American College of Cardiology

	ACC President Dr. Fye Participates in Bush Economic Forum
	Physicians Call for Medical Liability Reform at Illinois Hearing
	Final Rule on Medical Records Privacy Regulations Released
	NCCI Edits for Interventional Procedures Delayed
	Tissue Recall Doesn't Include Heart Valves
	Members Asked to Identify Onerous, Inadequate LMRPs
	Valsartan Approved for Treatment of Heart Failure
	Medical Practices Losing Money, Survey Finds
	FDA Approves Guidant Multi-Link Stents for AMI

ACC President Dr. Fye Participates in Bush Economic Forum
ACC President W. Bruce Fye, MD, participated in a special economic forum convened by President Bush on August 13 at Baylor University in Waco, Tex. Nearly 250 people participated in the forum, including thought and business leaders from across the country such as Charles Schwab and eBAY CEO Meg Whitman. The forum covered a broad range of issues, from corporate governance to health care's impact on the economy. The 30-person panel on health care—which included Dr. Fye and was led by HHS Secretary Tommy Thompson—discussed medical liability reform, the uninsured, and prescription drugs, among other things. President Bush spoke during the panel, and again reiterated his call for federal medical liability reform. During the panel discussion, Dr. Fye stressed the importance of access to specialty care, the need for more emphasis on prevention, the implications of a growing shortage of cardiovascular specialists and nurses, and the critical role of public and private funding of biomedical research. "As the President's economic forum demonstrates," Dr. Fye said, "the ACC continues to have increased access to make our message heard with the administration and other key policy makers."

Physicians Call for Medical Liability Reform at Illinois Hearing
Patient access to physicians and other health care providers is in serious jeopardy in Illinois as medical liability insurance rates continue to rise at an unprecedented rate, Jay Alexander, MD, a member of the ACC Political Action Committee board, testified during a state "roundtable" hearing last week in Illinois. The meeting was held by two U.S. congressmen from Illinois, Reps. Donald Manzullo, R, and Mark Steven Kirk, R. Dr. Alexander's 17-physician practice was hit with a 350 percent increase in its liability premium, from $233,000 to $798,000. "With a nearly 9 percent reduction in Medicare reimbursement and more cuts to follow in the next several years, combined with a $500,000 increase in medical malpractice premiums in a year, it's almost untenable to continue to practice," he said. Dr. Alexander and three other physicians who testified called for Congress to pass a medical liability reform bill introduced in the House and Senate, "The HEALTH Act of 2002." "Passage of tort reform on the federal level is absolutely necessary if we are going to stop this medical liability crisis in its tracks," Dr. Alexander said.

Final Rule on Medical Records Privacy Regulations Released
The Bush administration has released the final rule on medical records privacy under the Health Insurance Portability and Accountability Act, or HIPAA. The final rules have some important differences from the original rule released in the final days of the Clinton administration. One physician-supported change was the removal of a requirement for health care providers to obtain patients' written consent for treatment and before paying claims. "The prior regulation, while well-intentioned, would have forced sick or injured patients to run all around town getting signatures before they could get care or medicine," said HHS Sec. Tommy Thompson. Under the rule, physicians must obtain patients' specific authorization to use or disclose protected information in most nonroutine circumstances, such as releasing information to an employer, and offer satisfactory assurance that a "business associate" will safeguard protected health information. The final regulation takes effect on April 14, 2003.

NCCI Edits for Interventional Procedures Delayed
In response to concerns expressed by the ACC, American College of Radiology (ACR), and Society of Interventional Radiology (SIR), the CMS has delayed implementation of proposed National Correct Coding Initiative (NCCI) edits that affect interventional procedures. Following the delay, the ACC, ACR, and SIR have sent the CMS a formal letter of opposition to these edits and requested that they not be implemented in the future. The CMS had proposed the edits to prevent the reporting of percutaneous placement of an intravascular stent, percutaneous atherectomy, and percutaneous balloon angioplasty from being reported together unless the procedures are performed at separate vascular sites. In the letter, the three organizations explain that the separation of atherectomy, angioplasty, and stenting is clinically justified; that the edits contradict established CPT coding conventions; and that the edits do not reflect the valuation process and relative values assigned to these codes.

