According to Ezekiel J. Emanuel MD, an oncologist, a vice provost at the University of Pennsylvania and Obamacare architect, the bacteria are winning. His article in the New York Times points out that every year at least two million people are infected with bacteria that can’t be wiped out with antibiotics, and as a result, 23,000 people die. Direct health care costs from these illnesses are estimated to be as high as $20 billion annually. Should a health care worker or any injured worker become infected while undergoing treatment for an industrial injury, the claim cost would exponentially increase.
Just last week, the U.C.L.A. Health System announced that nearly 180 patients may have been exposed to the CRE superbug that was linked to two deaths in one of its hospitals. Today, 30 percent of severe strep pneumonia infections are resistant to multiple drugs and 30 percent of gonorrhea infections are resistant to all antibiotics. And drug-resistant enterobacteriaceae, enterococcus, acinetobacter and a slew of other unpronounceable bacteria pose serious threats.
Dr. Emanuel says "The development of antibiotics has been glacial. We need a completely new approach."
The number of F.D.A.-approved antibiotics has decreased steadily in the past two decades. The big pharmaceutical companies have largely stopped work on these drugs. Pfizer, long the leader in developing antibiotics, closed its antibiotic research operations in 2011. Smaller biotech companies now account for 80 percent of antibiotic development. There are now about 40 new antibiotics in development. That might sound promising - but not when compared with the 771 new drugs and vaccines in clinical trials or awaiting F.D.A. review for cancer. And most of these antibiotics are unlikely to come out of the testing process as F.D.A.-approved drugs.
There are ways, apart from developing new drugs, to combat the problem of superbugs and drug resistance. One is hand-washing, especially in hospitals. Another is reversing the overprescribing of antibiotics. It’s estimated that half of all antibiotics used are unnecessary. Animal feed accounts for 80 percent of the antibiotics used in the United States and contributes to antibiotic resistance. We could also fix our antiquated system for tracking drug-resistant bacteria.
But just as important, we need to develop new treatments. Bacteria figure out a way to become resistant to every new drug. We are in an endless life-or-death struggle with bacteria.
The big problem is profitability. Unlike drugs for cholesterol or high blood pressure, or insulin for diabetes, which are taken every day for life, antibiotics tend to be given for a short time, a week or at most a few months. So profits have to be made on brief usage. Furthermore, any new antibiotics that might be developed to fight these drug-resistant bacteria are likely to be used very sparingly under highly controlled circumstances, to slow the development of resistant bacteria and extend their usefulness. This also limits the amount that can be sold.
Even though antibiotics are lifesaving, they do not command a premium price in the marketplace. As a society we seem willing to pay $100,000 or more for cancer drugs that cure no one and at best add weeks or a few months to life. We are willing to pay tens of thousands of dollars for knee surgery that, at best, improves function but is not lifesaving. So why won’t we pay $10,000 for a lifesaving antibiotic?
Congress has tried to address the problem. In 2012, it passed an act that expedited F.D.A. review and gave drug companies five more years of market exclusivity without generic competition. That has increased drug company interest in developing antibiotics, but not enough. Because it costs at least $1 billion to develop a new drug ...
Just last week, the U.C.L.A. Health System announced that nearly 180 patients may have been exposed to the CRE superbug that was linked to two deaths in one of its hospitals. Today, 30 percent of severe strep pneumonia infections are resistant to multiple drugs and 30 percent of gonorrhea infections are resistant to all antibiotics. And drug-resistant enterobacteriaceae, enterococcus, acinetobacter and a slew of other unpronounceable bacteria pose serious threats.
Dr. Emanuel says "The development of antibiotics has been glacial. We need a completely new approach."
The number of F.D.A.-approved antibiotics has decreased steadily in the past two decades. The big pharmaceutical companies have largely stopped work on these drugs. Pfizer, long the leader in developing antibiotics, closed its antibiotic research operations in 2011. Smaller biotech companies now account for 80 percent of antibiotic development. There are now about 40 new antibiotics in development. That might sound promising - but not when compared with the 771 new drugs and vaccines in clinical trials or awaiting F.D.A. review for cancer. And most of these antibiotics are unlikely to come out of the testing process as F.D.A.-approved drugs.
There are ways, apart from developing new drugs, to combat the problem of superbugs and drug resistance. One is hand-washing, especially in hospitals. Another is reversing the overprescribing of antibiotics. It’s estimated that half of all antibiotics used are unnecessary. Animal feed accounts for 80 percent of the antibiotics used in the United States and contributes to antibiotic resistance. We could also fix our antiquated system for tracking drug-resistant bacteria.
But just as important, we need to develop new treatments. Bacteria figure out a way to become resistant to every new drug. We are in an endless life-or-death struggle with bacteria.
The big problem is profitability. Unlike drugs for cholesterol or high blood pressure, or insulin for diabetes, which are taken every day for life, antibiotics tend to be given for a short time, a week or at most a few months. So profits have to be made on brief usage. Furthermore, any new antibiotics that might be developed to fight these drug-resistant bacteria are likely to be used very sparingly under highly controlled circumstances, to slow the development of resistant bacteria and extend their usefulness. This also limits the amount that can be sold.
Even though antibiotics are lifesaving, they do not command a premium price in the marketplace. As a society we seem willing to pay $100,000 or more for cancer drugs that cure no one and at best add weeks or a few months to life. We are willing to pay tens of thousands of dollars for knee surgery that, at best, improves function but is not lifesaving. So why won’t we pay $10,000 for a lifesaving antibiotic?
Congress has tried to address the problem. In 2012, it passed an act that expedited F.D.A. review and gave drug companies five more years of market exclusivity without generic competition. That has increased drug company interest in developing antibiotics, but not enough. Because it costs at least $1 billion to develop a new drug ...
A global fund to speed development of new antibiotics to counter the growing threat of drug-resistant superbugs is likely to need up to $2 billion, the head of a review backed by the British government said on Thursday.
The Science - Business website reports that former Goldman Sachs chief economist Jim O'Neill has urged the establishment of an innovation fund to support research, arguing that far too little is currently invested in hunting for new drugs against drug-resistant infections. "We've not yet come up with a number," O'Neill told an Economist pharmaceuticals conference when asked how big the fund would be. "My guess is probably no more than $2 billion."
O'Neill, who was asked last year by British Prime Minister David Cameron to take an economist's view of the issue, said earlier this month that philanthropists and governments should create a new fund to support drug research. In his first assessment of the threat, O'Neill estimated that so-called anti-microbial resistance (AMR) could kill an extra 10 million people a year and cost up to $100 trillion by 2050 if it was not brought under control.
The UK Review on Antimicrobial Resistance has published its second report, outlining specific steps for action to tackle the rise of drug-resistant infections worldwide. The report says that while mounting concern about the rise of antimicrobial resistance is prompting an increase in infectious disease research, a lack of funding means it is difficult to take ideas forward and companies are deterred from entering the field.
"I am calling on international funders, philanthropic or governmental, to allocate money to a fund that can support blue sky science and incubate ideas that are more mature," said Jim O’Neill, chair of the review, launching the report. Such a targeted fund would support research needed to pave the way for new drugs, for alternatives to antibiotics, and for new diagnostics to make sure the right drugs are used. It could reverse the brain drain to research areas that are currently better-paid and held in higher academic esteem, such as cancer, diabetes and dementia.
The UK government set up the review in July 2014. The first report, published in December, scoped the problem, concluding that unless action is taken to address this huge global problem, it could cost the world at least an additional 10 million lives a year by 2050, more than the number of people who currently die from cancer each year. The second report says much innovative thinking is happening in infectious disease research at the moment. But lack of funding means that while people, machines and laboratories are ready to tackle the next challenges, they are unable to do so. It also deters new entrants to the field. Without new doctors and scientists in academia, hospitals and drug companies, the ability to innovate will decrease just at the time it needs to reach its peak.
"In researching our latest report, we found no shortage of ideas and promising new technologies but progress is too slow due to lack of investment, and much of the workforce is edging towards retirement," said O’Neill. The review team is currently investigating market incentives in preparation for its next report in the Spring. Antibiotics generate low or even negative returns on investment meaning new mechanisms are needed to pull companies back into the field ...
The Science - Business website reports that former Goldman Sachs chief economist Jim O'Neill has urged the establishment of an innovation fund to support research, arguing that far too little is currently invested in hunting for new drugs against drug-resistant infections. "We've not yet come up with a number," O'Neill told an Economist pharmaceuticals conference when asked how big the fund would be. "My guess is probably no more than $2 billion."
O'Neill, who was asked last year by British Prime Minister David Cameron to take an economist's view of the issue, said earlier this month that philanthropists and governments should create a new fund to support drug research. In his first assessment of the threat, O'Neill estimated that so-called anti-microbial resistance (AMR) could kill an extra 10 million people a year and cost up to $100 trillion by 2050 if it was not brought under control.
The UK Review on Antimicrobial Resistance has published its second report, outlining specific steps for action to tackle the rise of drug-resistant infections worldwide. The report says that while mounting concern about the rise of antimicrobial resistance is prompting an increase in infectious disease research, a lack of funding means it is difficult to take ideas forward and companies are deterred from entering the field.
"I am calling on international funders, philanthropic or governmental, to allocate money to a fund that can support blue sky science and incubate ideas that are more mature," said Jim O’Neill, chair of the review, launching the report. Such a targeted fund would support research needed to pave the way for new drugs, for alternatives to antibiotics, and for new diagnostics to make sure the right drugs are used. It could reverse the brain drain to research areas that are currently better-paid and held in higher academic esteem, such as cancer, diabetes and dementia.
The UK government set up the review in July 2014. The first report, published in December, scoped the problem, concluding that unless action is taken to address this huge global problem, it could cost the world at least an additional 10 million lives a year by 2050, more than the number of people who currently die from cancer each year. The second report says much innovative thinking is happening in infectious disease research at the moment. But lack of funding means that while people, machines and laboratories are ready to tackle the next challenges, they are unable to do so. It also deters new entrants to the field. Without new doctors and scientists in academia, hospitals and drug companies, the ability to innovate will decrease just at the time it needs to reach its peak.
"In researching our latest report, we found no shortage of ideas and promising new technologies but progress is too slow due to lack of investment, and much of the workforce is edging towards retirement," said O’Neill. The review team is currently investigating market incentives in preparation for its next report in the Spring. Antibiotics generate low or even negative returns on investment meaning new mechanisms are needed to pull companies back into the field ...
An report on Law360.com says that the Los Angeles law firm Reyes and Barsoum LLP launched a California state suit accusing Knox Ricksen LLP, its opposing counsel in a workers’ compensation dispute, of hacking into a computer network and illegally downloading confidential client information so it could gain an edge in the underlying case. The complaint alleges Knox Ricksen partner Eric Danowitz and associate Daniel Sharp violated California’s Computer Crime Law and business and professions code by executing a scheme in which they wrongfully obtained 2,000 case materials containing Reyes and Barsoum’s privileged documents. The attorneys allegedly gave the materials to two other Knox Ricksen attorneys, Russell Ching and Stella Mendoza, who were trying to win a discovery motion to compel deposition answers and production of documents in a workers’ compensation case pending in Marina del Rey, California.
A Workers' Compensation Judge later found the documents to be protected as privileged, noted ethical concerns and ordered the immediate return of the materials, according to allegations of the suit. "Plaintiff asked how they obtained possession of their attorney privileged documents and confidential communications. Defendants.....attempted to perpetuate and conceal a falsehood on the court," the suit alleges. "Under further questioning, for example whether someone gave them to you, the defendants said they didn’t know. Later, the defendants stated they were found on the Internet. When asked how they were found on the Internet, the defendants [sic] attorneys, Ching and Mendoza, spontaneously returned to their statement of lack of any knowledge."
In February 2013, defendants allegedly hacked into a password-protected computer network owned and operated by HQ Sign-Up Services Inc., which stored privileged and confidential documents for Reyes and Barsoum.
