NEW JERSEY SUED FOR CONSTITUTIONAL VIOLATIONS IN DENYING IMMIGRANT PARENTS ACCESS TO STATE-FUNDED MEDICAID

Class Action Seeks Relief for 12,000 Lawful Permanent Residents Affected by Immigration-Based Medicaid Cuts

NEWARK, NJ - Seton Hall Law School’s Center for Social Justice and Gibbons, P.C., filed a class action complaint today in New Jersey, alleging that the State’s Department of Human Services (”Agency”) is violating permanent residents’ equal protection rights under the United States and New Jersey Constitutions by denying them State-funded Medicaid because of their alienage and immigration status. The Plaintiffs, many of whom work at low-wage jobs, are lawful-permanent-resident parents in New Jersey, who because of their low-income were deemed eligible to receive and, until recently, did receive State-funded Medicaid known as New Jersey FamilyCare (”NJFC”). Citing the State’s financial crisis, however, in April and July of this year, the Agency terminated Plaintiffs’ Medicaid coverage, stating that Plaintiffs were no longer eligible for NJFC because they have not been lawful permanent residents for at least five years.

The complaint describes the harm experienced by the nearly 12,000 low-income, lawful permanent residents affected by those cuts: without NJFC assistance, Plaintiffs can no longer afford regular checkups, preventive care, and treatment for serious illness. One of the named plaintiffs, a single mother with two small children, had surgery to remove a kidney in 2007. She is now unable to afford monitoring of her kidney problems or medical care in the event of future illness. Two other plaintiffs-working parents from Haiti and Ecuador-required emergency medical care last month, but after being terminated from State-funded Medicaid, were unable to pay for such treatment. Several of the Plaintiffs have family histories of heart disease, high cholesterol and diabetes and worry that without regular check-ups and preventive care, they will be unable to prevent irreversible damage to their health.

The complaint alleges that by singling out this group of immigrants for termination of their healthcare coverage, the Agency is discriminating against plaintiffs on the basis of their alienage and immigration status in violation of the equal protection guarantees of the Federal and State Constitutions.

“Not only is it unconstitutional to distinguish between New Jersey residents on the basis of their alienage and immigration status when dispensing critical health care assistance-it is counterproductive,” said attorney Jenny-Brooke Condon, an Associate Professor at Seton Hall’s Center for Social Justice. “Many of the 12,000 lawful permanent residents affected by these State-Medicaid cuts are hard-working residents of the State, who pay taxes and support their families by working inlow-wage jobs. Ensuring that the working poor receive essential, preventive healthcare and treatment for illness keeps New Jersey residents healthy, which, in turn, keeps them working.”

Many of the Class Representatives named in the lawsuit expressed outrage at being singled out for healthcare cuts on the basis of their immigration status. “I work hard, pay taxes, and play by the rules; I am a lawful resident of this State,” said Class Representative Nadia Chery, a native of Haiti who works as a home healthcare aide. “So when the government said it was cutting my benefits because of my immigration status, it was as if I had done something wrong because I am an immigrant. I felt that I was being discriminated against.”

Class Representative Manual Guaman, a native of Ecuador who works as a cook to support his wife and three small children, described the anguish he felt when he suffered a severe allergic reaction in July after losing his NJFC assistance. “I didn’t know what to do. Should I get treatment at a hospital, knowing I will not be able to afford the bill, or should I take my chances that I will get better?” said Guaman. “I decided to go to the hospital, thinking that if I became sicker I might not be able to keep working and support my family. Being healthy for my family is my first priority.” But Guaman added that not being able to pay the hospital bill he received after his July emergency room visit has discouraged him from seeking follow-up care and additional medical assistance.

In addition to asserting equal protection claims, the complaint alleges that in denying Class Members NJFC assistance, the Agency has also violated a New Jersey statute governing the State Medicaid program. That statute provides that both citizens and lawful permanent residents are eligible for State-funded Medicaid. The complaint filed today amends a complaint filed by Plaintiffs on June 29, 2010, and newly challenges the Agency’s July 6, 2010 regulation, which the Agency published only after it had already terminated most Class Members’ NJFC assistance. Plaintiffs seek a declaration from the court that the agency’s actions and regulation violate the Federal and State Constitutions and the NJFC statute, and also seek injunctive relief restoring Class Members’ NJFC assistance.

