Original Story: freep.com
Waiting for a lung transplant is hard enough but waiting for one that fits could take even longer.
"Many of the patients on the waiting list have small lung sizes because of their disease," said Dr. Martin Strueber, a transplant specialist with Spectrum Health in Grand Rapids. "Especially, children have a hard time waiting for a suitable donor graft because of size issues. The organ donors have average lung sizes." A Grand Rapids health care lawyer is reviewing the details of this story.
The answer, Strueber has found, is a custom fitting of lungs to recipients.
"It's a the technique we learned from adult lung surgery," Strueber said. "It's a technique for reducing the size of patient lungs that have the disease of emphysema. We just modified this technique to use it to reduce oversized lungs for lung transplant patients."
The results have been shorter wait times for patients who risk death if they are delayed. This year, the Richard DeVos Heart and Lung Transplant Program at Spectrum, where Strueber works, performed 28 lung transplants and had just eight people on the waiting list. A Detroit health care attorney is following this story closely.
"We want our waiting list to be very short and we want our patients to be transplanted as fast as we can so that we have no mortality on the waiting list," Strueber said. "That's the goal."
The center logged a 93% survival rate for recipients one year after their transplants. One successful recipient was Sidney Whitaker, 66, of Hart. In April 2014, he was diagnosed with idiopathic pulmonary fibrosis, a condition where scar tissue forms in the lungs, causing them to thicken to the point that they can't move oxygen into the bloodstream properly.
"They didn't say it was it a death sentence," Whitaker said. "They weren't real sure initially what it was."
But after a lung biopsy, Whitaker learned how serious it was.
"You do nothing and you die or you get a transplant," Whitaker said.
On Dec. 31, 2014, he was officially listed on the transplant list and told to keep his phone charged to receive a call and to be ready to get to the hospital within three hours. On Jan. 31, he receive a new lung. But it didn't take. A Grand Rapids hospital lawyer has experience with hospital and health care related cases.
"The lung just wasn't working," said Dr. Reda Girgis, medical director for the lung transplant program at Spectrum. "That's why it was urgent to get that donor."
About a week later, Whitaker received a new, modified lung that took almost immediately.
"He got through it fairly well," Girgis said. "He's going to have his one-year anniversary in February. He's doing extremely well. He can do basically what he wants."
Whitaker's wife, Jill, was stunned by how quickly her husband responded.
"He was off oxygen in 24 hours," she said. Two months after his last surgery, he went home.
"I have zero restrictions," said Whitaker, who continues to pick garlic, corn, asparagus, and potatoes that he grows on his 10-acre farm and sells at his Many Blessings Market.
His wife, Jill, said she and her husband have become big advocates of the program.
"We got to celebrate our 45th wedding anniversary in July," Jill Whitaker said. "I wasn't sure we'd have that."
Strueber said the lungs can be modified in one of two ways to make them fit. One is known as a lobectomy, the removal of an entire lobe of a lung before transplanting. The other is what's known as lung shaving, surgically removing portions of a lobe.
"If the lung is really too big, it's usually a combination of a lobectomy and the lung shaving procedure," Strueber said. "You can take like 40% to 50% of it off. We have like donors being a huge male and then we transplant a small female, 100 pounds or less. It is all doable. It needs to be customized to the chest of the organ recipient."
In addition to being an expert in lung shaving, Strueber is a pioneer in what's known as minimally invasive lung transplants.
"The incisions are just in between the ribs," he said. "The chest bone stays intact."
Strueber was born and trained in Germany and was courted to Grand Rapids two years ago to be part of a growing transplant program in Grand Rapids.
"You have a community that needs the research. There is a lot of opportunity," he said. "I found that very interesting and challenging."
29 December 2015
20 November 2015
UNITEDHEALTH MAY DUMP OBAMACARE PLANS, PUTTING CALIFORNIA EXPANSION IN DOUBT
Original Story: latimes.com
Industry giant UnitedHealth has warned it may quit selling Obamacare coverage across the country, raising questions about an expansion in California.
The nation's largest health insurer cut its earnings forecast Thursday, citing slower growth on public exchanges under the Affordable Care Act and higher-than-expected claims for those individual policies. A San Diego health care lawyer have experience with multiple industry types and implications of detrimental health care practices or incidents.
The company said it was pulling back on its marketing of health-law coverage just a few weeks after open enrollment began Nov. 1. UnitedHealth said it will decide in the first half of next year “to what extent it can continue to serve the public exchange markets in 2017.”
UnitedHealth Chief Executive Stephen Hemsley told analysts and investors that “we cannot sustain these losses.... We can't really subsidize a marketplace that doesn't appear at the moment to be sustaining itself.”
The announcement comes as UnitedHealth is seeking a toehold in California’s Obamacare market — after snubbing the state two years ago. A Cleveland health care attorney is following this story closely.
Nationwide, UnitedHealth has more than 500,000 people enrolled on government exchanges out of about 10 million Americans who have signed up. Rivals Anthem and Aetna both have a bigger presence with a combined enrollment of about 1.6 million people.
Analysts said the exchanges can continue to function without UnitedHealth, but stagnant enrollment is a concern industrywide.
UnitedHealth’s exit “would be a blow to multiple exchange markets, but not a death knell,” said Bill Melville, a senior analyst for Decision Resources Group, a research firm in Burlington, Mass. “All insurers in the exchanges are facing similarly rough head winds.”
Enrollment growth has slowed as many of the uninsured balk at buying high-deductible health plans, even with federal subsidies available. It's crucial for insurers to sign up enough healthy people to help pay for sicker policyholders who eagerly seek out coverage.
Federal officials estimate that about 10.5 million uninsured Americans are eligible to sign up for coverage through the marketplaces but have not enrolled.
“The policies are still too expensive, and the deductibles and co-pays are too high for other than the poorest,” said Robert Laszewski, a healthcare consultant in Virginia who has closely tracked the overhaul.
He noted that much of the reduction in the ranks of the uninsured has come from expanding Medicaid, the government health program for the poor.
The Obama administration said the number of health plans offering exchange policies has increased since the 2014 launch, and it expects the individual market will stabilize as adjustments are made. A Houston health care lawyer is reviewing the details of this story.
“The health insurance marketplace is entering its third year and continues to grow, giving millions of Americans access to quality affordable insurance,” said Ben Wakana, a spokesman for the U.S. Department of Health and Human Services. “Today’s statement by one issuer is not indicative of the marketplace’s strength and viability.”
UnitedHealth just joined the Covered California exchange this month after sitting out the first two years. The company sought permission in January to sell statewide, but California officials limited the insurer to several smaller markets for 2016.
Those areas are predominantly rural counties in Northern California, but they also include Santa Barbara, Ventura and San Luis Obispo counties.
Covered California imposed that restriction because UnitedHealth left the state's individual market at the end of 2013 and spurned the launch of the exchange.
Peter Lee, executive director of Covered California, said he spoke with UnitedHealth officials Thursday and remains confident about the company’s continued expansion in the state.
"We have every indication they are all in for 2016 and 2017," Lee said in an interview. "The fact United did badly in other parts of the country, like many health plans did, is exactly why they want to be in California." A Coral Gables health care lawyer provides professional legal counsel and extensive experience in many aspects of health care law.
A spokesman for UnitedHealth said no decision has been made on its future participation in Covered California. “We will make an assessment of 2017 markets in the first quarter of 2016,” spokesman Tyler Mason said.
Many consumer groups welcomed UnitedHealth's arrival in Covered California in order to give people more choice and inject more competition into the market. The top four insurers in the exchange, led by Anthem and Blue Shield of California, control about 94% of Covered California enrollment.
The state has about 1.3 million people enrolled, and nearly 90% of them receive federal premium subsidies.
Covered California fell short of its enrollment goal during the second sign-up period, and it has acknowledged that reaching the remaining uninsured is difficult.
This week, the state said 34,000 new enrollees had picked out a health plan since Nov. 1. That's behind last year's pace but within state projections, officials said.
The announcement Thursday marked a sudden shift for UnitedHealth, which had sounded bullish about the health law in recent months. The company initially sold coverage on only four government-run exchanges before expanding to 23 this year. It will be selling in 34 states for 2016.
UnitedHealth said it cut its profit forecast to account for $425 million in losses it expects on individual policies this year and in 2016. The company expects 2015 earnings of about $6 a share, down from its previous estimate for $6.25 to $6.35 a share.
Shares of UnitedHealth slid $6.62, or 5.7%, to $110.63 in Thursday trading. Other health stocks took a beating after the company’s warning. Shares of Anthem, the nation’s second-largest health insurer, fell 7%, and hospital chain Tenet Healthcare dropped 8%.
After the news from UnitedHealth, HMO giant Kaiser Permanente reiterated its support for health-law exchanges.
“American healthcare is undergoing significant change and evolution, and the health exchanges are part of that disruption,” said Kaiser Permanente CEO Bernard Tyson. “While there have been challenges at times, we believe at the end of the day they are causing healthy disruption.”
Industry giant UnitedHealth has warned it may quit selling Obamacare coverage across the country, raising questions about an expansion in California.
The nation's largest health insurer cut its earnings forecast Thursday, citing slower growth on public exchanges under the Affordable Care Act and higher-than-expected claims for those individual policies. A San Diego health care lawyer have experience with multiple industry types and implications of detrimental health care practices or incidents.
The company said it was pulling back on its marketing of health-law coverage just a few weeks after open enrollment began Nov. 1. UnitedHealth said it will decide in the first half of next year “to what extent it can continue to serve the public exchange markets in 2017.”
UnitedHealth Chief Executive Stephen Hemsley told analysts and investors that “we cannot sustain these losses.... We can't really subsidize a marketplace that doesn't appear at the moment to be sustaining itself.”
The announcement comes as UnitedHealth is seeking a toehold in California’s Obamacare market — after snubbing the state two years ago. A Cleveland health care attorney is following this story closely.
Nationwide, UnitedHealth has more than 500,000 people enrolled on government exchanges out of about 10 million Americans who have signed up. Rivals Anthem and Aetna both have a bigger presence with a combined enrollment of about 1.6 million people.
Analysts said the exchanges can continue to function without UnitedHealth, but stagnant enrollment is a concern industrywide.
UnitedHealth’s exit “would be a blow to multiple exchange markets, but not a death knell,” said Bill Melville, a senior analyst for Decision Resources Group, a research firm in Burlington, Mass. “All insurers in the exchanges are facing similarly rough head winds.”
Enrollment growth has slowed as many of the uninsured balk at buying high-deductible health plans, even with federal subsidies available. It's crucial for insurers to sign up enough healthy people to help pay for sicker policyholders who eagerly seek out coverage.
Federal officials estimate that about 10.5 million uninsured Americans are eligible to sign up for coverage through the marketplaces but have not enrolled.
“The policies are still too expensive, and the deductibles and co-pays are too high for other than the poorest,” said Robert Laszewski, a healthcare consultant in Virginia who has closely tracked the overhaul.
He noted that much of the reduction in the ranks of the uninsured has come from expanding Medicaid, the government health program for the poor.
The Obama administration said the number of health plans offering exchange policies has increased since the 2014 launch, and it expects the individual market will stabilize as adjustments are made. A Houston health care lawyer is reviewing the details of this story.
“The health insurance marketplace is entering its third year and continues to grow, giving millions of Americans access to quality affordable insurance,” said Ben Wakana, a spokesman for the U.S. Department of Health and Human Services. “Today’s statement by one issuer is not indicative of the marketplace’s strength and viability.”
UnitedHealth just joined the Covered California exchange this month after sitting out the first two years. The company sought permission in January to sell statewide, but California officials limited the insurer to several smaller markets for 2016.
Those areas are predominantly rural counties in Northern California, but they also include Santa Barbara, Ventura and San Luis Obispo counties.
Covered California imposed that restriction because UnitedHealth left the state's individual market at the end of 2013 and spurned the launch of the exchange.
Peter Lee, executive director of Covered California, said he spoke with UnitedHealth officials Thursday and remains confident about the company’s continued expansion in the state.
"We have every indication they are all in for 2016 and 2017," Lee said in an interview. "The fact United did badly in other parts of the country, like many health plans did, is exactly why they want to be in California." A Coral Gables health care lawyer provides professional legal counsel and extensive experience in many aspects of health care law.
A spokesman for UnitedHealth said no decision has been made on its future participation in Covered California. “We will make an assessment of 2017 markets in the first quarter of 2016,” spokesman Tyler Mason said.
Many consumer groups welcomed UnitedHealth's arrival in Covered California in order to give people more choice and inject more competition into the market. The top four insurers in the exchange, led by Anthem and Blue Shield of California, control about 94% of Covered California enrollment.
The state has about 1.3 million people enrolled, and nearly 90% of them receive federal premium subsidies.
Covered California fell short of its enrollment goal during the second sign-up period, and it has acknowledged that reaching the remaining uninsured is difficult.
This week, the state said 34,000 new enrollees had picked out a health plan since Nov. 1. That's behind last year's pace but within state projections, officials said.
The announcement Thursday marked a sudden shift for UnitedHealth, which had sounded bullish about the health law in recent months. The company initially sold coverage on only four government-run exchanges before expanding to 23 this year. It will be selling in 34 states for 2016.
UnitedHealth said it cut its profit forecast to account for $425 million in losses it expects on individual policies this year and in 2016. The company expects 2015 earnings of about $6 a share, down from its previous estimate for $6.25 to $6.35 a share.
Shares of UnitedHealth slid $6.62, or 5.7%, to $110.63 in Thursday trading. Other health stocks took a beating after the company’s warning. Shares of Anthem, the nation’s second-largest health insurer, fell 7%, and hospital chain Tenet Healthcare dropped 8%.
After the news from UnitedHealth, HMO giant Kaiser Permanente reiterated its support for health-law exchanges.
“American healthcare is undergoing significant change and evolution, and the health exchanges are part of that disruption,” said Kaiser Permanente CEO Bernard Tyson. “While there have been challenges at times, we believe at the end of the day they are causing healthy disruption.”
02 November 2015
THE NARRATIVE FRAYS FOR THERANOS AND ELIZABETH HOLMES
Original Story: nytimes.com
Few people, let alone those just 31 years old, have amassed the accolades and riches bestowed on Elizabeth Holmes, founder and chief executive of the blood-testing start-up Theranos.
This year President Obama named her a United States ambassador for global entrepreneurship. She gave the commencement address at Pepperdine University. She was the youngest person ever to be awarded the Horatio Alger Award in recognition of “remarkable achievements accomplished through honesty, hard work, self-reliance and perseverance over adversity.” She is on the Board of Fellows of Harvard Medical School. Macomb elder care provides family respite care and adult and senior assistance.
She has been showered with rapturous media attention. Time named her one of the 100 Most Influential People in the World this year. She was the subject of lengthy profiles in The New Yorker and Fortune. Over the last week, she appeared on the cover of T: The New York Times Style Magazine, and Glamour anointed her one of its eight Women of the Year. She has been on “Charlie Rose,” as well as on stage at the Clinton Global Initiative, the World Economic Forum at Davos and the Aspen Ideas Festival, among numerous other conferences.
Theranos, which she started after dropping out of Stanford at age 19, has raised more than $400 million in venture capital and has been valued at $9 billion, which makes Ms. Holmes’s 50 percent stake worth $4.5 billion. Forbes put her on the cover of its Forbes 400 issue, ranking her No. 121 on the list of wealthiest Americans. Senior care in Grosse Pointe offers the highest quality of in-home care.
Her wealth and fame rest almost entirely on a simple but nonetheless “revolutionary” and “disruptive” technology: Theranos’s ability to run a wide range of lab tests from a tiny sample of blood from a finger prick, in that way eliminating the need for intravenous blood draws. (Ms. Holmes has said that her inspiration was a personal aversion to needles.)
Thanks to an investigative article in The Wall Street Journal this month by John Carreyrou, one of the company’s central claims, and the one most exciting to many investors and doctors, is being called into question. Theranos has acknowledged it was only running a limited number of tests on a microsample of blood using its finger-prick technology. Since then, it said it had stopped using its proprietary methods on all but one relatively simple test for herpes.
Theranos has denied many elements of the Journal article on its website.
For most of its tests, Theranos said that it uses conventional equipment on samples drawn intravenously by needle, which makes its approach pretty much like that of its big competitors, Quest Diagnostics and Laboratory Corporation of America Holdings, whose stocks have gyrated on the start-up’s perceived threat. Elderly care in Madison Heights provides medical and non-medical support for catastrophic care patients.
This week the Food and Drug Administration released reports based on inspections of Theranos facilities this summer. It concluded that the company’s miniature blood containers — called “nanotainers” — were “unapproved” medical devices for tests beyond herpes.
“While we work with the F.D.A. on clearance of our nanotainer tubes,” said Tilden Katz, a Theranos spokesman, “we have chosen to conduct our tests through venous draws.” He added: “Our proprietary devices are making it possible to run finger-stick samples for tests that could never be run on finger-stick before.”
Amid the controversy, Walgreens said it would not open new Theranos blood testing centers while it sought answers about the company’s technology.
“This isn’t how you introduce technology that claims to be groundbreaking and revolutionary in the health care field,” said Michael Cherny, an analyst at the investment bank Evercore Partners who was an early and vocal skeptic about many of Theranos’s claims.
“Every other person goes through some level of peer review,” Mr. Cherny told me this week. Theranos “decided to shun that approach.”
“In my view,” he said, “that calls into question what’s under the hood of the platform.”
Others raised questions about Theranos and what now appear to have been some pretty bold claims, in some cases long before The Journal’s exposé. Kevin Loria, a reporter on the Business Insider science team, wrote several pointed articles and produced a number of prominent skeptics among clinical pathologists and the broader medical community. The New Yorker and Fortune articles also were skeptical about the lack of peer review for Theranos’s technology. And Eleftherios Diamandis, the head of clinical biochemistry at Mount Sinai Hospital in Toronto, raised numerous issues in a June medical journal article.
“The constant was that nobody had any idea how this works or even if it works,” Mr. Loria told me this week. “People in medicine couldn’t understand why the media and technology worlds were so in thrall to her.”
The attention lavished on Ms. Holmes has been effusive. Her goal of facilitating the early detection and prevention of disease by making blood testing easier and convenient is laudable. And the relatively young company may still work through its current difficulties.
