ACC Continues Health Reform Message
The ACC continues to take its health care reform message to lawmakers and the media. The ACC released a statement about the Senate Finance Committee proposal, and has sent a letter to Committee Chair Sen. Max Baucus (D-Mont.) articulating its response to the proposal. Meanwhile, ACC CEO Jack Lewin, M.D., has appeared in several national media outlets discussing health care reform, including MedPage Today and the New York Times’ Prescriptions blog. The ACC supports reform that:

• Ensures access to affordable health care for all Americans;
• Includes delivery and payment system reforms that provide incentives for improvement of quality and outcomes;
• Repeals the sustainable growth rate (SGR) formula used to calculate Medicare physician payment;
• Emphasizes professionalism and patient-centered care;
• Improves care coordination across sources and sites through interoperable health information technology;
• Implements medical liability reforms that reduce legal and defensive medicine costs; and
• Promotes comparative effectiveness research to better inform guidelines, performance measures and appropriate use criteria.

On the proposed Medicare Physician Fee Schedule, following a highly successful 2009 Legislative Conference, ACC leaders continued meetings on the Hill last week to gather opposition to its implementation. More than one-fourth of the members of Congress have written letters or asked questions of the Department of Health and Human Services about the rule’s implementation. For more information on ACC’s health care reform campaign, Quality First, visit: http://qualityfirst.acc.org.

CMS Eliminates Noncoverage of MRI for Blood Flow Determination
The Centers for Medicare and Medicaid Services (CMS) finalized its proposal to eliminate blanket noncoverage of MRI for blood flow determination and will allow local carriers to determine coverage policies for this service. The ACC worked with Society of Cardiovascular Magnetic Resonance and the American College of Radiology to request that CMS consider current evidence on MRI blood flow determination and reverse its decision on noncoverage. Removal of the restriction on coverage will permit local carriers to cover blood flow determination performed with cardiac MR studies. In addition, a CPT coding change to be implemented in January 2009 will enable correct reporting of services. The CMS decision memo is online.

FDA Extends Tobacco Act Comment Period
The Food and Drug Administration (FDA) has extended the comment period for the implementation of the Family Smoking Prevention and Tobacco Control Act until Dec. 28. The deadline for comments originally was Sept. 29. The FDA said it received an extension request articulating concern that the 90-day comment period did not allow sufficient time to develop a meaningful or thoughtful response to the notice. Comments from the public will inform FDA's actions implementing the Tobacco Act. Comments can be submitted at: http://www.regulations.gov or in hard copy to: Division of Dockets Management (HFA305), Food and Drug Administration, 5630 Fishers Lane, RM. 1061, Rockville, MD 20852. The FDA notice is available online.

HHS Announces $27.8M in Health IT Awards
The Department of Health and Human Services (HHS) Secretary Kathleen Sebelius recently announced $27.8 million in awards for electronic health records (EHR) and other health information technology (IT) for health center-controlled networks and large multi-site health centers. The funds are part of the $2 billion allotted to HHS under the American Recovery and Reinvestment Act of 2009 to expand health care services to low-income and uninsured individuals through its health center program. The grants will support EHR implementation; the implementation of a variety of health IT innovations, including the creation of health information exchanges among different providers and the incorporation of health IT at dental delivery sites; and help health centers devise plans to use existing EHRs to improve patient health outcomes. For more information about ACC’s health IT initiatives and helpful resources, visit: http://www.acc.org/healthit.

FDA News Updates
The Food and Drug Administration (FDA) notified health care professionals of a Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in a physical interference between the SC catheter connector and the IsoMed pump. This can prevent the SC catheter from completely connecting to the IsoMed pump, which may lead to disruptions of therapy and revision surgery and pose a risk of serious injury or death. Read the complete MedWatch 2009 Safety summary.

The FDA has approved a smaller version of Johnson & Johnson’s Cypher stent, measuring 2.25 mm. The stent is designed for use in smaller blood vessels, which are more likely to become reclogged. More information is available from the Associated Press/Forbes.

Royal Philips Electronics recently said it is recalling about 5,400 HeartStart FR2 automated external defibrillators because of a problem with the memory chip, which may cause the device to malfunction. The company has had no reports of injuries and detected the malfunction in internal tests. More coverage is available from the Associated Press.