Showing posts with label Reports and Papers. Show all posts
Showing posts with label Reports and Papers. Show all posts

May 24, 2013

Personal Statement Draft #2

Earlier this year, I was told that I would be “irrelevant.” The physician who spoke those words cited numerous studies, stating, “Health care only contributes 10-15% to health outcomes and life span.” The remaining 85% stems from life circumstances that are out of a doctor’s control. In short, he wanted me to understand that “doctoring” is only part of the story.

While some would find this news disheartening, I see it as a challenge. Providing high quality care will require me to be both an excellent clinician and a physician-leader. I see no better vocation to meet this challenge than as an academic surgeon.

As an M3, I was enjoyed the intense connections my attending surgeons had with their patients. I eagerly sought to develop Dr. Johnson’s sincere compassion with his breast cancer patients, and Dr. Bradshaw’s knowledge base and technical competence in the operating room. Throughout the year, their mix of experience, procedural expertise, and kindness was unparalleled, leading me to consider the choice of surgery more seriously.

I elected to spend my sub-internship in rural General Surgery in Linville, NC. There, I met an elderly woman, Rose, who presented with stage IIA melanoma. She had been a patient at the Tate Clinic for 77 years. Her relationship with my preceptor, Dr. Tate, was special. His grandfather birthed her, his father removed her gallbladder, and now Dr. Tate would treat Rose’s cancer. Again I was inspired by the deep, meaningful relationships that surgeons developed with their patients, who were often objected to scary and terminal diagnoses. By the end of this rotation, I knew I wanted to pursue a career in surgery.

Dr. Tate and my other surgical preceptors were both role models and leaders. Through careful observation of their work, I have seen the value of leadership in the operating room and the clinic. Leadership as a core principal of success, and I have experienced its value as a student, a researcher, an EMT, and as captain of the UNC Men’s Swimming and Diving Team. During these last few years, I have begun to better understand the need for leadership in health care and policy.

Even with Medicare, Rose struggled to gain access to consistent primary care. Linville is in Avery County, which has one of the highest ratios of patients to PCPs, and ranks worst for clinical care in all of North Carolina. This is why I chose to pursue a Master of Public Policy, as a fellow at Harvard’s Center for Public Leadership. There, I have studied leadership in the classroom and the lab, and am currently finishing my Master’s thesis, which analyzes the role of reimbursement in hospital quality for the largest rural health system in North Carolina. During residency, I hope to continue these research interests in nontechnical skills and health policy.

My primary focus, however, is to become an excellent clinician, as all my role models are expert surgeons. I believe that academic surgery provides the best opportunity meet this goal, as well as the challenge I was presented earlier this year. “Eighty-five percent” is a daunting figure, but through practice, leadership, and good policy, surgeons can make an even greater impact on patients’ lives than they do today. I look forward to meeting this challenge every day as a surgical resident.

March 29, 2013

Op-Ed

I imagine myself as part of the first line of defense against disease. It’s an assumption that I have recently come to question.

As a medical student, I have learned much about treating illness, but how much does health care really have to do with health? As it turns out, not much. Health care contributes only 10-15 percent to a person’s overall health. Income level, access to higher education, where we live, whom we live with, our genetic make-up, job stress—factors such as these contribute the rest.

Since the famous “Whitehall study” in Britain revealed a link between work environment and health, researchers have continued to accumulate evidence on how life circumstances affect our well-being. A recent study in the American Journal of Public Health found, for example, that roughly 250,000 deaths a year can be attributed to the effects of not obtaining a high school diploma. That’s 50,000 more than the number who die each year from a heart attack—the leading medical cause of death in America.

There is broad agreement that medical care in America is too expensive. Medical bills are the cause for approximately 60% of all personal bankruptcy fillings. Health expenditures account for almost a fifth of our country’s Gross Domestic Product. Certainly we must reduce unnecessary health care spending, eliminate waste and fraud, and streamline medical care, all while improving quality. But maybe we should also try to prevent some of these costs from occurring. Maybe policymakers should redefine how they attempt to "bend the cost curve.”

If social factors affect over 80% of a person’s health, shouldn’t this be at the top of our conversations about how to achieve savings?

Doctors are waking up to the idea that education and social policy is our health policy, and policymakers should too. As Dr. Steven Woolf writes in the Journal of the American Medical Association, “The biggest threat to public health may come from funding cuts outside the health sector. Namely, budget decisions that affect basic living conditions – removing opportunities for education, employment, food security, and stable neighborhoods – could arguably have greater disease significance than disruptions in health care.”

Today, the sequester puts access to many social programs at risk. The Department of Housing and Urban Development estimates that 125,000 individuals and families could become homeless due to budget cuts. Hundreds of thousands of low-income families may lose access to WIC, a highly successful program that provides supplemental food and education to pregnant and breastfeeding women, as well as vital nutritional support to infants and children.

Many argue that we do not put enough emphasis on personal responsibility when it comes to health. In some ways, they are right. The foods we eat, the risks we take—these play a big role in health outcomes. But there are other things we cannot control. We do not choose to be born into a low-income family. We do not choose to lack access to nutritional food or be homeless as a child. We do not choose our genes. All of these factors play a larger role in our health than is commonly understood.

As a physician in training, I have learned much about the importance of “preventive medicine” – the concept that doctors should prioritize preventing disease instead of simply reacting to it acutely. This approach significantly enhances the quality of our health care dollars spent. The cost of a flu vaccine is trivial compared to the financial and emotional cost of a hospital stay for complications due to influenza.

North Carolina lawmakers should use this same preventive approach when addressing health care costs. They should focus on programs that reduce social disparities, promoting a healthier population that will have less need for avoidable medical care. Broad cuts to social programs only ensure higher costs down the line.

Time magazine recently featured Steven Brill’s stunning expose on the true cost of health care in America. While controversial in some respects, one cannot argue with the raw data: “We may be shocked at the $60 billion price tag for cleaning up after Hurricane Sandy. We spent almost that much last week on health care.”

Clearly it is time to give our state’s health care policy a dose of preventive medicine.

October 26, 2012

The CLASS Act and Long-Term Care

TO: Senator Kay Hagan (D-NC)
FROM: Robert Swendiman, MD MPP
DATE: October 26, 2012
RE: Demise of the Community Living Assistance Services and Supports (CLASS) Act

The CLASS Act program was an effort within the Affordable Care Act (ACA) to address the rising costs of long term care (LTC) for seniors and young workers with disabilities. Ultimately, the Obama Administration halted its implementation due to concerns regarding its fiscal sustainability. Unfortunately, in this political climate, new federal efforts to address LTC spending are likely to meet a similar end.

Financing Long-Term Care. As the cost of long-term medical care rises, both for public programs and individuals, lawmakers have sought ways to alleviate this financial burden. Medicaid now finances over 60% of this $208 billion annual price tag, and individuals pay about one-fifth of costs out-of-pocket. Approximately two-thirds of seniors will need some type of LTC in their lifetime, with services ranging from intermittent care in one’s private residence, to full-time observation in a nursing home or skilled facility. Given that fewer than 10% of all individuals 55 and older have private insurance policies for LTC, the CLASS Act was meant to serve as a voluntary, national insurance program that could attend to this growing financial risk.

With the goal of ensuring financial and personal independence for those with functional limitations in their daily activities, the CLASS program would offer all working individuals 18 and older the opportunity to purchase the LTC insurance, given a minimum yearly income of $1,200. Enrollees could collect a minimum of $50 as a daily benefit for LTC, which is about one-third the average daily benefit provided by similar insurance programs today. Premiums would be set based on 75-year cost projections to ensure solvency, and advocacy/counseling services would be established to aid individuals in LTC decision-making.

CLASS Program Limitations and its Demise. Due to a five-year vesting period, Congressional Budget Office (CBO) and the Centers for Medicare and Medicaid Services estimated that initial 10-year deficit savings would be $70 billion and $38 billion, respectively, though this trend would reverse in the ensuing years. However, the program’s sustainability was ultimately called into question, mainly due to the guarantee issue requirement and voluntary nature of the program. The concern was that patients who most needed the benefits would opt-in, and healthier patients would opt-out, also known as “adverse selection.” This, combined with the perceived modest benefit of the program, led the Secretary of Health and Human Services to send a letter to Congress, stating that the Administration did not see a viable path forward for implementation of the CLASS program at this time, and that implementation efforts would be halted.

“Fixing” CLASS. Thus, in addressing the question of paying for LTC through a federal program, the flaws that buried the CLASS program would have to be addressed:
  • Adverse Selection – It is vital to the program that those with pre-existing medical conditions are included, but is it possible to ensure that enough young and healthy individuals enroll to spread the risk? While some have suggested a universal mandate to purchase LTC insurance, this produces obvious political challenges.
  • Incentivizing Enrollment – Designing the program to require employees to “opt-out” would increase enrollment, but how would employers be incentivized to purchase this insurance? Without employer buy-in enrollment would remain low, as CBO already projects, estimating a 3% national participation rate.
  • Financing and Modest Benefits – The Secretary estimated that monthly premiums would rise to just under $400 a month, a figure that is unaffordable, especially given such a meager daily benefit ($50).
There have been a number of small tweaks proffered in order to revive the CLASS program, though implementation would be extremely difficult given the current political climate. Despite the President’s reelection, 51% of Americans still desire repeal of the ACA, with the individual mandate remaining exceedingly controversial. A mandate for LTC insurance has been proposed to account for adverse selection, but cost and popularity would likely hinder enactment. The income requirement could be raised to $12,000 in order to lower premiums; however, this would likely exclude many of the working-disabled, a key demographic target of the CLASS program, thus limiting access. The daily payout could be increased, while the duration of eligible benefits limited, but this poses similar concerns. Without a mandate, CLASS is unlikely to seriously address the LTC issues this country faces.

