HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Friday, March 7, 2008

Prescription Drug Prices

In response to President Bush's weekend radio address concerning the dangers of purchasing drugs on the internet, David Lazarus of the LA Times writes about the reason people often turn to the internet to purchase drugs - the cost of prescription drugs.

In his weekend radio address, President Bush warned of rogue pharmacists making potentially dangerous prescription drugs readily available online.  "The Internet has brought about tremendous benefits for those who cannot easily get to a pharmacy in person," Bush said. "However, it has also created an opportunity for unscrupulous doctors and pharmacists to profit from addiction."

That's undoubtedly true, as are most observations that the Internet has become a hotbed of fraud and flimflammery. And I think we can all agree that patients should see doctors face to face, rather than via an online chat or survey, before receiving prescriptions for painkillers and other such meds. But Dr. Bush is addressing a symptom and not the cause of one of the country's top medical problems.

Many Americans, including numerous seniors and people with chronic conditions, obtain prescription drugs from international sources not because they're scratching some itch for faraway places. The shameful reality is that they're looking abroad simply because they can't afford U.S. drug prices. "The United States has the most costly medications in the world, and a large percentage of the population either lacks insurance or is underinsured," said Andy Troszok, who runs a Calgary, Canada-based, mail-order drug supplier called Extended Care Pharmacy.  Nearly all his roughly 30,000 customers are Americans, he said. And increasingly, the people seeking cut-rate meds aren't retirees on fixed incomes but working people in their 30s. . . .

Bush illustrated his concern about online drug sales with the story of San Diego teenager Ryan Haight, who died after overdosing on the painkiller Vicodin in 2001. Bush noted that "with only a few clicks of the mouse, Ryan was able to get a prescription from a doctor he had never met and have the pills sent to his front door."  The president didn't mention that Haight purchased the pills by faking his age, an ailment and a doctor's name. In any case, a very sad story. But what about the thousands if not millions of other people forced to buy their meds online not because they're looking for a buzz but just to stay alive? Forty-seven million Americans lack health insurance and millions more do not have coverage for prescription drugs. . . . .  Any attempt to shut down such "illegal" online drug sales could result in cutting off medical supplies to Americans in need.

What's the answer? Clearly there need to be safeguards to prevent situations like what happened to Ryan Haight, as well as to protect people from possibly dangerous concoctions offered by fly-by-night pharmacies in Southeast Asia and elsewhere.  But until the U.S. can extend health coverage to everyone and limit drug prices to reasonable levels, many Americans will have no choice but to seek the best possible deal for their meds, and this will often require them to look beyond our borders, via the Internet.  . . . .


March 7, 2008 | Permalink | Comments (0) | TrackBack (0)

More on Autism/Vaccine Case

The Wall Street Journal's Health Blog provides some background on the recent case involving the girl who received childhood vaccines and developed autism-like symptoms.  Jacob Goldstein writes,

The father of a girl who developed autism-like symptoms after receiving several vaccinations in a single sitting doesn’t oppose vaccines.   “I want to make it clear I am not anti-vaccine,” Jon Poling, who has an MD and a PhD, told WebMD. “Vaccines are one of the most important, if not the most important advance, in medicine in at least the past 100 years.” But, he added, “every treatment has a risk and a benefit. To say there are no risks to any treatment is not true.”

The federal government conceded that the vaccines Poling’s daughter Hannah received as an infant may have combined with an underlying disorder to contribute to her neurological problems. The family will receive a payment from a special vaccine court that reimburses people who have been harmed by vaccines.

Hannah Poling has a disorder of the mitochondria, the part of the cell that provides energy. It is common for infants and toddlers with mitochondrial disorders to appear healthy, then develop problems when placed under certain kinds of common physical stress, such as dehydration or fever. Because the brain is such a heavy user of cellular energy, those problems are often neurological.

“Children who have mitochondrial disorders, even though they may appear normal initially, are actually somewhat pre-destined to have a regression of neurological function when placed under stress,” Edwin Trevathan, who runs the CDC’s Center on Birth Defects and Developmental Disabilities, said during a press call yesterday. . . . .

