Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

A recent OIG report, "Hospital Incident Reporting Systems Do Not Capture Most Patient Harm,” estimates that hospital incident reporting systems captured only about 14% of the “patient harm events” experienced by Medicare beneficiaries. Because of what the OIG characterizes as an “absence of clear event reporting requirements,” administrators classified the remainder of unreported events as either events that staff did not perceive as reportable (62% of events) or that staff commonly reported but did not report in this case (25%). The OIG also reports that few policy or practice changes were made as a result of reported events. The OIG recommended that: (1) the Agency for Healthcare Research and Quality (AHRQ) and CMS collaborate to create and promote a list of potentially reportable events for hospitals to use; (2) CMS provide guidance to accreditors regarding their assessments of hospital efforts to track and analyze events; (3) surveyors evaluate the information collected by hospitals using AHRQ's Common Formats; and (4) CMS review survey standards related to incident reporting systems. The agencies generally concurred.

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On October 22, 2010, the Agency for Healthcare Research and Quality (AHRQ) published a notice announcing the availability of a revised common format for reporting Device or Medical/Surgical Supply patient safety data. Specifically, the revised common format, “Device or Medical/Surgical Supply Including HIT Device,” now captures information about patient safety events related to health information technology. 

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On December 2-3, 2010, the National Institutes of Health and the Agency for Healthcare Research and Quality are co-sponsoring a conference on “Methodological Challenges in Comparative Effectiveness Research.”  The meeting will explore new methodologic, design and evidentiary approaches that can help “ensure the credibility, validity and reliability of applicable research findings to a diverse population, and to assist practitioners, patients and policymakers to come to the right personalized decisions.” Among other things, the conference will review case studies on particular treatments for medical conditions that pose difficult questions about what kinds of research, methods, and analyses should be used to address limitations in current evidence for interventions and tests being examined by decision-making bodies. The registration deadline is November 17, 2010.

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On October 12, 2010, the Agency for Healthcare Research and Quality (AHRQ) is hosting a free web conference on "Integrating Comparative Effectiveness Research into Everyday Practice." The conference will feature presentations on the "Role of CER in Health Care Improvement," "AHRQ's Existing CER Resources on Diabetes and Cardiac Conditions," and “Examples of Incorporating CER Into Clinical Practice.”  Registration is required to participate 
 

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The Agency for Healthcare Research and Quality (AHRQ) is seeking nominees to fill upcoming vacancies on the National Advisory Council for Healthcare Research and Quality (the Council). The mission of the Council is to advise the HHS Secretary and AHRQ Director on such issues as priorities for health care research, related training needs, health quality research dissemination, and opportunities for public private partnerships. AHRQ is seeking nominees who are distinguished in areas such as, among others, health care research; the practice of medicine; health care economics; public policy; and representatives of patients and the private health care sector.

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On June 11, 2010, the Agency for Healthcare Research and Quality (AHRQ) announced that it is awarding grants to support state and health system patient safety and medical liability reform efforts. The $25 million HHS Patient Safety and Medical Liability initiative provides grants for planning, evaluating, implementing patient safety and medical liability demonstrations.  (Note that these projects are separate from the demonstration grants authorized under the ACA that permit the Secretary to grant states up to $500,000 per year for five years beginning with FY 2011 for the development, implementation and evaluation of alternatives to current tort litigation for resolving disputes over injuries allegedly caused by health care providers or health care organizations. Funds for the ACA demonstration grants has not yet been appropriated.)

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The Agency for Healthcare Research and Quality (AHRQ) has released two reports on patient quality trends. The National Healthcare Quality Report includes information obtained through quality measures, while the National Healthcare Disparities Report summarizes health care quality and access among various populations. Among other things, the Quality Report found that little progress has been made on reducing health care-associated infections (HAIs), with rates for three of five types of HAIs actually increasing (although rates of postoperative pneumonia improved).  

