HealthLawProf Blog

Worth Reading This Week

Elizabeth Sepper, Whose Conscience Counts? SSRN

Aaron Kesselheim & Rahul Rajkumar, Who Owns Federally Funded Research? The Supreme Court and the Bayh–Dole Act, N Engl J Med

Sharona Hoffman & Andy Podgurski, Balancing Privacy, Autonomy, and Scientific Needs in Electronic Health Records Research, SSRN/SMU L.Rev. 

[NPT]

Conference on Accountable Care Organizations

Accountable Care Organizations (ACOs) are a hot health care reform topic. ACOs are supposed to improve quality and reduce waste by promoting coordination of care and best practices.  But they could spur clinical and business relationships that run afoul of antitrust law and other federal and state regulation.  On Oct. 28, 2011, Seton Hall University's Health Law and Policy Program will feature a stellar lineup of attorneys, academics, and physicians to address the thorny legal issues raised by (ACOs).  The luncheon keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers. Dr. Brenner was featured by Atul Gawande in a New Yorker story that applauded his tireless work to improve the quality of care for disadvantaged individuals in South New Jersey. Brenner has demonstrated that a rational health care system can “lower medical costs by giving the neediest patients better care.”

For more information and the registration, click here.

[FP]

Inspirational Healthcare In(ter)ventions

The New York Times has an excellent section on "low-cost innovations that can save thousands of lives." A conversation today focuses on Dr. Paul Polak, a 78-year-old former psychiatrist.

[Dr. Polak] has focused on creating devices that will improve the lives of 2.6 billion people living on less than $2 a day. But, he insists, they must be so cheap and effective that the poor will actually buy them, since charity disappears when donors find new causes.

His greatest success has been a treadle pump that lets farmers raise groundwater in the dry season, when crops fetch more money. He has sold more than two million, he said. He also helped develop a $25 artificial knee and a $400 hospital lamp to save newborns with life-threatening jaundice.

Dr. Polak's work reminded me of an inspirational conference in Boston, organized by Kevin Outterson, the Ewing Marion Kauffman Foundation, the Rhode Island College of Pharmacy, Universities Allied for Essential Medicines & Mind the Health Gap. Una Ryan, President & Chief Executive Officer of Diagnostics for All, gave a powerful presentation on her company's quest to bring tests to individuals for pennies. Developments like these indicate that conditions for the world's poorest can actually improve. X-Posted: Concurring Opinions. [FP]

ACA Amici

Kevin Outterson is tracking amicus briefs by health law professor groups at the Incidental Economist blog. You can send him updates for his chart, at mko@bu.edu

[DO]

 

Readmission Rates and HACs

Section 3025 of the Affordable Care Act, here, reduces Medicare payments by 1% in 2013, 2 % in 2014 and 3% thereafter for hospitals with exclusive readmissions. However, a report from the RWJ-funded Dartmouth Atlas Project, here examined 10.7 million Medicare discharges from almost 2000 hospitals from 2004-09. Their findings are disturbing; significant variations across hospitals and regions and, overall, no real progress nationwide in reducing the readmission rate. Indeed, almost half of the surveyed academic medical centers showed an increase in readmission rates. Will the imminence of CMS sanctions focus hospital attention on a potentially serious loss of revenue? And how will such readmission numbers caused by Hospital Acquired Conditions impact hospital revenues denied under state Medicaid programs as provided for by section 2702 of the Affordable Care Act and its resultant NPRM, here? [NPT]

 

When Unsafe Drinking Water Hits Home

Yesterday morning I brewed some tea, and then saw a newspaper story revealing that my town's water supply "contained high levels of lead," nearly "six times the national standard." Letters of warning has been sent out to residents, but I had not received mine - it came at noon.

As an environmental lawyer with knowledge about lead standards, I knew that lead is toxic over long priods, not just from limited morning teas. And I have always felt that the Safe Drinking Water Act (SDWA) has an adequate public notice section ("§141.85 Public education requirements") which requires customer notification to be "timely," and not more than 30 days. But I still resented being told yesterday about a problem discovered on August 30th. As the person ingesting the lead, I could not figure out why the chief water plant operator could not have picked up the phone and called the local newspaper the day he saw the test results. But the law did not require it - he just needed to provide the written notice within 30 days. "I did not try to drag it out" he said, "we're a small plant, we don't have great staffing, but I did it as fast as I could."

