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Stem Cell Research Improves Spine Injury Outcomes

An international team led by researchers at the University of California, San Diego School of Medicine reports that a single injection of human neural stem cells produced neuronal regeneration and improvement of function and mobility in rats impaired by an acute spinal cord injury (SCI). The findings are published in the May 28, 2013 online issue of Stem Cell Research and Therapy.

According to the summary published in Science Daily, Martin Marsala, MD, professor in the Department of Anesthesiology, with colleagues at UC San Diego and in Slovakia, the Czech Republic and The Netherlands, said grafting neural stem cells derived from a human fetal spinal cord to the rats’ spinal injury site produced an array of therapeutic benefits — from less muscle spasticity to new connections between the injected stem cells and surviving host neurons. “The primary benefits were improvement in the positioning and control of paws during walking tests and suppression of muscle spasticity,” said Marsala, a specialist in spinal cord trauma and spinal injury-related disorders. Spasticity — exaggerated muscle tone or uncontrolled spasms — is a serious and common complication of traumatic injury to the spinal cord. The human stem cells, said the scientists, appeared to vigorously take root at the injury site. “In all cell-grafted animals, there was robust engraftment, and neuronal maturation of grafted human neurons was noted,” Marsala said. “Importantly, cysts or cavities that can form in or around spinal injuries were not present in any cell-treated animal. The injury-caused cavity was completely filled by grafted cells.”

The rats received the pure stem cell grafts three days after injury (no other supporting materials were used) and were given drugs to suppress an immune response to the foreign stem cells. Marsala said grafting at any time after the injury appears likely to work in terms of blocking the formation of spinal injury cavities, but that more work would be required to determine how timing affects functional neurological benefit. The grafted stem cells, according to Marsala, appear to be doing two things: stimulating host neuron regeneration and partially replacing the function of lost neurons.

“Grafted spinal stem cells are rich source of different growth factors which can have a neuroprotective effect and can promote sprouting of nerve fibers of the host neurons. We have also demonstrated that grafted neurons can develop contacts with the host neurons and, to some extent, restore the connectivity between centers, above and below the injury, which are involved in motor and sensory processing.”

The scientists used a line of human embryonic stem cells recently approved for Phase 1 human trials in patients with chronic traumatic spinal injuries. Marsala said the ultimate goal is to develop neural precursor cells (capable of becoming any of the three main cell types in the nervous system) from induced pluripotent stem cells derived from patients, which would likely eliminate the need for immunosuppression treatment.

Pending approval by UC San Diego’s Institutional Review Board, the next step is a small phase 1 trial to test safety and efficacy with patients who have suffered a thoracic spinal cord injury (between vertebrae T2-T12) one to two years earlier, and who have no motor or sensory function at or below the spinal injury site. “This is exciting, especially because, historically, there has been very little to offer patients with acute spinal cord injury,” said study co-author Joseph Ciacci, MD, professor of surgery and program director of the Neurosurgery Residency at the UC San Diego School of Medicine. Ciacci, who is also chief of neurosurgery for the Veterans Affairs San Diego Healthcare System, will oversee the clinical trial at UC San Diego and the VA. Ciacci said if the initial study confirms safety and efficacy, as well as the viability of the implanted cells, neural regeneration and decreased spasticity, the protocol can be expanded to other patients with other forms of severe spinal cord injury.

Cal/OSHA Fines Oakland Hospital For Health and Safety Issues

State regulators have fined Alta Bates Summit Medical Center in Oakland $142,970 for not properly isolating nearly two dozen patients suspected of having tuberculosis. The story in Mercury News says that the hospital failed to put the patients in appropriately ventilated rooms to prevent the disease from spreading to other patients and hospital employees, Cal-OSHA said.

As it turned out, none of these patients tested positive for tuberculosis during the period from Nov. 15 to Jan. 15, so no one was infected, said Mike Hill, a registered nurse at the hospital who was among a group of employees that Cal-OSHA briefed on its findings. But that did not appease Hill and other members of the California Nurses Association/National Nurses United, who are in the midst of a seven-day strike against Alta Bates Summit and other Sutter Health-affiliated hospitals in the East Bay.

“The hospital knew for over a year and a half that the one negative pressure room (in the intensive care unit) did not adequately protect us, patients or anyone walking by,” Hill said. A negative pressure room has a ventilation system that sucks air out of the room to prevent it from spilling into hallways and other areas of the hospital. Cal-OSHA said the system wasn’t working properly.

The hospital plans to appeal the citations, two of which were labeled willful and serious, spokeswoman Stacey Wells said. She noted that the hospital has a team of infection control and other experts who work to ensure a safe environment. “We are also reviewing our policies and procedures — as we regularly do — to ensure we always implement best practices and procedures that maintain and ensure the safety and health of our staff and patients,” Wells said.

