The Patient Protection and Affordable Care Act (PPACA) has, in large part, overhauled the American health care system and the national dialogue that has resulted from PPACA’s enactment is seemingly infinite. The focus of this post, however, is one particular topic that has not often been a part of the national dialogue. It addresses PPACA’s expansion of the Employee Retirement Income and Security Act (ERISA) by requiring that external reviews be incorporated into employee benefits plans claim procedures. 
First, it is important to understand ERISA’s requirements prior to PPACA’s expansion of the statute. The purpose of ERISA is to protect the rights of individuals participating in employee benefit plans.  Among the types of employee benefit plans that ERISA regulates are group health plans.  To effectuate its purpose, ERISA mandates that if an employer chooses to establish an employee benefits plan, such a plan will fulfill certain requirements.  One requirement is that plan participants who receive an adverse determination of benefits are afforded the opportunity to have such a determination reviewed:In accordance with regulations of the Secretary, every employee benefit plan shall (1) provide adequate notice in writing to any participant or beneficiary whose claim for benefits under the plan has been denied, setting forth the specific reasons for such denial, written in a manner calculated to be understood by the participant, and (2) afford a reasonable opportunity to any participant whose claim for benefits has been denied for a full and fair review by the appropriate named fiduciary of the decision denying the claim.
ERISA § 503, 29 U.S.C § 1133.  Essentially, Section 503 requires that an employee benefits plan make available to plan participants claim procedures that enable a challenge to an adverse benefit determination.  Pre-PPACA, the review of adverse benefit determinations was an internal process, without any independent, external review of the determination. 
As previously mentioned, the enactment of PPACA expanded upon ERISA’s claim procedures requirement.  PPACA’s addition of external review processes aligns ERISA with the spirit of health care reform, which is to provide access to affordable health care to as many Americans possible. Since only an internal review process of an adverse benefit determination was formerly required for purposes of ERISA, the concern was that many Americans were, and would be, denied essential medical coverage.  Under the new requirement, the external review process provides that an independent review organization will make a final determination of the plan participant’s determination upon the exhaustion of the employee benefits plan internal claims process.  Thus, the external review process serves as a check on internal review processes and is the final, binding determination regarding health care coverage.  But it is important to note that in keeping with PPACA’s goal to cut health care costs, such an external review process may also result in the denial of health care coverage where the independent review organization deems medical treatment unnecessary.  In addition, PPACA’s modifications of ERISA do not extend to grandfathered health plans, which are plans instituted on or before March 23, 2010. 
 Kennedy, Kathryn J., and Paul T. Schultz, III. Employee Benefits Law: Qualifications and ERISA Requirements. 2nd Ed. New York: LexisNexis, 2012.
 Kennedy, Kathryn J., and Paul T. Schultz, III. Employee Benefits Law: Qualifications and ERISA Requirements. 2nd Ed. New York: LexisNexis, 2012.
 ERISA § 503, 29 U.S.C. § 1133.
In his article Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety , which is forthcoming in the Iowa Law Review, Ryan Abbott argues that third parties, including academics, insurance companies, and rival drug companies, should be incentivized via an “administrative bounty proceeding” to analyze the large and rich datasets that will be generated by health information exchanges. Should a third party’s original statistical analysis reveal safety or efficacy concerns about a drug, Abbott suggests, it could submit the results to the Food and Drug Administration and be paid a taxpayer-funded bounty, the amount of which would be based on the value of the new information to the government in terms of health care dollars saved. If a drug’s manufacturer knew or should have known about the concerns brought to light by the third party, Abbott proposes that the manufacturer fund the bounty, the amount of which would be based on the drug’s sales; depending on its degree of culpability, a manufacturer could even be liable to both the third party and the government for damages.
Abbott believes that the bounty system he proposes would level the pharmacovigilance playing field in a way that would redound to the benefit of consumers. In his words: “The public deserves an advocate as equally committed to challenging the safety and efficacy of approved drugs as product sponsors are to maintaining these drugs on the market.” Writing about Abbott’s proposal at the Bill of Health blog, Dov Fox distills it down to the following provocative question: Are we “better off evaluating medicines under an inquisitorial system or an adversarial system”?