But that so many eminent authorities — from Henry Kissinger, who had served on the company’s board; to prominent investors like the Oracle founder Larry Ellison; to the Cleveland Clinic — appear to have embraced Theranos with minimal scrutiny is a testament to the ageless power of a great story.
“It all fit together perfectly: the college dropout, the fear of needles, the humanitarian mission,” Mr. Cherny said. “She checked all the boxes.” Warren elder care provides high tech nursing services, including assistance with medical equipment.
Indeed, Ms. Holmes seems to have perfectly executed the current Silicon Valley playbook: Drop out of a prestigious college to pursue an entrepreneurial vision; adopt an iconic uniform; embrace an extreme diet; and champion a humanitarian mission, preferably one that can be summed up in one catchy phrase.
Like Bill Gates, Steve Jobs and Mark Zuckerberg, Ms. Holmes dropped out of college. Like Steve Jobs, she wears a uniform of black turtlenecks, suggesting she has loftier things to think about than what to wear. “I probably have 150 of these,” she told Glamour. Like Mr. Jobs, she’s picky about her diet. (She’s a vegan who shuns coffee and drinks green vegetable juices.)
And like Google’s co-founders, Larry Page and Sergey Brin (“Don’t Be Evil”), and Mark Zuckerberg (“Connect the World”), her mission is lofty. As she has repeatedly said, Ms. Holmes envisions “a world in which no one ever has to say goodbye too soon,” brought about through improved health care. Theranos also has a slogan: “One tiny drop changes everything.”
She stays relentlessly on message, as a review of her numerous conference and TV appearances make clear, while at the same time saying little of scientific substance.
The natural human tendency to fit complex facts into a simple, compelling narrative has grown stronger in the digital age of 24/7 news and social media, said Frank Partnoy, professor of law and finance at the University of San Diego, and author of “Wait: The Art and Science of Delay,” which explores the perils of hasty decision-making.
“We’re deluged with information even as pressure has grown to make snap decisions,” Professor Partnoy said. “People see a TED talk. They hear this amazing story of a 30-something-year-old woman with a wonder procedure. They see the Cleveland Clinic is on board. A switch goes off and they make an instant decision that everything is fine. You see this over and over: Really smart and wealthy people start to believe completely implausible things with 100 percent certainty.”
Ms. Holmes’s story also fits into a broader narrative underway in medicine, in which new health care entrepreneurs are upending ossified hospital practices with the goal of delivering more effective and patient-oriented care.
Two proponents of the approach, Dr. Delos Cosgrove, chief executive of the Cleveland Clinic, and Mark R. Laret, chief executive of the UCSF Medical Center, have enthusiastically endorsed Theranos’s potential to upend conventional medicine.
A Cleveland Clinic spokeswoman, Eileen Sheil, told me that the clinic’s “strategic partnership” with Theranos had not really gotten off the ground and that the clinic had yet to employ any Theranos technology. She said that a statement on the clinic’s website — “Theranos offers a full spectrum of laboratory tests, from the most common panels to highly specialized tests, on blood samples as small as a few drops” — is “their language, not ours, and we can’t verify that.”
Mr. Laret said he had “no information” about Theranos’s technology, but had great respect for Ms. Holmes and the company’s board.
While hot Silicon Valley start-ups like Uber and Airbnb have run into regulatory hurdles, as a medical technology company, Theranos has bumped up against something else: the scientific method, which puts a premium on verification over narrative.
“I don’t know if she’s another Steve Jobs,” said Jerry Yeo, professor of pathology at the University of Chicago and director of the Clinical Chemistry Laboratories there. “You have to subject yourself to peer review. You can’t just go in a stealthy mode and then announce one day that you’ve got technology that’s going to disrupt the world.”
Professor Yeo said that he and his colleagues wanted to see data and testing in independent labs. “We have a small army of people ready and willing to test Theranos’s products if they’d ask us,” he said. “And that can be done without revealing any trade secrets.”
Ms. Holmes said this week that Theranos would disclose data on the reliability and accuracy of its tests. “Data is a powerful thing because it speaks for itself,” she said at a conference at the Cleveland Clinic. “We were never against that.”
Whether that will satisfy Theranos’s growing number of critics will depend on the nature and quality of the data.
“Every other company in this field has gone through peer review,” said Mr. Cherny of Evercore. “Why hold back so much of the platform if your goal is the greater good of humanity?”
Few people, let alone those just 31 years old, have amassed the accolades and riches bestowed on Elizabeth Holmes, founder and chief executive of the blood-testing start-up Theranos.
This year President Obama named her a United States ambassador for global entrepreneurship. She gave the commencement address at Pepperdine University. She was the youngest person ever to be awarded the Horatio Alger Award in recognition of “remarkable achievements accomplished through honesty, hard work, self-reliance and perseverance over adversity.” She is on the Board of Fellows of Harvard Medical School. Macomb elder care provides family respite care and adult and senior assistance.
She has been showered with rapturous media attention. Time named her one of the 100 Most Influential People in the World this year. She was the subject of lengthy profiles in The New Yorker and Fortune. Over the last week, she appeared on the cover of T: The New York Times Style Magazine, and Glamour anointed her one of its eight Women of the Year. She has been on “Charlie Rose,” as well as on stage at the Clinton Global Initiative, the World Economic Forum at Davos and the Aspen Ideas Festival, among numerous other conferences.
Theranos, which she started after dropping out of Stanford at age 19, has raised more than $400 million in venture capital and has been valued at $9 billion, which makes Ms. Holmes’s 50 percent stake worth $4.5 billion. Forbes put her on the cover of its Forbes 400 issue, ranking her No. 121 on the list of wealthiest Americans. Senior care in Grosse Pointe offers the highest quality of in-home care.
Her wealth and fame rest almost entirely on a simple but nonetheless “revolutionary” and “disruptive” technology: Theranos’s ability to run a wide range of lab tests from a tiny sample of blood from a finger prick, in that way eliminating the need for intravenous blood draws. (Ms. Holmes has said that her inspiration was a personal aversion to needles.)
Thanks to an investigative article in The Wall Street Journal this month by John Carreyrou, one of the company’s central claims, and the one most exciting to many investors and doctors, is being called into question. Theranos has acknowledged it was only running a limited number of tests on a microsample of blood using its finger-prick technology. Since then, it said it had stopped using its proprietary methods on all but one relatively simple test for herpes.
Theranos has denied many elements of the Journal article on its website.
For most of its tests, Theranos said that it uses conventional equipment on samples drawn intravenously by needle, which makes its approach pretty much like that of its big competitors, Quest Diagnostics and Laboratory Corporation of America Holdings, whose stocks have gyrated on the start-up’s perceived threat. Elderly care in Madison Heights provides medical and non-medical support for catastrophic care patients.
This week the Food and Drug Administration released reports based on inspections of Theranos facilities this summer. It concluded that the company’s miniature blood containers — called “nanotainers” — were “unapproved” medical devices for tests beyond herpes.
“While we work with the F.D.A. on clearance of our nanotainer tubes,” said Tilden Katz, a Theranos spokesman, “we have chosen to conduct our tests through venous draws.” He added: “Our proprietary devices are making it possible to run finger-stick samples for tests that could never be run on finger-stick before.”
Amid the controversy, Walgreens said it would not open new Theranos blood testing centers while it sought answers about the company’s technology.
“This isn’t how you introduce technology that claims to be groundbreaking and revolutionary in the health care field,” said Michael Cherny, an analyst at the investment bank Evercore Partners who was an early and vocal skeptic about many of Theranos’s claims.
“Every other person goes through some level of peer review,” Mr. Cherny told me this week. Theranos “decided to shun that approach.”
“In my view,” he said, “that calls into question what’s under the hood of the platform.”
Others raised questions about Theranos and what now appear to have been some pretty bold claims, in some cases long before The Journal’s exposé. Kevin Loria, a reporter on the Business Insider science team, wrote several pointed articles and produced a number of prominent skeptics among clinical pathologists and the broader medical community. The New Yorker and Fortune articles also were skeptical about the lack of peer review for Theranos’s technology. And Eleftherios Diamandis, the head of clinical biochemistry at Mount Sinai Hospital in Toronto, raised numerous issues in a June medical journal article.
“The constant was that nobody had any idea how this works or even if it works,” Mr. Loria told me this week. “People in medicine couldn’t understand why the media and technology worlds were so in thrall to her.”
The attention lavished on Ms. Holmes has been effusive. Her goal of facilitating the early detection and prevention of disease by making blood testing easier and convenient is laudable. And the relatively young company may still work through its current difficulties.
But that so many eminent authorities — from Henry Kissinger, who had served on the company’s board; to prominent investors like the Oracle founder Larry Ellison; to the Cleveland Clinic — appear to have embraced Theranos with minimal scrutiny is a testament to the ageless power of a great story.
“It all fit together perfectly: the college dropout, the fear of needles, the humanitarian mission,” Mr. Cherny said. “She checked all the boxes.” Warren elder care provides high tech nursing services, including assistance with medical equipment.
Indeed, Ms. Holmes seems to have perfectly executed the current Silicon Valley playbook: Drop out of a prestigious college to pursue an entrepreneurial vision; adopt an iconic uniform; embrace an extreme diet; and champion a humanitarian mission, preferably one that can be summed up in one catchy phrase.
Like Bill Gates, Steve Jobs and Mark Zuckerberg, Ms. Holmes dropped out of college. Like Steve Jobs, she wears a uniform of black turtlenecks, suggesting she has loftier things to think about than what to wear. “I probably have 150 of these,” she told Glamour. Like Mr. Jobs, she’s picky about her diet. (She’s a vegan who shuns coffee and drinks green vegetable juices.)
And like Google’s co-founders, Larry Page and Sergey Brin (“Don’t Be Evil”), and Mark Zuckerberg (“Connect the World”), her mission is lofty. As she has repeatedly said, Ms. Holmes envisions “a world in which no one ever has to say goodbye too soon,” brought about through improved health care. Theranos also has a slogan: “One tiny drop changes everything.”
She stays relentlessly on message, as a review of her numerous conference and TV appearances make clear, while at the same time saying little of scientific substance.
The natural human tendency to fit complex facts into a simple, compelling narrative has grown stronger in the digital age of 24/7 news and social media, said Frank Partnoy, professor of law and finance at the University of San Diego, and author of “Wait: The Art and Science of Delay,” which explores the perils of hasty decision-making.
“We’re deluged with information even as pressure has grown to make snap decisions,” Professor Partnoy said. “People see a TED talk. They hear this amazing story of a 30-something-year-old woman with a wonder procedure. They see the Cleveland Clinic is on board. A switch goes off and they make an instant decision that everything is fine. You see this over and over: Really smart and wealthy people start to believe completely implausible things with 100 percent certainty.”
Ms. Holmes’s story also fits into a broader narrative underway in medicine, in which new health care entrepreneurs are upending ossified hospital practices with the goal of delivering more effective and patient-oriented care.
Two proponents of the approach, Dr. Delos Cosgrove, chief executive of the Cleveland Clinic, and Mark R. Laret, chief executive of the UCSF Medical Center, have enthusiastically endorsed Theranos’s potential to upend conventional medicine.
A Cleveland Clinic spokeswoman, Eileen Sheil, told me that the clinic’s “strategic partnership” with Theranos had not really gotten off the ground and that the clinic had yet to employ any Theranos technology. She said that a statement on the clinic’s website — “Theranos offers a full spectrum of laboratory tests, from the most common panels to highly specialized tests, on blood samples as small as a few drops” — is “their language, not ours, and we can’t verify that.”
Mr. Laret said he had “no information” about Theranos’s technology, but had great respect for Ms. Holmes and the company’s board.
While hot Silicon Valley start-ups like Uber and Airbnb have run into regulatory hurdles, as a medical technology company, Theranos has bumped up against something else: the scientific method, which puts a premium on verification over narrative.
“I don’t know if she’s another Steve Jobs,” said Jerry Yeo, professor of pathology at the University of Chicago and director of the Clinical Chemistry Laboratories there. “You have to subject yourself to peer review. You can’t just go in a stealthy mode and then announce one day that you’ve got technology that’s going to disrupt the world.”
Professor Yeo said that he and his colleagues wanted to see data and testing in independent labs. “We have a small army of people ready and willing to test Theranos’s products if they’d ask us,” he said. “And that can be done without revealing any trade secrets.”
Ms. Holmes said this week that Theranos would disclose data on the reliability and accuracy of its tests. “Data is a powerful thing because it speaks for itself,” she said at a conference at the Cleveland Clinic. “We were never against that.”
Whether that will satisfy Theranos’s growing number of critics will depend on the nature and quality of the data.
“Every other company in this field has gone through peer review,” said Mr. Cherny of Evercore. “Why hold back so much of the platform if your goal is the greater good of humanity?”
18 September 2015
ACLU: HOSPITAL DENIES TUBAL LIGATION TO WOMAN WITH TUMOR
Original Story: freep.com
A Flint-area Catholic hospital has until the end of Friday to change its mind and perform a tubal ligation on a pregnant woman with a brain tumor – or face a potential lawsuit from the American Civil Liberties Union. A San Diego healthcare lawyer is reviewing the details of this case.
The ACLU is fighting on behalf of Jessica Mann, 33, of Flushing, a pregnant woman with a life-threatening brain tumor who was denied a request to get her tubes tied at the time of her scheduled cesarean section next month.
According to the ACLU, Genesys Regional Medical Center in Grand Blanc won't allow the sterilization procedure on religious grounds. Mann's doctor requested a medical exception to the hospital's prohibition on sterilization, arguing that a future pregnancy could harm Mann because of her brain tumor, said the ACLU.
But Genesys wouldn't budge, triggering a demand letter from the ACLU last week. The ACLU argues the hospital could be violating state law by denying appropriate care. An Albany healthcare lawyer is following this story closely.
Johnny Smith Jr., a spokesman for the hospital's parent, Ascension, declined comment, citing patient privacy. He would only say that the company follows the "ethical and religious directives" of the Catholic church.
This issue isn't a first for the ACLU, which last month convinced a Catholic hospital in California to change course in a similar case involving tubal ligation.
Under the threat of a potential lawsuit from the ACLU, Mercy Medical Center in Redding, Calif., changed its mind in agreeing to perform a postpartum tubal litigation on a woman. The hospital had initially denied a request by the woman's doctor to tie her tubes, but changed course within days of receiving a demand letter from the ACLU.
According to the ACLU, tubal ligation, commonly known as getting one's “tubes tied,” is the contraception method of choice for more than 30% of married women in the U.S. An estimated 600,000 women annually undergo this procedure, which is often performed at the time of a cesarean section, the group said. A Chicago healthcare lawyer defends clients in a wide variety of large, complex health care and medical negligence cases.
Ten of the 25 largest hospital systems in the U.S. are Catholic-sponsored, and nearly one of nine hospital beds in the country is in a Catholic facility. According to the ACLU, these Catholic hospitals operate under binding “ethical and religious directives” issued by the U.S. Conference of Catholic Bishops. Among the directives is that sterilization for the purpose of contraception as “intrinsically evil.”
The ACLU argues that bishops should not be playing the role of doctors.
A Flint-area Catholic hospital has until the end of Friday to change its mind and perform a tubal ligation on a pregnant woman with a brain tumor – or face a potential lawsuit from the American Civil Liberties Union. A San Diego healthcare lawyer is reviewing the details of this case.
The ACLU is fighting on behalf of Jessica Mann, 33, of Flushing, a pregnant woman with a life-threatening brain tumor who was denied a request to get her tubes tied at the time of her scheduled cesarean section next month.
According to the ACLU, Genesys Regional Medical Center in Grand Blanc won't allow the sterilization procedure on religious grounds. Mann's doctor requested a medical exception to the hospital's prohibition on sterilization, arguing that a future pregnancy could harm Mann because of her brain tumor, said the ACLU.
But Genesys wouldn't budge, triggering a demand letter from the ACLU last week. The ACLU argues the hospital could be violating state law by denying appropriate care. An Albany healthcare lawyer is following this story closely.
Johnny Smith Jr., a spokesman for the hospital's parent, Ascension, declined comment, citing patient privacy. He would only say that the company follows the "ethical and religious directives" of the Catholic church.
This issue isn't a first for the ACLU, which last month convinced a Catholic hospital in California to change course in a similar case involving tubal ligation.
Under the threat of a potential lawsuit from the ACLU, Mercy Medical Center in Redding, Calif., changed its mind in agreeing to perform a postpartum tubal litigation on a woman. The hospital had initially denied a request by the woman's doctor to tie her tubes, but changed course within days of receiving a demand letter from the ACLU.
According to the ACLU, tubal ligation, commonly known as getting one's “tubes tied,” is the contraception method of choice for more than 30% of married women in the U.S. An estimated 600,000 women annually undergo this procedure, which is often performed at the time of a cesarean section, the group said. A Chicago healthcare lawyer defends clients in a wide variety of large, complex health care and medical negligence cases.
Ten of the 25 largest hospital systems in the U.S. are Catholic-sponsored, and nearly one of nine hospital beds in the country is in a Catholic facility. According to the ACLU, these Catholic hospitals operate under binding “ethical and religious directives” issued by the U.S. Conference of Catholic Bishops. Among the directives is that sterilization for the purpose of contraception as “intrinsically evil.”
The ACLU argues that bishops should not be playing the role of doctors.
16 September 2015
DMC COULD SETTLE NURSES LAWSUIT FOR $42 MILLION
Original Story: freep.com
The Detroit Medical Center could soon settle for $42 million its portion of a 2006 class lawsuit over pay brought by registered nurses against eight metro Detroit hospital systems.
U.S. District Judge Gerald Rosen gave preliminary approval on Monday for the proposed settlement involving DMC and the roughly 24,000 nurses who worked at either DMC or the other seven hospital systems between December 2002 and December 2006. The lawsuit alleged a conspiracy among the hospitals to suppress the nurses' pay. A San Diego healthcare lawyer is reviewing the details of this case.
Settlements totaling $48 million were previously reached with the other hospitals, and that money has already been distributed to nurses, according to a website of the Seattle-based law firm Keller Rohrback that represented the plaintiffs. With this latest proposed settlement, the total size of the settlement could be $90 million — before attorneys fees and taxes.
