Story first appeared in USA TODAY.
The U.S. Food and Drug Administration on Thursday issued new guidelines aimed at helping speed up the development of artificial pancreas systems.
If they become a reality, such technologies could make a huge difference for people with type 1 diabetes, who need insulin injections to control their blood sugar and survive.
Artificial pancreas systems combine current technologies for continuous blood sugar monitoring and pumps to deliver insulin as needed. These systems are designed to keep patients' insulin levels within normal ranges, by reacting to changes in blood sugar.
So far, however, equipment problems, computer glitches and problems with the insulin used have hampered development of these systems, the FDA said in a news release.
That's why the agency has taken the unusual step of developing a guidance for approval, something which is usually done after a device had been developed and tested, he said.
Zimliki said he has no idea when an approved device might be available. To date, the FDA has approved more than 20 clinical studies for artificial pancreas systems.
The FDA's new guidelines make designing, testing and safety and effectiveness requirements more flexible. For example, they propose more flexibility in the choice of clinical trial outcomes, number of patients needed and the length of the trial.
They really wanted to make a push; they felt like it was a good idea to give academicians and people that aren't familiar with the regulatory process a pathway to develop these systems. They want people to move these things forward; they think this guidance will allow people to get a safe and effective product on the market quickly.
In type 1 diabetes, the pancreas produces little or no insulin, an essential hormone necessary for controlling blood sugar. People with type 1 diabetes have to monitor their blood sugar throughout the day, and calculate how much insulin they need to lower their blood sugar, which is delivered using a syringe or insulin pump.
An artificial pancreas system combines an insulin pump and a continuous glucose monitor with a sensor placed under the patient's skin. The pump and monitor work together, tracking blood sugar and automatically pumping measured doses of insulin as determined by a computer algorithm.
These systems help eliminate, or reduce the severity of dangerous drops in blood sugar by stopping insulin administration when blood sugar levels near a predetermined threshold.
The device is not a cure, but it might reduce dangerous high and low blood sugar levels, giving patients a better quality of life and reducing the risk of diabetes-related complications, the FDA said.
The new guidelines recommend a three-phase clinical study progression so that studies may move to an outpatient setting as quickly as possible."The agency is also suggesting other ways to streamline the testing process, including ways to use existing safety and effectiveness data for the components that make up the system, and allowing data from clinical studies done outside of the United States to be used in the approval process.
In addition, those conducting the clinical trials have the option of demonstrating that the system controls blood sugar as well as standard therapies, or showing that it gives better blood sugar control when compared to other therapies.
In June, the FDA released a draft guidance on safety and effectiveness goals for researchers and industry in developing the Low Glucose Suspend System, a first-generation artificial pancreas system. Those results helped inform this new guidance.
Hurdles in developing these systems include making sure the implanted sensors remain clear, the need to periodically recalibrate blood sugar monitors, problems with the software needed to operate insulin infusion pumps, problems creating algorithms to deliver insulin that take into account how long it takes the body to absorb it, the need for a faster-acting insulin and the overall development of safer and more reliable algorithms.
Another issue is the lack of a glucagon formulation that can be used in infusion pumps. Glucagon is a hormone used to treat severe low blood sugar. There is a need for a glucagon formulation that is stable over several days and can be delivered by an infusion pump, the FDA said.
09 December 2011
29 November 2011
Blood Thinner Increases Heart Survival
Story first appeared in Bloomberg News.
Johnson & Johnson and Bayer AG’s blood-thinner Xarelto cut by 16 percent the risk of a subsequent heart attack, stroke or death from heart disease in patients who recently suffered a cardiac event, according to a study.
The data makes Xarelto the first in a new class of blood thinning medicines to show effectiveness for acute coronary syndromes, or ACS, when used in addition to standard treatment. The lowest dose, given twice daily, slashed deaths by one-third.
Xarelto was approved Nov. 17 in the U.S. to prevent strokes in people with atrial fibrillation, an irregular heartbeat that affects more than 2 million Americans. The data reported today at the American Heart Association meeting in Orlando, Florida, may create a new use in
1.2 million patients hospitalized yearly with ACS, which includes heart attack and severe chest pain. It’s a $1.4 billion market, said an analyst with Sanford C. Bernstein & Co. in San Francisco
A halo effect from having good ACS data could improve physicians overall perception of Xarelto and, importantly, help gain better coverage from payers.
Xarelto competes with Pradaxa from Boehringer Ingelheim GmbH of Ingelheim, Germany in the atrial fibrillation market. Another rival drug, Eliquis from Pfizer Inc. and Bristol-Myers Squibb Co., both based in New York, presented positive trial results in atrial fibrillation at a conference in August.
50-Year-Old Warfarin
All three drugs are attempting to replace warfarin, a more than 50- year-old medicine that is a form of rat poison. The Xarelto study was funded by New Brunswick, New Jersey-based Johnson & Johnson, which owns U.S. rights, and Leverkusen, Germany-based Bayer, which sells the treatment in Europe.
Until today’s results, it wasn’t clear that the new class of drugs would also work in acute coronary patients, who are treated with aspirin and the blood thinner Plavix from Paris- based Sanofi and Bristol. Pfizer’s Eliquis flopped in a trial of ACS patients a year ago, failing to prevent heart attacks and cardiac deaths while causing significantly more major bleeding.
A study of Merck & Co.’s vorapaxar, also presented at the meeting, boosted rates of severe bleeding in the brain more than three-fold and failed to reduce deaths, heart attacks, strokes and other complications in high-risk heart patients.
Low Doses
In the new trial, doctors used very low doses of Xarelto given twice daily and excluded patients with prior stroke treatment to minimize bleeding.
Still, patients on Xarelto had a more than 3- fold increase in major bleeding episodes. The rate of fatal bleeding did not increase significantly, according to results being published in the New England Journal of Medicine in conjunction with the conference.
Bayer has estimated that sales of Xarelto will top $2.8 billion annually. The companies plan to file for FDA approval for the acute coronary use by the end of the year. They will ask the FDA for a priority review, though it hasn’t decided whether it will request approval of both doses or just the lower dose, DiBattiste said.
Trenton Heart Doctors said the drug could improve care for acute coronary syndrome patients.
Study Results
Patients in the new Xarelto trial were given 2.5 milligrams of Xarelto, 5 milligrams of Xarelto or a placebo twice a day. Everyone also took aspirin and the vast majority used Plavix.
Taylor Heart Doctors followed the patients for a median of 13 months. Heart attacks, stroke and death from cardiovascular disease occurred in 8.9 percent of patients given Xarelto, compared with 10.7 percent of those on placebo.
Death from cardiovascular disease was reduced by 34 percent in the low- dose arm compared with placebo, while deaths from any cause were down 32 percent. The higher 5 milligram dose didn’t reduce mortality rates, for reasons that aren’t totally clear.
Doctors would need to treat 56 patients a year with Xarelto to prevent one death, the researchers calculated.
Bleeding Risk
Still, the increased bleeding seen with Xarelto is something doctors and patients need to keep in mind when determining treatment, experts at a Taylor Stroke Care center say.
Major bleeding episodes occurred in 2.4 percent of patients on the high dose of Xarelto and 1.8 percent of those on the low dose, versus 0.6 percent of those on placebo.
Johnson & Johnson and Bayer AG’s blood-thinner Xarelto cut by 16 percent the risk of a subsequent heart attack, stroke or death from heart disease in patients who recently suffered a cardiac event, according to a study.
The data makes Xarelto the first in a new class of blood thinning medicines to show effectiveness for acute coronary syndromes, or ACS, when used in addition to standard treatment. The lowest dose, given twice daily, slashed deaths by one-third.
Xarelto was approved Nov. 17 in the U.S. to prevent strokes in people with atrial fibrillation, an irregular heartbeat that affects more than 2 million Americans. The data reported today at the American Heart Association meeting in Orlando, Florida, may create a new use in
1.2 million patients hospitalized yearly with ACS, which includes heart attack and severe chest pain. It’s a $1.4 billion market, said an analyst with Sanford C. Bernstein & Co. in San Francisco
A halo effect from having good ACS data could improve physicians overall perception of Xarelto and, importantly, help gain better coverage from payers.
Xarelto competes with Pradaxa from Boehringer Ingelheim GmbH of Ingelheim, Germany in the atrial fibrillation market. Another rival drug, Eliquis from Pfizer Inc. and Bristol-Myers Squibb Co., both based in New York, presented positive trial results in atrial fibrillation at a conference in August.
50-Year-Old Warfarin
All three drugs are attempting to replace warfarin, a more than 50- year-old medicine that is a form of rat poison. The Xarelto study was funded by New Brunswick, New Jersey-based Johnson & Johnson, which owns U.S. rights, and Leverkusen, Germany-based Bayer, which sells the treatment in Europe.
Until today’s results, it wasn’t clear that the new class of drugs would also work in acute coronary patients, who are treated with aspirin and the blood thinner Plavix from Paris- based Sanofi and Bristol. Pfizer’s Eliquis flopped in a trial of ACS patients a year ago, failing to prevent heart attacks and cardiac deaths while causing significantly more major bleeding.
A study of Merck & Co.’s vorapaxar, also presented at the meeting, boosted rates of severe bleeding in the brain more than three-fold and failed to reduce deaths, heart attacks, strokes and other complications in high-risk heart patients.
Low Doses
In the new trial, doctors used very low doses of Xarelto given twice daily and excluded patients with prior stroke treatment to minimize bleeding.
Still, patients on Xarelto had a more than 3- fold increase in major bleeding episodes. The rate of fatal bleeding did not increase significantly, according to results being published in the New England Journal of Medicine in conjunction with the conference.
Bayer has estimated that sales of Xarelto will top $2.8 billion annually. The companies plan to file for FDA approval for the acute coronary use by the end of the year. They will ask the FDA for a priority review, though it hasn’t decided whether it will request approval of both doses or just the lower dose, DiBattiste said.
Trenton Heart Doctors said the drug could improve care for acute coronary syndrome patients.
Study Results
Patients in the new Xarelto trial were given 2.5 milligrams of Xarelto, 5 milligrams of Xarelto or a placebo twice a day. Everyone also took aspirin and the vast majority used Plavix.
Taylor Heart Doctors followed the patients for a median of 13 months. Heart attacks, stroke and death from cardiovascular disease occurred in 8.9 percent of patients given Xarelto, compared with 10.7 percent of those on placebo.
Death from cardiovascular disease was reduced by 34 percent in the low- dose arm compared with placebo, while deaths from any cause were down 32 percent. The higher 5 milligram dose didn’t reduce mortality rates, for reasons that aren’t totally clear.
Doctors would need to treat 56 patients a year with Xarelto to prevent one death, the researchers calculated.
Bleeding Risk
Still, the increased bleeding seen with Xarelto is something doctors and patients need to keep in mind when determining treatment, experts at a Taylor Stroke Care center say.
Major bleeding episodes occurred in 2.4 percent of patients on the high dose of Xarelto and 1.8 percent of those on the low dose, versus 0.6 percent of those on placebo.
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Florida Shuts Down Pill Mills
Story first appeared in USA TODAY.
When federal agents arrested a man with 6,000 oxycodone pills in a Stamford, Conn., hotel room in April, they stumbled onto an expansive criminal ring that exposed a growing trend: drug tourism.
The man, whom the Drug Enforcement Administration (DEA) has not identified because he is a witness in the case, told agents he traveled to Florida several times a week, taking advantage of lax laws governing pain clinics to purchase large quantities of prescription painkillers. His suppliers in Florida would send large groups of people into pain clinics with cash and medical cards to feign illness and buy the pills.
The man would return to Connecticut to sell them for a huge profit, bribing airport security officers and police so he could transport as many as 8,000 pills each trip.
He made more than 65 trips from November to April, court papers say. The ring involved more than a dozen people who sold tens of thousands of pills to addicts in Connecticut during the past year, U.S. Attorney David Fein said.
The case illustrates how drug dealers and addicts in search of potent prescription painkillers such as Vicodin and OxyContin are traveling to Florida and other states with lax prescription-drug laws to get their fix. Police say they have found drug tourists dead of overdoses in hotels and rental cars.
Now states are trying to outsmart the criminals by tracking prescriptions through statewide databases and by toughening their laws to make it more difficult for unscrupulous clinics to dispense large numbers of prescription pain pills. And in the latest move against drug tourists, states are linking their databases to try to stop dealers from roaming state to state.
Selling such prescription drugs is so profitable that dealers and operators of the high-volume pain clinics — known to authorities as pill mills — quickly find ways around the new laws or set up shop in another state to avoid them.
About 7 million people regularly use prescription drugs for non-medical purposes, the 2010 National Survey on Drug Use and Health found. The Centers for Disease Control and Prevention calls prescription-drug abuse a national epidemic. Prescription drugs, including narcotic pain relievers and anti-depressants, cause more overdose deaths than street drugs such as cocaine, heroin and methamphetamine, the CDC says.
In Florida, the problem has been devastating: The death rate from oxycodone increased 265% from 2003 to 2009, the CDC found. By 2009, the number of deaths involving prescription drugs was four times the deaths involving street drugs, the CDC said in a July report.
All but two states — Missouri and New Hampshire— have enacted laws that set up prescription drug monitoring programs.
The databases track prescriptions like those for Fibroids so doctors can access patients' records to determine whether they already have multiple orders for a narcotic. Pharmacists can flag police if they suspect a doctor or clinic is dispensing an unusually large amount of painkillers. Police can use the records to bolster their cases against pill mills that dispense massive quantities of pain pills with little or no examination of patients.
In August, Kentucky and Ohio became the first states to link their databases to make it tougher for addicts in one of the states to avoid detection by visiting a doctor in the other. Those states joined with West Virginia and Tennessee in an interstate alliance to coordinate databases, laws and investigations to try to keep pill mills shut down in one state from popping up across the border.
Kentucky and Ohio have already broken the code, says former executive director of the Governor's Office of Drug Control Policy in Florida. By agreeing to provide information to pursue investigation, you won't have people jumping back and forth over state lines and doing this with impunity.
Last month, the National Association of Boards of Pharmacy launched a database hub that allows a doctor or pharmacist to retrieve painkiller prescription data from any state linked into the hub, Executive Director Carmen Catizone says. Ohio, Indiana and Virginia have linked in and 20 other states have agreed to do so this year.
Addicts and dealers are clever, says Sherry Green, CEO of the National Alliance of Model State Drug Laws. They will cross borders to escape their state's tracking system or move a pill mill to another state if they think law enforcement is nosing around.
Here are people from Kentucky going down to Florida all the time, and it's not just the person who is addicted. You also have people who make a profit on it.
