Friday, September 18, 2009

Health-Care Reform: A Center for Comparative Effectiveness Research is Redundant and Therefore Unnecessary

One legislative proposal for health-care reform in the US House of Representatives is to establish, through the Secretary of Health and Human Services in the Agency for Healthcare Research and Quality, a Center for Comparative Effectiveness Research (H.R. 3200: Division B, TITLE IV–QUALITY, Subtitle A–Comparative Effectiveness Research). This entity would be charged “to conduct, support, and synthesize research… with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically”. Furthermore, there will be an independent Comparative Effectiveness Research Commission “to oversee and evaluate the activities carried out by the Center [for Comparative Effectiveness Research]”. Moreover, the bill designates that funding will be allocated for and to be managed by the Center [“amounts in the Comparative Effectiveness Research Trust Fund (referred to in this section as the ‘CERTF’) under section 9511 of the Internal Revenue Code of 1986 shall be available, without the need for further appropriations and without fiscal year limitation, to the Secretary to carry out this section”]. It also establishes the fund (“For provision establishing a Comparative Effectiveness Research Trust Fund and financing such Trust Fund…”). Establishing these entities would divert precious dollars from and duplicate existing efforts.

Three critical comments about the proposed Center:
(1) Comparative Effectiveness is an alternate phrase for the existing medical practice of using Evidence Based Medicine in daily clinical decision making;
(2) The Center and attendant organizations will interfere with effective organizations presently in existence, e.g. the National Institutes of Health (NIH);
(3) Guidelines from the Center will be rigidly interpreted by Medicare and Medicaid personnel (based on near universal previous experience of physicians) with the egregious result of reducing patient-physician autonomy thereby negatively impacting our flexibility to manage patients on an individualized basis.

The NIH’s mission statement is quite clear –
“….[to realize its goals] the NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research:
• in the causes, diagnosis, prevention, and cure of human diseases;
• in the processes of human growth and development;
• in the biological effects of environmental contaminants;
• in the understanding of mental, addictive and physical disorders; and
• in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists”.

Within NIH’s purview are the funding and overseeing of clinical trials (testing new treatments and procedures with sound and ethical research methods) and determining best treatments (outcomes research).

Other Existing Oversight
In addition to the NIH, independent professional medical societies (e.g. American College of Physicians-Internal Medicine, American College of Surgeons, American Psychiatric Association, American Academy of Pediatrics, et al) establish diagnostic, treatment and follow-up guidelines for specific diseases. Furthermore, these guidelines are based on best available evidence (equivalent to “comparative effectiveness”) and expert opinion.

So who is asking for the Center for Comparative Effectiveness Research? Other than the authors of the legislation, the answer is not all that clear. The request for this Center certainly does not emanate from physicians, scientists or research administrators. It appears that this legislation is nothing more than a further attempt at outside control of medical practice with the (un)intended consequence of reducing autonomy of patients, clinicians (practicing physicians) and clinical investigators. This reduction in autonomy will negatively impact our flexibility to manage patients on an individualized basis. How so? With guidelines for medical practice mandated by the Center more rigidly interpreted by Medicare and Medicaid (one size fits all approach), individual patient differences cannot be incorporated into clinical decision making. Think this doesn’t happen now? It recently happened to me regarding the cancer pain management of a patient of mine insured by Medicaid. It can only get worse with establishment of the proposed Center.

If there are gaps in existing (e.g. NIH’s) health-care missions, then rather than create another level of bureaucracy let’s make programs like the NIH more robust by expanding and solidifying its critical mission for Americans. Though a well-meaning proposal, establishing a Center for Comparative Effectiveness Research and its attendant organizations (Comparative Effectiveness Research Commission and Comparative Effectiveness Research Trust Fund) would duplicate existing efforts of successful programs, divert precious dollars from such work and reduce physician and patient autonomy.

