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Mental Health Update: Expanding Services, But Limiting Access

Posted Feb 06 2013 12:00am

zack-buck_4 As I mentioned here last month, government leaders are turning their attention to mental health issues focusing on diagnosis and access to treatment, in particular in the wake of the horrific shootings at Sandy Hook Elementary School in Newtown, Connecticut in December.  Even though it remains unclear whether or not the shooter suffered from any form of mental disorder, many leaders have argued that expanding treatment access for those suffering from mental disorders will prevent future tragedies.

As President Obama pledges to define the new mental health essential benefits under the Affordable Care Act (“ACA”), state leadership is also beginning to react.  Perhaps somewhat surprisingly, South Carolina Governor Nikki Haley (R) the leader of the state that had cut mental health funding by nearly 40 percent from 2009 to 2012 (mentioned here ) is now leading the call to increase funding and services for those diagnosed with mental illness.

In addition to her proposal to increase funding for mental health services by $16 million in the summer of 2012, Haley has now called for an additional $11.3 million in funding for the South Carolina Department of Mental Health (“SCDMH”); in fact, her total proposed budget for the SCDMH in the 2013 budget is $17 million .  Haley has been particularly outspoken on the issue, noting that “[t]here is nothing wrong with someone who has a mental health issue….  There is something very wrong when that person doesn’t get treatment….  These are good productive citizens that deserve to live good, healthy life [sic].  And if given treatment they can be incredibly successful.  If not given treatment, we as a state have failed.”

She has argued that increasing funding for mental health treatment can prevent another tragedy like the one seen at Newtown.  Treating an increase in mental health funding as an alternative to implementing additional gun control or gun safety measures, Haley mentioned that “[n]o amount of gun control can stop someone from getting a gun when they want to get it.  What we can do is control mental health in a way that we treat people.”

Undoubtedly, the increase in funding is an abrupt policy change from South Carolina’s recent history.  From 2008 to 2012, the state was cutting funding to the South Carolina Department of Mental Health by an average of $70 million per year .

Ironically, however, Governor Haley is speaking during the exact same time that all states are deciding whether or not to expand their Medicaid programs under the ACA which would affect many individuals’ access to mental health services.  Just earlier this week , Ohio Governor John Kasich (R) agreed to expand his state’s Medicaid program, while Pennsylvania Governor Tom Corbett (R) has decided to opt-out of the expansion.  Corbett’s refusal made Pennsylvania the eleventh state to decline to expand its Medicaid program.  And who else is staunchly opposed to expanding her state’s Medicaid program?

South Carolina Governor Nikki Haley.

This past summer, Governor Haley announced “ via Facebook that South Carolina ‘will NOT expand Medicaid, or participate in any health exchanges ’” (emphasis in original).  According to the Health Affairs Blog , South Carolina’s refusal to expand its Medicaid program would prevent more than 500,000 South Carolinians from being granted healthcare coverage.  In other words, if Haley had decided to expand her state’s Medicaid enrollment pursuant to the ACA, South Carolina’s Medicaid enrollment would increase from about 951,000 currently (which is nearly one in every five South Carolinians) to nearly 1.5 million in FY 2014.

Governor Haley’s recent positions create a situation in which the state is increasing funding for mental health service offerings in the state, but is refusing to expand coverage ( paid for in whole by the federal government for three years ) to many individuals who currently lack access to the services. Needless to say, positions taken on health policy issues cannot be examined in isolation.

Indeed, according to the Congressional Budget Office, if all states agreed to opt-in to the Medicaid expansion under the ACA, 13 million more Americans would have their mental health treatments covered by Medicaid.  However, given the policy positions like those of Governor Haley, this unfortunately remains highly unlikely.   Treatment offerings can increase, but if individuals do not have insurance coverage to pay for those services, access and receipt of those services is likely to remain largely elusive.

Being involved in the immigrant community as a member and a professional, my concerns in any legal field almost instinctively gravitate towards how my fellow immigrants would be affected. Thus, when examining the regulatory changes to health law under the Patient Protection and Affordable Care Act (PPACA), I was disappointed to discover that the large pool of undocumented immigrants living in the United States will continue to receive absolutely nothing, regardless of the impact that this might have on them, U.S. citizens and Legal Permanent Residents.

The most important changes in the United States health care system under PPACA are probably the requirements for all individuals to have medical insurance and the expansion for eligibility for government-funded health insurance under Medicaid which will include people from any age range so long as they meet certain financial criteria. However, none of the changes apply to undocumented immigrants. As noted by the Congressional Research Service,

PPACA expressly exempts unauthorized (illegal) aliens from the mandate to have health coverage and bars them from a health insurance exchange. Unauthorized aliens are not eligible for the federal premium credits or cost-sharing subsidies. Unauthorized aliens are also barred from participating in the temporary high-risk pools.

PPACA mandates that all individuals maintain “minimum essential” health insurance (public or private) or else pay a “shared responsibility payment” to the government in the form of additional taxes at the end of the year. The individual health insurance requirement is a smart move because it will have the effect of injecting financial resources into the health care system through payments to private and public insurances. However, the exemption of over 10 million undocumented immigrants currently living in the U.S. from the individual health insurance requirement under PPACA is disadvantageous because it wastes resources that are readily available to further fund the health care system. Specifically, the exemption is wasteful because statistics show that the undocumented immigrant community includes a large number of healthy individuals who would provide more financial support for the system, while not exacting more in health care costs than they have paid in.

Under Medicaid, an individual is eligible if he or she is a U.S. citizen or a legal permanent resident for at least 5 years; no changes to these criteria were made through PPACA. And, again, undocumented aliens are forbidden from taking part in the Health Insurance Exchange and thereby whatever discounts one might expect from this competitive marketplace. Thus, the desirable benefit of having health insurance will remain unattainable for undocumented immigrants who are unable to afford the costly expenses of having non-discounted and un-subsidized private insurance. So for the large undocumented immigrant population there will be no change with regard to their accessibility to the health care system, and the only available coverage will continue to be through the Emergency Medical Treatment and Active Labor Act (EMTALA) and any available local government health benefits that might be offered in each state.

Having EMTALA as one of the few viable options for medical treatment for all uninsured individuals, regardless of their immigration status, is harmful to the financial stability of the health care system because the type of treatment that must be made available under EMTALA is for emergency medical conditions. Inherently, the costs for treating an emergency condition, which is defined as a condition that could reasonably be expected to place the health of the individual in serious jeopardy or cause serious impairments to bodily functions, is much higher than providing care for preventive medical treatment before the emergency stage. Thus providing health care government assistance to undocumented immigrants for preventive treatment could save the government money in the long run.

The possibility of negative consequences to U.S. citizens when denying affordable medical care to undocumented immigrants should be contemplated when considering an extension of health coverage for minimal essential benefits to undocumented immigrants. For instance, it would be far less costly for the government to subsidize pre-natal treatment for undocumented mothers-to-be  (who will, by virtue of their being here, give birth to American citizens)   than to assume the costs for the lifetime of a U.S. citizen who is born with permanent disabilities. Similarly it would be less costly for the government to provide enough medical insurance coverage for an individual to be checked for HIV/AIDS rather than assume the costly treatment to U.S. citizens that could have acquired HIV/AIDS from an immigrant that did not know that he or she was carrying the disease.

Because providing undocumented immigrants some type of  health benefit or greater access to health insurance  would be more beneficial to the country in numerous ways, the U.S. government should consider putting to use all the financial and human power potential that the undocumented immigrant community offers rather than casting them out as less than worthy human beings.

Noemi Simbron is a native of Peru and a current law student at Seton Hall University School of Law. Her interest in immigration law stems from her current work as a law clerk at a well known immigration law firm in Newark, N.J., and her own background. She hopes to one day represent her fellow immigrants in a variety of legal fields– including immigration.

