The American College of Radiology (ACR; Washington) says it strongly supports the Excellence in Diagnostic Imaging Utilization Act of 2013 (H.R. 3705), which would require ordering physicians to consult physician-developed appropriateness criteria when ordering advanced diagnostic imaging studies for Medicare patients. This ACR-backed bipartisan bill is separate from, and in addition to, a similar appropriateness criteria policy included in the SGR Repeal and Medicare Beneficiary Access Act of 2013, currently under debate in the House and Senate. Congress will likely consider these bills in early 2014.
H.R. 3705, recently introduced by Reps. Erik Paulsen (R- Minnesota) and Jim Matheson (D-Utah), would require the Secretary of the Department of Health and Human Services (HHS) to specify appropriateness criteria from among those developed/endorsed by national professional medical specialty societies such as the ACR. Evidence-based ACR Appropriateness Criteria have been in existence for 20 years and are created and updated by multi-specialty panels of physicians. This allows them to serve as a national standard.
"The College applauds Reps. Paulsen and Matheson for reaching across the aisle to promote this policy, which helps ensure that Americans get the care that they need, preserves resources, and does so without interfering in the doctor patient relationship" said Paul Ellenbogen, MD, FACR.
H.R. 3705 would not give the secretary authority to create such guidelines, but would direct the secretary to identify mechanisms, such as clinical decision support (CDS) tools, by which ordering professionals could consult these criteria. CDS systems in Minnesota, and at Massachusetts General Hospital, based on these physician-created criteria, have been shown to reduce duplicate and/or unnecessary scanning and their associated costs.
The policy advocated in H.R. 3705 is in step with the ACR's Imaging 3.0 initiative that increases quality of imaging care and preserves healthcare resources.
Imaging 3.0 is a multiphase program consisting of services, technology tools and processes that enable radiologists to adapt how they manage their practices, patient care and their own futures. In effect, Imaging 3.0 positions radiologists as expert consultants to referring physicians and health systems, coordinates service and technology tools to support radiologists as diagnosticians and consultants in new healthcare models, empowers and informs patients and providers to improve efficiency and quality of care, and helps sensibly align payment incentives as medicine shifts from volume to value-based care.
NIH and NFL tackle concussion research
The National Institutes of Health has selected eight projects to receive support to answer some of the most fundamental problems on traumatic brain injury, including understanding long-term effects of repeated head injuries and improving diagnosis of concussions.
Funding is provided by the Sports and Health Research Program, a partnership among the NIH, the National Football League, and the Foundation for the National Institutes of Health (FNIH). In 2012, the NFL donated $30 million to FNIH for research studies on injuries affecting athletes, with brain trauma being the primary area of focus.
Traumatic brain injury (TBI) is a public health problem that affects all age groups and is the leading cause of death in young adults. Recently, concern has been raised about the potential long-term effects of repeated concussion, particularly in those most at risk: young athletes and those engaged in professions associated with frequent head injury, including men and women in the military. Current tests cannot reliably identify concussions, and there is no way to predict who will recover quickly, who will suffer long-term symptoms, and which few individuals will develop progressive brain degeneration, called chronic traumatic encephalopathy (CTE).
"We need to be able to predict which patterns of injury are rapidly reversible and which are not. This program will help researchers get closer to answering some of the important questions about concussion for our youth who play sports and their parents," said Story Landis, PhD, director of the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH.
Two ($6 million each) are large, cooperative agreements focused on defining the scope of long-term changes that occur in the brain years after a head injury or after multiple concussions. The cooperative awards form a partnership between NINDS, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and multiple academic medical centers.
NIH also will fund six pilot projects totaling just over $2 million that will last up to two years and are designed to provide support for the early stages of sports-related concussion projects. If the early results are encouraging, they may become the basis of more comprehensive projects. The NIH institutes responsible for managing these grants are NINDS, NICHD, and the National Institute on Deafness and Other Communication Disorders (NIDCD).
The NINDS is a funder of research on the brain and nervous system.
The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation.
The NIDCD supports and conducts research and research training on the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language and provides health information, based upon scientific discovery, to the public.
Alimera enters into labeling
discussions with FDA
Alimera Sciences (Atlanta) has entered into labeling discussions with the FDA for Iluvien and, as a result, reached an agreement with the FDA that Alimera's participation in the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting was no longer necessary. Alimera will focus instead on drafting its response to the Complete Response Letter (CRL) received from the FDA in October 2013 with a goal of submitting the response in 1Q14.
In its response, Alimera intends to address concerns the FDA raised regarding the facility at which Iluvien is manufactured. In addition, Alimera expects to provide a safety update on Iluvien, which will include data from Iluvien patients and from physician experience with the applicator in the UK and Germany, where Iluvien is currently commercially available. The FDA has indicated that Alimera will not be required to conduct any new clinical trials in connection with the FDA's review of Iluvien prior to approval.
"We are very pleased to have had the opportunity to meet with the FDA to discuss appropriate labeling for ILUVIEN and to determine the next steps required to move ILUVIEN closer to an FDA approval," said Dan Myers, president/CEO of Alimera. "We are committed to addressing the remaining issues that were raised in the CRL and plan to submit our response in 1Q14, which will include recent safety data gathered from our patients in Europe."
In addition to the UK, where the National Institute for Health and Care Excellence recently published positive final guidance, Iluvien is being sold in Germany and is expected to launch in France in 2014. Iluvien is also approved in Austria, Portugal and Spain and has been recommended for approval in Italy.
Iluvien (190 micrograms intravitreal implant in applicator) is a sustained release intravitreal implant indicated in Europe for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. Each Iluvien implant provides a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide. Iluvien is injected in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The applicator employs a 25-gauge needle, which allows for a self-sealing wound.