This article may be downloaded from my website:

Saturday, September 12, 2009

Health-Care Reform: Progression From a Government Run Public Option to a Universal Single Payer Health-Care System–By the Numbers (US Population)

Health-Care Reform: Progression From a Government Run Public Option to a Universal Single Payer Health-Care System – By the Numbers (Analysis of the US Population).*

What will be required for the federal government to take control of health-care in the US? A majority stake in US health-care is the answer. The proposed government run public option (GoRPO) is the first step in the process. This is the only possible conclusion upon analysis of health insurance data later combined with the GoRPO.

The US Census Bureau considers four major categories for Americans with health insurance: Medicare, Medicaid (includes the State Children’s Health Insurance Program; SCHIP), employment based (private) health insurance (includes the Federal Employee Health Benefits Program [FEHBP] and Tricare [covers active duty personnel, retirees and their dependants]) and self-pay. In addition to Medicare and Medicaid, the federal government is also responsible for insuring veterans (VHA) and Native Americans (IHA). Insurance data from the US Census Bureau show that 111 million Americans have their health-care insured and managed by the federal government (Medicare, Medicaid, VHA, IHA), about 33% (see Figure 1). [Note: The US Census Bureau realizes that many individuals with Medicare also have other insurance, but such data are not available).

Though not managed directly by the federal government, the health insurance coverage for Tricare beneficiaries and participants in the FEHBP (approximately 9 million Americans in each of these groups for a total of 18 million insured) is actually paid for by the federal government. Since the government is responsible for paying the health insurance for these individuals, the federal government in effect controls their health-care because the government negotiates with the entities to manage the health-care of those enrolled in either Tricare or the FEHBP. That is, the health-care of those enrolled in Tricare and the FEHP is de facto government run health-care. Rather than account for these 18 million individuals under the employer based (private) health insurance category, it would be more appropriate to include them as a government program (along with Medicare, Medicaid, VHA and IHA). Consequently, this now brings the total number of Americans whose health-insurance is controlled by the federal government to 129 million, an increase to 38% (see Figure 2).

Regardless of the veracity of the number of uninsured considered to be 47 million by the administration and much of congress, we will use this number as it seems to prevail in many discussions and speeches. If we now insure the 47 million presently uninsured in the GoRPO, this brings the total number of Americans whose health-insurance is controlled by the federal government to 176 million, an increase to 46% (see Figure 3).

Now let’s suppose, not an unrealistic supposition at that, that about 10 million individuals (21% or approximately one-fifth) who pay for their own insurance (the self-pay category) realize they are eligible to participate in the GoRPO [a rather conservative estimate, actually]…. and they elect to participate. This now brings the total number of Americans whose health-insurance is controlled by the federal government to 186 million, an increase to 49% (see Figure 4).

Some have predicted, and I think correctly so, that many businesses will find it far less expensive to pay a fee to the federal government than to cover their employee’s health insurance. Let’s make a conservative estimate (guess, if you will) that of the 159 million presently receiving employer based insurance, 20 million (or about 13%) find themselves seeking and receiving health insurance through the GoRPO. This now brings the total number of Americans whose health-insurance is controlled by the federal government to 206 million, an increase to 54%; that is, more than half of the US population (see Figure 5).

With the government providing for the health insurance of over 50% of the population, it would be the major health-care stakeholder in the US. Such control would, without question, directly lead to (A) terms dictating how health-care is managed in the US, (B) [initially] a two tiered health-insurance system, and (C) [eventually] a single-payer universal health care system. That GoRPO is the first step leading us toward a single-payer universal health care system is appreciated by REP Anthony Weiner D-NY who supports such a health-care system for the US. Given the example of Medicare and in an effort to control costs, health-care rationing on a fiscal basis is only a matter of time. (See my essay titled: Health-Care Rationing - A Practical Construct).

