Regulatory and legislative changes have always resulted in sleepless nights for stakeholders in the radiology industry due to the need to understand implications, interpretations and timeline facets that influence usage, workflow, payment, adoption, procurement and, eventually, choice. Legislation involves almost everyone in the value chain from original equipment manufacturer (OEM) research and development folks, product management, marketers, OEM sales and application specialists, hospital and radiology administrators, radiologists, radiographers, biomedical engineers and even finance staff linked to a radiology department.
Historically, while legislative changes have the potential to turn a business segment on its head overnight, the majority of regulations in radiology have made life easier for businesses, clinical professionals, department administrative staff and consumers. There is, however, the challenge created by local state regulations, presence of multi-system healthcare providers in a country such as the United States, and the increasing need to create additional legislation to clarify the original. Several legislative changes seem to be taking up a lot of bandwidth among clinicians and professional associations in radiology today.
Breast Density Laws
Almost five years to the date, the country’s first breast density notification laws were enacted. Considerable work is still taking place amongst policy makers, patient advocacy groups, radiology groups and professional associations. The issue stems from the need to educate and advise women who have undergone breast mammography screening about the next steps and options available to make an informed decision on supplementary screening and intervention, should the need warrant. The simplistic question of, “What do I do now?” has resulted in a lot of follow-up documentation based on evidence-based guidelines. This follow-up activity has not been easy as a result of complications arising from differences in risk levels of patients, differing standards of measurement across states and in some cases, confusion amongst healthcare providers on what to do. Luckily for the profession and consumers alike, a federal breast density notification law is pending and the U.S. Food and Drug Administration (FDA) is considering changes to the national mammography reporting guidelines through amendments to the Mammography Quality Standards Act (MQSA).
Medicare Physician Fee Schedule
The 2014 Medicare Physician Fee Schedule (MPFS) final rule includes several factors that will influence the reimbursement rate for radiology and radiation oncology services in the United States. While there are specific instances of increases in reimbursement rates, there is an overall decline in reimbursement levels across medical specialties including radiology. The American College of Radiology (ACR) has analyzed new and revised Current Procedural Terminology (CPT) codes and submitted them to the American Medical Association Relative Value Scale Update Committee (RUC) for 2014 finalization. The Centers for Medicare & Medicaid Services (CMS) will have a final say in finalizing the fee schedule. The industry waits with bated breath, as dramatic changes in fee schedules can jeopardize investment plans of radiology centers, thus impacting equipment upgrade plans.
Extension of MU Stage 2
In a Dec. 6, 2013, announcement, the CMS extended the Meaningful Use (MU) Stage 2 timeline by two years to 2016. The announcement also stipulates that Stage 3 will begin in 2017 for providers who have completed at least two years of Stage 2. With a large number of radiology information systems (RIS), picture archiving and communication systems (PACS) and other informatics vendors now MU-certified for one or more products and better prepared to help customers meet certification requirements, MU readiness is less of an area of vendor differentiation. Accordingly, MU will get less visibility as a main theme at medical imaging trade shows and conferences. Yet, the topic still captures a fair share of vendor discussions with current and prospective customers in an ongoing basis.
Amongst other legislative changes that are attracting a lot of attention, the Multiple Procedure Payment Reduction (MPPR) Act is impacting the professional component of diagnostic imaging services. Professional associations are still working on gaining consensus on repealing the 25 percent reduction in the professional component on multiple imaging services administered to the same patient by one physician in a single visit.
Dose documentation laws recommending making entries on radiation dose exposure in patient radiology reports and regulations regarding the licensure and credentialing requirements for out-of-state radiologists reporting on patient imaging interventions/interactions are also gaining a lot of attention. This has implications for both the technical and professional components of diagnostic imaging services provided.
All in all, these legislative changes have the patient/consumer at the heart of the justification process, which is good for all radiology industry stakeholders in the long-term.
Siddharth Saha is research director of advanced medical technologies for Frost & Sullivan.
April 24, 2024 
