The FIND Act — Access for patients to game-changing nuclear medicine procedures
June 03, 2022
By Geoffrey B. Johnson, Thomas A. Hope and Christina M. Arenas
Within the last year, we’ve seen two new imaging agents to detect prostate cancer and one revolutionary therapeutic. Although the science is state-of-the-art, the Medicare reimbursement policy for radiopharmaceuticals, particularly in the outpatient hospital setting, is lagging decades behind.
The bipartisan Facilitating Innovative Nuclear Diagnostics (FIND) Act will rectify reimbursement and ensure that patients have access to cost-effective nuclear medicine procedures that could change the course of their treatment.
Lack of proper Medicare reimbursement for diagnostic radiopharmaceuticals blocks patient access to novel diagnostics and cancer therapies
The ability of patients to get access to lifesaving next-generation diagnostic and therapeutic radiopharmaceuticals is at serious risk due to an outdated Medicare reimbursement policy for diagnostic radiopharmaceuticals. Often people outside of the nuclear medicine community struggle to understand how these radiopharmaceuticals are used and how critical they are in the care of patients — and by extension, the significant negative impact that lack of proper reimbursement has on patient care. The result of bundling a novel diagnostic radiopharmaceutical into the cost of a PET or SPECT scan is that medical centers lose significant amounts of money on every scan they perform with a novel diagnostic radiopharmaceutical on a Medicare patient. This results in medical centers choosing not to offer the new technology to any patients, especially in medical centers that are already struggling financially. This, in turn, blocks access to related anti-cancer radiopharmaceutical therapies. The Facilitating Innovative Nuclear Diagnostics (FIND) Act (H.R. 4479/S.2609) seeks to resolve this issue in a budget-neutral manner.
Medicare reimbursement policy was initially created in an environment when IV contrast used in CT and MR scans was the dominant consideration
People may think a diagnostic radiopharmaceutical is a relatively inexpensive and optional supply for a PET or SPECT scan — as, for example, IV contrast is when used during an MR or CT; however, this is inaccurate. A CT or an MR scan can be performed without IV contrast, or IV contrast can be added to improve the CT or MR for certain indications. CT and MR images are created by a CT or MR scanner interacting with the body, and the IV contrast is optional. The IV contrast is most often less expensive than the cost to perform the CT or MR scan.
The principles that apply to optional supplies such as IV contrast do not apply for most novel diagnostic radiopharmaceuticals; thus, reimbursement methods — including bundling — that were initially created for CT and MR scans should not be used for most novel diagnostic radiopharmaceuticals and PET scans.
Diagnostic radiopharmaceuticals are required to perform PET scans
Unlike IV contrast, a diagnostic radiopharmaceutical is not an optional part of the process of generating a PET or SPECT scan in a nuclear medicine department; in fact, it is essential. The scan is simply a 3D map of where in the body the diagnostic radiopharmaceutical has gone. Without the diagnostic radiopharmaceutical, the PET or SPECT scanner cannot create any images. One could say the diagnostic radiopharmaceutical is the scan. A diagnostic PET or SPECT radiopharmaceutical is injected into the blood and is designed to target sites of disease within the body. Advanced PET and SPECT scans use newer precision diagnostic radiopharmaceuticals for conditions such as cancer, neurological disorders, and heart disease. For example, 68Ga-DOTATATE PET finds neuroendocrine cancer hiding in the body, 68Ga-PSMA-11 PET finds prostate cancer hiding in the body, and 123I-Ioflupane SPECT assesses dopamine in the brain to help diagnose movement disorders. Therefore, the type of PET or SPECT image created by each diagnostic radiopharmaceutical is dependent on its indication. Also, unlike the IV contrast example used earlier, the newer precision diagnostic radiopharmaceuticals are often expensive for a medical center to purchase or produce, with a cost greater than the combined reimbursed insurance payment (e.g., Medicare) to perform and interpret the resulting PET or SPECT scan. Given these differences, it is not appropriate to think of newer precision diagnostic radiopharmaceuticals as optional inexpensive supplies for a PET or SPECT scan that can be bundled with the cost of the scan.
