Mar. 15, 2004

Newsletter Archive


ACC 2004 Annual Meeting Advocacy Highlights

Advocacy Weekly

ACC 2004 Annual Meeting Advocacy Highlights
First Lady Speaks to ACC’04 Attendees in New Orleans

Speaking at the Presidential Plenary Session on Mar. 8 at ACC’04 in New Orleans, First Lady Laura Bush urged cardiovascular specialists to educate women patients about their risks for heart disease, to volunteer to conduct heart-risk screenings as part of the National Heart, Lung, and Blood Institute’s Heart Truth campaign (NHLBI), and to talk to colleagues in primary care and emergency medicine about women’s risks. Mrs. Bush noted that women who make healthy behavior modifications decrease their risk of heart disease by as much as 82 percent. Later that afternoon, Mrs. Bush helped to open the NHLBI Red Dress Collection display in the convention center. The dresses were on display throughout the Annual Scientific Session.



Both Sides Agree: Health Care Issues a Major Focus in 2004 Elections
In introductory remarks at the ACC’04 "Health Care and Elections 2004" session in New Orleans, Dr. John Schaeffer, co-chair of the ACC Advocacy Committee, advised physicians to stay informed and pay attention to this year’s election messages. The two partisan experts who spoke at the session called health care issues among the most important in this year’s election. Political strategist, Ed Goeas of the Tarrance Group, a Republican polling firm identified the dominant election issues to be Medicare, health care, education, taxes, and morality. Goeas commented that voters believe that health care is a right, not a privilege and therefore have little tolerance for both the number of uninsured and increased costs, thus creating a difficult political challenge. Celinda Lake of Lake, Snell, Perry & Associates, representing the Democratic counterpart, forecast that voter turnout would be the key to winning, and that unmarried women have the potential to influence the outcome. According to Ms. Lake, voters will focus on health care access, quality, and choice, are concerned about health care costs and tend to view them as part of overall major economic stressors. Both agreed that voters are beginning to view medical liability as a key personal cost also and blame profit-taking health care management companies for the problem.




Symposium Offers Agency Views on Off-Label Usage
The ACC 04 Health Policy Symposium brought together representatives from the Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS) and Federal Trade Commission (FTC), to shed light on the increasing trend of off-label use of drugs and devices. Commenting that the problem of off-label use begins with the definition itself, Deborah Wolf, JD, regulatory counsel for the FDA Office of Compliance, directed physicians to a new FDA Web page that contains detailed information on approved products. Ashley Boam, MSBE, chief of the FDA's Interventional Cardiology Devices Branch, called on physicians and industry to construct research trials that better reflect diversity, noting that off-label uses sometime arise from the restrictive nature of clinical trials. Steve Phurrough, MD, director of CMS's Coverage and Analysis Group, said the Center leaves decisions on whether to cover off-label use to local carriers and emphatically stated that CMS is not planning any policy to prohibit coverage of off-label indications. Matthew Daynard, JD, senior attorney in the FTC's Division of Advertising Practices, noted that the FTC does not differentiate between drugs and devices used in accordance with approved labeling or in an off-label manner. Rather, the FTC focus is on whether claims made are substantiated and truthful.




Advocacy Weekly
Senate Readies for Second Round of Medical Liability Reform
During the week of March 29, 2004, it is expected that the U.S. Senate will vote on medical liability reform legislation. The "Pregnancy and Emergency Access to Care Protection Act," S. 2207, if passed would provide medical liability protections on emergency and trauma care (including emergency cardiovascular services) to the tune of a $250,000 cap on non-economic damages. The bill also contains the provisions of S. 2061; the first incremental liability measure would have extended liability protections to obstetricians and gynecologists. The Senate Republican leadership has signaled its desire to bring S. 2207 to the Senate floor as the second of an anticipated series of incremental bills on medical liability reform. On February 24, the Senate blocked consideration by a vote of 48-45 of a bill that would have provided medical liability protections to obstetricians and gynecologists. The ACC is encouraging all ACC members to contact their senators and tell them to support the "Pregnancy and Emergency Access to Care Protection Act." The Senate will be in recess March 13-21, and many senators will return home for public events and meetings with constituents. To find out whether your senator will be hosting or attending a public event this week, call your senator's local office. To obtain your senator's local office contact information, go to the Doctors for Medical Liability Reform Web site and click on your state.