A copy of the complaint can be found at http://law.shu.edu/ProgramsCenters/PublicIntGovServ/CSJ/upload/Guaman_Amended_Complaint.pdf

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 clinical education. The Center for Social Justice, a core of Seton Hall Law School’s Catholic mission, provides clinical education and volunteeropportunities to students and engages in various forms of advocacy, scholarship and direct legal services in an effort to secure equality, civil rights and legal protection for individuals and communities in need. Seton Hall Law School is located in Newark. For more information visit, http://law.shu.edu/.

The law firm Gibbons P.C. sponsors the John J. Gibbons Fellowship in Public Interest & Constitutional Law under the guidance of John J. Gibbons, former Chief Judge of the United States Court of Appeals, Third Circuit, and Lawrence S. Lustberg, Director of the Gibbons Fellowship Program. The Gibbons Fellowship, supported by the broader resources of the firm as a whole, undertakes public interest and constitutional law projects and litigation. Working with a broad cross-section of public interest groups, the Fellowship Program has become widely known in New Jersey and nationally as a voice for the poor and underrepresented. The Fellowship has been and remains involved in the most significant and controversial issues that confront the Federal and State courts today. For more information visit http://www.gibbonslaw.com/about/index.php?view_page=3

Florida Attorney General McCollum Falls Victim to Collective Mandate, Loses Bid for GOP Nomination for Governor

Attorney General Bill McCollum, noted of late for spearheading the state suits against the Individual Mandate in health reform, has lost his bid for the Republican Party nomination for governor of Florida. Political newcomer Rick Scott, a self styled “conservative outsider” and former hospital corporation CEO, poured over $30 million of his own money into the race and won the nomination.  According to Fox News/AP, Mr. Scott, who has never run for any office before, “was active last year opposing the health care legislation in Washington.”

With 93 percent of precincts reporting, Scott led McCollum 47 percent to 43 percent.

Fox/AP also reports that the result is the culmination “of months of personal attacks, name-calling and negative TV ads….”

And that

McCollum, who racked up endorsements from big Republican names, hit Scott hard for past Medicare fraud allegations. Scott was the CEO of HCA/Columbia Hospitals when it settled the biggest Medicare fraud case in history — Scott, who was forced out as CEO by his board amid the government investigation in 1997, has said repeatedly that he didn’t know about any criminal activity and was never charged.

Tip of the Hat to JanetHasty via good ol’ twitter.

Possible Repeal of Massachusetts Ban: A Gift to Prescribers, Patients or Industry?

Next month marks the second anniversary of the enactment of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct, a law requiring pharmaceutical and medical device manufacturing companies to designate a compliance officer and implement a compliance program reflecting the commonwealth’s regulations on meals, CME sponsorship, use of non-patient identified prescriber data, gifts and other payments, etc.  The law, which went into effect on July 1, 2009, builds upon the Pharmaceutical Research and Manufacturers of America’s revised Code  on Interactions with Healthcare Professionals (”PhRMA Code“) and the Advanced Medical Technology Association’s revised Code of Ethics on Interactions with Healthcare Professionals (”AdvaMed Code“), two voluntary codes intended to eliminate any influence — perceived or otherwise — of the industry over healthcare professionals with respect to gifts, entertainment, recreation, educational programs, professional meetings, scholarships, and the like.

The Massachusetts law is more restrictive, however, than its PhRMA and AdvaMed counterparts.  It prohibits companies from sponsoring continuing medical education programs that do not meet Accreditation Council for Continuing Medical Education guidelines.  The PhRMA and AdvaMed Codes do not.  It prohibits any company employee from providing meals outside of a hospital or office setting.  The PhRMA Code only restricts sales representatives and their immediate supervisors to a hospital or office setting.  The AdvaMed Code does not impose any restrictions on the location of meals.

