CMS Revises Policies for Drugs, Pharmaceuticals and Radiopharmalogicals

The Outpatient Prospective Payment System (OPPS) final rule updates payment policies and rates for drugs, biologicals, and radiopharmaceuticals furnished in HOPDs.

Packaging threshold for drugs and biologicals. Under the OPPS, CMS includes payment for many drugs and biologicals in the payment for the associated procedure in which the drug is administered. However, CMS makes separate payment for drugs and biologicals with estimated per day costs greater than the OPPS drug packaging threshold, which is a dollar amount specified in the rule. For CY 2009, the OPPS drug packaging threshold is $60. As in CYs 2007 and 2008, CMS has updated the drug packaging threshold based on the Producer Price Index (PPI) for prescription drugs, rounded to the nearest $5 increment.

Payment for separately payable drugs and biological. CMS will pay for separately payable drugs and biologicals at the manufacturer’s average sales price (ASP) plus 4 percent in CY 2009. Based on hospitals’ CY 2007 claims and most recent cost report data, CMS calculated hospitals’ average costs for drugs and biologicals (including both drug acquisition and pharmacy overhead costs) to be equivalent to ASP plus 2 percent. However, similar to CY 2008, CMS is continuing the transition to a claims-based payment rate for separately payable drugs and biologicals. For CY 2009, CMS will pay for these drugs and biologicals at a transitional rate of ASP plus 4 percent determined by blending the CY 2008 payment rate of ASP plus 5 percent and the rate from claims data of ASP plus 2 percent. This transitional payment will provide a single payment for hospital drug acquisition and associated pharmacy overhead costs, consistent with standard OPPS practice.

Pass-through payment for drugs and biological. CMS provides transitional pass-through payments for certain new drugs, biologicals, and radiopharmaceuticals for a period of at least two but not more than three years. CMS will continue to pay for pass-through drugs and biologicals at ASP plus 6 percent in CY 2009, equivalent to the rate these drugs and biologicals would receive in the physician’s office.

Payment for therapeutic and diagnostic radiopharmaceuticals. CMS will continue to pay for therapeutic radiopharmaceuticals at charges adjusted to cost for CY 2009. CMS will also continue to package payment for all diagnostic radiopharmaceuticals, which are used to perform a diagnostic nuclear medicine study, into the APC payment for their associated nuclear medicine procedures. Accordingly, CMS calculated the CY 2009 payment rates for nuclear medicine procedures using only those claims that include a charge for a required diagnostic radiopharmaceutical or other radioactive product. While currently no radiopharmaceutical products have pass-through status, CMS will pay for all new therapeutic radiopharmaceuticals that are granted pass-through status at charges adjusted to cost. If a diagnostic radiopharmaceutical is granted pass-through status in CY 2009, CMS will provide separate payment at ASP plus 6 percent.

Payment for IV immune globulin preadministration-related services> For CY 2009, CMS is packaging payment for IVIG preadministration-related services, rather than making a separate payment for these services as CMS did on a temporary basis from CY 2006 to CY 2008. Because it appears that market for IVIG has become more stable, the OPPS will now package the payment for IVIG preadministration-related services with the payment for the associated IVIG drug administration procedures, consistent with OPPS rule for the administration of other drugs and biologicals.

Payment for drug-administration services. CMS is restructuring the drug administration APCs from a 6-level into a 5-level structure for CY 2009 to more closely align payment to hospital claims data. This structure places the Current Procedural Terminology (CPT) codes for drug administration into five levels that are based on logical, clinically coherent principles and are consistent with observed differences in hospital resource costs, both across levels and within each level. Hospitals will continue to report CPT codes for drug administration services, and the five-level APC structure will continue to pay hospitals separately for each additional hour of infusion, in addition to the initial hour payment.

More detail on these changes is available here. The final rule with comment will appear in the Nov. 18 Federal Register. Comments on designated provisions are due by 5:00 p.m. Eastern on Dec. 29, and a final rule responding to the comments will be published at a later date. Get more information on the CY 2009 final rule with comment period for the OPPS.

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