I also recommend Jennifer Herbst’s article How Medicare Part D, Medicaid, Electronic Prescribing and ICD-10 Could Improve Public Health (but Only if CMS Lets Them) , which is forthcoming in Health Matrix: Journal of Law-Medicine. While the title might seem daunting, the article itself brings clarity to a murky, highly-technical area of the law with enormous significance for public policy. As Herbst explains, although both Medicare Part D and Medicaid limit reimbursement to drugs prescribed for “medically accepted indications,” this limitation is not enforced, at least not at the time of payment. And, while the government’s attempts to enforce it retroactively have led to headline-making settlements with pharmaceutical companies, they have not resulted in a significant dent in the rate of unscientifically-supported prescribing.
Herbst recommends that the government take advantage of the inroads made by electronic prescribing and require that patient diagnosis codes be made a condition of payment for outpatient prescription drugs. Linking drugs to diagnoses in this way would allow pharmacists to do a more thorough safety review of the prescriptions they fill and it would give the government a powerful pharmacovigilance tool. Of course, it would also allow the government to decline to provide reimbursement for drugs prescribed for indications that are not “medically accepted.” Herbst argues that this would be a mistake because it could lead to widespread miscoding – there’s a disconnect between what the government deems medically accepted and what providers consider sound medical practice – which would undermine the value of the data being collected. I wonder, however, whether it would be politically feasible for the Centers for Medicare & Medicaid Services “to continue its current policy of paying for all outpatient prescriptions not subject to prior authorization (contrary to the letter of the Medicare Part D and Medicaid statutes)” in the face of the data Herbst’s proposal would generate.
Bone marrow transplant recipients have been found to commit suicide at more than twice the rate of the general population, according to a recent European study. With a sample of almost 300,000 bone marrow transplant recipients, the rate of suicide was 21 per 100,000 people, as compared with 9 per 100,000 in the general population.  While the signs of depression that often coincide with the diseases that create the need for transplants may be a cause, this increased rate in suicide may also be attributable to the physical and mental toll of the transplant process. Irrespective of the precise cause, serious implications may result in the transplant allocation process if this study is given weight.
The scarcity of organs that we continue to struggle with in the United States and abroad justifies the goal of allocating organs to individuals who will best take care of them. In doing so, we create requirements for individuals who, for example, are in need of a liver transplant due to their alcohol abuse. It would be counterintuitive to give a liver to someone who, by his or her own volition, will abuse the anatomical gift. Among these requirements, alcoholic candidates are given their position on priority lists only after they can establish that they have abstained from alcohol for a given period of time. There are countless additional measures employed to attempt to ensure that the limited available organs are not wasted. This goal of distributing organs intelligently to avoid waste is critical to the United States’ system of allocation.
The moral principles behind the various methods of organ allocation create this intention of maximum preservation. This goal of saving the most lives creates an immediate dilemma when taking this study into consideration.
Depression has been found in greater rates among those in need of transplants when compared with the general population, and this fact is entirely unsurprising. But should an individual’s psychological reaction to his or her medical misfortune be a factor for consideration when allocating organs? It would seem to be in direct contrast to other allocation principles and criteria to ignore this fact when the goal is to save the most peopleespecially when the potential deaths after receipt are entirely caused by the individual. In terms of saving the most lives, taking into account the risk of suicide after receipt of an incredibly scarce resource may be a mandatory consideration.
However, this then demands that antidiscrimination be taken into account in organ allocation. While California has included antidiscrimination provisions in their Uniform Anatomical Gift Act,  New Jersey has proposed similar provisions that prohibit discrimination against potential organ transplant recipients on the basis of physical or mental disability. Depression appears to be the cause of this increased rate of suicide, and what is depression if not mental disability? The Americans With Disabilities Act (ADA) covers individuals who have a physical or mental impairment that substantially limits one or more major life activities. Therefore, candidates with depression that suffer from substantial limitations in their lives may be entitled to an ADA claim if they are discriminated against on the basis of their depression.
 Andrew M. Seaman, Suicide, accidents linked to bone marrow transplant, Reuters, (Apr. 12, 2013), .
 Cal. Health & Safety Code § 7151.35 (West 2013).
On March 25, 2013, oral arguments were given before the Supreme Court for , in what the government is calling a “pay to delay” case. This potentially very important case could have a deep impact on the way brand-name and generic drug companies settle patent disputes– and on the cost of drugs to consumers.
