Panel: Glucose monitor requires study
Medicare weighs wider coverage
BY JIM McCARTNEY
Pioneer Press
Circulation: 190,374
Despite pressure from Congress, officials in charge of Medicare still appear to be more than a year away from upping the reimbursement rate or expanding coverage for the continuous glucose monitor, a device that warns diabetics if their blood-sugar levels are too high or too low.
An advisory panel to the U.S. Center for Medicare and Medicaid Services made it clear Wednesday that members will need more data before they decide whether to cover the device, said Steve Sabicer, a spokesman for Fridley-based Medtronic Inc., who was at the meeting.
"They are still a ways from making any decisions on reimbursements," agreed Peter Cleary, a spokesman for the Juvenile Diabetes Research Foundation, a powerful Washington, D.C., lobbying organization, who also attended the all-day session in Baltimore. Earlier this year, Cleary's organization orchestrated a campaign in which 64 U.S. senators and 260 representatives, including Minnesota members of Congress, signed a letter to urge Medicare to reimburse for the monitor.
Medtronic and San Diego-based Dexcom are the only companies that sell continuous glucose monitors in the U.S., although Abbott Park, Ill.-based Abbott Labs is close to winning regulatory approval to sell its version, Cleary said.
The panel seems particularly interested in a Medtronic-sponsored clinical trial called Star 3, the results for which will not be available until 2008, Sabicer said.
"Star 3 will deal with outcomes, and that's the kind of data they are interested in," he said.
Aside from their alarms and improved control of blood sugars, monitors are considered a crucial step forward in the development of the artificial pancreas, in which a microcomputer reads the data from a monitor and tells the pump to adjust the insulin levels. At stake is a market that could run into the billions of dollars, according to Jan Wald, a securities analyst with A.G. Edwards.
This week's panel focused on patients age 65 and up who have Type 2 diabetes, a disease that can set in as people age and become overweight. Type 2 diabetes, considered a growing epidemic by the U.S. Centers for Disease Control, now afflicts an estimated 17 million people. About 3 million people have Type 1 diabetes, or juvenile diabetes, in which the pancreas no longer produces insulin, the hormone that breaks down glucose, or sugars, in the blood.
High levels of blood sugars can cause heavy damage to the body's organs, resulting in loss of limbs, blindness and death. Low levels, called hypoglycemia, are just as dangerous and can lead to a seizure, a coma and death.
Jim McCartney can be reached at 651-228-5436 or jmccartney@pioneerpress.com.
Pioneer Press
Circulation: 190,374
Despite pressure from Congress, officials in charge of Medicare still appear to be more than a year away from upping the reimbursement rate or expanding coverage for the continuous glucose monitor, a device that warns diabetics if their blood-sugar levels are too high or too low.
An advisory panel to the U.S. Center for Medicare and Medicaid Services made it clear Wednesday that members will need more data before they decide whether to cover the device, said Steve Sabicer, a spokesman for Fridley-based Medtronic Inc., who was at the meeting.
"They are still a ways from making any decisions on reimbursements," agreed Peter Cleary, a spokesman for the Juvenile Diabetes Research Foundation, a powerful Washington, D.C., lobbying organization, who also attended the all-day session in Baltimore. Earlier this year, Cleary's organization orchestrated a campaign in which 64 U.S. senators and 260 representatives, including Minnesota members of Congress, signed a letter to urge Medicare to reimburse for the monitor.
Medtronic and San Diego-based Dexcom are the only companies that sell continuous glucose monitors in the U.S., although Abbott Park, Ill.-based Abbott Labs is close to winning regulatory approval to sell its version, Cleary said.
The panel seems particularly interested in a Medtronic-sponsored clinical trial called Star 3, the results for which will not be available until 2008, Sabicer said.
"Star 3 will deal with outcomes, and that's the kind of data they are interested in," he said.
Aside from their alarms and improved control of blood sugars, monitors are considered a crucial step forward in the development of the artificial pancreas, in which a microcomputer reads the data from a monitor and tells the pump to adjust the insulin levels. At stake is a market that could run into the billions of dollars, according to Jan Wald, a securities analyst with A.G. Edwards.
This week's panel focused on patients age 65 and up who have Type 2 diabetes, a disease that can set in as people age and become overweight. Type 2 diabetes, considered a growing epidemic by the U.S. Centers for Disease Control, now afflicts an estimated 17 million people. About 3 million people have Type 1 diabetes, or juvenile diabetes, in which the pancreas no longer produces insulin, the hormone that breaks down glucose, or sugars, in the blood.
High levels of blood sugars can cause heavy damage to the body's organs, resulting in loss of limbs, blindness and death. Low levels, called hypoglycemia, are just as dangerous and can lead to a seizure, a coma and death.
Jim McCartney can be reached at 651-228-5436 or jmccartney@pioneerpress.com.
