Government health surveillance — a medical debate you need to know!

Diabetes is a gateway issue... the opening salvo, if you will.

An important debate on the ethical, legal and public health issues surrounding New York City’s creation of a mandatory registry of diabetes patients appears in the current issue of Annals of Internal Medicine. The journal devoted a notable amount of space to this because it is a hugely important issue with enormous, irreversible ramifications for the country.

In the name of public health and allocation of public resources, government agencies are working to seize private medical records on people without their consent to build a database of health indices and behaviors that can be said to “burden employers, insurers and ... touch everyone in our society.” More importantly, this information will be used to monitor how citizens conform to tenuous health indices and how physicians comply with government or third party practice guidelines. This may sound melodramatic, but won’t by the time you’ve read the discussion.

As you’ll remember, two years ago, in response to the “diabetes epidemic,” politicians enacted a NYC law making it mandatory that all laboratories electronically report hemoglobin A1c results (along with the people’s names, addresses and dates of birth) to the state Department of Health and Mental Hygiene for its database of diabetics. This summer, the governmental health department will begin sending letters to people who have what it considers high HbA1c scores, along with treatment recommendations. Physicians will receive daily alerts from the government of their patients who have high HbA1c levels and be given treatment recommendations. It is estimated that this will affect 1-2 million laboratory results each year.

Doctors Benjamin Littenberg, M.D. and Charles D. MacLean, MDCM, identified by the journal only as being with the University of Vermont in Burlington, argued for the registries. Vermont has had a registry of diabetics for several years and tracks HbA1c levels. They opened their article by saying the Chronic Care Model is the best model for “how health care should be delivered” and that one of its central features “is the use of registries to feed back organizational or health care provider performance to improve quality of care.” They explained that registries have a long history in healthcare:

Tracking births, deaths, and infectious diseases allowed the development of the science of epidemiology and supported major public health breakthroughs such as the eradication of small pox. Registry data led to improvements in our infrastructure that rendered cholera and yellow fever rare in this country. Registries for contact tracing are the foundation of programs to curb sexually transmitted diseases and control tuberculosis..

Accurate information on the numbers of patients, their locations, their needs, and the economic impact of their suffering is a necessary ingredient to rational program planning and budgeting by government, insurers, employers, philanthropies, and community organizations. If the scope of a problem cannot be made known, it is difficult or impossible to motivate policy makers, politicians, or the public to action. Certainly, the story of tobacco regulation speaks to the value of accurate epidemiologic data in the face of entrenched forces arrayed against the public interest.

Dr. Paula M. Trief, Ph.D. and Richard A. Ellison, J.D, with the departments of Psychiatry and Medicine at State University of New York, countered by first saying they “agree that registries are highly useful to monitor trends, look for patterns, and provide data for research.” There are already many disease and diabetes registries used for such public health goals, they said, but these have proven that “all of the stated goals can be achieved using deidentified data.”

However, there are very distinct differences between traditional health department disease registries and the radical programs in Vermont and NYC, they stressed. Now, information is being gathered about people without their explicit informed consent, using a passive opt-out procedure, they said. There is no ability for people to opt out of having their personal health information included on the registry. People are “sent a letter that allows them to opt out of being contacted by the Dept of Health,” they explained. If people don’t reply, “they are automatically eligible to be contacted, and in either case their information remains in the registry.” [The opt-out procedure is explained on the NY government website here.] In other words, in order to receive medical care, people are forced to participate.

Of added concern, they said, is that the government uses the information to contact patients and their physicians directly about their health status. They added:

The authors never forthrightly address the significant risks we believe are associated with this opt-out registry, including risks to privacy, to the physician-patient relationship, to potential discrimination, and to patient autonomy. Littenberg and MacLean use the example of tobacco regulation to make the point that epidemiologic data are critical to motivate decision makers. As evidence that subjects are “reassured” of the safety of their information, Littenberg and MacLean point to the fact that in one nongovernmental registry, less than 3% of “subjects” opted out. It is more likely that few opt out because patients (not subjects) often do not attend to, or understand, the opt-out procedure.

We are not dealing with absolutes. The government does not have the absolute right to have all the information it wants, and individuals do not have the right to total privacy. The constitutional law concept of least restrictive alternatives may be helpful here. Under this doctrine, the government may limit individual liberty (privacy) in the face of a public health emergency so long as its intent in doing so is compelling and uses the least restrictive means available.