“The government has made absolutely no statement indicating that vaccines are a cause of autism,” CDC chief Julie Gerberding said. “This does not represent anything other than a very special situation and a very sad situation for the family and the child.”

March 7, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, March 6, 2008

Autism and Childhood Vaccine Case

Law.com picks up an Associated Press account of an interesting case involving a girl for whom mandatory childhood vaccines worsened a genetic condition she had which led to 'autism-like symptoms."  Marilynn Marchione of the Associated Press writes,

Government health officials have conceded that childhood vaccines worsened a rare, underlying disorder that ultimately led to autism-like symptoms in a Georgia girl, and that she should be paid from a federal vaccine injury fund.   Medical and legal experts say the narrow wording and circumstances probably make the case an exception -- not a precedent for thousands of other pending claims.

The government "has not conceded that vaccines cause autism," said Linda Renzi, the lawyer representing federal officials, who have consistently maintained that childhood shots are safe.  However, parents and advocates for autistic children see the case as a victory that may help certain others. Although the science on this is very limited, the girl's disorder may be more common in autistic children than in healthy ones. . . . .

A lawyer for the 9-year-old girl has scheduled a news conference in Atlanta on Thursday. Her parents have declined to comment in the meantime because the case is not final and the payment amount has not been set.  Nearly 5,000 families are seeking compensation for autism or other developmental disabilities they blame on vaccines and a mercury-based preservative, thimerosal. It once was commonly used to prevent bacterial contamination but since 2001 has been used only in certain flu shots. Some cases contend that the cumulative effect of many shots given at once may have caused injuries.

The cases are before a special "vaccine court" that doles out cash from a fund Congress set up to pay people injured by vaccines and to protect makers from damages as a way to help ensure an adequate vaccine supply. The burden of proof is lighter than in a traditional court, and is based on a preponderance of evidence. Since the fund started in 1988, it has paid roughly 950 claims -- none for autism.

Studies repeatedly have discounted any link between thimerosal and autism, but legal challenges continue. The issue even cropped up in the presidential campaign, with Republican John McCain asserting on Friday that "there's strong evidence" autism is connected to the preservative.

The girl has a disorder involving her mitochondria, the energy factories of cells. The disorder -- which can be present at birth from an inherited gene or acquired later in life -- impairs cells' ability to use nutrients, and often causes problems in brain functioning. It can lead to delays in walking and talking. . . .   According to the document, five vaccines the girl received on one day in 2000 aggravated her mitochondrial condition, predisposing her to metabolic problems that manifested as worsening brain function "with features of autism spectrum disorder." In the 1990s, the definition of autism was expanded to take in a group of milder, related conditions, which are known as autism spectrum disorders.  The document does not address whether it was the thimerosal -- or something else entirely in the vaccines -- that was at fault.

A Portuguese study suggested that 7 percent of autistic children might also have the mitochondrial disorder, versus one in 5,000 people -- or 0.02 percent -- in the general population, said Dr. Marvin Natowicz, a Cleveland Clinic geneticist.  "Even if they're off by a factor of seven" and only 1 percent are afflicted, "it's still a striking statistic," he said.

Others said they doubt the Georgia case will have much effect.  "No link between mitochondrial disorders and autism spectrum disorder has been made in mainstream medicine," said Dr. Michael Pichichero of the University of Rochester in Rochester, N.Y., who has consulted for the government on vaccines and has received speaking fees from vaccine makers. . . .

March 6, 2008 | Permalink | Comments (0) | TrackBack (0)

House Passes Wellstone Mental Health and Addiction Equity Act

Yesterday, the House of Representatives passed the Paul Wellstone Mental Health and Addiction Equity Act.  The gavel describes the Act as follows:   

The House has just passed H.R. 1424, the Paul Wellstone Mental Health and Addiction Equity Act by a vote of 268-148. This bipartisan legislation will end discrimination against patients seeking treatment for mental illnesses by prohibiting insurers and group health plans from imposing treatment or financial limitations when they offer mental health benefits that are more restrictive from those applied to medical and surgical services.

