In collaboration with the Bergen County Prosecutor’s Office; 6 NJ/NY CLE credits. Click here for more information or to register.
Helen Oscislawski is the founder of Oscislawski, LLC in Princeton. She provides legal guidance on HIPAA, HITECH, state privacy laws, electronic health information exchanges and health information technology to HIEs, RHIOs and ACOs, and counsels other healthcare clients in various matters.
Ms. Oscislawski was appointed by Governor Jon Corzine in 2008 to the New Jersey Health Information Technology Commission (NJHITC) and was reappointed to the NJHITC by Governor Chris Christie in 2010 where she also served as Chair of the Privacy and Security Committee for NJHIT Coordinator. She is the primary author of Update to Privacy and Security Compliance Manual, which was developed for the New Jersey Hospital Association and, most recently, she has developed and authored several editions of the HIPAA-HITECH Helpbook, a manual that combines tools and sample forms that address HITECH changes, state law and other considerations and Meaningful Use and Health Information Exchanges.
Before founding Oscislawski, LLC, Ms. Oscislawski was a healthcare attorney at Fox Rothchild in Princeton, New Jersey, where she counseled healthcare clients on a wide range of legal matters. She received her BA from Rutgers University, Douglass College and her JD from Rutgers School of Law.
Professor Frank Pasquale is the Schering-Plough Professor in Health Care Regulation and Enforcement at Seton Hall Law School. Professor Pasquale has taught information and health law at Seton Hall since 2004. He has published over 20 scholarly articles. His research agenda focuses on challenges posed to information law by rapidly changing technology, particularly in the health care, internet, and finance industries.
Professor Pasquale is an Affiliate Fellow of Yale Law School’s Information Society Project. He has been named to the Advisory Board of the Electronic Privacy Information Center. He has served on the executive board of the Health Law Section of the American Association of Law Schools (AALS), and has served as chair of the AALS Section on Privacy and Defamation.
Professor Pasquale received his BA from Harvard University (summa cum laude), his M.Phil. from Oxford University, and his JD from Yale Law School.
Jaime S. Pego is a Director in the Short Hills, New Jersey, office of KPMG LLP’s Healthcare Advisory Services Practice and serves as the firm’s National HIPAA Privacy Director. She has substantial experience in healthcare regulatory compliance and healthcare-related advisory services.
Ms. Pego works with a variety of healthcare clients to assist with identifying and preventing compliance risks and complying with federal and state regulations. Her work for KPMG includes serving as lead director for OCR HIPAA audits, as well as acting as Privacy Lead for the KPMG HIPAA national service line assisting covered entities and business associates with HIPAA compliance. She has conducted internal investigations concerning a variety of topics, including fraud and abuse, HIPAA violations, as well as other legal and regulatory matters, and researched and developed compliance policies for institutions in the areas of gifting under the Anti-Kickback Statute and Stark Law, the DRA, HIPAA, EMTALA and others. She participates in the KMPG National HIPAA working group to develop tools and methodologies for client needs, and conducts and manages ICD-10 Impact Assessment at a variety of healthcare organizations to help identify gaps in ICD-10 readiness. She has also served as the firm’s lead manager for health care reform legislative analysis and research.
Prior to coming to KPMG, Ms. Pego was a Local Compliance Officer at a teaching hospital and outpatient center for one of New Jersey’s largest health care systems and has worked with some of the country’s leading health systems. She received her BA from American University and her JD from Seton Hall University School of Law, with a Concentration in Health Law, and is Certified in Healthcare Compliance (CHC) by the Health Care Compliance Association (HCCA).
Joy Pritts joined the Office of the National Coordinator for Health Information Technology (ONC), Department of Health & Human Services in February 2010 as its first Chief Privacy Officer. Ms. Pritts provides critical advice to the Secretary and the National Coordinator in developing and implementing ONC’s privacy and security programs under HITECH. She works closely with the Office for Civil Rights and other operating divisions of HHS, as well as with other government agencies to help ensure a coordinated approach to key privacy and security issues.
Prior to joining ONC, Ms. Pritts held a joint appointment as a Senior Scholar with the O’Neill Institute for National and Global Health Law and as a Research Associate Professor with the Health Policy Institute, Georgetown University. She has an extensive background in confidentiality laws including the HIPAA Privacy Rule, federal alcohol and substance abuse treatment confidentiality laws, the Common Rule governing federally funded research, and state health information privacy laws.
Ms. Pritts received her BA from Oberlin College and her JD from Case Western Reserve University.