HIPAA (Health Insurance Portability and Accountability Act) allows the disclosure of protected health information to public health agencies, however this exclusion was made because public health authorities typically deal with communicable diseases:

If we were dealing with a communicable disease that poses a serious health threat to the public (the traditional concern of public health), the government’s interest in obtaining identifiable information would be strong and compelling enough to outweigh the individual’s interest in privacy. However, we are not dealing with a serious communicable disease here. This is the very first time that a disease registry has been developed for a noncommunicable disease like diabetes.

The reality of these mandatory diabetes registries is that the government is assuming oversight over the healthcare decisions made by consumers and their care providers. This was made clear as Littenberg and MacLean went on to write that “registries can be instrumental in assessing the quality of care delivered..[and] support the rational, efficient and effective delivery of care” across the entire population:

Other data sources (e.g. medical records and insurance claims) tend to omit populations such as the underserved or uninsured...Perhaps the greatest good from registries can come when they are used to supplement or enhance services provided by the health care system. By following patients across sites of care and time and feeding back information to providers and patients, registries can improve the timeliness of monitoring and intervention, identify patients who would be lost to follow-up, stimulate better communication between patients and providers, and educate and empower patients.

It goes without saying that those slipping through the cracks and with the most poorly managed diabetes are not getting regular HbA1c levels drawn. But read that paragraph again and ask who they are referring to as doing the monitoring of providers and patients, using registries, medical records and insurance claims? And who is intervening between patients and providers? And, who is determining “quality of care” measures?

Trief and Ellison added that while Littenberg and MacLean suggest that registries can supplement or enhance services provided by the health care system, “they provide no evidence for this claim. Even if such evidence develops, and while this may be an important goal, we believe the means are too intrusive.”

Commentary: Treating numbers

Herein lies the crux of the medical controversy. ‘Quality of care’ and ‘improvement measures’ don’t mean what they sound like. They actually refer to ‘performance measures’ determined by a third party and adherence to them. They are typically based on health indices outcomes (proxy laboratory measures such as cholesterol and blood sugar; and other measures such as blood pressure and BMI) and the assumption that treating numbers to get everyone’s indices down to arbitrary lower thresholds will ensure better clinical outcomes and reduce healthcare costs. But, these measures are considerably more controversial among medical professionals than the public likely realizes or than the evidence supports.

Performance measures are not always supported by sound evidence for improving actual clinical outcomes in patients. JFS has examined the questions surrounding BMI, cholesterol and blood pressure, including the aggressive management of blood sugars to reach low HbA1C levels. As was shown in the United Kingdom Prospective Diabetes Study (UKPDS), the largest-scale study of type 2 diabetic patients in our lifetime and followed them for ten years, tight control of HbA1c levels did not improve clinically meaningful outcomes. The ACCORD trial, which evaluated intense medical management to lower blood sugars, cholesterol levels and blood pressures in 10,251 adult diabetics to see if it reduced heart attacks, strokes and cardiovascular deaths actually resulted in excessive deaths.

What were once clinical care 'guidelines,' developed using the best evidence to assist doctors in their clinical decision-making, have become third-party mandates. The current enforcement of performance measures has been justified mostly using case reports showing changes in “process” and surrogate endpoints, rather than clinical outcomes. Many doctors argue that treating numbers to meet the guidelines can have unintended consequences, especially harmful for significant numbers of people, such as high risk patients, minorities, the obese, elderly and poor.

Yet, these measures now dictate the tests and prescriptions that healthcare providers must follow, and their oversight and enforcement means a third party comes between doctors and their patients — eliminating the ability of physicians to use their clinical judgment as to what is best for each individual patient, his/her situation and comorbidities and wishes. All toll, the “quality measures” in the new performance program recently launched by the Centers for Medicare & Medicaid Services, for example, would encourage some 15 different prescriptions for adults over age 50 in order to meet the requisite health indices.

Public health agencies have a track record of creating public health policies and preventive health programs affecting adults and children that are not evidence-based. The push for government managed care and nationalized electronic databases has similarly shown itself to not be immune to vested interests. And these governmental agencies have already demonstrated that they will apply coercive means to compel compliance with their guidelines, such as cutting reimbursements from healthcare providers and public assistance from the poor.

Evidence-based medicine is the ideal for every patient and involves three critical components that work together, as Dr. David Sackett and colleagues at the NHS Research and Development Centre for Evidence Based Medicine at Oxford, wrote in the British Medical Journal:

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer.

Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannized by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best evidence, practice risks becoming rapidly out of date, to the detriment of patients.

Performance or “quality” measures exclude two of the most important parts of evidence-based medicine: the clinical judgment of the doctor, who must consider the whole patient, and the preferences and wishes of the individual patient. [And this assumes that sound, clinically-relevant research evidence has gone into the development of clinical guidelines in the first place, which very often hasn’t.] As Dr. Sackett and colleagues said: “External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision.”

Patients and their care providers

Getting back to this issue of Annals of Internal Medicine, similarly, Trief and Ellison argued that these mandated diabetes registries that monitor health indices are ineffective and will not benefit people with diabetes. Yet:

The registry will cost approximately $2.3 million per year [just in NYC]. We believe that this money should be used to institute other more effective and less intrusive methods of improving diabetes care and reducing barriers to good care, such as addressing the significant inequities in the health care system...

But, they argued, government registries such as these have far more serious consequences in undermining the relationship between patients and their physicians. They ethically compromise patient privacy and could be dangerous, they said:

One major risk is the threat to the physician-patient relationship. Confidentiality is at the core of the physician-patient relationship. The expectation of privacy and confidentiality enables patients to disclose the most intimate details of their lives for the purpose of receiving appropriate care and treatment... The notification of high HbA1c level from a governmental agency is likely to lead to a breach of trust that could cause patients to avoid medical visits and laboratory tests, thus fostering greater nonadherence and interfering with the physician’s ability to work effectively with the patient.

Assurances that the information will remain strictly confidential and released only to patients and healthcare providers are understandably suspect among the public, given regular reports of privacy breaches of personal health information. But a third risk, they said, is the potential for discrimination should this information be accessed by other agencies, insurers or employers:

We read with heightened concern the authors’ statement that providers, payers, and employers are becoming interested in registries because of the associated “efficiency enhancements.” This is the somewhat frightening scenario we anticipated. As these types of registries become commonplace, employer and insurance groups are certainly going to be interested in them. Does any diabetic patient, especially one with poor glycemic control, want his or her employer or insurance company to have this information?

Their final argument was the most critical to understand, as it highlighted that, while these registries might sound benign and in the public good, they sacrifice far more:

Finally, there is an infringement on the patient’s autonomy, a primary principle of medical ethics. Autonomy is the right of patients to make their own choices about medical care, a right that is especially strong when dealing with a noncommunicable disease. Even advocates of the registry describe it as relying on the “purely paternalistic assumption that patients and their physicians need state supervision...,” assumptions that challenge the patient’s autonomy and reflect a lack of respect.

That attitude of the government knowing better than doctors or patients was seen when Littenberg and MacLean wrote:

[P]rimary care clinicians are not in a position to understand why only 30% of patients with hypertension are achieving their target blood pressure or why only 7% of diagnosed patients with diabetes are on target for all 3 major clinical outcomes (blood glucose, blood pressure, and cholesterol values).

As is clear, blood glucose isn’t the only health index being envisioned for governmental oversight. Trief and Ellison closed by saying that calling them “registries” is disingenuous: “We suggest that we call this what it is, a governmental database of identified diabetic patients who are in poor glycemic control. Still sound benign?”

© 2008 Sandy Szwarc

Revealing: Filling in a few pieces

The significance of the “Chronic Care Model” referred to by Drs. Littenberg and MacLean was likely missed by most readers. It was created in the early 1990s by a project of MacColl Institute for Healthcare Innovation funded by the Robert Wood Johnson Foundation, and was published in 1998. Improving Chronic Illness Care is a national program of RWJF based on this model and is working to change healthcare delivery to an integrated managed care system, and change clinical practice through “quality” measures and protocols focused on intense management of chronic health conditions. This collaborative of departments of health, healthcare delivery systems and stakeholders is sponsored by RWJF and the Agency for Healthcare Research and Quality. The accreditation and certification programs and national guidelines for the management of chronic diseases, as well as provider performance measures (“quality indicators”) under the National Committee on Quality Assurance and the Joint Commission have been based on the RWJF’s Chronic Care Model.