Emblem-notice.svg Health experts and non-experts alike agree that the U.S. healthcare system is in need of significant reforms. Yearly increases in health insurance premiums are particularly vexing. To relieve some of the pressure, President Barack Obama promised significant reforms when he signed the Affordable Care Act (“ACA”) into law –- arguably the biggest healthcare overhaul in U.S. healthcare history since the passage of Medicare and Medicaid in 1965.

One of the key additions to the ACA is section 2718 of the Public Health Service Act, which requires health insurance issuers offering individual or group coverage to submit annual reports to the Secretary of Health and Human Services on the percentages of premiums that the issuer spends on reimbursement for clinical services and activities that improve healthcare quality and to provide rebates to enrollees when the issuers fail to meet the given year’s minimum requirements.

Under the direction of section 2718, the National Association of Insurance Commissioners (“NAIC”) developed uniform definitions and standardized calculating methodologies, which the HSS fully adopted, for requiring issuers to spend at least 80-85% of their premiums on actual medical care, with the remaining 15-20% going towards administrative costs, marketing, and other non-health care-related expenses. The NAIC defined these activities as the Medical Loss Ratio (“MLR”), also known as the 80/20 rule.

In response to consumer advocates’ concerns the final rule implementing the MLR standards, was revised to establish a mandatory onetime simple MLR informational notice requirement for issuers in the group and individual markets that meet or exceed the applicable MLR standard. The purpose of the notice was to inform the current subscribers of the new regulation. These onetime MLR informational notices are different from MLR rebate notices, which have to be send every time the issuer fails to comply with the 80-85% requirement The final MLR regulation entered finally into effect on June 15, 2012.

This new MLR rule reflects the ACA’s main goal to ensure that “hardworking, middle class families […] get the security they deserve” and that every American is protected from the “worst insurance company abuses.” Essentially, the MLR is intended to help ensure that all of us receive value for our premium dollars by requiring health insurance companies to spend at least 80-85% on healthcare and activities that improve the quality of healthcare (“QIA”). However, if the issuers spend less than the required minimum of 80-85%, they will have to return the portion of the premium revenue in excess of the limit as a rebate.

The new amendment requires all issuers, independent of whether they complied with the 80-85% MLR rule to notify their subscribers of this new regulation, which is an important step towards reinforcing consumer protection. However, as I argue in this post even the improved notice rule falls somewhat short of addressing all of the consumer advocates’ concerns.

In the global scheme of the current MLR regulation, consumer advocates are satisfied with the added notice requirements. However, they demand that the Department of Human Health and Services (“HHS”) strengthens the notice requirement, removes ambiguities and takes a step further by requiring health insurance companies to disclose how much they have spent on healthcare and quality of care in their current and previous year.

Consumer advocates believe that these improvements will increase health plan transparency, reduce consumer confusion, and ensure that all consumers receive information about how their premiums are spend. However, there is some criticism from health insurance companies about the added notice requirement. They claim that, in addition to the added cost of preparing and sending out notices, providing consumers with more information will only lead to more confusion as to how the 80-85% MLR is calculated. They reason that because the MLR has many value enhancing services that, according to the issuers, are not captured by the MLR formula, but nevertheless benefit all of us, we as consumers will draw mistaken inferences about insurer’s spending. Essentially, keeping us in the dark about how insurance companies spend OUR premium dollars, as was the case in the past, will only benefit us – along the lines “I know what’s best for you, so the less you the know/care the happier you’ll be.”

In an attempt to meet the demands of consumer and health insurance advocacy groups, the HHS adopted a balanced approach seeking to minimize the cost of additional notice requirement to the issuers while protecting the interests of consumers. Essentially, the HHS determined that while failing to require MLR information notices from issuers would result in reduced transparency, any greater notice requirements, like those demanded by the consumer advocates, would impose a greater burden on the issuers than is necessary. As such, the HHS decided to merely impose a simple onetime notice that only provides standard limited information about the MLR rule. However, the HHS misses the mark.

First, the MLR notices are intended to simply inform consumers of the existence of the new law. The fact that they were required to be sent only this year, raises the question of whether the notices will reach every subscriber as intended. Also, even assuming that they do reach every subscriber, the problem with the onetime notice is that all future subscribers will be out of luck and thus remain ignorant. However, Issuers that owe rebates will still be required to send out rebate notifications. There is an interesting notion in the regulation where the HHS explicitly “allows” issuers to voluntarily send out MLR notices. But, relying on issuers’ willingness to volunteer additional disclosure is not only impractical, but can be counterproductive because sending out random notices will only increase confusion and irritation among consumers. The ongoing annual MLR notices, on the other hand, will establish a ubiquitous presence, which is essential in creation of new expectations among consumers. Knowing where and how the premiums are spend, will likely reduce consumers’ resentment and disappointment with the relentless annual health insurance cost increases.

Second, the general information about the MLR rule and the actual MLR percentages is available on the HHS website and must be referenced in the MLR informational notices. Thus, the issuers’ fear that providing such detailed MLR information to the consumers in the notices will be too burdensome and counterproductive, is unjustified. Rather, by requiring the issuers to provide more information in the actual MLR notices, the HHS would only ease consumers’ access to such information and enable consumers to evaluate their issuer’s performance on the spot. Likewise, issuers contention that consumers might misinterpret the MLR information because the MLR formula is too complex and contains value enhancing services that according to the issuers, are not captured in the MLR formula, is unpersuasive because the NAIC and the HHS have already determined that MLR is a reliable measure of issuers’ performance in terms of their healthcare and quality of care versus administrative spending. Accordingly, the HHS should require issuers to include more information about the MLR in general, and demand that issuers’ provide their current and past year’s MLRs.

Finally, issuers argue vehemently that the mandatory notice requirement is too costly and imposes a great burden on the issuers. There appears little support for that. The HHS has already determined that the benefits to consumers will outweigh the administrative costs incurred by insurers through the issuance of notices to the policyholders. In particular, according to the HHS estimates, the total administrative cost for preparing and mailing notices to issuers that meet or exceed the MLR target would merely amount to approximately three million dollars, an average cost of $9,000 to 10,000 per issuer for the 2011 reporting year, translating to an average added cost of $0.16 per enrollee for preparing and sending a notice by mail, including labor and supply costs. Importantly, the estimates are for the first time notices only. By requiring frequent annual notices, the cost of such notices can be reduced even further as the notices become more automated. This only supports the recommendation that the HHS should require annual notices.

With these important amendments to the final rule the HHS can expect to achieve greater transparency and more accountability regarding how the issuers use their premium revenue, which is the main purpose of the ACA.

The HHS has promulgated an important consumer empowering regulation, but there is still a lot of work to be done. Consumers deserve to know how their premium dollars are spent and demand that the bulk of their premium dollars is primarily spent on health care.  The MLR rules help move us toward that goal.


Ina Ilin-Schneider is a fourth year part-time student at Seton Hall University School of Law. She graduated summa cum laude from Hunter College in 2008 with a B.A. in Psychology and a minor in Economics. While an undergraduate, Ina worked as a teaching assistant in the “Statistical Methods in Psychology” class and as a research intern at the Memorial Sloan-Kettering Cancer Center performing analysis on prevalence of alcohol abuse in the gay community. During her second year of law school, Ina served as a Judicial Intern to the Magistrate Judge, the Honorable Mark Falk, providing assistance in legal research and drafting memoranda on legal questions. Ina intends to practice compliance law after she graduates in May of 2013.

seton hall law review Just a quick note to commend this issue to readers of HRW. As I note in an introduction to the volume, the articles are uniformly insightful contributions to very topical issues in health law and policy.




