Information about oversight of protected health information for research in canada
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February 15, 2009 ----------------- Government-oversight of healthcare — End of discussion?
As we all know, Congress passed the American Recovery and Reinvestment Act (H.R.1). Whether or not the enormity of this legislation, and what it means for the future of our healthcare, is understood probably depends on whether people have read the 1,434 pages of legislation and get the real meaning of words like quality, cost effective, harmonize, biosurveillance, public health, health disparities, genomics and preventive wellness. There are seven versions of the legislation at various stages, including the final version the House approved, the Senate’s amended sections, and the most current print version for the public. There are widespread misunderstandings, rumors and healthy doses of doublespeak in the media about what the legislation says. The simplest solution is to go directly to the source.
The sections that will potentially have the most significant impact on our healthcare are those referring to health information technology and the National Coordinator for Health Information Technology, the Agency for Healthcare Research and Quality (AHRQ) and Public Services Act, and the establishment of a Prevention and Wellness Fund. Prevention and Wellness
A Prevention and Wellness Fund pages 184+ in the House version, however, was struck out by the Senate in its version. Whether it’s off the table for good is yet to be determined. This Fund would be administered through the office of the Secretary of the Department of Health and Human Service Department, launched with a $3 billion outlay, to carry out provisions under the Public Health Services Act. A small portion of the fund was to go towards immunizations, but most: “Not less than $545,000,000, shall be used as an additional amount to carry out chronic disease, health promotion, and genomics programs, as jointly determined by the Secretary of Health and Human Services and the Director of the Centers for Disease Control and Prevention.” Included in this fund: Not less than $335,000,000 shall be used as an additional amount to carry out domestic HIV/AIDS, viral hepatitis, sexually-transmitted diseases, and tuberculosis prevention programs, as jointly determined by the Secretary and the Director…
Provided further, That of the amount appropriated under this heading $500,000,000 shall be used to carry out evidence-based clinical and community-based prevention and wellness strategies and public health workforce development activities authorized by the Public Health Service Act, as determined by the Secretary, that deliver specific, measurable health outcomes that address chronic and infectious disease rates and health disparities, which shall include evidence-based interventions in obesity, diabetes, heart disease, cancer, tobacco cessation and smoking prevention, and oral health, and which may be used for the Healthy Communities program administered by the Centers for Disease Control and Prevention and other existing community-based programs administered by the Department of Health and Human Services. The Secretary of the HHS will not only determine the programs funded under this provision, but “will directly or through contracts with public or private entities, provide for annual evaluations of programs carried out with funds provided under this heading in order to determine the quality and effectiveness of the programs” and make recommendations for future community prevention and wellness activities. Further:
The Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by no later than 1 year after the date of enactment of this Act that includes recommendations on the national priorities for clinical and community-based prevention and wellness activities that will have a positive impact in preventing illness or reducing healthcare costs and that considers input from stakeholders. Despite their popularity, there are no evidence-based “healthy community” prevention and wellness interventions that have been shown to be effective for reducing obesity or most chronic diseases of aging, or to offer benefits that outweigh the potentials for harm. Regular readers will note that the agendas in this Fund are the same as those of the stakeholders most sponsoring their review by the private organization, the Institute of Medicine. They are also the largest funders of the war on obesity and working to redefine public health — to manage lifestyles, rather than its traditional, proven role in communicable diseases.
Agency for Healthcare Research and Quality Under this legislation pages 806+ of current public print version, the AHRQ is to be expanded and receive increased funding of $700 million for comparative clinical effectiveness research — $400 million to the NIH Director — with an additional $400 million for comparative clinical effectiveness research to be allocated at the discretion of the Secretary of HHS:
The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph and that considers input from stakeholders Provided further, That the Secretary shall consider any recommendations of the Federal Coordinating Council for Comparative Clinical Effectiveness Research established by section 802 of this Act and any recommendations included in the Institute of Medicine report pursuant to the preceding provision designating activities to receive funds provided in this paragraph and may make grants and contracts with appropriate entities. Section 802 (pages 826+) establishes this new Federal Coordinating Council “to coordinate the conduct or support of comparative clinical effectiveness and related health services research; and advise the President and Congress on strategies with respect to the infrastructure needs, appropriate organizational expenditures… to assure optimum coordination of comparative clinical effectiveness and related health services research conducted or supported by relevant Federal departments and agencies with the goal with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.”
The members of the Council will be political appointees from each of the federal agencies, “all of whom are senior Federal officers or employees with responsibility for health-related programs, appointed by the President and acting through the Secretary of HHS.” Whether consumers and medical professionals feel the government or political appointees are the best entities to determine the medical efficacy of clinical care guidelines, should establish federalized electronic clinical registries and data networks for surveillance and data collection, or should contract with a private organization with strong ties to stakeholders to make recommendations for national priorities and what clinical research is funded and conducted — this would have been worthy of public discussion and input from the medical community.
