Though Texas will join 26 other states in defaulting to a federal marketplace for purchasing health insurance — a major component of the Affordable Care Act — it is one of only six that will not enforce new health insurance reforms prescribed by the law. It's a decision some say could lead to confusion over who's responsible for protecting Texas insurance consumers.
Because Texas did not create its own state-based marketplace, known as a health insurance exchange, under the Affordable Care Act, it must use a federally facilitated one instead. By federal law, the state must enforce provisions and regulations related to the insurance exchange and market reforms unless it notifies the federal government that it cannot or will not. If a state does not enforce those reforms, the federal Centers for Medicare and Medicaid Services will step in to do it.
Texas, Arizona, Alabama, Missouri, Oklahoma and Wyoming have all notified the federal government that they will not be policing the health law. John Greeley, a spokesman for the Texas Department of Insurance, said his agency cannot enforce regulations tied to the federal insurance exchange or market reforms because it is not authorized to do so.
"We can't act on anything that doesn't exist in state law," he said.
Officials with CMS, who sent a letter to TDI acknowledging the state's decision, declined to comment for this story.
Stacey Pogue, a health policy analyst with the liberal Center for Public Policy Priorities, said she doesn't believe TDI's hands are tied. In the past, she said, the agency has responded to federal laws by "taking actions that ensure that they do have oversight."
The practical effects of the state's decision are not entirely clear yet. In the first show of autonomy, Texas was not required to comply with a federal request for information about its insurance plans. Most states defaulting to the federal health insurance exchange had to submit that information by July 31.
In the states that will not enforce the exchange and market reforms, the federal government will have to review insurance forms and respond to consumer complaints about health insurance, said Kevin Lucia, an assistant research professor with the Georgetown University Health Policy Institute’s Center on Health Insurance Reforms. Those duties, he added, are “typically reserved for state insurance departments.”
Pogue said the state's decision could create an “administrative burden” for insurance plans and could result in confusion for Texans who purchase health insurance under the federal exchange. For instance, she said, if people worry their insurance providers are discriminating against them based on their gender — a practice banned by the federal reforms — they may not know whether to report a complaint to CMS or to TDI.
“There’s all this opportunity to be bounced back and forth, which is a burden for consumers,” she said. If consumers have to report insurance violations to the federal government, that could prevent TDI from having a complete picture of consumers’ experience with insurance providers, she added.
“Consumers can be experiencing a lot of problems on the market that the state regulator doesn’t know about,” Pogue said.
Greeley said TDI has worked to make sure “insurers understand what their responsibilities are” under the ACA. And he said even if the state does not enforce federal regulations, TDI will still work to protect insurance consumers.
“Anybody that buys an insurance policy in Texas — no matter what line or how they got to it — can come to the Texas Department of Insurance for their questions,” he said.
David Gonzales, executive director of the Texas Association of Health Plans, said it’s unclear what impact the state's decision could have on insurance companies.
“I suspect it will be more of a burden for some plans than for others,” he said.
Pogue said inefficiencies could stem from the state’s refusal to enforce insurance reforms. TDI is the agency best equipped to regulate insurance plans in Texas, she said.
“Without a doubt they are the appropriate body,” she said.
_____________________________________
Source: Texas Tribune (Luthra, 8/07)
Monday, August 12, 2013
Monday, August 5, 2013
Warrant issued for bar patron in fatal DWI
Montgomery County officials issued an arrest warrant for a man who allegedly gave drinks to an already intoxicated 24-year-old Nicole Baukus before she drove away from a bar and caused a fatal accident.
Baukus, who pleaded guilty Thursday to two counts of intoxication manslaughter and one count of intoxication assault in the July 29, 2012, accident, was sentenced Friday to 38 years in prison.
After a night of drinking at a bar then called On the Rox, Baukus drove her pickup the wrong way on Interstate 45, colliding head-on around 2:50 a.m. with a Chevrolet Aveo near FM 242. The crash killed Nicole Adams, 19, and Travis Saunders, 18, and injured David Porras, now 23.
As an outgrowth of the trial, a warrant was issued Friday for Kambiz Michael Duran, 29, who is in the Harris County Jail after pleading guilty last month to possession of marijuana. On July 10, he was sentenced to 180 days in a state jail.
Harris County online records show that a hold from Montgomery County was placed on the Spring resident Friday, meaning that before Duran is freed, Montgomery County will have the opportunity to detain him.
Duran, a fellow bar patron, was seen on surveillance video giving Baukus a few drinks toward the end of the night, but authorities didn't know his identity, said Assistant District Attorney Warren Diepraam, co-prosecutor for the case.
"We could see him giving her drinks in the video but nobody would identify him," Diepraam said. "It was only during the trial when witnesses started testifying (that we learned his name)."
The same statute that makes it illegal to sell drinks to an intoxicated person also prohibits giving alcohol to someone who has already consumed too much, Diepraam explained.
On the Rox was cited for over-serving a customer and had its license suspended from Feb. 27 to March 28, according to the TABC. Since then, the bar's insurance company has agreed to a $1 million settlement for over-serving a patron.
The money is to be divided among Porras and the estates of Adams and Saunders.
Oscar Williams, a Texas Alcoholic Beverage Commission agent based in Conroe, testified during the trial that Baukus drank 17 shots and four beers. Most of the shots were a mix of bourbon, Red Bull and either peach schnapps or watermelon schnapps, William said.
Baukus and Duran apparently ran into each other at the bar, rather than arriving together, Diepraam said. He said he didn't know if the two were acquainted previously.
The bar is now known as the Flying Pug Sports Pub, according to the alcoholic beverage commission.
_______________________________________
Source: Chron (Christian, 8/03)
Baukus, who pleaded guilty Thursday to two counts of intoxication manslaughter and one count of intoxication assault in the July 29, 2012, accident, was sentenced Friday to 38 years in prison.
After a night of drinking at a bar then called On the Rox, Baukus drove her pickup the wrong way on Interstate 45, colliding head-on around 2:50 a.m. with a Chevrolet Aveo near FM 242. The crash killed Nicole Adams, 19, and Travis Saunders, 18, and injured David Porras, now 23.