Anna Spencer is a partner in Sidley Austin’s Washington, D.C. office whose practice focuses on health care. Ms. Spencer primarily works on matters involving the privacy and security of health information and she is the firm’s global coordinator for health information privacy. She regularly counsels a broad range of clients on healthcare information privacy and security issues. This includes assisting clients with respect to HIPAA and HITECH and has significant experience in investigating and responding to data breaches and information security incidents. She has represented clients in connection with data breach reporting obligations under the HITECH regulations for breaches of protected health information and defended health care providers in investigations initiated by the Office of Civil Rights, Department of Health and Human Services.
On behalf of covered entities and entities that qualify as HIPAA business associates, Ms. Spencer has developed multiple HIPAA privacy and security compliance and training programs. She has negotiated hundreds of Business Associate Agreements on behalf of various clients.
Ms. Spencer has spoken on privacy/security matters on behalf of numerous groups such as BNA and the American Conference Institute. She has authored a variety of articles on privacy/security issues, Medicare coverage, and fraud and abuse. She is currently authoring a book for BNA on health information privacy. Ms. Spencer received her BA from Sewanee and her JD from Vanderbilt University School of Law.
Mark Swearingen coordinates the HIPAA practice and provides counsel on health information privacy and security matters such as breach response and notification and the creation, use, disclosure, retention and destruction of medical records and other health information at the Indianapolis law firm, Hall, Render, Killian, Heath & Lyman, P.C. His counsel to clients also includes a variety of health care topics related to regulatory compliance, physician and clinical services contracting, risk management and Independent Review Organization services. He has provided such services to a broad spectrum of health system, hospital, physician practice, diagnostic imaging center, ambulatory surgical center and long-term care facility clients.
Mr. Swearingen has spoken and written nationally and regionally on numerous topics, including antitrust, electronic medical records and health information privacy and confidentiality. He is an adjunct professor of a course in Law and Medicine at the Indiana University School of Informatics at IUPUI.
Mr. Swearingen received his BA from Indiana University and his JD from Seton Hall Law School.
Seton Hall Professor and Health Care Regulation Expert Frank Pasquale to Present Draft White Paper Outlining Options and then Moderate a Discussion on its Pros and Cons with Fellow Academics
Washington, D.C. – Seton Hall University School of Law hosted an academic roundtable discussion on how our current healthcare law will respond to the new technology environment – in particular, maintaining privacy for consumers as the health industry expands adoption of cloud computing, on Friday, March 22, 2013. Seton Hall Professor Frank Pasquale moderated the event, “The Future of HIPAA and The Cloud,” and also released a white paper he coauthored with Tara Adams Ragone on the challenges that cloud computing technologies pose to the Health Insurance Portability and Accountability Act (HIPAA).
As the recent HIPAA Omnibus Rule showed, regulation must both reflect and shape technological advances. As stakeholders face new challenges and opportunities, the roundtable asked: What is the future of HIPAA in the cloud? How will patient data be used? What is the role for third party vendors? And who should be held responsible for security breaches in the cloud?
White paper abstract:
This white paper examines how cloud computing generates new privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare entities. Nevertheless, more needs to be done to assure that health privacy and all the values it is meant to protect are actually vindicated in an era of ever faster and more pervasive data transfer and analysis.
After describing how cloud computing is now used in healthcare, this white paper examines nascent and emerging cloud applications. Current regulation addresses many of these scenarios, but also leaves some important decision points ahead. Business associate agreements between cloud service providers and covered entities will need to address new risks. To meaningfully consent to new uses of protected health information, patients will need access to more sophisticated and granular methods of monitoring data collection, analysis, and use. Policymakers should be concerned not only about medical records, but also about medical reputations used to deny opportunities. In order to implement these and other recommendations, more funding for technical assistance for health privacy regulators is essential.
Professor Andrew Koppelman
Q. (Tim Jost) Your book explains, for the general reader, what was at stake in the health care fight and what the Supreme Court did. Why should the general reader care? All this is old news.
A. (Andy Koppleman) If you’re sitting on a hill, and a large boulder rolls past you, it’s a good idea to look uphill to see if any more boulders are coming. The history matters because it shows that there are real dangers.
Last spring, the Supreme Court came within one vote of taking health insurance away from more than 30 million people. Chief Justice John Roberts declined to join the four judges who wanted to do that, but he embraced all their principles. Those principles are nasty. All five judges think that universal health care would be unconstitutional. All are suspicious of a law that asks the healthy and rich to support medical care for the sick and poor. All of them are still on the Supreme Court. They continue to exercise political power over the rest of us. Americans need to understand what happened.
Q. So what do you tell us that we don’t already know from the news stories?
A. My book explains why Obama decided to include the unpopular provision requiring everyone to have insurance. I also show that the Republicans, who originally proposed that idea, turned against it just because they wanted to deny Obama a victory. Most importantly, I show where they got the idea that the mandate was somehow a violation of an important liberty.
