 POWER OPERATED VEHICLE, GROUP 1 STANDARD, PATIENT WEIGHT CAPACITY UP TO AND

INCLUDING 300 POUNDS $1,023.30

K0801 POWER OPERATED VEHICLE, GROUP 1 HEAVY DUTY, PATIENT WEIGHT 301 TO 450 POUNDS $1,649.76

K0802  POWER OPERATED VEHICLE, GROUP 1 VERY HEAVY DUTY, PATIENT WEIGHT CAPACITY 451 TO 600 POUNDS $1,867.01

K0806 POWER OPERATED VEHICLE, GROUP 2 STANDARD, PATIENT WEIGHT CAPACITY UP TO AND

INCLUDING 300 POUNDS $1,237.91

K0807 POWER OPERATED VEHICLE, GROUP 2 VERY HEAVY DUTY, PATIENT WEIGHT CAPACITY 301 TO 450 POUNDS $1,878.39

K0808 POWER OPERATED VEHICLE, GROUP 2 VERY HEAVY DUTY, PATIENT WEIGHT CAPACITY 451 TO 600 POUNDS $2,906.27

K0812 POWER OPERATED VEHICLE, NOT OTHERWISE CLASSIFIED $0.00

K0813 POWER WHEELCHAIR, GROUP 1 STANDARD, PORTABLE, SLING/SOLID SEAT AND BACK, PATIENT WEIGHT CAPACITY UP TO $2,171.16

K0814 POWER WHEELCHAIR, GROUP 1 STANDARD, PORTABLE, CAPTAIN'S CHAIR, PATIENT WEIGHT CAPACITY UP TO AND $2,779.02


K0815 POWER WHEELCHAIR, GROUP 1 STANDARD, SLING/SOLID SEAT AND BACK, PATIENT WEIGHT CAPACITY UP TO AND INCLUDING 300 $3,164.67


Medicare Guidelines - HMO

For example, if a beneficiary received a manual wheelchair under a HMO/Managed Care plan, he or she would need to meet Medicare coverage criteria and documentation requirements for manual wheelchairs. He or she would have to obtain a Certificate of Medical Necessity (CMN), and would begin an entirely new rental period, just as a beneficiary enrolled in FFS, to obtain a manual wheelchair for the first time.

Customized items are rarely necessary and are rarely furnished. In accordance with 42 CFR Section 414.224, in order to be considered a customized item, a covered item (including a wheelchair) must be uniquely constructed or substantially modified for a specific beneficiary according to the description and orders of a physician and be so different from another item used for the same purpose that the two items cannot be grouped together for pricing purposes. For example, a wheelchair that is custom fabricated or substantially modified so that it can meet the needs of wheelchair-confined, conjoined twins facing each other is unique and cannot be grouped with any other wheelchair used for the same purpose. It is a one-of-a-kind item fabricated to meet specific needs. Items that are measured, assembled, fitted, or adapted in consideration of a patient’s body size, weight, disability, period of need, or intended use (i.e., custom fitted items) or have been assembled by a supplier or ordered from a manufacturer who makes available customized features, modification or components for wheelchairs that are intended for an individual patient’s use in accordance with instructions from the patient’s physician do not meet the definition of customized items. These items are not uniquely constructed or substantially modified and can be grouped with other items for pricing purposes. The use of customized options or accessories or custom fitting of certain parts does not result in a wheelchair or other equipment being considered as customized. The item must be uniquely constructed using raw materials or there must be  a necessary, substantial modification to the base equipment (e.g., wheelchair frame) for the item to be considered a customized item.

The definition of customized DME set forth in regulations at 42 CFR Section 414.224 is based on the longstanding definition of customized DME used in making decisions regarding when to make individual payment determinations outside the normal process for calculating customary and prevailing charges under the reasonable charge payment methodology used for DME prior to 1989. Public Law 101-508, Omnibus Budget Reconciliation Act (OBRA), November 5, 1990 (104 Stat. 1388-79) amended the criteria for treatment of wheelchair as ‘a customized item at section 1834 (a) (4) of the Social Security Act by adding a clause that in case of a wheelchair furnished on or after January 1, 1992, the wheelchair shall be treated as a customized item if the   wheelchair has been measured, fitted, or adapted in consideration of the patient’s body size, disability period of need, or intended use, and has been assembled by a  supplier or ordered from a manufacturer who makes available customized features, modification or components for wheelchairs that are intended for an individual  patient’s use in accordance with instructions from the patient’s physician. The amendment further noted that this clause applied only to items furnished on or after  January 1, 1992, unless the Secretary developed specific criteria before that date for the treatment of wheelchairs as customized items for purposes of section 1834(a)  (4) of the Social Security Act (in which case the amendment made by such clause would not become effective.’ CMS issued an interim final rule on December 20, 1991 (56  FR 65995) to announce the decision not to use the optional definition of customized wheelchairs in section 1834 (a) (4) of the Act and add a new section 414.224 to 42  CFR to provide in regulation criteria that must be met for a covered item to be considered a customized item for payment purposes. The final rule (58 FR 34919) was  published on June 30, 1993.

Effective May 1, 1991, suppliers must give beneficiaries entitled to electric wheelchairs the option of purchasing them at the time the supplier first furnishes the item. DME MACs or A/B MACs (HHH) make no rental payment for the first month for electric wheelchairs until the supplier notifies the MAC that it has given the beneficiary the option of either purchasing or renting. Information contained in Exhibit 2 may be furnished to beneficiaries by suppliers to help them make a rent/purchase decision. MACs provide copies of Exhibit 2 to suppliers. Payment must be on a lump-sum fee schedule purchase basis where the beneficiary chooses the purchase option. If the beneficiary declines to purchase the electric wheelchair initially, MACs make rental payments in the same manner as any other capped rental item, including the instructions in §30.5.2.

If you need an electric wheelchair prescribed by your doctor, you may already know that Medicare can help pay for it. Medicare requires (specify name of supplier) to give you the option of either renting or purchasing it. If you decide that purchase is more economical, for example, because you will need the electric wheelchair for a long  time, Medicare pays 80 percent of the allowed purchase price in a lump sum amount. You are responsible for the 20 percent coinsurance amounts and, for unassigned  claims, the balance between the Medicare allowed amount and the supplier's charge. However, you must elect to purchase the electric wheelchair at the time your medical  equipment supplier furnishes you the item. If you elect to rent the electric wheelchair, you are again given the option of purchasing it during your 10th rental month.

If you continue to rent the electric wheelchair for 10 months, Medicare requires (specify name of supplier) to give you the option of converting your rental agreement to a purchase agreement. This means that if you accept this option, you would own the medical equipment. If you accept the purchase option, Medicare continues making rental payments for your equipment for 3 additional rental months. You are responsible for the 20 percent coinsurance amounts and, for unassigned claims, the balance between the Medicare allowed amount and the supplier's charge. After these additional rental payments are made, title to the equipment is transferred to you. You have until (specify the date one month from the date the supplier notifies the patient of this option) to elect the purchase option. If you decide not to elect the purchase option, Medicare continues making rental payments for an additional 5 rental months, a total of 15 months. After a total of 15 rental months have been paid, title to the equipment remains with the medical equipment supplier; however, the supplier may not charge you any additional rental amounts.

Elevating/stair climbing power wheelchairs are class III devices. Suppliers billing the DMERCs must submit claims for the base power wheelchair portion of this device using HCPCS code K0011 (programmable power wheelchair base) with modifier KF for claims submitted on or after April 1, 2004, with dates of service on or after January 1, 2004. For claims with dates of service on or after January 1, 2004, the elevation feature for this device should be billed using HCPCS code E2300 and the stair climbing feature for this device should be billed using HCPCS code A9270.

Regional home health intermediaries (RHHIs) will not be able to implement the KF modifier until January 1, 2005. Therefore, for claims with dates of service prior to January 1, 2005, HHAs must submit claims for the base power wheelchair portion of stair climbing wheelchairs with HCPCS code E1399. For claims with dates of service  on or after January 1, 2005, HHAs must submit claims for the base power wheelchair portion of stair climbing wheelchairs with HCPCS code K0011 with modifier KF.

The fee schedule amounts for K0011 with and without the KF modifier appear on the fee schedule file referenced at www.cms.hhs.gov/providers/pufdownload/default.asp#dme. For claims with dates of service prior to January 1, 2005, RHHIs should pay claims for stair climbing wheelchair bases billed with code E1399 using the fee schedule amounts for K0011 with the KF modifier. All other claims for programmable power wheelchair bases should be paid using the fee schedule amounts for K0011 without the KF modifier.

The DMEPOS fee schedules are updated on an annual basis in accordance with the statute and regulations. The update process for the DMEPOS fee schedule is located in Pub.100-04, Medicare Claims Processing Manual, chapter 23, section 60. Payment on a fee schedule basis is required for certain durable medical equipment (DME) by §1834(a) of the Social Security Act. Section1834(a)(1)(F)(ii) of the Act mandates adjustments to the fee schedule amounts for certain DME items furnished on or after January 1, 2016, including wheelchair accessories and seat and back cushions, in areas that are not competitive bid areas, based on information from competitive bidding programs (CBPs) for DME.

Providers/suppliers must use modifier “KU” for claims submitted on or after July 1, 2016, with dates of service on or after January 1, 2016, and before January 1, 2017, for any HCPCS code describing a wheelchair accessory or seat or back cushion when furnished in connection with a Group 3 complex rehabilitative power wheelchair.

Effective July 1,

2017, CMS has taken into consideration the exclusion at section 1847(a)(2)(A) of the Act to revise the policy. As a result, payment for these items furnished in connection with a Group 3 complex rehabilitative power wheelchair and billed with the KU modifier will be based on the unadjusted fee schedule amounts updated in accordance with section 1834(a)(14) of the Act.

The payment amount for a given service or item, whether rented or purchased, must be consistent with what is reasonable and medically necessary to serve the intended purpose (See the Medicare Benefit Policy Manual, Chapter 15). Additional expenses for "deluxe" features, or items that are rented or purchased for aesthetic reasons or added convenience, do not meet the reasonableness test. Thus, where a service or item is medically necessary and covered under the Medicare program, and the patient wishes to obtain such deluxe features, the payment is based upon the payment amount for the kind of service or item normally used to meet the intended purpose (i.e., the standard item.) Usually this is the least costly item. DME MACs may, of course, determine that the payment amount for a more expensive service or item is reasonable when the additional expense is for an added feature that is medically necessary in a given case. For example, a more expensive item may be medically necessary where a patient in a weakened condition needs a poweroperated wheelchair or a power-operated vehicle that may be appropriately used as a wheelchair since the patient is not strong enough to operate a manual wheelchair.

Diagnosis Codes - Listed in the first space is the diagnosis code that represents the primary reason for ordering this item. Additional diagnosis codes that would further describe the medical need for the item (up to 3 codes) are also listed. A given CMN may have more than one item billed, and for each item, the primary reason for ordering may be different. For example, a CMN is submitted for a manual wheelchair (K0001) and elevating leg rests (K0195). The primary reason for K0001 is stroke, and the primary reason for K0195 is edema.

Power wheelchair additional documentation requirements re: make and model name/number

There must be no requirement that all claims for power wheelchairs include the make and model name/number of the wheelchair separate from the claim or the CMN. The CMN, an OMB approved information collection form, can be used to collect this information. Specifically, DME MACs can require that the make and model name/ number of the power wheelchair be included in Section C of the CMN. Section C requires the supplier to include a narrative description of the items, options and accessories ordered.

EXCEPTION: Medicare makes a separate payment for a full month for DMEPOS items, provided the beneficiary was in the home on the “from” date or anniversary date defined below.

For capped rental items of durable medical equipment (DME) where the DME supplier submits a monthly bill, the date of delivery (“from” date) on the first claim must be the “from” or anniversary date on all subsequent claims for the item. For example, if the first claim for a wheelchair is dated September 15, all subsequent bills must be dated for the 15th of the following months

A beneficiary rents a wheelchair beginning on January 1. The DME MAC determines that the wheelchair is medically necessary and that the beneficiary meets all coverage criteria, and so begins to make payment on the wheelchair. The beneficiary enters a covered a hospital on February 15 and is discharged on April 5. In this example, Medicare pays for the entire month of February, because the patient was in the home for part of the month. However, the DME MAC denies the claim for March, because the patient was in a covered hospital stay for the entire month.

Because the anniversary date (“from” date) of the monthly bill was April 1, and the patient was still in the covered hospital stay on that date, the DME supplier must not submit another claim until April 5 (the date of discharge). April 5 becomes the new anniversary date (“from” date) for billing purposes, so the supplier would now bill on the 5th of the month rather than the 1st of the month for the remainder of the capped rental period. The supplier should annotate the claim to indicate that the patient was in a hospital on the first claim with the new anniversary date.

A beneficiary rents a wheelchair beginning December 15. On January 1, the patient enters a hospital and is discharged on January 31.

In this example, the DME MAC denies the claim dated January 15. The supplier submits a new claim dated January 31, which becomes the anniversary date for billing purposes. The supplier should annotate the claim to indicate that the patient was in a hospital on the first claim with the new anniversary date. The February claim would be dated February 28 because there is no 31st day in February.

For capped rental DME items where the DME supplier submits a monthly bill, the date of delivery (the “from” date) on the first claim must be the “from”, or “anniversary date”, on all subsequent claims for the item. For example, if the first claim for a wheelchair is dated September 15, all subsequent bills must be dated on the 15th of the following months (October 15, November 15, etc.).

The following instructions discuss DME payment when the DME is furnished during a month in which the beneficiary spends part of the month in a SNF, and part of the month in his or her own home. In accordance with DME payment policy, Medicare will make separate payment for a full month for DME items in such situations, provided the beneficiary was in the home on the “from” date or “anniversary date” defined above.

A beneficiary rents a wheelchair beginning on January 1. The DME MAC determines that the wheelchair is medically necessary and that the beneficiary meets all coverage criteria, and so begins to make payment on the wheelchair. The beneficiary enters a covered Part A stay in a SNF on February 15 and is discharged on April 5. In this example, Medicare will make payment for the entire month of February, because the patient was in the home for part of the month. However, the DME MAC will deny the claim for March, because the patient was in a covered Part A stay in the SNF for the entire month.

Because the anniversary date (“from” date) of the monthly bill was April 1, and the patient was still in the covered Part A stay in a SNF on that date, the DME supplier must not submit another claim until April 5 (the date of discharge). April 5 becomes the new anniversary date (“from” date) for billing purposes, so the supplier would now bill on the 5th of the month rather than the 1st of the month for the remainder of the capped rental period. The supplier should annotate the claim to indicate that the patient was in a SNF on the first claim with the new anniversary date.

For a DME item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

Nebulizers require an in-person or face-to-face interaction between the beneficiary and their treating physician prior to prescribing the item, specifically to document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered. A dispensing order is not sufficient to provide these items. A WOPD (written order prior to delivery) is required.

Detailed documentation requirements are outlined in Nebulizer LCD

HCPCS Code Description

A4217 Sterile water/saline, 500 ml
A4218 Sterile saline or water, metered dose dispenser, 10 ml
A4619 Face tent
A7003 Administration set, with small volume nonfiltered pneumatic nebulizer, disposable
A7004 Small volume nonfiltered pneumatic nebulizer, disposable
A7005 Administration set, with small volume nonfiltered pneumatic nebulizer, nondisposable
A7006 Administration set, with small volume filtered pneumatic nebulizer
A7007 Large volume nebulizer, disposable, unfilled, used with aerosol compressor
A7008 Large volume nebulizer, disposable, prefilled, used with aerosol compressor (noncovered per LCD) A7009 Reservoir bottle, non-disposable, used w/ large volume ultrasonic nebulizer (noncovered per LCD)
A7010 Corrugated tubing, disposable, used with large volume nebulizer, 100 feet
A7011 Corrugated tubing, non-disposable, used with large volume nebulizer, 10 feet
A7012 Water collection device, used with large volume nebulizer
A7013 Filter, disposable, used with aerosol compressor or ultrasonic generator
A7014 Filter, nondisposable, used with aerosol compressor or ultrasonic generator
A7015 Aerosol mask, used with DME nebulizer
A7016 Dome and mouthpiece, used with small volume ultrasonic nebulizer
A7017 Nebulizer, durable, glass or autoclavable plastic, bottle type, not used with oxygen
A7018 Water, distilled, used with large volume nebulizer, 1000 ml
A7525 Tracheostomy mask, each
G0333 Pharmacy dispensing fee for inhalation drug(s); initial 30-day supply as a beneficiary
J2545 Pentamidine isethionate, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, per 300 mg
J7604* Acetylcysteine, inhalation solution, compounded product, administered through DME, unit dose form, per gram
J7605 Arformoterol, inhalation solution, FDA approved final product, non-compounded, administered through DME, unit dose form, 15 micrograms
J7606 Formoterol fumarate, inhalation solution, FDA approved final product, noncompounded, administered through DME, unit dose form, 20 micrograms
J7607* Levalbuterol, inhalation solution, compounded product, administered through DME, concentrated form, 0.5 mg
J7608 Acetylcysteine, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, per gram
J7609* Albuterol, inhalation solution, compounded product, administered through DME, unit dose, 1 mg
J7610* Albuterol, inhalation solution, compounded product, administered through DME, concentrated form, 1 mg
J7611 Albuterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, 1 mg
J7612 Levalbuterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, concentrated form, 0.5 mg
J7613 Albuterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose, 1 mg
J7614 Levalbuterol, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose, 0.5 mg
J7615* Levalbuterol, inhalation solution, compounded product, administered through DME, unit dose, 0.5 mg


QUESTIONS AND ANSWERS

Q: Is a large volume ultrasonic nebulizer (HCPCS E0575) covered by Medicare?

A: A large volume ultrasonic nebulizer offers no proven clinical advantage over a pneumatic compressor and nebulizer and will be denied as not reasonable and necessary.


Q: Are compound inhalation solutions covered by Medicare?

A: CMS revoked coverage of compounded inhalation solutions in 2007.


Q: Are there any restrictions around nebulizers and home oxygen use?

A large volume pneumatic nebulizer (HCPCS E0580) and water or saline (HCPCS A4217 or A7018) are not separately payable and should not be separately billed when used for beneficiaries with rented home oxygen equipment.

Reason codes, and the text messages that define those codes, are used to explain why a claim may not have been paid in full. For instance, there are reason codes to indicate that a particular service is never covered by Medicare, that a benefit maximum has been reached, that non-payable charges exceed the fee schedule, or that a psychiatric reduction has been made. Under the standard format, only reason codes approved by the American National Standards Institute (ANSI) Insurance Subcommittee and Medicare-specific supplemental messages approved by CMS may be used.

The ANSI reason codes were designed to replace the large number of different codes used by health payers in this country, and to relieve the burden of medical providers to interpret each of the different coding systems. Although reason codes and CMS message codes will appear in the body of the remittance notice, the text of each code that is used will be printed at the end of the notice to facilitate interpretation. The approximately 10,000 different messages used by Medicare carriers nationwide have been reduced to fewer than 400 messages. The standard messages may expand or change occasionally as the need arises, but CMS plans to limit the frequency of such changes.

