|FDA Amends Requirements for Facilities to Report Breast Density Info|
By Amerigo Allegretto | March 9, 2023
The U.S. Food and Drug Administration (FDA) has updated its mammography regulations to require reporting of breast density information by facilities, according to a March 9 statement by the administration.
The update will strengthen the FDA’s oversight and enforcement of facilities, as well as help interpreting physicians improve their categorizing and assessment of mammograms, the agency said.
These updates amend regulations under the Mammography Quality Standards Act (MQSA) of 1992, which authorizes FDA oversight over mammography facilities. This includes overseeing facilities’ accreditation, certification, annual inspections, and enforcement of standards to help ensure quality imaging and care.
Breast density is a known risk factor of breast cancer due to conventional screening mammography struggling to detect suspicious lesions in dense breast tissue. However, many women are not aware of this risk, and 12 states do not require some level of breast density notification after women receive a mammogram. Other states, meanwhile, have breast density reporting and education efforts that do not require facilities to notify women.
Dr. Hilary Marston, chief medical officer of the FDA, said the updated regulation represents the agency’s “broader commitment to support innovation” to prevent, detect, and treat cancer.
“Since 1992, the FDA has worked to ensure patients have access to quality mammography,” she said in the statement. “The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards. This means that more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
Recent legislative efforts spearheaded by health advocates and lawmakers have drawn attention to breast density. In December 2022, the “Find It Early Act” was introduced in Washington, DC, by U.S. Representative and House Appropriations Chair Rosa DeLauro (D-CT) and co-sponsor Brian Fitzpatrick (R-PA). The act would make sure that all health insurance plans cover screening and diagnostic mammograms, as well as supplemental imaging, with no cost-sharing.
The effort was also led by award-winning journalist Katie Couric, who revealed in 2022 that she had dense breasts after receiving treatment for her breast cancer, and JoAnn Pushkin, executive director of DenseBreast-Info.org.
Also, a bipartisan bill introduced February in Wisconsin would require insurance providers to provide supplemental breast cancer screenings. This expands on a 2018 law passed that requires medical facilities to give patients with dense breast tissue information about this risk factor.
The FDA’s amendments are required to be implemented within 18 months. The administration said that “nearly all” certified mammography facilities continue to meet quality standards.
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How E/M Payment Policy Changes Impacted Physician Reimbursement
By Victoria Bailey | March 8, 2023
Evaluation and management (E/M) payment policy changes implemented in 2021 resulted in higher Medicare reimbursement for most physicians but only led to a modest decrease in the payment gap between primary care and specialty physicians, according to a study published in JAMA.
Medicare payment policies have historically undervalued E/M visits. These visits are common in primary care settings, leading to lower reimbursement for primary care physicians compared to specialists. There have been some concerns that the payment gap is larger than appropriate and may deter physicians from primary care specialties.
In January 2021, CMS increased Medicare reimbursement for E/M services provided by all physicians. The agency also reduced the Medicare conversion factor for all specialties, resulting in reimbursement cuts for non-E/M services.
At the same time, the American Medical Association (AMA) eased documentation requirements for E/M codes and modified time-based billing guidelines, making it easier to bill higher-intensity, more profitable E/M codes.
Researchers conducted an observational study to assess how the E/M payment policy changes impacted Medicare reimbursement and E/M coding intensity among primary care and specialty physicians. In addition, they simulated the volume-constant effect of the policy changes on Medicare payments and compared the simulated changes to the observed changes.
The study used data from July to December 2020, known as the pre-period relative to the policy changes, and July to December 2021, defined as the post-period. The sample included 180,624 office-based physicians who billed Medicare.
Following the E/M policy changes, reimbursement increases for E/M services ranged from 2.3 percent to 23.5 percent.
When repricing services provided in the pre-period at 2021 payment rates, radiology (-3.3 percent), ophthalmology (-2.8 percent), and general surgery physicians (-0.1 percent) lost reimbursement. However, most specialists would have gained revenue, the study found.