PET and SPECT scans are required to select patients for radiopharmaceutical anti-cancer therapy
Some of these novel diagnostic radiopharmaceuticals and the PET and SPECT scans they create are required to identify if patients are eligible for related radiopharmaceutical anti-cancer therapies. These scans allow doctors to see if a diagnostic radiopharmaceutical sticks to a given patient’s cancer as intended, and in this way the PET scan helps predict whether the related therapeutic radiopharmaceutical is also likely to stick to a given patient’s cancer, and thus, whether the patient is a good candidate for the therapy. Therefore, a PET or SPECT scan generated from a novel diagnostic radiopharmaceutical is often required prior to billing for a therapeutic anti-cancer radiopharmaceutical. For example, a PET scan with 68Ga-DOTATATE or similar radiopharmaceutical is required prior to 177Lu-DOTATATE anti-cancer therapy, and a PET scan performed with 68Ga-PSMA-11 or similar radiopharmaceutical is required prior to 177Lu-PSMA-617 anti-cancer therapy. Thus, lack of access to a novel diagnostic radiopharmaceutical can result in lack of access to a related cancer therapy.
The initial intent of the Medicare pass-through policy was to increase patients’ access
Under current hospital outpatient prospective system (HOPPS) policy, Medicare reimburses for the true cost of these novel diagnostic radiopharmaceuticals within a 3-year period of transitional pass-through, a designation given to certain “new drugs, devices and biological agents that were not paid for as a hospital outpatient department service, and whose cost is ‘not insignificant’ in relation to the payment for the procedures or services associated with it.” For products with pass-through status that are used in a hospital setting, 100% of the cost for patients is covered by Medicare Part B, and no copayment applies. Pass-through is intended to encourage the use of newly FDA-approved products and to boost Medicare patients’ access to innovative diagnostics and therapies by temporarily paying more than established facility fees. The Medicare payment during these three years equals average sales price plus 6%. However, after the term expires, the diagnostic radiopharmaceutical reimbursement rate is sometimes as low as 7% of their pass-through rate. The resulting financial loss is absorbed by the medical facility and as a result they may close the practice. Unfortunately, the cost of these novel diagnostic radiopharmaceuticals does not fall fast enough to make this model successful for the intended goal of increasing access.
There is widespread support for a change in Medicare policy around diagnostic radiopharmaceuticals
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) and its partners, the Medical Imaging and Technology Alliance (MITA) and the Council on Radionuclides and Radiopharmaceuticals (CORAR), have been working together for over a decade to reform CMS’s bundling of diagnostic radiopharmaceuticals. Though packaged payment models may work in certain instances, they have created a significant disincentive for the use of a small subset of novel, high-value diagnostic radiopharmaceuticals in hospitals. Consequently, Medicare beneficiaries are not getting access to medically necessary diagnostic radiopharmaceuticals for many types of cancer, Alzheimer’s, and Parkinson’s diseases.
The FIND act proposes to resolve this issue in a cost-neutral manner
The Facilitating Nuclear Diagnostics (FIND) Act, introduced in the House and Senate in the summer of 2021, seeks to fix the patient access issues by allowing diagnostic radiopharmaceuticals (whose mean cost per day is equal to or above $500) to be reimbursed separately in the outpatient hospital setting. This means the diagnostic radiopharmaceuticals would be reimbursed close to their pass-through rate. The FIND Act is budget-neutral and waives diagnostic radiopharmaceuticals copayments for Medicare beneficiaries.
About the authors: Geoffrey B. Johnson, M.D., Ph.D., is the chair of nuclear medicine at Mayo Clinic in Rochester, MN. Thomas A. Hope, M.D., is associate professor in residence at University of California, San Francisco. Christina M. Arenas, J.D., MPH, is associate director of health policy & regulatory affairs at SNMMI.