Furthermore, starting on July 1, 2010, the law requires companies to annually certify their compliance with commonwealth regulations and, among other things, to disclose any gifts or payments valued over $50 and given to anyone who can prescribe, purchase, or dispense drugs or devices.  Effectively, it’s a ban on all gifts to prescribers (and in so doing goes a step further than the PhRMA and AdvaMed Codes which make an exception for educational gifts).  Companies must also submit $2,000, payable to the commonwealth’s Department of Public Health, with each annual disclosure report.  Violations can result in penalties up to $5,000 per occurrence.  The first round of disclosures were due 16 days ago and covered activities for the July 1, 2009 to December 31, 2009 period.  Next year companies will be expected to report on their activities for the January 1, 2010 to December 31, 2010 period.  Or will they?

The Massachusetts House recently passed an economic development bill that repeals the disclosure requirement/gift ban (the bill also establishes a sales tax holiday and consolidates commonwealth economic agencies).  The Senate version of the bill does not include the repeal.  It’s a wait-and-see as to how the two chambers will work out the final bill through their conference committee.

Opponents of the gift ban claim it has adversely affected pharmaceutical clinical research as well as the restaurant and convention industries.  Almost two years ago, PhRMA Senior Vice President Ken Johnson expressed his disappointment over the law, saying:

[it is] very likely damaging for medical partnerships, clinical research and patients in Massachusetts….

Public disclosure of a pharmaceutical company’s arrangements with principal investigators of its clinical trials also could reveal sensitive, proprietary business information to a company’s competitors.  This could erode the independent decision-making of companies trying to bring science from research facilities to patient care setting….

The disclosure requirements subjects all of the physicians, academic institutions and hospitals involved in such trials to publicity in a form that may be difficult to understand and likely will generate unwanted and unnecessary public scrutiny.  This could make Massachusetts an unattractive place for academic scientists to live and work — and for pharmaceutical research companies to do business.  Such a policy clearly is not in the best interest of public health — and it flies in the face of the ongoing efforts to further cultivate the life sciences industry within Massachusetts.

Indeed, the Wall Street Journal and Boston Herald report that some medical groups either have threatened to take their annual meetings elsewhere or have actually done so in protest of the law.

Supporters of the law say otherwise.  Health Care For All, a Massachusetts-based advocacy organization, views banning gifts as a step in the right direction.  According to the organization:

[t]he pharmaceutical industry gives gifts to promote their drugs and make a higher profit.  Under the guise of promoting welfare for all, the industry maximizes their own revenue….

Experts living within the guidelines of the gift ban find that it is not interfering with their work or professional relationships according to Dr. David Coleman, Boston University School of Medicine.

‘The Massachusetts Gift Ban legislation is an important step in the process of reducing both biases in therapeutic decision-making and healthcare costs.  The Ban has not adversely impacted the important relationships of our physician-faculty with the pharmaceutical and device industries….’

Health Care For All also maintains there is no connection between the decrease in restaurant revenues and the law as:

[t]he Massachusetts Prescription Reform Coalition has researched the decrease in restaurant profits, and found sales are down across the country — including in states without a gift ban.   According to the trade paper, Restaurants & Institutions, sales at the nation’s top 100 independent restaurants were down 10% in 2009….

Massachusetts Senators, who recognize the value of the gift ban legislation, also see that these lost profits mirror similar recession-caused losses in the restaurant industry across the country.

Georgia Maheras, Private Market Policy Manager at the Massachusetts Prescription Reform Coalition, considers the current House bill to be a “significant step backward” in the fight to curb medical costs.

Massachusetts is not alone in attempting to reform pharmaceutical and medical device marketing practices.  Neighboring Vermont has a similar, and in fact more stringent, law which even allows the Attorney General’s office to track free samples given to physicians (though a reporter for the Times Argus, a Vermont newspaper, worries how a repeal in Massachusetts might have a ripple effect).  California, the District of Columbia, Maine, Minnesota, Nevada, and West Virginia also have some form of a marketing code.  The federal government’s Patient Protection & Affordable Care Act includes the Physician Payment Sunshine Provision (”Provision”) requiring disclosure of payments made to physicians and teaching hospitals by manufacturers of products covered under Medicaid, Medicare, and SCHIP (click here to read a summary).