Next Steps. Given barriers to implementing a program like CLASS, one must seek other viable options to improve access to LTC. Two such solutions to consider would be 1) creating a private insurance market for LTC under the Medicare program, much like Medicare Part D for prescription drug coverage. This again would be a voluntary system, but one that could potentially obtain more visibility and better buy-in, especially with seniors. 2) Allow individuals to use a small portion of their Social Security benefits to purchase LTC insurance in the private market. Coupling LTC insurance with Social Security may allow better planning for future health needs. However, cost and access remain unknown considerations in both of these proposals.


References
  • U.S. Congressional Research Service. Community Living Assistance Services and Supports Provisions in the Patient Protection and Affordable Care Act (R40842; February 15, 2012), by Janemarie Mulvey and Kristen J. Colello. Text in: LexisNexis® Congressional Research Digital Collection. Accessed: November 5, 2012.
  • H. Stephen Kaye, Charlene Harrington, and Michell P. LaPlante. Long-Term Care: Who Gets It, Who Provides It, Who Pays, and How Much? Health Affairs, 29, no.1 (2010):11-21.
  • Terence Ng, Charlene Harrington, and Martin Kitchener. Medicare and Medicaid In Long-Term Care. Health Affairs, no. 1 (2010):22-28.
  • Howard Gleckman. Requiem for the CLASS Act. Health Affairs, 30, no. 12 (2011):2231-4.

October 12, 2012

Early Liver Transplantation in Acute Alcoholic Hepatitis

More than 16,000 Americans are waiting for a liver transplant, according to federal data from the Organ Procurement and Transplant Network. Only 6,000 organs are available a year and nearly 2,000 people will die waiting for one to become available. Should an alcoholic who is likely to die from liver cirrhosis in the immediate future be allowed an early transplant (i.e. prior to the required six months of abstinence), if she is commits to abstinence from alcohol and has family support to help keep her promise, even as thousands of others who have not abused their bodies with alcohol or drugs await a new liver?

We first must agree that there are circumstances in which human beings deserve a second chance. Mistakes are made, and we ought to have the opportunity to learn from them. If the mistake is egregious enough, we, as a society, invoke laws requiring restitution and punishment. When found guilty in a court of law, a criminal may pay a fine, provide community service, or spend time in prison (or sometimes a combination of all three). Only then can the person return to society as a free citizen. A former criminal may also be subject to a period of probation, during which the individual must prove she can adhere to the rules of society without recidivism.

There are also circumstances in which society determines that a criminal does not deserve a second chance to be a free citizen. In these cases, the criminal may be banished from society permanently, sentenced to prison for life or put to death. These offenses almost always involve intense violation of someone else’s bodily integrity, not one’s own. Applying this dichotomy, if one views alcoholism as a “crime” that involves “fault,” it is certainly not worthy of complete condemnation; alcoholics deserve a second chance.

Sometimes, that second chance at life is a liver transplant. If so, should all alcoholics not abide by some form of "penance," i.e., evidence of abstinence from alcohol, in order to be eligible for a transplant? In fact, the United States transplant system already includes this requirement. Patients must abstain for at least six months before they can receive a new liver. These six months are the required justification to become a "free citizen" again, and be accorded the same rights as other persons to "life, liberty, and the pursuit of happiness." Some will argue that despite this six month penance, despite the probation, reformed alcoholics still deserve to be treated as second class citizens in terms of priority for liver transplantation. It is their fault, so they should wait behind those who have not ravaged their bodies with alcohol.

While this argument may “comport with basic intuitions about fairness” (Wikler, 110), society generally discards the notion that personal fault should play a role in medical treatment. The medical community, in particular, has rejected this idea of “priority” based on fault entirely, believing that all patients deserve medical treatment regardless of whether or not they may have caused their own illness. Imagine an Emergency Room where physicians prioritize patient care in terms of “fault” instead of “need.” A doctor would be obligated to treat a patient with warts before an individual who is bleeding to death from a skiing accident. While the latter person had arguably knowingly engaged in a dangerous sport, can a lack of immediate treatment truly be justified? Few would argue so.

Some scholars also argue that social injustices account for many health injustices, and thus society cannot be completely exculpated. Daniel Wikler presents this view eloquently in Personal and Social Responsibility for Health, and it is worth noting that the belief that alcoholics are completely at fault for their illness is shaky at best. There are too many genetic and societal factors that contribute to this disease. Without a clear concept of “fault,” it follows that “need” is the only justifiable means of priority, despite limited resources.

Unfortunately with liver disease, sometimes six months of abstinence is a death sentence in itself. Patients with severe alcoholic hepatitis may deteriorate over days and weeks, not months. So if we agree that these patients are morally justified in obtaining a new liver after six months of abstinence, what of their dire prognosis? I believe there are two requirements for providing a new liver without strict adherence to the six month rule. The first deals with “intent.” The patient must state her intention to become or remain abstinent. If the opposite were true, the patient would never actually have completed the required penance in the first place. Therefore, a new liver would not have been transplanted, and would not be justified.

I would further argue that this patient population (those who are alcoholics, have less than six months to live, and swear abstinence) should be studied in terms of rates of recidivism. If 100% of these patients typically fall back into alcoholism post-surgery, then one could argue that early transplantation is not morally justified. However, if patients who meet these criteria are found to have similar rates of recidivism to those who were able to abstain for six months, there is no question that early transplantation would be moral justifiable. There is current evidence to support this argument. Thus, with the caveats of “intent” and that it would be prudent to study the population at hand, our patient with acute alcoholic hepatitis deserves a new liver.


References
  • Wikler, Daniel. “Personal and Social Responsibility for Health.” Public Health, Ethics, and Equity. Eds: Sudhir Anand, Fabienne Peter, Amartya Sen. New York: Oxford University Press, 2004. 109-134.
  • Mathurin P, Moreno C, Samuel D, et al. Early liver transplantation for severe alcoholic hepatitis. N Engl J Med. 2011;365(19):1790-800.
  • Brown RS Jr. Transplantation for alcoholic hepatitis—time to rethink the 6-month “rule.” N Engl J Med. 2011; 365(19):1836-8.

September 28, 2012

Understanding the Ryan Medicare Plan

TO: Senator Richard Burr (R-NC)
FROM: Robert Swendiman, MD MPP
DATE: September 28, 2012
RE: The Path to Prosperity Plan

While your joint proposal with Senator Coburn (R-OK) and Representative Ryan’s “Path to Prosperity” are both constructed around the concept of premium support for Medicare beneficiaries, there are key differences that warrant your consideration. Rep. Ryan’s plan places hard limits on future Medicare expenditures, by means of fixed annual caps on spending, which may expose seniors to higher out-of-pocket medical bills over time. The Path to Prosperity also raises the age of Medicare eligibility gradually over the next two decades. These effects should be weighed carefully in light of financial risk to current and future Medicare enrollees.

Cost Containment. Rep. Ryan's plan allows private insurance companies to compete with traditional fee-for-service (FFS) Medicare, mitigating cost growth through competition. The Path to Prosperity also establishes a new “Medicare Exchange,” overseen by the Centers for Medicare and Medicaid Services, where seniors can choose among a range of insurance plans (with traditional Medicare included as a choice). In the Exchange, the second lowest bid will determine the exact amount of federal premium support to individuals, estimated at about $7,500 per person in 2023. All plans must offer actuarially equivalent benefits to traditional FFS Medicare, though it is important to note that these benefits will not necessarily be the same. Individuals who choose higher cost plans will have to pay the difference in premiums, and those who pick the lowest cost option will receive a rebate.

In contrast to your proposal, the Seniors’ Choice Act, Rep. Ryan would limit the annual per capita premium support to match growth of nominal (adjusted for inflation) GDP plus 0.5%. If premiums rise faster than this rate, seniors will have to cover the excess expenses out-of-pocket (with some adjustment for income). This lower cap contributed to the loss of the bipartisan support of Senator Ron Wyden (D-OR), because it shifts more costs to seniors in the future. He had originally cosponsored a similar plan with Rep. Ryan, employing a 1% cap. In March, the Congressional Budget Office (CBO) evaluated Rep. Ryan's proposal against current predictions of Medicare spending. Using its “extended alternative fiscal scenario,” which more accurately predicts the political climate than an evaluation with no changes in current law, CBO estimated that traditional Medicare expenditures would increase from 3.25% of GDP today to 7.25% by 2050. In comparison, Rep. Ryan’s proposal would cut 2050 spending projections by a third, with Medicare representing only 4.75% of GDP.

With passage of the Affordable Care Act (ACA) in 2010, the Medicare Board of Trustees estimated an extension of the Medicare Trust Fund’s solvency from 2016 to 2024. Repeal of ACA, as proposed by Rep. Ryan, would reverse these dates; however, his plan would provide significant long term savings, and few believe Medicare would ever be allowed to “go broke” in the short run.