Q. Why did the constitutional case take the form it did?
A. The Republicans’ objection to the Act was a combination of politics and substance. Some of them honestly thought it was bad policy. But you can’t challenge a law in court because you don’t like the policy. You need to make a constitutional objection. The constitutional objection was invented, in sketchy form, just as the bill neared passage and almost instantly became Republican Party orthodoxy. It relied on an extreme libertarian philosophy, which holds that, if you get sick and can’t pay for it, that’s your tough luck. The challengers’ arguments would have struck down the Act even if the alternative was a huge population of uninsured. The dark heart of the case against the ACA is the notion that the law’s trivial burden on individuals was an outrageous invasion of liberty, even when the alternative was a regime in which millions were needlessly denied decent medical care.
Q. What about the legal arguments?
A. These are less complex than many people think. Insurance is part of commerce among the several states. Congress can regulate it. Therefore, Congress can prohibit health insurers from discriminating on the basis of preexisting conditions. Under the Necessary and Proper Clause, it gets to decide what means it may employ to make that regulation effective. I explain how the challengers tried, and failed, to get around this simple argument.
Q. Much of your book deals with the history of these constitutional provisions that formed the basis for the ACA litigation. Why should we care about this history?
There are two reasons. One is that, in interpreting any law, it is helpful to know the reasons why the law was passed. The second is that the framers of the Constitution were very bright people, and their insights are useful in addressing today’s problems.
The Constitution was adopted specifically in order to give Congress power adequate to address the nation’s problems. That is its fundamental and overriding purpose. The health care issue is one that the states had tried and failed to address: only Massachusetts did it, and its circumstances were very unusual. A situation in which neither the states nor the federal government could solve the country’s problems was what we had under the Articles of Confederation. It is precisely what the Constitution was intended to prevent.
Q. What are the boulders that you suggest may still be coming down the hill?
A. The real moral force behind the challenge to the ACA wasn’t any technical legal argument. It was most clearly stated at the oral argument, by Justice Antonin Scalia. The counsel for the United States argued that the state legitimately could compel Americans to purchase health insurance, because the country is obligated to pay for the uninsured when they get sick. Scalia responded: “Well, don’t obligate yourself to that.”
Q. Does Justice Scalia really think that there’s no obligation to care for sick people? Why was he saying this?
A. The answer has to do with the structure of constitutional law. If you want to trash the ACA –- and Scalia did –- you have to assert constitutional limits that would exist even if there were no other way to deliver medical care to everyone.
This is why so many people (including, in the end, a near-majority of the Court) who were not Tough Luck Libertarians at all, who would find that philosophy repellent, nonetheless found themselves saying Tough Luck Libertarian things, and making claims based on a Tough Luck Constitution –- a constitution in which there is no realistic path to universal health care. That Constitution won’t be attractive unless Tough Luck Libertarianism is right that it is acceptable to deny people the medical care they need. The challengers to the ACA talked a lot about slippery slopes – at the bottom of this one was a law requiring you to buy broccoli – but there’s a slope in the other direction as well. Once you decide that it’s acceptable to hold your nose and make this kind of argument, it will be easier next time.
Q. The NFIB case which the Supreme Court decided was only one of dozens of cases that have been brought challenging the Affordable Care Act. One of those cases brought by Liberty University challenged that provision of the ACA requiring large employers to offer health insurance to their employees or pay a tax penalty. Liberty University lost that case in the Fourth Circuit Court of Appeals, but the Supreme Court remanded it for reconsideration. Is there any possibility the courts will find that Congress lacks the power to require large employers to offer health insurance? Would Tough Luck Libertarianism go this far?
A. It’s hard to see how. The employer mandate is described as a tax in the statute. The individual mandate isn’t, but the Court upheld it as a tax. Chief Justice Roberts also objected to the mandate because you don’t have to do anything to be subject to it. To be subject to the employer mandate, you have to decide to employ people. Congress has had the power to regulate economic transactions for nearly a century. Even the Roberts Court isn’t going to change that.
Q. Several states are refusing to implement the insurance market reforms imposed by the ACA and one state is considering legislation that would prohibit the licensure of an insurance plan that would participate in an ACA exchange. Does the Supreme Court’s decision give any hope to states that are still refusing to assist in implementing the ACA?
A. If states won’t participate in the health exchanges, then the Federal government can and will do it for them. That has already been happening. It has been well settled for years that state laws designed to disrupt the operation of a federal law are unconstitutional.