After a judge in the workers’ compensation case allegedly ordered the return of the documents, the defendants in the civil suite allegedly filed a petition for the judge’s removal, according to the complaint. A workers’ compensation appeals board denied the request, however, and a similar writ to the court of appeals was also dismissed.
The complaint alleges that, "on November 24, 2015," the defendants were admonished by another judge who ordered them not to use plaintiff’s intake forms, because they were privileged documents, as ruled by the judge in the workers’ compensation case. The suit further claims the defendants still haven’t turned over the materials at issue. Furthermore, they allegedly admitted to Reyes and Barsoum that they have obtained more than 30,000 attorney files, documents and property of the plaintiff and other lawyers from the HQSU website.
"Proud of the fruits of their scheme and business practices defendant, Danowitz even showed plaintiff’s [sic] a video of how easy it was to steal, hack and illegally download paintiff’s [sic] attorney privileged documents and confidential communications and property, conceding that their conduct was an intentional, unethetical [sic], unauthorized accessing, taking, use, disclosure and dissemination of plaintiff’s attorney privileged [materials]........Subsequently, the plaintiff’s [sic] have discoved [sic] that defendants have shared its files and property with other law firms."
The suit seeks unspecified damages, an order restraining defendants from accessing plaintiff’s privileged electronic communications, an order that defendants return all documents they allegedly illegally downloaded and other relief.
The case is Reyes and Barsoum LLP v. Knox Ricksen LLP et al., case number BC572975, in the Superior Court of the State of California for the County of Los Angeles. The lawsuit and this report are allegations of one party in litigation and cannot be assumed to be true until proven in a court of law ...
A Workers' Compensation Judge later found the documents to be protected as privileged, noted ethical concerns and ordered the immediate return of the materials, according to allegations of the suit. "Plaintiff asked how they obtained possession of their attorney privileged documents and confidential communications. Defendants.....attempted to perpetuate and conceal a falsehood on the court," the suit alleges. "Under further questioning, for example whether someone gave them to you, the defendants said they didn’t know. Later, the defendants stated they were found on the Internet. When asked how they were found on the Internet, the defendants [sic] attorneys, Ching and Mendoza, spontaneously returned to their statement of lack of any knowledge."
In February 2013, defendants allegedly hacked into a password-protected computer network owned and operated by HQ Sign-Up Services Inc., which stored privileged and confidential documents for Reyes and Barsoum.
After a judge in the workers’ compensation case allegedly ordered the return of the documents, the defendants in the civil suite allegedly filed a petition for the judge’s removal, according to the complaint. A workers’ compensation appeals board denied the request, however, and a similar writ to the court of appeals was also dismissed.
The complaint alleges that, "on November 24, 2015," the defendants were admonished by another judge who ordered them not to use plaintiff’s intake forms, because they were privileged documents, as ruled by the judge in the workers’ compensation case. The suit further claims the defendants still haven’t turned over the materials at issue. Furthermore, they allegedly admitted to Reyes and Barsoum that they have obtained more than 30,000 attorney files, documents and property of the plaintiff and other lawyers from the HQSU website.
"Proud of the fruits of their scheme and business practices defendant, Danowitz even showed plaintiff’s [sic] a video of how easy it was to steal, hack and illegally download paintiff’s [sic] attorney privileged documents and confidential communications and property, conceding that their conduct was an intentional, unethetical [sic], unauthorized accessing, taking, use, disclosure and dissemination of plaintiff’s attorney privileged [materials]........Subsequently, the plaintiff’s [sic] have discoved [sic] that defendants have shared its files and property with other law firms."
The suit seeks unspecified damages, an order restraining defendants from accessing plaintiff’s privileged electronic communications, an order that defendants return all documents they allegedly illegally downloaded and other relief.
The case is Reyes and Barsoum LLP v. Knox Ricksen LLP et al., case number BC572975, in the Superior Court of the State of California for the County of Los Angeles. The lawsuit and this report are allegations of one party in litigation and cannot be assumed to be true until proven in a court of law ...
A new study from Mass.-based Workers Compensation Research Institute (WCRI), updates a recently published 33-state study with an extra year of data and the early impact analysis of major regulatory changes. The study, Hospital Outpatient Cost Index for Workers’ Compensation, 4th Edition, which was summarized by the Claims Journal compares hospital outpatient costs across states, identifies key cost drivers, and measures the impact of reforms.
"Rising hospital costs have been a concern and focus of recent public policy debates in many states," said Dr. Olesya Fomenko, co-author of the report and an economist at WCRI. “To assist policymakers and business decision makers in managing this growth, WCRI has created this unique study, which is updated regularly, to help them better understand hospital payments associated with outpatient surgeries." The following findings are highlighted in the study:
1) States with percent-of-charge-based fee regulations or no fee schedules had the highest payments to hospitals for outpatient surgical episodes for knee and shoulder surgeries. In particular, states with no hospital outpatient fee schedules had 60 to 141 percent higher hospital outpatient payments per episode compared with the typical state with fixed-amount fee schedules.
2) There was tremendous variation in the rates of change in hospital payments per surgical episode across states. From 2006 to 2013, South Carolina saw a reduction of 31 percent in this metric while in Alabama the average hospital payment per surgical episode grew by 81 percent. States with percent-of-charge-based fee regulations or no fee schedules had more rapid growth in hospital outpatient payments per episode than states with other regulatory approaches. In particular, most percent-of-charge-based fee regulation states that did not have updates to the reimbursable percentage of charges experienced growth in hospital payments per surgical episode that was 157–286 percent faster than the median of states with fixed-amount fee schedules
.3) States with cost-to-charge ratio fee regulations had similar levels and growth rates in hospital outpatient payments per episode to states with fixed-amount fee schedules. Hospital outpatient payments per episode in states with cost-to-charge ratio regulations grew 10–25 percent from 2006 to 2013.
The hospital outpatient cost indices compare payments per surgical episode for common outpatient surgeries under workers’ compensation from state to state for each study year and the trends within each state from 2005 to 2013. To capture only payments for services provided and billed by hospitals, the indices exclude professional services billed by nonhospital medical providers (such as physicians, physical therapists, and chiropractors) and transactions for durable medical equipment and pharmaceuticals billed by providers other than hospitals. This study also excludes payments made to ambulatory surgery centers.
The study covers 33 large states representing 86 percent of workers’ compensation benefits paid in the United States. Geographically diverse, they represent a wide range of industries and a variety of regulation choices for hospital payments under workers’ compensation. The states are Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia, and Wisconsin. For additional information about this study or to purchase a copy, visit http://www.wcrinet.org/result/HCI_4_result.html ...
"Rising hospital costs have been a concern and focus of recent public policy debates in many states," said Dr. Olesya Fomenko, co-author of the report and an economist at WCRI. “To assist policymakers and business decision makers in managing this growth, WCRI has created this unique study, which is updated regularly, to help them better understand hospital payments associated with outpatient surgeries." The following findings are highlighted in the study:
1) States with percent-of-charge-based fee regulations or no fee schedules had the highest payments to hospitals for outpatient surgical episodes for knee and shoulder surgeries. In particular, states with no hospital outpatient fee schedules had 60 to 141 percent higher hospital outpatient payments per episode compared with the typical state with fixed-amount fee schedules.
2) There was tremendous variation in the rates of change in hospital payments per surgical episode across states. From 2006 to 2013, South Carolina saw a reduction of 31 percent in this metric while in Alabama the average hospital payment per surgical episode grew by 81 percent. States with percent-of-charge-based fee regulations or no fee schedules had more rapid growth in hospital outpatient payments per episode than states with other regulatory approaches. In particular, most percent-of-charge-based fee regulation states that did not have updates to the reimbursable percentage of charges experienced growth in hospital payments per surgical episode that was 157–286 percent faster than the median of states with fixed-amount fee schedules
.3) States with cost-to-charge ratio fee regulations had similar levels and growth rates in hospital outpatient payments per episode to states with fixed-amount fee schedules. Hospital outpatient payments per episode in states with cost-to-charge ratio regulations grew 10–25 percent from 2006 to 2013.
The hospital outpatient cost indices compare payments per surgical episode for common outpatient surgeries under workers’ compensation from state to state for each study year and the trends within each state from 2005 to 2013. To capture only payments for services provided and billed by hospitals, the indices exclude professional services billed by nonhospital medical providers (such as physicians, physical therapists, and chiropractors) and transactions for durable medical equipment and pharmaceuticals billed by providers other than hospitals. This study also excludes payments made to ambulatory surgery centers.
The study covers 33 large states representing 86 percent of workers’ compensation benefits paid in the United States. Geographically diverse, they represent a wide range of industries and a variety of regulation choices for hospital payments under workers’ compensation. The states are Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, West Virginia, and Wisconsin. For additional information about this study or to purchase a copy, visit http://www.wcrinet.org/result/HCI_4_result.html ...
The Department of Industrial Relations announced a reduction in Independent Medical Review and Independent Bill Review fees effective January 1, 2015. This is the second reduction in fees since the inception of the IMR/IBR program and will no doubt be good news to the workers' compensation community. The following are the announced fee reductions.
IMR Fees - Any IMR application submitted on or after January 1, 2015 will be subject to the following fee schedule:
Standard IMRs Involving Non-Pharmacy Claims*
Fee effective April 1, 2014: $420 per IMR
Fee effective Jan. 1, 2015: $390 per IMR
Standard IMRs Involving Pharmacy Only Claims**
Fee effective April 1, 2014: $390 per IMR
Fee effective Jan. 1, 2015: $345 per IMR
IMRs Terminated or Dismissed Not Forwarded to a Medical Professional Reviewer:
Fee effective April 1, 2014: $160 per IMR
Fee effective Jan. 1, 2015: $123 per IMR
IBR Fees - Any IBR application submitted on or after January 1, 2015 will be subject to the following fee schedule:
Completed IBR
Fee effective April 1, 2014: $250 per IBR
Fee effective Jan. 1, 2015: $195 per IBR
Ineligible IBR Not Sent to Review***
Fee effective April 1, 2014: $50 per IBR
Fee effective Jan. 1, 2015: $47.50 per IBR
* A "non-pharmacy-only" IMR is an IMR where not all treatments in dispute fall under the service category, "pharmaceuticals."
** A "pharmacy-only" IMR is an IMR where all treatments in dispute fall under the service category "pharmaceuticals."
*** Sending an IBR to review means assigning and providing the complete file to a certified coding specialist with the expertise necessary to evaluate and render decisions on all line items in dispute ...
IMR Fees - Any IMR application submitted on or after January 1, 2015 will be subject to the following fee schedule:
Standard IMRs Involving Non-Pharmacy Claims*
Fee effective April 1, 2014: $420 per IMR
Fee effective Jan. 1, 2015: $390 per IMR
Standard IMRs Involving Pharmacy Only Claims**
Fee effective April 1, 2014: $390 per IMR
Fee effective Jan. 1, 2015: $345 per IMR
IMRs Terminated or Dismissed Not Forwarded to a Medical Professional Reviewer:
Fee effective April 1, 2014: $160 per IMR
Fee effective Jan. 1, 2015: $123 per IMR
IBR Fees - Any IBR application submitted on or after January 1, 2015 will be subject to the following fee schedule:
Completed IBR
Fee effective April 1, 2014: $250 per IBR
Fee effective Jan. 1, 2015: $195 per IBR
Ineligible IBR Not Sent to Review***
Fee effective April 1, 2014: $50 per IBR
Fee effective Jan. 1, 2015: $47.50 per IBR
* A "non-pharmacy-only" IMR is an IMR where not all treatments in dispute fall under the service category, "pharmaceuticals."
** A "pharmacy-only" IMR is an IMR where all treatments in dispute fall under the service category "pharmaceuticals."
*** Sending an IBR to review means assigning and providing the complete file to a certified coding specialist with the expertise necessary to evaluate and render decisions on all line items in dispute ...