The specialty estimated to see the largest gains relative to pre-period payments was primary care, consisting of family practice (11 percent) and internal medicine (10.8 percent). Psychiatry (9.2 percent), neurology (5.7 percent), and obstetrics/gynecology (4.6 percent) followed.
Between July and December 2020, the reimbursement gap between primary care physicians and specialists was $40,259.8. After repricing pre-period services at 2021 rates, the gap narrowed slightly to $37,759.5.
To read more, go to Revcycle Intelligence.
FDA Clears First Commercially Available Blood Test for Traumatic Brain Injury, Reducing Need for CT
By Marty Stempniak | March 8, 2023
The U.S. FDA has cleared the first commercially available blood test for traumatic brain injury, eliminating the need for CT scans to assess such patients.
Industry giant Abbott announced the breakthrough on Tuesday, noting that the product will be made widely available to U.S. hospitals. The Alinity i TBI lab test is able to reach a result in 18 minutes, helping physicians to quickly assess and triage concussion patients.
Abbott estimated that the test could reduce the number of unnecessary CT scans by up to 40%, dropping wait times while cutting costs to the healthcare system and patients.
“Now that this test will be widely available in labs across the country, medical centers will be able to offer an objective blood test than can aid in concussion assessment,” neurologist Beth McQuiston, MD, medical director in Abbott’s diagnostics business, said in a statement. “That’s great news for both doctors and people who are trying to find out if they have suffered a traumatic brain injury.”
Concussion assessment has remained constant for decades, with doctors using the Glasgow Coma Scale, along with computed tomography, to detect any lesions or damage in brain tissue.
Abbott said its test works by measuring complementary biomarkers in blood plasma and serum. It has demonstrated 96.7% sensitivity and 99.4% negative predictive value in previous use cases. Alinity i TBI is meant for patients aged 18 and older who present with a suspected mild TBI (registering 13-15 on the Glasgow scale) within 12 hours of the injury.
Regulators in Europe previously approved the lab test, with it available in markets outside of the U.S. since 2021, Abbott said.
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Employers Could Face Legal Risk if They Don’t Use Price Transparency Data
By Rylee Wilson | March 8, 2023
Insurer price transparency could be a double-edged sword for employers, Bloomberg reported March 8.
Price transparency requirements that call for payers to disclose their negotiated rates with providers can illuminate costs for consumers and give employers more information about where their employee benefit dollars go.
But with more information comes more responsibility for employers to make sure their employees’ money is spent wisely, groups representing employers told Bloomberg.
“They now have the information they couldn’t access before, but they also have to act on that,” Elizabeth Mitchell, CEO of the Purchasers Business Group on Health, which represents large employers, told Bloomberg.
Employers who don’t act on price transparency information to ensure their employees get the best value for their money could face lawsuits, James Gelfand, president of the ERISA Industry Committee, a lobbying group for large companies, told Bloomberg.
“Plan sponsors always had the responsibility not to waste the employees’ money. But all the healthcare prices were secret,” Mr. Gelfand said.
To read more, go to Becker’s Payer Issues.
American College of Radiology Urges CMS to Resume Dispute Resolutions Under Surprise-billing Act
By Marty Stempniak | March 7, 2023
The American College of Radiology and two other specialty societies are urging the federal government to resume dispute resolutions that have been paused under the surprise-billing legislation. Failure to act, they charge, could prove detrimental to physicians and their patients.
On Feb. 6, CMS halted the process for settling payment disputes between providers and payers under the No Surprises Act, which took effect in 2022. The move came after a federal judge ruled that parts of the process for solving such disagreements are in violation of the Administrative Procedure Act.
ACR, the American College of Emergency Physicians and the American Society of Anesthesiologists applauded the judge’s decision last month. But now they want the federal government to resume the process.
“The medical associations assert that the government’s pause exacerbates the existing backlog of IDR determinations, causing harm to healthcare providers who provided those services,” ACR et al. said in a news update shared on Monday, March 6.
All three societies made their case to CMS in a Feb. 28 letter to Ellen Montz, PhD, deputy administrator and director of the Center for Consumer Information and Insurance Oversight. They contend that payers have been using “unreasonably low” initial payments and “aggressive” negotiation techniques that push practices out of network. This leaves no choice but to utilize the IDR process to receive a reasonable payment.