Tissue Recall Doesn't Include Heart Valves
Following the death of man undergoing reconstructive knee surgery possibly linked to contaminated soft tissue, the FDA has ordered CryoLife, Inc. to recall distributed human tissue processed from October 3, 2001, to the present. The recall—which affects certain nonvalved cardiac tissues, but not heart valves—is being ordered, the agency said in a statement, because it determined that "CryoLife cannot ensure that the human tissue it processes for transplantation is free from fungal and bacterial contaminants." During multiple inspections of CryoLife's processing facility in Georgia, the FDA reported, "numerous, significant violations of FDA regulations" were discovered—violations that CryoLife failed to rectify following a June 17 warning letter from the FDA. CryoLife supplies 70 percent of the heart valves obtained from human donors in the United States. According to an FDA spokesperson, although recall does not include heart valves, the agency is "actively evaluating" the processing of the company's heart valves and will take "appropriate regulatory action" based on the results of that evaluation. Under the FDA order, CryoLife must also quarantine undistributed tissue processed after last October 3. Pending the results of an appeal of the recall by CryoLife, the FDA spokesperson said, the company does not yet have to destroy all recalled or quarantined material.

Members Asked to Identify Onerous, Inadequate LMRPs
Beginning October 1, 2002, the Centers for Medicare and Medicaid Services (CMS) will implement a new process that encourages physicians to identify onerous and inadequate local Medicare policies. The ACC would like to identify the Local Medical Review Policies (LMRPs) that cause cardiovascular specialists and their patients problems with the Medicare program and provide the information needed to influence needed changes. Members are encouraged to report to the College "problem" LMRPs, the most commonly denied services by their Medicare carriers, and the most commonly appealed issues that result in coverage decisions being overturned. Information should be forwarded to Denise Garris at (800) 435-9203, ext. 496, or dgarris@acc.org.

Valsartan Approved for Treatment of Heart Failure
The FDA last week approved the angiotensin II receptor blocker valsartan (Diovan) to treat heart failure in patients who cannot tolerate ACE inhibitors. According to a statement from the drug's manufacturer, Novartis, the approval was based largely on Val-HeFT, a heart failure trial that included more than 5,000 patients. In the trial, overall mortality was similar in patients treated with valsartan or a placebo, but in patients who were not on an ACE inhibitor, valsartan improved survival and reduced morbidity and hospitalization for heart failure. Last October, the FDA Cardiovascular and Renal Drugs Advisory Committee split four to four in its decision on whether to recommend that the FDA approve valsartan to treat heart failure.

Medical Practices Losing Money, Survey Finds
The most recent survey on the financial status of the nation's medical group practices by the American Medical Group Association (AMGA) indicates that physician practices are facing tough financial times. The survey, according to an AMGA news release, confirms that "physician groups are experiencing significant losses in the midst of an increasingly competitive and regulatory environment." The average group lost $16,840 per physician, the survey found. The survey represents financial reports for 2001 and does not reflect the cutbacks in Medicare reimbursement that went into effect January 2002. Physician group performance varied by region, with practices in the western United States reporting the largest declines, and practices in the eastern part of the country actually showing improvements in their financial performance. Practices in the western region, AMGA noted, tend to have "some of the highest percentages of capitated revenue."

FDA Approves Guidant Multi-Link Stents for AMI
Based on the results of the CADILLAC trial, the FDA has approved the use of Guidant's MULTI-LINK family of stents in patients presenting with an AMI, Guidant reported last week. "The clinical data from the CADILLAC trial demonstrates conclusively the benefit of stent implantation as an immediate treatment for heart attack victims," said CADILLAC principal investigator Gregg W. Stone, M.D., in a Guidant statement. In the CADILLAC trial, which was published earlier this year in the New England Journal of Medicine, when compared to angioplasty alone, stenting after AMI reduced major adverse cardiac events by nearly 50 percent.