The Comparative Effectiveness Research Act of 2008, introduced last week in the Senate as S. 3408 (which can be found through a search at
the Thomas legislation site), is a proposal worth examining because, although it would impose a tax on health insurance in order to fund "comparative effectiveness research," it seems to be slipping under the radar because so many other issues are getting attention in the press. As I interpret the legislation, people would be funding research designed to compare the effectiveness of differing approaches to dealing with a disease, illness, or medical condition. The few Senators who have commented on the legislation claim that the funding is a tax rather than a fee, but for me, regardless of what the charge is called, the initial question should focus on what people are acquiring in exchange for what they would be paying.
The fee, or tax, or whatever it is called, would be imposed by new Internal Revenue Code sections 4375 and 4376. Section 4375 would impose a $1 fee on each person covered under any accident or health insurance policy, including group health policies, issued with respect to individuals residing in the United States. The $1 would be reduced to 50 cents during 2012. The issuer of the policy would be required to pay the fee, but it would be a good guess to conclude that this cost would be passed along to insureds. The fee would not be imposed on an insurance policy if substantially all of its coverage is limited to accident insurance, disability income insurance, supplemental liability insurance, workers' compensation, automobile medical payment insurance, credit-only insurance, coverage for on-site medical clinics, and coverage described in regulations as being secondary or incidental to insurance benefits other than medical care. Starting with policy years ending in any fiscal year beginning after September 30, 2013, the $1 amount is increased to reflect the percentage increase in the projected per capita amount of national health expenditures. An identical fee is imposed on self-insured health plans, defined by the legislation as plans providing accident or health insurance through a means other than an insurance policy, if established or maintained by one or more employers for their employees, by one or more employee organizations for their members, and by several other specified associations or organizations. Under section 4377(c), the fee would be treated as a tax for purposes of the procedural and administrative provisions of the Code.
The fee, or tax, collected under sections 4375 and 4376 would be transferred to the Comparative Effectiveness Research Trust Fund, known as the CERTF. In addition to the fee or tax imposed by sections 4375 and 4376, there would also be transferred to CERTF fixed dollar amounts, ranging from $5 million in fiscal 2009 to $75 million in fiscal 2012 through 2018, to be taken from the Treasury general fund. Amounts in the fund are to be made available to the Health Care Comparative Effectiveness Research Institute, which I am going to call the HCCERI even though the statute does give it an acronym as it does for the CERTF.
The HCCERI is established as a D.C. nonprofit organization, though the statute provides that it is "neither an agency nor establishment of the United States Government." According to the proposed legislation, "The purpose of the [HCCERI] is to improve health care delivered to individuals in the United States by advancing the quality and thoroughness of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, and managed clinically through research and evidence synthesis, and the dissemination of research findings with respect to the relative outcomes, effectiveness, and appropriateness of the medical treatments, services, and items described in subsection (a)(2)(B)." Those items are " health care interventions, protocols for treatment, procedures, medical devices, diagnostic tools, pharmaceuticals (including drugs and biologicals), and any other processes or items being used in the treatment and diagnosis of, or prevention of illness or injury in, patients."
The HCCERI is charged with eleven duties. First, it must identify national priorities for comparative clinical effectiveness research, taking into account factors such as disease incidence, prevalence, and burden in the United States, evidence gaps in terms of clinical outcomes, practice variations, including variations in delivery and outcomes by geography, treatment site, provider type, and patient subgroup, the potential for new evidence concerning certain categories of health care services or treatments to improve patient health and well-being, and the quality of care, and the effect or potential for an effect on health expenditures associated with a health condition or the use of a particular medical treatment, service, or item. Second, it must establish and update a research project agenda to address the priorities identified under the first duty, Third, it must conduct a study on the feasibility of conducting research in-house and issue a report within five years. Fourth, it must collect data from specified federal agencies and "Federal, State, or private entities." Fifth, it may appoint advisory penels. Sixth, it must establish a methodology committee. Seventh, it must ensure that there is a peer-review process in place for its research. Eighth, it must share its findings with clinicians, patients, and the general public. Ninth, it must adopt the national priorities described with respect to the first duty, the methodological standards described with respect to the sixth duty, the peer-review process described with respect to the seventh duty, and the dissemination protocols and strategies developed with respect to the eighth duty. Tenth, it must take steps to avoid duplicating research conducted by other public and private agencies and organizations. Eleventh, it must submit annual reports to the Congress and the President, making it available to the public.
The HCCERI would be directed by a Board of Governors, and the statute elaborates on how its 21 members would be selected, not only in terms of constituencies but also in terms of "diverse representation of perspectives" and considerations, though not elimination, of conflicts of interest. Members of the Board would be compensated. The Board would be authorized to hire a director and other employees, to retain experts, to enter into contracts, to provide expense reimbursements, and to issue rules and regulations for operation of the HCCERI. There would be financial oversight by a private sector auditor and the Comptroller General, who would be required to review a variety of information with respect to research priorities and funding. Procedures would be established to ensure transparency, credibility and access, through public comment opportunities, forums for public feedback such as the media and web sites, and disclosure of the process and methods for conducting its research and other information.
So we will be paying for the establishment of another bureaucracy, a rather elaborate one that will conduct research into the efficacy of various medical treatments, but only if it does not duplicate what the private sector and other federal and state government agencies are researching. I suppose there are medical diseases and conditions with respect to which no one is researching the effectiveness and cost efficiency of available treatments. Surely there are private sector organizations, and existing government agenices, looking at the best ways to treat heart disease, various types of cancer, diabetes, tennis elbow, migraine headaches, drug and alcohol addiction, depression, athlete's foot, broken bones, concussions, insect bites, and just about every other medical problem other than, perhaps, the diseases for which the so-called orphan drug credit was designed to alleviate. The proposed legislation does not mention any specific medical illness or condition, so it's rather difficult to figure out what this legislation really is designed to accomplish. It's not as though it is designed to reduce or eliminate Medicare fraud or medical profession malpractice, in which case it would be contributing to the preservation of the free aspect of a free market. It's not as though it is designed to evaluate new pharmaceuticals, because an agency already exists that does that.
Before deciding if it makes sense to impose a tax, or fee, the nation must understand what that tax or fee would be funding and why whatever would be funded needs to be funded. Whether the imposition is called a tax or fee doesn't answer those primary questions. Again I invite the Congress to explain what truly is going on with respect to this proposed legislation.