The provision requires that manufacturers of drugs, devices, biologics, or medical supplies report to HHS certain payments made to physicians and teaching hospitals, the groups said in a letter to HHS Secretary Kathleen Sebelius.

The letter was signed by the Advanced Medical Technology Association (AdvaMed), the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), Community Catalyst (CC), Consumers Union (CU), Medical Imaging & Technology Alliance (MITA), and the Pew Health Group (PHG).

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The institute’s committee urged junking the 510(k) after concluding that assessing devices for substantial equivalence doesn’t reliably screen for safety and effectiveness (D&DL, Sept. 26). Eight groups and individuals had commented by the Sept. 30 deadline.

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According to the BCBSA’s document, “Building Tomorrow’s Healthcare System: The Pathway to High-Quality, Affordable Care in America,” U.S. health care spending exceeds $2.5 trillion annually and 30 cents of every health care dollar feeds ineffective, redundant care.

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The action plan, “Building Tomorrow’s Healthcare System: The Pathway to High-Quality, Affordable Care in America,” provides specific recommendations to improve healthcare quality and tackle rising costs and is based on the experience of BCBSA’s 39 plans in all 50 states and federal territories.

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Contrary to what some policymakers have assumed, the rate of growth in imaging utilization rates has flattened in recent years. In fact, imaging is now one of the slowest growing components of the Medicare Physician Fee Schedule. Since 2006, Congress and the Centers for Medicare and Medicaid Services (CMS) have cut imaging reimbursements five times in five years, with several services being cut by more than 60 percent. Even in light of these trends, policymakers continue to propose further reductions to Medicare reimbursement for imaging services, as well as prior authorization–both of which threaten to restrict seniors’ access to life-saving medical imaging and diagnostic services.

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The Medical Imaging & Technology Alliance announced Sept. 20 that it was one of five recipients of Commerce’s 2011 International Trade Administration Market Development Cooperator Program awards, intended to increase exports in targeted industries. The MITA award is specifically intended to help streamline approval processes for diagnostic imaging and radiation therapy equipment in China and India.

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The agreement is designed to promote international standards, reduce unnecessary regulation, and expand market access to enhance the global competitiveness of MITA member companies, including small and medium enterprises.

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While the fundamental technology of imaging remains clinically relevant, each generation of imaging devices enhances physicians’ ability to detect, stage, and treat disease. Due to continuous innovations, imaging device lifecycles are often only one to two years, making a consistent, predictable, and efficient review process essential to ensure that patients have access to the most advanced medical technology available. The Food and Drug Administration’s (FDA) 510(k) review process has stood the test of time in ensuring safety, while increasing patient access to these innovative medical devices.

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Reimbursement and Prior Authorization Proposals Threaten Patient Access, Disregard Downward Trends in Imaging Volume and Spending

Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) today called on Congress to reject the proposals included in President Obama’s deficit reduction plan that will reduce patient access to life-saving advanced medical imaging. Despite the downward trends in use of and spending on imaging services in the Medicare program, the President’s plan includes reimbursement cuts.

“The Administration’s proposal for yet another round of reimbursement cuts are built on the faulty premise that imaging use and spending are growing,” said David Fisher, Executive Director of MITA. “In reality, Congress and the Administration have cut imaging seven times in the past six years and both spending and utilization per beneficiary are declining. The proposed cuts will create barriers to advanced imaging services and be detrimental for Medicare beneficiaries. While we recognize that tough decisions need to be made, I’m hopeful that policymakers will carefully assess where to make cuts and base their recommendations on the recent data instead of misperceptions.”

The proposed reimbursement cuts include a new prior authorization program for Medicare. Previously, the Department of Health and Human Services (HHS), noted that a prior authorization program would be “inconsistent with the public nature of the Medicare program,” given that the programs lack transparency and rely on private companies using proprietary systems to deny care prescribed by a physician.” HHS also noted that the Medicare appeals process could overturn a “high proportion” of denials, rendering such a policy ineffective and highly burdensome. Further, there is no research showing that prior authorization actually saves Medicare any money. In a recent American Medical Association physician survey, 63 percent of the 2,400 respondents said that they typically wait several days for a response to a prior authorization request, while 13 percent said they generally wait more than a week for a response.

“Health care decisions should be made by health care professionals and their patients not by a manager whose focus is reducing spending. Placing additional hurdles between patients and necessary diagnostic and screening services is not the answer,” said Fisher. “Instead, policymakers should embrace evidence-based, physician-developed appropriateness criteria to guide the proper use of imaging services, while still preserving patient access to the right scan at the right time. Appropriateness criteria is a proven, more targeted and more effective approach than continued arbitrary cuts and restrictive policies that are rife with unintended consequences.”

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The Medical Imaging & Technology Alliance (MITA), a division of the Association for Electrical & Medical Imaging Manufacturers (NEMA), is the collective voice of medical imaging and therapy equipment manufacturers, innovators, and product developers. For more information visit www.medicalimaging.org.

In a draft 2012 physician fee schedule released July 1, CMS proposed a 50% reduction in payment for the professional component of all but the highest-paying of multiple advanced imaging services performed in a single patient sitting. (See “CMS Looks To Deepen ‘Multiple Procedure’ Physician Imaging Payment Cuts” – “The Gray Sheet” July 11, 2011.)

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