Many state workers' compensation medical fee schedules are based upon Medicare rates. A new study from US Government Accounting Office reports that the underlying rate making scheme is biased and the GAO recommends increased transparency of the process.
The American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) has a process in place to regularly review Medicare physicians' services' work relative values (which reflect the time and intensity needed to perform a service). Its recommendations to the Centers for Medicare & Medicaid Services (CMS), the agency within the Department of Health and Human Services (HHS) that administers Medicare, though, may not be accurate due to process and data-related weaknesses.
First, the RUC's process for developing relative value recommendations relies on the input of physicians who may have potential conflicts of interest with respect to the outcomes of CMS's process. While the RUC has taken steps to mitigate the impact of physicians' potential conflicts of interest, a member of the RUC told GAO that specialty societies' work relative value recommendations may still be inflated.
RUC staff indicated that the RUC may recommend a work relative value to CMS that is less than the specialty societies' median survey result if the value seems accurate based on the RUC members' clinical expertise or by comparing the value to those of related services.
Second, GAO found weaknesses with the RUC's survey data, including that some of the RUC's survey data had low response rates, low total number of responses, and large ranges in responses, all of which may undermine the accuracy of the RUC's recommendations. For example, while GAO found that the median number of responses to surveys for payment year 2015 was 52, the median response rate was only 2.2 percent, and 23 of the 231 surveys had under 30 respondents.
CMS's process for establishing relative values embodies several elements that cast doubt on whether it can ensure accurate Medicare payment rates and a transparent process.
First, although CMS officials stated that CMS complies with the statutory requirement to review all Medicare services every 5 years, the agency does not maintain a database to track when a service was last valued or have a documented standardized process for prioritizing its reviews.
Second, CMS's process is not fully transparent because the agency does not publish the potentially misvalued services identified by the RUC in its rulemaking or otherwise, and thus stakeholders are unaware that these services will be reviewed and payment rates for these services may change.
Third, CMS provides some information about its process in its rulemaking, but does not document the methods used to review specific RUC recommendations. For example, CMS does not document what resources were considered during its review of the RUC's recommendations for specific services.
Finally, the evidence suggests—and CMS officials acknowledge—that the agency relies heavily on RUC recommendations when establishing relative values. For example, GAO found that, in the majority of cases, CMS accepts the RUC's recommendations and participation by other stakeholders is limited. Given the process and data-related weaknesses associated with the RUC's recommendations, such heavy reliance on the RUC could result in inaccurate Medicare payment rates.
CMS has begun to research ways to develop an approach for validating RUC recommendations, but does not yet have a specific plan for doing so. In addition, CMS does not yet have a plan for how it will use funds Congress appropriated for the collection and use of data on physicians' services or address the other data challenges GAO identified.
Why GAO Did This Study
Payments for Medicare physicians' services totaled about $70 billion in 2013. CMS sets payment rates for about 7,000 physicians' services primarily on the basis of the relative values assigned to each service. Relative values largely reflect estimates of the physician work and practice expenses needed to provide one service relative to other services.
The Protecting Access to Medicare Act of 2014 included a provision for GAO to study the RUC's process for developing relative value recommendations for CMS. GAO evaluated (1) the RUC's process for recommending relative values for CMS to consider when setting Medicare payment rates; and (2) CMS's process for establishing relative values, including how it uses RUC recommendations. GAO reviewed RUC and CMS documents and applicable statutes and internal control standards, analyzed RUC and CMS data for payment years 2011 through 2015, and interviewed RUC staff and CMS officials.
What GAO Recommends
CMS should better document its process for establishing relative values and develop a process to inform the public of potentially misvalued services identified by the RUC. CMS should also develop a plan for using funds appropriated for the collection and use of information on physicians' services in the determination of relative values. HHS agreed with two of GAO's recommendations, but disagreed with using rulemaking to inform the public of RUC-identified services. GAO clarified that the recommendation is not limited to rulemaking.
Click here to read the full report.
Better Data and Greater Transparency Could Improve Accuracy
GAO-15-434: Published: May 21, 2015. Publicly Released: May 21, 2015.
Monday, June 1, 2015
Saturday, May 30, 2015
Confronting Europe's Asbestos Disaster
Brussels, Belgium and London, UK: On 24 June, 2015, the European Economic and Social Committee and the Committee of the Regions are hosting a joint conference on asbestos under the title: Freeing Europe Safely From Asbestos. The European Federation of Building and Woodworkers (EFBWW) are supporting the event together with the Belgian Asbestos Victims’ Group (ABEVA), and the International Ban Asbestos Secretariat (IBAS).
The objective of this all day session is to reinforce demands by EU politicians, trade unionists, asbestos victims and campaigners for a coordinated response to the European asbestos epidemic which is claiming over 15,000 lives a year. Speakers will call for EU action on a safe removal strategy, a policy for the recognition and compensation of victims and recommendations for gold standard medical screening and treatment for Europeans at-risk of contracting asbestos-related diseases.
Topics such as EU legislation, asbestos management and/or removal, workers’ training, decontamination, screening and the human impact of Europe’s asbestos catastrophe will be covered by experts from more than a dozen countries. Commenting on this event, Ulrik Spannow Chairman of the EFBWW Occupational Health and Safety Coordination Group said: “In the past workers were exposed to asbestos, but in fact they still are. In this connection, EFBWW sees the European ban of asbestos as an important but only the first step towards an asbestos free Europe.
We therefore welcome the initiatives of the European Parliament and the European Economic and Social Committee focusing on practical action on asbestos in the various policy areas concerned. We like to contribute to the implementation of these initiatives into practical policy action and consider the asbestos conference on 24th June as an excellent occasion to discuss the various aspects with European and national authorities.” 1
On April 30, 2015, the World Health Organization confirmed the devastation asbestos continues to cause in Europe in a media release which confirmed that 300 million Europeans are living in countries where the use of asbestos remains legal. The WHO Regional Director for Europe estimated that 15,000 lives were lost in Europe every year because of exposure to asbestos.