Neither DMC nor the other hospital systems have admitted to any wrongdoing or to underpaying nurses. All eight hospital systems contended they acted independently in setting their nurses' pay and benefits and didn't collude to keep wages low. A Grand Rapids healthcare lawyer is knowledgeable in all areas of general health care.
The other hospitals and health systems were Henry Ford Health System, Mt. Clemens General Hospital (now McLaren Macomb), what is now St. John Providence, Oakwood Healthcare, the former Bon Secours Cottage Health Services, Beaumont Hospital and Trinity Health.
The DMC on Tuesday referred all comment to its attorney in the case, Veronica Lewis of Dallas-based Gibson, Dunn & Crutcher, who said in a statement that "The settlement is not an admission of liability but rather a business decision to bring the matter to a resolution. We remain committed to our nurses and value the hard work and dedication of all our hospital staff." A Charleston healthcare lawyer is following this story closely.
An attorney representing the nurses, Mark Griffin of Keller Rohrback, declined comment.
More information regarding the settlement is available at detroitnursewages.com. The size of each individual check would be determined by the number of hours a nurse worked and his or her pay rate.
The Detroit Medical Center could soon settle for $42 million its portion of a 2006 class lawsuit over pay brought by registered nurses against eight metro Detroit hospital systems.
U.S. District Judge Gerald Rosen gave preliminary approval on Monday for the proposed settlement involving DMC and the roughly 24,000 nurses who worked at either DMC or the other seven hospital systems between December 2002 and December 2006. The lawsuit alleged a conspiracy among the hospitals to suppress the nurses' pay. A San Diego healthcare lawyer is reviewing the details of this case.
Settlements totaling $48 million were previously reached with the other hospitals, and that money has already been distributed to nurses, according to a website of the Seattle-based law firm Keller Rohrback that represented the plaintiffs. With this latest proposed settlement, the total size of the settlement could be $90 million — before attorneys fees and taxes.
Neither DMC nor the other hospital systems have admitted to any wrongdoing or to underpaying nurses. All eight hospital systems contended they acted independently in setting their nurses' pay and benefits and didn't collude to keep wages low. A Grand Rapids healthcare lawyer is knowledgeable in all areas of general health care.
The other hospitals and health systems were Henry Ford Health System, Mt. Clemens General Hospital (now McLaren Macomb), what is now St. John Providence, Oakwood Healthcare, the former Bon Secours Cottage Health Services, Beaumont Hospital and Trinity Health.
The DMC on Tuesday referred all comment to its attorney in the case, Veronica Lewis of Dallas-based Gibson, Dunn & Crutcher, who said in a statement that "The settlement is not an admission of liability but rather a business decision to bring the matter to a resolution. We remain committed to our nurses and value the hard work and dedication of all our hospital staff." A Charleston healthcare lawyer is following this story closely.
An attorney representing the nurses, Mark Griffin of Keller Rohrback, declined comment.
More information regarding the settlement is available at detroitnursewages.com. The size of each individual check would be determined by the number of hours a nurse worked and his or her pay rate.
10 September 2015
PROTESTERS BLOCK MICHIGAN AVENUE OVER CUTS TO HOME CARE FOR SENIORS
Original Story: chicago.suntimes.com
Blocking traffic along Michigan Avenue on the Magnificent Mile, chanting and waving signs, hundreds of protesters gathered Monday to rail against Gov. Bruce Rauner’s proposed budget cuts, which they say will be devastating to Illinois’ poorest and most vulnerable citizens.
One particular budget item attracted dozens of protesters in their 70s and 80s. It would affect senior citizens who depend on the Community Care Program, which provides state money to pay for home care for seniors.
And Patricia Drennan wasn’t having any of it.
“A lot of us old ladies don’t have kids that live here that can take us to the doctor and come in and run the vacuum cleaner and get us to the grocery store and all that,” said Drennan, 82, who lives alone in the North Center neighborhood.
The program, she said, helps seniors live independently and keeps them out out nursing homes, an expense that would be much greater to taxpayers.
Drennan feared a plan by Rauner that would implement new qualifying restrictions that would make it harder for seniors to gain access to the program. Livonia senior care provides highly skilled nurses ready to serve even the most advanced medical needs.
About 30 protesters held hands and blocked Michigan Avenue just north of the Michigan Avenue Bridge for nearly 20 minutes at about 11:30 a.m. before police escorted the group off the roadway.
Sister Gwen Farry, 81, with the Sisters of Charity of the Blessed Virgin Mary, was among the group of traffic blockers who expected to receive citations from police.
“This is a moral issue,” said Farry, of St. Thomas the Apostle Catholic Church in Hyde Park. “I’ve made phone calls and signed online petitions but wanted to do more to protest the cuts that will affect the most vulnerable in our state.” Plymouth MI elder care services provides medical and non-medical support for catastrophic care patients.
Protesters called for wealthy corporations and residents in Illinois to pay more taxes.
Critics say Rauner is using potential cuts to state social service programs as leverage to gain support for fighting unions.
A statement issued by a Rauner spokeswoman after the protest read: “The administration has taken a series of management steps to responsibly manage the state’s finances, because Speaker Madigan, Senate President Cullerton and the legislators Madigan controls overspent taxpayer money causing a $4 billion deficit. The governor has tried to negotiate on critical reforms to free up resources to help the most vulnerable and pass a balanced budget, but unfortunately, the Speaker continues to block those reforms at the expense of the most vulnerable and the middle class.” A Livonia elder care provider is following this story closely.
The protest was organized by a number of activist groups, including Jane Addams Senior Caucus and Fair Economy Illinois.
Blocking traffic along Michigan Avenue on the Magnificent Mile, chanting and waving signs, hundreds of protesters gathered Monday to rail against Gov. Bruce Rauner’s proposed budget cuts, which they say will be devastating to Illinois’ poorest and most vulnerable citizens.
One particular budget item attracted dozens of protesters in their 70s and 80s. It would affect senior citizens who depend on the Community Care Program, which provides state money to pay for home care for seniors.
And Patricia Drennan wasn’t having any of it.
“A lot of us old ladies don’t have kids that live here that can take us to the doctor and come in and run the vacuum cleaner and get us to the grocery store and all that,” said Drennan, 82, who lives alone in the North Center neighborhood.
The program, she said, helps seniors live independently and keeps them out out nursing homes, an expense that would be much greater to taxpayers.
Drennan feared a plan by Rauner that would implement new qualifying restrictions that would make it harder for seniors to gain access to the program. Livonia senior care provides highly skilled nurses ready to serve even the most advanced medical needs.
About 30 protesters held hands and blocked Michigan Avenue just north of the Michigan Avenue Bridge for nearly 20 minutes at about 11:30 a.m. before police escorted the group off the roadway.
Sister Gwen Farry, 81, with the Sisters of Charity of the Blessed Virgin Mary, was among the group of traffic blockers who expected to receive citations from police.
“This is a moral issue,” said Farry, of St. Thomas the Apostle Catholic Church in Hyde Park. “I’ve made phone calls and signed online petitions but wanted to do more to protest the cuts that will affect the most vulnerable in our state.” Plymouth MI elder care services provides medical and non-medical support for catastrophic care patients.
Protesters called for wealthy corporations and residents in Illinois to pay more taxes.
Critics say Rauner is using potential cuts to state social service programs as leverage to gain support for fighting unions.
A statement issued by a Rauner spokeswoman after the protest read: “The administration has taken a series of management steps to responsibly manage the state’s finances, because Speaker Madigan, Senate President Cullerton and the legislators Madigan controls overspent taxpayer money causing a $4 billion deficit. The governor has tried to negotiate on critical reforms to free up resources to help the most vulnerable and pass a balanced budget, but unfortunately, the Speaker continues to block those reforms at the expense of the most vulnerable and the middle class.” A Livonia elder care provider is following this story closely.
The protest was organized by a number of activist groups, including Jane Addams Senior Caucus and Fair Economy Illinois.
24 August 2015
ALPHABET/GOOGLE HAS GIVEN BIRTH TO A HEALTHCARE TECH COMPANY
Original Story: latimes.com
Over the past couple of years, Google has hired experts in diseases and physiology, pairing them with top software engineers, to tackle major healthcare issues.
Projects include developing contact lenses to allow diabetics to constantly monitor glucose levels, defining “healthy” traits and testing disease-detection pills capable of communicating to a special wristband.
None of that is a part of Google anymore but there is still a connection. The 150-employee Life Sciences team is becoming its own company within Alphabet, a corporation Google recently formed to organize its array of offbeat ventures. Life Sciences becomes a sister company to Google, which includes the search engine, Gmail, Maps, Android and other familiar offerings. An official corporate name is coming soon, a Google spokeswoman said.
Changing the reporting structure could give Life Sciences more autonomy while providing Alphabet, nee Google, executives a clearer picture of the division’s spending. Google’s new Chief Financial Officer Ruth Porat counts Life Sciences as a forthcoming source of significant long-term revenue.
The group’s goal won’t change, said Google co-founder and Alphabet President Sergey Brin in an online post Thursday.
“They’ll continue to work with other life sciences companies to move new technologies from early stage R&D to clinical testing—and, hopefully—transform the way we detect, prevent and manage disease,” he wrote. Rankin Biomedical is a leading provide of remanufactured histology equipment for medical testing needs.
One partner, Dexcom Inc., announced earlier this month that it will make and sell miniature glucose monitors based on Google technology. Life Sciences collects an upfront fee, additional payments throughout the development and then revenue-based royalties after a certain sales level, Dexcom said.
Andy Conrad, a co-founder of the National Genetics Institute who had been leading Life Sciences, becomes the new company’s chief executive. Life Sciences will be separate from Calico, an Alphabet division working to counteract aging. BrightStar Care specializes in Plymouth elder care services providing customized companion and healthcare needs.
Over the past couple of years, Google has hired experts in diseases and physiology, pairing them with top software engineers, to tackle major healthcare issues.
Projects include developing contact lenses to allow diabetics to constantly monitor glucose levels, defining “healthy” traits and testing disease-detection pills capable of communicating to a special wristband.
None of that is a part of Google anymore but there is still a connection. The 150-employee Life Sciences team is becoming its own company within Alphabet, a corporation Google recently formed to organize its array of offbeat ventures. Life Sciences becomes a sister company to Google, which includes the search engine, Gmail, Maps, Android and other familiar offerings. An official corporate name is coming soon, a Google spokeswoman said.
Changing the reporting structure could give Life Sciences more autonomy while providing Alphabet, nee Google, executives a clearer picture of the division’s spending. Google’s new Chief Financial Officer Ruth Porat counts Life Sciences as a forthcoming source of significant long-term revenue.
The group’s goal won’t change, said Google co-founder and Alphabet President Sergey Brin in an online post Thursday.
“They’ll continue to work with other life sciences companies to move new technologies from early stage R&D to clinical testing—and, hopefully—transform the way we detect, prevent and manage disease,” he wrote. Rankin Biomedical is a leading provide of remanufactured histology equipment for medical testing needs.
One partner, Dexcom Inc., announced earlier this month that it will make and sell miniature glucose monitors based on Google technology. Life Sciences collects an upfront fee, additional payments throughout the development and then revenue-based royalties after a certain sales level, Dexcom said.
Andy Conrad, a co-founder of the National Genetics Institute who had been leading Life Sciences, becomes the new company’s chief executive. Life Sciences will be separate from Calico, an Alphabet division working to counteract aging. BrightStar Care specializes in Plymouth elder care services providing customized companion and healthcare needs.
19 August 2015
MICHIGAN AGENCY: HEALTH INSURANCE TO RISE 6.5% IN 2016
Original Story: detroitnews.com
Lansing — Michigan consumers will pay an average 6.5 percent more for health insurance in 2016, which is less than the rate hike they paid during the past year, state officials said Tuesday.
State officials and industry leaders called the increases modest compared with an 8 percent rise in 2015, but some health care advocates said too little information is available about how rates are calculated for consumers to judge whether the hikes are warranted. Farmington Hills elder care services assist individuals with even the most advanced medical needs.
The 2016 rate increases approved by the Michigan Department of Insurance and Financial Services are lower than those in several other states for federally required health insurance under the 2010 federal law, state officials noted.
The average approved rate changes on a premium weighted basis increased 6.5 percent for the 560,357 consumers in the individual market and 1 percent for the 345,077 consumers in the small group or small business market.
“Many states are reporting rate increases well in excess of 10 percent which is significantly higher than the rate of health care inflation,” Department of Insurance and Financial Services Director Patrick McPharlin said in a Tuesday statement. “We are pleased that Michigan consumers are seeing more modest increases.” In-home caregivers tailor home care services to the needs of each client and family including private duty skilled nursing.
Josh Fangmeier, senior policy analyst with the University of Michigan’s Center for Heathcare Research and Transformation, noted that some insurance companies asked for minimal rate increases, or even decreased their rates. But consumers in some parts of the state have few plans to choose from.
“Not all of these insurers are statewide, so ... it’s important to keep in mind that consumer experiences will vary depending on where you live,” Fangmeier said.
In 2015, the average increase was 8 percent in the individual market and 5.7 percent in the small group market, DIFS spokeswoman Andrea Miller said Tuesday. The rate changes for 2014 were not estimated because of essential health benefits and other requirements of the federal Affordable Care Act that took effect that year. Plymouth elder care services provides patients with intensive, highly specialized care.
A Michigan health insurance industry official said in June the possible loss of federal insurance subsidies through a U.S. Supreme Court case was in part to blame for the proposed rate hikes. But the court later that month kept the Affordable Care Act subsidies in place and decided they were constitutional in a 6-3 ruling.
Rick Murdock, executive director of the Michigan Association of Health Plans, noted this is the industry’s third year of business in the health care marketplace created by the federal Affordable Care Act.
“Year one was sort of pricing it blind; year two, which was last year, there were significant adjustments — double-digit reductions for some, and double-digit increases for others, as they were trying to get to the middle,” Murdock said. “This year everyone seems to have made a modest adjustment based on what’s going on in health care.”
The rate hikes proposed by insurance companies were reviewed by state officials, who determined they are actuarially appropriate and comply with state and federal laws. But Ryan Sullivan, policy director for Michigan Consumers for Healthcare, said state regulators don’t provide information about the process that consumers can understand.
“We really don’t know how to put (the rate increases) into context because of a lot of lagging transparency in the process,” Sullivan said Tuesday. “What consumers can access via the web and by calling the department is pretty slim pickings.”
The state defended its practices. Miller said consumers can access rate increase filings and other detailed information through the department’s website at http://www.michigan.gov/difs.
“We’re trying to be as transparent as we possibly can be,” she said.
The state’s dominant insurer — Blue Cross Blue Shield of Michigan — will apply a double-digit increase of 11.4 percent. Its health maintenance organization, Blue Care Network, plans to hike its rates 9.7 percent.
In June, a Blues official said an increase in prescription and specialty drug costs is behind the rate hike. Blue Cross had 138,169 people sign up for individual plans in 2015, while another 171,831 people with individual Blue Care Network policies will see average increases of 9.7 percent. A Chicago health care lawyer is following this story closely.
Blues spokeswoman Helen Stojik noted their small group customers will benefit from a downward rate adjustment. Rates for employers renewing coverage in the third and fourth quarters of 2015 will be, on average, 3.3 percent lower for Blues customers and 0.8 percent higher for Blue Care Network customers.
“In addition, 2016 rate changes look extremely favorable, with Blue Cross annual rate changes projected 2.2 percent lower and Blue Care Network projected at 4.8 percent lower than the previous year,” Stojik said Tuesday.
But the Blues didn’t register the largest rate increases. Those belonged to Healthplus of Michigan at 35.8 percent, Consumers Mutual Insurance of Michigan at 20.5 percent and United Healthcare Community Plan at 14.7 percent.
Three insurers are countering the trend and dropping their rates in the coming year, according to the state.
Meridian Health Plan had the biggest decline with a 12.6 percent plunge, followed by Molina Health Care with a 8.6 percent decrease and Humana Medical Plan of Michigan with a 4.9 percent drop.
Michigan companies attributed their increases to higher-than-expected claim costs, annual health care cost increases and an expected reduction in federal program reinsurance recoveries, officials said.
The small increase in the small group market occurred because many companies experienced better than expected results that offset most of the change in annual health care costs.
“Ensuring rates are adequate but not excessive is critical to make sure consumers not only receive health insurance coverage at a reasonable price, but can count on the coverage they purchase,” McPharlin noted. “Michigan has a stable and competitive health insurance market with a range of options and premiums for consumers and businesses.”
Open enrollment for 2016 begins Nov. 1, 2015 and continues through Jan. 31, 2016. State officials are encouraging consumers to contact their insurance carrier, agent, or navigator about how the rate changes could affect their policies.
Lansing — Michigan consumers will pay an average 6.5 percent more for health insurance in 2016, which is less than the rate hike they paid during the past year, state officials said Tuesday.
State officials and industry leaders called the increases modest compared with an 8 percent rise in 2015, but some health care advocates said too little information is available about how rates are calculated for consumers to judge whether the hikes are warranted. Farmington Hills elder care services assist individuals with even the most advanced medical needs.
The 2016 rate increases approved by the Michigan Department of Insurance and Financial Services are lower than those in several other states for federally required health insurance under the 2010 federal law, state officials noted.
The average approved rate changes on a premium weighted basis increased 6.5 percent for the 560,357 consumers in the individual market and 1 percent for the 345,077 consumers in the small group or small business market.
“Many states are reporting rate increases well in excess of 10 percent which is significantly higher than the rate of health care inflation,” Department of Insurance and Financial Services Director Patrick McPharlin said in a Tuesday statement. “We are pleased that Michigan consumers are seeing more modest increases.” In-home caregivers tailor home care services to the needs of each client and family including private duty skilled nursing.
Josh Fangmeier, senior policy analyst with the University of Michigan’s Center for Heathcare Research and Transformation, noted that some insurance companies asked for minimal rate increases, or even decreased their rates. But consumers in some parts of the state have few plans to choose from.
“Not all of these insurers are statewide, so ... it’s important to keep in mind that consumer experiences will vary depending on where you live,” Fangmeier said.
