Healthcare Policy

Health Care 2008: Where Do the Candidates Stand? Part 1-Clinton and Guliani

January 2, 2008

election08.jpgWelcome to the first post of our newest series. In this series, we’ll try to cut through some of the media hype and summarize the health care proposals put forward by the leading candidates for President.

Commentary by Aaron Lord MD, PGY-1, and Zackary Berger MD PhD, PGY-2, Health Care Policy Section Editor

Post # 1: A Subway Series

First up in this series are New York’s Hillary Clinton (D) and Rudy Guliani (R). We’ll devote more space to Clinton’s plan because hers offers more specifics.

Hillary Clinton (D)
Clinton would require every individual to choose an insurance plan. Anyone could keep their current insurance if they were satisfied with it. Two other choices would be available: a menu of private options offering the same benefits that members of Congress receive, the other a Medicare-style public plan. Tax credits would be offered to working families to make it easier for them to afford insurance.

How would this be paid for? The details aren’t spelled out, and this is where the complications come in. (See the detailed analysis of Clinton’s plan at the blog Health Care Policy and Marketplace Review.) In particular, the Clinton plan predicts that “most savings [will] come through lowering spending due to quality and modernization.” As Robert Laszewski of the Health Care Policy blog says, this could be Clinton’s most dangerous assumption. If quality and modernization cannot ensure savings by themselves, if providers and payers cannot agree on cost-limiting measures, if more taxes on the higher brackets (i.e. the rich) will not be enough to balance the books (as Clinton assumes), what will happen to the Clinton plan?

Alongside Clinton’s individual mandate for health insurance, there are requirements for other participants in the system. Insurance companies “will end discrimination” and “ensure high value,” while “drug companies will offer fair prices”; providers will work collaboratively to deliver high-quality, affordable care; “large employers” will be expected to provide health insurance or contribute to the cost of coverage (small employers will receive a tax credit to offer coverage, or start doing so).

What “fair prices,” “high quality,” and “large employers” are supposed to mean has been a source of debate even before the first Clinton health plan. How will affordable coverage be mandated when some estimates place the cost of family health coverage at $12,000 per year? If twenty-five employees is the cutoff definition for “large business” (as the Clinton campaign has indicated), what would smaller businesses be required to provide?

Rudy Giuliani (R)

The main component of his proposal is “an income exclusion of up to $15,000 for those without employer coverage to make insurance more affordable.” This would make buying insurance fairer for those who do not have access to employee-sponsored coverage (who must currently purchase their coverage with pre-tax dollars). Under this plan, individuals would move from employer-sponsored plans to individually purchased private plans, making for a freer market of health insurance. His plan would also establish “a Health Insurance Credit to low-income Americans” to purchase health insurance; reform medical liability; streamline FDA approval of new drugs; invest in information technology, improve and expand Health Savings Accounts, and “infus[e] incentives in insurance markets…to promote healthy lifestyles and wellness programs.” Giuliani does not discuss in his proposal how these changes would be paid for.

Republicans and Democrats

Laszewski points out that “from thirty thousand feet,” all Democratic healthcare plans look the same: lots of new spending to guarantee access for all Americans to some sort of health care plan, whether public, private, or in between. Republican plans, for their part, tend to invoke individual mandates, a vibrant free market of competing health care choices, and technological efficiency. Informed consumers with the proper incentives would know to allocate their resources efficiently. (Whether Medicare Part D proves this assumption is open to question.) If Clinton’s health plan stakes out a centrist position in between these two, in what direction will the “sausage factory” of legislation push the finished product? Will Giuliani’s plan be enough for dissatisfied healthcare consumers? We’ll see . . . if they get that far.

Pay-for-Performance: The Future of Medicine?

September 26, 2007

dollar.jpgCommentary by Sandeep Mangalmurti MD, JD PGY-2 

“Pay-for performance” is the broadly encompassing term used to describe recent efforts to restructure physician compensation so that rewards are commensurate to performance. Initially limited to small pilot programs, pay-for-performance has rapidly expanded over the past decade; currently over half of all HMOs have implemented some form of it1, and plans are underway to introduce pay-for-performance measures into Medicare and Medicaid2.