Friday, May 29, 2015
Defective airbag recall expanded by millions of more vehicles
The largest recall of defective auto parts has been yet expanded by millions of more vehicles as the nation's auto makers react to announcement by Takata that their airbag inflators are allegedly defective.
Today's post is shared from usatoday.com
Automakers were adding millions of cars Thursday to their official lists of models recalled because of potentially dangerous Takata airbag inflators.
Fiat Chrysler Automobiles said it will add another 1.4 million vehicles globally. Honda announced the addition of 350,000 in the U.S. And BMW added 420,100, also in the U.S.
Click here to read more.
Today's post is shared from usatoday.com
Automakers were adding millions of cars Thursday to their official lists of models recalled because of potentially dangerous Takata airbag inflators.
Fiat Chrysler Automobiles said it will add another 1.4 million vehicles globally. Honda announced the addition of 350,000 in the U.S. And BMW added 420,100, also in the U.S.
Click here to read more.
….
Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
Related articles
Thursday, May 28, 2015
In the name of privacy...
After the massive US IRS data breach announcement this week, CMS has posted that it is establishing a more secure system for access to Medicare Secondary Payer Information. This is pretty consistent with President Obama's announcement to take Social Security Numbers off of Medicare Cards.
The real issue is that while workers' compensation records are supposedly confidential in State systems, the Federal government has consistently neglected to insure that privacy whether be: medical records under HIPPA; by integration of state's motor vehicle or workers' compensation records utilizing Social Security Numbers, or by Medicare Secondary Payer Act electronic data systems.
Additionally, the Federal government will probably be mandating the reporting workers' compensation payment information, in Federal Income Returns shortly. The batting record of the IRS this week on privacy has been dismal.
Time will only tell whether workers' compensation data can actually be shielded from intruders.
CMS announced today:
"As part of the Strengthening Medicare and Repaying Taxpayers (SMART) Act, the Centers for Medicare & Medicaid Services (CMS) will be implementing optional MFA services on the MSPRP. MFA is the use of two or more different authentication factors to verify the identity of an end user. Verified users will have access to view unmasked claim data on the Portal.
"Non debtors will still need to have a Verified Proof of Representation or Consent to Release authorization to perform actions on cases. Please note that MFA and the associated identity proofing process will be optional to portal users. Portal users may continue to use the portal without going through the MFA process but will not have the benefit of viewing un-masked data.
"MFA is scheduled to be available beginning on July 13, 2015. Updated user guides and training materials will be available on CMS.gov and within the portal upon implementation.
The real issue is that while workers' compensation records are supposedly confidential in State systems, the Federal government has consistently neglected to insure that privacy whether be: medical records under HIPPA; by integration of state's motor vehicle or workers' compensation records utilizing Social Security Numbers, or by Medicare Secondary Payer Act electronic data systems.
Additionally, the Federal government will probably be mandating the reporting workers' compensation payment information, in Federal Income Returns shortly. The batting record of the IRS this week on privacy has been dismal.
Time will only tell whether workers' compensation data can actually be shielded from intruders.
CMS announced today:
"As part of the Strengthening Medicare and Repaying Taxpayers (SMART) Act, the Centers for Medicare & Medicaid Services (CMS) will be implementing optional MFA services on the MSPRP. MFA is the use of two or more different authentication factors to verify the identity of an end user. Verified users will have access to view unmasked claim data on the Portal.
"Non debtors will still need to have a Verified Proof of Representation or Consent to Release authorization to perform actions on cases. Please note that MFA and the associated identity proofing process will be optional to portal users. Portal users may continue to use the portal without going through the MFA process but will not have the benefit of viewing un-masked data.
"MFA is scheduled to be available beginning on July 13, 2015. Updated user guides and training materials will be available on CMS.gov and within the portal upon implementation.
Wednesday, May 27, 2015
Pending Before the NJ Supreme Court
A-89-13 Estate of Myroslava Kotsovska v. Saul Liebman (073861)
Should the trial court have transferred this wrongful death and survival action to the Division of Workers' Compensation for a determination of the decedent's employment status where defendant raised the workers' compensation bar as an affirmative defense?
Certification granted: 5/19/14
Posted: 5/20/14
Argued: 3/16/15
Case below:
Should the trial court have transferred this wrongful death and survival action to the Division of Workers' Compensation for a determination of the decedent's employment status where defendant raised the workers' compensation bar as an affirmative defense?
Certification granted: 5/19/14
Posted: 5/20/14
Argued: 3/16/15
Case below:
Argued March 20, 2013. Decided Dec. 26, 2013.
Background: Estate of driver's home health aid filed wrongful death action against driver, stemming from accident in which driver accelerated vehicle while parking, hitting home health aid. Following jury trial, the Superior Court, Law Division, Union County, 2012 WL 3965151, determined home health aid was independent contractor, found in favor of estate, and denied driver's motion for new trial. Driver appealed.
Holdings: The Superior Court, Appellate Division, Accurso, J.A.D., held that:
(1) Division of Workers' Compensation was proper forum for resolution of whether home health aid was driver's employee;
(2) jury instruction as to whether home health aid was employee or independent contractor did not adequately convey the law;
(3) taking judicial notice that person would suffer pain if leg was traumatically amputated while conscious was harmless error; and
(4) damages would be preserved pending remand.
Affirmed in part, reversed in part, and remanded.
Lumbermen's Underwriting Alliance in Receivership
On May 19, 2015, Lumbermen’s Underwriting Alliance, a reciprocal inter-insurance exchange organized under the laws of the State of Missouri ("Lumbermen's"), was ordered into receivership for the purposes of rehabilitation by the Circuit Court of Cole County, Missouri (the "Court").
The Court appointed John M. Huff, Director of the Missouri Department of Insurance, Financial Institutions & Professional Registration, and his successors in office, as the statutory Receiver of Lumbermen's. U.S. Epperson Underwriting Company, as Attorney-in-Fact for Lumbermen's, consented to the receivership.
Pleadings and other information can be found by clicking here. The Judgment, and all subsequent proceedings concerning Lumbermen's, will be conducted in accordance with Mo. Rev. Stat. §§ 375.1150 to 375.1246.