*Abbreviations in Figures:
GoRPO – Government Run Public Option
FEHBP – Federal Employees Health Benefits Program
IHA – Indian Health Affairs
VHA – Veterans Health Administration

This article may be downloaded from my website:

Monday, September 7, 2009

Health-Care Reform: Lessons Learned – A Brief History of Medicare Legislation and Its Relevance to the Health-Care Reform Debate in the 111th Congress

The proponents of the rush to complete a health-care reform bill for the purpose of meeting an arbitrary deadline have failed to visit the congressional efforts and legislative chronology for enacting an earlier albeit much smaller health-care reform: Medicare. The take home lessons from a review of pre-enactment history of Medicare include: (1) take your time [8 years, shy one month, from submission of the Forand bill to the signing by President Lyndon B. Johnson of the 1965 amendments to the Social Security Act which contained the Medicare and Medicaid legislation]; (2) success is incremental (many fits and starts in the process); and (3) congressional hearings are an integral part of the process (at least 6 major hearings between 1957 and 1965).

Though proposals for government run health-care, including a nationalized health-care system, preceded the enactment of Medicare legislation by decades, the introduction of the Forand bill is a reasonable place to start as it was the first serious attempt toward Medicare and because the key players in the end-game were in position.

When President Franklin D. Roosevelt signed into law the Social Security Act of 1945, there was no health insurance clause in the legislation. He correctly diagnosed that such a clause was unpopular with Americans and inclusion should wait for a later time. His successor, President Harry S. Truman wanted to incorporate national health-care into his Fair Deal program. This approach proved unsuccessful; however, the seeds were sewn for limiting government assisted health-care to those eligible for Social Security (that is, over age 65).

After ten years, false starts and much push by the AFL-CIO* as well as others, on August 27, 1957 REP Aime J. Forand D-RI of the House Ways and Means Committee introduced H.R. 9467 (health-care legislation targeting Social Security beneficiaries only) to the 85th Congress. As this was submitted at the end of the session, nothing further was done until the next session when Congressional hearings were held in June 1958. The bill was re-introduced on February 18, 1959 by REP Forand in the next Congress (86th) as H.R. 4700. From March 14, 1960 the House Ways and Means Committee held extensive sessions in an attempt to amend the Social Security Act. The Forand bill was defeated twice in committee: first on March 31, 1960 and again, this time with a stripped-down bill (hospital only benefits), on June 3, 1960 – however, these were the first official votes regarding health-care legislation ever held by the Ways and Means Committee. Between these defeats, hearings were held by the Senate Subcommittee on the Problems of the Aged investigating issues related to the health-care of the aged – these hearings further clarified the plight of the elderly. During the presidential campaign of 1960, candidate SEN John F. Kennedy D-MA and others popularized the moniker “Medicare”, later attached to health-care proposals for the elderly.

Soon after, REP Wilbur D. Mills D-AR introduced another health insurance bill H.R.12580 (the Mills bill) on June 13, 1960; the bill offered a program for States to provide medical care to elderly considered “medically indigent” and who did not meet State criteria for welfare – this was not a fully fledged insurance program. Sponsored in the Senate by SEN Robert F. Kerr D-OK, the bill was modified and became known as the Kerr-Mills bill. The bill passed both the House and the Senate, the first time health-care legislation reached a floor vote in the Senate. This bill was signed into law September 13, 1961 (Public Law 86-778).

On February 13, 1961, SEN Clinton P. Anderson D-NM and REP Cecil R. King D-CA introduced hospital insurance bills as S. 909 and H.R. 4222 in the Senate and House, respectively; known as the King-Anderson bill, it covered some hospital and nursing home costs. Hearings on the bill were held during July and August. A compromise health-care amendment (Anderson-Javits [SEN Jacob I. Javits R-NY] amendment) was attached to a welfare bill (H.R. 10606) on July 17, 1962; this bill was tabled by the Senate. The following year, revised King-Anderson bills were re-introduced as H.R. 3920 and S. 880 (February 21, 1963). The House Ways and Means Committee started hearings on the King-Anderson bill in November 1963; these were completed in January 1964 after being interrupted because of President John F. Kennedy’s assassination.

