Feature | Radiation Dose Management | June 13, 2017| Dominic Siewko

Regulatory Requirements: The Impact on Cardiac Imaging and Dose Management

Philips Dosewise portal allows X-ray radiation dose tracking for individual patients

An example of radiation dose tracking software is Philips Dosewise portal, which allows X-ray radiation dose tracking for individual patients by modality, body region and exam type.

Philips Dosewise portal allows X-ray radiation dose tracking for individual patients
Philips Dosewise portal allows X-ray radiation dose tracking for individual patients

In recent years, radiation dose management awareness has heightened across the healthcare industry to address growing concerns around the consequences of too much exposure, and a lack of standardization around dose management protocols and practices. Industry stakeholders have responded by introducing new regulations and requirements for healthcare providers, including the Centers for Medicare and Medicaid Services’ (CMS) recent Medicare Access and Chip Reauthorization Act (MACRA) ruling,[1] along with updated Joint Commission standards,[2] which call for more stringent dose management and reimbursement requirements. Understanding exactly what prompted these changes is paramount for health systems around the world to ensure compliance and success in this evolving environment.

While radiation dose monitoring and tracking is part and parcel of a hospital’s radiation dose management and safety program, one big obstacle many providers face is implementing the behavioral and operational changes required to replace current habits with new and improved best practices. Without understanding the big picture risk of too much radiation exposure, a radiologist deciding whether or not to conduct an imaging procedure involving radiation may opt in favor of a non-X-ray procedure such as ultrasound.  

The practice of “justifying” the correct imaging procedure for the patient is taking center stage, meaning more emphasis should be placed on choosing an appropriate imaging procedure to achieve the desired clinical result, taking radiation exposure to the patient into account. This will not only prevent exposing that patient to unneeded radiation, but also contribute to solving a larger public health issue.

In recent years, there has been a dramatic increase in the volume of imaging exams — for example, the volume of nuclear SPECT myocardial perfusion imaging alone increased threefold over the course of a decade.[3] Coupled with the intense magnitude of cardiac imaging radiation doses, where one exam can equal between 250-1,250 chest X-rays,[4] or up to a lifetime of screening mammograms, medical radiation exposure is en route to becoming a public health problem. 

In fact, the National Council on Radiation Protection and Measurements conducted two studies, 25 years apart, as a comprehensive review of radiation exposure to the American population from all sources over the past 30 years. Between 1980 and 2006, non-medical radiation exposure remained steady, however medical radiation exposure increased six-fold,[3] with cardiac imaging accounting for about 17 percent of all ionizing radiation to the American public.

The public’s growing concern over patient and staff radiation started in 2009 with the high profile CT over-exposure of more than 200 patients in California[5] and was intensified a year later by the New York Times’ “Radiation Boom” blog series.[6] 

This prompted advocacy and governing bodies — including the American College of Radiology (ACR), Joint Commission, CMS and Medical Imaging and Technology Alliance (MITA) — to take action to protect patients and staff from unnecessary and harmful radiation dose. In 2015, the Joint Commission released new standards for managing patient radiation dose, made effective Sept. 1, 2016, which included expanded requirements for clinical decision support and radiologic technologist education, with five key points that serve to guide healthcare providers’ enhancement or development of their department radiation protection program. 

In an effort to reward quality patient care and accelerate their goal of tying physician payment to performance, in March 2015 CMS passed MACRA, establishing new methods to determine physician reimbursement for caring for Medicare beneficiaries, including several metrics for radiation dose management. Underscored by the focus on paying for value over volume, MACRA enables physicians to benchmark, measure and improve diagnostic imaging practices. 

MITA has also established industry best practices for radiation dose equipment to ensure it meets their Smart Dose XR-29 standard, and hospitals are encouraged to work with manufacturers committed to MITA’s requirements aimed at lowering dose and making imaging safer.

These regulations serve the healthcare industry’s effective shift toward value-based care by aiming to increase access to meaningful data critical for clinicians to make informed decisions and customize treatment for patient needs. Hospitals also face potential repercussions of failing to meet these standards, including accreditation risk and associated revenue loss. Not to mention that patients are now more educated than ever, with a wealth of information available to them via the Internet and mainstream publications, meaning more and more patients will be asking for transparency around radiation dose levels. 

Even with new regulatory requirements, there is still room for improvement. As part of the effort to improve access to meaningful data, making radiation dose data available via electronic medical records (EMR) will be a big step in the right direction, especially for cardiac patients who must undergo complex imaging procedures for diagnosis and/or treatment. However, with the advent and continuous development of new cardiac PET radiopharmaceuticals, as well as the proliferation of cardiac CT imaging, patient radiation dose will continue to be a challenge.

In the meantime, it is important for us to come together as an industry — regulatory bodies, vendors and providers — to continue ensuring patients receive the highest quality care possible. Radiology departments have a responsibility (to both patients and staff) to tackle radiation dose management by both justifying exposure before it happens and then, if necessary, optimizing the dose using technology and administrative controls.

