HHS Issues Interim Guidance to Begin Implementing the Patient Safety and Quality Improvement Act of 2005

28 October 2008 Publication
Authors: Shirley P. Morrigan Judith A. Waltz J. Mark Waxman

Legal News Alert: Health Care

On October 14, 2008, the U.S. Department of Health & Human Services (HHS) released Interim Guidance to begin implementing the Patient Safety and Quality Improvement Act of 2005 (Act). The Interim Guidance announces that the Agency for Healthcare Research and Quality (AHRQ) will begin certifying Patient Safety Organizations (PSOs) as defined in the Act. The Interim Guidance describes a temporary legal framework consisting of the Act, Interim Guidance that closely follows the regulations proposed in a February 12, 2008 notice of proposed rulemaking (NPRM), and explanatory guidance detailing HHS’ interim procedures. The framework described by the Interim Guidance is effective immediately and will remain effective until the issuance of a final rule, which HHS expects to release before the end of 2008.

HHS hopes that the certification of PSOs will be the first step toward overall patient care improvement. The Act was designed to remove what Congress perceived as regrettable barriers that prevented hospitals, doctors, and other health care entities and practitioners (collectively, “providers”) from participating in multi-provider quality review activities. The Act granted privilege and confidentiality to work product prepared by a provider for the purpose of transmittal to a PSO, known as patient safety work product (PSWP). HHS, following Congress, believes this protection will be sufficient to encourage hospitals to provide data voluntarily about adverse events, medical errors, or “near misses” to PSOs. PSOs will then aggregate and analyze the data from multiple providers, permitting the identification of patterns suggestive of systemic or underlying causes of patient risks and hazards. Providers can then address these causes and improve patient safety.

The Interim Guidance includes an appendix of regulations that are binding until they are superseded by the issuance of a final rule. The remainder of the Interim Guidance is non-binding and offered only as HHS’ “current interpretation” of the Act and its “current thinking” on the topics. All discussion not explicitly declared binding creates no rights and imposes no legal obligation.

The Interim Guidance’s binding regulations republish most of the NPRM’s regulatory framework for certifying, listing, and delisting PSOs. Notable aspects include: (1) removal of provisions defining the scope of several exceptions to the confidentiality of PSWP, and (2) reasserting that component PSOs must maintain the separation of PSWP from the rest of the parent organization. All of the provisions contained in the Interim Guidance may be applied in any way not inconsistent with the Act.

The Interim Guidance’s procedures for certification are intended to be minimal. To be certified, applicants must attest to a number of statements regarding their ability to comply with requirements of the Act. The certification form is available on AHRQ’s PSO Web site. Specific certifications apply to applicant entities that are components of other organizations. These entities must certify that:

  • PSWP will be maintained separately from the rest of the organization
  • The entities will prevent unauthorized disclosure of PSWP to any person in the rest of the organization
  • The mission of the entity does not create a conflict with the rest of the organization

HHS may accept, deny, or conditionally approve PSO applications and maintains a list of certified PSOs on the AHRQ Web site. HHS also has the power to delist PSOs, conduct investigations, and levy significant civil monetary penalties for violations of the Act.

HHS issued the Interim Guidance in light of the public interest in beginning the PSO program as quickly as possible, but uncertainties remain, including the following:

  • The procedures created by the Interim Guidance for the certification of PSOs and the permissible disclosure of PSWP may be altered by a final rule. Changes in a final rule will not result in automatic delisting of a PSO, but PSOs will be required to comply with any new requirements. Information submitted to a PSO as PSWP during the interim period will remain privileged and confidential once a final rule is promulgated, but its permissible use will be governed according to any exceptions included in a final rule.
  • Like the NPRM, the Interim Guidance tracks the statutory definition of PSWP, which grants confidentiality and privilege only to a provider’s reports that are made for the purpose of communication with a PSO and are actually communicated to a PSO. Reports unknowingly made to a decertified PSO, or which are a result of a hospital’s separate peer review, compliance, quality assurance, or risk management programs, do not receive confidentiality and privilege under the Act, even if they are turned over to a PSO.
  • The Interim Guidance does not address questions about the potential effect on a provider’s breach of confidentiality, which could expose the provider to lawsuits.
  • The Act and the Interim Guidance expressly deny an intent to preempt or affect state laws. Any disclosure to a PSO may constitute a waiver of peer review protection under state laws, potentially diminishing the scope of a provider’s legal protection.

The Interim Guidance makes it clear that HHS intends to begin implementing the Act. AHRQ can be expected to certify PSOs during the interim period in the manner described in the Interim Guidance. 

Legal News Alert is part of our ongoing commitment to providing up-to-minute information about pressing concerns or industry issues affecting our health care clients and colleagues. If you have any questions about this alert or would like to discuss this topic further, please contact your Foley attorney or any of the following individuals: 

Janice A. Anderson

Chicago, Illinois

Tina E. Dunsford
Tampa, Florida

M. Leanne Habte
Los Angeles, California

Shirley P. Morrigan
Los Angeles, California

Cheryl L. Wagonhurst

Los Angeles, California

Judith A. Waltz
San Francisco, California

Mark J. Waxman
Boston, Massachusetts

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