Dealers are willing to travel long distances if they feel they can make money selling the drugs on the black market.
Pills purchased in a Florida pharmacy cost $4 to $6 for a 30-milligram tablet, DEA Special Agent says. That tablet would sell for $30 on the street in Connecticut.
It's been a disaster for Florida
Until Florida enacted tough laws on Sept. 1, the Sunshine State was the undisputed epicenter of prescription-painkiller distribution. Of the estimated 53 million oxycodone doses sold in 2010 to medical practitioners in the USA, nearly 45 million were purchased in Florida.
It's been a disaster for Florida.
Drug tourism emerged as a major problem. Agents routinely saw out-of-state license plates jamming the parking lots outside the rogue clinics. The state averaged seven deaths a day from prescription-drug overdoses, and local police chiefs had their hands full with related crimes.
People would do deals right outside the pill mills. Other people would feed off them. They had burglaries, thefts of pills from cars. It even resulted in a murder.
Terry Williams, 46, of Johnson City, Tenn., was beaten and strangled for his stash of oxycodone pills, police said. A maid at the Red Roof Inn in Oakland Park, Fla., found Williams dead in his hotel room on April 29, 2010.
Williams had arrived from Tennessee three days earlier with his ex-wife, Sandy Bulla, their 5-year-old son and a friend, Gregory Brummitt, 20, to buy narcotics at a pill mill, sheriff's deputies said in their report. With the child in the room, Bulla and Brummitt allegedly beat Williams to death, took his 200 pills and $1,600 and fled in Williams' pickup truck. Bulla and Brummitt are charged with murder and are being held without bail in Broward County Jail.
If you're in Tennessee, you've got to have a reason to drive to Florida. You're not doing it for the scenery. These people will try to find the path of least resistance. Florida used to be the path of least resistance.
Florida's laws were so lax that dealers and addicts created elaborate, organized networks to obtain the pills and bring them back to Kentucky, says Van Ingram, executive director of the Kentucky Office of Drug Control Policy.
The Florida Legislature had passed a law to establish the drug database, but Florida Gov. Rick Scott's budget did not include funding for the program and included a provision that would repeal the law.
Pressure increased. The governors of West Virginia and Kentucky and four U.S. senators wrote a letter in February to Scott urging him to fund Florida's prescription-drug monitoring system. In March, Purdue Pharma, the manufacturer of OxyContin, offered Florida $1 million to support the prescription-drug database.
Meanwhile, local police teamed with the DEA to identify hundreds of clinics and conduct dozens of raids.
In just six months, Florida has attacked from every angle what can only be described as a homegrown prescription drug epidemic.
In June, Scott signed a compromise law that requires doctors to use tamper-proof prescription pads or electronic prescribing, toughens penalties for doctors who overprescribe painkillers and bans most doctors from dispensing the drugs.
The new law allows the prescription-drug database to operate and shortens from 15 days to seven the amount of time pharmacists have to report prescription information. It prohibits pharmaceutical companies from funding the database. A private foundation is paying for it with $750,000 in federal grants and donations.
The law marks the beginning of the end of Florida's infamous role as the nation's pill mill capital.
The database is going to catch some, it's going to deter some others. But it's not an instant fix. It's going to take a few months for the database to build to a point where it's useful.
Because the new law prohibits doctors and clinics from dispensing the pain medicine on-site, patients must go to a pharmacy to fill their prescriptions. Now federal agents say they will be focused on rogue pharmacies.
Applications for pharmacies have doubled over the past year. Pill mill operators just go next door and try to open up a pharmacy.
Ingram of Kentucky says Florida's big busts and new laws are beginning to discourage Kentucky's drug shoppers.
Concerns rising in New England
As pill mill operators felt the heat in Florida, some headed north, and problems emerged in Georgia.
During the past 18 months, Georgia has seen a steady increase in pill mills setting up shop in Atlanta-area strip malls and near interstate highways, says Inspector Fred Stephens of the Georgia Bureau of Investigation.
Georgia's Legislature has approved a prescription drug monitoring program, but it won't be ready until January 2013.
Addicts and dealers come from Ohio, Tennessee, Maryland, Kentucky and other states to visit the clinics, which usually accept all walk-in patients and want to be paid in cash, Stephens says. Often, large groups will come in vans, old medical records tucked under their arms, he says.
Last year, prescription-drug overdoses in Georgia increased at least 10% — to 560 — from 2009, a study by the bureau's medical examiner found. The study did not include the Atlanta area.
Now, Derr of Connecticut worries that with the Southern states cracking down on drug tourism, pill mills will emerge in New England. He recently saw an ad on Craigslist in Connecticut from a clinic looking to hire doctors.
When federal agents arrested a man with 6,000 oxycodone pills in a Stamford, Conn., hotel room in April, they stumbled onto an expansive criminal ring that exposed a growing trend: drug tourism.
The man, whom the Drug Enforcement Administration (DEA) has not identified because he is a witness in the case, told agents he traveled to Florida several times a week, taking advantage of lax laws governing pain clinics to purchase large quantities of prescription painkillers. His suppliers in Florida would send large groups of people into pain clinics with cash and medical cards to feign illness and buy the pills.
The man would return to Connecticut to sell them for a huge profit, bribing airport security officers and police so he could transport as many as 8,000 pills each trip.
He made more than 65 trips from November to April, court papers say. The ring involved more than a dozen people who sold tens of thousands of pills to addicts in Connecticut during the past year, U.S. Attorney David Fein said.
The case illustrates how drug dealers and addicts in search of potent prescription painkillers such as Vicodin and OxyContin are traveling to Florida and other states with lax prescription-drug laws to get their fix. Police say they have found drug tourists dead of overdoses in hotels and rental cars.
Now states are trying to outsmart the criminals by tracking prescriptions through statewide databases and by toughening their laws to make it more difficult for unscrupulous clinics to dispense large numbers of prescription pain pills. And in the latest move against drug tourists, states are linking their databases to try to stop dealers from roaming state to state.
Selling such prescription drugs is so profitable that dealers and operators of the high-volume pain clinics — known to authorities as pill mills — quickly find ways around the new laws or set up shop in another state to avoid them.
About 7 million people regularly use prescription drugs for non-medical purposes, the 2010 National Survey on Drug Use and Health found. The Centers for Disease Control and Prevention calls prescription-drug abuse a national epidemic. Prescription drugs, including narcotic pain relievers and anti-depressants, cause more overdose deaths than street drugs such as cocaine, heroin and methamphetamine, the CDC says.
In Florida, the problem has been devastating: The death rate from oxycodone increased 265% from 2003 to 2009, the CDC found. By 2009, the number of deaths involving prescription drugs was four times the deaths involving street drugs, the CDC said in a July report.
All but two states — Missouri and New Hampshire— have enacted laws that set up prescription drug monitoring programs.
The databases track prescriptions like those for Fibroids so doctors can access patients' records to determine whether they already have multiple orders for a narcotic. Pharmacists can flag police if they suspect a doctor or clinic is dispensing an unusually large amount of painkillers. Police can use the records to bolster their cases against pill mills that dispense massive quantities of pain pills with little or no examination of patients.
In August, Kentucky and Ohio became the first states to link their databases to make it tougher for addicts in one of the states to avoid detection by visiting a doctor in the other. Those states joined with West Virginia and Tennessee in an interstate alliance to coordinate databases, laws and investigations to try to keep pill mills shut down in one state from popping up across the border.
Kentucky and Ohio have already broken the code, says former executive director of the Governor's Office of Drug Control Policy in Florida. By agreeing to provide information to pursue investigation, you won't have people jumping back and forth over state lines and doing this with impunity.
Last month, the National Association of Boards of Pharmacy launched a database hub that allows a doctor or pharmacist to retrieve painkiller prescription data from any state linked into the hub, Executive Director Carmen Catizone says. Ohio, Indiana and Virginia have linked in and 20 other states have agreed to do so this year.
Addicts and dealers are clever, says Sherry Green, CEO of the National Alliance of Model State Drug Laws. They will cross borders to escape their state's tracking system or move a pill mill to another state if they think law enforcement is nosing around.
Here are people from Kentucky going down to Florida all the time, and it's not just the person who is addicted. You also have people who make a profit on it.
Dealers are willing to travel long distances if they feel they can make money selling the drugs on the black market.
Pills purchased in a Florida pharmacy cost $4 to $6 for a 30-milligram tablet, DEA Special Agent says. That tablet would sell for $30 on the street in Connecticut.
It's been a disaster for Florida
Until Florida enacted tough laws on Sept. 1, the Sunshine State was the undisputed epicenter of prescription-painkiller distribution. Of the estimated 53 million oxycodone doses sold in 2010 to medical practitioners in the USA, nearly 45 million were purchased in Florida.
It's been a disaster for Florida.
Drug tourism emerged as a major problem. Agents routinely saw out-of-state license plates jamming the parking lots outside the rogue clinics. The state averaged seven deaths a day from prescription-drug overdoses, and local police chiefs had their hands full with related crimes.
People would do deals right outside the pill mills. Other people would feed off them. They had burglaries, thefts of pills from cars. It even resulted in a murder.
Terry Williams, 46, of Johnson City, Tenn., was beaten and strangled for his stash of oxycodone pills, police said. A maid at the Red Roof Inn in Oakland Park, Fla., found Williams dead in his hotel room on April 29, 2010.
Williams had arrived from Tennessee three days earlier with his ex-wife, Sandy Bulla, their 5-year-old son and a friend, Gregory Brummitt, 20, to buy narcotics at a pill mill, sheriff's deputies said in their report. With the child in the room, Bulla and Brummitt allegedly beat Williams to death, took his 200 pills and $1,600 and fled in Williams' pickup truck. Bulla and Brummitt are charged with murder and are being held without bail in Broward County Jail.
If you're in Tennessee, you've got to have a reason to drive to Florida. You're not doing it for the scenery. These people will try to find the path of least resistance. Florida used to be the path of least resistance.
Florida's laws were so lax that dealers and addicts created elaborate, organized networks to obtain the pills and bring them back to Kentucky, says Van Ingram, executive director of the Kentucky Office of Drug Control Policy.
The Florida Legislature had passed a law to establish the drug database, but Florida Gov. Rick Scott's budget did not include funding for the program and included a provision that would repeal the law.
Pressure increased. The governors of West Virginia and Kentucky and four U.S. senators wrote a letter in February to Scott urging him to fund Florida's prescription-drug monitoring system. In March, Purdue Pharma, the manufacturer of OxyContin, offered Florida $1 million to support the prescription-drug database.
Meanwhile, local police teamed with the DEA to identify hundreds of clinics and conduct dozens of raids.
In just six months, Florida has attacked from every angle what can only be described as a homegrown prescription drug epidemic.
In June, Scott signed a compromise law that requires doctors to use tamper-proof prescription pads or electronic prescribing, toughens penalties for doctors who overprescribe painkillers and bans most doctors from dispensing the drugs.
The new law allows the prescription-drug database to operate and shortens from 15 days to seven the amount of time pharmacists have to report prescription information. It prohibits pharmaceutical companies from funding the database. A private foundation is paying for it with $750,000 in federal grants and donations.
The law marks the beginning of the end of Florida's infamous role as the nation's pill mill capital.
The database is going to catch some, it's going to deter some others. But it's not an instant fix. It's going to take a few months for the database to build to a point where it's useful.
Because the new law prohibits doctors and clinics from dispensing the pain medicine on-site, patients must go to a pharmacy to fill their prescriptions. Now federal agents say they will be focused on rogue pharmacies.
Applications for pharmacies have doubled over the past year. Pill mill operators just go next door and try to open up a pharmacy.
Ingram of Kentucky says Florida's big busts and new laws are beginning to discourage Kentucky's drug shoppers.
Concerns rising in New England
As pill mill operators felt the heat in Florida, some headed north, and problems emerged in Georgia.
During the past 18 months, Georgia has seen a steady increase in pill mills setting up shop in Atlanta-area strip malls and near interstate highways, says Inspector Fred Stephens of the Georgia Bureau of Investigation.
Georgia's Legislature has approved a prescription drug monitoring program, but it won't be ready until January 2013.
Addicts and dealers come from Ohio, Tennessee, Maryland, Kentucky and other states to visit the clinics, which usually accept all walk-in patients and want to be paid in cash, Stephens says. Often, large groups will come in vans, old medical records tucked under their arms, he says.
Last year, prescription-drug overdoses in Georgia increased at least 10% — to 560 — from 2009, a study by the bureau's medical examiner found. The study did not include the Atlanta area.
Now, Derr of Connecticut worries that with the Southern states cracking down on drug tourism, pill mills will emerge in New England. He recently saw an ad on Craigslist in Connecticut from a clinic looking to hire doctors.
28 November 2011
100,000 Seniors Hospitalized Yearly for Adverse Drug Reactions
Story first appeared in USA TODAY.
An estimated 100,000 older Americans are hospitalized for adverse drug reactions yearly, and most of those emergencies stem from four common medications, a new study finds.
The four types of medication -- two for diabetes and two blood-thinning agents -- account for two-thirds of those drug-related emergency hospitalizations.
Of the thousands of medications available to older patients, a small group of blood thinners and diabetes medications caused a high proportion of emergency hospitalizations for adverse drug events among elderly Americans.
Medications previously designated "high-risk" were implicated in only 1.2 percent of hospitalizations, the study found.
Working with a nationally representative database, CDC researchers identified more than 5,000 cases of drug-related adverse events that occurred among people aged 65 and older from 2007 to 2009 and used that to make their estimates for the whole population.
Nearly half (48 percent) of the hospitalizations occurred among adults 80 and up, according to the study, published in the Nov. 24 issue of the New England Journal of Medicine. Nearly two-thirds (66 percent) were the result of unintentional overdoses.
The four medications, used alone or together, most often cited:
The blood thinning medication warfarin (Coumadin, Jantoven), which is used to treat blood clots, was involved in 33 percent of emergency hospitalizations.
Insulin, used to control blood sugar in diabetes patients, was involved in 14 percent of cases.
Antiplatelet drugs such as aspirin and clopidogrel (Plavix), which are used to prevent blood clots, were involved in 13 percent of cases.
Oral hypoglycemic agents -- diabetes medications taken by mouth -- were involved in 11 percent of cases.
With antiplatelet or blood thinning drugs, bleeding was the main problem. For insulin and other diabetes medications, about two-thirds of cases involved changes in mental status such as confusion, loss of consciousness or seizures.
This study highlights a few key issues that are important for doctors and patients to be aware of. The first is that serious adverse reactions to drugs are common among older people, particularly among people over 80. But even those 65 and older are at substantial risk of having an adverse effect from their drugs.
