Deadline Approaches: How Nuclear Labs Prep for Accreditation
Independent nuclear laboratories are under a mandate to achieve accreditation by Jan. 1, 2012, to continue receiving Medicare reimbursement. While maneuvering the varied accreditation processes requires practice management savvy—causing some practices to prolong the process—the impending deadline is approaching fast.
The Medicare Improvements for Patients and Providers Act of 2008 stipulates that one of three accreditation bodies must give its rubber stamp of approval to non-hospital providers of advanced diagnostic imaging—including PET and nuclear medicine—by Jan. 1, 2012, for those facilities to continue to receive Medicare reimbursement. The Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories (ICANL), the American College of Radiology (ACR) and The Joint Commission each approach the process differently, with varying fee structures and requirements. While many private laboratories appear to be holding their breath on the quickly approaching deadline, the Centers for Medicare & Medicaid Services (CMS) had indicated its intent to remain firm on the date.
For those practices that have applied, they can do various things to prepare. "The three bodies have different philosophies on how they approach accreditation," says Carl Grieco, RT, a nuclear medicine technologist and consultant who assists labs with the accreditation process. "ICANL focuses more on administrative areas such as final report turnaround time, patient satisfaction and quality assurance, while the ACR focuses on the quality control of the gamma camera. The Joint Commission doesn't just accredit the lab, they accredit the whole facility."
Regardless of the organization, accreditation lasts for three years. However, the laboratories should be aware of the different fee structures and requirements among the three bodies, Grieco says. ICANL charges $3,300 for nuclear cardiology, but use of a consultant can tack an additional $2,000 to the price tag. The ACR charges $1,200 per facility as well as $600 per imaging module. It also requires the use of a Jaszczak phantom—used for evaluating system performance—which can cost an additional $1,500 if the laboratory does not own one, says Grieco. There also could be an additional annual charge for health physicist consulting, although the phantom studies can be performed by the nuclear cardiologist. The Joint Commission, meanwhile, uses a formula that calculates fees based on annual visits and additional sites.
"Depending on which body you choose, it could cost betweeen $7,000 and $10,000," says Grieco.
Each of the three organizations stress applying early, as accreditation is an ongoing process that can take months to complete. And, paying careful attention to procedures and protocols is critical.
Grieco says quality reports and meeting Continuing Medical Education (CME) requirements are the two greatest considerations in preparing for accreditation.
Peter L. Tilkemeier, MD, a nuclear cardiologist at Miriam Hospital in Providence, R.I., agrees. "The big areas for attention are CMEs and assuring your reports meet the criteria," says Tilkemeier, a former ICANL board member. "Labs need to work very diligently with CMEs throughout the interval between accreditation cycles. Technologists and physicians are required to obtain 15 hours of CMEs every three years. It's very hard to get 15 hours completed in the last three days."
Other phases of accreditation include laboratory processes—such as environmental safety, radiation reduction and properly functioning equipment—as well as image quality and reporting, notes Tilkemeier. "Do the physicians report the required elements? Do the reports adequately reflect what's present in the image set, and are they reading it correctly?"
"All of this comes back to the lab as feedback, with a decision to accredit or delay," says Tilkemeier. "If the decision was to delay, laboratories have time windows to fix things and submit evidence. If they pass muster, ICANL issues accreditation." Additionally, he notes, there is a randomly generated interim visit by ICANL to assess the laboratory. "It's not unannounced, but there are pretty short turnaround times on notification versus day of visit."
Michael Kulczycki, The Joint Commission's executive director for its Ambulatory Care Accreditation Program, stresses a "holistic" approach to the review process.
"We're not accrediting just a machine or a technologist. We're accrediting the whole practice," Kulczycki says. "If the technology is embedded in a broader practice, unless they run the imaging services as a separate company or component, we have to accredit the whole practice. That's the most significant thing that organizations should be aware of in considering The Joint Commission."
While The Joint Commission recommended a date of July 1 to submit applications to meet the deadline, Kulczycki says those that haven't can still apply. Not unlike ICANL, preparation includes close attention to protocols and quality.
