Legislative Report-Dealing with Amendment 7
Christopher L. Nuland
Chapter General Counsel
Since its passage in November of 2004, Amendment 7 (the Patient's Right to Know About Adverse Medical Incidents) has been the subject of no less than 26 different lawsuits, as well as implementing legislation that was designed to clarify any ambiguities and mitigate the negative impact of the Amendment upon physicians.
Unfortunately, that implementing legislation has recently been found to be unconstitutional by two separate judicial circuits, again throwing into chaos the implementation of the constitutional amendment, with providers and facilities no longer sure as to what records are confidential and which are subject to production upon a patient's request.
What Does the Amendment Do?
A literal interpretation of the Constitutional Amendment is that any patient who is seeking, is undergoing, or has undergone treatment by a facility or provider must have the ability to inspect and copy "any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident."
One key source of confusion is that the Amendment's definition of "adverse medical incident" is significantly broader than the definition used for purposes of adverse incident reporting to the State. Rather than being an incident over which the provider could exercise control and which results in a significant injury, the Amendment defines an adverse incident as any act or neglect that could have caused injury to a patient, including those incidents that are required to be reported to the government or are reported to any health care facility peer review, risk management, quality assurance, credentials or similar committee.
To What Records Is a Patient Entitled?
Without doubt, a patient is entitled to all medical records regarding his or her own medical care. What is at issue is the extent to which patients are entitled to records of other patients or records pertaining to their physicians.
The Amendment explicitly states that all HIPAA restrictions must be upheld, and the identity of patients may not be revealed. As a result, any records divulged concerning any patient other than the requestor must have all patient identifying information redacted.
What has been debated is whether a patient has the right to a physician's credentialing file or the minutes of peer review committee meetings. So long as the credentialing or peer review minutes concern "adverse medical incidents," an argument may be made that they are available to patients. However, to the extent that these records do not pertain to adverse medical incidents, they should not be made available to patients.
Another issue of contention is whether records made prior to the Amendment's effective date remain protected. While the implementing legislation explicitly protected all peer review material involving incidents that occurred prior to Election Day, 2004, courts have held that the Amendment applies retroactively, with patients having the right to older documents. This issue likely will remain a key point of future litigation.
Others have wondered if reports to or by the National Practitioner Data Bank would be accessible. Because of the Supremacy Clause of the U.S. Constitution and the language of the Amendment itself, federal law prohibiting the disclosure of this information remains in force, and NPDB information remains confidential.
How May Physicians and Hospitals Respond?
Most facilities and providers have responded to Amendment 7 by minimizing the amount of records that must be reported. For instance, many hospitals continue to perform peer review (as required by JCAHCO), but no longer take notes that may otherwise be disclosed. Moreover, they have limited the type of incidents that must be revealed to peer review committees to only reportable Code 15-type reports, again minimizing the amount of records available. However, when written complaints against a physician are made to a peer review committee, these complaints do become available to a patient.
While an argument can be made that the identities of those sitting on peer review committees remains confidential (as explicitly stated by the implementing legislation), many facilities no longer keep written records of the members of such committees.
Is the Office Based Physician Subject to the Same Rules?
While the office-based physician technically is subject to the Amendment to the same extent as a hospital or ambulatory surgical facility, as a practical matter they have less material that may be requested. For instance, because most offices are not required to have peer review or credentialing committees, no such records are kept and therefore available for inspection. While risk management programs are required for Level II and III office facilities, such programs need only focus on adverse incidents as defined by statute, and may confine their other activities to prospective quality improvement.
Without doubt, the recent judicial events once again have caused justifiable consternation. However, the battles over the implementation of Amendment 7 are still in their early stages, although physicians are advised to take practical steps to immediately to minimize the potentially harmful aspects of the law.
Page updated: 12/1/05
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