Dr. Munir Ghesani

Assessing the reimbursement challenges facing radiopharmaceuticals

June 25, 2021
by Gus Iversen, Editor in Chief
As with anything else in healthcare, access to radiopharmaceuticals depends on adequate reimbursement. Without that financial support, no matter how affective a treatment may be for a patient, providers are unable to offer them. These challenges are prevalent in nuclear medicine, but progress is being made.

We sat down with Dr. Munir Ghesani, chair of SNMMI’s Government Relations Committee and SNMMI vice president-elect, to talk about the state of reimbursement in nuclear medicine, and why it’s likely to be one of the most discussed topics at the society’s upcoming meeting.

HCB News: Can you tell us a bit about your own background in medicine and how you became involved in the reimbursement side of healthcare?
Dr. Munir Ghesani: I have been practicing nuclear medicine in the academic setting for the past 25 years, with training and certification in internal medicine, nuclear medicine and radiology. I am actively involved in various societies and organizations. As the chair of the SNMMI Government Relations Committee for the past 9 years, I have been working with the SNMMI staff, members and industry partners. We collectively strive to create an awareness of the important role of diagnostic and therapeutic nuclear medicine in improving patient outcomes and would like to ensure appropriate reimbursement of nuclear medicine procedures. I am fortunate to have an excellent group of dedicated individuals with diverse backgrounds on the team. We all share a common goal of safeguarding the viability of our field so that we can continue to provide cutting-edge diagnostic and therapeutic procedures to our patients.

HCB News: The last time we spoke (2018), you explained how bundled payments for radiopharmaceuticals were hurting access to certain exams. Has there been any progress with that?
MG: SNMMI and our coalition partners, the Medical Imaging and Technology Alliance (MITA) and the Council on Radionuclides and Radiopharmaceuticals (CORAR), explained this issue to the U.S. Government Accountability Office (GAO) last year, and they listened. In their report, the GAO acknowledged that hospitals’ use of precision diagnostic radiopharmaceuticals was higher when drugs were eligible for the initial pass-through payments (i.e., under the HOPPS rule, the Centers for Medicare and Medicaid Services [CMS] initially pays separately for a diagnostic radiopharmaceutical at actual cost to the hospital for up to 3 years) than when they were eventually bundled with the scan.

The GAO Report also included information from the New IDEAS Study organizers highlighting the challenges now faced with recruitment. Those challenges are due to a change in CMS policy from paying separately for the radiopharmaceuticals to packaging them into procedural bundles, resulting in significant losses to hospitals in the Medicare outpatient setting. Additionally, at the CMS Advisory Panel on Hospital Outpatient Payment meeting on August 31, 2020, the panel recommended that “CMS pay separately for all diagnostic radiopharmaceuticals.”

HCB News: In your opinion, what are some of the prerequisites for bringing meaningful change to the reimbursement landscape?
MG: Having policy makers understand the issues is extremely important for bringing meaningful change. As you may imagine, nuclear medicine and radiopharmaceuticals are not easy to explain to a lay audience. To begin, diagnostic radiopharmaceuticals are essential to scans for diagnosis of cancer, Alzheimer’s disease and Parkinson’s disease. Lack of awareness of reimbursement issues causes a ripple effect, impeding patient access to this safe, innovative technology. For example, although diagnostic radiopharmaceuticals are classified as “drugs” according to the Food and Drug Administration (FDA), CMS classifies them as “supplies” in the Hospital Outpatient Prospective Payment System (HOPPS). Hence, they are policy-packaged (bundled) and treated the same way one would treat ancillary supplies (like gauze or syringes) used for the scan.

SNMMI and our coalition partners have been educating our regulators and legislators about how bundling newer precision diagnostic radiopharmaceuticals with their respective scans actually impedes their use for patients. This is due to the fact that the diagnostic radiopharmaceutical costs vary significantly, and the HOPPS average reimbursement amount, applied to the radiopharmaceutical drug portion of the scan, provides an average of only 10% of the actual cost of precision diagnostic radiopharmaceuticals.