Within the last year, we’ve seen two new imaging agents to detect prostate cancer and one revolutionary therapeutic. Although the science is state-of-the-art, the Medicare reimbursement policy for radiopharmaceuticals, particularly in the outpatient hospital setting, is lagging decades behind.
The bipartisan Facilitating Innovative Nuclear Diagnostics (FIND) Act will rectify reimbursement and ensure that patients have access to cost-effective nuclear medicine procedures that could change the course of their treatment.
Lack of proper Medicare reimbursement for diagnostic radiopharmaceuticals blocks patient access to novel diagnostics and cancer therapies
The ability of patients to get access to lifesaving next-generation diagnostic and therapeutic radiopharmaceuticals is at serious risk due to an outdated Medicare reimbursement policy for diagnostic radiopharmaceuticals. Often people outside of the nuclear medicine community struggle to understand how these radiopharmaceuticals are used and how critical they are in the care of patients — and by extension, the significant negative impact that lack of proper reimbursement has on patient care. The result of bundling a novel diagnostic radiopharmaceutical into the cost of a PET or SPECT scan is that medical centers lose significant amounts of money on every scan they perform with a novel diagnostic radiopharmaceutical on a Medicare patient. This results in medical centers choosing not to offer the new technology to any patients, especially in medical centers that are already struggling financially. This, in turn, blocks access to related anti-cancer radiopharmaceutical therapies. The Facilitating Innovative Nuclear Diagnostics (FIND) Act (H.R. 4479/S.2609) seeks to resolve this issue in a budget-neutral manner.
Medicare reimbursement policy was initially created in an environment when IV contrast used in CT and MR scans was the dominant consideration
People may think a diagnostic radiopharmaceutical is a relatively inexpensive and optional supply for a PET or SPECT scan — as, for example, IV contrast is when used during an MR or CT; however, this is inaccurate. A CT or an MR scan can be performed without IV contrast, or IV contrast can be added to improve the CT or MR for certain indications. CT and MR images are created by a CT or MR scanner interacting with the body, and the IV contrast is optional. The IV contrast is most often less expensive than the cost to perform the CT or MR scan.
The principles that apply to optional supplies such as IV contrast do not apply for most novel diagnostic radiopharmaceuticals; thus, reimbursement methods — including bundling — that were initially created for CT and MR scans should not be used for most novel diagnostic radiopharmaceuticals and PET scans.
Diagnostic radiopharmaceuticals are required to perform PET scans
Unlike IV contrast, a diagnostic radiopharmaceutical is not an optional part of the process of generating a PET or SPECT scan in a nuclear medicine department; in fact, it is essential. The scan is simply a 3D map of where in the body the diagnostic radiopharmaceutical has gone. Without the diagnostic radiopharmaceutical, the PET or SPECT scanner cannot create any images. One could say the diagnostic radiopharmaceutical is the scan. A diagnostic PET or SPECT radiopharmaceutical is injected into the blood and is designed to target sites of disease within the body. Advanced PET and SPECT scans use newer precision diagnostic radiopharmaceuticals for conditions such as cancer, neurological disorders, and heart disease. For example, 68Ga-DOTATATE PET finds neuroendocrine cancer hiding in the body, 68Ga-PSMA-11 PET finds prostate cancer hiding in the body, and 123I-Ioflupane SPECT assesses dopamine in the brain to help diagnose movement disorders. Therefore, the type of PET or SPECT image created by each diagnostic radiopharmaceutical is dependent on its indication. Also, unlike the IV contrast example used earlier, the newer precision diagnostic radiopharmaceuticals are often expensive for a medical center to purchase or produce, with a cost greater than the combined reimbursed insurance payment (e.g., Medicare) to perform and interpret the resulting PET or SPECT scan. Given these differences, it is not appropriate to think of newer precision diagnostic radiopharmaceuticals as optional inexpensive supplies for a PET or SPECT scan that can be bundled with the cost of the scan.
