HealthLawProf Blog

Environmental Public Health Law

In the Spring 2011 Special Supplement to the Journal of Law, Medicine & Ethics, Richard J. Jackson and Timothy F. Malloy explore the emerging field of Environmental Public Health Law (EPH). In “Environmental Public Health Law: Three Pillars,” 39 J.L. Med. & Ethics 34 (2011) the authors point out how the protection of human populations (a focus of Public Health law) and the protection of plant and animal species, the oceans, and other natural systems (the focus of environmental law) are often inextricably linked. They argue that more resources should be put in studying the role of the environment in disease genesis and prevention, and developing the law to incorporate those scientific findings. EPH threats are “immense and complex”, and “cross many disciplines and bureaucratic jurisdictions.” The article concludes by applying organizing principles of prevention, systems thinking, and an interdisciplinary framework, a partnership between science and the law “will yield substantial public health benefits for the future.”

This brief but insightful article is a good reminder that environmental laws, whose stated purposes are often to protect human health, belong in the health law debates. Lawyers from environmental agencies need to better liaise with scientists in public health agencies and practitioners, who have long acknowledged the need to reduce environmental health threats. The World Health Organization long ago acknowledged the links between environment and public health in its Health and Environment Linkages Initiative. The mission of the National Institutes of Environmental Health Sciences is to “reduce the burden of human illness and disability by understanding how the environment influences the development and progression of Human disease.” So environmental agencies are working on the front lines of public health protection.  

The Environmental Protection Agency (EPA) has a division that conducts research on health and environmental effects. Four of EPA’s seven priorities mention actions to protect human health. Despite this, the major political discourse on EPA administered laws like the Clean Air Act and the Clean Water Act is often dominated by debates about the laws’ adverse effects on business or the economy.  The programs and laws that the EPA administers need to be analyzed in the discussions about public health care and disease prevention approaches in a more comprehensive way. The growth of the EPH Law field, by creating platforms for interdisciplinary and cross-agency interaction, will hopefully provide EPA with more support in its mission to protect the public.

Worth Reading This Week

Susan Appleton & Robert Pollak, Exploring the Connections between Adoption and IVF: Twibling Analyses, SSRN/Minnesota L.Rev. Headnotes

Eleanor Kinney, Realizing the International Human Right to Health: The Challenge of For-Profit Health Care, SSRN/West Virginia Law Review

Paul B. Ginsburg, Spending to Save — ACOs and the Medicare Shared Savings Program, NEJM

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Stimulus Checks Get Cut

As tediously explained here the HITECH stimulus package provided approximately $27 billion for CMS to reimburse eligible providers (non-hospital based doctors) and hospitals for the meaningful use of certified EHR technology. 

CMS has now cut the first checks under the program, paying out $75 million, as noted here. The first checks went to three Massachusetts physicians (starting at $18,000) and to Beth Israel Deaconess Medical Center ($2.57 million), as described here.

Meanwhile the Meaningful Use Workgroup of the Health IT Policy Committee at ONC continues to refine the standards for Stage 2 of Meaningful Use, as documented here.

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Medicare lessons from NY-26

Republicans won big with seniors in 2010 by attacking Democrats over the reform law’s Medicare cuts. How predictable was it that, this year, Democrats would attack Republicans if they put out a plan with Medicare cuts? About as predictable as politics can get.

And likewise, now that the Democrats have gotten so much mileage out of beating up on the Ryan plan — a process that will continue with the upcoming Senate vote on it — expect a sharper Republican attack against any Medicare savings plan the Democrats put out on their own. That includes Obama’s deficit reduction plan, which strengthens the Independent Payment Advisory Board, the reform law’s panel of experts who are supposed to propose more Medicare savings. 

Perceptive piece by David Nather in Poliitco, available here, on the lessons to be learned about Medicare reform and electoral cycles. For an early piece on IPAB by Tim Jost in NEJM, see here and for current attacks on the Board from all sides as reported by the New York Times, see here.