“Our members’ practices, particularly small and medium sized community-based practices, are being hurt every day as they provide the needed patient care and then have to await long-delayed payment determinations,” they wrote.
CMS provided some relief on Feb. 24 when it announced that arbitrators could resume making some payment determinations. However, this only applied to any out-of-network services furnished before Oct. 25, ACR noted in a separate news update issued on March 2. The doc groups emphasized that the hold only applies to payment determinations made by the independent dispute resolution entities, and “all other timelines for the IDR process continue to apply.”
In its recent update, CMS said the federal government is working “diligently” to complete necessary guidance and system updates to allow IDR entities to resume processing payment determinations for all instances.
To read more, go to Radiology Business.
Commercially Available AI Tool Could Reduce Radiologists Workloads by 10% or More
By Hannah Murphy | March 7, 2023
An automated AI tool can differentiate between normal and abnormal chest x-rays, resulting in an impactful workload reduction for radiologists.
That’s according to new research published in Radiology that details an external evaluation of a commercially available AI tool. In a cohort of more than 1,500 patients, the tool achieved a sensitivity of 99.1% for identifying abnormal chest radiographs.
X-rays included in the analysis were performed on patients from emergency departments, in-hospital, and outpatient settings. Three thoracic radiologists labeled the radiographs and filed them as either critical, other remarkable, unremarkable, or normal (no abnormalities), while the AI tool categorized them as high confidence of normal or abnormal.
The AI tool was able to correctly classify 28% of the images labeled as normal. This equates to approximately 7.8% of the entire cohort that could be safely classified using AI alone.
The tool’s sensitivity was recorded as 99.1% for abnormal radiographs and 99.8% for critical radiographs—better than two board-certified radiologists who also interpreted the exams.
To read more, go to Health Imaging.
Bills to Expand Nonphysicians’ Scope of Practice ‘Rampant’ Across US, American College of Radiology Says
By Marty Stempniak | March 3, 2023
Bills to expand nonphysician providers’ scope of practice are “rampant” in state legislatures, including one that was recently defeated in South Dakota, the American College of Radiology said Friday.
ACR and the local radiological society helped quash the Mount Rushmore State measure, which would have allowed experienced physician assistants to take X-rays and perform radiologic procedures autonomously. The college labeled the legislation as “dangerous” and “harmful,” urging South Dakota lawmakers to block its passage.
“The [South Dakota Radiological Society] and ACR value the commitment of physician assistants to the team-based model of care and greatly respect the contributions physician assistants make to the healthcare team,” the two organizations wrote last month to the head of the state’s Senate Committee on Health and Human Services. “However, we do not believe their education and training prepare them to independently oversee patient care. The SRDS and ACR are deeply concerned that [Senate Bill] 175 eliminates physician-led teams.”
Following pressure from radiology and other specialties, the bill failed to pass in the South Dakota Senate, ACR said in a March 2 news update. However, similar measures are in the works elsewhere.
Lawmakers in Iowa, for one, have introduced a bill that would repeal the state requirement that physician assistants must practice under a licensed medical doctor’s supervision. ACR sent a letter to a key lawmaker in the Hawkeye State in January, opposing a proposal that would allow physical therapists to order diagnostic imaging. The college pointed to a JAMA Internal Medicine studyshowing that nonphysicians order more imaging exams than docs following outpatient encounters.
“The findings suggest that expanding the authority to order imaging to nonphysicians has resulted in increased imaging and may have ramifications on care and overall costs,” ACR CEO William T. Thorwarth Jr., MD, wrote. “While we share the concerns for patients to be able to receive care they need, we believe this measure may further elevate healthcare costs and potentially increase unnecessary radiation exposure.”
ACR has made fighting scope creep a key advocacy issue, launching a webpage on the topic and establishing a fund to help radiologists lobby against such bills in their states. Other recent letter writing campaigns have targeted lawmakers in Louisiana, Utah, and Wyoming.
To read more, go to Radiology Business.