"Our process is in large part built around a patient tracer, in which we randomly pull patient records that the organization has kept. We follow the path of those patients who staff members of the lab would have encountered throughout the process and use that as the principle way of evaluating the care they were provided," says Kulczycki. "It's not simply focused on technology."
A quality improvement program is something that each accrediting body stresses, Grieco adds, which includes administrative, technical and physical aspects. "They want you to evaluate the quality of your laboratory by looking at different parameters to find ways to improve patient care," he says. A myocardial perfusion imaging and catheterization correlation study could meet the physician requirement, while a technical evaluation of the studies could suffice for technical improvement, and patient surveys or actual reports could serve administrative improvement.
Another item, he notes, is report turnaround time. "Once the study is complete, the final report must be transmitted to the referring healthcare provider within four working days. By 2012, all final signed reports must be transmitted to the referring healthcare provider within four working days. Also by 2012, all final signed reports must be transmitted within two working days," says Grieco.
"What if a doctor buys a new piece of equipment after Jan. 1, or splits up and starts a new facility?" Grieco asks. "CMS basically said you do not get reimbursed until you're accredited and you can't retrospectively bill after you're accredited. The Catch-22 is you can't actually become accredited until your equipment is up and running and the review process can take months."
While an answer is not yet set in stone, Kulczycki notes that CMS has heard the concerns and is working on a solution. "CMS has not yet finalized this, but they were made acutely aware of concerns from the industry about laboratories that don't get started up until after Jan. 1," says Kulczycki. "CMS is considering a provisional accreditation process, which will be time-limited, to allow them to start up and bill for services, provided they get accredited within a specific timeframe."
Meanwhile, he dispels rumors that CMS will delay the deadline for currently operating laboratories. "CMS has made it very clear they need the organization fully accredited by the deadline. I can guarantee that they will not push it back."
While accreditation means additional time and costs to laboratories, it also adds value and denotes a mark of quality that imaging centers should strive for, says Tilkemeier.
"Accreditation is of high value, requiring work and continuous attention to detail, but the outcome is worth the effort," he says.
The Medicare Improvements for Patients and Providers Act of 2008 stipulates that one of three accreditation bodies must give its rubber stamp of approval to non-hospital providers of advanced diagnostic imaging—including PET and nuclear medicine—by Jan. 1, 2012, for those facilities to continue to receive Medicare reimbursement. The Intersocietal Commission for the Accreditation of Nuclear Medicine Laboratories (ICANL), the American College of Radiology (ACR) and The Joint Commission each approach the process differently, with varying fee structures and requirements. While many private laboratories appear to be holding their breath on the quickly approaching deadline, the Centers for Medicare & Medicaid Services (CMS) had indicated its intent to remain firm on the date.
For those practices that have applied, they can do various things to prepare. "The three bodies have different philosophies on how they approach accreditation," says Carl Grieco, RT, a nuclear medicine technologist and consultant who assists labs with the accreditation process. "ICANL focuses more on administrative areas such as final report turnaround time, patient satisfaction and quality assurance, while the ACR focuses on the quality control of the gamma camera. The Joint Commission doesn't just accredit the lab, they accredit the whole facility."
Regardless of the organization, accreditation lasts for three years. However, the laboratories should be aware of the different fee structures and requirements among the three bodies, Grieco says. ICANL charges $3,300 for nuclear cardiology, but use of a consultant can tack an additional $2,000 to the price tag. The ACR charges $1,200 per facility as well as $600 per imaging module. It also requires the use of a Jaszczak phantom—used for evaluating system performance—which can cost an additional $1,500 if the laboratory does not own one, says Grieco. There also could be an additional annual charge for health physicist consulting, although the phantom studies can be performed by the nuclear cardiologist. The Joint Commission, meanwhile, uses a formula that calculates fees based on annual visits and additional sites.
"Depending on which body you choose, it could cost betweeen $7,000 and $10,000," says Grieco.
Each of the three organizations stress applying early, as accreditation is an ongoing process that can take months to complete. And, paying careful attention to procedures and protocols is critical.
Preparation 101
"Usually, the first thing we do is look at the overall operation. We examine protocols to make sure they are appropriate and doses are correct. Most importantly, we look at their final reports," says Grieco, adding that nine times out of 10, reports are not sufficient. "They often are lacking information required by ICANL, which is going to be required by Medicare and many insurance companies."Grieco says quality reports and meeting Continuing Medical Education (CME) requirements are the two greatest considerations in preparing for accreditation.
