Drugs, Biologicals, and Radiopharmaceuticals

90.2 - Drugs, Biologicals, and Radiopharmaceuticals (Rev. 4204, Issued: 01-17-19, Effective: 01-01-19, Implementation: 01-07-19) A. General Billing and Coding for Hospital Outpatient Drugs, Biologicals, and Radiopharmaceuticals Hospitals should report charges for all drugs, biologicals, and radiopharmaceuticals, regardless of whether the items are paid separately or packaged, using the correct HCPCS codes for the items used. It is also of great importance that hospitals billing for these products make certain that the reported units of service of the reported HCPCS code are consistent with the quantity of a drug, biological, or radiopharmaceutical that was used in the care of the patient. Payment for drugs, biologicals and radiopharmaceuticals under the OPPS is inclusive of both the acquisition cost and the associated pharmacy overhead or nuclear medicine handling cost. Hospitals should include these costs in their line-item charges for drugs, biologicals, and radiopharmaceuticals. Under the OPPS, if commercially available products are being mixed together to facilitate their concurrent administration, the hospital should report the quantity of each product (reported by HCPCS code) used in the care of the patient. Alternatively, if the hospital is compounding drugs that are not a mixture of commercially available products, but are a different product that has no applicable HCPCS code, then the hospital should report an appropriate unlisted drug code (J9999 or J3490). In these situations, it is not appropriate to bill HCPCS code C9399. HCPCS code C9399, Unclassified drug or biological, is for new drugs and biologicals that are approved by FDA on or after January 1, 2004, for which a specific HCPCS code has not been assigned. The HCPCS code list of retired codes and new HCPCS codes reported under the hospital OPPS is published quarterly via Recurring Update Notifications. The latest payment rates associated with each APC and HCPCS code may be found in the most current Addendum A and Addendum B, respectively that can be found under the CMS quarterly provider updates on the CMS Web site at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/HospitalOutpatientPPS/index.html Future updates will be issued in a Recurring Update Notification. B. Pass-Through Drugs, Biologicals, and Radiopharmaceuticals Payment for drugs, biologicals, and radiopharmaceuticals may be made under the pass- through provision which provides additional payments for drugs, biologicals, and radiopharmaceuticals that meet certain requirements relating to newness and relative costs. According to section 1833(t) of the Social Security Act, transitional pass-through payments can be made for at least 2 years, but no more than 3 years. For the process and information required to apply for transitional pass-through payment status for drugs, biologicals, and radiopharmaceuticals, go to the main OPPS Web page, currently at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/HospitalOutpatientPPS/index.html to see the latest instructions. (NOTE: Due to the continuing development of the new cms.hhs.gov Web site, this link may change.) Payment rates for pass-through drugs, biologicals, and radiopharmaceuticals are updated quarterly. The all-inclusive list of billable drugs, biologicals, and radiopharmaceuticals for pass-through payment is included in the current quarterly Addendum B. The most current Addendum B can be found under the CMS quarterly provider updates on the CMS website. C. Non Pass-Through Drugs and Biologicals Under the OPPS, drugs and biologicals that are not granted pass-through status receive either packaged payment or separate payment. Payment for drugs and biologicals with estimated per day costs equal to or below the applicable drug packaging threshold is packaged into the payment for the associated procedure, commonly a drug administration procedure. Drugs and biologicals with per day costs above the applicable drug packaging threshold are paid separately through their own APCs. D. Radiopharmaceuticals 1. General Beginning in CY 2008, the OPPS divides radiopharmaceuticals into two groups for payment purposes: diagnostic and therapeutic. Diagnostic radiopharmaceuticals function effectively as products that enable the provision of an independent service, specifically, a diagnostic nuclear medicine scan. Therapeutic radiopharmaceuticals are themselves the primary therapeutic modality. Beginning January 1, 2008, the I/OCE requires claims with separately payable nuclear medicine procedures to include a radiolabeled product (i.e., diagnostic radiopharmaceutical, therapeutic radiopharmaceutical, or brachytherapy source). Hospitals are required to submit the HCPCS code for the radiolabeled product on the same claim as the HCPCS code for the nuclear medicine procedure. Hospitals are also instructed to submit the claim so that the services on the claim each reflect the date the particular service was provided. Therefore, if the nuclear medicine procedure is provided on a different date of service from the radiolabeled product, the claim will contain more than one date of service. More information regarding these edits is available on the OPPS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/HospitalOutpatientPPS/index.html There are rare situations where a hospital provides a radiolabeled product to an inpatient, and then the patient is discharged and later returns to the outpatient department for a nuclear medicine imaging procedure but does not require additional radiolabeled product. In these situations, hospitals are to include HCPCS code C9898 (Radiolabeled product provided during a hospital inpatient stay) with a token charge (of less than $1.01) on the same claim as the nuclear medicine procedure in order to receive payment for the nuclear medicine procedure. HCPCS code C9898 should only be reported under the circumstances described above, and the date of service for C9898 should be the same as the date of service for the diagnostic nuclear medicine procedure. 2. Diagnostic Radiopharmaceuticals Beginning in CY 2008, payment for nonpass-through diagnostic radiopharmaceuticals is packaged into the payment for the associated nuclear medicine procedure. 3. Therapeutic Radiopharmaceuticals The OPPS will continue to pay for therapeutic radiopharmaceuticals at charges adjusted to cost from January 1, 2008 through December 31, 2009 E. Biosimilars The payment rate for biosimilars is calculated as the Average Sales Price (ASP) of the biosimilar described by the HCPCS code + 6 percent of the ASP of the biosimilar reference product. Biosimilars will also continue to be eligible for transitional pass- through payment for which payment will be made at ASP of the biosimilar described by the HCPCS code + 6 percent of the ASP of the biosimilar reference product. F. 340B-Acquired Drugs Beginning January 1, 2018, separately payable Part B drugs and biologicals (assigned status indicator “K”), other than vaccines (assigned status indicator “L” or “M”) and drugs and biologicals on pass-through payment status (assigned status indicator “G”), that are acquired through the 340B Program or through the 340B prime vendor program will be paid at the ASP minus 22.5 percent of the ASP of the drug or biological when billed by a hospital paid under the OPPS that is not excepted from the payment adjustment. Biosimilars that are acquired through the 340B Program or through the 340B prime vendor program will be paid at the ASP minus 22.5 percent of the ASP of the drug or biological when billed by a hospital paid under the OPPS that is not excepted from the payment adjustment. Hospital types that are excepted from the 340B payment policy in CY 2018 include rural sole community hospitals (SCHs), children’s hospitals, and PPS- exempt cancer hospitals. Critical Access Hospitals and Maryland waiver hospitals are not paid under the OPPS and therefore are not impacted by this policy. Medicare will continue to pay separately payable drugs and biologicals that were not purchased with a 340B discount at ASP+6 percent. In addition, effective January 1, 2018, hospitals paid under the OPPS that are not excepted from the 340B drug payment policy for CY 2018, are required to report modifier “JG”( (Drug or biological acquired with 340B Drug Pricing Program Discount) on the same claim line as the drug HCPCS code to identify a 340B-acquired drug. Since rural SCHs, children’s hospitals and PPS-exempt cancer hospitals are excepted from the 340B payment adjustment in CY 2018, these hospitals will be required to report informational modifier “TB” (Drug or Biological Acquired With 340B Drug Pricing Program Discount, Reported for Informational Purposes) for 340B-acquired drugs, and will continue to be paid ASP+6 percent.