So who has it right?  It would seem as though PhRMA and AdvaMed opened the door for state and federal government to codify modified versions of these industry codes.  From a compliance perspective, it must be quite inefficient — and headache inducing — to wade through state marketing disclosure laws that lack uniformity.  Starting January 1, 2012, the Provision will preempt state disclosure laws except for where the state requires additional information.  Maybe this will help, maybe it will add to the headache, or maybe this particular episode will no longer matter.   For now, though, from a patient perspective, a repeal of the Massachusetts disclosure requirement/gift ban, or that of any other state, would feel more like a gift to the industry and prescribers than a service to the “best interest of public health.”

The Center for Health & Pharmacy Law & Policy here at Seton Hall Law has issued two white papers addressing these issues: Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” in which the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research; and Drug and Device Promotion: Charting a Course for Policy Reform,” in which the Center proposes legal and policy changes to address conflicts of interest in the relationship of medicine and industry– including the recommendation “that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians.”

The Center has also recommended “the adoption of federal legislation to ban the use of gifts, meals, and other perks to promote drugs and devices. The states have taken the lead to date–Massachusetts, California, Minnesota, and the District of Columbia have passed laws to limit or ban gifts and meals that are now routine in marketing practices. Concluding that industry self-regulation is not sufficient, the Center calls for national legislation to create uniform practices by industry and physicians. As urged by Professor Boozang, ‘the benefits of drugs and devices should drive promotion and physicians’ decision to prescribe, not a marketing model that depends on gifts and meals.’”

Obviously, the adoption of additional federal standards in this regard will lessen the ability of industry to pit one state against another and make compliance easier. The Physician Payment Sunshine Provision is a step in that direction, the Massachusetts development bill is a step back.

State Long-Term Care Partnership Programs

By Brian Seguin

Long-term care refers to end of life care where a person can no longer take care of themselves. These people require either the assistance of a trained professional, such as a home health aide, to help them care for themselves in their home, or they need to be housed in a nursing home and cared for there. Since Medicare does not cover long-term care, people who require it need to either pay for it themselves, or if they have almost no savings and get a low enough monthly income that they qualify, they can apply for Medicaid which does cover it. If someone pays for it themselves and winds up spending all of their savings and still needs care, they can then apply for Medicaid to cover it if their monthly income is under the threshold set by their state in order to qualify for the program.

In the early 1980’s, states began to worry that as the baby boomer generation got closer to retirement age and might start requiring long-term care, it could cause increases in their Medicaid expenditures and thus budget deficits. One possible solution forwarded for this impending problem, and eventually implemented by four states in 1993, was the idea of state long-term care partnership programs. Under these programs states would incentivize their citizens to purchase private health insurance to cover at least part of the long-term care they may eventually require and thus spare Medicaid from covering some of the costs. Insurance companies who participated in the programs had to meet certain regulations of what type of care was provided and had to report certain data back to the states so they could effectively monitor the impact the programs were having.

Proponents hoped these plans would cause people to buy their own long-term care insurance coverage and hopefully never need to turn to Medicaid to pay for it. They also hoped this would stop the perceived threat of people transferring their assets (savings) to family members early in order to appear qualified for Medicaid. Of the four original states, California and Connecticut incentivized their citizens by allowing them to disregard assets they had above the threshold allowed to qualify for Medicaid in the amount that the partnership plan had paid towards their long-term care. In other words if a person purchased a partnership plan and it paid out $200,000 towards their long-term care, that person would still qualify for Medicaid even if they had up to $200,000 in assets over the amount usually allowed to qualify. This was called the “dollar for dollar approach.” New York required citizens to purchase more comprehensive plans that had higher lifetime benefits, and if they did they could disregard all of their assets in determining if they qualified for Medicaid, known as the “total assets approach.” Indiana allowed a “dollar for dollar” disregard if the person purchased a plan covering less than four years of care and a “total asset” disregard if they purchased a plan covering more than four years.

