Position Paper In Support of the “New Jersey Compassionate Use Medical Marijuana Act”

[Ed. note: mpp.org: "On February 23, the New Jersey Senate voted 22-16 to pass S119, also known as the New Jersey Compassionate Use Medical Marijuana Act. The Assembly health committee voted 8-1 to pass an amended version of the bill on June 4. It must now pass the full Assembly [If the amended bill clears the Assembly, it would return to the Senate for a second vote because of the changes] before it goes to Gov. Jon Corzine (D), who has said that he will sign the bill if it makes it to his desk.”]

Seton Hall University School of Law

Center for Health & Pharmaceutical Law & Policy

Statement In Support of the “New Jersey Compassionate Use Medical Marijuana Act”

The Center for Health & Pharmaceutical Law & Policy supports the passage of the New Jersey Compassionate Use Medical Marijuana Act (the “Act”) because the legislation has been carefully drafted to allow New Jersey residents with debilitating medical conditions access to marijuana to ease their suffering without creating an undue risk of abuse or diversion.

• Medical Evidence. Available medical evidence supports the use of marijuana to treat each of the debilitating medical conditions set forth in the Act: AIDS/HIV; cachexia (wasting syndrome); cancer; glaucoma; severe and persistent muscle spasms; severe nausea; severe or chronic pain; and seizures.
• Need for Access to Marijuana Despite Availability of Cesamet and Marinol Pills. While smoking carries with it certain health risks, smoked marijuana has meaningful advantages over the Cesamet and Marinol pills, which contain synthetic compounds that mimic marijuana’s primary active ingredient. Smoked marijuana is faster-acting, allows for more reliable dosing, and has fewer psychoactive side effects than the pills. In addition, smoked marijuana can be the only option for patients who can not swallow pills due to severe nausea and vomiting as a result, for example, of treatment for cancer.
• Abuse and Diversion. No state that has passed a medical marijuana law has subsequently experienced an increase in recreational marijuana use among its children and youth. The Act’s multiple safeguards against abuse and diversion of medical marijuana provide further reassurance. If passed, the Act would be among the most restrictive of all the states’ medical marijuana laws.

Below please find a brief position paper setting forth the medical evidence and policy arguments in support of the Act.

Seton Hall University School of Law

Center for Health & Pharmaceutical Law & Policy

Position Paper In Support of the “New Jersey Compassionate Use Medical Marijuana Act”

Medical Evidence

Medical evidence supports the use of marijuana to relieve symptoms or ameliorate the side effects of primary treatments of each of the debilitating medical conditions set forth in the Act: AIDS/HIV; cachexia (wasting syndrome); cancer; glaucoma; severe and persistent muscle spasms; severe nausea; severe or chronic pain; and seizures.  While conventional treatments are available for some of these conditions for some patients, smoked marijuana has the potential to help those individuals who do not benefit from, or can not tolerate, currently available therapies.[1]

AIDS/HIV and Cachexia (Wasting Syndrome)

Marijuana is an effective treatment for cachexia, also known as wasting syndrome, an involuntary loss of appetite and weight linked to disease progression and death in patients with AIDS/HIV.  The American College of Physicians has concluded that abundant support exists for the use of the cannabinoid delta-9-tetrahydrocannabinol (”THC”), one of the primary active ingredients in marijuana, as an appetite stimulant.[2] The FDA concurs, as evidenced by its approval of Marinol, a pill containing a synthetic version of THC, to treat “anorexia associated with weight loss in patients with AIDS.”[3]

Marijuana is also an effective treatment for AIDS/HIV-associated sensory neuropathy, a condition characterized by excruciating pain in the nerve endings that afflicts over a third of patients with AIDS/HIV.[4] In the past two years, three placebo-controlled, randomized, double-blind clinical trials published in the medical literature have demonstrated Read more

Turning Up the Heat on Fraud and Abuse–Part of the Solution to Health Reform?

