Seton Hall Law Places First at UM Carey Law’s Health Law Regulatory and Compliance Competition

February 28, 2014 by · Leave a Comment
Filed under: Compliance, Health Law, Seton Hall Law 

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At Seton Hall Law’s website, Victoria Dorum reports that Seton Hall Law students Lindsey Borgeson, Joyce Crawford, and Phillip DeFedele (pictured above, from left), along with alternate Cynthia Frumanek, recently came in first at the University of Maryland Francis King Carey School of Law’s Health Law Regulatory and Compliance Competition.

Dorum writes:

Not only did the team members distinguish themselves among other top schools, they also made a profound impression on the judges. Virginia Rowthorn, Managing Director of the Law & Health Care Program at the University of Maryland School of Law, wrote a note to [Seton Hall Law Professor Tara Adams Ragone] to  commend the team and their teachers for the team’s excellent presentation. She wrote, “One of the judges who heard them told me they knocked it out of the ballpark with their knowledge, and also with the professional way they presented their ‘case’.”

Read Dorum’s full article on the Health Law Regulatory and Compliance Competition here; UM Carey Law’s coverage is here.

This has been a great academic year for Seton Hall Law, which also won the National Health Law Moot Court Competition in November.   Dorum covered that victory as well, here.

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Changing Landscape of New York Hospitals

Nina K. ShumanHospital mergers and other forms of transactions, such as joint ventures and affiliations, have been occurring more frequently in recent years. A report issued by the accounting firm Dixon Hughes Goodman noted the predominant reasons for hospitals to undergo these structural changes are: (1) to achieve economies of scale; (2) to benefit from a partner’s unique clinical or managerial strength; and (3) to expand geographically to better provide for patient and community needs. An economy of scale is the theory by which long-run average total costs decrease as output increases. When hospitals merge or undergo other forms of transactions, the result is increased efficiency, which ultimately reduces average costs. Often, a smaller hospital or a hospital that is not as nationally recognized will strategically merge with a larger hospital to attain the benefits of the larger hospital’s managerial or clinical strengths.

Recently, NYC hospitals have undergone significant organizational changes. Mount Sinai Medical Center has merged with Continuum Health Partners (CHP). Mount Sinai Medical Center is a 1,171-bed hospital nationally-ranked by U.S. News and World Report and internationally recognized for several specialties including: Cardiology & Heart Surgery, Diabetes & Endocrinology, Ear, Nose & Throat, Gastroenterology & GI Surgery, Geriatrics, Nephrology, Neurology & Neurosurgery, and Rehabilitation. While CHP’s hospitals are renowned and recognized in various clinical areas, these hospitals will now have a stronger force in the New York area under the Mount Sinai Health System umbrella. Another significant organizational change is the expansion of Manhattan’s Memorial Sloan-Kettering Cancer Center (MSKCC) to Connecticut. These changes will likely have positive impacts on quality of care and improved access for patients of these hospitals. Further, the proposed closure of Brooklyn’s Long Island College Hospital (LICH) has been postponed, allowing consideration of alternatives to closure, as closure would have a negative impact on area residents that rely on its services for primary care (see discussion here, here, and here). Accordingly, the changing landscape of NYC hospitals will have implications on patient care.

Mount Sinai and Continuum Health Partners: The Love Triangle

Once upon a time, in the late 1990s, Mount Sinai Medical Center and NYU Langone Medical Center wooed one another and eventually merged; the merger proved to be a failure three years later. Read more

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Bring the New Australian Living Donor Compensation Scheme to the United States

August 29, 2013 by · Leave a Comment
Filed under: Bioethics, Health Law 

Jared SteppThe Australian government has announced a new scheme that will compensate living organ donors with cash payments during their recovery period. This is said to be intended not as a payment for the organ, but as a way to minimize the financial burden of donation. The plan should be seen as a step in the right direction for those who favor legalizing payment for organ donation in the United States, and Congress should seriously consider authorizing a similar pilot program.