As an outgrowth of the trial, a warrant was issued Friday for Kambiz Michael Duran, 29, who is in the Harris County Jail after pleading guilty last month to possession of marijuana. On July 10, he was sentenced to 180 days in a state jail.
Harris County online records show that a hold from Montgomery County was placed on the Spring resident Friday, meaning that before Duran is freed, Montgomery County will have the opportunity to detain him.
Duran, a fellow bar patron, was seen on surveillance video giving Baukus a few drinks toward the end of the night, but authorities didn't know his identity, said Assistant District Attorney Warren Diepraam, co-prosecutor for the case.
"We could see him giving her drinks in the video but nobody would identify him," Diepraam said. "It was only during the trial when witnesses started testifying (that we learned his name)."
The same statute that makes it illegal to sell drinks to an intoxicated person also prohibits giving alcohol to someone who has already consumed too much, Diepraam explained.
On the Rox was cited for over-serving a customer and had its license suspended from Feb. 27 to March 28, according to the TABC. Since then, the bar's insurance company has agreed to a $1 million settlement for over-serving a patron.
The money is to be divided among Porras and the estates of Adams and Saunders.
Oscar Williams, a Texas Alcoholic Beverage Commission agent based in Conroe, testified during the trial that Baukus drank 17 shots and four beers. Most of the shots were a mix of bourbon, Red Bull and either peach schnapps or watermelon schnapps, William said.
Baukus and Duran apparently ran into each other at the bar, rather than arriving together, Diepraam said. He said he didn't know if the two were acquainted previously.
The bar is now known as the Flying Pug Sports Pub, according to the alcoholic beverage commission.
_______________________________________
Source: Chron (Christian, 8/03)
Monday, July 29, 2013
Car Insurance Rates Are Higher Based On Education, Report Says
People may be paying higher auto insurance rates if they didn’t go to college or work blue-collar jobs, according to a new report from the Consumer Federation of America (CFA)
The CFA found major auto insurance companies like GEICO, Farmers, Liberty Mutual, and Progressive charge higher rates from drivers who only have a high school diploma or a lower-status job.
Liberty Mutual, for example, charges a high school graduate 10 to 13 percent more that a college graduate, according to the report.
Companies must be doing this for a reason, but the CFA doesn’t offer any. It is unclear how education and occupation affects the level of risk involved when driving a car. Do people with less education or lower-level jobs get into more accidents? If that’s the case, then why don’t other companies like Travelers, USAA, State Farm, and Allstate use education or work status to calculate their rates? There could be a trade-off, like taking into consideration claim history, credit score, and whether the company also insures your house, business, etc., instead.
A 2012 survey showed the majority of American consumers believes using occupation or education to set rates is unfair.
CFA says it is working to stop the discriminatory factors used in calculating auto insurance premiums. The group seems to assert that giving auto quotes based on occupation is akin to a quote based on race.
“The American public knows that it is unfair for auto insurers to use factors like education and occupation in setting rates,” said J. Robert Hunter, CFA’s Director of Insurance, a former Texas Insurance Commissioner and former Federal Insurance Administrator. “In effect, auto insurers are discriminating on the basis of income and race. States should prohibit the use of these demographic factors that bear no logical relation to insurer risk.”
__________________________________
Source: Opposing Views (Fruchtnicht, 7/28)
The CFA found major auto insurance companies like GEICO, Farmers, Liberty Mutual, and Progressive charge higher rates from drivers who only have a high school diploma or a lower-status job.
Liberty Mutual, for example, charges a high school graduate 10 to 13 percent more that a college graduate, according to the report.
Companies must be doing this for a reason, but the CFA doesn’t offer any. It is unclear how education and occupation affects the level of risk involved when driving a car. Do people with less education or lower-level jobs get into more accidents? If that’s the case, then why don’t other companies like Travelers, USAA, State Farm, and Allstate use education or work status to calculate their rates? There could be a trade-off, like taking into consideration claim history, credit score, and whether the company also insures your house, business, etc., instead.
A 2012 survey showed the majority of American consumers believes using occupation or education to set rates is unfair.
CFA says it is working to stop the discriminatory factors used in calculating auto insurance premiums. The group seems to assert that giving auto quotes based on occupation is akin to a quote based on race.
“The American public knows that it is unfair for auto insurers to use factors like education and occupation in setting rates,” said J. Robert Hunter, CFA’s Director of Insurance, a former Texas Insurance Commissioner and former Federal Insurance Administrator. “In effect, auto insurers are discriminating on the basis of income and race. States should prohibit the use of these demographic factors that bear no logical relation to insurer risk.”
__________________________________
Source: Opposing Views (Fruchtnicht, 7/28)
Friday, July 26, 2013
Elder abuse claim adds new liability risk for doctors
A physician who allegedly failed to refer a patient to a specialist can be liable for elder abuse, a California appeals court has ruled. The decision by the Court of Appeal for the State of California, 2nd Appellate District, said doctors can be sued for elder abuse for their outpatient treatment of seniors, regardless of whether they had “custodial obligations” to the patient.
Legal experts say the ruling broadens liability for doctors who treat older patients and exposes them to additional legal penalties when negligence claims arise. Plaintiff attorneys in states with similar elder abuse laws probably will use the California ruling as fuel to expand physician liability in their jurisdictions, legal analysts said.
“This is going to open the door for medical malpractice plaintiffs over the age of 65 to start pleading elder abuse in addition to medical malpractice,” said attorney Cassidy C. Davenport, who represents Pioneer Medical Group, the defendant in the case. “This is going to allow them to circumvent tort reform statutes” since elder abuse is not included in such medical liability reforms.
In the California case, Elizabeth Cox, 83, began receiving care at Pioneer Medical Group in Cerritos in about 2000, according to court documents. Several health professionals treated her for onychomycosis, which limits mobility and indirectly impairs peripheral circulation.
In 2007, Cox’s vascular issues worsened, and a Pioneer family physician diagnosed her with peripheral vascular disease, according to court documents. The patient’s condition continued to deteriorate, and she visited Pioneer Medical Group at least seven more times during the next two years complaining of various aliments associated with peripheral vascular disease. She was admitted to a hospital with gangrene in 2009, and her right leg was amputated. She died from blood poisoning in 2010, court documents say.
