(Medicare Claims Processing Manual)

If the claim for an anti -emetic drug is denied because FDA did not approve it, the contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.   Group Code: CO  CARC: 114  RARC: N/A  MSN:  6.2   If the claim for an anti -emetic drug is denied because the drug is not being used as part of an anticancer chemotherapeutic regimen, the contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.   Group Code: CO  CARC: 96  RARC: M100  MSN:  6.4  80.2.4 - Billing and Payment Instructions for A/B MACs (A)  (Rev. 3085, Issued: 10- 03-14, Effective: ICD -10: Upon Implementation of ICD -10; ASC X12: January 1, 2012, Implementation: ICD -10: Upon Implementation of ICD -10; ASC X12: November 4, 2014)   Claims for the oral anti- emetic drug aprepitant, either as a 3 -day supply dispensed in a Tri -Pak or as the first day supply (not dispensed in a Tri -Pak), must be billed to the A/B MAC (A) on the ASC 837 institutional claim format or on hard copy Form CMS -1450 with the appropriate cancer diagnosis and HCPCS code or Current Procedural Terminology (CPT) code.   Claims for the second and third dose of the oral anti -emetic drug aprepitant not dispensed in a Tri -Pak must be billed to the DME MAC.   The following payment methodologies apply when hospital and SNF outpatient claims are processed by the A/B MAC (A):    Based on APC for hospitals subject to the outpatient prospective payment system (OPPS);    Under current payment methodologies for hospitals not subject to OPPS; or    On a reasonable cost basis for SNFs.   Institutional providers bill for aprepitant under Revenue Code 0636 (Drugs requiring detailed coding).   NOTE:   Inpatient claims submitted for oral anti- emetic drugs are processed under the current payment methodologies.  Medicare contractors shall pay claims submitted for services provided by a CAH as follows:  Method I technical services are paid at 101% of reasonable cost; Method II technical services are paid at 101% of reasonable cost, and, Professional services are paid at 115% of the Medicare Physician Fee Schedule Data Base.   80.3 - Billing for Immunosuppressive Drugs  (Rev.11764, Issued: 12-22-2022; Effective:01-01- 23; Implementation:01-03 -23 )  Medicare covers a beneficiarys immunosuppressive drugs following a transplant, in accordance with 1861(s)(2)(J) of the Social Security Act, which states that Medicare covers prescription drugs used in immunosuppressive therapy furnished to an individual who receives an organ transplant for which payment is made under this title.   Medicare pays for FDA approved immunosuppressive drugs and for drugs used in immunosuppressive therapy with specific restrictions.  (See 42 CFR 430.10 and the Medicare B enefit Policy Manual, Chapter 15 for detailed coverage requirements. )  Generally, contractors pay for self -administered immunosuppressive drugs that are specifically labeled and approved for marketing as such by the FDA, or identified in FDA -approved labeling for use in conjunction with immunosuppressive drug therapy.  This benefit is subjec t to the Part B deductible and coinsurance provision.  Contractors are expected to keep informed of FDA additions to the list of the immunosuppressive drugs and notify providers.  Prescriptions for immunosuppressive drugs generally should be non- refillable and limited to a 30 -day supply.  The 30- day guideline is necessary because dosage frequently diminishes over a period of time, and further, it is not uncommon for the physician to change the prescription from one drug to another.  Also, these drugs are expensive and the coinsurance liability on unused drugs c ould be a financial burden to the beneficiary.  Unless there are special circumstances, contractors will not consider a supply of drugs in excess of 30 days to be reasonable and necessary and should deny payment accordingly.  Entities that normally bill the A/B MAC (B) bill the DME MAC.  Entities that normally bill the A/B MAC (A) continue to bill the A/B MAC (A), except for hospitals subject to OPPS, which must bill the DME MAC.   Prior to December 21, 2000 coverage was limited to immunosuppressive drugs received within 36 months of a transplant.  In practice, ESRD beneficiaries continue to be limited to 36 months of coverage after a Medicare covered kidney transplant because their Medicare entitlement would end 36 months after a successful organ transplant.  See 42 CFR 406.13(f)(2). Effective with immunosuppressive drugs furnished on or after December 21, 2000, there is no time limit, but an organ transplant must have occurred for w hich immunosuppressive therapy is appropriate.  That is, the time limit for immunosuppressive drugs was eliminated for transplant beneficiaries that will continue Medicare coverage after 36 months based on disability or age.  In 2020, section 402 of the Consolidated Appropriations Act (CAA) amended sections 226(a), 1836, 1837, 1838, 1839, 1844, 1860- D-1, 1902, and 1905 of the Act to make an exception for eligibility for enrollment under Medicare Part B solely for the purposes of coverage of immunosuppressive drugs described in section 1861(s)(2)(J) of the Act. Effective January 1, 2023, this provision allows individuals whose Medicare entitlement based on ESRD ends 36 months after the month in which they received a successful kidney transplant to continue enrollment under Medicare Part B only for the coverage of immunosuppressive drugs described in section 1861(s)(2)(J) Act without a time limit. T his benefit is referred to as the Part B immunosuppressive drug benefit or Part B -ID or PBID.  