In 2015, the average increase was 8 percent in the individual market and 5.7 percent in the small group market, DIFS spokeswoman Andrea Miller said Tuesday. The rate changes for 2014 were not estimated because of essential health benefits and other requirements of the federal Affordable Care Act that took effect that year. Plymouth elder care services provides patients with intensive, highly specialized care.
A Michigan health insurance industry official said in June the possible loss of federal insurance subsidies through a U.S. Supreme Court case was in part to blame for the proposed rate hikes. But the court later that month kept the Affordable Care Act subsidies in place and decided they were constitutional in a 6-3 ruling.
Rick Murdock, executive director of the Michigan Association of Health Plans, noted this is the industry’s third year of business in the health care marketplace created by the federal Affordable Care Act.
“Year one was sort of pricing it blind; year two, which was last year, there were significant adjustments — double-digit reductions for some, and double-digit increases for others, as they were trying to get to the middle,” Murdock said. “This year everyone seems to have made a modest adjustment based on what’s going on in health care.”
The rate hikes proposed by insurance companies were reviewed by state officials, who determined they are actuarially appropriate and comply with state and federal laws. But Ryan Sullivan, policy director for Michigan Consumers for Healthcare, said state regulators don’t provide information about the process that consumers can understand.
“We really don’t know how to put (the rate increases) into context because of a lot of lagging transparency in the process,” Sullivan said Tuesday. “What consumers can access via the web and by calling the department is pretty slim pickings.”
The state defended its practices. Miller said consumers can access rate increase filings and other detailed information through the department’s website at http://www.michigan.gov/difs.
“We’re trying to be as transparent as we possibly can be,” she said.
The state’s dominant insurer — Blue Cross Blue Shield of Michigan — will apply a double-digit increase of 11.4 percent. Its health maintenance organization, Blue Care Network, plans to hike its rates 9.7 percent.
In June, a Blues official said an increase in prescription and specialty drug costs is behind the rate hike. Blue Cross had 138,169 people sign up for individual plans in 2015, while another 171,831 people with individual Blue Care Network policies will see average increases of 9.7 percent. A Chicago health care lawyer is following this story closely.
Blues spokeswoman Helen Stojik noted their small group customers will benefit from a downward rate adjustment. Rates for employers renewing coverage in the third and fourth quarters of 2015 will be, on average, 3.3 percent lower for Blues customers and 0.8 percent higher for Blue Care Network customers.
“In addition, 2016 rate changes look extremely favorable, with Blue Cross annual rate changes projected 2.2 percent lower and Blue Care Network projected at 4.8 percent lower than the previous year,” Stojik said Tuesday.
But the Blues didn’t register the largest rate increases. Those belonged to Healthplus of Michigan at 35.8 percent, Consumers Mutual Insurance of Michigan at 20.5 percent and United Healthcare Community Plan at 14.7 percent.
Three insurers are countering the trend and dropping their rates in the coming year, according to the state.
Meridian Health Plan had the biggest decline with a 12.6 percent plunge, followed by Molina Health Care with a 8.6 percent decrease and Humana Medical Plan of Michigan with a 4.9 percent drop.
Michigan companies attributed their increases to higher-than-expected claim costs, annual health care cost increases and an expected reduction in federal program reinsurance recoveries, officials said.
The small increase in the small group market occurred because many companies experienced better than expected results that offset most of the change in annual health care costs.
“Ensuring rates are adequate but not excessive is critical to make sure consumers not only receive health insurance coverage at a reasonable price, but can count on the coverage they purchase,” McPharlin noted. “Michigan has a stable and competitive health insurance market with a range of options and premiums for consumers and businesses.”
Open enrollment for 2016 begins Nov. 1, 2015 and continues through Jan. 31, 2016. State officials are encouraging consumers to contact their insurance carrier, agent, or navigator about how the rate changes could affect their policies.
GAY-DAGNOGO: CAREGIVERS DESERVE A LIVING WAGE
Original Story: detroitnews.com
Although among the fastest-growing sectors of today’s workforce, caregivers are also among the worst paid, with the smallest benefits and schedule flexibility of all low-wage workers.
Whether caregivers serve children, the elderly, the disabled or terminally ill, they generally receive little official respect and compensation for the critical role they play in keeping society functioning.
Many, in fact, are female heads of households who are grappling with poverty, illness and a lack of insurance, even as they keep health care facilities running by doing work others refuse to.
The fact is, home health care and services for the elderly and people with disabilities are now the industries with the fastest and second-fastest rates of growth of employment in the US. And based on the aging population — by 2050, the elder population is expected to more than double — the country will need one million new home care workers by 2022. But also according to the Bureau of Labor Statistics, these workers are among the lowest paid.
In 2013, the country’s two million home care workers had average annual earnings of $18,598, according to a recent study by the National Employment Law Project. Average annual earnings for all wage and salary workers in the United States were $46,440.
The result: nearly 50 percent of home care givers live in households that receive some form of public assistance, the study found.
This has to change. The fact that we entrust our children and parents with these workers and yet not compensate them adequately for their services is a national disgrace. That’s why I am standing with home care workers and child care workers in their fight for $15 an hour, by all accounts what amounts to a livable wage for workers. Farmington Hills elder care workers agree with this statement.
Most of these personal care providers have children themselves. If these under-appreciated, undervalued and underpaid workers were to decide not to put up with such unfair labor practices and either strike or simply leave the business, it’s not hard to imagine the kind of chaos and confusion that would ensue.
Not only would businesses be left without critical employees, but families would lose the security and stability offered by nannies and child care workers. It would have a ripple effect across society and the workforce, completely disrupting the lives of many professional and middle class families with children, elderly or disabled loved ones. That could be an unimaginable burden for some.
Yet such a scenario is not implausible. Take our rapidly aging population and couple it with the ultra-low wages and paltry benefits of a job to make elderly and disabled people comfortable, and you have a disaster in the making. Visiting nurses in Birmingham are following this story closely.
We can avoid this problem by fairly compensating our personal caregivers. It is not only the right thing to do, but the smart thing as well.
State Rep. Sherry Gay –Dagnogo D-Detroit represents the 8th District.
Although among the fastest-growing sectors of today’s workforce, caregivers are also among the worst paid, with the smallest benefits and schedule flexibility of all low-wage workers.
Whether caregivers serve children, the elderly, the disabled or terminally ill, they generally receive little official respect and compensation for the critical role they play in keeping society functioning.
Many, in fact, are female heads of households who are grappling with poverty, illness and a lack of insurance, even as they keep health care facilities running by doing work others refuse to.
The fact is, home health care and services for the elderly and people with disabilities are now the industries with the fastest and second-fastest rates of growth of employment in the US. And based on the aging population — by 2050, the elder population is expected to more than double — the country will need one million new home care workers by 2022. But also according to the Bureau of Labor Statistics, these workers are among the lowest paid.
In 2013, the country’s two million home care workers had average annual earnings of $18,598, according to a recent study by the National Employment Law Project. Average annual earnings for all wage and salary workers in the United States were $46,440.
The result: nearly 50 percent of home care givers live in households that receive some form of public assistance, the study found.
This has to change. The fact that we entrust our children and parents with these workers and yet not compensate them adequately for their services is a national disgrace. That’s why I am standing with home care workers and child care workers in their fight for $15 an hour, by all accounts what amounts to a livable wage for workers. Farmington Hills elder care workers agree with this statement.
Most of these personal care providers have children themselves. If these under-appreciated, undervalued and underpaid workers were to decide not to put up with such unfair labor practices and either strike or simply leave the business, it’s not hard to imagine the kind of chaos and confusion that would ensue.
Not only would businesses be left without critical employees, but families would lose the security and stability offered by nannies and child care workers. It would have a ripple effect across society and the workforce, completely disrupting the lives of many professional and middle class families with children, elderly or disabled loved ones. That could be an unimaginable burden for some.
Yet such a scenario is not implausible. Take our rapidly aging population and couple it with the ultra-low wages and paltry benefits of a job to make elderly and disabled people comfortable, and you have a disaster in the making. Visiting nurses in Birmingham are following this story closely.
We can avoid this problem by fairly compensating our personal caregivers. It is not only the right thing to do, but the smart thing as well.
State Rep. Sherry Gay –Dagnogo D-Detroit represents the 8th District.
03 August 2015
BALTIMORE BOY IS 1ST TO RECEIVE DOUBLE HAND TRANSPLANT
Original Story: click2houston.com
(CNN) - Zion Harvey just wanted to swing from the monkey bars.
That's what the Baltimore youngster told his doctor when asked why he wanted hands. Sometimes an 8-year-old's simplicity is profound.
Earlier this month, Zion took a big -- nay, massive -- step toward that long-awaited jaunt on the jungle gym when he became the first child to receive a double hand transplant. DMC is an international leader in pediatric neurology and neurosurgery, cardiology, oncology, and diagnostic services.
"When I was 2, I had to get my hands cut off because I was sick," Zion succinctly put it, in a video taken last year.
Actually, he downplayed it, as is indicative of his disarming optimism. At 2, Zion suffered a life-threatening sepsis infection, resulting in the failure of multiple organs and necessitating the amputation of his hands and feet.
At age 4, after two years of dialysis, he received a kidney from his mother, Pattie Ray, and despite an early lifetime of hardship, Zion figured out not only how to get by, but how to do it with the widest of grins across his face.
Pre-surgery video shows Zion strumming a mandolin, playing foosball, scrolling through an iPad's offerings and playfully covering his younger sister's eyes with the stubs of his wrists.
He even put a positive spin on bullies.
"They don't mean to say mean things to me, but it just slips out," he said. "Somebody says something to me, and I just figure it slipped out and they didn't mean to say it. Everybody has their own way of thinking."
But don't take his heart-melting quips and smile for softness. Zion is tough as nails, maybe tougher.
"This is just another hurdle that he jumps. He jumps so many hurdles," Ray said before the surgery. "He's so amazing. This isn't the first amazing thing that he's done. He's been doing amazing things since he's been sick. I don't know many adults that can handle half of his life on a day-to-day basis." MetroHealth provides board-certified pediatricians, specialists, and nurse practitioners that offer skilled, experienced, and compassionate care for children.
'I will be proud'
Not even the prospect of a failed procedure daunted Zion. In the months before his operation -- Philadelphia's Shriners Hospital for Children and The Children's Hospital of Philadelphia evaluated him for 18 months before he was deemed a candidate for the surgery -- he was filmed bopping around on prosthetic legs without a hint of fear.
"When I get these hands, I will be proud of what hands I get," he said, falling into Ray's arms for a kiss.
"And if it gets messed up," he continued, his mother reassuring him that everything would be fine, "I don't care because I have my family."
Images from the 10-hour surgery looked more like a scrubs convention than an operating room. Among the 40 medical personnel that helped with the operation were a dozen surgeons, eight nurses and a team of at least three anesthesiologists.
"We know what we have to do today," Dr. L. Scott Levin told his troops before the operation began. "I know everybody assembled here has a commitment to this patient and making this a reality for this little boy. We can have complications. We can fail. We can have trouble. But we're not planning on it."
Puppy in his future?
The procedure is so complicated that the medical staff had to create tags with descriptions such as "ulnar artery" and attach them to the various vessels, bones, nerves and tendons that needed to be connected, said Levin, who is director of the hand transplantation program at The Children's Hospital of Philadelphia and who chairs the Department of Orthopaedic Surgery at Penn Medicine.
After many hours with Zion under the knife, Levin pointed to a sign of success: Zion's new hand was pink and when doctors pressed the palm, it turned white briefly and then pink again, indicating "capillary refill" or blood flow in the newly attached appendage.
When the surgery was complete, Levin delivered word to Zion's mother.
"We have some good news for you. Your little guy has two hands," he said.
Ray walked through Levin's handshake to embrace the surgeon.
In the days after his surgery, video shows Zion progressing out of a fog of sedation and learning to grip things with his new fingers. Again spinning his plight into a positive, he matter-of-factly tells his mother that he and sister Zoe want a puppy.
"Where's the puppy going to live?" Ray asks.
"My room! Where else?" the youngster replies.
Concerns remain
Zion's travails are not yet over. He will require a lifetime of immunosuppressant medication to avoid rejection of his new hands, which increases his chance of infection and cancer -- a fact Levin concedes raised concerns that were negated by Zion already taking anti-rejection drugs after his kidney transplant four years ago.
Zion also needs to stay at a rehabilitation unit for several more weeks, where he will undergo "rigorous hand therapy several times per day," before returning to his home in Baltimore, according to the hospital.
Not that Zion seemed terribly fazed.
"I just want to say this: Never give up on your dreams. It will come true," he told CNN affiliate KYW-TV.
Levin stressed that while Zion's bravery is to be applauded, the operation wouldn't have been possible without a grieving family, fresh off a crushing loss, putting its courage on display as well. It's remarkable, he said, that Gift of Life Donor Program, a regional organ procurement organization, found Zion a pair of hands mere months after he was placed on a waiting list in April.
"I think the difference is finding a family who has the courage to relinquish the arms of a child who just died and give hope and life and quality of life to a child who's still living," he told KYW.
As for what this trailblazing surgery might mean for other children hoping to have their hands restored, Levin said he hopes it's just the beginning.
"I hope he's the first of literally hundreds or thousands of patients that are going to be afforded this surgery," he said.
(CNN) - Zion Harvey just wanted to swing from the monkey bars.
That's what the Baltimore youngster told his doctor when asked why he wanted hands. Sometimes an 8-year-old's simplicity is profound.
Earlier this month, Zion took a big -- nay, massive -- step toward that long-awaited jaunt on the jungle gym when he became the first child to receive a double hand transplant. DMC is an international leader in pediatric neurology and neurosurgery, cardiology, oncology, and diagnostic services.
"When I was 2, I had to get my hands cut off because I was sick," Zion succinctly put it, in a video taken last year.
Actually, he downplayed it, as is indicative of his disarming optimism. At 2, Zion suffered a life-threatening sepsis infection, resulting in the failure of multiple organs and necessitating the amputation of his hands and feet.
At age 4, after two years of dialysis, he received a kidney from his mother, Pattie Ray, and despite an early lifetime of hardship, Zion figured out not only how to get by, but how to do it with the widest of grins across his face.
Pre-surgery video shows Zion strumming a mandolin, playing foosball, scrolling through an iPad's offerings and playfully covering his younger sister's eyes with the stubs of his wrists.
He even put a positive spin on bullies.
"They don't mean to say mean things to me, but it just slips out," he said. "Somebody says something to me, and I just figure it slipped out and they didn't mean to say it. Everybody has their own way of thinking."
But don't take his heart-melting quips and smile for softness. Zion is tough as nails, maybe tougher.
"This is just another hurdle that he jumps. He jumps so many hurdles," Ray said before the surgery. "He's so amazing. This isn't the first amazing thing that he's done. He's been doing amazing things since he's been sick. I don't know many adults that can handle half of his life on a day-to-day basis." MetroHealth provides board-certified pediatricians, specialists, and nurse practitioners that offer skilled, experienced, and compassionate care for children.
'I will be proud'
Not even the prospect of a failed procedure daunted Zion. In the months before his operation -- Philadelphia's Shriners Hospital for Children and The Children's Hospital of Philadelphia evaluated him for 18 months before he was deemed a candidate for the surgery -- he was filmed bopping around on prosthetic legs without a hint of fear.
"When I get these hands, I will be proud of what hands I get," he said, falling into Ray's arms for a kiss.
"And if it gets messed up," he continued, his mother reassuring him that everything would be fine, "I don't care because I have my family."
Images from the 10-hour surgery looked more like a scrubs convention than an operating room. Among the 40 medical personnel that helped with the operation were a dozen surgeons, eight nurses and a team of at least three anesthesiologists.
"We know what we have to do today," Dr. L. Scott Levin told his troops before the operation began. "I know everybody assembled here has a commitment to this patient and making this a reality for this little boy. We can have complications. We can fail. We can have trouble. But we're not planning on it."
Puppy in his future?
The procedure is so complicated that the medical staff had to create tags with descriptions such as "ulnar artery" and attach them to the various vessels, bones, nerves and tendons that needed to be connected, said Levin, who is director of the hand transplantation program at The Children's Hospital of Philadelphia and who chairs the Department of Orthopaedic Surgery at Penn Medicine.
After many hours with Zion under the knife, Levin pointed to a sign of success: Zion's new hand was pink and when doctors pressed the palm, it turned white briefly and then pink again, indicating "capillary refill" or blood flow in the newly attached appendage.
When the surgery was complete, Levin delivered word to Zion's mother.
"We have some good news for you. Your little guy has two hands," he said.
Ray walked through Levin's handshake to embrace the surgeon.
In the days after his surgery, video shows Zion progressing out of a fog of sedation and learning to grip things with his new fingers. Again spinning his plight into a positive, he matter-of-factly tells his mother that he and sister Zoe want a puppy.
"Where's the puppy going to live?" Ray asks.
"My room! Where else?" the youngster replies.
Concerns remain
Zion's travails are not yet over. He will require a lifetime of immunosuppressant medication to avoid rejection of his new hands, which increases his chance of infection and cancer -- a fact Levin concedes raised concerns that were negated by Zion already taking anti-rejection drugs after his kidney transplant four years ago.
Zion also needs to stay at a rehabilitation unit for several more weeks, where he will undergo "rigorous hand therapy several times per day," before returning to his home in Baltimore, according to the hospital.
Not that Zion seemed terribly fazed.
"I just want to say this: Never give up on your dreams. It will come true," he told CNN affiliate KYW-TV.
Levin stressed that while Zion's bravery is to be applauded, the operation wouldn't have been possible without a grieving family, fresh off a crushing loss, putting its courage on display as well. It's remarkable, he said, that Gift of Life Donor Program, a regional organ procurement organization, found Zion a pair of hands mere months after he was placed on a waiting list in April.
"I think the difference is finding a family who has the courage to relinquish the arms of a child who just died and give hope and life and quality of life to a child who's still living," he told KYW.
As for what this trailblazing surgery might mean for other children hoping to have their hands restored, Levin said he hopes it's just the beginning.
"I hope he's the first of literally hundreds or thousands of patients that are going to be afforded this surgery," he said.