Giotto di Bondone, The Seven Vices: Envy (1266-1337)

[Ed. note: As noted in the post above, we are very pleased to welcome the Executive Director of the Center for Health & Pharmaceutical Law & Policy, Tracy E. Miller, J.D., to Health Reform Watch today.]

As the search for new sources to fund health care reform intensifies, it seems more certain that increased enforcement of fraud and abuse will be part of the equation.  Both the House and Senate have incorporated increased enforcement as part of health care reform legislation. The health care reform bill released by House Democrats on July 14, 2009, included an additional $100 million to combat fraud and abuse as well as increased mandates for regulatory oversight and provider compliance programs.  The reform bill adopted by the Senate Health, Education, Labor and Pensions Committee on July 15 also embraced new enforcement measures, creating senior level positions at HHS and DOJ to coordinate oversight activities.  The bills follow on the heels of an announcement in May by the Obama Administration that it had created an interagency task force to coordinate fraud and abuse enforcement.

These new enforcement initiatives and proposals add to an already burgeoning increase in enforcement initiatives at the state and national levels, raising the question of whether additional programs can actually have a substantial impact beyond those already underway to combat fraud and abuse in the  health care sector.

The Deficit Reduction Act (DRA) of 2005 provided states with an incentive to enact False Claims Act statutes similar to the Federal False Claims Act, allowing states to retain 10% of any funds collected under such acts. The impact of the laws adopted in the wake of the DRA is unfolding now in many states and will no doubt lead to a significant jump in qui tam actions.  After a hiatus caused by litigation challenging the program, CMS has continued to roll out the Recovery Audit Contractors Program (RAC) which retains contractors paid on a contingency basis to identify fraud and abuse in the Medicare program.  With funding and a mandate from Congress, CMS also established the Medicaid Integrity Program. The program authorizes CMS contractors to use data mining and analysis techniques that combine health care quality indicators, billing practices, and Medicaid reimbursement rules to predict aberrant billing practices in order to identify providers for audit.

At the state level, Attorneys General as well as state Medicaid fraud offices are also turning to data mining and analysis, enhancing their capacity to identify fraud and target their investigations.[1] State Attorneys General have increased their cooperation nationally, heightening the effectiveness of investigations and actions against corporations that conduct business in multiple states.

Whether increased enforcement funds and cooperation among federal agencies will actually produce significant dollars for health reform remains to be seen. But without question, the combined effect of mounting federal and state enforcement efforts has substantially increased the stakes for health care providers in undertaking a proactive approach to compliance.  Indeed, growing use by federal and state enforcement agencies on data mining and analysis challenges providers to determine how they can use their own internal data to identify compliance problems and address them in advance of government action.[2]

Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy program focused on best practices by industry to use data for compliance, and government use of data mining and analysis to enhance oversight. Lori Queisser, Senior Vice President, Global Compliance & Business Practices of Schering Plough and Eileen Erdos, Principal of Ernst and Young, provided insight about how industry can use data to inform internal compliance programs. James Sheehan, New York State Medicaid Inspector General and John Krayniak, Assistant Attorney General, New Jersey Medicaid Fraud Control Unit, spoke about government initiatives to use data to target and pursue enforcement. The program, by invitation only, afforded industry counsel the opportunity to have a dialogue with the region’s two leading state prosecutors. The point being, that the success of enforcement initiatives is not only measured in prosecutions, but also in industry tailoring its behavior to be in compliance.

[2] Using Data to Advance Compliance
On March 16, 2009, the Center for Health and Pharmaceutical Law & Policy co-sponsored a program with KPMG on Using Data to Advance Compliance.  The program, held in New York City for an audience comprised primarily of hospital leaders in compliance, finance, and in-house legal services, featured a presentation by James Sheehan, Medicaid Inspector General for New York State, who discussed how the Office of Medicaid Inspector General is using data to target and pursue investigations.  Experts from KPMG presented practical, concrete strategies for how facilities can use data to advance internal compliance efforts. Ed Kornreich, a partner at Proskauer Rose, examined the implications of data mining for Board fiduciary duties.