Friday, May 22, 2015
Compensable Mental Stress and Conflict of Law Decisions Posted
The NJ Division of Workers' Compensation [NJDWC] today published 3 Court of Compensation trial level decisions. All were favorable to the injured workers and their dependents.
1. Mental Stress: Stress (harassment) particular to employment results in compensable psychiatric claim
Ross v. City of Asbury Park
06–28659; decided July 28, 2008 by the Honorable Leslie A. Berich
Petitioner alleged compensable injury as a result of mental stress created by prolonged exposure to a hostile work environment. Respondent denied these allegations. After applying the Goyden test along with other relevant legal principles, the Judge of Compensation found that there were objectively stressful working conditions peculiar to the petitioner’s working environment which entitled the petitioner to workers compensation benefits.
2. Mental Stress: Specific event (Hurricane) results in compensable suicide claim
Wilde v. Township of Cranford
99–40680; decided January 17, 2008 by the Honorable Leslie A. Berich
Petitioner filed a claim for dependency benefits for herself and her two children by asserting that her husband suffered a stress-induced occupational suicide. The respondent defended against the claim by contending that the work of the deceased, including his work as a policeman during Hurricane Floyd, was not causally related to his suicide. After careful consideration of the evidence, the Judge of Compensation awarded dependency benefits based on her finding that the work of the deceased as a policeman during this storm "lead to a loss of normal rational judgment that resulted in his suicide".
3. Conflict of Laws: NJ law applied where a special state interest existed
Spiros v. Atlantic Ambulatory Anesthesia Assocs. & Shrewsbury Surgical Center
12–22032; 13-1069 decided October 27, 2014 by the Honorable Leslie A. Beric
Medical providers filed applications for payment/reimbursement of medical expenses, which alleged that the insurance carrier for the employer unreasonably reduced the petitioner’s bills for services rendered. The carrier filed an answer in which it denied liability and jurisdiction, asserting the petitioner’s bills could be paid only at a contractual rate highly limited by Tennessee statute. The carrier also filed motions to dismiss the medical provider claims. In analyzing whether New Jersey has a special state interest in cases where medical providers provide services in New Jersey to injured workers, the Judge of Compensation found that N.J.S.A. 34:15-15 gives New Jersey’s Division of Workers’ Compensation exclusive subject matter jurisdiction and New Jersey law applies where the workers’ compensation benefits were provided in this state. Accordingly, the carrier’s motions to dismiss the medical providers’ claims were denied.
Summaries were provided by the NJ DWC.
1. Mental Stress: Stress (harassment) particular to employment results in compensable psychiatric claim
Ross v. City of Asbury Park
06–28659; decided July 28, 2008 by the Honorable Leslie A. Berich
Petitioner alleged compensable injury as a result of mental stress created by prolonged exposure to a hostile work environment. Respondent denied these allegations. After applying the Goyden test along with other relevant legal principles, the Judge of Compensation found that there were objectively stressful working conditions peculiar to the petitioner’s working environment which entitled the petitioner to workers compensation benefits.
2. Mental Stress: Specific event (Hurricane) results in compensable suicide claim
Wilde v. Township of Cranford
99–40680; decided January 17, 2008 by the Honorable Leslie A. Berich
Petitioner filed a claim for dependency benefits for herself and her two children by asserting that her husband suffered a stress-induced occupational suicide. The respondent defended against the claim by contending that the work of the deceased, including his work as a policeman during Hurricane Floyd, was not causally related to his suicide. After careful consideration of the evidence, the Judge of Compensation awarded dependency benefits based on her finding that the work of the deceased as a policeman during this storm "lead to a loss of normal rational judgment that resulted in his suicide".
3. Conflict of Laws: NJ law applied where a special state interest existed
Spiros v. Atlantic Ambulatory Anesthesia Assocs. & Shrewsbury Surgical Center
12–22032; 13-1069 decided October 27, 2014 by the Honorable Leslie A. Beric
Medical providers filed applications for payment/reimbursement of medical expenses, which alleged that the insurance carrier for the employer unreasonably reduced the petitioner’s bills for services rendered. The carrier filed an answer in which it denied liability and jurisdiction, asserting the petitioner’s bills could be paid only at a contractual rate highly limited by Tennessee statute. The carrier also filed motions to dismiss the medical provider claims. In analyzing whether New Jersey has a special state interest in cases where medical providers provide services in New Jersey to injured workers, the Judge of Compensation found that N.J.S.A. 34:15-15 gives New Jersey’s Division of Workers’ Compensation exclusive subject matter jurisdiction and New Jersey law applies where the workers’ compensation benefits were provided in this state. Accordingly, the carrier’s motions to dismiss the medical providers’ claims were denied.
Summaries were provided by the NJ DWC.
Memorial Day
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| Harry S. Truman speaking at Memorial Day services at the Amphitheatre of Arlington National Cemetery. May 30, 1948. |
Monday, May 18, 2015
Bill delays compensation for asbestos victims, puts privacy at risk
Washington, D.C. — The following is a statement from American Association for Justice CEO Linda Lipsen on today’s markup of the Furthering Asbestos Claims Transparency (FACT) Act (H.R. 526) in the U.S. House of Representatives Committee on the Judiciary:
“Asbestos is still legal in the United States, and with 12,000 to 15,000 Americans suffocating to death every year from asbestos diseases, Congress should act to protect the public by demanding transparency from asbestos corporations. Instead, the FACT Act will grant a handout to the very corporations that poisoned and killed hundreds of thousands of Americans, while doing nothing to prevent further exposure to this deadly toxin.
“The asbestos industry is the only supporter of the FACT Act, and to date, this committee has refused to hear testimony from people who have experienced the ravages of asbestos diseases. Americans should be outraged that this markup will go forward without consideration of the people who will shoulder the entire burden of this one-sided bill – asbestos victims and their families."
“Asbestos is still legal in the United States, and with 12,000 to 15,000 Americans suffocating to death every year from asbestos diseases, Congress should act to protect the public by demanding transparency from asbestos corporations. Instead, the FACT Act will grant a handout to the very corporations that poisoned and killed hundreds of thousands of Americans, while doing nothing to prevent further exposure to this deadly toxin.