(I also learned that the water tanks were painted with lead based paint. As the plant operator candidly admitted, "I never thought they would put lead inside a tank.")

From a water consumer's standpoint, the SDWA regulations can be improved by simply adding a requirement for media announcements of standard violations. That may not reach everyone, and dissemination depends on outlets' decisions to carry the story. But it would have improved the likelihood that I would not have been drinking lead tainted tea for the past 25 days.

[MM]

Sharp Increase in the Cost of Health Insurance

The full details of the Kaiser Family Foundation's Employer Health Benefits 2011 Annual Survey are here. [NPT]

SCOTUS, Meet ACA

The White House has decided to forego a request for an 11th Circuit rehearing on the constitutionality of ACA (that likely would have delayed resolution to 2013) and go directly to the Supreme Court. Jennifer Haberkorn and Sarah Kliff have good pieces in Politico, here, and the Washington Post, here, discussing the reasons and ramifications.Will this be the most politically charged Supreme Court case since Bush v. Gore? Randy Barnett read those tea leaves 18 months ago, here. [NPT]

Worth Reading This Week

David Challoner & William Vodra, Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices, N Engl J Med

Micah Berman, A Public Health Perspective on Health Care Reform, SSRN/Health Matrix

Abigail Moncrieff, Safeguarding the Safeguards: The ACA Litigation and the Extension of Structural Protection to Non-Fundamental Liberties, SSRN 

Lorian Hardcastle, A Critique of the Governmental Health Sector Tort Jurisprudence, SSRN

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International Neuroethics Society Meeting, November 11 and 12, 2011

The International Neuroethics Society Annual Meeting will be held on Thursday, November 10, and Friday, November 11, 2011. This meeting will be held in conjunction with the meeting of the Society for Neuroscience, a 30,000 person plus meeting in Washington, D.C., which will be held from Saturday, November 12 through Wednesday, November 16, 2011. 

Of particular interest will be the law panel which will focus on neuroscience in real cases. The three speakers, each of whom was involved as a professional in one of the iconic cases involving law and neuroscience, will briefly present his thoughts on his case and then participate in a question and answer period. As described by Professor Hank Greely:   

∙  Steve Greenberg is the lawyer who introduced fMRI evidence of psychopathy into a capital sentencing case (the Dugan case in Illinois).  There's a fascinating write-up of that case in Nature magazine - 464 Nature 340 (Mar. 18, 2010). 

∙  Houston Gordon is the lawyer who tried, unsuccessfully, to introduce for the defense some fMRI lie detection evidence into a federal criminal trial. This led to a 2 day evidentiary hearing and an extensive written opinion in United States v. Semrau. 

∙  Russell Swerdlow is a neurologist who was the treating physician for a man who pleaded guilty to sexual molestation of his 12 year old step-daughter after a year or so of increasing interest in pornography.  Just before sentencing, the man was found to have a tumor the size of a chicken egg pressing on his left frontal lobe.  When the tumor was removed, the defendant reported that his urges disappeared.  He was released on probation; about 10 months later, his urges returned.  So had the tumor.  When the tumor was surgical removed again, so were the urges.  See the case report at 60 Arch. Neurol. 437 (2003). 

This session is scheduled for 2:45 to 4:00 on Friday, November 11, 2011. 

The Annual Meeting has a poster session on November 10 in the evening.  If you are interested in participating in the poster session, please submit a 500 word abstract by October 1. The top 25 abstracts will be published in an on-line issue of The American Journal of Neuroethics - Neuroscience.  Submitters of the top 5 abstracts will be presented orally at the Annual Meeting.  And the two best abstracts will win $250 each in travel reimbursement from the Society. See the Call for Abstracts here.