Adopting Accountable Care Through the Medicare Framework
Baraba J. Zabawa, Louise G. Trubek, and Felice F. Borisy-Rudin

Temi Kolarova
Executive Editor
Daniel E. Bonilla
Managing Editor
Desiree L. Grace
Symposium Editor
Gianna Cricco-Lizza
Business Editor
Michael C. Smith
Senior Articles Editor
Jason S. Cetel
Articles Editors
Christopher Fox
Meghan McSkimming
Elizabeth C. Ralston
Lauren Winchester
Comments Editors
Eric M. Dante
Melissa M. Ferrara
Brandon M. Fierro
Rebecca Garibotto
Terrance Romasco Gallogly
Joseph K. Jakas
Submissions Editors
Robert S. Garrison Jr.
Ryan P. Montefusco
Andrew L. Van Houter

Health Law, anti-fraud In response to the jarring and horrific shooting at Sandy Hook Elementary School in Newtown, Conn. on Dec. 14 , Pres. Obama signed a number of executive orders last week, flanked by schoolchildren and Vice Pres. Biden .  The official investigation into the contributing factors and details surrounding the mass shooting continues, but much of the public discourse on the policy response has already begun in earnest.  Most solutions seem to be focused on addressing two identifiable “causes” of the shooting:  first, the availability of guns (and especially, semiautomatic weapons), and second, the lack of mental health care services available to Americans who struggle with mental disorder.

Although it is clear that a high-capacity gun was used to perpetrate the assault, there has been no clear evidence that the shooter had been diagnosed with any mental disorder.  In fact, assuming a link between mental disorder and the Newtown shooting continues to reinforce destructive stereotypes and stigma about mental illness, according to many experts .  As many who study the subject area know, mental disorder does not equal violence .  Instead, those with mental disorder are no more likely to be dangerous than those without a diagnosis .  Further, at this point, no one could say with confidence that mental illness was a contributing cause or even a factor that led to the magnitude or occurrence of the shooting – opposite, of course, from the individual’s ability to get a high-capacity semiautomatic weapon.

Ironically, however, given President Obama’s response last week, this may be a vital inflection point in the fight to extend healthcare coverage for those diagnosed with mental illness.  As I have noted in the past here , states are trimming back their mental health budgets – even while up to 20 percent of Americans are diagnosed with some form of mental illness each year.  In a confounding policy response, a handful of states have cut funding by more than 30 percent since 2009.

In such a climate, many advocates hailed the Affordable Care Act (“ACA”) as an opportunity to improve mental health parity and coverage throughout the country.  Finally, many argued, individuals diagnosed with mental disorder would have their treatments covered by plans established within state-run exchange plans and the Medicaid expansion.  But, through last year, this seemed to be likely an unrealized hope, as the Department of Health and Human Services (“HHS”) loosened the regulations governing the scope of essential health benefit coverage under the ACA.

Assumedly in an effort to increase the likelihood of state buy-in to the ACA, two recent publications  by HHS gave states extremely wide latitude in determining what each state’s benchmark plans were required to cover for mental health services.  In addition to giving states the ability to substitute coverage for certain services each state saw fit, HHS did not explicitly tell the states which mental health services they must cover.  In other words, HHS guidance did not set a “federal floor” for the states’ plans.  Further, other guidance seemed to conflict with a liberal reading of mental health essential health benefits.  In defining an essential health benefit under the ACA, a 2011 Institute of Medicine report noted that states were required to only cover services that were “ medically necessary ,” without sufficient guidance .  Indeed, holistic mental health treatment does not always meet this limiting requirement.  Thus, it seemed – to the dismay of many mental health advocates – that insurance coverage may not be substantially changed or expanded under the celebrated ACA.

That is, until last week.  As part of President Obama’s response to the shootings, he said he would address that gap in the ACA.  He specifically noted that he would contact state officials to clarify both Medicaid requirements and new exchange plan requirements .  In effect, the President may be establishing a specific “federal floor” – a minimum of mental health services that states must cover.  Importantly, President Obama also mentioned that regulations that require equal coverage for mental health services (parity requirements) would be finalized .

Thus, even as advocates cringe to hear the public’s further stigmatizing and (at least to this point) unfounded linkage between mental disorder and the horror seen at Sandy Hook, mental health coverage under the ACA may actually be expanded after all.  This reversal in policy is undoubtedly stunning, but how much coverage for individuals diagnosed with mental disorder actually changes – and how and if this expansion actually prevents future incomprehensible massacres like Newtown – remains to be seen.

Tara Ragone On January 10, 2013, New York City Mayor Michael Bloomberg announced [1] that the City’s eleven public hospitals will comply with voluntary emergency room guidelines aimed at stemming the abuse of prescription opioid painkillers.

The New York City Emergency Department Discharge Opioid Prescribing Guidelines (“Guidelines”) highlight that the federal Emergency Medical Treatment and Active Labor Act (“ EMTALA ”) “does not require the use of opioid analgesics to treat pain.”   Given their risks, “[o]pioid analgesics should not be considered as the primary approach to pain management in discharge planning for patients.”

According to the Guidelines, only when deemed professionally appropriate to prescribe these drugs, emergency department (“ED”) prescribers should prescribe no more than a short course of short-acting opioid analgesics, such as hydrocodone (e.g., Vicodin), immediate-release oxycodone (e.g., Percocet), and hydromorphone (e.g., Dilaudid), for acute pain.  The Guidelines define “short course” as no more than three days’ worth of medication for most patients.

ED providers should altogether avoid prescribing long-acting or extended release opioid analgesics, like OxyContin, Methadone, and Duragesic patches, however, because they “are not indicated in the management of acute or intermittent pain.”

The Guidelines further recommend that EDs as a matter of policy refuse to replace prescriptions for opioid analgesics that are claimed to be lost, stolen, or destroyed.  In rare instances, it may be reasonable to dispense a single dose of the medication from the ED, but only where the ED physician “confirmed the need directly with the patient’s physician.”

An article in the New York Times reports some critics’ concerns that the Guidelines will prevent doctors from providing care to poor and uninsured patients who may use EDs as their primary source of medical care.  In addition, Dr. Alex Rosenau, president-elect of the American College of Emergency Physicians, is quoted as criticizing the Guidelines for preventing him from being a professional and using his judgment.

In fairness to the Bloomberg Administration, the Guidelines expressly note that they are not intended to apply to “patients in palliative care programs or with cancer pain.”    They further recognize that they “do not replace clinical judgment in the appropriate care of patients nor are they intended to provide guidance on the management of patients while they are in the ED.”

This suggests doctors retain the ability to exercise their professional judgment to deviate from the Guidelines in appropriate cases. Indeed, Dr. Rosenau apparently does not speak for the New York State Chapter of the American College of Emergency Physicians, which endorses the Guidelines, according to Bloomberg’s press release .

But implicit in the Guidelines is the assumption that appropriate prescribers are available to provide palliative care or substance abuse treatment to patients with needs that demand more than the Guidelines permit.

The number of uninsured Americans remains significant, even with the Affordable Care Act’s reforms.  Many individuals with health insurance, moreover, have difficulty finding specialists who participate in their plans or may have to wait weeks or months for an available appointment.  How are ED prescribers supposed to know which patients will be able to secure a timely follow-up appointment and which ones require ED discretion?

Another potential concern with the Guidelines is how they may impact ED use by patients seeking opioid prescriptions.

It is possible that the Guidelines will drive up demand for painkillers from ED services at private emergency rooms in New York City and public or private emergency rooms in areas bordering New York City that are not bound by the Guidelines.   As the New York Times article reports, although the City cannot impose the Guidelines on its 50 or so private hospitals, some already have agreed to adopt them, including NYU Langhone Medical Center and Maimonides Medical Center.   If they don’t, it’s reasonable to predict demand for pain medications may spike at these facilities, which effect would not address the underlying problem but instead would just shift its locus.

