A Medical Device Daily

The Centers for Medicare & Medicaid Services has threatened for some time to stop paying for preventable adverse outcomes in hospitals, and the agency recently announced that the time has come to do just that.

The rule, which formally came into being when CMS published in July its inpatient prospective payment system for 2009, will allow the agency to refuse payment to hospitals if a patient acquires any of several urinary tract infections, bloodstream infections and surgical site infections. Other conditions that are subject to the rule include bedsores, objects left in patients' bodies after surgery, and post-surgical blood clots.

In a Sept. 30 statement, Lisa McGiffert, director of the Stop Hospital Infections campaign – operated by Consumers Union (Washington), said that the policy "will help prevent needless suffering and deaths and ultimately ensure that the healthcare taxpayers pay for is safe and effective."

Hospitals have another reason to clamp down on these events. A recently published study by insurance firm Aon (Chicago) indicates that hospital-acquired conditions accounted for more than 12% of total legal liability costs last year as well as about one of every six claims.

The most expensive "never" event in liability terms was the pressure ulcer. Each suit for this condition hit the defendant hospital for an average of $145,000. The Aon study examined almost 78,000 claims from more than 1,200 facilities between 1998 and last year. Total losses were $9.3 billion, but there was no indication whether any downward or upward trends were seen in the data.

PTO, EU sign up for patent pilot

The U.S. Patent and Trademark Office has worked with its counterparts in other nations over the past few years to stitch together an international patent prosecution system, and USPTO recently announced that it and the European Patent Office (EPO; Munich) have entered into an agreement to run a pilot project to coordinate patent work.

According to the Sept. 22 statement, the pilot will allow an application filed in one office to essentially move to the head of the queue, as it were, in the other office. The office of the second filing, as it is described in the USPTO statement, will be able to draw on the resources of the office of the first filing "to exploit the search and examination results" of the first office.

USPTO noted that it had commenced with a similar venture with Japan in 2006 and the program became a permanent feature this past January. The PTO/EPO pilot commenced Sept. 29 and will have run its course one year later. USPTO notes that the program "may be extended for up to a year if necessary to adequately assess the feasibility" of the program.

USPTO has commenced with such programs with several Western nations, including Canada, the United Kingdom and Australia, but bringing in economies such as German and France, both of which boast substantial intellectual property activity, may help clear out many more patent problems before they become a transoceanic legal problem.

Reimbursement conference slated

The Medical Device Manufacturers Association (MDMA; Washington) will hold its annual Coverage, Reimbursement and Health Policy Conference Nov. 11-12 in Washington. The event brings together public officials, industry members and consultants for two days of give-and-take over reimbursement, which is the make-or-break question for many device makers.

According to the announcement at the MDMA web site, the conference will cover the basics of reimbursement strategy and updates on prospective payment systems.

Among the scheduled speakers are Beth Roberts, a partner at Hogan & Hartson (Washington) with several years of experience lobbying Capitol Hill regarding legislation, and Marc Hartstein, acting deputy director of CMS's Hospital and Ambulatory Policy Group.

Congressional staffers also will be on hand to give attendees a closer look at the leanings of the current Congress, and MDMA has invited Sen. Max Baucus (D-Montana), chairman of the Senate Finance Committee, to address attendees during the second-day lunch.

MDMA Executive Director Mark Leahey said the conference "provides attendees a unique opportunity to interact with leaders in the field as well as key decision-makers."

Medtronic warns physicians of pump issues

Medtronic (Minneapolis) has warned physicians about issues with some of its implantable drug pump systems that have been linked to one patient death and dozens of other problems.

The FDA posted a notice about problems with the tubing connecting the company's catheters to its drug pumps. The pumps are implanted in the abdomen to deliver drugs to treat chronic pain.

Medtronic said the misconnections could block the flow of drugs, cause overdoses and other potentially fatal complications.

A spokeswoman said that Medtronic is not recalling the products, which were manufactured according to company standards. The company's letter to physicians provided guidance on how to make sure the devices are functioning properly.