Financial Risk to Seniors. The primary concern with these hard caps on federal subsidies is that premiums will rise faster than nominal GDP plus 0.5%. Over the past few decades, the annual cost of health insurance per capita has risen approximately 2% per year faster than GDP growth. While competition within the Exchange and incentives for diminished utilization would help private plans lower costs, CBO in 2011 predicted that this scheme would still raise out-of-pocket costs for seniors over time. This is true for two reasons: first, private insurance plans have higher administrative costs and provider payment rates compared to traditional Medicare; and second, the federal premium support will grow proportionally smaller as medical inflation continues to surge.

CBO admits that its predictions contain significant uncertainties, and partisanship has steered the rhetoric concerning the merits and limitations of this approach. However, one thing is clear: with rapidly rising costs, along with fiscal uncertainties that surround the health care industry in general, the potential risk of cost-shifting medical expenses to seniors is real. This hard limit on spending is the fundamental difference between your Seniors’ Choice Act and Rep. Ryan’s Path to Prosperity.

Access to Care. Both your proposal and Rep. Ryan's plan would increase the Medicare eligibility age to 67, although the latter takes a more gradual approach. Medicare beneficiaries who are eligible prior to 2023 would remain in traditional FFS Medicare. Starting that year, the Medicare eligibility age would increase by two months each year until it reaches age 67 in 2034. CBO analysis projects that raising the Medicare age would cut total Medical spending in 2035 from five percent of GDP to 4.7%, a net savings of about $150 billion. However, many unemployed seniors would bear the cost of insurance themselves in those last two years, likely finding themselves either paying for expensive plans in the individual insurance market, or uninsured.

The Bottom Line. Like many current proposals, Rep. Ryan’s plan does little to change the underlying drivers of rising costs in the health care industry. The Path to Prosperity does, however, have a very strong emphasis on reducing federal Medicare expenditures, though it appears to expose seniors to more out-of-pocket costs in the future. These issues should be considered simultaneously when weighing support for this plan.

September 21, 2012

Breaking Down the New York Soda Ban

In my Ethics and Political Philosophy class, I had the opportunity to contemplate the following prompt... Recently, New York City made international headlines by banning sodas and other sugary drinks larger than 16 oz. from being sold in restaurants, on the street, etc. Can this sort of paternalism be justified in terms of political morality? Take a stand and defend it.

While pundits debate whether the now famous “soda ban” will improve the general health of the New York City citizenry, the merits of this law are defensible without employing arguments regarding social harm. With over a third of Americans categorized as obese, this legislation encourages residents to make health-conscious decisions regarding their diet (albeit in an unapologetic fashion). However, for this clear example of state paternalism to be justified, it must satisfy several conditions: the choice must be inherently “irrational;” there must be a demonstrated lack of information present; true choice must not be limited; and the state’s restriction must prevent serious and irrevocable harm.

We must first agree that choosing to become morbidly obese would be irrational. This is by no means an argument of aesthetics, but rather one of self-preservation. Research has proven that obesity is directly linked to high blood pressure, diabetes, heart disease, etc., and most Americans do not find these debilitating conditions desirable. These diseases are extremely costly, and they severely impair an individual’s quality of life. Excessive consumption of high-caloric beverages is a major contributor to the obesity crisis. Soda is not the only form of “empty calories,” but it is an obvious target for improving public health. As a physician in training, I was taught numerous ways of counseling patients about weight loss. First trick of the trade? Eliminate “liquid sugar,” which patients can do without changing the foods they eat. The proof? An extra-large Coca Cola from McDonalds is about one fifth of a person’s recommended daily caloric intake.

Some say, “Everyone knows sodas are bad for you.” I would suggest that advocates of this statement spend a few days in a family doctor’s office, where they will see just how wrong this assertion is. There is much confusion about how diet can affect our health, and even more denial about seemingly straightforward scientific data. But there are also structural reasons for the lack of good information about healthy choices. In the present case, the “default” size of sugary drink options at fast food chains is often 20 ounces. This is promoted as “normal,” and generally there are no choices smaller in the value meal. Such a marketing strategy immediately biases the consumer towards making an irrational decision; a “normal” person does not need over 200 calories in a drink at each meal (in the 1950s, the only drink size McDonalds offered was 7 ounces… have our bodily needs changed that much?!). While the soda ban does add a new limitation, consumers were already limited by their default options. Under the new soda ban law, consumers will have to make an active choice to opt out of the healthier option, back to the unhealthy, former status quo.

Yet, even if excessive consumption is irrational, and even if consumers have all the information needed to make an educated decision, isn’t how much soda I drink still my choice? Absolutely, and it is imperative to understand that consumers’ fundamental choices have not changed. At establishments affected by the soda ban, a citizen who wishes to drink 40 ounces of soda will still be able to purchase 40 ounces of soda (by purchasing two 20 ounce drinks). True, the transactional cost may rise, but choice has not been limited; the purchaser’s options have simply changed. In addition, large sodas will still be sold in grocery stores, vending machines, and at any institution that does not receive a health grade. Dairy drinks, fruit drinks, and alcoholic beverages will be, for all intents and purposes, spared. And the size of “diet” drinks will not be regulated in any capacity.

Some argue this legislation will not curb obesity rates in New York City. However, whether or not the ban works does not affect the original justification. Others argue that this ban sets a dangerous precedent. If the size of soda cups should be regulated, why not the ban sale of any burger over half a pound? Or ban the purchase of more than a hundred French fries at a time? I understand this concern, but this argument misses the point of the New York City legislation. Our country needs to be having this conversation. Obesity is killing this nation, both financially (in terms of health costs) and literally. New York City is not banning the consumer from drinking 600 calories; the law simply empowers consumers to ask themselves, should I drink 600 calories? We can still answer an emphatic “Yes.” But so long as people choose irrationally, one can argue that public policy can and should foster positive and educated decision-making. This law is not a limit on personal freedom; it provides a forum in which Americans can make healthier choices. The soda ban does this while still tipping its hat to political morality.


(see conditions as described by Thompson in Political Ethics and Public Office and Thaler and Sunstein in Libertarian Paternalism is not an Oxymoron)

July 29, 2011

Master Clinician Series - Diverticulitis

This morning I presented a case-study on "diverticulitis." At 0700, a Master Clinician Series was held where I led a discussion on one of my surgical cases: a patient who required colonic resection due to recurrent disease. In the standard 3 minutes, I presented the patient's chief complaint, history of present illness, past medical/surgical/family history, current medications, allergies, a systems review, and physical exam and laboratory findings. From there, the faculty led a discussion of the medical and surgical issues involved in this person's care. I obviously pulled out the pink tie and blue shirt for the affair (brings out my eyes), and I wrote a short little summary of diverticular disease for the class.

So. In an effort to chart my progress throughout my medical training, and to see how medicine changes in the years to come, here is my short little ditty on diverticulitis...

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When describing diverticular disease, it is important to first clarify a few terms. A “diverticulum” is an outward protrusion of the colonic wall. “Diverticulosis” simply comprises the existence of diverticula in the colon, and “diverticulitis” is active inflammation of these diverticula. The disease itself encompasses all three pathologies. Diverticula are usually formed in areas of weakness, caused by increased intraluminal pressure. These colonic projections are common: 30% of all individuals age 60 have diverticular disease, and the incidence jumps to 65% by age 85. The disease is found equally in men and women, although a preponderance of males are diagnosed with acute diverticulitis under the age of 40. Diverticular disease is almost exclusively left-sided in “westernized nations,” with perhaps only 1.5 percent of patients presenting with right-sided disease. This summary will briefly describe the pathophysiology, clinical manifestations and complications, and treatment of diverticular disease.

Pathophysiology. Diverticula develop near the vasa recta in the colonic wall. As the wall of the colon grows thicker with age (due to multiple dietary and hereditary factors), these weaknesses in the wall undergo greater and greater stress. Anything that increases intraluminal pressure will exacerbate the diverticula. As the colon thickens over time, pressure in the sigmoid colon becomes the greatest of any segment, since it’s lumen is the smallest in diameter. Diverticular disease is associated with a high fat diet, red meat consumption, and low dietary fiber intake (RR: 2.35 and 3.32 in different cohorts). High dietary fiber intake, resulting regular, large, and bulky stools, may normalize intraluminal pressure, and decrease the risk of hard stools that precipitate constipation and straining during defecation. However, it is important to note that “there is no clear correlation between constipation and diverticular disease,” due to the difficulty of designing an appropriate study for this association.

It is also important to note that use of alcohol, tobacco products, and caffeine does not increase one’s risk for diverticular disease. The presence of diverticula is inversely related to strenuous physical exercise: patients who exercise more are less likely to develop this disease. As a corollary, obese patients typically have a propensity for developing symptoms.

Diverticulitis, which results from inflammation of the diverticula, is due to micro- or macro-perforations along the bowel. Although fecaliths were initially thought to be the primarily etiology, the mechanism of injury actually involves erosion of the diverticular wall due to high intraluminal pressure or “inspissated food particles” (such as indigestible small nuts and seeds). After inflammation begins, necrosis of the bowel wall ensues, resulting in perforation. Depending on size and the surrounding anatomy of the perforation, a patient may present with different pathologies. Mesentery and nearby fat may “wall off” a small perforation; or, if the tear is near another organ, a fistula or obstruction may result. However, if the leaking contents are not well-contained, peritonitis can be a major complication. In these cases, generalized tenderness of the entire abdomen is seen.

