What Our CON Work Tells Us About the Future of PET

CON/CHNA/Regulatory

If you want a sneak peek at the technology trends that are most likely to transform healthcare delivery, just ask a regulatory consultant (like me). We may not have a crystal ball, but regulatory filings can be the next best thing.

Take a Certificate of Need (CON) application, for instance. Analyzing large amounts of data and information for a CON can help us see patterns in technology demand and utilization that might not be noticeable otherwise. In this piece, I’d like to highlight one such technology – PET (positron emission tomography).

Recent advances in PET, supported by regulatory and payor changes, are expanding the use of this important technology well beyond its traditional role in oncology. As a result, we are seeing CON applications that address growing utilization and expanded use cases across several states.

Here are three examples.

Transforming Alzheimer’s disease care

Previously, CMS would pay for only one brain PET scan per person over the course of a lifetime ­– and then only if the person was in a clinical trial. But in October 2023, CMS updated its national coverage determination (NCD) to remove both requirements, effectively increasing coverage of brain amyloid PET scans for Alzheimer’s disease. We’re waiting to see data for 2024 that would indicate if PET scans have started to pick up in this space.

It’s clear the potential is there. Alzheimer’s disease is characterized by excess beta-amyloid protein in the brain. These amyloid plaques can be detected through new radiotracers that target and bind to the plaques and then can be seen on the PET scan.

According to the Alzheimer’s Association, one in nine Americans aged 65 and older are living with Alzheimer’s today, with absolute numbers increasing every year due to the aging of the population. Furthermore, the condition begins 20 years or more before symptoms develop, which highlights the benefit of detecting and treating excess brain plaques earlier.

As new treatment options emerge to target these amyloid plaques (the first drug received FDA approval last year), more PET scanning may be needed to determine treatment eligibility, establish baseline amyloid plaque levels, and then monitor amyloid levels over the course of treatment.

Changing the cardiac imaging landscape

Over the last 15 years, myocardial perfusion imaging (MPI) with PET using radioisotope tracers has proven to have many benefits compared to traditional MPI with SPECT.

PET technology offers better images, decreased radiation exposure, and higher diagnostic accuracy. Additionally, cardiac PET scanning has a faster protocol – well under an hour compared to three to four hours with the traditional SPECT protocol – which translates into greater convenience for patients and greater efficiency for providers. Benefits have also been found for specific patient populations including those with high BMIs or dense breast tissue.

Though cardiac PET is expanding, the technology continues to be underutilized and inaccessible across the US, according to a recent piece in the Journal of Nuclear Cardiology. Among the reasons: existing PET scanners stay busy with in-demand cancer services; cardiac radioisotope tracer availability is limited; and local physicians often don’t know or champion the technology. And, as usual, there are payment issues. Aetna, for instance, began covering cardiac PET just two years ago following an outcry from nuclear medicine professional groups.

Still, with heart disease reigning as the leading cause of death in the country, the improved diagnostic accuracy of cardiac PET suggests that the technology may soon take its place among key cardiac imaging tools.

Advancing the diagnosis and treatment of prostate cancer

Demand for PET in oncology also continues to grow beyond applications in the diagnosis and management of the more established cancer types such as breast, lung, thyroid, and head and neck cancers.

Following FDA approval of the first Prostate Specific Membrane Antigen (PSMA) isotope in 2020 and continued related isotope approvals since that time, PSMA PET imaging has exploded in the US. The PSMA tracer in PET scanning is 27% more accurate than conventional imaging, which enables more targeted treatment planning for prostate cancer.

An increase in early detection and treatment of prostate cancer has great potential, as prostate cancer is the second leading cause of death in American men.

Conclusion

In sum, it’s exciting to follow these advances in the PET space and learn about populations being positively impacted by this transformative technology. For health system providers interested in evaluating the opportunity for their own communities, consider the following:

1. Check PET utilization at your facilities and across the market.
2. Explore options to optimize existing PET units to expand capacity.
3. Explore newer uses, new isotopes, and expanded service line offerings. Ensure that collaborative discussions are occurring with oncology, cardiac, and neurosciences service lines. Since the bulk of your PET volume is likely oncology, be sure oncology is at the table.
4. Seek physician champions across service lines for input and involvement.
5. Be aware of potential new entrants in the PET landscape, such as specialty or multi-specialty physician groups that may complement or compete with your program.