CHAMPVA - Preauthorization of Durable Medical Equipment

This final rule amends the Department of Veterans Affairs (VA) 
medical regulations for the Civilian Health and Medical Program of the 
Department of Veterans Affairs (CHAMPVA) preauthorization section by 
increasing the dollar ceiling for purchase or rental of durable medical 
equipment (DME) from $300 to $2,000.

The final rule is effective July 31, 2009.

Company claims federal approval for 9-mm handgun as 'medical device'

World Net Daily - December 13, 2008 Matthew Carmel, president of Constitution Arms in Maplewood, N.J., says the Palm Pistol is designed to be fired by people who have disabling conditions that prevent them from holding a normal handgun and pulling the trigger. "It's something that they need to assist them in daily living," Carmel, who hopes to manufacture the device, told New Scientist. Currently the Palm Pistol is just at the patent stage. "The justification for this would be no more or less for a walker or wheelchair, or any number of things that are medical devices," he said. Constitution Arms reportedly claimed on a medical technology blog to have received U.S. Food and Drug Administration approval for the handgun as a medical device – specifically, a "daily activity assist device." Constitution Arms has said the firm is now attempting to obtain a Durable Medical Code for the pistol which would allow doctors to prescribe it and qualified patients to receive reimbursement through Medicare and, possibly, private insurers. A spokesman for FDA disputed Carmel's claim to New Scientist, saying, "At this time, there have been no formal designations of the Palm Pistol by the FDA as a medical device." Even if the gun is recognized as a legitimate medical device, Carmel has little chance of getting Medicare to pay for it, said Kevin Schulman, an expert on medical device regulation at North Carolina's Duke University Medical Center. "Medicare does not cover everything that FDA approves," said Schulman. "The first question for Medicare is whether this would be potentially beneficial, and the answer seems to be obviously no. It's not implanted in the body, but the obvious result of this thing could be."

South Florida Durable Medical Equipment Suppliers: Results of Appeals

For a March 2007 report, OIG conducted unannounced site visits to 1,581 South Florida durable medical equipment suppliers. Four hundred ninety-one (491) of these suppliers failed to meet Medicare supplier standards, and CMS revoked the suppliers' billing privileges. Nearly half of the revoked suppliers appealed the revocations and received hearings. Hearing officers reinstated the billing privileges for 91 percent of these suppliers. Two-thirds of suppliers whose billing privileges were reinstated have subsequently had their privileges revoked again or inactivated, and some individuals connected to reinstated suppliers have been indicted. We found that because there are no criteria regarding the types of evidence necessary to reinstate the billing privileges of suppliers, hearing officers reinstated the suppliers' billing privileges based on a variety of evidence. Examples of evidence that suppliers provided include photographs, affidavits, utility bills, and leases. Based on the report's findings, we recommended that CMS strengthen the appeal process by developing criteria regarding the types of evidence required for hearing officers to reinstate suppliers' billing privileges. CMS agreed that it should consider establishing guidelines regarding the evaluation of evidence that a hearing officer will review during the appeal process.

VA: Preauthorization for Durable Medical Equipment

This document proposes to amend the Department of Veterans Affairs (VA) regulations for the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) related to preauthorization requirements that apply to the purchase or rental of durable medical equipment. It would increase from $300 to $2,000 the cost of purchase or rental above which preauthorization would be required. This is intended to remove from the CHAMPVA claims process an administratively inefficient requirement. DATES: Comments must be received on or before December 29, 2008.

Flaws in medical coding can kill

Spread of computers creates new dangers, FDA officials warn By Jonathan D. Rockoff Sun reporter June 30, 2008 After a routine piece of medical equipment started mysteriously killing hospital patients a few years ago, the federal government turned to a small team of its software experts in suburban Maryland for help. The team's discovery - a flaw in a computer code that caused a drug pump to administer heavy overdoses - led to a recall, warnings and rewriting of the equipment's software. The discovery also illustrated a new threat behind some lifesaving medical devices.