There are various versions of pay-for-performance, and each presents its own advantages and disadvantages. The “traditional” version is also the most intuitive: compensate providers who keep costs down. One of the most common ways this is done is to give providers a monetary reward for limiting referrals to specialty providers. However, many physicians feel that incentive plans of this structure can compromise patient care by placing selective pressure on providers, and prefer a system that rewards for patient satisfaction instead3. In addition, paying physicians to reach a fixed common target may simply reward providers with higher levels of baseline performance instead of inducing improvements in care or efficiency.

Another version of pay-for-performance is more correctly thought of as “pay-for-participation.” Instead of direct individual rewards for individual performance, providers are compensated for participation in larger collaborative activities designed to improve outcomes. Providers receive regular feedback on their performance from peers, and then work collaboratively to improve efficiency, as well as collective morbidity and mortality. A highly effective program in interventional cardiology is currently in place in Michigan, with resultant improvements in mortality and post-procedure complications4. The major disadvantage, and a major point of contention, is public disclosure of provider performance. As expected, providers are strongly opposed to public reporting, and contend that disclosure results in avoidance of high-risk patients, and hinders open collaboration5. Others counter that public reporting helps create incentives for quality improvement and accountability6.

For surgical procedures, pay-for-performance presents unique challenges, as surgical outcomes are often more difficult to fairly quantify and compare. In response, a model based on “Centers of Excellence” has developed at sites nationwide, involving identifying and funneling patients towards hospitals and providers with proven track records of high quality care. One example is the Leapfrog Group, a consortium which has developed evidence based referral practices for five surgical procedures, based on risk-adjusted mortality rates, process measures, and minimum procedure volume7.

Read more »

Medicare Changes and their Implications

September 18, 2007

unclesam.jpgCommentary by Zackary Berger MD PhD, PGY-2

A recent article in the New York Times publicized changes in Medicare subsidies. In the article’s own words, “Medicare will no longer pay the extra costs of treating preventable errors, injuries and infections that occur in hospitals, a move [that] could save lives and millions of dollars.” This change was widely discussed, no less so in our hospitals.

But the devil is in the details. What is a preventable error? How was the list modified, and whose idea was this in the first place? What are the implications for our daily practice?

To understand, return for a moment to 2006. Among the notable events of last year was the passage of Public Law 109-171, a huge budget bill. Section 5001 (Hospital Quality Improvement) mandated that Medicare modify its payment system to take into account conditions that “could reasonably have been prevented under evidence-based guidelines.” More particularly, Medicare was ordered to identify ICD-9 codes for conditions that are (a) common or expensive; (b) associated with cost increases in a given case; and (c) reasonably preventable.

Through 2006 and 2007, Medicare solicited public comments about which conditions to include. No explicit definitions of prevalence, cost, “evidence-based,” or “reasonable” were specified in the law. Evidence-based medicine, in this case as well as in general, meant whatever expert opinion says it does.

After all was said and done, many conditions were included in the final list: infections from urinary catheters, infections from central venous catheters, pressure ulcers, objects left in the body after surgery, air embolism, injuries from blood incompatibilities, mediastinitis as a complication of heart surgery, and falls.

Even more interesting, perhaps, are the conditions which did not meet the specified criteria: surgical site infections, ventilator-associated pneumonia, Staph aureus bacteremia, methicillin resistant Staph aureus infection, deep venous thrombosis, and Clostridium difficile colitis. While several of these will be considered in future years for inclusion on the “do-not-reimburse” list, they weren’t listed this year for a variety of reasons. In the case of ventilator associated pneumonia, a consensus definition of the condition itself is lacking. While Staph aureus infection and MRSA are certainly prevalent, without widespread screening (a strategy that some advocate) before admission, it is difficult to know whether the bacteremia was present before the patient came to the hospital. Similarly, only routine admission screening would establish whether DVTs found in the hospital are new or old. C. difficile colitis is a difficult case both because C. difficile is a prevalent organism in the healthy population, and because the colitis is often not preventable – just the opposite, because the antibiotics which place the patient at a greater risk are necessary for treatment.

How will this list of non-reimbursable conditions (and those which might be included in the list in the future) affect our current care? Unsurprisingly, institutions like our own will try and incorporate professional guidelines for the prevention of these conditions into their day-to-day practice. Which hospitals will try to get ahead of the game, and which of the conditions that are not yet non-reimbursable will they try to limit through systems-based initiatives? Stay tuned for new regulations in your mailbox.