Peter L. Tilkemeier, MD, a nuclear cardiologist at Miriam Hospital in Providence, R.I., agrees. "The big areas for attention are CMEs and assuring your reports meet the criteria," says Tilkemeier, a former ICANL board member. "Labs need to work very diligently with CMEs throughout the interval between accreditation cycles. Technologists and physicians are required to obtain 15 hours of CMEs every three years. It's very hard to get 15 hours completed in the last three days."
Other phases of accreditation include laboratory processes—such as environmental safety, radiation reduction and properly functioning equipment—as well as image quality and reporting, notes Tilkemeier. "Do the physicians report the required elements? Do the reports adequately reflect what's present in the image set, and are they reading it correctly?"
"All of this comes back to the lab as feedback, with a decision to accredit or delay," says Tilkemeier. "If the decision was to delay, laboratories have time windows to fix things and submit evidence. If they pass muster, ICANL issues accreditation." Additionally, he notes, there is a randomly generated interim visit by ICANL to assess the laboratory. "It's not unannounced, but there are pretty short turnaround times on notification versus day of visit."
Michael Kulczycki, The Joint Commission's executive director for its Ambulatory Care Accreditation Program, stresses a "holistic" approach to the review process.
"We're not accrediting just a machine or a technologist. We're accrediting the whole practice," Kulczycki says. "If the technology is embedded in a broader practice, unless they run the imaging services as a separate company or component, we have to accredit the whole practice. That's the most significant thing that organizations should be aware of in considering The Joint Commission."
While The Joint Commission recommended a date of July 1 to submit applications to meet the deadline, Kulczycki says those that haven't can still apply. Not unlike ICANL, preparation includes close attention to protocols and quality.
"Our process is in large part built around a patient tracer, in which we randomly pull patient records that the organization has kept. We follow the path of those patients who staff members of the lab would have encountered throughout the process and use that as the principle way of evaluating the care they were provided," says Kulczycki. "It's not simply focused on technology."
A quality improvement program is something that each accrediting body stresses, Grieco adds, which includes administrative, technical and physical aspects. "They want you to evaluate the quality of your laboratory by looking at different parameters to find ways to improve patient care," he says. A myocardial perfusion imaging and catheterization correlation study could meet the physician requirement, while a technical evaluation of the studies could suffice for technical improvement, and patient surveys or actual reports could serve administrative improvement.
Another item, he notes, is report turnaround time. "Once the study is complete, the final report must be transmitted to the referring healthcare provider within four working days. By 2012, all final signed reports must be transmitted to the referring healthcare provider within four working days. Also by 2012, all final signed reports must be transmitted within two working days," says Grieco.
'The Catch-22'
While accreditation before the Jan. 1, 2012, deadline will determine whether providers that bill Part B for the technical component of the exam receive Medicare reimbursements for imaging, Grieco notes the deadline creates a separate issue."What if a doctor buys a new piece of equipment after Jan. 1, or splits up and starts a new facility?" Grieco asks. "CMS basically said you do not get reimbursed until you're accredited and you can't retrospectively bill after you're accredited. The Catch-22 is you can't actually become accredited until your equipment is up and running and the review process can take months."
While an answer is not yet set in stone, Kulczycki notes that CMS has heard the concerns and is working on a solution. "CMS has not yet finalized this, but they were made acutely aware of concerns from the industry about laboratories that don't get started up until after Jan. 1," says Kulczycki. "CMS is considering a provisional accreditation process, which will be time-limited, to allow them to start up and bill for services, provided they get accredited within a specific timeframe."
Meanwhile, he dispels rumors that CMS will delay the deadline for currently operating laboratories. "CMS has made it very clear they need the organization fully accredited by the deadline. I can guarantee that they will not push it back."
While accreditation means additional time and costs to laboratories, it also adds value and denotes a mark of quality that imaging centers should strive for, says Tilkemeier.
"Accreditation is of high value, requiring work and continuous attention to detail, but the outcome is worth the effort," he says.