After postponing action on Medicare in June 1964, H.R. 11865 (which included amendments to Social Security but without a health-care component) was introduced July 7, 1963 and passed by the House on July 24th. The Senate Finance Committee took up H.R. 11865 and began hearings on August 6. The Senate attached Medicare as an amendment to H.R.11865 and the bill passed September 2, 1964. By October 2, it was clear the House-Senate Conference Committee could not reach a consensus to address differences in the House (without Medicare) and Senate (with Medicare) versions of the bill.

As the first bills in the new year, the King-Anderson bills were re-introduced as H.R. 1 and S. 1 in January 1965. On March 23rd, the House Ways and Means Committee replaced the King-Anderson bill with H.R. 6675 (the Mills bill) which was passed by the house on April 8th. From April through June, the Senate Finance Committee held further hearings; the Senate passed the bill on July 9th. The House-Senate Conference Committee met for one week (July 14 – July 21) and resolved differences in the House and Senate bills. Over July 27th and 28th, the report by the Conference Committee was passed by the House and Senate and included two amendments to the Social Security Act: Title 18 (Medicare; Parts A and B) and Title 19 (Medicaid). On July 30, 1965 President Lyndon B. Johnson signed the bill into law – Public Law 89-87.

The present health-care legislation before congress has not been adequately vetted with the American people. One month (August 2009) of scattered Town Hall meetings cannot adequately substitute for extensive hearings required of such comprehensive legislative measures.

The April 1959 report from the Department of Health, Education and Welfare (predecessor of the present Department of Health and Human Services) to the House Ways and Means Committee contains a segment that is germane today:

In our society the existence of a problem does not necessarily indicate that action by the Federal Government is desirable. The basic question is: Should the Federal Government at this time undertake a new program to help pay the costs of medical care…, or should it wait and see [first if other options are effective]?

Eight years were necessary to enact Medicare from the time REP Aime J. Forand D-RI submitted his bill to enactment into law. Medicare has serious issues with cost containment in large part because of fraud and waste; not anticipated by proponents and Congressional authors. Do we want to repeat this error?

*AFL-CIO: American Federation of Labor-Congress of Industrial Organizations; this group is lobbying hard for the present congress to steadfastly keep the public option.

This article may be downloaded from my website:

Friday, September 4, 2009

Health-Care Reform: A Government Run Public Option is Not An Option

The administration and most health-care reform bills pending in congress propose a government run public option (GoRPO) for the purposes of insuring the uninsured and reducing health-care costs by providing competition (“making insurance companies honest”). Such a proposal is hardly the panacea it is touted to be.

This essay (in bullet format*) will explore:
 the reasons to reject a GoRPO,
 the logic behind a GoRPO,
 the pathway to a government run universal national health-care system,
 failure of the Massachusetts system, and
 alternatives to a GoRPO that will insure the uninsured and, through competition among private health insurers, reduce health-care costs.
[*The bullet format best serves the purpose of this discussion].

There are substantial reasons to reject a GoRPO:
 A GoRPO will eventually lead to a universal nationalized health-care program, changing the face of American medicine, with the resultant (un)intended consequences (to include, but not limited to: raising taxes, rationing, reducing medical innovations [technology and pharmaceutical], decimation of private medical practices).
 The cost of a GoRPO will be significant and won’t be “budget neutral” (definition of budget neutral: won’t increase the cost to the government). The Congressional Budget Office has recently refuted the administration’s claim of budget neutrality for establishing and maintaining a GoRPO. Moreover, generally missed is the administration’s oft repeated statement that proposed health-care reform will be “budget neutral in the first ten years”. What happens after the first ten years? [During its development, Medicare was predicted to be “budget neutral”; it is not].
 The Massachusetts system, a GoRPO on a smaller scale, is a failure.
 Non-government alternatives to a GoRPO exist.
 Medicare recipients will suffer as the government takes Medicare funds (cuts in reimbursements to health-care providers and hospitals rather than reducing fraud and waste) to support a GoRPO.
 A GoRPO will place additional burdens on all hospitals (community and teaching hospitals alike) because low reimbursements to health-care providers for Medicare/Medicaid and GoRPO (Medicare rates) participants will lead to these individuals seeking their health-care at emergency departments and teaching hospitals. This will be especially detrimental to academic hospitals as work effort for their teaching and research missions is deflected to take care of the additional patient workload.
 Medicare recipients will experience reduced access to health-care as more practices decline to see these patients due to further lowering of reimbursements (a result of funds diverted from Medicare for support of a GoRPO and other Medicare budgetary reductions). Worse, many rural Medicare/Medicaid recipients will forego seeking medical care as the travel expenses to city hospitals will be prohibitive.