More precisely, the Act:

Requires equity in financial requirements. Under the bill, an insurer or group health plan must ensure that any financial requirements – such as deductibles, copayments, coinsurance, and out-of-pocket expenses – applied to mental health and addiction benefits are no more restrictive or costly than the financial requirements applied to comparable medical and surgical benefits that the plan covers.

Requires equity in treatment limits. Under the bill, a group health plan must ensure that the treatment limitations – such as frequency of treatment, number of visits, and days of coverage – applied to mental health and addiction benefits are no more restrictive than the treatment limitations applied to comparable medical and surgical benefits that the plan covers.

Does not mandate mental health benefits. The bill does not mandate insurers or group health plans to provide any mental health coverage. The bill’s provisions only apply to plans that choose to offer mental health coverage.

Exempts certain businesses. The bill exempts small businesses with 50 or fewer employees. It also exempts those businesses that experience an overall premium increase of 2 percent or more in the first year and 1 percent in subsequent years.

Covers same mental illnesses and addiction disorders as FEHBP. The bill ensures that group health plans cover the same range of mental illnesses and addiction disorders covered by the Federal Employees Health Benefits Program – i.e., the mental illnesses and addiction disorders included in the mental health practitioner’s guide, the Diagnostic and Statistical Manual of Mental Disorders (DSM).

Does not mandate out-of-network benefits. The bill simply states that if a plan already offers out-ofnetwork benefits, it must offer out-of-network benefits on the same terms for mental health services as it does for medical and surgical services.

Does not pre-empt stronger state parity laws. The bill establishes a federal standard, a floor of protections that would apply to job-based health coverage, but allows states to be more protective of their residents with stronger parity laws.

Explicitly permits medical management of health benefits. The bill allows the use of medical management tools that are based on valid medical evidence and pertinent to the patient’s medical condition so that specific coverage is not arbitrary in its application and more transparent to the patient.

Provides for enforcement. The bill provides remedies to protect beneficiaries’ rights and permits enforcement of the bill’s equity requirements by the Internal Revenue Service, the Department of Health and Human Services, and the Department of Labor.

The Senate had already passed a mental health parity bill earlier.  The New York Times has a more detailed discussion of the politics behind the Act's passage and the ability of the House and Senate to reach a compromise and send the Act to the President.

March 6, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, March 5, 2008

Genetic Testing and Genetic Discrimination

A contributor to mydisabilityblog posts about recent announcements of new blood tests that reveal that an an individual has a mental illness.  The contributor finds some excitement in the news but also much worry: 

Recently, I read an article about a blood test that may have the capability of revealing mental illness and I must say that the possibility both excited and worried me. Speaking as a daughter and mother of bipolar individuals, the thought that medical professionals would be better equipped to diagnose my loved one’s mental status through a blood test excited me. It is often difficult for medical professionals to assess the severity of their patients’ moods by observations and conversations with them. . . .

Presently, medical professionals relay upon their observations and the patient’s statements, consequently the severity of an individual’s illness is easily underestimated or overestimated by their treating physician. Dr. Alexander Niculescu, III, the lead researcher of the study, which was published recently in the Journal of Molecular Psychiatry, believes that an objective test that enables a medical professional to determine mental status, severity of illness, and assessment of response to treatment is a huge step in the right direction. Other medical professionals are rightly concerned about the possible ethical questions that a blood test for mental illness would raise. For instance, insurance companies to deny benefits to potential clients could use these same blood tests; blood tests could be used to determine an individual’s competence, enrollment in college, to screen potential employees, or a myriad of other controversial ways.

After considering all of the above, I have to say that I would not wish for my child to be denied access to educational or employment opportunities because of a blood test. I worry that blood tests used to assess mental illness may become a weapon for employers, law enforcement, and insurance companies. In fact these blood tests will most likely be used for the reasons listed above as much or more than as a tool for improved assessment of the severity of an individual’s bipolar disorder, depression, schizophrenia, or anxiety disorders. As with so many other medical advancements, we as a society must be careful not to open a Pandora’s box.