Senate Passes Legislation Calling for Medicare Fee Fix by 2006

On March 5, by voice vote, the Senate Budget Committee adopted a Sense of the Senate Resolution calling for a new formula for updating the Medicare physician fee schedule by 2006. In an effort to keep the momentum and visibility for the issue, the Alliance of Specialty Medicine, of which the ACC is an active member, drafted and convinced Sen. Jim Bunning, R-KY, to introduce the resolution which calls for both Congress and CMS to adopt a new formula or mechanism for physician payments to ensure the long-term stability of Medicare payments and continued patient access to services. While a Sense of the Senate resolution does not carry the weight of law, it does very tangibly reflect the Senate's recognition of the ongoing problem, and its intent to pursue a long-term fix. The Resolution was adopted in the form of an amendment to the FY 2005 Budget bill.




CMS Limits 14-Day Period to HIPAA-Compliant Claims
CMS is modifying its HIPAA implementation plan that provided for electronic media claims (EMCs) submitted in a pre-HIPAA format to be accepted temporarily after October 15, 2003. As of July 1, 2004, only EMCs that are compliant with the HIPAA transactions standards will be eligible for payment 14 days after the date of receipt. CMS says that this operational change, effective July 1, 2004, is meant to encourage compliance with HIPAA standards requirements as soon as possible. All other claims, including paper and non-HIPAA-compliant EMCs, will be paid no sooner than 27 days after they are received. ACC has resources do deal with HIPAA, specifically the “How to Manual” for compliance for claims processing, to view go to http://www.acc.org/pmr/hipaa/hipaa.htm




E-Prescriptions Part of the Future in Medicare
A lesser known section of the recent Medicare act provides for a future systemwide switch to e-prescriptions for Medicare patients. The goal of e-prescribing is to eliminate handwriting errors, confusion on medication names and dosages, and drug interactions; to reduce the number of callbacks to a physician's office; and to encourage the effortless movement of a prescription to a patient's chosen pharmacy. According to a 1999 study by the Institute of Medicine, the high cost of medication errors caused by illegible handwritten prescriptions or avoidable drug interactions runs more than $1 billion a year. Plans are for the U.S. Department of Health and Human Services (HHS) to develop a set of standards for prescriptions transmitted electronically; release these rules in 2005, and then conduct a one-year, e-prescription pilot program in 2006. HHS is to report back to Congress with the program's results in April 2007, with final standards to be issued later that year.




Senate Confirms McClellan as CMS Head
The Senate confirmed Mark McClellan’s appointment as administrator of the Centers for Medicare and Medicaid Services (CMS) early Mar. 12. Sen. Byron Dorgan (D-SD) who had blocked early efforts for a floor vote because of McClellan’s opposition to drug reimportation. allowed the vote to go forward when he realized that Sen. Bill Frist (R-TN) had secured the votes necessary for confirmation. Dorgan also said that Frist had agreed to begin a process that could lead to legislation that would allow the reimportation of lower-cost, U.S.-manufactured prescription drugs from other nations. (AP/Houston Chronicle) The efforts of Sens. Dorgan and John McCain (R-AZ) to bring the issue of drug reimportation to the forefront by holding up McClellan’s confirmation seems to have been successful. The administration faces a groundswell of support for legal importation of drugs as Sens. Trent Lott (R-MS) and John Cornyn (R-Tex.), among others, now indicate their support for importation legislation.(Washington Post)




FDA Launches New Easy-to-Use Drug Information Web Site
On Mar. 3 the Food and Drug Administration (FDA) launched a new web site to help consumers and health professionals find information about FDA-approved drug products more quickly and efficiently. The new interface, Drugs@FDA is a searchable database that includes information on approved prescription drugs, some over-the-counter drugs, and discontinued drugs. Located on the Center for Drug Evaluation and Research (CDER) Web page, the site provides a complete overview of a drug product's approval history. Drugs@FDA makes all drug approval information available on one site by establishing a database that incorporates information from all parts of CDER's Web site, including Consumer Information Sheets, Medication Guides, labeling, and other information. Eventually information on recalls, warnings, and drug shortages will be included. More information, as well as access to the site, is available at http://www.fda.gov.




Projected Obesity among Elderly May Consume Medical Dollars
A study conducted by the Rand Group think tank in Calif. projects that by 2020 medical problems related to obesity will consume one in five health care dollars in people aged 50 – 69. The study predicts that growing obesity among older Americans could reverse the health gains this group has experienced due to their reduced exposure to disease, better medical care, and changing behavior, including smoking habits. Severely obese older people are more than twice as likely as people of normal weight to be in fair or poor health and have about twice as many chronic medical conditions. The study, in the current edition of Health Affairs, found a 44% increase in health-care costs among people who are moderately or severely obese, compared with those of normal weight. The study flies in the face of some earlier evidence that older Americans are getting healthier, causing disability rates to drop.




Advocacy Weekly is a product of the Advocacy Division of the American College of Cardiology. Questions or comments regarding this publication should be directed to the Advocacy Division at 800-435-9203 or to advocacydiv@acc.org.
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