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
Patient Safety
Patient Safety and Quality Improvement Act Penalties
By Debra A. McCurdy on
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 …
Noncoverage of Preventable Surgical Errors
By Debra A. McCurdy on
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)…
Final Rule Implementing Patient Safety Act
By Debra A. McCurdy on
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, …
Draft FDA Guidance: Evaluating Drug/Biological Proprietary Names
By Debra A. McCurdy on
On November 24, 2008, the Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled “Contents of a Complete Submission for the Evaluation of Proprietary Names.”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…
Listening Session on Hospital-Acquired Conditions
By Debra A. McCurdy on
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…
Patient Safety Act Implementation
By Debra A. McCurdy on
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 Reporting
By Debra A. McCurdy on
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 …
Committee Markups
By Debra A. McCurdy on
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…