One challenge for doctors and patients is that the medications may be necessary.
These are often critical medicines for patients' health. Patients who are on these medicines should tell all their doctors what they are taking and work together with their doctors and pharmacist to make sure that they are taking these medicines correctly.
Among U.S. adults aged 65 and up, 40 percent take five to nine medications and 18 percent take 10 or more, according to the study authors. Prior research has also found that older adults are nearly seven times more likely than younger people to have an adverse drug event that requires hospitalization. As most people age, there often are changes in how their kidneys, liver, heart, and other organs work that can make them more susceptible to adverse drug events.
And though taking lots of pills raises safety issues, in 82 percent of cases the treating physician attributed the overdose to a single drug.
To reduce risks, Steinman said doctors and patients need to discuss whether the drug is truly necessary. For people with very high blood pressure or blood sugar, the answer is almost always "yes," you should treat it. But if you have only mildly elevated blood pressure or blood sugar, the benefits of treating it versus the harms start to shift. Do these drugs really provide enough benefit that it's worth taking them?
Physicians and patients need to consider a person's age, overall health, other medications they take (keep a list including dosages) and patient preference, such as how easy they find it to keep track of blood sugar and dosages, he said.
With anticlotting or blood-thinning agents, stopping them is probably not an option, Steinman said. So patients need to be attuned to any side effects they experience, even if they seem minor. Catching side effects early can prevent more serious problems later on, and doctors may be able to change the medication or lower the dosage, he said.
An estimated 100,000 older Americans are hospitalized for adverse drug reactions yearly, and most of those emergencies stem from four common medications, a new study finds.
The four types of medication -- two for diabetes and two blood-thinning agents -- account for two-thirds of those drug-related emergency hospitalizations.
Of the thousands of medications available to older patients, a small group of blood thinners and diabetes medications caused a high proportion of emergency hospitalizations for adverse drug events among elderly Americans.
Medications previously designated "high-risk" were implicated in only 1.2 percent of hospitalizations, the study found.
Working with a nationally representative database, CDC researchers identified more than 5,000 cases of drug-related adverse events that occurred among people aged 65 and older from 2007 to 2009 and used that to make their estimates for the whole population.
Nearly half (48 percent) of the hospitalizations occurred among adults 80 and up, according to the study, published in the Nov. 24 issue of the New England Journal of Medicine. Nearly two-thirds (66 percent) were the result of unintentional overdoses.
The four medications, used alone or together, most often cited:
The blood thinning medication warfarin (Coumadin, Jantoven), which is used to treat blood clots, was involved in 33 percent of emergency hospitalizations.
Insulin, used to control blood sugar in diabetes patients, was involved in 14 percent of cases.
Antiplatelet drugs such as aspirin and clopidogrel (Plavix), which are used to prevent blood clots, were involved in 13 percent of cases.
Oral hypoglycemic agents -- diabetes medications taken by mouth -- were involved in 11 percent of cases.
With antiplatelet or blood thinning drugs, bleeding was the main problem. For insulin and other diabetes medications, about two-thirds of cases involved changes in mental status such as confusion, loss of consciousness or seizures.
This study highlights a few key issues that are important for doctors and patients to be aware of. The first is that serious adverse reactions to drugs are common among older people, particularly among people over 80. But even those 65 and older are at substantial risk of having an adverse effect from their drugs.
One challenge for doctors and patients is that the medications may be necessary.
These are often critical medicines for patients' health. Patients who are on these medicines should tell all their doctors what they are taking and work together with their doctors and pharmacist to make sure that they are taking these medicines correctly.
Among U.S. adults aged 65 and up, 40 percent take five to nine medications and 18 percent take 10 or more, according to the study authors. Prior research has also found that older adults are nearly seven times more likely than younger people to have an adverse drug event that requires hospitalization. As most people age, there often are changes in how their kidneys, liver, heart, and other organs work that can make them more susceptible to adverse drug events.
And though taking lots of pills raises safety issues, in 82 percent of cases the treating physician attributed the overdose to a single drug.
To reduce risks, Steinman said doctors and patients need to discuss whether the drug is truly necessary. For people with very high blood pressure or blood sugar, the answer is almost always "yes," you should treat it. But if you have only mildly elevated blood pressure or blood sugar, the benefits of treating it versus the harms start to shift. Do these drugs really provide enough benefit that it's worth taking them?
Physicians and patients need to consider a person's age, overall health, other medications they take (keep a list including dosages) and patient preference, such as how easy they find it to keep track of blood sugar and dosages, he said.
With anticlotting or blood-thinning agents, stopping them is probably not an option, Steinman said. So patients need to be attuned to any side effects they experience, even if they seem minor. Catching side effects early can prevent more serious problems later on, and doctors may be able to change the medication or lower the dosage, he said.
10 October 2011
Basic Health Benefits for Millions to be Designed by Feds
Story first appeared on the Associated Press.
The federal government is taking on a crucial new role in the nation's health care, designing a basic benefits package for millions of privately insured Americans. A framework for the Obama administration was released Thursday.
The report by independent experts from the Institute of Medicine lays out guidelines for deciding what to include in the new "essential benefits package," how to keep it affordable for small businesses and taxpayers, and also scientifically up to date.
About 68 million Americans, many of them currently insured, ultimately would be affected by the new benefits package. That's bigger than the number of seniors enrolled in Medicare.
The advisers recommended that the package be built on mid-tier health plans currently offered by small employers, expanded to include certain services such as mental health, and squeezed into a real-world budget.
They did not spell out a list of services to cover, but they did recommend that the government require evidence of cost effectiveness.
In this day and age, when we are talking about fiscal responsibility, it's a report that recognized that we have to take account of what we can afford while trying to make sure that people have adequate coverage.
Until now, designing benefits has been the job of insurers, employers and state officials. But the new health care law requires insurance companies to provide at least the federally approved package if they want to sell to small businesses, families and individuals through new state markets set to open in 2014.
Most existing workplace plans won't be required to adopt the federal model, but employers and consumer advocates alike predict it will become the nation's benchmark for health insurance over time.
With the nation divided over President Barack Obama's health care overhaul law, and Republicans condemning it as a government takeover, the administration reacted cautiously to the recommendations.
Health and Human Services officials would hold listening sessions around the country before any final decisions are made, which could take months. The IOM panel recommended an extensive effort to engage the public.
Before they put forward a proposal, it is critical that they hear from the American people. The law extends coverage to about 30 million uninsured people.
Actually, work on the benefits package is already well under way within the HHS department. On the outside, a huge lobbying campaign to shape the final package is about to take off.
Employer groups - particularly those representing low-wage industries - want to keep benefits fairly basic. Since the government is going to be subsidizing coverage for millions of people, a generous plan will drive up costs for taxpayers, they argue. But consumer and patient advocacy groups that helped pass the overhaul law want to make sure their priorities are included.
The health care law requires that essential benefits include outpatient, hospital, emergency, maternal, newborn and children's care, prescription drugs, mental health and substance abuse treatment, rehabilitation, labs, prevention and wellness. But Congress gave the administration lots of leeway to determine the specifics.
In its 300-page report, the Institute of Medicine panel stressed that the package has to be affordable if Obama's overhaul is going to stand the test of time.
The panel used the analogy of a shopper at the supermarket. One option is to fill up your cart with all the groceries you want, and find out the cost at the register.
The first option compares to what the government now does with Medicare and Medicaid - it pays all the bills. But the advisers said Obama's plan should be on a budget.
The panel proposed a tough financial test. Few small employer plans currently offer comprehensive mental health coverage, for example. As such services are added, the total cost of the package should stay within a realistic budget target to be set by the administration. That would help keep premiums affordable.
The panel's rough estimate put annual premiums for individual coverage under the plan at $5,500 to $7,000 in 2014, comparable to what employers pay now.
The federal government is taking on a crucial new role in the nation's health care, designing a basic benefits package for millions of privately insured Americans. A framework for the Obama administration was released Thursday.
The report by independent experts from the Institute of Medicine lays out guidelines for deciding what to include in the new "essential benefits package," how to keep it affordable for small businesses and taxpayers, and also scientifically up to date.
About 68 million Americans, many of them currently insured, ultimately would be affected by the new benefits package. That's bigger than the number of seniors enrolled in Medicare.
The advisers recommended that the package be built on mid-tier health plans currently offered by small employers, expanded to include certain services such as mental health, and squeezed into a real-world budget.
They did not spell out a list of services to cover, but they did recommend that the government require evidence of cost effectiveness.
In this day and age, when we are talking about fiscal responsibility, it's a report that recognized that we have to take account of what we can afford while trying to make sure that people have adequate coverage.
Until now, designing benefits has been the job of insurers, employers and state officials. But the new health care law requires insurance companies to provide at least the federally approved package if they want to sell to small businesses, families and individuals through new state markets set to open in 2014.
Most existing workplace plans won't be required to adopt the federal model, but employers and consumer advocates alike predict it will become the nation's benchmark for health insurance over time.
With the nation divided over President Barack Obama's health care overhaul law, and Republicans condemning it as a government takeover, the administration reacted cautiously to the recommendations.
Health and Human Services officials would hold listening sessions around the country before any final decisions are made, which could take months. The IOM panel recommended an extensive effort to engage the public.
Before they put forward a proposal, it is critical that they hear from the American people. The law extends coverage to about 30 million uninsured people.
Actually, work on the benefits package is already well under way within the HHS department. On the outside, a huge lobbying campaign to shape the final package is about to take off.
Employer groups - particularly those representing low-wage industries - want to keep benefits fairly basic. Since the government is going to be subsidizing coverage for millions of people, a generous plan will drive up costs for taxpayers, they argue. But consumer and patient advocacy groups that helped pass the overhaul law want to make sure their priorities are included.
The health care law requires that essential benefits include outpatient, hospital, emergency, maternal, newborn and children's care, prescription drugs, mental health and substance abuse treatment, rehabilitation, labs, prevention and wellness. But Congress gave the administration lots of leeway to determine the specifics.
In its 300-page report, the Institute of Medicine panel stressed that the package has to be affordable if Obama's overhaul is going to stand the test of time.
The panel used the analogy of a shopper at the supermarket. One option is to fill up your cart with all the groceries you want, and find out the cost at the register.
The first option compares to what the government now does with Medicare and Medicaid - it pays all the bills. But the advisers said Obama's plan should be on a budget.
The panel proposed a tough financial test. Few small employer plans currently offer comprehensive mental health coverage, for example. As such services are added, the total cost of the package should stay within a realistic budget target to be set by the administration. That would help keep premiums affordable.
The panel's rough estimate put annual premiums for individual coverage under the plan at $5,500 to $7,000 in 2014, comparable to what employers pay now.
Job’s Rare Form of Pancreatic Cancer
Story first appeared in the Associated Press.
Steve Jobs managed to live more than seven years with a rare form of pancreatic cancer that grows more slowly than the common kind. But his need for a liver transplant two years ago was a bad sign that his troubles with the disease probably were not over.
The Apple founder long kept information on his illness behind a firewall, and no new details emerged immediately after his death.
However, medical experts unconnected with his care say Jobs most likely needed the transplant because his cancer came back or spread. They said his death could have been from cancer, the new liver not working, or complications from immune-suppressing medicines to prevent organ rejection.
One doctor said a liver transplant can cure Jobs' type of cancer, but if it were to come back, it's usually in one to two years.
Jobs declared he was cured after surgery in 2004 for an islet cell neuroendocrine tumor, a much more treatable form of pancreatic cancer than the more common form of the disease that killed actor Patrick Swayze two years ago.
But the Apple chief never revealed whether the cancer had spread to his lymph nodes or liver, or how extensive his surgery was. Many doctors speculated he had a Whipple procedure, in which part of the pancreas, part of the small intestine and in some cases part of the stomach are removed and the digestive system is reconstructed.
Several years later, Jobs was dramatically thinner and gaunt. In January 2009, he attributed those problems to a hormone imbalance and said there was a simple treatment for it. A few weeks later, he went on a medical leave and then had a liver transplant that was kept secret for two months.
Even then, Jobs would not say why the transplant was needed, though doctors said spread of his cancer to the liver was the likely explanation.
Usually transplants aren't done for people with cancer, but there is some support for the idea that a liver transplant can be curative or a neuroendocrine tumor as long as the cancer has not spread beyond the liver.
Average survival for people with neuroendocrine tumors that have spread is seven to eight years, and some patients have survived 20 to 30 years.
It was not to be for Jobs.
In January, he announced his third and final leave of absence, and resigned in August.
Steve Jobs managed to live more than seven years with a rare form of pancreatic cancer that grows more slowly than the common kind. But his need for a liver transplant two years ago was a bad sign that his troubles with the disease probably were not over.
The Apple founder long kept information on his illness behind a firewall, and no new details emerged immediately after his death.
However, medical experts unconnected with his care say Jobs most likely needed the transplant because his cancer came back or spread. They said his death could have been from cancer, the new liver not working, or complications from immune-suppressing medicines to prevent organ rejection.
One doctor said a liver transplant can cure Jobs' type of cancer, but if it were to come back, it's usually in one to two years.
Jobs declared he was cured after surgery in 2004 for an islet cell neuroendocrine tumor, a much more treatable form of pancreatic cancer than the more common form of the disease that killed actor Patrick Swayze two years ago.
But the Apple chief never revealed whether the cancer had spread to his lymph nodes or liver, or how extensive his surgery was. Many doctors speculated he had a Whipple procedure, in which part of the pancreas, part of the small intestine and in some cases part of the stomach are removed and the digestive system is reconstructed.
Several years later, Jobs was dramatically thinner and gaunt. In January 2009, he attributed those problems to a hormone imbalance and said there was a simple treatment for it. A few weeks later, he went on a medical leave and then had a liver transplant that was kept secret for two months.
Even then, Jobs would not say why the transplant was needed, though doctors said spread of his cancer to the liver was the likely explanation.
Usually transplants aren't done for people with cancer, but there is some support for the idea that a liver transplant can be curative or a neuroendocrine tumor as long as the cancer has not spread beyond the liver.
Average survival for people with neuroendocrine tumors that have spread is seven to eight years, and some patients have survived 20 to 30 years.
It was not to be for Jobs.
In January, he announced his third and final leave of absence, and resigned in August.
STUDY SHOWS THAT THE “WORST” HOSPITALS OFTEN TREAT MORE POOR PEOPLE
Story first appeared in the Associated Press.
The nation's worst hospitals treat twice the proportion of elderly black patients and poor patients than the best hospitals, and their patients are more likely to die of heart attacks and pneumonia, new research shows.
