Monday Morning Recap: The Week (3.31.14-4.6.14) in Drug & Device Law & Policy

Picture3What follows is a weekly feature here at Health Reform Watch.  Each Monday, we provide a recap of the drug and device law and policy developments over the previous week that caught our eye and made us think.  Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.

1. This week the New York Times published the seventh part  of Elisabeth Rosenthal’s gripping series Paying Till It Hurts, this one on the increasingly-costly drugs and devices relied on by Type I diabetics.

2. At The Atlantic, Clara Ritger summarizes “[a] new report from the Centers for Disease Control and Prevention find[ing] that states don’t offer many of the Health and Human Services Department’s recommended [tobacco cessation] treatments, and the services they do cover come with co-pays, limits on the duration of use, and other barriers to access for Medicaid patients.” Ritger explains that “[a]lthough more states increased the number of [tobacco cessation] treatments covered between 2008 and 2014, more states also added barriers to accessing those treatments. That trend can be attributed, in part, to the Affordable Care Act’s requirement that state Medicaid programs cover all FDA-approved tobacco cessation medications by January 2014. Not all states used to offer that benefit, so as some added it, they also added it with restrictions.”

3. The Philadelphia Inquirer ran a story about a campaign by Hooman Noorchashm, a cardiothoracic surgeon, and his wife, Amy Reed, an anesthesiologist, to end the use of electric tissue-cutting morcellators in gynecologic surgery. ”Power morcellation, introduced in 1993, enables tissue removal through tiny abdominal incisions, but in rare cases it can also spread a hidden uterine cancer called leiomyosarcoma. Reed, a mother of six, has become the poster woman for that awful scenario. During a minimally invasive hysterectomy in October at Brigham and Women’s Hospital in Boston, the morcellator hurled uterine tumor fragments that were implanted in her abdominal cavity. She now has stage-four leiomyosarcoma, and the hospital acknowledges the procedure likely worsened her prognosis.”

4. Sachin Jain, Michael Rosenblatt, and Jon Duke published a piece in JAMA about a partnership between the Indiana University School of Medicine’s Regenstrief Institute and Merck to conduct research on electronic clinical data from the Indiana Network for Patient Care (INPC), a health information exchange. The authors write: “Neither industry nor academia can navigate this terrain alone—nor should they. Working together, governments, health plans, academic delivery systems, electronic medical record vendors, and private sector companies have the potential to analyze data to improve care and enhance the sophistication of this research.” That said, “[r]igorous controls on how the data are used and by whom, careful and considered alignment of interests, and focused investments in long-term capability-building are important starting points for this new and expanding frontier of collaboration.”

5. Finally, at the FCPA Professor Mike Koehler discusses the Foreign Corrupt Practices Act in light of the Supreme Court’s recent campaign finance decision, McCutcheon v. FEC.  He writes: “In the end, the double standard between the meaning of corruption as it relates to ‘foreign officials’ vs. U.S. ‘officials’ matters as it undermines the legitimacy and moral authority on which the U.S. government acts.”


John Denver v. Cynicism

February 18, 2013 by · 1 Comment
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John Denver Best Buy TheaterWe live longer now but I don’t know that we live demonstrably better. Perhaps as a testament to my devotion, I bought tickets and brought my girlfriend to see John Denver w/band at the Best Buy theater in Manhattan. She’s a fan; I could not be described as such. The band was live, John Denver decidedly not– he having died in a plane crash back in 1997. But a video screen brought Mr. Denver back for the evening, and the band played wonderfully along in the foreground as video John Denver talked and sang– never once coming close to a dissonant note while  looking and sounding like something that could only be described as the long lost innocence of a culture past.

Maybe his act was nothing but hokhum even back then, the unabashed optimism of his Country Roads, Sunny Shoulders and Rocky Mountain Highs just something we wanted to believe about ourselves: unbridled, essentially good and not particularly complicated. But in the 70s and into the 80s until his death, John Denver sold millions of records, hosted the Grammys five times, and an annual Christmas show on television which is said to have been viewed by over 60 million people; today he would be laughed away in a maelstrom of derision.

Maybe this is just the plaint of someone whose beard has gone gray and has answered one too many emails during dinner; maybe there is nothing essentially different in this lament than what I heard as a kid when old people pined for Glenn Miller and Benny Goodman: lost youth. But it seems like something more was lost in these last few decades. Face to face with John Denver’s stark exuberance, profoundly, I was driven to tears.

And yes, I sang along.

I’m not quite ready to give up a life in the law and what I learned from Voltaire, but will note that there appears to be a correlation between cynicism, pessimism and adverse health– and a good case is made for an inverse correlation between cynicism and success. Maybe take a minute or two and click and have a listen– think about it as a moment’s analog vacation from the drivers of modernity, from data mining dossiers, writ of attainder drones and thousand page statutes. Or, for the more adventurous, an evening with the posthumous Mr. Denver is still available– but be careful, if you’re of a certain age you may find yourself , inexplicably, crying over something you hadn’t even realized you lost.