Code Description

01 Deductible amount.
02 Coinsurance amount.
03 Co-payment amount.
04 The procedure code is inconsistent with the modifier used, or a required modifier is missing.
05 The procedure code/bill type is inconsistent with the place of service.
06 The procedure/revenue code is inconsistent with the patient’s age.
07 The procedure/revenue code is inconsistent with the patient's gender.
08 The procedure code is inconsistent with the provider type/specialty (taxonomy).
09 The diagnosis is inconsistent with the patient's age.
10 The diagnosis is inconsistent with the patient's gender.
11 The diagnosis is inconsistent with the procedure.
12 The diagnosis is inconsistent with the provider type.
13 The date of death precedes the date of service.
14 The date of birth follows the date of service.
15 Payment adjusted because the submitted authorization number is missing, invalid, or does not apply to the billed services or provider.
16 Claim/service lacks information which is needed for adjudication. Additional information is supplied using remittance advice remarks codes whenever appropriate.
17 Payment adjusted because requested information was not provided or was insufficient/incomplete. Additional information is supplied using remittance advice remarks codes whenever appropriate.
18 Duplicate claim/service.
19 Claim denied because this is a work-related injury/illness and thus the liability of the Worker’s Compensation Carrier.
20 Claim denied because this injury/illness is covered by the liability carrier.
21 Claim denied because this injury/illness is the liability of the no-fault carrier.
22 Payment adjusted because this care may be covered by another payer per coordination of benefits.
23 Payment adjusted because charges have been paid by another payer.
24 Payment for charges adjusted. Charges are covered under a capitation agreement/managed care plan.
25 Payment denied. Your stop loss deductible has not been met.
26 Expenses incurred prior to coverage.
27 Expenses incurred after coverage terminated.
28 Coverage not in effect at the time the service was provided.
29 The time limit for filing has expired.
30 Payment adjusted because the patient has not met the required eligibility, spend down, waiting, or residency requirements.
31 Claim denied as patient cannot be identified as our insured.
32 Our records indicate that this dependent is not an eligible dependent as defined.
33 Claim denied. Insured has no dependent coverage.
34 Claim denied. Insured has no coverage for newborns.
35 Benefit maximum has been reached.
36 Balance does not exceed co-payment amount.
37 Balance does not exceed deductible.
38 Services not provided or authorized by designated (network) providers.
39 Services denied at the time authorization/pre-certification was requested.
40 Charges do not meet qualifications for emergent/urgent care.
41 Discount agreed to in Preferred Provider contract.
42 Charges exceed our fee schedule or maximum allowable amount.
43 Gramm-Rudman reduction.
44 Prompt-pay discount.
45 Charges exceed your contracted/legislated fee arrangement.
46 This (these) service(s) is (are) not covered.
47 This (these) diagnosis(es) is (are) not covered, missing, or are invalid.
48 This (these) procedure(s) is (are) not covered.
49 These are non-covered services because this is a routine exam or screening procedure done in conjunction with a routine exam.
50 These are non-covered services because this is not deemed a "medical necessity" by the payer.
51 These are non-covered services because this is a pre-existing condition.
52 The referring/prescribing provider is not eligible to refer/prescribe/order/perform the service billed.
53 Services by an immediate relative or a member of the same household are not covered.
54 Multiple physicians/assistants are not covered in this case.
55 Claim/service denied because procedure/ treatment is deemed experimental/ investigational by the payer.
56 Claim/service denied because procedure/ treatment has been deemed “proven to be effective” by the payer.
57 Payment denied/reduced because the payer deems the information submitted does not support this level of service, this many services, this length of service, this dosage, or this day’s supply.
58 Payment adjusted because treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of service.
59 Charges are reduced based on multiple surgery rules or concurrent anesthesia rules.
60 Charges for outpatient services with this proximity to inpatient services are not covered.
61 Charges adjusted as penalty for failure to obtain second surgical opinion.
62 Payment denied/reduced for absence of, or exceeded, precertification/ authorization.
63 Correction to a prior claim.
64 Denial reversed per Medical Review.
65 Procedure code was incorrect. This payment reflects the correct code.
66 Blood deductible.
67 Lifetime reserve days.
68 DRG weight.
69 Day outlier amount.
70 Cost outlier. Adjustment to compensate for additional costs.
71 Primary payer amount.
72 Coinsurance day.
73 Administrative days.
74 Indirect Medical Education Adjustment.
75 Direct Medical Education Adjustment.
76 Disproportionate Share Adjustment.
77 Covered days.
78 Non-covered days/Room charge adjustment.
79 Cost report days.
80 Outlier days.
81 Discharges.
82 PIP days.
83 Total visits.
84 Capital Adjustment.
85 Interest amount.
86 Statutory Adjustment.
87 Transfer amount.
88 Adjustment amount represents collection against receivable created in prior overpayment.
89 Professional fees removed from charges.
90 Ingredient cost adjustment.
91 Dispensing fee adjustment.
92 Claim paid in full.
93 No claim level adjustments.
94 Processed in excess of charges.
95 Benefits adjusted. Plan procedures not followed.
96 Non-covered charges.
97 Payment is included in the allowance for another service/procedure.
98 The hospital must file the Medicare claim for this inpatient non-physician service.
99 Medicare Secondary Payer Adjustment amount.
100 Payment made to patient/insured/responsible party.
101 Predetermination. Anticipated payment upon completion of services or claim adjudication.
102 Major Medical Adjustment.
103 Provider promotional discount (e.g., Senior citizen discount).
104 Managed care withholding.
105 Tax withholding.
106 Patient payment option/election not in effect.
107 Claim/service denied because the related or qualifying claim/service was not paid or identified on the claim.
108 Payment adjusted because rent/purchase guidelines were not met.
109 Claim not covered by this payer/contractor. You must send the claim to the correct payer/contractor.
110 Billing date predates service date.
111 Not covered unless the provider accepts assignment.
112 Payment adjusted as not furnished directly to the patient and/or not documented.
113 Payment denied because service/procedure was provided outside the United
States or as a result of war.
114 Procedure/product not approved by the Food and Drug Administration.
115 Payment adjusted as procedure postponed or cancelled.
116 Payment denied. The advance indemnification notice signed by the patient
did not comply with requirements.
117 Payment adjusted because transportation is only covered to the closest facility that can provide the necessary care.
118 Charges reduced for ESRD network support.
119 Benefit maximum for this time period has been reached.
120 Patient is covered by a managed care plan.
121 Indemnification adjustment.
122 Psychiatric reduction.
123 Payer refund due to overpayment.
124 Payer refund amount – not our patient.
125 Payment adjusted due to a submission/billing error(s). Additional information
is supplied using the remittance advice remarks codes whenever appropriate.
126 Deductible – Major Medical.
127 Coinsurance – Major Medical.
128 Newborn’s services are covered in the mother’s allowance.
129 Payment denied. Prior processing information appears incorrect.
130 Claim submission fee.
131 Claim specific negotiated discount.
132 Prearranged demonstration project adjustment.
133 The disposition of this claim/service is pending further review.
134 Technical fees removed from charges.
135 Claim denied. Interim bills cannot be processed.
136 Claim adjusted. Plan procedures of a prior payer were not followed.
137 Payment/Reduction for Regulatory Surcharges, Assessments, Allowances or Health Related Taxes.
138 Claim/Service denied. Appeal procedures not followed or time limits not met.
139 Contracted funding agreement. Subscriber is employed by the provider of the services.
140 Patient/Insured health identification number and name do not match.
141 Claim adjustment because the claim spans eligible and ineligible periods of coverage.
142 Claim adjusted by the monthly Medicaid patient liability amount.
143 Portion of payment deferred.
144 Incentive adjustment, e.g., preferred product/service.
145 Premium payment withholding.
146 Payment denied because the diagnosis was invalid for the date(s) of service reported.
147 Provider contracted/negotiated rate expired or not on file.
148 Claim/service rejected at this time because information from another provider was not provided or was insufficient/incomplete.
A0 Patient refund amount.
A1 Claim denied charges.
A2 Contractual adjustment.
A3 Medicare Secondary Payer liability met.
A4 Medicare Claim PPS Capital Day Outlier Amount.
A5 Medicare Claim PPS Capital Cost Outlier Amount.
A6 Prior hospitalization or 30 day transfer requirement not met.
A7 Presumptive Payment Adjustment.
A8 Claim denied; ungroupable DRG.
B1 Non-covered visits.
B2 Covered visits.
B3 Covered charges.
B4 Late filing penalty.
B5 Payment adjusted because coverage/program guidelines were not met or were exceeded.
B6 This payment is adjusted when performed/billed by this type of provider, by this type of provider in this type of facility, or by a provider of this specialty.
B7 This provider was not certified/eligible to be paid for this procedure/service on this date of service.
B8 Claim/service not covered/reduced because alternative services were available, and should not have been utilized.
B9 Services not covered because the patient is enrolled in a Hospice.
B10 Allowed amount has been reduced because a component of the basic procedure/test was paid. The beneficiary is not liable for more than the charge limit for the basic procedure/test.
B11 The claim/service has been transferred to the proper payer/processor for processing. Claim/service not covered by this payer/processor.
B12 Services not documented in patient’s medical records.
B13 Previously paid. Payment for this claim/service may have been provided in a previous payment.
B14 Payment denied because only one visit or consultation per physician per day is covered.
B15 Payment adjusted because this service/procedure is not paid separately.
B16 Payment adjusted because "new patient" qualifications were not met.
B17 Payment adjusted because this service was not prescribed by a physician, not prescribed prior to delivery, the prescription is incomplete, or the prescription is not current. B18 Payment denied because this procedure code/modifier was invalid on the
date of service or claim submission.
B19 Claim/service adjusted because of the finding of a Review Organization.
B20 Payment adjusted because procedure/service was partially or fully furnished by another provider.
B21 The charges were reduced because the service/care was partially furnished by another physician.
B22 This payment is adjusted based on the diagnosis.
B23 Payment denied because this provider has failed an aspect of a proficiency testing program.
D1 Claim/service denied. Level of subluxation is missing or inadequate.
D2 Claim lacks the name, strength, or dosage of the drug furnished.
D3 Claim/service denied because information to indicate if the patient owns the equipment that requires the part or supply was missing.
D4 Claim/service does not indicate the period of time for which this will be needed.
D5 Claim/service denied. Claim lacks individual lab codes included in the test.
D6 Claim/service denied. Claim did not include patient's medical record for the service.
D7 Claim/service denied. Claim lacks date of patient's most recent physician visit.
D8 Claim/service denied. Claim lacks indicator that "x-ray is available for review”.
D9 Claim/service denied. Claim lacks invoice or statement certifying the actual cost of the lens, less discounts or the type of intraocular lens used.
D10 Claim/service denied. Completed physician financial relationship form not on file.
D11 Claim lacks completed pacemaker registration form.
D12 Claim/service denied. Claim does not identify who performed the purchased diagnostic test or the amount you were charged for the test.
D13 Claim/service denied. Performed by a facility/supplier in which the ordering/referring physician has a financial interest.
D14 Claim lacks indication that plan of treatment is on file.
D15 Claim lacks indication that service was supervised or evaluated by a physician. W1 Workers Compensation State Fee Schedule Adjustment.

Insurance Cigna denial codes list

Code Description Denial Language

1 Services after auth end The services were provided after the authorization was effective and are not covered benefits under this plan.
2 Services prior to auth start The services were provided before the authorization was effective and are not covered benefits under this plan.
3 No auth on file There is no authorization on file for these services.
4 Max Days This claim exceeds the maximum allowed days per benefit period
5 Not member Denied: No coverage effective at time of service.
6 Benefit Day Limit Exceeded. Benefit Day Limit Exceeded.
7 No benefit The patient does not have benefits for this service under this Plan.
8 Not covered The service provided is not a covered benefit under this plan.
9 Before eff date The date you received medical services on the above claim was prior to your effective date of eligibility with this Plan. Please submit your claim to the appropriate Plan.
10 Prior auth required Utilization Management has denied prior authorization for this service.
11 Not a benefit Not a benefit
12 Exceeds annual amount This claim exceeds the annual amount allowed for this benefit.
13 Lifetime max This claim exceeds the lifetime maximum allowed for this benefit.
14 Visit limit This claim exceeds the visit limit allowed for this benefit.
15 Dollar limit This claim exceeds the dollar limit allowed for this benefit.
16 Exceeds auth This services exceeds the number of services authorized.
17 Auth for different provider The authorization on file was issued to a different provider.
18 Experimental Procedure has been determined as being experimental in nature.
19 Mental Health This claim is the responsibility of Bravo Health's Delegated Mental Health Vendor. This claim has been forwarded on your behalf.
20 Not covered This service is not a covered benefit for this plan
21 Capitated This is a capitated service.
22 Hospice Hospice Member - Submit to Original Medicare
23 Capitated This is a capitated service.
24 CompCare Submit all Inpatient Mental Health to Comp Care
26 Vision This claim is the responsibility of Bravo Health's Delegated Vision Vendor. This claim has been forwarded on your behalf.
27 Health and Wellness This claim is the responsibility of Bravo Health's Delegated Health & Wellness Vendor. This claim has been forwarded on your behalf.
28 Dental This claim is the responsibility of Bravo Health's Delegated Dental Vendor. This claim has been forwarded on your behalf.
29 Adjusted claim This is an adjusted claim.
30 Auth match The services billed do not match the services that were authorized on file.
31 Not covered Medicare This service is not covered by Medicare.
32 Not covered benefit This service is not a covered benefit for this plan however the patient is not liable for payment as the Noncoverage provided to the patient did not comply with the program requirements
33 POS Please resubmit this claim with the correct place of service.
35 Per Diem Services included in Per Diem
36 Facility Services included in facility fee
37 RUGS Services included in RUGS rate
38 Visit Services included in visit rate
39 Invalid revenue code Claim has been submitted with an invalid revenue code. Please resubmit a corrected claim.
40 Invalid modifier The modifier submitted on this claim is invalid for the date of service. Please resubmit claim with a valid modifier.
41 Invalid procedure code The procedure code billed is not valid. Please resubmit this claim with a valid code.
42 Invalid ICD9 code Please resubmit this claim with a valid ICD9 diagnosis code.
43 Par filing deadline exceeded All claims for participating providers must be submitted within 180 days of the date of service. This claim was submitted after the filing deadline.
44 No detail Please resubmit this claim with a detailed bill showing the charges and specific services for each date of service. Itemized bills can be faxed to 1(877)-788-2764
45 No EOB Please resubmit with EOB in order to complete processing of the claim.
46 No occurrence code Please resubmit with corrected Occurrence Code on claim
47 Correct occurrence span Please resubmit with corrected Occurrence Code Span on claim.
48 Correct condition code Please resubmit with corrected Condition Code on claim.
49  Duplicate Claim Line (SameMember/DOS/CPT(REV) Duplicate Claim Line (Same Member/DOS/CPT(REV)
50 Duplicate Mem/DOS/Pay To/Rendering Phys/Charges Duplicate Mem/DOS/Pay To/Rendering Phys/Charges
51 Invalid claim data found on IRF claim. Invalid claim data found on IRF claim.
52 Benefit Requires Contracted (PAR) provider. Benefit Requires Contracted (PAR) provider.
53 Benefit requires non-contracted (NONPAR) provider. Benefit requires non-contracted (NONPAR) provider.
54 Service not within the scope of your contract. Service provided is not included within the scope of your contract.
55 Incorrect value code Please resubmit with corrected Value Code on claim
56 Incorrect admission date Please resubmit with corrected Admission Date on claim
57 Discharge status required Discharge status is required for inpatient and SNF claims.
58 Admission source required Admission source required
59 Incorrect patient status Please resubmit with corrected patient status for bill type on claim
61 HIPPS RUGS DOS billed dollars HH PPS and RUGS DOS billed amount should not have a dollar amount.
62 HIPPS RUG requires rehab HIPPS RUG rate code requires rehabilitation therapy
63 Submit EOB Please resubmit with a EOB in order to complete the processing of the claim
64 Duplicate service code Duplicate service code on same claim with no modifier. Please resubmit with corrected modifier on claim.
65 Incorrect From DOS Please resubmit with corrected From DOS on claim.
66 Incorrect To DOS Please resubmit with corrected TO DOS on claim.
67 Incorrect Admit Type Please resubmit with a correct Admit Type on claim.
68 Incorrect HIPPS code Please resubmit with corrected HIPPS code on IRF claim.
69 Incorrect IRF charges Please resubmit with corrected charges on IRF claim
70 Incorrect Rev code/HCPC rate Please resubmit with corrected Revenue Code and HCPCS/Rate on claim
71 Invalid claim line units Claim line units not equal to days reflected with span code 74
72 Annual benefit amount exceeded Annual benefit amount exceeded
73 Lifetime benefit amount exceeded Lifetime benefit amount exceeded
74 Individual Lifetime visits exceeded Individual Lifetime visits exceeded
75 Not covered This service is not a covered benefit under the plan for this date of service.
76 Benefit visit limit exceeded Benefit visit limit exceeded
77 Benefit dollar limit exceeded Benefit dollar limit exceeded
78 Excluded from provider contract This service is excluded from the Provider's contract. Reimbursement will be made only on services covered by the contract.
79 Duplicate Mem/DOS/Service Code/Pay To/Modifier Duplicate Mem/DOS/Service Code/Pay To/Modifier
80 Dup mem/DOS/Svc Code/ Pay To/Rend Phys/Mod Duplicate member/DOS/Service Code/ Pay To/Rendering Physician/Modifier
81 One 0024 revenue code is permitted per claim Per CMS guidelines, only one 0024 revenue code is permitted per claim
82 Resubmit with appropriate diagnosis codes. Please resubmit the claim with appropriate diagnosis codes.
83 Duplicate claim line Duplicate claim line (same provider/member/DOS/CPT(REV)
84 Not covered/Not allowable by contract Service not covered/Not allowable by contract for provider.
85 Duplicate Claim (Provider/Member/DOS) Duplicate Claim (Provider/Member/DOS)
86 No RAP A Request for Anticipated Payment (RAP) has not yet been submitted for this episode. A RAP must be submitted before payment can be made on the final claim of the episode.
87 Unmatched HIPPS The HIPPS code that was submitted on the RAP for this episode does not match the HIPPS code that was billed on the final claim. Please resubmit a corrected claim or RAP.
88 No RAP 2 A Request for Anticipated Payment (RAP) has not yet been submitted for this episode. A RAP must be submitted before payment can be made on the final claim of the episode.
89 Invalid from date The From statement date must equal the date on the service line item. Please submit a corrected claim.
90 The statement From date is a required field. The statement From date is a required field. Please resubmit a corrected claim.
91 Duplicate RAP A Request for Anticipated Payment (RAP) has already been submitted for this episode. A cancellation of the original RAP must be submitted before payment can be made on a corrected RAP.
92 RAP date discrepancy The statement From and Through date on the Request for Anticipated Payment (RAP) should be equal. Please submit a corrected claim.
93 Include rev and HCPC codes for each service. Please resubmit the claim and include both valid revenue and HCPC codes for each service.
94 HIPPS RUGS DOS not in time period. HIPPS RUGS Date of Service is not within the assessment modifier time period.
95 Not a member Denied: No coverage effective at time of service.
96 Need EOB Please resubmit with an Explanation of Benefits from the primary insurance carrier
97 Incorrect bill type Please resubmit this claim with a corrected bill type
98 Incorrect number of units Please resubmit with the correct number of units on claim.
99 Inpatient hospital days have been exhausted. Inpatient hospital days have been exhausted.
100 Rebundled Two or more procedure codes were rebundled into one comprehensive code.
101 Pre-op included Pre-Operative services are included in the surgical package.
102 Post-op included Post-Operative services are included in the surgical package.
103 Medical visit is not separately reimbursable. Medical visit is not separately reimbursable.
104 One initial/3 years Initial visit is only billed once per patient/provider every three years.
105 Duplicate claim. Duplicate claim.
106 Incidental Incidental service(s) to primary procedure do not require separate reimbursement - The patient is not liable for payment.
107 Obsolete or invalid procedure code Obsolete or invalid procedure code
108 Multiple unit or multiple modifier denial. Multiple unit or multiple modifier denial.
109 Unilateral/Bilateral procedure code Unilateral/Bilateral procedure code
110 Mutually exclusive Two or more procedure codes are considered mutually exclusive.
111 Procedure does not require an Assistant Surgeon. Procedure does not require an Assistant Surgeon.
112 Age range discrepancy Provider assigned an age-specific procedure to a patient whose age is outside of the designated age range.
113 Gender discrepancy Provider assigned a gender-specific procedure to a patient of the opposite sex.
114 Invalid diagnosis code Invalid diagnosis code
116 OPPS The services reported on this claim are not separately reimbursable under OPPS.
117 Incorrect blood Line items billing for blood and products is incorrect. Please resubmit a corrected claim.
118 Radiopharm Certain nuclear medicine procedures are performed with specific diagnostic radiopharmaceuticals. The required radiopharmaceutical is not present on the claim. Please resubmit corrected claim.
119 G0739 G0379 must be billed in conjunction with G0378.
120 Inc in Part A The services billed on this claim are considered directly related to an inpatient admission and are not separately billable. These services are included in the Part A payment.
121 Need mod Component of comprehensive procedure that would be allowed if appropriate modifier were present
122 T or S Medical visit on same day as a type T or S procedure without modifier 25.
123 Rev Code Please resubmit with corrected Revenue Code.
124 Mileage Mileage included in base rate.
125 Invoice Submit claim with invoice.
126 Total mismatch Claim total does not match detail line total.
127 Diag required Per CMS regulations this benefit requires specific diagnosis codes.
128 EOB required The primary carrier's explanation of benefits is necessary to consider these services.
129 Single HIPPS Effective January 1, 2008, episodes paid under the refined HH PPS will be paid based on a single HIPPS code. Please submit a corrected claim.
130 Missing Modifier Please resubmit with appropriate or missing modifier.
131 Rendering Provider Rendering Provider Required on Claim
132 POA Please resubmit with a valid POA code
133 SUBMITTED W/O NDC NUMBERS Please resubmit with National Drug Code (NDC) numbers.
134 SUBMITTED W/INVALID NDC #S Please resubmit with a valid National Drug Code (NDC) number. The number submitted is not valid.
135 INVALID NDC NUMBER Please resubmit with a valid National Drug Code (NDC) number. The number submitted is not valid.
136 NDC NUMBER(S) ILLEGIBLE Please resubmit this claim with legible NDC numbers.
137 FIN and NPI mismatch Our data indicates a FIN and NPI mismatch as billed. Please submit a corrected claim.
138 Acute Rehab This is an acute rehab admit. Please resubmit claim with the appropriate case mix group code.
139 OON The benefit for this service is not covered out of network.
140 Add On Add-on billed without primary code.
141 Drug Coverage Only No Medical Coverage. Member has Drug Coverage Only.
142 Bundled Service Bundled Service
143 HIPPS A HIPPS codes is required for this type of claim. Please resubmit with appropriate coding.
144 A8A9 Please resubmit claim with value codes A8 & A9
146 Old Services not billable for the Fiscal Year.
147 OPPS Code not recognized by OPPS; alternate code for the same service may be available.
148 CMS Code not recognized by CMS; alternate code for the same service may be available.
149 Not enrolled Member not enrolled on DOS.
150 Not enrolled group Member was not enrolled with this Medical Group on DOS .
151 Bill on 1500 Resubmit ASC Claims on HCFA ASCs are required to submit claims on form CMS-1500. Please resubmit claim on appropriate form.
152 RUGS Submit with RUGS code.
153 DevCode Claim lacks required device code.
154 Report Code is used for reporting performance measurements only.
155 Invalid G/I- This service code is not valid for Medicare purposes. Medicare uses an alternate code for the reporting and payment of these services. Please resubmit claim with appropriate coding.
156 Excl E- This service code is excluded from the Physician fee schedule by regulation. No payment is made under the MPFS for this code.
157 No RVU J- This code has no Relative Value Unit and no payment amount. The intent of this code is to facilitate the identification of anesthesia services only.
158 APC Reimbursement for this service is included in the APC reimbursement.
159 DRG Payment for this service is included in the DRG rate.
160 Age The diagnosis code includes an age range and the age is outside that range.
161 Gender The diagnosis code includes sex designation and the sex does not match.
162 E Dx The first letter of the principle diagnosis code in an E. This edit is not applicable to the admit diagnosis.
163 Gender Match The sex of the patient does not match the sex designated for the procedure on the record.
164 Bilateral 2x The same bilateral procedure code occurs two or more times on the same service date.
165 Bilateral 2xx The same bilateral procedure code occurs two or more times on the same service date or the same inherent
bilateral procedure code occurs two or more times on the same service date.
166 Mut Excl The procedure is one of a pair of mutually exclusive procedures in the NCCI table coded on the same day, where the use of a modifier is not appropriate.
167 No Mod The procedure is identified as part of another procedure on the claim coded on the same day, where the use of a modifier is not appropriate.
168 No Blood A blood transfusion or exchange is coded but no blood product is coded.
169 Obs A 762 (observation) revenue code is used with a HCPCS other than observation (99217-99220, 99234-99236, G0378, G0379).
170 HCPCS Req Revenue center requires HCPCS.
171 Comp EM Composite E/M conditions not met for observation and line item.
172 Inv Rev Revenue code not recognized by Medicare.
173 No Proc Claim lacks allowed procedure code.
176 Not covered This is not a covered service.
177 Max Maximum out of Pocket has been reached. Eligible Amounts have been paid at 100%.
178 Max copay Maximum copay per diem has been satisfied for this benefit period. No copay per diem applied.
179 Cosurgeon Co-Surgeon Not Covered
180 Credit Credit applied for prior RAP payment
181 MedSurg This service has been down graded to Med/Surg Day
182 Skilled This service has been down graded to Skilled Nursing
183 Subacute This service has been down graded to Subacute
184 Telemetry This service has been down graded to Telemetry
185 Obs 2 This service has been down graded to the Observation Rate
186 Per Diem This service is included in the In-patient Per Diem
187 Obs Rate This service is included in the Observation Rate
188 Package This service is included in the Package Price