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Finding Good Drugs Is Harder Than It Sounds

Interesting piece, available here, in The Atlantic by Megan McArdle discussing the translational hurdle in drug development and the relationship between pharma and academic research. [NPT]

Call For Speakers: “Reaching Out Beyond the Classroom: Health Law Professors Interacting with the Real World”

The AALS Section on Law, Medicine, and Health Care will hold a program during the AALS 2012 Annual Meeting in Washington, D.C. We are issuing an open Call for Speakers to fill the remaining slot on this panel.  To be considered, please submit a one or two paragraph summary of your topic to [email protected] by August 22, 2011.  Submissions will be reviewed by members of the Executive Committee of the Section on Law, Medicine, and Health Care, and authors will be notified in September 2011.

 The brief description is as follows: 

“Reaching Out Beyond the Classroom: Health Law Professors Interacting with the Real World”

 In addition to the law school clinical programs that directly represent patients in hospital and other health care settings, there are many ways in which health law professors are interacting with the medical community outside of the classroom. Jennifer S. Bard, Alvin R. Allison Professor of Law at Texas Tech University School of Law, will moderate and speak of her experience as a professor in a law and medical school developing a JD/MD program; JoNel Newman, Director of the Health and Elder Law Clinics at the University of Miami School of Law, will discuss her innovative program in which a hospital-based clinic has developed into a setting where law students and medical students work together to learn about and address patients’ legal and medical needs. Next, Marshall B. Kapp, Director, Center for Innovative Collaboration in Medicine & Law and Courtesy Professor of Law at Florida State University will present on his efforts to bring the legal and medical professions closer together. Finally, Wendy E. Parmet, George J. and Kathleen Waters Matthews Distinguished University Professor of Law at Northeastern University School of Law, will discuss the role of Northeastern's innovative co-op program in bringing students with interests in health law directly into health care settings beyond what would be possible in an externship or summer clerkship. 

We encourage you to share your own experiences bringing health law outside of the classroom by submitting a proposal. 

Participants will be responsible for paying their Annual Meeting registration fee and travel expenses.  Full-time faculty members of AALS member and fee-paid schools are eligible to submit papers.  Foreign, visiting, and adjunct faculty members, graduate students, and fellows are not eligible to submit. 

Inquiries should be submitted to Professor Jennifer Bard, Texas Tech University School of Law, [email protected] 

Guest Blogger Vickie J. Williams: Liberalizing Credentialing and Privileging for Telemedicine

In a development that may have more immediate and practical effect on the way many of us receive our health care than all the health-care reform going on at the congressional and executive level, in the May 5, 2011 Federal Register, The Centers for Medicare and Medicaid Services (CMS) quietly published their final rule on Telemedicine Credentialing and Privileging for Medicare-participating hospitals and Critical Access Hospitals (CAHs).  The rule liberalizes the Medicare Conditions of Participation (CoPs) to allow hospitals and CAHs to rely on practitioner credentialing and privileging that has been done by another Medicare-participating hospital to allow the practitioner to provide telemedicine services to the hospital’s patients.  Prior to this rule, CMS required a hospital to go through a full credentialing and privileging process for all practitioners providing services to its patients, including those providing telemedicine services, even when the practitioner was never going to set foot in the hospital or physically touch a patient.  In order to take advantage of the liberalized credentialing and privileging process for telemedicine providers, the receiving hospital must also ensure that the telemedicine practitioner holds a license issued or recognized by the state in which the hospital whose patients are receiving the telemedicine services is located, and the receiving hospital must have evidence of an internal review of the distant-site practitioner’s performance of the distant-site’s privileges.  At a minimum, the review must include all adverse events that result from telemedicine services provided by the distant-site practitioner to the hospital’s patients, and all complaints that the hospital has received about the distant-site physician or practitioner.  42 CFR §482.22.  The final rule is very similar to the proposed rule that was published a year ago, but expands the reach of the alternative credentialing for telemedicine providers to allow a hospital or CAH to contract with non-hospital entities providing telemedicine services to hospitals and CAHs, as long as such contracts meet Medicare CoPs.  The new rules are effective as of July 5, 2011.