March 5, 2008 | Permalink | Comments (0) | TrackBack (0)

Jonathan Cohn on McCain's Health Care Plan

Well, since John McCain has the Republican Presidential nomination, it seems like a good time to look at this health care plan.  At least one commentator is not too excited.  Jonathan Cohn, the New Republic's health care writer, states,

So the question is: What type of reform would he be willing to swallow in this much more ambitious moment? Probably the best clue comes from the reform plan he unveiled back in October, but has gotten little attention since. That proposal suggests he'd act less like TR than William Howard Taft--and even a little like George W. Bush.

McCain, of all people, should be sensitive to the way America's health care system fails some of its most vulnerable citizens. He is a three-time survivor of melanoma, the potentially deadly skin cancer. Although he was last treated for cancer six years ago--and although he takes all the right precautions, dutifully donning sunscreen whenever he's outside--he's still at a higher-than-normal risk of getting cancer again.

This sort of history doesn't seriously affect people who get their insurance from big-time employers. In any large organization of relatively random people--say, the employees of the federal government, of which McCain happens to be one--insurers know that most of the people will be healthy, which means premiums from those folks will be sufficient to cover the relatively few with serious medical problems.

But if McCain were, hypothetically, to shop for insurance on his own, he would discover that insurers were far less accommodating. Cancer, even one in remission, would qualify as one of those infamous "preexisting conditions." The insurers might offer him an exorbitantly priced policy or exclude coverage of anything related to cancer. Or they simply might refuse him coverage outright.  Either way, the very last thing McCain should want is to expose even more people to this sort of scrutiny--since, almost certainly, it'd leave even more of them uninsured. But it's entirely possible--some would say likely--that's what McCain's reforms would do.

The main thrust of his plan is to change the tax treatment of health benefits, which sounds arcane but could actually have far-reaching effects. At the moment, if you get your insurance through your employer, you can pay for the premiums with pre-tax dollars. In effect, a dollar your employer gives you for health insurance is worth more to you than a dollar in regular wages. If you buy insurance on your own, directly from a carrier, you get no such benefit. This distinction, which the federal government created back in the 1940s, goes a long way to explaining why, today, most working people with health insurance get it from their jobs. . . .

McCain, to his credit, understands that simply equalizing the tax deduction wouldn't help a lot of low-income people, since they don't pay much--if anything--in income taxes. So, in the one key (and laudible) break with conservative orthodoxy, McCain has said he would offer his new tax break as a refundable credit. Credits, by definition, are available to everybody. Better still, their value doesn't change depending on the tax bracket. Somebody making $100,000 could claim it, but so could somebody making just $30,000--for the very same value.

The McCain campaign says this will help a lot of people. And they are probably right. The trouble is that McCain's tax break--worth $5,000 to a family--still won't be enough for many others. In areas of the country where the cost of living is high, it would be less than half the cost of the average policy. As campaign officials freely admit, this means the plan won't come even close to universal coverage. Nor is it clear how serious McCain is about pushing for that amount. Unlike the Democrats, whose campaigns published detailed plans complete with cost projections and financing options, McCain's "plan" is really more a set of principles and talking points. He doesn't even bother to say how much his subsidy would cost in the end.

That's not to say that McCain has no important insights into reform. While McCain mouths all the platitudes about the inherent superiority of U.S. health care, he understands that we waste all sorts of money on care that is either unnecessary or counterproductive. To thwart this, he has embraced an idea known in wonkier precincts as "pay-for-performance" (the McCain campaign doesn't like to use that phrase, but that's how many people refer to it). Today, Medicare pays for outpatient work (doctor visits, many tests, and so on) based on the procedure. With hospital care, it's a little more complicated, but even there the rewards frequently flow to those who provide the most care rather than those who provide the best care. Under McCain's vision, Medicare would start focusing payments more on the patient's overall condition--paying, say, a fixed sum for every patient with certain types of heart disease. It would also reward doctors and hospitals that avoid medical errors.

This might seem like a lot of micromanaging for a self-described conservative. And it is, especially relative to other Republican plans. But, at the same time, it's also micromanaging without the proper information. While the Democrats also have proposed variations on pay-forperformance, they would set up new government-chartered research institutes to develop guidelines for the best medical care. The idea is to first establish the best way of treating disease and then to reward doctors and hospitals when they adhere to those guidelines. Both Democratic candidates would also provide incentives for better care of chronic disease. Whether or not this actually saves a lot of money in the long run--there's a raging debate about that in academia--it would certainly make people healthier.