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A recent OIG report, “Adverse Events in Hospitals: Methods for Identifying Events,” reviews five methods for identifying adverse events in hospitals: nurse reviews of medical records, interviews of Medicare beneficiaries, two types of analysis of hospital billing data, and reviews of internal hospital incident reports. In a two-county case study, physician reviewers determined that 62% of the possible events identified by these five screening methods were not associated with actual events. Moreover, patient diagnosis codes were inaccurate or absent for 7 of the 11 Medicare hospital-acquired conditions (HAC) identified by the physician reviewers, which could impact Medicare payment for HAC-associated care. Reviewed hospitals also did not generate incident reports for 93% of the events, including some of the most serious events. The OIG recommends that CMS and the Agency for Healthcare Research and Quality (AHRQ) explore ways to identify adverse events when conducting medical record reviews for other purposes. CMS also should: (1) ensure that hospitals code claims accurately and completely to allow for identification of Medicare HACs, and (2) provide guidelines for state survey agencies on assessing hospital compliance with adverse event tracking requirements. Finally, AHRQ should inform patient safety organizations that internal hospital incident-reporting systems may provide insufficient information about adverse events. The agencies agreed with the recommendations. 

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The Government Accountability Office (GAO) has issued a report entitled, “Patient Safety Act: HHS Is in the Process of Implementing the Act, So Its Effectiveness Cannot Yet Be Evaluated.” The report seeks to assess the early implementation of the Patient Safety and Quality Improvement Act of 2005, which included provisions to encourage health care providers to voluntarily report information on medical errors and other events to patient safety organizations (PSOs). The GAO notes that at the time of its review in July 2009, few of the 17 PSOs it interviewed had entered into contracts to work with providers or had begun to receive patient safety data. Some PSOs are waiting for the Agency for Healthcare Research and Quality (AHRQ) to finalize the common formats for PSOs and providers to use in submitting patient safety data to the network of patient safety databases (NPSD). According to AHRQ, if development of the patient safety system remains on schedule, the NPSD could begin receiving patient safety data from hospitals by February 2011. 

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A recent OIG report, “Adverse Events in Hospitals: Public Disclosure of Information about Events,” focuses on policies and practices associated with the public disclosure of hospital adverse event information, including mechanisms for protecting patient privacy. In the OIG review of 17 state adverse event reporting systems, eight Patient Safety Organizations overseen by AHRQ, and CMS Medicare claims data, the OIG found only limited public disclosure of information about adverse events (defined as harm experienced by a patient as a result of medical care). The OIG notes, however, that seven state systems disclosed more extensive information than others (e.g., analysis of the causes of adverse events, guidance for reducing future occurrences, and information about improvements made by hospitals), which can serve as models for other entities.

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The Agency for Healthcare Research and Quality (AHRQ) has released a "Horizon Scan" entitled "To What Extent do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?" The analysis examines the extent to which payment policies may be influencing clinical trial participant recruitment, participation, and retention rates   The report found that several large-scale clinical trials have encountered substantial difficulties due to the deterrent effect of payment policy on participation, with a bigger impact on medical device trials than drug trial. The report called for better coordination among all parties involved in trials, including a strategy covering which costs will be covered and which party will be responsible for such costs.

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The Agency for Healthcare Research and Quality (AHRQ) has released for public comment its draft Technology Assessment, "Report on the Evidence Regarding Off-Label Indications for Targeted Therapies used in Cancer Treatment." The document reviews the medical literature regarding 19 different drug/diseases indications that, at the time of their selection, were all off-label. The report concludes that for "some diseases, despite limited and/or ambiguous data, the use of an off-label indication may be a reasonable clinical decision." The report suggests additional research in this area.  Comments will be accepted until November 16, 2009 (extended from initial November 9 deadline). 

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The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program is soliciting applications for a total of $100 million in Recovery Act funding for AHRQ Clinical and Health Outcomes Initiative in Comparative Effectiveness Grants. The purpose of the grants is to conduct large projects in comparative effectiveness aimed at generating new knowledge to help inform decision making in priority areas of clinical care. Research priorities highlighted in the funding announcement include: arthritis and non-traumatic joint disorders; cancer; cardiovascular disease; dementia; depression and other mental health disorders; developmental delays, attention-deficit hyperactivity disorder and autism; diabetes mellitus; functional limitations and disability; infectious diseases including HIV/AIDS; obesity; peptic ulcer disease and dyspepsia; pregnancy including pre-term birth; pulmonary disease/asthma; and substance abuse. Letters of intent are due November 18, 2009.  