 

It is nice to see CMS acting relatively quickly to facilitate what can be a cost-effective and relatively simple way to enhance quality-of-care and provide access to specialists for people in rural and outlying areas.  As a resident of a small city that is a medical hub for a large, sparsely populated, I am well aware of the value of telemedicine services, and I support this liberalization.  Nevertheless, the comments submitted in response to the proposed regulations, and CMS’ responses to those comments, raise a few interesting legal questions that I have been pondering for a while (but have not yet managed to put in a law review article).  For example, if the receiving hospital is relying on the credentialing and privileging process of the distant-site hospital or telemedicine entity, the potential defendant pool in a negligent-credentialing malpractice case is expanded to include a hospital or entity that never actually treated the patient.  And if a hospital or entity in a remote location is accused of negligent credentialing or other malpractice-type wrongdoing, there could be a serious question regarding whose standard of care applies to the situation.  The requirement that the actual practitioner providing the telemedicine services be licensed in the same state as the receiving hospital may dictate that the law of the state of the receiving hospital will apply to any malpractice alleged against the practitioner, but presumably the credentialing and privileging by the distant-site entity took place in the remote location.  There could also be questions about personal jurisdiction and venue for a suit against the distant-site entity, which probably make you shudder just to consider.  You might have guessed from my articulation of these issues that I teach Conflict of Laws and Civil Procedure in addition to Health Law, and I see a really good exam question coming out of this scenario in some law students’ futures.

 

Another interesting thought was raised by a commenter who believes that the liberalized credentialing and privileging contemplated under the rule are likely to be misused by hospital and CAH governing bodies to “sidestep” medical staff decisions regarding credentialing and privileging, and to economically pressure hospital-based practitioners because it will now be easier to replace them with distant-site practitioners.  CMS’ response basically brushed this comment aside, stating that the process of privileging by proxy has been common for hospitals accredited by The Joint Commission (TJC) for some time, and that there are no indications that such problems have arisen.   Besides feeling sorry for the practitioner who submitted the comment, who must have a very distrustful relationship with the hospital or CAH that employs the commenter, I am also not so sure that I would dismiss this comment so cavalierly.  Hospitals that use economic reasons or “business decisions” as rationales for closing departments and terminating staff privileges without going through the processes outlined in the medical staff bylaws have been relatively successful in having courts uphold those decisions.  To the extent that the liberalized credentialing and privileging rules make telemedicine less expensive and more convenient for hospitals and CAHs, the rules may very well have the ultimate effect of making it easier for hospitals to terminate physicians or other practitioners without triggering the protections of the medical staff bylaws.  This is not necessarily a bad thing, nor is it necessarily within the realm of things that CMS should consider when making this rules change, but there is evidence that it is a real issue.  How one feels about this depends on whether one views medical staffs as anti-competitive cartels that need to be busted, or as legitimate protectors of quality and independence for physicians and medical practitioners.  Sort of like the way people line up in the debate about whether tenure for faculty is a good thing or a bad thing, but I won’t get into that here.

 

Finally, the most amusing thing in the regulations was contained in a part of federal register that I usually just skim over, and I suspect most of you do the same.  In the section about “Anticipated Effects” of the new rule, the CMS states that it believes that in order to implement the new rule, the initial services of a hospital or CAH attorney will be needed for 12 hours at a cost of $86 per hour.  This salary figure is based on recent wage estimates from the Bureau of Labor Statistics (BLS), and marked-up 33% for benefits.    Does anybody know a brand new attorney with even minimal knowledge of health care regulation who could produce a regulation-compliant contract, and who bills at $86 per hour?  If you do, I think we can promise him or her a steady stream of customers!

- Vickie J. Williams

I drove up to the emergency room and the emergency room was gone!

How many thousands of hypos have we spun about hospitals? But, I'm guessing, we never got close to what happened at St. John's Regional Medical Center in Joplin Mo., as detailed here. Our prayers to everyone there.

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Feds Rebuff Assault on Planned Parenthood

The federal government has objected to Indiana's effort to block federal family planning dollars from going to Planned Parenthood in the state.  Under legislation passed this year, Indiana would no longer cover cancer screening, treatment of sexually transmitted diseases or other services at Planned Parenthood clinics in its Medicaid program.  As the New York Times reported today, Indiana's law violates the federal requirement that states permit Medicaid beneficiaries freedom of choice in choosing their health care providers.