The one part of the Court’s decision that empowers the states to stay out of the federal scheme is Chief Justice Roberts’s decision that states could refuse to provide Medicaid to their poorest citizens. The Court ruled that the states could turn down the Medicaid expansion while continuing to participate in the old Medicaid program. One might have expected that no state would turn down such a good deal: the federal government will pick up 100% of the costs until 2016, with its contribution gradually declining to 90% in 2020 and thereafter. And there is added pressure to take the money, because previous forms of federal aid were cut off. Hospital associations agreed to accept cuts to their reimbursement rates, expecting that this would be more than made up by money from patients newly insured through Medicaid. States refusing the money would not only be hurting their own working poor. They’d be rejecting a huge infusion of cash into their economies, creating many, many jobs –- good jobs, for doctors and well-paid medical technicians. That money has a powerful multiplier effect, creating jobs outside the health sector as well.
Many Republican governors have now turned down the money, but that number is shrinking. Gov. Rick Scott of Florida, for instance, recently changed his mind. The big question mark is Texas. One in four Texans is uninsured. The ACA would insure almost two million of them. The expansion would give Texas an additional $52.5 billion from 2014-2019, which is more than half of the state’s annual budget. Gov. Rick Perry has insisted that he won’t take the money. If you are a hospital executive in Texas, you probably have a fiduciary duty to do all you can to defeat Rick Perry. Meanwhile, the Court has succeeded in hurting millions of people. Four days before Perry announced his decision, the federal Agency for Healthcare Research and Quality ranked Texas as having the worst health care in the nation. This is the Court’s notion of “liberty.”
Timothy S. Jost holds the Robert L. Willett Family Professorship of Law at the Washington and Lee University School of Law. He is a co-author of the casebook, Health Law, used widely throughout the United States in teaching health law, and of a treatise and hornbook by the same name. His other publications are simply to numerous to list.
Andrew Koppelman is John Paul Stevens Professor of Law, Northwestern University. He has written extensively about the legal debate surrounding the Affordable Care Act for Salon . His latest book, The Tough Luck Constitution and the Assault on Healthcare Reform , will be published by Oxford University Press on March 22, 2013 and available online and through bookstores everywhere.
“Andrew Koppelman has magnificently captured the current legal, political and policy-related lay of the land in Washington. His insightful analysis here should be mandatory reading for anyone concerned about the future of health care in America.”
–Tom Daschle, former Senate Majority Leader
Governor Christie left unchanged his veto of the state’s exchange law. When he vetoed the Legislature’s bill that would have created a New Jersey exchange, Christie decided to leave the task to the federal government, citing the possible costs the state would incur running the exchange. The governor was correct that there would have been costs, notwithstanding the offer of extensive federal funding. And the rejoinder of some opponents of the governor’s position that the costs could be covered by assessments on insurers is too easy an answer. Insurance assessments, after all, raise the cost of coverage for individuals and businesses. But the burden of the assessments was worth the cost, and, as I describe below, the risk of pushing the task off to the federal government puts the most vulnerable of New Jersey’s residents at risk.
Read The Record’s featured Op-ed, “ Health reform: a lost opportunity. ”
Expect to keep hearing more talk about health care cost cutting, despite charts like this . It’s an idee fixe of the Wall Street/Washington corridor, and will only be implemented more vigorously over time. So perhaps we should take stock of a few cost cutting initiatives. Medicare Part D, it seems, is coming way under its projected budget. But maybe that’s because of ”a sharp fall in the number of breakthrough drugs,” a sign that innovation in pharma is stalling. Cost cutting triumph, or logical outgrowth of a system that fails to reward actual contributions to health ?
There’s also been a lot of pressure on skilled nursing facilities to hold the line on costs. What are we getting in return? Here’s a summary from OIG :
I’m sure the health care cost cutters will use this evidence to demand the SNFs be paid even less–rather than, say, investing real funding in proper training and pay in this vital service sector. At some point, though, costs get cut so much that Medicaid will become little more than a meaningless plastic card, and “SNF” will stand for “Scarce Nursing Forever.”
This post first appeared on HealthLawProf Blog .
Paper Warns Against ‘Nonexistent Safety Data’ and Charts a Course for FDA Oversight
Seton Hall Law Professor Jordan Paradise has released her newest paper, “No Sisyphean Task: How the FDA can Regulate Electronic Cigarettes,” scheduled to be published this Spring in Volume 13 of the Yale Journal of Health Policy, Law, and Ethics.
A report issued in February 2013 by the Centers for Disease Control and Prevention (CDC) estimates that as of 2011 “about one in five U.S. adult cigarette smokers have tried an electronic cigarette,” nearly twice as many as in 2010. CDC’s director, Tom Frieden, MD, MPH, remarked that “E-cigarette use is growing rapidly” but also noted that “there is still a lot we don’t know about these products….”