A little background…
The protection of patents given to inventors originates in the Constitution in Art. I Sec. 8. Patents are given to novel, non-obvious inventions, and a term of a patent lasts 20 years from the earliest filing date. A patent gives the holder an exclusive right to develop, market, produce and sell their product (or not to). The patent also allows the holder to sell or license these rights to others.
Patents and their protections existed before the Federal Trade Commission (FTC) was created and the Federal Antitrust laws were passed, and are a complete exception to the competition laws. Antitrust seeks to prevent companies from engaging in anticompetitive conduct– those actions that lead to “fewer choices, less innovation, and higher prices.” (FTC website)
Typically the Government protects scientific patents with the justification that this maintains the incentive for companies to do the expensive research and development for new drugs and therapies. However, Congress tried to strike a balance when it passed the Hatch-Waxman act, which encourages generic companies to challenge brand-name patents. This was in the hope of giving generics the opportunity to enter the market earlier to manufacture and sell the “identical or acceptable bioequivalent” at a lower cost to consumers.
How this case began…
This case, , began like many other drug company challenges with the brand name drug company (Solvay Chemicals Inc.) on one side of litigation and the generic company (Actavis, Inc.) on the other. Solvay held the patent for a topical testosterone gel drug, granted until the year 2020, which Actavis later began to develop a generic for before the patent had expired. Solvay Chemicals notified Actavis that they were challenging their actions and were preparing to bring a patent infringement lawsuit. Actavis responded by claiming that Solvay’s patent on this particular testosterone gel should not have been granted in the first place because it was not novel (too similar to it’s previous patent for a very similar drug). So, the two companies began the song and dance of litigation, which continued for several years.
In 2006 the FDA granted its approval to Actavis for its generic version. Later that year, and before a court could rule on the infringement case, the two companies met and entered into a settlement agreement. The agreement stipulated that the companies would split the remaining patent term, allowing the generic to come to market 5 years before the brand-name patent was set to expire. In addition, Actavis agreed to assist Solvay with some marketing in exchange for annual payments between $20 and $30 million dollars.
You say “pay-to-delay,” we say “reverse-settlement”…
Now the brand name and generic companies find themselves on the same side, this time facing suit against the government. Though this practice of “reverse settlements” has been around for a little over a decade, the FTC pursued the case to settle a circuit split over whether these payments were unlawful. The FTC claims that this agreement is not a “bona-fide,” “good-faith” settlement as the companies argue, but rather a presumptively illegal agreement between two competitors not to compete. The FTC alleges that if the companies had continued with the initial lawsuit and the brand-name drug patent found to be wrongfully granted, then Actavis would have had the right to begin distribution of its generic in 2006 when it received FDA approval. The FTC calls this a “pay-to-delay” agreement and wants the Court to adopt the Third Circuit approach from , 686 F.3d 197 (2012), which held that these specific types of agreements should be reviewed with heightened scrutiny (the quick-look test).
The drug companies argue that the Eleventh Circuit is the one which got it right, and that these are simply “reverse settlement” agreements and should be validly upheld as “independent business transactions.”
Before the Supreme Court…
Before an eight member court, as Justice Alito has recused himself, the possibility of a split decision and the perpetuated circuit split remains. The Justices primarily questioned the two sides on why either the Rule of Reason approach or the Per Se approach to addressing whether these agreements were antitrust violations were appropriate. Though there seemed to be some agreement that these types of agreements might be anticompetitive, there was no seeming majority as to which approach the court should take in their analysis. The Justices seemed to lean toward allowing federal district court judges the flexibility to analyze these cases on an individual basis as to the underlying intentions of the parties.
The Justices also asked many questions regarding the unintended consequences and “loop-holes” that were created by the Hatch-Waxman act. They acknowledged that the act and its subsequent amendments were intended to encourage generic companies to challenge brand-name patents, but they also noted that there were no real requirements on the generic companies to bring these challenges and there was an incentive to bring them with no real monetary loss if they did not prevail.
The government argued that if these were merely settlements regarding the patents that the agreement should only be allowed to include a splitting of the exclusive period, and no payment. The government added that their analysis of these payments as presumptively illegal could be rebutted by various justifications by the drug companies such as precompetitive reasons, or payment for wholly separate reasons.