In a surprising decision two weeks ago, a federal district court denied Planned Parenthood's request for a temporary restraining order.  The statute also raises serious constitutional questions with its definition of viability at 20 weeks, its requirement that doctors tell women that their fetuses can experience pain, and other provisions.

Dollars for Doctors

Pro Publica continues its series subtitled "How Industry Money Reaches Physicians," available here, with new reports on drug industry ties to medical societies and enforcement failures in medical schools' conflict of interest policies. 

Worth Reading This Week

Victor R. Fuchs & Arnold Milstein,The $640 Billion Question — Why Does Cost-Effective Care Diffuse So Slowly? NEJM,  May 18, 2011 (subscription)

Beatrice Jesse Hill, "Whose Body? Whose Soul? Medical Decision-Making on Behalf of Children and the Free Exercise Clause Before and After Employment Division v. Smith," SSRN/Cardozo Law Review

Jeffrey A. Parness, State Damage Caps and Separation of Powers, SSRN/Penn State Law Review

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Questioning Body Modification

[I've decided to put the whole post beneath the fold, since the topic reminds me of Leontius's Tale, and I don't want anyone to accidentally click through to something they don't want to see.]

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USDA Creates the "Food Desert Locator" - Locations with Limited Access to Nutritious Food

The U.S. Department of Agriculture's (USDA) Economic Research Service (ERS) has created the online Food Desert Locator which pinpoints the location of what the U.S. government calls "food deserts." Food deserts are areas where people have limited access to affordable and nutritious foods. The Food Desert Locator is on the Web at www.ers.usda.gov/data/fooddesert. 

The departments of Treasury, Health and Human Services and USDA define a "food desert" as a low-income census tract where either a substantial number or share of residents has low access to a supermarket or large grocery store.

 According to Food Safety News:

"Low income" tracts are defined as those where at least 20 percent of the people have income at or below the federal poverty levels for family size, or where median family income for the tract is at or below 80 percent of the surrounding area's median family income.

Tracts qualify as "low access" tracts if at least 500 persons or 33 percent of their population live more than a mile from a supermarket or large grocery store (for rural census tracts, the distance is more than 10 miles).

According to the USDA, about 10 percent of the 65,000 census tracts in the United States meet that definition.  Mostly in urban areas, these food desert tracts are home to 13.5 million people.The USDA, in a news release, said the tool can be used by policy makers, community planners and others to identify places where public-private intervention might help make fresh, healthy food more readily available, one of the goals of First Lady Michele Obama's Let's Move! initiative to address the epidemic of childhood obesity.

[KVT]

EPA Rules on Hazardous Emissions Delayed

Yesterday, the U.S. Environmental Protection Agency (EPA) issued a stay postponing the effective date of emissions standards for major source boilers and commercial and industrial solid waste incinerators. Because the original boiler rule was vacated, there is no rule currently in place.  

On February 21, 2011, the EPA established Clean Air Act emissions standards for large and small boilers and incinerators that burn solid waste and sewage sludge. The standards cover more than 200,000 boilers and incinerators that emit air pollutants, including mercury, cadmium, dioxins and particle pollution.  The final rule, published on March 21, 2011, called for an effective date of May 20, 2011 with compliance deadlines beginning three years later.

An industry coalition    4 led by the American Forest & Paper Association and the National Association of Manufacturers fought the standards for dioxin and other dangerous emissions, claiming in a petition that they were not achievable, and that the companies forced to comply would suffer economic harm.  

An excellent report about the boiler rule, and the legal claims in the industry’s successful petition to stay the rule, was done by the Environmental Newswire, available here.

Guest Blogger Vickie J. Williams: Physician Work Hours and Expanded Insurance Coverage

With all of the attention being paid to the various challenges to PPACA currently winding their way through the appellate courts, it is easy to forget that there is other interesting work being done that could impact health care reform.  The Government Accountability Office recently released a study entitled “The Effect of a Major Coverage Expansion on Physician Work Hours:  Evidence from the Children’s Health Insurance Program.”  The study found that there was a large negative relationship between the magnitude of a state’s CHIP expansion and trends in pediatricians’ work hours.  When more children became insured by an expanded public health insurance program, pediatricians who would presumably be treating this population actually worked fewer hours, despite an increase in demand for their services.  States that implemented a large CHIP expansion experienced a larger drop in pediatrician hours worked than states that implemented more modest CHIP expansions.   The authors of the study conclude that a possible explanation for this is that the reimbursement rates in the CHIP program are much lower than those of private insurers.  This supply-driven theory goes as follows:  CHIP expansions reduced average reimbursement rates for pediatricians. Physicians control the volume and type of services they provide (they don’t take all comers).  Physicians will continue to have the same fixed costs, such as durable equipment or office capacity (including the number of hours the office is open and the number of hours they work), regardless of the reimbursement rate they receive.  Therefore, physicians will realign their fixed-cost decisions to fit better with the types of patients they are seeing.  In this model, pediatricians would choose to work fewer hours as CHIP enrollment expands, because the reimbursement rates for seeing CHIP patients do not meet their supply-side needs.  These results are consistent with an older study from the New England Journal of Medicine which showed that when universal coverage for physician services was implemented in Quebec, Canada in 1970, average physician work hours fell by about 15 percent.

These results are intriguing for a number of reasons.  First of all, they have implications for how successful the PPACA will be (assuming it survives the current legal challenges) in increasing access to health care.  In addition to expanding the market for private insurance, PPACA relies on expanded enrollment in public insurance to reduce the number of uninsured.  To presume that increased access to public insurance, which will continue to pay rates below those paid by private insurers, will translate to increased access to health care, may be a mistake.  Unless health care providers are incentivized in some way (financial or otherwise) to treat these patients, increased demand will not necessarily increase supply.  As long as there are enough people with better-paying private insurance to keep health care providers busy, providers have no incentive to increase supply to meet the increased demand.  After all, for most people, if you make enough to live comfortably doing the amount of work you are currently accustomed to doing, any extra work you do has to really be worth it.  Children covered by public insurance programs, such as Medicaid and CHIP, are more likely to have medical problems that are complicated by less-than-ideal living or social conditions.  Yet rather than pay pediatricians more to deal with these children’s complex problems and make the extra work worth it, according to a 2009 study by Ingenix Consulting, we pay physicians who treat these children more than 40% less than the national average reimbursement rate for a physician office visit.  Clearly, expanded insurance coverage alone is not the answer to our nation’s health care problems.

Although the PPACA provides for an increase in Medicaid payments to primary care physicians to equal the somewhat higher Medicare payment rate for 2013 and 2014, I don’t think this is likely to be enough to incentivize physicians to take these complex Medicaid patients when private insurance pays far more for physicians to do what is often far less. In the absence of appropriate incentives to make publicly funded patients attractive to physicians, the other option would be to change the supply-side predicate that physicians do not take all comers—mandate that physicians who accept any federal money treat all comers. This is what became necessary to ensure that hospital emergency rooms did not refuse to treat patients, resulting in the wildly unpopular (amongst hospitals) unfunded mandate the Emergency Medical Treatment and Labor Act (EMTALA). Another option would be for state licensing authorities to require physicians to treat a certain number of publicly funded patients as a condition of licensure.  Of course, if all states did not do this at the same time, this would result in a flood of physicians fleeing any state that implemented such a mandate.  

Physicians and other providers must make some hard decisions regarding whom they are willing to treat, and for how much, if they want to avoid having those decisions made for them.  I presume it would be more palatable to physicians if we reduce incentives to treat only privately insured patients by lowering payment rate differentials between privately and publicly insured patients, than to force physicians to treat all comers (or some percentage of comers).  If the GAO’s suggested supply-driven model of physician behavior holds true, and physicians truly want freedom from the tyranny of state or federal mandates, they should probably be embracing the changes in the private and public insurance market that would equalize coverage for all persons currently being debated in Congress and the courts.

- Vickie J. Williams

PPACA at the 4th Circuit

Dahlia Lithwick at slate.com has a nice review of the 4^th Circuit oral argument last week.  My own take on the individual mandate and the activity-inactivity distinction will be appearing later this month at Southern California Law Review Postscript.

[DO]

Worth Reading This Week

Elizabeth Weeks Leonard, Can You Really Keep Your Health Plan? The Limits of Grandfathering under the Affordable Care Act, SSRN/Journal of Corporation Law

Classen DC et al, 'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured, Health Affairs (subscription)

David Hyman, PPACA in Theory and Practice: The Perils of Parallelism, SSRN/Virginia Law Review

Alain Enthoven, Reforming Medicare by Reforming Incentives, NEJM

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2011 Milliman Medical Index

The annual Milliman Medical Index is available, here, and as usual contains some useful (and scary) statistics. The cost of healthcare jumped another 7.3% over the last year, with costs doubling in just nine years. Even though the rate of increase is flattening it still exceeds other sectors of the economy. The two largest drivers of cost increase this year? Outpatient facility costs (up 10%) and hospital inpatient care (up 8.6%). The 2011 report also stirs healthcare reform into the mix noting that it is a minor player in the current trends (no surprise) and may not lead to significant changes in the underlying cost of medicine as measured by the index (somewhat surprising?). The full report is available here (PDF).

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The HEALTH Act Moves On

The Help Efficient, Accessible, Low Cost, Timely Health Care (HEALTH) Act, H.R. 5, discussed here last week, has been approved by the House Energy and Commerce Committee, here. The bill contains the core AMA/MICRA wish-list (on which see the RAND study here); noneconomic caps, contingency fee controls, collateral source abrogation, punitive damages standard and cap, several liability, and periodic payments. 

Probably the most interesting feature of the bill is Section 11, the partial preemption provision (Congress clearly hasn't learned much from HIPPA's "more stringent…" language). The statute is broadly preemptive of state laws unless those laws are more favorable to providers. There is a partial exception for caps which states may set lower or higher than the federal ceiling.

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Ag-Gag: A Black-Boxed Food Supply

I recently discussed the OIRA’s contribution to some terrible incidents in egg safety. Denis Sterns has written a challenging article on the bigger picture, explaining “Why Food in the United States May Never be Safe:”

This article . . . interrogates the idea of food safety by opening the question of whether a rational economic actor in a free market for food can reasonably be expected to invest in improving the safety of the food products he makes and sells. It is precisely the lack of (cr)edibility in the market – i.e., the absence of reliable quality signals, the lack of traceability, the high degree of anonymity, and the destruction of trust – that creates the structural impediments and powerful disincentive for improving the quality and safety of food. . . . Recall the huge public uproar, and swift policy changes, that followed the release of video of “downer” cattle being abused at a California meat plant. To obtain the video, the Humane Society had to sneak someone inside the plant to secretly record the offending conduct.

The secrecy of some food suppliers is very troubling. Stearns proposes constant surveillance of their actions: “With video cameras always in place . . . one can only expect that most of the shocking conditions that are found after the fact of an outbreak would be less likely to occur in the first place.” Stearns also criticizes FDA’s “wholly voluntary and largely ineffective” traceback regulations, which would make it easier to find the source of contaminated food. (Maybe the FDA is too busy chasing down raw milk co-ops.)

Unfortunately, Big Meat appears all too eager to hide their actions from both concerned citizens and animal rights activists. Consider the rash of legislation designed to deter actions like the Humane Society’s:

The animal advocacy group Mercy for Animals sent an undercover investigator to E6 Cattle Company in Texas, where he filmed calf abuse over a two-week period. To prevent such whistleblowing, several states have passed so-called “Ag-gag” laws that would make it illegal to clandestinely film inside slaughterhouses, sparking what animal rights activists fear will be a nationwide trend. . . . “They’re trying to criminalize someone being an eyewitness to a crime,” Jeff Kerr, [PETA]’s general counsel, said.

One of Chinese dissident Ai WeiWei’s biggest “offenses” against the Chinese government was trying to publicize the names of the children killed when shoddy schools collapsed after an earthquake. Criminalization of exposes of contamination and animal abuse in America’s heartland could be one more step toward the convergence of Chinese and US politico-economic structures.

[FP]