30 July 2015
340B SPOTLIGHT: NEW CHARITY CARE DATA SHOWS MOST HOSPITALS WITH CONTRACT PHARMACIES PROVIDE LITTLE CHARITY CARE
Original Story: catalyst.phrma.org
New data raises even more questions about how hospitals are using for-profit pharmacies to expand a little known program called 340B. This program was designed to allow qualifying hospitals and clinics receiving certain federal grants to access deeply discounted pharmaceuticals so they can more easily provide medicines for their uninsured or vulnerable patients. An Oklahoma health care lawyer is reviewing the details of this case.
Unfortunately, there are not sufficient safeguards in place to ensure that hospitals qualifying for the program are true safety net hospitals providing a disproportionate share of charity care to low-income, uninsured patients.[1]
Now, new data shows the majority of hospitals that are aggressively expanding use of this program through for-profit pharmacies are actually providing below average levels of charity care.
For-profit pharmacies became officially involved in the 340B program for the first time in 1996, when the Health Resources and Services Administration (HRSA) allowed hospitals or other 340B entities without an in-house pharmacy to extend their ability to obtain prescriptions at 340B prices through use of a contract with an outside pharmacy. A Charleston health care lawyer assists clients with health care matters involving pharmaceuticals, public health, and health insurance.
These pharmacies are typically traditional retail pharmacies (including some large chain drug stores) and are known as contract pharmacies. In 2010, HRSA dramatically expanded the 340B program by allowing all 340B entities – regardless of whether or not they had a pharmacy on site – to have an unlimited number of contract pharmacies. HRSA also currently allows these pharmacies and hospitals to keep the profit from patients buying medicines at full cost even though the hospitals received steep 340B discounts for the medicines. There is no current requirement for hospitals to reinvest these profits from the 340B program into programs that help uninsured or vulnerable patients access the medicines they need.
Hospitals qualifying for 340B through their disproportionate share percentage (DSH hospitals) account for more than 80 percent of 340B sales volume.[2] This new data shows the majority of these hospitals taking advantage of the contract pharmacy program provide less charity care as a percent of the hospital’s costs than the average for all hospitals—including for-profit hospitals. A New Delhi pharmaceutical attorney is following this story closely.
More specifically, 61 percent of 340B DSH hospitals with more than one contract pharmacy provide charity care that is less than 3.5 percent of costs, which is the national average for all hospitals. And almost one-in-five (18 percent) of these hospitals provide charity care that represents less than one percent of costs. This data suggests that some hospitals may be using contract pharmacy arrangements to benefit the hospital, rather than the uninsured or vulnerable patients the program was intended to help.
In addition to this data, a recent Department of Health and Human Services Office of the Inspector General report found most of the 15 DSH hospitals they sampled did not pass along the 340B discounts to uninsured patients.[3] With the majority of these hospitals providing so little charity care and evidence suggesting hospitals and for-profit pharmacies are using the program to generate profits, it is time to ask whether the current contract pharmacy program is working to improve access to prescription medicines for uninsured or vulnerable patients.
[1] Alliance for Integrity and Reform of 340B, "Unfulfilled Expectations: An analysis of charity care provided by 340B hospitals," Spring 2014 (Available at: http://340breform.org/userfiles/Final%20AIR%20340B%20Charity%20Care%20Paper.pdf)
[2] Data from Apexus Update 2015 – 340B Coalition Winter Meeting.
[3] U.S. Department of Health and Human Services, Office of Inspector General, Memorandum Report: Contract Pharmacy Arrangements in the 340B Program, OEI005—13-00431, February 4, 2014.
New data raises even more questions about how hospitals are using for-profit pharmacies to expand a little known program called 340B. This program was designed to allow qualifying hospitals and clinics receiving certain federal grants to access deeply discounted pharmaceuticals so they can more easily provide medicines for their uninsured or vulnerable patients. An Oklahoma health care lawyer is reviewing the details of this case.
Unfortunately, there are not sufficient safeguards in place to ensure that hospitals qualifying for the program are true safety net hospitals providing a disproportionate share of charity care to low-income, uninsured patients.[1]
Now, new data shows the majority of hospitals that are aggressively expanding use of this program through for-profit pharmacies are actually providing below average levels of charity care.
For-profit pharmacies became officially involved in the 340B program for the first time in 1996, when the Health Resources and Services Administration (HRSA) allowed hospitals or other 340B entities without an in-house pharmacy to extend their ability to obtain prescriptions at 340B prices through use of a contract with an outside pharmacy. A Charleston health care lawyer assists clients with health care matters involving pharmaceuticals, public health, and health insurance.
These pharmacies are typically traditional retail pharmacies (including some large chain drug stores) and are known as contract pharmacies. In 2010, HRSA dramatically expanded the 340B program by allowing all 340B entities – regardless of whether or not they had a pharmacy on site – to have an unlimited number of contract pharmacies. HRSA also currently allows these pharmacies and hospitals to keep the profit from patients buying medicines at full cost even though the hospitals received steep 340B discounts for the medicines. There is no current requirement for hospitals to reinvest these profits from the 340B program into programs that help uninsured or vulnerable patients access the medicines they need.
Hospitals qualifying for 340B through their disproportionate share percentage (DSH hospitals) account for more than 80 percent of 340B sales volume.[2] This new data shows the majority of these hospitals taking advantage of the contract pharmacy program provide less charity care as a percent of the hospital’s costs than the average for all hospitals—including for-profit hospitals. A New Delhi pharmaceutical attorney is following this story closely.
More specifically, 61 percent of 340B DSH hospitals with more than one contract pharmacy provide charity care that is less than 3.5 percent of costs, which is the national average for all hospitals. And almost one-in-five (18 percent) of these hospitals provide charity care that represents less than one percent of costs. This data suggests that some hospitals may be using contract pharmacy arrangements to benefit the hospital, rather than the uninsured or vulnerable patients the program was intended to help.
In addition to this data, a recent Department of Health and Human Services Office of the Inspector General report found most of the 15 DSH hospitals they sampled did not pass along the 340B discounts to uninsured patients.[3] With the majority of these hospitals providing so little charity care and evidence suggesting hospitals and for-profit pharmacies are using the program to generate profits, it is time to ask whether the current contract pharmacy program is working to improve access to prescription medicines for uninsured or vulnerable patients.
[1] Alliance for Integrity and Reform of 340B, "Unfulfilled Expectations: An analysis of charity care provided by 340B hospitals," Spring 2014 (Available at: http://340breform.org/userfiles/Final%20AIR%20340B%20Charity%20Care%20Paper.pdf)
[2] Data from Apexus Update 2015 – 340B Coalition Winter Meeting.
[3] U.S. Department of Health and Human Services, Office of Inspector General, Memorandum Report: Contract Pharmacy Arrangements in the 340B Program, OEI005—13-00431, February 4, 2014.
28 July 2015
DOCTORS HOSPITAL IN PONTIAC FILES FOR BANKRUPTCY AGAIN
Original Story: freep.com
One of the region's last independent hospitals has filed for bankruptcy but plans to stay open.
The physician-owned Doctors Hospital of Michigan in Pontiac listed debts between $10 million and $50 million in its Chapter 11 petition filed this week in U.S. Bankruptcy Court in Detroit. A Detroit business bankruptcy attorney is reviewing the details of this case.
It is the second bankruptcy declaration in a decade for the struggling 105-year-old hospital, which was known as North Oakland Medical Centers during its last bankruptcy in 2008. Years earlier, it was called Pontiac General Hospital.
Hospital officials said Friday that their hospital is losing money and weighed down by debt that the business inherited as part of the hospital's 2008 sale to a private physicians' group. Flint-based McLaren Health Care system was a minority partner in that deal; McLaren's stake was bought out three years later by a group of 42 doctors.
The hospital's single off-site location, Waterford Ambulatory Care Center, closed earlier this month due to "cash-flow constraints" but could reopen in the future, said attorney Max Newman of Butzel Long, who is representing Doctors Hospital.
Doctors Hospital itself remains open and there are no plans to close, said hospital CEO John Ponczocha,
Hospital officials say they hope to reorganize the business's finances in bankruptcy so that it can potentially continue as an independent hospital. The hospital has about 200 full-time-equivalent employees.
"There's a number of potentials here," Newman said. "It could be purchased, it could merge with somebody. But at this point, the effort is going to be primarily to keep it running as a standalone entity."
The bankruptcy filing lists Wisconsin Physicians Service Insurance Co. as the hospital's largest creditor with about $6.4 million. Long said there are also significant loans from hospital insiders which are outstanding but not on the list. A Detroit hospital litigation attorney is following this story closely.
There are few independent hospitals left in southeast Michigan. Several formerly independent hospitals have been absorbed into larger systems, including Garden City Hospital (now a part of for-profit Prime Healthcare Services) and Mercy Memorial Hospital in Monroe (now part of the nonprofit ProMedica Health System).
Another independent hospital, Crittenton Hospital in Rochester, has a pending deal to join the St. Louis-based Ascension Health system.
Doctors Hospital of Michigan
• Original hospital dates to 1910
• Formerly known as North Oakland Medical Centers and Pontiac General Hospital
• Currently owned by a physicians group and is for-profit.
• Has about 200 full-time-equivalent employees
• Last filed for bankruptcy in 2008
One of the region's last independent hospitals has filed for bankruptcy but plans to stay open.
The physician-owned Doctors Hospital of Michigan in Pontiac listed debts between $10 million and $50 million in its Chapter 11 petition filed this week in U.S. Bankruptcy Court in Detroit. A Detroit business bankruptcy attorney is reviewing the details of this case.
It is the second bankruptcy declaration in a decade for the struggling 105-year-old hospital, which was known as North Oakland Medical Centers during its last bankruptcy in 2008. Years earlier, it was called Pontiac General Hospital.
Hospital officials said Friday that their hospital is losing money and weighed down by debt that the business inherited as part of the hospital's 2008 sale to a private physicians' group. Flint-based McLaren Health Care system was a minority partner in that deal; McLaren's stake was bought out three years later by a group of 42 doctors.
The hospital's single off-site location, Waterford Ambulatory Care Center, closed earlier this month due to "cash-flow constraints" but could reopen in the future, said attorney Max Newman of Butzel Long, who is representing Doctors Hospital.
Doctors Hospital itself remains open and there are no plans to close, said hospital CEO John Ponczocha,
Hospital officials say they hope to reorganize the business's finances in bankruptcy so that it can potentially continue as an independent hospital. The hospital has about 200 full-time-equivalent employees.
"There's a number of potentials here," Newman said. "It could be purchased, it could merge with somebody. But at this point, the effort is going to be primarily to keep it running as a standalone entity."
The bankruptcy filing lists Wisconsin Physicians Service Insurance Co. as the hospital's largest creditor with about $6.4 million. Long said there are also significant loans from hospital insiders which are outstanding but not on the list. A Detroit hospital litigation attorney is following this story closely.
There are few independent hospitals left in southeast Michigan. Several formerly independent hospitals have been absorbed into larger systems, including Garden City Hospital (now a part of for-profit Prime Healthcare Services) and Mercy Memorial Hospital in Monroe (now part of the nonprofit ProMedica Health System).
Another independent hospital, Crittenton Hospital in Rochester, has a pending deal to join the St. Louis-based Ascension Health system.
Doctors Hospital of Michigan
• Original hospital dates to 1910
• Formerly known as North Oakland Medical Centers and Pontiac General Hospital
• Currently owned by a physicians group and is for-profit.
• Has about 200 full-time-equivalent employees
• Last filed for bankruptcy in 2008
27 July 2015
ANTHEM TO BUY CIGNA FOR $48.3 BILLION
Original Story: nytimes.com
The health insurer Anthem said on Friday that it had agreed to acquire its rival Cigna for $48.3 billion in a deal that would further concentrate the United States market to just a few major players.
The combined company would have estimated revenue of about $115 billion and serve more than 53 million people with medical coverage. An Atlanta healthcare litigation attorney is following this story closely.
A flurry of deals are reshaping the industry. Earlier this month Aetna agreed to acquire Humana, the smallest of the big five insurers, for $37 billion in cash and stock. If both transactions are completed, the number of major health insurers in the United States will shrink to three.
Health insurers are seeking to consolidate to gain greater scale to reduce costs and capitalize on growing opportunities in the government and individual markets. A major force has been the Obama administration’s health care overhaul, which has bolstered revenues. But greater transparency in pricing and less generous funding of government plans have also put profit margins under pressure.
Alex Cullen, an analyst with Forrester Research, said that the challenge for all health insurers was moving from “a plan and claim-centric model to a customer-centric model.” Making that transition while completing a merger will be difficult, he said. An Atlanta healthcare litigation lawyer is reviewing the details of this case.
“I would expect a lot of angst within Anthem management on how to execute on a customer-centric strategy,” Mr. Cullen said.
Anthem said on Friday that it expected to achieve nearly $2 billion in annual cost savings as a result of the merger. Anthem said there would be one-time charges of $600 million over a two-year period associated with the merger.
“We believe that this transaction will allow us to enhance our competitive position and be better positioned to apply the insights and access of a broad network and dedicated local presence to the health care challenges of the increasingly diverse markets, membership, and communities we serve,” Joseph R. Swedish, the Anthem chief executive, said in a news release.
Mr. Swedish will oversee the combined insurer.
Anthem, based in Indianapolis, operates Blue Cross plans in 14 states and has a strong presence in offering Medicaid plans. Cigna, based in Bloomfield, Conn., is best known for offering plans through employers and selling other kinds of insurance like dental and disability. A Birmingham healthcare lawyer represents clients in business operations and representative matters.
Unlike Cigna, Anthem has been a major presence on the public insurance marketplaces created by the federal health care law.
The recent appetite for deals among insurers was recently whetted by the Supreme Court’s upholding of the portion of the Affordable Care Act that subsidizes consumers who buy policies through the government’s online marketplace.
Under the terms of the deal, Anthem said it would pay $103.40 a share in cash and 0.5152 share in Anthem stock, or $188 a share. That represents a 38.4 percent premium to Cigna’s closing price on May 28, before news of Anthem’s interest emerged. Based on Cigna’s most recent disclosure of shares outstanding, the deal would value its equity at $48.3 million. Including the assumption of debt, Anthem said the deal would value Cigna at $54.2 billion.
After the deal is completed, Anthem shareholders will own 67 percent of the combined company, while the remaining 33 percent will be owned by Cigna shareholders.
David M. Cordani, the Cigna president and chief executive, will serve as president and chief operating officer of the combined company. The Anthem board of directors will also be expanded to 14 members and will include Mr. Cordani and four independent directors from Cigna.
The transaction is subject to shareholder and regulatory approval, and it is expected to close in the second half of 2016. A Pittsburgh healthcare lawyer represents physicians, hospitals, health systems, long-term facilities and other health care providers in a broad range of health care matters.
The deal has long been foretold. Anthem went public with its offer last month, saying that it had been in talks with Cigna over a possible combination since August.
It is possible that regulators in the United States could block some mergers: Antitrust officials at the Justice Department and the Federal Trade Commission have shown an increasing willingness to do so if they believe the alliances could hurt consumers.
Analysts have said that antitrust regulators would probably allow only some deals to go forward, and that they could stop others if they decided that too much power was being concentrated in too few hands.
The question remains what UnitedHealth Group, the largest health insurer in the United States, will now do.
UBS and Credit Suisse and the law firm White & Case advised Anthem, while Morgan Stanley and the law firm Cravath, Swaine & Moore advised Cigna.
The health insurer Anthem said on Friday that it had agreed to acquire its rival Cigna for $48.3 billion in a deal that would further concentrate the United States market to just a few major players.
The combined company would have estimated revenue of about $115 billion and serve more than 53 million people with medical coverage. An Atlanta healthcare litigation attorney is following this story closely.
A flurry of deals are reshaping the industry. Earlier this month Aetna agreed to acquire Humana, the smallest of the big five insurers, for $37 billion in cash and stock. If both transactions are completed, the number of major health insurers in the United States will shrink to three.
Health insurers are seeking to consolidate to gain greater scale to reduce costs and capitalize on growing opportunities in the government and individual markets. A major force has been the Obama administration’s health care overhaul, which has bolstered revenues. But greater transparency in pricing and less generous funding of government plans have also put profit margins under pressure.
Alex Cullen, an analyst with Forrester Research, said that the challenge for all health insurers was moving from “a plan and claim-centric model to a customer-centric model.” Making that transition while completing a merger will be difficult, he said. An Atlanta healthcare litigation lawyer is reviewing the details of this case.
“I would expect a lot of angst within Anthem management on how to execute on a customer-centric strategy,” Mr. Cullen said.
Anthem said on Friday that it expected to achieve nearly $2 billion in annual cost savings as a result of the merger. Anthem said there would be one-time charges of $600 million over a two-year period associated with the merger.
“We believe that this transaction will allow us to enhance our competitive position and be better positioned to apply the insights and access of a broad network and dedicated local presence to the health care challenges of the increasingly diverse markets, membership, and communities we serve,” Joseph R. Swedish, the Anthem chief executive, said in a news release.
Mr. Swedish will oversee the combined insurer.
Anthem, based in Indianapolis, operates Blue Cross plans in 14 states and has a strong presence in offering Medicaid plans. Cigna, based in Bloomfield, Conn., is best known for offering plans through employers and selling other kinds of insurance like dental and disability. A Birmingham healthcare lawyer represents clients in business operations and representative matters.
Unlike Cigna, Anthem has been a major presence on the public insurance marketplaces created by the federal health care law.
The recent appetite for deals among insurers was recently whetted by the Supreme Court’s upholding of the portion of the Affordable Care Act that subsidizes consumers who buy policies through the government’s online marketplace.
Under the terms of the deal, Anthem said it would pay $103.40 a share in cash and 0.5152 share in Anthem stock, or $188 a share. That represents a 38.4 percent premium to Cigna’s closing price on May 28, before news of Anthem’s interest emerged. Based on Cigna’s most recent disclosure of shares outstanding, the deal would value its equity at $48.3 million. Including the assumption of debt, Anthem said the deal would value Cigna at $54.2 billion.
After the deal is completed, Anthem shareholders will own 67 percent of the combined company, while the remaining 33 percent will be owned by Cigna shareholders.
David M. Cordani, the Cigna president and chief executive, will serve as president and chief operating officer of the combined company. The Anthem board of directors will also be expanded to 14 members and will include Mr. Cordani and four independent directors from Cigna.