PET and SPECT scans are required to select patients for radiopharmaceutical anti-cancer therapy
Some of these novel diagnostic radiopharmaceuticals and the PET and SPECT scans they create are required to identify if patients are eligible for related radiopharmaceutical anti-cancer therapies. These scans allow doctors to see if a diagnostic radiopharmaceutical sticks to a given patient’s cancer as intended, and in this way the PET scan helps predict whether the related therapeutic radiopharmaceutical is also likely to stick to a given patient’s cancer, and thus, whether the patient is a good candidate for the therapy. Therefore, a PET or SPECT scan generated from a novel diagnostic radiopharmaceutical is often required prior to billing for a therapeutic anti-cancer radiopharmaceutical. For example, a PET scan with 68Ga-DOTATATE or similar radiopharmaceutical is required prior to 177Lu-DOTATATE anti-cancer therapy, and a PET scan performed with 68Ga-PSMA-11 or similar radiopharmaceutical is required prior to 177Lu-PSMA-617 anti-cancer therapy. Thus, lack of access to a novel diagnostic radiopharmaceutical can result in lack of access to a related cancer therapy.
The initial intent of the Medicare pass-through policy was to increase patients’ access
Under current hospital outpatient prospective system (HOPPS) policy, Medicare reimburses for the true cost of these novel diagnostic radiopharmaceuticals within a 3-year period of transitional pass-through, a designation given to certain “new drugs, devices and biological agents that were not paid for as a hospital outpatient department service, and whose cost is ‘not insignificant’ in relation to the payment for the procedures or services associated with it.” For products with pass-through status that are used in a hospital setting, 100% of the cost for patients is covered by Medicare Part B, and no copayment applies. Pass-through is intended to encourage the use of newly FDA-approved products and to boost Medicare patients’ access to innovative diagnostics and therapies by temporarily paying more than established facility fees. The Medicare payment during these three years equals average sales price plus 6%. However, after the term expires, the diagnostic radiopharmaceutical reimbursement rate is sometimes as low as 7% of their pass-through rate. The resulting financial loss is absorbed by the medical facility and as a result they may close the practice. Unfortunately, the cost of these novel diagnostic radiopharmaceuticals does not fall fast enough to make this model successful for the intended goal of increasing access.
There is widespread support for a change in Medicare policy around diagnostic radiopharmaceuticals
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) and its partners, the Medical Imaging and Technology Alliance (MITA) and the Council on Radionuclides and Radiopharmaceuticals (CORAR), have been working together for over a decade to reform CMS’s bundling of diagnostic radiopharmaceuticals. Though packaged payment models may work in certain instances, they have created a significant disincentive for the use of a small subset of novel, high-value diagnostic radiopharmaceuticals in hospitals. Consequently, Medicare beneficiaries are not getting access to medically necessary diagnostic radiopharmaceuticals for many types of cancer, Alzheimer’s, and Parkinson’s diseases.
The FIND act proposes to resolve this issue in a cost-neutral manner
The Facilitating Nuclear Diagnostics (FIND) Act, introduced in the House and Senate in the summer of 2021, seeks to fix the patient access issues by allowing diagnostic radiopharmaceuticals (whose mean cost per day is equal to or above $500) to be reimbursed separately in the outpatient hospital setting. This means the diagnostic radiopharmaceuticals would be reimbursed close to their pass-through rate. The FIND Act is budget-neutral and waives diagnostic radiopharmaceuticals copayments for Medicare beneficiaries.
About the authors: Geoffrey B. Johnson, M.D., Ph.D., is the chair of nuclear medicine at Mayo Clinic in Rochester, MN. Thomas A. Hope, M.D., is associate professor in residence at University of California, San Francisco. Christina M. Arenas, J.D., MPH, is associate director of health policy & regulatory affairs at SNMMI.