At the 2004 Epidemiology, Biostatistics and Clinical Research Methods Summer Session at the University of Washington, Dr. Edward Wagner, M.D., MPH, director of Improving Chronic Illness Care, said that for them, “chronic illness is defined broadly to include any condition that requires ongoing activities and response from patients and care givers, as well as a response from the medical care system.” Their model, he said, includes traditional chronic conditions, such as diabetes, heart disease, and asthma, but also mental disorders like depression, behavioral disorders like ADHD, addictions, and harmful behaviors like cigarette smoking. He said that over 100 million Americans have some type of chronic condition or behavior that affects work productivity and burdens society, and necessitates changing “the system.”

He cited the same paper in JAMA, which he co-authored, as Drs. Littenberg and MacLean which actually only presented case studies of four managed healthcare organizations using their chronic care model, none of which have fully implemented it — and, as Trief and Ellison noted, have not provided any evidence of improving clinical outcomes. The chronic care model includes increasing compliance of providers to “evidence-based” performance measures, educating patients, changing the design of practices, and new information systems. A third party (i.e. government health agency) is given the authority of monitoring care as it would be given access to patient information, decision support and resources. Registries are key to providing them feedback. Another key component of their model is clinical case management and “intense monitoring of adherence” to guidelines by patients with repeated contacts and reminders.

As Dr. Wagner told audiences: If providers are willing to relinquish some of their autonomy and decision-making, passive patients can be convinced by repeated contacts of their role in managing their conditions.

A few other disclosures may also help readers better understand what’s going on behind this issue. Dr. MacLean is the Project Director of the Vermont Diabetes Information System, which he originated. He is also a consultant to the Vermont Department of Health, the NYC Department of Health and Mental Hygiene, and the Vermont Program for Quality in Health Care.

Dr. Littenberg is a Robert Wood Johnson Clinical scholar and member of the Technical Advisory Panel of the National Quality Forum. This independent nonprofit organization was created to develop and implement a national strategy for “quality measurement and reporting.” Its 27 partners, including government agencies, will be familiar to JFS readers, as identical to those behind the “medical homes” being created to manage your care, clinical guidelines for obesity and other conditions, performance measures for providers, insurer/employer wellness programs, and the creation of a nationalized electronic health database.

He was also co-investigator with Dr. MacLean and together they are recipients of a number of relevant research grants: a $2,031,287 grant (in 2002-2005) from the NIH to implement the Vermont Diabetes Information System, a $266,781 grant (2001-2002) from the CDC on information systems in diabetes care, and a $40,000 grant (2001-2002) on diabetes case management in primary care.

But the most important, and missing, disclosure is that Dr. Littenberg is the Chief Executive Officer, and Dr. MacLean is the Chief Medical Director, of Vermedx™ Diabetes Information System (VDIS). The Vermont and NYC diabetes registries were “engendered based on VDIS” and both registries now contract with VDIS. This electronic communication system takes blood tests from laboratories and pulls out (currently) diabetes-specific lab tests and electronically sends it to VDIS. It generates a flow sheet of A1c, blood lipids (cholesterol), Albumin-to-Creatinine ratio, and creatinine values and compares them to targeted numbers and generates letters sent to patients. If a patient is overdue in setting up an appointment, VDIS sends both the doctor and patient a reminder. It also generates population reports for analyzing compliance with measurement goals.

VDIS was recognized in February by the National Business Coalition on Health and is the largest diabetes registry service available. Last May, it had announced it had been selected by the NYC Department of Health and Mental Hygiene to operate its diabetes registry program. And last month, VDIS signed the multi-year contract with NYC Dept. of Health as part of its initiative to combat what Health Commissioner has “labeled a crisis that is becoming an epidemic.”

Its company media page notes the company’s progress: journal articles identifying “major problems” resulting from lack of managed care and the inability to monitor provider compliance with pay-for-performance measures (“The Vermedx Diabetes Information System uses a proprietary method to overcome these barriers...”); a study by the Department of Health and Mental Hygience claiming that one-third of people with diabetes aren’t aware of it, as well as many with “prediabetes;” VDIS as a model for the NYC diabetes registry; and NYC making diabetes a reportable disease. As its website says: “Vermedx staff have been involved in numerous clinical research projects and have many publications to their credit.” There you’ll also find the groundwork being laid for monitoring blood pressure, cholesterol, depression, health literacy, etc. This summer, they are participating in the plans for national public health surveillance of chronic diseases.

Behind every “epidemic” claimed to need massive government intervention and oversight, you’ll find a lot more going on than objective measures of health problems. Will Americans wake up in time?

© 2008 Sandy Szwarc

(all emphases added)