Hurricane Sandy: Effects on Healthcare Seekers and Providers Alike

February 14, 2013 by · Leave a Comment
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NJ National Guard Soldiers_assist_residents_displaced_by_Hurricane_Sandy_in_Hoboken,_N.J.Although the madness and overt preparedness that accompanies most major storms is enough to keep most American families safe until the power returns and the roads are cleared, the ferocity of natural disasters in recent years has deprived many of the ability to reach healthcare services, as well as subjecting others to new or unforeseen health risks. As was evident in last year’s atrocious Hurricane Irene, the dangers of large scale weather events are far reaching and effect both those who are or will be in need of medical care, as well as the systems of healthcare providing and insurance.
This year’s most recent disaster, Hurricane Sandy has been no different, with at least fourteen states effected, and the death toll reaching twenty four in New York alone.  Boasting wind speeds above eighty miles an hour, and widespread flooding, millions of households across the American East have been put at risk. As citizens may require heightened healthcare needs due to the specific dangers of the storm, many individuals may face obstacles to appropriate health care, as well exposure to new dangers which may require access to health care.
With millions cut off from society due to fallen trees, flooded streets, and the dangers of fallen power lines, many individuals simply cannot travel to the nearest health care provider in a convenient manner. Due to mass telephone unavailability and overused cellular systems, many other citizens could not even signal for help in the event that they needed emergency assistance. Geographical bars to healthcare services are possibly the most expected and normal dangers that this natural disaster posed to the healthcare system. Claims of differing and unforeseen health risks have also been reported from many different areas effected by the storm, ranging from the typical flooding and structural collapses to more unusual dangers.
For example, in New York City, the “Positive Pest Management Corp” as well as other members of the scientific community have voiced concern over the viability of two less evident threats: rodents and raw sewage. While it is estimated that a large number of rats which dwell below the water level may have drowned, there have been reports of increased rat sightings as well as warnings that the large number of rats out on the street can exacerbate the risks posed by disease. Sources have also hypothesized that the flooded landscape may provide much more food for the newly surfaced rats that usually habitate in the underbellies of now-flooded urban areas; this may necessitate heightened pest-control needs in order to promote general health.
Although the rising tides may, allegedly, dilute the disease pathogens associated with rats and other disease-bearing creatures, as reported by the Huffington Post, researcher Joan Rose, the chairman of water research at the University of Michigan, was reported as saying that there is almost always an uptick in illness after a major flooding event due to the spreading of pathogens in flooded sewage waters– most notably E. Coli. This could be cause for concern in some of the more flood-afflicted portions of New York, New Jersey, and the greater eastern seaboard.
Regardless of exposure to sewage, flood waters in general may pose considerable risks to the public. For example, health officials in Atlantic City, New Jersey, are advising residents to not use water unless it is boiled. Dr. Rick Hong, an emergency medicine specialist at Cooper University Hospital asserted, “To be on the safe side, make sure you boil water first, right after an event, so you don’t get sick from the bacteria, the parasites that might be in the contaminated water.” This type of danger has pushed many residents to bottled water, as the safety of their tap water appears to be in question.
Although the everyday citizen faces increased health care difficulties created by Hurricane Sandy, the health care system as a whole is also significantly strained and damaged by the costly hurricane. For example, in its most immediate form, the hurricane itself bars emergency and health care services from running at efficient levels due to power outages, flooding, and the unreliability of phone services. As healthcare providers must struggle to meet the needs of the public, providers and insurers alike must bear the heightened cost of mitigating the health-related damage from the hurricane.
On top of the costs of meeting health needs, Sandy has also lead to the cancellation of more than 300 American Red Cross blood drives across fourteen afflicted states. These cancellations stopped approximately nine thousand lost units of blood and blood plasma from reaching those patients who are in need. This situation is exacerbated by the fact that hospitals and emergency health facilities could face heightened workloads due to Sandy before the noticeable dip in the blood supply.
Aside from risks to the everyday citizen, Hurricane Sandy also poses significant risks to the health care system at large– and will have significant economic and healthcare availability consequences in time. Hopefully, future natural disaster damages can be prevented given the knowledge gathered during this particular event.
1) “storm barrels through region, leaving destructive path.” James Barron
2) “rats add health concerns to list of new york’s problems.” Liz Kilmas.
3) “hurricane sandy hinders blood and platelet donations.” American Red Cross.
4) “health: drinking water safety after hurricane sandy.” Stephanie Stahl.
This post originally appeared on the Health and Law Blog.

The ACA and Immigrants

February 4, 2013 by · Leave a Comment
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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.


New York City’s Attempt to Crackdown on Prescription Drug Abuse Through the Emergency Room

January 20, 2013 by · 1 Comment
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Tara RagoneOn 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.


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