In 2011, Cox’s daughters sued Pioneer Medical Group and several staff members for elder abuse. The plaintiffs said the medical group’s continued failure not to refer Cox to a vascular specialist constituted abuse and neglect.
The medical group contended it was not liable for elder abuse because doctors treated Cox as an outpatient, and liability for elder abuse “requires assumption of custodial obligations.” The group argued the alleged conduct constituted only professional negligence and not the “reckless neglect” required for an elder abuse claim. A lower court ruled in favor of Pioneer, throwing out the case.
Appeals judges reversed. They sent the case back to the lower court, allowing the elder abuse claim to move forward against Pioneer Medical Group. Whether the defendants’ conduct was reckless is for a jury to decide, the judges said.
“The jury may view defendants failure to refer Mrs. Cox to a vascular specialist as deliberate indifference to her increasingly urgent medical needs without regard for the excessive risk to which they exposed her by their failure to seek appropriate specialized care,” the May 24 opinion said.
Pioneer Medical Group in July asked the California Supreme Court to review the decision. At this article’s deadline, the court had not said whether it would accept the case.
Investigations stem from adult protective laws
The California Medical Assn. was disappointed with the decision, saying it blurs the lines between conduct that falls under the state’s Medical Injury Compensation Reform Act and the Elder Abuse Act. The CMA issued a friend-of-the-court brief in support of Pioneer Medical Group.
“The opinion really will hurt the goals of both MICRA and the Elder Abuse Act,” said Alicia Wagnon, CMA legal counsel. “The facts of this case are so clearly professional negligence. That [these actions] can also be deemed elder abuse is simply wrong, and it really eviscerates MICRA’s definition and the purposes of MICRA.”
All states have some form of adult protective services statutes that authorize and regulate investigation of elder abuse cases. Generally, APS laws establish a system for the reporting and review of elder abuse claims and for the provision of social services to help victims, according to the American Bar Assn.’s Commission on Law and Aging. Most jurisdictions also have separate elder abuse laws that provide for civil or criminal damages in cases of elder abuse and neglect, either by individuals or institutions.
The intent of such laws is to prevent custodians from abusing and taking advantage of elderly patients, Davenport said. She notes the majority of elder abuse claims arise in the nursing home context and involve repeated acts of ignoring an elderly patient’s basic needs such as adequate food and water.
“We have an aging population in nursing homes [who are at risk] for being abused physically and financially,” she said. Elder abuse laws are intended “as an incentive to go after those who are abusing these elders. It wasn’t to say elders get extra incentive to sue the physician for medical malpractice.”
The California ruling confirms that physicians should be held responsible for recklessly failing to provide necessary medical care, said Clay Robbins III, the plaintiffs’ attorney.
“Merely because a person withholding [medical care] also happens to be a physician should not have bearing as to whether that individual should be responsible for the enhanced remedies under the act,” he said.
Jury awards not covered by insurers
The ruling is concerning for physicians who treat elderly patients, said William E. Hopkins, a health law attorney and partner at Brown McCarroll in Texas.
“Physicians are now on notice that they’re not just being judged on a negligence standard; they’re now being judged on negligence and this other standard,” he said. “I would not be surprised if [elder abuse] is pled in most cases where there’s some level of medical negligence with elderly people.”
Hopkins said Texas has an elder abuse law similar to California’s, and that he can foresee a similar case playing out in his state.
“This is the kind of case that certainly will have plaintiffs lawyers’ minds working with regard to, “Is this something I should be pleading?’ ” he said. “They’re going to pull the elder abuse act in their state and see if this kind of argument applies.”
If the decision stands, physicians found liable of elder abuse would be forced to pay jury awards out of pocket, Davenport said. Insurance policies generally do not cover elder abuse claims. Fear of such payments probably would lead to more settlements, she said.
The decision jeopardizes doctors’ professional medical judgment and could negatively affect patient care, said Bret C. Perry, an Ohio medical liability defense attorney who defends physicians, assisted-living facilities and nursing homes.
“The practice of medicine and decisions made on a daily basis by physicians and health care professionals cannot be legislated, and those decisions clearly fall within the purview of professional judgment,” he said in an email. “If this ruling is permitted to stand, I can foresee a chilling effect and negative impact on the future of medical care for the elderly and potentially an exodus of professionals leaving the state due to this type of potential liability.”
______________________________________________
Source: Amed (Gallegos, 7/22)
Legal experts say the ruling broadens liability for doctors who treat older patients and exposes them to additional legal penalties when negligence claims arise. Plaintiff attorneys in states with similar elder abuse laws probably will use the California ruling as fuel to expand physician liability in their jurisdictions, legal analysts said.
“This is going to open the door for medical malpractice plaintiffs over the age of 65 to start pleading elder abuse in addition to medical malpractice,” said attorney Cassidy C. Davenport, who represents Pioneer Medical Group, the defendant in the case. “This is going to allow them to circumvent tort reform statutes” since elder abuse is not included in such medical liability reforms.
In the California case, Elizabeth Cox, 83, began receiving care at Pioneer Medical Group in Cerritos in about 2000, according to court documents. Several health professionals treated her for onychomycosis, which limits mobility and indirectly impairs peripheral circulation.
In 2007, Cox’s vascular issues worsened, and a Pioneer family physician diagnosed her with peripheral vascular disease, according to court documents. The patient’s condition continued to deteriorate, and she visited Pioneer Medical Group at least seven more times during the next two years complaining of various aliments associated with peripheral vascular disease. She was admitted to a hospital with gangrene in 2009, and her right leg was amputated. She died from blood poisoning in 2010, court documents say.
In 2011, Cox’s daughters sued Pioneer Medical Group and several staff members for elder abuse. The plaintiffs said the medical group’s continued failure not to refer Cox to a vascular specialist constituted abuse and neglect.