The defendant drug companies argued that these are not anticompetitive agreements, and even the Rule of Reason analysis is not appropriate because the prima facie element of “anticompetitive effect” cannot be shown unless the underlying patent infringement case went all the way to judgment with the generic company prevailing. Though the drug companies stated that there is nothing in Hatch-Waxman that encourages or requires patent litigation to go to judgment, or discouraging settlement, Congressman Waxman (sponsor of the bill) filed an Amicus brief in which he wrote that upholding these types of “reverse settlement” payments would “turn [the legislation] on its head.”
What it might mean for consumers…
If the Supreme Court decides on a rule of reasons analysis, it will be very difficult for the government to bring their antitrust case. In these circumstances, the government must show either anticompetitive effect, or go through the often long and difficult process of defining the market and demonstrating market power. If they decide on the “Quick Look” approach, the government does not have to go through this market definition so long as there is some basic reasonable demonstration of anticompetitive effect, and the burden would shift to the drug companies to argue some precompetitive justification. Finally, if the court decides on per se illegality, this type of agreement would always be unlawful (though it seems unlikely the court will choose this path).
Under either the rule of reason or Quick Look approach these types of settlements will continue. Perhaps the effect may be that generic companies will only bring Hatch-Waxman patent challenges when they believe they have a stronger case, or believe that the patent is very weak.
If the Supreme Court sides with the FTC, then perhaps Hatch-Waxman litigation will continue to judgment more often, but this could have both positive and negative effects. If these suits go to judgment and the generic companies win, more products will enter the market at generic prices sooner a positive for the consumer. However, if generic companies lose and brand-name companies have to continue to take on these suits (where generic companies may not risk much), and bear the costs of expensive litigation, these costs may be passed on to the consumer in the form of even higher brand name drug prices.
One interesting point of the oral arguments was when Justice Kennedy attempted to pry into the underlying premise that these monopoly protections for brand name patents help cover the very high cost of research and development. Justice Kennedy pressed the respondant counsel four times over whether there was any evidence in the record as to the actual cost of development of drugs. The answer was vague, and perhaps intentionally so. There are many skeptics who criticize that there is no transparency as to the real cost of drug development, and perhaps that drug companies keep it that way so as to avoid challenge of their high cost of drugs to consumers. For now these questions remain unanswered, and we will have to wait for the Supreme Court’s decision later this year to see if they issue a decisive opinion.
Such duty is based on an individual’s right to privacy and on the general principle that people seeking medical help should not be hindered or inhibited by fear that their medical conditions will become known to others. Such assurance is necessary in order for the doctor to provide proper treatment.
Neither AMA’s ethical guidelines nor Hippocratic oath, however, is binding by law.
So to what extent can we really trust that out private information will not be shared with the rest of the world? Under the existing law such assurance seems to be quite vague.
HIPAA, for example, prohibits healthcare providers from disclosing personal health information. Healthcare providers seem to strictly adhere to the Act (sometimes overzealously ). Similarly, New York Public Health Law § 4410 imposes a duty upon healthcare providers to maintain confidentiality of patient treatment records.
These statues, however, do not create a private cause of action, which means that if your health information was improperly disclosed to third parties you can’t go to court and sue a healthcare provider for a violation of the statute. Both statues mainly provide a standard under which doctors and hospitals should operate.
Therefore, if you are in New York and your medical information has been disclosed, your only remedy is a common-law claim of breach of fiduciary duty of confidentiality, which springs from the implied covenant of trust and confidence that is inherent in the physician patient relationship, and the breach of which is actionable as a tort.
But in an unexpected twist, which the Court Of Appeals is scheduled to address, these common law protections could soon be effectively eviscerated.
Under the common law doctrine of respondeat superior an employer is vicariously liable for the actions of its employees, but only when they commit a negligent act within the scope of their employment and in furtherance of an employer’s business. Thus, if a hospital employee accidentally sends your medical records to your neighbor, the hospital will be liable for this act. But what would happen if a nurse looked into your medical chart, learned that you have an STD and called your girlfriend to inform her about it? In this scenario she does not act within the scope of her employment; she commits a willful wrong motivated by personal interest. Will the hospital be liable and should it?