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The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program has issued two reports that examine when AHRQ should update comparative effectiveness reviews (CERs). The first document is a draft research review on "Updating Comparative Effectiveness Reviews". This guidance sets forth a framework for identifying new evidence or evidence not considered in a previous CER, how the update process will be used, and how new data will be incorporated. Comments will be accepted until October 19, 2009. The second document is a final report entitled "Assessment of the Need to Update Comparative Effectiveness Reviews: Report of an Initial Rapid Program Assessment (2005-2009)." This document assesses whether previous CERs need to be updated and prioritizes those CERs for review.

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The Agency for Healthcare Research and Quality (AHRQ) has published a notice announcing an updated version of the common definitions and reporting formats that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events under the Patient Safety and Quality Improvement Act of 2005. The notice also describes AHRQ’s process for continued development and refinement of the common formats.

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The Agency for Healthcare Research and Quality (AHRQ) is seeking public comment on a series of white papers to support its ongoing project on “Registries for Evaluating Patient Outcomes.”  The white papers, which address interfacing registries with electronic health records, stopping a registry, data linkage, and the use of registries in product safety assessment, eventually will be incorporated into a registries handbook. The public comment period ends on September 15, 2009.

** Note:  The comment period subsequently was extended until September 29, 2009.

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The Agency for Healthcare Research and Quality (AHRQ) has announced plans to solicit contracts for comparative effectiveness research projects with $300 million in ARRA funding. Separately, AHRQ has added two new chapters to its "Methods Guide for Comparative Effectiveness Reviews" under the AHRQ Effective Health Care Program: (1) Principles for Developing Guidance for Comparing Medical Interventions; and (2) Grading the Strength of a Body of Evidence when Comparing Medical Interventions. Other topics under development include: Avoiding Potential Biases when Comparing Medical Interventions; Updating Reports Comparing Medical Interventions; and Comparing Diagnostic Technologies.

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The Agency for Healthcare Research and Quality (AHRQ) has released its annual report on state quality of care, based on data from the 2008 National Healthcare Quality Report. The 2008 “State Snapshots” summarize health care quality by: (1) type of care (preventive, acute and chronic care); (2) setting of care (hospitals, ambulatory, nursing homes and home health care); and (3) clinical areas (cancer, diabetes, heart disease, maternal and child health and respiratory disease). This year the report also includes information regarding the following special focus areas: diabetes, asthma, Healthy People 2010, clinical preventive services, and health disparities. As in previous years, the 2008 report found that no state does well or poorly on all quality measures.

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The AHRQ Effective Healthcare Program has released a final research report on "Developing Evidence-Based Research Priorities for Off-Label Drug Use." The report finds that more than 20% of outpatient prescriptions are for off-label use and identifies 14 top-priority drugs that are commonly used for off-label indications with inadequate supporting evidence. The report recommends that future research into off-label drug use focus on drugs used frequently without such evidence, particularly if further concerns are raised by known safety issues, high drug cost, recent market entry, and extensive marketing. Additional research is especially needed in the area of antipsychotic and antidepressant medication. Top priority drugs were quetiapine, warfarin, escitalopram, risperidone, montelukast, bupropion, sertraline, venlafaxine, celecoxib, lisinopril, duloxetine, trazodone, olanzapine, and epoetin alfa.

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On June 25, 2009, the Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program will be releasing a draft technology assessment on “Use of Bayesian Techniques in Randomized Clinical Trials: A CMS Case Study.” Comments on the draft will be accepted until July 10, 2009.