ED use could even increase at hospitals electing to comply with the Guidelines.  A patient who previously obtained a ten-day dosage of pain medication from a single ED visit, for example, might more than triple her ED use because now she may only obtain a three-day dosage in each visit.  This risks exacerbating the ED high utilizer problem that so many current reforms aim to reduce.

There also seem to be holes in New York’s prescription monitoring program that limit its value as a tool to help ED physicians decide how to exercise their discretion.

For one, although the Guidelines recognize that prescribers can “access the New York State Controlled Substance Information (CSI) on Dispensed Prescriptions Program for information on patients’ controlled substance prescription history,” the Guidelines do not require ED prescribers to do so.

Even if ED physicians access the database, current law only requires pharmacists to update the registry every two weeks.  While this may identify historical patterns of abuse, the reporting delay severely hampers the ability of physicians to timely identify concurrent or more recent doctor shopping.

Effective August 27, 2013, New York’s database arguably should become more valuable as a tool for identifying drug seeking behavior.   Pursuant to Public Health Law Section 3343-a , prescribers in New York will have to check the database before prescribing controlled substances, and pharmacists will have to update the database in real time.

But importantly, subparagraph (2)(a)(v) of this law exempts ED prescribers from the requirement to check the database prior to prescribing controlled substances as long as the prescription does not exceed a five day supply, which the Guidelines generally prohibit.   New York’s registry also will not contain information about prescribing in other states, such as bordering New Jersey and Connecticut.

Although not a substantive criticism of the Guidelines, it also is interesting to note the potential tension between this initiative and news that New York City’s public hospitals are negotiating to experiment with performance pay.  As a recent article in Forbes chronicled, there is evidence that doctors overprescribe medications, including powerful narcotics, to help secure higher patient satisfaction scores and, in turn, greater compensation.  If this performance plan goes through, it will be worth watching how ED doctors in New York City public hospitals balance the need to comply with the Guidelines with their desire to maximize their compensation.

Mayor Bloomberg rather cavalierly dismissed critics’ concerns about the Guidelines in his weekly radio show , reportedly responding, “[S]o you didn’t get enough painkillers and you did have to suffer a little bit. The other side of the coin is people are dying and there’s nothing perfect …. There’s nothing that you can possibly do where somebody isn’t going to suffer, and it’s always the same group [claiming], ‘Everybody is heartless.’ Come on, this is a very big problem.”

Certainly, prescription drug abuse is a very big problem. But that does not mean the Guidelines are the best we can do.  We must continue to evaluate and revise our reform efforts.

Bloomberg’s announcement also touted the creation of NYC RxStat, which is a joint effort of the Mayor’s Task Force on Prescription Painkiller Abuse and the New York/New Jersey High Intensity Drug Trafficking Areas (HIDTA) Program to “leverage relevant public health and public safety data in support of monitoring and combating the problem of prescription painkiller abuse.”

Undoubtedly it is critical to bring together city, state, and federal agencies to address this cross-border problem by sharing data, assessing trends, and evaluating strategies to reduce prescription drug abuse.  I hope part of its charge will be evaluating the Guidelines and similar efforts in places like Seattle , Ohio , and Milwaukee to address potential flaws and to make more effective use of prescription monitoring programs without denying appropriate care to patients in need.

[1] Although the Mayor’s press release states that the guidelines are included in the January 2013 Interim Report of the Mayor’s Task Force on Prescription Painkiller Abuse, this report references distinct, though related, evidence-based clinical guidelines for prescribing prescription painkillers that the New York City Department of Health and Mental Hygiene distributed to New York City providers in December 2011.

ahla-pharma-med-devi(2) The Seton Hall Law Center for Health & Pharmaceutical Law & Policy, American Health Lawyers Association (AHLA) and the Food and Drug Law Institute (FDLI) have released the first edition of the Pharmaceutical and Medical Device Compliance Manual. The Manual is a guide to deciphering the intricate web of federal and state laws and the practices of regulatory and enforcement authorities within the healthcare and life sciences arena, while also providing the practical skills needed to implement an effective compliance program.

Designed to aid health law attorneys, compliance professionals and others in the pharmaceutical and medical device field, the Manual explains the law in layman’s terms in addition to providing advice and guidelines on creating, managing, monitoring and auditing an effective compliance program, in essence, marrying legal expectations with the operational demands of business units.

The book was co-edited by Seton Hall Law Associate Dean Kathleen M. Boozang, J.D., LL.M., who founded the school’s Health Law program in 1990, ranked among the top 10 by U.S. News & World Report for the past 16 years; and by Simone Handler-Hutchinson, J.D. ’93, Executive Director of the Center for Health & Pharmaceutical Law & Policy .

Dean Boozang notes: “Over the last two decades the trend in government oversight has resulted in a regulatory environment of increased accountability among organizations across a number of sectors, with the health and life sciences industries being the subject of particular attention – a trend that shows no sign of waning. We produced this manual for compliance officers, health and life sciences lawyers and their clients to enable them to build a framework for creating and sustaining an effective compliance function.”

As co-editor, Ms. Handler-Hutchinson said, “Each chapter was written by a leading regulatory official, practicing attorney, or healthcare consultant who has either shaped the policies as an official and/or counsel in the nation’s regulatory agencies, served as counsel to or built compliance functions within life science corporations. They offer first hand, in-depth compliance insight and actionable advice.”

The Pharmaceutical and Medical Device Compliance Manual is available as a softbound book and a variety of eBook formats; it may be ordered by visiting .

The Seton Hall Law Center for Health & Pharmaceutical Law & Policy advances scholarship and recommendations for policy on the varied and complex issues that emerge within pharmaceutical and health law. Additionally, the Center is a leader in providing compliance training on the wide-ranging state, national and international mandates that apply to the safety, promotion and sale of drugs and devices. Seton Hall University School of Law, New Jersey’s only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching with a strong focus on experiential learning. Founded in 1951, Seton Hall Law School is located in Newark and offers both day and evening degree programs. For more information visit .

The American Health Lawyers Association (AHLA) is the nation’s largest nonpartisan educational organization devoted to legal issues in the healthcare field. The Association’s 11,000 members practice in a variety of settings in the healthcare community. For information about our resources, publications, and educational offerings, visit .

sullivan_charles Apparently, some hospitals are now requiring older physicians to undergo physical examinations as a condition of maintaining privileges. According to the Washington Post , this is in response to the aging of America’s physician population and some notable examples of physicians who have continued practicing long after their abilities have declined to unacceptable levels.  State licensing authorities don’t address the problem directly, thus impelling hospitals to do so. According to the Post, “a small but growing number of hospitals including the University of Virginia Health System, Stanford Hospital and Clinics, and Driscoll Children’s Hospital in Corpus Christi, Tex. have recently adopted policies requiring doctors over a certain age 70 at U-Va. and Driscoll, 75 at Stanford to undergo periodic physical and cognitive exams as a condition of renewing their privileges.”

Whether or not it is a good idea in the abstract, such a policy generates a number of legal questions. Most obviously, it raises the issue of whether such requirements can be squared with employment discrimination laws, in particular the Age Discrimination in Employment Act and maybe the Americans with Disabilities Act. If applicable, the former law would likely bar age-based examinations, and the latter might well preclude such examinations unless the hospital could document its concerns.

The quick response might be the traditional one: doctors with admitting privileges are not “employees” of hospitals, and, thus, are beyond the reach of employment discrimination statutes (including the ADEA and ADA) which only protect “employees” from discrimination by their “employers.” inapplicable.   But this might well be wrong for two reasons.

