- After significant ASTRO-led advocacy efforts in Congress and the Nuclear Regulatory Commission (NRC), NRC commissioners voted in January to maintain the status quo and not approve NRC staff-recommended changes to the current training and experience requirements for radiopharmaceuticals. ASTRO had significant concerns with the staff's proposal and applauds the Commission for their decision that protects patient safety and access to care for patients. The staff had recommended a performance-based approach that would remove the NRC and Agreement States from review and approval of T&E for AUs, and instead would require that physicians be certified by a medical specialty board recognized by the NRC or an Agreement State. This recommendation would have also removed the so-called "alternate pathway" for obtaining AU status. In their responses, the Commissioners overwhelmingly understood ASTRO's argument about the staff recommendation and agreed that maintaining the status quo was appropriate.
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.
Post by Bio-Med Physicist William Moloney · January 31, 2017
The Consolidated Appropriations Act of 2016, which was signed into law by President Barack Obama in December 2015, included provisions related to the reimbursement for analog radiography (film), computed radiography (CR), and digital radiography (DR) imaging services. The law’s intention is to encourage the transition to digital radiography based imaging services.
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* |
| 2017 | 20% | -- |
| 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.
What typed of services will be impacted?
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.
What are the advantages of DR?
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.
What are the disadvantages of DR?
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.
Do I need to replace my entire X-ray system to switch to DR?
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.
Post by Bio-Med Physicist William Moloney · January 1, 2017
The Protecting Access to Medicare Act (PAMA) went into effect on January 1, 2016. Among the requirements, health care providers must comply with the National Electrical Manufacturers Association (NEMA) XR-29 Standard Attributes on CT Equipment Related to Dose Optimization and Management, also known as MITA Smart Dose or face a reduction in reimbursement from the Centers for Medicare and Medicaid Services (CMS).What is XR-29?
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:
- DICOM-compliant radiation dose structured reporting. See NEMA XR 29-2013 (Standard Attributes on CT Equipment Related to Dose Optimization and Management)
- Dose check features. See NEMA XR 25-2010 (Computed Tomography Dose Check).
- Automatic exposure control. See NEMA XR-28-2013 (Supplemental Requirements for User Information and System Function Related to Dose in CT).
- Reference adult and pediatric protocols. See NEMA XR-28-2013 (Supplemental Requirements for User Information and System Function Related to Dose in CT).
What are the penalties for non-compliance with XR-29?
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.
Where and to what procedures does the law apply?
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.
- 70450–70498
- 71250–71275
- 72125–72133
- 72191–72194
- 73200–73206
- 73700–73706
- 74150–74178
- 74261–74263
- 75571–75574
- Any succeeding codes
How will imaging facilities be expected to document to CMS that their CT scanners do or do not comply with XR-29?
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.
I have more questions regarding CMS’s requirements for CT scanner compliance with XR-29 and reimbursement. How do I contact CMS?
See the following:
- CMS FAQs included in their April 8, 2016 memo to State Survey Agency directors
- You may also contact CMS at ADIAccreditation@cms.hhs.gov
- ACR NEMA XR-29 Standard: FAQs from 11/4/16
How can I determine if my CT scanner is compliant with XR-29?
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.
Our CT scanner manufacturer has informed us that they are unable to upgrade our scanner so that it is compliant with XR-29. May we modify our CT scanner with a commercial 3rd party solution to meet XR-29 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.
- On July 1, 2015, a new era of intense scrutiny and documentation will arrive for CT and other imaging modalities, thanks to new Joint Commission accreditation requirements that become effective on that date. Unfortunately, most radiology departments aren't remotely ready to fulfill the requirements, according to a talk at the International Symposium on Multidetector-Row CT.
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).
- A radiologic technologist in Georgia accused of marking nearly 1,300 mammograms as normal when they were never interpreted by a radiologist today pleaded guilty in the case and has received a sentence of at least five months in jail.
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.
- Providers should inform patients of radiation exposure with cardiac imaging procedures and doses of more than 20 mSv warrant more extensive discussion, according to recommendations published online Feb. 12 in the Journal of the American College of Cardiology.
Source: NRC · August 23, 2013
The intent of this regulatory issue summary (RIS) is to inform the addressees that on April 18, 2013, NRC issued Enforcement Guidance Memorandum (EGM) EGM-13-003 concerning dispositioning inspection findings related to a licensee’s implementation of calibration requirements for Rubidium-82 (Rb-82) activity measurement systems in accordance with 10 CFR 35.60, and the requirement to determine the Rb-82 dosage before medical use in accordance with 10 CFR 35.63. No specific action or written response is required. The NRC is providing this RIS to the Agreement States for their information and for distribution to their licensees as appropriate.
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.
- Hoping to avoid the rash of radiation overexposures that shook California radiology like an earthquake a few years back, the state of Texas has decided to implement its own radiation exposure rule beginning May 1.
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.
Source: Reuters · May 2, 2013
Drugs from Amgen Inc, Teva Pharmaceutical Industries and Sanofi that boost white blood cells are being evaluated by U.S. regulators as treatments for radiation exposure caused by a nuclear attack or accident.
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.
- The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The manufacturer, Bracco Diagnostics Inc., has decided to voluntarily recall CardioGen-82 this week after two patients set off radiation detectors at a U.S. border crossings due to strontium contamination.