Clinical Manifestations and Complications. While approximately 70% of patients with diverticulosis are asymptomatic, one out of every four may develop diverticulitis, and one out of ten will experience bleeding. These are considered the two major complications of diverticulosis. While symptoms such as “cramping, bloating, flatulence, and irregular defecation” may be present, “it is unclear if these symptoms are attributable to the underlying diverticulosis or to coexistent irritable bowel syndrome.” Left lower quadrant (LLQ) pain is the most common presenting symptom of diverticulitis in Western countries. Past history of similar episodes, nausea, vomiting, constipation or diarrhea, and urinary symptoms may help to narrow the differential diagnosis toward diverticular disease. LLQ tenderness, low grade fever, and mild leukocytosis may also be present. Hematochezia may be discovered in the patient history or physical exam. This is due to progressive injury to the surrounding vasa recta, leading to diverticular bleeding. Painless, self-limited rectal bleeding is a common manifestation.

There is also some evidence that diverticulosis may be associated with an increased risk of colon cancer; however, the line between these two diseases is blurred, as the risk factors that precipitate both diverticula and colon cancer are very similar.

Diagnosis and Treatment. History and physical exam are the primary tools when diagnosing acute symptomatic diverticular disease. Abdominal radiographs can be used to evaluate for free air in the peritoneum, but a CT scan with IV and oral contrast is the gold standard for diagnosis. “The sensitivity, specificity, positive, and negative predictive values of helical CT…were 97, 100, 100, and 98 percent, respectively, in a study that included 150 patients presenting to the emergency department with clinically suspected diverticulitis.” Since diverticulitis is a disease of the soft tissue, a CT scan allows for better visualization of bowel wall thickening, inflammation, and masses. In the non-acute setting, colonoscopy is the preferred approach, allowing for both direct visualization and biopsy.

Treatment recommendations depend on whether the disease is “uncomplicated” or “complicated.” Complicated diverticulitis includes inflammation with subsequent perforation, obstruction, abscess, or fistula. Conservative therapy of antibiotics and bowel rest (clear liquid diet, etc.) is currently recommended for patients with uncomplicated disease, and ciprofloxacin plus metronidazole are the medications of choice to target enteric bacteria. “Following successful conservative therapy for a first attack of diverticulitis, 30 to 40 percent of patients will remain asymptomatic, 30 to 40 percent will have episodic abdominal cramps without frank diverticulitis, and one-third will proceed to a second attack of diverticulitis.” Treatment of complicated diverticulitis or recurrent uncomplicated disease commonly requires surgical intervention. These cases should be managed on a patient to patient basis, with regard to differences in pathology and treatment goals.
  1. Young-Fadok T, Pemberton JH. Epidemiology and pathophysiology of colonic diverticular disease. In: UpToDate, Basow, DS (Ed), UpToDate, Waltham, MA, 2011.
  2. Acosta JA, Grebenc ML, Doberneck RC, et al. Colonic diverticular disease in patients 40 years old or younger. Am Surg 1992;58:605.
  3. Fischer MG, Farkas AM. Diverticulitis of the cecum and ascending colon. Dis Colon Rectum 1984;27:454.
  4. Young-Fadok T, Pemberton JH. Clinical manifestations and diagnosis of colonic diverticular disease. In: UpToDate, Basow, DS (Ed), UpToDate, Waltham, MA, 2011.
  5. Rao PM, Rhea JT, Novelline RA, et al. Helical CT with only colonic contrast material for diagnosing diverticulitis: prospective evaluation of 150 patients. AJR Am J Roentgenol 1998;170:1445.
  6. Young-Fadok T, Pemberton JH. Treatment of acute diverticulitis. In: UpToDate, Basow, DS (Ed), UpToDate, Waltham, MA, 2011.

December 17, 2010

Evaluating the Utility of Prehospital ETI in Adult Nontraumatic Out-of-Hospital Cardiac Arrest Patients: A Qualitative Review

Abstract
This qualitative review examines three retrospective cohort studies that evaluated endotracheal intubation (ETI) in nontraumatic adult out-of-hospital cardiac arrest (OOHCA) patients, as performed by paramedics in the prehospital setting. Studies were identified through a MEDLINE search, and three articles were discovered that compared intubation versus no intubation for these OOHCA patients with survival to hospital discharge as the measured outcome. Careful consideration and examination of these studies and their data supports the conclusion that ETI is associated with decreased survival to hospital discharge among adult nontraumatic OOHCA patients.

Introduction
Each year nearly 300,000 people with cardiovascular disease die from out-of-hospital cardiac arrest (OOHCA). For a quarter of a century, endotracheal intubation (ETI) has been the standard practice intervention for appropriate airway protection and subsequent ventilation during cardiopulmonary resuscitation (CPR) in the prehospital setting. Traditional CPR begins with securing a proper airway, breathing for the patient, and establishing circulatory support (commonly known as the “ABCs”). This mnemonic also establishes the initial priority and order of CPR interventions, although this priority has shifted in light of research demonstrating better survival in patients receiving chest compressions with minimal interruption (“cardiocerebral resuscitation” or CCR). The amount of time it takes to intubate a patient in the prehospital setting has been demonstrated to be significant, and thus the utility of ETI in OOHCA patients has been called into question. Today, intubating these patients remains a controversial topic, and the evolution of simpler advanced airway devices has fueled the fire for ongoing debate. The decrease in survival for OOHCA patients in trauma has been well defined, however studies exclusively comparing ETI with basic life support (BLS) airway management in nontraumatic OOHCA patients remain scarce. This paper reviews these few studies in a qualitative manner in order to discuss whether successful prehospital ETI affects survival in adult patients in nontraumatic OOHCA.

Methods
Search Strategy
A comprehensive MEDLINE search was used to identify a list of studies applicable to the focused clinical question. All potential articles were required to include ETI as the intervention and survival to hospital discharge as the appropriate outcome. The following MeSH criteria were searched in various combinations to generate a broad pool of potential articles: “prehospital,” “cardiac arrest,” “endotracheal intubation” or “intubation,” and “nontraumatic.” The search was limited to research written in the English language. Articles specifically examining ETI in OOHCA trauma patients were discarded, as well as those examining cardiac arrest intubations in the pediatric population (under 18 years of age). This search strategy identified three articles that met the criteria for this review.

Study Selection and Evaluation
Three retrospective cohort studies were identified. This study design was deemed appropriate for evaluating the clinical question, based on the accuracy of data collection and the possible ethical issues that a randomized-control trial (RCT) might pose in this setting. Patient care reports (PCRs) from Emergency Medical Services (EMS) records and/or hospital databases were examined by the three studies in order to synthesize data and evaluate survival outcomes. All three papers were published in 2010 and 2011, reflecting data that incorporated more recent CPR guidelines and standard practices. The ability to thoroughly analyze PCRs and hospital electronic medical records within the past few years allowed the three studies to be deemed a reliable method to answer the clinical question. A more comprehensive evaluation of each study follows.

Study Reviews
Studnek et al.
Summary. Acknowledging the growing research that shows CCR improves survival in OOHCAs, the authors sought to further investigate the advanced airway management of these patients. ETI may cause a significant interruption in chest compressions, and multiple unsuccessful attempts will decrease the amount of time that proper CPR is administered. Provider-performed unintentional hyperventilation (i.e. sufficiently raising intrathoracic pressure so that coronary perfusion is decreased) also remains a concern with advanced airway management. With this in mind, Studnek et al. retrospectively analyzed data from Mecklenburg County, NC, tracking OOHCAs that occurred between July 1, 2006 and December 31, 2008. Adult patients were excluded if they were involved in a drowning, electrocution, trauma, inter-facility transfer, or were pronounced dead on arrival (DOA). Patients were also removed if documentation did not provide the number of successful or failed ETI attempts during patient care. A total of 1,142 patients met the inclusion criteria. Of this group, 577 individuals (50.5%) were successfully intubated on the first attempt, 292 (25.5%) required multiple attempts, and 203 (17.8%) of the patients did not receive any ETI attempts.

Results. Of the 1,142 patients, 299 had prehospital return of spontaneous circulation (ROSC) and 118 (39.5%) survived to hospital discharge. Forty-eight (16.0%) had an unknown discharge status, and were thus conservatively classified as not surviving to discharge. It was determined that when comparing patients with one successful ETI attempt versus those with no attempts, the latter group of patients were 5.46 times more likely to survive to hospital discharge (95% CI = 3.36 to 8.90). This means that there is a 95% chance that when an ETI is not attempted, patients are between 3.36 to 8.90 times more likely to survive to hospital discharge than those who have received such an attempt. Despite this relatively wide confidence interval, the authors rightly concluded that there is “a negative association between prehospital endotracheal intubation attempts and survival from out-of-hospital cardiac arrest” (924). As survival is an important patient-oriented outcome, and since the confidence interval is statistically significant, these results were deemed substantial and the patient sample size adequate.