Cal-OSHA also faulted the hospital for not ensuring that employees use a respirator when they perform certain procedures on patients suspected of having an infectious disease such as tuberculosis.

No Judicial Misconduct Reported in DWC Ethics Advisory Committee 2012 Annual Report

The Division of Workers’ Compensation (DWC) has posted the 2012 Ethics Advisory Committee’s annual report on its Web site. The Workers’ Compensation Ethics Advisory Committee is a state committee, independent from the DWC, charged with reviewing and monitoring complaints of misconduct filed against workers ’ compensation administrative law judges. The nine-member Ethics Advisory Committee is required to make a public report each year summarizing activities in the previous calendar year.

As civil servants, the WCALJs are not subject to review by the California Commission on Judicial Performance, the agency which is responsible for investigating misconduct complaints directed at judges serving on the Supreme, Superior and Appellate courts. The EAC’s authority and duties are set forth in the California Code of Regulations, title 8, sections 9722 through 9723.

The EAC meets at regular intervals to review complaints of judicial misconduct and to make recommendations to the Chief Judge and the Administrative Director of the DWC if a complaint warrants a formal investigation by the Administrative Director’s staff. Pursuant to California Code of Regulations, title 8, section 9722, the Ethics Advisory Committee is composed of nine members, each appointed by the Division of Workers’ Compensation’s Administrative Director for a term of four years. The EAC’s composition reflects the constituencies within the California workers’ compensation community, and is composed of a member of the public representing organized labor; A member of the public representing insurers; A member of the public representing self-insured employers; An attorney who formerly practiced before the Workers’ Compensation Appeals Board and who usually represented insurers or employers; An attorney who formerly practiced before the Workers’ Compensation Appeals Board and who usually represented applicants (injured workers); A presiding judge; A judge or retired judge, and, two members of the public outside the workers’ compensation community.

The EAC meets four times each year at the DWC Headquarters located at 1515 Clay Street, in Oakland, California. Although EAC meetings are open to the public, the Committee meets in executive session when it engages in the review and discussion of actual complaints, and that portion of the proceedings is closed to the public.

In 2012, the DWC had authority over 168 active judges. The EAC received 19 new complaints in the calendar year of 2012, 6 complaints resulted in investigations. The complaints set forth a wide variety of grievances. Three complaints were filed by employees represented by attorneys. Nine by non represented attorneys. One by a defense attorney. And one each by a hearing rep, lien claimant, and an attorney representing a lien claimant.

The Ethics Advisory Committee identified no judicial misconduct in 15 complaints, and did not recommended further action by the Chief Judge or the Administrative Director on any complaints. Three complaints presently remain pending and under investigation from complaints filed in 2012.

DWC Makes SB 863 Changes to QME Writing Course

The Division of Workers’ Compensation (DWC) is advising physicians who wish to be certified as Qualified Medical Evaluators (QMEs) in the California workers’ compensation system that the required 12-hour report writing course has been revised to conform to Senate Bill (SB) 863. The report writing course requirements are slated for revision as detailed below as a result of SB 863 provisions that affect QMEs:

  • SB 863 eliminated the need for the QME to address medical treatment disputes. For injuries after 1/1/13 and for all dates of injury where treatment is disputed after 7/1/13, medical treatment disputes will be addressed by the Independent Medical Review (IMR) process.
  • SB 863 limited the number of office locations for the QME to ten (10), effective 1/1/13.
  • Effective 1/1/13, in cases involving a physical injury, injured workers will no longer be able to collect additional permanent disability (PD) benefits for sleep disorders or sexual dysfunction that did not directly result from those injuries. Additional PD for “add-on” psychiatric injuries will be limited to cases in which the physical injury is catastrophic or where the injured worker was the victim of, or a witness to a violent crime. QMEs, like Primary Treating Physicians (PTPs), will not be able to comment on PD arising from sleep disorder, sexual dysfunction and non-accepted psychological add-ons, but can still comment on an injured worker’s need for treatment for any of those conditions.
  • After 1/1/14 QMEs may not also be reviewers under the Independent Medical Review (IMR) process.

QME 12-hour report writing courses may be offered only by providers certified by DWC in the document titled “Report writing course providers.”

As previously announced, DWC will hold its next QME exam on Oct. 19.

50% of Physicians Now Use Electronic Health Records

Wider adoption of electronic health recrords (EHR) is critical to the broader health care improvement efforts, including efficiencies within the workers’ compensation health system. These efforts – improving care coordination, reducing duplicative tests and procedures, and rewarding hospitals for keeping patients healthier – are all made possible by widespread use of EHRs. Health IT systems give doctors, hospitals, and other providers the ability to better coordinate care and reduce errors and readmissions that can cost more money and leave patients less healthy. In turn, efforts to improve care coordination and efficiency create further incentive for providers to adopt health IT.

