The Business of Molecular Imaging: A Panoply of Challenges

As is true in all clinical disciplines, nuclear medicine practitioners face challenges and obstacles that do not end with procedures and patient care. The business of molecular imaging also presents its share of sticky wickets. Reimbursement woes, bureaucracy and limitations on biomarkers have led to fits and starts and ultimately a slowing of growth in the industry, but there are ways forward, including legal checks and balances and streamlining in operations that can improve the bottom line.

“Lack of reimbursement or inadequate reimbursement” and regulatory issues top the list of molecular imaging business challenges, says Gary L. Dillehay, MD. In addition to being the immediate past president of the Society of Nuclear Medicine and Molecular Imaging, Dillehay is a professor of radiology at Northwestern University Feinberg School of Medicine and a nuclear medicine physician at Northwestern Medical Group, both in Chicago. Reimbursement for molecular imaging agents is case in point. In the hospital outpatient setting, reimbursement for radiopharmaceuticals is bundled with procedure reimbursements—with agents being treated as supplies rather than as drugs. “The consequence is not only inadequate reimbursement, but inappropriate reimbursement,” Dillehay states.

Complicating matters, data that lag at least two years behind current costs are used to calculate reimbursement rates. Within the existing system, increases in production costs are not recognized early enough for updated bundled payments for a minimum of two years, and sometimes three or more. Some hospitals and clinics are grappling with this problem by substituting less desirable diagnostic tools, while others accept lower reimbursements for radiopharmaceuticals and attempt to compensate for the shortfall in another aspect of their business or cease to offer a particular procedure or group of procedures, Dillehay explains

Reimbursement for beta amyloid PET scans comprises another prime example of a reimbursement-related business obstacle. In September 2013, the U.S. Centers for Medicare & Medicaid Services (CMS) released a decision stipulating that it would issue Medicare reimbursement for such scans only under certain circumstances as part of clinical studies, also known as coverage with evidence development. This type of stance “places barriers in the path of appropriate patients and patient care,” in turn impeding the advancement of nuclear medicine and potentially, practice growth, says Dillehay.

Other stakeholders, including Eli Lilly, makers of Amyvid (F-18 florbetapir), the first FDA approved amyloid PET agent, have taken a more aggressive stance by funding a legal battle with CMS to improve government reimbursement for dementia imaging. The lawsuit, filed Sept. 5, urges the court system to review the body of research already available that demonstrate the benefits of amyloid PET imaging.

Just as troubling is the possible effect of the Affordable Care Act of 2010 (ACA) on the perceived value of molecular imaging studies and hence, practitioners’ ability to perform them. The ACA’s focus on quality and appropriate use as a means of improving healthcare and reducing costs has spurred a shift away from volume payment and toward value along with the delivery of quality care. “There is nothing wrong with and everything right about enhancing the caliber of patient care,” Dillehay says. “But right now, we are dealing with the very real possibility that certain high-end molecular imaging procedures may be completely jettisoned in the shift—although they are not necessarily priced any different than, say, CT scans.” He adds that CMS also wants to decrease reimbursements for patients who undergo multiple studies in a day.

Price wars

Obstacles also surround the availability and price of molecular imaging agents. “New imaging agents are needed to rejuvenate the practice of nuclear medicine,” observes David R. Vera, professor of radiology at the University of California, San Diego (UCSD) and co-director of the UCSD In Vivo Cancer and Molecular Imaging Center. Vera notes that the National Institutes of Health (NIH) and the FDA have been very willing to see such agents move through Phase I clinical trials, yet few of these ever see the light of day in the clinic. Instead, he says, industry players are more interested in developing new scanner technology. One exception is Lymphoseek (Tc-99m tilmanocept), which was approved for sentinel node mapping in 2013 and has since acquired two more approvals for expanded use.

Nuclear medicine and molecular imaging practice are being hit especially hard by tenuousness in the supply of molybendum-99 (Mo-99), the parent element from which technetium-99m (Tc-99m) is produced. This agent is used in what SNMMI quantifies as more than 40,000 medical procedures daily and whose price has increased by double-digits at many nuclear medicine facilities nationwide. Of 522 SNMMI members who responded to a 2014 poll conducted by the Society, 90 percent reported that they had experienced increases in radiopharmaceutical prices since December 2013, and most characterized the hikes as “significant.”

While 87 percent of respondents to the survey said their ability to accommodate patients in the wake of rising Mo-99 prices has not been impeded, 13 percent claimed the increases have wrought revenue losses and employee pay cuts. Some facilities are juggling and changing appointments in tandem with isotope supply; others have been canceling scans due to the unavailability of requisite isotopes, decreasing patient loads and instituting other policies to ease the strain. Some survey respondents (9 percent) in the hospital outpatient setting category are offsetting Mo-99 price increases by billing or planning to bill for the $10 per dose premium offset payment accessible through CMS and applicable to procedures using Tc-99m from sources that don’t use highly enriched uranium (HEU) production lines.

Tech and staffing snafus

The requisite initial and ongoing investment that must be made in molecular imaging equipment also continues to pose business-related challenges, as do staffing expenditures. “The price of the average PET/CT is $2 million to $3 million, and PET/MR runs $6 million to $7 million,” which, particularly when combined with maintenance costs and outlays for upgrades, places significant burdens on the average private practice, observes J. James Frost, MD, PhD,  president of BioMolecular Imaging in Baltimore.

While manufacturers are sometimes willing to offer discounts on equipment purchases in academic environments or to incorporate a research component into a deal, this is not necessarily the case in the private sector. However, certain vendors are amenable to granting discounts on equipment purchases to practices that agree to acquire multiple units of the same modality or to commit to buying different pieces of equipment exclusively. The numbers and types of scanners can impact the workflow and cross-training full-time employees across modalities may also help improve equipment utilization efficiency.

Simply put, all of the moving parts of molecular imaging will need to be very finely orchestrated to improve the development of biomarkers and to stabilize their production through innovative means with long-term viability, and practices will need to cinch up their protocols to optimize procedure workflow and equipment utilization in order to make all of the industry’s investments worth while from a business perspective. If all parties can come to better agreement, it can be done.