Home Test Coverage Expanded

The Centers for Medicare and Medicaid Services issued a final decision to expand coverage of home prothrombin time (or International Normalized Ratio) testing for patients taking anticoagulation therapy for chronic atrial fibrillation and venous thromboembolism. Patients have to meet certain other criteria, and the home tests can't be used more than once a week. Medicare has covered home testing since 2002, but only for patients with mechanical heart valves.

The request for expanded coverage was made in June 2007 by the three main manufacturers of home testing devices (Roche Diagnostics, International Technidyne Corp., and HemoSense Inc.). The companies said there was plenty of new evidence to support home testing for the two other conditions. The CMS agreed. “Medicare's coverage extension of home blood testing of prothrombin time… is based on current evidence for these two conditions,” CMS Acting Administrator Kerry Weems said in a statement. Currently, PT testing is conducted about every 4–6 weeks, primarily in physicians' offices, according to the CMS. Fewer than 5% of patients on anticoagulation therapy monitor PT at home.

“Those Medicare beneficiaries and their physicians managing conditions related to chronic atrial fibrillation or venous thromboembolism will benefit greatly through the use of the home test,” Mr. Weems said. In a statement, Roche estimated that Medicare beneficiaries would pay &dollar;35 for training in use of at-home devices, and about &dollar;30 a month for test strips. Patients who have supplemental insurance might not have any out-of-pocket costs, the company said.

Inquiry Request on Stolen NIH Data

A National Heart, Lung, and Blood Institute researcher had the misfortune of having his laptop stolen out of the trunk of his car in late February. More unfortunately, the laptop held confidential information from ongoing cardiac studies of about 3,200 patients, including unsecured Social Security numbers for about 1,200 patients. Most unfortunately, among those whose data are at risk is Rep. Joe Barton (R-Tex.), ranking minority member of the House Energy and Commerce Committee.

Rep. Barton was informed of the breach on March 28 and quickly wrote to the Department of Health and Human Services' Inspector General seeking an inquiry into why the data were not secure and why the NHLBI took almost a month to inform patients of the breach.

The data in the researcher's computer were from ongoing studies of MRI's potential to quickly determine the source of chest pain in the emergency department, and to determine the impact of myocardial infarction on heart structure and function, according to the NHLBI. A spokesman said in an interview that for now, it appears no data were lost, as they were backed up shortly before the theft on an institute server. Also, the NHLBI has offered free credit monitoring and up to &dollar;20,000 in identity theft insurance to those whose Social Security numbers were on the laptop.

The National Institutes of Health is now taking steps to ensure encryption of all data storage devices, said the spokesman. The theft and the NHLBI response are being investigated by the Energy and Commerce Committee and the panel's Oversight and Investigations Subcommittee.

Gene Group to Look at Long QT

A new global collaboration led by the NIH and Japan's Center for Genomic Medicine will explore how genes may play a role in drug-induced long QT syndrome, among its first projects. The Global Alliance for Pharmacogenomics will identify genetic factors that influence individuals' responses to pharmaceuticals. The collaborative will also work with the International Warfarin Consortium to develop dosing recommendations based on patients' genetic profiles. Other initial projects include looking at how genes influence the effectiveness of aromatase inhibitors for breast cancer, and side effects from gemcitabine and bevacizumab.

“We expect this international agreement to speed scientific discovery and the translation of results into improved treatments for cancer, heart disease, and other serious conditions,” Dr. Elias Zerhouni, NIH director, said in a statement. The alliance is supported by public funds.

Health Sector Biggest Lobby

The health care industry was the biggest spender when it came to lobbying Congress in 2007. Pharmaceutical, medical device, physician, and hospital groups spent &dollar;227 million, a larger tally than for any other sector, according to the Center for Responsive Politics, a Washington-based watchdog group.

Of individual lobbying concerns, the U.S. Chamber of Commerce was number one, spending &dollar;53 million on in-house and external personnel, the center reported. Close behind was General Electric (&dollar;24 million), followed by the Pharmaceutical Research and Manufacturers of America (&dollar;23 million), the American Medical Association (&dollar;22 million), and the American Hospital Association (&dollar;20 million).

Broken out by industries, the pharmaceutical sector has spent more than any other industry in the last decade, laying out an accumulated &dollar;1.3 billion since 1997, said the center.

The data are taken from official lobbying reports that are submitted to the Senate Office of Public Records. The figures do not include other spending that is still aimed at influencing policy, according to the center.

Policy & Practice