In the healthcare literature, the terms “quality improvement,” “quality management,” and “performance improvement” are interchangeable. The Risk Analysis generally utilizes “quality manager” and “quality professional.”
The federal government has launched several new patient safety initiatives due to increased public awareness of the problem of medical errors. There were prescriptive initiatives, hospital consultating, and punitive initiatives. Both initiatives are discussed here and their implications for patient safety officers.
Prescriptive Measures
Prescriptive measures were implemented via the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) by issuing COPs (Conditions of Participation for Hospitals).
Hospital Medicare Conditions of Participation
Medicare’s Conditions of Participation for Hospitals have been revised to require that hospitals participate in a quality assessment and performance improvement program. The program must include the following measures to maintain quality of care at acceptable levels:
1. Designing and implementing corrective action activities.
2. The second method is to assess the success of the intervention and to detect any new problems or opportunities.
In its explanation of the final COP rule, CMS specifically acknowledged the significance of the IOM report in providing a focus on systemic and procedural flaws in preventing medical errors. The COP enforcement mechanism implemented by CMS relies on state health agencies to assess compliance with the COPs through surveys. CMS specifically defined errors as “problems with practice, products, procedures, and systems.”.
Hospitals found out compliance with COPs may be subject to civil monetary penalties or lost Medicare funding if their plan of correction is not accepted.
OIG Hospital Supplemental Guidance
Hospitals are encouraged to review the OIG Supplemental Compliance Guidance, published in January 2005, for insight into how OIG has recently addressed fraud and abuse issues, along with specific risk areas hospitals may wish to consider. The Guidance reminds hospitals that the OIG can exclude them from federal healthcare programs if they provide unnecessary or substandard care.
It further asserts that hospitals should adopt quality of care protocols and develop protocols to assess compliance. Its exclusion authority is broad, and the hospital does not need to prove that substandard care occurred on its part, nor that the patient was a Medicare or Medicaid beneficiary. According to the OIG’s Guidance, hospital quality assurance should include both hospital employees and physicians on the medical staff.
Punitive Measures
Feds have targeted nursing homes for quality failures in recent years. Federal prosecutors have successfully used the federal False Claims Act (“Act”) to punish poor quality care, despite no explicit anti-fraud law. The FCA is a Civil War-era statute that aims to prosecute and prevent fraud by government contractors. The govt may seek triple the amount of the alleged false claim and up to $10,000 per alleged fraudulent claim under a civil statute.
Congress revised the law in 1986 so that citizens with firsthand knowledge of fraud could act as whistleblowers and sue healthcare providers. When the federal government intervenes and assumes prosecution, whistleblowers can receive up to 25% of the settlement or award as well as the penalties imposed by the OIG; providers convicted under the Act may be barred from Medicare and Medicaid. To avoid this dire outcome, many providers will settle their cases with fines paid but no wrongdoing admitted—thus, liability under the Act and exclusion are avoided.
Prosecutors use the following fraud theory connected with the Act’s quality of care failures. Providers agree to adhere to all Medicare and Medicaid requirements in return for payment; if the quality of care is so substandard that it is not even a claim, it is a false claim defined by the Medicare and Medicaid Acts. Inappropriate nutrition and hydration, wound care, poor staffing patterns, and inadequate facilities are examples of substandard nursing home care.
As prosecutors have repeatedly stated, the Act does not address a single instance of poor quality care; instead, it focuses on patterns or practices that indicate a failure in treatment.