American College of Cardiology

Senate Holds Private Discussions on Reform Options; HHS Secretary Confirmed

Today the Senate Finance Committee is holding a closed-door walk through of the policy options described in a document release late yesterday by the committee: "Transforming the Health Care Delivery System: Proposals to Improve Patient Care and Reduce Health Care Costs." During the walk through, Chair Max Baucus (D-Mont.) and ranking member Charles Grassley (R-Iowa) will solicit comments from the Committee members on the policy options paper and give them the opportunity to offer other options. ACC staff is reviewing the document, which contains policy options related to the short and long-term payment reform; infrastructure investments, the Physician Quality Reporting Initiative, imaging, workforce, comparative effectiveness and more. The committee is accepting public comments on the document until May 15. The Committee is expected to hold similar walk throughs on coverage and financing throughout May, with the goal of drafting a bipartisan health reform proposal to act on in early June.

Meanwhile, the Senate on April 28 voted to confirm former Kansas Governor Kathleen Sebelius (D) as secretary of the Department of Health and Human Services, and she was sworn in hours later. Sebelius has said she is committed to reforming the health care system in 2009, including the physician payment system.

Urge Your Senator to Support Tobacco Bill

The Senate is expected to debate the “Family Smoking Prevention & Tobacco Control Act” (H.R. 1256), which would grant the Food and Drug Administration (FDA) authority to regulate tobacco products. The bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to grant the FDA the authority to restrict tobacco marketing and sales to youth; require detailed disclosure of ingredients; allow FDA to require changes to tobacco products; and require larger, more specific health warnings. The FDA activity would be funded by a user fee on cigarette manufacturers, allocated by market share. The House on April 2 approved the bill in a 298-112 vote.

The ACC highly encourages members to contact their senators in support of this important bill. Please call the toll-free Capitol Switchboard at (202) 224-3121 to ask your senator to support HR 1256.

Alert: FTC “Red Flags” Identity Theft Rule

In an effort to address the growing risk of identity theft, the Federal Trade Commission (FTC) released rules in November 2007 requiring all financial institutions and "creditors" to develop and implement a written program to protect consumers by identifying potentially suspicious "red flags” that may signal identity theft. The rules, as currently written, define health care providers as "creditors" because they regularly defer payment for goods and services.

The ACC, the American Medical Association (AMA), Medical Group Management Association (MGMA) and other medical associations have challenged the inclusion of physicians as creditors and were able to delay the rule’s implementation date until May 1, 2009. However, given the fast-approaching deadline, the ACC strongly recommends that practices prepare a written identity theft detection and prevention program. The AMA and MGMA have developed Red Flags Rule guidance documents and sample policies that can be modified, which can be accessed at: MGMA Red Flags Rule Resource Center and AMA Red Flags Rule Physician Resources. Visit ACC.org for more information, or contact Gretchen Wyatt at gwyatt@acc.org.

FDA Panels Votes to Approve New AFib Device; More
The FDA Circulatory Devices Committee on April 23 voted 7 to 5 to recommend for approval the Watchman, a parachute-shaped cardiac device, for the treatment of atrial fibrillation patients, MedPage Today reports. The committee recommended that the device could be approved for “warfarin-eligible” patients with nonvalvular atrial fibrillation, but rejected the manufacturer’s suggestion the device be considered an “alternative” to warfarin because of the lack of clinical data on use of the device without the use of warfarin. The FDA panel used data from the PROTECT-AF study, which was presented in March at the i2 Summit 2009. A summary and slides of the study are available. The FDA usually follows the recommendations of its panels, although it is not required.

Meanwhile, the FDA earlier this month sent a warning letter to St. Jude Medical over manufacturing issues related to a version of the company’s Safire ablation catheter, the Minneapolis Star Tribune reports. The FDA will not allow for the exportation of products named in the letter or approve Class III devices from the plant. The company says it has proposed corrective action.

The FDA also recently approved Abiomed’s catheter-based heart pump Impella 5.0, which is similar to the Impella 2.5 approved by the FDA in June, the Associated Press reports. The newest Impella pumps blood for periods up to six hours.

Patient Identifier Would Improve Quality, ACC Document Finds
The ACC Informatics Committee recently released a document articulating its stance on unique patient identifiers (UPI). The current methods used to match patients with their data are prone to error, which can cause serious quality issues and lead to deleterious consequences. The ACC believes that the benefits resulting from implementing a UPI, thus improving quality of care, are primarily realized by patients. The ACC advocates that the UPI only be used for accessing health information and not be tied to a social security number. The ACC plans to use the document to gather support from other health care organizations to move its principles forward. Read the UPI Principles document online.

State Advocacy Critical, BOG Chair States
In related news, Board of Governors Chair John Gordon Harold, M.D., F.A.C.C., yesterday discussed the importance of state advocacy on ACC’s online forum, The Lewin Report. Dr. Harold writes, “ACC chapters work together with the ACC to pursue critical state legislative initiatives, such as maintaining access to office-based imaging, ensuring appropriate STEMI care, championing health advocacy and promoting public safety.” He gives an example from his home Chapter of California of how partnerships can lead to legislative victories. Read the post in full.

Save the Date! 2009 Legislative Conference
SAVE THE DATE: The American College of Cardiology’s 2009 Legislative Conference will take place Sept. 13-15 at the Fairmont Hotel in Washington, D.C. We hope you will take advantage of this opportunity to help educate Congress about the important work the ACC is doing in the areas of Medicare reform, health care reform, and research and prevention. Reservation information is coming soon. Check acc.org for updates.