HHS Secretary Kathleen Sebelius announced this week that more than half of all doctors and other eligible providers have received Medicare or Medicaid incentive payments for adopting or meaningfully using electronic health records (EHRs). HHS has met and exceeded its goal for 50 percent of doctor offices and 80 percent of eligible hospitals to have EHRs by the end of 2013.

Since the Obama administration started encouraging providers to adopt EHRs, usage has increased dramatically. According to the Centers for Disease Control and Prevention survey in 2012, the percent of physicians using an advanced EHR system was just 17 percent in 2008. Today, more than 50 percent of eligible professionals (mostly physicians) have demonstrated meaningful use and received an incentive payment. For hospitals, just nine percent had adopted EHRs in 2008, but today, more than 80 percent have demonstrated meaningful use of EHRs.

“We have reached a tipping point in adoption of electronic health records,” said Secretary Sebelius. “More than half of eligible professionals and 80 percent of eligible hospitals have adopted these systems, which are critical to modernizing our health care system. Health IT helps providers better coordinate care, which can improve patients’ health and save money at the same time.”

The Obama administration has encouraged the adoption of health IT starting with the passage of the Recovery Act in 2009 because it is an integral element of health care quality and efficiency improvements. Doctors, hospitals, and other eligible providers that adopt and meaningfully use certified electronic health records receive incentive payments through the Medicare and Medicaid EHR Incentive Programs. Part of the Recovery Act, these programs began in 2011 and are administered by the Centers for Medicare and Medicaid Services and the Office of the National Coordinator of Health Information Technology.

Feds Seek to Regulate Compounding Pharmacies

A bill, approved Wednesday by the Senate Health, Education, Labor and Pensions Committee, would create a new category of regulation by the Food and Drug Administration for some drug compounding companies. The bill now heads to the full Senate.

According to the story in the Washington Post, the Senate bill would establish a new category of FDA oversight that would apply to a part of the industry that has grown rapidly over the past two decades, from small corner pharmacies into businesses that operate like large-scale drug manufacturers. Many of these pharmacies, known as compounders, make a wide array of sterile medications, including antibiotics and painkillers, and ship them across state lines. Unlike traditional compounding pharmacies that custom-mix medication for individual patients based on prescriptions, these compounders often ship drugs without a prescription. These products, unlike drugs made by major pharmaceutical manufacturers, are not ­FDA-approved. And the enterprises do not face the same level of scrutiny from the FDA that traditional drugmakers do.

Under the Senate bill, companies that make sterile products without or in advance of a prescription and sell those products across state lines would be required to register with the FDA and be subject to regular inspections.

Some consumer groups say the category is too narrowly defined. Only companies that meet all the criteria would be covered. Excluded would be large compounding pharmacies that sell defective or life-threatening oral drugs, topical creams and gels, said Nasima Hossain with the U.S. Public Interest Research Group, a consumer advocacy organization. A compounder that sells in only one state would also be exempt. In addition, “anything in pill form wouldn’t qualify, and many chemotherapy drugs are in pill form,” said Diana Zuckerman, president of the Cancer Treatment and Prevention Fund. Public Citizen, a consumer advocacy group, has opposed the creation of a separate category of FDA oversight for large-scale compounding pharmacies. It says it would be better to require the companies to follow the safety requirements that apply to commercial drug manufacturers. The FDA has sought greater oversight of certain types of compounding pharmacies since the fall outbreak.

But in a statement, the FDA said it was concerned that certain aspects of the Senate bill would limit the agency’s enforcement ability. “Unfortunately, the proposed bill does not yet provide the clarity necessary to appropriately oversee this industry and may limit FDA’s ability to effectively protect the public health,” the statement said.

One small wording change in the bill that passed the Senate panel could weaken the FDA’s authority, industry experts said. It says traditional compounding pharmacies are to be defined “pursuant to state law.” State laws vary, so a company that might be considered a drug manufacturer in one state could be defined as a traditional compounding pharmacy in another and be regulated differently depending on state law.

Allison Preiss, a spokeswoman for Sen. Tom Harkin (D-Iowa), chair of the panel, said the bill is a work in progress and will continue to be refined as it moves through the legislative process.

New Federal Bill Seeks to Fix “Broken” Medicare Set Aside Process

Congress is again being asked to amend the Medicare Secondary Payment Act, just six months after enacting reform legislation dealing with the issue, which took five years to pass congressional muster. The Medicare Secondary Payer and Workers’ Compensation Settlement Agreements Act of 2013 was introduced this month in the House, sponsored by Rep. Dave Reichert, R-Wash., and Mike Thompson, D-Calif. The new legislation seeks to reform the processes and procedures used by Centers for Medicare and Medicaid Services (CMS) in its review of workers’ compensation settlement agreements.