First, there is at least one recent court decision that suggests that the increasing control hospitals exercise over physicians who practice there might be sufficient to convert such physicians into employees.  Salamon v. Our Lady of Victory Hosp., 514 F.3d 217, 228-229 (2d Cir. 2008), reversed the district court’s finding in a sex discrimination case that plaintiff’s exercise of professional judgment was sufficient to negate employee status: the lower court’s “reasoning would carve out all physicians, as a category, from the protections of the antidiscrimination statutes.”  Rather, the proper focus was on the relationship between the parties, and, taking plaintiff’s allegations as true, the hospital “exercised substantial control not only over the treatment outcomes of her practice, but over the details and methods of her work. Members of the OLV administration were designated as her supervisors, with the job of ‘maintain[ing] continuing surveillance of [her] professional performance.’” In short, the hospital’s   application of its quality assurance standards might result in the requisite level of control to make plaintiff an employee. It is true that Salamon has not been much followed yet, but it’s definitely a straw in the wind.  Indeed, pay-for-performance and the variety of on-going CMS demonstration projects attendant to health care reform advance the trend of hospital influence if not control over physicians’ practice, thereby increasing the chances that other courts will be persuaded to subscribe to the Second Circuit’s analysis.

Second, and even if Salamon is wrong, hospitals have for years had some physician-employees and are now busy acquiring physician practice groups, see recent story here , and the acquired physicians may well be viewed as hospital employees. It’s possible, of course, that corporate structures will insulate the hospital from liability (although there will be many other considerations that factor into the decision how to structure the acquisition of a practice group), but that is by no means a sure bet.  Employment law has doctrines such as “integrated enterprise” and “joint employer,” which could render a hospital responsible as an “employer” for its privileging decisions under the antidiscrimination statutes regardless of the formal structure.  One might expect hospitals to claim that privileging is separate from any (direct or indirect) employment relation, but the notion that an employer could avoid liability by claiming its action were taken when it was wearing a non-employment hat may be a nonstarter.

That takes us back to whether requiring physical and cognitive examinations may violate the law.  We have ADEA cases that answer that question yes when the examinations are triggered by an age cutoff. In EEOC v. Massachusetts, 987 F.2d 64 (1st Cir. 1993), the court struck down a Massachusetts law requiring government officials to pass a physical examination at age 70 as a condition of continued employment. It’s true, as the Supreme Court had noted in EEOC v. Wyoming, 460 U.S. 226 (1983), an earlier case challenging retirement at age 55 for game wardens, that such a policy could be justified if the employer could show that the age criterion was a “bona fide occupational qualification.” However, the requirements of the “BFOQ” are stringent, and it is by no means clear that hospitals could satisfy them. For example, the varying ages pegged by the hospitals now using such policies – 70 and 75 – raise questions about the justification for the particular policies. Of course, subjecting a particular doctor to such tests on the basis of a reason to suspect declining competence would pose no ADEA problem, as long as such suspicion is truly formed on the basis of age-independent facts or occurrences.

As for the ADA, again assuming the hospital is an employer, the law is somewhat more complicated. Physical examinations (which presumably would include cognitive tests) are not prohibited entirely for current employees, but their permitted uses are limited. See EEOC Enforcement Guidance on Disability-Related Inquiries and Medical Examinations of Employees (July 27, 2000). Once employment has begun, an employer may require medical examinations only upon a showing that the inquiry or examination is job-related and consistent with business necessity. That would include situations where a physician’s performance raised doubts about her continued fitness.  Even a policy requiring all physicians to periodically undergo such tests (whether or not at a given age) is permissible when the demands of the job require checks of employees’ ability to do the job, with the burden on the employer to make the necessary showing.

Most of the cases upholding examinations are in law enforcement; indeed, the EEOC’s Guidance regarding periodic medical examinations is phrased in terms of “employees in positions affecting public safety (e.g., police officers and firefighters),” and its examples are limited to those contexts. Nevertheless, it’s not much of a stretch to bring physicians within this framework.  An analogy is theADA cases approving limitations because of the risk an HIV-positive provider poses to patients.

The more serious question is whether the examinations are narrowly tailored to address specific job-related concerns [and thus] are permissible.”  Further, of course, identification of a particular condition by such an examination is only the first step in the analysis. The EEOC requires an employer who decides to take an adverse action (in this context denying or severely limiting privileges) to “demonstrate that the employee is unable to perform his/her essential job functions or, in fact, poses a direct threat that cannot be eliminated or reduced by reasonable accommodations.

Further, there’s even a question about the intersection of the ADEA and ADA, although the courts haven’t addressed this yet.  Given the multiple physical and mental conditions that may affect physician performance, one might wonder why a hospital would use an age cutoff rather than conditioning all renewals of privileges on passing physical and cognitive tests.  This approach would conduce to patient safety and avoid any ADEA problems. On the other hand, such a policy might be too broad to pass muster under the ADA, since it might not be “narrowly tailored” to the most significant risks.

Finally, there is one more twist to this interesting problem: the ADA covers employment, but a separate Title bars discrimination on the basis of disability in “public accommodations.” While we tend to think of public accommodations as physical venues, there is at least one case that views a hospital as providing a public accommodation by virtue of its privileging decisions and therefore that the ADA applies to those actions. Menkowitz v. Pottstown Mem’l Med. Ctr., 154 F.3d 113 (3d Cir. 1998). This would suggest that the commands of that statute might have to be met entirely without regard to employment.  Still, as with a number of the matters previously discussed, the future trajectory of ADA public accommodation doctrine as applied to hospital privileging decisions remains highly uncertain.

Charles A. Sullivan

Andrea J. Catania Endowed Professor of Law

Seton Hall Law School


Kate Greenwood_high res 2011 comp I highly recommend Kimani Paul-Emile’s provocative article in the latest issue of the UCLA Law Review, Patients’ Racial Preferences and the Medical Culture of Accommodation , in which she “makes the counterintuitive claim … that the law does and should permit” physicians and hospitals to accommodate “patients’ racial preferences with respect to their choice of physician … in the hospital setting.”  Such accommodation is, Professor Paul-Emile reports, a quiet, but routine , occurrence, one that recent studies suggest “may not only alleviate race-based health disparities but also constitute a life-saving measure for many racial-minority patients.”

Professor Paul-Emile’s article begins with a concise and helpful summary of the relevant default legal rules, in particular the right of patients to refuse medical treatment and the obligation of hospitals to provide care in an emergency.  As Professor Paul-Emile explains, “[i]f a patient who desires treatment will not yield in his preference for a provider of a particular race and will not agree to a transfer, then the hospital is faced with the dilemma of choosing between (1) having a physician unwanted by the patient forcibly perform the [Emergency Medical Treatment and Active Labor Act]-mandated medical screening, thereby violating informed consent and battery laws, and (2) rejecting the patient in violation of EMTALA, thereby risking liability and the chance that this decision will cause the patient to suffer, experience grievous harm, or die.”

The article goes on to analyze hospitals’ decisions to accommodate a patient’s race-based request for a new doctor under Titles II, VI, and VII of the 1964 Civil Rights Act, and concludes that although “it is difficult to imagine preferences of this sort indulged in any other sector,” in the hospital setting such accommodation does not violate anti-discrimination laws.  Professor Paul-Emile goes further, arguing that accommodation “may be one of the best available means of enforcing Title VI’s mandate to enable individuals to enjoy the benefits of a covered entity or program, regardless of race, color, or national origin” to the extent that it “counter[s] the effects of implicit bias, discrimination, and stereotyping by physicians[.]”