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
Source: ACR · February 1, 2011
Beginning Feb. 7, 2011, the Centers for Medicare & Medicaid Services will reimburse sites participating in the National Oncologic Positron Emission Tomography (PET) Registry (NOPR) for F-18 sodium fluoride (NaF) PET scans. This is yet another example of how the NOPR is facilitating greater access to PET scans with the potential to help physicians provide the most appropriate care for their patients.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.
- The New Jersey DEP Bureau of X-Ray Compliance now requires all CT facilities to begin submitting copies of their annual survey results, for surveys conducted on or after January 1, 2011.
Failure to respond to this request may result in the issuance of an enforcement action and/or penalty assessment.
See also: NJ DEP Bureau of X-Ray Compliance web site
Source: ImagingBiz · October 13, 2010
Gov Arnold Schwarzenegger of California has signed into law a medical radiation protection bill aimed at protecting patients from excessive radiation exposure received during CT scans and radiation therapy procedures. Greasing the wheels for the first state law of its kind in the U.S., SB 1237, as the bill is known, mandates strict new procedures and reporting requirements when it becomes effective July 1, 2012. It also provides an accreditation mandate for CT scanners slated to take effect six months later.- As a result of the Medicare Improvements for Patients and Providers Act (MIPPA) passed July 2008, effective January 1, 2012, all non-hospital providers that bill for MRI, CT, PET and nuclear medicine under the Medicare Part B Physician Fee Schedule must be accredited in order to receive technical component reimbursement from Medicare.
See also: Bio-Med Associates' MIPPA Accreditation Assistance Services
Source: GE Healthcare · September 1, 2010
FMI12142 applies to Senographe DS and Senographe Essential systems and will bring significant enhancements, such as:
- Software stability enhancement, especially on AUTOPUSH, AUTODELETE and AUTO PRINT functions,
- Stereo features enhancement,
- Enables Utilizatian Reporting, through the web-based iCenter application.
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).
Source: ACR · December 18, 2009
Confusion continues to grow over the recent U.S. Preventive Services Task Force\'s (USPSTF) recommendations that women under the age of 50 no longer be screened for breast cancer. Women are wondering if their mammograms will now be covered by their insurance company and radiology practices are beginning to receive calls from women who want to cancel their scheduled yearly mammogram.- The Society of Breast Imaging publishes a 12 point discussion regarding the US Preventive Services Task Force (USPSTF) recent mammography screening guidelines.
Source: AAPM · December 18, 2009
American Association of Physicists in Medicine states: There have been a number of CT related issues in the news over the past months pertaining to radiation dose, however there have been several misleading statements made with respect to radiation hazards from CT scanning. AAPM also addresses the recent articles published in the Archives of Internal Medicine and reported on National Public Radio this week stating that "much smaller radiation exposures (such as with CT) to many individuals can cause substantial increases in cancer incidence is certainly controversial and not universally accepted."Source: ACR · December 18, 2009
The Federally Supported U.S. Preventative Services now recommends:
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.
Source: ACR · December 18, 2009
If cost-cutting U.S. Preventive Services Task Force (USPSTF) mammography recommendations are adopted as policy, two decades of decline in breast cancer mortality could be reversed and countless American women may die needlessly from breast cancer each year. The recommendations - created by a federal government-funded committee with no medical imaging representation - would advise against regular mammography screening for women 40-49 years of age, provide mammograms only every other year for women between 50 and 74, and stop all breast cancer screening in women over 74.Source: ACR · December 10, 2009
The ACR has revised its requirements for Medical Physicists and MR Scientists, as a result of receiving many thoughtful comments from individuals currently providing medical physics services, and after consultation with ACR legal counsel as well as the chairs of the Quality and Safety Commission and ACR Accreditation Subcommittees on Physics. These new requirements will go into effect on January 1, 2010. The new requirements (and this most recent revision) are critical for several reasons.
Source: FDA · December 8, 2009
FDA has identified at least 50 additional patients who were exposed to excess radiation during CT perfusion scans and involved more than one CT scanner manufacturer. Furthermore they have received reports of possible excess exposures from healthcare providers in other states.Source: FDA · December 7, 2009
On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure. These recommendations apply to all CT perfusion images, including brain and heart, because they use similar procedures and protocols.- The majority of breast cancer patients who received MammoSite balloon brachytherapy treatment developed symptoms of moderate breast distortion within two years of treatment, according to an RSNA presentation on Tuesday.
Source: FDA · October 8, 2009
Over an 18-month period, 206 patients at a particular facility received radiation doses that were approximately eight times the expected level. Instead of receiving the expected dose of 0.5 Gy (maximum) to the head, these patients received 3-4 Gy.
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.
Source: FDA · August 27, 2009
Mammography Tech pleads guilty to 3rd degree forgery and is ordered to pay a $2000.00 fined and was sentenced to 1 year incarceration (suspended).- The Committee on Professional Licensure introduced a Bill to the PA House of Representative for licensure of individuals practicing medical physics in the State of PA citing in the Bill that "The practice of medical physics by unqualified individuals is a threat to public health and safety. It is, therefore, the responsibility of the Commonwealth to protect public health and safety from the harmful effects of excessive and unnecessary radiation by ensuring that the practice of medical physics is entrusted only to individuals licensed under this act."