189 Stoploss This service is included in the Stop Loss Rate
190 Unequal Itemized Bill not equaled to charges
191 Missing Anes Time Please rebill. The service is billed is missing Anesthesia Time Units
192 Missing CPT MISSING CPT CODE
193 Mult Proc MULTIPLE PROCEDURES BILLED WITHOUT MODIFIER
194 Mult Surg Multiple Surgery Reduction
195 Non Par Timely NON PAR PROVIDER TIMELY FILING
196 Not Quest Lab NON QUEST LAB PROVIDER
197 Convenience Patient convenience items are not covered under this benefit plan.
198 Rebill REBILL USING MEDICARE G CODES
199 Facility Payment Reimbursement for service is included in the payment made to the facility.
200 HH Claims Resubmit HH Claims on UB Home Health Agencies are required to submit claims on form CMS-1450, the UB-04. Please resubmit claim on appropriate form.
201 Self Admin Self administered drugs are not covered services under this plan.
202 SNF Exhaustted SKILLED NURSING DAYS EXHAUSTED
203 3 Units Blood The first three units of blood are not covered services under this plan.
204 UR Denied Days UR DENIED HOSPITAL DAYS
205 After Death This date of service is after the date of the patient's death.
206 DRG Invalid The DRG submitted on this claim is not valid for the fiscal year billed. Please resubmit claim with a corrected DRG.
207 ER in 72 hrs Emergency Room visits within 72 hours of an inpatient admission cannot be billed and reimbursed separately.
208 Inc in case This service is included in the Case Rate
209 Inc in CMG Reimbursement for this service in included in the CMG
210 Denied Days These hospital days have been denied by our Health Services Department.
211 Spec Dx Payment for this benefit requires specific diagnosis codes per CMS guidelines.
212 Dup This is a duplicate of a claim that was previously adjudicated.
213 Location Service Facility Location Required.
214 Adjust for Cap This claim is an adjustment for services capitated incorrectly according to your contract.
215 BT 710 Payment for claims submitted using bill type 710 will be $0.00 as this is a non-payment claim.
216 Excl Excluded Service Not Covered
217 NotMember2 Denied: No coverage effective at time of service.
220 Qual Physician Quality Reporting Indicator codes are for reporting purposes only and are not eligible for reimbursement.

221 Item Bill Itemized Bill Request: Itemized bills can be faxed to 1(877)-788-2764
223 ASC INCLUDED IN ASC RATE
224 CG CLAIMSGUARD ADJUSTMENT
225 Inc Included in other procedure.
226 Dup Duplicate Line on Same Claim
227 IncPay Service included in payment for surgical procedure.
228 NoCov Denied: No coverage effective at time of service.
230 PHP The required Bravo Personal Health Profile Form was not received or was incomplete. Please submit completed/corrected form.
231 Cap This is a capitated service
232 Therapy Please resubmit with the appropriate code to reflect the correct amount of therapies billed.
233 Insuf Svc Insufficient services on a day of a partial hospitalization.
301 Admit Hour Please resubmit with a valid admit hour.
302 Bill Type Please resubmit claim with appropriate bill type for inpatient procedure.
303 Multiple NPI Our data indicates this claim has multiple Rendering NPI Numbers. Please submit a corrected claim.
304 Inpt Proc Inpatient Procedure
305 Dialysis Claim lacking CBSA Dialysis claims require a CBSA. Please resubmit.
306 Invalid CPT for benefit This CPT code is not valid for this benefit. Resubmit claim with Medicare approved code for benefit.
307 RAP received RAP received. Payment for this episode has been paid.
308 Mbr not approved for in home podiatry. This member is not approved to receive podiatry services in the home. No fee-for-service payment will be made.
309 Inpt claim with same DOS as ER Inpatient claim/auth exists for same DOS as ER claim.
310 Code not recognized by OPPS Codes not recognized by OPPS when submitted on an outpatient hospital Part B bill type (12x, 13x, 14x). Not paid under OPPS.
311 Operating Physician required Operating Physician Information Required.
312 HomeHealth claim for prev episode not submitted Payment Denied. Previous Episode Final Not Submitted.
313 HIPPS/RUGS charges not equal to $0 HIPPS/RUGS billed charges should equal zero.
314 Invalid RAP Invalid/Incorrect RAP submitted for this episode. Valid/Corrected RAP must be submitted before FINAL can pay
315 Submit TOB 328 to cancel paid final claim Unable to cancel RAP because FINAL has PAID. TOB 328 must be submitted in order to cancel a paid FINAL.
316 Rendering provider name required Individual provider name needed. Please resubmit with corrected information.
317 Max rental period exceeded Based on Medicare pricing guidelines, the rental units have exceeded the maximum rental period of 13 months. The member now owns the equipment.
318 Attending physician NPI missing Attending Physician with identifying NPI is a required field on Home Health claims. Please resubmit with corrected information.
319 TOB 327 for denied claim Unable to process 327 bill type for a previously DENIED claim.
320 Date required for line item BILL WITH SPECIFIC DATES
321 Resubmitted Claim Duplicate of claim in review
322 Invalid date INVALID DATE OF SERVICE
323 Cosurgeon not allowed Co-surgeon not allowed
324 Episode canceled Bill type 328 received; episode and associated claims cancelled.
325 Pay to provider does not match Bravo affiliations The name in box 33 does not match what Bravo has on file. Please resubmit this claim.
326 Group TIN submitted The Tax ID submitted is associated to a Group. Please resubmit this claim with your individual Tax ID.
327 Signature does not match what is on file The signature on the claim does not match the signature Bravo has on file. Please resubmit this claim.
328 Submit to Part D Please submit to your Pharmacy Program.
329 Noncovered OON dental Dental Services Performed by Non-Par Specialists are Not Covered
330 E code cannot be principal DX E code cannot be used as principal diagnosis.
331 Payment for non Medicare covered services Additional payment for services not provided by Medicare.
332 Place of service not covered under OPPS Code indicates a site of service not included in OPPS.
333 Service unit out of range for procedure Service unit out of range for procedure.
334 invalid age Invalid age for service provided
335 invalid sex Invalid sex
336 Mental Health dx required Partial hospitalization service for non-mental health diagnosis.
337 Only therapy services provided Only activity therapy and/or occupational therapy services provided.
338 Invalid units for bilateral procedure Terminated bilateral procedure or terminated procedure with units greater than one.
339 Implanted dev code & administered sub do not match Inconsistency between the implanted device or the administered substance and the implantation or associated procedure.
340 Inpt procedures not payable Inpatient separate procedures not paid.
341 Multiple codes for same service Multiple codes for same service.
342 Invalid dx for clinical trial Clinical trial requires diagnosis codes V707 as other than primary diagnosis.
343 Modifier CA billed for multiple procedures Use of modifier CA with more than one procedure not allowed.
344 Invalid service for OT code This OT code only billed on partial hospitalization claims.
345 Invalid service for AT code AT service not payable outside the partial hospitalization program.
346 Service not FDA approved Service provided prior to FDA approval.
347 Service not approved by NCD Service provided prior to date of National Coverage Determination (NCD) approval.
348 Service provided outside approval period Service provided outside approval period.
349 Invalid pt status for CA modifier CA modifier requires patient status code 20.
350 Billed amt cannot exceed $1.01) Charge exceeds token charge ($1.01).
351 Invalid condition code for bill type Partial hospitalization condition code 41 not approved for type of bill.
352 Claim does not meet obs criteria Observation does not meet minimum hours, qualifying diagnoses, and/or 'T' procedure conditions.
353 Invalid bill type for observation Observation G codes only allowed with bill type 13x.
354 Non-reportable for site of service Non-reportable for site of service.
355 E/M conditions not met for observation criteria E/M conditions not met and line item date of obs code G0244 is not 12/31 or 01/01.
357 Incorrect billing of modifier FB or FC. Incorrect billing of modifier FB or FC.
358 Invalid code for place of service Mental health code not approved for partial hospitalization.
359 Invalid code for place of service Mental health service not payable outside the partial hospitalization program.
360 Service provided outside approval
period Service provided on or after effective date of NCD non-coverage.
361 Not a covered Medicaid benefit The patient does not have benefits for this service under this Medicaid Plan.
365 Medical documentation required Please resubmit claim with the appropriate medical documentation.
369 No OON Medicaid coverage for this benefit The benefit for this service is not covered out of network service for this Medicaid Plan.
370 Code billed in excess of once per 90 period Report only once every 90 days per CPT.
371 TOB 328 received with no matching claim in history
328 Received. No matching claim found for cancellation request. Cancellation request must match claim on file.
372 Invalid admin code Resubmit with appropriate administration code.
373 Submit to ASH This claim is the responsibility of Bravo Health's Delegated Chiropractor Vendor. This claim has been forwarded on your behalf.
374 Service paid previously to another provider. Payment Denied. Information on file indicates services are provided by another provider.
375 Incorrect Admission Source Please submit with correct Admission Source.
376 CMS Noncovered ICD9/CPT Mods billed This claim has been denied for payment since it contains one or more of the ICD-9 codes or CPT modifiers CMS
has identified as not eligible for payment.
377 Resubmit proc code Please resubmit with a specific procedure code.
378 Resubmit claim form Please resubmit claim on the correct claim form type.
379 Invalid ASC Code The service billed is not an approved ASC procedure.
380 Invalid Date Span The "from" and "to" dates must be different.
381 IB fax number Please fax bills to 1(877)-788-2764.
382 Invalid DRG No DRG found for the codes used.
383 Invalid secondary diagnosis Invalid secondary diagnosis code.
384 Invalid discharge date Invalid discharge date.
385 Global day overlap Not reimbursable. Services rendered are within the global day billing period.
386 HHDisenroll This member disenrolled during the home health episode. A claim for a partial episode payment must be submitted in order for charges to be adjudicated properly.
387 BPHP previously paid The Bravo Personal Health Profile has already been reimbursed for this member for the current calendar year.
388 Claim cancelled Bill Type 118 received and claim was cancelled.
389 Leave of Absence and Level of Care mismatch Leave of Absence and Level of Care cannot be billed with same Date of Service 390 Service cannot be billed on same date as LOC Code cannot be billed without Level of Care on same Date of Service
393 Invalid Discharge Status Invalid Discharge Status
998 Negative Check This amount has been credited to a prior adjustment.
999 Reversed Claim This claim represents an adjustment to claim ___ processed on mm/dd/yyyy.
1001 MUE Edit The units of service billed exceeds our acceptable maximum units (MUE-medically unlikely edits)
1002 Incorrect TOB ESRD Hospitals with a Medicare certified renal dialysis facility should have outpatient ESRD related services billed by the hospital-based renal dialysis facility on bill type 72x.
1003 EOP Required Please resubmit with a copy of the Explanation of Payment from the primary carrier.
1004 MSP This claim has been paid in full by the primary carrier.
1005 HH Treatment Code not billed 18 digit Alpha/Numeric MCR Treatment Authorization code not present on claim. Please resubmit claim.
1006 Resubmit with RUGs code Resubmit claim with valid RUGS code.
1007 Multiple rev code 0023 Multiple instances of revenue code 0023 billed on a single claim.
1008 Missing or invalid Admit Date Admit date is missing or invalid.
1009 Negative charges not allowed Negative charges are not permitted on a claim service line
1011 Team surgeon not allowed Team surgeon not allowed.
1012 HCPCS required Surgical procedure requires HCPCS.
1013 Benefit not separately reimbursed This benefit is not separately reimbursed.
1014 Member not within age range for benefit The benefit for the service rendered is not within the age range for the member.
1015 Only one anesthesia code per surgical session Only one primary anesthesia should be reported for a surgical session.
1017 Service Not Covered Service Not Covered
1018 Missing EMS report Need ambulance EMS report.
1019 Invalid anesthesia code Need valid anesthesia code.
1020 Admit date under previous contract Service dates not matching proper 60 Day Episodic span from Start of Care, Admit date under previous contract. Services reimbursed under previous contract due to Admit date
1021 Missing form A single case agreement referral form must accompany each claim submitted.
1023 Missing OP report Resubmit with OP report.
1024 Invalid discharge hour Invalid Discharge Hour
1025 ERAP payment Payment denied. Information on file indicates payment was made to another provider.
1026 Units billed exceeds auth The number of units billed exceeds the number of units authorized.
1027 Refund received due to billing error Refund received due to billing error
1028 Refund Received resubmit to LifeSynch Refund Received resubmit to LifeSynch
1029 Raytel and service location not in
box 33 Please resubmit using Raytel's Tax ID and the service location along with Raytel's name in box #33.
1030 Invalid primary or admitting dx code Invalid primary or admitting diagnosis code – please resubmit with appropriate Dx code
1031 Primary dx paired with secondary dx Primary Dx is not acceptable unless paired with appropriate secondary Dx
1032 Billable visit not appropriate level First billable visit not skilled at appropriate level
1033 Supply revcodes not on claim Provider billed HHPPS FINAL indicating Medical/Surgical supplies. Supply Revenue Code 027x and/or 062x not present on claim. Please resubmit corrected claim
1034 Revcode requires HCPCS, DOS and amount Revenue code 0274 requires an HCPCS code, the date of service units and a charge amount
1035 Cancellation submitted prior to up/downcoding

In order to bill new HHPPS HHRG code, a 328 cancellation needs to be submitted to cancel current HHPPS HHRG code on file before new up coded or down coded HHRG/HHPPS code can be billed.
1036 Unable to adjust RAPS Unable to adjust RAPS. RAPS must be canceled and re-billed in order to correct information on file.
1037 No claim in std benefit period No claim in std benefit period before use of reserve days
1038 Other agency responsible for payment Other agency may be responsible for payment
1040 Timely filing This claim was submitted after the filing deadline.
1046 Invalid specialty for svc Provider specialty invalid for service rendered.
1049 Resubmit to TX Mcaid , MCO not responsible for InP Submit Inpatient Acute Care Claims to TMHP.
1050 MOOP This member has reached the max out-of-pocket amount for 2011. If cost-share in excess of what is shown on the EOP has been collected, please reimburse the difference to the member.
1051 Medicare not reimbursing procedure code This procedure code is not reimbursable through Medicare. Please resubmit with a valid code.
1052 Not medically necessary Medical necessity not established for services rendered.
1053 Attendant Care Payment Based upon Participation Level, Attendant Care Enhanced Payment is included in claim payment.
1054 Resubmit with CMS rate sheet Resubmit claim with a CMS rate sheet.
1055 Cancellation recd, claim cancelled. The cancellation claim was received; claim was cancelled.
1056 327 recd; adjustment adjudicated TOB 327 received; adjustment adjudicated.
1057 Billed service to DMERC Service can only be billed to the DMERC.
1058 Denied for wrong surgery Claim detail denied due to wrong surgery performed on client
1059 Pending Rate Hearing State has not issued procedure code pricing. Claims will be reprocessed when State issues rates.
1060 ICRS DRG audit Claim reversal is due to ICRS DRG audit.
1061 Resubmit with a DRG Please resubmit your claim with a DRG.
1062 Code is Included Services included per CPT Guidelines.
1064 CODE CHANGED PROCEDURE CODE CHANGED PER REVIEW
1065 INCLUDED IN PRIMARY PROCEDURE INCLUDED IN PRIMARY PROCEDURE
1066 PROCEDURE INAPPROPRIATELY CODED PROCEDURE INAPPROPRIATELY CODED
1067 NOT A COVERED SERVICE NOT A COVERED SERVICE
1068 NOT A COVERED SERVICE FOR PROVIDER SPECIALTY NOT A COVERED SERVICE FOR PROVIDER SPECIALTY

Surgical Treatment of Obstructive Sleep Apnea (OSA) and Upper Airway Resistance Syndrome (UARS) 

Uvulopalatopharyngoplasty (UPPP) may be considered medically necessary for the treatment of clinically significant obstructive sleep apnea syndrome (OSA) in appropriately selected adult patients who have not responded to or do not tolerate nasal continuous positive airway pressure (CPAP). Clinically significant OSA in this case is defined as those patients who have:

• Apnea/hypopnea index (AHI) or respiratory disturbance index (RDI) greater than or equal to 15 events per hour, or

• AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.