Professor Paul-Emile concedes that “the notion of white patients rejecting minority physicians for bigoted reasons in emergency departments and other hospital settings is deeply troubling and uncomfortably reminiscent of the type of discrimination that the civil rights statutes were designed to eliminate[,]” but she counters with empirical evidence (1) that “requests for treatment by a physician of a particular race are more often accommodated when made by racial minority patients” and (2) that the benefits of racial concordance are many, including longer visits characterized by patient-centered participatory decision-making.

Reading Professor Paul-Emile’s article, it struck me that for every patient who insists on a change of doctor, there are likely many more who assume, rightly or wrongly, that they have no choice and so endure discriminatory treatment in the hospital setting.  Accommodating the demands of the few who speak up is at best a partial solution.  Professor Paul-Emile does not deny this.  She concludes her article with a call for an increase in the diversity of doctors and for an expansion of “cultural awareness at all levels of practice and training to enable providers to interact more effectively with various patient populations”worthy, if daunting, goals.

Medical repatriations of undocumented immigrants likely to rise as result of federal funding reductions to safety net hospitals under Affordable Care Act

New York, NY, and Newark, New Jersey, December 17, 2012 –Today, the Center for Social Justice (CSJ) at Seton Hall University School of Law and New York Lawyers for the Public Interest (NYLPI) released a report documenting an alarming number of cases in which U.S. hospitals have forcibly repatriated vulnerable undocumented patients, who are ineligible for public insurance as a result of their immigration status, in an effort to cut costs. This practice is inherently risky and often results in significant deterioration of a patient’s health, or even death. The report asserts that such actions are in violation of basic human rights, in particular the right to due process and the right to life.

According to the report, the U.S. is responsible for this situation by failing to appropriately reform immigration and health care laws and protect those within its borders from human rights abuses. The report argues that medical deportations will likely increase as safety net hospitals, which provide the majority of care to undocumented and un- or underinsured patients, encounter tremendous financial pressure resulting from dramatic funding cutbacks under the Affordable Care Act.

The report cites more than 800 cases of attempted or actual medical deportations across the country in recent years, including: a nineteen-year-old girl who died shortly after being wheeled out of a hospital back entrance typically used for garbage disposal and transferred to Mexico; a car accident victim who died shortly after being left on the tarmac at an airport in Guatemala; and a young man with catastrophic brain injury who remains bed-ridden and suffering from constant seizures after being forcibly deported to his elderly mother’s hilltop home in Guatemala.

According to Lori A. Nessel, a Professor at Seton Hall University School of Law and Director of the School’s Center for Social Justice, “When immigrants are in need of ongoing medical care, they find themselves at the crossroads of two systems that are in dire need of reformhealth care and immigration law. Aside from emergency care, hospitals are not reimbursed by the government for providing ongoing treatment for uninsured immigrant patients. Therefore, many hospitals are engaging in de facto deportations of immigrant patients without any governmental oversight or accountability. This type of situation is ripe for abuse.”

“Any efforts at comprehensive immigration reform must take into account the reality that there are millions of immigrants with long-standing ties to this country who are not eligible for health insurance. Because health reform has excluded these immigrants from its reach, they remain uninsured and at a heightened risk of medical deportation,” added Shena Elrington, Director of the Health Justice Program at NYLPI. “Absent legislative or regulatory change, the number of forced or coerced medical repatriations is likely to grow as hospitals face mounting financial pressures and reduced Charity Care and federal contributions.”

Rachel Lopez, an Assistant Clinical Professor with CSJ stated, “The U.S. is bound to protect immigrants’ rights to due process under both international law and the U.S. Constitution. Hospitals are becoming immigration agents and taking matters into their own hands. It is incumbent on the government to stop the disturbing practice of medical deportation and to ensure that all persons within the country are treated with basic dignity.”

More information about this issue can be found at , a NYLPI- and CSJ-run website that monitors news and advocacy developments on the topic of medical deportation.

New York Lawyers for the Public Interest (NYLPI) advances equality and civil rights, with a focus on health justice, disability rights and environmental justice, through the power of community lawyering and partnerships with the private bar. Through community lawyering, NYLPI puts its legal, policy and community organizing expertise at the service of New York City communities and individuals.

The Center for Social Justice (CSJ) is one of the nation’s strongest pro bono and clinical programs, empowering students to gain critical, hands-on experience by providing pro bono legal services for economically disadvantaged residents in the region. The cases on which students work span the range from the local to global. Providing educational equity for urban students, litigating on behalf of the victims of real estate fraud, protecting the human rights of immigrants, and obtaining asylum for those fleeing persecution are just some of the issues that CSJ faculty and students team up to address.

Research Fellow & Lecturer in Law Kate Greenwood published a Featured Op-ed in Pharmalot on the U.S. Supreme Court and the prospect of liability for personal injury from defects in generic drugs. In “Betting on Liability for Generic Defects,” Ms. Greenwood writes:

As reported on Pharmalot, the US Supreme Court has agreed to review the First Circuit Court of Appeals’ decision in Mutual Pharmaceutical Company v. Bartlett that federal law did not preempt a New Hampshire jury’s determination that the generic drug sulindac had a “design defect” and so should have been recalled ( back story with briefs ).

It is highly likely that the Supreme Court will reverse the First Circuit’s decision, and, in so doing, confirm that manufacturers cannot be held liable for failing to re-design or recall unsafe generic drugs, just as they cannot be held liable for failing to update the labeling of such drugs. The ball will then be in Congress’ court to fill the resulting postmarketing safety gap.

As the First Circuit explained in the Bartlett decision, New Hampshire law provides that a drug has a design defect “‘if the magnitude of the danger outweighs the utility of the product.’” At trial, plaintiff Karen Bartlett’s expert testified that sulindac met this standard and the jury agreed, finding Mutual Pharmaceutical liable for selling a product with a defective design and awarding Bartlett over $21 million for the horrific SJS/TEN-related injuries she suffered after taking sulindac.

Read more in the feature Op-ed, “ Betting on Liability for Generic Defects .”


The degree of effort put into selecting health care professionals varies among consumers.  For instance, many relatively young users of health care may only go through the motions of selecting a primary care physician, whom they may seldom visit, and never investigate specialists that provide more particularized care.  A recurring question, however, amongst more frequent health care consumers is “who provides the best care?”  As consumers become older, mature, develop ailments more frequently, and raise families, this question becomes asked more and more frequently.  Where is such a consumer to look for reliable information?  Yes, rating systems of health care professionals are available.  But the objectivity of such systems is often questioned because of the agenda of those developing the rating systems.  For instance, Andrew Cuomo, the former New York Attorney General, injected New York State into the practices through which an insurance company rated the health care providers in its network.  The concern identified by the Attorney General’s office was that insurance companies would rate health care providers based upon their ability to provide care cheaply, rather than on their ability to provide quality care.  This concern stemmed from the undeniable profit self-interest of the insurance company. However, was such a stance by the now Governor necessary or appropriate?  I think not.

Determining the quality of care delivered by a health care provider is an inherently subjective task.  The outcomes of individual patients will depend upon a multitude of factors, many of which are out of the control of the provider.  Different patients will react differently to different treatments because of their unique physiology.  The same ailment will have indiscernibly progressed to varying degrees in different patients.  A doctor could follow all the proper protocols, provide the care called for (i.e., satisfy the standard of care), yet a poor outcome could nonetheless result. The outcome in these instances is largely the result of the “luck of the draw” with respect to a patient pool.  Thus, trying to determine which doctors provide the best care is inevitably a limited, if not fruitless, endeavor.

Additionally, a mechanism is already in place to ensure that substandard doctors are not practicing.  The training to become a doctor and the required certifications to practice serves as the screening mechanism to ensure that health care providers have the requisite skill to perform their trade.  So long as doctors are meeting this minimum established by their field, patients should be led to believe in the ability of those doctors to provide adequate care.  Ranking doctors based on outcomes naturally leads consumers to believe that entry level standards are watered down such that doctors “at the bottom” are not competent to perform; which is simply not the case.