The meeting will be at the Carnegie Institution for Science, 1530 P Street, Washington, D.C.  Registration for the meeting is $135 for members who register before September 15 and $145 if after September 15. For any questions, please contact Professor Hank Greely. [KVT]

Obama Retreats on Ozone Standards, but Improvements are Going Forward

Earlier this month, the Obama administration withdrew draft ozone ambient air quality standards that the U.S. Environmental Protection Agency (EPA) was about to issue. However, it is important to understand that despite the retreat, the ”fallback” ozone standards are still an improvement over the 1997 standards we have in place today. But it is too bad politics and jobs rhetoric intervened.

In a statement, the President indicated he was abandoning the proposed scientifically recommended ozone standards of 60-70 parts per billion, due to concerns about easing regulatory burdens during this time of economic recovery. According to the Bloomberg news article, the EPA rule was one of the seven most costly rules to business, since it would create many new non-attainment areas where businesses would need to spend considerable money to achieve compliance. According to the L.A. Times,  Obama’s decision was a direct result of criticism by the business community and the Republican Party that such rules would be “job killers.”

However, the proposed standards had also been strongly supported by others, with the EPA Administrator herself admitting that the standards promulgated under Bush, were “legally indefensible, as reported by the N.Y. Times. 

The decision to back down on the stricter standards upset many health and environment factions.  A Huffington Post article quoted Janice Nolen, assistant vice president of the American Lung Association, as being "outraged," given that "the current standard used was based on the science as of 14 years ago -- before we knew that ozone killed people."  The National Latino Coalition on Climate Change issued a report criticizing this decision as “leaving hundreds of millions of people in the United States facing unacceptable level of risk” and that ozone risks disproportionately affect Latinos, since they live in areas with the most exposure. The American Academy of Pediatrics, American Thoracic Society and the American College of Preventive Medicine are among many organizations that supported the now-abandoned standards, according to the American Medical Association news. 

This seems to be another example of where Obama has chosen to back down on health measures and capitulated to criticisms that his measures would hurt jobs. In commenting on the President’s lack of spine, I think Al Gore said it the best in his blog:

“Instead of relying on science, President Obama appears to have bowed to pressure from polluters who did not want to bear the cost of implementing new restrictions on their harmful pollution—even though economists have shown that the US economy would benefit from the job creating investments associated with implementing the new technology. The result of the White House’s action will be increased medical bills for seniors with lung disease, more children developing asthma, and the continued degradation of our air quality.”

The lack of spine is regrettable but perhaps understandable. The President's proposed American Jobs Act is a centerpiece of his activites this month, highlighted in his speech at joint session of Congress two weeks ago. He may view this action as heading off criticisms that he claims to be creating jobs while killing them off by regulations. However, to bolster his leadership, he could have deflected criticisms by defending the proposed standards, asserting that a need for new ozone control technology would create jobs (as Al Gore suggests above). Now the President is open to criticims that he is weak, and appears to flip flop on science based issues.

However, as mentioned above, the news is not completely bad. The 2008 Bush-era standard (75 parts per billion instead of the proposed 60-70 ppb standard) is still an improvement. Because these 2008 national standards had been suspended while the new proposal was being promulgated, since 2008 states have been allowed to enforce an earlier, 1987 standard of 84 ppb. The history is explained well in a recent Wall Street Journal article.

[MM]

Expensive Glasses: Monopol-eye?

Why are eyeglasses so expensive? Take a listen to this podcast. If you're like me, you'll learn a lot about how to save on your next pair. And there's a lesson or two about the failures of contemporary antitrust law. Finally, it mentioned a company called WarbyParker.com, which apparently not only has reasonable prices, but also gives away a free pair to the needy for every pair it sells. [FP]

State Medical Boards Can Place Restrictions on Physicians in Practice Specialties

Puerto Rico regulations that prohibit physicians from performing cosmetic surgery if they are not trained in that specialty do not violate the U.S. Constitution pursuant to a federal appeals court ruling in Gonzalez-Droz v. Gonzalez-Colon, 1st Cir., No. 10-1881, 9/16/11. According to BNA Reports,

[t]he U.S. Court of Appeals for the First Circuit said the regulations satisfied the constitutional test that they reflect a “rational basis” for creating a regulatory distinction between different classes of physicians—those who are trained to perform cosmetic surgery and those who are not. The court also found the application of those regulations to a specific physician, Dr. Efrain Gonzalez-Droz, did not violate his civil rights.