Hyoid suspension, surgical modification of the tongue, and/or maxillofacial surgery, including mandibular-maxillary advancement (MMA), may be considered medically necessary in appropriately selected adult patients with clinically significant OSA and objective documentation of hypopharyngeal obstruction who have not responded to or do not tolerate CPAP. Clinically significant OSA in this case is defined as those patients who have:

• AHI or RDI greater than or equal to 15 events per hour, or

• AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease, or history of stroke.

CPAP (E0601) may be considered medically necessary for:

• Patients in whom polysomnography has documented sleep disordered breathing, with an RDI (respiratory disturbance index) of greater than fifteen, or

• Patients in whom polysomnography has documented sleep disordered breathing, with an RDI (respiratory disturbance index) of greater than five and any of the following associated symptoms:

Excessive daytime sleepiness

Impaired cognition

Mood disorders

Insomnia

Documented hypertension

Ischemic heart disease

History of stroke

• Patients who do not have sleep apnea, but who have restrictive lung disease and documented desaturation at night, requiring nocturnal ventilation

• Under individual consideration APAP may be allowed in selective patients in lieu of repeated CPAP titration when the attending sleep center physician indicates that, in his/her opinion the member would be a suitable candidate for this approach based upon member’s knowledge, behavior, and health status.

Diagnosis of OSA with abnormal Apnea Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI)

1. AHI or RDI =15; Or

2. AHI or RDI between 5 and 14 (requires one)

a. Excessive daytime sleepiness (ESS)

b. Impaired cognition

c. Insomnia

d. Mood disorder

e. Hypertension;

MSLT is considered not medically necessary in the following four situations:

• When performed for routine diagnosis of obstructive sleep apnea; OR

• For routine follow-up after treatment of sleep related disorders; OR

• For evaluation of sleepiness in medical or neurological disorders (other than narcolepsy or idiopathic hypersomnia), including, but not limited to, insomnia,
circadian rhythm disorders, and Shift Work Sleep Disorder (SWSD); OR

• Portable MSLT performed in the home setting.


ICD-10 DiagnosisCode ICD-10 Diagnosis Description

F40.241 Acrophobia

F43.0 Acute stress reaction

F43.22 Adjustment disorder with anxiety

F43.21 Adjustment disorder with depressed mood

F43.24 Adjustment disorder with disturbance of conduct

F43.23 Adjustment disorder with mixed anxiety and depressed mood

F43.25 Adjustment disorder with mixed disturbance of emotions and conduct

F43.29 Adjustment disorder with other symptoms

F43.20 Adjustment disorder, unspecified

F51.01 Primary insomnia

F51.02 Adjustment insomnia

F51.03 Paradoxical insomnia

F51.04 Psychophysiologic insomnia

F51.05 Insomnia due to other mental disorder

F51.09 Other insomnia not due to a substance of known physiological condition

F98.5 Adult onset fluency disorder

F40.01 Agoraphobia with panic disorder

F40.02 Agoraphobia without panic disorder

F40.00 Agoraphobia, unspecified

F10.180 Alcohol abuse with alcohol-induced anxiety disorder

F10.14 Alcohol abuse with alcohol-induced mood disorder

F10.150 Alcohol abuse with alcohol-induced psychotic disorder with delusions

F10.151 Alcohol abuse with alcohol-induced psychotic disorder with hallucinations

F10.159 Alcohol abuse with alcohol-induced psychotic disorder, unspecified

F10.181 Alcohol abuse with alcohol-induced sexual dysfunction

F10.182 Alcohol abuse with alcohol-induced sleep disorder

F10.121 Alcohol abuse with intoxication delirium

F10.188 Alcohol abuse with other alcohol-induced disorder

F10.19 Alcohol abuse with unspecified alcohol-induced disorder

F10.280 Alcohol dependence with alcohol-induced anxiety disorder

F10.24 Alcohol dependence with alcohol-induced mood disorder

F10.26 Alcohol dependence with alcohol-induced persisting amnestic disorder

F10.27 Alcohol dependence with alcohol-induced persisting dementia

F10.250 Alcohol dependence with alcohol-induced psychotic disorder with delusions

F10.251 Alcohol dependence with alcohol-induced psychotic disorder with hallucinations

F10.259 Alcohol dependence with alcohol-induced psychotic disorder, unspecified

F10.281 Alcohol dependence with alcohol-induced sexual dysfunction

F10.282 Alcohol dependence with alcohol-induced sleep disorder

F10.221 Alcohol dependence with intoxication delirium

F10.288 Alcohol dependence with other alcohol-induced disorder

F10.29 Alcohol dependence with unspecified alcohol-induced disorder

F18.951 Inhalant use, unspecified with inhalant-induced psychotic disorder with hallucinations

F18.959 Inhalant use, unspecified with inhalant-induced psychotic disorder, unspecified

F18.921 Inhalant use, unspecified with intoxication with delirium

F51.05 Insomnia due to other mental disorder

F51.12 Insufficient sleep syndrome

F63.81 Intermittent explosive disorder

F63.2 Kleptomania

F33.2 Major depressive disorder, recurrent severe without psychotic features

F33.42 Major depressive disorder, recurrent, in full remission

F33.41 Major depressive disorder, recurrent, in partial remission

F33.40 Major depressive disorder, recurrent, in remission, unspecified

F33.0 Major depressive disorder, recurrent, mild

F33.1 Major depressive disorder, recurrent, moderate

F33.3 Major depressive disorder, recurrent, severe with psychotic symptoms

F33.9 Major depressive disorder, recurrent, unspecified

F32.5 Major depressive disorder, single episode, in full remission

F32.4 Major depressive disorder, single episode, in partial remission

F32.0 Major depressive disorder, single episode, mild

F32.1 Major depressive disorder, single episode, moderate

F32.3 Major depressive disorder, single episode, severe with psychotic features

F32.2 Major depressive disorder, single episode, severe without psychotic features

F32.9 Major depressive disorder, single episode, unspecified

F52.21 Male erectile disorder

F52.32 Male orgasmic disorder

F30.4 Manic episode in full remission

F30.3 Manic episode in partial remission

F30.11 Manic episode without psychotic symptoms, mild

F30.12 Manic episode without psychotic symptoms, moderate

F30.10 Manic episode without psychotic symptoms, unspecified

F30.2 Manic episode, severe with psychotic symptoms

F30.13 Manic episode, severe, without psychotic symptoms

F30.9 Manic episode, unspecified

F42.2 Mixed obsessional thoughts and acts

F06.31 Mood disorder due to known physiological condition with depressive features

F06.32 Mood disorder due to known physiological condition with major depressive-like episode

F06.33 Mood disorder due to known physiological condition with manic features

F06.34 Mood disorder due to known physiological condition with mixed features

F06.30 Mood disorder due to known physiological condition, unspecified

F91.8 Other conduct disorders

F32.8 Other depressive episodes

F80.89 Other developmental disorders of speech and language

F88 Other disorders of psychological development

F50.8 Other eating disorders

F98.29 Other feeding disorders of infancy and early childhood

F64.8 Other gender identity disorders

F45.29 Other hypochondriacal disorders

F63.8 Other impulse disorders

F51.09 Other insomnia not due to a substance or known physiological condition

F42.8 Other obsessive compulsive disorder

F30.8 Other manic episodes

F41.3 Other mixed anxiety disorders

F40.228 Other natural environment type phobia

F65.89 Other paraphilias

F34.8 Other persistent mood ºaffective» disorders

F07.89 Other personality and behavioral disorders due to known physiological condition

F84.8 Other pervasive developmental disorders

F40.8 Other phobic anxiety disorders

F19.121 Other psychoactive substance abuse with intoxication delirium

F19.122 Other psychoactive substance abuse with intoxication with perceptual disturbances

F19.188 Other psychoactive substance abuse with other psychoactive substance-induced disorder

F19.180 Other psychoactive substance abuse with psychoactive substance-induced anxiety disorder

F19.14 Other psychoactive substance abuse with psychoactive substance-induced mood disorder

F19.16 Other psychoactive substance abuse with psychoactive substance-induced persisting amnestic disorder

F19.17 Other psychoactive substance abuse with psychoactive substance-induced persisting dementia

F19.150 Other psychoactive substance abuse with psychoactive substance-induced psychotic disorder with delus

F19.151 Other psychoactive substance abuse with psychoactive substance-induced psychotic disorder with hallu

F19.159 Other psychoactive substance abuse with psychoactive substance-induced psychotic disorder, unspecifi

F19.181 Other psychoactive substance abuse with psychoactive substance-induced sexual dysfunction

F19.182 Other psychoactive substance abuse with psychoactive substance-induced sleep disorder

F15.159 Other stimulant abuse with stimulant-induced psychotic disorder, unspecified

F15.181 Other stimulant abuse with stimulant-induced sexual dysfunction

F15.182 Other stimulant abuse with stimulant-induced sleep disorder

F15.19 Other stimulant abuse with unspecified stimulant-induced disorder

F15.221 Other stimulant dependence with intoxication delirium

F15.222 Other stimulant dependence with intoxication with perceptual disturbance

F15.288 Other stimulant dependence with other stimulant-induced disorder

F15.280 Other stimulant dependence with stimulant-induced anxiety disorder

F15.24 Other stimulant dependence with stimulant-induced mood disorder

F15.250 Other stimulant dependence with stimulant-induced psychotic disorder with delusions

F15.251 Other stimulant dependence with stimulant-induced psychotic disorder with hallucinations

F15.259 Other stimulant dependence with stimulant-induced psychotic disorder, unspecified

F15.281 Other stimulant dependence with stimulant-induced sexual dysfunction

F15.282 Other stimulant dependence with stimulant-induced sleep disorder

F15.29 Other stimulant dependence with unspecified stimulant-induced disorder

F15.921 Other stimulant use, unspecified with intoxication delirium

F15.922 Other stimulant use, unspecified with intoxication with perceptual disturbance

F15.988 Other stimulant use, unspecified with other stimulant-induced disorder

F15.980 Other stimulant use, unspecified with stimulant-induced anxiety disorder

F15.94 Other stimulant use, unspecified with stimulant-induced mood disorder

F15.950 Other stimulant use, unspecified with stimulant-induced psychotic disorder with delusions

F15.951 Other stimulant use, unspecified with stimulant-induced psychotic disorder with hallucinations

F15.959 Other stimulant use, unspecified with stimulant-induced psychotic disorder, unspecified

F15.981 Other stimulant use, unspecified with stimulant-induced sexual dysfunction

F15.982 Other stimulant use, unspecified with stimulant-induced sleep disorder

F95.8 Other tic disorders

F45.41 Pain disorder exclusively related to psychological factors

F45.42 Pain disorder with related psychological factors

F41.0 Panic disorder ºepisodic paroxysmal anxiety» without agoraphobia

F51.03 Paradoxical insomnia

F60.0 Paranoid personality disorder

F20.0 Paranoid schizophrenia

F65.9 Paraphilia, unspecified

F63.0 Pathological gambling

F65.4 Pedophilia

F34.9 Persistent mood ºaffective» disorder, unspecified

F07.0 Personality change due to known physiological condition

F60.9 Personality disorder, unspecified

F84.9 Pervasive developmental disorder, unspecified

F40.9 Phobic anxiety disorder, unspecified

F98.3 Pica of infancy and childhood

F43.11 Post-traumatic stress disorder, acute

F43.12 Post-traumatic stress disorder, chronic

F43.10 Post-traumatic stress disorder, unspecified

F07.81 Postconcussional syndrome

F52.4 Premature ejaculation

F32.81 Premenstrual dysphonic disorder

F51.11 Primary hypersomnia

F51.01 Primary insomnia

F48.2 Pseudobulbar affect

F06.2 Psychotic disorder with delusions due to known physiological condition

F06.0 Psychotic disorder with hallucinations due to known physiological condition

F53 Puerperal psychosis

F63.1 Pyromania

F43.9 Reaction to severe stress, unspecified

F94.1 Reactive attachment disorder of childhood

F20.5 Residual schizophrenia

F98.21 Rumination disorder of infancy

F65.50 Sadomasochism, unspecified

F25.0 Schizoaffective disorder, bipolar type

F25.1 Schizoaffective disorder, depressive type

F25.9 Schizoaffective disorder, unspecified

F60.1 Schizoid personality disorder

F20.9 Schizophrenia, unspecified

F20.81 Schizophreniform disorder

F21 Schizotypal disorder

F13.121 Sedative, hypnotic or anxiolytic abuse with intoxication delirium

F13.188 Sedative, hypnotic or anxiolytic abuse with other sedative, hypnotic or anxiolyticinduced disorder

F13.180 Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic or anxiolyticinduced anxiety disorde

F13.14 Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic or anxiolyticinduced mood disorder

F13.151 Sedative, hypnotic or anxiolytic abuse with sedative, hypnotic or anxiolyticinduced psychotic disor

CONTENT OF SERVICE

Content of service refers to specific services and/or procedures that are considered to be an integral part of previous or concomitant services or procedures to the extent that separate reimbursement is not recognized. Not all content of service issues are identified in the policies and procedures. BCBSKS staff may identify and classify specific coding and nomenclature issues as they arise. Examples of services that can be considered content of service are:


• Examination of the patient.
• History of illness and/or review of patient records.
• Evaluation of tests or studies (i.e., radiology or pathology).
• Any entries into the patient's records.
• Evaluation of reports of tests or studies earlier referred to another physician for an opinion and subsequently returned for use in the office visit being conducted.
• Advice or information provided during or in association with the visit.
• Case management.
• The prescription of any medicinals, home supplies or equipment during or as a result of the visit.
• The application or the re-application of any standard dressing during a visit.
• Therapeutic, prophylactic, or diagnostic injection administration provided on the same day as an office visit, home visit, or nursing home visit.
• Additional charges beyond the regular charge for services requested after office hours, holidays or in an emergency situation.
• Items of office overhead such as malpractice insurance, telephones, personnel, supplies, cleaning, disinfectants, photographs, equipment sterilization, etc.
• Telephone calls and web-based correspondence are content of service when billed with another service on the same day. Such services are not covered if billed separately and the only service rendered on that day.
• Anesthesia provided in an office setting is considered content of service and not reimbursed separately. The provider cannot require the patient to sign a waiver or bill the patient for this service.
Some content of service issues related to specific services and/or procedures are identified throughout the policy and procedure documents.

NOTE: All-inclusive procedure codes must be used when available.


PATIENT-DEMANDED SERVICES

A. If a provider prescribes services that he knows will not be covered because of a lack of medical necessity or the procedure being considered is experimental or investigational and he alerts the patient of the non-coverage, yet the patient still insists on the services, the provider may bill the patient if the request is properly documented and signed by the member. (See Section X. WAIVER FORM)

B. Providers must obtain a waiver on any mental health consultation, testing, or evaluation that is performed by agreement or at the direction of a court for the purpose of assessing custody, visitation, parental rights, or to determine damages of any kind of personal injury action and if the service is not otherwise medically necessary. To enable the provider to bill a patient for such services, BCBSKS will deny benefits for such services as lacking medical necessity.

BACKGROUND AND INTRODUCTION TO AMBULATORY PATIENT GROUPS (APGS)

PURPOSE:

The purpose of this document is to provide Medicaid policy and billing guidance to Article 28 providers billing under the Ambulatory Patient Groups Payment methodology to the extent this methodology is applicable to hospital-based outpatient, ambulatory surgery, and emergency departments, and to free-standing diagnostic and treatment centers and free-standing ambulatory surgery centers.



1.4 SCOPE OF SERVICES:

The APG payment methodology is applicable to outpatient, ambulatory surgery and emergency department services provided by general hospitals and to ambulatory care services provided by diagnostic and treatment centers and free-standing ambulatory surgery centers.

The APG payment methodology is not applicable to:
** services provided outside of a facility’s licensure under Article 28 of the Public Health Law (e.g. APGs are not currently applicable to services certified under the Mental Hygiene Law)
** capitated payments made on behalf of Medicaid managed care or Family Health Plus enrollees;
** payment for Ordered Ambulatory services
** payment for physicians’ services in hospital settings billed using the Physician Fee Schedule;
** payment to Federally Qualified Health Centers (FQHCs), except when the FQHC has voluntarily agreed to participate in the APG reimbursement system, or;
** payment for long term care, home care, personal care.



BLENDING OF APG PAYMENT:

Both hospital-based ambulatory surgery and emergency department services received 100% APG payment with the implementation of the APG reimbursement methodology. However, APG reimbursement for hospital  outpatient departments, diagnostic and treatment centers and free-standing ambulatory surgery centers is phased-in as required by law. In the initial phase of blending, reimbursement for each individual visit is based on 25% of the full amount that the APG methodology would calculate for the visit (based on coded procedures and diagnoses) and 75% of a provider-specific existing payment for the blend amount. The existing payment used for blending purposes is based on a provider’s average per visit reimbursement for services moving to APGs for calendar year 2007.

The APG portion of the blend increases on December 1, 2009, January 1, 2011,and January 1, 2012 according to the following schedule:


Hospital Outpatient Department December 1, 2008 Starting Dec 1, 2008, 25% of payment will be based on APGs. The percentage will increase to 50% on December 1, 2009; to 75% on Jan 1, 2011; and to 100% on Jan 1, 2012.

Hospital Emergency Room January 1, 2009 100% of payment will be based on APGs starting Jan 1, 2009.

Hospital-Based Ambulatory Surgery December 1, 2008 100% of payment will be based on APGs starting Dec 1, 2008.

