Thursday, 9 April 2015

Princess Health andBaby is born on Interstate 65 in Louisville during traffic blockage for President Obama's motorcade; father, nurse tell story.Princessiccia

Nurse and EMT worker and baby
Photo from Floyd Memorial
Hospital
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A baby boy was born along Interstate 65 April 2 in Louisville because the road was closed for President Barack Obama's motorcade and they couldn't get to the hospital.

Because he stayed in Washington to announce the nuclear deal with Iran, Obama was three hours late, putting him in Louisville right at the beginning of rush hour and causing a traffic nightmare.

MetroSafe told WAVE-TV it received a call at 5:25 p.m. saying a woman was in labor on I-65. And just before 6 p.m., the baby, an 8-pound, 9-ounce boy, Arley Keith Satterly, son of Jessica Brown and Zakk Satterley was born, WHAS reports. �We couldn't get nowhere, so I called 911,� Satterly said.

After Brown and Satterly realized that the baby was coming and they were in "traffic gridlock," Satterly began to ask the cars around them for help, Shalanna Taylor reports for WLKY-TV. �I started asking people in different cars if they knew anything about having a baby,� Satterly said.

One of them was a nurse, Tonia Vetter, Gill Corsey reports for WDRB-TV. "I told the dad, I said, 'I'm a high-risk nursery nurse at Floyd Memorial'," the hospital in New Albany, Ind., Vetter said. "It actually happened very, very quickly. ... I think she pushed one time and the head delivered, and then she pushed again and the baby was born." Other drivers provided a shoestring for the umbilical cord and a blanket to keep the baby warm, Corsey reports.

"I've attended a lot of deliveries, but I've never delivered a baby on my own, and I've certainly never delivered one in the middle of an interstate," Vetter said. "God was definitely watching over me, the baby, the mom, because she could have hemorrhaged. The baby could of had a cord or a shoulder or any number of complications could've happened."

An ambulance took Brown and Arley to the University of Louisville Hospital, where a spokesperson said the mom and baby were doing just fine and were in good condition.

Princess Health andLiving in a community with high income inequality is bad for your health, study says, and much of Ky. is high in inequality.Princessiccia

A study by researchers at the University of Wisconsin for the Robert Wood Johnson Foundation found that not only factors such as smoking and crime rate but also income inequality influenced lifespan, Margot Sanger-Katz writes for The New York Times.
This close-up of a New York Times graphic shows income inequality in Kentucky,
Tennessee and parts of surrounding states. Lighter areas have less inequality,
and darker areas have more inequality.
"It's not just the level of income in a community that matters�it's also how income is distributed," said Bridget Catlin, the co-director of the County Health Rankings and Roadmap project. "The effect of inequality was statistically significant, equivalent to a difference of about 11 days of life between high- and low-inequality places," Sanger-Katz reports. "The differences were small, but for every increment that a community became more unequal, the proportion of residents dying before the age of 75 went up."

Other research shows that income inequality affects life expectancies of citizens in countries around the world. Why exactly this happens is debatable. One idea is that though money buys better health, "It makes a bigger difference for people low on the income scale than those at the top," Sanger-Katz writes. That means a having very few poor individuals in an area will improve average health more than having very few rich individuals will reduce it.

Another theory is that areas where wealthy individuals can "buy their way out of social services may have less cohesion and investment in things like education and public health that we know affect life span," Sanger-Katz writes. Also, some research indicates that living around richer people is stressful, causing mental health problems or cardiac disease.

To measure inequality, the researchers compared incomes of individuals living in a certain area who earned the 80th percentile with the incomes of those who earned the 20th percentile. They recorded all those who died before age 75 and the age at which they died, calculating "potential life years lost." A person who died at 70 would have lost five years of potential life.

"For every one-point increase in the ratio between high and low earners in a county, there were about five years lost for every 1,000 people," Sanger-Katz writes. "That's about the same difference they observed when a community's smoking rate increased by 4 percent or its obesity rate rose by 3 percent."

Through the Patient Protection and Affordable Care Act, Americans at the lower end of the income spectrum are receiving health insurance, at least in states like Kentucky that have expanded Medicaid eligibility, and researchers will track whether those provisions will reduce the effects of inequality in the coming years. (Read more)

Wednesday, 8 April 2015

Princess Health and Three More Settlements by Medtronic of Allegations of Deceptive Behavior, but No Umpire Says "You're Out". Princessiccia

Medtronic, the giant, previously US based device maker settled three lawsuits, all alleging deceptive practices, over three months in early 2015.  I will summarize the settlements in chronological order.