HCB News: What are some of the biggest reimbursement hurdles you've been focused on over the last year?
MG: Separate payment of diagnostic radiopharmaceuticals in the HOPPS setting has been the biggest hurdle. The FIND Act’s predecessor, H.R. 3772 (the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019), was introduced in July 2019. While this effort was gathering steam, the world was afflicted by the COVID-19 pandemic, and most non-COVID legislative efforts in 2020 went dormant. Still, we wrapped up the year with 24 cosponsors. Now that the U.S. is reopening and healing from the impact of COVID-19, we are confident that the bill will soon be introduced.

We have also been working with commercial payers to reverse their non-coverage policies regarding PET/CT and have been successful for oncologic indications, mirroring Medicare. We continue our efforts for SPECT/CT and PET/CT coverage of cardiac and neurologic indications into 2021.

HCB News: Tell us about the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 and how it's poised to impact the reimbursement landscape.
MG: Much like H.R. 3772 but with a catchier name, the FIND Act of 2021 seeks to level the playing field when it comes to reimbursing precision diagnostic radiopharmaceuticals. Therapeutic radiopharmaceuticals are reimbursed separately, as are diagnostic radiopharmaceuticals in physician offices and independent diagnostic testing facilities (IDTFs). However, in the outpatient hospital setting, CMS arbitrarily treats diagnostic radiopharmaceuticals as supplies and bundles their reimbursement with the scan. We need to fix that to promote human health and longevity.

The FIND Act targets those drugs approved by the FDA since 2008 with a mean cost per day of $500 or above. Currently, this list involves eight diagnostic radiopharmaceuticals, including three for Alzheimer’s, but the list is expanding. Precision diagnostic radiopharmaceuticals for diagnosis of breast, prostate and neuroendocrine cancer will lose pass-through payment in 2-3 years and be subject to bundling. The bill is also budget-neutral and contains a no-copayment clause for Medicare beneficiaries.

HCB News: Did you have a role in developing the FIND Act? If so, can you tell us a bit about that?
MG: As chair of SNMMI’s Government Relations Committee and SNMMI vice president-elect, obtaining separate payment for diagnostic radiopharmaceuticals in the outpatient hospital setting has been at the top of my list. I strategized with our government relations team and lent a hand whenever I could, including in the naming of the bill. Although Capitol Hill was closed due to COVID-19, I participated in various virtual fly-ins and communicated with members of Congress in my home state of New Jersey.

HCB News: Coming off a year in which cancer screening was largely delayed, reimbursement for those scans seems more important than ever. Do you expect the pandemic to shape reimbursement going forward in any way?
MG: With enhanced financial pressure due to the COVID-19 pandemic, hospitals may be reluctant to offer innovative nuclear medicine services because of inadequate reimbursement imposed by existing Medicare policy payment methodologies. Hospitals are going to be less likely than ever to continue providing these services at a loss if the reimbursement issues are not addressed soon.

As Congress contemplates additional policies to support our healthcare system, it is necessary to ensure that Medicare beneficiaries (as well as all Americans) have access to newer precision diagnostic radiopharmaceuticals. Therefore, we will continue to urge Congress to consider enacting the FIND Act.

HCB News: Will reimbursement to be a big topic at the upcoming SNMMI meeting?
MG: Yes. We are at a very crucial juncture with uncertainties regarding the path of recovery from the pandemic. Our members are deeply concerned about inadequate reimbursement, and our industry partners — who are developing innovative nuclear medicine procedures — need to be informed about the various efforts underway to ensure financial viability of their efforts. Therefore, reimbursement will certainly be a big topic at the upcoming SNMMI meeting.

HCB News: What can healthcare leaders do to make their own voices heard and become more engaged with ongoing reimbursement debates?
MG: SNMMI and its coalition partners are encouraging healthcare leaders, patient groups and industry stakeholders to engage with their elected officials in the Congress to support the FIND Act. We encourage healthcare leaders to participate in the virtual fly-ins that are being organized for coming months.