Free-standing Diagnostic and Treatment Center September 1, 2009 Starting on September 1, 2009, 25% of payment will be based on APGs. The percentage will increase to 50% on December 1, 2009; to 75% on Jan 1, 2011; and to 100% on Jan 1, 2012.

Free-standing Ambulatory Surgery September 1, 2009 Starting on September 1, 2009, 25% of payment will be based on APGs. The percentage will increase to 50% on December 1, 2009; to 75% on Jan 1, 2011; and to 100% on Jan 1, 2012.

When APGs are implemented in facilities licensed under the Mental Hygiene Law, free standing mental hygiene providers (not hospital based providers) will have an APG phase-in period that is distinct from the phase-in schedule for D&TC clinic services listed above. The variable blend percentages will be linked to the APG rate code.


APG GROUPING LOGIC AND USE OF MODIFIERS

2.1 MORE ON THE APG PAYMENT METHODOLOGY:

As previously discussed, APGs are a patient classification system designed to pay providers based on the amount and type of resources used during a patient encounter. Patients in a given APG have similar clinical characteristics as well as similar resource use and cost. APGs require facilities to report all services provided during the patient encounter. Provider payments are directly related to the actual services provided based on patient diagnosis and the CPT/HCPCS codes reported on the Medicaid claim. Medical services requiring a higher level of professional and ancillary care are paid a higher rate than those of a lower intensity.

APG processing uses software that examines the procedure codes and any associated modifiers reported in each of a claim’s service lines and assigns each line an APG code, along with other relevant values (e.g. APG weights, packaging flags, discounting percentages, etc.). Each APG code carries a “weight” based on the group’s average cost, from which appropriate payment levels are established. The APG “weight” can be multiplied by a percentage to reduce or increase the weight, depending on the APG grouper’s evaluation of the service line, resulting in the service line’s final “weight.” For medical visits, the assignment of an APG is dependent on the ICD-9 Primary Diagnosis Code recorded on the claim.

There are a number of procedures (primarily pertaining to eyeglasses, mental hygiene services, rehabilitation therapies and hearing aids) which are assigned a procedure-based weight that is different from the APG weight. In the APG payment methodology, the procedure based weight overrides the APG weight. Additionally, if a procedure is assigned a procedure-based

weight it will pay even if it groups to a Never Pay APG. However, if the procedure groups to an “If Stand Alone Do Not Pay APG”, it will not pay if it is the only procedure on the claim or is accompanied by non-paying procedures. Discounting and consolidating logic will still occur where applicable. Some of the procedure-based weights also recognize units. For example, the physical therapy APG includes units based and non-units based procedures. The units based physical therapy procedures are assigned a procedure based weight that is different from the physical therapy APG weight. When coding a unit- based procedure, the number of units should also be reported on the claim. The procedure-based weight and the number of units are both used in the APG payment calculation for the units based procedure.

The “final weight” for a given visit is multiplied by a provider-associated base rate as part of the APG payment calculation. For hospital outpatient departments and diagnostic and treatment centers, the APG payment is “blended” with a historical weighted average payment of the provider’s pre-APG rates to arrive at the final payment amount. A single claim can be assigned one or more APG values, each of which carries its own “weight,” depending on the service line procedure codes, modifiers, and in some cases, diagnosis codes. The eMedNY system will use the EAPG Grouper/Pricer for processing institutional outpatient claims upon the effective dates of APG implementation as identified in section 1.5 of this document. Affected providers are required to use new rate codes on and after those effective dates. Use of the new rate codes results in payments for services based on the APG classification and payment rules. When a visit consists entirely of “no capital add-on APGs” or “no capital add on procedures” a capital add-on payment is not included in the final APG payment for the visit.

For a complete list of “no capital add-on APGs and procedures” please visit:
http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_no_capital_add.pdf.
http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_no_capital_procedures.pdf.

APG TYPES:

The EAPG Grouper/Pricer maps CPT and HCPCS procedure codes and ICD-9 diagnosis codes reported on a claim to APGs to define the ambulatory visit. Multiple APGs may be assigned to a visit. The four primary types of APGs are described below.

Significant Procedures: A procedure/service which constitutes the reason for the visit and dominates the time and resources expended during the visit. (Examples: excision of skin lesion, stress test, insertion of a central venous catheter, treating fractured limb)

Medical Visits: A visit during which a patient receives medical treatment but does not have a significant procedure performed. Evaluation and management codes are assigned to one of the medical visit APGs based on the primary diagnosis reported on the claim. (Examples: follow-up visit for patient with congestive heart failure, chronic obstructive pulmonary disease, hypertension)

Ancillary Tests and Procedures: A test or procedure ordered by the primary physician to assist in patient diagnosis or treatment. (Examples: immunizations, plain film x-rays, laboratory tests) Incidental Procedures: An integral part of a medical visit usually associated with professional services being given to the recipient. (Example: range of motion measurements)

 APG CLASSIFICATION LOGIC:

In the APG classification system, the patient is described by a list of APGs that corresponds to services provided to the patient. The significant procedure (rather than diagnosis) is the initial classification variable. Procedures that could be performed on an ambulatory basis are categorized as either significant procedures or ancillary services. Patients who undergo a significant procedure are assigned to a significant procedure APG on the basis of the CPT code that describes the precise significant procedure. Patients receiving medical treatment that does not involve a significant procedure are assigned to a medical APG based on the ICD-9 diagnosis code. In some instances, a patient may receive a significant procedure and a medical visit, in which case the visit would be assigned to a significant procedure APG. Under the default APG logic, the procedure would be paid at the line level and the medical visit payment would be included (packaged) in the payment for the significant procedure. A patient who neither received medical treatment nor underwent a significant procedure but had an ancillary service performed would be assigned an ancillary service APG. Patients with any significant procedures or therapies are assigned to one or more significant procedure APGs.

If there are no significant procedures present and there is a medical visit (Evaluation and Management CPT code reported), the patient is assigned to a medical visit APG. If there is neither a significant procedure nor a medical visit code, but there are ancillary test(s) or procedure(s) present, then the patient is assigned one or more ancillary APGs.

If there is no significant procedure CPT code, medical visit (evaluation and management CPT) code or ancillary code, the claim is considered an error.

The figure below provides an overview of the APG assignment logic as discussed above. Effective January 1, 2010, the EAPG grouper logic was revised to recognize a list of significant procedures with which medical visits will no longer package. Medical visits will no longer package with: the more significant ancillaries; dental procedures; physical, speech and occupational therapy; and counseling services. When certain significant procedures are performed on the same day as a medical visit, no packaging would occur and payments would be received by the provider for both the medical visit and significant procedure at the line level.

For a complete list of “significant procedures with which medical visits do not package,” please visit: http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_not_package.pdf.

2.4 GROUPING ELEMENTS OF THE APG PAYMENT SYSTEM:

The APG System uses three methods for grouping different services provided into a single payment unit: ancillary packaging, significant procedure consolidation or bundling; and multiple significant procedure and ancillary discounting.

Ancillary Packaging: Ancillary packaging refers to the inclusion of certain ancillary services in the APG payment rate for a significant procedure or a medical visit. When ancillaries are packaged, the costs of the ancillaries are included in the payment amount for the significant procedure or medical visit. Under APGs, ancillary lab and radiology services that are inexpensive or frequently provided are generally packaged into the payment for the significant procedure or medical visit. Other ancillary services, particularly those that are expensive or infrequently ordered such as MRIs are paid as separate ancillary APGs. Uniform packaging of ancillaries is used in the APG payment system. Ancillaries that are uniformly packaged include ancillaries that are performed for a wide range of different visits and which are relatively low cost in comparison with the average cost of the significant procedure and medical visit APGs.

To view the list of ancillaries which are always packaged, called the Uniform Packaged Ancillary List, please visit: www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_uniform_packaging.pdf.

Significant Procedure Consolidation: Significant procedure consolidation refers to the collapsing of multiple related significant procedure APGs into a single APG for the purpose of determining payment. The APG system relies on a significant procedure consolidation list developed on the basis of clinical judgment which identifies for each significant procedure APG, the other significant procedure APGs that are an integral part of the procedure and which can be performed with relatively little additional effort. The APG grouping logic consolidates related significant procedures. (Example: a Level I (primarily diagnostic) lower gastrointestinal endoscopy is consolidated into the Level II (primarily therapeutic) gastrointestinal endoscopy.) Unrelated significant procedures are not consolidated. Multiple unrelated significant procedures on the same date of service also are not consolidated in the APG classification system, but payment for additional unrelated significant procedures will be discounted.

Discounting: Discounting refers to a reduction in the standard payment rate for an APG. The APG payment system applies discounting when multiple unrelated significant procedures are performed or the same ancillary service is performed multiple times during a visit. Discounting recognizes that the marginal cost of providing a second procedure to a patient during a single visit is less than the cost of providing the procedure itself (e.g. the cost of doing two procedures at the same time is less than the cost of doing those same procedures at two different times).

In summary, the APG payment system is a visit-based prospective payment system with uniform ancillary packaging, significant procedure consolidation and multiple unrelated procedure discounting. Packaged ancillaries, incidental procedures, and lower cost drugs, biologicals and supplies are included in the payment amount for a significant procedure and medical visit. Exceptions are identified in Chapter 4. Effective January 1, 2010, medical visits will no longer package with higher intensity significant ancillary procedures (e.g., mammograms, MRIs, CAT scans, etc.) and will pay separately at the line level. Similarly, medical visits will no longer package with dental procedures; physical, speech and occupational therapy; and counseling services. When provided on the same date as an E&M visit, these services will pay at the line level.

Effective January 1, 2010, multiple same APG discounting (rather than consolidation) which currently applies to most dental services (e.g., APG 352 Periodontics) will be expanded to include occupational therapy ( APG 270), physical therapy (APG 271), speech therapy (APG 272) and most mental hygiene APGs (APG 323). For a complete list of APGs that will discount rather than consolidate when combined with other same or similar APGs, visit: http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_multiple_discounting.pdf Also, effective April 1, 2010, some APGs will discount at rates other than 50%.

For a complete list of “variable discounting’ APGs, please visit: http://www.nyhealth.gov/health_care/medicaid/rates/apg/docs/apg_discounting_percentage.pdf

2.5 USE OF MODIFIERS IN APGS:

Use of modifiers provides the means by which providers can indicate that a service or procedure has been altered by some specific circumstances while not changing the definition or the code for the service. The APG system recognizes the following seven billing modifiers.

CPT Modifier 25 (Distinct Service): This modifier is used when there is a significant, separately identifiable evaluation and management service by the same physician on the same date of service as a significant procedure.

The CPT Modifier 25 should be used on an E&M code only when the patient’s condition requires a significant, separately identifiable E&M service above and beyond the significant procedure performed on the same date of service. This modifier should not be used to report an E&M service that resulted in a decision to perform the significant procedure.

** Note: During the initial phase of APGs, Modifier 25 will be disabled and the use of Modifier 25 will have no effect on payment. The EAPG Grouper/Pricer will package the cost of the medical visit flagged with a Modifier 25 in the payment for the significant procedure APG (i.e., the initial APG weights were developed taking into account the disabling of Modifier 25 logic). In the future, Modifier 25 may be activated and the APG weights will be modified accordingly.

CPT Modifier 27 (Multiple E&M visit): This modifier is used when there are multiple outpatient E&M encounters on the same date of service. The CPT Modifier 27 should be used when a patient receives multiple E&M services performed by different physicians in multiple outpatient settings (e.g. hospital emergency department and clinic) on the same date of service. Modifier 27 should be appended to the second E&M code

when reporting more than one E&M service to indicate that the E&M service is a “separate and distinct” encounter provided the same day.

** Note: This Modifier should not be used for reporting of multiple E&M services performed by the same physician on the same date of service.

** Note: Normally, the second E&M will group into APG 449, “additional undifferentiated medical visit,” when Modifier 27 is used. However, during the initial phase of APGs, the weight for APG 449 will be set to zero, which will disable Modifier 27. The initial APG weights for medical visits were developed taking into account the disabling of Modifier 27 (i.e., payment for additional medical visits on the same date of service was packaged in the payment for the primary medical visit). In the future, Modifier 27 may be activated by re-weighting APG 449, with the other medical visit APG weights revised accordingly.

CPT Modifier 50 (Bilateral Procedure): CPT Modifier 50 should be used to report bilateral procedures that are performed during the same operative session.

** Note: This modifier should not be used to report surgical procedures that are identified in code terminology as “bilateral” or to report procedures identified in code terminology as “unilateral or bilateral.” When Modifier 50 is used, both procedures will be reimbursed, but the APG Grouper/Pricer calculates the payment at 100% rate for the first procedure and at 50% of the rate for the second procedure.

CPT Modifier 52 (Reduced Services): CPT Modifier 52 should be used when a service or procedure is partially reduced or eliminated at the physician’s discretion or when an initial bilateral procedure cannot be performed as such. As with CMS, NYSDOH does not allow the use of Modifier 52 when the endoscopic procedure is incomplete and there is a CPT or HCPCS/level II code to describe the actual service performed. If a code is available that fully describes the outpatient procedure performed, this code choice supersedes the reporting of a code describing the intended, albeit not performed, procedure. When Modifier 52 is used, the payment for the procedure will be discounted by 50%.

CPT Modifier 59 (Separate Procedures or Distinct Procedural Service): CPT Modifier 59 should be used to designate instances when distinct and separate multiple services with the same APG are provided to the patient on a single date of service (eg. separate encounters, different surgeries, different sites or organ systems, separate incisions). Modifier 59 may also be used to report those procedures/services considered a component of another procedure, when the service is carried out independently or considered unrelated or distinct from the other procedures/services provided at the same time. Normally when multiple procedures map to the same APG, the additional occurrences (beyond the first) will consolidate (i.e., no payment at the line level). However, when Modifier 59 is used, the additional same APG procedures will pay at 50% of the amount paid for the first procedure.

CPT Modifier 73 (Terminated Procedure): CPT Modifier 73 should be used when a surgical procedure is cancelled subsequent to the patient’s surgical preparation (but prior to the administration of anesthesia) due to extenuating circumstances or those that threaten the well-being of the patient. ** Note: Modifier 73 should not be used for elective cancellation of a procedure before administration of anesthesia. If Modifier 73 is reported and the procedure is an approved Ambulatory Surgery Center service, the payment will be discounted by 50%.

CPT Modifier UD (340B Drugs): Drugs obtained at the 340B price are identified by the UD modifier and it is not required that an NDC code be provided when submitting a claim. However, the actual acquisition cost of the drug should be listed on the claim. See the Medicaid Update (December 2007 and April 2008) articles entitled ‘National Drug Code Required on Medicaid Claims’ and ‘Coming Soon: Easy Identification of 340B Priced Claims’ for details at the following links:

http://nyhealth.gov/health_care/medicaid/program/update/2007/index.htm.
http://nyhealth.gov/health_care/medicaid/program/update/2008/index.htm.

3.2 SERVICES NOT PAID UNDER APGS:

Certain rate codes and claims remain outside of APGs and will continue to be paid under existing Medicaid payment mechanisms. These include:
** Services provided outside of a facility’s licensure under Article 28 of the Public Health Law (e.g. Mental Hygiene and OMRDD specialty services);
** Child rehabilitation;
** Payments made to Medicaid Obstetrical & Maternal Services (MOMS) Programs and Health Supportive Services providers;
** Payments for HIV Counseling/Testing;
** Payments for Tuberculosis/Directly Observed Therapy;
** Payments for Ordered Ambulatory Services;
** Monthly billings of Medicare co-pays and deductibles for dual eligible enrollees;
** Payments for Screening for Orthodontic Treatment;
** Payments for Comprehensive Medicaid Case Management/Targeted Case Management.

Rate codes which have not been subsumed by APG rate codes are referred to as carved out rate codes.

GENERAL

Q: Why is CMS testing CPC+?

CMS believes that through multi-payer payment reform and practice transformation, primary care practices will be able to build capabilities and care processes to deliver patient-centered, high quality care and lower the use of unnecessary services that drive total costs of care. Payment redesign by payers, both public and private, will offer the ability for greater cash flow and flexibility for primary care practices.

Q: When will CPC+ Round 2 start and how long will it last? Can my practice join later? CPC+ Round 2 is expected to begin on January 1, 2018. Eligible practices located in the CPC+ Round 2 regions can apply from May 18-July 13, 2017.

CPC+ Round 2 consists of five performance years, as identified in the table below. CMS expects practices to participate for the full five years of their respective round of the model and will not allow practices to join the model after CMS selects practices to participate in each round of the Model.

PERFORMANCE YEARS FOR CPC+ Round 2 Calendar Year Round 2 Performance Year

2018 1
2019 2
2020 3
2021 4
2022 5

Q: Are practices required to participate in CPC+ for the full five years?

CMS expects practices to participate in CPC+ for the full five years. However, participation in CPC+ is voluntary and practices may withdraw from the model without penalty during the fiveyear performance period. Practices are required to notify CMS at least 90 calendar days before the planned day of withdrawal. Departing the model before completion of a performance year (PY) puts a practice at risk for recoupment of unearned CPC+ payments.

Q: Where will CPC+ Round 2 be implemented?

CPC+ Round 2 will be implemented in four regions throughout the U.S.:

1. Louisiana: Statewide
2. Nebraska: Statewide
3. North Dakota: Statewide
4. New York: Greater Buffalo Region

The CPC+ Round 2 regions were selected based on payer alignment and market density to ensure that CPC+ practices have sufficient payer support to make fundamental changes in their primary care delivery.

Q: How is CMS defining the “Greater Buffalo Region (NY)”? 

Based on payer alignment and market density, CMS is defining the Greater Buffalo region with the following counties:

• New York: Greater Buffalo Region: Erie County, NY; Niagara County, NY Only practices located in these counties are eligible to apply and participate in CPC+ Round 2.

Q: Which payers have been selected to partner in CPC+ Round 2?

 CPC+ Round 2 payer partners in the four new CPC+ Round 2 regions:

1. Louisiana: Amerigroup Louisiana, Inc., AmeriHealth Caritas Louisiana, Inc., Blue Cross Blue Shield of Louisiana

2. Nebraska: Blue Cross Blue Shield of Nebraska

3. New York: Greater Buffalo Region: HealthNow New York Inc., Independent Health Association, Inc.

4. North Dakota: Blue Cross Blue Shield of North Dakota

Q: When and how can a practice apply to participate in CPC+ Round 2? 

Based on payer interest and proposed alignment, CMS announced four regions for CPC+ Round

2. Practices located in these regions are eligible to apply via an online portal (https://app1.innovation.cms.gov/cpcplus/) from May 18-July 13, 2017. For questions about the Model or the solicitation process, please email CPCPlusapply@telligen.com or call 1-877-309- 6114.

Q: How many practices will be accepted in CPC+ Round 2? 

CMS expects to accept up to 1,000 practices in CPC+ Round 2.

Q: Why will new practice applications only be accepted in CPC+ Round 2 regions? CPC+ is a voluntary test of primary care payment and delivery system changes at the practice level, and will be independently evaluated throughout the five years of each Round of the model. The evaluation compares practices in each region to similar practices in the same region. CMS is unable to add new practices in the existing regions without potentially compromising the evaluation. Therefore, new practices will only be able to apply for participation in CPC+ in new regions selected for CPC+ Round 2, not in the 14 Round 1 regions.

Q: What is expected of the control group practices in CPC+ Round 2?