Discussion. It is important to note that management of OOHCA patients is one of the most difficult tasks in the prehospital setting. This complexity partly accounts for the substantial confounding variables that are present in all three of these retrospective cohort studies. Confounding factors include patient demographics (age, ethnicity), comorbidities (diabetes, infection), initial cardiac arrest rhythm, witnessed vs. unwitnessed arrests, presence of prearrival CPR, length of time from dispatch to arrival on scene, and time between arrest and 911 call, just to name a few. Studnek et al. attempted to account for some of these variables using regression analysis; however the confounding bias remains significant. This study demonstrated little selection bias, as all nontraumatic OOCHAs in the county were included in the study (with very specific and important exceptions). Since survival to hospital discharge was the clearly defined clinical outcome, and since it was contrasted a well-defined intervention – an ETI attempt, defined as “performing an intubation procedure by inserting the laryngoscope into the mouth, past the anterior teeth” – measurement bias was also minimized. However, ETI attempts were self-reported, thus there is indeed a possibility of misclassification of the intervention by the provider; this misclassification was most likely nondifferential, biasing the results towards the null, since there was no evidence or reasoning to suggest that different study groups would have an incentive to misreport their data. Measurement may also have been affected by the use of other advanced airway devices (e.g. King airway, Combitube) in non-intubated patients. This type of bias would be differential, as the effects of these techniques were not considered, and are unknown.

Several factors lend credibility to the study. The data was collected after 2005, which included the most recent American Heart Association (AHA) guidelines related to CPR and advanced cardiac life support (ACLS). Studnek et al. had the advantage of working in a county staffed with at least one paramedic on each ambulance, and with all firefighters having basic life support (BLS) and CPR certification (as did the other two studies). Also, if the discharge status or the medical record was unavailable, the patient was conservatively classified as not surviving to hospital discharge. This would bias the results towards the null, lending further credibility to the study’s conclusion. Generalizability, however, was scored lower due to the fact that most transports in Mecklenburg County occurred in the City of Charlotte. This should lead to shorter run times to scenes, and faster at-hospital arrivals. Thus it is difficult to assess the effectiveness of ETI in the rural setting.

Conclusion. Overall this study was fairly well-controlled as there was moderate accountability for confounding factors. The confidence interval was significant and the results were extremely patient-oriented and generalizable to the urban population. Score = 3 out of 4 (see Table 1).

Arslan Hanif et al.
Summary. The authors in this study sought to more clearly define the role of ETI in nontraumatic OOHCA adult patients; no one had compared ETI specifically against the use of the bag-valve mask (BVM), the most widely used airway management in basic life support. Arslan Hanif et al. retrospectively analyzed patient records from November 1, 1994 to June 30, 2008 from a 533-bed general hospital in southwestern Los Angeles County, searching for OOHCAs undergoing either airway management. Adult patients were excluded if they were involved in drowning, trauma, or drug overdose. DOA patients were not included since they were not transported to the hospital. A total of 1,294 OOHCAs met these inclusion criteria, and 55 (4.3%) of these patients survived to hospital discharge. A total of 1,027 (79.4%) patients were intubated, and 131 (10.1%) received BVM ventilation only. Five patients had incomplete medical records; three of these survived to discharge.

Results. It was determined that when comparing patients that were intubated to those only receiving BVM ventilations, the latter patients were 4.5 times more likely to survive to hospital discharge than those with ETI (95% CI = 2.3 to 8.9 – see Studnek et. al. results for explanation of terms), after adjusting for confounding factors. This analysis resulted in a p value less than 0.0001. This extremely small p value confirms the significance of the results, corresponding to a 0.01% chance that the null hypothesis (no difference between ETI and BVM in terms of survival) is true. Thus the authors concluded that “when compared to bag-valve-mask ventilation, endotracheal intubation was associated with decreased survival to hospital discharge among adult nontraumatic out-of-hospital cardiac arrest patients” (930). Since the results were statistically significant and survival is clearly a patient-oriented outcome, the sample size was deemed substantial and the findings significant.

Discussion. Arslan et al. also attempted to control for confounding variables. The authors adjusted for age, sex, race, notable past medical history (CHF, renal failure, MI, diabetes, etc.), and site of arrest (nursing facility, home), and rhythm upon arrival. Because past medical history specifically was controlled for, this study should score slightly better on adjusting for confounding bias, but the risk for bias remains significant due to collection of data since 1994. The AHA guidelines have changed substantially over the years, with more focus on compressions during CPR, and EMS practices have also advanced since the mid-1990s. Most of the OOHCAs in this study were pre-2005. Both of these factors would increase the amount of confounding bias present. This study had different exclusion criteria, although the two were comparable. All OOHCA patients were included (limiting selection bias), and since the non-intubated patients had a clearly defined intervention (BVM), the authors did a better job at controlling for measurement bias, specifically the differential type.

Other important considerations include the identification of patients with incomplete medical records. Statistical analysis demonstrated that inclusion of these patients would be insignificant to the findings, lending more credibility to the study. Generalizability, however, must be scored lower, as the study began in 1994 and was limited to an urban environment.

Conclusion. This study had moderate accountability for confounding variables, but did much better at controlling for measurement bias. The confidence interval and the p value were very significant, and the study was also patient-oriented with fair generalizability. Score = 4 out of 4.

Egly et al.
Summary. The authors noted the growing literature documenting adverse neurological outcomes and survival rates in trauma OOHCAs, and so decided to retrospectively study the outcomes of nontraumatic OOCHCAs in adult patients. Data was collected from a large tertiary care center in suburban Royal Oak, Michigan from January 1, 1995 to December 31, 2006. The authors noted that these cases would not have been significantly affected by the 2005 AHA guidelines. Patients were excluded if there was ROSC upon immediate defibrillation on scene, unknown age or intubation status, a traumatic origin of arrest, or if the patient was DOA. Egly et al. took the analysis one step further, dichotomizing patients with “shockable” rhythms (ventricular fibrillation and ventricular tachycardia, VF and VT respectively), and “non-shockable” rhythms (asystole and pulseless electrical activity), with survival to discharge still as the primary outcome. Ultimately, 1,515 total adult OOHCAs were examined, with 1,220 (86.2%) being intubated, and 93 (7.0%) surviving to hospital discharge.

Results. Of the 1,220 patients who were intubated, 75 (6.5%) survived to hospital discharge; of the 194 patients not intubated, 18 (10.0%) reached the same outcome. The authors concluded that “survival to hospital discharge was no different between the intubated and nonintubated groups (6.5% vs. 10.0%, p = 0.09)” (45). This corresponds to a 9% chance of rejecting the null hypothesis (no difference in survival between the two groups) when it is actually true, and thus these findings were deemed to be not significant (p values < 0.05 are often used an indicator of statistical significance). However, in patients with a VF/VT rhythm, patients who were intubated were less likely to survive to discharge (OR = 0.52, 95% CI = 0.27 to 0.998). Interestingly, patients who presented with a non-VF/VT rhythm were 2.68 times more likely to survive to hospital admission (OR = 2.68, 95% CI = 1.04 to 8.43), but they were no more likely to be discharged alive than their counterparts. Concluding that ETI correlated with a decreased survival rate to discharge for VF/VT patients, with a statistically significant confidence interval, these findings were deemed substantial and the patient size adequate for this conclusion.

Discussion. As in the previous two studies, the authors made a strong attempt to control for confounding variables. They specifically controlled for demographics, arrest location, bystander CPR, and arrest rhythm. Adjusted odds ratios were used, but the confounding bias that is inherent in retrospective cohort analyses remains significant. Including only patients that received ACLS with pre-2005 AHA guidelines worsens this bias. Again, similar exclusion criteria were used for choosing the patients. Egly et al. removed all selection bias by including all adult OOHCAs within the time frame in the study, and as with the previous two studies, measurement bias was minimized. Like Studnek et al., however, measurement bias may have been affected by the use of other advanced air devices in non-intubated patients (differential bias). The sample size was larger in this study, and the suburban environment may have increased the number of distant transports, lending credibility to the findings. Nonetheless, this observation is simply speculation. If true, it would increase the generalizability to the rural population, though overall generalizability is hindered by the use of pre-2005 AHA guidelines.

Conclusion. This study was moderately accountable for confounding variables, and other biases were adequately well-controlled. The p value demonstrated minimal correlation between ETI and decreased survival, except for in patients presenting with a VF/VT rhythm. Score = 3 out of 4.

Discussion
The results of this systematic review lead to the conclusion that ETI in adult nontraumatic OOHCA patients is negatively correlated with survival to hospital discharge. Some evidence suggests that this may be particularly valid for patients with a prehospital ventricular fibrillation or ventricular tachycardia rhythm. The three retrospective cohort studies were all conducted in the appropriate setting, with adequate sample size. Selection bias in all three was essentially zero, as each study used all the identifiable patients within similar exclusion criteria, and no research team was able to control for the confounding bias present in the study design (although valiant attempts were made). The major difference among the studies was the ability of Arslan Hanif et al. to control for added measurement bias by clearly dichotomizing the interventions: ETI vs. BVM. Use of a King Airway, Combitube, or other advanced airway device would have unknown effects on the data. For this reason, when summing the internal validity, generalizability, and relevance, Arslan Hanif et al. scored a 4, while Studnek et al. and Egly et al. scored a 3. All three studies, however, were well-controlled, had reasonable generalizability, and measured a very important patient outcome: survival.

Limitations
It is important to note that with only three studies in the literature, further research on the subject is needed. Randomized-controlled trials would be the better study design, and would be able to account for the many confounding biases that were present in these studies. This would give a better assessment of risk and benefit of ETI in this patient population. Also, all three authors admitted that they could not account for the lack of ETI in some patients. Why did some patients received ETI and others not? This is a curious finding and should be explored.

Conclusion
The results of this qualitative review lead to the conclusion that ETI in adult nontraumatic OOHCA patients is negatively correlated with survival to hospital discharge. Some evidence from the examined studies suggests that this may be particularly valid for patients with a prehospital ventricular fibrillation or ventricular tachycardia rhythm.