Now, these hospitals, mostly in the South, may be at higher risk of financial failure, too. That's because the nation's new health care law punishes bad care by withholding some money, says the lead author of the study published Wednesday in the journal Health Affairs.
These hospitals are going to have a much harder time in the new funding environment. It is worried that they're going to get worse over time and possibly even fail, and that this will happen to several over the next three to five years.
Under the Affordable Care Act, hospitals that fail to improve will see their Medicare payments shrink by 1 percent starting October 2012. That could jeopardize some hospitals already on the brink of closure.
That unintended consequence of the health overhaul could increase health disparities for minorities.
The study shows that we have to make sure we pay attention to what the results of those policies are and be ready to change directions if they're causing harm in the marketplace.
The study doesn't name the 178 hospitals the researchers rated as "worst" because of their low quality of care and high costs. A data use agreement with Medicare prevented the researchers from identifying the hospitals publicly.
The study found 122 "best" hospitals with high quality and low costs. Those best hospitals were more likely to be in the Northeast, to be nonprofit and to have cardiac intensive care units compared to the worst hospitals.
Elderly blacks made up 15 percent of patients in the worst hospitals and about 7 percent in the best hospitals. There were similar differences for people on Medicaid, the state-federal health program for the poor. Worst-hospital patients with heart attacks or pneumonia were more likely to die than similar patients at the best hospitals.
Medicare chief called the study valuable, but not completely new. He said the federal government is working to help all hospitals improve.
The health law's so-called "value-based purchasing" rewards hospitals for their rate of improvement, not just for attaining goals. So hospitals that start farther behind can get rewarded for making efforts to catch up. And the law provides money for hospital improvement programs.
For the study, the researchers used data from six sources to determine which hospitals were worst and best. They divided the hospitals into four ranked groups for quality of care and divided them again into four ranked groups for cost.
Of 3,229 hospitals analyzed, 122 were in the top group for quality and also in the group that had the lowest costs. The researchers compared those hospitals to the 178 that were in the bottom group for quality and had the highest costs.
With the health law's expansion of insurance in 2014, patients may have more choice in hospitals. But most patients don't use tools like Hospital Compare to find the best ones nearby. Hospital Compare is a government website that rates how hospitals measure up to certain standards, such as giving heart attack patients aspirin.
People go to hospitals because they've always gone there or their families have always gone there or their doctors have always referred them there.
One person of the American Hospital Association said the group is worried about whether the new funding formula will put safety net hospitals at financial risk, but believes all hospitals can improve.
The nation's worst hospitals treat twice the proportion of elderly black patients and poor patients than the best hospitals, and their patients are more likely to die of heart attacks and pneumonia, new research shows.
Now, these hospitals, mostly in the South, may be at higher risk of financial failure, too. That's because the nation's new health care law punishes bad care by withholding some money, says the lead author of the study published Wednesday in the journal Health Affairs.
These hospitals are going to have a much harder time in the new funding environment. It is worried that they're going to get worse over time and possibly even fail, and that this will happen to several over the next three to five years.
Under the Affordable Care Act, hospitals that fail to improve will see their Medicare payments shrink by 1 percent starting October 2012. That could jeopardize some hospitals already on the brink of closure.
That unintended consequence of the health overhaul could increase health disparities for minorities.
The study shows that we have to make sure we pay attention to what the results of those policies are and be ready to change directions if they're causing harm in the marketplace.
The study doesn't name the 178 hospitals the researchers rated as "worst" because of their low quality of care and high costs. A data use agreement with Medicare prevented the researchers from identifying the hospitals publicly.
The study found 122 "best" hospitals with high quality and low costs. Those best hospitals were more likely to be in the Northeast, to be nonprofit and to have cardiac intensive care units compared to the worst hospitals.
Elderly blacks made up 15 percent of patients in the worst hospitals and about 7 percent in the best hospitals. There were similar differences for people on Medicaid, the state-federal health program for the poor. Worst-hospital patients with heart attacks or pneumonia were more likely to die than similar patients at the best hospitals.
Medicare chief called the study valuable, but not completely new. He said the federal government is working to help all hospitals improve.
The health law's so-called "value-based purchasing" rewards hospitals for their rate of improvement, not just for attaining goals. So hospitals that start farther behind can get rewarded for making efforts to catch up. And the law provides money for hospital improvement programs.
For the study, the researchers used data from six sources to determine which hospitals were worst and best. They divided the hospitals into four ranked groups for quality of care and divided them again into four ranked groups for cost.
Of 3,229 hospitals analyzed, 122 were in the top group for quality and also in the group that had the lowest costs. The researchers compared those hospitals to the 178 that were in the bottom group for quality and had the highest costs.
With the health law's expansion of insurance in 2014, patients may have more choice in hospitals. But most patients don't use tools like Hospital Compare to find the best ones nearby. Hospital Compare is a government website that rates how hospitals measure up to certain standards, such as giving heart attack patients aspirin.
People go to hospitals because they've always gone there or their families have always gone there or their doctors have always referred them there.
One person of the American Hospital Association said the group is worried about whether the new funding formula will put safety net hospitals at financial risk, but believes all hospitals can improve.
04 October 2011
Incentives to Lower Health Care Costs
Story first appeared in USA TODAY.
Sarah Gardner wants her company's employees to be savvy medical shoppers.
So this year, she rolled out a plan that sets limits on how much the company will pay toward a range of tests and procedures, from MRIs to hysterectomies. Workers at Buffalo-based Prodigy Health now know to call their employee insurance plan to find a list of local doctors and facilities that meet the price. Or they can choose to go to a higher-price center elsewhere in the insurer's network and pay the difference themselves.
Before the new program, workers' incentive to shop around was limited because they had no idea — or any easy way to find out — that prices for many types of medical treatments varied widely. A test at one center might be $3,700, while right down the street they could get it for $900. Prodigy provides benefit management for self-insured employers.
Other employers and insurers are pursuing the same strategy, experimenting with ways to slow rapidly rising spending on medical care. Some, like Prodigy, are going beyond simply offering high-deductible insurance to being more directive, using financial incentives to promote doctors, hospitals or medications they've deemed more cost efficient.
Safeway employees in the San Francisco Bay Area, for example, face higher payments if they choose centers that cost more than $1,500 for a routine colonoscopy. And in January, the giant California Public Employees' Retirement System (Calpers) said it would not pay more than $30,000 toward knee or hip replacement. Workers who choose a hospital that costs more pay the difference. Next year, the program will be expanded to outpatient colon cancer tests, as well as some surgeries, including cataract repair for the 345,000 people enrolled in Calpers' preferred provider plans.
Employers say they hope the efforts, often called reference pricing, will get patients to act more like consumers — and drive down the cost of some procedures.
This sends a signal to (medical) providers about what is considered a reasonable and acceptable price. These providers should also seek Hipaa Training.
Still, patient advocates fear the trend may leave workers not only footing more of the cost of health care, but also choosing among providers mainly with information on price, not quality.
Kathleen Stoll at the advocacy group Families USA worries that some employers may be simply picking an arbitrary number for the price they're willing to pay and not considering accessibility (of the centers) or quality.
Medicare, some private insurers and a few states track a few quality measures, such as mortality rates at hospitals, but there is generally little information on the outcomes of specific procedures, especially at facilities that are not part of a hospital, says Elliott Fisher, a Dartmouth Medical School professor well known for his research into quality and cost variation in medical care.
A lack of data on quality is a concern, as it is even with high-deductible plans, which can require workers to spend thousands of their own dollars before coverage begins.
The criticism has been that it's not fair to give people cost responsibility without the ability to make quality decisions. Maybe the $500 colonoscopy is done in a terrible factorylike environment, and the $1,200 one is better, but we don't know.
Gardner says her workers, many of whom are nurses, did raise the issue.
When she broached it last November their main concern was, “Are you going to send me to some low-quality provider just to save money?”
She countered by pointing out that the providers who met reference prices were ones employees were already using. Pretty much the places they suggest they go are the big places, the well-known places.
Checking medical claims
Before officially rolling out the program in March, Prodigy hired an outside firm called Healthcare Blue Book to comb through Prodigy's medical claims spending, looking particularly for tests and procedures for which there was high demand and wide price variation.
Working with the Blue Book information, Prodigy eventually settled on nine broad categories of tests or procedures that would fall under the new program. Included are imaging services, such as computed tomography (CT scans), sleep apnea tests and some non-emergency surgeries, including arthroscopic knee procedures. What Prodigy pays for each service varies based on local costs in the cities where its 1,200 covered employees live, including Buffalo; Minneapolis; Columbus, Ohio; Evansville, Ind.; and Okemos, Mich.
The rate is set at about the median (half were higher and half were lower) that Prodigy had paid in the past for the services. About 90% so far have chosen to go to medical providers who meet the price limits, she says. The rest go to higher-price centers and pay the difference themselves.
In the program's first two months, Prodigy saved an estimated $17,000. But Gardner says her main goal is not so much saving money as arming workers with information and getting them to pay attention and ask questions.
Facing challenges
The idea of having employees pay the difference for higher-cost services is not new. About 39% of large employers surveyed in an August National Business Group on Health report said they use the technique in their prescription-drug programs, often by requiring workers who want a brand-name drug when a generic is available to pay the difference. Some employers encourage workers to use high-performance networks of doctors or hospitals by lowering their co-payments if they seek care there.
But only about 1% of employers in the August survey use reference pricing like Prodigy, for lab tests, radiology exams or other medical services.
The approach faces challenges. For one thing, it can be hard to explain to employees. Prodigy, for example, hired someone solely to help workers select a facility that meets the price limits.
Also, patients may be hesitant to question their doctor about costs or reluctant to switch to a different physician or hospital.
Focus groups show that people generally don't like shopping around for health care.
It's one thing to go from store to store to see how much toilet paper costs, but with doctors, you don't have an easy way to find out. It feels unnatural and uncomfortable to ask a doctor how much they would charge.
Still, the trend is further fueling efforts by employers and other groups to push for more quality data, Lansky says. He recalls a recent conversation with members of the American Gastroenterological Association who are developing a registry that will eventually track the quality of colonoscopy providers. They don't want to see a market where (only) the cheapest places do well. They want to reward physicians who are doing high-quality care and put in place a system that makes that visible.
Checking on doctors
Consumers can't yet check the registry to find out if their doctor does a better job than one across town. But it is under development.
Anthem, the insurer running the new hip and knee program for Calpers, says it will track the outcomes to make sure they are at least as good as what was seen before the change. About 90% of the hospitals in Anthem's California network met the reference price for hip or knee replacement, including Cedars-Sinai, UCLA and other well-known medical centers.
Anthem provides transportation costs for patients who live too far from one of the centers. About 77% of the covered workers having the procedure since launch have gone to a reference-price hospital.
The 46 hospitals were chosen after Calpers analyzed what it was paying for hip and knee replacements under its previous arrangement and found it ranged from as little as $15,000 to more than $100,000.
The $30,000 limit for hips and knees is not a median but was selected after looking at the range in costs and taking off the really high and really low numbers. The program should save Calpers about 20% of the cost of the procedures.
This is the future for select procedures where people can shop.
Sarah Gardner wants her company's employees to be savvy medical shoppers.
So this year, she rolled out a plan that sets limits on how much the company will pay toward a range of tests and procedures, from MRIs to hysterectomies. Workers at Buffalo-based Prodigy Health now know to call their employee insurance plan to find a list of local doctors and facilities that meet the price. Or they can choose to go to a higher-price center elsewhere in the insurer's network and pay the difference themselves.
Before the new program, workers' incentive to shop around was limited because they had no idea — or any easy way to find out — that prices for many types of medical treatments varied widely. A test at one center might be $3,700, while right down the street they could get it for $900. Prodigy provides benefit management for self-insured employers.
Other employers and insurers are pursuing the same strategy, experimenting with ways to slow rapidly rising spending on medical care. Some, like Prodigy, are going beyond simply offering high-deductible insurance to being more directive, using financial incentives to promote doctors, hospitals or medications they've deemed more cost efficient.
Safeway employees in the San Francisco Bay Area, for example, face higher payments if they choose centers that cost more than $1,500 for a routine colonoscopy. And in January, the giant California Public Employees' Retirement System (Calpers) said it would not pay more than $30,000 toward knee or hip replacement. Workers who choose a hospital that costs more pay the difference. Next year, the program will be expanded to outpatient colon cancer tests, as well as some surgeries, including cataract repair for the 345,000 people enrolled in Calpers' preferred provider plans.
Employers say they hope the efforts, often called reference pricing, will get patients to act more like consumers — and drive down the cost of some procedures.
This sends a signal to (medical) providers about what is considered a reasonable and acceptable price. These providers should also seek Hipaa Training.
Still, patient advocates fear the trend may leave workers not only footing more of the cost of health care, but also choosing among providers mainly with information on price, not quality.
Kathleen Stoll at the advocacy group Families USA worries that some employers may be simply picking an arbitrary number for the price they're willing to pay and not considering accessibility (of the centers) or quality.
Medicare, some private insurers and a few states track a few quality measures, such as mortality rates at hospitals, but there is generally little information on the outcomes of specific procedures, especially at facilities that are not part of a hospital, says Elliott Fisher, a Dartmouth Medical School professor well known for his research into quality and cost variation in medical care.
A lack of data on quality is a concern, as it is even with high-deductible plans, which can require workers to spend thousands of their own dollars before coverage begins.
The criticism has been that it's not fair to give people cost responsibility without the ability to make quality decisions. Maybe the $500 colonoscopy is done in a terrible factorylike environment, and the $1,200 one is better, but we don't know.
Gardner says her workers, many of whom are nurses, did raise the issue.
When she broached it last November their main concern was, “Are you going to send me to some low-quality provider just to save money?”
She countered by pointing out that the providers who met reference prices were ones employees were already using. Pretty much the places they suggest they go are the big places, the well-known places.
Checking medical claims
Before officially rolling out the program in March, Prodigy hired an outside firm called Healthcare Blue Book to comb through Prodigy's medical claims spending, looking particularly for tests and procedures for which there was high demand and wide price variation.
Working with the Blue Book information, Prodigy eventually settled on nine broad categories of tests or procedures that would fall under the new program. Included are imaging services, such as computed tomography (CT scans), sleep apnea tests and some non-emergency surgeries, including arthroscopic knee procedures. What Prodigy pays for each service varies based on local costs in the cities where its 1,200 covered employees live, including Buffalo; Minneapolis; Columbus, Ohio; Evansville, Ind.; and Okemos, Mich.
The rate is set at about the median (half were higher and half were lower) that Prodigy had paid in the past for the services. About 90% so far have chosen to go to medical providers who meet the price limits, she says. The rest go to higher-price centers and pay the difference themselves.