CMS will randomly assign eligible practices to an intervention group and a control group. The control group practices will not be required to implement the CPC+ care delivery practice changes, will not receive CPC+ Payments, and will not participate in the CPC+ learning communities, and will sign a different CPC+ Participation Agreement with CMS than the   intervention group. Additionally, they will not be considered participants in an Advanced APM through participation in the CPC+ control group, but may otherwise be Advanced APM participants through their participation in other CMS models or programs. Control group practices may be compensated for their participation in CPC+ evaluation-related activities. CMS also expects to promulgate a rule that could allow for control group practices to potentially receive favorable scoring under the Improvement Activities category of the Merit-based Incentive Payment System (MIPS), subject to notice and comment rulemaking. More details for control group practices will be announced in late 2017.

Q: Are practices outside of the CPC+ Round 2 regions eligible to apply and participate in CPC+?

Practices will only be eligible to apply to Round 2 if they are located in one of the selected Round 2 regions. The purpose of the CPC+ multi-payer design is to ensure that primary care practices receive the adequate support from multiple payers to change care delivery for a practice’s entire panel of patients. The CPC+ regions were carefully selected to ensure adequate payer support for participating practices.

a Greater Kansas City Region is defined as Johnson County, KS; Wyandotte County, KS; Clay County, MO; Jackson County, MO; Platte County, MO

b North Hudson-Capital Region of New York is defined as Albany County, NY; Columbia County, NY; Dutchess County, NY; Greene County, NY; Montgomery County, NY; Orange County, NY; Rensselaer County, NY; Saratoga County, NY; Schenectady County, NY; Schoharie County, NY; Sullivan County, NY; Ulster County, NY; Warren County, NY Washington County, NY

c Ohio-Northern Kentucky Region is defined as all counties in Ohio; Boone County, KY; Campbell County, KY; Grant County, KY; Kenton County, KY

d Greater Philadelphia Region is defined as Bucks County, PA; Chester County, PA; Delaware County, PA; Montgomery County, PA; Philadelphia County, PA

e Greater Buffalo Region is defined as Erie County, NY and Niagara County, NY

Q: Is CPC+ an Advanced APM under the Quality Payment Program?

CPC+ is included on the list of Advanced APMs. This determination was based on medicalhome model-specific requirements. For payment years 2019 through 2024, clinicians who meet the threshold for sufficient participation in Advanced APMs and who meet requirements, as applicable for 2018 onward, regarding parent organization size are excluded from the Meritbased Incentive Payment System (MIPS) reporting requirements and payment adjustments and qualify for a five percent APM incentive payment.

Q: Where can practices find more information about the QPP and Advanced APMs? 

More information about the QPP and Advanced APMs can be found on the new website from CMS: https://qpp.cms.gov.

Q. What role do other payers play in CPC+?

Multi-payer engagement is an essential goal of CPC+, as it enables both public and private payers to sponsor comprehensive primary care reform. CMS will partner with payers that share Medicare’s interest in strengthening primary care in each of the CPC+ regions. Payer partners, both public and private, will provide their own financial support to practices, separate from that of Medicare Fee-for-Services (FFS). Any questions regarding non-Medicare payer support should be directed to the payer partner.

Code Description CPT

0030U Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823) (new code effective 1/1/18)

HCPCS
G9143 Warfarin responsiveness testing by genetic technique using any method, any number of specimen(s)




Introduction

Warfarin (Coumadin) is a blood thinner that works by reducing the blood’s ability to clot. It’s often prescribed to prevent blood clot formation in people who have conditions like atrial fibrillation. Finding the correct dose can be complicated. Too high a dose can cause bleeding. Too low a dose can result in blood clots being formed. Factors such as age, weight, use of other medications, and smoking go into the calculation of how much is prescribed. Once the drug is prescribed, the doctor then adjusts the dose based on blood tests. Two genes have been associated with how well the body processes warfarin. Genetic tests have been developed to look at these genes to try to determine warfarin dosing. These genetic tests are investigational (unproven). Medical studies do not show whether genetic testing to try to adjust warfarin doses leads to better health results. More studies are needed.



Test Investigational 

Testing of cytochrome p450 2C9 (CYP2C9), P450 4F2 (CYP4F2), and vitamin K epoxide reductase subunit C1 (VKORC1)

Coding Genotyping for CYP2C9, CYP4F2, and VKORC1 variants is considered investigational to manage the administration and dosing of warfarin, including: * Guiding the initial  warfarin dose  * Decreasing the time needed to achieve a stable international  normalized ratio (INR) * Reducing the risk of serious bleeding




Related Information 

Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see  Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.  The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants  represent expert opinion from both organizations, in addition to the College of American Pathologists. These  recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the  recommended standard terminology*“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”*to describe variants identified that cause  Mendelian disorders.

Table 1. Nomenclature to Report on Variants Found in DNA
Previous  Updated  Definition

Mutation Disease-associated variant
 
Disease-associated change in the DNA sequence
Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives
Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology.

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.



Evidence Review 

Description

Using information about an individual’s genotypes may help in guiding warfarin dosing and could reduce the time to dose stabilization and selection of an appropriate maintenance dose that might avoid the consequences of too much or too little anticoagulation.

Background

Warfarin is administered to prevent and treat thromboembolic events in high-risk patients;   warfarin dosing is a challenging process due to the narrow therapeutic window, variable response to dosing, and serious bleeding events in 5% or more of patients (depending on definition). Patients are typically given a starting dose of 2 to 5 mg and are frequently monitored with dose adjustments until a stable international normalized ratio value (a standardized indicator of clotting time) between 2 and 3 is achieved. During this adjustment period, a patient is at high risk of bleeding.
Stable or maintenance warfarin dose varies among patients by more than an order of magnitude. Factors influencing stable dose include body mass index, age, interacting drugs, and  indication for therapy. 

Warfarin, which is primarily metabolized in the liver by the CYP2C9 enzyme, exerts an anticoagulant effect by inhibiting the protein vitamin K epoxide reductase complex, subunit 1 (VKORC1). Three single nucleotide variants, two in the CYP2C9 gene and one in the VKORC1 gene play key roles in determining the effect of warfarin therapy on coagulation.

 CYP2C9*1 metabolizes warfarin normally, CYP2C9*2 reduces warfarin metabolism by 30%, and CYP2C9*3 reduces warfarin metabolism by 90%. Because warfarin given to patients with *2 or *3 variants will be metabolized less efficiently, the drug will remain in circulation longer, so lower warfarin doses will be needed to achieve anticoagulation. CYP2C9 and VKORC1 genetic variants account for approximately 55% of the variability in warfarin maintenance dose.
1,11

 Recent genome-wide association studies have also identified that a single nucleotide variant in the CYP4F2 gene has been reported to account for a small proportion of the variability in stable dose (the CYP4F2 gene encodes a protein involved in vitamin K oxidation).

Medicare National Coverage

In 2009, the Centers for Medicare and Medicaid Services published a national coverage determination on pharmacogenomic testing for warfarin response.

The Centers for Medicare & Medicaid Services stated that “the available evidence does not demonstrate that pharmacogenomic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness improves health outcomes in Medicare beneficiaries outside the context of CED, and is therefore not reasonable and necessary….” 
However, the Centers also “believes that the available evidence supports that coverage with evidence development (CED) …. 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 described standards.”

Policy Coverage Criteria  Test Investigational  Cytochrome P450 2D6 (CYP2D6) testing 

Coding 
 
Genotyping to determine cytochrome P450 2D6 (CYP2D6) variants is considered investigational for the purpose of managing treatment with tamoxifen for women at high risk for or with breast cancer.

Code Description CPT


81225 CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *8, *17)

81226 CYP2D6 (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) 

81227 CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *5, *6) 

81479 Unlisted molecular pathology procedure 

81599 Unlisted multianalyte assay with algorithmic analysis 





Introduction
Certain types of breast cancer are affected by hormones. Cancer cells that are said to be estrogen receptor positive (ER-positive) have receptors that attach to estrogen. Once attached, estrogen then acts like a fertilizer to help the cancer grow. Hormone therapy is used to prevent estrogen from connecting to the receptors. Tamoxifen is a type of hormone therapy that can be used for ER-positive breast cancer to prevent it from coming back and to treat breast cancer that’s already spread to other parts of the body. It’s also used for ER-positive ductal carcinoma in situ (DCIS). To process tamoxifen into its more active form, the body uses a specific, important enzyme (CYP2D6) that’s made by a particular gene. A small percentage of people (about 10%) have a form of the gene that doesn’t make as much of this important enzyme as most other people make. A genetic test has been developed to try to see if a person has the gene form that makes a smaller amount of the needed enzyme. This genetic test is investigational (unproven). Large, well-designed medical studies don’t show a strong link between this gene and tamoxifen’s effectiveness. More studies are needed. 




Related Information 

Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics. It is being implemented for genetic testing medical evidence review updates starting in 2017 (see Table 1).


The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.

The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology*“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”*to describe variants identified that cause Mendelian disorders.

Table 1. Nomenclature to Report on Variants Found in DNA 

Previous  Updated  Definition
Mutation Disease-associated variant
Disease-associated change in the DNA sequence
Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives

Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
ACMG: American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology. 


Description

Tamoxifen is prescribed as a component of adjuvant endocrine therapy to prevent endocrine receptor-positive breast cancer recurrence, to treat metastatic breast cancer, and to prevent disease in high-risk populations and in women with ductal carcinoma in situ. Tamoxifen is a prodrug that undergoes extensive metabolism to yield its active form: 4-hydroxy tamoxifen and endoxifen (primary active form) via the CYP2D6 enzyme. Variants in the CYP2D6 gene are associated with significant alterations in endoxifen concentrations leading to the hypothesis that CYP2D6 variation may affect the clinical outcomes of women treated with tamoxifen but not with drugs not metabolized by CYP2D6, such as anastrozole.

Background  Tamoxifen Metabolism 

Tamoxifen is a pro-drug that undergoes extensive metabolism to yield its active form: 4hydroxytamoxifen (4-OH tamoxifen) and 4-hydroxy-N-desmethyltamoxifen (endoxifen).

Among these 2 metabolites, endoxifen is thought to be the major metabolite that exerts the pharmacodynamic effect of tamoxifen. The metabolism of tamoxifen into 4-OH tamoxifen is catalyzed by multiple enzymes, while endoxifen is formed predominantly by the CYP2D6 enzyme. Plasma concentrations of endoxifen exhibit high interindividual variability, as described in breast cancer patients.

Because CYP2D6 enzyme activity is known to vary across individuals, variants in the CYP2D6 gene are of great interest for understanding tamoxifen metabolism variability and variation in levels of circulating active metabolites. Moreover, known variability in endoxifen levels has been hypothesized to result in variable response to tamoxifen treatment.

Metabolic Enzyme Genotypes 

The CYP2D6 gene exhibits a high degree of polymorphism, with more than 100 allelic variants identified. The relations among genotype, phenotype, and clinical implications are summarized in Table 3.

The prevalence of CYP2D6 poor metabolizers is approximately 7% to 10% in whites of Northern European descent, 1.9% to 7.3% in blacks, and 1% or less in most Asian populations studied. The poor metabolizer phenotype in whites is largely accounted for by CYP2D6*3 and *4 nonfunctional variants, and in black and Asian populations, by the *5 nonfunctional variant. Some poor metabolizers may have 1 nonfunctional allele and 1 reduced-function allele. Among reduced function variants, CYP2D6*17, *10, and *8 are the most important in blacks, Asians, and whites, respectively. Few studies have investigated the frequency of CYP2D6-variant alleles or of poor metabolizers in the Hispanic population.

Endocrine Therapy Regimens 

Tamoxifen has several labelled indications

* Chemoprevention of invasive breast cancer in high-risk women without current disease or with ductal carcinoma in situ
* Adjuvant treatment of primary breast cancer
* Treatment of metastatic disease


In women with breast cancer, endocrine receptor-positive disease predicts a likely benefit from tamoxifen treatment. Tamoxifen is currently the most commonly prescribed adjuvant treatment to prevent recurrence of endocrine receptor-positive breast cancer in premenopausal or perimenopausal women. 

For post-menopausal women with osteoporosis or at high risk for invasive breast cancer, raloxifene is an alternative treatment for invasive cancer risk reduction. Currently, raloxifene is indicated for treatment of reduction in the “risk of invasive breast cancer in postmenopausal women with osteoporosis” or those at “high risk for invasive breast cancer.”

Pharmacologic Inhibitors of Metabolic Enzymes 

CYP2D6 activity may be affected not only by genotype but also by co-administered drugs that block or induce CYP2D6 function. Studies of selective serotonin reuptake inhibitors, in particular, have shown that fluoxetine and paroxetine, but not sertraline, fluvoxamine, or venlafaxine, are potent CYP2D6 inhibitors.

Some individuals treated with fluoxetine or paroxetine have changed from extensive metabolizer phenotype to poor metabolizer.

The degree of inhibition may depend on selective serotonin reuptake inhibitors dose.
Thus, CYP2D6 inhibitor use must be considered in assigning CYP2D6 functional status, and potent CYP2D6 inhibitors may need to be avoided when tamoxifen is administered.

Summary of Evidence

For individuals who are treated with tamoxifen for breast cancer or are high risk for breast cancer who receive CYP2D6 genotype-guided tamoxifen treatment, the evidence includes multiple retrospective cohort studies and nonconcurrent prospective studies. Relevant outcomes include overall survival, disease-specific survival, medication use, and treatment-related morbidity. Data in most of these studies derived from a convenient sample, which was further limited by relatively small numbers of patients and lack of comprehensive genotype data, patient data (eg, concomitant medications), and detailed clinical outcomes data. Three influential nonconcurrent prospective studies nested within large prospective, randomized double-blind clinical trials in postmenopausal women with hormone receptor–positive earlystage breast cancer also reported contradictory results. Two larger studies failed to show statistically significant associations between phenotype (patients classified as poor, intermediate, or extensive metabolizer) and recurrence of breast cancer. No trials of genotype-directed dosing or drug choice that compared health outcomes for patients managed with and without the test were identified. It is not known whether CYP2D6 genotype-guided tamoxifen treatment results in the selection of a treatment strategy that would reduce the rate of  breast cancer recurrence, improve disease-free survival or overall survival, or reduce adverse events. The evidence is insufficient to determine the effects of the  technology on health outcomes.

Policy Coverage Criteria 

Type of Test Investigational
Gene expression profiling Gene expression profiling is considered investigational to evaluate the site of origin of a tumor of unknown primary, or to distinguish a primary from a metastatic tumor.

Coding   code Description CPT

81479 Unlisted molecular pathology procedure

81504 Oncology (tissue of origin), microarray gene expression profiling of > 2000 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as tissue similarity scores

81540 Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main cancer type and subtype, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype

81599 Unlisted multianalyte assay with algorithmic analysis


Introduction

A primary site is the part of the body where cancer started. Cancers are named on this primary site, even when they spread to other parts of the body. For example, if cancer starts in the breast but spreads to the bones, lungs, or liver, it is still classified as breast cancer. Cancer treatment is often based on the primary cancer. In rare cases, a cancer may have already spread before the original cancer is found. This is known as cancer of unknown primary. Cancers of unknown primary happen in three to four percent of all cancers in the United States. Certain genetic tests are being studied as one way to try to find the original site of the cancer. There is not yet enough scientific evidence about how these genetic tests might affect overall health outcomes. These tests are considered unproven (investigational).




Related Information 

Genetics Nomenclature Update 

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the Human Genome Organization, and by the Human Genome Variation Society itself.


The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders.

Table 1. Nomenclature to Report on Variants Found in DNA
Previous  Updated  Definition
Mutation Disease-associated variant Disease-associated change in the DNA sequence
 Variant Change in the DNA sequence 

Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives
Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification  Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology

Genetic Counseling
Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of  genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing,  including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the  utilization of genetic testing substantially and may reduce  inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Evidence Review 

Description

Cancers of unknown primary represent 3% to 4% of cancers diagnosed in the United States. These cancers are heterogeneous and many accompanied by poor prognoses. A detailed history and physical combined with imaging and tissue pathology can identify some, but not all, primary sources of secondary tumors. It is suggested that identifying the likely primary source with gene expression profiling to direct treatment may improve health outcomes.

Background

Cancers of Unknown Primary

Cancers of unknown primary (CUPs), or occult primary malignancies, are tumors that have metastasized from an unknown primary source; they make up about 3% to 4% of all cancers in the United States. Identifying the primary origin of a tumor can dictate cancer-specific treatment, expected outcome, and prognosis.

Most CUPs are adenocarcinomas or undifferentiated tumors; less commonly, they may be squamous carcinomas, melanoma, soft tissue sarcoma, or neuroendocrine tumors. Osteo- and chondrosarcomas rarely produce CUPs. The most common primary sites of CUPs are the lung and pancreas, followed by colon and stomach, then breast, ovary, prostate, and solid-organ carcinomas of the kidney, thyroid, and liver. Conventional methods used to aid in the identification of the origin of a CUP include a thorough history and physical examination; computed tomography scans of the chest, abdomen, and pelvis; routine laboratory studies; and targeted evaluation of specific signs and symptoms.

Diagnosis and Classification

Biopsy of a CUP with detailed pathology evaluation may include immunohistochemical (IHC) analysis of the tumor. IHC analysis identifies different antigens present in different types of tumors and can usually distinguish an epithelial tumor (ie, carcinoma) from melanoma or sarcoma. Detailed cytokeratin panels often allow further classification of carcinoma; however, tumors of different origins may show overlapping cytokeratin expression. Results of IHC may provide a narrow differential of possible sources of a tumor’s origin, but not necessarily a definitive answer.
Recent advances in the understanding of gene expression in normal and malignant cells have led researchers to explore molecular classification to improve the identification of the site of origin of a CUP. The molecular classification of cancers is based on the premise that, despite different degrees of differentiation, tumors retain sufficient gene expression “signatures” as to their cell of origin, even after metastasis. Theoretically, it is possible to build a gene expression database spanning many different tumor types to compare to the expression profile of very poorly differentiated tumors, or a CUP, to aid in the identification of the tumor type and organ of origin. The feasibility of using molecular classification schemes with gene expression profiling (GEP) to classify these tumors of uncertain origin has been demonstrated in several studies.

Tissue of Origin Testing, Treatment Selection, and Health Outcomes 

Patients with CUP have generally poor prognoses. For example, patients with disease limited to lymph nodes have a median survival of 6 to 9 months, and those with a disease that is extranodal 2 to 4 months.

The premise of tissue of origin testing in CUPs is that identifying a likely primary tumor site will inform treatment selection leading to improved survival and other outcomes or as a predictive test. To evaluate whether treatment selection can be improved, the ability of a test to suggest a likely site of origin (clinical validity) must be first be shown. But demonstrating clinical validity may be problematic because patients with CUPs have no identified primary tumor for a reference standard.
Imperfect reference standards must be relied on such as the available presumptive or a reference pathologic diagnosis, known tumor types, or comparisons IHC. A primary tumor diagnosed during follow-up might also be used as a reference standard, but its use would be subject to potential selection bias. Therefore, even substantial evidence supporting the ability of a test to suggest a likely site of origin will be insufficient to infer benefit. Convincing evidence for benefit requires demonstrating that using a test to select treatment will improve outcomes. 

Code Description CPT

37243 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction.

75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation

79445 Radiopharmaceutical therapy, by intra-arterial particulate administration

Code Description HCPCS

S2095 Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using ytrrium-90 microspheres


Introduction

Embolization is procedure to block blood flow. Combined with radiation, it is a way to treat cancer in the liver in some situations. In this procedure a catheter (a long, thin, hollow tube) is inserted in an artery near the groin. It’s threaded to the tumor’s blood supply. Tiny radioactive particles are released into the artery that feeds the tumor. The particles travel into the tumor and block off — embolize — the blood supply feeding the tumor, causing it to shrink. The radiation works to kill the cancer cells. The radiation dissipates in a few weeks and the particles stay in the liver permanently. The radiation usually doesn’t affect the healthy liver tissue around the tumor very much. This policy describes when radioembolization may be considered medically necessary.

