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'Just Say No' to Substitution

The terms “therapeutic substitution” and “therapeutic interchange” refer to two very different practices, and cardiologists should not accept the former but may be comfortable with the latter, according to a policy statement from the American College of Cardiology Foundation. Substitution occurs without a doctor's consent, whereas interchange is when a pharmacy dispenses a similarly acting drug with the physician's permission. If a payer is considering approving a certain interchange, it needs to take into account the strength of the evidence that the two drugs will work similarly, and it needs to consider the patient's specific medical condition. “Cost should be a consideration in this decision but not be the primary factor,” according to the policy statement, which also recommends procedures for health care facilities and payers to follow when they are developing a therapeutic-interchange policy.

Heart Disease Is Most Costly

Heart disease in both women and men was the most expensive condition in the United States in 2008, while hypertension and hyperlipidemia also made the top-10 list, according to the Agency for Healthcare Research and Quality. The analysis found that the cost for inpatient and outpatient care, emergency department visits, home care, and prescriptions for men with heart disease reached $47.3 billion, while payers spent $43.6 billion to treat women for heart disease. Medicare paid more than half of those expenditures for women but only about 38% of the cost for men. In the same year, more men and women suffered from hypertension than from any of the other 10 most costly conditions: 29.5 million women and 25.6 million men were subject to expenditures that were related to hypertension, according to the agency.

FDA Warns on Contrast Generator

The Food and Drug Administration is warning health care professionals to stop using CardioGen-82, a generator of rubidium-82 chloride, for cardiac positron emission tomography scans. The device's manufacturer, Bracco Diagnostics, announced that it will voluntarily recall the product. The FDA had received reports of two patients who were getting more radiation than was expected from CardioGen-82, although the agency said that the individuals' risk of harm was minimal. However, the FDA determined that Bracco Diagnostics's manufacturing procedures are not sufficient to ensure reliable performance of the device. The agency said it also is investigating procedures that are used to detect radiation exposure from the CardioGen-82.

Senators: Stop the Imaging Cuts

A bipartisan group of seven senators has called on President Obama to reject any further cuts to medical-imaging payments under Medicare, saying that the cuts already in place are harming both patients and the developers of these technologies. “As a result of these cuts, physicians are holding onto their old equipment longer, which means fewer patients have access to the newest technologies that are better at finding early-stage disease and guiding life-saving treatment,” the senators wrote. Instead of cutting imaging payments, the group said, Medicare should implement clinical decision-support systems that will help doctors determine when imaging is necessary. The senators signing the letter, many of whom come from states with strong biotech industries, are John Kerry (D-Mass.), David Vitter (R-La.), Scott Brown (R-Mass.), Ron Wyden (D-Ore.), Herb Kohl (D-Wis.), Lamar Alexander (R-Tenn.), and Maria Cantwell (D-Wash.).

Cardiologist Convicted of Fraud

A federal jury in Baltimore has convicted Salisbury, Md.–based cardiologist Dr. John McLean of six counts of fraud for implanting unnecessary cardiovascular stents, ordering unnecessary tests, and making false entries in patients' medical records. According to evidence that was presented at his trial, Dr. McLean performed cardiac catheterizations and implanted unnecessary stents in more than 100 patients at the Peninsula Regional Medical Center in Salisbury. He also recorded false evidence or coronary artery blockages in patients' medical records to justify the stents that he implanted, the U.S. attorney's office alleged. Dr. McLean, who is scheduled to be sentenced on Nov. 10, faces a maximum sentence of 35 years in prison and more than $711,000 in forfeited profits.

Another Top Ranking for Harvard

The Harvard Clinical Research Institute received the highest payment from Eli Lilly of all physicians and physician groups in the United States in the first 3 months of 2011 – $767,564 – for its work on the Dual Antiplatelet Therapy study, according to the drug manufacturer's new physician-payment registry. The antiplatelet therapy double-blind randomized controlled trial, which is sponsored by the Harvard Clinical Research Institute and has multiple collaborators, including Eli Lilly, is designed to determine the appropriate combination of aspirin and a second anticlotting therapy. Many of the top 10 payments on Eli Lilly's first quarter 2011 registry went to psychiatrists, neurologists, and rheumatologists. The company, which has started disclosing its payments to physicians under a corporate-integrity agreement with the federal government, indicated that 63% of its payments in the first quarter were related to research projects.

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