In the program's first two months, Prodigy saved an estimated $17,000. But Gardner says her main goal is not so much saving money as arming workers with information and getting them to pay attention and ask questions.
Facing challenges
The idea of having employees pay the difference for higher-cost services is not new. About 39% of large employers surveyed in an August National Business Group on Health report said they use the technique in their prescription-drug programs, often by requiring workers who want a brand-name drug when a generic is available to pay the difference. Some employers encourage workers to use high-performance networks of doctors or hospitals by lowering their co-payments if they seek care there.
But only about 1% of employers in the August survey use reference pricing like Prodigy, for lab tests, radiology exams or other medical services.
The approach faces challenges. For one thing, it can be hard to explain to employees. Prodigy, for example, hired someone solely to help workers select a facility that meets the price limits.
Also, patients may be hesitant to question their doctor about costs or reluctant to switch to a different physician or hospital.
Focus groups show that people generally don't like shopping around for health care.
It's one thing to go from store to store to see how much toilet paper costs, but with doctors, you don't have an easy way to find out. It feels unnatural and uncomfortable to ask a doctor how much they would charge.
Still, the trend is further fueling efforts by employers and other groups to push for more quality data, Lansky says. He recalls a recent conversation with members of the American Gastroenterological Association who are developing a registry that will eventually track the quality of colonoscopy providers. They don't want to see a market where (only) the cheapest places do well. They want to reward physicians who are doing high-quality care and put in place a system that makes that visible.
Checking on doctors
Consumers can't yet check the registry to find out if their doctor does a better job than one across town. But it is under development.
Anthem, the insurer running the new hip and knee program for Calpers, says it will track the outcomes to make sure they are at least as good as what was seen before the change. About 90% of the hospitals in Anthem's California network met the reference price for hip or knee replacement, including Cedars-Sinai, UCLA and other well-known medical centers.
Anthem provides transportation costs for patients who live too far from one of the centers. About 77% of the covered workers having the procedure since launch have gone to a reference-price hospital.
The 46 hospitals were chosen after Calpers analyzed what it was paying for hip and knee replacements under its previous arrangement and found it ranged from as little as $15,000 to more than $100,000.
The $30,000 limit for hips and knees is not a median but was selected after looking at the range in costs and taking off the really high and really low numbers. The program should save Calpers about 20% of the cost of the procedures.
This is the future for select procedures where people can shop.
03 October 2011
CareTech Solutions Invests $1.5 Million in Hospital IT Help Desk
Company’s Service Desk Undergoes Major Renovation in Preparation for Growth Explosion
(TROY, Mich., Sept. 29, 2011) CareTech Solutions, an information technology (IT) and
Web products and services provider for U.S. hospitals today unveiled its newly re-configured and remodeled Service Desk, a 24x7x365, on-shore medical help desk that currently responds to nearly one million contacts a year from hospital users seeking IT support with clinical and business systems. The $1.5 million investment enables additional growth and hiring for the Service Desk which is on track this year to experience twenty five percent growth in revenue.
“The Service Desk is the fastest growing piece of our business, largely due to the recent explosion of electronic medical records and healthcare technologies,” said Jim Giordano, president and CEO, CareTech Solutions. “Service Desk is more than a call center, it’s a highly-specialized technology support organization with analysts trained to quickly resolve doctors and clinicians’ IT issues so they can get back to what they do best, caring for patients.”
The Service Desk, based in Troy, Michigan, was launched by CareTech Solutions in 1998 with less than 30 employees. In 2008, CareTech added a dedicated physician-only hotline, remote control tools, and a knowledge base that holds over eight thousand answers for all major clinical systems and business applications. Today, the Service Desk staff has grown to almost 160 employees, with more than 45 added this year.
About CareTech Solutions
CareTech Solutions, Inc., an information technology and Web products and services provider for more than 180 U.S. hospitals and health systems, creates value for clients through customized IT solutions that contribute to improving patient care while lowering healthcare costs. From implementing emerging technologies to supporting day-to-day IT operations, CareTech offers clients expert health information management services across the entire patient data lifecycle earning it the 2008, 2009 and 2010 Best in KLAS award for IT Outsourcing (Extensive) as ranked by healthcare executives and professionals in the Top 20 Best in KLAS Awards: Software & Professional Services report.
For more information, please visit www.caretech.com.
(TROY, Mich., Sept. 29, 2011) CareTech Solutions, an information technology (IT) and
Web products and services provider for U.S. hospitals today unveiled its newly re-configured and remodeled Service Desk, a 24x7x365, on-shore medical help desk that currently responds to nearly one million contacts a year from hospital users seeking IT support with clinical and business systems. The $1.5 million investment enables additional growth and hiring for the Service Desk which is on track this year to experience twenty five percent growth in revenue.
“The Service Desk is the fastest growing piece of our business, largely due to the recent explosion of electronic medical records and healthcare technologies,” said Jim Giordano, president and CEO, CareTech Solutions. “Service Desk is more than a call center, it’s a highly-specialized technology support organization with analysts trained to quickly resolve doctors and clinicians’ IT issues so they can get back to what they do best, caring for patients.”
The Service Desk, based in Troy, Michigan, was launched by CareTech Solutions in 1998 with less than 30 employees. In 2008, CareTech added a dedicated physician-only hotline, remote control tools, and a knowledge base that holds over eight thousand answers for all major clinical systems and business applications. Today, the Service Desk staff has grown to almost 160 employees, with more than 45 added this year.
About CareTech Solutions
CareTech Solutions, Inc., an information technology and Web products and services provider for more than 180 U.S. hospitals and health systems, creates value for clients through customized IT solutions that contribute to improving patient care while lowering healthcare costs. From implementing emerging technologies to supporting day-to-day IT operations, CareTech offers clients expert health information management services across the entire patient data lifecycle earning it the 2008, 2009 and 2010 Best in KLAS award for IT Outsourcing (Extensive) as ranked by healthcare executives and professionals in the Top 20 Best in KLAS Awards: Software & Professional Services report.
For more information, please visit www.caretech.com.
27 September 2011
IS NEW BREAST CANCER BILL HELPING PATIENTS OR CAUSING UNDO ANXIETY?
Story first appeared in the Traverse City Record-Eagle.
It took seven years of annual mammograms and a cancer diagnosis for Amy Colton to learn something her doctors had realized for the beginning: Her breast tissue is so dense that it could have masked tumors on earlier exams.
She requested a copy of the report send from her radiologist to her primary care physician, and every single one said, “Patient has extremely dense breast tissue.” The registered labor and delivery nurse was really outraged that she didn’t know this.
About 40 percent of women over 40 have breast tissue dense enough to mask or mimic cancers on mammograms, but many of them don’t know it. Mammogram providers in California will be required to notify those patients, and suggest that they discuss additional screening with their doctors based on their individual risk factor, if Gov. Jerry Brown signs a bill that the Legislature passed this month. Similar laws have passed in Texas and Connecticut in the past two years but no data is available yet from either state on the effect of the legislation.
Researcher studying breast density, a relatively young field, said such requirements may end up causing undo anxiety in millions of women and lead to unnecessary and expensive ultrasound or MRI screening.
The California Medical Association, which represents 35,000 doctors, recommended a public education campaign instead of individual notifications, and said there isn’t enough evidence to support the idea the extra money spent on additional screening will save more lives.
Those test could cost the state more than $1 billion, and may women wouldn’t be able to afford them, said a professor of radiology and chief of breast imaging.
It took seven years of annual mammograms and a cancer diagnosis for Amy Colton to learn something her doctors had realized for the beginning: Her breast tissue is so dense that it could have masked tumors on earlier exams.
She requested a copy of the report send from her radiologist to her primary care physician, and every single one said, “Patient has extremely dense breast tissue.” The registered labor and delivery nurse was really outraged that she didn’t know this.
About 40 percent of women over 40 have breast tissue dense enough to mask or mimic cancers on mammograms, but many of them don’t know it. Mammogram providers in California will be required to notify those patients, and suggest that they discuss additional screening with their doctors based on their individual risk factor, if Gov. Jerry Brown signs a bill that the Legislature passed this month. Similar laws have passed in Texas and Connecticut in the past two years but no data is available yet from either state on the effect of the legislation.
Researcher studying breast density, a relatively young field, said such requirements may end up causing undo anxiety in millions of women and lead to unnecessary and expensive ultrasound or MRI screening.
The California Medical Association, which represents 35,000 doctors, recommended a public education campaign instead of individual notifications, and said there isn’t enough evidence to support the idea the extra money spent on additional screening will save more lives.
Those test could cost the state more than $1 billion, and may women wouldn’t be able to afford them, said a professor of radiology and chief of breast imaging.
22 September 2011
Database of Physician Discipline and Malpractice Actions Removal
Story first appeared in The New York Times
Three journalism organizations on Thursday protested a decision by the Obama administration to remove a database of physician discipline and malpractice actions from the Web.
The National Practitioner Data Bank, created in 1986, is used by state medical boards, insurers and hospitals. The “public use file” of the data bank, with physician names and addresses deleted, has provided valuable information for many years to researchers and reporters investigating oversight of doctors, trends in disciplinary actions and malpractice awards.
On Sept. 1, responding to a complaint, the Health Resources and Services Administration, an agency of the Department of Health and Human Services, removed the public use file from its Web site, said an agency spokesman, Martin A. Kramer. The agency also wrote a reporter a letter to warn he could be liable for $11,000 or more in civil fines for violating a confidentiality provision of the federal law. Both actions outraged journalism groups.
“Reporters across the country have used the public use file to write stories that have exposed serious lapses in the oversight of doctors that have put patients at risk. Their stories have led to new legislation, additional levels of transparency in various states, and kept medical boards focused on issues of patient safety.”
Two other national journalism organizations, Investigative Reporters and Editors and the Society of Professional Journalists, joined the health reporters’ group in a letter to Mary K. Wakefield, administrator of the federal office. “If anything, the agency erred on the side of physician privacy,” they wrote.
The agency, contacted by a doctor, had become concerned that a Kansas City reporter obtained information from the full data bank, not just its public use file.
That concern and the letter, though, were made moot when the reporter explained that he had been getting information from the public use file.
Nonetheless the agency is reviewing the public use file and may change it to further assure confidentiality before placing it back on the Web, he said, adding that he hoped it would be public again within six months.
“We are going to do everything we can to get the data back up in a public use file as quickly as we possibly can. We want to make sure the public, researchers and reporters have access to all the information that we can legally make available.”
Mr. Kramer said he could not speculate about how the public use file would be changed. He said the agency was still reviewing complaints made by the journalist organizations.
The Kansas City Star, despite the letter to its reporter, published its article on Sept. 3, titled, “Doctors With Histories of Alleged Malpractice Often Go Undisciplined.”
“To see whether other doctors with long malpractice payment histories are practicing in Kansas and Missouri, The Star analyzed thousands of records in the National Practitioner Data Bank,” the article said. It found 21 doctors had at least 10 malpractice payments but had never been disciplined by the states.
Like many others across the country, had performed broad research of courts, state agencies and hospital actions, “allowing them to connect the dots” to individual doctors. But he said the federal database itself did not reveal identities.
Other recent notable articles based partly on the database have appeared in The Duluth News Tribune in Minnesota and The St. Louis Post-Dispatch, which published a series last year titled, “Who Protects the Patients?”
Three journalism organizations on Thursday protested a decision by the Obama administration to remove a database of physician discipline and malpractice actions from the Web.
The National Practitioner Data Bank, created in 1986, is used by state medical boards, insurers and hospitals. The “public use file” of the data bank, with physician names and addresses deleted, has provided valuable information for many years to researchers and reporters investigating oversight of doctors, trends in disciplinary actions and malpractice awards.
On Sept. 1, responding to a complaint, the Health Resources and Services Administration, an agency of the Department of Health and Human Services, removed the public use file from its Web site, said an agency spokesman, Martin A. Kramer. The agency also wrote a reporter a letter to warn he could be liable for $11,000 or more in civil fines for violating a confidentiality provision of the federal law. Both actions outraged journalism groups.
“Reporters across the country have used the public use file to write stories that have exposed serious lapses in the oversight of doctors that have put patients at risk. Their stories have led to new legislation, additional levels of transparency in various states, and kept medical boards focused on issues of patient safety.”
Two other national journalism organizations, Investigative Reporters and Editors and the Society of Professional Journalists, joined the health reporters’ group in a letter to Mary K. Wakefield, administrator of the federal office. “If anything, the agency erred on the side of physician privacy,” they wrote.
The agency, contacted by a doctor, had become concerned that a Kansas City reporter obtained information from the full data bank, not just its public use file.
That concern and the letter, though, were made moot when the reporter explained that he had been getting information from the public use file.
Nonetheless the agency is reviewing the public use file and may change it to further assure confidentiality before placing it back on the Web, he said, adding that he hoped it would be public again within six months.
“We are going to do everything we can to get the data back up in a public use file as quickly as we possibly can. We want to make sure the public, researchers and reporters have access to all the information that we can legally make available.”
Mr. Kramer said he could not speculate about how the public use file would be changed. He said the agency was still reviewing complaints made by the journalist organizations.
The Kansas City Star, despite the letter to its reporter, published its article on Sept. 3, titled, “Doctors With Histories of Alleged Malpractice Often Go Undisciplined.”
“To see whether other doctors with long malpractice payment histories are practicing in Kansas and Missouri, The Star analyzed thousands of records in the National Practitioner Data Bank,” the article said. It found 21 doctors had at least 10 malpractice payments but had never been disciplined by the states.
Like many others across the country, had performed broad research of courts, state agencies and hospital actions, “allowing them to connect the dots” to individual doctors. But he said the federal database itself did not reveal identities.
Other recent notable articles based partly on the database have appeared in The Duluth News Tribune in Minnesota and The St. Louis Post-Dispatch, which published a series last year titled, “Who Protects the Patients?”
Failure of Metal Hips
Story first appeared in The New York Times
In a troubling development for people with all-metal artificial hips, a registry that tracks orthopedic implants in Britain reported on Thursday that the failure rate of the devices was increasing.
The National Joint Registry for England and Wales said that an all-metal artificial hip once sold by Johnson & Johnson had failed in an estimated one-third of the patients who had been followed for the longest time. The device was recalled by the company last year.
The British registry also found that the early failure rate of some other metal-on-metal hips — ones in which both the ball and the socket components of an artificial joint are made of metal — was significantly higher than for those made from other materials, including a combination of metal and plastic.