Policy Coverage Criteria

Service Medical Necessity 

Radioembolization Radioembolization may be considered medically necessary in the following situations: * Treatment of primary hepatocellular carcinoma that is  unresectable and limited to the liver (size of 3cm or larger, and patient with good performance status)   OR * Treatment of primary hepatocellular carcinoma as a bridge to  liver transplantation OR * Treatment of primary intrahepatic cholangiocarcinoma in  patients with unresectable tumors OR * Treatment of hepatic metastases from neuroendocrine tumors  (carcinoid and noncarcinoid) with diffuse and symptomatic disease when systemic therapy has failed to control symptoms. (symptoms related to excess hormone production)  OR * Treatment of unresectable hepatic metastases 

o From breast, colorectal or melanoma (ocular or cutaneous)       AND  o That are progressive and unresectable in patients with liver dominant disease
AND o That are refractory to chemotherapy or are not candidates  for chemotherapy   Service Investigational  Radioembolization Radioembolization is considered investigational for all other hepatic metastases except as noted in the Medical Necessity section above. 


Service Investigational

Documentation Requirements
Radioembolization is considered investigational for all other indications not described in the Medical Necessity section above.
The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include office visit notes that contain the relevant history and physical supporting ANY of the following situations: * Patient with primary liver cancer that cannot be removed by surgery and limited to the liver  (size of 3 cm or larger, and patient with good performance status) * Treatment for hepatocellular carcinoma before a liver transplant *
Treatment of primary   intrahepatic cholangiocarcinoma that cannot be removed by surgery * Treatment of hepatic metastases from neuroendocrine tumors (carcinoid and noncarcinoid)  with diffuse and symptomatic disease when systemic therapy has failed to control symptoms (symptoms related to excess hormone production)

* Treatment of hepatic metastases that cannot be removed by surgery: o From breast, colorectal, or melanoma (ocular or cutaneous)
AND o That are progressive and unresectable in patients with liver dominant disease ND * Has failed chemotherapy or are not candidates for chemotherapy

Coding


The coding for radioembolization may depend on the medical specialty providing the therapy.



Related Information


In general, radioembolization is used for unresectable hepatocellular carcinoma that is greater than 3 cm.

There is little information on the safety or efficacy of repeated radioembolization treatments or about the number of treatments that should be administered.
Radioembolization should be reserved for patients with adequate functional status (Eastern Cooperative Oncology Group Performance Status 0-2), adequate liver function and reserve, Child-Pugh class A or B, and liver-dominant metastases.
Symptomatic disease from metastatic neuroendocrine tumors refers to symptoms related to excess hormone production.

Definition of Terms

Child-Pugh Score: This score is used to assess the prognosis of chronic liver disease, usually cirrhosis. 
Eastern Cooperative Oncology Group (ECOG): The ECOG performance status is used to assess the patient’s disease progression and how the disease impacts the patient’s activities of daily living (ADLs). http://www.ecog.org/  (Accessed September 2018)


Description

Radioembolization (RE), also referred to as selective internal radiotherapy, delivers small beads (microspheres) impregnated with yttrium 90 intra-arterially via the hepatic artery. The microspheres, which become permanently embedded, are delivered to tumors preferentially, because the hepatic circulation is uniquely organized, whereby tumors greater than 0.5 cm rely on the hepatic artery for blood supply while the normal liver is primarily perfused via the portal vein. Radioembolization has been proposed as a therapy for multiple types of primary and metastatic liver tumors.

Background

Treatments for Hepatic and NeuroEndocrine Tumors

The use of external-beam radiotherapy and the application of more advanced radiotherapy approaches (eg, intensity-modulated radiotherapy) may be of limited use in patients with multiple diffuse lesions due to the low tolerance of normal liver to radiation compared with thehigher doses of radiation needed to kill the tumor.

Various nonsurgical ablative techniques have been investigated that seek to cure or palliate unresectable hepatic tumors by improving locoregional control. These techniques rely on extreme temperature changes (cryosurgery or radiofrequency ablation), particle and wave physics (microwave or laser ablation), or arterial embolization therapy including chemoembolization, bland embolization, or radioembolization.

Radioembolization

Radioembolization, (radiotherapy in older literature) delivers small beads (microspheres) impregnated with yttrium 90 intra-arterially via the hepatic artery. The microspheres, which become permanently embedded, are delivered to tumors preferentially because thehepatic circulation is uniquely organized, whereby tumors greater than 0.5 cm rely on the hepatic arteryfor blood supply while normal liver is primarily perfused via the portal vein. Yttrium-90 is a pure beta-emitter with a relatively limited effective range and short half-life that helps focus the radiation and minimize its spread. Candidates for radioembolizationare initially examined by hepatic angiogram to identify and map the hepatic arterial system. At that time, a mixture of technetium 99-labeled albumin particles is delivered via the hepatic artery to simulate  microspheres. Single-photon emission computed tomography is used to detect possible shunting of the albumin particles into gastrointestinal or pulmonary vasculature.

Currently 2 commercial forms of yttrium-90 microspheres are available: a glass sphere, (TheraSphere) and a resin sphere (SIR-Spheres). Noncommercial forms are mostly used outside the United States. While the commercial products use the same radioisotope (yttrium-90) and have the same target dose (100 Gy), they differ in microsphere size profile, base material (ie, resin vs glass), and size of commercially available doses. The physical characteristics of the active and inactive ingredients affect the flow of microspheres during injection, their retention at the tumor site, spread outside the therapeutic target region, and dosimetry calculations. The  Food and Drug Administration (FDA) granted premarket approval of SIR-Spheres for use in combination with 5-floxuridine chemotherapy by hepatic arterial infusion to treat unresectable hepatic metastases from colorectal cancer. In contrast, TheraSphere’s glass sphere was approved under a humanitarian device exemption for use as monotherapy to treat unresectable hepatocellular carcinoma. In 2007, this humanitarian device exemption was expanded to include patients with hepatocellular carcinoma who have partial or branch portal vein thrombosis. For these reasons, results obtained with 1 product do not necessarily apply to other commercial (or non-commercial) products (see Regulatory Status section). 

Coding   Code Description CPT

11055 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); single lesion

11056 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); 2 to 4 lesions

11057 Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); more than 4 lesions

11719 Trimming of nondystrophic nails, any number

11720 Debridement of nail(s) by any method(s); 1 to 5

11721 Debridement of nail(s) by any method(s); 6 or more


HCPCS

G0127 Trimming of dystrophic nails, any number

S0390 Routine foot care; removal and/or trimming of corns, calluses and/or nails and preventive maintenance in specific medical conditions (eg, diabetes), per visit






Introduction

Most adults are able to provide their own routine foot care, such as trimming nails or filing calluses. Therefore, this type of foot care is not covered under the medical benefits. However, for some individuals with certain medical conditions, it may be important to have professional help with routine foot care in order to prevent serious problems. Routine foot care includes services such as cutting corns and calluses or trimming, cutting, clipping, or removing part of the nail (debridement). This benefit coverage guideline discusses when routine foot care may be covered.

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

Indication Medical Necessity
Conditions associated with poor blood flow to the legs and feet
Routine foot care may be considered medically necessary for patients with conditions associated with poor blood flow to the legs and feet such as peripheral vascular disease and/or numbness (desensitization). 



Routine foot care Routine foot care, such as trimming nails or removing corns and calluses, does not typically require the skills of a qualified provider of foot care services and is therefore considered not medically necessary.



ICD-10 Diagnosis Codes - Covered

A52.16 Charcot's arthropathy (tabetic)
B35.1 Dermatophitosis (Tinea unquium)
B37.2 Candidiasis of skin and nail
B52.0 Plasmodium malariae with neuropathy
E08.00 – E13.9 Diabetes Mellitus
O24.011 – O24.93 Diabetes mellitus in pregnancy
G13.0 – G13.1 Systemic atrophy and neuropathy
G6281 – G65.2 Polyneuropathies


Code Description
G73.3 Myasthenic syndromes in other diseases classified elsewhere
G90.09 Peripheral neuropathy
G99.0 Autonomic neuropathy
I70.201 – I70.799 Atherosclerosis of arteries, lower extremities
I73.00 – I79.8 Peripheral vascular disease
I80.00 – I80.3 Phlebitis and thrombophlebitis, lower extremities
I82.501 – I87.9 Chronic embolism and thrombosis, lower extremities
I89.0 Lymphedema
I99.8 Circulatory system disorder
L02.415 – L03.129 Infections of skin and subcutaneous tissue, lower limb
L11.0 Acquired keratosis follicularis
L60.0 – L60.9 Nail disorders
L84 – L85.2, L86, L87.0, L87.2, L97.501 – L97.529
Disorders of skin and subcutaneous tissue
M05.571 – M05.59 Polyarthropathies
M14.671 – M14.69 Arthropathies, Charcot's joint, ankle and foot  
M20.10 – M02.12 Hallus valgus
M34.83 Systemic sclerosis with polyneuropathy
M90.561 – M90.59 Osteonecrosis, lower ley, ankle and foot
M90.861 – M90.89 Osteopathy, lower leg, ankle and foot
Q82.0 Hereditary lymphedema
R20.0 – R20.9 Disorders of skin and subcutaneous tissue
R60.0 – R60.9 Edema
Note:  CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).


This coverage guideline describes the clinical indications for routine foot care services.  

Routine foot care includes:

* Cutting or removal of corns and calluses
* Trimming, cutting/clipping and debridement of nails

Generally, routine foot care services are performed by the member or the caregiver. However, if certain medical conditions are present they may pose a hazard when foot care is performed by a non-professional. 

The following conditions may pose a risk to life or limb loss, so a qualified provider of foot care services should perform the routine foot care. Conditions that may require a qualified provider to perform routine foot care include but are not limited to any of the following:

* Arteriosclerosis of the extremities
* Buerger’s disease (ie, thromboangiitis obliterans)
* Chronic thrombophlebitis of lower extremities
* Diabetes
* Peripheral neuropathies
* Peripheral vascular disease

This policy only addresses routine foot care. It does not address the treatment of symptomatic diseases and medical conditions of the feet, which may include:
* Bunion
* Bursitis
* Hammer toe
* Heel spur
* Ingrown toenail
* Neuroma
* Plantar fasciitis
* Sprain/strain of the foot
* Warts, including

Code Description CPT

81405 Molecular pathology procedure, Level 6 (eg, analysis of 6-10 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 11-25 exons, regionally targeted cytogenomic array analysis). This code includes:
* ACTC1 (actin, alpha, cardiac muscle 1) (eg, familial HCM), full gene sequence * MYL2 (myosin, light chain 2, regulatory, cardiac, slow) (eg, familial HCM), full gene
sequence * MYL3 (myosin, light chain 3, alkali, ventricular, skeletal, slow) (eg, familial HCM),
full gene sequence * TNNC1 (troponin C type 1 [slow]) (eg, hypertrophic cardiomyopathy or dilated
cardiomyopathy), full gene sequence * TNNI3 (troponin I, type 3 [cardiac]) (eg, familial HCM), full gene sequence
* TPM1 (tropomyosin 1 [alpha]) (eg, familial HCM), full gene sequence

81406 Molecular pathology procedure, Level 7 (eg, analysis of 11-25 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of 26-50 exons, cytogenomic array analysis for neoplasia). This code includes:
* TNNT2 (troponin T, type 2 [cardiac]) (eg, familial HCM), full gene sequence

81407 Molecular pathology procedure, Level 8 (eg, analysis of 26-50 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of >50 exons, sequence analysis of multiple genes on one platform). This code includes:
* MYBPC3 (myosin binding protein C, cardiac) (eg, familial HCM), full gene sequence
* MYH7 (myosin, heavy chain 7, cardiac muscle, beta) (eg, familial HCM, Liang distal myopathy), full gene sequence


81439 Inherited cardiomyopathy (eg, hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy) genomic sequence analysis panel, must include sequencing of at least 5 genes, including DSG2, MYBPC3, MYH7, PKP2, and TTN


S3865 Comprehensive gene sequence analysis for hypertrophic cardiomyopathy

S3866 Genetic analysis for a specific gene mutation for hypertrophic cardiomyopathy (HCM) in an individual with a known HCM mutation in the family


Introduction

Hypertrophic cardiomyopathy is a condition where the muscle cells of the heart become big. This can make the walls of the heart thicker than normal, and because the walls surrounding the heart’s pumping chambers get thicker, the chambers become smaller than they should be. Hypertrophic cardiomyopathy is usually inherited, and is caused by changes to one or more of the person’s genes. The muscle problems eventually lead to enlargement of the heart and possible problems with the heart’s rhythm and valves. This policy discusses when genetic testing for this form of cardiomyopathy may be considered medically necessary.

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



Testing Medical Necessity

Genetic testing for predisposition to HCM
Genetic testing for HCM gene variants
Genetic testing for predisposition to HCM

Genetic testing for predisposition to HCM may be considered medically necessary for individuals who are at risk for developing HCM.  * “At risk” is defined as having a first-degree relative who has a  confirmed diagnosis of HCM and the relative has a documented pathogenic gene variant (see below).

Genetic testing for HCM gene variants may be considered medically necessary for the index patient with confirmed clinical HCM, when used to assist unaffected first degree family members (see Benefit Application section).

Genetic testing for predisposition to HCM is considered not medically necessary for patients with a family history of HCM in which a first-degree relative has tested negative for pathologic variants.

Due to the complexity of genetic testing for hypertrophic cardiomyopathy (HCM) and the potential for misinterpretation of results, the decision to test and the interpretation of test results should be performed by, or in consultation with, an expert in the area of medical genetics and/or HCM.

To inform and direct genetic testing for at-risk individuals, genetic testing should initially be performed in at least one close relative with a confirmed diagnosis of HCM (index case), if possible. See Practice Guidelines and Position Statements and Benefit Application section for information regarding testing of the index case. 
Because there are varying degrees of penetrance for different HCM variants, consideration for testing of second- or third-degree relatives may be appropriate in certain circumstances. Some judgment should be allowed for these decisions, for example, in the case of a small family pedigree. Consultation with an expert in medical genetics and/or the genetics of HCM, in conjunction with a detailed pedigree analysis, is appropriate when testing of second- or third- degree relatives is considered.


Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics. (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.

The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders.

Table 1. Nomenclature to Report on Variants Found in DNA  Previous  Updated  Definition
Mutation Disease-associated variant Disease-associated change in the DNA sequence

Variant Change in the DNA sequence 
Familial variant Disease-associated variant identified in a proband for use in subsequent targeted genetic testing in first-degree relatives

Table 2. ACMG-AMP Standards and Guidelines for Variant Classification
Variant Classification Definition
Pathogenic Disease-causing change in the DNA sequence
Likely pathogenic Likely disease-causing change in the DNA sequence 
Variant of uncertain significance Change in DNA sequence with uncertain effects on disease
Likely benign Likely benign change in the DNA sequence
Benign Benign change in the DNA sequence
American College of Medical Genetics and Genomics; AMP: Association for Molecular Pathology.


Genetic Counseling

Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Benefit Application

Some Plans may have contract or benefit exclusions for genetic testing. Recommendations indicate that, when possible, genetic testing for hypertrophic
cardiomyopathy be performed in an affected family member so that testing in unaffected, atrisk family members can focus on the variant found in the affected family member. This testing is intended to document whether a known pathologic variant is present in the family and to optimize the predictive value of predisposition testing for at-risk relatives. However, coverage for testing of the affected index case depends on contract benefit language when there is no conclusive evidence of clinical benefit to the index case from testing.

Specific contract language must be reviewed and considered when determining coverage for testing. In some cases, coverage for testing the index case may be available through the contract that covers the unaffected, at-risk individual who will benefit from knowing the results of the genetic test.

CMS is finalizing our proposals to pay separately for two newly defined physicians’ services furnished using communication technology,


1. Brief communication technology-based service, e.g. virtual check-in (HCPCS code G2012)

2. Remote evaluation of recorded video and/or images submitted by an established patient (HCPCS code G2010)

3. Chronic care remote physiologic monitoring -CPT codes 99453, 99454, and 99457.

4. Interprofessional internet consultation - CPT codes 99451, 99452, 99446, 99447, 99448, and 99449.


Practitioners could be separately paid for the brief communication technology-based service when the patient checks in with the practitioner via telephone or other telecommunications device to decide whether an office visit or other service is needed.


This would increase efficiency for practitioners and convenience for beneficiaries. Similarly, the service of remote evaluation of recorded video and/or images submitted by an established patient would allow practitioners to be separately paid for reviewing patient-transmitted photo or video information conducted via pre-recorded “store and forward” video or image technology to assess whether a visit is needed.



E&M Documentation Changes for 2019


For CY 2019 and CY 2020, CMS will continue the current coding and payment structure for E/M office/outpatient visits and practitioners should continue to use either the 1995 or 1997 E/M documentation guidelines to document E/M office/outpatient visits billed to Medicare. For CY 2019 and beyond, CMS is finalizing the following policies:

1. For established patient office/outpatient visits, when relevant information is already contained in the medical record, practitioners may choose to focus their documentation on what has changed since the last visit, or on pertinent items that have not changed, and need not re-record the defined list of required elements if there is evidence that the practitioner reviewed the previous information and updated it as needed. Practitioners should still review prior data, update as necessary, and indicate in the medical record that they have done so.


2. Additionally, we are clarifying that for E/M office/outpatient visits, for new and established patients for visits, practitioners need not re-enter in the medical record information on the patient’s chief complaint and history that has already been entered by ancillary staff or the beneficiary. The practitioner may simply indicate in the medical record that he or she reviewed and verified this information.




New codes for professional evaluation services:

• Testing evaluation services must always be performed and reported by professional (Physician & other qualified health care professional), using codes 96130, 96131, 96132 & 96133.

* Elements of professional work in the new evaluation service codes include:
▪ Integration of patient data.
▪ Interpretation of standardized test results and clinical data.
▪ Clinical decision making.
▪ Treatment planning and report.
▪ Interactive feedback to the patient, family member(s) or caregiver(s).
• Testing evaluation services may be billed on the same or different days.
• Testing evaluation services cannot be reported by the technician


Hint: Interactive feedback- Based on patient specific cognitive and emotional strengths and weaknesses, interactive feedback may include promoting adherence to medical and/or psychological treatment plans; educating and engaging the patient about his or her condition to maximize patient collaboration in their care; addressing safety issues; facilitating psychological coping; coordinating care; and engaging the patient in planning given the expected course of illness or condition, when performed.

Code Description CPT

48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells

HCPCS

G0341 Percutaneous islet cell transplant, includes portal vein catheterization and infusion
G0342 Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion
G0343 Laparotomy for islet cell transplant, includes portal vein catheterization and infusion
S2102 Islet cell tissue transplant from pancreas; allogeneic


Islet Transplantation

Introduction

The pancreas is an organ that stretches lengthwise across the abdominal area below the stomach. Within the pancreas are cell clusters commonly called “the islets.” Included in the islets are beta cells which make, store, and release insulin. Treating chronic inflammation of the pancreas may mean removing the pancreas. Removing the pancreas also removes the islets and the beta cells, which then leads to type 1 diabetes. To prevent the development of type 1 diabetes in people who have their pancreas removed, their own islet cells can be harvested and injected into a specific vein in the liver. Published medical studies show that islet cell transplantation appears to significantly decrease the development diabetes after the pancreas is removed. In this situation, islet cell transplantation may be considered medically necessary. Islet cell transplantation using donor cells is being studied as a technique to treat existing type 1 diabetes. There is not enough medical evidence to show how well this works to treat type 1 diabetes. Larger and longer studies are needed. For these reasons, islet cell transplantation to treat existing type 1 diabetes is investigational (unproven).