The Appellate Division, Third Department recognized that a reliance on the traditional doctrine on respondeat superior in such a case will render protection of medical information a nullity because in most cases wrongful disclosure would be made outside of employee’s scope of employment. In Doe v. Cmty Health Plan-Kaiser Corp. (709 N.Y.S.2d 215 (3d Dep’t 2000)) the court has explained that a corporation always acts through its agents, servants and employees and should be directly responsible if patient’s confidences are breached.
The Second Circuit recently declined to follow this one precedent in Doe v. Guthrie Clinic, LTD. and on March 25, 2013, certified the issue to the New York Court of Appeals.
If the Court of Appeals rules that the corporation should be liable, the ruling will dramatically expand the doctrine of respondeat superior. Such an expansion may very well be justified in the light of the high sensitivity of medical information, but when the law creates one exception there is always the risk of going down the slippery slope.
If the Court, on the other hand, adheres to the traditional doctrine, the protections afforded to patients’ healthcare information will continue to be limited, and if our medical information that the hospital is under the duty to protect appears on facebook the hospital may simply wash its hands of any responsibility.
Featuring Robert E. Rudnick and Thomas J. Bean , Directors in the Gibbons P.C. Intellectual Property Department, and Kenneth Corsello of IBM, along with industry, regulatory and academic leaders, this program will address post-grant proceedings under the American Invents Act (AIA), from both the patent owner’s and challenger’s perspectives as well as discovery and other new rules of practice before the Patent Trial and Appeal Board (PTAB).
APRIL 23, 2013 | 5:30p.m.-7:30 p.m. | 2.0 NY/NJ CLE credit hours | CLE Financial Assistance available – click here | Cost: $30 (includes CLE credits, parking and reception)
Location: The event will take place at Seton Hall Law School. For further information about the event, please contact Teresa Rizzo at email@example.com .
Or Register here .
Since its release last month, Sheryl Sandberg’s bestseller Lean In has attracted seemingly continuous attention and controversy. Critics charge that the book encourages women to “lean in” to their outside-of-the-home work without fully addressing the barriers that might be impeding women’s advancement. They express concern that too intense a focus on what individual women can do to address the persistent achievement gap between women and men will only result in women blaming themselves for structural, societal problems. Similar concerns underlie the controversy over workplace wellness programs. While almost no one is against “wellness,” there is concern that emphasizing what individuals should do to achieve it, potentially on pain of losing their jobs, could be ineffective and even counterproductive.
Workplace wellness programs run the gamut from providing more nutritious food in the office cafeteria, to building an on-site gym, to providing counseling and other supportive services, to positive financial incentives keyed to achieving goals such as blood pressure control or smoking cessation, to negative incentives including hiring bans, health insurance surcharges, and, ultimately, termination. With regard to variations in the price of health insurance, Tara Ragone has explained that “[a]lthough the [Patient Protection and Affordable Care Act] prohibits issuers in the individual and small group markets from basing premium variations on health status or claims experience, Federal law permits insurers to offer premium discounts to enrollees in the small and large group markets based on participation in certain wellness programs.” The statute provides for wellness rewards of up to 30 percent of the cost of coverage, and the Secretaries of Labor, Health and Human Services, and the Treasury have discretion to increase the rewards to up to 50 percent.
In Jessica Roberts’ latest article, Healthism and The Law of Employment Discrimination , which is available on SSRN, she explains that while “issues of income, insurance, and health” seem discrete, in fact they are “intimately intertwined.” Wellness programs could exacerbate existing health disparities by restricting relatively unhealthy individuals’ access to wages, wellness programs, and employer-provided health insurance. Moreover, while “using tobacco and being overweight are conduct-based statuses”and thus not fully protected under the federal statutes that outlaw trait-based employment discrimination“the underlying choices are not simple ones.” As Roberts notes, “[t]he lack of access to healthy foods and time to work out or a longstanding addiction to tobacco may be difficult obstacles to overcome without some help.” Roberts recommends that Congress, or the substantial number of state legislatures that have not already done so, pass legislation shielding employees from discrimination not just on the basis of their health-related traits, but also on the basis of their health-related conduct. She recommends that such legislation permit employers “to promote the healthy lifestyle choices of their employees through rewards programs that do not relate directly to employment status or compensation.” I recommend Roberts’ article for its helpful (and thought-provoking) overview of the intersection between employment discrimination law, insurance regulation, and workplace wellness programs and for its nuanced legislative proposal.