Clearly, any clinical care this Council might deem suboptimum, ineffective or inconsistent with national priorities will die from lack of funding. And any healthcare professional whose practice fails to comply with its determination of clinically effective care will find him/herself not only uncompensated by third party payers, but vulnerable to claims of malpractice. But how likely, in reality, will political appointees of Federal agencies with huge programs under their control be to shut down their own programs when they are shown to be clinically ineffective or for stakeholders to recommend discontinuing clinical guidelines that profit themselves?
● Does this mean that the CDC’s massive Division of Nutrition and Physical Activity will be closed, since its own NHANES data has shown that after fifteen years, its 5-A-Day program has been a complete bust and that its war on obesity focused on diet and exercise is similarly medically unsupported, even by AHRQ’s own evidential reviews? ● Will the National Center for Complementary and Alternative Medicine be shut down, since by its own definition and research, these modalities are not evidence-based?
● Will the 134 Pay-for-Performance clinical practice measures for physicians currently mandated by the Centers for Medicare and Medicaid Services be eliminated, since they are not being shown to improve actual clinical outcomes for patients or to reduce mortality or to save costs? Even the 2003 expert committee under the AHRQ found little benefit of many of the tests and clinical guidelines for the management of indices for a wide range of conditions (diabetes, cardiovascular disease, obesity, etc.) and suggested they only serve to increase the cost of healthcare and make money for pharmaceutical companies, while exposing many individual patients to unnecessary risks? ● As published this month (in upcoming post), Medicare’s major comparative clinical effectiveness research of 15 disease (“chronic condition”) management programs across the country found these programs did not reduce healthcare costs, hospitalizations or improve clinical outcomes or mortality. Will Medicare discontinue these costly care management programs as a result?
Or, is this not really about science and eliminating wasteful, ineffective and potentially harmful government programs and government-mandated clinical guidelines at all? Will this Council be most focused on finding support for programs behind the national agenda determined by the president and his HHS Secretary? National Coordinator for Health Information Technology
For years, JFS has been warning of the plans being made for nationalized integrated Health IT, the research on its effects on patients' clinical outcomes, costs (both financial and to lives and medical errors), the public-private stakeholder interests behind this agenda, and privacy and multiple security concerns. As reviewed here, the National Coordinator for Health IT position was created in 2004. To date, it has focused efforts on mandating integrated electronic medical records for providers of care to Medicare and Medicaid beneficiaries. This legislation expedites the adoption of nationalized electronic medical records with $3 billion in additional funding and empowers the Office of the National Coordinator to establish the technical standards, certify and regulate electronic medical records (EMRs) in accordance with the determinations of the Secretary of HHS and “towards a coordinated national goal.” It also “updates the Federal Health IT Strategic plan to include specific objectives.” These include mandating:
The electronic exchange and use of health information and the enterprise integration of such information. The utilization of an electronic health record for each person in the United States by 2014… Strategies to enhance the use of health information technology in improving the quality of health care, reducing medical errors, reducing health disparities, improving public health, increasing prevention and coordination with community resources, and improving the continuity of care among health care settings.
Specific plans for ensuring that populations with unique needs...are appropriately addressed in the technology design, as appropriate, which may include technology that automates enrollment and retention for eligible individuals. Remember, words such as “quality” no longer mean what the public popularly believes them to mean. Despite the incorrect claims that EMRs won’t affect clinical care standards and that people can keep potentially damaging information private, as we’ve covered extensively, the critical aspect of nationalized, integrated electronic medical records means all information— from doctor and hospital records, diagnostic tests, lab results, prescription drug records, etc. — is automatically populated into the federal database and shared among a wide birth of interested parties, with no ability of consumers to opt-out or give their consent. Title XXX, Section 3000 Definitions (pages 900+) states:
The term ‘certified EHR technology’ means a qualified electronic health record and that is certified pursuant to section 3001(c)(5) as meeting standards adopted under section 3004 …The term ‘enterprise integration’ means the electronic linkage of health care providers, health plans, the government, and other interested parties, to enable the electronic exchange and use of health information among all the components in the health care infrastructure in accordance with applicable law, and such term includes related application protocols and other related standards. The term ‘health care provider’ means a hospital, skilled nursing facility, nursing facility, home health entity, or other long-term care facility, health care clinic, community mental health center (as defined in section 913(b)), renal dialysis facility, blood center, ambulatory surgical center described in section 1833(i) of the Social Security Act, emergency medical services provider, Federally qualified health center, group practice (as defined in section 1877(h)(4) of the Social Security Act), a pharmacist, a pharmacy, a laboratory, a physician (as defined in section 1861(r) of the Social Security Act), a practitioner (as described in section 1842(b)(18)(C) of the Social Security Act), a provider operated by, or under contract with, the Indian Health Service or by an Indian tribe (as defined in the Indian Self-Determination and Education Assistance Act), tribal organization, or urban Indian organization (as defined in section 4 of the Indian Health Care Improvement Act), a rural health clinic, a covered entity under section 340B, and any other category of facility or clinician determined appropriate by the Secretary.