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

Policy Coverage Criteria

Procedure Medical Necessity  Autologous pancreas islet transplantation

Autologous pancreas islet transplantation may be considered medically necessary as an adjunct to a total or near total pancreatectomy in patients with chronic pancreatitis.

Procedure Investigational
Allogeneic islet transplantation
Islet transplantation, all other

Documentation Requirements

Allogeneic islet transplantation is considered investigational for the treatment of type 1 diabetes.  Islet transplantation is considered investigational in all other situations.

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following: * Office visit notes that contain the relevant history and physical:
o Patient had pancreas removed because of chronic pancreatitis 


Guidelines Nationally Covered Indications

Whole organ pancreas transplantation is nationally covered by Medicare when performed simultaneous with or after a kidney transplant.  If the pancreas transplant  occurs after the kidney transplant, immunosuppressive therapy begins with the date of discharge from the inpatient  stay for the  pancreas transplant.

Pancreas transplants alone (PA) are reasonable and necessary for Medicare beneficiaries in the following limited circumstances:

• PA will be limited to those facilities that are Medicare-approved for kidney transplantation. Approved centers can be found at Approved Transplant Programs

• Patients must have a diagnosis of type I diabetes:

* Patient with diabetes must be beta cell autoantibody positive; or

* Patient must demonstrate insulinopenia defined as a fasting C-peptide level that  is less than  or equal to 110% of the lower limit of normal of the laboratory's measurement method. Fasting C-peptide levels will only be considered valid with a concurrently obtained fasting glucose ≤ 225 mg/dL;

• Patients must have been optimally and intensively managed by an endocrinologist for at least 12 months with the most medically-recogni
zed advanced insulin formulations and delivery systems;

•Patients must have a history of medically -uncontrollable labile (brittle) insulin-dependent  diabetes mellitus with documented recurrent, severe, acutely life-threatening metabolic complications that require hospitalization.

Aforementioned complications include frequent hypoglycemia unawareness or recurring severe ketoacidosis, or recurring severe hypoglycemic attacks;

• Patients must have the emotional and mental capacity to understand the significant risks associated with  surgery and to effectively manage the lifelong need for immunosuppression; and,

• Patients must otherwise be a suitable candidate for transplantation.

If a kidney and pancreas transplants are performed simultaneously, the claim should contain a diabetes diagnosis code and a renal failure code or one of the hypertensive renal failure diagnosis codes. The claim should also contain two transplant procedure codes. If the claim is for a pancreas transplant only, the claim should contain a diabetes diagnosis code and a status code to indicate a previous kidney transplant. If the status code is not on the claim for the pancreas transplant, UnitedHealthcare will  search the beneficiary's claim history for a status  code indicating  a prior kidney transplant.

CPT Code Description

48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or  pancreatic islet cells (Not  covered by Medicare)

48554 Transplantation of pancreatic allograft (CMS sourced)

ICD- 10 Procedure Code Description

0FYG0Z0 Transplantation of pancreas, alloge neic, open approach  (CMS sourced)

0FYG0Z1 Transplantation of pancreas, syngeneic, open approach  (CMS sourced)




Blue Cross and Blue Shield Association Islet Cell Transplantation Billing /Coding/Physician Documentation Information


Applicable service codes:

48160, 48999, G0341, G0342, G0343, S2102

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless  all specific information needed to make a medical necessity determination is included. 


Coding 



Evidence Review 

Description

Performed in conjunction with pancreatectomy, autologous islet transplantation is proposed to reduce the likelihood of insulin-dependent diabetes. Allogeneic islet cell transplantation is being investigated as a treatment or cure for patients with type 1 diabetes.

Background  Chronic Pancreatitis

Primary risk factors for chronic pancreatitis may be categorized as the following: toxicmetabolic, idiopathic, genetic, autoimmune, recurrent and severe acute pancreatitis, or obstructive (TIGAR-O classification system). Patients with chronic pancreatitis may experience intractable pain that can only be relieved with a total or near total pancreatectomy. However, the pain relief must be balanced against the certainty that the patient will be rendered an insulin-dependent diabetic.

Type 1 Diabetes

Glucose control is a challenge for individuals with type 1 diabetes. Failure to prevent disease progression can lead to long-term complications such as retinopathy, neuropathy, nephropathy, and cardiovascular disease.


Islet Transplantation

In autologous islet transplantation during the pancreatectomy procedure, islet cells are isolated from the resected pancreas using enzymes, and a suspension of the cells is injected into the portal vein of the patient’s liver. Once implanted, the beta cells in these islets begin to make and release insulin. 

Allogeneic islet transplantation potentially offers an alternative to whole-organ pancreas transplantation. In the case of allogeneic islet cell transplantation, cells are harvested from a deceased donor’s pancreas, processed, and injected into the recipient’s portal vein. Up to 3 donor pancreas transplants may be required to achieve insulin independence. However, a limitation of islet transplantation is that 2 or more donor organs are usually required for successful transplantation, although experimentation with single-donor transplantation is occurring. A pancreas that is rejected for whole-organ transplant is typically used for islet transplantation. Therefore, islet transplantation has generally been reserved for patients with frequent and severe metabolic complications who have consistently failed to achieve control with insulin-based management. Allogeneic transplantation may be performed in the radiology department. 

In 2000, a modified immunosuppression regimen increased the success of allogeneic islet transplantation. This regimen is known as the “Edmonton protocol.”

Medically Necessary Code Description CPT

95940 Continuous intraoperative neurophysiology monitoring in the operating room, one on one monitoring requiring personal attendance, each 15 minutes (List separately in addition to code for primary procedure) 

95941 Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operating room, per hour (List separately in addition to code for primary procedure)

HCPCS

G0453 Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby), per patient, (attention directed exclusively to one patient) each 15 minutes (list in addition to primary procedure)

Reimbursement Guidelines - UHC

Per the American Medical Association Intraoperative Neuromonitoring (IONM) is the use of electrophysiological methods to monitor the functional integrity of certain neural structures during surgery. The purpose of IONM is to reduce the risk of damage to the patient’s nervous system and to provide functional guidance to the surgeon and anesthesiologist.

IONM codes are reported based upon the time spent monitoring only, and not the number of baseline tests performed or parameters monitored. In addition, time spent monitoring excludes time to set up, record, and interpret the baseline studies, and to remove electrodes at the end of the procedure. Time spent performing or interpreting the baseline neurophysiologic study(ies) should not be counted as intraoperative monitoring, as it represents separately reportable procedures.

According to The Centers for  Medicare and Medicaid Services (CMS) , Intraoperative neurophysiology testing (HCPCS/CPT codes 95940, 95941 and G0453) should not be reported by the physician performing an operative or anesthesia procedure since it is included in the global package.
The use of either modifier 26 or TC does not apply to codes 95940, 95941 or G0453.

The American Academy of Neurology states IONM services 95940, and 95941 should be performed in Place of Service (POS) 19,21, 22 or 24. Therefore,UnitedHealthcare will only reimburse 95940, 95941 and G0453 services when reported with POS 19, 21,22 and 24.


Questions and Answers

1Q: Will IONM services be reimbursed when reported with POS 15 (mobile unit)?

A :  No. Services furnished in a mobile unit are often provided to serve an entity for which another POS code exists. When this is the case, the POS for that entity should be reported. UnitedHealthcare will only allow reimbursement for IONM services when reported with POS 19, 21
, 22and 24

2Q:Are IONM codes with a status “I” allowed when reported in a facility setting?
A: No, per CMS guidance the status “I” code is not reimbursable. For more information please review other  reimbursement policies, including but not limited to the Replacement Codes Policy.

Continuous intraoperative neurophysiology monitoring: BCBS Guideline

codes 95940, 95941 and G0453 are considered incidental to the surgeon’s or anesthesiologist’s primary service and not eligible for separate  reimbursement when performed and billed by the surgeon or anesthesiologist. HCPCS Code G0453 will not be allowed when billed during the same operative session as 95940 or 95941.

Q. How many units of G0453 may be billed per hour? 

A.  Under Medicare, total billed units for G0453 for all Medicare patients may not sum to more than the total time available. For example, when  more than one 15-minute timed code is billed during a single  hour, then the total number of timed units that can be billed for that hour across all Medicare patients is constrained by 60 minutes, or 4 units of G0453. Physicians may use the method of their choice to allocate time to patients being simultaneously monitored subject to the above restriction (only one unit of service can be billed for a 15- minute increment of time).  The physician’s attention does not have to be continuous for a 15-minute block of time; the physician may add up any non-continuous time directed at one patient to determine how many units of G0453 may be billed

.  If Medicare and non -Medicare patients are being seen, physicians must account for the exclusive, non-continuous time spent monitoring Medicare patients when billing Medicare.


General CPT instructions for time d codes indicate that a unit of time is attained when the mid -point is passed. Medicare recognizes this CPT guidance for many timed codes, including G0453. Therefore, physicians may bill for one unit of G0453 if at least 8 minutes of service is provided as long as no more than 4 units of G0453 are billed for each 60 minutes


Intraoperative Neurophysiologic Monitoring

Introduction

Tests can be done on specific nerves during complex brain, spine, and neck surgeries to help make sure the nerves are not being harmed. This is known as intraoperative neurophysiologic monitoring (IONM). There are a number of ways to perform this monitoring. It often involves the use of sophisticated medical devices to assess the muscle or electrical response when a nerve is stimulated. The goal is to provide the surgeon with immediate feedback about whether a nerve is at risk of being injured. The surgeon can make a correction right away to avoid permanent damage. This type of monitoring is well proven in specific types of surgeries. Some surgeons are using IONM during surgery for nerves located outside of the brain and spinal cord (the peripheral nerves). There is not enough medical evidence to show whether IONM leads to better health results when used for the peripheral nerves. For this reason, IONM is considered not medically necessary for peripheral nerve surgery.

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


Intraoperative Monitoring

* Somatosensory-evoked potentials
* Motor-evoked potentials using transcranial electrical stimulation
* Brainstem auditoryevoked potentials
* Electromyography (EMG) of cranial nerves
* Electroencephalography * Electrocorticography
* EMG

Medical Necessity

The types of Intraoperative neurophysiologic monitoring, listed on the left, may be considered medically necessary when there is significant risk of nerve or spinal cord injury during the following spinal, intracranial, vascular or recurrent laryngeal nerve surgical procedures: (this list may not be all inclusive) *  Aortic, thoracic, and abdominal aneurysm repair * Aortic cross-clamping * Arteriovenous malformation repair of the spinal cord * Brachial plexus surgery * Cerebral vascular surgery (eg, carotid endarterectomy, cerebral  aneurysm) * Clipping of intracranial aneurysms * Cortical localization * Interventional neuroradiology * Pelvic fracture surgery * Release of a tethered cord * Repair of coarctation of the aorta * Resection of fourth ventricular cyst * Resection of intracranial vascular lesions * Resection of spinal cord tumor, cyst, or vascular lesion * Scoliosis correction with instrumentation * Surgical stabilization of spine fractures * Stereotactic surgery of the brain or brain stem, thalamus, or  cerebral cortex * Thalamus tumor resection or thalamotomy * Thyroid surgery * Anterior cervical spinal fusions * Thoracic spine surgery  Intraoperative neurophysiologic monitoring for ANY other indication, including during lumbar surgery below L1/L2 is considered not medically necessary. (see Related Information)  The types of intraoperative neurophysiologic monitoring,


Intraoperative Monitoring

* Nerve conduction velocity monitoring

Intraoperative Monitoring
* Somatosensory-evoked potentials
* Motor-evoked potentials using transcranial electrical stimulation
* Brainstem auditoryevoked potentials
* Electromyography (EMG) of cranial nerves
* Electroencephalography * Electrocorticography

Motor-evoked potentials using transcranial magnetic stimulation

Coding 

Medical Necessity

listed on the left during surgery on the peripheral nerves are considered not medically necessary.

Investigational

The types of intraoperative neurophysiologic monitoring, listed on the left during the following surgical procedure is considered investigational: * Esophageal surgeries

Due to the lack of monitors approved by the U.S. Food and Drug Administration, intraoperative monitoring of motorevoked potentials using transcranial magnetic stimulation is considered investigational.



Related Information 
 
These policy statements refer only to use of these techniques as part of intraoperative monitoring. Other clinical applications of these techniques, such as visual-evoked potentials and EMG, are not considered in this policy.

Intraoperative neurophysiological monitoring is indicated in select spine surgeries when there is risk for additional spinal cord injury. Intraoperative monitoring has not been shown to be of clinical benefit for routine lumbar or cervical nerve root decompression (AANEM 2014), or during routine lumbar or cervical laminectomy or fusion (AANEM, 1999a) in the absence of myelopathy or other complicating conditions, which could increase the potential risk of damage to the nerve root or spinal cord, Resnick et al (2005) in published guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine reported that based on the medical evidence of the literature reviewed there did not appear to be support for the hypothesis that any form of intraoperative monitoring improves patient outcomes following lumbar decompression or fusion procedures for degenerative spinal disease. The authors concluded in a 2014 update there was no evidence that intraoperative monitoring can prevent injury to the nerve roots.

Intraoperative neurophysiologic monitoring including somatosensory-evoked potentials and motor-evoked potentials using transcranial electrical stimulation, brainstem auditory-evoked potentials, electromyography of cranial nerves, electroencephalography, and electrocorticography has broad acceptance, particularly for spine surgery and open abdominal aorta aneurysm repairs. Additionally, this policy addresses monitoring of the recurrent laryngeal nerve during neck surgeries and monitoring of peripheral nerves.

Intra-operative monitoring is considered reimbursable as a separate service only when a licensed physician, other than the operating surgeon, performs the monitoring while in attendance in the operating room or present by means of a real-time remote mechanism and is immediately available to interpret the recording and advise the surgeon throughout the procedure.
Intra-operative monitoring consists of a physician monitoring not more than three cases simultaneously.

Constant communication between surgeon, neurophysiologist, and anesthetist are required for safe and effective intraoperative neurophysiologic monitoring.

ACES Program Codes

Some provider groups rely on the ACES program codes to help them determine if the client is on a state-only program or is on a Washington Apple Health Medicaid program to identify their funding sources. The following table lists these program codes.

SSI and SSI Related SSI and SSI related, also called Aged/Blind/Disabled (ABD); disability is determined by SSA or by NGMA referral to DDDS 

ACES DESCRIPTION  SCOPE 

S01 SSI Recipients CN
S02 ABD Categorically Needy CN
S03 QMB  Medicare Savings Program (MSP)  Medicare premium and co-pays MSP
S04 QDWI Medicare Savings Program   MSP
S05 SLMB Medicare Savings Program. Medicare Premium only  MSP
S06 QI-1 (ESLMB) Medicare Savings Program  MSP
S07 Undocumented Alien. Emergency Related Service Only ERSO 
S95 Medically Needy no Spenddown MN
S99 Medically Needy with Spenddown MN SSI Related
Living in an alternate living facility (nonmedical institution) adult family home, boarding home or DDA group home.


SSI Related Healthcare for Workers With Disability

Institutional  HCBS Waivers (HCS/DDA) and Hospice; SSI related  G03
Non Institutional Medical in ALF CN-P Income under the SIL plus under state rate x 31 days + 38.84
G95 Medically Needy Non Institutional in ALF no spenddown MN
G99 Medically Needy Non Institutional  in ALF with Spenddown MN
S08  Healthcare for Workers with Disability CN-P Premium based program.  Substantial Gainful Activity (SGA) not a factor in Disability determination.  
L21 Categorically Needy DDA/HCS Waiver or Hospice on SSI CN  L22
L24  Categorically Needy DDA/HCS Waiver or Hospice – gross income under the SIL Undocumented Alien/Non-Citizen LTC - residential placement. Must be preapproved by ADSA program manager. Emergency Related Service Only (45 slots)
L31 PACE or hospice on SSI (effective 10/1/15) CN
L32 PACE or hospice – SSI-related (effective 10/1/15) CN
L41 Roads to Community Living on SSI (effective 10/1/15) CN
L51 Community First Choice (CFC) on SSI (effective 10/1/15) CN
L52  Community First Choice (CFC) – SSI related at home or in an ALF (effective 10/1/15)
L99 Medically Needy Hospice in Medical Institution.  With Spenddown MN Institutional  SSI  L01
SSI recipient in a Medical Institution - Residing in a medical institution 30 days or more
CN Institutional
SSI Related Residing in a medical institution 30 days or more   
L02 SSI related CN-P in a Medical Institution Income under the SIL CN  L04  L95
L99  Undocumented Alien/Non-Citizen LTC must be pre-approved by ADSA program manager. Emergency Related Service Only (45 slots)
SSI related Medically Needy no Spenddown Income over the SIL. Income under the state rate.
SSI related Medically Needy with Spenddown Income over the SIL. Income over the state rate but under the private rate. Locks into state NF rate  CN  CN
ERSO – CN scope  CN
ERSO – CN scope  MN  MN


Categorically Needy Program (CNP)

This program has the largest scope of care.  A few of the services are:doctors, dentists, physical therapy, eye exams, eyeglasses (children only), mental health, prescriptions, hospitals, and family planning for men, women, and teens. There is limited coverage for maternity case management, orthodontia, private duty nursing, and psychological evaluations.Chiropractic care and nutrition therapy are limitedto the Healthy Kids program.


Alternative Benefits Plan (ABP)

This program is available to persons eligible to receive health care coverage under Washington Medicaid’s Modified Adjusted Gross Income (MAGI)-based adult coverage.  The scope of services available is equivalent to that available to CNP-covered clients with the addition of a benefit for habilitative services.  Washington Administrative Code (WAC) program policies are applicable to this new eligibility group, as are the instructions in the ProviderOne Billing & Resource Guide and program-specific provider guides.  This client population does not include those eligible for Medicare.


Emergency Related Services Only (ERSO) –PA may be required


This program has coverage for only specific medical conditions: a qualifying emergency, end stage renal disease on dialysis, cancer actively receiving treatment, or post-transplant status on anti-rejection medications. Prior authorization for some services may be required. Services not related to the medical condition are not covered. HCA determines if the client has a qualifying condition for any of these programs in accordance with the Washington Administrate Code (WAC) criteria. For specific details please see Chapter 182 - 507 WAC


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Take Charge –Family Planning Service Only (TCFPO)

This program is for both women and men.It covers family planning services such as annual examinations, family planning education and risk reduction counseling, FDA approved contraceptive methods such as birth control pills and IUDs, emergency contraception,and sterilization procedures.

Family Planning Services Only (FPSO)

This program is  for women. Services includecoverage for all birth control methods, sterilization, OB-GYN exams, and counselingto help with family planning.

Medical Care Services (MCS) -no out of state care

This program covered many of the most basic services such as doctor's visits, prescriptions, and hospitalizations. However, some services, such as dental and mental health treatment may have restrictions that require prior authorization or may not be covered. This benefit was previously known as General Assistance (GA) and Disability Lifeline (DL).

Alcoholism and Drug Addiction Treatment and Support Act (ADATSA) -no out of state care

This program covered many of the most basic services such as doctor's visits, prescriptions, and hospitalizations.However, some services, such as dental and mental health treatment may have restrictions that require prior authorization or may not be covered.Coverage is equivalent to Medical Care Services (MCS) below, with the addition of treatment for alcohol and drug addiction.


Limited Casualty Program – Medically Needy Program (LCP-MNP)

This program covers many medical services. A few of the services are:doctors, dentists, eye exams, eye glasses (children only), mental health , prescriptions, and hospitals, family planning for men, women, and teens.There are some services that are not covered, such as physical therapy.There are also limited services: maternity case management is one example. Chiropractic care and nutrition therapy are limited to the Healthy Kids program.