American College of Cardiology

National Coverage Decision on ICDs Limited to MADIT II Subgroup
In a long-waited announcement, the Centers for Medicare and Medicaid Services (CMS) said late Friday afternoon that it was expanding national coverage of the use of ICDs, but not to the extent that had been requested by ICD manufacturer Guidant or recommended by a Medicare advisory panel. The coverage decision expands coverage to patients with a previous MI, LVEF less than or equal to 30 percent, and QRS duration greater than 120 ms. Guidant had requested, and the Medicare Coverage Advisory Committee (MCAC) had recommended, broader coverage consistent with population of the MADIT II trial: a previous MI and EF less than or equal to 30 percent. "CMS's limited coverage decision is inconsistent with the findings of the MADIT II trial, which demonstrated a significant reduction in the risk of death for all patients who received ICD therapy," said MADIT II lead investigator Arthur J. Moss, MD, in a Guidant news release. The agency said they made the decision based on a substudy done by a MADIT II investigator that showed patients in the trial with a QRS greater than 120 ms had a 63 percent mortality reduction compared to control patients. The decision also expands coverage for ICDs to use in patients with coronary artery disease with previous MI, LVEF less than or equal 35 percent, and inducible, sustained ventricular tachycardia or ventricular fibrillation at electrophysiological study. The ACC testified before the MCAC in favor of coverage for the MADIT II indication and is studying this coverage decision.

Frist, Scully Address Medicare, Liability Reform at Alliance Event
Majority Leader Bill Frist, R-Tenn., last week encouraged physicians to keep the pressure on Congress to pass medical liability reform. “Frivolous lawsuits are killing the system,” Sen. Frist said during a legislative “fly-in” being held by the Alliance of Specialty Medicine, a coalition of 13 physician specialty societies, of which the ACC is a member. A bill nearly identical to the House-passed liability-reform bill is likely to be brought up for consideration in early July, Sen. Frist said. CMS Administrator Tom Scully, who also addressed Alliance representatives during the two-day event, discussed the 4.2 percent cut in physicians’ Medicare fees the CMS is projecting for 2004. Scully offered little in the way of encouragement for physicians, stressing that the Bush administration’s priority at the moment as far as Medicare is concerned is a $400 billion prescription drug benefit. The administration has also indicated that it supports Sen. Grassley’s push to help rural providers in the Medicare reform bill (see next story). A detailed report on the event is available on the ACC Web site. Video footage of Scully's comments is now available. Please check back to Advocacy Weekly then. Participating in the fly-in on behalf of the ACC was ACC Political Action Committee Chair Steve West, MD, and ACC Fellows Sharon Hecker, MD, Butte, Mont., and Theodore Silver, MD, Bangor, Maine.

Senate Medicare Reform Bill Will Include Help for Rural Providers, Change in Reimbursement for Administered Drugs
Medicare reform legislation to be introduced in the Senate would increase reimbursement to health care providers in rural areas and likely reduce the average whole sale price that Medicare pays for drugs administered by physicians in outpatient settings. The bill, the cornerstone of which is a prescription drug benefit, is part of a compromise between Senate Finance Committee Chair Charles Grassley, R-Iowa, and Max Baucus, D-Mont. Details of how the rural provider payments would work were not released, but in announcing the legislation, Sen. Grassley said that the reimbursement changes would be “paid for with other program changes, not our reserve fund resources.” According to a Health News Daily report, Grassley was likely referring, in part, to provisions in the legislation that will reduce the average wholesale price (AWP) paid to physicians who administer drugs in their offices—namely oncologists, but also some cardiologists. However, Health News Daily reported, oncologists will also see reimbursement increases to make up for some of the losses from drug payment reductions. CMS Administrator Scully has promised to address the AWP issue administratively if Congress fails to pass legislation doing so. As reported previously, such a move could result in practice expense reimbursement reductions for other specialists, including cardiologists.

Liability Reform Bill Passed in Texas
Texas moved one step closer last week to enacting a medical liability reform law that caps noneconomic damages. Both the House and Senate approved a bill that would cap noneconomic damages in liability cases at $250,000 per case for physicians and $500,000 for hospitals or other health care facilities, with a total cap of $750,000. Gov. Rick Perry, R, has been a proponent of liability reform and is expected to sign the bill, the Dallas Morning News reported. Even if Gov. Perry signs the legislation, however, the Texas state constitution bars caps on damages in lawsuits. As a result, a referendum has been added to the September election ballot to change the state constitution.

Additional Lots of Counterfeit Lipitor Found
Additional lots of counterfeit atorvastatin (Lipitor) have been found, the Food and Drug Administration (FDA) reported last week. The announcement is in follow-up to an earlier warning from the FDA that three lots of atorvastatin (Lipitor) had been voluntarily recalled by Albers Medical Distributors, Inc. The labels of the counterfeit drugs say "Repackaged by: MED-PRO, Inc. Lexington, Neb." In the most recent warning, the FDA said that its investigation turned up additional lots of counterfeit products. More information on the situation is available on the FDA Web site.

Fla. Biggest Medical Liability Insurer To Reduce Rates if Reform Bill Passed
Florida’s largest medical liability insurer said it will reduce premiums by 20 percent if legislation is passed capping noneconomic damages in medical liability cases at $250,000. The insurer, FPIC Insurance Group, sent a letter to Florida Governor Jeb Bush, R, saying premiums would be reduced “as long as the provisions stay intact,” the Associated Press reported. The Florida legislature will meet in special session on June 16-19 to take up a comprehensive liability reform package, including a $250,000 cap, introduced by Gov. Bush.

AMA “Organization of Organizations” Plan To Be Scrapped
Efforts to restructure the AMA to become an organization of state medical and national specialty societies will apparently be scrapped. According to a Modern Physician report, members of the committee to develop a plan to make the AMA an “organization of organizations” are indicating that at the AMA House of Delegates meeting this weekend, they will recommend against the change. The concept “has kind of gone away,” American Academy of Family Physicians President James Martin, MD, told Modern Physician. Among other things, the story noted, issues related to funding from participating medical societies and governance issues could not be worked out. The Committee’s report does recommend that the AMA significantly reduce its scope of activities and focus on the core functions of advocacy, communications, and ethics.

Bill Would Expand Medicare Coverage of Cover Chronic Conditions
Legislation introduced in the House and Senate by Rep. Pete Stark, D-Calif., and Sen. John Rockefeller, D-W. Va., would expand Medicare coverage of care for chronic conditions. According to a news release from Rep. Stark, the bill, the “Medicare Chronic Care Improvement Act of 2003,” would expand coverage for care coordination and assessment services for Medicare beneficiaries with chronic conditions; implement a chronic care quality improvement program; and provide federal matching grants for clinical information technology systems that improve the coordination and quality of chronic care. According to Rep. Stark, among Medicare beneficiaries, 20 percent suffer from five or more chronic medical conditions, accounting for nearly two-thirds of Medicare spending.