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

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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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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On August 25, 2009, the HHS Office for Civil Rights (OCR) published a direct final rule adjusting for inflation the maximum civil money penalty amounts for violations of the confidentiality provisions of the November 21, 2008 Patient Safety and Quality Improvement Rule. The inflation adjustment is being made to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990, and is effective November 23, 2009. The OCR is using direct final rulemaking for this action because it expects no significant adverse comment on the rule. If adverse comment is received by September 24, 2009 on a companion proposed rule, OCR will withdraw the direct final rule.  

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On January 15, 2009, CMS announced three final national coverage determinations (NCDs) to deny Medicare coverage of certain types of serious, preventable surgical errors. Specifically, CMS will no longer cover: (1) wrong surgical or other invasive procedures performed on a patient; (2) surgical or other invasive procedures performed on the wrong body part; or (3) surgical or other invasive procedures performed on the wrong patient. The coverage policy complements CMS’s hospital-acquired conditions payment policy, under which Medicare will not make higher payments to hospitals for care associated with certain reasonably-preventable conditions unless the conditions were reported as present on admission. The NCDs are effective immediately, although implementation guidance will be issued at a later date. 

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On November 21, 2008, the Department of Health and Human Services (HHS) published a final rule to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). By way of background, the Patient Safety Act 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 final rule establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to PSOs, on a privileged and confidential basis, for the aggregation and analysis of patient safety events. The regulation outlines the requirements that entities must meet to become PSOs and the processes by which the Secretary will review and accept certifications and list PSOs. It also describes the privilege and confidentiality protections for the information that is assembled and developed by providers and PSOs, the exceptions to these privilege and confidentiality protections, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product. The final rule is effective January 19, 2009. When the final rule goes into effect, it will supersede interim guidance released October 14, 2008, although any information that became PSWP under the interim guidance criteria will remain PSWP, and thus privileged and confidential, after the interim period. 

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On November 24, 2008, the Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled “Contents of a Complete Submission for the Evaluation of Proprietary Names.” The document is intended to help prevent medication errors by assisting industry in the submission of complete product information that will enable FDA to evaluate the safety of proposed proprietary drug and biological product names. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names. The FDA will accept comments on the draft until January 23, 2009.   

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On December 18, 2008, CMS and the Centers for Disease Control and Prevention are holding a listening session to solicit informal comments on hospital-acquired conditions and hospital outpatient healthcare-associated conditions in preparation for the fiscal year 2010 inpatient prospective payment systems and calendar year 2010 OPPS rulemaking processes. Hospitals, hospital associations, representatives of consumer purchasers, payors of health care services, and other interested parties are invited to attend and make comments in person or in writing. It also will be possible to listen to the session by teleconference. Registration is required.

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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 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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On September 10, 2008, the Senate Finance Committee approved an amended version of S. 1070, the “Elder Justice Act of 2008.”  The legislation includes a number of provisions aimed at protecting residents of nursing facilities, including a requirement that crimes occurring in federally-funded long-term care facilities be reported to law enforcement agencies; increased funding for training of long-term care ombudsmen and surveyors investigating allegations of abuse, neglect, and misappropriation of property in long-term care facilities; notification and planning requirements in the event of an impending nursing facility closure; and incentives for individuals to train for employment as direct care providers in long-term care facilities. The panel also approved an amended version of S. 1577, the “Patient Safety and Abuse Prevention Act of 2008,” which would, among other things, expand requirements for background checks employees of long-term care facilities with direct patient access. Separately, on September 11, the Senate Judiciary Committee approved S. 2838, the "Fairness in Nursing Home Arbitration Act"; which would render unenforceable pre-dispute arbitration agreements between long-term care facilities and residents. The House Judiciary Committee approved its version of the measure, H.R. 6126, on July 30, 2008

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