The Division of Workers’ Compensation will hold a public meeting to discuss issues related to the home health services fee schedule. The meeting will take place on Tuesday, March 3, 2015 from 10:00 a.m. to Noon at the Elihu Harris State Office Building - Auditorium located at 1515 Clay Street in Oakland.
The purpose of the meeting is to hear input from the public regarding issues including assessing the need for home health services, service provider requirements, fee amounts, and billing codes. The agenda for the meeting has been posted online.
On January 27, 2014, the DWC posted the 2015 RAND study Home Health Care for California’s Injured Workers - Options for Implementing a Fee Schedule.
California Senate Bill 863 requires the Administrative Director to establish a fee schedule for home health services. Home health services range from skilled nurses and therapy services provided by home health agencies to unskilled personal care or chore services that may be provided by family members or other personal care aides. The RAND study identifies options for a single fee schedule that would cover the full range of home health services ...
The purpose of the meeting is to hear input from the public regarding issues including assessing the need for home health services, service provider requirements, fee amounts, and billing codes. The agenda for the meeting has been posted online.
On January 27, 2014, the DWC posted the 2015 RAND study Home Health Care for California’s Injured Workers - Options for Implementing a Fee Schedule.
California Senate Bill 863 requires the Administrative Director to establish a fee schedule for home health services. Home health services range from skilled nurses and therapy services provided by home health agencies to unskilled personal care or chore services that may be provided by family members or other personal care aides. The RAND study identifies options for a single fee schedule that would cover the full range of home health services ...
The State Fund Compensation Insurance Fund’s Board of Directors has approved a $37 million dividend to qualifying policyholders for the 2014 policy year. The dividend represents approximately 2.6 percent of policyholders’ 2014 estimated annual premium.
"In addition to declaring a $37 million dividend, we strengthened our reserve position to improve State Fund’s financial strength for the long term, thanks to strong investment returns," said Vern Steiner, President and CEO.
In order to be eligible for the 2014 policy year dividend, policyholders must:
1) Have completed no less than 335 days of continuous coverage during their 2014 policy term.
2) Have not canceled during their 2014 policy term.
3) Have complied with the State Fund audit and as a result the final audit was completed within 18 months of the 2014 policy inception. No dividend shall be paid on any premium owed or paid as a result of an audit.
4) Be current on 2014 premium payments.
Payments for a dividend will be based on the inception dates of policies. This action brings total dividends declared by State Fund since 2011 to $287 million.
San Francisco-based State Fund is the largest workers’ compensation insurance carrier in the state with more than 130,000 employer policyholders. Dividends were temporarily suspended after a $92 million dollar distribution in 2001 until the approval of a $50 million dividend in 2011 followed by a $100 million dividend for the 2012 policy year and another $100 million dividend for the 2013 policy year and now a $37 million dividend for last year. Since its inception in 1914, the State Fund has paid more than $5 billion in dividends to policyholders ...
"In addition to declaring a $37 million dividend, we strengthened our reserve position to improve State Fund’s financial strength for the long term, thanks to strong investment returns," said Vern Steiner, President and CEO.
In order to be eligible for the 2014 policy year dividend, policyholders must:
1) Have completed no less than 335 days of continuous coverage during their 2014 policy term.
2) Have not canceled during their 2014 policy term.
3) Have complied with the State Fund audit and as a result the final audit was completed within 18 months of the 2014 policy inception. No dividend shall be paid on any premium owed or paid as a result of an audit.
4) Be current on 2014 premium payments.
Payments for a dividend will be based on the inception dates of policies. This action brings total dividends declared by State Fund since 2011 to $287 million.
San Francisco-based State Fund is the largest workers’ compensation insurance carrier in the state with more than 130,000 employer policyholders. Dividends were temporarily suspended after a $92 million dollar distribution in 2001 until the approval of a $50 million dividend in 2011 followed by a $100 million dividend for the 2012 policy year and another $100 million dividend for the 2013 policy year and now a $37 million dividend for last year. Since its inception in 1914, the State Fund has paid more than $5 billion in dividends to policyholders ...
A landscaper operating in Contra Costa County is facing 34 felony and misdemeanor charges for allegedly taking exorbitant down payments from prospective clients and never completing the work. Adan "Adam" Rivas, 34, of Concord, is alleged to have defrauded 11 families in Danville, San Ramon, Alamo, Lafayette, Orinda and Walnut Creek, prosecutors said. He has a $139,000 warrant for his arrest. For each alleged victim, Rivas faces felony charges of diverting construction funds and misdemeanor charges of entering into unlawful home improvement contracts and failing to secure worker’s compensation insurance.
In May last year, one family was so perturbed by his actions, they created the website adamrivastreescam.com in the hopes of reaching other potential victims. Commenters complained of back yards torn up and left "a huge mess," elderly neighbors who had driveways ripped up and never re-paved, and dozens of calls or text messages that went unanswered. Reviews on Yelp show a similar modus operandi. Deputy District Attorney William Murphy said the district attorney’s office believes there are additional unreported victims.
It’s a pattern that appears to repeat itself as more victims come forward, District Attorney Mark Peterson said. "These families are looking to hire someone to help them," Peterson said in a statement. "Instead, they are getting nothing but messed up yards and depleted bank accounts."
Deputy District Attorney William Murphy said the bids would often range from $8,000 to $12,000 and Rivas would ask for down payments of $3,000 to $5,000. Contractors are only legally able to take 10 percent of the estimated cost as a down payment, Murphy said. "Sometimes he would do additional negotiations for more work and take more down payment monies," Murphy said.
The website lists several aliases for the landscaping service such as "New View Tree Care," "New View Tree Service," "One Way Tree Service," "View Maintenance and Landscaping," "View Landscaping and Tree Service," and "High Tech Tree Care." ...
In May last year, one family was so perturbed by his actions, they created the website adamrivastreescam.com in the hopes of reaching other potential victims. Commenters complained of back yards torn up and left "a huge mess," elderly neighbors who had driveways ripped up and never re-paved, and dozens of calls or text messages that went unanswered. Reviews on Yelp show a similar modus operandi. Deputy District Attorney William Murphy said the district attorney’s office believes there are additional unreported victims.
It’s a pattern that appears to repeat itself as more victims come forward, District Attorney Mark Peterson said. "These families are looking to hire someone to help them," Peterson said in a statement. "Instead, they are getting nothing but messed up yards and depleted bank accounts."
Deputy District Attorney William Murphy said the bids would often range from $8,000 to $12,000 and Rivas would ask for down payments of $3,000 to $5,000. Contractors are only legally able to take 10 percent of the estimated cost as a down payment, Murphy said. "Sometimes he would do additional negotiations for more work and take more down payment monies," Murphy said.
The website lists several aliases for the landscaping service such as "New View Tree Care," "New View Tree Service," "One Way Tree Service," "View Maintenance and Landscaping," "View Landscaping and Tree Service," and "High Tech Tree Care." ...
Victor Santiesteban was employed by American City Pest and Termite as a service technician until American learned he was simultaneously working for his son at another pest-control company in violation of his agreement with American. While employed by American, Santiesteban worked a night route from 4:00 p.m. to about 10:00 p.m. in a company-assigned vehicle. Santiesteban’s last day of work for American was October 26, 2009. Santiesteban filed a claim for Unemployment Insurance, which was denied on December 8, 2009. His appeal of the denial of the insurance claim was denied on or about April 7, 2010.
On January 25, 2010, Santiesteban filed a workers’ compensation claim for an injury he allegedly suffered on October 1, 2009. In the workers’ compensation claim form, Santiesteban stated he had been rear-ended while in an American truck and had suffered injuries to his "trunk." Santiesteban’s workers’ compensation claim ultimately went to the Workers’ Compensation Appeal Board where it was denied. Although no award was made to Santiesteban, investigation fees, copy service fees, and defense attorney fees were paid out.
Santiesteban was deposed in connection with his workers’ compensation claim. At the deposition, Santiesteban testified he had suffered injuries in an accident in October 2009 while driving his assigned American truck northbound on the 110 Freeway toward the 101 Freeway after fumigating a restaurant on Figueroa Street. Santiesteban did not remember the precise date of the accident. He remembered the accident occurred at night, but did not remember the exact time. When his truck was struck, he pulled to the side of the road. Five other vehicles were involved in the collision. Based on what other drivers told him, he believed the driver of a black Chevrolet Blazer caused the accident. He obtained insurance information from that driver, but he "hardly remembered anything" about the vehicle that struck him because he was too nervous.
Santiesteban attempted to contact his supervisor to report the accident but was unable to reach him. It was not until the following day that he was first advised there was an accident form in the glove compartment of his vehicle that needed to be completed. Santiesteban indicated he realized the night of the accident he had been injured. He felt pain that night and the pain worsened the following day. When he reported the accident to his employer the following day, he indicated he was experiencing pain from the accident. Santiesteban described going to Harbor UCLA Hospital a few days after the accident and receiving treatment for his injuries.
A jury convicted Santiesteban of the offense of making a fraudulent statement in his workers’ compensation claim in violation of Insurance Code section 1871.4, subdivision (a)(1) (count 1), and of the offense of attempted perjury under oath in violation of Penal Code sections 118, subdivision (a), 664, subdivision (a) (count 2). Santiesteban appealed the conviction, and the Court of Appeal affirmed the conviction in the case of People v Santiesteban.
In addition to other evidence presented in the criminal case, it was shown that Santiesteban’s vehicle was equipped with a "Teletrac" global positioning device at all times. Katie Witman, Teletrac’s Director of Customer Implementation, testified Telectrac tracks vehicles through cell towers. A report of Santiesteban’s vehicle’s movements and locations was generated for the period from September 30, 2009, through October 2, 2009. At 3:00 a.m. on October 2, 2009, Santiesteban’s vehicle was on the 101 Freeway traveling at 44 miles per hour. At 3:05 a.m., Santiesteban’s vehicle was traveling to 5851 Sunset Boulevard. The vehicle spent about 10 minutes on the 101 Freeway and was never at the 110/101 Freeway interchange. A vehicle stopped for 20 to 25 minutes would have been noted on the Teletrac report.
Edward Messinger, an insurance fraud investigator for the Orange County District Attorney’s office, was assigned to Santiesteban’s case. Messinger verified Santiesteban’s identity and matched it to the records involving his claim. Messinger also matched Santiesteban’s medical records from UCLA to his medical history. The records contained no mention of the October 1, 2009, accident or back pain. The records reflected no doctor visit during September and October 2009.
A review of the record including the possible issues raised by appellate counsel, has disclosed no reasonably arguable appellate issue. On its own motion, an appellate court with jurisdiction of a case may order correction of clerical errors contained in the abstract of judgment. The case is remanded to the trial court with directions to amend the sentencing minute order to reflect the jail sentence was imposed on both counts ...
On January 25, 2010, Santiesteban filed a workers’ compensation claim for an injury he allegedly suffered on October 1, 2009. In the workers’ compensation claim form, Santiesteban stated he had been rear-ended while in an American truck and had suffered injuries to his "trunk." Santiesteban’s workers’ compensation claim ultimately went to the Workers’ Compensation Appeal Board where it was denied. Although no award was made to Santiesteban, investigation fees, copy service fees, and defense attorney fees were paid out.
Santiesteban was deposed in connection with his workers’ compensation claim. At the deposition, Santiesteban testified he had suffered injuries in an accident in October 2009 while driving his assigned American truck northbound on the 110 Freeway toward the 101 Freeway after fumigating a restaurant on Figueroa Street. Santiesteban did not remember the precise date of the accident. He remembered the accident occurred at night, but did not remember the exact time. When his truck was struck, he pulled to the side of the road. Five other vehicles were involved in the collision. Based on what other drivers told him, he believed the driver of a black Chevrolet Blazer caused the accident. He obtained insurance information from that driver, but he "hardly remembered anything" about the vehicle that struck him because he was too nervous.