*** Update:  Comment period extended until July 17.

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AHRQ has posted a draft chapter 5 of the "Methods Guide for Comparative Effectiveness Reviews." The topic of the chapter is "Using Existing Systematic Reviews to Replace de Novo Processes in CERs," in which AHRQ proposes a five-step process to standardize the approach that Evidence-based Practice Centers use to decide whether existing systematic reviews might provide value. Comments will be accepted until June 26, 2009.

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 AHRQ is hosting a Clinical and Comparative Effectiveness Research Methods symposium on June 1 - 2. The conference will include discussions on the future of federal comparative effectiveness efforts and emerging research methods.

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On April 10, 2009, the Agency for Healthcare Research and Quality (AHRQ) announced that it is seeking nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF). The USPSTF is a standing panel of outside experts that makes evidence-based recommendations to the health care community and the public regarding the provision of clinical preventive services. Nominations are due by May 15, 2009. 

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The National Advisory Council for Healthcare Research and Quality will meet on April 3, 2009 to discuss Agency for Healthcare Research and Quality (AHRQ) initiatives, including the AHRQ budget for FY 2009, comparative effectiveness, and AHRQ activities under the American Recovery and Reinvestment Act (ARRA).

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On January 9, the Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program posted for review a draft technology assessment entitled “Horizon Scan: To What Extent Do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?”  Comments will be accepted until January 23, 2009.

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The Agency for Healthcare Research and Quality, through its Effective Health Care program, will sponsor an invitational symposium on clinical and comparative effectiveness research methods in June 2009 (dates to be confirmed). The symposium is a follow up to the 2006 AHRQ conference on Emerging Methods in Comparative Effectiveness and Safety; papers presented at that conference appeared in a 2007 Medical Care supplement. The 2009 conference will focus on empirical studies and methodological advances appropriate for publication as a supplement in a peer-reviewed journal. AHRQ is inviting participation in this second symposium through submission of a brief abstract on relevant research by February 13, 2009. Preference will be given to research that can be presented at the symposium as a prelude to publication in the journal supplement and that will be complete or nearly so by early summer 2009.

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On October 14, 2008, the Agency for Healthcare Research and Quality (AHRQ) and the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) published a notice announcing the availability of an interim guidance document entitled “Implementing the Patient Safety and Quality Improvement Act of 2005, Including How to Become a Patient Safety Organization.'' The guidance document explains how HHS will begin implementing the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), which is designed to encourage health care providers to voluntarily report patient safety information, medical errors, and “near misses” to Patient Safety Organizations (PSOs). In order to facilitate such disclosure, the law creates certain legal privilege and confidentiality protections for any patient safety work product (PSWP) either developed by a PSO or prepared by a health care provider and delivered to a PSO.   The new guidance explains how an entity can become a PSO, and how information may be protected as PSWP in the period prior to the promulgation of a final regulation that the agencies indicate will be issued before the end of 2008 (but that schedule is subject to change).  The interim guidance is effective October 14, 2008 until the effective date of a final rule.   While the final regulation will supersede this interim guidance, any information that became PSWP during this interim period based upon the Patient Safety Act criteria will remain PSWP, and thus privileged and confidential, after the interim period.

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The AHRQ's Technology Assessment Program develops systematic reviews and health technology assessments at the request of CMS in order to inform national Medicare coverage policies. AHRQ has announced that beginning October 15, 2008, it will post draft Technology Assessment Program reports for public comment on its website.  In a related development, on October 14, 2008, AHRQ has announced that it will be releasing for public comment a draft White Paper on "Potential Conflict of Interest in the Production of Drug Compendia" on October 22, and comments will be accepted on the draft until November 5, 2008.

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The Agency for Healthcare Research and Quality (AHRQ) has published a notice regarding Patient Safety and Quality Improvement Act of 2005 reporting requirements. By way of background, the Act authorizes Patient Safety Organizations (PSOs) to collect and analyze confidential patient safety information reported by healthcare providers. AHRQ has coordinated the development of a set of common definitions and reporting formats to facilitate the voluntary collection of the patient safety data and reporting of this information to PSOs. The agency invites public input on the initial common formats and describes its process for developing future versions.

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