Medical Physics News
The Commission also voted to approve a staff proposal to establish requirements for Rb-82 generators and emerging medical technologies. The staff recommendation will develop performance-based requirements for Rb-82 generators, GSR units, and microspheres, and would evaluate how to make additional sections of 10 CFR 35 more flexible. ASTRO was initially concerned with this approach because it could open the current T&E requirements to change. However, we believe that the vote on T&E trumps those concerns. ASTRO will continue to monitor this issue as it moves through the rulemaking process.
The law will be implemented by the Centers for Medicare and Medicaid Services (CMS). Medicare reimbursements of the technical component under the Physician Fee Schedule and the Hospital Outpatient Prospective Payment System will be reduced according to the schedule below for radiographic examinations conducted using fiIm or CR.
Reimbursement for film based radiography will be reduced by 20% starting January 1, 2017. Reimbursement for CR based radiography will be reduced by 7% starting January 1, 2018.
|Calendar Year||Film Reduction*||CR Reduction*|
|2018 to 2022||20%||7%|
|2023 & Beyond||20%||10%|
*It should be noted that the reductions are NOT compounded year over year, i.e. that the reduction percentage will be from the then current CMS reimbursement rate.
Certain outpatient radiography services that are delivered in physician offices, free-standing imaging centers, and hospital outpatient departments will be impacted. Acute care hospitals are exempt from payment changes as they are reimbursed under a different payment system.
Because the conversion of X-Rays to a digital image is more direct compared to CR and film, Digital Radiography has the capability to produce an equal or greater quality image at a lower dose to the patient. DR imaging has the advantage of significant improvements in processing time, which will allow for increased workflow. DR also requires less of a physical equipment footprint in your department without the need for cassette storage, a CR cassette reading station, or a dark room for film processing.
The upfront cost of Digital Radiography is the main disadvantage to DR systems. However, the ability to increase a facility’s patient throughput has the potential to offset these initial costs. The reduction in reimbursement for film and CR based imaging services is being implemented to encourage the transition to DR and further offset the cost of switching to Digital Radiography.
No. The reimbursement reduction is tied to the image acquisition technology and not the X-Ray system itself. Most modern radiography systems are compatible with both DR and CR based image processing. However, there are exceptions, so check with your X-Ray manufacturer or the DR system manufacturer before purchasing new equipment.
The NEMA XR-29 standard (MITA Smart Dose) specifies four attributes of CT scanners that "contribute to or help perform optimization and or management of doses of ionizing radiation while still enabling the system to deliver the diagnostic image quality needed by the physician."
CT scanners meeting the XR-29 Standard have the following:
On January 1, 2016, CT equipment not in compliance with all four attributes of the XR- 29 Standard will be subject to a 5 percent per scan reduction. The reduction will increase to 15 percent January 1, 2017.
This penalty applies only to the technical component and the technical component of the global fee on diagnostic CT procedures (see list of CPT codes below) billed in imaging centers, physician offices and hospital outpatient settings. If a facility bills for both inpatient and outpatient CT scans on the same scanner, the reduction applies only to those scans billed as Medicare outpatient procedures. The policy does not affect scans billed under the hospital inpatient setting including those at critical access hospitals.
CMS created the modifier "CT" (computed tomography services furnished using equipment that does not meet each of the attributes of the National Electrical Manufacturers Association (NEMA) XR-29-2013 standard) to assist practices in identifying noncompliant equipment. The rule specifies that:
See MLN Matters MM9250 for the official information from CMS.
See the following:
To determine if your CT equipment complies with the NEMA XR-29 standard, please contact your CT scanner’s manufacturer. You should also visit your manufacturer’s XR- 29 Vendor Certification Web Portal on the MITA Smart Dose website to download verification of compliance.
CMS is currently developing procedures for accrediting organizations to monitor and report CT system compliance with XR-29. We anticipate that these procedures will include CMS’s determination if certificates of XR-29 compliance issued for upgrades or modifications provided by 3rd party vendors will be acceptable.
And while the Joint Commission rules will make a big splash, they're not alone in the pool. New guidelines for CT protocols and radiation dose reporting are coming from every direction, from state laws to federal legislation, to say nothing of accreditation standards from the American College of Radiology (ACR).
Rachael Michelle Rapraeger of Macon, GA, pleaded guilty to one count of felony computer forgery and 10 counts of misdemeanor reckless conduct before Judge Katherine Lumsden of Houston County Superior Court. Rapraeger was sentenced to 160-180 days in a felony detention center and 10 years of probation.
Without development of the EGM, every NRC licensee using the Rb-82/Sr-82 generator would be in non-compliance with the regulations in 10 CFR 35.60 and 35.63 and would be cited for repeated violations for which there would be no acceptable corrective actions. The EGM provides three criteria that, if met, will permit NRC to use Enforcement Discretion and not cite violations for failure to comply with the requirements for Rb-82 generator systems in 10 CFR 35.60 and 10 CFR 35.63.
Unlike the California law, however, Texas will administer its new regime as an administrative directive by the Texas Department of State Health Services (DSHS).