 

Related Radiation Dose Management Content

VIDEO: Eye-tracking For Dose Reduction in the Cath Lab

VIDEO: Radiation Dose Monitoring in Medical Imaging

Read the article “States Making A Difference in Radiation Safety.”

Read the article “Discussion on CT Dose Reduction.”

 

Editor’s note: Dominic Siewko is the clinical marketing leader for Philips Healthcare’s DoseWise Solutions and former radiation safety officer at Philips. He is responsible for leading and coordinating radiation health issues globally for all Philips Healthcare imaging systems. Dominic supports radiation emitting medical devices for compliance with international/FDA standards and performs incident analysis/investigation, regulatory body liaison and operates as an internal expert radiation consultant.

 

References:
1. “MACRA — Delivery System Reform, Medicare Payment Reform. What's the Quality Payment Program?” CMS website. Accessed May 2017.  https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/macra-mips-and-apms.html

2. “Approved: Standards Changes for Providers of Diagnostic Imaging Services.” Joint Commission Perspectives, March 2016, Volume 36, Issue 3. https://www.jointcommission.org/assets/1/6/approved_standards_changes_providers_diag_imaging.pdf

3. Andrew J. Einstein. “Effects of Radiation Exposure From Cardiac Imaging: How Good Are the Data?” J Am Coll Cardiol. 2012 Feb 7; 59(6): 553–565. doi:  10.1016/j.jacc.2011.08.079. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272627/

4. Eugenio Picano. “The Risks of Inappropriateness in Cardiac Imaging.” Int J Environ Res Public Health. 2009 May; 6(5): 1649–1664. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2697934/

5. Walt Bogdanich.  “After Stroke Scans, Patients Face Serious Health Risks.” New York Times, JULY 31, 2010. http://www.nytimes.com/2010/08/01/health/01radiation.html

6. Walt Bogdanich. “Radiation Boom” Blog Series. New York Times. http://topics.nytimes.com/top/news/us/series/radiation_boom/index.html

Related Content

A comparison of CT image of heavily calcified coronary arteries that appear to present a significant hemodynamic blockages and the correspending FFR-CT showing the patient had adequate blood flow and does not need a diagnostic angiogram or intervention.

A comparison of a CT image of heavily calcified coronary arteries that appear to present a significant hemodynamic blockage and the corresponding FFR-CT showing the patient had adequate blood flow and does not need a diagnostic angiogram or intervention. Image courtesy of Kavitha Chinnaiyan, William Beaumont Hospital.

Feature | CT Angiography (CTA) | July 23, 2018 | Dave Fornell, Editor
The use of non-invasive fractional flow reserve CT (FFR-CT) was the hottest topic discussed at the Society of Cardiov
Videos | CT Angiography (CTA) | July 19, 2018
Kavitha Chinnaiyan, M.D., FACC, FSCCT, associate professor, Oakland University, William Beaumont School of Medicine,
Videos | CT Angiography (CTA) | July 18, 2018
A discussion with Gianluca Pontone, M.D., Ph.D., FSCCT, director of cardiovascular MRI, Centro Cardiologico Manzino,
Videos | CT Angiography (CTA) | July 17, 2018
A discussion with Todd Villines, M.D., FACC, FAHA, FSCCT, cardiologist, Georgetown Medical Center, and president of t
HeartFlow Announces New Commercial Coverage With UnitedHealthcare
News | CT Angiography (CTA) | July 03, 2018
HeartFlow Inc. announced that UnitedHealthcare now covers the HeartFlow FFRct Analysis, extending access to their 45...
Post-Mortem CT Angiography Illuminates Causes of Death
News | CT Angiography (CTA) | June 25, 2018
Computed tomography (CT) angiography is a useful adjunct to autopsy that is likely to increase the quality of post-...
iSchemaView Receives FDA Clearance for Rapid CTA
Technology | CT Angiography (CTA) | May 01, 2018
Cerebrovascular imaging analysis company iSchemaView received final clearance from the U.S. Food and Drug...
The use of metal artifact reduction software on this CCTA (CTA) cardiac CT from an Canon, Toshiba, Aquilion Precision, allows clear visualization inside a coronary stent. The 0.25 mm high-resolution reconstruction also helps delineate the various components of plaque.

The use of metal artifact reduction software on this Aquilion Precision image allows clear visualization inside a coronary stent. The 0.25 mm high-resolution reconstruction also helps delineate the various components of plaque.

Feature | CT Angiography (CTA) | April 26, 2018 | Dave Fornell
There have been a few big, recent advancements in cardiac computed tomography angiography (CCTA) imaging technology.
Siemens Healthineers, Florida Hospital Collaborate to Improve Healthcare Outcomes
News | CT Angiography (CTA) | January 23, 2018
January 23, 2018 – Siemens Healthineers and Florida Hospital, part of Adventist Health System, have announced a multi
Videos | CT Angiography (CTA) | July 21, 2017
DAIC and ITN Editor Dave Fornell discusses some of the most innovative new computed tomography (CT) technology and tr
Overlay Init