Legislation to Ensure Patient Access to Innovative Imaging Drugs
A bill introduced in the 115th Congress, the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018, would modify current reimbursement rules and enable more appropriate payments for diagnostic radiopharmaceuticals used in molecular imaging procedures. Plans are underway to reintroduce the bill in the 116th Congress, sworn in at the beginning of January 2019.
Diagnostic radiopharmaceuticals assist physicians as they diagnose and determine the severity of potentially life-threatening diseases. These procedures improve diagnostic accuracy, which in turn help physicians develop treatment strategies to avoid potentially unnecessary procedures for multiple cancers such as prostate, lymphoma, colon, breast, melanoma, and lung. Radiopharmaceuticals also assist in the diagnosis of cardiac conditions and degenerative neurological diseases such as Parkinson’s and Alzheimer’s diseases.
Summary of the bill
MITA believes diagnostic radiopharmaceuticals should be reimbursed appropriately under the Hospital Outpatient Prospective Payment System (OPPS) to ensure that patients receive medically appropriate tests that provide the most accurate diagnosis and treatment plans. Specifically, this legislation:
- Directs the Secretary of HHS to pay separately for all diagnostic radiopharmaceuticals with a cost per day that exceeds $500 – which will safeguard access to new innovations;
- Ensures Medicare patients receive medically necessary studies their physicians prescribe at readily-accessible healthcare facilities;
- Supports innovations that enhance Medicare patient care, improve clinical outcomes, and deliver more cost efficient care; and
- Ensures that HHS implements these changes in a budget neutral manner.
Why is this bill important?
Molecular imaging benefits physicians and patients. Nuclear medicine and molecular imaging procedures are safe, painless, and cost-effective; they provide a way for physicians to gather medical information that would otherwise be unavailable. Physicians can determine—almost in real-time—the effectiveness of a treatment, allowing them to offer patients highly-targeted therapies and to ensure that higher doses of medicine are directed more precisely at problem areas.
Molecular imaging can help diagnose or determine most effective treatments for a number of diseases. Nuclear medicine and molecular imaging procedures are used in the diagnosis and evaluation of treatment of cancer, cardiovascular disease, gastrointestinal disorders, lung disorders, lymphoma, melanoma, Alzheimer’s disease, Parkinson’s disease, epilepsy, renal disorders and thyroid disorders.
Further innovation in radiopharmaceuticals may stall without payment reform. Diagnostic radiopharmaceuticals are necessary for all nuclear medicine and molecular imaging studies. In the Medicare Modernization Act (MMA) of 2003, Congress specifically designated radiopharmaceuticals as drugs. Under the Hospital Outpatient Prospective Payment System (OPPS), radiopharmaceuticals were paid separately.
In 2008, CMS interpreted the MMA provisions as expired and they began to “package” diagnostic radiopharmaceuticals into Ambulatory Payment Classifications (APCs). Diagnostic radiopharmaceutical costs may vary widely within a nuclear medicine procedure APC. The cost of some diagnostic radiopharmaceuticals significantly exceeds the APC payment rate (which is intended to cover both the diagnostic radiopharmaceutical cost and the procedure cost).