Medtronic Subsidiary EV3 Settled Suit Alleging it Coached Hospitals about How to Overbill Medicare

This was actually an old case, originally against a company that Medtronic bought out, but only settled this year, in February.  As reported by the Minneapolis Star-Tribune,


A Plymouth medical device company owned by Medtronic has agreed to pay $1.25 million to settle a federal lawsuit alleging that it wasted Medicare dollars.

The medical device company EV3 is settling a whistleblower�s claims that in 2006 and 2007, a company it acquired improperly coached hospitals across the country on how to overbill Medicare for minimally invasive procedures to remove hardened plaque from patients� arteries using one of its devices, called the Silver Hawk.

Specifically, former sales representative Amanda Cashi alleged that the company told hospitals that 80 percent of their patients for the Silver Hawk procedure should stay overnight in the hospital following an atherectomy, leading to higher Medicare payments. The promises of higher reimbursement were intended to drive sales of Silver Hawk devices. Cashi and federal prosecutors who joined her lawsuit said most of the patients should have gotten lower-paying same-day procedures in an outpatient setting.

As is standard operating procedure for such litigation,

[Irish Medtronic subsidiary] Covidien, which negotiated the settlement agreement, is not admitting wrongdoing and specifically denies the allegations in the six-year-old lawsuit, the settlement agreement says.

'Medtronic is committed to the highest standards of ethical conduct, and we take responsibility for delivering outstanding results to our partners, patients and colleagues,' a company statement said. 'The case relates to historical conduct that took place under Fox Hollow. � We are pleased to have the matter resolved.'

Of course, there may be a bit of irony there, since I doubt that the original manufacturer of Silver Hawk, FoxHollow, or its successors were pushing to get the case resolved quickly, and Medtronic likely ultimately financially benefited from the prolonged delay. 

Note that in 2005 we first posted about the questionable clinical research data that FoxHollow used to promote the device

Medtronic Settled Suit Alleging it Gave Kickbacks to Doctors to Promote Unjustified Procedure that Used Medtronic Neuromodulation Device

Just two days later, the Star-Tribune reported,

Medtronic PLC will pay $2.8 million to the U.S. Justice Department to settle a false-claims case that alleged that the Minnesota devicemaker made illegal payments to doctors to recommend a medical procedure that was neither safe nor effective.

In particular,

The case surrounds allegations of corporate promotion of uses of a neurostimulation device that were not approved by the U.S. Food and Drug Administration. The Justice Department said Medtronic paid doctors in 20 states 'tens of thousands of dollars' to encourage health providers to use the device off-label.

This 'created a new, rapidly expanding market for their devices and a potentially huge source of profit for themselves at the expense of the federal Treasury,' the government said in a federal lawsuit.

As in the previous case, the settlement allowed Medtronic to deny "it did anything wrong."

Medtronic Settled Suit that Alleged it Sold Chinese or Malaysian Spinal Surgery Devices as Made in the USA

Finally, in April, 2015, the Star-Tribune again reported,

In its third federal settlement in two months, Medtronic PLC has agreed to pay $4.4 million to settle allegations that it deliberately violated U.S. law requiring that devices sold to the military be manufactured in the United States or its international trading partners.

The False Claims Act lawsuit, handled by Minnesota U.S. Attorney Andrew Luger�s office, alleged among other things that the formerly Fridley-based med-tech company brought spinal surgery devices in from China and then relabeled them 'Manufactured in Memphis, TN,' where its spinal division is based, before selling them to the government.

Of course,

Medtronic spokeswoman Cindy Resman said that although the company has since improved its country-of-origin disclosures in government contracts, it 'makes no admission that any of its activities were improper or unlawful.'

The settlement focused on 'a limited number of accessories and surgical instruments used in spinal surgeries that were provided to Medtronic by third-party suppliers and were manufactured in China or Malaysia. The overwhelming majority of Medtronic�s products are manufactured in the United States or its trading partners, such as Mexico or Ireland,' she said in an e-mail.

But can you believe them now?

Discussion

Medtronic made three settlements over three months, all of allegations that it deceived, directly or indirectly, doctors, patients, or the government.  These settlements were not isolated events.  In June, 2014 we discussed a settlement Medtronic made of allegations that  Medtronic gave kickbacks (that is, bribes) to doctors to get them to use its cardiac devices.  Previously, as we noted then, ...   As Bloomberg summarized,


 Medtronic agreed in 2007 to pay about $130 million to settle consumer suits accusing the device maker of hiding defects in its defibrillators. The company agreed to a $268 million settlement of suits in 2010 over allegations that fractured wires in another line of defibrillators caused at least 13 patient deaths.