I also recommend Wendy Mariner’s article, The Affordable Care Act and Health Promotion: The Role of Insurance in Defining Responsibility for Health Risks and Costs , published last year in the Duquesne Law Review. In it, Mariner argues, pithily, that “wellness program incentive systems range from minor and marginally effective, to major and possibly coercive.” She believes that the wellness rewards that PPACA permits “are likely to be too crude to significantly improve the population’s health or save money, and they pose an unnecessary threat to the [statute’s] underlying goals[.]” By fostering the idea that the unhealthy are at fault for their condition, such rewards may increase resistance to the “public programs to provide preventive services, safer social and built environments, research and education” for which Mariner advocates. She calls for the elimination of PPACA’s wellness program exception to the ban on basing the price of health insurance on health status or claims experience. With the projected cost of premiums in the new health insurance exchanges widely-reported and much decried, elimination of the wellness program exception is unlikely. Mariner’s article nonetheless offers a valuable note of caution as 2014 approaches.
In February 2013, a historic $26.1 million settlement was reached under the False Claims Act and Anti-Kickback Statute in a qui tam action against Florida dermatologist Steven Wasserman. U.S. ex rel. Freedman v. SuarezHoyos et al., No. 04-933 (M.D. Fla. 2012).
False Claims Act
The False Claims Act (FCA) is written to protect against physicians and hospitals presenting false claims to Medicare and Medicaid for reimbursement. The FCA imposes civil liability for an individual or entity that “knowingly presents or causes to be presented, a false or fraudulent claim for payment or approval” to the federal government. 31 U.S.C. § 3729 . This includes, but is not limited to, presenting claims for reimbursement of medically unnecessary services as well as reimbursement of claims for services that were never performed. Violation of the FCA carries high civil penalties of not less than $5,500 and not more than $11,000 for each claim filed plus three times the damage sustained by the government. § 3729(a)(1) .
Alan Freedman, a former employee of Suarez and Tampa Pathology Laboratory (TPL), brought this qui tam action. A qui tam action is one in which an individual brings a suit under the FCA on behalf of the government. 31 U.S.C. § 3730(b) . Within sixty days of the filing of a qui tam action, the government has the option to intervene and conduct the action. § 3730(b)(4)(A) . In this case, the government intervened and proceeded with the action. The government alleged that beginning in 1997 Steven Wasserman, a Florida dermatologist, entered into a kickback arrangement with SuarezHoyos, a pathologist and the owner of TPL. DOJ Report Feb. 11, 2013 . According to the DOJ Report: in order to increase lab referrals Wasserman would send biopsy specimens to TPL for testing. Id. The biopsy specimens sent to TPL were taken from Medicare beneficiaries. Id. TPL would return the specimens to Wasserman in a report that included space for Wasserman to sign his name indicating that he performed the test, even though it was TPL that performed the test. Id. In passing this work off as his own, Wasserman was able to bill Medicare for the biopsies, receiving around $6 million in Medicare payments for services he did not perform. Id. In addition to this, Wasserman allegedly “substantially increased the number of skin biopsies” he performed in order to increase referral business for TPL. Lastly, Wasserman allegedly performed thousands of medically unnecessary skin surgeries in order to receive Medicare reimbursement for them. Id.
If each of the government’s allegations is true, Wasserman’s arrangement with TPL violates both the Anti-Kickback Statute and the False Claims Act. Wasserman was receiving a kickback in the form of Medicare reimbursements for increasing the referrals to TPL, in violation of the AKS. In return for increasing the number of referrals to TPL, Wasserman was sent the results from TPL with space for him to sign his name indicating that he had personally performed the test. In turn he presented these results to the government and received Medicare reimbursement. Thus, in return for referrals to TPL, Wasserman indirectly received remuneration in the form of Medicare reimbursements, made possible by the signature line on the report from TPL. This violation is also linked to the alleged FCA violation. By presenting claims for reimbursement for the biopsies, and representing that he had performed them when he had not, Wasserman violated the FCA. Further, by performing medically unnecessary surgeries and presenting claims for reimbursement by Medicare, Wasserman has violated the FCA.