Studnek JR, Thestrup L, Vandeventer S, Ward SR, Staley K, Garvey L, Blackwell T. The association between prehospital endotracheal intubation attempts and survival to hospital discharge among out-of-hospital cardiac arrest patients. Acad Emerg Med. 2010;17(9):918-25.

Arslan Hanif M, Kaji AH, Niemann JT. Advanced airway management does not improve outcome of out-of-hospital cardiac arrest. Acad Emerg Med. 2010;17(9):926-31.

Egly J, Custodio D, Bishop N, Prescott M, Lucia V, Jackson RE, Swor RA. Assessing the Impact of Prehospital Intubation on Survival in Out-of-Hospital Cardiac Arrest. Prehosp Emerg Care. 2011;15(1):44-9.

(other sources and tables available upon request)

December 10, 2010

Memorandum to the President on Tort Reform

Controversy surrounding the passage of the Patient Protection and Affordable Care Act (“Affordable Care Act”; “ACA”) has not abated. Despite important improvements addressing quality of care and access issues in our health care system, many Republicans continue to challenge the new health care law, arguing that the American people support their efforts. Many cite impressive gains in the midterm elections and new GOP control of the House of Representatives as evidence for dissatisfaction over health care reform. Some members of the GOP have called for “repeal and replace,” an effort to overturn the current law and pass legislation aimed improving health care through more conservative means. While “repeal and replace” may be unrealistic in the next few years, additional health care legislation and/or compromise with Republican leadership on certain issues could prove politically beneficial.

Republicans have cited medical malpractice (tort) reform as an area for significant savings and quality improvement in our health care system. Although the Affordable Care Act provides funding for state demonstration projects aimed at innovation and developing alternatives to the current medical liability system, little else in the law addresses tort reform (ACA: Section 10607). Republicans are likely to call for more significant reforms to the current system in the new Congress. Working with the GOP to solve the country’s ongoing health care woes could be viewed as a bi-partisan attempt to help restore the American people’s faith in Washington politics.

The goals of medical malpractice reform are to improve patient safety, quality of care, and contain this country’s sky-rocketing health care costs, while legally protecting the patient against medical negligence. Negligence may be defined as conduct “which falls below the standard established by law for the protection of others against unreasonable risk of harm” (Cohen 2006: 2). Since the Commerce Clause of the Constitution allows Congress to regulate medical malpractice (Cohen 2006: 2), this memorandum seeks to address national tort reform in the context of working with Congress to pass legislation addressing these aforementioned goals. A summary of the current advantages and disadvantages of the system is provided, major options considered, and recommendations offered in light of recent research and the current political climate.

Medical Malpractice in the United States
Exactly how much medical malpractice claims and torts contribute to rising health care costs is controversial. With expenditures in 2008 totaling around $2.6 trillion, many experts, including the nonpartisan Congressional Budget Office (CBO), find little evidence supporting the notion that tort reform would have a “measurable impact on health care spending” in relation to the overall costs of health care in the United States (Webel 2009: 2; CBO 2008: 154). A CBO analysis of individual state savings due to medical malpractice reforms did not find significant spending reductions, seeing maximal savings of only 4-6% (Webel 2009: 2); others considered even these estimates generous (Thomas 2010: 1578). Yet for decades tort reform has continually remained a hot button political issue. Why?

The answer lies in the cyclic nature of insurance, i.e. the waxing and waning of “hard” and “soft” markets, and the effect of premiums on providers. When investment returns are good and payouts on claims are low, insurance companies are able to offer lower premiums to their clients. However, when investment returns are low and/or when payouts become burdensome, higher premiums are the only means an insurer has to recoup losses. Withdrawal from coverage can occur and companies may go out of business if increased rates do not generate adequate revenue. In health care, premiums may vary depending on specialty or geographic region, but insurers are also rarely immune to the cycle. The most recent “hard” market began in the late 1990s. In 2002, rates increased for providers around 22.5%. By 2008 rates began to fall again, decreasing by 4.3%. (Webel 2009: 3-10).

If investment returns determine an insurance company’s revenue, then the tort system determines their payouts; this is the driver for an insurer’s financial losses and risk adjustment. Viable threats and successful lawsuits can result in compensatory damages awarded to the plaintiff, which can include economic and non-economic compensation. The former provides for plaintiff damages due to fiscal losses such as uncollected wages, while the latter may include recompense for emotional suffering and hardship. The defendant also may be subject to punitive damages, specifically aimed at punishing the physician for negligent behavior. With rising costs and the possibility of lifetime economic compensation for egregious errors, medical malpractice rates have increased dramatically; the added unpredictability of the non-economic and punitive damages adds further instability to the medical insurance system. (Webel 2009: 5-6).

Clamor for tort reform is loudest during these “hard” markets. With reports of physicians retiring or moving to areas with lower premiums, patients fear the inability to access physicians and proper care (Webel 2009: 1). High profile tort cases have fueled this fire. Yet even during years of relatively lower malpractice insurance premiums, the specter of “defensive medicine” and overuse of diagnostic tests loom in the literature and lay press. Some evidence suggests that tort reform may not significantly affect medical decision making (Sloan 2009: 490; Carrier 2010, 1585), yet there is general agreement that there are some physicians who do practice “defensive medicine,” and some who do order unnecessary tests in fear of lawsuits. Malpractice insurance also allows for an important transfer of risk for providers. Some argue that even if a 6% savings in health care costs is considered meager, it is still a viable means of cost containment. This can be deemed another means of “bending the cost curve” in health care, which is a major goal of the Affordable Care Act and this Administration. Since tort reform is an arena for achieving possible cost-savings, potential areas of tort reform should be closely examined.

Tort Reform
Caps on Damages
Many proponents of tort reform suggest that one way to reduce the number of frivolous lawsuits, and thus lower premiums, would be to “cap” the amount of noneconomic and punitive damages for which providers may be responsible. Without some limit to the financial awards given to plaintiffs for noneconomic remuneration, a significant amount of unpredictability remains inherent in the current system. It is relatively simple to calculate opportunity costs through wages lost, but assigning a dollar amount to pain, suffering, and punishment is significantly more subjective. Others argue that noneconomic awards are often exaggerated in order to cover attorney fees, and these sums are blatantly arbitrary. Some research supports this argument, finding that “laws limiting malpractice payments lower state health expenditures by between 3% and 4%” in 28 states (Hellinger 2006: 1375). Opponents of capping damages often argue that this ceiling would be unfair to those who are recipients of the most severe negligence, and that punitive damages are necessary to punish providers for the most egregious offenses. Their research demonstrates that these reforms lead to almost no savings (Morrisey 2008: 2138-9), and they argue that, even if mild savings are indeed evident, these reforms do little for the bottom line of most hospitals (Ellington 2010: 132-3). Other potential reforms concerning noneconomic damages involve structured settlements. Instead of paying a lump sum, defendants could offer plaintiffs their remuneration over a period of time, thus spreading the cost over a number of years. (Cohen 2006: 1-5, 8-10).

Provider Liability
Some states follow a common law rule that “if more than one defendant is found liable for a plaintiff’s injuries, then each defendant may be held 100 percent liable” (Cohen 2006: 5). This principle, called “joint and several liability,” is intended to ensure that a plaintiff is fully compensated for the transgression, leaving the defendants to work out who is proportionally responsible. The idea is that a plaintiff should receive complete remuneration in a timely manner rather than wait for the defendants to decide culpability. The plaintiff cannot recover more than his or her share, but can recoup 100% of the damages upfront, suing any or all of the defendants as necessary. Joint and several liability is also closely related to the “collateral source rule.” This evidence rule keeps any information out of court that relates to whether a plaintiff can or has received compensation for injuries from someone other than the defendant. This permits a plaintiff to recover full damages from a provider even if the plaintiff is owed compensation from other sources. For example, if a plaintiff has received compensation for medical expenses after an accident from his or her insurance company, a judge or jury is not allowed to take this into consideration when calculating damages. After the trial, the plaintiff may have to return money received from other sources if the damages the defendant has to pay the plaintiff duplicate the plaintiff’s “collateral sources.” Eliminating the collateral source rule would reduce the malpractice award from a defendant if other providers or sources (health insurance companies, hospitals, etc.) are liable as well, and eliminate additional costs and time spent on medical malpractice claims. Abolishing these sometimes inequitable tort rules are seen as potential reforms. (Cohen 2006: 5-6).

Limiting Attorney’s Fees
Attorneys in medical malpractice cases typically receive a percentage of the plaintiff’s total award (or may receive nothing if the suit fails). This fee can be as large as 40 percent of the remunerated damages. Tort reform proponents argue that these fees are exorbitant and increase the cost of malpractice claims. There is some evidence to suggest that larger awards for noneconomic damages directly correlate to these increased fees. This is an attempt to cover attorney expenses for the plaintiff. Advocates also argue that these fees promote the manufacture of frivolous lawsuits in the hopes of reaching a settlement. Creating a sliding scale for attorneys’ fees or capping the maximum percentage that lawyers may charge are two ways of decreasing the expenses incurred with medical malpractice claims and insurance. Opponents of limiting fees quickly note that hourly compensation would make hiring an attorney prohibitive for many Americans. By not charging an hourly rate, plaintiffs who are not well to-do could more easily afford to file claims relatively risk free. (Cohen 2006: 7-8).

