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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Memorial Day, Remembering our Veterans With Treatment

May 27, 2013 by · 1 Comment
Filed under: Health Law 

It is Memorial Day, and like in past years I will ask that we take a moment here to consider the sacrifices at the heart  of this holiday—we remember our fallen, we memorialize our dead. At present, the Veterans Administration is having great difficulty in treating and compensating our war wounded.

Number of Veterans Affected, Multiple Deployments

Since the U.S. went to war in Afghanistan in 2001 and Iraq in 2003, about 2.5 million service members have been deployed in the Afghanistan and Iraq wars, according to Department of Defense data. Of those, more than 800,000 were deployed more than once; 400,000 have done three or more deployments, and nearly 37,000 were deployed more than five times.[1] Obviously, multiple deployments increase the likelihood of service related injuries.

Wounded & Injured

It is worth noting that although considered the longest wars in U.S. history, Iraq and Afghanistan have produced relatively few U.S. service member deaths: 6,648 (as of March, 2013), but have produced a large number of wounded in action (roughly 50,000). According to reports such as Modern Warfare, by Alec C. Beekley, MD, FACS, LTC, MC, US Army, Harold Bohman, MD, CAPT, MC, US Navy, and Danielle Schindler, MD,[2] compared to Vietnam, the mortality rate of combat wounded in Afghanistan and Iraq has decreased by nearly half. New medical procedures, protective gear such as body armor and faster medical evacuation are saving more than 90 percent of all those who fall in battle, many of whom would have died on the battlefield just a generation ago. They live, but they are compromised substantially.

Type of Injuries

Notably, according to Modern Warfare, prior wars “had a higher proportion of thoracic injuries and fewer head and neck injuries. There has been a decreased incidence of wounds to the abdomen since the Persian Gulf War. The percentage of blast-related injuries is now higher.”

The number of injured are estimated by many to be ten and twenty times the number wounded in action.[3]

As would be expected with the dominance of “blast related injuries,” hearing loss, traumatic brain injury (TBI), PTSD and clinical depression, are leading injuries, with hearing loss first.[4] A 2005 Department of Veterans Affairs research paper found that one third of returning soldiers were referred to audiologists due to exposure to blasts, and 72% of them were identified as having hearing loss;[5] a 2013 report by the U.S. Congressional Research Service estimates that 255,330 members of the military suffer from TBI;[6] a 2008 study by the Rand Corp found that 14% of Iraq and Afghanistan Veterans screened positive for PTSD, 14% for major depression, and 19% had a probable traumatic brain injury.[7]

And notably, the VA reports that 37% of the claims it has backlogged at present are from Vietnam Veterans, a great influx of which (260,000) occurred after the VA finally expanded the number of illnesses presumed to be associated with Agent Orange.[8]

VA Backlog

The Center for Investigative Reporting recently released a report[9] (featured on NPR)[10] which found:

  • Despite assurances from the Obama Administration that the VA would be streamlined, “the internal documents show the VA expects the number of veterans waiting – currently about 900,000 – to continue to increase throughout 2013 and top a million by the end of this month [March, 2013].
  • The VA’s internal documents “show that the average wait time for veterans filing disability claims fell by more than a third under President George W. Bush, even as more than 320,000 Iraq and Afghanistan veterans filed disability claims.
  • The documents show delays escalated only after Obama took office and have more than doubled since, as 455,000 more returning veterans filed their claims.”
  • Pointedly, under President Obama “the ranks of veterans waiting more than a year for their benefits grew from 11,000 in 2009, the first year of Obama’s presidency, to 245,000 in December – an increase of more than 2,000 percent.”
  • Although the VA tracks and widely publishes the avg. number of days it takes to process a claim (273 days), that number pointedly does not refer to new claims. The average number of days to process a new claim in Newark is 371.6 days[11]

That amounts to roughly a year and a week for an initial claim in Newark, New Jersey– a very long time to live for a disabled veteran without much needed payments.

And importantly, if a veteran fails to characterize the claim correctly, the appeals process can literally take 2 and 3 years.

 



[1] Chris Adams, Millions went to war in Iraq, Afghanistan, leaving many with lifelong scars, McClatchy News (March 14, 2013), http://www.mcclatchydc.com/2013/03/14/185880/millions-went-to-war-in-iraq-afghanistan.html.

[2] Alec. C. Beckley, et al., Modern Warfare, in Lessons Learned from OEF and OIF: Combat Casualty Care (Office of the Surgeon General Department of the Army, 2012), available at http://www.cs.amedd.army.mil/borden/book/ccc/UCLAchp1.pdf .

[3]See Linda J. Bilmes, The Financial Legacy of Iraq and Afghanistan: How Wartime Spending Decisions will Cancel Out the Peace Dividend (2013) citing VBA Office of Performance, VA Benefits Activity, Veterans Deployed to the Global War on Terror (through September 2012) (noting that 56% of veterans deployed have received VA medical facility service and that one in two have filed disability claims— and that 2.5 million have served), http://costsofwar.org/sites/all/themes/costsofwar/images/Financial_leg.pdf;  Dan Froomkin, How many U.S. soldiers were wounded in Iraq? We have no idea, Nieman Foundation for Journalism at Harvard University (Dec. 30, 2011), at http://www.niemanwatchdog.org/index.cfm?fuseaction=ask_this.view&askthisid=545.