Image courtesy of Wikimedia Commons

An Update on Domestic Violence

September 6, 2007

purple-ribbon.jpgCommentary by Sean Cavanaugh MD, Associate Editor, Clinical Correlations

Most doctors are aware that Domestic Violence, or Intimate Partner Violence (IPV), is a serious health care issue, but the statistics are still startling to most of us. Some surveys have reported that IPV affects up to 30% of women and up to 7.5% of men. These numbers are highly variable and depend on the type of survey being conducted and the population being surveyed. Actual report-statistics of IPV are widely acknowledged as seriously underestimating the prevalence of the issue. There seems to be a higher prevalence of IPV in couples of lower socio-economic status, but it is a public health issue that extends across all demographics and in significant enough numbers to require screening at clinical visits. The rates of IPV seem roughly comparable in homosexual and heterosexual relationships – with the qualification that the incidence of male victims may be higher in gay male relationships than in heterosexual relationships. The USPTF has stated that there is insufficient data to recommend screening in primary care settings, largely because the data is so variable and clear evidence of decreasing morbidity and mortality is lacking. This position has been criticized for possibly perpetuating the tautological problem of under-reporting and insufficient evidence, and almost all state health agencies recommend screening. Screening has been shown to increase disclosure and facilitate referral, and surveys indicate that most patients want their provider to inquire about IPV. Surveys have demonstrated that most physicians believe it is an important public health concern and warrants screening – but recent surveys have published that only 7% of women reported that they were asked about IPV at their clinical visits (JGIM). The question, then, is why are the rates of screening so low?

It is assumed that providers are often unaware of the extent of the problem or, more commonly, do not have the time to open what is recognized to be an important and time-consuming part of the interview. There is also evidence that providers are both not confident in their own ability to obtain information and not aware of what to do with the information that they might obtain. What is confidential and what must be reported? What interventions can be made?

There are standardized screening tools that can be used – but the most important thing for providers to remember is to ask. Routinely. Screenings should occur in private and with an effective translator. Primary care offices should have mechanisms in place to conduct these screenings (whether they are done by nurses or social workers or physicians) and information on resources ready to hand to their patients. If you have concerns about IPV but are unable to conduct a screening, it is recommended to note as much in the medical record. Because medical documentation can be used in court or even required to obtain appropriate social services, the medical record should be prepared carefully and should include at least the following:

– an assessment of patient safety and children safety (including presence or use of weapons)
– a medical history that includes a history of trauma
– an evaluation of mental health, including anxiety, depression and suicidality
– a physical examination with particular attention paid to descriptions of injuries

Read more »

The Discharge Summary: A Prerequisite for Quality Care

August 24, 2007

bellevue_hospital_1950.jpgCommentary by Cara Litvin MD, Executive Editor, Clinical Correlations

I frowned as my patient handed over some papers to me at a regularly scheduled follow-up clinic visit. For the second time in a row, he had been admitted to an outside hospital for syncope in the interval between his visits with me. The cryptic discharge summaries provided very little information about his work-up. “Follow-up with primary MD” was scribbled on the latest discharge summary, without any test results provided. My initial instinct was to be become angry at my patient for allowing this to happen, but fortunately my more rationale side quickly overcame me as I tried to explain the importance of obtaining detailed records to my patient and his wife.

A recent article in JAMA, “Deficits in Communication and Information Transfer Between Hospital-Based and Primary Care Physicians,” reviews this very issue. The authors of this article extracted data from both observational studies investigating information transfer at hospital discharge and controlled studies evaluating interventions to improve such transfers. Not surprisingly, despite the enormous role adequate communication plays in assuring the provision of quality of care, accurate data evaluating the transmission of information is limited.

A review of observational studies from audits of hospital discharge summaries is unnerving. Discharge summaries frequently did not identify the hospital physician (missing from a median of 25%), diagnostic test results (38%), and specific follow-up plans (14%). Legibility was a concern in 10-50% of the discharge summaries. Outpatient physicians estimated that their subsequent management was adversely affected in nearly one fourth of cases due to inadequate communication.

Eighteen studies evaluating interventions to improve transfer at hospital discharge were included for this review, yet few standardized outcomes were used, making these difficult to interpret. Many of these studies compared computer-generated with manually created discharge summaries and largely favored the computerized summaries.