In fact, Medtronic has provided our blog with lots of material.  We first discussed detailed and vivid allegations that Medtronic had been paying off doctors starting in 2003 here in 2006.  Medtronic has been involved in other lawsuits alleging various kinds of deception.
-  In 2011, it settled for $23.5 million two other federal lawsuits alleging it paid kickbacks to encourage physicians to implant its devices (look here).  
- In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link here)
- In 2006, Medtronic subsidiary Sofamor Danek settled for $40 million allegations that it gave kickbacks to doctors in the form of sham consulting fees and lavish trips (look here).

One loses count of all the settlements and cases in which Medtronic was accused of deceptive practices.  Some settlements were for larger amounts, some for smaller.  Yet none of the settlements were large enough to really affect a company which reported earnings of just under $1 billion in 2014 (per this WSJ article.)   None of the later legal settlements seem to have taken into account the company's previous record.

But this is typical of how legal settlements made by large health care corporations are handled.  Almost never is the settlement big enough to have deterrent value.   

The revenues of the company could very well have been increased by the activities alleged to have occurred in the course of this litigation, and these revenues were likely used to justify outsize compensation for top corporate managers.  According to the company's 2014 proxy statement, in fiscal 2014, CEO Omar Ishrak got $12,118,846 in total compensation.  All other listed executives got at least $3.5 million.  In none of these cases did anyone at the company who might have authorized, directed, or implemented bad, and particularly deceptive behavior suffer any negative consequences.   

But this is typical of the impunity seemingly granted to top health care organizational managers.

In baseball, it's three strikes and you're out.  For the leaders of big health care corporations, however, no matter how many strikes your company makes, you never seem to be out.  Despite a continuing stream of ethical issues occurring on their watch, management usually succeeds in becoming filthy rich.


Maybe that would change if the public, or health care professionals, knew all about such things.  However, these settlements remain anechoic.  Although the latest Star-Tribune article did note that the latest 2015 settlement occurred after two previous settlements this year, none of the reporting about these settlements seems to have noted all the previous settlements.  Finally, the discussion of these cases involving a prominent device company and multiple allegations of deceptive, dishonest, unethical behavior never seems to go beyond business sections of media outlets.  Even though such continuing dishonest behavior could have corrosive cumulative effects on health care ethics, the morale of health professionals who have to deal with such deception, and patients' and the public's health, discussion of it never makes it into the medical and health care literature, a striking example of the anechoic effect.

Maybe if more health care professionals, and the public at large, knew the story better, they might ask what sort of stewardship was exerted by the Medtronic board of directors? Maybe they could ask current Medtronic board members, like Rensellaer Polytechnic Institute President Shirley Ann Jackson, and  former US Secretary of Health and Human Services Michael O Levitt,  and former board members, like Dr Victor J Dzau, who was pressured to leave the Medtronic board after he became President of the Institute of Medicine and this membership was noticed (look here)  These board members were making over $200,000 a year, and piling up Medtronic stock, supposedly for exerting stewardship over the company.

But typically board members of big health care organizations remain unaccountable.  

There seems to be increasing recognition that the continuing rise in US health care costs is unsustainable, and that these costs are not buying us good health care.  There are calls to avoid unnecessary, and sometimes harmful care.  Yet there is a persistent disconnect between how continuing dishonest behavior by health care organizations, impunity of their leaders, and lack of accountability by their board members fuel rising costs, shrinking access, and bad outcomes for patients.

To truly reform health care, we will have to at least recognize the causes of the current dysfunction.  Recognizing how health care dysfunction is created by unaccountable, dishonest leadership should lead to true reform that would promote well-informed, honest, accountable leadership that puts patients' and the public's health ahead of personal gain.  

Tuesday, 7 April 2015

Princess Health andHigher-income Kentuckians' reported health keeps declining; reports from those with lower incomes go up, marginally.Princessiccia

A statewide poll again finds that Kentuckians with higher incomes consider themselves in better health than those with lower incomes.

The latest Kentucky Health Issues Poll, taken Oct. 8 through Nov. 6, found that 55 percent of Kentucky adults who are above 200 percent of the federal poverty level (FPL) said their health was either "excellent" or "very good," compared to 29 percent of Kentucky adults at or below 200 percent of the FPL. The FPL for a family of four in 2014 was $47,700.