[4] Froomkin, supra at note 5.

[5] Stephen A. Fausti, et al., Hearing health and care: The need for improved hearing loss prevention and hearing conservation practices, 42-4 J. of Rehab. Res. & Dev. 45 (July/Aug. 2005) at http://www.rehab.research.va.gov/jour/05/42/4suppl2/fausti.html

[6] U.S. Congressional Research Service, U.S. Military Casualty Statistics: Operation New Dawn, Operation Iraqi Freedom, and Operation Enduring Freedom, Feb.5, 2013; See also Spencer Ackerman, The Cost of War Includes at Least 253,330 Brain Injuries and 1,700 Amputations, Wired, Feb. 8, 2013, http://www.wired.com/dangerroom/2013/02/cost-of-war/.

[7] Rand Corp., Invisible Wounds of War, (2008), available at http://www.rand.org/pubs/monographs/MG720.html.

[8] Allison Hickey, Balancing the Record on the Claims Backlog, Vantage Point: Dispatches from the U.S. Department of Veterans Affairs (Mar . 19, 2013), http://www.blogs.va.gov/VAntage/8995/balancing-the-record-on-the-claims-backlog/.

[9] Aaron Glantz, VA’s ability to quickly provide benefits plummets under Obama, Center for Investigative Reporting (March 11, 2013), http://cironline.org/reports/va%E2%80%99s-ability-quickly-provide-benefits-plummets-under-obama-4241

[10] Fresh Air, Veterans Face Red Tape Accessing Disability, Other Benefits, Phila. Public Radio (March 18, 2014), http://www.npr.org/2013/03/19/174639343/veterans-face-red-tape-accessing-disability-other-benefits.

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Professor John Jacobi In NJ BIZ & NJ Spotlight on New Jersey Health Reform

May 23, 2013 by · Leave a Comment
Filed under: Health Law 

jacobi_johnProfessor John Jacobi took part in the Council on State Public Affairs’ “New Jersey State of Health” symposium, covered by NJ BIZ and NJ Spotlight. The symposium brought together the state’s leading health policy experts to discuss and formulate responses to the challenges wrought by the implementation of the ACA.

NJ Spotlight reports that:

The discussion on the future of long-term future of healthcare followed panel discussions on the implementation of the health benefit exchange and Medicaid eligibility expansion, key features of the 2010 Affordable Care Act that are both scheduled to beginning covering more New Jersey residents on January 1, 2014.

Seton Hall health law professor John V. Jacobi noted the challenge involved in informing uninsured residents about the new options. The exchange will be an online marketplace in which uninsured people can buy coverage and learn whether they are eligible for federal subsidies.

NJ Biz notes that:

Seton Hall Law School Professor John V. Jacobi said that between Medicaid expansion and the subsidized health plans to be sold on the exchange, “there will certainly be hundreds of thousands of people covered,” among New Jersey’s nearly 1 million uninsured.

“There are several barriers to getting those people covered, and one is the information deficit,” Jacobi said. “People who are uninsured are typically very busy people who struggle to make their rent and put food on the table, and they are not engaged in the rollout of the ACA. So getting navigators and health educators and information to those people is going to be very important.”

The federal Department of Health and Human Services has allocated $1.5 million to fund navigators in New Jersey, which health care experts have said won’t be adequate.

[Assemblyman Herb Conaway Jr. (D-Delran), chair of the Assembly health committee] said outreach to the public will be crucial. The state Department of Banking and Insurance still has an unspent federal grant of nearly $7.6 million it received to help plan a state-run exchange; the state opted instead for HHS to build the exchange for New Jersey. DOBI is talking to HHS about how that money can be used, and Conaway said it’s key that navigators get that money.

“It’s really going to be those community-based organizations that know how to reach and communicate with (the uninsured) that are going to be so important for reaching the people who need to be in the exchange,” he said. “That certainly would be an appropriate use for that money.”

Jacobi said the uninsured in New Jersey, “are mostly people associated with the workplace. Most are in families with workers, full-time or part-time workers, and dependents of workers,” who either can’t afford to buy insurance at their workplace, or their employer doesn’t offer it.

Read the NJ BIZ article, “Health panel reveals concerns about Obamacare rollout, future”

Read the NJ Spotlight article, “Healthcare Leaders Envision a Shared Future”

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Online Health Law Graduate Certificate Programs

May 8, 2013 by · Leave a Comment
Filed under: Health Law 

Online Learning e-Mailer 5-8-13 v5ntFINAL

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USPTO Patent Post-Issuance Proceedings Under the American Invents Act — A New Frontier

Gibbons_Institute_196_7Featuring 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).

Presented by
The Gibbons Institute of Law, Science & Technology
Seton Hall University School of Law

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)
(Free to Seton Hall Law Students & Faculty) (+ refund policy)

Location: The event will take place at Seton Hall Law School. For further information about the event, please contact Teresa Rizzo at teresa.rizzo@shu.edu.

Or Register here.

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