The transaction is subject to shareholder and regulatory approval, and it is expected to close in the second half of 2016. A Pittsburgh healthcare lawyer represents physicians, hospitals, health systems, long-term facilities and other health care providers in a broad range of health care matters.
The deal has long been foretold. Anthem went public with its offer last month, saying that it had been in talks with Cigna over a possible combination since August.
It is possible that regulators in the United States could block some mergers: Antitrust officials at the Justice Department and the Federal Trade Commission have shown an increasing willingness to do so if they believe the alliances could hurt consumers.
Analysts have said that antitrust regulators would probably allow only some deals to go forward, and that they could stop others if they decided that too much power was being concentrated in too few hands.
The question remains what UnitedHealth Group, the largest health insurer in the United States, will now do.
UBS and Credit Suisse and the law firm White & Case advised Anthem, while Morgan Stanley and the law firm Cravath, Swaine & Moore advised Cigna.
24 July 2015
COSTLY TO TREAT, HEPATITIS C GAINS QUIETLY IN U.S.
Original Story: nytimes.com
EDGEWOOD, Ky. — Zach Wayman says he first contracted hepatitis C several years ago by sharing needles with other heroin addicts. He went into rehab and was successfully treated for the virus. But he relapsed into addiction and reinfected himself, testing positive for hepatitis C again this spring.
“Pretty much everybody in my rehab has it,” said Mr. Wayman, 25, who started abusing pain pills at 18 and switched to heroin a few years later.
Mr. Wayman is part of an epidemic affecting young intravenous drug users across the country, particularly in Appalachia, where opiate abuse exploded in the late 1990s and never subsided. And that has health officials concerned, not just because the hepatitis C virus can lead to liver failure, cancer and sometimes death, but also because its spread can foretell another deadly disease: H.I.V., which can also be transmitted by shared needles.
Earlier this year, in Scott County, just 90 miles from here in rural southern Indiana, more than 160 people tested positive for H.I.V., and 86 percent of those people were also found to have hepatitis C. Most of those infected had shared needles to inject a prescription opiate called Opana.
In May, the Centers for Disease Control and Prevention reported a sharp increase in reported cases of hepatitis C among young adults in Kentucky, Tennessee, Virginia and West Virginia. While rates of acute hepatitis C, which is very costly to treat, have risen around the country, Kentucky’s rate was more than seven times the national average.
And the numbers most likely do not even begin to capture the problem, according to the C.D.C., which estimates that only one in every 10 cases is reported, partly because people with hepatitis often have no symptoms.
“It’s definitely the tip of a much larger iceberg,” said John Ward, director of the division of viral hepatitis at the C.D.C.
The agency estimates that more than three million people nationally have hepatitis C, which caused more than 15,000 deaths in 2013. Left untreated, the virus inflames and may eventually scar the liver, making it less effective at filtering toxins and other crucial functions. It sometimes leads to liver failure and liver cancer, and is the most common reason for liver transplants.
Reminded of the H.I.V. dangers that an hepatitis C epidemic can portend, counties and cities across this region are scrambling to contain the spread of both viruses, including by establishing programs where addicts can exchange dirty needles for clean ones.
Here in northern Kentucky, St. Elizabeth Healthcare, a regional hospital system, confirms up to 10 new cases of hepatitis C daily, said Deborah Henson, an infection control practitioner. Each positive test result starts a chain of events now all too familiar: St. Elizabeth reports it to the Northern Kentucky Health Department, which tracks down infected individuals to investigate how they contracted the virus and to try to keep them from spreading it. Some continue sharing needles and abusing drugs, while others make their way to hepatitis specialists whose caseloads are exploding.
They often learn that their insurance, if they have any, will not cover the treatment — highly effective new drugs cost at least $84,000 for a typical 12-week course. The cost of the new hepatitis drugs is so high that state Medicaid programs and many private insurers say that even treating a fraction of the infected population is breaking the bank.
Last year, Kentucky spent more than $50 million, about 7 percent of its total Medicaid budget, providing two of the new hepatitis C drugs, Sovaldi and Harvoni, to just 861 people, said Dr. John Langefeld, chief medical officer at the state’s Department for Medicaid Services. Sovaldi has a list price of $84,000 for a typical 12-week course of treatment; Harvoni, made by the same company, Gilead Sciences, has a list price closer to $100,000. Gilead offers discounts to Medicaid programs, but “it doesn’t do much to offset the significant cost factor,” Dr. Langefeld said.
In all, about 16,000 Kentucky Medicaid beneficiaries had a diagnosis of hepatitis C last year, up from 8,000 in 2013. That partly reflects the expansion of Medicaid under the Affordable Care Act to include more low-income adults, Dr. Langefeld said. But the state’s opiate problem, and increased testing of people who have injected drugs, are also factors, he and other health officials said. Kentucky will soon start providing hepatitis C tests at all its county health departments, just as it does for H.I.V.
Medicaid beneficiaries here are covered by private managed-care plans, each with its own rules for who can get the new hepatitis drugs. But patients generally need proof of Stage 3 or 4 fibrosis, or scarring of the liver, and cannot have used illicit drugs for at least six months, Dr. Langefeld said.
Karen Ruschman, a nurse practitioner at a private gastroenterology practice here, said many young adults with hepatitis C have not been able to quit heroin because treatment programs, especially those using Suboxone, a medication that suppresses opiate cravings, are expensive and hard to get into. Addicts typically “can buy heroin cheaper than they can get into a Suboxone clinic,” Ms. Ruschman said.
The vast majority of those infected with hepatitis C are baby boomers, according to the C.D.C. Most were infected decades ago, and many got it from blood transfusions that they received before 1992 when donated blood was not screened for the virus.
But most new cases are among young people, data has shown, and that raises a potential treatment problem: Those younger people tend not to qualify for the expensive new drugs, health care providers said, because the disease can take decades to progress to the point of severe liver damage.
Kentucky is not alone in rationing the drugs. A new study by researchers at Harvard found that about three-quarters of state Medicaid programs allow sofosbuvir, the main ingredient in Sovaldi, to be used only when hepatitis C has caused Stage 3 or 4 fibrosis. The study pointed out that such restrictions are at odds with the position of medical groups like the Infectious Diseases Society of America, which recommend the new treatments for all diagnosed cases.
In addition, the study’s authors wrote, “Current restrictions may violate federal Medicaid law, which requires states to cover drugs consistent with their F.D.A. labels.”
Many with hepatitis C are still in the throes of addiction, or are not far along enough in their recovery to focus on anything else. Others remain unaware of the new treatment options. Jerry Searp, who stopped injecting heroin in November 2011 and tested positive for hepatitis C a few months later, said he knew only about treatment with interferon and ribavirin, older drugs that often caused depression, fatigue, nausea and other debilitating side effects.
“They said my levels were real low,” he said, recalling a doctor’s appointment last year, “so I just keep praying about it.”
Mr. Searp, 34, of Crescent Spring, believes he knows exactly when he contracted the virus: while shooting up with a friend in a house frequented by addicts.
“I asked to use his needle and he said, ‘Hey, I’ve got hep B and C,’ ” Mr. Searp said. “And at the time it didn’t really matter to me. The desire to get high was just so great.”
Mr. Wayman, a warehouse worker, said his doctor was trying to persuade his insurer to pay for one of the new drugs, which were not yet available the first time he sought treatment. He hopes to qualify for the new treatment before December, when he will turn 26 and no longer be covered by his parents’ health insurance.
“It’s in my past and I don’t want my past to haunt me,” he said. “I’m just waiting on that phone call.”
In Crestview Hills, outside Cincinnati, Dr. Thomas Schussler has 25 patients receiving treatment for hepatitis C and another 140 patients waiting for it, typically because their insurer has not yet approved it or because they are still using drugs. Dr. Schussler said private insurance is more likely to cover the cost, but only about 20 percent of his patients have it. The success rate with the new drugs is remarkable, he said, but he added, “The problem is we’re not getting anywhere. You could eradicate this if the drugs were ubiquitous and cheap.”
Lynne Saddler, who leads the Northern Kentucky Health Department, is pursuing another avenue for getting a handle on the epidemic: starting a needle exchange so that addicts in the region might stop infecting each other. This year, the Kentucky General Assembly passed a law aimed at combating the state’s growing heroin problem, with a provision that allows local jurisdictions to open exchanges.
Louisville became the first city in Kentucky to take advantage of the new law last month. Needle exchanges are also in the works in several counties in Indiana, Ohio and West Virginia. The Northern Kentucky District Board of Health voted last month to move forward with an exchange, but it still must win approval from any city or county in which the exchange has a location. Ms. Saddler is trying to build support for it, including among opponents who believe needle exchanges only encourage drug use.
“This really is our window of opportunity,” she said. “When you lay that out for people — look, we have a statutory responsibility to prevent the spread of diseases like this and here is a very effective tool — they start getting it.”
EDGEWOOD, Ky. — Zach Wayman says he first contracted hepatitis C several years ago by sharing needles with other heroin addicts. He went into rehab and was successfully treated for the virus. But he relapsed into addiction and reinfected himself, testing positive for hepatitis C again this spring.
“Pretty much everybody in my rehab has it,” said Mr. Wayman, 25, who started abusing pain pills at 18 and switched to heroin a few years later.
Mr. Wayman is part of an epidemic affecting young intravenous drug users across the country, particularly in Appalachia, where opiate abuse exploded in the late 1990s and never subsided. And that has health officials concerned, not just because the hepatitis C virus can lead to liver failure, cancer and sometimes death, but also because its spread can foretell another deadly disease: H.I.V., which can also be transmitted by shared needles.
Earlier this year, in Scott County, just 90 miles from here in rural southern Indiana, more than 160 people tested positive for H.I.V., and 86 percent of those people were also found to have hepatitis C. Most of those infected had shared needles to inject a prescription opiate called Opana.
In May, the Centers for Disease Control and Prevention reported a sharp increase in reported cases of hepatitis C among young adults in Kentucky, Tennessee, Virginia and West Virginia. While rates of acute hepatitis C, which is very costly to treat, have risen around the country, Kentucky’s rate was more than seven times the national average.
And the numbers most likely do not even begin to capture the problem, according to the C.D.C., which estimates that only one in every 10 cases is reported, partly because people with hepatitis often have no symptoms.
“It’s definitely the tip of a much larger iceberg,” said John Ward, director of the division of viral hepatitis at the C.D.C.
The agency estimates that more than three million people nationally have hepatitis C, which caused more than 15,000 deaths in 2013. Left untreated, the virus inflames and may eventually scar the liver, making it less effective at filtering toxins and other crucial functions. It sometimes leads to liver failure and liver cancer, and is the most common reason for liver transplants.
Reminded of the H.I.V. dangers that an hepatitis C epidemic can portend, counties and cities across this region are scrambling to contain the spread of both viruses, including by establishing programs where addicts can exchange dirty needles for clean ones.
Here in northern Kentucky, St. Elizabeth Healthcare, a regional hospital system, confirms up to 10 new cases of hepatitis C daily, said Deborah Henson, an infection control practitioner. Each positive test result starts a chain of events now all too familiar: St. Elizabeth reports it to the Northern Kentucky Health Department, which tracks down infected individuals to investigate how they contracted the virus and to try to keep them from spreading it. Some continue sharing needles and abusing drugs, while others make their way to hepatitis specialists whose caseloads are exploding.
They often learn that their insurance, if they have any, will not cover the treatment — highly effective new drugs cost at least $84,000 for a typical 12-week course. The cost of the new hepatitis drugs is so high that state Medicaid programs and many private insurers say that even treating a fraction of the infected population is breaking the bank.
Last year, Kentucky spent more than $50 million, about 7 percent of its total Medicaid budget, providing two of the new hepatitis C drugs, Sovaldi and Harvoni, to just 861 people, said Dr. John Langefeld, chief medical officer at the state’s Department for Medicaid Services. Sovaldi has a list price of $84,000 for a typical 12-week course of treatment; Harvoni, made by the same company, Gilead Sciences, has a list price closer to $100,000. Gilead offers discounts to Medicaid programs, but “it doesn’t do much to offset the significant cost factor,” Dr. Langefeld said.
In all, about 16,000 Kentucky Medicaid beneficiaries had a diagnosis of hepatitis C last year, up from 8,000 in 2013. That partly reflects the expansion of Medicaid under the Affordable Care Act to include more low-income adults, Dr. Langefeld said. But the state’s opiate problem, and increased testing of people who have injected drugs, are also factors, he and other health officials said. Kentucky will soon start providing hepatitis C tests at all its county health departments, just as it does for H.I.V.
Medicaid beneficiaries here are covered by private managed-care plans, each with its own rules for who can get the new hepatitis drugs. But patients generally need proof of Stage 3 or 4 fibrosis, or scarring of the liver, and cannot have used illicit drugs for at least six months, Dr. Langefeld said.
Karen Ruschman, a nurse practitioner at a private gastroenterology practice here, said many young adults with hepatitis C have not been able to quit heroin because treatment programs, especially those using Suboxone, a medication that suppresses opiate cravings, are expensive and hard to get into. Addicts typically “can buy heroin cheaper than they can get into a Suboxone clinic,” Ms. Ruschman said.
The vast majority of those infected with hepatitis C are baby boomers, according to the C.D.C. Most were infected decades ago, and many got it from blood transfusions that they received before 1992 when donated blood was not screened for the virus.
But most new cases are among young people, data has shown, and that raises a potential treatment problem: Those younger people tend not to qualify for the expensive new drugs, health care providers said, because the disease can take decades to progress to the point of severe liver damage.
Kentucky is not alone in rationing the drugs. A new study by researchers at Harvard found that about three-quarters of state Medicaid programs allow sofosbuvir, the main ingredient in Sovaldi, to be used only when hepatitis C has caused Stage 3 or 4 fibrosis. The study pointed out that such restrictions are at odds with the position of medical groups like the Infectious Diseases Society of America, which recommend the new treatments for all diagnosed cases.
In addition, the study’s authors wrote, “Current restrictions may violate federal Medicaid law, which requires states to cover drugs consistent with their F.D.A. labels.”
Many with hepatitis C are still in the throes of addiction, or are not far along enough in their recovery to focus on anything else. Others remain unaware of the new treatment options. Jerry Searp, who stopped injecting heroin in November 2011 and tested positive for hepatitis C a few months later, said he knew only about treatment with interferon and ribavirin, older drugs that often caused depression, fatigue, nausea and other debilitating side effects.
“They said my levels were real low,” he said, recalling a doctor’s appointment last year, “so I just keep praying about it.”
Mr. Searp, 34, of Crescent Spring, believes he knows exactly when he contracted the virus: while shooting up with a friend in a house frequented by addicts.
“I asked to use his needle and he said, ‘Hey, I’ve got hep B and C,’ ” Mr. Searp said. “And at the time it didn’t really matter to me. The desire to get high was just so great.”
Mr. Wayman, a warehouse worker, said his doctor was trying to persuade his insurer to pay for one of the new drugs, which were not yet available the first time he sought treatment. He hopes to qualify for the new treatment before December, when he will turn 26 and no longer be covered by his parents’ health insurance.
“It’s in my past and I don’t want my past to haunt me,” he said. “I’m just waiting on that phone call.”
In Crestview Hills, outside Cincinnati, Dr. Thomas Schussler has 25 patients receiving treatment for hepatitis C and another 140 patients waiting for it, typically because their insurer has not yet approved it or because they are still using drugs. Dr. Schussler said private insurance is more likely to cover the cost, but only about 20 percent of his patients have it. The success rate with the new drugs is remarkable, he said, but he added, “The problem is we’re not getting anywhere. You could eradicate this if the drugs were ubiquitous and cheap.”
Lynne Saddler, who leads the Northern Kentucky Health Department, is pursuing another avenue for getting a handle on the epidemic: starting a needle exchange so that addicts in the region might stop infecting each other. This year, the Kentucky General Assembly passed a law aimed at combating the state’s growing heroin problem, with a provision that allows local jurisdictions to open exchanges.
Louisville became the first city in Kentucky to take advantage of the new law last month. Needle exchanges are also in the works in several counties in Indiana, Ohio and West Virginia. The Northern Kentucky District Board of Health voted last month to move forward with an exchange, but it still must win approval from any city or county in which the exchange has a location. Ms. Saddler is trying to build support for it, including among opponents who believe needle exchanges only encourage drug use.
“This really is our window of opportunity,” she said. “When you lay that out for people — look, we have a statutory responsibility to prevent the spread of diseases like this and here is a very effective tool — they start getting it.”
06 July 2015
VICTIMS LINE UP FOR CANCER DOCTOR'S SENTENCING
Original Story: detroitnews.com
Geraldine Parkin will face cancer doctor Farid Fata in Detroit federal court on Monday morning, as she and 24 other victims or family members of victims prepare to make statements as part of the cancer doctor's sentencing hearing. A Detroit health care lawyer has experience with multiple industry types and implications of detrimental health care practices or incidents.
"For me, I want the pleasure of looking him in the eye," says Parkin, who says her husband, Tim Parkin, is largely disabled as a result of his treatment. Fata once looked into her eyes and those of her adult children, insisting that her husband needed chemotherapy. Now she is ready to respond.
"I want to say to him, 'You gave us a life of the unknown, of misery, and now you're going to have a life behind bars.' "
The hearing, which is expected to last all week, likely will conclude with Judge Paul D. Borman sentencing Fata, who faces life in prison for his crimes. About 150 victims filed victim impact statements with the court. A Detroit medical malpractice lawyer is following this story closely.
Fata's north Oakland County cancer treatment empire collapsed after his arrest two years ago. He pleaded guilty to 16 counts of fraud in September.
But fraud doesn't accurately describe Fata's crimes, victims and former associates say, and victims are being allowed to speak in open court. While that's common in other kinds of criminal trials, it's unusual in a sentencing proceeding for victims of Medicare fraud.
In this case, though, some of Fata's patients were given chemotherapy treatments, some for years, after false or inflated cancer diagnoses by Fata. Many others were treated, and billed for, drugs on schedules designed for profitability rather than therapeutic value. The government has estimated there are at leat 550 people who were victimized by the doctor.
"Whether they were cancer or non-cancer patients, solid tumor or liquid, Fata did not discriminate: his ultimate goal was to maximize his profit on the backs of his patients," federal prosecutors argued in a sentencing memorandum.
