(Medicare Claims Processing Manual)

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.  Group Code: CO  CARC: 107  RARC: N.A  MSN: N/A   80.3.3  Special Requirements for Immunosuppressive Drugs (Rev.  3932, Issued: 12- 08-17, Effective: 08 -01-16, Implementation: 03- 09-18) Inpatient facilities (for example hospitals) are responsible for providing drugs during a beneficiarys inpatient stay. However, once the beneficiary has returned home, Part B suppliers (including pharmacies) provide immunosuppressive drugs, and the DME MACs make payments for Part B covered immunosuppressive drugs.  Under normal circumstances, the date of service listed on a suppliers claim must be the date the supplier actually delivered or mailed the item. However, suppliers that utilize mail- order delivery may wish to mail immunosuppressive drug prescriptions one or two days prior to the date that a beneficiary will be discharged from an inpatient facility, so that the drugs will be available at the beneficiarys home immediately after the beneficiary returns. In this situation, the systems will reject the supplier s immunosuppressive drug claim because the date of service precedes the beneficiarys  date of discharge; the hospital remains responsible for the provision of immunosuppressive drugs while the beneficiary is still an inpatient.  In order to obtain payment for immunosuppressive drug prescriptions that have been mailed one or two days before a beneficiarys discharge, the supplier may enter the date of discharge as the date of service on the first claim it submits for the beneficiar y after the beneficiary is discharged from an inpatient facility. Note that this is an optional, not mandatory, process. If the supplier chooses not to mail the immunosuppressive drug(s) prior to the beneficiarys date of discharge from the hospital, they may wait for the beneficiary to be discharged before delivering the drugs, and follow all applicable Medicare and DME MAC rules for immunosuppressive drug billing (for example, the date of service will be the date of delivery).  Note that the following conditions also apply:  1) The facility remains responsible for all immunosuppressive drugs required by the beneficiary for the duration of the beneficiarys inpatient stay. The supplier must not receive separate payment for immunosuppressive drugs prior to the date the beneficia ry is discharged.  2) The supplier must not mail or otherwise dispense the drugs any earlier than 2 days before the beneficiary is discharged. It is the suppliers responsibility to confirm the beneficiarys discharge date if they choose to take advantage of this option. 3) The supplier must not submit a claim for payment prior to the beneficiarys date of discharge.  4) The beneficiarys discharge must be to a qualified place of service (for example, home, or custodial facility), but not to another facility (for example, inpatient hospital or skilled nursing facility) that does not qualify as the beneficiarys home.      80.4 - Billing for Hemophilia Clotting Factors  (Rev. 1564, Issued: 07- 25-08, Effective: 04 -01-08, Implementation: 01- 05-09)  Blood clotting factors not paid on a cost or prospective payment system basis are priced as a drug/biological under the drug pricing fee schedule effective for the specific date of service.  As of January 1, 2005, the average sales price (ASP) plus 6 perce nt shall be used.  If a beneficiary is in a covered part A stay in a PPS hospital, the clotting factors are paid in addition to the DRG/HIPPS payment.  For FY 2005, this payment is based on 95 percent of AWP.  For FY 2006, the add- on payment for blood clotting factor adminis tered to hemophilia inpatients is based on average sales price (ASP) + 6 percent and a furnishing fee.  The furnishing fee is updated each calendar year.  For a SNF subject to SNF/PPS, the payment is bundled into the SNF/PPS rate.   For hospitals subject to OPPS, the clotting factors, when paid under Part B, are paid the APC.  For SNFs the clotting factors, when paid under Part B, are paid based on cost.  A/B MACs (B) shall process non- institutional blood clotting factor claims.   The A/B MACs (A) shall process institutional blood clotting factor claims (Part A and Part B institutional).   80.4.1 - Clotting Factor Furnishing Fee  (Rev. 1 2201; Issued:0 8-10-23; Effective: 01 -01-24; Implementation: 01 -02-24)  The Medicare Modernization Act section 303(e)(1) added section 1842(o)(5)(C) of the Social Security Act which requires that, beginning January 1, 2005, a furnishing fee will be paid for items and services associated with clotting factor.   Beginning January 1, 2005, a clotting factor furnishing fee is separately payable to entities that furnish clotting factor unless the costs associated with furnishing the clotting factor is paid through another payment system.   