Read more »

Health Care Reform: An Overview of Recent Proposals

August 9, 2007

611px-usseal.pngCommentary by Zackary Berger MD PhD, PGY-2 

In the political arena, reforming health care is continually a major domestic issue. It’s no surprise that the lead 2008 democratic contenders cite the same statistic on each of their websites, “Nearly 45 million Americans, including 9 million children, are without health insurance.” Moreover, on each of their sites, the candidates ambitiously describe plans that would provide universal and affordable healthcare for all Americans. Their tactics largely entail expanding Medicaid, holding employers more accountable to providing coverage, and lowering costs by modernizing healthcare.

The presidential candidates are not alone in their plight to reform healthcare. The true movers and shakers of reforming healthcare are professional organizations and advocacy groups, both of whom have inspired a number of solutions which can be organized into two broad categories, incremental or single-payer. The current democratic political candidates generally support incremental healthcare reform. A true single payer system would require an extreme change of our current system.

In a single payer system, universal coverage is provided by a single public agency that organizes health financing, yet care is still delivered by private providers. More recently, nationalized health care has garnered more attention by Michael Moore’s new documentary Sicko, which contrasts the US system with the universal health care systems of Canada, France, the UK, and Cuba. The advocacy group “Physicians for a National Health Program” (http://www.phnp.org) provides information about the benefits and practical implications of a single-payer health care system in the US. The list of members of its advisory board includes their organizational affiliations, but (as its name indicates) the group is composed of physicians, not medical organizations or professional societies.

Incrementalism is a less radical approach to healthcare reform and is supported by The National Coalition for Covering the Uninsured (NCCU), a broad-based coalition of a number of organizations, including the AMA, the American Hospital Association, the American Public Health Association, the American Academy of Family Physicians, pharmaceutical companies, insurance companies and other organizations. Given the divergent range of interests and philosophies represented by this list, it’s understandable that the NCCU’s plan involves a number of less wide-reaching improvements in the current system, including transparent pricing; personal Medical Savings Accounts; and the expansion of public programs to cover the very poor.

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$50,000: The price of a car or the price of life?

June 14, 2007

Commentary by Vlad Fridman MD, PGY-2

$50,000. This is the price of a new (and cheap) model BMW, and also a price the US government is willing to spend to prolong your medically trained (or everyone else’s for that matter) life by one year. Before describing why $50,000 was chosen it’s necessary to describe what this number stands for.

For years, health economists have been struggling to determine a way to ration health care. Since resources are limited, who is to say which treatments should be offered, and who should get them? For example, what is more important: 10 males not living with impotence for a year, or a person staying in an ICU for 3 days? How about immunizing 500 children against measles? The numbers here are not exact, but you get the idea.

Economists solved this problem by inventing a measurement called the QALY: quality-adjusted life years. QALY technically equals: å Fidiki (Gerber and Phelps, 1997). However, for the non-mathematically inclined, one QALY represents one year in perfect health. The benefit of this system is that it incorporates both the length of life and the quality in health care calculations. The QALY can range from 0 to 1: if a person has to live without an eye or without a leg, the QALY goes below 1, if a person only lives for ½ year after an intervention, the QALY is 0.5. If a person will live for 3 more years, but with “½” of a quality of life, the treatment is deemed as having 3*0.5=1.5 QALYs.

Now, onto $50,000. In the United Kingdom, such a cost-utility analysis actually determines which treatments are offered. In 2005, the National Institute for Health and Clinical Excellence (NICE) is believed to have set a threshold about £30,000 (around $55,500) per additional QALY as the cutoff for what treatment costs are acceptable. In the US, the process is a little different. The policy of the US Public Health Service Panel on cost-effectiveness is that any threshold should be recognized as a guide to health care spending decisions, not a determinant of such decisions.

However, in many health economics papers, this threshold value is listed as $50,000 (Ubel 2003; McGregor, 2003). This value represents the approximate cost of one year of dialysis treatment. Under Medicare rules, renal dialysis is a federal entitlement to all United States citizens, and is thus considered cost-effective by US standards. As such, any other treatment that costs $50,000 or less per QALY is considered cost-effective as well.