Santiesteban attempted to contact his supervisor to report the accident but was unable to reach him. It was not until the following day that he was first advised there was an accident form in the glove compartment of his vehicle that needed to be completed. Santiesteban indicated he realized the night of the accident he had been injured. He felt pain that night and the pain worsened the following day. When he reported the accident to his employer the following day, he indicated he was experiencing pain from the accident. Santiesteban described going to Harbor UCLA Hospital a few days after the accident and receiving treatment for his injuries.
A jury convicted Santiesteban of the offense of making a fraudulent statement in his workers’ compensation claim in violation of Insurance Code section 1871.4, subdivision (a)(1) (count 1), and of the offense of attempted perjury under oath in violation of Penal Code sections 118, subdivision (a), 664, subdivision (a) (count 2). Santiesteban appealed the conviction, and the Court of Appeal affirmed the conviction in the case of People v Santiesteban.
In addition to other evidence presented in the criminal case, it was shown that Santiesteban’s vehicle was equipped with a "Teletrac" global positioning device at all times. Katie Witman, Teletrac’s Director of Customer Implementation, testified Telectrac tracks vehicles through cell towers. A report of Santiesteban’s vehicle’s movements and locations was generated for the period from September 30, 2009, through October 2, 2009. At 3:00 a.m. on October 2, 2009, Santiesteban’s vehicle was on the 101 Freeway traveling at 44 miles per hour. At 3:05 a.m., Santiesteban’s vehicle was traveling to 5851 Sunset Boulevard. The vehicle spent about 10 minutes on the 101 Freeway and was never at the 110/101 Freeway interchange. A vehicle stopped for 20 to 25 minutes would have been noted on the Teletrac report.
Edward Messinger, an insurance fraud investigator for the Orange County District Attorney’s office, was assigned to Santiesteban’s case. Messinger verified Santiesteban’s identity and matched it to the records involving his claim. Messinger also matched Santiesteban’s medical records from UCLA to his medical history. The records contained no mention of the October 1, 2009, accident or back pain. The records reflected no doctor visit during September and October 2009.
A review of the record including the possible issues raised by appellate counsel, has disclosed no reasonably arguable appellate issue. On its own motion, an appellate court with jurisdiction of a case may order correction of clerical errors contained in the abstract of judgment. The case is remanded to the trial court with directions to amend the sentencing minute order to reflect the jail sentence was imposed on both counts ...
Labor Code §§ 129 and 129.5, require the Audit Unit of the Division of Workers’ Compensation to conduct a routine profile audit review (PAR audit) for all adjusting locations of California workers’ compensation claims at least once every five years. The performance of an audit subject is rated for provision of specific workers’ compensation benefits and measured against standards set by the results of prior audits within the industry. The Administrative Director annually establishes the profile audit review and full compliance audit standards. The 2015 standards are based on the audit results of calendar years 2011 through 2013.
The Profile Audit Review (PAR) Performance Standard for audits conducted in 2015 is 1.53446. Audit subjects with PAR performance ratings of 1.53446 or lower will be required to pay any unpaid compensation, but no penalties will be assessed. If a PAR audit subject’s PAR Performance rating is 1.53447 or higher, the audit will expand to a Full Compliance Audit, and an additional sample of indemnity claims will be audited.
It is estimated that approximately 80% of audit subjects meet or exceed the PAR Performance Standard and that approximately 20% of audit subjects will be subject to a Full Compliance Audit.
The Full Compliance Audit (FCA) Performance Standard for audits conducted in 2015 is 1.68525. FCA audit subjects with an FCA performance rating of 1.68525 or less will be required to pay any unpaid compensation and penalties will be assessed for all violations involving unpaid and late paid compensation. If an FCA subject’s full compliance audit performance rating is 1.83496 or higher, an additional sample of denied claims as well as the expanded samples of indemnity claims will be audited. Penalties will be assessed for all violations as appropriate pursuant to 8CCR§§10111 though 10111.2.
It is estimated that approximately 50% of FCA audit subjects (10% of the PAR audit subjects) will meet or exceed the FCA Performance Standard and that approximately 50% (the 10% poorest performing of all audit subjects) will fail the Full Compliance Audit ...
The Profile Audit Review (PAR) Performance Standard for audits conducted in 2015 is 1.53446. Audit subjects with PAR performance ratings of 1.53446 or lower will be required to pay any unpaid compensation, but no penalties will be assessed. If a PAR audit subject’s PAR Performance rating is 1.53447 or higher, the audit will expand to a Full Compliance Audit, and an additional sample of indemnity claims will be audited.
It is estimated that approximately 80% of audit subjects meet or exceed the PAR Performance Standard and that approximately 20% of audit subjects will be subject to a Full Compliance Audit.
The Full Compliance Audit (FCA) Performance Standard for audits conducted in 2015 is 1.68525. FCA audit subjects with an FCA performance rating of 1.68525 or less will be required to pay any unpaid compensation and penalties will be assessed for all violations involving unpaid and late paid compensation. If an FCA subject’s full compliance audit performance rating is 1.83496 or higher, an additional sample of denied claims as well as the expanded samples of indemnity claims will be audited. Penalties will be assessed for all violations as appropriate pursuant to 8CCR§§10111 though 10111.2.
It is estimated that approximately 50% of FCA audit subjects (10% of the PAR audit subjects) will meet or exceed the FCA Performance Standard and that approximately 50% (the 10% poorest performing of all audit subjects) will fail the Full Compliance Audit ...
The Second District Court of Appeal reversed the WCAB finding that the medical evidence on the cause of the psychiatric injury and sleep disorder was not substantial evidence because it is based on an inadequate medical history. Here is what happened in the unpublished case of Radiator USA v. WCAB.
Am Kang sustained an admitted injury to his back on December 24, 2010 while working as a driver for Radiator USA. Kang additionally claimed to have sustained injury to his psyche in the form of a sleep disorder. David B. Pechman, M.D. was the AME in orthopedics. He noted that compression fractures in Kang’s vertebrae appeared old and he thought that most of Kang’s pain related to the compression fractures. Dr. Pechman apportioned 50 percent of the orthopedic injury to nonindustrial preexisting metabolic bone disease.
Rodney Bluestone, MD, the qualified medical evaluator of rheumatology, confirmed Kang had metabolic bone disease (osteopenia and osteoporosis) but could not determine a cause. Although Dr. Bluestone requested additional testing to determine the cause of the metabolic bone disease, there was no supplemental report that addressed causation.
Ana L. Nogales, Ph.D., evaluated Kang as a secondary treating physician in psychology. Dr. Nogales obtained a history of the injury, history of the treatment, and physical and emotional complaints exclusively from Kang. Dr. Nogales explicitly noted that she did not receive medical or employment records for review.
On the issue of causation, Dr. Nogales found that, as a "consequence of his industrial accident, Mr. Kang developed anxiety that increased with the passage of time and deteriorated at the end of 2011 when he saw that his condition is not improving." Dr. Nogales opined that the "percentage of total causation of Mr. Kang’s current mental disorder is estimated at a higher level than the legal threshold of industrial causation of 50 [percent]." She specifically noted a nonindustrial causal factor of a dog bite in 2005 requiring stitches. Dr. Nogales made no mention of Dr. Pechman’s orthopedic diagnosis or his apportionment to the preexisting bone disease.
The matter was heard on September 26, 2013. The sole medical evidence of psychiatric industrial causation came from psychologist Dr. Nogales. Based upon this evidence, the WCJ issued findings of fact concluding Kang sustained industrial injury to his back, to his psyche, and in the form of a sleep disorder. Reconsideration was sought based "upon a lack of medical evidence to support this finding." Reconsideration was denied. The appeals board found the doctors "based their opinions on extensive discussions with [Kang] regarding how he sustained his injury and his condition thereafter." The appeals board found that, based on these discussions, Dr. Nogales concluded the industrial cause of Kang’s psychiatric injury was higher than the legal threshold. However the Court of Appeal reversed and remanded in the unpublished case.
In reversing the Court of Appeal noted that Dr. Nogales was completely unaware of the fact that Dr. Pechman had apportioned 50 percent of the orthopedic injury to nonindustrial preexisting metabolic bone disease. The Court posed the question does "this mean that 50 percent of the psychiatric injury is attributable to nonindustrial causes?"
The Court acknowledge that "these determinations cannot be made with mathematical precision, it is at least a major issue what portion of the psychiatric injury is attributable to nonindustrial causes. Although 50 percent is a reasonable surmise, on this silent record it is equally plausible to suppose that, given that psychiatric evaluations are unavoidably case-specific, 60 percent of the psychiatric injury - or 40 percent thereof - is attributable to nonindustrial causes. In short, what is needed here is an expert opinion that is based on a complete medical history, which necessarily includes Dr. Pechman’s finding that 50 percent of the orthopedic injury is attributable to nonindustrial causes."
"Given the lack of competent medical evidence on causation, the decision of the appeals board cannot stand. It is now well established that the appeals board has an affirmative duty to develop an adequate record. As an example, where the medical evidence was evenly balanced on the issue of industrial causation, our Supreme Court held that the appeals board was not free to simply rule that the employee had failed to sustain his burden of proof but was required to take additional evidence in order to resolve the doubts raised by the existing medical reports".
The decision of the appeals board is annulled and the matter is remanded for further proceedings consistent with this opinion ...
Am Kang sustained an admitted injury to his back on December 24, 2010 while working as a driver for Radiator USA. Kang additionally claimed to have sustained injury to his psyche in the form of a sleep disorder. David B. Pechman, M.D. was the AME in orthopedics. He noted that compression fractures in Kang’s vertebrae appeared old and he thought that most of Kang’s pain related to the compression fractures. Dr. Pechman apportioned 50 percent of the orthopedic injury to nonindustrial preexisting metabolic bone disease.
Rodney Bluestone, MD, the qualified medical evaluator of rheumatology, confirmed Kang had metabolic bone disease (osteopenia and osteoporosis) but could not determine a cause. Although Dr. Bluestone requested additional testing to determine the cause of the metabolic bone disease, there was no supplemental report that addressed causation.
Ana L. Nogales, Ph.D., evaluated Kang as a secondary treating physician in psychology. Dr. Nogales obtained a history of the injury, history of the treatment, and physical and emotional complaints exclusively from Kang. Dr. Nogales explicitly noted that she did not receive medical or employment records for review.
On the issue of causation, Dr. Nogales found that, as a "consequence of his industrial accident, Mr. Kang developed anxiety that increased with the passage of time and deteriorated at the end of 2011 when he saw that his condition is not improving." Dr. Nogales opined that the "percentage of total causation of Mr. Kang’s current mental disorder is estimated at a higher level than the legal threshold of industrial causation of 50 [percent]." She specifically noted a nonindustrial causal factor of a dog bite in 2005 requiring stitches. Dr. Nogales made no mention of Dr. Pechman’s orthopedic diagnosis or his apportionment to the preexisting bone disease.
The matter was heard on September 26, 2013. The sole medical evidence of psychiatric industrial causation came from psychologist Dr. Nogales. Based upon this evidence, the WCJ issued findings of fact concluding Kang sustained industrial injury to his back, to his psyche, and in the form of a sleep disorder. Reconsideration was sought based "upon a lack of medical evidence to support this finding." Reconsideration was denied. The appeals board found the doctors "based their opinions on extensive discussions with [Kang] regarding how he sustained his injury and his condition thereafter." The appeals board found that, based on these discussions, Dr. Nogales concluded the industrial cause of Kang’s psychiatric injury was higher than the legal threshold. However the Court of Appeal reversed and remanded in the unpublished case.
In reversing the Court of Appeal noted that Dr. Nogales was completely unaware of the fact that Dr. Pechman had apportioned 50 percent of the orthopedic injury to nonindustrial preexisting metabolic bone disease. The Court posed the question does "this mean that 50 percent of the psychiatric injury is attributable to nonindustrial causes?"