In “No Sisyphean Task: How the FDA can Regulate Electronic Cigarettes,” Professor Paradise investigates the rise of the e-cigarette phenomenon in the wake of the recently enacted Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), the tumultuous history of attempts at tobacco regulation through Congress, the FDA and the courts and suggests a feasible approach to strengthening regulation of e-cigarettes under the existing statutory framework. These measures would facilitate oversight and the compilation of a safety profile for e-cigarettes; such a profile is conspicuously absent at present.
In the paper, Professor Paradise explains that because e-cigarettes contain nicotine, and are “derived from tobacco,” they have been found to fall under the designation of “tobacco products” under the TCA. Any product designated a Tobacco Product may not be considered a drug or medical device for FDA oversight purposes. Although e-cigarettes have been found to be a tobacco product, they are neither “cigarettes” nor “smokeless tobacco” under the statutory definitions. This leaves their regulation unclear as neither drug-devices absent blatant health claims (which would subject them to rigorous preapproval clinical trials) nor cigarettes (subjecting them to flavor additive bans, advertising restrictions, and graphic warnings). These perceived statutory gaps have thus far allowed the manufacturers, marketers and distributors of e-cigarettes to sell their product to the public, largely unregulated and unsupervised.
Professor Paradise notes, “E-cigarettes are one of those products for which the technology has seemingly outpaced the law. In fact, most of the core provisions of the TCA aimed at restricting youth access to smoking apply only to cigarettes and smokeless tobacco. But there is sufficient foundation under the TCA for oversight of e-cigarettes, and that oversight can be used to inform consumers of the potential risks to health as well as any benefits.” She continued, “Although there seems to be a great many people who have benefitted from e-cigarettes to quit or drastically reduce their smoking, there is currently a dearth scientific testing, comparative data, manufacturing and quality controls, limits on nicotine levels, product standards, or labeling requirements. This results in vials of the addictive drug nicotine being distributed for public consumption unchecked. We don’t necessarily know what’s in e-cigarettes, we don’t know how much, nor do we know what e-cigarettes will ultimately do, health wise, to those who use them or those who are exposed to them second hand.”
As an example of potential for oversight of e-cigarettes under the existing statutory framework, Professor Paradise points out that the statute provides for heightened requirements for what are known as “modified risk tobacco products,” defined as “any tobacco product that is sold or distributed for use to reduce the harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” The FDA has clarified the definition to say that what constitutes a “modified risk tobacco product” may be found through a product’s label, and it’s advertisingeither explicit or implicit and through any type of media. Products which meet this definition are subject to satisfying the scientific data and comparative study requirements set out by the FDA.
In addition, Professor Paradise notes that “products which make ‘therapeutic claims,’ such as signaling that a product is intended for use as an aid in smoking cessation, reduction, or as a healthy alternative to smoking, will trigger the drug or medical device provisions under the Food Drug and Cosmetics Act as a threshold matterbringing with it, again, the need for scientific data and comparative studies. The intent in ‘Intended use’ may be determined through explicit claims or ‘expressions’ by the original manufacturer or subsequent marketer or affiliates, or, according to the FDA, ‘be shown by the circumstances surrounding the distribution of the article.’”
A good look at the advertising for e-cigarettes and the circumstances surrounding their distribution is compelling, she said.”
o Product standards
o Good manufacturing practices and quality control mechanisms
o Uniform labeling and listing of ingredients on the label
o Prominent and uniform display of nicotine levels
The paper, “No Sisyphean Task: How the FDA can Regulate Electronic Cigarettes,” may be found here on SSRN: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2118802;
Contact info may be found here .
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 law.shu.edu .
Research Fellow & Lecturer in Law Tara Ragone appeared in Modern Healthcare on the potential impact of a recent U.S. Supreme Court decision which found a hospital not exempt from antitrust scrutiny, despite its claim to be protected from such through “state action immunity doctrine,” which, according to Modern Healthcare, “gives states wide latitude to regulate competition.”
The Court’s decision was unanimous, citing the fact that although the hospital system in question, Phoebe Putney Health System, “operates public hospitals under a $1-a-year lease from the Albany-Dougherty Hospital Authority,” it did not dispute that its latest hospital acquisition would give it “control of 86% of a six county market after the sale.” The Court, according to Modern Healthcare, ruled that Phoebe Putney’s financial relationship with the state was not sufficient to render its state action immunity defense tenable, and that “states must expressly grant antitrust immunity to local entities.”