Many economists see problems with this number. First, it really only represents a floor of a QALY expenditure, not a ceiling (McGregor, 2003), meaning, that if the US funds something that costs $50,000, it should fund everything below that, but not necessarily reject everything above it. Another problem with the QALY statistics is the QALY itself. How does anybody go about measuring this value? Usually, extremely sophisticated statistical models based on many variables and assumptions are used for such calculations.

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Clinical Commentary: The Travesty of Grinding Axes with Science: Rosiglitazone and Cardiac Risk

June 12, 2007

Welcome to our first blog commentary. One of the purposes of the blog is to generate discussion about issues in health care. This “Clinical Commentary” section is an invitation to our housestaff and faculty to submit their own thoughts and viewpoints on current issues. The views expressed in this section are soley those of the authors and do not necessarily represent the views of Clinical Correlations.

Commentary by Gregory Mints MD and Nirav Shah MD, MPH

The meta-analysis of Rosiglitazone’s effect on cardiovascular events by Nissen(1) had the effect of an exploding bomb in both the lay and medical media. Unfortunately, much of the ensuing discussion had relatively little to do with the quality of the paper itself (2), with disproportionate attention to the failure of drug safety oversight in general and to the attempts at assigning blame for it on the manufacturer of Rosiglitazone and/or the FDA(3, 4). It thus appears that the paper has become a political leverage tool in the fight over the future direction of drug oversight in this country. We contend that the concerns about the medication approval process in the U.S. and the impact of drug manufacturers on that process, however important and acute, should not interfere with objective analysis of the presented studies. We do not believe that the ends justify the means (i.e. wrong arguments are o.k. for the right reasons), but also think that politicizing the data interpretation is harmful to the cause of reforming the relationships among the FDA, the pharmaceutical companies and the consumers. Most of our thoughts on this issue came about in the discussions we had with the two other members of our faculty: Drs. Natalie Levy and Tanping Wong. It is our opinion that the meta-analysis in question is of extremely poor methodological quality, which precludes any meaningful interpretation of the data. We therefore believe that no change in current existing practice is warranted, a conclusion supported by a recent editorial in the Lancet (5).

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Conflicts of Interest

March 21, 2007

DollarThe debate about the ethically questionable relationship between physicians and the pharmaceutical industry opened up again this morning on the front page of the New York Times. Although the article is heavy on interview and anecdote and a little short on evidence, it is difficult to avoid casting a critical eye on this relationship. The impetus for the article is the new laws in a handful of states requiring drug makers to disclose all payments made to doctors. These laws have made public previously hidden relationships that many doctors have had with the pharmaceutical industry and the article highlights a number of physicians who engage in such relationships. The article opens with a discussion about Dr. Allan Collins the president of the National Kidney Foundation who has received significant criticism over the amount of money he has received from Amgen, the makers of Erythropoietin and Darbopoietin. Multiple doctors and former employees from the pharmaceutical industry are interviewed and quoted extensively regarding the potential bias found in not only in lectures given to doctors but even in the guidelines written to guide decision making. The slant of the piece is clear especially in light of the sections titled Unknown to Most Patients and A Silent Quid Pro Quo. Nevertheless, it is difficult to argue that the influence that the pharmaceutical industry holds over all of us is not problematic. There’s a certain skepticism that flows through many of us when we hear the terms such as pre-hypertension and pre-diabetes likely coined by a pharmaceutical industry hoping to increase the numbers of patients taking prescription drugs. For those physicians interested in the topic there is an excellent website that clearly shares the perspective expressed in the NY Times article: www.nofreelunch.org.

-Sean Cavanaugh, MD Associate Program Director NYU Internal Medicine Residency Program

References:

New York Times Article

Pharmaceutical Company Payments to Physicians: Early Experiences With Disclosure Laws in Vermont and Minnesota Ross.J et. al. JAMA. 2007;297:1216-1223.

Image Courtesy of Wikimedia Commons

The Vioxx Wars

February 23, 2007

vioxx 2Commentary By: Sandeep Mangalmurti MD, JD PGY-1

The continuing legal battles over Vioxx remain at the center of a fascinating intersection of law and medicine. Most physicians are well acquainted with the basics of the case, but like most complicated health care issues, the deeper one probes, the more interesting it becomes.