According to the story in Property Casualty 360, strong supporters include members of the American Insurance Association and the Coalition for Medicare Secondary Payer Reform. The bill seeks to resolve the serious delays and confusion in the review of workers’ compensation Medicare set- asides by CMS, says to Melissa Shelk, AIA vice president for federal affairs, and Douglas Holmes, president of Strategic Services on Unemployment and Workers’ Compensation (UWC) and coordinator of the Coalition for Medicare Secondary Payer Reform.

“The CMS workers’ compensation Medicare Set-Aside (WCMSA) review process is broken, and this legislation seeks to fix the costly delays and problems within the system,” Shelk said. “We believe that the CMS review process needs clear and consistent standards, timely resolution of coverage decisions and the ability to enable appeals when necessary.”

Holmes said reform is being sought because the current procedure for review of workers’ compensation settlements provides no effective recourse. He said, “There is no avenue to compel a timely decision or appeal a bad one. The legislation introduced by Representatives Reichert and Thompson corrects this situation and many other costly problems and delays, for the benefit of all parties involved.”

In December, Congress passed legislation sought by the insurance industry and other stakeholders since late 2008 that streamlines enforcement of the Medicare Secondary Payment program. The legislation is H.R. 1063, the SMART Act, or The Strengthening Medicare and Repaying Taxpayers Act. The bill is example of how difficult it is to get special interest legislation through Congress is so difficult. The SMART Act was first introduced in Congress in the fall of 2010, but momentum for passage was not generated until last September, when the House Energy and Committee staff coalesced on a rewritten bill crafted with bipartisan support and passed it in late September.

The reason that bill finally got through Congress is that supporters included plaintiffs and defense attorneys, brokers, insureds, insurers, insurance and trade associations, self-insureds and third-party administrators.

DWC Publishes Proposed Interpreter Regulations

The Division of Workers’ Compensation (DWC) has modified the proposed Interpreter Services regulations. DWC posted the modified regulation text and forms on the DWC website and electronically distributed the 15 – day notice of modification to interested parties. Members of the public may comment on the modifications until 5 p.m. on June 5, 2013.

The proposed modifications include:

  • A new section that explains how an interpreter may be certified or provisionally certified to interpret at hearings, depositions or arbitrations.
  • A new section that explains how an interpreter may be certified for medical treatment appointments or medical legal exams by passing the Certification Commission for Healthcare Interpreters (CCHI) exam.
  • Revisions to the remaining sections to be consistent with the changes made by the two new section

The notice, text of the regulations, and forms can be found here

DWC Struggles With Delays in QME Panels

The DWC published the following update on the processing of QME panels

“The Department of Industrial Relations (DIR) and the Division of Workers’ Compensation (DWC) are commencing a thorough review of the existing delays in processing represented injured workers’ requests for Qualified Medical Examiner (QME) panels. DIR is committed to addressing the root cause of the delays and is taking steps to ensure that it is addressed systemically .

The delays were eliminated in the past through significant amounts of overtime work by DWC staff as well as the use of temporary student assistants. While those efforts were successful in the short-term, they were not sustainable, leading to reoccurring problems in processing QME panel requests for represented injured worker cases.

All available resources are currently being directed towards reducing the timelines in represented cases. We are conducting a thorough review of the work processes and the applicable regulations, and exploring long-term solutions to reduce the amount of staff time required to process panel requests and make the process more efficient. A technological infrastructure repair is underway.

We further estimate a reduction in the rate of incoming panel requests after July 1, 2013, when Independent Medical Review becomes applicable to all dates of injury. We are confident that the combination of re-directing resources, implementing new technology and the expected IMR – related decrease in panel requests will result in the permanent elimination of the processing delays . Thank you for your patience during this transition.”

CWCI Study Shows Improvement in California Comp

As the economy recovers and Californians head back to work, the Sacramento Bee reports that total direct written premium in the Golden State’s workers’ compensation market continues to rise. Workers’ comp premium reached $9 billion last year, which was $1.2 billion above 2011, the California Workers’ Compensation Institute reported. That marked the third consecutive year of premium growth, and it brought premium back up to the amount in 2007.

California premium level hit a low point of $6.9 billion in 2009 after soaring to a record $16.1 billion in 2004, CWCI said.

The Oakland-based nonprofit analyzed data compiled by the National Association of Insurance Commissioners and released by the California Department of Insurance.

In other findings, State Compensation Insurance Fund lost market share to 10 percent in 2012, down from 12.9 percent the previous year, CWCI said. Even so, State Fund, a quasi-public group, is still California’s largest provider of workers’ comp insurance.

Zurich Insurance Group maintained the second spot, with the next three slots filled by Travelers Group, Hartford Fire and Casualty Group and Berkshire Hathaway Group.