Recommendations
This list of potential reforms is by no means exhaustive. Some have suggested that malpractice claims should be decided in specialized medical courts, where medically trained judges decide claims and expedite malpractice cases (Common Good: Health Care). Other countries have found different means of reducing costs. New Zealand has established a “no-fault” liability system where plaintiffs do not sue the party at fault, but instead seek remuneration from a government-run entity (the “Accident Compensation Corporation”) that expedites the claims process in an effort to reduce the cost of insurance and diminish defensive medicine practices, while still ensuring patient safety (Bismark 2006: 889).

So long as there are different ideologies in the United States, tort reform will remain a contentious issue. Although the CBO sees little economic merit in policy changes regarding medical malpractice reform, the literature remains mixed. Not only has cost-savings, state expenditures, and the effects on defensive medicine been substantially analyzed, but so have the effects of tort reform on physician supply. Between 1985 and 2001, “the physician supply grew 2.4% more in direct-reform states than in non-reform states… Researchers [also] found a similar impact for certain physician specialties associated with high premiums for malpractice insurance” (Fernadez and Webel 2006: 7). With access to health care being a core principle of the Affordable Care Act, and so vital to its success, it is difficult not to at least consider the possibilities of medical malpractice reform.

So what is the best course of action for this Administration? Pilot programs and funding for state demonstration projects are a start, but tort reform may be the best potential area to compromise with Republican leadership on health care, pushing Congress toward bipartisan solutions. As long as patient safety (i.e. the safety of the American people), and the people’s right to seek compensation for negligence and egregious medical errors, is protected, reforming the medical malpractice system on a national level could win important political points as 2012 approaches. Working with House and Senate Republicans would demonstrate the President’s commitment to bringing change to Washington, as well as confirm Mr. Obama’s obligation to the American people, ready and willing to hear their voices.

However, it is also important to remember that the American Association of Justice (AAJ) is a powerful lobby in Washington and a significant contributor to the Democratic Party and its candidates (OpenSecrets.org: AAJ). Overtly attacking trial lawyers would not be in the best interest of this Administration, especially in light of the recent Supreme Court ruling concerning campaign finance and advertising. It is also important to remember that an approach deemed too aggressive may actually be detrimental to the health and safety of the American people. This, however, is the tradeoff: bipartisan change in Washington versus the influence of politically important special interests.

This author suggests that the President pursue “token” or “symbolic” medical malpractice reform. It is best to not to attack attorneys’ interests by pushing Congress to limit fees directly or impose tight caps on noneconomic damages. Instead, capping the amount of punitive damages might be a worthy alternative. This would not limit the amount of the award that the plaintiff would receive, but it would protect the provider from the possibly of exorbitant economic punishment, subsequently lowering overall costs to the health care system. Benign revisions to provider liability laws in terms of medical malpractice should also be considered, as well as increased funding for demonstrations and pilot projects surrounding medical malpractice research. Will these reforms significantly reduce costs? The numbers say, “Probably not.” However, with the adequate public relations support, this type of reform and open commitment to fiscal responsibility could be an important political move when considering reelection in 2012.


(sources available upon request)

August 13, 2010

The Patient-Centered Medical Home: Prospects for Individual and Small Provider Groups

With a growing shortage of primary care physicians (PCPs) and an increased prevalence of chronic disease among patients in the United States, the Patient-Centered Medical Home (PCMH) has become an ideal 21st century model for primary care. It promises to “strengthen the physician-patient relationship by replacing episodic care based on illness and patient complaints with coordinated care and a long-term healing relationship.” In this model, each patient has access to a single, personal physician, and develops an ongoing relationship with this provider, allowing the physician to assume responsibility for their health care needs. The providers and their staff form the physician-led medical team, dedicated to enhancing care through increased access, open scheduling and communication, transparency and accountability, resources for improved patient decision making, and appropriate referral when necessary. Utilizing the successes of providers such as Group Health Cooperative of Puget Sound, this model focuses on “whole patient orientation” in an effort to anticipate the needs of the patient instead of reacting to crises, thus decreasing waste and preventable medical emergencies.

Providers may become accredited PCMHs through the National Committee of Quality Assurance (NCQA), allowing them to distinguish themselves as optimal providers in the market, as well as receiving increased reimbursements for services from some payers. Any PCP-directed medical practice can request a survey and apply for accreditation from NCQA; even individual physician practices may qualify as PCMHs. However, to achieve the high standards required for accreditation, these practices would require significant resources to acquire the technology and staff necessary for enhanced clinical integration. The largest medical groups have demonstrated the best ability to adapt to this model nationally, but primary care in the United States is dominated by small PCP practices. In a 2009 survey of family practice physicians in Virginia, only 1% of the provider groups exhibited all elements critical to the PCMH model, and fewer than 40% reported use of electronic medical records (EMRs). Since the NCQA guidelines focus heavily on EMR use and reporting for quality improvement, most providers would require significant funding to transform into an NCQA accredited practice. Some estimate this transformation might require between $80,000 and $120,000 upfront per clinician. With this low percentage of PCMH-ready provider groups and the significant resources needed to achieve model guidelines in mind, this report briefly reviews the fiscal viability of individual and small group providers to become NCQA accredited.

Most research has relied on surveys to assess the readiness of the organizational structures of primary care practices for PCMH implementation. These studies appear congruent. In a statewide survey of primary care clinicians in Massachusetts in practices ranging from 2-74 physicians (median = 4), similar results were obtained in comparison to Goldberg et al in Virginia. Larger practices were significantly more likely than smaller practices to have the tools necessary to implement PCMH technologies and enhanced care. Specifically, “larger practice size and network affiliation were both associated with higher prevalence of capabilities in 3 domains of improvement: feedback and improvement infrastructure, linguistic capabilities, and EHRs,” all key elements of NCQA standards. Thus, individual physicians and physician groups will require much more support and funding to achieve NCQA accreditation. Other research specifically related to quality improvement and EHRs further strengthens this hypothesis: the smaller the practice, the less likely it is to be capable of immediately adopting PCMH elements.

The Deloitte Center for Health Solutions (the “Center”), part of Deloitte and Touche USA LLP, recently examined the medical home model, estimating both startup costs and potential savings. The Center looked at the current state of primary care, contrasting it with its future in the PCMH model. The Center’s estimates for achieving the PCMH model require more patient visits, the addition of “health coaches” and other staff, physician incentives and performance bonuses, and a one-time investment of approximately $100,000 for EMR infrastructure, plus hundreds of thousands of dollars each year to manage IT systems, data, and technical support. With this fiscal budget in mind, a practice would have to “reduce annual net costs by at least $148,347-$163,347 per primary care physician to break even. For a panel of 1,000 patients who need care coordination, net costs for health services must be reduced by at least $150 per patient per month.” The Center notes that this may indeed be feasible, given the savings from reduced hospital and emergency department admissions (assuming proper incentives). Thus, the PCMH model could more than pay for itself over the long run, so long as the initial capital investment could be managed.

Small primary care practices may find their path toward NCQA accreditation blocked due to fiscal constraints. According to the Center, individual physicians would need to invest approximately $150,000 each year to sustain a PCMH (after the one-time ~$100,000 investment in health information technology). This would most likely require assistance from strategic partners, and “the projected risk level for an individual clinician could be high relative to the return unless the physician is part of a community based care management model supported through a strategic collaboration among local payers and a community-based health information exchange.” This high associated-risk inevitably would make it difficult for small practices to be moved toward the PCMH model.

Current PCMH demonstrations, including over 14,000 physicians caring for nearly 5 million patients, have seen “median incremental revenue per physician per year [at] $22,834 (range $720 to $91,146),” so there is indeed a fiscal incentive for physicians to move to the PCMH model. However, these demonstrations do not exist in a vacuum. This model requires collaboration among physicians, payers, and patients, as well as federal support. Significant capital would be needed for any practice to achieve NCQA accreditation, and smaller groups would find this move exceedingly difficult without the addition of other stakeholders. Yet if primary care can move toward this patient-centered model, physicians, patients, and payers combined could see significant cost-savings and enhanced care.


(sources available upon request)

July 30, 2010

Accountable Care Organizations: Prospects in the New Era of Health Care Reform

An Accountable Care Organization (ACO) is a relatively new patient care model that has received much attention over the past few months, particularly in the context of recent health care reform efforts attempting to "bend the cost curve" of growing national health expenditures. First coined in late 2006 by Fisher et al, an ACO may be described as a group of geographically linked providers that are accountable for the cost and quality of care for a specific patient population within a region. Under this model, providers such as primary care physicians, specialists, and hospitals would coordinate care in a longitudinal fashion, thereby improving quality and producing tangible cost-savings. These providers would then be reimbursed for a certain percentage of their total savings, or be held accountable for their inefficiencies and waste. Recently the ACO definition has been broadened to include “virtual networks” of providers, as opposed to distinct, extant organizations. These loosely connected regional networks could improve patient care through use of electronic health records (EHRs), better coordination, e-prescribing, fewer re-hospitalizations, and a stronger emphasis on primary care, allowing them to rein in rising costs, and then share in resulting savings as an incentive. Essentially, the ACO framework is modeled off the successes of integrated delivery systems like Geisinger and Intermountain Health Care, and may now be extended to virtual networks that only cover a specific subset of the patient population.