“The asbestos industry is the only supporter of the FACT Act, and to date, this committee has refused to hear testimony from people who have experienced the ravages of asbestos diseases. Americans should be outraged that this markup will go forward without consideration of the people who will shoulder the entire burden of this one-sided bill – asbestos victims and their families."
The Role Workers’ Compensation Plays in the Amtrak Train 188 Derailment
The unfortunate crash of Amtrak 188 left 8 people dead and injured over 200 people. Compensation benefits for victims and their families face a host of complex and conflicting legal remedies. The National Transportation Safety Board is investigating an Amtrak derailment in Philadelphia, Pa.
Today's post is by guest author Brianne Rohner Erickson of the Nebraska Bar.
Our sympathies go out to all of the friends and families of the victims of Tuesday’s Amtrak passenger train derailment in Philadelphia, as well as a wish for the recovery of those injured. The latest news reports indicate that, as of Friday morning, the crash has left at least eight dead and more than 200 injured.
Today's post is by guest author Brianne Rohner Erickson of the Nebraska Bar.
Our sympathies go out to all of the friends and families of the victims of Tuesday’s Amtrak passenger train derailment in Philadelphia, as well as a wish for the recovery of those injured. The latest news reports indicate that, as of Friday morning, the crash has left at least eight dead and more than 200 injured.
Thursday, May 7, 2015
NJ State Bar Association Opposes Workers' Compensation COLA Bill
"The New Jersey State Bar Association respectfully has concerns with S-929 (Sweeney) which concerns
certain workers' compensation supplemental benefits.
The New Jersey State Bar Association opposes this legislation in order to preserve the “Reverse Offset”
provision in New Jersey, visa vie Social Security, which provides for a reduction of the workers'
compensation benefit of a worker also receiving disability insurance. Enacting this legislation has the
potential of harming the economic integrity of New Jersey’s current cost effective system by allowing for
a double recovery of disability benefits and workers’ compensation benefits, which will in turn increase
the cost of doing business in New Jersey. A potential alternative that would limit these adverse
consequences would be to limit the application of the bill to survivor/death benefits.
For the reasons set for above, the New Jersey State Bar Association respectfully opposes this bill."
Wednesday, May 6, 2015
Professor John F Burton Jr: Illinois Proposed Changes Are Obectionable
The former chair of the 1972 National Commission on Workers' Compensation told the Illinois legislature yesterday that the proposed changes to the Illinois Workers' Compensation Act will degrade the system and reduce benefits to injured workers. Profession Emeritis John F. Burton, Jr., yesterday presented a statement to the Committee of the Whole before the Illinois House of Representatives.
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| Professor John F. Burton Jr. |
Tuesday, May 5, 2015
Look Who Is Prescribing What
“This transparency will give patients, researchers, and providers access to information that will help shape the future of our nation’s health for the better,” said acting CMS Administrator Andy Slavitt. “Beneficiaries’ personal information is not available; however, it’s important for consumers, their providers, researchers, and other stakeholders to know how many prescription drugs are prescribed and how much they cost the health care system, so that they can better understand how the Medicare Part D program delivers care.”
The new data set contains information from over one million distinct health care providers who collectively prescribed approximately $103 billion in prescription drugs and supplies paid under the Part D program. The data characterizes the individual prescribing patterns of health providers that participate in Medicare Part D for over 3,000 distinct drug products. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed, which include original prescriptions and any refills, and the total drug cost paid by beneficiaries, Part D plans, and other sources.
CMS created the new data set using drug claim information submitted by Medicare Advantage Prescription Drug plans and stand-alone Prescription Drug Plans. With this data, it will be possible to conduct a wide array of prescription drug analyses that compare drug use and costs for specific providers, brand versus generic drug prescribing rates, and to make geographic comparisons at the state level.
The Administration has set measurable goals and a timeline to move Medicare toward paying providers based on the quality, rather than the quantity, of care they give patients. This is part of a wide set of initiatives to achieve better care, smarter spending and healthier people through our health care system. Open sharing of data securely, timely and more broadly supports insight and innovation in health care delivery.
Today’s Part D prescriber data availability adds to the unprecedented information previously released on services and procedures provided to Medicare beneficiaries, including hospital charge data on common impatient and outpatient services as well as utilization and payment information for physicians and other healthcare professionals. In addition, under the Qualified Entity (QE) program, CMS releases Medicare data to approved entities for the purposes of producing public performance reports on physicians, hospitals, and other providers. To date, CMS has certified 11 regional QEs and one national QE.
To view a fact sheet on the Medicare Part D prescriber data, visit: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Part-D-Prescriber.html
Updated: May 15, 2015
Related articles
How Proposed Part D Changes Are Playing On Capitol Hill (workers-compensation.blogspot.com)
The new data set contains information from over one million distinct health care providers who collectively prescribed approximately $103 billion in prescription drugs and supplies paid under the Part D program. The data characterizes the individual prescribing patterns of health providers that participate in Medicare Part D for over 3,000 distinct drug products. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed, which include original prescriptions and any refills, and the total drug cost paid by beneficiaries, Part D plans, and other sources.
CMS created the new data set using drug claim information submitted by Medicare Advantage Prescription Drug plans and stand-alone Prescription Drug Plans. With this data, it will be possible to conduct a wide array of prescription drug analyses that compare drug use and costs for specific providers, brand versus generic drug prescribing rates, and to make geographic comparisons at the state level.
The Administration has set measurable goals and a timeline to move Medicare toward paying providers based on the quality, rather than the quantity, of care they give patients. This is part of a wide set of initiatives to achieve better care, smarter spending and healthier people through our health care system. Open sharing of data securely, timely and more broadly supports insight and innovation in health care delivery.
Today’s Part D prescriber data availability adds to the unprecedented information previously released on services and procedures provided to Medicare beneficiaries, including hospital charge data on common impatient and outpatient services as well as utilization and payment information for physicians and other healthcare professionals. In addition, under the Qualified Entity (QE) program, CMS releases Medicare data to approved entities for the purposes of producing public performance reports on physicians, hospitals, and other providers. To date, CMS has certified 11 regional QEs and one national QE.