Texas Administrative Code rule §289.227 includes guidelines for radiation reporting, training personnel, and establishing acceptable dose thresholds, according to department spokesperson Christine Mann.
"The major thing in the new rule would be requiring healthcare providers that perform fluoroscopically guided interventional procedures and CT to develop a radiation protocol committee," Mann told AuntMinnie.com. "Another change is the requirement for radiation safety awareness -- that's for physicians or those delegated by a physician to perform interventional fluoroscopy or CT, but it doesn't apply to radiologists or oncologists."
By May 1, all healthcare providers using fluoroscopy and CT must have a radiation program in place, the department wrote in its announcement of the new program on March 1.
The drugs, known as leukocyte growth factors, will be the subject of a Friday meeting of an advisory committee to the U.S. Food and Drug Administration.
Treatment with Amgen's Neupogen and Neulasta, Teva's Tbo-filgrastim and Sanofi's Leukine, may decrease death rates from radiation exposure, according to FDA staff documents released ahead of the meeting.
Now, two new studies find that a safer, lower dose of radioactive iodine is just as effective as the higher dose at getting rid of any such cells that remain after surgery.
The research also found that patients were just as likely to have their thyroid shrunk away if they took a drug called Thyrogen (thyrotropin) as if they underwent thyroid hormone withdrawal -- which leads to fatigue, pain and weight gain -- before embarking on the radioiodine treatment.
It is the only FDA-approved generator-based PET myocardial perfusion agent. It uses a strontium (Sr)-82 generator to produce a rubidium (Rb)-82 radiotracer injection.
The FDA has received reports of two patients who underwent PET myocardial perfusion imaging scans with CardioGen-82 who had detectable levels of radiation several months after their PET scans. Both patients were crossing the border to/from the United States when radiation detectors identified radiation originating from the patients.
The radiation was found to originate from strontium (Sr-82 and Sr-85). A PET scan had been performed in each patient approximately two and four months earlier, respectively. Since Rb-82 has a half-life of 75 seconds and both patients reported that they had no other exposure to radioactive substances, the residual radiation is likely due to undetected strontium breakthrough.
See also: FDA Alert
The total dose to the thyroid from bilateral 2-view mammography is 4.5 microGray. Using the weighting factor for the thyroid of 0.04 (from ICRP Report #103, 2007), the effective dose to the thyroid is 0.18 microsievert (4.5 microgray x 0.04 microsievert/microgray). Compared to the average annual natural background radiation received by each person in the United States of 3.1 millisievert, the effective dose to the thyroid from a bilateral 2-view mammogram is equivalent in terms of detriment to 30 minutes of natural background radiation (1/17,222th of annual natural background radiation).
In short, mammography results in a negligible amount of radiation dose to the thyroid, even without thyroid shielding.
See also: Mammography Saves Lives web site
Approximately 1.5 million patients are diagnosed with cancer each year in the United States. Many of these patients will develop metastases to bone during the course of their disease. Now, physicians treating Medicare patients with known or suspected cancer metastatic to bone can much more widely order PET scans using the NaF radiotracer to help formulate treatment plans.
Failure to respond to this request may result in the issuance of an enforcement action and/or penalty assessment.
It brings critical asset information, provides overview reports to download and detailed exam information to enhance system performance. This offer is only included in some performance service contract (please contact you local service sales representative).
This FMI consists of software and/or hardware upgrades of the several of the major sub-systems of the mammography machine (AWS, IDC, Generator, and Gantry).
According to the MQSA policy, "Software changes or upgrades are considered by FDA to be major repairs, thus the facility must have a mammography equipment evaluation performed after installation of such a change or upgrade". The FDA also states that if any of the necessary tests after the software upgrade are required to be performed by the medical physicist, the mammography equipment evaluation must be performed in its entirety by the medical physicist on site.
Because of this requirement, we recommend that a medical physicist conducts a complete equipment evaluation after the application of the FMI12142, by performing the QC tests described in "Chapter 2 QC Tests for the Medical Physicist" from the Quality Control Manual 5305863-6-S-1EN (Senographe Essential)/5305756-4-S-1EN (Senographe DS).
AGAINST routine screening mammography in women age 40-49
AGAINST teaching breast self examinations
AGAINST clinical breast examinations
AGAINST previously recommended routine screening for women 75 years or older
AGAINST annual screening mammograms for women age 50-74 (Recommending screening every OTHER year versus the currently recommended annual screening)
In other words, USPSTF is recommending against ALL commonly accepted routine breast cancer screening methods for women in their forties despite their statement that the ten year risk for breast cancer in a 40 year old woman is 1 in 69. They also rescind their previous recommendation providing for screening beyond 74 because "the shortened life among woman 75 and older" makes it more likely that she could die from another cause before the cancer kills her. Finally, even for those for whom they do recommend screening, delays in treatment resulting from less frequent screening will cost lives and result in more aggressive and debilitating treatment.
The American Association of Physicists in Medicine published a statement stating that it is premature to comment in depth regarding the FDA alert as all the facts surrounding the incidences have not been released.
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