Regulatory Update: September 2010

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CMS plans to implement a two-year Medicare Imaging Demonstration Project [PDF] that will test whether decision-support systems can promote the appropriate ordering of imaging services using criteria established in current medical-specialty guidelines. The project will focus on MRI, CT, and nuclear-medicine diagnostic-imaging services. The 11 targeted services chosen within these modalities—CT of the brain, sinuses, thorax, abdomen, lumbar spine, and pelvis; MRI of the brain, lumbar spine, shoulder, and knee; and nuclear imaging of the heart—have high expenditures and utilization among Medicare fee-for-service beneficiaries. The decision-support system “captures a physician attestation that the data to determine appropriateness and recommendations were reviewed by the physician and confirmed with the beneficiary,” according to the CMS solicitation for proposals. Decision-support systems include point-of-order systems, which are defined as computerized provider order entry systems that require supporting information at time of referral; also included are point-of-service systems, which are defined as electronic or paper forms that allow physicians to certify that data were collected and confirmed with the beneficiary before an imaging service is provided. CMS is currently seeking up to six conveners, or organizations that will recruit physicians for the demonstration and handle other responsibilities such as collecting data and ensuring that the decision-support system meets current medical-specialty criteria. Each convener will be responsible for recruiting 200 to 1,000 physicians. Applications to become a convener are due by September 21, and more information can be found on the CMS website [PDF]. “Physician practices apply through a convener,” according to the agency; physician practices must also meet other requirements, including having appropriate access to the Internet, as well as other capabilities for transmitting and receiving data. As part of the demonstration project, conveners and physician practices will receive additional payments for reporting the data necessary to determine the appropriateness of an order for one of the 11 imaging services targeted for study. The ACR® “advocated for this project during the health care reform debate in order to demonstrate that future savings in imaging could be derived through increasing quality and decreasing utilization rather than implementing broad across-the-board cuts to advanced imaging services,” according to its statement. MedPAC Reviews Options for Addressing Growth in Ancillary Services The Medicare Payment Advisory Commission http://www.medpac.gov/ (MedPAC) highlighted concerns in its Aligning Incentives in Medicare [PDF] report about the growth of services—such as imaging, radiation therapy, home health, durable medical equipment, physical therapy, and others—provided in physicians’ offices under the in-office ancillary services (IOAS) exception. Jonathan W. Berlin, MD, MBA, clinical associate professor of radiology at the University of Chicago Pritzker School of Medicine, says, “This report marks a growing trend by the government actually to notice self-referral increases in imaging. For a long time, that wasn’t the case. We can say that it’s great they’re noticing it, but we also have to look at what’s happening as a result of the government noticing it.” Berlin notes that many radiologists might think that the government will simply eliminate the IOAS exception, but the report actually presents lawmakers and regulators with several different options, including some that might result in simply cutting fees. In its report, MedPAC reviews three broad options available to curb the growth of ancillary services: limiting the types of services or physician groups covered by the IOAS exception; developing payment tools (such as bundling services or parts of the payment rates together) to lessen incentives that promote volume growth; or requiring self-referring physicians to participate in a prior-authorization program. The Coalition for Patient-Centered Imaging (CPCI) strongly opposed MedPAC’s report, noting that it does not reflect current data or reimbursement policies. Policies recently adopted in the Patient Protection and Affordable Care Act, for example, will already begin to move the current payment system away from volume and toward appropriate, high-quality care. “While the physician community continues to diligently work to ensure appropriate imaging by using physician-developed, evidence-based appropriate use criteria, policies should not arbitrarily cut or limit patients’ access to these life-saving technologies,” the CPCI said in a statement. MedPAC met most recently on September 13–14 in Washington, DC. The FDA/FCC and Wireless Health Devices The Federal Communications Commission (FCC) and the FDA recently announced a collaborative effort to improve the efficiency of the regulatory processes that apply to broadband- and wireless-enabled medical devices. The announcement was prompted by recommendations of the FCC National Broadband Plan, an ongoing, congressionally mandated effort to ensure that every US resident can access broadband Internet service; the plan sets benchmarks on reaching that goal. Health care is one industry that the plan is reviewing as part of its efforts, and a two-day conference in July reviewed the latest technology and ongoing regulatory efforts. Margaret Hamburg, MD, FDA commissioner, said in a statement [PDF], “The benefits that wireless technologies can provide to health care are clear, but to harness the full power of those benefits, we must navigate a delicate balance between innovation and safety and effectiveness. Working alongside the FCC, we can improve the efficiency of regulatory processes in areas where our jurisdictions overlap.” The FDA is responsible for ensuring the safety of medical devices, while the FCC regulates the country’s airwaves. For imaging providers, according to Michael Tilkin, the ACR’s CIO, “It is important to keep in mind that mobile and wireless broadband considerations specific to medical imaging are constantly changing, and we should keep imaging’s communications requirements in mind when discussing an evolving [mobile health] infrastructure in the United States.” Tilkin also participated in the July event. OIG Advisory Opinion The OIG released an advisory opinion [PDF] noting that a freestanding radiation-oncology center could provide the services of a dietitian and social worker at no additional charge to Medicare beneficiaries without violating the anti-kickback statute. In its opinion, the OIG notes that free dietitian and social-worker services offered to Medicare patients could involve anti-kickback violations. The law calls, among other things, for civil monetary penalties against someone who gives something of value to a Medicare or Medicaid beneficiary if it might influence the patient’s selection of a provider or supplier; however, “in this instance, we have been advised by [CMS] that, if dietitian and social worker services are provided in the freestanding radiation oncology center setting, the expenses of such services are included in the Medicare payment for radiation oncology services,” the opinion states. Physician groups and others can request OIG review of existing or proposed business arrangements for potential fraud/abuse violations. These opinions release the requesting parties from OIG administrative sanctions, as long as the agreement is conducted according to submitted facts. The opinion does not apply to other government agencies or physician practices, and it is limited to the arrangement that OIG specifically reviewed. Medicare Trust Fund: Solvency Extended The Medicare Hospital Insurance (HI) trust fund is projected to remain solvent for an additional 12 years, through 2029, according to the 2010 annual report [PDF] from the Medicare Board of Trustees. In addition, projected costs for the Supplementary Medical Insurance (SMI) trust fund (Part B) will also be much lower. The report notes that several factors contribute to the improved outlook, including the increased 0.9% tax on taxpayers who earn more than $200,000 annually (or $250,000, for married couples). The largest savings comes from lowering the annual rate increases that Medicare pays to hospitals, skilled-nursing facilities, home-health agencies, and other providers. “It is important to note, however, that the substantially improved results for HI and SMI Part B depend in part on the long-range feasibility of lower increases in Medicare payment rates to most categories of health care providers, as mandated by the Affordable Care Act,” the report says. “Moreover, in the context of today’s health care system, these adjustments would probably not be viable indefinitely into the future.” Jane Cys is a contributing writer for ImagingBiz.com.