However, the percentage of Kentucky adults in the higher-income category reporting excellent or very good health has dropped significantly since the poll started asking this question in 2008, to 55 percent in 2014 from 66 percent in 2008. So has the overall percentage of Kentucky adults reporting excellent or very good health, dropping to 41 percent in 2014 from 49 percent in 2008.

The percentage of lower-income Kentucky adults reporting excellent or very good has been about the same since 2008. This year the poll found a 3 percent increase among those in this group who reported very good or excellent health. The difference is not statistically significant, but coincides with implementation of federal health reform, and and if it continues could show the law's impact.

The poll also found that 52 percent of adults age 45 and younger considered their health as excellent or very good while 33 percent of those over age 45 reported excellent or very good health.


�KHIP provides important data regarding the connections among a person�s age, earnings level and perceived health status,� said Susan Zepeda, president and CEO of the Foundation for a Healthy Kentucky, which co-sponsored the poll. �By asking the same question year to year, we can spot trends in perceived health. The latest results are an important reminder of the links between poverty and poor health.�

The poll is conducted by the Institute for Policy Research at the University of Cincinnati and is co-sponsored by Interact for Health, formerly the Health Foundation of Greater Cincinnati. It surveyed a random sample of 1,597 adults via land lines and cell phones, and has a margin of error of plus or minus 2.5 percentage points. That applies to each figure, making the 3 percent difference statistically insignifcant.
Princess Health and Not with a bang but with a whimper. Princessiccia

Princess Health and Not with a bang but with a whimper. Princessiccia

This is the way the world ends
This is the way the world ends
This is the way the world ends
Not with a bang but with a whimper
     -- T. S. Eliot, The Hollow Men, 1925

Those across the Commonwealth of Pennsylvania who lived through the disaster known as AHERF, the story of the Allegheny Health and Education Research Foundation, ending in one of the biggest non-profit health care bankruptcies in US history, may now note in passing the death some months ago--just recently announced--of its architect, one Sherif Abdelhak.

Many books and articles have been written about this hubristic exercise in go-go corporatism. It was a fiasco that left many endowments decimated and the remnants of two Philadelphia medical schools in shreds.

For those who lived through that era, the death of "the sheriff" is bittersweet. It has passed virtually unnoticed until now. But it's worth remarking, not just for its local but also its national meaning. By the high-rolling mid-1990s, tellingly, the Association of American Medical College's prestigious Cooper Lectureship led through the following roster. Here is the list for the decade commencing 1985 and leading to its 1995 apogee

  • 1985 John A. D. Cooper
  • 1986 Paul B. Beeson
  • 1987 Uwe E. Reinhardt
  • 1988 Henry G. Cisneros
  • 1989 Lauro F. Cavazos
  • 1990 John F. Sherman
  • 1991 Margaret Catley-Carlson
  • 1992 Leroy Hood
  • 1993 Bruce M. Alberts
  • 1994 Merwyn R. Greenlick
  • 1995 Sherif S. Abdelhak

A nice progression. Three years later, in 1998, AHERF and Allegheny University of the Health Sciences, went belly up. Its successors are still recovering. But too many parts of our health educational and health care systems still show signs of the sheriff's avaricious behavior.

Sunday, 5 April 2015

Princess Health andNew diabetes cases in expanded-Medicaid states much higher than other states; 46,000 new Ky. Medicaid clients got screened.Princessiccia

Princess Health andNew diabetes cases in expanded-Medicaid states much higher than other states; 46,000 new Ky. Medicaid clients got screened.Princessiccia

By Melissa Patrick
Kentucky Health News

New diabetes cases among poor Americans are much more numerous in Kentucky and other states that have embraced the Patient Protection and Affordable Care Act, a medical testing company has found. The diagnoses rose 23 percent in the Obamacare states and barely rose in the others, apparently because state Medicaid programs are encouraging screening for diabetes.

Quest Diagnostics conducted the study by analyzing laboratory test results from all 50 states and the District of Columbia in its large database over two six-month periods, Sabrina Tavernise reports for The New York Times. The authors determined that because in January 2014, 26 states and the District of Columbia had expanded Medicaid and 24 had not, it was a good time to conduct this study, which is reported in the journal Diabetes Care.

The research team used the results of the basic test for diabetes, which measures a form of hemoglobin that has interacted with glucose, A1c. "In the states that expanded Medicaid, the number of Medicaid enrollees with newly identified diabetes rose by 23 percent, to 18,020 in the first six months of 2014, from 14,625 in the same period in 2013," Tavernise reports. "The diagnosis rose by only 0.4 percent � to 11,653 from 11,612 � in the states that did not expand Medicaid."