In upholding the regulations, the court found Puerto Rico reasonably determined that a general license to practice medicine was insufficient to ensure patients were not injured and that the regulations were needed to guide and protect patients. Using board certification in dermatology or cosmetic surgery was a reasonable surrogate for classifying those authorized to provide those services, the court said.

[KVT]

Drug Deaths Now Outnumber Traffic Fatalities

According to a story in the LA Times, drug deaths now outnumber traffic fatalities:

Propelled by an increase in prescription narcotic overdoses, drug deaths now outnumber traffic fatalities in the United States, a Times analysis of government data has found. Drugs exceeded motor vehicle accidents as a cause of death in 2009, killing at least 37,485 people nationwide, according to preliminary data from the U.S. Centers for Disease Control and Prevention. While most major causes of preventable death are declining, drugs are an exception. The death toll has doubled in the last decade, now claiming a life every 14 minutes. By contrast, traffic accidents have been dropping for decades because of huge investments in auto safety.

[KVT]

The Flu Season Is Coming, But Where Is Tylenol?

"Summer is ending and that means we can look forward to the flu season. But reaching for the Tylenol is no longer a sure thing, since the venerable pain reliever remains largely out of stock. This is due, of course, to ongoing manufacturing difficulties that Johnson & Johnson has had for nearly two years thanks to bottles that smelled musty, contained too much active ingredients or metallic specks, among other things." Read More. Hat to tip Pharmalot. [KVT]

Florida Law Prohibiting Firearm Questions Fails First Amendment Scrutiny

 According to BNA Reports:

A Florida law that prohibits physicians from asking patients whether they own firearms likely violates physicians' free speech rights under the First Amendment to the U.S. Constitution, a federal district court ruled Sept. 14 (Wollschlaeger v. Farmer, S.D. Fla., No. 1:11-cv-22026, 9/14/11). The U.S. District Court for the Southern District of Florida preliminary enjoined enforcement of Fla. Stat. §790.338, popularly known as the “Firearm Owners' Privacy Act.” The court said the act interfered with physicians' rights to counsel their patients on safety issues involved in firearm ownership.

[KVT]

Roche Halts Delivery To Greece Over Payments

For the second time since Greece began facing a fiscal crisis, a big drugmaker has stopped delivering drugs to the beleaguered nation. More specifically, Roche is no longer sending meds for cancer and other afflictions to state-owned hospitals that have not paid their bills and the drugmaker may do the same in other countries, such as Spain, Italy and Portugal, where bills are going unpaid. Read More. Hat tip to Pharmalot. [KVT]

Worth Reading This Week

Jaime King, And Genetic Testing for All....The Coming Revolution in Prenatal Genetic Testing, SSRN/Rutgers L J 

Rebecca Rausch, Health Cover(age)ing: The Weight of Health Insurance Fat Taxes, SSRN/Nebraska L. Rev.

Margaret Gilhooley, Commercial Speech, Drugs, Promotion and a Tailored Television Advertisement Moratorium, SSRN/Health Matrix

[NPT]

 

An Icarian Arc: From Therapy to Enhancement to Self-Harm?

The publication of The Philosophy of Viagra: Bioethical Responses to the Viagrification of the Modern World, edited by Thorsten Botz-Bornstein, has capped a series of recent responses to medical technology at the borders of normal human functioning and enhanced experience. The editor diagnoses Viagra "as the drug of a capitalist society convinced that any efficient medication approved by the state signifies progress and higher levels of happiness." He asserts a skepticism that Pascal Bruckner and Michel Foucault would each find congenial (in their own ways). The book looks to be an excellent theoretical companion to Hard Sell: The Evolution of a Viagra Salesman. Men might want to consider reading either book before resorting to "pills marketed as male sexual enhancement supplements," since they "sometimes contain up to seven times the recommended dose" of "sildenafil citrate, the active ingredient in Viagra." [FP]

Sacrificing Seniors

Sarah Kliff on why the healthcare industry favors raising the Medicare eligibility age, here.