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Volume XXI, Number
FDA: Fluoroquinolones Associated with Increased Risk of Peripheral Neuropathy
On August 15, the U.S. Food and Drug Administration (FDA) issued a new drug safety communication (DSC), announcing label changes for antibacterial fluoroquinolone drugs. The FDA is requiring that labels and medication guides for these drugs (administered via injection or taken orally) to “better describe the serious side effect of peripheral neuropathy.” According to the communication, onset of this severe nerve damage “may occur soon after these drugs are taken and may be permanent.”
Table of Contents
Increasing Demand for Services Requires Effective Use of “Incident To” Services
AUA Members Urged to Contact Lawmakers, Urge Opposition to Anti-IOASE Bill
The AUA has strongly supported the current in-office ancillary services exception (IOASE) within the Stark physician self-referral law. This exception is threatened by some who claim the exception results in overuse and increases Medicare spending and has expanded beyond its intended scope of tests.
Recently, Reps. Jackie Speier (D-CA), Jim McDermott (D-WA) and Dina Titus (D-NV) introduced H.R. 2914, the “Promoting Integrity in Medicare Act of 2013” (PIMA), which would eliminate the IOASE to the Stark Law for advanced imaging, anatomic pathology, radiation therapy, and physical therapy. The bill sponsors argue that the original intent for the IOAS exception was to permit physicians to provide ancillary services in their offices to better inform diagnosis and treatment decisions at the time of the patient's initial office visit. Therefore, they seek to distinguish between routine clinical laboratory services or simple x-rays that are provided during the patient's initial office visit, and other health care services (such as advanced imaging, anatomic pathology, etc.) that cannot be performed during the patient's initial office visit.
The bill language cites a 2012 Health Affairs study, stating that “urologists' self-referrals for anatomic pathology services of biopsy specimens is linked to increased use and volume billed along with a lower detection of prostate cancer.” The bill also cites several major newspapers, including a November 2012, Bloomberg News report stating that “California prostate cancer patients treated by a urology clinic that owns radiation therapy equipment… resulted in a detrimental impact on patient care and drove up health care costs in the Medicare program.”
CMS’ New Mobile Apps Track Transfers Under the Physician Payment Sunshine Act
Recently, the Centers for Medicare & Medicaid Services (CMS) launched free mobile applications, or “apps,” to facilitate accurate reporting of financial interactions between physicians and industry as part of the "Sunshine" final rules, now referred to as CMS' National Physician Payment Transparency Program, Open Payments.
Physician Fee Schedule Policy Changes Proposed for 2014
Last month, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule proposed rule for 2014. In addition to an estimated 24.4 percent decrease in physician reimbursement rates, the proposed rule contains a number of policy and payment revisions. The proposed rule also would implement several statutory provisions for quality program initiatives, including the Physician Compare website, the Physician Quality Reporting System (PQRS) and the Physician Value-Based Payment Modifier and Feedback Program. Many of the quality provisions are directly related to the Affordable Care Act and would substantially affect how AUA members participate in these programs. CMS has issued a fact sheet on the proposed policy and payment changes and another fact sheet on the physician quality programs and the Value-Based Payment Modifier.