Tort Reform: JCAHO’s Vision for Change

In a recently released white paper, entitled Health Care at the Crossroads: Strategies for Improving the Medical Liability System and Preventing Patient Injury, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) presents concepts to improve the medical liability system and decrease patient injuries.

Current efforts to curb the rise in liability insurance premiums have mostly revolved around seeking caps on noneconomic damages awarded in medical liability cases, JCAHO states, however, that this addresses the problem at the front end, but does nothing to solve issues involving patient care that lead up to medical malpractice suits. To discuss the various solutions for improving the current medical malpractice system, JCAHO assembled an expert roundtable, which established three main recommendations for improving the medical liability issue: pursue patient safety initiatives that prevent medical injury; promote open communication between patients and practitioners; and create an injury compensation system that is patient-centered and serves the common good.

Pursue Patient Safety Initiatives that Prevent Medical Injury . According to the report, the main roadblocks to efficiently pursuing patient safety initiatives that prevent medical injury are lack of will, resources, and knowledge. Physicians are often reluctant to engage in patient safety activities and be open about errors because of lack of legal protection. The 2000 Institute of Medicine (IOM) report, To Err Is Human, which tracked the frequency of medical errors, suggested that 90% of medical mishaps are the result of failed systems and procedures that are poorly designed to accommodate the complexity of health care delivery. The broken systems are usually identified only when a serious event has occurred and little can be done to research the factors that contributed to the error. Other factors, such as the lack of access to open liability claims by health care researchers (to permit early identification of problematic trends in clinical care), also lead to the overall inefficiency of promoting patient safety to avoid a medical injury. JCAHO attests that providing patient safety researchers with access to open claims could vastly improve efforts aimed at identifying worrisome patterns in care and designing appropriate safety interventions.

The JCAHO report also suggests that the opening of an Office of Health Care Quality in the Department of Health and Human Services could provide a platform for setting priorities and direction for improving patient safety and health care quality, as well as coordinate and enhance the efforts of established private and public sector facilities already engaged in patient safety and quality improvement activities.

Promote Open Communication Between Patients and Practitioners . Health care consumers need to be active members of the health care team, and open communication between practitioners and patients—when an adverse event occurs—should be encouraged, states the report. The current tort system drives suppression of the information necessary to build safer systems of health care delivery by not providing physicians with a safe legal harbor for talking to patients after a medical error has occurred; apologies are seen as a threat to legal defense. Recent studies, however, have shown that prompt explanation of errors and its probable effects, assurance that an analysis will take place to understand what went wrong, follow-up based on the analysis to make it unlikely that such an event will happen again, and an apology decrease the chances that patients will sue. Although most hospitals are still afraid to comply with this standard for fear of medical liability suits, a growing number of hospitals, doctors, and insurers are getting comfortable with the idea that apologies may save money by reducing error-related payouts and the frequency of litigation.

To encourage this openness between the physician and the patient when a medical error has occurred, a growing number of states are passing laws that protect an apology from being used against a physician in court. Open communication between patients and practitioners can also be encouraged through nonpunitive reporting of errors to third parties that promote sharing of information and data analysis as the bases for developing safety improvement strategies. JACHO itself has had a voluntary reporting system since 1996, but it receives only about 400 new reports of events each year—far below the 44,000 to 98,000 medical error-related deaths estimated by the IOM report to occur each year. Additionally, federal patient safety legislation that provides legal protection for information reported to designated patient safety organizations could assure confidentiality and encourage the sharing of lessons learned from the analyses of adverse events.

Create an Injury Compensation System That Is Patient-Centered and Services the Common Good . According to the JCAHO report, only 2% to 3% of patients who are injured through medical negligence ever pursue litigation, and even fewer ever receive compensation for their injuries; those who are awarded compensation wait an average of 5 years to receive it. Knowing this, a pertinent question should be: how can the medical liability system be restructured to actively encourage physicians and other health care professionals to participate in patient safety improvement activities? The goal of any such restructuring should be to reduce lawsuits by decreasing patient injury, and by encouraging open communication and disclosure among patients and providers, and assuring prompt and fair compensation when safety systems fail.

The 50-page JCAHO report presents many more strategies for improving the current medical liability system. The long-term goal? JACHO’s optimistic vision for tort reform and injury prevention:

  • All health care organizations acculturate patient safety—making it a precondition of all other priorities—with the goal of reducing incidences of malpractice.
  • When a medical error occurs, the injured patient is promptly informed of the error and receives an apology, and analysis of the error informs the prevention of such error in the future.
  • An early offer of compensation for losses is promptly provided to the patient.
  • If a claim of injury remains in dispute, an alternative dispute mechanism is employed to bring the claim to a swift, fair, and efficient resolution.

New Regulations for Teleradiologists

The latest guidelines from the American College of Radiology for overseas radiologists require that they are licensed by the states and credentialed by the US hospitals that contract their services, and are covered by medical malpractice insurance. The standards are published in the February issue of the Journal of the American College of Radiology .