For additional information on PBID eligibility please see section 40.9.1 of IOM publication 100- 01, chapter 2.   The date of transplant is reported to the A/B MAC (A) with occurrence code 36.  CWF will edit claim records to determine if a history of a transplant is on record.  If not an error will be returned.  See Chapter 27 for edit codes and resolution.  As explained below, there are circumstances in which Medicare cannot locate the Medicare claim for the transplant in the claims databases which would have confirmed that Medicare paid for the transplant. In such cases, where the supplier appropriately subm its the KX modifier, Medicare makes the assumption that Medicare paid for the transplant, in accordance with the statute, that the supplier has on file documentation that indicates the date of the transplant, and that the services furnished are medically n ecessary.   The use of the KX modifier is not required. In the case of immunosuppressive drugs, submission of the KX modifier is intended for adjudicating claims when the supplier attests that it maintains documentation that the beneficiary was eligible for Medicare P art A on the date of his/her transplant, but where Medicare cannot identify a claims record indicating the transplant was paid for by fee -for-service Medicare. The additional information provided by the use of the KX modifier permits Medicare to reasonably assume that a Medicare payment for an organ transplant was made.   For claims received on and after July 1, 2008, DME MACs will accept claims for immunosuppressive drugs without a KX modifier but will deny such claims if CMS cannot identify a record of a claim indicating that the transplant was paid for by fee -for-service Medicare.   For claims filed with the KX modifier on and after July 1, 2008, suppliers that furnish an immunosuppressive drug to a Medicare beneficiary, when such drug has been prescribed due to the beneficiary having undergone an organ transplant, must: 1) secure from the prescriber the date of such organ transplant and retain documentation of such transplant date in its files, 2) attest that it has on file documentation that the beneficiary was eligible to receive Medicare Part A benefits at the particular date of the transplant and retain the documentation in its files, and 3) retain such documentation of the beneficiarys transpl ant date, Medicare Part A eligibility, and that such transplant date precedes the Date of Service (DOS) for furnishing the drug.   Use of the KX modifier permits Medicare to make a reasonable assumption that Medicare paid for the transplant even when the transplant claim does not appear in the claims database. A claim may not appear in the claims database for reasons such as:   1. At the time of the transplant, the beneficiary was enrolled in a Medicare  Advantage plan that paid for the transplant.  Medicare Advantage data is not included in the Medicare FFS claims database. Although some encounter data may be available, it may be i ncomplete or may not contain coding information sufficient to identify a transplant claim.  2. There may be instances where claims related to a transplant are old and may not be identifiable in the claims database despite Medicares payment for the claim.  1. Medicares payment for the claim.   80.3.1 - Requirements for Billing A/B MAC (A) for Immunosuppressive Drugs  (Rev. 3085, Issued: 10- 03-14, Effective: ICD -10: Upon Implementation of ICD -10; ASC X12: January 1, 2012, Implementation: ICD -10: Upon Implementation of ICD -10; ASC X12: November 4, 2014)   Hospitals not subject to OPPS bill on ASC X12 837 institutional claim format or paper Form CMS -1450 (if approved) with bill type 12x (hospital inpatient Part B) or l3x (hospital outpatient) as appropriate.   For claims with dates of service prior to April 1, 2000, providers report the following entries:    Occurrence code 36 and date;    Revenue code 0250; and    Narrative description.  NOTE:   Information regarding the claim form locators that correspond with these fields is found in Chapter 25.  For claims with dates of service on or after April 1, 2000, hospitals report:    Occurrence code 36 and date;    Revenue code 0636;    HCPCS code of the immunosuppressive drug; and    Number of units (the number of units billed must accurately reflect the definition of one unit of service in each code narrative.  E.g.,: If fifty 10- mg.  Prednisone tablets are dispensed, the hospital bills J7506, 100 units (1 unit of J7506 = 5 mg.).  NOTE:   Information regarding the claim form locators that correspond with these fields is found in Chapter 25.  The hospital completes the remaining items in accordance with regular billing instructions.  80.3.2 - MSN/Remittance Messages for Immunosuppressive Drugs  (Rev. 3721, Issued: 02- 24-17, Effective: 05 -25-17, Implementation: 05- 25-17)   Remittance codes/messages for denied Immunosuppressive Drugs are as follows:    If the immunosuppressive drug is not approved by the FDA, contractor shall deny the claim. The contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.   Group Code: CO  CARC: 114  RARC: N.A  MSN: 6.2   If the claim is denied because the benefit period has expired or because of the 30 day limitation, the contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scenario Three.   Group Code: CO  CARC: 35  RARC: N.A  MSN: 4.3  If the claim is denied for the immunosuppressive drug because a transplant was not covered, the contractor shall use the following remittance advice messages and associated codes when rejecting/denying claims under this policy. This CARC/RARC combination is compliant with CAQH CORE Business Scenario Two.