For the past several months I have been following the story loosely as I do not practice in New York and the legislation it would seem would have no impact on my practice or my ability to speak directly with patients.
A recent CAP Statline last week brought the attention to my mind again. And once you go back through the history with some recent changes to federal legislation and the New York State Department of Health’s response to date there is no other conclusion here other than this is ludicrous for pathologists AND their patients.
First some history and background.
In February of this year, The Department of Health and Human Services (HHS) granted greater access to laboratory results in a final rule, that among other provisions of the law:
- Allowed for patients to access laboratory results upon direct request to the testing facility.
- Did not require the ordering physician to disclose the identity of the testing laboratory to patients, however, HHS encouraged physicians to inform patients where specimens are being sent AND
- Preempted state laws that impede patients directly receiving test results from the laboratory.
The final rule amended the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, which cover the reporting of test results. In recent years, a federal health information technology (HIT) policy committee had found that CLIA regulations prevented exchanges of HIT, and the HHS decided to revisit regulatory barriers that impede patient access to information.
A week later the College of American Pathologists (CAP) called upon the New York State Department of Health to repeal a regulation in New York prohibiting pathologists from conferring with patients on their laboratory test result.
The letter (PDF) referenced the HHS rule granting greater patient access that also preempted state laws that impede patients receiving test results directly from the laboratory.
The College’s request made by its president, Dr. Gene Herbek, specifically requested “repeal of the New York State regulation (10 NYCRR § 34-2-11(v)) that prohibits patient contact with the pathologist medical director of the laboratory providing their diagnosis, in furtherance of the implementation of federal preemption.”
The letter goes on to read “This regulation constitutes a legal impediment to physician pathologists’ ability, in their capacity as laboratory medical directors, to confer with patients regarding their test results and reports to which patients are now entitled, under federal law, to receive directly from the laboratory.
This legal impediment is based upon an anachronistic practice paradigm that has placed New York patients at a significant medical disadvantage compared with patients in other states who are able, without state legal constraint, to seek and receive pathologist medical input on their diagnosis, prognosis and even course of therapy. There is no sound medical reason for placing any such legal barrier, as currently exists in New York, between pathologists, as physicians and laboratory directors, and their patients.”
In response, the New York State Department of Health had declined to repeal the regulation that prohibits patients from discussing their test results with pathologists.
Their response states, “A clinical laboratory that provides a patient with the meaning or interpretation of the test results is discharging the ordering physician’s responsibilities and such discharge is of decided benefit to the physician, precluding the practioner from incurring expenses or expending time.”
The response also adds, “Traditionally, the physician, as part of the physician/patient relationship, explains test results and their implications, tracks patient medical history, and arranges for follow-up care. However, care coordination teams are being implemented to improve the quality of patient care and the cost effectiveness of health care. I would be interested to learn if there are models for this interdisciplinary approach to health care that involves pathologists.”
In return, the CAP sent back a response dated October 21 providing additional claims, arguments and references to have this state regulation repealed.
The letter mentions a “Medical Consensus Statement of over 108 physicians in New York from 40 hospitals, laboratories and medical academic institutions, located throughout the state. Please note these 108 New York physicians have affixed their signature to this document to make clear their strong personal conviction and support for the clinical position enunciated in the document”.
A few items strike me as bizarre here:
- What clinician in their right mind would not want a patient speaking to a pathologist (whether he/she is the “medical laboratory director” or not and this part of the wording here is unclear to me) about his/her test results performed in their laboratory?
- I gather that most pathologists if they engaged in this type of care with a patient directly would not be compensated by insurance companies to do so and would ultimately pay for it themselves in terms of their time to their lab/practice/group/hospital and
- May not be willing to do so; which may have potentially been a contributor to this legislation in the first place unless pathologists put up a fight to this when it was enacted; I simply do not know
- The New York State Department of Health response makes reference to “care coordination teams…to improve quality of patient care…I would be interested to learn if there are models for this interdisciplinary approach to health care that involves pathologists.”
- This is perhaps the most insulting comment in this dialogue thus far. First of all, the terms “care coordination team” and “clinical care teams” are widely overused. Secondly, all of us are integral members of healthcare delivery systems that provide a critical role, with likely varying degrees of personal interaction with our clinical colleagues, admittedly. However, are we are now supposed to propose models for an interdisciplinary approach that involves pathologists? Apparently the New York State Department of Health holds pathologists in very high regard, first by claiming we would interfere with the physician-patient relationship by speaking with patients directly, and second, making a statement that we need to justify our roles in an interdisciplinary approach to health care of patients.
- Last but not least, unfortunately, and I applaud the CAP’s efforts here, just over 100 docs signing their names to a petition is a very weak advocacy effort. I could get 150 guys that play in our over 40 Friday night hockey league to put their names to something “for a good cause”.
We as physicians and pathologists have a morale, ethical and legal responsibility to put patient’s interests first, whether that be performing the laboratory test, interpreting the result or discussing the results with a provider or a patient.
In part, I think we have solidified our place in health care as “The Doctor’s Doctor” and until recently I embraced that title, role and responsibility. We appreciated our clients and customers as other physicians that put their trust in us to help them perform and interpret results from appropriate laboratory tests.
However, we are also “The Patient’s Doctor” and despite what regulators think, pathologists should, can and are willing to be patient advocates as they advocate for themselves in their own care.
So, the next time a patient calls my laboratory to inquire about their TSH level, Hemoglobin A1c or calls to inquire about what “multifocal” means on her breast biopsy, I will be sure to do my part by answering their questions.
Pathologists Cannot Talk to Patients? Fuggedaboutit
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