Electronic medical information is to be developed by the National Coordinator to allow the federal government to use and share the information “to reduce healthcare costs” (ration), monitor and ensure the ‘appropriateness’ of care delivered and ‘guide medical decisions’ made by individual care providers, to ensure compliance with its “quality” (performance) guidelines, and enable the government to identify people with chronic conditions for management (such as lab surveillance systems to identify those with treatable blood sugars, cholesterol levels and positive cultures for sexually transmitted diseases): The National Coordinator shall perform the duties under subsection (c) in a manner consistent with the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information and that… improves health care quality, reduces medical errors, and advances the delivery of patient-centered medical care; reduces health care costs resulting from inefficiency, medical errors, inappropriate care, duplicative care, and incomplete information; provides appropriate information to help guide medical decisions at the time and place of care;.. improves the coordination of care and information among hospitals, laboratories, physician offices, and other entities through an effective infrastructure for the secure and authorized exchange of health care information;… promotes early detection, prevention, and management of chronic diseases;… and improves efforts to reduce health disparities.
As pages 919+ note, the HIT policy committee will determine how to use EMRs to coordinate care among health care providers to improve the ‘quality of care’ by “improving population health, reducing chronic disease, and by advancing research and education and to ensure the comprehensive collection of patient demographic data, including, at a minimum, race, ethnicity, primary language, and gender information.” It has been tasked to also advise on the use of a “nationwide health information infrastructure” for the purposes of collecting data, public reporting, “biosurveillance and public health.” Here, again, race and ethnicity as markers for biological weaknesses and disease risks, as well as undesirable lifestyles, and genetics has resurfaced as a disturbing line of public health policy under the guise of ‘health disparities’. A critically important discussion of science and history of race genetics was here. While reducing chronic disease in developed countries such as ours for improving population health may sound good to lay people, as we’ve examined at length, when the specifics are narrowed down, they fail to hold up to the science. These are euphemisms for lifestyle medicine and the unsupported beliefs that diet, lifestyle and pharmaceuticals are effective for the primary prevention of chronic diseases of aging — such as the big three: diabetes, cancer and heart disease — and obesity.
Despite claims that compliance with electronic medical records and the clinical performance measures it tracks aren’t compulsory, any healthcare provider who might ever want to provide care for any patient who is a beneficiary of federal health care coverage has no choice: Each Federal agency shall require in contracts or agreements with health care providers, health plans, or health insurance issuers that as each provider, plan, or issuer implements, acquires, or upgrades health information technology systems, it shall utilize, where available, health information technology systems and products that meet standards and implementation specifications adopted under section 3004(b) of the Public Health Service Act.
This legislation pages 1006+ not only enables the sharing of everyone’s private medical information with little privacy protections (as covered here at length, HIPAA offers little actual protection, either), it allows the sale of our protected health information to just about anyone who might want it. It even allows private health information to be sold for any purpose or in order to treat people as the Secretary of HHS might determine necessary and appropriate — not that which individuals and their doctors might choose or seek treatment for. Look closely at the exceptions under the Prohibition on the Sale of Protected Health Information: Except as provided in paragraph (2), a covered entity or business associate shall not directly or indirectly receive remuneration in exchange for any protected health information of an individual unless the covered entity obtained from the individual, in accordance with section 164.508 of title 45, Code of Federal Regulations, a valid authorization ..
(2) EXCEPTIONS. —Paragraph (1) shall not apply in the following cases: (A) The purpose of the exchange is for research or public health activities… (B) The purpose of the exchange is for the treatment of the individual, subject to any regulation that the Secretary may promulgate… (C) The purpose of the exchange is the health care operation… (D) The purpose of the exchange is for remuneration that is provided by a covered entity to a business associate for activities involving the exchange of protected health information that the business associate undertakes on behalf of and at the specific request of the covered entity pursuant to a business associate agreement.. (E) The purpose of the exchange is to provide an individual with a copy of the individual’s protected health information… (F) The purpose of the exchange is otherwise determined by the Secretary in regulations to be similarly necessary and appropriate as the exceptions provided. On page 1034, the legislation notes a point that’s also been covered here at length, but few consumers may yet realize: that vendors of personal health records and online personal health records are not “covered entities” under HIPAA and, therefore, not required to protect the privacy or access of people’s private health information at all.
The bottom line, electronic medical records have met resistance among medical professionals, who have been reticent to adopt them and who share a multitude of concerns both for patient safety and cost viability. The evidence continues to fail to support these systems as ready for prime time and even their proponents admit that they’re still experimental and being pioneered. Meanwhile, the potentials for abuse and misuse are mind boggling. It is one thing for an individual doctor’s practice or hospital to put their records into electronic form, or for a patient to voluntarily put their own records into an electronic form (such as on an inexpensive flash drive) for portability or convenience — it is a far different thing to make them part of a nationalized database under the dictates of the government and that are freely accessible and exchanged among a massive group of entities, with patients or doctors having no say about the matter. But, of course, any public discussions were gagged as this massive healthcare legislation was inserted into an unrelated economic stimulus bill and rushed through Congress. That makes the government's motives behind nationalized, integrated Health IT feel more suspect among consumers. And, reading the legislation, perhaps, rightly so.
© 2009 Sandy Szwarc posted by Sandy at 2/15/2009Bookmark and Share
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