Finally, ranking doctors based upon efficiency or cost factors serves a valid societal purpose.  Firstly, putting utility aside, such metrics are readily quantifiable, accurate, and objective.  And with respect to utility, many patients want efficiency.  An efficient doctor is, it would seem, much less likely to engage in “defensive medicine.”  For a time pressed patient, as many of us are, reassurance that our time will not be wasted with unnecessary tests and precautions holds real value.  And on a societal level, it is obvious that health care costs are out of control.  I have recently been put in a position where I must acquire a policy for my family on the open market (I am leaving a secure government position with subsidized health benefits for a position as a law clerk with a small law firm, which does not extend health benefits to its clerks). My monthly contribution is currently $330 for a health plan with no deductible and $20 co-pays.  It appears as though my best option on the open market is a $1200/month plan, with a $1,000 deductible.  My family is young and healthy. Our annual doctor visits consist of well visits, totaling approximately $1,000 in total costs. With this in mind, if insurance companies can encourage the use of efficient providers (who have been vetted by their profession as proficient at what they do), then this practice should be encouraged.  A “high efficiency” network at a reasonable cost would certainly perform well on the open market, particularly among us consumers that don’t actually anticipate using their policies.  Health care is or will be a significant factor in everyone’s life at some point.   However, if we can prevent it from becoming the driving financial concern among the middle class, that would appear to be a worthy cause.

Adam Peterson is a third-year evening student at Seton Hall University School of Law. He received his B.S. in Conservation Biology from the State University of New York College at Cortland in 2007. Since that time he has worked for the New York State Department of Environmental Conservation as an Environmental Analyst, reviewing development projects for compliance with New York State environmental regulations.

Image by Ludraman .

Earlier this week, the Second Circuit Court of Appeals at last issued its decision in United States v. Caronia and it is momentous (and predicted to be heading to the Supreme Court).  A two-judge majority of the Circuit Court held that Alfred Caronia, a pharmaceutical sales representative, “was convicted for his speech – for promoting [the central nervous system depressant Xyrem] for an off-label use – in violation of his right of free speech under the First Amendment.”

The majority’s decision begins with a threshold question.  Was Caronia convicted for conspiracy to misbrand Xyrem because he engaged in off-label promotion qua off-label promotion, that is, for his speech?  Or, was his speech simply “evidence that the ‘off-label uses were intended ones[] for which Xyrem’s labeling failed to provide [the required] directions[,]” as the government argued on appeal?  The former would implicate the First Amendment, but the latter would not.  The Supreme Court has held that “[t]he First Amendment … does not prohibit the evidentiary use of speech to establish the elements of a crime or to prove motive or intent.”  As the Caronia dissent (colorfully) explained, “Abby and Martha [do not have] a First Amendent right to offer arsenic-laced wine to lonely old bachelors with the intent that they drink it. … And any statements Abby or Martha made suggesting their intenteven if all of the statements were truthful and not misleadingwould not be barred from evidence by the First Amendment…”

The majority found that Caronia was convicted for his speech alone, pointing to the lower court’s instructions to the jury and to a number of statements that the government made at trial including “[Caronia] conspired through some act of misbranding, and that act of misbranding … was the promotion on October 26th and November 2nd[,] marketing [a] drug for unapproved uses.”  Caronia’s conviction must therefore be vacated, the majority concluded.  The Food Drug and Cosmetic Act does not “criminaliz[e] the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.”   The majority did not disagree with the general proposition that speech may be used as evidence of intent, and it expressly declined to decide the specific question whether the FDCA violates the First Amendment by “defin[ing] misbranding in terms of whether a drug’s labeling is adequate for its intended use, and permit[ting] the government to prove intended use by reference to promotional statements made by drug manufacturers or their representatives.”  Even if the Second Circuit’s decision stands, then, the government may be able to argue that Caronia is a case about an erroneous jury instruction with limited practical effect

The majority went on to hold that a ban on off-label promotion qua off-label promotionlike the Vermont law barring drug companies from using physician-specific prescribing data to craft physician-specific sales pitches at issue in the Supreme Court’s 2011 decision in Sorrell v. IMS Health (which I discussed on this blog here )is unconstitutional regardless of whether strict or intermediate scrutiny applies.  The majority gave short shrift (no shrift, really) to the argument that the ban on off-label promotion is necessary to preserve the integrity of the FDA’s drug approval process, suggesting that the government could “minimize … manufacturer evasion of the approval process” by imposing “ceilings or caps on off-label prescriptions.”

The majority did not elaborate on how ceilings or caps on off-label prescriptions would work, on the grounds that the First Amendment puts the burden on the government to demonstrate that they would not.  Here, too, there may be an opening for the government, to make a stronger case to the Supreme Court than it did before the Second Circuit (in its briefs or at oral argument ) that ceilings or caps would not be “administrable, feasible, or otherwise effective” and that the ban on off-label promotion therefore provides a direct, narrowly-tailored, and crucial incentive to clinical research into already-approved drugs.  As the dissent suggested, “[a] ceiling on off-label prescriptions would require collecting data from countless numbers of doctors and patients and, given the medical uncertainties involved, could needlessly (and simultaneously) result in the denial of some effective treatments and the overprescription of ineffective and even dangerous ones.”


There was a time in medical science when doctors did not wash their hands prior to operating on their patients (some might say, that to a greater extent than seems possible, this is still the case among medical professionals and point to a number of recent studies as uncomfortable proof). This failure of doctors to wash hands in the medical forum led to the otherwise avoidable death of many of their patients. Up until the mid 1800s, medical science had simply not made the connection between bacteria, transference, infection and death.

Ignaz Semmelweis, a Hungarian physician who was Director of the maternity clinic at the Vienna General Hospital in Austria, made the connection after what is said to have been an extensive statistical analysis in the 1840s, and demonstrated that hand-washing could drastically reduce the number of women dying during childbirth. He introduced a rigorous hand scrubbing protocol and enough women stopped dying to earn him the honorific, “savior of our mothers.”

But as an article from the UK’s Science Museum, Exploring the History of Medicine , points out

Until the late 1800s surgeons did not scrub up before surgery or even wash their hands between patients, causing infections to be transferred from one patient to another. Doctors and medical students routinely moved from dissecting corpses to examining new mothers without first washing their hands, causing death by puerperal or ‘childbed’ fever as a consequence. As  dissection became more important to medical practice in the 1800s, this only increased.

Semmelweis showing again that the common sense of one era is the uncommon brilliance of one bygone.

Which brings us to this latest study/project showing new solutions which decrease the risk of colorectal surgical site infection. According to the Associated Press in an article about the project,

“Almost 2 million health care-related infections occur each year nationwide; more than 90,000 of these are fatal.”


“Infections linked with colorectal surgery are particularly common because intestinal tract bacteria are so abundant.”


According to the press release regarding the Project ,

The participating hospitals were able to reduce superficial incisional SSIs, which affect skin and underlying tissue, by 45 percent and all types of colorectal SSIs by 32 percent. The average length of stay for hospital patients with any type of colorectal SSI decreased from an average of 15 days to 13 days. In comparison, patients with no SSIs had an average length of stay of eight days.

The press release further notes that

Colorectal surgery was identified as the focus of the project because SSIs are disproportionately higher among patients following colorectal surgeries. Colorectal surgery is a common procedure across different types of hospitals, can have significant complications, presents significant opportunities for improvement, and has high variability in performance across hospitals. The project addressed preadmission, preoperative, intraoperative, postoperative and post discharge follow-up processes for all surgical patients undergoing emergency and elective colorectal surgery, with the exception of trauma and transplant patients and patients under the age of 18. Project participants studied the potential factors that contribute to all three types of colorectal SSIs – superficial incisional, deep incisional and organ space SSIs, which affect organs and the space surrounding them.