A Kentucky study indicates that more screening isn't the only reason for such numbers; the Medicaid expansion population appears to be more susceptible to diabetes than normal.

The study by Deloitte Consulting found that chronic conditions, including diabetes, were more than twice as prevalent in the expansion population than other people of the same age and gender who were on Medicaid before it expanded. That comparative group was considered to be the group most similar to the Medicaid expansion population, since the state lacks historical data for the expansion group.

The study found that the Medicaid expansion group had a 102.5 percent higher prevalence of diabetes than the comparative group. About two of every 1,000 in the expansion group had diabetes, compared to one of every 1,000 members of the traditional-Medicaid group.

About 46,000 of the 400,000 people in the expansion group had a diabetes screening in the first year of the expansion. Both studies suggest better access and utilization of preventive care and early diagnosis will promote earlier treatment and better long-term outcomes.

Kentucky ranks 17th among the states in prevalence of diabetes, according to the 2014 "States of Obesity" report.  The state Cabinet for Health and Family Services reports an estimated 233,000 adult Kentuckians have pre-diabetes. For county-by-county data on diabetes, click here.

Quest Diagnostics recognized that its study only looked at changes in raw numbers of the lab results from one company and did not have access to a federal data set. This has caused some to voice skepticism that the study results are a result of the Medicaid expansion. Others, while recognizing that the study did not "have the precision of a scientific drug trial," Tavernise writes, said "the changes in the numbers are real ... 23 percent versus zero," and that "the health-care law was the most plausible explanation for the findings." Another said, "for an observational study, it�s really very strong."

Kentucky Health News is an independent news service of the Institute for Rural Journalism and Community Issues, based in the School of Journalism and Telecommunications at the University of Kentucky, with support from the Foundation for a Healthy Kentucky.
Princess Health andAuditor will hold meetings in Prestonsburg, Princeton and Somerset to discuss his report on financial status of rural hospitals.Princessiccia

Princess Health andAuditor will hold meetings in Prestonsburg, Princeton and Somerset to discuss his report on financial status of rural hospitals.Princessiccia

State Auditor Adam Edelen will hold three public meetings in rural communities to discuss the findings of his special report about the financial health of rural hospitals.

The meetings will be held Monday, April 21 at 1 p.m. at the Mountain Arts Center in Prestonsburg; Monday, May 4 at 11 a.m. (CT) at the Caldwell County Memorial Hospital in Princeton; and Thursday, May 6 at 1 p.m. at the Liberty center of Somerset Community College.

The report, which covers fiscal years 2011 through 2013, found that as many as one-third of Kentucky's rural hospitals were in poor financial shape, with 68 percent of them ranking below the national average financially.

�Although closure may be an unfortunate reality for some," Edelen said in the press conference, "I believe more can and should be done to help these hospitals rethink their models of business in delivering health care in the 21st century." He went on to suggest rural hospitals consider hiring outside managers, merge with larger hospitals, form coalitions with other rural hospitals or find a specialized health niche as possible alternate business models to consider.

The report calls for the creation of a state work group to monitor rural hospitals, including making sure state law gives them the flexibility to retool their business models. Susan Zepeda, president and CEO of the Foundation for a Healthy Kentucky, suggested that the proposed work "could be incorporated into the work already under way under a State Innovation Model grant, which is engaging many sectors of health service in Kentucky in an ambitious, collaborative redesign effort."

Edelen said some of the primary problems faced by rural hospitals stem from the many changes in health care since the inception of Medicaid managed care, a decrease in the number of health-care providers, and an economic climate in some areas that doesn't support the current health payment model, which depends on the majority of its users to have private health insurance.

The report suggested that the Cabinet for Health and Family Services negotiate better contracts with managed-care organizations as it approaches the June 30 deadline, especially to address provider payments, stricter penalties for non-compliance and increased administrative burdens that managed care has put on hospitals. Edelen and Haynes sounded hopeful that this was going to happen.

Gov. Steve Beshear called Edelen's report "a dated snapshot" because the 2013 data used in the report does not include 2014 information,when the federal health reform was fully implemented through expansion of Medicaid to people with incomes up to 138 percent of the federal poverty line. Beshear said hospitals received $506 million to care for such people in 2014 while seeing significant reductions in losses on patients who couldn't or wouldn't pay.

Edelen's spokeswoman, Stephenie Hoelscher, said in an email that Edelen believes the full effect of all the changes in health care to hospitals' bottom line is still not clear, and his report establishes a baseline for critical analysis going forward.