Opponents of this idea worried that these public partnerships would inappropriately promote private plans with limited values, and that they could lead to increases in Medicaid expenditures by allowing wealthier people who would purchase private long-term care plans anyway keep their assets and now have access to Medicaid that they wouldn’t have otherwise had. As a result of these fears part of the Omnibus Budget Reconciliation Act of 1993 (OBRA) required any state that started a partnership program after 1993 to recover any disregarded assets of a deceased Medicaid recipient from their estate. Although this Federal law did not apply to the four states already operating partnership programs and did not ban other states from starting their own programs, it effectively eliminated any other states from trying to start their own programs by removing the incentives for citizens to join. This is because although a person could keep some of their assets while still alive, and still qualify for Medicaid, the state would now have to take those assets from their estate. So there was no longer any incentive for a person to purchase a partnership plan which they may never need, and thus shift some of the potential costs of long-term care on private insurers rather than Medicaid.

The Federal government finally decided to give long-term care partnership programs another chance in 2005 with the passage of the Deficit Reduction Act (DRA). Parts of that bill removed the estate recovery requirement of OBRA and allowed states (other than the original four who have continued their programs and are again not subject to this bill) to start their own partnership programs provided they use the “dollar for dollar” approach. Insurance companies participating in these new programs will have to be certified by the state, using new federal guidelines, and will have specific data reporting requirements. The “dollar for dollar” approach is mandated to avoid the grant of Medicaid benefits to those who do not need or deserve them. This approach only allows beneficiaries to keep the amount of assets they would have presumably spent for long-term care themselves and then qualified for Medicaid anyway, had their partnership plans not paid that amount. The federal government has finalized its rule of what data needs to be submitted by partnership insurers after consulting with the National Association of Insurance Companies, insurance companies who issue long-term care plans, the four original states with programs, and consumers who purchase long-term care plans. The data collected is meant to cost insurers as little as possible while still allowing the federal government to accurately track the effectiveness of these programs. While no states or private insurers are required to participate in these partnership programs, as of August 2008, 13 states (in addition to the original four) are now offering partnership plans and 12 more are in the process of implementing them.

New Jersey Medical Marijuana Legislation Update: Poised to Pass?

Supporters are hopeful that before Governor-Elect Chris Christie takes office next month, the New Jersey legislature will pass — and current Governor Jon Corzine will sign — medical marijuana legislation.  In February 2009, the “New Jersey Compassionate Use Medical Marijuana Act,” which would allow patients suffering from “debilitating medical conditions” to treat their symptoms with marijuana without fear of state criminal reprisals, passed the state Senate.

In June 2009, Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy issued a position paper calling on the full legislature to pass the Act, arguing that it would “allow New Jersey residents with debilitating medical conditions access to marijuana to ease their suffering without creating an undue risk of abuse or diversion.”  Soon thereafter, the Act cleared the Assembly Health, Human Services and Senior Citizens Committee, albeit with a number of amendments, including several bolstering the Act’s already strict safeguards against abuse and diversion.  (For a detailed summary of the differences between the Senate and Assembly versions of the Act, see below.)

According to an article in the New Jersey Law Journal, a legislative aide “says they are trying to get the [Act] posted for a floor vote on Dec. 7, Jan. 7 or Jan. 11, the remaining voting sessions in the current term.  The Assembly is expected to pass it.”  Due to the amendments added by the Assembly Committee, the Senate would need to pass the Act again before it would reach the Governor’s desk.  Even if the Act is not passed during the current lame-duck session, however, there is hope for its passage in sessions to come. Governor-Elect Christie has indicated that, with sufficient restrictions in place, “he would be supportive of such legislation.”

Summary of Differences between Assembly and Senate Versions

Change to definition of “bona fide physician-patient relationship.”

The Senate’s version of the Act (S119) requires that patients who wish to use medical marijuana obtain a “written certification” from a physician with whom they have a “bona fide physician-patient relationship.”  Such a relationship is said to exist whenever a physician has completed a full assessment, including a physical examination, of a patient.  The Assembly’s version (A804) includes a significantly narrower definition, providing that only the physician with “ongoing primary responsibility” for treating a patient’s “debilitating medical condition” can approve that patient to use marijuana.  Such a physician must be “board-certified, if available” in the specialty appropriate for caring for the condition which qualifies the patient to use marijuana.