The medical group contended it was not liable for elder abuse because doctors treated Cox as an outpatient, and liability for elder abuse “requires assumption of custodial obligations.” The group argued the alleged conduct constituted only professional negligence and not the “reckless neglect” required for an elder abuse claim. A lower court ruled in favor of Pioneer, throwing out the case.
Appeals judges reversed. They sent the case back to the lower court, allowing the elder abuse claim to move forward against Pioneer Medical Group. Whether the defendants’ conduct was reckless is for a jury to decide, the judges said.
“The jury may view defendants failure to refer Mrs. Cox to a vascular specialist as deliberate indifference to her increasingly urgent medical needs without regard for the excessive risk to which they exposed her by their failure to seek appropriate specialized care,” the May 24 opinion said.
Pioneer Medical Group in July asked the California Supreme Court to review the decision. At this article’s deadline, the court had not said whether it would accept the case.
Investigations stem from adult protective laws
The California Medical Assn. was disappointed with the decision, saying it blurs the lines between conduct that falls under the state’s Medical Injury Compensation Reform Act and the Elder Abuse Act. The CMA issued a friend-of-the-court brief in support of Pioneer Medical Group.
“The opinion really will hurt the goals of both MICRA and the Elder Abuse Act,” said Alicia Wagnon, CMA legal counsel. “The facts of this case are so clearly professional negligence. That [these actions] can also be deemed elder abuse is simply wrong, and it really eviscerates MICRA’s definition and the purposes of MICRA.”
All states have some form of adult protective services statutes that authorize and regulate investigation of elder abuse cases. Generally, APS laws establish a system for the reporting and review of elder abuse claims and for the provision of social services to help victims, according to the American Bar Assn.’s Commission on Law and Aging. Most jurisdictions also have separate elder abuse laws that provide for civil or criminal damages in cases of elder abuse and neglect, either by individuals or institutions.
The intent of such laws is to prevent custodians from abusing and taking advantage of elderly patients, Davenport said. She notes the majority of elder abuse claims arise in the nursing home context and involve repeated acts of ignoring an elderly patient’s basic needs such as adequate food and water.
“We have an aging population in nursing homes [who are at risk] for being abused physically and financially,” she said. Elder abuse laws are intended “as an incentive to go after those who are abusing these elders. It wasn’t to say elders get extra incentive to sue the physician for medical malpractice.”
The California ruling confirms that physicians should be held responsible for recklessly failing to provide necessary medical care, said Clay Robbins III, the plaintiffs’ attorney.
“Merely because a person withholding [medical care] also happens to be a physician should not have bearing as to whether that individual should be responsible for the enhanced remedies under the act,” he said.
Jury awards not covered by insurers
The ruling is concerning for physicians who treat elderly patients, said William E. Hopkins, a health law attorney and partner at Brown McCarroll in Texas.
“Physicians are now on notice that they’re not just being judged on a negligence standard; they’re now being judged on negligence and this other standard,” he said. “I would not be surprised if [elder abuse] is pled in most cases where there’s some level of medical negligence with elderly people.”
Hopkins said Texas has an elder abuse law similar to California’s, and that he can foresee a similar case playing out in his state.
“This is the kind of case that certainly will have plaintiffs lawyers’ minds working with regard to, “Is this something I should be pleading?’ ” he said. “They’re going to pull the elder abuse act in their state and see if this kind of argument applies.”
If the decision stands, physicians found liable of elder abuse would be forced to pay jury awards out of pocket, Davenport said. Insurance policies generally do not cover elder abuse claims. Fear of such payments probably would lead to more settlements, she said.
The decision jeopardizes doctors’ professional medical judgment and could negatively affect patient care, said Bret C. Perry, an Ohio medical liability defense attorney who defends physicians, assisted-living facilities and nursing homes.
“The practice of medicine and decisions made on a daily basis by physicians and health care professionals cannot be legislated, and those decisions clearly fall within the purview of professional judgment,” he said in an email. “If this ruling is permitted to stand, I can foresee a chilling effect and negative impact on the future of medical care for the elderly and potentially an exodus of professionals leaving the state due to this type of potential liability.”
______________________________________________
Source: Amed (Gallegos, 7/22)
Wednesday, July 17, 2013
Bone-Chilling Mistakes Hospitals Make And Why They Don't Want You To Know
Claire* was detained by security at the airport when the metal detector went off. Guards couldn’t figure out why. Eventually, they let her board the flight, but when she arrived home she immediately asked her doctor to order an X-Ray. The result: There in Claire’s abdomen, clear as day, was a retractor, a surgical instrument the size of a crowbar, somehow left behind from her recent surgery.
This story is not as unusual as we would all hope. Indeed, the story is instructive enough that it appears in the leading textbook on patient safety, “Understanding Patient Safety” by Bob Wachter. There’s even a well-vetted medical term for this kind of error: “foreign objects retained after surgery,” one among many scary mishaps labeled as “serious adverse events.” The Leapfrog Group, my nonprofit which represents employers and other purchasers of healthcare, has another name for these outrageous errors: “never events” – mistakes that should never happen, no excuses. Surgical never events – Claire’s experience, plus some other errors you don’t want to hear about during lunch, occur about 11 times a day, according to a study from Johns Hopkins. There is a host of grisly mishaps known to happen beyond the surgical suite in the walls of a hospital, from excruciating and fully preventable Stage 3 or 4 bedsores to collapsed lungs. When you count all the non-surgical and surgical never events, they happen about 200 times a day to Medicare beneficiaries alone.
Here’s the kicker: Though I don’t know Claire, I bet the offending hospital billed her for the surgery to remove the crowbar. They probably weren’t brazen enough to bill her to replace the missing retractor in the operating room, but stranger things have shown up on hospital bills.
Employers and other purchasers have long been outraged by these astonishing misadventures in hospitals, and they are tired of paying for them. In recent years, they’ve adopted a set of purchasing principles that include refusing to pay for never events and demanding an apology to the patient. It’s amazing that we even needed to establish such guidelines in the first place. But according to the Leapfrog Hospital Survey, while the majority of reporting hospitals committed to adhere to our guidelines, hundreds more refused.
A few years ago, after many battles, Medicare finally started requiring hospitals to publicly report on some of them, including the following nine events:
Foreign object retained after surgery
Air embolism
Pressure ulcers, Stage 3 and 4
Trauma and falls
Collapsed lung due to medical treatment
Breathing failure after surgery
Postoperative PE/DVT (a preventable and often deadly blood clot)
Wound split open after surgery
Accidental cuts or tears from medical treatment
We used these nine measures in our Hospital Safety Scores – letter grades assigned to more than 2,500 general hospitals warning consumers of their propensity for deadly mistakes. We found that some hospitals have many more of these never events than others. And the public deserves to know which hospitals protect patients best.
But the American Hospital Association (AHA) and its lobbyists disagree. They did not want hospital data on these never events, as well as some other terrible measures, publicly reported. They acknowledge these events happen, but they say the government wasn’t measuring them in a way that’s perfectly fair to hospitals.
Purchasers continually fight this effort to suppress reporting. The best-known and most well-respected national coalition of employers, unions and consumer advocates, the Consumer-Purchaser Disclosure Project, pleaded in a letter last year to Secretary of Health and Human Services Kathleen Sebelius, “When it comes to patient safety, we simply cannot afford – in either human or financial terms – to delay or derail progress toward greater transparency and accountability. Nor can we wait until the arrival of perfect measures before addressing patient safety gaps in our health care system.”
The hospital lobbyists nearly won suppression of never events. Last fall, the Centers for Medicare & Medicaid Services (CMS), the agency that runs Medicare, announced they would stop reporting the never events listed above, plus other key measures. However, the agency recently told us they do, indeed, plan to continue reporting these measures, at least through 2013, so we’ll keep working with them to continue the level of transparency the public deserves.
The good news is that the administration has taken steps to identify other measures of patient safety for public reporting and pledges to tie Medicare payment to performance on those measures in the future. These are new measures of infection, errors and accidents. Just last month, CMS put out for public comment a proposed rule to make a number of important new safety measures public.
Last week, the hospital lobby submitted a 58-page comment letter complaining (among other things) that these measures aren’t perfect enough, but consumer and purchaser organizations responded, saying the measures, in fact, meet the requirements of good science and give the public the information we need to protect ourselves and our families.
Our advocates ask for reporting on more critical measures, faster and with more detail. AHA asks for fewer measures, reported later instead of now, and reported in generalities so you can’t discern among hospitals using the data. For instance, Leapfrog wants to end the exemption of Maryland, Puerto Rico and Guam from public reporting. We ask for data to be reported for each and every facility that calls itself a hospital; currently, CMS only reports data by hospital system, and a system can have several hospitals in a wide geographical area. (Patients care about their individual hospital, not what corporate system it belongs to. And we have found major differences among hospitals in the same network).
Meanwhile, before the ink was dry on its letter to CMS complaining about the imperfection of measures and requesting delays, AHA was quick to submit testimony to the Senate about its commitment to public reporting — as long as it’s on its own terms. AHA’s testimony asks for fewer measures to be publicly reported, and although the lack of progress nationally on patient safety is well established, the testimony reports glowing achievements by some of its member hospitals in improving on several important measures of performance. Ironically, the important measures it touts to Congress are among the same ones it tells CMS aren’t good enough for public reporting.
We can only hope for bipartisan common sense to prevail when hospitals ask to suppress information from the public that they themselves use to improve their performance. While we’re hoping for the right response from Congress, consumer and purchaser advocates will need all the support we can get to protect patients — and protect our right to know.
_______________________________________
Source: Forbes (Binder, 7/15)
This story is not as unusual as we would all hope. Indeed, the story is instructive enough that it appears in the leading textbook on patient safety, “Understanding Patient Safety” by Bob Wachter. There’s even a well-vetted medical term for this kind of error: “foreign objects retained after surgery,” one among many scary mishaps labeled as “serious adverse events.” The Leapfrog Group, my nonprofit which represents employers and other purchasers of healthcare, has another name for these outrageous errors: “never events” – mistakes that should never happen, no excuses. Surgical never events – Claire’s experience, plus some other errors you don’t want to hear about during lunch, occur about 11 times a day, according to a study from Johns Hopkins. There is a host of grisly mishaps known to happen beyond the surgical suite in the walls of a hospital, from excruciating and fully preventable Stage 3 or 4 bedsores to collapsed lungs. When you count all the non-surgical and surgical never events, they happen about 200 times a day to Medicare beneficiaries alone.
Here’s the kicker: Though I don’t know Claire, I bet the offending hospital billed her for the surgery to remove the crowbar. They probably weren’t brazen enough to bill her to replace the missing retractor in the operating room, but stranger things have shown up on hospital bills.
Employers and other purchasers have long been outraged by these astonishing misadventures in hospitals, and they are tired of paying for them. In recent years, they’ve adopted a set of purchasing principles that include refusing to pay for never events and demanding an apology to the patient. It’s amazing that we even needed to establish such guidelines in the first place. But according to the Leapfrog Hospital Survey, while the majority of reporting hospitals committed to adhere to our guidelines, hundreds more refused.
A few years ago, after many battles, Medicare finally started requiring hospitals to publicly report on some of them, including the following nine events:
Foreign object retained after surgery
Air embolism
Pressure ulcers, Stage 3 and 4
Trauma and falls
Collapsed lung due to medical treatment
Breathing failure after surgery
Postoperative PE/DVT (a preventable and often deadly blood clot)
Wound split open after surgery
Accidental cuts or tears from medical treatment
We used these nine measures in our Hospital Safety Scores – letter grades assigned to more than 2,500 general hospitals warning consumers of their propensity for deadly mistakes. We found that some hospitals have many more of these never events than others. And the public deserves to know which hospitals protect patients best.
But the American Hospital Association (AHA) and its lobbyists disagree. They did not want hospital data on these never events, as well as some other terrible measures, publicly reported. They acknowledge these events happen, but they say the government wasn’t measuring them in a way that’s perfectly fair to hospitals.
Purchasers continually fight this effort to suppress reporting. The best-known and most well-respected national coalition of employers, unions and consumer advocates, the Consumer-Purchaser Disclosure Project, pleaded in a letter last year to Secretary of Health and Human Services Kathleen Sebelius, “When it comes to patient safety, we simply cannot afford – in either human or financial terms – to delay or derail progress toward greater transparency and accountability. Nor can we wait until the arrival of perfect measures before addressing patient safety gaps in our health care system.”
The hospital lobbyists nearly won suppression of never events. Last fall, the Centers for Medicare & Medicaid Services (CMS), the agency that runs Medicare, announced they would stop reporting the never events listed above, plus other key measures. However, the agency recently told us they do, indeed, plan to continue reporting these measures, at least through 2013, so we’ll keep working with them to continue the level of transparency the public deserves.
The good news is that the administration has taken steps to identify other measures of patient safety for public reporting and pledges to tie Medicare payment to performance on those measures in the future. These are new measures of infection, errors and accidents. Just last month, CMS put out for public comment a proposed rule to make a number of important new safety measures public.
Last week, the hospital lobby submitted a 58-page comment letter complaining (among other things) that these measures aren’t perfect enough, but consumer and purchaser organizations responded, saying the measures, in fact, meet the requirements of good science and give the public the information we need to protect ourselves and our families.
Our advocates ask for reporting on more critical measures, faster and with more detail. AHA asks for fewer measures, reported later instead of now, and reported in generalities so you can’t discern among hospitals using the data. For instance, Leapfrog wants to end the exemption of Maryland, Puerto Rico and Guam from public reporting. We ask for data to be reported for each and every facility that calls itself a hospital; currently, CMS only reports data by hospital system, and a system can have several hospitals in a wide geographical area. (Patients care about their individual hospital, not what corporate system it belongs to. And we have found major differences among hospitals in the same network).
Meanwhile, before the ink was dry on its letter to CMS complaining about the imperfection of measures and requesting delays, AHA was quick to submit testimony to the Senate about its commitment to public reporting — as long as it’s on its own terms. AHA’s testimony asks for fewer measures to be publicly reported, and although the lack of progress nationally on patient safety is well established, the testimony reports glowing achievements by some of its member hospitals in improving on several important measures of performance. Ironically, the important measures it touts to Congress are among the same ones it tells CMS aren’t good enough for public reporting.
We can only hope for bipartisan common sense to prevail when hospitals ask to suppress information from the public that they themselves use to improve their performance. While we’re hoping for the right response from Congress, consumer and purchaser advocates will need all the support we can get to protect patients — and protect our right to know.
_______________________________________
Source: Forbes (Binder, 7/15)
Thursday, July 11, 2013
FDA reconsiders generic drug warning labels
In a recent post, I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win compensation from the manufacturer if they can show the drug was unreasonably dangerous or that its warning label didn't disclose the risks properly. But those injured by a generic medicine can't hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.
The Food and Drug Administration has been considering changes to its labeling rules aimed at giving generic drug users more protection. And last week, the Obama administration filed notice that the FDA's efforts are coming closer to bearing fruit.
According to the notice, the FDA is working on a rule that would "revise and clarify procedures for changes to the labeling" of approved drugs, whether they be name brand names, generics or biologics. The change would either enable or require -- it's not clear from the limited information released by the FDA -- drug makers to make public possible changes to their warnings while the FDA was considering them. And it would make clear that both the brand-name and the generic versions of the drug would have to change their warning labels in the event that the FDA acted on a proposed change emanating from either camp.
The FDA is expected to formally propose its new rule sometime in September.
At issue is something called a "changes being effected" supplement. When drug makers learn of adverse reactions to their products or have new reasons to doubt the adequacy of their warning labels, they're obligated to inform the FDA. The makers of brand-name drugs can seek approval for new warnings and are allowed to alert the public about such developments through a "changes being effected" supplement before the FDA acts.
Generic drug makers aren't allowed to do that, however, even though they are required to tell the FDA about new evidence that might demand a change in their warning labels. They have to wait until the FDA formally decides that the warning label for that drug -- and its brand-name counterparts -- must be changed. If the brand-name version is no longer being marketed, the FDA has some flexibility to work with the makers of generic versions to update their labels, a spokeswoman for the FDA said.
The notice filed Wednesday says the FDA's new rules "would create parity" between brand-name and generic drug makers "with respect to submission of [changes being effected] labeling supplements." That strongly suggests generic drug makers would be able to make unilateral changes to their warning labels too.
The implication of the new rule is that it would reopen the door to lawsuits by such victims as Karen Bartlett, who was disfigured and nearly blinded by an adverse reaction to a generic anti-inflammatory drug. The Supreme Court overturned a New Hampshire jury's decision to award Bartlett $21 million, saying that as long as the drug manufacturer complied with federal requirements to use the same formulation and warning label as the brand-name product, it could not be held liable under New Hampshire law for selling an unreasonably dangerous drug. Justice Samuel A. Alito Jr. said the state law put generic drug makers in an impossible bind because the only way they could avoid liability for products that prove to be unreasonably dangerous would be to change the warning labels that federal law forbids them to alter.
The FDA's new approach, however, may permit generic drug makers to give supplemental warnings about new or heightened risks before the agency formally approves changes to the label for the brand-name and generic versions of the drug. That, in turn, would invite lawyers for injured patients to argue in court that generic drugs were unreasonably dangerous if they could have carried such an extra warning but didn't.
The trade association for generic drug makers sounded a cautious note about the FDA's minimally detailed proposal. "Our members have a long history of working closely with FDA to ensure that Americans have access to safe, affordable generic medicines, and we look forward to working with FDA on this important issue," said Ralph G. Neas, head of the Generic Pharmaceutical Assn.
____________________________________________
Source: Opinio L.A. (Healey, 7/08)
The Food and Drug Administration has been considering changes to its labeling rules aimed at giving generic drug users more protection. And last week, the Obama administration filed notice that the FDA's efforts are coming closer to bearing fruit.
According to the notice, the FDA is working on a rule that would "revise and clarify procedures for changes to the labeling" of approved drugs, whether they be name brand names, generics or biologics. The change would either enable or require -- it's not clear from the limited information released by the FDA -- drug makers to make public possible changes to their warnings while the FDA was considering them. And it would make clear that both the brand-name and the generic versions of the drug would have to change their warning labels in the event that the FDA acted on a proposed change emanating from either camp.
The FDA is expected to formally propose its new rule sometime in September.
At issue is something called a "changes being effected" supplement. When drug makers learn of adverse reactions to their products or have new reasons to doubt the adequacy of their warning labels, they're obligated to inform the FDA. The makers of brand-name drugs can seek approval for new warnings and are allowed to alert the public about such developments through a "changes being effected" supplement before the FDA acts.
Generic drug makers aren't allowed to do that, however, even though they are required to tell the FDA about new evidence that might demand a change in their warning labels. They have to wait until the FDA formally decides that the warning label for that drug -- and its brand-name counterparts -- must be changed. If the brand-name version is no longer being marketed, the FDA has some flexibility to work with the makers of generic versions to update their labels, a spokeswoman for the FDA said.
The notice filed Wednesday says the FDA's new rules "would create parity" between brand-name and generic drug makers "with respect to submission of [changes being effected] labeling supplements." That strongly suggests generic drug makers would be able to make unilateral changes to their warning labels too.
The implication of the new rule is that it would reopen the door to lawsuits by such victims as Karen Bartlett, who was disfigured and nearly blinded by an adverse reaction to a generic anti-inflammatory drug. The Supreme Court overturned a New Hampshire jury's decision to award Bartlett $21 million, saying that as long as the drug manufacturer complied with federal requirements to use the same formulation and warning label as the brand-name product, it could not be held liable under New Hampshire law for selling an unreasonably dangerous drug. Justice Samuel A. Alito Jr. said the state law put generic drug makers in an impossible bind because the only way they could avoid liability for products that prove to be unreasonably dangerous would be to change the warning labels that federal law forbids them to alter.
The FDA's new approach, however, may permit generic drug makers to give supplemental warnings about new or heightened risks before the agency formally approves changes to the label for the brand-name and generic versions of the drug. That, in turn, would invite lawyers for injured patients to argue in court that generic drugs were unreasonably dangerous if they could have carried such an extra warning but didn't.
The trade association for generic drug makers sounded a cautious note about the FDA's minimally detailed proposal. "Our members have a long history of working closely with FDA to ensure that Americans have access to safe, affordable generic medicines, and we look forward to working with FDA on this important issue," said Ralph G. Neas, head of the Generic Pharmaceutical Assn.
____________________________________________
Source: Opinio L.A. (Healey, 7/08)
Monday, July 8, 2013
The human cost of drunk driving in Texas
Approximately every 20 minutes, there is an alcohol-related car crash in Texas. Each one of the 1,170 deaths caused by drunk driving in Texas last year were represented by an individual flag in front of the Gerald D. Hines Waterfall by Williams Tower Wednesday, June 26, as the Texas Department of Transportation held a press conference announcing the launch of facesofdrunkdriving.com, a website that shares the stories of more than a dozen people whose lives and families were irreparably altered by a person who chose to get behind the wheel after consuming alcohol, as well as the agency’s support of the “no refusal” activities conducted by law enforcement across the state this holiday weekend.
“There were more than 25,000 alcohol-related crashes in our state in 2012,” said TxDot Spokeswoman Raquelle Lewis during opening remarks. “The numbers alone can’t describe the impact of these crashes on individuals and their families.”
Dennis Pennywell was the first to speak after Lewis, accompanied to the podium by his wife Kae and son Jack. The Pennywells know the toll that drunk driving takes on families as well as anyone. On June 25, 2011, 20-year-old Aaron Pennywell was driving home through Cypress from a late-night dinner at Whataburger when a drunk driver with a blood .241 alcohol level — over three times the legal limit — slammed into his car. The drunk driver survived; Aaron did not.
The totaled Mustang Aaron was driving that night was on display in front of Williams tower, serving as a grim reminder of drunk driving’s dire consequences.
Since investigators couldn’t conclusively determine who ran the red light where the crash occurred, Michael Giacona, the drunk driver, received only about 90 days in jail for a second offense DWI charge. He received shock probation on the condition that he spend four consecutive Saturdays on a street corner bearing a sign stating, “I killed Aaron Coy Pennywell while driving drunk.” After one Saturday, Giacona argued that holding the sign put his personal safety at risk, and the judge remanded him back to jail. After another few days he was released, Pennywell said.
“The truth is though, he’ll have to live with knowing that he killed an innocent young man because of driving drunk,” Pennywell said. “As a result of the crash, we had to immediately organize and pay for a funeral, something a parent shouldn’t have to do. There is enough disease and enough other reasons for parents to have to bury their child; drunk driving is 100 percent preventable. We had to learn a whole lot more about our justice system than we ever cared to know. We’ve spent a lot more time in the courthouse than we ever cared to spend. And we have to see that empty space at special occasions — Christmas, Thanksgiving, Fourth of July, birthdays — Aaron’s not there, it’s an empty chair.”
Will Womble, chair of the Mothers Against Drunk Drivers (MADD) Houston chapter, took the podium to praise the benefits of the “no-refusal weekend” a program that gives law enforcement the authority to force suspected drunk drivers to submit to intravenous blood-alcohol testing if they refuse a breathalyzer.
“MADD supports the no refusal program,” Womble said, “and is proud to say that statistics show that over the last few years with the incorporation of no refusal programs in and around our community, the effects of drunk driving have gone down.”
Harris County Sheriff Adrian Garcia spoke next, flanked on both sides by deputies to accentuate the point that the crime of drunk driving is taken extremely seriously by his office. He said his staff will be on the lookout this holiday weekend, as well as year-round, for anyone unwilling to abstain from alcohol consumption before operating a vehicle.
“We have a jail cell ready for you if … you’re too proud to have a designated driver,” Garcia said. “We have plenty of designated drivers at the Harris County Sheriff’s Office to drive you to jail. And we will. Because the faces of drunk driving can’t be made any more clear than what you heard from the Pennywell family [or] from the fact the MADD had to come into existence.”
HPD Capt. Larry Baimbridge expanded upon Garcia’s remarks, elaborating on the activities of HPD traffic enforcement division officers whose sole target are drunk drivers.
“These guys are tasked with looking for, detecting and arresting drunk drivers,” Baimbridge said. “That’s their sole job, that’s their sole goal in the Houston Police Department … and they do a very good job of it. So the message here is clear: drive sober, find a safe ride home. It’s simply not worth the risk.”
Jeff Kaufman, the Houston-Galveston Area Council’s transportation program coordinator, told those in attendance how H-GAC received a step grant for smaller law enforcement agencies in the area to qualify for funding to conduct their own drunk driving enforcement efforts, a task force which Kaufman said has now grown to 15 agencies.
“As of Memorial Day weekend, we’ve conducted three waves,” Kaufman said. “This is a pilot project, this is something that hasn’t been done regionally or for the state, but we’ve made 115 arrests for suspected DWIs over these three weekends. DWI is easily avoidable, just don’t’ drink and drive. Get a designated driver, don’t overdo the celebration, just be responsible. Because it’s really not worth risking other people’s lives, it’s not worth risking time in jail.”
Though the efforts of these different agencies won’t bring back Aaron Pennywell — whose story is one of many on facesofdrunkdriving.com — his parents are hoping that by relating the senseless and tragic nature of their eldest son’s death, at least something positive will come from the abrupt end to Aaron’s life.
“Mainly it’s to tell these [people to] make choices when you are going to drink,” Kae Pennywell told Houston Community Newspapers. “Get a cab, call a friend to come pick you up, sleep it off, have a designated driver.
_________________________________________
Source: The Rancher (Haverkamp, 7/2)
“There were more than 25,000 alcohol-related crashes in our state in 2012,” said TxDot Spokeswoman Raquelle Lewis during opening remarks. “The numbers alone can’t describe the impact of these crashes on individuals and their families.”
Dennis Pennywell was the first to speak after Lewis, accompanied to the podium by his wife Kae and son Jack. The Pennywells know the toll that drunk driving takes on families as well as anyone. On June 25, 2011, 20-year-old Aaron Pennywell was driving home through Cypress from a late-night dinner at Whataburger when a drunk driver with a blood .241 alcohol level — over three times the legal limit — slammed into his car. The drunk driver survived; Aaron did not.
The totaled Mustang Aaron was driving that night was on display in front of Williams tower, serving as a grim reminder of drunk driving’s dire consequences.
Since investigators couldn’t conclusively determine who ran the red light where the crash occurred, Michael Giacona, the drunk driver, received only about 90 days in jail for a second offense DWI charge. He received shock probation on the condition that he spend four consecutive Saturdays on a street corner bearing a sign stating, “I killed Aaron Coy Pennywell while driving drunk.” After one Saturday, Giacona argued that holding the sign put his personal safety at risk, and the judge remanded him back to jail. After another few days he was released, Pennywell said.
“The truth is though, he’ll have to live with knowing that he killed an innocent young man because of driving drunk,” Pennywell said. “As a result of the crash, we had to immediately organize and pay for a funeral, something a parent shouldn’t have to do. There is enough disease and enough other reasons for parents to have to bury their child; drunk driving is 100 percent preventable. We had to learn a whole lot more about our justice system than we ever cared to know. We’ve spent a lot more time in the courthouse than we ever cared to spend. And we have to see that empty space at special occasions — Christmas, Thanksgiving, Fourth of July, birthdays — Aaron’s not there, it’s an empty chair.”
Will Womble, chair of the Mothers Against Drunk Drivers (MADD) Houston chapter, took the podium to praise the benefits of the “no-refusal weekend” a program that gives law enforcement the authority to force suspected drunk drivers to submit to intravenous blood-alcohol testing if they refuse a breathalyzer.
“MADD supports the no refusal program,” Womble said, “and is proud to say that statistics show that over the last few years with the incorporation of no refusal programs in and around our community, the effects of drunk driving have gone down.”
Harris County Sheriff Adrian Garcia spoke next, flanked on both sides by deputies to accentuate the point that the crime of drunk driving is taken extremely seriously by his office. He said his staff will be on the lookout this holiday weekend, as well as year-round, for anyone unwilling to abstain from alcohol consumption before operating a vehicle.
“We have a jail cell ready for you if … you’re too proud to have a designated driver,” Garcia said. “We have plenty of designated drivers at the Harris County Sheriff’s Office to drive you to jail. And we will. Because the faces of drunk driving can’t be made any more clear than what you heard from the Pennywell family [or] from the fact the MADD had to come into existence.”
HPD Capt. Larry Baimbridge expanded upon Garcia’s remarks, elaborating on the activities of HPD traffic enforcement division officers whose sole target are drunk drivers.
“These guys are tasked with looking for, detecting and arresting drunk drivers,” Baimbridge said. “That’s their sole job, that’s their sole goal in the Houston Police Department … and they do a very good job of it. So the message here is clear: drive sober, find a safe ride home. It’s simply not worth the risk.”
Jeff Kaufman, the Houston-Galveston Area Council’s transportation program coordinator, told those in attendance how H-GAC received a step grant for smaller law enforcement agencies in the area to qualify for funding to conduct their own drunk driving enforcement efforts, a task force which Kaufman said has now grown to 15 agencies.
“As of Memorial Day weekend, we’ve conducted three waves,” Kaufman said. “This is a pilot project, this is something that hasn’t been done regionally or for the state, but we’ve made 115 arrests for suspected DWIs over these three weekends. DWI is easily avoidable, just don’t’ drink and drive. Get a designated driver, don’t overdo the celebration, just be responsible. Because it’s really not worth risking other people’s lives, it’s not worth risking time in jail.”
Though the efforts of these different agencies won’t bring back Aaron Pennywell — whose story is one of many on facesofdrunkdriving.com — his parents are hoping that by relating the senseless and tragic nature of their eldest son’s death, at least something positive will come from the abrupt end to Aaron’s life.
“Mainly it’s to tell these [people to] make choices when you are going to drink,” Kae Pennywell told Houston Community Newspapers. “Get a cab, call a friend to come pick you up, sleep it off, have a designated driver.
_________________________________________
Source: The Rancher (Haverkamp, 7/2)
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