What is the true logic behind the GoRPO?
 Medicare spending is out of control.
 The administration and many members of congress want to control Medicare/Medicaid expenditures.
 There are grave difficulties in controlling Medicare/Medicaid spending when:
(a) Medicare/Medicaid enrollees expect the same benefit coverage for state of the art services as individuals with private health insurance, and
(b) there exists in Medicare/Medicaid unchecked waste and fraud.
 Medicare and Medicaid costs can be reduced if the US government is the primary (or near majority) insurer of US citizens.
 The opening to this is the GoRPO.
 [Don’t believe me? REP Anthony Weiner (D-NY), among many others, would like a nationalized health-care program as part of the overhaul but he will accept a GoRPO because he understands this to be the open door to a nationalized health-care program (on MSNBC’s Hardball)].

So what would be the path from a GoRPO to a nationalized health-care program?
 Individuals without health-care insurance will participate in a GoRPO.
 A GoRPO will offer premiums lower than those of private health insurers.
 Individuals with health-care insurance will gradually migrate to a GoRPO.
 Some employers will find it less expensive to pay a government fee than to provide health-care coverage for their employees and these employees will find it less expensive to participate in a GoRPO than to self-pay for insurance coverage.
 Over time, a GoRPO will grow in size.
 Combined with other government run (or funded) health-care programs (Medicare [includes SCHIP], Medicaid, Veterans Health Administration, Indian Health Service, TRICARE, Federal Employees Health Benefit Program), over time the US government will be the single largest, if not the majority, health-care insurer.
 The only possible outcome will be effective government control of medicine through mandates to health-care providers (physicians, nurses, etc), hospitals and pharmaceutical companies.
 Health-care providers and hospitals will effectively be government employees.
 [I’m not the only person to reach this conclusion (health-care providers as civil servants). Paul Gigot, news journalist, has said as much (on FOX News’ FOX News Sunday) – the discussion panel unanimously laughed at the inherent and unambiguous truth in this conclusion].
Is this truly what Americans want?

Established in 2006, the Massachusetts universal health-care system has reduced the number of uninsured to 2.6% of the state’s population. The system is a failure in every other respect:
 The insured have difficulty finding physicians because many practices have limited the number of individuals the see with this insurance as the practices cannot survive if a large percentage of their practice is comprised of individuals with this insurance – this is a direct consequence of low reimbursements to healthcare providers. This result should have been no surprise to the architects of the Massachusetts plan – similar issues have existed (and continue) for Medicare/Medicaid patients. [Will the federal government mandate, by statute or financial pressure on individual states, that physicians will be required to accept these patients?]
 Because of the difficulty in finding physicians, many insured continue to visit hospital emergency rooms for their health care.
 The budget of the Massachusetts system is $9 billion in the red, i.e. not “budget neutral”. It is most reasonable to investigate the failures of the Massachusetts system before the federal government embarks on a similar system albeit on a much larger scale.

Are there credible alternatives to the GoRPO? Yes there are. Some ideas I favor:
Reduce costs: Allow all citizens to seek insurance across state lines.
Insure the uninsured: Establish not-for-profit participant owned health insurance cooperatives.
These alternatives will force insurance companies to compete and “keep them honest” without the need for a GoRPO. In other words, a GoRPO is not required to force competition.

This article may be downloaded from my website: