HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, February 25, 2011

I Cannot Recommend Him/Her Highly Enough

Is it reference-writing season where you are? Before putting pen to paper consider a couple of prime physician reference cases. New out of the blocks is Chi v. Loyola University Medical Center, N.D. Ill., 2/16/11, available here. An oncology resident brought an action against his Chicago residency training hospital and professor. After completing the residency program notwithstanding a period of academic probation (subsequently remediated) the resident was offered a job in Arizona. The professor filled out forms provided by the new employer. The professor filled out the first form noting "sufficient ability to practice competently and independently in his specialty" but disclosed the probation and noted some "difficulties in interpersonal communication." The professor answered the second form by cross-referencing the first and checked a box next to the phrase "I cannot recommend him/her."

Dealing swiftly with the plaintiff's claims the court held that as a matter of law the defendants' conduct could not be considered extreme or outrageous (Intentional Infliction of Emotional Distress) and that there was no general duty of fair treatment (argued under a Negligent Infliction of Emotional Distress theory). The court also dismissed the plaintiff's claims of tortious interference and defamation.

Chi is an interesting counterpoint to the better known Kadlec v. Lakeview Anesthesia Center, available here. Kadlec is altogether more serious fare. An anesthesiologist at the defendant practice group was suspected of on-duty use of narcotics. Eventually he was terminated. He later found work at the plaintiff hospital. There he became addicted to Demerol and allegedly was responsible for a tubal ligation patient ending up in a permanent vegetative state. After settling that case the hospital and its insurer brought suit against the practice group, the doctor's prior employer, alleging negligent misrepresentation regarding requested references. The Fifth Circuit, applying Louisiana law, found that there could be liability for letters that were affirmatively misleading but that the defendants had no affirmative duty to disclose (referencing a form letter that was sent to the hospital by the Practice Group that confirmed the doctor's prior privileges but said no more). 

I agree with Sallie Sanford's argument that Kadlec notwithstanding "a requirement of greater candor is likely to be adopted either in a subsequent case, by statute, or through hospital accreditation standards." See Candor After Kadlec: Why, Despite the Fifth Circuit's Decision, Hospitals Should Anticipate an Expanded Obligation to Disclose Risky Physician Behavior, 1 Drexel L. Rev. 383 (2009), available here. So let's not forget why we have that Nation Practitioner Data Bank, here, and caveat referrer! [NPT]


February 25, 2011 | Permalink | Comments (0) | TrackBack (0)

Worth Reading This Week

Thursday, February 24, 2011

Naughty or Nice? Quality-Based Reimbursement in Action

Maryland seems to be ahead of PPACA on some quality improvement fronts. The state's Health Services Cost Review Commission operates under a CMS waiver and exclusively sets rates for Maryland hospitals. The Commission uses quality-related measures across three initiatives, Process Measures, Complications, and Readmissions, as described here. The Commission tracks 49 "complications" such as bed sores, infections, and falls (see here). According to an article in today's Washington Post by Julie Appleby of Kaiser Health News, available here, the program seems to have real teeth. Recently, nine hospitals have been denied $2.1m in reimbursement while twenty-three will receive small bonuses. [NPT]


February 24, 2011 | Permalink | Comments (0) | TrackBack (0)

From Viral Marketing to Medical Profile Contagion

As ACA implementation lumbers ahead, and challenges to it slouch toward the Supremes, the U.S. health care system's arbitrary old ways continue to mystify and frustrate. Consider this story on one person's quest to obtain insurance:
Most employees assume that if they lose their job and the health coverage that comes along with it, they’ll be able to purchase insurance somewhere. . . .My husband, teenage daughter and I were all active and healthy, and I naïvely thought getting health insurance would be simple. . . .
Then the first letter arrived — denied. . . .What were these pre-existing conditions that put us into high-risk categories? For me, it was a corn on my toe for which my podiatrist had recommended an in-office procedure. My daughter was denied because she takes regular medication for a common teenage issue. My husband was denied because his ophthalmologist had identified a slow-growing cataract. Basically, if there is any possible procedure in your future, insurers will deny you. . . .
As I filled out more applications, I discovered a critical error in my strategy. The first question was “Have you ever been denied health insurance”? Now my answer was yes, giving the new companies reason to be wary of my application. I learned too late that the best tactic is to apply simultaneously to as many companies as possible, so that you don’t have to admit to a denial.
As was recently reported, "50 to 129 million (19 to 50 percent of) non-elderly Americans have some type of pre-existing health condition." The "health care market" is sending a strong signal: don't step out of the system if you have any continuing need for even minor care. But what's more worrisome are the types of information circulating about you that you aren't even aware of. Consider this story from Businessweek about the profiling of insurance applicants by third-party intermediaries:
Most consumers and even many insurance agents are unaware that Humana, UnitedHealth Group , Aetna (AET), Blue Cross plans, and other insurance giants have ready access to applicants' prescription histories. These online reports, available in seconds from a pair of little-known intermediary companies at a cost of only about $15 per search, typically include voluminous information going back five years on dosage, refills, and possible medical conditions. The reports also provide a numerical score predicting what a person may cost an insurer in the future. . . .
[A] 57-year-old safety consultant in the oil and gas industry, says he tried to explain that the medications weren't for serious ailments. The blood-pressure prescription related to a minor problem his wife, Paula, had with swelling of her ankles. The antidepressant was prescribed to help her sleep—a common "off-label" treatment doctors advise for some menopausal women. But drugs for depression and other mental health conditions are often red flags to insurers. Despite his efforts to reassure Humana, the phone interview with the company representative "just went south," Walter recounts. He and his wife remain uninsured [as of 2008].
Health-related data from a wild west of unregulated intermediaries may spread to employers and other decisionmakers, just as credit scores have migrated from the bank context to influencing insurance pricing, and credit histories now influence employers. Sharona Hoffman has observed that "It is not uncommon for employers to obtain applicants’ and employees’ medical records. According to one source, every year, over ten million authorizations for release of medical information are signed by workers prior to the commencement of employment." She has predicted disturbing possibilities arising out of that accesss to data:
Existing laws, including the ADA, GINA, HIPAA, and their state counterparts, provide important assurances to applicants and employees but are insufficient to guarantee that they will suffer no ill consequences as a result of EHR disclosure to employers. Employees may be especially concerned in times of recession, knowing that financial pressures make workers with health problems particularly unattractive to employers. Employers or their hired experts may develop complex scoring algorithms based on EHRs to determine which individuals are likely to be high-risk and high-cost workers. In addition, in times of financial difficulty, limited resources may be available to implement technology and policies that will secure EHR confidentiality.
Secondary uses of health data could be a very lucrative niche for profilers of the future. Given these possibilities, individuals should at least have the right to access and correct the health data that intermediaries have compiled about them. The FTC recognized this right, and "forced the [insurance] industry to begin disclosing the use of prescription information under . . . the Fair Credit Reporting Act. . . . Copies of prescription reports are supposed to be available to consumers at no charge under federal law." This is a small step forward. But if the "scores" assessing individual risk are compiled according to proprietary algorithms, the consumer may still feel "in the dark," unable to adequately influence the presentation of herself to the insurer. As Esther Dyson has stated in another context, mysterious data flows can jeopardize individual autonomy:
The comforting thing about the kind of data that Facebook primarily deals with is that it’s public. If your friends and other people can see it, so can you.
More troubling is the data you don’t even know about – the kind of data about your online activities collected by ad networks and shared with advertisers and other marketers, and sometimes correlated with offline data from other vendors. By and large, that’s information you can’t see – what you clicked on, what you searched for, which pages you came from and went to – and neither can your friends, for the most part. But that information is sold and traded, manipulated with algorithms to classify you and to determine what ads you see, what e-mails you receive, and often what offers are made to you. Of course, some of that information could go astray.
Online advertisers already slice and dice population segments (and distribute opportunities & exposure to ads) via marketing discrimination. Will the "e-health revolution" bring their methods out of cyberspace, and into the deadly serious business of offering employment and insurance based on estimates of health status that applicants can't understand or challenge? [FP]

February 24, 2011 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 23, 2011

Third Judge Finds New Healthcare Law's Individual Mandate Constitutional

For Those Keeping Score: The WSJ reports that U.S. District Court Judge Gladys Kessler is the third U.S. trial judge to hold that Congress was within its constitutional authority to regulate interstate commerce when it chose to penalize people who forgo health insurance.

'Congress had a rational basis for its conclusion that the aggregate of individual decisions not to purchase health insurance substantially affects the national health insurance market,' Judge Kessler wrote in a 64-page opinion. 'Consequently, Congress was acting within the bounds of its Commerce Clause power.'

The judge also rejected an argument that the law was an undue burden on people who opt not to receive any medical services for religious reasons.

Two other judges have ruled against all or part of it. Most recently U.S. District Court Judge Roger Vinson in Florida, who ruled on a legal challenge brought by a group of 26 states, voided the entire law. [KVT]

February 23, 2011 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 22, 2011

The Price of Privacy

Ever since the HITECH Act (42 U.S.C. 1320d–5, here) toughened up HIPAA enforcement and Secretary Sibelius consolidated security and privacy enforcement in the Office of Civil Rights we have been anticipating a "statement" case. Maybe that day has come. In a News Release today HHS announced the imposition of a $4.3 million civil money penalty on Cignet Health of Prince George’s County, Maryland. [NPT]


February 22, 2011 | Permalink | Comments (0) | TrackBack (0)

House of Representatives Votes to Cut Environmental Programs

The House voted for a Continuing Resolution on Friday that would seriously undermine environmental protections if the Senate fails to counter it effectively. H.R.1 reflects a decrease of $100 billion from the President’s FY 2011 budget. It includes a 30% cut to EPA's budget, the largest percentage reduction in 30 years. The sweeping cuts have generated outrage from environmentalists, illustrated by this release from the Sierra Club. Piling on amendments, the House voted to:

- eliminate US funding to the IPCC (Intergovernmental Panel on Climate Change) for the rest of 2011.

- repeal Clean Air Act provisions aimed at reducing Green House Gases.

- defund certain NASA's satellites.

- scale back environmental regulation of mountaintop removal protections.

- prevent the overhaul of a major federal climate research program.

- sharply slash funding for green energy R&D.

Click here for a wry commentary on these amendments by one of my favorite writers.  

Mary Munson

February 22, 2011 | Permalink | Comments (0) | TrackBack (0)

Monday, February 21, 2011

Conscience Clauses and Health Care

The U.S. Department of Health and Human Services announced its new rule regarding health care and conscience clauses.  The new rule replaces a rule issued in 2008.  It ensures that the law protects health care providers who object to performing or assisting an abortion, while eliminating the confusion from the previous rule that the definition of abortion also included contraception.  Kaiser Health News provided a digest of press reports on the revision. [DO]


February 21, 2011 | Permalink | Comments (0) | TrackBack (0)

Sunday, February 20, 2011

Camille Nelson: "Racializing Disability, Disabling Race: Policing Race and Mental Status"

Camille Nelson, Dean and Professor of Law at Suffolk University School of Law, posted "Racializing Disability, Disabling Race: Policing Race and Mental Status" on SSRN. Here is the abstract:

Camille Nelson This article focuses on police practices in arresting and detaining criminal suspects who have mental illnesses. It identifies three modalities police may adopt when detaining a mentally ill suspect: medical modality (and its subset the family mode), the criminal modality, and the disciplinary modality. This article examines archetypal cases in which harsher treatment of a suspect may be meted out by the police against mentally ill persons of color.

To illustrate the different modalities, this article examines the case study of Donald Winters. Mr. Winters was a Caucasian male who was diagnosed with Delusional Disorder. He had threatened to kill the police officers when they attempted to apprehend him. Police understood they were dealing with a mentally ill suspect, and they restrained themselves from using violence in order to subdue him. In Coghlan v. Phillips, Mr. Coghlan, a white male known to have a criminal record and a history of mental illness, fired four to ten shots at police officers when they initially attempted to arrest him. The police officers did not return fire, but returned with a bullhorn and told Mr. Coghlan they wished to take him to a doctor. These cases are illustrative of the medical and criminal modalities and represent more appropriate police responses to mentally ill suspects. However, police seemingly demonstrate far less tolerance for suspects whose Suspect Identity Construction (“SIC”) is both a minority and mentally ill.

In Banks ex rel. Banks v. Modesto City Schools District, Rosie Banks was a thirteen year old, autistic, African American girl attending a junior high school. Rosie entered a new school and at first behaved in an aggressive manner. She was taken to the principal’s office where an officer confronted Rosie as she became more aggressive and pepper sprayed her in the face. In Reynolds v. City of Little Rock, John Willie Reeves, an African American man known by police to be mentally ill, was shot to death by several officers after waving a pocket knife. In Ali v. City of Louisville, Mr. Marlby was a homeless African American man who was known by several officers to be mentally ill. He was shot to death after an encounter with police. In each of these cases, police officers often chose the disciplinary modality, and often without prior utilization of a lesser modalities.

In these and other cases, the police do not utilize lesser modalities despite their knowledge that the suspect is mentally ill. This article explores the intersection of race and mental status as one that attracts heightened police scrutiny and which disparately leads to excessive use of force. It appears from the case law that the selection of the modality often depends on the racialization of the alleged offender.

February 20, 2011 | Permalink | Comments (0) | TrackBack (0)

Terry Carney: "Mental Health Tribunals as Governance: Lessons from an Australian Study?"

Terry Carney, Professor at the University of Sydney Law School, posted "Mental Health Tribunals as Governance: Lessons from an Australian Study?" on SSRN:

Terry Carney This article draws on a multi-year Australian collaborative study of mental health review tribunals in three jurisdictions (Victoria, New South Wales and the Australian Capital Territory) undertaken in conjunction with the NSW Law and Justice Foundation, using qualitative and quantitative methods to examine the role of mental health tribunals in advancing goals such as fairness, legality and access to treatment. In recognition of shrinkage of state resources available for treatment and care of the mentally ill in many jurisdictions, and limited time and resources for review bodies, the article reflects on stakeholder and client concerns about access to quality treatment and associated support services, review of treatment adequacy and drug regimes, and their ‘participation’ or dignity of engagement in review processes. Building on earlier arguments in favour of equipping tribunals to adequately engage the clinical and social domains in addition to the domain of ‘legal rectitude’, and for ‘flexibility’ of process more characteristic of case-conferencing modes, this article examines the implications of such findings for the interests of clients and overall ‘governance’ in mental health.

February 20, 2011 | Permalink | Comments (0) | TrackBack (0)

Data Segmentation

We continue to see the tensions in patient data protection play out in new and interesting ways. For example, as HHS continues to study the comments from its HITECH-authorized lock-down of HIPAA Privacy NPRM, available here, the White House's OSTP has been touting its "Blue Button" initiative, available here and according to the Markle foundation, here, strongly supported by both doctors and patients. Clicking on the Blue Button will copy a person's PHI from a HIPAA-protected zone (an EMR curated by a covered entity) to a HIPAA-free zone (a PHR).

Two useful reports prepared for ONC by GW's Department of Health Policy provide detail on some of the options available to policymakers seeking to both protect patient data (or at least patient choice regarding such data) and yet share such data for patient and societal benefits. The first report, “Consumer Consent Options for Electronic Health Information Exchange: Policy Considerations and Analysis,” available here, details the various patient consent models with their advantages and disadvantages. The second, "Data Segmentation in Electronic Health Information Exchange: Policy Considerations and Analysis," available here, builds on familiar exceptionalism or data segregation models, such as the treatment of HIV/AIDS tests under state laws or the protection of psychotherapy notes under HIPAA Privacy. With EHRs, of course, we are talking about segmenting the patient's data within the record. Questions posed in this useful report include identifying who should define the segments, whether patient or physician should control the segmentation. Additionally, we will need to study whether there should be an emergency protocol for overriding the segmentation choices.

These are important questions that in many ways will define the future of the relationship of the patient with her EHR far more than the privacy, confidentiality, and consent models heretofore explored.

Nic Terry

February 20, 2011 | Permalink | Comments (0) | TrackBack (0)

Recording the Beginning of Life

Monty Python's Miracle of Birth, the opening sketch from The Meaning of Life (and an inspiration for my work), ends with a fake doctor (played by a real doctor) instructing the new mother, "So, it's lots of happy pills for you, and you can find out all about the birth when you get home. It's available on Betamax, VHS, and Super Eight."  

In 2009 a Minnesota couple live streamed the birth of their child on the Internet, available here and one Idaho hospital allows Skype video transmission to, for example, fathers serving in the military as noted here. Recently, however, a New York Times, article, Rules on Cameras in Delivery Rooms Stir Passions, has noted growing the growing reluctance of hospitals to allow cameras at all or, for example, until five minutes after the birth.

The hospitals' explicit arguments seem to be protection of the privacy of the medical staff (although, with anonymizing masks and other surgical gowns the chance of identification seem limited) and stopping the technology getting in the way of the care and treatment of mother and child (which seems fair enough until one factors in the miniaturization and low light sensitivity of the modern pocket camera). The Times article implies that provider concerns over the evidentiary power  of video recordings in the case of an adverse event is an important additional factor. 

It is hard to identify any kind of legal right in the patient that would permit cameras in the delivery room (or during any other kind of hospital-based procedure) unless, for example, the hospital was in breach of contract or, possibly, its own regulations. More likely to be the subject of litigation are cases where the hospital films or tweets a procedure (as here or fictionalized here) given the difficulty in  extracting appropriate informed consent in such scenarios (as discussed here), or where one of the parties seeks to make use of surveillance video footage. See e.g., Ykimoff v. Foote Mem. Hosp., 285 Mich.App. 80 (2009). 

Nic Terry


February 20, 2011 | Permalink | Comments (0) | TrackBack (0)

Worth Reading This Week

Richard J. Bonnie, James S. Reinhard, Phillip Hamilton, & Elizabeth L. McGarvey, Tragedy and Mental Health System Transformation in Virginia, SSRN

Dayna B. Royal, The Skinny on the Federal Menu-Labeling Law & Why it Should Survive a First Amendment Challenge, SSRN

Jennifer Prah Ruger, Shared Health Governance, SSRN/AJOB

Timothy Stoltzfus Jost, Can Congress Regulate “Inactivity” (and Make Americans Buy Health Insurance)? NEJM, February 16, 2011

Nic Terry

February 20, 2011 | Permalink | Comments (0) | TrackBack (0)

Thursday, February 17, 2011

Most disagree with defunding of health care reform

According to a CBS News Poll 55 percent of Americans disapprove of the plan to cut off funding and 35 percent approve. "Among Republicans, approval rises to 57 percent. Forty-nine percent of independents disapprove, and 38 percent approve… Overall, Americans are wary of the new health care reform laws: 21 percent think the new law will make the system better, but 23 percent think the law will make the system worse."

Nic Terry

February 17, 2011 | Permalink | Comments (0) | TrackBack (0)

What Public Health Can Teach Internet Security Experts

The tech industry is always promising a "new Messiah" to cure what it sees as a backward health sector. I've tried to make the case that internet firms can learn something from health care (here and here). So I was happy to hear of this talk from Scott Charney, corporate vice president for trustworthy computing at Microsoft, on "parallels between real-life viral epidemics and internet viruses." According to an article on the topic:
[S]topping computer malware from spreading should mirror efforts to collectively protect people from public health risks, said Scott Charney. . . . He made the remarks in one of the opening keynotes at the RSA security conference in San Francisco . . . . That means companies, governments and other entities will have to collaborate to eliminate risks to everyone, rather than just look out for themselves.
Charney urged the government to create a bullet-proof identification system that creates online trust and preserves privacy. Companies should also keep making their defenses more secure. But greater effort should be put into the collective defense of the internet, Charney said.
Developing a "bullet-proof identification system" is a huge challenge today, as secondary (mis)uses of data become more pervasive. But I appreciate Charney's argument that no computer, like no person, is an island. - Frank Pasquale

February 17, 2011 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 16, 2011

Jennifer Prah Ruger: "Shared Health Governance"

Jennifer Prah Ruger, Associate Professor at Yale University School of Medicine, posted "Shared Health Governance" on SSRN:

Jennifer Prah Ruger In Health and Social Justice I developed the 'health capability paradigm,' a conception of justice and health in domestic societies. This idea undergirds an alternative framework of social cooperation I call 'shared health governance' (SHG). SHG puts forth a set of moral responsibilities, motivational aspirations and institutional arrangements, and apportions roles for implementation in striving for health justice. I now develop further the SHG framework and explain its importance and implications for governing health domestically.




February 16, 2011 | Permalink | Comments (0) | TrackBack (0)

Expansion of the Government Provision of Health Care and Individual Rights: Panacea or Pandora’s Box?

“The proposal that promoting and protecting human rights is inextricably linked to the challenge of promoting and protecting health derives in part from recognition that health and human rights are complementary approaches to the central problem of defending and advancing human well-being.”  Jonathan Mann.

The Patient Protection and Affordable Care Act will create a much needed expansion of government supported health programs which will improve access to health care for many Americans. However, under current jurisprudence, if the policy makers who craft these new programs fail to proceed with great caution, the expansion of the government provision of health care could come at a significant cost to individual rights. Our country sits at a crossroads with the choice to either proceed to promote the health and well-being of the population while promoting and protecting individual rights or to enhance public health at the expense of these rights.

The threat to individual rights which lurks within the expansion of government supported health care programs originates with the body of jurisprudence built around Rust v. Sullivan. In Rust, the Supreme Court upheld legislation that barred health care providers who accepted government funds from engaging in abortion counseling, referral and activities. The Court held that:

[t]he Government can, without violating the Constitution, selectively fund a program to encourage certain activities it believes to be in the public interest, without at the same time funding an alternative program, which seeks to deal with the problem in another way. A legislature’s decision not to subsidize the exercise of a fundamental right does not infringe the right. There is a basic difference between direct state interference with a protected activity and state encouragement of an alternative activity consonant with legislative policy.

This body of jurisprudence opens the door for programs like the one being pilot tested in West Virginia that I blogged on last week. In early 2007, the federal government approved the West Virginia Pilot Project which provides health care for low-income, Medicaid beneficiaries. This program, and ones like it, is an attempt to respond to the ‘obesity crisis’ and the overall rise in health care costs. The West Virginia Pilot Project punishes those who do not join, and religiously adhere to, weight-loss or anti-smoking programs, or who otherwise fail to strictly comply with doctor's orders or to comply with government mandates. The punishment for this failure to conform is the denial of important medical services. A recent study of the program indicates that it is, in fact, negatively impacting access to health care. This type of paternalistic program violates the harm principle as it reaches out to broadly regulate the behavior of low-income individuals that is self-regarding; in other words, conduct that impacts only the individual. It is the first step on a slippery slope of potentially ever-expanding limitations on freedom of choice and individual rights, all in the name of public health.

Advances in genetic testing and in the science of pharmacogenomics that presage a new world of individualized medicine elevate the seriousness of this concern. Will this mean, for example, that a person with a particular genetic code must take a medication that pharmacogenomics dictates as the recommended treatment to ameliorate the condition and the long-term costs associated with treatment of the condition in order to qualify for future treatment of that medical condition? Taking this to the hypothetical extreme, what about a woman who has a BRACA-1 or 2 mutation with a very high probability of the future development of breast/ovarian cancer? Will she be forced to undergo surgical removal of her breasts and ovaries in her 20s in order to maintain her  health care coverage and obtain treatment later in life if she contracts cancer? Is there a principled way to draw a line between what is acceptable regulation of self-regarding behavior with relation to health and what is not?

As we move forward to develop public health programs that deal with the rising cost of health care, it is hoped that we are able to design programs that seek to both promote public health while protecting individual rights.


February 16, 2011 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 15, 2011

Mark Rienzi: "The Constitutional Right to Refuse: Roe, Casey, and the Fourteenth Amendment Rights of Healthcare Providers"

Mark Rienzi, Assistant Professor at Catholic University of America - Columbus School of Law, posted "The Constitutional Right to Refuse: Roe, Casey, and the Fourteenth Amendment Rights of Healthcare Providers" on SSRN:

Mark Rienzi The Fourteenth Amendment rights of various parties in the abortion context – the pregnant woman, the fetus, the fetus’ father, the state – have been discussed at length by commentators and the courts. Surprisingly, the Fourteenth Amendment rights of the healthcare provider asked to provide the abortion have not. Roe and Casey establish a pregnant woman’s Fourteenth Amendment right to decide for herself whether to have an abortion. Do those same precedents also protect her doctor’s right to decide whether to participate in abortion procedures?

The Court’s substantive due process analysis typically looks for rights that are “deeply rooted” in our history and traditions. Accordingly, this article addresses the historical basis for finding that providers do indeed have a Fourteenth Amendment right to refuse to perform abortions. This historical analysis shows that the right to refuse passes the Court’s stated test for Fourteenth Amendment protection. In fact, the right to refuse actually has better historical support, and better satisfies the Court’s stated tests, than the abortion right itself.

Beyond this historical case, a healthcare provider’s right to make this decision also fits squarely within the zone of individual decision-making protected by the Court’s opinions in Casey and Lawrence v. Texas, and protects providers from the types of psychological harm that the Court recognized in Roe and Casey. For these reasons, under Roe and Casey, a healthcare provider has a Fourteenth Amendment right to refuse to participate in abortions.

February 15, 2011 | Permalink | Comments (0) | TrackBack (0)

Protecting Public Health and Welfare against Greenhouse Gases Hits a Snag

 Last week, Republican leaders made it clear that the Environmental Protection Agency (EPA) will not have an easy time with proposals to regulate carbon dioxide and other greenhouse gas (GHG) emissions. At a congressional hearing on Wednesday, EPA Administrator Lisa P. Jackson was assailed for her plans to begin setting emission limits, with a NY Times article reporting that she was accused of “putting the American economy in a straitjacket.” Rep. John Shimkus (R-Ill.), chair of the House Energy Committee was quoted in a Washington Post article saying that  EPA's "regulation will skyrocket costs that will destroy jobs."

On Friday, House Republicans introduced legislation that would strip U.S. EPA of its funding to regulate CO2 emissions, gut the State Department's climate aid programs and slash funding for energy and climate research across the federal government. It would also prevent the president from replacing departing climate and energy czar Carol Browner or creating "any substantially similar position." See description of the bill here. On January 31, 2011 Republican Senator John Barrasso of Wyoming introduced Senate Bill 228 that would prevent EPA from regulating GHGs without specific congressional authorization. Texas Rep. Ralph Hall, the new chairman of House Committee on Science and Technology, has called climate change a "massive international scientific fraud, quoted by the Miami Herald here


In 2009, the EPA issued a finding that  CO2 and other GHGs pose a danger to public health and welfare based on evaluations of the risks associated with changes in air quality, increases in temperatures, changes in extreme weather events, increases in food- and water-borne pathogens, and changes in aeroallergens. This GHG endangerment rule became effective a year ago. This was a major step in the struggle to regulate GG under the Clean Air Act, sparked off by the Supreme Court’s landmark decision in Massachusetts v. EPA that held that the agency has authority to regulate GHG emissions. In a December 2010 press release, the EPA announced that it was now working on GHG standards for fossil fuel power plants and petroleum refineries—two of the largest industrial sources, representing nearly 40 percent of the GHG pollution in the United States.

Even if the EPA is undermined, states are taking up the slack by launching their own programs to combat GG emissions, according to an article in USA Today.

- Mary Munson

February 15, 2011 | Permalink | Comments (0) | TrackBack (0)

Monday, February 14, 2011

Margaret Gilhooley: "Drug User Fees, Health Priorities, Politics, the Deficit and Reform Directions"

Margaret Gilhooley, Professor Emeritus at Seton Hall Law School, posted "Drug User Fees, Health Priorities, Politics, the Deficit and Reform Directions" on SSRN:

Margaret Gilhooley The Food and Drug Administration now depends on user fees paid by drug companies to support more than half the salaries of the medical reviewers who advise the agency on the appropriateness of approving a drug. The funding creates a substantial risk of "capture" of the agency by the industry. Under the program, which started in 1992, drug companies pay a fee that permits the agency to hire additional reviewers to make more timely reviews on whether a drug can be approved. Under the law, the agency seeks to meet performance goals for the timing of reviews, giving the program the appearance of having a fee-for-service basis.

The legislative authorization for the fees expires every five years, and the agency and the industry negotiate behind closed doors on the renewal and the performance goals for the reviews. The need for renewal creates an opportunity for the passage of laws that might not have been enacted separately. Some believe the Administration may accept measures of debatable merit to avoid having to layoff needed reviewers. Limiting the user fee support to half the Government appropriation for the program, and making the program permanent can alleviate the capture and linkage problems.

This paper maintains that reforms and changes in the policy rationale for the program are needed before locking-in a permanent funding commitment at a time of debate about growing budget shortfalls. Instead of a fee-for-service rationale, the program should be based on a health review rationale. A study is needed to identify better priority rankings and goals for drug reviews, rather than the simple categories and negotiations that now exist. To avoid the risk of capture, the revenues from the fees should not exceed the Government funding for the program. Making the fee program permanent would address the linkage problem but providing permanent funding can undercut Congress' responsibility to determine important budget allocations in a time of concern about deficits. If the program is made permanent, the law should make clear that Congress can reduce the funding level for the fees to deal equitably with funding cutbacks in other programs made in light deficit considerations. Congress should also have to approve any major increases in the fee levels. The significance of the user fee program and the reforms needed, before it is made permanent, warrant wide attention.

February 14, 2011 | Permalink | Comments (0) | TrackBack (0)