The Modern Healthcare article notes, however, that the decision may also have impact on Medicaid ACOs under the ACA.
Modern Healthcare writes:And it also could affect Medicaid ACOs. “The state action doctrine has been expanded, expanded, expanded to essentially immunize them,” [Matthew] Cantor said. “The Supreme Court is going to look a bit wary about stark anti-competitive behavior.” But Tara Adams Ragone, a research fellow and lecturer at Seton Hall University School of Law who has written about how to structure Medicaid ACOs to avoid antitrust scrutiny, noted that the laws in New Jersey, New York, Oregon and Washington do state that they intend to authorize anti-competitive behavior. “It doesn’t change things from my analysis,” she said about the Phoebe Putney decision. Yet she added that states may have to review statutes that don’t contain that explicit language. The Phoebe Putney decision also doesn’t address the second prong of the state action doctrine, which requires states to actively oversee the anti-competitive behavior. “That’s where there’s a lot of work to be done,” she said. Ragone and Cantor pointed out that it’s still unclear whether the FTC and U.S. Justice Department even intend to challenge ACOs as anti-competitive. A classic antitrust case involves entities colluding to fix pricesbut the whole goal of an ACO is to reduce costs.
Read the full Modern Healthcare article, “ Phoebe Putney dealt legal blow by Supreme Court .”
Professor Jacobi writes:GOVERNOR CHRISTIE’S decision to expand Medicaid coverage to more residents will improve the health of many low-income New Jerseyans, and save the lives of some. In addition, the expansion dovetails with other reform efforts in the state, furthering implementation of innovative programs for the poor and vulnerable. The governor’s announcement is great news for low-income individuals. The Rutgers Center for State Health Policy estimates that the expansion will lead to an enrollment increase of about 234,000 in NJ FamilyCare, which combines New Jersey’s Medicaid and Children’s Health Insurance Program. The expansion addresses gaps in the current Medicaid system, under which many poor people were ineligible even if they had absolutely no income or assets. The expansion will plug those gaps, allowing people to enroll so long as they are lawful residents with an income of no more than about $15,414 per year, which is about the gross income of a full-time minimum wage worker. Health insurance coverage is important to personal health, and it is simply not true that all Americans have meaningful access to health care. As the Institute of Medicine of the National Academy of Sciences has found, people who have health insurance including Medicaid have better access to a regular source of health care. Those with no coverage, in contrast, are more likely to do without medically necessary care, particularly for chronic conditions, and to not fill prescriptions due to cost. As a consequence, the uninsured are more likely to be in “fair” or “poor” health and to die before their time. Medicaid expansion will keep people healthy and even save lives.
Read the full feature, “ How Medicaid expansion will help New Jerseyans ”
This past September, the Food and Drug Administration (FDA) issued a Warning Letter against L’Oreal, the world’s largest cosmetics company. The FDA cited claims gathered online from a subsidiary of L’Oreal, Lancôme, about its expensive Genifique, Absolue, and Renergie anti-aging creams and serums. Claims such as “[U]nique R.A.R.E. oligopeptide helps to re-bundle collagen” and “[B]oosts the activity of genes and stimulates the production of youth proteins” were deemed “intended to affect the structure or any function of the body,” thus rendering the claims to be drug-like under section 201(g)(1)(c) of the FDCA. Lancôme could either submit their cosmetics to the rigorous New Drug Approval process, in which safety and efficacy would be tested, or discontinue making such claims. Lancôme chose the latter.
Although the FDA possesses the authority to regulate cosmetics companies, traditionally the agency has not enforced provisions of the FDCA against big name cosmetics corporations. However, Lancôme has not been the only major cosmetics company to recently receive a Warning Letter for making drug-like claims. In October of 2012, the FDA sent a Warning Letter to Avon citing claims from their Anew product line. The drug-like claims included, “The at-home answer to wrinkle filling injections. Start rebuilding collagen in just 48 hours;” “[W]rinkles are a result of micro-injuries to the skin, so AVON studied how skin heals… ANEW’s Activinol Technology helps reactivate skin’s repair process to recreate fresh skin & help dramatically reverse visible wrinkles;” and, “In just 3 days, see tighter, firmer, more lifted skin.” As with Lancôme’s products, the FDA concluded that these products “are not generally recognized among qualified experts as safe and effective for the above referenced uses.”
The ultimate impact of an FDA Warning Letter in terms of litigation remains unclear, but the legal industry has taken notice. Attorneys at Venable LLP point out in their analysis of the FDA’s Warning Letter to Lancôme, “[F]ederal action has been shown to encourage consumer class action lawsuits.” Attorneys at Shook Hardy & Bacon LLP note, “Plaintiffs will allege that consumers were defrauded into purchasing the product because of illegal marketing claims and trumpet those same FDA warning letters as proof that the marketing claims were deceptive under state consumer fraud statutes.”