ACR and RSNA Defend Use of Medical Imaging

The American College of Radiology (ACR) and the Radiological Society of North America (RSNA) were quick to respond to the latest report by the National Toxicology Program, which includes ionizing radiation, such as x-rays and gamma rays, on the list of 246 known or suspected cancer-causing agents.

The ACR released a statement saying that the National Toxicology Program report is misleading and may negatively impact patient care. The ACR stressed that appropriately used radiological procedures administered by trained, certified medical physicists and technicians in conjunction with radiologists, radiation oncologists, and nuclear medicine physicians present no undue health risk to patients.

The RSNA responded to the National Toxicology Program report with a statement encouraging patients not to forgo medical imaging examinations, saying that the actual cancer risk to people from diagnostic studies is relatively low compared to the benefits of undergoing a necessary examinations.

The National Toxicology Program went beyond its usual limits of occupational and environmental causes of cancer when releasing its latest updates to its list of known or suspected causes of cancer. In addition to x-rays, lead, compounds in grilled meats, and viruses, such as hepatitis B and C made the list.

AAA Screening for Male Smokers Advised

The Annals of Internal Medicine recently published a report recommending that all men between the ages of 65 and 75 who are or have been smokers have a one-time ultrasound to screen for abdominal aortic aneurysms. According to the US Preventive Services Task Force, new evidence indicates screening and surgery to repair large abdominal aortic aneurysms of at least 5.5 cm are effective in reducing deaths. No recommendations about routine screening in men who have never smoked were made. The task force is supported by the Agency for Healthcare Research and Quality.

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Stroke-related diagnostic imaging procedures accounted for approximately 7 million procedures4.7% of the total 148.8 million diagnostic imaging procedures performed in 2003generating $266.4 million in sales and accounting for 4.9% of the overall diagnostic imaging products, according to US Markets for Stroke Management Products, a report from Medtech Insight LLC, Newport Beach, Calif. But the real action will occur in sales of carotid artery stenting systems and other emerging surgical/interventional products, with a predicted compound annual growth rate (CAGR) of 22% through 2008, more than doubling sales to $210 million. Stroke-related diagnostic imaging product sales are expected to increase at an annual rate of 4.4% through 2008, reaching $330.6 million.

Source: Medtech Insight ( www.medtechinsight.com ) Market & Technology Report #A225, U.S. Markets for Stroke Management Products, published November 2004.

Industry News

Barco, Kortrijk, Belgium, received 510(k) premarket clearance by the FDA for its Voxar 3D vessel analysis software module, VesselMetrix…Analogic Corp, Peabody, Mass, sold the 4,580,461 shares representing its 14.6% interest in Cedara Software Corp, Mississauga, Ontario, Canada, resulting in net proceeds of $50,751,508…Agfa, Mortsel, Belgium, acquired GWI, Bonn, Germany, a private company that develops and markets ORBIS® administrative and clinical IT solutions for hospitals. The company recently received the Frost and Sullivan 2004 Healthcare Imaging Industry Product of the Year Award for its IMPAX imaging information management system…Misys Healthcare Systems, Raleigh, NC, received first-place rankings in the Top 20 Year-End Best in KLAS Awards for several of its products in the Misys Optimum™ family of products, including Misys Laboratories™, CoPathPlus®, and Misys Homecare™…GE Healthcare and ETS-Lindgren announced a partnership in which ETS-Lindgren will provide multiple shielded enclosures to GE for its complex MR systems…IDX Systems Corp, Burlington, Vt, acquired PointDx Inc, Winston-Salem, NC, a developer of structured medical reporting technology, which will be directly integrated into the IDX Imagecast™ RIS/PACS. IDX has renewed and extended its technology partnership with Stentor Inc, Brisbane, Calif, for the delivery of integrated PACS until 2015. Stentor was ranked the #1 PACS vendor in the 2004 KLAS PACS Report and also received the highest marks in three out of four categories: product technology, business, and success indicators…SmartPACS, Irvington, NJ, has partnered with Provox Technologies Corp, Roanoke, Va, to integrate Provox VoxReports™ radiology speech recognition reporting with StarPACS diagnostic workstations…WebMD Practice Services, Tampa, Fla, will market the IntegradWeb PACS, by Dynamic Imaging, Allendale, NJ, as part of WebMD’s radiology solutions product offerings…Emageon Inc, Birmingham, Ala, began trading on the Nasdaq National Market on February 9, 2005, under the symbol EMAG. The company closed its initial public offering of 5,000,000 shares of its common stock at $13 a share and granted underwriters a 30-day overallotment option to purchase up to an additional 750,000 shares…McKesson, San Francisco, received FDA 510(k) clearance for its Horizon Rad Station™ release 11.0 PACS workstation for reading, distributing, and storing full-field digital mammography images…The National Research Council of Canada (NRC), Winnipeg, Manitoba, and Mednovus Inc, Leucadia, Calif, have entered into a worldwide exclusive technology license agreement that enables Mednovus to build and sell highly sensitive, walk-through ferromagnetic detectors, which are based on a patent-pending design developed by NRC’s researchers…Zonare Medical Systems, Mountain View, Calif, and Sea Ridge Software, Menlo Park, Calif, entered into a strategic alliance, under which Zonare will offer Sea Ridge’s imorgan ultrasound mini-PACS system as an option with Zonare’s new z.one ultrasound platform…InSiteOne Inc, Wallingford, Conn, and eRAD, Greenville, SC, have signed a distribution agreement, under which eRAD will bundle InSiteOne’s pay-as-you-go digital storage and disaster recovery options with its line of PACS and related products…StorageTek®, Louisville, Colo, received Frost & Sullivan’s 2004 Best Bang for the Buck award, for the strength of its economical, high-performance, integrated enterprise storage solutions. StorageTek is conducting a seminar tour to educate attendees on regulatory compliance issues and challenges, including strategies for archiving and retrieving compliance-affected information, balancing cost of ownership with compliance needs, and optimizing management processes and IT infrastructures for compliance with retention and privacy regulations; the remaining two seminar dates are on March 23 in Indianapolis and March 24 in Boston.