Changes to list of eligible “debilitating medical conditions.”

• Whereas S119 would have granted eligibility for marijuana to patients suffering from “severe and persistent muscle spasms, including, but not limited to, those characteristic of multiple sclerosis or Crohn’s disease,” A804 limits eligibility to those with “intractable skeletal muscular spasticity,” which would, it would seem, include some patients with multiple sclerosis, but exclude those with Crohn’s disease.
• Whereas S119 made all patients with cachexia or wasting syndrome, severe nausea, or severe or chronic pain eligible, under A804 patients with those conditions are only eligible if their symptoms are the result of AIDS or cancer. Concomitantly, neither AIDS nor non-terminal cancer render a patient eligible unless they cause cachexia or wasting syndrome, severe nausea, or severe or chronic pain.
• A804 adds to the list of those eligible for marijuana, patients suffering from amyotrophic lateral sclerosis and multiple sclerosis. Patients with cancer that is “terminal” and glaucoma that is “resistant to conventional therapy” are also eligible; under S119 all cancer and glaucoma patients were eligible.
• Notably, both versions include a provision allowing for additional medical conditions to be added by regulation.

Changes to rules governing “medical marijuana alternative treatment centers.”

Under A804, eligible patients will no longer be permitted to grow marijuana.  The statute’s protection will only apply to patients who obtain marijuana from New Jersey Department of Health and Senior Services-approved “medical marijuana alternative treatment centers.”  A804 adds as a requirement of approval that such centers be operated on a nonprofit basis.  They do not have to be recognized as such by the IRS but they do need to comply with all state nonprofit laws.  Perhaps in an effort to mitigate hardship that might arise as a result of these, more restrictive, provisions, A804 exhorts DHSS to “seek to ensure the availability of alternative treatment centers throughout the State, including, to the maximum extent practicable, at least two each in the northern, central, and southern regions of the State.”

Other potentially-significant changes.

• Unlike S119, A804 does not protect patients and others from arrest or prosecution; its protection is limited to waiver of applicable “civil or administrative penalties.”
• A804 also eliminates protection for caregivers who assist patients with medical marijuana use. Instead, it provides that “[t]he commissioner shall adopt regulations to: (1) provide for the use by a registered qualifying patient of a designated individual in an emergency situation to transport marijuana to the patient who is otherwise unable to obtain marijuana from an alternative treatment center[.]“

Autism, Autistic-Like, and Health Insurance Reform

In his post Implementing Reform: Children with Special Health Care Needs, Professor John Jacobi notes that providing “health insurance” to children with special health care needs (”CSHCN”) does not ensure that their needs will be met.  Many private health insurance plans do not cover services such as occupational, physical, or speech therapy for CSHCN.  Private plans frequently limit coverage for such therapies to otherwise healthy children who need therapy to facilitate their recovery from an illness or injury.

Through their power to regulate insurance, states can require private plans to extend coverage for needed therapies to CSHCN.  For example, in legislation passed earlier this year, New Jersey became one of an estimated 15 states to specifically require insurers to provide treatment for individuals with autism.  Children with autism have benefited from a wave of recent legislation — 8 states enacted laws related to autism and insurance coverage in 2009 alone.  Children with other special needs have been largely left behind.  Many go without services; others may be shoehorned into an inappropriate autism diagnosis.  A recent documentary, Autistic-Like, tells the story of parents pressured to accept an autism diagnosis in order to access state-funded services for their son.  While New Jersey’s autism mandate is admirably broad, requiring private insurers to cover occupational, physical, and speech therapy for individuals with “autism or another developmental disability,” other states’ mandates are strictly limited to children on the autism spectrum.

Insurance mandates are attractive to legislators because they are off budget.  They are not, however, without cost.  The Council for Affordable Health Insurance, an insurance industry association, estimates that “an autism mandate increases the cost of health insurance by about 1 percent.”  Mandates like New Jersey’s, which extends beyond autism, could lead to even greater cost increases.  Piecemeal reform that privileges some special needs over others has costs of its own, however, not the least of which are borne by children living with labels that do not fit.