For McCain, these steps apparently go too far in the direction of government-regulated health care. But perhaps McCain should consider his own experience. After the war, McCain would have been eligible for medical care from the Veterans Administration. As a member of Congress, he can get insurance through the federal employees' plan; when he turned 65, he became eligible for Medicare. It may have escaped McCain's notice, but those are all government programs. And, if that care is good enough for him, then why not everybody else?

Click here to find out more!

March 5, 2008 | Permalink | Comments (0) | TrackBack (0)

Increase Regulation of Drug Companies?

Ezra Klein notes that the latest Kaiser Family Foundation survey on attitudes towards pharmaceutical companies demonstrates that Americans would like greater government regulation of pharmaceutical companies.  Americans express this desire even though there could be a negative impact on innovation.  Here are some of the charts:

pharmaregulation.jpg

Note:  The Associated Press reported yesterday that drug manufacturers increased their prices last year about 2.5 times overall inflation, continuing a long-standing trend.

March 5, 2008 | Permalink | Comments (0) | TrackBack (0)

Oregon's Financial Woes and Health Care Access

The Wall Street Journal's Health Blog reports on the sad state of affairs concerning health care access.  It points to a recent Oregon decision to ration health care by lottery.  The Associated Press report describes the lottery in more detail.  It states,

Oregon is conducting a one-of-a-kind lottery, and the prize is health insurance. The state will start drawing names this week for the chance to enroll in a health care program designed for people not poor enough for Medicaid but too cash-strapped to buy their own insurance.

More than 80,000 people have signed up since registration for the lottery opened in January. Only a few thousand will be chosen for the program. "It's better than nothing, it's at least a hope," said Shirley Krueger, 61, who signed up the first day.  It's been more than six months since she could afford to take insulin regularly for her diabetes. That puts her at higher risk for a number of complications, such as kidney failure, heart disease and blindness. Her part-time job leaves her ineligible for her employer's insurance plan and with too little income to buy her own. "I'm worried about it. I know it's a death sentence," Krueger said.

An estimated 600,000 people in Oregon are uninsured, according to the Oregon Department of Human Services.  Those selected in the lottery will be eligible for a standard benefit program, which was once a heralded highlight of the Oregon Health Plan.  At its peak in 1995, the program covered 132,000 Oregonians. State budget cuts forced the program to close to newcomers by 2004, but it now has several thousand openings. The program covers their most basic health services, medications and limited dental, hospital and vision services at little or no cost. . . .

March 5, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, March 3, 2008

Critique of Health Care Mandates

The Health Care Blog has an interesting post entitled, "What’s wrong with individual health insurance mandates,"  by Claudia Chaufan.  She supports a single payer program and worries that a mandate-approach ignores the financial realities of our current insurance system.  She writes,

Lately, legislation including a universal mandate – a legal obligation that everybody purchase a health insurance policy – has been hailed as the solution to the health care crisis in America. At the state level, mandates have been included, for instance, in Gov. Schwarzenegger and Speaker Nunez’s “Health Care Security and Cost Reduction Act”, and at the federal level, by Hillary Clinton in her “American Health Choice Plan”. Yet many of us remain skeptical. Why? After all, if everybody is forced to buy a health insurance plan – maybe with a subsidy if you are “poor enough” – would this not resolve the problem of uninsurance? Maybe so. But the real question is: would mandating universal health insurance guarantee universal access to medical care? And the short answer is no. 

A longer answer would include that many health reform proposals promising heaven on earth rely on fantasy numbers, not facts: for instance, there is reason to believe that Swcharzenegger’s stillborn legislation would have run out of money by the fifth year of operation. Indeed, often these proposals offer no numbers at all, fantasy or otherwise: a sound study estimating the capacity of “Hillary Care” to guarantee that those who “like” their current health insurance “will be able to keep it”, as Hillary promises, has yet to be produced.  But worst of all is the tendency, popular among many health care experts, including M.I.T. professors, to commit the capital sin in health policy: confusing universal health insurance with universal access to comprehensive medical care. . . .