Fata has been compared by government lawyers to financial fraudster Bernard Madoff for the brazen scope of his crimes and his willingness to prey on those who trusted him. At least two expert medical witnesses for the government are scheduled to testify during the sentencing hearing. An expert for the defense who reviewed some of Fata's cases defended the treatment of 17 out of 20 cases — but could not defend the rest. A Detroit negligence lawyer is experienced in the effective resolution of negligence lawsuits as related to improper care or practice in a professional setting.
About 40 members of the victims' group are traveling to the courthouse in a chartered bus, wearing special T-shirts and buttons emblazoned with the slogan "Army of One," united in their quest for justice and their shared experience. Speakers are allotted 10 minutes each to make their statements.
But beyond the hearing, complex issues of compensation for the victims remain. About 40 lawsuits are pending in Oakland County Circuit Court. Borman will hold a restitution hearing at least 90 days after Fata's sentencing to adjudicate the distribution of assets. The government has claimed Medicare is owed $34 million.
In addition to Medicare and former patients, private insurance companies, including Blue Cross/Blue Shield of Michigan, and a former employee turned whistle-blower have a financial stake in the outcome.
Compensation even for the most devastated victims is not clear-cut. Some couldn't file lawsuits because the statute of limitations had expired by the time Fata was arrested, says Donna MacKenzie, of Olsman Mueller Wallace & MacKenzie, a Ferndale law firm handling 13 cases against Fata and his practice. Many others who were harmed were turned away, for various reasons, because of the cost of litigating their claims.
Brian McKeen, who represents other former patients, says Fata's practice was "drastically under-insured" for a total of $3.6 million. Victims say they've been told the government has recovered about $10 million in assets.
"I'm on a mission to make the public realize how heavily the justice system is skewed toward providers and against the plaintiffs, the victims," he said. "Nobody cares about victim's rights until they become a victim."
Fata's arrest was triggered two years ago, on August 2, 2013, when the clinic's practice business manager, George Karadsheh, notified the FBI of Fata's potential crimes. On Aug. 5, 2013, Karadsheh officially filed a so-called qui tam or whistle-blower lawsuit in federal court. The FBI then interviewed Dr. Soe Maunglay, an oncologist at the clinic who had reported his concerns to Karadsheh. Fata was arrested the following morning.
Karadsheh's identity became public June 10, when a Detroit News article named him as the Fata practice insider who first called the FBI. The government subsequently unsealed the lawsuit.
"I've handled a lot of Medicare fraud but this is unspeakable," says David Haron, Karadsheh's lawyer. "Mr. Karadsheh has incredible concern for the patients. He lost his job but they lost so much more."
Parkin, the wife of a victim, knows her family will never regain what they have lost. "For us, the hearing is important because we don't want this to go down in history as fraud," she says. "We want it to go down as murder."
Geraldine Parkin will face cancer doctor Farid Fata in Detroit federal court on Monday morning, as she and 24 other victims or family members of victims prepare to make statements as part of the cancer doctor's sentencing hearing. A Detroit health care lawyer has experience with multiple industry types and implications of detrimental health care practices or incidents.
"For me, I want the pleasure of looking him in the eye," says Parkin, who says her husband, Tim Parkin, is largely disabled as a result of his treatment. Fata once looked into her eyes and those of her adult children, insisting that her husband needed chemotherapy. Now she is ready to respond.
"I want to say to him, 'You gave us a life of the unknown, of misery, and now you're going to have a life behind bars.' "
The hearing, which is expected to last all week, likely will conclude with Judge Paul D. Borman sentencing Fata, who faces life in prison for his crimes. About 150 victims filed victim impact statements with the court. A Detroit medical malpractice lawyer is following this story closely.
Fata's north Oakland County cancer treatment empire collapsed after his arrest two years ago. He pleaded guilty to 16 counts of fraud in September.
But fraud doesn't accurately describe Fata's crimes, victims and former associates say, and victims are being allowed to speak in open court. While that's common in other kinds of criminal trials, it's unusual in a sentencing proceeding for victims of Medicare fraud.
In this case, though, some of Fata's patients were given chemotherapy treatments, some for years, after false or inflated cancer diagnoses by Fata. Many others were treated, and billed for, drugs on schedules designed for profitability rather than therapeutic value. The government has estimated there are at leat 550 people who were victimized by the doctor.
"Whether they were cancer or non-cancer patients, solid tumor or liquid, Fata did not discriminate: his ultimate goal was to maximize his profit on the backs of his patients," federal prosecutors argued in a sentencing memorandum.
Fata has been compared by government lawyers to financial fraudster Bernard Madoff for the brazen scope of his crimes and his willingness to prey on those who trusted him. At least two expert medical witnesses for the government are scheduled to testify during the sentencing hearing. An expert for the defense who reviewed some of Fata's cases defended the treatment of 17 out of 20 cases — but could not defend the rest. A Detroit negligence lawyer is experienced in the effective resolution of negligence lawsuits as related to improper care or practice in a professional setting.
About 40 members of the victims' group are traveling to the courthouse in a chartered bus, wearing special T-shirts and buttons emblazoned with the slogan "Army of One," united in their quest for justice and their shared experience. Speakers are allotted 10 minutes each to make their statements.
But beyond the hearing, complex issues of compensation for the victims remain. About 40 lawsuits are pending in Oakland County Circuit Court. Borman will hold a restitution hearing at least 90 days after Fata's sentencing to adjudicate the distribution of assets. The government has claimed Medicare is owed $34 million.
In addition to Medicare and former patients, private insurance companies, including Blue Cross/Blue Shield of Michigan, and a former employee turned whistle-blower have a financial stake in the outcome.
Compensation even for the most devastated victims is not clear-cut. Some couldn't file lawsuits because the statute of limitations had expired by the time Fata was arrested, says Donna MacKenzie, of Olsman Mueller Wallace & MacKenzie, a Ferndale law firm handling 13 cases against Fata and his practice. Many others who were harmed were turned away, for various reasons, because of the cost of litigating their claims.
Brian McKeen, who represents other former patients, says Fata's practice was "drastically under-insured" for a total of $3.6 million. Victims say they've been told the government has recovered about $10 million in assets.
"I'm on a mission to make the public realize how heavily the justice system is skewed toward providers and against the plaintiffs, the victims," he said. "Nobody cares about victim's rights until they become a victim."
Fata's arrest was triggered two years ago, on August 2, 2013, when the clinic's practice business manager, George Karadsheh, notified the FBI of Fata's potential crimes. On Aug. 5, 2013, Karadsheh officially filed a so-called qui tam or whistle-blower lawsuit in federal court. The FBI then interviewed Dr. Soe Maunglay, an oncologist at the clinic who had reported his concerns to Karadsheh. Fata was arrested the following morning.
Karadsheh's identity became public June 10, when a Detroit News article named him as the Fata practice insider who first called the FBI. The government subsequently unsealed the lawsuit.
"I've handled a lot of Medicare fraud but this is unspeakable," says David Haron, Karadsheh's lawyer. "Mr. Karadsheh has incredible concern for the patients. He lost his job but they lost so much more."
Parkin, the wife of a victim, knows her family will never regain what they have lost. "For us, the hearing is important because we don't want this to go down in history as fraud," she says. "We want it to go down as murder."
FORMER DMC CHIEF DIES IN PANAMA AMID KICKBACK PROBE
Original Story: freep.com
A former head of the Detroit Medical Center who was later charged in one of the largest fraud and corruption investigations in Canadian history has died in custody in Panama.
Dr. Arthur Porter, 59, CEO of DMC from 1999 through 2003, died Wednesday of cancer while under armed guard in a Panama City hospital. The death was announced by Porter's biographer, Jeff Todd, who said the cause was lung cancer that had spread to the bone and liver.
Before his transfer to the hospital this spring, Porter had been in Panama's La Joya Prison following his 2013 arrest in that country on fraud, conspiracy and money laundering charges related to the construction of a $1.3 billion so-called super hospital in Montreal. A Birmingham criminal lawyer is following this story closely.
Porter, who left the DMC to head McGill University's hospital network, was accused of taking as much as $22.5 million in bribes in a kickback scheme for the super hospital's construction contract.
At least seven other individuals also faced criminal charges for the kickback allegations, according to the Montreal Gazette.
The newspaper reported that Porter's extradition to Quebec had been put on hold earlier this year as his lawyer challenged his detention in prison. It does not appear that Porter ever faced trial for the allegations.
A spokeswoman for the Canadian Department of Foreign Affairs would not comment Wednesday night on any specifics of Porter's case. A Harrisonburg white collar crime lawyer is experienced in the effective resolution of white collar crime lawsuits as related to business related crimes.
A native of Sierra Leone, Porter was a radiation oncology specialist who became CEO of DMC in May 1999, when the then-struggling hospital system was burning through nearly $100 million a year. Although he slashed thousands of jobs, consolidated hospitals and sold off clinics, DMC was still a money-loser by September 2003, when Porter resigned under pressure.
In a memoir released last year that he wrote while in prison, Porter claimed that in 2001, he received a phone call from President George W. Bush offering him the job of U.S. Surgeon General, according to the Montreal Gazette. Porter declined Bush's offer.
Porter left the U.S. in 2004 to become executive director of McGill University's hospital network. In 2008, he was named to a seat on Canada's spy agency watchdog committee, gaining access to Canadian state secrets.
At the time of Porter's arrest in 2013, DMC officials told the Free Press that he was never suspected or accused of any wrongdoing during his years in Detroit. He arrived in Detroit in 1991 as a member of the radiation oncology department at the DMC-affiliated Wayne State University School of Medicine.
"We certainly didn't see any behavior that would have caused us to believe he was involved in improper activities," a former DMC board member, Stephen D'Arcy, said at the time. "It's almost bizarre the kinds of things he was involved in apparently in Canada."
A DMC spokesperson could not be reached for comment late Wednesday.
According to Porter's biographer, Porter was forced to smuggle chemotherapy drugs into prison to keep himself alive and, despite repeated letters to the Canadian embassy in Panama for better medical care, wasn't granted access to cancer treatment until this year.
He spent his final days on high doses of morphine for the pain, his biographer wrote in a statement posted online.
The Montreal Gazette reported that Porter's wife pleaded guilty in December to money laundering and was sentenced to two years in prison. A San Francisco corporate lawyer represents clients in corporate criminal charges and corporate finance cases.
In attempts to recover $17.5 million of the $22.5 million that was allegedly defrauded, Quebec authorities have seized properties belonging to Porter and his family in Michigan, Florida and the Caribbean and bank accounts in the U.S. and other countries, the newspaper said.
A former head of the Detroit Medical Center who was later charged in one of the largest fraud and corruption investigations in Canadian history has died in custody in Panama.
Dr. Arthur Porter, 59, CEO of DMC from 1999 through 2003, died Wednesday of cancer while under armed guard in a Panama City hospital. The death was announced by Porter's biographer, Jeff Todd, who said the cause was lung cancer that had spread to the bone and liver.
Before his transfer to the hospital this spring, Porter had been in Panama's La Joya Prison following his 2013 arrest in that country on fraud, conspiracy and money laundering charges related to the construction of a $1.3 billion so-called super hospital in Montreal. A Birmingham criminal lawyer is following this story closely.
Porter, who left the DMC to head McGill University's hospital network, was accused of taking as much as $22.5 million in bribes in a kickback scheme for the super hospital's construction contract.
At least seven other individuals also faced criminal charges for the kickback allegations, according to the Montreal Gazette.
The newspaper reported that Porter's extradition to Quebec had been put on hold earlier this year as his lawyer challenged his detention in prison. It does not appear that Porter ever faced trial for the allegations.
A spokeswoman for the Canadian Department of Foreign Affairs would not comment Wednesday night on any specifics of Porter's case. A Harrisonburg white collar crime lawyer is experienced in the effective resolution of white collar crime lawsuits as related to business related crimes.
A native of Sierra Leone, Porter was a radiation oncology specialist who became CEO of DMC in May 1999, when the then-struggling hospital system was burning through nearly $100 million a year. Although he slashed thousands of jobs, consolidated hospitals and sold off clinics, DMC was still a money-loser by September 2003, when Porter resigned under pressure.
In a memoir released last year that he wrote while in prison, Porter claimed that in 2001, he received a phone call from President George W. Bush offering him the job of U.S. Surgeon General, according to the Montreal Gazette. Porter declined Bush's offer.
Porter left the U.S. in 2004 to become executive director of McGill University's hospital network. In 2008, he was named to a seat on Canada's spy agency watchdog committee, gaining access to Canadian state secrets.
At the time of Porter's arrest in 2013, DMC officials told the Free Press that he was never suspected or accused of any wrongdoing during his years in Detroit. He arrived in Detroit in 1991 as a member of the radiation oncology department at the DMC-affiliated Wayne State University School of Medicine.
"We certainly didn't see any behavior that would have caused us to believe he was involved in improper activities," a former DMC board member, Stephen D'Arcy, said at the time. "It's almost bizarre the kinds of things he was involved in apparently in Canada."
A DMC spokesperson could not be reached for comment late Wednesday.
According to Porter's biographer, Porter was forced to smuggle chemotherapy drugs into prison to keep himself alive and, despite repeated letters to the Canadian embassy in Panama for better medical care, wasn't granted access to cancer treatment until this year.
He spent his final days on high doses of morphine for the pain, his biographer wrote in a statement posted online.
The Montreal Gazette reported that Porter's wife pleaded guilty in December to money laundering and was sentenced to two years in prison. A San Francisco corporate lawyer represents clients in corporate criminal charges and corporate finance cases.
In attempts to recover $17.5 million of the $22.5 million that was allegedly defrauded, Quebec authorities have seized properties belonging to Porter and his family in Michigan, Florida and the Caribbean and bank accounts in the U.S. and other countries, the newspaper said.
24 June 2015
HEALTH OFFICIALS WARN OF FLESH-EATING BACTERIA IN FLORIDA
Original Story: chicagotribune.com
Florida health officials are warning residents and tourists a rare form of flesh-eating, potentially deadly bacteria has made its way to Florida beaches. If you may have been exposed to this deadly bacteria, seek emergency medical attention.
The Vibrio vulnificus bacterium grows fastest in warm saltwater and has already infected at least seven people, killing two this year in Florida. The state health department says there have been 32 cases in the past 12 months. Officials say a spike in cases occurs from May to October when water is the warmest.
Florida Health Department spokeswoman Mara Burger says consuming or handling raw shellfish and swimming in warm saltwater can put people at risk. People with open wounds can also be exposed to Vibrio vulnificus through direct contact with seawater. For expert medical care, trust DMC for your emergency care needs.
The bacterial infection can cause gastroenteritis, sepsis and can lead to amputation.
Florida health officials are warning residents and tourists a rare form of flesh-eating, potentially deadly bacteria has made its way to Florida beaches. If you may have been exposed to this deadly bacteria, seek emergency medical attention.
The Vibrio vulnificus bacterium grows fastest in warm saltwater and has already infected at least seven people, killing two this year in Florida. The state health department says there have been 32 cases in the past 12 months. Officials say a spike in cases occurs from May to October when water is the warmest.
Florida Health Department spokeswoman Mara Burger says consuming or handling raw shellfish and swimming in warm saltwater can put people at risk. People with open wounds can also be exposed to Vibrio vulnificus through direct contact with seawater. For expert medical care, trust DMC for your emergency care needs.
The bacterial infection can cause gastroenteritis, sepsis and can lead to amputation.
19 June 2015
DETROIT AREA DOCTOR COULD FORFEIT COIN TROVE WORTH MILLIONS IN FRAUD CASE
Original Story: detroitnews.com
A West Bloomfield neurologist who reaped millions by allegedly cheating Medicare spent more than $9.3 million on baseball cards, ancient coins, collectable currency and stamps — a rare collection he could soon lose to the government. A medical malpractice lawyer is reviewing the details of this case.
Dr. Gavin Awerbuch amassed the collection — including coins from ancient Rome — using cash generated by an alleged five-year crime wave, according to federal court records that offer rare insight into the secretive world of coin collecting. At the upper end, the world is filled with hobbyists who, due to security concerns, protect the scope and value of their prized possessions.
Awerbuch's case shows a unique twist on a growing trend of health care professionals nationwide accused of spending money from fraudulent activities on valuable possessions, including homes and automobiles.
"This flabbergasts me. I never knew that his firepower extended that far," said Metro Detroit currency dealer Frederick Bart, who sold the doctor $360,225 worth of collectable currency printed before 1928. "He didn't have a target on his back where you thought 'here comes moneybags.' "
Federal prosecutors want the collection — experts say it could be among the richest in Michigan — forfeited to the government, along with $2.9 million in cash and a million-dollar Arizona vacation home.
Awerbuch, 57, is free on $10,000 unsecured bond. If convicted, he faces 10 years or more in federal prison. A preliminary exam has been set for June 29.
Though court records do not specify exactly which collectible items Awerbuch purchased, the extent of his coin collection is emerging more than one year after he was charged with health care fraud and distribution of controlled substances. A Medicaid and Medicare lawyer is following this story closely.
He was accused of defrauding Medicare of $7 million and prescribing so much of the cancer painkiller Subsys that he was the top dispenser in the country, according to the U.S. Attorney's Office.
Awerbuch's defense lawyer, Mark Kriger, declined comment.
Newly filed court records show how Awerbuch spent money generated by allegedly fraudulent activity.
"(Sizable) purchases were made with dealers of rare and collectible coins, as well as dealers of other types of collectible items," Assistant U.S. Attorney Jonathan Grey wrote in a court filing. "These assets were purchased, at least in part, with criminally derived proceeds commingled in Awerbuch's various accounts." A Detroit insurance defense lawyer represents insurers in insurance fraud cases.
From 2008 through 2013, Awerbuch spent $9,343,527 at more than a dozen coin and collectible dealers in Michigan and across the country, according to court records.
The bulk, $7 million, was spent at Kagin's Inc. The California firm deals in rare coins, such as a pioneer gold coin for $999,999 and the first coin struck in North America, a shilling priced at $299,500.
"He was a good client," company President Donald Kagin told The News this week. "Over the years, we've had good transactions with him with different types of coins."
Kagin would not reveal what Awerbuch bought from his store, citing client confidentiality.
