Safeguarding innovation and access with nuclear medicine policy

Cathy Sue Cutler, PhD © Society of Nuclear Medicine & Molecular Imaging - SNMMI.org

The field of nuclear medicine has revolutionized modern health care, particularly in cancer, heart disease and treatment of neurological disorders. Millions of patients in the U.S. benefit from nuclear medicine’s precise diagnostic and therapeutic capabilities every year. Patient experiences range from imaging tools like positron emission tomography (PET) scans to advanced radiopharmaceutical therapies (RPTs). However, legislative proposals like the Nuclear Medicine Clarification Act of 2023 pose new challenges, potentially disrupting patient access to these critical therapies by altering established regulatory processes.

As we prepare for a new Congress in January, it’s essential to ensure legislators and their staff fully understand the implications of such policy shifts on patient care and medical innovation.

The value of nuclear medicine in patient care

Nuclear medicine’s capability to target specific cancer cells is among the most groundbreaking advancements in health care today. Radiopharmaceutical therapies offer targeted, minimally invasive cancer treatments, providing vital relief and extending survival for patients with advanced cancers, such as prostate cancer that has metastasized to the lymph nodes or bones. With an impressive response rate of more than 60%, these therapies demonstrate profound clinical benefits, such as reduced pain, prolonged remission and a significant increase in life expectancy. For patients, this means fewer invasive surgeries and faster treatment response times, often noticeable within weeks.

Innovations in imaging technologies like PET, single-photon emission computed tomography (SPECT), computed tomography (CT) and magnetic resonance imaging (MRI) have also become indispensable in shaping effective treatment plans for complex conditions, from prostate and liver cancers to neuroendocrine tumors. These technologies allow for highly personalized and cost-effective care, sparing patients unnecessary procedures and directing resources to treatments with proven efficacy. In addition, with nuclear medicine’s ability to precisely target diseased cells, healthy tissues remain largely unaffected, further reducing risks and side effects.

Established safety and rigorous oversight

The safety track record of nuclear medicine is robust. With more than 80 years of use, the field has established itself as a trusted and reliable aspect of health care. Worldwide, more than 60 million nuclear medicine procedures are performed annually, underscoring the specialty’s safety and efficacy.

Regulatory bodies, including the U.S. Nuclear Regulatory Commission (NRC) and the U.S. Food and Drug Administration (FDA), play a key role in overseeing nuclear medicine practices. The NRC regulates the use of radioactive materials for safety, while the FDA evaluates and approves nuclear medicine drugs and devices for efficacy and safety. The radiation exposure in these procedures is carefully managed and minimized, especially when considering the significant diagnostic and therapeutic benefits they provide to patients.

Challenges with the nuclear medicine clarification act of 2023

Despite the clear benefits, recent legislative proposals could alter the current regulatory framework for nuclear medicine. The Nuclear Medicine Clarification Act (H.R. 6815) seeks to modify existing oversight, transferring regulatory responsibilities from the NRC to other entities – specifically Congress. This shift could lead to unintended consequences, potentially complicating access to nuclear medicine therapies that patients rely on, particularly in rural or underserved areas where health care access is already limited.

The NRC, alongside its Advisory Committee on Medical Uses of Isotopes (ACMUI), employs rigorous scientific standards to monitor and adapt regulations based on the latest research. These committees consist of scientific and medical experts whose sole focus is patient safety and effective care.

Involving Congress in this regulatory role could introduce political agendas into what should remain a medically driven decision-making process. Allowing this regulatory expertise to become politicized risks undermining the timely delivery of life-saving therapies.

Congressional oversight might inadvertently slow access to nuclear medicine procedures, delaying treatments critical for conditions requiring immediate intervention. With rural hospitals often facing challenges in maintaining access to cutting-edge treatments, the proposed legislative changes could compound these disparities, preventing some patients from receiving the best care available.

Advocating for patient access and innovation in the next congress

As the new Congress convenes, it’s crucial that legislators and their staff recognize the importance of preserving access to nuclear medicine’s life-saving diagnostics and therapies. Misguided regulatory changes could restrict access to essential nuclear medicine procedures, jeopardizing patient outcomes and hampering the field’s ongoing innovation. The NRC’s existing oversight model, grounded in scientific rigor, has proven effective in adapting to advancements while prioritizing patient safety. This balance must remain intact.

Additionally, as the Centers for Medicare & Medicaid Services (CMS) approves new payment models, there is an opportunity to address the financial disparities that hinder equal access to nuclear medicine diagnostics. Through a fair reimbursement structure, the nuclear medicine community can ensure that all patients, regardless of location or financial status, receive access to the diagnostic tools essential for managing their conditions effectively.

Looking ahead: maintaining safety, innovation and access

For nuclear medicine to continue transforming patient care, policies governing this field must maintain a balance that promotes safety without impeding innovation. It’s essential to keep this delicate balance in the regulatory framework, supporting the NRC’s ability to lead nuclear medicine regulation based on scientific expertise rather than political influence.

With informed and engaged legislators, the new Congress can help sustain nuclear medicine’s capacity to meet modern health care demands, ultimately advancing patient care and upholding the innovations that define this critical field.

Cathy Sue Cutler, PhD, is President of the Society of Nuclear Medicine and Molecular Imaging