However, Wasserman has not plead guilty to these charges, and this settlement is not an admission of liability to any charge. Wasserman settled with the government for more than $26 million and has also agreed to be excluded from treating patients and being reimbursed by Medicare, Medicaid or any other federally funded healthcare program. Id. The government also settled the same allegations with TPL and SuarezHoyos for $950,000. Robert O’Neill, the U.S. Attorney for the Middle District of Florida hailed this settlement as a “watershed achievement in [the] district’s civil health care fraud enforcement program,” and stated that “[s]chemes of this magnitude require extraordinary remedies, and [the district is] proud to have reached such an outstanding resolution for the taxpayers and their health programs.” Id. “The settlement is the largest ever with an individual under the False Claims Act in the Middle District of Florida and one of the largest with an individual under the False Claims Act in U.S. history.” Id.
O. Carter Snead, William P. and Hazel B. White Director of the Center for Ethics and Culture and Professor of Law, Notre Dame University
“Embryos are living members of the human species,” declared Professor O. Carter Snead of Notre Dame Law School during a presentation to Professor Jordan Paradise’s Law and Genetics class at Seton Hall Law School. Professor Snead, former General Counsel to The President’s Council on Bioethics under President George W. Bush, lectured and met with students during his residence as Visiting Health Law Scholar at Seton Hall Law School. Professor Snead presented a lecture to the Law and Genetics class that compared embryonic stem cell patenting in the United States and Europe.
In an interview with Health Reform Watch before his presentation, Professor Snead reflected on his career in bioethics, the role bioethics plays in politics, and the current need for bioethical input.
Regarding what informs his beliefs as a lawyer practicing in bioethics, Professor Snead said before serving as General Council member he “didn’t have settled opinions” and decided his opinions by “listening to debates” and following the teachings of bioethicists such as Michael Sandel, Robert George, Leon Kass, and George Annas. However, he noted that he has always had one main concern: self-governance. As such, he disapproves of an “enclave of elite thinkers telling everybody what to do and think.” In order to better democratize bioethical issues, Professor Snead emphasized the importance of recognizing “We all have standing to debate and discuss. There’s no special expertise necessary to reflect on normative questions.”
In promoting the need for debate on bioethical issues, Professor Snead used physician-assisted suicide as an example to explain the shortfallings of a purely normative approach. In setting-up a situation where physician-assisted suicide may seem reasonable to many, or “in a vacuum” as Professor Snead referred to it, moral dispute may be limited. However, he stressed looking at the issue and its “collateral” effects including “exploitation of the poor, abuse of the disabled, and fraud and abuse.” Professor Snead contended that in order to avoid the collateral consequences, “We have to sacrifice [the] liberty of the small sliver of people who might be able to autonomously choose to end their own lives free from coercion, fraud, and abuse.” Which is to say that those most vulnerable the poor, the disabled and those most readily susceptible to fraud and abuseare not necessarily best situated to advocate for themselves. If these most vulnerable are to be properly considered, “the vacuum,” and those who construct it, must be left behind and the actualityin its broader senseconsidered.
This example led Professor Snead to advocate for responsible discussion on bioethical issues and criticism for politicians who inappropriately use the issue on their campaign platform. ”Politicians I.D. wedge issues and try to spin the issues. We end-up with a dishonest discussion,” stated Professor Snead.
In answering a question on what role American bioethical principles play in the global community, Professor Snead said he disfavors “exporting our bioethical approach,” noting that bioethics and moral anthropology closely coincide. He stated, “Who you think human beings are, what are our relations to each other” is what informs a nation’s bioethical beliefs and that there is “no formulaic way.” However, Professor Snead did note, “Bioethics is an application of deeper human principles across a variety of factual and cultural contexts.” As a law professor, he uses this philosophy and teaches “by exposing students to competing views in a neutral fashion, exploring the strengths and weaknesses of the various approaches.”
On the topic he presented to the Law and Genetics class, Professor Snead’s bioethical standpoint is that embryos are human subjects entitled to “A baseline of inalienable rights,” and further noted that, “Embryonic stem cells are not yet capable of producing therapies.” He pointed to the potential therapeutic value of induced pluripotent stem (iPS) cells, a type of adult stem cell, and described the cells: “easier to work with, less ethically contentious, and seems to be doing the same as embryos.” Addressing concerns of other nations conducting research with embryonic stem cells, Professor Snead stated: “The best researchers are in the US. I’m not worried about falling behind in any area of scientific inquiry.”
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.