Australia’s new program has several features, designed to mitigate fears and concerns about paying organ donors. First, the plan reduces the fear that individuals will look to donate their organs out of desperation and economic necessity. This is accomplished by limiting the payments to the currently employed, including self-employed and part-time workers. Additionally the compensation is not extravagant, topping out at $606 a week for up to six weeks. This limited compensation is unlikely to attract financially distressed donors who would otherwise choose not to donate, though it may make it easier for those who are not well-off to commit to a process that will entail significant time off from work. That being the case, most donors would find themselves afterwards in relatively the same financial situation as before they donated.

Second, the money comes from the Australian government, rather than from the recipients themselves.  This reduces the appearance of a cash-for-organs system that might be unpopular and ethically problematic. A third party payment system for bone marrow is already developing in the US. The group moremarrowdonors.org has led the effort for such after the 2012 decision of Flynn v. Holder held that payment for donating bone marrow by apheresis is allowed under the current law. If third parties, be they charitable organizations or the US government, make payments to donors a gap is created between the donor and the recipient. This gap will, presumably,  allow donors to still feel that they have actually donated and not sold their organ. And, if the altruistic component of donation can be preserved while reducing the financial burden to the donor then it is unlikely that this new scheme will drive away potential donors who do not like the idea of selling their organs.

If this scheme were adopted by the United States it has the potential to drastically increase the supply of kidneys, especially in minority communities. There is currently a huge gap between the supply and demand for kidneys. For racial minorities this gap is even wider. Modest payment for missed work time, coupled with an awareness campaign, would allow low-income individuals to donate their organs without placing themselves in financial jeopardy from missed work. If the amount of money paid to the donor was kept modest, like the Australian scheme, claims of exploitation would be less persuasive.

The US government should closely monitor the Australian pilot program to see if it is effective. If so, it should be rapidly adopted by the US. If not, then consideration should be given to other means of increasing organ donation, including larger cash payments to donors. A US program similar to the new Australian scheme would go a long way to closing the gap between the need for kidneys and the supply of living donors.

Links:

Paid leave for organ donation needs monitoring

Australian organ donors to be paid cash grants

Paid leave for organ donors

Cash for kidneys as organ donors set to get wage from government

Organ donors to be paid six-weeks’ salary

Trial minimum wage payment for organ donors

Hopes paid leave for organ donors will boost donations

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We’re Back!

Kate Greenwood_high res 2011 compHere at Seton Hall Law, the halls are filled with the sounds of students again, which means our summer-long blog hiatus has come to an end.  We’re excited to get back to blogging at Health Reform Watch!

As always, the blog will feature analysis and commentary from Seton Hall’s health law faculty and Recommended Reading posts highlighting the health law scholarship we’ve been reading and enjoying.  It will also include contributions from the students in our health law program as well as announcements of program activities.

Guest posts on health and pharmaceutical law and policy topics are welcome, so please contact me, Kate Greenwood, at kate.greenwood@shu.edu if there’s something you’d like to share.

. . .

From the beginning, the content of Health Reform Watch has been driven by the diverse interests and expertise of Seton Hall’s health law faculty.  In my case, that’s maternal and child health, drug and device law and policy, and, most especially, the intersection of the two.  In recent months, I have focused on the regulation of orphan drugs (a video of me opining about the same can be found here), and so yesterday’s news that the Australian government has decided to pay the $110,000 per-course-of-treatment price for Bristol-Myers Squibb’s melanoma drug Yervoy caught my attention.  What’s newsworthy is not Australia’s decision to pay – other countries are, too – but rather its plan for making sure it is getting its money’s worth.  As reporter Wendy Carlisle explains, Australia’s Pharmaceutical Benefits Advisory Committee will for the first time be conducting its own epidemiological study.