While the patients tracked by the British registry are not in the United States, doctors and patients here pay close attention to the registry’s findings because no such body exists in this country, where there is far greater use of artificial hips and knees. Australia also keeps a registry.
There was already heightened concern in the United States about the all-metal hips. In the first six months of this year, the Food and Drug Administration received more reports about problems with the all-metal hips than it had in the previous four years combined, according to an analysis by The New York Times. In May, the F.D.A. took the unusual step of ordering producers of the devices to study how frequently they were failing and to examine the health implications for patients.
While traditional artificial hips typically last 15 years or more before they need to replaced, some of the all-metal models are failing in large numbers of patients within just a few years. Early failure rates for all-metal devices were far higher in women than in men, the British report found.
According to the report, the highest failure rates involved the Johnson & Johnson device, which is known as the Articular Surface Replacement, or the A.S.R. The registry is following about 2,100 patients who received a version of the device that is used as a traditional hip implant. That is also how the A.S.R. was used in this country.
Of those patients in the British group who received the device six years ago, about 29 percent have since had it replaced.
The percentage is slightly lower, about 17 percent, in patients who got the device five years ago, but that number could rise over the next year.
DePuy officials recalled the A.S.R. last year around the time that the previous report of the British registry was released.
Along with a traditional hip model, another version of the device was sold outside this country for use in an alternative hip replacement technique known as “resurfacing.” It was also recalled.
While it is difficult to draw direct comparisons between device failure rates in Britain and in the United States, the new registry findings appear to bode ill for patients here who received an A.S.R. About 40,000 of the 90,000 units sold worldwide were used in this country.
The British data suggests that complaints will continue to grow in the United States in coming years because the A.S.R. was used overseas before its adoption here.
The British data also shows that the failure rate for all-metal devices as a group, even when the A.S.R. is excluded, is accelerating faster than for traditional hip replacements.
Though immediate problems with the hip implants are not life-threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that were shed by the metal devices as they wore.
Such debris generation is also believed to be a cause of earlier device failure.
Until a recent sharp decline in their use, all-metal hip implants accounted for nearly one-third of the estimated 250,000 replacements performed in this country each year. According to one estimate, some 500,000 patients in this country have received an all-metal replacement hip.
In the case of devices used for hip resurfacing, which is popular among younger patients, a model known as the Birmingham Hip Resurfacing device had the lowest replacement rate at five years, the registry found.
However, the report noted that further studies needed to be performed to determine whether hip resurfacing conferred true advantages over standard hip replacement.
In a troubling development for people with all-metal artificial hips, a registry that tracks orthopedic implants in Britain reported on Thursday that the failure rate of the devices was increasing.
The National Joint Registry for England and Wales said that an all-metal artificial hip once sold by Johnson & Johnson had failed in an estimated one-third of the patients who had been followed for the longest time. The device was recalled by the company last year.
The British registry also found that the early failure rate of some other metal-on-metal hips — ones in which both the ball and the socket components of an artificial joint are made of metal — was significantly higher than for those made from other materials, including a combination of metal and plastic.
While the patients tracked by the British registry are not in the United States, doctors and patients here pay close attention to the registry’s findings because no such body exists in this country, where there is far greater use of artificial hips and knees. Australia also keeps a registry.
There was already heightened concern in the United States about the all-metal hips. In the first six months of this year, the Food and Drug Administration received more reports about problems with the all-metal hips than it had in the previous four years combined, according to an analysis by The New York Times. In May, the F.D.A. took the unusual step of ordering producers of the devices to study how frequently they were failing and to examine the health implications for patients.
While traditional artificial hips typically last 15 years or more before they need to replaced, some of the all-metal models are failing in large numbers of patients within just a few years. Early failure rates for all-metal devices were far higher in women than in men, the British report found.
According to the report, the highest failure rates involved the Johnson & Johnson device, which is known as the Articular Surface Replacement, or the A.S.R. The registry is following about 2,100 patients who received a version of the device that is used as a traditional hip implant. That is also how the A.S.R. was used in this country.
Of those patients in the British group who received the device six years ago, about 29 percent have since had it replaced.
The percentage is slightly lower, about 17 percent, in patients who got the device five years ago, but that number could rise over the next year.
DePuy officials recalled the A.S.R. last year around the time that the previous report of the British registry was released.
Along with a traditional hip model, another version of the device was sold outside this country for use in an alternative hip replacement technique known as “resurfacing.” It was also recalled.
While it is difficult to draw direct comparisons between device failure rates in Britain and in the United States, the new registry findings appear to bode ill for patients here who received an A.S.R. About 40,000 of the 90,000 units sold worldwide were used in this country.
The British data suggests that complaints will continue to grow in the United States in coming years because the A.S.R. was used overseas before its adoption here.
The British data also shows that the failure rate for all-metal devices as a group, even when the A.S.R. is excluded, is accelerating faster than for traditional hip replacements.
Though immediate problems with the hip implants are not life-threatening, some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that were shed by the metal devices as they wore.
Such debris generation is also believed to be a cause of earlier device failure.
Until a recent sharp decline in their use, all-metal hip implants accounted for nearly one-third of the estimated 250,000 replacements performed in this country each year. According to one estimate, some 500,000 patients in this country have received an all-metal replacement hip.
In the case of devices used for hip resurfacing, which is popular among younger patients, a model known as the Birmingham Hip Resurfacing device had the lowest replacement rate at five years, the registry found.
However, the report noted that further studies needed to be performed to determine whether hip resurfacing conferred true advantages over standard hip replacement.
Coming Together to Make Aging a Little Easier
Story first appeared in The New York Times
LAST summer, Shoya Zichy was about to drop off a prescription at a friend’s house when she tripped and dislocated her elbow in Midtown Manhattan.
As Ms. Zichy lay helpless on the sidewalk, Pam Ramsden came along, on her way to visit the same woman, who was recovering from a traffic accident.
Ms. Ramsden, 67, spent the next 10 hours in a hospital emergency room with Ms. Zichy and accompanied her home in a taxi at 1 a.m.
The women had met once before; both are members of the Caring Collaborative, a program offering volunteer assistance to women with health problems. Started in 2008 by the Transition Network, a New York-based nonprofit group for professional women in or near retirement, the collaborative has 200 volunteers. They provide network members, who pay a small fee, with short-term, nonemergency caregiving, like pet care, Fall Lawn Care, meal and prescription delivery, hospital visits and escorted medical appointments. The network is not organized to help the frail elderly or provide long-term care. A similar program for Senior Health Detroit is being considered.
Members of the Caring Collaborative also meet in neighborhood groups, organized by ZIP code, for confidential discussions of doctors, hospitals and surgical procedures. The collaborative, a pilot program available only to the network’s New York City members, is under consideration at some of the network’s 14 chapters nationwide.
That August night, Ms. Ramsden took on far more than the collaborative’s usual dog-walking or accompanying a recipient home from a colonoscopy. She corralled medical providers, lobbied for more pain medicine and tried to distract Ms. Zichy, who spent hours without food or water on a gurney in the hallway.
Innovative approaches to managing some of the difficulties of aging are bubbling up around the country, often initiated by women who want to stay independent. Women by nature congregate around shared interests, so they are seeing informal networks popping up in church groups, book clubs, unions and lifelong learning programs.
A 65-year-old woman can expect to live at least 20 more years, often alone and in need of help to live independently, yet 40 percent of boomer women don’t know that long-term planning involves complicated decisions about your home, family and community.
The Caring Collaborative was created by Charlotte Frank, a retired executive with the Port Authority of New York and New Jersey and co-founder of the Transition Network. Complications following thyroid surgery a few years ago left her dependent on friends to provide meals, take her to visit the doctor and stay in her Manhattan apartment.
Many New York professional women over age 50 - the core of the Transition Network’s membership - are single or childless and live far from family, “It’s part of the protective armor of being a New Yorker that you don’t get close to your neighbors. So who are you going to ask for help when you need it?”
The program, financed with $144,000 from the New York State Health Foundation, uses software to match caregivers and care recipients. Members can build credits by helping others and later redeem the credit if needed. (There is no need to bank credits - recipients can volunteer later.)
Transition Network chapters on Long Island and in the San Francisco area are interested in adapting the Caring Collaborative model to their geographic requirements, said Ms. Frank. The founders have also prepared three guides to help other organizations create similar networks, peer groups and “vertical villages” in high-rise apartment buildings.
Project Renewment in California, a volunteer organization for professional women in transition from their primary careers, is interested in the Caring Collaborative model. Like the Transition Network, Project Renewment members make friends in small peer groups focused on second career options, volunteering and travel.
The Caring Collaborative is just a first step in resolving older women’s potential vulnerabilities, said Ms. Burns, who heads AARP’s campaign - called “Decide. Create. Share” - aimed at helping older women plan for their later years. “You need to ask difficult questions: ‘Can my home be modified so I can age in place? Does my community have services I might need? Could I afford to hire in-home care? What are my last wishes?’ ”
Ms. Zichy’s accident prompted her to look into a continuing-care retirement community in Philadelphia.
And Ms. Ramsden has given thought to moving near one of her children.
LAST summer, Shoya Zichy was about to drop off a prescription at a friend’s house when she tripped and dislocated her elbow in Midtown Manhattan.
As Ms. Zichy lay helpless on the sidewalk, Pam Ramsden came along, on her way to visit the same woman, who was recovering from a traffic accident.
Ms. Ramsden, 67, spent the next 10 hours in a hospital emergency room with Ms. Zichy and accompanied her home in a taxi at 1 a.m.
The women had met once before; both are members of the Caring Collaborative, a program offering volunteer assistance to women with health problems. Started in 2008 by the Transition Network, a New York-based nonprofit group for professional women in or near retirement, the collaborative has 200 volunteers. They provide network members, who pay a small fee, with short-term, nonemergency caregiving, like pet care, Fall Lawn Care, meal and prescription delivery, hospital visits and escorted medical appointments. The network is not organized to help the frail elderly or provide long-term care. A similar program for Senior Health Detroit is being considered.
Members of the Caring Collaborative also meet in neighborhood groups, organized by ZIP code, for confidential discussions of doctors, hospitals and surgical procedures. The collaborative, a pilot program available only to the network’s New York City members, is under consideration at some of the network’s 14 chapters nationwide.
That August night, Ms. Ramsden took on far more than the collaborative’s usual dog-walking or accompanying a recipient home from a colonoscopy. She corralled medical providers, lobbied for more pain medicine and tried to distract Ms. Zichy, who spent hours without food or water on a gurney in the hallway.
Innovative approaches to managing some of the difficulties of aging are bubbling up around the country, often initiated by women who want to stay independent. Women by nature congregate around shared interests, so they are seeing informal networks popping up in church groups, book clubs, unions and lifelong learning programs.
A 65-year-old woman can expect to live at least 20 more years, often alone and in need of help to live independently, yet 40 percent of boomer women don’t know that long-term planning involves complicated decisions about your home, family and community.
The Caring Collaborative was created by Charlotte Frank, a retired executive with the Port Authority of New York and New Jersey and co-founder of the Transition Network. Complications following thyroid surgery a few years ago left her dependent on friends to provide meals, take her to visit the doctor and stay in her Manhattan apartment.
Many New York professional women over age 50 - the core of the Transition Network’s membership - are single or childless and live far from family, “It’s part of the protective armor of being a New Yorker that you don’t get close to your neighbors. So who are you going to ask for help when you need it?”
The program, financed with $144,000 from the New York State Health Foundation, uses software to match caregivers and care recipients. Members can build credits by helping others and later redeem the credit if needed. (There is no need to bank credits - recipients can volunteer later.)
Transition Network chapters on Long Island and in the San Francisco area are interested in adapting the Caring Collaborative model to their geographic requirements, said Ms. Frank. The founders have also prepared three guides to help other organizations create similar networks, peer groups and “vertical villages” in high-rise apartment buildings.
Project Renewment in California, a volunteer organization for professional women in transition from their primary careers, is interested in the Caring Collaborative model. Like the Transition Network, Project Renewment members make friends in small peer groups focused on second career options, volunteering and travel.
The Caring Collaborative is just a first step in resolving older women’s potential vulnerabilities, said Ms. Burns, who heads AARP’s campaign - called “Decide. Create. Share” - aimed at helping older women plan for their later years. “You need to ask difficult questions: ‘Can my home be modified so I can age in place? Does my community have services I might need? Could I afford to hire in-home care? What are my last wishes?’ ”
Ms. Zichy’s accident prompted her to look into a continuing-care retirement community in Philadelphia.
And Ms. Ramsden has given thought to moving near one of her children.
16 September 2011
There is a medical code for “burn due to water-skis on fire?” Why?
Story first appeared in the Wall Street Journal.
Today, hospitals and doctors use a system of about 18,000 codes to describe medical services in bills they send to insurers. Apparently, that doesn't allow for quite enough nuance.
A new federally mandated version will expand the number to around 140,000—adding codes that describe precisely what bone was broken, or which artery is receiving a stent.
It will also have a code for recording that a patient's injury occurred in a chicken coop.
Indeed, health plans may never again wonder where a patient got hurt. There are codes for injuries in opera houses, art galleries, squash courts and nine locations in and around a mobile home, from the bathroom to the bedroom.
Health insurers, doctors and hospitals are bracing for chaos as they prepare to adopt a new federally mandated format for medical billing.
Some doctors aren't sure they need quite that much detail. Brian Bachelder, a family physician in Akron, Ohio want to know what difference does it make where the injury happened…bedroom or bathroom?"
The federal agencies that developed the system—generally known as ICD-10, for International Classification of Diseases, 10th Revision—say the codes will provide a more exact and up-to-date accounting of diagnoses and hospital inpatient procedures, which could improve payment strategies and care guidelines. It's for accuracy of data and quality of care, says Pat Brooks, senior technical adviser at the Centers for Medicare and Medicaid Services.
Billing experts who translate doctors' work into codes are gearing up to start using the new system in two years. They say the new detail is welcome in many cases. But a few aspects are also causing some head scratching.
Some codes could seem downright insulting: R46.1 is "bizarre personal appearance," while R46.0 is "very low level of personal hygiene."
It's not clear how many klutzes want to notify their insurers that a doctor visit was a W22.02XA, "walked into lamppost, initial encounter" (or, for that matter, a W22.02XD, "walked into lamppost, subsequent encounter").
Why are there codes for injuries received while sewing, ironing, playing a brass instrument, crocheting, doing handcrafts, or knitting—but not while shopping, wonders Rhonda Buckholtz, who does ICD-10 training for the American Academy of Professional Coders, a credentialing organization.
Code V91.07XA, which involves a "burn due to water-skis on fire," is another mystery she ponders: "Is it work-related?" she asks. "Is it a trick skier jumping through hoops of fire? How does it happen?"