In a social health insurance system everybody gets insurance by virtue of being a citizen or a resident, everybody contributes to the system according to ability to pay, and everybody is guaranteed an amount and type of services. This is possible because the system, whose ultimate goal is to provide the most and best care to all participants with whatever budget it has, counts on a predictable influx of money, has as sole incentive finding the most efficient ways to spend it, is able to estimate the needs of participants, and can utilize their collective purchasing power to bargain for best prices of services and goods.

In contrast, in a system based on mandates, nobody “gets” anything, really. Rather, everybody is compelled to buy a policy, by law. Hence guaranteeing a decent amount of medical care to the population at large, that many consider a social problem, is turned into a “problem” of “every” individual or “every” family, who are forced to comparative-shop for affordable policies, while second-guessing current or future medical needs as they decide which is the best investment for their resources – a more comprehensive health policy, rent, or food.

A key assumption underlying individual mandates is that forcing an influx of “customers” into the health insurance marketplace, flooded with private insurers’ “products” made to suit a range of personal preferences will, through the powerful and reveered “invisible hand”, improve the quality of medical goods and services and bring their prices down, such that on average they will be affordable to everybody. This of course would be true, if shopping for medical services were functionally equivalent to shopping for designer shoes. Faced with an offer, you are always free to take it or leave it, depending on how good the deal is. If it is not good enough, you can always wait until the next Christmas sale. Or you can decide that you are not so crazy about those shoes after all, and shop for something else, until those recalcitrant shoe sellers realize that if they want your dollars, they have to behave reasonably, and offer the best they can at the least possible price. . . .

Under our current system, which relies heavily on private insurance, paying for medical care is insurers’ greatest “cost”. Now, like any other business, insurers’ ultimate goal is to control the costs of running their business while maximizing profits. Hence the increasingly bewildering range of “choices” of “insurance products” that make sure that insurers will not have to pay more for medical care than they collect in premiums and that there remains enough spare change to keep CEOs and shareholders happy.  And because profit is the essence of business, however much “mandate” fans boast they will force insurers to not turn people down on the basis of “pre-existing conditions”, they will not – they cannot – force them to sell policies that will not meet insurers’ profit maximizing goals. So mandate supporters remain conveniently vague whenever asked how much “consumers” will have to pay for policies offering more than minimum coverage or even what will count as minimum coverage, hoping that we won’t notice when they fail to compute out-of-pocket costs to “consumers” – deductibles, co-pays, co-insurance – as “costs”. . . .

Now, the point is not to force business to do business at a loss. The point is why, when it comes to health care, we should insist on a model that confuses health care with designer shoes and that has failed to deliver the goods. Because it is clear that choices that are meaningful, not of health policies but of doctors and services when and to the extent we need them are increasingly out of reach for ordinary Americans.

Which is why only a system based on the principle of social insurance, that spreads the risk over a large pool – all Californians, or even better, all Americans – to which all participants contribute an affordable proportion of their income, and where individuals are guaranteed real choice, not of policies but of medical services, constitutes meaningful universal health care reform.   And sound legislation exists: it is the single-payer model proposed by SB840, the California Universal Healthcare Act, vetoed by Schwarzenegger, who appears to dislike “big government bureaucracies” but can live with the 30% mark-up of the bureaucracy of private insurers. It is also HR676, the expanded and improved Medicare for All Act, conveniently made invisible every time the major media or policy thinktanks report on the health care crisis, and disqualified by Hillary as “difficult to achieve” for reasons that we are never given. . . .

March 3, 2008 | Permalink | Comments (0) | TrackBack (0)

My Father's Heart: Diane Rehn Show Today

cnThe Diane Rehm show has Steve McKee, editor for the Wall Street Journal, discussing his book, "My Father's Heart."  The blurb for the show states,

After watching his father die from a massive heart attack when he was only fifty-five, Steve McKee decided to do his best to avoid a similar fate. But after a life-time of healthy eating and exercise, he one day discovered he also suffered from heart disease. He talks with Diane about his fight to save his own life, and what he learned about his father.

Amazon reviews of the book here.

March 3, 2008 | Permalink | Comments (0) | TrackBack (0)