The collectibles Awerbuch purchased were spread across several locations. Federal agents struck gold — literally — during searches at several locations.
Investigators found gold and silver coins at his medical office in Saginaw, along with Roman coins honoring Emperors Titus and Claudius.
"If they are in nice condition, those can go for many thousands of dollars, and do," said Thomas Klunzinger, who serves on the board of the Michigan State Numismatic Society, which encourages and promotes the study and collection of currency. "Every dye was different. If you have a Roman coin, maybe it was highlighting some battle or commemorating a victory. Those (coins) were the media of the day."
Investigators also found a coin from ancient Judea, according to a search warrant inventory.
At his $1.1 million West Bloomfield home overlooking Upper Straits Lake, investigators found boxes of coins, stamps and Costa Rican currency, prosecutors allege.
Awerbuch stashed more coins, collectible currency, baseball cards, jewelry and stamps in at least 16 safe deposit boxes at PNC and Fifth Third banks, according to court records.
On Thursday, federal prosecutors asked a judge to have the coins and collectibles forfeited to the government, alleging the items were purchased with proceeds of a crime.
Federal prosecutors have not itemized the individual pieces of Awerbuch's collection.
Just a few coins could be worth millions, said Julianna Wostyn, president of the Michigan State Numismatic Society.
"You can spend a horrendous amount of money, and it doesn't have to be gold," she said. "When you're talking paper money, in the last 10 years, paper money has skyrocketed."
She has never heard of Awerbuch or met him at area conventions.
"People don't want to make themselves known," she said. "Number one: They don't want to be knocked over. I won't say they look homeless, but coin collectors are not flashy people and do not go about bragging about themselves."
Besides the coins, prosecutors want to keep almost $3 million seized from Awerbuch's bank accounts.
The money includes $622,800 seized after Awerbuch sold his home in July 2014.
Prosecutors also want the doctor to forfeit his home in the Arizona desert, saying it was purchased with money generated by health care fraud and unlawfully distributing prescription drugs. An insurance defense lawyer represents insurance companies in disputes and fraud cases.
His ex-wife is fighting the request, saying she is the innocent owner of the 4,700-square-foot home, which has a putting green, wine room, outdoor pool and waterfall.
Awerbuch bought the home two years ago for $940,000, according to court records.
He paid cash.
A West Bloomfield neurologist who reaped millions by allegedly cheating Medicare spent more than $9.3 million on baseball cards, ancient coins, collectable currency and stamps — a rare collection he could soon lose to the government. A medical malpractice lawyer is reviewing the details of this case.
Dr. Gavin Awerbuch amassed the collection — including coins from ancient Rome — using cash generated by an alleged five-year crime wave, according to federal court records that offer rare insight into the secretive world of coin collecting. At the upper end, the world is filled with hobbyists who, due to security concerns, protect the scope and value of their prized possessions.
Awerbuch's case shows a unique twist on a growing trend of health care professionals nationwide accused of spending money from fraudulent activities on valuable possessions, including homes and automobiles.
"This flabbergasts me. I never knew that his firepower extended that far," said Metro Detroit currency dealer Frederick Bart, who sold the doctor $360,225 worth of collectable currency printed before 1928. "He didn't have a target on his back where you thought 'here comes moneybags.' "
Federal prosecutors want the collection — experts say it could be among the richest in Michigan — forfeited to the government, along with $2.9 million in cash and a million-dollar Arizona vacation home.
Awerbuch, 57, is free on $10,000 unsecured bond. If convicted, he faces 10 years or more in federal prison. A preliminary exam has been set for June 29.
Though court records do not specify exactly which collectible items Awerbuch purchased, the extent of his coin collection is emerging more than one year after he was charged with health care fraud and distribution of controlled substances. A Medicaid and Medicare lawyer is following this story closely.
He was accused of defrauding Medicare of $7 million and prescribing so much of the cancer painkiller Subsys that he was the top dispenser in the country, according to the U.S. Attorney's Office.
Awerbuch's defense lawyer, Mark Kriger, declined comment.
Newly filed court records show how Awerbuch spent money generated by allegedly fraudulent activity.
"(Sizable) purchases were made with dealers of rare and collectible coins, as well as dealers of other types of collectible items," Assistant U.S. Attorney Jonathan Grey wrote in a court filing. "These assets were purchased, at least in part, with criminally derived proceeds commingled in Awerbuch's various accounts." A Detroit insurance defense lawyer represents insurers in insurance fraud cases.
From 2008 through 2013, Awerbuch spent $9,343,527 at more than a dozen coin and collectible dealers in Michigan and across the country, according to court records.
The bulk, $7 million, was spent at Kagin's Inc. The California firm deals in rare coins, such as a pioneer gold coin for $999,999 and the first coin struck in North America, a shilling priced at $299,500.
"He was a good client," company President Donald Kagin told The News this week. "Over the years, we've had good transactions with him with different types of coins."
Kagin would not reveal what Awerbuch bought from his store, citing client confidentiality.
The collectibles Awerbuch purchased were spread across several locations. Federal agents struck gold — literally — during searches at several locations.
Investigators found gold and silver coins at his medical office in Saginaw, along with Roman coins honoring Emperors Titus and Claudius.
"If they are in nice condition, those can go for many thousands of dollars, and do," said Thomas Klunzinger, who serves on the board of the Michigan State Numismatic Society, which encourages and promotes the study and collection of currency. "Every dye was different. If you have a Roman coin, maybe it was highlighting some battle or commemorating a victory. Those (coins) were the media of the day."
Investigators also found a coin from ancient Judea, according to a search warrant inventory.
At his $1.1 million West Bloomfield home overlooking Upper Straits Lake, investigators found boxes of coins, stamps and Costa Rican currency, prosecutors allege.
Awerbuch stashed more coins, collectible currency, baseball cards, jewelry and stamps in at least 16 safe deposit boxes at PNC and Fifth Third banks, according to court records.
On Thursday, federal prosecutors asked a judge to have the coins and collectibles forfeited to the government, alleging the items were purchased with proceeds of a crime.
Federal prosecutors have not itemized the individual pieces of Awerbuch's collection.
Just a few coins could be worth millions, said Julianna Wostyn, president of the Michigan State Numismatic Society.
"You can spend a horrendous amount of money, and it doesn't have to be gold," she said. "When you're talking paper money, in the last 10 years, paper money has skyrocketed."
She has never heard of Awerbuch or met him at area conventions.
"People don't want to make themselves known," she said. "Number one: They don't want to be knocked over. I won't say they look homeless, but coin collectors are not flashy people and do not go about bragging about themselves."
Besides the coins, prosecutors want to keep almost $3 million seized from Awerbuch's bank accounts.
The money includes $622,800 seized after Awerbuch sold his home in July 2014.
Prosecutors also want the doctor to forfeit his home in the Arizona desert, saying it was purchased with money generated by health care fraud and unlawfully distributing prescription drugs. An insurance defense lawyer represents insurance companies in disputes and fraud cases.
His ex-wife is fighting the request, saying she is the innocent owner of the 4,700-square-foot home, which has a putting green, wine room, outdoor pool and waterfall.
Awerbuch bought the home two years ago for $940,000, according to court records.
He paid cash.
09 June 2015
NO-CONSENT MEDICAL EXPERIMENTS PUT ETHICS TO TEST
Original Story: usatoday.com
Imagine waking up after a serious accident to discover you've become an unwitting subject in a medical study without ever agreeing to participate.
It's a controversial reality of emergency research, and now concern is growing that dwindling research budgets are making it harder to alert the community about the studies so people can decide ahead of time whether to opt in or out. Emergency care centers provide care to patients with life-threatening illnesses.
A case in point: a Department of Defense-sponsored study led by the University of Pittsburgh, which is currently testing the practice of giving bleeding patients plasma to help their blood clot during flights to the hospital. Each of six sites gets $20,000 out of a total $6.5 million budget for community awareness efforts such as sending out letters and paying for radio spots. People are told if they don't want to take part in the research, they can get a free bracelet to wear at all times, letting emergency workers know their wishes.
Though millions of people could potentially be trauma victims at the various sites, only 300 people at one site – members of a Jehovah's Witness congregation in Louisville – have asked for bracelets. Researchers say this meager response shows the notification has reached far too few people.
"Certainly you would like to reach everyone. But there's no way," says Laura Trachtenberg, research coordinator at the University of Louisville. "So if you do the due diligence, you've done the best you can. It's very challenging."
Fellow researcher Clifton Callaway, a professor of emergency medicine at the University of Pittsburgh, says it would be a lot easier with more research dollars. A January study in the Journal of the American Medical Association found U.S. funding for medical research overall increased 6% a year from 1994 to 2004, then slowed dramatically to 0.8% a year through 2012.
With drug companies spending an estimated $2.5 billion annually on advertising to consumers, "the average person is much more likely to hear about (the fibromyalgia drug) Lyrica or something," Callaway says. "One ad costs more than the entire research budget of a trial like ours." Emergency care centers support clinical researchers by providing comprehensive legal and regulatory consultation on in-patient and out-patient studies.
But Lynne Richardson, a professor of emergency medicine at the Icahn School of Medicine at New York's Mount Sinai who researches community notification, says money matters less than reaching out to potential subjects in an effective way. She says most people who learn about such studies are OK with participating, and a mechanism for opting out isn't required by the federal government.
Plus, she says, "no matter how much money you spend, some people aren't going to pay attention."
Research without consent
Informed consent is rooted in the Nuremberg code of 1947, drafted in the wake of Nazi experimentation. Exception-from-consent studies are rare; Richardson estimates there are about six large national trials and a handful of small studies currently enrolling people. They are allowed only when patients or their families can't possibly give their permission, such as when someone is alone and unconscious.
Arthur Caplan, head of the division of medical ethics at New York University's Langone Medical Center, says research without consent "absolutely should be the last resort."
It's highly regulated. The U.S. Food and Drug Administration has a special rule requiring, among other things, that patients are in life-threatening situations and that currently-available treatments are unproven or unsatisfactory. Researchers must apply to institutional review boards for waivers, be closely monitored and report any problems.
Caplan says the trials are designed to find better ways to save lives in emergencies and can be stopped when initial results show outcomes are the same or worse. Callaway says he has been involved in more than one cardiac arrest study stopped because it showed no clear benefit.
Some studies actually have harmed patients. A 2008 JAMA review of 16 clinical trials showed blood substitutes, including some tested without consent, were associated with "a significantly increased risk" of heart attacks and death.
Callaway says it's too early to know what his current four-year plasma study will find, but no problems or deaths have been attributed to the study so far. Researchers point out that giving plasma isn't a new practice; surgeons at trauma centers now may give plasma in the hospital. The study aims to find out if giving it in transport helicopters instead reduces the chance of death or severe complications.
A similar no-consent study in Denver, also sponsored by the defense department, tests giving another plasma product with slightly lower levels of clotting proteins during ambulance rides. And a third study in Maryland tests administering cold fluid to lower body temperature in bleeding patients to buy time for resuscitation.
Callaway says such studies "are definitely worth it" given what researchers can learn. Rosamond Rhodes, director of bioethics education at Mount Sinai, agrees.
But Caplan says while the research can lead to breakthroughs, there's always a chance of hurting unwitting subjects, and "that's the gamble (the nation) took when we allowed this sort of research to proceed."
Buying in, opting out
Ethicists say that gamble makes FDA-required community awareness all the more important.
The first step is community consultation, which happens before the study is launched and can determine whether it takes place in a certain location at all.
Richardson says effective consultation involves soliciting opinions from area leaders and also reaching out to groups most likely to be affected, which in the case of blood-related studies include Jehovah's Witnesses, who believe blood transfusions are forbidden.
"Public notification" or "public disclosure" involves telling the public what's happening through media such as radio, brochures or the Internet – and letting them know about opt-out methods like bracelets.
Richardson currently is studying the best ways to reach those most likely to be affected. As far as opting out, she says people who do so often oppose being a part of any research or have had bad experiences with the hospital involved.
Some ethicists argue that opting out is an important choice and say public notification often isn't up to par. "I don't see (community outreach) happening quite that aggressively," Caplan says.
That's because of the limited resources, researchers say. In Louisville, for example, researchers couldn't afford television spots or newspaper ads; half their awareness budget went to radio spots and the other half went to develop a website and fund printing and postage for the letter sent to Jehovah's Witness congregations.
"We did the best we could," says Brian Harbrecht, who heads up the plasma study there.
Rhodes acknowledges public notification could be done better but says it's an open question whether more of the limited research dollars should be diverted away from the studies themselves.
Such questions need to be answered, researchers and ethicists say, because the stakes are high: They are expecting people to unknowingly accept risk to advance medical science.
"Everyone's well aware you're experimenting without permission," Caplan says. But with emergency research, "I realistically trust there's no other way."
Imagine waking up after a serious accident to discover you've become an unwitting subject in a medical study without ever agreeing to participate.
It's a controversial reality of emergency research, and now concern is growing that dwindling research budgets are making it harder to alert the community about the studies so people can decide ahead of time whether to opt in or out. Emergency care centers provide care to patients with life-threatening illnesses.
A case in point: a Department of Defense-sponsored study led by the University of Pittsburgh, which is currently testing the practice of giving bleeding patients plasma to help their blood clot during flights to the hospital. Each of six sites gets $20,000 out of a total $6.5 million budget for community awareness efforts such as sending out letters and paying for radio spots. People are told if they don't want to take part in the research, they can get a free bracelet to wear at all times, letting emergency workers know their wishes.
Though millions of people could potentially be trauma victims at the various sites, only 300 people at one site – members of a Jehovah's Witness congregation in Louisville – have asked for bracelets. Researchers say this meager response shows the notification has reached far too few people.
"Certainly you would like to reach everyone. But there's no way," says Laura Trachtenberg, research coordinator at the University of Louisville. "So if you do the due diligence, you've done the best you can. It's very challenging."
Fellow researcher Clifton Callaway, a professor of emergency medicine at the University of Pittsburgh, says it would be a lot easier with more research dollars. A January study in the Journal of the American Medical Association found U.S. funding for medical research overall increased 6% a year from 1994 to 2004, then slowed dramatically to 0.8% a year through 2012.
With drug companies spending an estimated $2.5 billion annually on advertising to consumers, "the average person is much more likely to hear about (the fibromyalgia drug) Lyrica or something," Callaway says. "One ad costs more than the entire research budget of a trial like ours." Emergency care centers support clinical researchers by providing comprehensive legal and regulatory consultation on in-patient and out-patient studies.
But Lynne Richardson, a professor of emergency medicine at the Icahn School of Medicine at New York's Mount Sinai who researches community notification, says money matters less than reaching out to potential subjects in an effective way. She says most people who learn about such studies are OK with participating, and a mechanism for opting out isn't required by the federal government.
Plus, she says, "no matter how much money you spend, some people aren't going to pay attention."
Research without consent
Informed consent is rooted in the Nuremberg code of 1947, drafted in the wake of Nazi experimentation. Exception-from-consent studies are rare; Richardson estimates there are about six large national trials and a handful of small studies currently enrolling people. They are allowed only when patients or their families can't possibly give their permission, such as when someone is alone and unconscious.
Arthur Caplan, head of the division of medical ethics at New York University's Langone Medical Center, says research without consent "absolutely should be the last resort."
It's highly regulated. The U.S. Food and Drug Administration has a special rule requiring, among other things, that patients are in life-threatening situations and that currently-available treatments are unproven or unsatisfactory. Researchers must apply to institutional review boards for waivers, be closely monitored and report any problems.
Caplan says the trials are designed to find better ways to save lives in emergencies and can be stopped when initial results show outcomes are the same or worse. Callaway says he has been involved in more than one cardiac arrest study stopped because it showed no clear benefit.
Some studies actually have harmed patients. A 2008 JAMA review of 16 clinical trials showed blood substitutes, including some tested without consent, were associated with "a significantly increased risk" of heart attacks and death.
Callaway says it's too early to know what his current four-year plasma study will find, but no problems or deaths have been attributed to the study so far. Researchers point out that giving plasma isn't a new practice; surgeons at trauma centers now may give plasma in the hospital. The study aims to find out if giving it in transport helicopters instead reduces the chance of death or severe complications.
A similar no-consent study in Denver, also sponsored by the defense department, tests giving another plasma product with slightly lower levels of clotting proteins during ambulance rides. And a third study in Maryland tests administering cold fluid to lower body temperature in bleeding patients to buy time for resuscitation.
Callaway says such studies "are definitely worth it" given what researchers can learn. Rosamond Rhodes, director of bioethics education at Mount Sinai, agrees.
But Caplan says while the research can lead to breakthroughs, there's always a chance of hurting unwitting subjects, and "that's the gamble (the nation) took when we allowed this sort of research to proceed."
Buying in, opting out
Ethicists say that gamble makes FDA-required community awareness all the more important.
The first step is community consultation, which happens before the study is launched and can determine whether it takes place in a certain location at all.
Richardson says effective consultation involves soliciting opinions from area leaders and also reaching out to groups most likely to be affected, which in the case of blood-related studies include Jehovah's Witnesses, who believe blood transfusions are forbidden.
"Public notification" or "public disclosure" involves telling the public what's happening through media such as radio, brochures or the Internet – and letting them know about opt-out methods like bracelets.
Richardson currently is studying the best ways to reach those most likely to be affected. As far as opting out, she says people who do so often oppose being a part of any research or have had bad experiences with the hospital involved.
Some ethicists argue that opting out is an important choice and say public notification often isn't up to par. "I don't see (community outreach) happening quite that aggressively," Caplan says.
That's because of the limited resources, researchers say. In Louisville, for example, researchers couldn't afford television spots or newspaper ads; half their awareness budget went to radio spots and the other half went to develop a website and fund printing and postage for the letter sent to Jehovah's Witness congregations.
"We did the best we could," says Brian Harbrecht, who heads up the plasma study there.
Rhodes acknowledges public notification could be done better but says it's an open question whether more of the limited research dollars should be diverted away from the studies themselves.
Such questions need to be answered, researchers and ethicists say, because the stakes are high: They are expecting people to unknowingly accept risk to advance medical science.
"Everyone's well aware you're experimenting without permission," Caplan says. But with emergency research, "I realistically trust there's no other way."
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