Much of the new system is based on a World Health Organization code set in use in many countries for more than a decade. Still, the American version, developed by the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services, is considerably more fine-grained.
The WHO, for instance, didn't see the need for 72 codes about injuries tied to birds. But American doctors whose patients run afoul of a duck, macaw, parrot, goose, turkey or chicken will be able to select from nine codes for each animal, notes George Alex, an official at the Advisory Board Co., a health-care research firm.
There are 312 animal codes in all, he says, compared to nine in the international version. There are separate codes for "bitten by turtle" and "struck by turtle."
U.S. hospitals and insurers are bracing for possible hiccups when the move to ICD-10 happens on Oct. 1, 2013, even though they've known it was coming since early 2009.
Jeremy Delinsky, chief technology officer for athenahealth Inc., which provides billing services to doctors commented that you have millions of transactions flowing in the health-care system and this is an opportunity to mess them all up.
Medicare officials say they believe many big insurers and hospital systems are making preparations, but there may be some issues with smaller ones that won't be ready.
With the move to ICD-10, the one code for suturing an artery will become 195 codes, designating every single artery, among other variables, according to OptumInsight, a unit of UnitedHealth Group Inc. A single code for a badly healed fracture could now translate to 2,595 different codes, the firm calculates. Each signals information including what bone was broken, as well as which side of the body it was on.
Some companies hope to grab business from the shift. One medical-coding website operator, Find A Code LLC, has created a series of YouTube videos with the tagline, "Yeah, there's a code for that." Snow White biting the poisoned apple, the firm says, may be a case of T78.04, "anaphylactic shock due to fruits and vegetables." On April 1, the company posted a document with the secret "X-codes" to describe medical conditions stemming from encounters with aliens.
Other coding cognoscenti spot possible hidden messages in the real codes. The abbreviation some use for the new system itself, I10, is also a code for high blood pressure. Several codes involving drainage devices end in "00Z." Then there are two of the codes describing sex-change operations that end in N0K1 and M0J0. You could see it ripple through the room as people said, “nookie and mojo!” says Kathryn DeVault, who has been teaching ICD-10 classes for the American Health Information Management Association.
Medicare agency's Ms. Brooks, who says the codes are built according to a consistent pattern in which each digit has a meaning not on hidden messages.
Medicare and CDC officials say codes were selected based on years of input from medical experts in various fields. Codes describing the circumstances of injuries are important for public-health researchers to track how people get hurt and try to prevent injuries, they say.
Being able to tabulate risks tied to locations such as chicken coops could be important as far as surveillance activities for public health research, says Donna Pickett, a medical systems administrator at the CDC. She says the current code for a badly healed fracture is so vague it isn't useful.
Another CMS official, Denise M. Buenning, compares ICD-10 to a phone book. She says you are not going to use all the numbers, but all the numbers you need are in there.
Today, hospitals and doctors use a system of about 18,000 codes to describe medical services in bills they send to insurers. Apparently, that doesn't allow for quite enough nuance.
A new federally mandated version will expand the number to around 140,000—adding codes that describe precisely what bone was broken, or which artery is receiving a stent.
It will also have a code for recording that a patient's injury occurred in a chicken coop.
Indeed, health plans may never again wonder where a patient got hurt. There are codes for injuries in opera houses, art galleries, squash courts and nine locations in and around a mobile home, from the bathroom to the bedroom.
Health insurers, doctors and hospitals are bracing for chaos as they prepare to adopt a new federally mandated format for medical billing.
Some doctors aren't sure they need quite that much detail. Brian Bachelder, a family physician in Akron, Ohio want to know what difference does it make where the injury happened…bedroom or bathroom?"
The federal agencies that developed the system—generally known as ICD-10, for International Classification of Diseases, 10th Revision—say the codes will provide a more exact and up-to-date accounting of diagnoses and hospital inpatient procedures, which could improve payment strategies and care guidelines. It's for accuracy of data and quality of care, says Pat Brooks, senior technical adviser at the Centers for Medicare and Medicaid Services.
Billing experts who translate doctors' work into codes are gearing up to start using the new system in two years. They say the new detail is welcome in many cases. But a few aspects are also causing some head scratching.
Some codes could seem downright insulting: R46.1 is "bizarre personal appearance," while R46.0 is "very low level of personal hygiene."
It's not clear how many klutzes want to notify their insurers that a doctor visit was a W22.02XA, "walked into lamppost, initial encounter" (or, for that matter, a W22.02XD, "walked into lamppost, subsequent encounter").
Why are there codes for injuries received while sewing, ironing, playing a brass instrument, crocheting, doing handcrafts, or knitting—but not while shopping, wonders Rhonda Buckholtz, who does ICD-10 training for the American Academy of Professional Coders, a credentialing organization.
Code V91.07XA, which involves a "burn due to water-skis on fire," is another mystery she ponders: "Is it work-related?" she asks. "Is it a trick skier jumping through hoops of fire? How does it happen?"
Much of the new system is based on a World Health Organization code set in use in many countries for more than a decade. Still, the American version, developed by the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services, is considerably more fine-grained.
The WHO, for instance, didn't see the need for 72 codes about injuries tied to birds. But American doctors whose patients run afoul of a duck, macaw, parrot, goose, turkey or chicken will be able to select from nine codes for each animal, notes George Alex, an official at the Advisory Board Co., a health-care research firm.
There are 312 animal codes in all, he says, compared to nine in the international version. There are separate codes for "bitten by turtle" and "struck by turtle."
U.S. hospitals and insurers are bracing for possible hiccups when the move to ICD-10 happens on Oct. 1, 2013, even though they've known it was coming since early 2009.
Jeremy Delinsky, chief technology officer for athenahealth Inc., which provides billing services to doctors commented that you have millions of transactions flowing in the health-care system and this is an opportunity to mess them all up.
Medicare officials say they believe many big insurers and hospital systems are making preparations, but there may be some issues with smaller ones that won't be ready.
With the move to ICD-10, the one code for suturing an artery will become 195 codes, designating every single artery, among other variables, according to OptumInsight, a unit of UnitedHealth Group Inc. A single code for a badly healed fracture could now translate to 2,595 different codes, the firm calculates. Each signals information including what bone was broken, as well as which side of the body it was on.
Some companies hope to grab business from the shift. One medical-coding website operator, Find A Code LLC, has created a series of YouTube videos with the tagline, "Yeah, there's a code for that." Snow White biting the poisoned apple, the firm says, may be a case of T78.04, "anaphylactic shock due to fruits and vegetables." On April 1, the company posted a document with the secret "X-codes" to describe medical conditions stemming from encounters with aliens.
Other coding cognoscenti spot possible hidden messages in the real codes. The abbreviation some use for the new system itself, I10, is also a code for high blood pressure. Several codes involving drainage devices end in "00Z." Then there are two of the codes describing sex-change operations that end in N0K1 and M0J0. You could see it ripple through the room as people said, “nookie and mojo!” says Kathryn DeVault, who has been teaching ICD-10 classes for the American Health Information Management Association.
Medicare agency's Ms. Brooks, who says the codes are built according to a consistent pattern in which each digit has a meaning not on hidden messages.
Medicare and CDC officials say codes were selected based on years of input from medical experts in various fields. Codes describing the circumstances of injuries are important for public-health researchers to track how people get hurt and try to prevent injuries, they say.
Being able to tabulate risks tied to locations such as chicken coops could be important as far as surveillance activities for public health research, says Donna Pickett, a medical systems administrator at the CDC. She says the current code for a badly healed fracture is so vague it isn't useful.
Another CMS official, Denise M. Buenning, compares ICD-10 to a phone book. She says you are not going to use all the numbers, but all the numbers you need are in there.
Health Of Alpha Males
Story first appeared in the Wall Street Journal.
One evening a week, a group of CEOs meets in a Manhattan psychiatrist's office and engages in an ancient ritual. Ostensibly, it is a support group. Inevitably, it becomes a battle for dominance.
T. Byram Karasu, the veteran psychiatrist who has run the sessions for the past 23 years said whenever you put alpha males together, the most aggressive will overpower the others. The fighting is subtle, but it's vicious. Even giving advice is geared toward lowering the others' self-esteem. Those at the lower end of the group come away doubting themselves, and their testosterone falls. They tell me they can't have sex for three or four days afterward.
Alpha males get the girls, but beta males have fewer stress-related health problems, at least among baboons, according to a recent Princeton study. As Melinda Beck explains, that appears to have health consequences for humans, too.
It isn't easy being an alpha male. Getting to the top and staying there takes a physical toll.
The latest evidence comes from wild baboons in Kenya's Amboseli basin. Researchers from Princeton and Duke universities studied 125 males in five groups over nine years and found that while the alpha males got the best food and the most mates, they experienced far more stress than the beta males just beneath them in the hierarchy, based on the levels of cortisol, a stress hormone, in fecal samples.
The beta males had almost as many mates and got just as much grooming from others, but they didn't have to spend as much time fighting or following females around to keep other males away.
In the human savannah, where smarts matter more than brute strength, alphas run companies, amass fortunes and dominate any meeting they're in. They are ambitious, assertive, confident and competitive.
Masters of the Universe
In the work world, alpha males are ambitious, assertive, confident and competitive. Here's a quiz that helps define who's an alpha male:
Alpha Strengths
• 1. No matter what, I don't give up until I reach my end goal.
• 2. I always say exactly what I think.
• 3. I have no problem challenging people.
• 4. I make the decision I believe is correct, even when I know other people don't agree.
• 5. I seldom have any doubts about my ability to deliver.
Alpha Risks
• 6. I believe that my value is defined by the results I achieve.
• 7. I don't care if my actions hurt people's feelings, if that's what's required to produce results.
• 8. When people disagree with me, I often treat it as a challenge or an affront.
• 9. If I have a good idea and I'm asked to hold off and listen to inferior ideas, I can quickly become visibly annoyed.
• 10. People say I become curt, brusque, or frustrated when I have to repeat myself.
Scoring:
• If all or nearly all of your responses to statements 1 to 5 were "yes," you are probably an alpha with many of the strengths that make alphas such dynamic and influential leaders.
• If all or nearly all of your responses to items 6 to 10 were "yes," you mostly likely have some alpha risks that deserve your attention.
• Don't be confused if you scored high in both categories. Because alpha liabilities are mainly alpha assets taken too far or applied inappropriately, that is to be expected. (The exceptions to the rule are healthy alphas who have worked hard to reduce their negative tendencies.)
While they may appear cool and calm, many human alphas thrive on adrenaline, the hormone that primes the body to fight or flee in times of danger. Those short bursts of power helped our ancestors outrun predators. But if the perceived threat never lets up, the chronic state of alarm increases cortisol, too, and can eventually weaken the immune system, raise blood-pressure, cholesterol and insulin levels, block arteries and spread inflammation.
Some alphas have so-called Type-A personalities, a combination of aggression, impatience and anger first linked to a higher risk of heart disease in the 1960s. Hostility is the main culprit, according to more recent research. A study of 1,750 Canadians in the Journal of the American College of Cardiology last week found that people who displayed signs of hostility—whether they admitted feeling hostile or not—had twice the risk of cardiovascular problems as those who did not. Not all alpha males are Type A, but the combination can be deadly from a health standpoint, Dr. Karasu says.
Women, of course, can be alphas or betas as well, and have the same fight-or-flight response to danger. But some researchers theorize females may experience a tend-and-befriend response as well, pumping out extra oxytocin and prolactin, hormones that enhance nurturing. Shielding offspring and blending into the crowd might have enhanced their chances of survival more than running or fighting, the theory goes. The oxytocin surge has been documented in animal studies, but is unproven in humans.
Many alphas are also dedicated to exercise, which helps burn off excess adrenaline and cortisol. But some alphas take exercise, like everything else, to the extreme. Cardiologists, psychiatrists and executive coaches all say it is critical for alphas to find some way to manage excess stress—be it moderate exercise, sports, yoga, music, meditation, mindfulness training or downtime with family and friends. Some also advise simple deep-breathing exercises, with long exhalations, which can counteract cortisol and increase endorphins, the feel-good brain chemical.
Many alphas find they are happier, healthier and more successful if they learn to temper some of their competitive zeal. Some alphas compete with their own children, says Eddie Erlandson, a former vascular surgeon who now runs an executive coaching company, Worth Ethic Corp., with his wife, Dr. Ludeman.
Some primate studies have found that alpha males that survive longest are those who cultivate friendships. That applies to humans as well with a vengeance
Beta males, by contrast, are nice guys, peacemakers and team players. They make good husbands, fathers and friends. Some experts say they tend to be happier than alphas, since they aren't driven by the need to be on top. Betas can come in many forms—from competent wingmen to extreme introverts who are so determined to avoid conflict they suffer anxiety of their own.
Many observational studies of people and primates have shown that, in general, it's more stressful at the bottom of the social hierarchy than the top. Two long-running studies of British civil-service workers found that people in the lowest ranks had many more health problems and were three times as likely to die as the highest-grade administrators in a 10-year period—even though they all had access to health-care services.
To date, there have been few studies assessing whether human alphas or betas are healthier. But interest is exploding in studying how such social and psychological experiences affect human biology—how they get under our skin, says Richard Suzman, director of Behavioral and Social Research at the National Institute of Aging, which helped fund the baboon research and is studying how social status affects longevity. The National Institute of Mental Health is using brain scans to track how winning and losing changes brain circuits.
Some of the most intriguing questions involve how and when these traits emerge in childhood. Researchers with the National Institute of Child Health and Human Development have observed alpha and beta behavior even in kindergartners and found that the subordinate tots have more cortisol in their saliva.
One evening a week, a group of CEOs meets in a Manhattan psychiatrist's office and engages in an ancient ritual. Ostensibly, it is a support group. Inevitably, it becomes a battle for dominance.
T. Byram Karasu, the veteran psychiatrist who has run the sessions for the past 23 years said whenever you put alpha males together, the most aggressive will overpower the others. The fighting is subtle, but it's vicious. Even giving advice is geared toward lowering the others' self-esteem. Those at the lower end of the group come away doubting themselves, and their testosterone falls. They tell me they can't have sex for three or four days afterward.
Alpha males get the girls, but beta males have fewer stress-related health problems, at least among baboons, according to a recent Princeton study. As Melinda Beck explains, that appears to have health consequences for humans, too.
It isn't easy being an alpha male. Getting to the top and staying there takes a physical toll.