Reimbursement News

Expanded Medicare Coverage for PET Oncology Scans
The Centers for Medicare and Medicaid Sciences (CMS) released a final national coverage decision expanding Medicare coverage for PET scans for brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancer, and all other cancers not presently covered. The CMS coverage policy will cover the PET scans either when the provider participates in a PET clinical trial that meets the requirements of a FDA category B investigational device exemption or data is submitted to an FDG-PET registry designed to provide additional information on the use of PET for diagnosis, staging, restaging, and monitoring of therapeutic response for cancer.

CMS Activates PET CPT Codes, Discontinues G Codes
CMS activated the adoption of CPT codes for PET procedures, essentially overriding previously used G series HCPCS codes. The coding change will be implemented in April 4, 2005, and be retroactive to January 30, 2005. The adoption of CPT codes for PET procedures will activate three cardiac, two brain, and six new tumor PET CPT codes for Medicare and other patients covered by CMS programs. Details of the change can be viewed in the document called Change Request 3726, posted at www.cms.hhs.gov (PDF).

Medicare Updates Reimbursement Rules
Medicare has updated its reimbursement rules for compensator-based IMRT treatment delivery that apply to hospital outpatient departments and freestanding cancer centers effective January 1, 2005. For the hospital outpatient setting, Medicare has assigned a new Category III code for compensator-based IMRT treatment delivery, 0073T, to APC 0412 with a status indicator of “S” (significant procedure). Both 0073T and 77418 (MLC-based IMRT delivery) are assigned to APC 412 with an average 2005 payment of $309.20. For the Physician Fee Schedule, which applies to freestanding radiation oncology centers and physician offices, Medicare approved the use of a national payment policy for compensator-based IMRT using the new Category III code 0073T. The 0073T will be assigned 18.15 interim RVUs, more than MLC-based IMRT (18.11 RVUs). The 2005 national average payment for 0073T is $687.84.

People

Patrick T. Fitzgerald

Patrick T. Fitzgerald has been appointed president of Dunlee, Aurora, Ill, following the retirement of Robert J. Malnar. Fitzgerald previously served as general manager of Dunlee’s commercial business…Anne Vleminckx, has been appointed as chief financial officer of Agfa, Mortsel, Belgium…Mitch C. Hill was appointed as executive vice president and chief financial officer of InSight Health Services Holdings Corp, Lake Forest, Calif…Andrew C. Cowen has been elected as president and CEO of CMS Inc, St Louis…Robert Hoffman joined eRAD, Greenville, SC, as executive vice president of sales…Jay D. Miller, president and CEO of Vital Images, Minneapolis, was named CEO of the Year in the medical imaging industry by Frost & Sullivan…Susan Wood was named chief operating officer of Medicsight, London…Hartmuth C. Kolb, PhD, was named chief technology officer of CTI Molecular Technologies Inc, Knoxville, Tenn…Joseph D. Biegel is now the vice president of product management for the medical imaging group of McKesson Corp, Vancouver, British Columbia, Canada.

Kevin J. Hobert

Kevin J. Hobert has been named president of Eastman Kodak Co’s Health Group, Rochester, NY, and senior vice president of Eastman Kodak Co. Hobert, who replaces Daniel Kerpelman, will report to Antonio M. Perez. Kodak also announced the following appointments: Mike Jackman, formerly chief technology officer, has become general manager of health care information systems; Jeff Markin, formerly general manager of health care information systems, is now general manager of regional operations; Marco Bucci, chief technology officer; John Farrell, acting general manager of services for the health imaging group; and Pan Benkert will serve as general manager of specialty markets and continue responsibilities as general manager of the health imaging group’s film capture and output systems group.