The Patient Safety and Quality Improvement Act of 2005 (Patient
Safety Act) authorized the creation of Patient Safety
Organizations (PSOs) to improve the quality and safety of U.S.
health care delivery. The Patient Safety Act encourages
clinicians and health care organizations to voluntarily report
and share quality and patient safety information without fear of
legal discovery. The Affordable Care Act strongly incentivizes
PSO participation for hospitals of 50 beds or more.
CMS has finalized the requirements for PSO participation for
2017. There continues to be an alternative to PSO participation,
but it is stricter than before, requiring an evidence-based
program using patient safety event reports. The following
regulatory text illustrates the difference between the prior
(before January 1, 2017) and new standards.
(a) Patient safety standards. A QHP issuer that
contracts with a hospital with greater than 50 beds must verify
that the hospital, as defined in section 1861(e) of the Act:
Providers are now faced with conflicting interpretations of The Patient Safety Rule—the May 24 sub-regulatory guidance by HHS conflicts with legal opinions issued by organizations representing many health care providers (e.g., Joint Commission, AHA). The US Supreme Court may take up a case to resolve this conflict. We should know by the end of June as to whether the Court will act.
In a proposed rule issued December 2, 2015, CMS outlines its
vision for compliance with the quality provisions of the
Affordable Care Act. The full text of the discussion is worth
reading, as it lays out the plans for 2017 as well as anticipated
March 11, 2014, the Centers for Medicare & Medicaid Services (CMS) issued the final rule implementing a number of provisions of the Affordable Care Act (ACA), including the provision that hospitals must satisfy certain patient safety and quality improvement requirements to contract with a qualified health plan (QHP) through Covered California, the state’s health insurance exchange.
The Department of Health and Human Services (HHS) issued a
proposed rule implementing a number of provisions of the
Affordable Care Act (ACA), including the provision that hospitals
must satisfy certain patient safety and quality improvement
requirements in order to contract with a qualified health plan
(QHP) through the new health insurance exchange (in California,
that is Covered
The Supreme Court’s June 28 ruling upholding the Affordable Care
Act leaves intact the mandate that hospitals with 50 beds or more
must participate in a PSO by Jan. 1, 2015 in order to contract
with health plans in state insurance exchanges. Except for the
ruling that allows states to forgo Medicaid expansion, the
decision keeps the entire Act in place.
The Affordable Care Act of 2010 calls for states to create health
insurance exchanges, which must be operational by Jan. 1, 2014.
Health insurance exchanges are charged with expanding coverage
for the uninsured, improving health care quality, reducing costs,
and empowering consumers to choose a health plan that gives them
the best value.
By January 1, 2017, qualified health plans in insurance exchanges
may not contract with a hospital of 50 beds or more unless that
hospital has a patient safety evaluation system and reports data
to a PSO. The deadline originally was 2015, but has been extended
two years to allow hospitals time to choose a PSO and begin
Although January 1, 2017 may seem a way off, it is not. Contracts
with health plans are typically for terms of one year or more.
This means that by January 1, 2016, new contracts must comply
with 2017 requirements, or face cancellation at year end.
Members can call CHPSO at (916) 552-2600 to obtain support for
implementing a patient safety evaluation system and automating
The following is an excerpt from the Affordable Care Act
related to health insurance exchanges and hospital PSO
Health insurance exchanges. Participating health plans may only
contract with hospitals with greater than 50 beds when the
hospital is working with a PSO. State-based health insurance
exchanges are to be in place by January 1, 2014, and the
compliance date for hospital contracts is January 1, 2015.
Federal Register - Vol. 73, No. 226 Friday, November 21, 2008
This final rule outlines the requirements that entities must meet
to become PSOs and the processes by which the Department of
Health and Human Services 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.
Federal Register - Vol. 73, No. 29 Tuesday, February 12, 2008
This document proposes regulations to implement certain aspects
of the Patient Safety and Quality Improvement Act of 2005. The
proposed regulations establish a framework by which hospitals,
doctors, and other health care providers may voluntarily report
information to Patient Safety Organizations (PSOs), on a
privileged and confidential basis, for analysis of patient safety
events. The proposed regulations also outline the requirements
that entities must meet to become PSOs and the processes for the
Secretary to review and accept certifications and to list PSOs.
An excerpt from Sen. Edward Kennedy’s Senate floor speech
July 21, 2005:
For even one American to die from an avoidable medical error is a
tragedy. When thousands die every year from such errors, it is a
national tragedy, and it is also a national disgrace, and an
urgent call to action.
Interested counsel may join a discussion group that offers
support and an opportunity to learn about the new legal
privileges and challenges of the Patient Safety and Quality
Improvement Act of 2005. You can request to join the
group by following this link: eepurl.com/rKJaf. This group
generally holds conference calls quarterly.