The Patient Protection and Affordable Care Act (ACA), signed into law by President Obama this past March, defines an ACO as any network of physicians or individual practices, physician-hospital organizations (PHOs), or hospitals that meets specific requirements as set forth by Section 3022 and the Secretary of Health and Human Services (HHS). The Secretary will work with networks “willing to become accountable for the quality, cost, and overall care of the Medicare fee-for-service beneficiaries assigned to it” for at least a three year period. Medicare ACOs would be responsible for most Part A and B items and services, and would be obligated to incorporate a sufficient number of primary care physicians to care for a minimum of 5,000 Medicare beneficiaries. ACOs must also be able to implement and report specific quality, performance, and cost measures in order to be eligible for this “shared savings program.” If an ACO can reduce total spending in relation to average Medicare expenditures per capita (after adjustment for beneficiary characteristics), then that organization will be able to share the savings. In other words, if an ACO meets all the applicable requirements, the Secretary will define a certain percentage of the cost-savings that may be reimbursed, using a partial capitation or related payment system. However, reimbursements will not be doled out if the formation of an ACO results in greater spending than would otherwise be expended if the model were not implemented.

Section 3022 of ACA, which encourages the formation of ACOs under the Medicare program, is only five pages in length. This may be attributed to the novelty of the ACO concept. Therefore, framework suggestions and implementation strategies must be found in the literature, which is sparse. Most agree that coordinating care and better oversight among providers will improve quality of care for patients, and there is empirical data to suggest that organized multispecialty medical groups with this goal in mind have achieved just that. However, in order to implement this longitudinal model of care, many potential ACOs will require significant technical assistance. All but the most advanced and integrated providers will require the establishment of “organizational, legal, financial, and budgeting relationships with payers” in order to create the overarching ACO framework, as well as mechanisms specific to meeting performance and quality standards. Stakeholders would require significant practice redesign, focused on leadership development, EHR implementation, and quality improvement. Since this type of organizational structure cannot be created overnight, researchers have suggested different means of implementation.

One such strategy demonstrates how the ACO model could be achieved in stages, slowly increasing organization, performance, and risk. One of the difficulties of developing a new ACO is the acquisition of associated downside risk. In this implementation approach, a Level 1 ACO would receive reimbursement if shared savings were achieved, but would not be responsible for the fallout if these initial conditions were not met. As a more advanced infrastructure is created, the ACO would become accountable for an increasing share of the costs if targets were not met, eventually becoming fully responsible. Other variations on this approach have been suggested, but again the major impediment confronting a fledgling ACO is the initial acquisition of risk. There is little doubt that better coordination of care can improve quality, but providers are unlikely to invest in this framework without proof of financial success or added financial backing. A number of pilot programs in states such as Vermont and Massachusetts have begun with these goals and limitations in mind.

ACA, however, mentions nothing about gradual implementation, leaving the overall execution plan vague. The statute states that that a contracted ACO will be “at financial risk for some, but not all, of the items and services covered under parts A and B.” This implies that ACOs which contract with the Secretary of HHS are likely to have already jumped many of the hurdles impeding implementation. These groups are probably already integrated health systems, or ones likely to become integrated in the very near future.

For this reason, some researchers have postulated that Academic Health Centers (AHCs) are in an excellent position to lead the ACO charge. Some AHCs arguably have a unique ability to become ACOs due to the broad social, political, and economic power that many hold, and the access to resources that independent physician practices and smaller PHOs may not have. In order for AHCs to become leaders in this arena, however, they would have to fully commit to primary care within the community, potentially through the development of patient-centered medical homes. Researchers suggest that fragmentation, emphasis on research, and higher costs due to medical education may hinder the progress of AHCs in reaching this goal. Thus, incentivizing AHCs to become leaders in this field most likely will follow upon successes of current ACO projects and demonstrations, and will subsequently require federal subsidies and a great deal of funding for broader integration and implementation.

Critics of ACOs point to the lack of empirical data for their structure. Some note that the reward of “partial capitation,” while perhaps efficacious in reducing spending, lacks evidence for significant improvement in the quality of patient care. Even though performance measures are included in ACA, ACOs will have to prove that these two concepts are linked. Dove et al also note that health information technology (HIT) and EHRs will need to deliver on their lofty expectations to improve quality of care, otherwise ACOs will find themselves holding expensive technology yielding few benefits. Others remain skeptical of the “virtual” framework, noting that though this model might be theoretically aesthetic, it lacks pragmatism. Since an ACO is fundamentally defined by geography, integration and coordination of care will require cooperation among competing physicians and their practices, a model of physician collegiality that some critics deem unlikely. While existing integrated health systems might see some success, the rest of the health care delivery system may not follow suit. Still others question the role of AHCs in the ACO framework. Qualitative evidence shows that large integrated provider groups, such as AHCs, dominate negotiations with private insurers, causing premiums and payment rates to soar to levels much higher than Medicare. In other words, by squeezing one end of the balloon, the other end expands, inevitably hurting consumers and private insurers. This raises several antitrust issues, which, despite legal precedents favoring the ACO concept, will require major investments in legal expertise by potential ACOs.

There is also the question of how consumers would be “assigned” to an ACO. Sixty percent of physicians doing only inpatient work are affiliated with a single hospital, and of the remaining 40%, three-quarters of their work is at a one “primary” hospital. Consequently, for physicians engaged in any inpatient work, 90 percent or more is at a “primary” hospital. A loose network could be built around this, and patients could be assigned accordingly. Questions remain, however, about whether patients should be informed of this “assignment.” In the case of a fully integrated PHO, patients generally have the option of leaving the network (as patients have the option of not joining an HMO or any other provider network), whereas when a loose network spans an entire region – as many of the ACO designers have in mind – patients may not be given a choice. Will they be subjected to this model without a means of opting out? Or do consumers even need to be informed? These pragmatic and ethical questions linger.

Despite being such a small part of this year’s health reform law, the ACO model has broad implications for variations in regional health spending, a controversial topic put forth by the Dartmouth Atlas of Health Care (“the Atlas”). Tracking the Care of Patients with Severe Chronic Illness was published by the Dartmouth Institute for Health Policy and Clinical Practice, arguing that in the United States, “more care does not equal better care” and “some chronically ill and dying Americans receive too much care: more than they or their families actually benefit from.” This study focused on Medicare beneficiaries who had at least one chronic illness, summing their total medical expenses in the last two years of life. Researchers then mapped these findings geographically, analyzing Medicare Part A and B spending per state, per hospital referral region (HRR), and for the 2,826 U.S. hospitals with at least 400 patient deaths between 2001 and 2005. Extrapolating from these results, many have argued that physicians in areas such as the upper Midwest offer cheaper, and thus better, care for their patients, as opposed to their colleagues in the South, where end-of-life care costs are much higher. “Too much care” correlated to increases of up to 52% in Medicare reimbursements between the highest and lowest spending regions. Further data suggests that “after adjustment for demographic and baseline health characteristics and changes in health status, the difference in [spending] between the highest and lowest quintiles can be reduced to 33%,” but the fact remains that at least a third of all expenditures in certain regions of the country may be deemed wasteful.

Fully integrated provider systems, such as the Geisinger Health System or the Group Health Cooperative of Puget Sound, may see moderate cost-savings results utilizing the ACO framework, but regions identified by the Atlas as high spending districts arguably could see the greatest reduction in expenditures if they buy into this model. The difficulty is, however, incentivizing these providers to form ACOs. Decreasing health care expenditures in these areas correlates with a decrease in profits for their physicians and hospitals. Even with partial reimbursement for substantial cost-savings, the question remains, will it be enough to improve their bottom-line? Should providers in these regions receive a higher initial percentage of reimbursement to draw them into the system, or does this simply reward years of waste? Should they begin as Tier 1 ACOs? Organizations that want to be held accountable for their care are not the ones the Secretary of HHS needs to court for ACO Medicare contracts; it is the providers that do not.

Furthermore, these studies acknowledge that there are large differences among regions of the country. Demographics, health characteristics, cost of living, and health outcomes, for example, vary throughout the United States. So will a “one-size-fits-all” model work nationally? If there are to be different agreements among providers and Medicare, how should these statistical variations be adjusted, or should they be adjusted at all? One of the attractive aspects of the ACO concept is the fluidity and malleability of the framework across provider groups of different sizes and levels of integration. Whether the Medicare payment process will achieve this same type of flexibility is yet to be determined.

Ultimately, ACA does not provide significant funding incentives for the formation of ACOs. There is funding in the health reform law and the American Recovery and Reinvestment Act of 2009 for EHRs and HIT, but subsidies to develop infrastructure for legal and leadership needs, as well as practice redesign are limited. Congress has to provide a larger carrot in the future if the ACO model is to become a national success, and pilots and demonstrations projects will have to achieve significant cost-savings in order for the model to catch on. And as far as shared savings, “the fundamental question is whether there are enough physicians interested in doing the hard work of forming and managing ACOs capable of directly managing even partial capitation risk. It is possible that for all of the theoretical advantages of this approach, there would be few takers in a voluntary ACO program using any form of capitation.” However, the future is not entirely bleak. Four years after the ACO model was first proposed, Congress has recognized its value and has provided legislative support for implementation of Medicare ACOs in an effort to decrease health care costs while concordantly improving quality. As this model evolves over time, look for innovations and potential successes; however, the status quo will remain until there is true payment reform and a larger commitment to expanding primary care.


(sources available upon request)