Those predictions turned out to be true. Both Avon and L’Oreal and subsidiary Lancôme have been named defendants in multiple proposed class action suits for defrauding consumers. For cases naming L’Oreal and Lancôme as defendants, see Nino v. L’Oreal USA Inc., Case No. 1:12-cv-12362 (S.D. Fl.), Schwartz v. L’Oreal USA, Inc., Case No. 2:12-cv-5557 (N.D. Cal.), and Kallen v. L’Oreal USA, Inc., Case No. 12-9479 (C.D. Cal.). For cases naming Avon as defendants, see Trujillo v. Avon Products, Inc., Case No. 12-9084, (C.D. Cal), Quinta v. Avon Products Inc., Case No. CV12-09629 (C.D. Cal.).
Attorneys at Morelli Ratner PC, who took part in filing Nino v. L’Oreal USA, Inc., write on their website: “The complaint alleges that the Defendants have advertised their “anti-aging” creams as having been scientifically tested, making claims and promising results to consumers that the Defendants know to be unfounded. Earlier this month, the Food and Drug Administration sent Lancôme a formal warning letter about the misleading advertising. The complaint alleges that L’Oreal has made millions of dollars by knowlingly [sic] and willfully misleading consumers.” The complaint addresses that the lawsuit seeks restitution and disgorgement of profits, along with “benefits and other compensation obtained by Defendants from their wrongful conduct.”
All of the complaints for the proposed class actions cite to the Warning Letters issued against the companies. The class actions against L’Oreal and Lancôme are to be centralized in the New Jersey District Court in the Newark Office with presiding Judge William J. Martini. In re L’Oreal Wrinkle Cream Mktg. & Sales Practices Litig., 2012 U.S. Dist. LEXIS 177694 (J.P.M.L. Dec. 12, 2012). With the potential rise in Warning Letters used in consumer fraud litigation against cosmetics companies, cosmetic companies, as Shook Hardy & Bacon LLP write, can no longer afford “to take a sit-back-and-wait approach.” It would seem that big name cosmetic companies have been put on notice: complying with FDA cosmetics regulations is now necessary for those who wish to maintain good public standing and to avoid costly litigation.
As health providers and patients use more technology, new ways of addressing health care disparities are emerging. In 2009 Congress passed important federal legislation that addresses the digital infrastructure for medical care, the Health Information Technology for Economic and Clinical Health Act (HITECH). Recently in 2010, Congress passed the Patient Protection and Affordable Care Act (PPACA), which reduced barriers to health information technology (HIT). In line with the technological spirit of both laws, this blog post focuses on online social networking as a digital health care solution for elderly Hispanics who face disparities in the care that they receive.
Hispanics in the United States are twice as likely as non-Hispanics to lack a regular primary care physician (PCP). Those Hispanics that do not have a PCP suffer because they tend to experience disparities in health care when compared to other patient populations. Real-time health care-focused social networking sites (SNSs) or applications within an established SNS can provide beneficial health care solutions for vulnerable patient populations such as elderly Hispanics. One-way in which a SNS can benefit elderly Hispanics and reduce their health care disparities is by supporting the Patient-Centered Medical Home (PCMH) with digital applications. In fact, if real-time social networking transpired among 1) patients, 2) patients and their health care providers, and 3) between health care providers, elderly Hispanics could potentially receive better care.
As the role of HIT increases, it has led to a growing interest in understanding the potential role of HIT in “addressing healthcare disparities among racial and ethnic minority populations.” In order to properly evaluate the potential of HIT to address health care disparities, “adoption and utilization barriers must be understood.” Because this blog post is concerned with social networking sites, the discussion here will focus on social media and its emergence as “a potent resource among healthcare consumers.” Some studies have shown that “social media utilization patterns by race suggest potential opportunities to help address healthcare disparities via” increased communication between patients and physicians.
Social media has begun to infiltrate the health care system in several ways. First, entrepreneurs who understand “health care trends and consumer demands are leading creative business startups that are developing health-oriented social networks, health content aggregators, medical and wellness applications, and tools to enable health-related vertical searches (searches focused on a specific content area).” There are a growing number of condition-specific communities such as patientslikeme , QuitNet , and CureTogether .