To view a fact sheet on the Medicare Part D prescriber data, visit: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Part-D-Prescriber.html
Updated: May 15, 2015
Related articles
How Proposed Part D Changes Are Playing On Capitol Hill (workers-compensation.blogspot.com)
CMS Defines Further Defines Policy Implementation on Part D Coverage of Benzodiazepines and Barbiturates (workers-compensation.blogspot.com)
Study: Cancer costs 'skyrocketed' despite drug cuts (workers-compensation.blogspot.com)
Big Pharma: More corruption reported in the architecture of evidence based medicine (workers-compensation.blogspot.com)
Public Comment Sought on Draft Document for Workplace Tobacco Policies (workers-compensation.blogspot.com)
Sunday, May 3, 2015
Synchromed II Implantable Infusion Pump Systems: FDA Consent Decree To Limit Use
Medtronic, Inc. cited for manufacturing violations
The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufacture.
The consent decree cites violations of the quality system regulation for medical devices, which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe us
The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment.
The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.
Once Medtronic receives permission from the FDA to resume the design, manufacture and distribution of these products, the company must continue to submit audit reports so the agency can verify the company’s compliance. In addition to these audits, the FDA will monitor the company’s activities through its own inspections.
The FDA first approved the Synchromed II Implantable Infusion Pump Systems in 2004, and first identified problems with the manufacture of these pumps in 2006. These problems can result in over- or under-infusion or a delay in therapy for patients.
Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s Neuromodulation facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications.
“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”
Patients who are implanted with a Synchromed II Implantable Infusion Pump System should maintain regular follow-up appointments with their physicians. Patients who experience a change or return of symptoms, or hear a device alarm, should contact their physician immediately.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Friday, May 1, 2015
WHO Reports Widespread Asbestos Exposure Continues In Europe
WHO (Photo credit: Wikipedia)
The WHO (UN World Health Organization) reports that 1 in every 3 Europeans are still exposed to asbestos.
"We cannot afford losing almost 15 000 lives a year in Europe, especially workers, from diseases caused by exposure to asbestos. Every death from asbestos-related diseases is avoidable," says Dr Zsuzsanna Jakab, WHO Regional Director for Europe. "We urge all countries to leave the Haifa meeting to fulfil their 2010 commitment and develop policies by the end of this year that will eliminate asbestos-related diseases from the face of Europe. There is very little time left for that."
Elimination of asbestos-related diseases was one of the major issues discussed at the Haifa meeting. Over 200 representatives of European countries and international and nongovernmental organizations attended the meeting to evaluate overall progress on environment and health in Europe.
An "eye-opener" report: progress toward the elimination of asbestos-related diseases
The report Progress toward the elimination of asbestos-related diseases, presented at the meeting, indicates that asbestos, a group of natural fibrous minerals, is responsible for about half of all deaths from cancers developed at work. According to new estimates, deaths from mesothelioma in 15 European countries cost society more than 1.5 billion euros annually (see table in Annex).
While 37 of the 53 Member States in the Region have banned the use of all forms of asbestos, the remaining 16 countries still use asbestos, especially for building materials, and some continue to produce and export it. Even after its use has ceased, asbestos lingers in the environment, so it needs to be safely removed and disposed without delay.
"Asbestos is known as a silent killer as health disorders from exposure to it usually appear after several decades. This means that many more people are expected to fall sick and die in the coming years throughout Europe", says Dr Guénaël Rodier, Director, Division of Communicable Diseases, Health Security and Environment. "This new report assesses how far European countries have got in eliminating asbestos-related diseases and provides recommendations for the future."
In one week, the Chemical Review Committee of the Rotterdam Convention will consider listing chrysotile or white asbestos, the most common form of asbestos, among the substances for which importing countries have to give their consent to the exporting party for the trade to occur.
"Elimination of asbestos-related diseases is a priority for Israel. Already in 2011 we have passed a law prohibiting the use of new asbestos, requesting removal of existing friable asbestos and guiding disposal of asbestos cement,", says Mr David Leffler, Director-General, Ministry of Environmental Protection for Israel. "An asbestos waste removal project is conducted in Western Galilee where by December 2014, 80 thousand cubic meters of waste were cleaned in 221 sites. Databases on asbestos-related diseases are considered key to monitor asbestos' health effects and are regularly maintained."
Paving the way ahead for better environment and health in Europe
All European countries present at the meeting renewed their pledges to work towards meeting the time-bound targets they adopted in 2010. This includes concrete steps to:
strengthen or establish partnerships with different stakeholders and processes, and utilize already existing policy instruments and tools;
- enhance the understanding and use of economic arguments to support action on environment and health; and
- harmonize with the forthcoming post-2015 sustainable development agenda.
They also agreed to address the environment and health challenges of the 21st century posed by:
complex risk factors: air, water, waste or chemicals;
complex systems of direct relevance to environment and health: food, energy or cities; and
matters of international environment and health security: disasters and climate change.
The conclusions of the high-level meeting in Haifa are an important milestone in the run up to the Sixth Ministerial Conference on Environment and Health planned for 2017.
The 16 countries that have not yet banned all forms of asbestos are: Albania, Andorra, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Kazakhstan, Kyrgyzstan, Monaco, the Republic of Moldova, the Russian Federation, Tajikistan, Turkmenistan, Ukraine and Uzbekistan.
The five time-bound targets adopted by countries in the European Region in 2010 are to: provide safe water and sanitation to all children by 2020; create healthy and safe environments for children in their daily life by 2020; make children's indoor environments free from tobacco smoke by 2015; safeguard children's environments from toxic chemicals by 2015; develop policies to eliminate asbestos-related diseases by 2015.
The seventh meeting of the Conference of the Parties to the Rotterdam Convention (RC COP-7) will be held from 4 to 15 May 2015, back-to-back with the twelfth meeting of the Conference of the Parties to the Basel Convention (BC COP-12) and the seventh meeting of the Conference of the Parties to the Stockholm Convention (SC COP-7).
