The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Training Overview

This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity under the act. The HCQIA itself will be reviewed, including a detailed look at the Congressional purpose for the act. The legislative history of the act will be reviewed to gain an understanding of the intent of Congress in passing the act.

The Federal Health Care Quality Improvement Act of 1986 (HCQIA) was passed by Congress partially in response to Patrick v. Burget, et al., but also in response to what was perceived to be a tremendous malpractice crisis in the country. Medical malpractice lawsuits were rising significantly during the years leading up to passage of the Act. It was claimed that physicians with a history of malpractice suits could move easily from state to state with no mechanism of interstate reporting available.

The substantial rise in the number of malpractice suits during the 1970s and 1980s created what has been referred to as the “malpractice crisis.” In fact, the number of malpractice cases filed during the period ending in 1987 was more than "the entire previous history of American tort law."

The HCQIA was designed to address two problems that were considered endemic to the medical community: honest peer review by physicians and the ability of practitioners to move from hospital to hospital and state to state without any record of their previous misdeeds.

To further this goal, HCQIA grants limited immunity, in suits brought by physicians who have been the subject of peer review proceedings, from liability for money damages to those who participate in professional peer review activities.

 Next will be a review of the standards under the act. We will conduct a detailed review of each of the standards and the actions that are required to meet the intent of the standards. Specifically, there are four standards under the act that must be met. We will review each of these with an eye toward court interpretation of what actions an organization must take to achieve the protections granted by the act.

First, the action must be taken “in the reasonable belief that the action was in the furtherance of quality health care.” We will examine what this means and what is required for the entity taking the action to have a “reasonable belief.” 

Second, the action must be taken “after a reasonable effort to obtain the facts of the matter.” The webinar will discuss in some depth what is required to conduct an adequate investigation. Before any definitive action is taken, there must be an adequate investigation to determine the facts of the matter. This seems like simple common sense, but one would be surprised at how often the investigation is found to be less than what is expected. The focus of this portion of the webinar is to review what constitutes an adequate investigation, particularly one that will withstand the scrutiny of the court when the hospital or other professional review body is asking for immunity under the Health Care Quality Improvement Act (HCQIA).

Third, the action must be taken, “after adequate notice and hearing procedures are afforded to the physician involved or after such other procedures as are fair to the physician under the circumstances.” The act sets forth the "safe harbor" conditions that a health care entity must meet regarding adequate notice and hearing procedures. We will examine these safe harbor conditions and discuss in detail what must be done to achieve immunity under this standard. In addition, we will discuss what actions must be taken when a practitioner asks for a hearing but it is not possible to provide one.

Fourth, the action must be taken, “in the reasonable belief that the action was warranted by the facts known after such reasonable effort to obtain facts and after meeting the [notice and hearing] requirement.” While the analysis of this standard generally tracts the analysis of the first standard, “in the reasonable belief,” there is considerable interpretation by the courts of exactly what this standard means and what must be done to accomplish it. We will review that court review and analyze the actions required to meet it.

We will also review cases that discuss the situation where the peer review committee reached incorrect conclusions, and the implications that such a conclusion has for immunity under the act.

Why Should You Attend

You should attend this webinar to gain an understanding of how the HCQIA protects your organization and those who participate in the peer review process in your organization, as well as gain an appreciation of the actions that are required to perfect the HCQIA immunity. Failure to take the appropriate actions and to follow the correct protocol can result in a disastrous situation.

You will learn how to facilitate the frank exchange of information among professionals conducting peer review inquiries without the fear of reprisals in civil lawsuits. The statute attempts to balance the chilling effect of litigation on peer review with concerns for protecting physicians improperly subjected to disciplinary action; accordingly, Congress granted immunity from monetary damages to participants in properly conducted peer review proceedings while preserving causes of action for injunctive or declaratory relief for aggrieved physicians. Not only will you gain an understanding of the immunity provisions, you will gain an appreciation of the standards that professional review actions must satisfy to entitle the participants to such protection.

We will discuss what is required to provide a “fair” hearing, including the actions that must be taken before and during the hearing process. You will gain an understanding of how to conduct an investigation of the allegations that form the basis of the professional review action and the standards that the courts review to ensure that the investigation was adequate. You will learn how the courts interpret the mandate in the HCQIA that the action was taken “in the reasonable belief that the action was in the furtherance of quality health care.” You will also gain an understanding of what is required to meet the standard, “after adequate notice and hearing procedures are afforded to the physician involved or after such other procedures as are fair to the physician under the circumstances.”

Webinar Takeaway

• The Health Care Quality Improvement Act.
• Legislative history of the Act.
• Immunity under the Act.
• Standards required to achieve immunity under the Act.
• Review of the Act by the courts.

Who will Benefit

• Hospital executives, particularly those involved with medical staff activities.
• Medical staff officers.
• Physicians who serve on peer review committees.
• Medical staff support staff.

Our Participants Testimonial

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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