The latest evidence comes from wild baboons in Kenya's Amboseli basin. Researchers from Princeton and Duke universities studied 125 males in five groups over nine years and found that while the alpha males got the best food and the most mates, they experienced far more stress than the beta males just beneath them in the hierarchy, based on the levels of cortisol, a stress hormone, in fecal samples.
The beta males had almost as many mates and got just as much grooming from others, but they didn't have to spend as much time fighting or following females around to keep other males away.
In the human savannah, where smarts matter more than brute strength, alphas run companies, amass fortunes and dominate any meeting they're in. They are ambitious, assertive, confident and competitive.
Masters of the Universe
In the work world, alpha males are ambitious, assertive, confident and competitive. Here's a quiz that helps define who's an alpha male:
Alpha Strengths
• 1. No matter what, I don't give up until I reach my end goal.
• 2. I always say exactly what I think.
• 3. I have no problem challenging people.
• 4. I make the decision I believe is correct, even when I know other people don't agree.
• 5. I seldom have any doubts about my ability to deliver.
Alpha Risks
• 6. I believe that my value is defined by the results I achieve.
• 7. I don't care if my actions hurt people's feelings, if that's what's required to produce results.
• 8. When people disagree with me, I often treat it as a challenge or an affront.
• 9. If I have a good idea and I'm asked to hold off and listen to inferior ideas, I can quickly become visibly annoyed.
• 10. People say I become curt, brusque, or frustrated when I have to repeat myself.
Scoring:
• If all or nearly all of your responses to statements 1 to 5 were "yes," you are probably an alpha with many of the strengths that make alphas such dynamic and influential leaders.
• If all or nearly all of your responses to items 6 to 10 were "yes," you mostly likely have some alpha risks that deserve your attention.
• Don't be confused if you scored high in both categories. Because alpha liabilities are mainly alpha assets taken too far or applied inappropriately, that is to be expected. (The exceptions to the rule are healthy alphas who have worked hard to reduce their negative tendencies.)
While they may appear cool and calm, many human alphas thrive on adrenaline, the hormone that primes the body to fight or flee in times of danger. Those short bursts of power helped our ancestors outrun predators. But if the perceived threat never lets up, the chronic state of alarm increases cortisol, too, and can eventually weaken the immune system, raise blood-pressure, cholesterol and insulin levels, block arteries and spread inflammation.
Some alphas have so-called Type-A personalities, a combination of aggression, impatience and anger first linked to a higher risk of heart disease in the 1960s. Hostility is the main culprit, according to more recent research. A study of 1,750 Canadians in the Journal of the American College of Cardiology last week found that people who displayed signs of hostility—whether they admitted feeling hostile or not—had twice the risk of cardiovascular problems as those who did not. Not all alpha males are Type A, but the combination can be deadly from a health standpoint, Dr. Karasu says.
Women, of course, can be alphas or betas as well, and have the same fight-or-flight response to danger. But some researchers theorize females may experience a tend-and-befriend response as well, pumping out extra oxytocin and prolactin, hormones that enhance nurturing. Shielding offspring and blending into the crowd might have enhanced their chances of survival more than running or fighting, the theory goes. The oxytocin surge has been documented in animal studies, but is unproven in humans.
Many alphas are also dedicated to exercise, which helps burn off excess adrenaline and cortisol. But some alphas take exercise, like everything else, to the extreme. Cardiologists, psychiatrists and executive coaches all say it is critical for alphas to find some way to manage excess stress—be it moderate exercise, sports, yoga, music, meditation, mindfulness training or downtime with family and friends. Some also advise simple deep-breathing exercises, with long exhalations, which can counteract cortisol and increase endorphins, the feel-good brain chemical.
Many alphas find they are happier, healthier and more successful if they learn to temper some of their competitive zeal. Some alphas compete with their own children, says Eddie Erlandson, a former vascular surgeon who now runs an executive coaching company, Worth Ethic Corp., with his wife, Dr. Ludeman.
Some primate studies have found that alpha males that survive longest are those who cultivate friendships. That applies to humans as well with a vengeance
Beta males, by contrast, are nice guys, peacemakers and team players. They make good husbands, fathers and friends. Some experts say they tend to be happier than alphas, since they aren't driven by the need to be on top. Betas can come in many forms—from competent wingmen to extreme introverts who are so determined to avoid conflict they suffer anxiety of their own.
Many observational studies of people and primates have shown that, in general, it's more stressful at the bottom of the social hierarchy than the top. Two long-running studies of British civil-service workers found that people in the lowest ranks had many more health problems and were three times as likely to die as the highest-grade administrators in a 10-year period—even though they all had access to health-care services.
To date, there have been few studies assessing whether human alphas or betas are healthier. But interest is exploding in studying how such social and psychological experiences affect human biology—how they get under our skin, says Richard Suzman, director of Behavioral and Social Research at the National Institute of Aging, which helped fund the baboon research and is studying how social status affects longevity. The National Institute of Mental Health is using brain scans to track how winning and losing changes brain circuits.
Some of the most intriguing questions involve how and when these traits emerge in childhood. Researchers with the National Institute of Child Health and Human Development have observed alpha and beta behavior even in kindergartners and found that the subordinate tots have more cortisol in their saliva.
15 September 2011
Should Hospitals Continue To Be Tax Exempt?
Story first appeared in Bloomberg News.
More than a dozen hospitals in Illinois face the prospect of paying millions of dollars in property taxes or, in some cases, shutting down as a result of a state ruling denying exemptions for three nonprofit healthcare providers, according to a ESOP Lawyer.
The uncertainty has prompted at least one hospital to postpone a $23 million construction bond sale while several others that built facilities say they won’t be able to pay the bill if they lose the break.
Tracy Bauer, chief executive officer of Midwest Medical Center in Galena, a 25-bed hospital that is on the hook for a $2.3 million property tax bill if its nonprofit exemption is revoked said they will go out of business without it.
The challenge to such exemptions comes as Illinois confronts two financial stresses -- the state’s $8 billion in unpaid bills and hospitals struggling with cuts in Medicare and Medicaid payments.
While other states have battled for decades in court over the obligation to treat the poor in exchange for tax breaks, Illinois intensified the fight on Aug. 16 when its Revenue Department denied exemptions for facilities in Chicago, Naperville and Decatur, saying they provided too little charity care.
Windfall for Schools
A reversal of the exemptions would represent a windfall for school districts, which collect the lion’s share of property taxes and have watched state aid shrink and revenue fall during the economic and housing slide.
Pat Schou, executive director of the Illinois Critical Access Hospital Network said there are school districts that are so hungry for this money that there’s a tug and pull in these communities.
The lobbying group for the state’s towns and cities supports the decision to collect the money.
Larry Frang, executive director of the Illinois Municipal League said in a perfect world, everybody ought to pay property taxes.
This is a fight with roots that go back centuries, when the fear of God persuaded governments not to tax churches because they worried about getting struck down by a lightning bolt, Colombo said. Many hospitals gained exemptions because of their religious affiliation or care for the indigent.
‘Poorhouses’ No More
Colombo said hospitals aren’t poorhouses anymore, and that just because they were exempt in 1900 doesn’t mean they should be exempt in 2011.
The Illinois Revenue Department is to rule in the coming months on the tax-exemption status of 15 hospital groups involving hundreds of parcels of property, said spokeswoman Susan Hofer. The Illinois Hospital Association, the industry’s lobbying arm, has asked for a moratorium on decisions until a legislative solution can be worked out, said Danny Chun, a spokesman.
There are no clear statutory guidelines, though the Illinois constitution and a 2010 state Supreme Court ruling provide guidance.
The constitution states that exemptions can be granted when property is used exclusively for charitable purposes.
High Court Ruling
The state’s highest court used that standard in a case involving an Urbana hospital, Provena Covenant Medical Center, which challenged the state’s denial of tax-exempt status. In a March 18, 2010 ruling, the court noted that a mere 302 of the hospital’s 110,000 patients received free care in 2002. Provena failed to meet its burden that the hospital was used exclusively for charitable purposes, the court said.
Although the decision’s immediate impact was confined to Provena, it put other nonprofits on notice. About 75 percent of hospitals in Illinois are nonprofits, according to a 2009 report from the Chicago- based Center for Tax and Budget Accountability.
The center reported that in metropolitan Chicago nonprofit hospitals received $489.5 million in tax exemptions and delivered charity care valued at $175.7 million.
Ralph Martire, executive director of the center, said for the most part, hospitals are very good members of the community, but that doesn’t mean you evade the legal standard. He added that if you’re not doing that in an adequate amount, you lose your exemption.
Jobs Rebuttal
The rebuttal from hospitals is rooted in economics --namely jobs. The Illinois jobless rate in July was 9.5 percent, above the national average of 9.1 percent, and the hospital association said its members provide more to their communities than can be measured by charity care.
Some lawmakers are pushing for a more clearly defined standard. State Senator Iris Martinez, a Chicago Democrat, proposed that hospitals devote 3 1/2 percent of their patient load to charity care as a requirement to receive the tax break. She said the situation cries out for clarity.
Martinez said you have some hospitals that are making big revenues and not doing charity care with billions in revenues without charity.
The hospital association rejects a specific amount and opposes Martinez’s bill, which remains bottled up in a committee.
Hospitals Waiting
Other hospitals are awaiting a decision from the state on their tax- exempt status. Mark Rossi, chief operating officer of Hopedale Medical Complex in Bloomington, said the uncertainty forced the hospital to shelve a $23 million construction bond sale.
Rossi said they were in the process of designing a brand-new hospital, and then this thing happened.If the hospital doesn’t get a tax exemption on the land on which the facility would be built, the annual tax liability would be about $400,000 annually, Rossi said. He said that matches their profits.
At the Midwest Medical Center in Galena, a new $45.5 million replacement hospital would be hit with a $2.3 million total obligation if the facility lost its exemption. Construction for the addition began before the Provena decision.
With high unemployment and governments struggling to provide services, the pressure will build for Illinois lawmakers to broker a compromise that would preserve tax exemptions while boosting charity care, Colombo said.
More than a dozen hospitals in Illinois face the prospect of paying millions of dollars in property taxes or, in some cases, shutting down as a result of a state ruling denying exemptions for three nonprofit healthcare providers, according to a ESOP Lawyer.
The uncertainty has prompted at least one hospital to postpone a $23 million construction bond sale while several others that built facilities say they won’t be able to pay the bill if they lose the break.
Tracy Bauer, chief executive officer of Midwest Medical Center in Galena, a 25-bed hospital that is on the hook for a $2.3 million property tax bill if its nonprofit exemption is revoked said they will go out of business without it.
The challenge to such exemptions comes as Illinois confronts two financial stresses -- the state’s $8 billion in unpaid bills and hospitals struggling with cuts in Medicare and Medicaid payments.
While other states have battled for decades in court over the obligation to treat the poor in exchange for tax breaks, Illinois intensified the fight on Aug. 16 when its Revenue Department denied exemptions for facilities in Chicago, Naperville and Decatur, saying they provided too little charity care.
Windfall for Schools
A reversal of the exemptions would represent a windfall for school districts, which collect the lion’s share of property taxes and have watched state aid shrink and revenue fall during the economic and housing slide.
Pat Schou, executive director of the Illinois Critical Access Hospital Network said there are school districts that are so hungry for this money that there’s a tug and pull in these communities.
The lobbying group for the state’s towns and cities supports the decision to collect the money.
Larry Frang, executive director of the Illinois Municipal League said in a perfect world, everybody ought to pay property taxes.
This is a fight with roots that go back centuries, when the fear of God persuaded governments not to tax churches because they worried about getting struck down by a lightning bolt, Colombo said. Many hospitals gained exemptions because of their religious affiliation or care for the indigent.
‘Poorhouses’ No More
Colombo said hospitals aren’t poorhouses anymore, and that just because they were exempt in 1900 doesn’t mean they should be exempt in 2011.
The Illinois Revenue Department is to rule in the coming months on the tax-exemption status of 15 hospital groups involving hundreds of parcels of property, said spokeswoman Susan Hofer. The Illinois Hospital Association, the industry’s lobbying arm, has asked for a moratorium on decisions until a legislative solution can be worked out, said Danny Chun, a spokesman.
There are no clear statutory guidelines, though the Illinois constitution and a 2010 state Supreme Court ruling provide guidance.
The constitution states that exemptions can be granted when property is used exclusively for charitable purposes.
High Court Ruling
The state’s highest court used that standard in a case involving an Urbana hospital, Provena Covenant Medical Center, which challenged the state’s denial of tax-exempt status. In a March 18, 2010 ruling, the court noted that a mere 302 of the hospital’s 110,000 patients received free care in 2002. Provena failed to meet its burden that the hospital was used exclusively for charitable purposes, the court said.
Although the decision’s immediate impact was confined to Provena, it put other nonprofits on notice. About 75 percent of hospitals in Illinois are nonprofits, according to a 2009 report from the Chicago- based Center for Tax and Budget Accountability.
The center reported that in metropolitan Chicago nonprofit hospitals received $489.5 million in tax exemptions and delivered charity care valued at $175.7 million.
Ralph Martire, executive director of the center, said for the most part, hospitals are very good members of the community, but that doesn’t mean you evade the legal standard. He added that if you’re not doing that in an adequate amount, you lose your exemption.
Jobs Rebuttal
The rebuttal from hospitals is rooted in economics --namely jobs. The Illinois jobless rate in July was 9.5 percent, above the national average of 9.1 percent, and the hospital association said its members provide more to their communities than can be measured by charity care.
Some lawmakers are pushing for a more clearly defined standard. State Senator Iris Martinez, a Chicago Democrat, proposed that hospitals devote 3 1/2 percent of their patient load to charity care as a requirement to receive the tax break. She said the situation cries out for clarity.
Martinez said you have some hospitals that are making big revenues and not doing charity care with billions in revenues without charity.
The hospital association rejects a specific amount and opposes Martinez’s bill, which remains bottled up in a committee.
Hospitals Waiting
Other hospitals are awaiting a decision from the state on their tax- exempt status. Mark Rossi, chief operating officer of Hopedale Medical Complex in Bloomington, said the uncertainty forced the hospital to shelve a $23 million construction bond sale.
Rossi said they were in the process of designing a brand-new hospital, and then this thing happened.If the hospital doesn’t get a tax exemption on the land on which the facility would be built, the annual tax liability would be about $400,000 annually, Rossi said. He said that matches their profits.
At the Midwest Medical Center in Galena, a new $45.5 million replacement hospital would be hit with a $2.3 million total obligation if the facility lost its exemption. Construction for the addition began before the Provena decision.
With high unemployment and governments struggling to provide services, the pressure will build for Illinois lawmakers to broker a compromise that would preserve tax exemptions while boosting charity care, Colombo said.
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