The AP article:

Solutions included having patients shower with special germ-fighting soap before surgery, and having surgery teams change gowns, gloves and instruments during operations to prevent spreading germs picked up during the procedures.

Some hospitals used special wound-protecting devices on surgery openings to keep intestine germs from reaching the skin.

The average rate of infections linked with colorectal operations at the seven hospitals dropped from about 16% of patients during a 10-month phase when hospitals started adopting changes to almost 11% once all the changes had been made.

The AP article further notes the timely nature of the Project’s benefits:

Besides wanting to keep patients healthy, hospitals have a monetary incentive to prevent these infections. Medicare cuts payments to hospitals that have lots of certain health care-related infections, and those cuts are expected to increase under the new health care law.

Here are some highlights from recent headlines affecting licensing and liability of health care professionals:

  • Professional liability for failing to report child abuse in New Jersey: In L.A. v. Div. of Youth & Family Servcs. , the Appellate Division of the Superior Court of New Jersey held that an emergency room physician must stand trial for medical malpractice because he failed to report to the State that a two year-old child brought to the ER had ingested cologne.   The applicable standard of care is established by N.J.S.A. 9:6-8.10, which requires “[a]ny person having reasonable cause to believe that a child has been subjected to child abuse or acts of child abuse” to report this information to the Division of Child Protection and Permanency (previously DYFS).  Although this statute does not expressly mention neglect, the court held that it “requires the reporting of injuries resulting from conduct that is reckless, or grossly or wantonly negligent, but not conduct that is merely negligent.”  The court further held “that the triggering of the obligation to report, especially in the context of civil litigation involving professional malpractice, does not require the potential reporter to possess the quantum of proof necessary for an administrative or judicial finding of abuse or neglect.  All that is required by N.J.S.A. 9:6-8.10 is ‘reasonable cause to believe.’”   Because the paramount concern is the safety of children, “a physician has ‘reasonable cause to believe’ that there has been abuse if a ‘probable inference’ from the medical and factual information available to the physician is that the child’s condition is the result of child abuse, including ‘reckless’ or ‘wantonly negligent’ conduct or inaction by a parent of caregiver.  The inference need not be the ‘most probable,’ but it must be more than speculation or suspicion.”  The court found that it was a jury question whether the doctor here failed to satisfy this standard of care.  Because there is a jury question as to the doctor’s liability, the court also reversed the dismissal of the plaintiff’s claim against the hospital based on the doctrine of respondeat superior.  As Charles Toutant highlighted  in a recent article in the New Jersey Law Journal, health care professionals need to pay attention to this case.   The court reminded in a footnote that more than professional liability could be at issue because it is a disorderly persons offense under N.J.S.A. 9:6-8.14, 2C:43-8 to fail to make the required report.


  • A supervising doctor in Vermont is not subject to professional discipline based solely on the unprofessional conduct of the physician assistant he supervised: The Vermont Supreme Court in In re Porter , 2012 Vt. 97, held that the state Board of Medical Practice may not find a doctor guilty of unprofessional conduct based only on the unprofessional acts of the physician assistant (PA) whom he supervised where the supervising physician met or exceeded all standards of care.  The PA had admitted that his improper prescribing of opiates constituted professional negligence and unprofessional conduct.  Under Vermont law, “[t]he supervising physician delegating activities to a physician assistant shall be legally liable for such activities of the physician assistant, and the physician assistant shall in this relationship be the physician’s agent” (emphasis added).  26 V.S.A. § 1739.  The Court distinguished “between legal liability, typically at issue in a civil action or for a monetary penalty, and unprofessional conduct at issue in a professional licensing disciplinary proceeding.”  Because the statute references only legal liability, the Court concluded that the statute “encompasses only the concept of civil liability, and does not render a supervising physician vicariously answerable or guilty for the unprofessional acts of his or her PA simply on the basis of their relationship.”  That the statute made the PA the physician’s agent did not change the analysis because “agency theory applies in tort or contract cases, not professional responsibility actions.”
  • Bill to permit advanced practice nurses to prescribe medication without supervision in New Jersey: New Jersey Senator Joseph Vitale introduced S.2354 on November 21 to permit advanced practice nurses (APNs) with more than twenty-four months or 2,400 hours of licensed, active advanced practice experience to prescribe medication without a joint protocol with a physician; reportedly Assemblywoman Nancy Munoz will introduce an Assembly version on December 3. Under current New Jersey law, although APNs may practice independently of physicians, they are only permitted to write prescriptions pursuant to a joint protocol developed with a collaborating physician.  See N.J. Stat. § 45:11-49(b)-(c); N.J.A.C. 13:35-6.6; N.J.A.C. 13:37-8.1.  According to a recent Health Affairs Health Policy Brief , eighteen states and the District of Columbia permit nurse practitioners, which are a type of APN, to prescribe without a doctor’s involvement.  A 2010 report from the Institute of Medicine urged more states to move in this direction.  Although the language of S.2354 is not yet available on the Legislature’s web site , Andrew Kitchenman reports in NJ Spotlight that it would make it easier for APNs to open their own practices.   A study published in the November/December 2012 Annals of Family Medicine predicts that the United States will require nearly 52,000 additional primary care physicians by 2025 while noting that the number of internal medicine residents choosing primary care is decreasing.  Given the existing shortage of primary care providers throughout the country and in New Jersey , which is expected to intensify with Medicaid expansion and increased coverage under the Affordable Care Act, S.2354 could help relieve the primary care supply pressures in New Jersey.   Although this bill circumvents the turf battles between the State Boards of Medical Examiners and Nursing, it is sure to meet substantial pressure from physician groups in the State.   The Health Affairs Health Policy Brief provides helpful context for this important debate.
  • New York begins accepting applications for professional licenses from nonimmigrant aliens: Following the Second Circuit’s decision in Dandamudi v. Tisch , 686 F.3d 66 (Jul. 10, 2012), New York has begun accepting applications for thirteen professional licenses, including medical, podiatric, chiropractic, dental, pharmacy, and veterinary, from applicants who previously were categorically precluded from licensure because they are neither citizens nor legal permanent residents (LPRs).  At issue in Dandamudi was New York’s requirement that pharmacists be citizens or legal permanent residents, which denied licensure to a “subclass of aliens known as nonimmigrants who are lawfully admitted to the United States pursuant to a policy granting those aliens the right to work in this country . . . .”  Because the Circuit in Dandamudi found that these nonimmigrant aliens are a suspect class, “[a]ny discrimination by the state against this group is subject to strict scrutiny review.”  The state had conceded that it lacked any compelling interest in treating this class differently, and thus the court found the New York law violated nonimmigrant aliens’ right to equal protection.  Although limiting its ruling to equal protection grounds, the court also credited Supremacy Clause and preemption concerns with New York’s law because it stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress’ decision to admit these individuals to the country for the express purpose of working in these specialty professions.  In reaching its decision, the Second Circuit expressly refused to follow decisions of the Fifth (see, e.g., Van Staden v. St. Martin , 664 F.3d 56 (5th Cir. 2011)) and Sixth ( LULAC v. Bredesen , 500 F.3d 523 (6th Cir. 2007)) Circuits that required only rational basis review of statutes that treated nonimmigrant aliens differently than citizens or LPRs.  Despite the circuit split created by Dandamudi, the United States Supreme Court on October 1, 2012 denied the petition for certiorari filed in Van Staden.  Although the New York professions web site states that the time to seek a petition for certioriari in Dandamudi has not yet expired, a search of the Supreme Court’s online docket does not reveal that New York has filed a petition within 90 days of the decision or sought an extension of time in which to do so.


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