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Part D Battle Begins
As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007. It would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. Two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—but it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as intially written, the bill will have new prices go into effect for the plan year starting Jan. 1, 2008.
2007 Advocacy Agenda
Finding a permanent solution to how Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect, but that was only a stopgap, according to the AMA. “This year we will work with Congress, the administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push this year for an expansion of health insurance coverage for the uninsured. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies.
Unique New Drugs on Decline
The Food and Drug Administration approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research and development spending rose 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.
FDA Panels Held Less Often
An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen's letter in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.
Cancer Care Time Costs Add Up
The cost of the time spent by cancer patients in fighting their illness amounted to about $2.3 billion in 2005, according to a study in the January issue of the Journal of the National Cancer Institute. Researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumors. They analyzed records for 767,010 patients who were initially diagnosed during 1973–1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.
New Osteoporosis Health Claims
FDA officials are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. Currently, only calcium supplements may claim they have the potential to do so. The new proposal also would broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age since the benefits apply to both sexes and all ages and races. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.
Part D Battle Begins
As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007. It would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. Two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—but it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as intially written, the bill will have new prices go into effect for the plan year starting Jan. 1, 2008.
2007 Advocacy Agenda
Finding a permanent solution to how Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect, but that was only a stopgap, according to the AMA. “This year we will work with Congress, the administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push this year for an expansion of health insurance coverage for the uninsured. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies.
Unique New Drugs on Decline
The Food and Drug Administration approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research and development spending rose 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.
FDA Panels Held Less Often
An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen's letter in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.
Cancer Care Time Costs Add Up
The cost of the time spent by cancer patients in fighting their illness amounted to about $2.3 billion in 2005, according to a study in the January issue of the Journal of the National Cancer Institute. Researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumors. They analyzed records for 767,010 patients who were initially diagnosed during 1973–1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.
New Osteoporosis Health Claims
FDA officials are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. Currently, only calcium supplements may claim they have the potential to do so. The new proposal also would broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age since the benefits apply to both sexes and all ages and races. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.
Part D Battle Begins
As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007. It would require the Health and Human Services department to negotiate prices with drug makers. The legislation was passed by the House in January by a vote of 255–170. Two Senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—but it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If enacted as intially written, the bill will have new prices go into effect for the plan year starting Jan. 1, 2008.
2007 Advocacy Agenda
Finding a permanent solution to how Medicare pays physicians is at the top of the agenda for both the American Medical Association and the American Academy of Family Physicians. Congress acted at the end of last year to stop a 5% Medicare pay cut from going into effect, but that was only a stopgap, according to the AMA. “This year we will work with Congress, the administration, and seniors to stop the 2008 Medicare cut and enact a more permanent solution to the flawed Medicare physician payment formula,” Dr. Cecil Wilson, AMA board chair, said in a statement. Both groups also plan to push this year for an expansion of health insurance coverage for the uninsured. Other top AMA priorities include reforming the medical liability system, closing health care gaps for minority patients, and preparing for and responding to public health emergencies.
Unique New Drugs on Decline
The Food and Drug Administration approved 18 new molecular entities last year, on par with the previous year, but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993–2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993–2004, research and development spending rose 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Over the same period, FDA has continued to approve most submissions, but the number approved overall has declined, GAO said.
FDA Panels Held Less Often
An advocacy group is charging that the FDA is holding outside advisory panel meetings less often than it did a decade ago. Public Citizen's Health Research Group analyzed the 275 advisory committee meetings held from 1997 to 2006. In 1998 and 1999, almost half of approved NMEs were preceded by panel meetings; from 2000 to 2006, only 24% (35) of the 147 NMEs approved had a committee meeting first, according to Public Citizen's letter in the Dec. 23 issue of The Lancet. The group also found that the FDA did not present its scientific opinion as a counterbalance to the drug maker's presentation at 18%, or 49 of the 275 meetings. The FDA overruled the panel conclusions 28% of the time, “a figure higher than is generally assumed,” according to Public Citizen.
Cancer Care Time Costs Add Up
The cost of the time spent by cancer patients in fighting their illness amounted to about $2.3 billion in 2005, according to a study in the January issue of the Journal of the National Cancer Institute. Researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumors. They analyzed records for 767,010 patients who were initially diagnosed during 1973–1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.
New Osteoporosis Health Claims
FDA officials are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. Currently, only calcium supplements may claim they have the potential to do so. The new proposal also would broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age since the benefits apply to both sexes and all ages and races. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.