Council on Radionuclides and Radiopharmaceuticals, Inc.

CORAR advocates for public policies that impact health care, transportationsafety, homeland security, and manufacturing in an effort to expandaccess to safe and affordable health care treatments for all.

CORAR Supports Separate Payment for All Diagnostic Radiopharmaceuticals Under the Hospital Outpatient Prospective Payment System (OPPS)

CORAR has worked closely with Congress and the Centers for Medicare & Medicaid Services (CMS) in the past to support Medicare beneficiary access to appropriate nuclear medicine/nuclear cardiology procedures in all health care settings.  We are pleased that for services reimbursed under the Medicare physician fee schedule, Congress has long ensured that physicians are reimbursed separately for all radiopharmaceuticals administered in connection with nuclear medicine procedures.  In other words, a physician receives one payment for the office procedure in addition to reimbursement for the radiopharmaceutical, which varies based on the particular drug used.  CMS has followed Congressional directive in carrying out this policy.  Medicare contractors establish the payment basis for the radiopharmaceuticals, with some paying based on invoice cost and others using a percentage of average wholesale price (AWP). 

Unfortunately, in the hospital outpatient setting, CMS has not followed the Congressionally-mandated, statutory language to treat diagnostic radiopharmaceuticals the same as other types of drugs (including therapeutic radiopharmaceuticals) for payment purposes.  Instead, since 2008 CMS has considered diagnostic radiopharmaceuticals to be supplies, and it has packaged all diagnostic radiopharmaceutical costs into the hospital payment for the procedure.  In some cases, the procedural payment does not even cover the costs of the diagnostic RP alone, let alone adequately compensate the hospital for the cost of administering the nuclear medicine test plus furnish the RP.

CORAR supports separate payment of all diagnostic radiopharmaceuticals under OPPS and believes this policy will support medical advancements and patient access to innovative new diagnostic radiopharmaceuticals.  Separate payment will ensure adequate payment for important higher-cost, low-volume radiopharmaceuticals where the current packaged payment policy does not cover even a fraction of the radiopharmaceutical cost.  In addition, separate payment will support the White House national security initiative to encourage a reliable, adequate and sustainable supply of medical radioisotopes from non-Highly-Enriched Uranium (non-HEU) production sources, which is imposing new costs into the production and use of RPs derived from non-HEU sources.

Separate payment for all diagnostic radiopharmaceuticals under OPPS will ensure that CMS provides appropriate payment in the hospital outpatient setting that is consistent with other specified covered outpatient drugs as well as provide a consistent payment policy for diagnostic radiopharmaceuticals under both OPPS and the physician office setting.

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