The Court acknowledge that "these determinations cannot be made with mathematical precision, it is at least a major issue what portion of the psychiatric injury is attributable to nonindustrial causes. Although 50 percent is a reasonable surmise, on this silent record it is equally plausible to suppose that, given that psychiatric evaluations are unavoidably case-specific, 60 percent of the psychiatric injury - or 40 percent thereof - is attributable to nonindustrial causes. In short, what is needed here is an expert opinion that is based on a complete medical history, which necessarily includes Dr. Pechman’s finding that 50 percent of the orthopedic injury is attributable to nonindustrial causes."
"Given the lack of competent medical evidence on causation, the decision of the appeals board cannot stand. It is now well established that the appeals board has an affirmative duty to develop an adequate record. As an example, where the medical evidence was evenly balanced on the issue of industrial causation, our Supreme Court held that the appeals board was not free to simply rule that the employee had failed to sustain his burden of proof but was required to take additional evidence in order to resolve the doubts raised by the existing medical reports".
The decision of the appeals board is annulled and the matter is remanded for further proceedings consistent with this opinion ...
CRE or Carbapenem-Resistant Enterobacteriaceae is the new and frightening "superbug." The bacteria can kill up to half of patients who get bloodstream infections, a rate much higher than other resistant infections such as MRSA or Clostridium difficile. The bacteria are also sometimes referred to as the "nightmare bacteria"
According to a report in USA Today, the deadly pattern of illnesses began to emerge in 2012 at hospitals in Seattle, Pittsburgh and Chicago. CRE is perhaps the most feared of superbugs, because it resists even "last defense" antibiotics. And in each hospital case, investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system. They found that the devices, often called duodenoscopes, accumulate bacteria that are not always removed by conventional cleaning, so infections can pass from patient to patient.
CRE has now infected patients closer to home. The Los Angeles Times reports that nearly 180 patients at UCLA's Ronald Reagan Medical Center may have been exposed to potentially deadly bacteria from contaminated medical scopes, and two deaths have already been linked to the outbreak. The Times has learned that the two people who died are among seven patients that UCLA found were infected by CRE - a number that may grow as more patients get tested. UCLA said it discovered the outbreak late last month while running tests on a patient. This week, it began to notify 179 other patients who were treated from October to January and offer them medical tests. By some estimates, if the infection spreads to a person's bloodstream..
UCLA said it immediately notified public health authorities after discovering the bacteria in one patient and tracing the problem to two of these endoscopes. The university said it had been cleaning the scopes "according to standards stipulated by the manufacturer," and it changed how it disinfects the instruments after the infections occurred. Dale Tate, a university spokeswoman, said "the two scopes involved with the infection were immediately removed and UCLA is now utilizing a decontamination process that goes above and beyond the manufacturer and national standards."
Yet neither the scopes' manufacturers nor the Food and Drug Administration, which regulates them, have publicized or offered guidance on the problem. So, many doctors who use the scopes - and most of the patients they treat - don't know the risks. Nor do they know that steps can be taken to cut those risks dramatically. "Most hospitals that do these procedures are not even looking for this problem, or they may not be aware, and that's got to change," says Jeffrey Duchin, a physician who heads communicable disease control at the Seattle and King County Public Health Department.
The FDA says in a written statement to USA TODAY that it is "aware of and closely monitoring" the infection risks associated with the scopes. "Some parts of the scopes may be extremely difficult to access and clean thoroughly," the agency adds, "and effective cleaning of all areas of the duodenoscope may not be possible." The agency is studying the problem and working with manufacturers to determine whether new cleaning protocols should be mandated or the scopes should be redesigned entirely. Meanwhile, the scopes' "lifesaving" ability to detect and treat potentially fatal digestive disorders outweighs their infection risks, the statement adds. "It (is) important for these devices to remain available." Few dispute the scopes' importance.
But public health officials and endoscopy experts who have studied the problem believe the FDA and scope manufacturers have been slow to bring attention to the infection risks and publicize steps hospitals can take to reduce them dramatically. "It's fair to ask whether the FDA could have been doing more to regulate these devices and significantly reduce the risk of patient harm," says Lawrence Muscarella, a biomedical engineer and independent consultant who advises hospitals on endoscope safety. "Patients have died, and the agency seems to be moving slowly." ...
According to a report in USA Today, the deadly pattern of illnesses began to emerge in 2012 at hospitals in Seattle, Pittsburgh and Chicago. CRE is perhaps the most feared of superbugs, because it resists even "last defense" antibiotics. And in each hospital case, investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system. They found that the devices, often called duodenoscopes, accumulate bacteria that are not always removed by conventional cleaning, so infections can pass from patient to patient.
CRE has now infected patients closer to home. The Los Angeles Times reports that nearly 180 patients at UCLA's Ronald Reagan Medical Center may have been exposed to potentially deadly bacteria from contaminated medical scopes, and two deaths have already been linked to the outbreak. The Times has learned that the two people who died are among seven patients that UCLA found were infected by CRE - a number that may grow as more patients get tested. UCLA said it discovered the outbreak late last month while running tests on a patient. This week, it began to notify 179 other patients who were treated from October to January and offer them medical tests. By some estimates, if the infection spreads to a person's bloodstream..
UCLA said it immediately notified public health authorities after discovering the bacteria in one patient and tracing the problem to two of these endoscopes. The university said it had been cleaning the scopes "according to standards stipulated by the manufacturer," and it changed how it disinfects the instruments after the infections occurred. Dale Tate, a university spokeswoman, said "the two scopes involved with the infection were immediately removed and UCLA is now utilizing a decontamination process that goes above and beyond the manufacturer and national standards."
Yet neither the scopes' manufacturers nor the Food and Drug Administration, which regulates them, have publicized or offered guidance on the problem. So, many doctors who use the scopes - and most of the patients they treat - don't know the risks. Nor do they know that steps can be taken to cut those risks dramatically. "Most hospitals that do these procedures are not even looking for this problem, or they may not be aware, and that's got to change," says Jeffrey Duchin, a physician who heads communicable disease control at the Seattle and King County Public Health Department.
The FDA says in a written statement to USA TODAY that it is "aware of and closely monitoring" the infection risks associated with the scopes. "Some parts of the scopes may be extremely difficult to access and clean thoroughly," the agency adds, "and effective cleaning of all areas of the duodenoscope may not be possible." The agency is studying the problem and working with manufacturers to determine whether new cleaning protocols should be mandated or the scopes should be redesigned entirely. Meanwhile, the scopes' "lifesaving" ability to detect and treat potentially fatal digestive disorders outweighs their infection risks, the statement adds. "It (is) important for these devices to remain available." Few dispute the scopes' importance.
But public health officials and endoscopy experts who have studied the problem believe the FDA and scope manufacturers have been slow to bring attention to the infection risks and publicize steps hospitals can take to reduce them dramatically. "It's fair to ask whether the FDA could have been doing more to regulate these devices and significantly reduce the risk of patient harm," says Lawrence Muscarella, a biomedical engineer and independent consultant who advises hospitals on endoscope safety. "Patients have died, and the agency seems to be moving slowly." ...
As authorities conducted a drug raid on Salinas’ Chinatown last Thursday, a second set of federal officers searched a Salinas doctor’s office and home in connection with an alleged fraud case.
The Californian reports that Dr. Steven Mangar, who runs Pacific Pain Care Institute, was arrested on Valentine’s Day last year on suspicion of driving under the influence of methamphetamine. A California Highway Patrol officer stopped 44-year-old Mangar at Highway 101 and Sanborn Road. But, prosecutor Ed Hazel said the U.S. Department of Justice crime lab in Sacramento is so backed up, Mangar’s toxicology report was not available until last month. Mangar was charged Jan. 21. He was ultimately arraigned 364 days after his arrest. Mangar’s arraignment in Monterey County Superior Court followed a day after federal agents swooped down on his West Alisal Street office and his home on Madeira Avenue in Salinas. Authorities with the Monterey County District Attorney’s Office’s Health Care and Workers’ Compensation fraud units served the search warrant with help from the State Medical Board, the Department of Insurance, the Drug Enforcement Agency and the DOJ Office of the Inspector General. At the same time, another alphabet soup of agents searched Salinas’ Chinatown for methamphetamine, heroin, marijuana and cash. Twelve arrests stemmed from that raid.
Between 2005 and 2012, Mangar collected 10 traffic citations for minor incidents, Hazel said. In that time period, he was also sued four times in civil court. This was not the first time Mangar has come under scrutiny from the State Medical Board. On Oct. 5, 2012, Mangar was placed on three years’ probation following an investigation into his treatment between 2003 and 2010 of a 60-year-old man who had chronic neck pain. According to court documents, Mangar kept shoddy records that indicated he examined the patient at times when, in fact, he hadn’t. Mangar prescribed the man Percocet and Oxycontin, both powerful pain killers, according to the records. After the investigation, he was ordered to enroll in prescribing practices and record-keeping courses.
On May 15, 2013, Mangar was cited and fined $350 for failing to submit a quarterly declaration in conjunction with his probation.
On Nov. 6, 2014, Medical Board officials filed a petition to revoke Mangar’s probation. Doing so could result in the loss of Mangar’s physician’s and surgeon’s certificate. The petition revolved around Mangar’s treatment of a 40-year-old man with chronic back pain, according to court records. Although the patient’s quality of life didn’t improve, Mangar continued prescribing him Oxycontin. He later added in Ritalin when the man said he couldn’t stay awake. In doing so, Mangar acted unprofessionally and failed to develop an objective-oriented treatment plan, according to the allegation. A decision is still pending in that petition.
ProPublica analysis shows Mangar was the third-leading hydrocodone prescriber in California in 2012. Hydrocodone, also known as Vicodin, is another powerful pain killer. In 2012, 72 percent and 55 percent of Mangar’s 241 patients filled Schedule II and Schedule III drug prescriptions, respectively, according to ProPublica. Drugs are classified into five categories, per the DEA. Schedule II drugs are potentially highly addictive. Schedule III drugs carry a moderate to low risk of abuse. On average, specialists in Mangar’s area only prescribed Schedule II and Schedule III drugs 4 percent and 13 percent of the time, respectively. Only 23 percent of Mangar’s prescriptions were for brand names, compared with a 29 percent average at other specialists’ offices. But Mangar’s prescriptions also cost $170 on average compared with $99 from other prescribers.
Mangar, who is represented by defense attorney Susan Chapman, is expected to return to court March 5, Hazel said. Mangar and Chapman weren’t immediately available for comment ...
The Californian reports that Dr. Steven Mangar, who runs Pacific Pain Care Institute, was arrested on Valentine’s Day last year on suspicion of driving under the influence of methamphetamine. A California Highway Patrol officer stopped 44-year-old Mangar at Highway 101 and Sanborn Road. But, prosecutor Ed Hazel said the U.S. Department of Justice crime lab in Sacramento is so backed up, Mangar’s toxicology report was not available until last month. Mangar was charged Jan. 21. He was ultimately arraigned 364 days after his arrest. Mangar’s arraignment in Monterey County Superior Court followed a day after federal agents swooped down on his West Alisal Street office and his home on Madeira Avenue in Salinas. Authorities with the Monterey County District Attorney’s Office’s Health Care and Workers’ Compensation fraud units served the search warrant with help from the State Medical Board, the Department of Insurance, the Drug Enforcement Agency and the DOJ Office of the Inspector General. At the same time, another alphabet soup of agents searched Salinas’ Chinatown for methamphetamine, heroin, marijuana and cash. Twelve arrests stemmed from that raid.
Between 2005 and 2012, Mangar collected 10 traffic citations for minor incidents, Hazel said. In that time period, he was also sued four times in civil court. This was not the first time Mangar has come under scrutiny from the State Medical Board. On Oct. 5, 2012, Mangar was placed on three years’ probation following an investigation into his treatment between 2003 and 2010 of a 60-year-old man who had chronic neck pain. According to court documents, Mangar kept shoddy records that indicated he examined the patient at times when, in fact, he hadn’t. Mangar prescribed the man Percocet and Oxycontin, both powerful pain killers, according to the records. After the investigation, he was ordered to enroll in prescribing practices and record-keeping courses.
On May 15, 2013, Mangar was cited and fined $350 for failing to submit a quarterly declaration in conjunction with his probation.
On Nov. 6, 2014, Medical Board officials filed a petition to revoke Mangar’s probation. Doing so could result in the loss of Mangar’s physician’s and surgeon’s certificate. The petition revolved around Mangar’s treatment of a 40-year-old man with chronic back pain, according to court records. Although the patient’s quality of life didn’t improve, Mangar continued prescribing him Oxycontin. He later added in Ritalin when the man said he couldn’t stay awake. In doing so, Mangar acted unprofessionally and failed to develop an objective-oriented treatment plan, according to the allegation. A decision is still pending in that petition.
ProPublica analysis shows Mangar was the third-leading hydrocodone prescriber in California in 2012. Hydrocodone, also known as Vicodin, is another powerful pain killer. In 2012, 72 percent and 55 percent of Mangar’s 241 patients filled Schedule II and Schedule III drug prescriptions, respectively, according to ProPublica. Drugs are classified into five categories, per the DEA. Schedule II drugs are potentially highly addictive. Schedule III drugs carry a moderate to low risk of abuse. On average, specialists in Mangar’s area only prescribed Schedule II and Schedule III drugs 4 percent and 13 percent of the time, respectively. Only 23 percent of Mangar’s prescriptions were for brand names, compared with a 29 percent average at other specialists’ offices. But Mangar’s prescriptions also cost $170 on average compared with $99 from other prescribers.
Mangar, who is represented by defense attorney Susan Chapman, is expected to return to court March 5, Hazel said. Mangar and Chapman weren’t immediately available for comment ...
The Division of Workers’ Compensation has posted an order adjusting the Physician Services/Non-Physician Practitioner Services section of the Official Medical Fee Schedule (OMFS) to conform to relevant 2015 changes in the Medicare payment system as required by Labor Code section 5307.1.
The Physician and Non-Physician Practitioner Fee Schedule based on the federal Resource Based Relative Value Scale (RBRVS) was adopted pursuant to the requirements of Senate Bill 863 (SB 863) and became effective for services rendered on or after January 1, 2014. As mandated by SB 863, the fee schedule starts with separate conversion factors for surgery, radiology, and "all other services" in 2014 and transitions to a single conversion factor (CF) beginning in 2017, for all services except anesthesia. The 2015 transition conversion factors reflect a blend of 50 percent pre-2014 OMFS CF and 50 percent 120% RBRVS Medicare CF.
The Physician and Non-Physician Practitioner Fee Schedule update order adopts revisions to several sections of Title 8 California Code of Regulations, including the following changes
1) Adopts the CMS Medicare National Physician Fee Schedule Relative Value File(RVU file) RVU15A and related files for services rendered on or after March 1,2015
2) Updates the Conversion Factors, applying the Medicare relative value scaleadjustments and the Medicare Economic Index (MEI) inflation increase to thetransitional conversion factors set forth in the regulation
3) Updates the Statewide Geographic Adjustment Factors
4) Adopts the 2015 National Correct Coding Initiative Edits/2015 NCCI PolicyManual
5) Updates the California specific codes with the MEI inflation increase
The administrative director update order adopting the OMFS adjustments effective for services rendered on or after March 1, 2015, can be found on the DWC website. An explanation of changes is attached to the order, identifying the basis for the changes included in the update ...
The Physician and Non-Physician Practitioner Fee Schedule based on the federal Resource Based Relative Value Scale (RBRVS) was adopted pursuant to the requirements of Senate Bill 863 (SB 863) and became effective for services rendered on or after January 1, 2014. As mandated by SB 863, the fee schedule starts with separate conversion factors for surgery, radiology, and "all other services" in 2014 and transitions to a single conversion factor (CF) beginning in 2017, for all services except anesthesia. The 2015 transition conversion factors reflect a blend of 50 percent pre-2014 OMFS CF and 50 percent 120% RBRVS Medicare CF.
The Physician and Non-Physician Practitioner Fee Schedule update order adopts revisions to several sections of Title 8 California Code of Regulations, including the following changes
1) Adopts the CMS Medicare National Physician Fee Schedule Relative Value File(RVU file) RVU15A and related files for services rendered on or after March 1,2015
2) Updates the Conversion Factors, applying the Medicare relative value scaleadjustments and the Medicare Economic Index (MEI) inflation increase to thetransitional conversion factors set forth in the regulation
3) Updates the Statewide Geographic Adjustment Factors
4) Adopts the 2015 National Correct Coding Initiative Edits/2015 NCCI PolicyManual
5) Updates the California specific codes with the MEI inflation increase
The administrative director update order adopting the OMFS adjustments effective for services rendered on or after March 1, 2015, can be found on the DWC website. An explanation of changes is attached to the order, identifying the basis for the changes included in the update ...
The case of Fernando Martinez v Santa Clarita Community College District involves a denied claim of continuous trauma injury to his back, circulatory system, psyche, nervous system, hypertension,diabetes, and upper and lower gastrointestinal system.
The applicant objected to the report from the treating orthopedist Dr. Robert Reisch dated October 3, 2012, based upon "The disability status of the applicant's medical condition." The applicant simultaneously filed three separate requests for QME panels in the specialties of orthopedic, psychiatric and internal medicine. All of the requests are dated January 9, 2014. In each of the Form I 06s, the applicant checked off the box indicating that the reason that the QME panel is being requested is "§4062 (nonmedical treatment dispute under 4062)."
An Orthopedic panel issued February 7, 2014. Panels were issued in the specialties of psychiatry and internal medicine on February 10, 2014. The Defendant objected to the internal and psychiatric panels. The parties proceed to trial regarding the limited issue of whether the applicant is entitled to undergo QME panels in orthopedics, psychiatry and internal medicine. The WCJ ordered the defendant to authorize the orthopedic PQME evaluation and found that the applicant was not entitled to undergo PQME evaluations in the specialties of psychiatry and internal medicine, at the time of trial and that issues regarding applicant's entitlement to psychiatric and internal PQME(s) after completion of the orthopedic PQME evaluation were deferred, with jurisdiction reserved.
The applicant petitioned for removal which was denied in what Lexis is characterizing as a "noteworthy panel decision." The denial incorporated the reasoning of the WCJ as follows.
The applicant must first complete an initial PQME examination prior to obtaining PQME evaluations in other specialties. The applicant has not met the criteria in rule §31.7 for obtaining different specialties at the time of trial. The applicant also failed to submit the appropriate form to request QME panels regarding other specialties. As per Title 8 California Code of Regulations §31 7 a party "shall" utilize Form 31.7 to request an additional QME panel in a different specialty. It is noted that Fonn 31.7 requires that the prior PQME panel number be identified when requesting other specialties, which could not have been done in this case, as all three QME panels were improperly requested at the same time.
The applicant also failed to comply with the requirements of Labor Code §4062 regarding psychiatric and internal PQMEs. The applicant stated in the three QME requests that the reason for the QME panel is "§4062 (nonmedical treatment dispute under 4062)." However, the letter attached to each PQME request objects solely to the opinions rendered by orthopedist Dr. Reisch in his report dated October 3, 2012. In said report Dr. Reisch stated that the applicant was given refills of Voltaren gel, and was given a Toradol injection. Further, Dr. Reisch stated that the applicant was to continue working modified duties as previously. There is no reference in said report with regard to any alleged internal or psychiatric injuries or complaints. Moreover, the applicant did not object to the findings of a psychiatrist or internal doctor prior to requesting PQME panels in the specialties of psychiatry and internal medicine. Accordingly, the applicant failed to comply with the requirements of Labor Code 4062 with regard to obtaining a PQME panel in specialties other than orthopedics, at the time of trial ...
The applicant objected to the report from the treating orthopedist Dr. Robert Reisch dated October 3, 2012, based upon "The disability status of the applicant's medical condition." The applicant simultaneously filed three separate requests for QME panels in the specialties of orthopedic, psychiatric and internal medicine. All of the requests are dated January 9, 2014. In each of the Form I 06s, the applicant checked off the box indicating that the reason that the QME panel is being requested is "§4062 (nonmedical treatment dispute under 4062)."
An Orthopedic panel issued February 7, 2014. Panels were issued in the specialties of psychiatry and internal medicine on February 10, 2014. The Defendant objected to the internal and psychiatric panels. The parties proceed to trial regarding the limited issue of whether the applicant is entitled to undergo QME panels in orthopedics, psychiatry and internal medicine. The WCJ ordered the defendant to authorize the orthopedic PQME evaluation and found that the applicant was not entitled to undergo PQME evaluations in the specialties of psychiatry and internal medicine, at the time of trial and that issues regarding applicant's entitlement to psychiatric and internal PQME(s) after completion of the orthopedic PQME evaluation were deferred, with jurisdiction reserved.
The applicant petitioned for removal which was denied in what Lexis is characterizing as a "noteworthy panel decision." The denial incorporated the reasoning of the WCJ as follows.
The applicant must first complete an initial PQME examination prior to obtaining PQME evaluations in other specialties. The applicant has not met the criteria in rule §31.7 for obtaining different specialties at the time of trial. The applicant also failed to submit the appropriate form to request QME panels regarding other specialties. As per Title 8 California Code of Regulations §31 7 a party "shall" utilize Form 31.7 to request an additional QME panel in a different specialty. It is noted that Fonn 31.7 requires that the prior PQME panel number be identified when requesting other specialties, which could not have been done in this case, as all three QME panels were improperly requested at the same time.
The applicant also failed to comply with the requirements of Labor Code §4062 regarding psychiatric and internal PQMEs. The applicant stated in the three QME requests that the reason for the QME panel is "§4062 (nonmedical treatment dispute under 4062)." However, the letter attached to each PQME request objects solely to the opinions rendered by orthopedist Dr. Reisch in his report dated October 3, 2012. In said report Dr. Reisch stated that the applicant was given refills of Voltaren gel, and was given a Toradol injection. Further, Dr. Reisch stated that the applicant was to continue working modified duties as previously. There is no reference in said report with regard to any alleged internal or psychiatric injuries or complaints. Moreover, the applicant did not object to the findings of a psychiatrist or internal doctor prior to requesting PQME panels in the specialties of psychiatry and internal medicine. Accordingly, the applicant failed to comply with the requirements of Labor Code 4062 with regard to obtaining a PQME panel in specialties other than orthopedics, at the time of trial ...
The Los Angeles Times reports that California's Obamacare exchange sent erroneous tax forms to about 100,000 households that received federal premium subsidies last year. At issue is Form 1095-A, which health-law exchanges must send to individuals and families showing how much money they received in 2014 from the federal government to subsidize their health insurance premiums. Covered California said it sent incorrect information on some forms because its customer data didn't match what health plans had on file. For instance, there may have been a discrepancy for the person's length of coverage in 2014 and amount of subsidy received.
Amy Palmer, an exchange spokeswoman, said the agency is reconciling that information and sending revised forms to the affected customers later this month. She said customers will also be notified by email when the updated forms are available in their online account. Overall, Covered California sent tax forms to more than 800,000 households statewide.
Obamacare customers who take taxpayer subsidies to cut down the price of health coverage must later fill out Form 1095-A, which documents how much money they received in subsidies in all of 2014. But the total amount of subsidies were incorrect for a large chunk of the exchange’s customers due to the disconnect between the exchange and health insurers. In some cases, the length of time a customer was insured was incorrect, changing the total amount of taxpayer assistance received.
The error affects 100,000 households in the state, out of 800,000 households that received Covered California forms in total. The accurate information is important for people when filing their 2014 taxes. Consumers may have to repay some portion of that government assistance as part of their tax return if their income was higher than what they estimated during enrollment. The blunder puts an extra burden on 100,000 households with Obamacare customers in California just ahead of tax season, who were already facing what experts warn will be the most complicated tax season ever. The 1095-A forms in question are new this year, the government’s answer to the complications Obamacare introduces into filing taxes. Each health-care exchange will issue the forms to customers who received subsidies in the form of tax subsidies. The federal government will issue about 4 million of the new 1095-A forms to Obamacare customers using the federal website this year.
Four in ten low-income Obamacare participants will face sticker shock this April 15 when they discover they owe a great deal of money to the IRS because of a little-known "clawback" provision in the health-care law. A family of four could owe the government as much as $11,200, according to a 2013 prediction by researchers at the University of California, Berkeley. Authors of the UC study, written by supporters of the health-care law, warned the repayment feature could kill future support for Obamacare. "Repayment requirements could lead to public dissatisfaction with the exchanges. And if there is much media attention to the need for repayments, some people could be dissuaded from participating in the exchanges," they cautioned. The California researchers admitted even a $2,500 repayment could be devastating to a couple. "A repayment requirement of $2,500 could be a financial shock to a family of two earning $50,000 a year," they stated ...
Amy Palmer, an exchange spokeswoman, said the agency is reconciling that information and sending revised forms to the affected customers later this month. She said customers will also be notified by email when the updated forms are available in their online account. Overall, Covered California sent tax forms to more than 800,000 households statewide.
Obamacare customers who take taxpayer subsidies to cut down the price of health coverage must later fill out Form 1095-A, which documents how much money they received in subsidies in all of 2014. But the total amount of subsidies were incorrect for a large chunk of the exchange’s customers due to the disconnect between the exchange and health insurers. In some cases, the length of time a customer was insured was incorrect, changing the total amount of taxpayer assistance received.
The error affects 100,000 households in the state, out of 800,000 households that received Covered California forms in total. The accurate information is important for people when filing their 2014 taxes. Consumers may have to repay some portion of that government assistance as part of their tax return if their income was higher than what they estimated during enrollment. The blunder puts an extra burden on 100,000 households with Obamacare customers in California just ahead of tax season, who were already facing what experts warn will be the most complicated tax season ever. The 1095-A forms in question are new this year, the government’s answer to the complications Obamacare introduces into filing taxes. Each health-care exchange will issue the forms to customers who received subsidies in the form of tax subsidies. The federal government will issue about 4 million of the new 1095-A forms to Obamacare customers using the federal website this year.
Four in ten low-income Obamacare participants will face sticker shock this April 15 when they discover they owe a great deal of money to the IRS because of a little-known "clawback" provision in the health-care law. A family of four could owe the government as much as $11,200, according to a 2013 prediction by researchers at the University of California, Berkeley. Authors of the UC study, written by supporters of the health-care law, warned the repayment feature could kill future support for Obamacare. "Repayment requirements could lead to public dissatisfaction with the exchanges. And if there is much media attention to the need for repayments, some people could be dissuaded from participating in the exchanges," they cautioned. The California researchers admitted even a $2,500 repayment could be devastating to a couple. "A repayment requirement of $2,500 could be a financial shock to a family of two earning $50,000 a year," they stated ...
Every year, the FDA inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However according to an investigation published in the JAMA Internal Medicine, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.
Charles Seife, a New York University journalism professor conducted literature research "to identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature." He reviewed 78 published papers on clinical trials with which the Food and Drug Administration (FDA) labeled "official action indicated" (OAI), meaning the agency found objectionable conditions or practices significant enough to warrant regulatory action, yet he found that only three of the papers mentioned the OAI status of the trials. The violations included researchers falsifying data and occurrences where clinical trial participants should have been ruled ineligible. His finding was published in the JAMA Internal Medicine "Research Misconduct Identified by the US Food and Drug Administration Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature."
"This investigation has found numerous studies for which the FDA determined there was significant evidence of fraudulent or otherwise problematic data. Such issues raise questions about the integrity of a clinical trial, and mention of these problems is missing from the relevant peer-reviewed literature. The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds. The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct." Seife concluded "When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct."
In one of the illustrative cases he reviewed, a case involving a trial of a chemotherapy regimen, the researcher eventually pleaded guilty to fraud and was sentenced to prison after poor results were hidden and a patient died from the treatment (United States of America v. Paul H. Kornak, 03-cr-00436 (Northern District of New York). "Although this episode is described in detail in FDA documents as well as court documents, none of the publications in the peer-reviewed literature associated with the chemotherapy study in which the patient died have any mention of the falsification, fraud, or homicide. The publications associated with two of the three other studies for which the researcher falsified documents also do not report on the violations," according to the study.
"The FDA has legal as well as ethical responsibilities regarding the scientific misconduct it finds during its inspections. When the agency withholds the identity of a clinical trial affected by scientific misconduct, it does so because it considers the identity to be confidential commercial information, which it feels bound to protect. However, failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health. Such allegations are relevant to include in the peer-reviewed literature on which physicians and other medical researchers rely to help them choose treatments that they offer to patients and other research participants."
The article concludes by saying "To better serve the public health, the FDA should make unredacted information about its findings of research misconduct more readily available. The agency should make sure that any substantial evidence of misconduct is available to editors and readers of the scientific literature. One possible mechanism for this would be to use the national clinical trials database: any OAI inspection affecting a trial site should be promptly noted at http://www.clinicaltrials.gov. The FDA should also create a website or a publicly available database that lists all OAI-rated inspections of clinical sites and provides links to copies of the relevant, unredacted, inspection-related documents."
"The FDA should be more transparent about its findings of research misconduct; however, most of the burden for ensuring the integrity of the research in the peer-reviewed literature falls to the authors of the articles submitted to peer-reviewed journals. Currently, there is no formal requirement for authors seeking to publish clinical trial data to disclose any adverse findings noted during FDA inspections. Journals should require that any such findings be disclosed. Voluntary disclosures are never foolproof, but, as with conflict-of-interest statements, requiring authors and journals to be forthcoming about significant departures from good clinical practice will help raise the standard for the reporting of research toward greater transparency." ...
Charles Seife, a New York University journalism professor conducted literature research "to identify published clinical trials in which an FDA inspection found significant evidence of objectionable conditions or practices, to describe violations, and to determine whether the violations are mentioned in the peer-reviewed literature." He reviewed 78 published papers on clinical trials with which the Food and Drug Administration (FDA) labeled "official action indicated" (OAI), meaning the agency found objectionable conditions or practices significant enough to warrant regulatory action, yet he found that only three of the papers mentioned the OAI status of the trials. The violations included researchers falsifying data and occurrences where clinical trial participants should have been ruled ineligible. His finding was published in the JAMA Internal Medicine "Research Misconduct Identified by the US Food and Drug Administration Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature."
"This investigation has found numerous studies for which the FDA determined there was significant evidence of fraudulent or otherwise problematic data. Such issues raise questions about the integrity of a clinical trial, and mention of these problems is missing from the relevant peer-reviewed literature. The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds. The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct." Seife concluded "When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct."
In one of the illustrative cases he reviewed, a case involving a trial of a chemotherapy regimen, the researcher eventually pleaded guilty to fraud and was sentenced to prison after poor results were hidden and a patient died from the treatment (United States of America v. Paul H. Kornak, 03-cr-00436 (Northern District of New York). "Although this episode is described in detail in FDA documents as well as court documents, none of the publications in the peer-reviewed literature associated with the chemotherapy study in which the patient died have any mention of the falsification, fraud, or homicide. The publications associated with two of the three other studies for which the researcher falsified documents also do not report on the violations," according to the study.
"The FDA has legal as well as ethical responsibilities regarding the scientific misconduct it finds during its inspections. When the agency withholds the identity of a clinical trial affected by scientific misconduct, it does so because it considers the identity to be confidential commercial information, which it feels bound to protect. However, failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health. Such allegations are relevant to include in the peer-reviewed literature on which physicians and other medical researchers rely to help them choose treatments that they offer to patients and other research participants."
The article concludes by saying "To better serve the public health, the FDA should make unredacted information about its findings of research misconduct more readily available. The agency should make sure that any substantial evidence of misconduct is available to editors and readers of the scientific literature. One possible mechanism for this would be to use the national clinical trials database: any OAI inspection affecting a trial site should be promptly noted at http://www.clinicaltrials.gov. The FDA should also create a website or a publicly available database that lists all OAI-rated inspections of clinical sites and provides links to copies of the relevant, unredacted, inspection-related documents."
"The FDA should be more transparent about its findings of research misconduct; however, most of the burden for ensuring the integrity of the research in the peer-reviewed literature falls to the authors of the articles submitted to peer-reviewed journals. Currently, there is no formal requirement for authors seeking to publish clinical trial data to disclose any adverse findings noted during FDA inspections. Journals should require that any such findings be disclosed. Voluntary disclosures are never foolproof, but, as with conflict-of-interest statements, requiring authors and journals to be forthcoming about significant departures from good clinical practice will help raise the standard for the reporting of research toward greater transparency." ...
The average amount paid to a California workers’ compensation treating physician for a medical report fell more than 30 percent in the first quarter of 2014 as the state began to transition to a Resource-Based Relative Value Scale (RBRVS) fee schedule, though a CWCI analysis traces the decline to changes in how various evaluation and management (E/M) services are reimbursed rather than reductions in the fees assigned to the report codes.
California’s transition to an RBRVS fee schedule that began a year ago led to 2 changes affecting physician reporting: 1) consulting physician evaluation services are now billed using an initial visit code, and associated reports are no longer separately reimbursable unless requested by the DWC Administrative Director, the Appeals Board or a Qualified Medical Evaluator in the context of a med-legal evaluation; and 2) the reimbursement to the primary treating physician for medical records review outside the context of a face-to-face E/M service has been bundled into the face-to-face E/M service fee, and there is no longer a separate allowance for a prolonged service fee.
To monitor how physician reporting changed after these changes took effect, CWCI Senior Research Associate Stacy Jones compared data on medical reports for service dates from the first quarter of 2014, when the transition to the new schedule began, to corresponding data from the first quarters of 2011, 2012 and 2013, when the old fee schedule was still in effect. After determining the average amounts paid and the distribution of reports by the nature of the underlying E/M service (i.e., reports associated with initial visits, consultations, follow-up visits, prolonged services), Ms. Jones found that while the average amount paid for all physician reports fell more than 30 percent under the RBRVS fee schedule, the changes in the average reimbursements varied dramatically by type of report.
Comparing the mix of reports associated with the various E/M services revealed that after the rules changed under the new schedule, relatively inexpensive reports on follow-up visits increased from 78 percent to 86 percent of all physician reports, while the biggest declines were in consultation and prolonged service reports, which historically received the highest reimbursements. Consultation reports, which had represented 6 percent of physician reports under the old schedule, and prolonged service reports, which had accounted for 4 percent, both dwindled to less than 1 percent of all reports after the RBRVS schedule took effect. Thus, the initial results on physician reporting following adoption of the new schedule indicate that the change in the mix of reports has been the key factor in reducing the average amount paid for physician reports.
CWCI will continue to monitor the volume, distribution and reimbursement of physician reports in California workers’ comp as more developed data become available. In the meantime, the Institute has published a Research Update report, "Changes in Workers’ Compensation Physician Reporting Under California’s RBRVS Fee Schedule: Initial Results," which provides additional details and graphics from the latest study. The Research Update report is available to CWCI members and subscribers in the Research section at www.cwci.org ...
California’s transition to an RBRVS fee schedule that began a year ago led to 2 changes affecting physician reporting: 1) consulting physician evaluation services are now billed using an initial visit code, and associated reports are no longer separately reimbursable unless requested by the DWC Administrative Director, the Appeals Board or a Qualified Medical Evaluator in the context of a med-legal evaluation; and 2) the reimbursement to the primary treating physician for medical records review outside the context of a face-to-face E/M service has been bundled into the face-to-face E/M service fee, and there is no longer a separate allowance for a prolonged service fee.
To monitor how physician reporting changed after these changes took effect, CWCI Senior Research Associate Stacy Jones compared data on medical reports for service dates from the first quarter of 2014, when the transition to the new schedule began, to corresponding data from the first quarters of 2011, 2012 and 2013, when the old fee schedule was still in effect. After determining the average amounts paid and the distribution of reports by the nature of the underlying E/M service (i.e., reports associated with initial visits, consultations, follow-up visits, prolonged services), Ms. Jones found that while the average amount paid for all physician reports fell more than 30 percent under the RBRVS fee schedule, the changes in the average reimbursements varied dramatically by type of report.
Comparing the mix of reports associated with the various E/M services revealed that after the rules changed under the new schedule, relatively inexpensive reports on follow-up visits increased from 78 percent to 86 percent of all physician reports, while the biggest declines were in consultation and prolonged service reports, which historically received the highest reimbursements. Consultation reports, which had represented 6 percent of physician reports under the old schedule, and prolonged service reports, which had accounted for 4 percent, both dwindled to less than 1 percent of all reports after the RBRVS schedule took effect. Thus, the initial results on physician reporting following adoption of the new schedule indicate that the change in the mix of reports has been the key factor in reducing the average amount paid for physician reports.
CWCI will continue to monitor the volume, distribution and reimbursement of physician reports in California workers’ comp as more developed data become available. In the meantime, the Institute has published a Research Update report, "Changes in Workers’ Compensation Physician Reporting Under California’s RBRVS Fee Schedule: Initial Results," which provides additional details and graphics from the latest study. The Research Update report is available to CWCI members and subscribers in the Research section at www.cwci.org ...
The unpublished Court of Appeal decision in Electronic Waveform Lab v. EK Health Services addresses whether UR is an "official proceeding" within the meaning of Code of Civil Procedure section 425.16, subdivision (e)(2) (the anti-SLAPP statute [SLAPP is the abbreviation for strategic lawsuit against public participation]) and whether the trial court correctly resolved the motion to dismiss under that statute filed by defendant State Compensation Insurance Fund.
Waveform manufactures and sells an electrotherapy device, commonly known as an H-Wave device, which physicians may prescribe to assist in treating various muscular injuries. State Fund contracts with EK Health and "independent contractor individual physician reviewers" to provide UR services to workers covered by their employers’ workers’ compensation policies issued by State Fund. Waveform filed suit against EK Health, alleging that EK Health was "situated as a monopolistic ‘gate keeper’ to a significant and substantial market share of patients who are injured on the job." Waveform further alleged that EK Health and the Reviewers conspired to defame Waveform and consistently denied the H-Wave device for treatment of individual patients, with the result that treating physicians asked Waveform to remove H-Wave equipment from doctors’ offices and physical therapy clinics. Waveform alleged that the conduct of all of the defendants violated the Cartwright Act (Bus. & Prof. Code, §§ 16720 et seq.) and that the acts of EK Health and of a subset of the Reviewers constituted intentional interference with prospective economic advantage and trade libel.
EK Health and the Reviewers filed a special motion to strike the complaint under section 425.16 (anti-SLAPP motion) which was denied. The denial of the EK Health motion was not appealed.
Waveform then filed a first amended complaint adding State Fund as a defendant. Waveform alleged that State Fund had implemented through EK Health a "blanket policy" to deny and reject physicians’ prescriptions for utilization of the H-Wave device in treatment of patients’ injures and that "[w]hile creating the appearance of reviewer independence, EK Health and the reviewers in fact complied with State Fund’s policy that all H-Wave requests be denied." Waveform alleged, the policy "violates the independent medical decision-making that reviewers are required to engage in. . . ."
State Fund filed its own anti-SLAPP motion seeking to dismiss both causes of action alleged against it. The trial court ruled that State Fund had established that its actions arose from "official proceedings" as its actions constituted "statements made in connection with an issue under consideration in a legally-authorized official proceeding." The trial court also concluded that plaintiff had not shown a probability of prevailing against State Fund at trial and for these reasons granted the State Funds anti-SLAPP motion and it was dismissed. The Court of Appeal reversed.
The parties contest whether UR is an "official proceeding authorized by law" as that term is used in section 425.16, subdivision (e)(2). State Fund argues that "official proceedings" include administrative agency actions involving review and investigation of grievances, and that the workers’ compensation UR system, which involves resolution of claims for medical treatment, should be similarly viewed. Waveform argues that the UR process is not quasi-judicial or part of a comprehensive statutory licensing scheme which is subject to judicial review by administrative mandate. The Court of Appeal ruled that it was not an official proceeding and distinguished UR from case law on arbitration proceedings by saying "UR review is medical rather than legal and informal rather than formal." "For this reason alone, the trial court erred in concluding that UR is an "official proceeding" within the meaning of that term in section 425.16, subdivision (e)(2)."
The judgment dismissing State Fund from Waveform’s first amended complaint was reversed ...
Waveform manufactures and sells an electrotherapy device, commonly known as an H-Wave device, which physicians may prescribe to assist in treating various muscular injuries. State Fund contracts with EK Health and "independent contractor individual physician reviewers" to provide UR services to workers covered by their employers’ workers’ compensation policies issued by State Fund. Waveform filed suit against EK Health, alleging that EK Health was "situated as a monopolistic ‘gate keeper’ to a significant and substantial market share of patients who are injured on the job." Waveform further alleged that EK Health and the Reviewers conspired to defame Waveform and consistently denied the H-Wave device for treatment of individual patients, with the result that treating physicians asked Waveform to remove H-Wave equipment from doctors’ offices and physical therapy clinics. Waveform alleged that the conduct of all of the defendants violated the Cartwright Act (Bus. & Prof. Code, §§ 16720 et seq.) and that the acts of EK Health and of a subset of the Reviewers constituted intentional interference with prospective economic advantage and trade libel.
EK Health and the Reviewers filed a special motion to strike the complaint under section 425.16 (anti-SLAPP motion) which was denied. The denial of the EK Health motion was not appealed.
Waveform then filed a first amended complaint adding State Fund as a defendant. Waveform alleged that State Fund had implemented through EK Health a "blanket policy" to deny and reject physicians’ prescriptions for utilization of the H-Wave device in treatment of patients’ injures and that "[w]hile creating the appearance of reviewer independence, EK Health and the reviewers in fact complied with State Fund’s policy that all H-Wave requests be denied." Waveform alleged, the policy "violates the independent medical decision-making that reviewers are required to engage in. . . ."
State Fund filed its own anti-SLAPP motion seeking to dismiss both causes of action alleged against it. The trial court ruled that State Fund had established that its actions arose from "official proceedings" as its actions constituted "statements made in connection with an issue under consideration in a legally-authorized official proceeding." The trial court also concluded that plaintiff had not shown a probability of prevailing against State Fund at trial and for these reasons granted the State Funds anti-SLAPP motion and it was dismissed. The Court of Appeal reversed.
The parties contest whether UR is an "official proceeding authorized by law" as that term is used in section 425.16, subdivision (e)(2). State Fund argues that "official proceedings" include administrative agency actions involving review and investigation of grievances, and that the workers’ compensation UR system, which involves resolution of claims for medical treatment, should be similarly viewed. Waveform argues that the UR process is not quasi-judicial or part of a comprehensive statutory licensing scheme which is subject to judicial review by administrative mandate. The Court of Appeal ruled that it was not an official proceeding and distinguished UR from case law on arbitration proceedings by saying "UR review is medical rather than legal and informal rather than formal." "For this reason alone, the trial court erred in concluding that UR is an "official proceeding" within the meaning of that term in section 425.16, subdivision (e)(2)."
The judgment dismissing State Fund from Waveform’s first amended complaint was reversed ...
A story published in ChicoER says that an Antioch businesswoman will serve 60 days in jail and pay restitution after pleading guilty to wage theft, tax fraud and a workers' compensation violation in her operation of elderly care facilities in Antioch and Brentwood, the first conviction in an industry authorities say is "rampant" with fraud.
Florinda Yambao, 62, accepted the plea deal last week, according to the Contra Costa District Attorney's Office. Yambao's six Florin White Dove care homes in Antioch and Brentwood remain in operation, however her three-year probation term requires her to install proper payroll systems and undergo state audits, said prosecutor William Murphy. She is required to pay $453,000 in back wages and yet-to-be determined tax charges and state fines as part of her deal.
Nearly $72,000 was recovered from Yambao during a series of September raids on care homes throughout Contra Costa County, all accused of paying workers under the table and for as little as $4 an hour. In some cases, officials have said, caregivers in her employ worked 12 to 16 hours a day for $50 to $80 total.
After an article by the ChicoER on the searches, Murphy said his office, which has worked with state and federal officials in a yearlong investigation, was flooded with accusations against more homes. "We were inundated with similar problems in other homes in Contra Costa County," Murphy said. "It appears to be rampant."
The Contra Costa Employer Fraud Task Force is investigating the owners of nine other care homes that operate 40 facilities in the county. The investigation has uncovered a pattern of underground economy violations where these businesses increased their profits by avoiding taxes, insurance and fair wages, according to the Contra Costa DA's office. The probe has also found many of the workers are mistreated, working long hours for less than minimum wage, living in substandard conditions, and being forced to care for patients during their time off, the task force said in a statement.
In addition to Yambao, police arrested Sara Abraham and Annette and Julio Sanchez of Abraham Rest Homes Inc. and Sanchez Abraham Corp. after a series of September raids on 19 residential care homes in Walnut Creek, Concord, Brentwood and Antioch. Authorities said about 60 workers were owed $2 million, and $624,000 in state fines against the companies would be split among the workers. Authorities said they were also investigating the owners of Scienn Hall Care homes in Brentwood, but no arrests were made.
While there were no allegations of mistreatment of patients at Yambao's homes, state records showed that five facilities shown as "Floran Care Home" or "Floran White Dove Care Home" received as many as 19 citations in their inspections. "Ms. Yambao, as the owner and boss of these care facilities, was in a position of power over her employees," District Attorney Mark Peterson said. "She used that position to exploit the workers and line her own pockets with the cash. It was pure greed." ...
Florinda Yambao, 62, accepted the plea deal last week, according to the Contra Costa District Attorney's Office. Yambao's six Florin White Dove care homes in Antioch and Brentwood remain in operation, however her three-year probation term requires her to install proper payroll systems and undergo state audits, said prosecutor William Murphy. She is required to pay $453,000 in back wages and yet-to-be determined tax charges and state fines as part of her deal.
Nearly $72,000 was recovered from Yambao during a series of September raids on care homes throughout Contra Costa County, all accused of paying workers under the table and for as little as $4 an hour. In some cases, officials have said, caregivers in her employ worked 12 to 16 hours a day for $50 to $80 total.
After an article by the ChicoER on the searches, Murphy said his office, which has worked with state and federal officials in a yearlong investigation, was flooded with accusations against more homes. "We were inundated with similar problems in other homes in Contra Costa County," Murphy said. "It appears to be rampant."
The Contra Costa Employer Fraud Task Force is investigating the owners of nine other care homes that operate 40 facilities in the county. The investigation has uncovered a pattern of underground economy violations where these businesses increased their profits by avoiding taxes, insurance and fair wages, according to the Contra Costa DA's office. The probe has also found many of the workers are mistreated, working long hours for less than minimum wage, living in substandard conditions, and being forced to care for patients during their time off, the task force said in a statement.
In addition to Yambao, police arrested Sara Abraham and Annette and Julio Sanchez of Abraham Rest Homes Inc. and Sanchez Abraham Corp. after a series of September raids on 19 residential care homes in Walnut Creek, Concord, Brentwood and Antioch. Authorities said about 60 workers were owed $2 million, and $624,000 in state fines against the companies would be split among the workers. Authorities said they were also investigating the owners of Scienn Hall Care homes in Brentwood, but no arrests were made.
While there were no allegations of mistreatment of patients at Yambao's homes, state records showed that five facilities shown as "Floran Care Home" or "Floran White Dove Care Home" received as many as 19 citations in their inspections. "Ms. Yambao, as the owner and boss of these care facilities, was in a position of power over her employees," District Attorney Mark Peterson said. "She used that position to exploit the workers and line her own pockets with the cash. It was pure greed." ...