Although there are many benefits to HIT, there are also barriers that prevent physicians from adopting HIT. One major benefit stemming from HIT is that it can lead to positive communication in “which providers share thoughts, opinions, and information by speech, in writing, or through peer professional or social networks [which have] been shown to be associated with provider health IT adoption.” One major issue is the inability of electronic health records (EHRs) and HIT systems to communicate with each other, the impact of HIT on clinical workflows, and the absence of technical assistance for office staff and physicians. Additional barriers from the patient perspective will exist if a patient does not perceive a benefit to be gained from using technology; in fact, without a perceived benefit they are highly unlikely to use it. There is also the perception that patients might be too busy to incorporate HIT into their busy everyday lives. Also there may be “poor computer knowledge, literacy, and skills ” prevalent among target populations which could benefit from HIT. Additionally, “lack of cultural relevance as well as privacy and trust concerns all have been reported as barriers to the use of [consumer health informatics] tools and applications.” In framing technological health care solutions for a minority population such as Hispanics, it is important to consider cultural issues in any implementation because cultural issues could deter use by a given patient population.
There are several proposed ways in which HIT can reduce health care disparities. For example, if clear and accurate patient information were to be presented to a physician in an electronic setting it could lead to the promotion of high-quality personalized care and reducing select health care disparities. Additionally, EHRs could provide the physicians that serve elderly Hispanics more accurate information and help them make better treatment decisions. The largest benefit would be the ability to connect “physicians with other [physicians or patients]…[and also] tools such as e-mail, e-consultation, e-prescribing, [which could] enable providers to connect with other healthcare professionals” in a more fluid manner.
It is important that the above mentioned benefits are implemented in communities where there are underserved Hispanics or other vulnerable patient populations. It is urgent that those with the highest health care disparities benefit from such technologies because historically their needs have not been met. Scholars have already noted that “telemedicine, remote monitors and sensors, patient e-mail, and increasingly the Internet and social media, connect providers and healthcare systems to patients and caregivers.” The idea is that greater communication can reduce health care disparities. When dealing with a historically vulnerable patient population such as elderly Hispanics who face various types of social issues, I believe that easier access to their health providers can make a big difference in improving their health care outcomes.
An HIT tool that connects providers with patients could reduce health care disparities by “enabling increased monitoring of important clinical parameters” in a way that is not currently taken advantage of for minority patients. Increased communication will allow physicians to stay in contact and monitor their sickliest patients through enhanced doctor-patient communication. As technology and health care merge, it is vital that vulnerable patient populations, such as elderly Hispanics, are identified so that they can be included in the technological healthcare solutions being proposed.
Felipe De Los Santos is in his last year at Seton Hall University, School of Law. Felipe is set to graduate from Seton Hall in May 2013 with a Health Law Concentration. He graduated from Connecticut College in 2007 with a B.A. in English and Economics. From 2007-2009, he worked in finance as a Consultant for ALaS consulting between New York and Delaware. During his first year of law school Felipe interned with the New York State Majority Leader (2009-10).
Presently Felipe works as a Project Manager for a New York State health care company in the Community Based Programs division. Felipe manages and develops projects that focus on chronically ill elderly patients in New York City. As part of his responsibilities Felipe develops marketing strategies and action plans to support targeted patient populations who can benefit from managed long-term care. Currently, Felipe is involved in launching a Medicare/Medicaid Advantage Plan. Felipe’s work with vulnerable patient populations and interests in technology, have made the crossroad of technology and healthcare an interest that he has written about in law school. Felipe’s health reform interests include improving health care access and outcomes for vulnerable patient populations.
Felipe may be reached at email@example.com
A few years ago, I noted that the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC) has a dominant role in suggesting payment levels to CMS. It raises hard questions about price-setting in the health care sector, many of which cannot be answered because its processes are opaque. Now we know that judicial relief will not improve things any time soon. As Brian Klepper reports , “On January 7, a federal appeals court rejected six Georgia primary care physicians’ (PCPs) challenge to the Centers for Medicare and Medicaid Services’ (CMS) 20-year, sole-source relationship with the secretive, specialist-dominated federal advisory committee that determines the relative value of medical services.” What was the complaint?
This is a sad example of opacity in health pricing . In ordinary markets, publicity would tend to narrow the price differential between similar quality services. In health care, however, there is a triple layer of agency between care and patients whose physicians’ recommendations are often constrained by an insurer that is chosen by the patient’s employer or government. Even if we assume away the agency problems in such an arrangement, it is difficult for buyers and sellers to truly understand “market” dynamics, or even the governmental processes that underlie them.
Originally posted at Health LawProf Blog .
We 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.
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. TheBlaze.com
3) “hurricane sandy hinders blood and platelet donations.” American Red Cross. PortageLife.com
4) “health: drinking water safety after hurricane sandy.” Stephanie Stahl. CBS.com/Philladelphia
This post originally appeared on the Health and Law Blog .