The Vioxx saga begins in 2000, with the VIGOR trial. (1) This study was a randomized control trial comparing the gastrointestinal toxicity of Vioxx to naproxen, and was notable for demonstrating an increased risk of myocardial infarction for users of the former. Merck (the manufacturer of Vioxx) contended that the increased risk of MI was not due to Vioxx, but instead reflected a decreased risk of MI due to the cardioprotective effects of naproxen. Nevertheless, based on the VIGOR study, the Food and Drug Administration sent a warning letter to Merck in 2001 accusing them of minimizing the cardiovascular risks of Vioxx. (2) In 2002, Merck was forced to alter its packaging to include a new warning label explaining the potential cardiovascular risks of the medication. (3) These issues came to a boiling point in September, 2004, when Merck voluntarily removed Vioxx from the marketplace after the APPROVe study demonstrated an increased risk of thrombotic events for those who had used Vioxx for more than 18 months. (4)

Then began the lawsuits….. Keeping track of the multitude of Vioxx trials is beyond the scope of this article. For up to date information, please refer to learnaboutvioxx.com, a Merck sponsored website that provides updated information on pending lawsuits, as well as the company’s official response to its critics’ accusations. Thousands of claims against Merck were dismissed prior to trial, but approximately thirty have made it to a courtroom. Many of these were eventually dismissed as well; so far Merck has successful defended about 9 of these cases. Four verdicts have been returned in favor of the plaintiff; needless to say, Merck has vigorously appealed these decisions. (5) Read more »

Medical Malpractice 101

January 19, 2007

Commentary By: Sandeep Mangalmurti, MD, JD PGY-1

For many physicians, medical malpractice is like paying taxes; inevitable, but incomprehensible.  This is unfortunate, since most physicians offer unique insights into the current debate on malpractice reform.  Hopefully this article will begin to familiarize the reader with the general landscape of current trends in medical malpractice law.

When a physician complains of the current “malpractice crisis,” the complaint is usually about rising premiums.  The concern is generally not only over their high cost, but their volatility.  Virtually every physician knows a colleague who has seen their premiums increase almost exponentially in a matter of years (or months!) for no discernable reason.  Take, for example, the case of general surgeons in Philadelphia, who saw a more than doubling of their premiums in less than 3 years. [i]  

Some may argue that the underlying cost to doctors (and insurers) is needed in order to adequately compensate those injured by physician negligence.  However, there is ample data to suggest that the current malpractice framework does an extremely poor job of compensating the injured, or punishing the negligent.  An ideal system is one under which every person injured by negligence receives compensation, at a level commensurate to either their injury, or the level of negligence.  Furthermore, under this system, every physician who commits negligence faces punishment in the form of lawsuits or increasing malpractice premiums, while those without negligence are not punished in any way. Read more »

As Power Shifts in Washington…

December 5, 2006

In the summer of 2002, I worked in DC for the Pharmaceutical Researchers and Manufacturers of America (PHRMA), which is an umbrella organization that represents the largest pharmaceutical companies.  It was the height of Republican power and PHRMA lobbyists were at the forefront of influencing the policy debate.   One of the crowning achievements of the Bush’s domestic policy was the Medicare prescription drug benefit.  Passed in 2003 at an initial cost of $534 billion over ten years, it is now projected to cost the government $1.2 trillion.   To put that in perspective, Americans have now spent more than $340 billion for the war in Iraq .  As physicians, we know it as Medicare Part D and it is a government run program that provides seniors with prescription drugs for reduced prices.  A major criticism of the bill was that the government was not allowed to negotiate lower drug prices like other buyers who buy drugs in bulk.  For instance, insurance companies negotiate lower prices with pharmaceutical companies. One government agency that does negotiate like this is the VA.  As a bulk buyer, the government would have the potential to bring down the cost of prescription drugs for the benefit of seniors.  PHRMA argues that having the government act as a single buyer would amount to price controls as the government would essentially dictate the price of prescription drugs, which would then be used by insurance companies to negotiate similar prices.  The Democrats will introduce a bill in the coming months that would allow the government to negotiate lower prices.  We’ll be following the progress of this bill at Clinical Correlations as it goes through Congress.  If you ever wonder how change occurs, following this bill would be a good place to start.  This article in the New York Times outlines the debate…

Khandwalla, R, As Power Shifts in Washington. Clinical Correlations Vol 3 #3  Dec 4, 2006