Lab Worker Infected by Vaccinia Virus Infection Despite Recent Immunized
The US CDC reported:
Occupational exposures to orthopoxviruses in laboratories can result in infections. The most effective means of prevention are preexposure smallpox vaccination, training, and laboratory safety measures such as proper handling and disposal of needles. In addition, incident reporting and timeliness of seeking medical treatment for inadvertent exposures are critical components of laboratory response plans.
Occupational exposures to orthopoxviruses in laboratories can result in infections. The most effective means of prevention are preexposure smallpox vaccination, training, and laboratory safety measures such as proper handling and disposal of needles. In addition, incident reporting and timeliness of seeking medical treatment for inadvertent exposures are critical components of laboratory response plans.
Wednesday, April 29, 2015
Bumble Bee Foods, Two Others Charged in Death of Employee Trapped Inside Industrial Oven
Los Angeles County District Attorney Jackie Lacey today announced that Bumble Bee Foods LLC and two others were charged with willfully violating worker safety rules, allegedly causing the 2012 death of an employee who became trapped inside an industrial oven at the company’s Santa Fe Springs plant.
Tuesday, April 28, 2015
A More Efficient Process
The NJ Appellate Court reversed a Compensation Judge's dismissal of an employee's claim petition citing, delay in adjudication, and an inadequate record at the trial record.
The reviewing court in an opinion reversing the trial judge and reinstating the case wrote that the motion had lingered for too many years, ie. 4 years, the record below on the motion was vague and incomplete, and the legislative intent for an efficient and liberally construed process was not met.
The Appellate Division cited a 30 year old decision declaring the need for a more efficient process to adjudicate workers' compensation claims.
The reviewing court in an opinion reversing the trial judge and reinstating the case wrote that the motion had lingered for too many years, ie. 4 years, the record below on the motion was vague and incomplete, and the legislative intent for an efficient and liberally construed process was not met.
The Appellate Division cited a 30 year old decision declaring the need for a more efficient process to adjudicate workers' compensation claims.
Roderick v. Taxi & Limousine Three, LLC
Not Reported in A.3d, 2015 WL 1859321 (N.J.Super.A.D. 2015)
Monday, April 27, 2015
The Circus: OSHA Settlement
Ringling Bros. to enhance safety for all aerial acts after settlement agreement
9 employees injured in May 2014 fall in Providence, Rhode Island
Ringling Bros. and Barnum & Bailey Circus, will implement ongoing safety enhancements in aerial acts to protect employees against injuries like those sustained by its aerialists during a May 4, 2014, performance in Providence, Rhode Island. Feld Entertainment Inc., headquartered in Palmetto, Florida, owns the circus.
9 employees injured in May 2014 fall in Providence, Rhode Island
Ringling Bros. and Barnum & Bailey Circus, will implement ongoing safety enhancements in aerial acts to protect employees against injuries like those sustained by its aerialists during a May 4, 2014, performance in Providence, Rhode Island. Feld Entertainment Inc., headquartered in Palmetto, Florida, owns the circus.
Saturday, April 25, 2015
Medical Costs: Why Target the Drug Industry Now
The pharmaceutical industry may indeed be a major factor in the future success of reducing workers' compensation treatment costs and improve the success rate of care. Such action will reduce the cost of medical treatment and likewise reduce permanent disability awards.
US FDA: Designation for CRS-207 in Mesothelioma Treatment
Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease
This week several landmark announcements were made regarding the treatment of mesothelioma and Hepatitis C. The pharmaceutical industry is making great strides if treatment and cure.
Perhaps targeting the drug industry at this time merely to reduce costs is short sighted. The entire program needs to be encouraged.
US FDA: Designation for CRS-207 in Mesothelioma Treatment
Merck Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease
Friday, April 24, 2015
First Capital Insulation faces $490K in fines for willfully allowing unsafe asbestos removal
 |
| Workers safely remove asbestos. Source: OSHA.gov |
Three workers removing thermal pipe insulation at an unoccupied residence on North Second Street in Harrisburg were exposed to these serious risks because their employer failed to protect them properly.
U.S. Department of Labor Occupational Safety and Health Administration inspectors found that First Capital Insulation Inc. of York regularly exposed employees to asbestos hazards.
"Asbestos exposure can cause chronic lung disease and cancer. With the right safeguards, employees can be protected from these deadly hazards," said Kevin Kilp, director of OSHA's area office in Harrisburg. "We found employees removing insulation containing asbestos without first wetting the material, which reduces the danger of exposure. A little water could have made all the difference and the company knew this."
First Capital Insulation faces a $490,000 penalty for seven willful violations, including allowing workers to remove asbestos improperly; failing to make sure their employees' respirators fit correctly; and not decontaminating employees and their clothing before leaving the work site.
The clothing of workers who handle asbestos creates a significant risk for secondary exposure. Its microscopic particles can easily attach to hair, skin and clothes. If the worker and his clothing are not properly cleaned before leaving the work site, others with whom the worker has contact risk secondary exposure. A worker who fails to change out of asbestos-contaminated clothing before returning home can leave fibers embedded in couches, chairs, carpets, beds and other furniture.
OSHA requires employers to treat thermal system insulation and surfacing material found in buildings constructed before and in 1980 as asbestos, unless they can prove that the material is free of asbestos. In this inspection, the building was built in 1928, and the company made no attempt to test the removed materials.
To read the citations, visit http://www.osha.gov/ooc/citations/FirstCapitalInsulationInc_1002754_0420_15.pdf*.
First Capital Insulation is an environmental services company. It provides asbestos, lead abatement and insulation installation services. The company has 15 business days from receipt of its citations and proposed penalties to comply, request an informal conference with OSHA's area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
….
Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
CMS Posts Sample Notice To Beneficiaries Regarding Appeal Rights
CMS has posted the following notice regarding MSP Appeal Rights under the SMART Act. Under the process the the Social Security Beneficiary is only a party of notice and the the direct parties become the Insurance Carrier or Workers' Compensation Entity who initiates the appeal. The process has yet to unfold when an injured workers moves for standing to appear and participate in the process.
On February 27, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing certain provisions of the Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART ACT). This final rule establishes a formal appeals process for applicable plans (liability insurance (including self-insurance), no-fault insurance, and workers’ compensation laws or plans) in situations where the Secretary seeks Medicare Secondary Payer (MSP) recovery directly from an applicable plan. The rule is effective April 28, 2015, and applies to demand letters issued on or after April 28, 2015.
Beneficiaries will be notified in writing if an item or service they received is the subject of an appeal by the insurer or workers’ compensation entity.
A new document titled Appeals Process for Insurers and Workers’ Compensation Entities and Required Notice to Medicare Beneficiaries has been loaded to the downloads section of the What’s New page on the Beneficiary Services section of CMS.gov. The following link can be used to access the main page http://go.cms.gov/beneficiary. Once on the main page click the “What’s New” link in the left side menu and scroll to the bottom of the page.
Health Care Workers' Hazard: Cloth Based Masked Face Masks
Infection in the workplace is now becoming a major concern as new epidemics of disease spread worldwide facilitated by the ever increasing global transportation network. The recent and urgent concerns over Flu, Ebola, Measles and Polio highlight the need to protect health workers.
A recent study published the British Medical Journal focuses on the inadequacy of current medical practices. The study of Clinical respiratory illness (CRI), influenza-like illness (ILI) and laboratory-confirmed the spread of respiratory virus infection and highlights the the problems with cloth face masks.
"We have provided the first clinical efficacy data of cloth masks, which suggest HCWs should not use cloth masks as protection against respiratory infection. Cloth masks resulted in significantly higher rates of infection than medical masks, and also performed worse than the control arm. The controls were HCWs who observed standard practice, which involved mask use in the majority, albeit with lower compliance than in the intervention arms. The control HCWs also used medical masks more often than cloth masks. When we analysed all mask-wearers including controls, the higher risk of cloth masks was seen for laboratory-confirmed respiratory viral infection."
Click here to read the entire report.
"A cluster randomised trial of cloth masks compared with medical masks in healthcare workers"
BMJ Open 2015;5:e006577 doi:10.1136/bmjopen-2014-006577
"We have provided the first clinical efficacy data of cloth masks, which suggest HCWs should not use cloth masks as protection against respiratory infection. Cloth masks resulted in significantly higher rates of infection than medical masks, and also performed worse than the control arm. The controls were HCWs who observed standard practice, which involved mask use in the majority, albeit with lower compliance than in the intervention arms. The control HCWs also used medical masks more often than cloth masks. When we analysed all mask-wearers including controls, the higher risk of cloth masks was seen for laboratory-confirmed respiratory viral infection."
Click here to read the entire report.
"A cluster randomised trial of cloth masks compared with medical masks in healthcare workers"
BMJ Open 2015;5:e006577 doi:10.1136/bmjopen-2014-006577
Thursday, April 23, 2015
US FDA: Designation for CRS-207 in Mesothelioma Treatment
Today's post is shared from finance.yahoo.com/news
Aduro Biotech, Inc. today announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CRS-207, a novel immuno-oncology product candidate, for the treatment of mesothelioma. This designation potentially allows Aduro seven years of limited marketing exclusivity in the United States if it is the first to obtain FDA marketing approval for mesothelioma, and qualifies the company for grant funding to offset the cost of clinical testing as well as tax credits for certain research and a waiver of the Biologics License Application user fee. The FDA previously granted orphan designation to CRS-207 and GVAX Pancreas for the treatment of pancreatic cancer.
“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer,” said Dirk Brockstedt, Ph.D., senior vice president of research and development at Aduro. “We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing Phase 1b study later this year.”
Click here to read the entire article
Aduro Biotech, Inc. today announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CRS-207, a novel immuno-oncology product candidate, for the treatment of mesothelioma. This designation potentially allows Aduro seven years of limited marketing exclusivity in the United States if it is the first to obtain FDA marketing approval for mesothelioma, and qualifies the company for grant funding to offset the cost of clinical testing as well as tax credits for certain research and a waiver of the Biologics License Application user fee. The FDA previously granted orphan designation to CRS-207 and GVAX Pancreas for the treatment of pancreatic cancer.
“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer,” said Dirk Brockstedt, Ph.D., senior vice president of research and development at Aduro. “We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing Phase 1b study later this year.”
Click here to read the entire article
….
Jon L. Gelman of Wayne NJ is the author of NJ Workers’ Compensation Law (West-Thompson-Reuters) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson-Reuters). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
Equitable Relief Permits Reinstatement of Dismissed Workers’ Compensation Case
The principles of equitable relief were invoked by a NJ Appellate Court to restore a dismissed workers’ compensation case to the active calendar.
The Appellate Court, reviewing the facts, considered that the original dismissal, was based on “omissions and misrepresentations” of his prior attorney and the "Petitioner's dilemma was not caused by his own dereliction or ambivalence."
The Appellate Court stated:
Although N.J.S.A. 34:15–54 does not expressly create an exception to the oneyear
requirement for filing a motion for reinstatement, our courts have recognized
that compensation judges possess the inherent power to excuse the one-year time
bar upon the grounds set forth in Rule 4:50–1. Beese v. First Nat'l Stores, 52
N.J. 196, 200 (1968) ; see also Estelle v. Bd. of Educ. of Red Bank, 14 N.J. 156,
261 (1954); Stone v. Dugan Bros. of N.J., 1 N.J.Super. 13, 16–17 (App.Div.1948) .
Relevant here is consideration of Rule 4:50–1(f), which provides that a court may
vacate a judgment for “any other reason justifying relief from the operation of
the judgment or order.”
When considering relief under that basis, “[n]o categorization can be made of
the situations which would warrant redress under subsection (f) .... the very essence
of (f) is its capacity for relief in exceptional situations. And in such
exceptional cases its boundaries are as expansive as the need to achieve equity
and justice.” Court Inv. Co. v. Perillo, 48 N.J. 334, 341 (1966) (citation omitted).
Wednesday, April 22, 2015
Single Payer: State v Federal
Does the demise of the Vermont Single Payer system signal that change is on the horizon on a national level for a more sweeping program? The medical costs of state workers' compensation programs have become so profitable for cottage industries that are directly and ancillary connected to the delivery of work related medical care that the system is our of balance. One has to look seriously at the comments by John E. McDonough in the NEJM.
"At some point, perhaps 5 to 15 years from now, as the size and scope of Medicare, Medicaid, and the ACA subsidy structure balloon far beyond today's larger-than-life levels, our political leaders may discover the inanity of running multiple complex systems to insure different classes of Americans. If advanced by the right leaders at the right time, the logic of consolidation may become glaringly evident and launch us on a new path. If such consolidation is to occur, like it or not, I believe it will happen federally and not in the states — and no time soon."
The Demise of Vermont's Single-Payer Plan
John E. McDonough, Dr.P.H., M.P.A.
N Engl J Med 2015; 372:1584-1585 April 23, 2015 DOI: 10.1056/NEJMp1501050
"At some point, perhaps 5 to 15 years from now, as the size and scope of Medicare, Medicaid, and the ACA subsidy structure balloon far beyond today's larger-than-life levels, our political leaders may discover the inanity of running multiple complex systems to insure different classes of Americans. If advanced by the right leaders at the right time, the logic of consolidation may become glaringly evident and launch us on a new path. If such consolidation is to occur, like it or not, I believe it will happen federally and not in the states — and no time soon."
The Demise of Vermont's Single-Payer Plan
John E. McDonough, Dr.P.H., M.P.A.
N Engl J Med 2015; 372:1584-1585 April 23, 2015 DOI: 10.1056/NEJMp1501050
Tuesday, April 21, 2015
CMS will be presenting a webinar on “Applicable Plan” Appeals
“Applicable Plan” Appeals Webinar – April 28, 2015
CMS will be presenting a webinar on “Applicable Plan” Appeals.
The term “applicable plan” means liability insurance (including self-insurance), no-fault insurance and workers’ compensation laws or plans. Effective for recovery demand letters issued directly to applicable plans as the identified debtor on or after April 28, 2015, applicable plans have formal appeal rights.
The presentation will include:
-an introduction to the appeals process (as the process is new to applicable plans), information on the appeals process specific to applicable plans, and
-tips/suggestions to applicable plans regarding the recovery process, including appeals.
Date: April 28, 2015 Start time: 1:00 PM Eastern time.
URL: https://webinar.cms.hhs.gov/r2g9kffqc46/
Please begin logging in approximately 15 minutes before the start time, due to the large number of participants
CMS will be presenting a webinar on “Applicable Plan” Appeals.
The term “applicable plan” means liability insurance (including self-insurance), no-fault insurance and workers’ compensation laws or plans. Effective for recovery demand letters issued directly to applicable plans as the identified debtor on or after April 28, 2015, applicable plans have formal appeal rights.
The presentation will include:
-an introduction to the appeals process (as the process is new to applicable plans), information on the appeals process specific to applicable plans, and
-tips/suggestions to applicable plans regarding the recovery process, including appeals.
Date: April 28, 2015 Start time: 1:00 PM Eastern time.
URL: https://webinar.cms.hhs.gov/r2g9kffqc46/
Please begin logging in approximately 15 minutes before the start time, due to the large number of participants
CDC Alert to U.S. Hospitals and Long-Term Care Facilities: Patients at Risk of Listeriosis from Certain Blue Bell Brand Ice Cream Products
Blue Bell Creameries has expanded its recall to now include all of its products currently on the market made at any of its facilities. CDC recommends that hospitals and long-term care facilities not serve or sell any Blue Bell brand products. Please check your freezer and inventory for these products. Visit CDC’s Advice to Consumers, Institutions, and Retailers to learn more.
Certain Blue Bell brand ice cream products may be contaminated with Listeria and can cause illness. Some of these products were distributed to institutions.
State and local health officials, CDC, and FDA are collaborating to investigate an outbreak of Listeria monocytogenesinfections (listeriosis) linked to Blue Bell Creameries ice cream products. Information available to date suggests that ill people likely acquired L. monocytogenes infections from ice cream products they consumed while hospitalized for unrelated causes.
As of April 20, 2015, a total of ten patients infected with several strains of Listeria monocytogenes were reported from four states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). Illness onset dates ranged from January 2010 through January 2015. The patients with illness onsets ranging from 2010-2014 were identified through a retrospective review of the PulseNet database for DNA fingerprints matching isolates collected from Blue Bell ice cream samples. Since the last update on April 8, 2015, two additional patients, one each from Arizona and Oklahoma, were confirmed to be a part of the outbreak by whole genome sequencing. All ten (100%) patients were hospitalized. Three deaths were reported from Kansas.
One additional isolate from a patient with listeriosis is undergoing further molecular laboratory testing to determine whether this illness may be related to this outbreak. Results of this testing will be reported once they are available. CDC and state and local public health partners are continuing laboratory surveillance through PulseNet to identify any other ill persons that may be part of this outbreak.
People at higher risk for listeriosis include pregnant women, adults 65 and older, and people with weakened immune systems. Hospitalized patients are at higher risk of listeriosis than the general population because many are immunocompromised and of older age (1).
A recent review article indicates that hospital-acquired listeriosis represents a substantial proportion of overall listeriosis cases that are not associated with pregnancy.
For updates, please visit CDC’s outbreak website.
Silk BJ, McCoy MH, Iwamoto M, Griffin PM. Foodborne listeriosis acquired in hospitals. Clinical Infectious Diseases. 2014 May 20, 2014. doi:10.1093/cid/ciu365.
CDC: Blue Bell Listeria Outbreak Started In 2010
For updates, please visit CDC’s outbreak website.
Silk BJ, McCoy MH, Iwamoto M, Griffin PM. Foodborne listeriosis acquired in hospitals. Clinical Infectious Diseases. 2014 May 20, 2014. doi:10.1093/cid/ciu365.
CDC: Blue Bell Listeria Outbreak Started In 2010
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