The clotting factor furnishing fee is updated each calendar year based on the percentage increase in the consumer price index (CPI) for medical care for the 12 -month period ending with June of the previous year. The clotting factor furnishing fees applicable for dates of service in each calendar year (CY) are listed below:   CY 2005 - $0.140 per unit  CY 2006 - $0.146 per unit  CY 2007 - $0.152 per unit  CY 2008 - $0.158 per unit  CY 2009 - $0.164 per unit  CY 2010 - $0.170 per unit  CY 2011 - $0.176 per unit  CY 2012 - $0.181 per unit  CY 2013 - $0.188 per unit  CY 2014 - $0.192 per unit  CY 2015 - $0.197 per unit  CY 2016 - $0.202 per unit  CY 2017 - $0.209 per unit  CY 2018 - $0.215 per unit  CY 2019 - $0.220 per unit  CY 2020 - $0.226 per unit  CY 2021 - $0.238 per unit  CY 2022 - $0.239 per unit  CY 2023 - $0.250 per unit  CY 2024 - $0.250 per unit   Annual updates to the clotting factor furnishing fee are  subsequently communicated by a Recurring Update Notification .    CMS includes this clotting factor furnishing fee in the nationally published payment limit for clotting factor billing codes. When the clotting factor is not included on the Average Sales Price (ASP) Medicare Part B Drug Pricing File or Not Otherwise Class ified (NOC) Pricing File, the contractor must make payment for the clotting factor as well as make payment for the furnishing fee.   80.5 - Self-Administered Drugs  (Rev. 1539:  Issued:  06- 20-08; Effective/Implementation Date:  07 -21-08)  See Pub. 100- 02, Medicare Benefit Policy Manual, chapter 15, section 50.2.  80.6 - Intravenous Immune Globulin  (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)   Beginning for dates of service on or after January 1, 2004, Medicare pays for intravenous immune globulin administered in the home.  (See the Medicare Benefit Policy Manual, Chapter 15 for coverage requirements.)  Contractors pay for the drug, but not the items or services related to the administration of the drug when administered in the home, if deemed medically appropriate.   Contractors may pay any entity licensed in the State to furnish intravenous immune globulin.  Payment will be furnished to the entity with the authority to furnish the drug. intravenous immune glogulin Beneficiaries are ineligible to receive payment for the drug.   Pharmacies and hospitals dispensing intravenous immune globulin for home use would bill the DME MAC.  If the beneficiary is receiving treatment in an outpatient hospital, the bill must be sent to the A/B MAC (A).  If the beneficiary is receiving treatment in a physicians office, the bill must be sent to the A/B MAC (B).  Home Health Agencies dispensing intravenous immune globulin would bill the A/B MAC (HHH).  Physicians furnishing intravenous immune globulin for the refilling of an external pump for home infusion would bill the DME MAC.  Effective January 1, 2006, Medicare makes an additional payment once per day per beneficiary for preadministration- related services whenever a beneficiary receives intravenous immune globulin.  80.7 - Pharmacy Supplying Fee and Inhalation Drug Dispensing Fee  (Rev. 754, Issued: 11- 10-05, Effective: 01 -01-06, Implementation: 01- 03-06)  Section 303(e) (2) of the MMA implements a supplying fee for immunosuppressive drugs, oral anti -cancer chemotherapeutic drugs, and oral anti -emetic drugs used as part of an anti -cancer chemotherapeutic regimen.  Effective January 1, 2005, Medicare paid a separately billable supplying fee of $24.00 to a pharmacy, dialysis facility in the State of  Washington or any hospital outpatient department not subject to the OPPS  for each supplied prescription of the above -mentioned drugs.  In addition, Medicare also paid a separately billable supplying fee of $50.00 for the initial supplied prescription of the immunosuppressive drugs during the first month following the patients  transplant.  Effective January 1, 2006, we are changing the supplying fee when multiple prescriptions are supplied in a 30- day period.  Medicare will pay $24 for the first prescription of the above -mentioned drugs supplied by a pharmacy in a 30- day period, and will pay $16 for each subsequent prescription, after the first one, supplied in that 30- day period.  A pharmacy will be limited to one $24 fee per 30- day period even if the pharmacy supplies more than one category of the abovementioned drugs (for example, an oral -anticancer drug and an oral anti -emetic drug) to a beneficiary.  If two different pharmacies supply the above -mentioned drugs to a beneficiary during a 30- day period, each pharmacy will be eligible for one $24 supplying fee for the first prescription suppl ied during that 30- day period, and a supplying fee of $16 for each subsequent prescription supplied in that 30-day period.  For a refill prescription, Medicare will allow payment of a $24 supplying fee to a particular supplier up to seven days before the e nd of the 30 -day period for which the last $24 supplying fee was paid to that supplier; however, each supplier will be limited to twelve $24 supplying fees per beneficiary per year.  Medicare will pay a supplying fee for each prescription, including prescriptions for different strengths of the same drug supplied on the same day (for example, a prescription for 100 mg tablets and 5 mg Tablets).  These changes do not alter the one -time $50 supplying fee for the first immunosuppressive prescription after a tra nsplant.