As is the case with many orphan drugs, Yervoy was approved on the basis of clinical trials that were relatively small.  A 2011 review conducted by Aaron Kesselheim, Jessica Meyers, and Jerry Avorn of all new oncology drug approvals from 2004 through 2010 in oncology revealed that “the FDA ha[d] approved alternative trial designs that allowed most orphan cancer drugs to be approved on the basis of single-group, nonrandomized trials that enrolled comparatively small numbers of patients.”  EvaluatePharma recently estimated that regulators require a median phase III trial size of 528 patients, at an estimated average cost of $85 million, for orphan drugs, as compared to 2,234 patients, at an estimated average cost of $186 million, for non-orphan drugs.

When it comes to clinical trials, smaller is not better.  As the chair of Australia’s Pharmaceutical Benefits Advisory Committee, Dr. Suzanne Hill, explains, “[i]f we are going to look at new products and try to judge them on the basis of smaller clinical trials – which is what is happening – then we are going to be less confident about the clinical trial data when we see them for making recommendations[.]“  To shore up the Committee’s confidence in Yervoy, it will be tracking “who gets prescribed it, what happens to them, how long do they get treatment for, how is the treatment … put in the context of other treatments that they have and what happens to the outcome?”  The Committee’s ultimate goal is to determine whether “we get the survival benefit in the community that we saw in the trials[.]”

The number of orphan drugs, many of which cost in excess of $100,000, is climbing and is expected to continue to do so.  EvaluatePharma estimates that “the worldwide orphan drug market is set to grow to $127 [billion], a compound annual growth rate of +7.4% per year between 2012 and 2018[,]” which “is double that of the overall prescription drug market, excluding generics, which is set to grow at +3.7% per year.”  Given these expected trends, there is no doubt that regulators and payers will increasingly look to post-marketing studies to supplement the available clinical trial data about orphan drugs, whether they conduct the studies themselves, as Australia is doing, or require manufacturers to shoulder the burden.  Care must be taken to ensure that manufacturers remain incentivized to develop treatments for rare diseases, but there is evidence to suggest that regulators have room to maneuver.  EvaluatePharma reports that “[t]he current stock of Phase III/Filed orphan products is expected to yield a return on investment of x10.3,” while the current stock of non-orphan products is only expected to yield a return on investment of x6.0.

 

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Healthcare Compliance Certification Program at Seton Hall Law School

June 3, 2013 by · Leave a Comment
Filed under: Health Law 

HCCP-learnmore3June 10-13, 2013, Newark, New Jersey

NY/NJ CLE credits available

Program Overview

This four-day educational program, held twice a year, immerses attendees in the statutes, regulations, and other guidance that comprise the body of law known as “fraud and abuse law,” as well as other healthcare-related laws and regulations, to help them understand the legal underpinnings of the compliance programs they develop and enforce.

Who Should Attend

Pharmaceutical and medical device professionals in compliance, legal, regulatory and medical affairs, sales, marketing, grants and related areas, as well as outside counsel who represent healthcare companies.

Cost & Registration

Tuition for the Program: $2,400. To register, go to http://law.shu.edu/hccp.

Program Details

  1. Program faculty include high-level government and private lawyers who are experts in pharmaceutical and medical device fraud and abuse issues.
  2. Session topics include Federal and State False Claims Acts, Federal Anti-Kickback Statute, the Food, Drug & Cosmetic Act (FDCA), Data Privacy (HIPAA, HITECH, and others), Food & Drug Administration Amendment Act of 2007 (FDAAA), Foreign Corrupt Practices Act (FCPA), Prescription Drug Marketing Act of 1987 (PDMA), PhRMA Code and AdvaMed Code, The Federal Sunshine Law, federal and state marketing and disclosure laws, OIG compliance guidance, and much more.
  3. Attendees receive extensive resource materials which will aid them in their ongoing compliance efforts.
  4. Attendees will receive a certificate issued by Seton Hall Law School upon completion of the Program, and may apply for approximately 26 CEUs for HCCA and SCCE certification and/or NY and NJ CLE credit.

More Information

For more information regarding the Program, please contact Sara Simon at sara.simon@shu.edu or call 973-642-8190.

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