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

Common Denominator in Failed State Health Reform: Budget Woes

But the states may be a different story.  A round up of failed– or at least disappointing– health reform state initiatives over the past two weeks shows a consistent factor in the process: budget woes.  Many states have shown themselves to be not willing to overlook state budget crises in favor of immediate health reform.

Case in point: Washington State.  The state’s House approved a bill last week that would remove thousands of beneficiaries from basic state health care.  State officials would have authority to remove residents receiving separate benefits from the state’s Department of Social and Health Services, as well as discretionary removal of residents based on income, perceived access to private insurance, and how long a particular resident has received basic state health care.  The bill, according to the AP/Seatle Post-Intelligender, is likely to save the state $250 million (of the $9 billion annual budget gap that the state hopes to close).  The proposal is currently awaiting a vote in the state Senate.

Washington also recently imposed a new rule that would cut Medicaid reimbursements for brand-name prescription drugs– an intended savings of $1 million dollars a month.  However, two weeks ago the AP/Seattle Post-Intelligencer reported that a federal judge imposed a ban on enforcement of the new measure over concerns that it would restrict access to prescription drugs.  A hearing on May 18^th will determine whether the ban will be lifted or stayed.  Read more

Mergers In State Health Reform: Increased Efficacy or More Bureaucracy?

State Delegate Don Perdue told the The Herald-Dispatch, “Health reform has been tried a number of times.  It fails because one agency is not talking to another, because the vision somewhere gets lost in the process.”  One might imagine Delegate Perdue to be referring to health reform in just about any state– and even the federal government.  Are West Virginia legislators so far ahead of our representatives in Washington?  Hopefully not.  As our blog reported last week (Obama Officially Establishes White House Office of Health Reform), President Obama recently signed an executive order with an arguably similar purpose: work with several federal executive branch agencies, states and local officials, and Congress to enact health reform and develop and implement strategic initiatives to strengthen the performance of the health care system.

In Massachusetts, Governor Deval Patrick isn’t having as much luck.  The Boston Globe reports of a letter the Governor wrote to the chair of the state’s Health and education Facilities Authority (HEFA) instructing the agency to merge with the state’s Development Finance Agency by July 1, 2009.  The Governor’s office maintains that the merge will enhance HEFA’s ability to provide tax-exempt financing for hospitals and health facilities (as well as state educational institutions).  Critics see the attempt as a “power grab” and an attack on the safeguards that keep HEFA, and other quasi-public authorities like it, safe from political pressure and “gubernatorial interference.” Read more

Iowa Turns to Health Care in Finding Same-Sex Plaintiffs “Similarly Situated”

The Iowa Supreme Court unanimously ruled today that marriage should not be limited to a man and a woman after reviewing Iowa’s marriage statute under strict scrutiny.  The case is Varnum v. Brien.  Interestingly, when it came to the important constitutional touchstone of whether same-sex couples are in fact “similarly situated” with straight couples, the Court cited two examples to rule affirmatively– one of which is family health care decisions.

“Society benefits…from providing same-sex couples a stable framework within which to raise their children and the power to make health care and end-of-life decisions for loved ones, just as it does when that framework is provided for opposite-sex couples.”

That notion as expressed is a first.  While a handful of American states’ high courts have ruled that marriage should be afforded to same-sex couples, the Iowa Supreme Court is the first to expressly mention family health care decisions in the evaluation of whether same-sex couples are similarly situated with heterosexual couples.  Two courts’ opinions ruled in favor of same-sex marriage without a “similarly situated” finding: Hawaii in Baer v. Lewin (74 Haw. 530 (1993)) and Massachusetts in Goodridge v. Department of Health (440 Mass. 309 (2003)).  And although California (In re Marriage Cases, 43 Cal. 4th 757 (2008)) and Connecticut (Kerrigan v. Commissioner of Public Health,  289 Conn. 135 (2008)) ruled similarly under an Equal Protection argument, these opinions found plaintiffs “similarly situated” based on their intent to enter into formal, legal, recognized family relationship– without highlighting the importance of family health care decisions.

The ruling has already caused a stir in the State Capital.  Reactions vary across the political spectrum.  Proponents of same-sex marriage are ecstatic.  Opponents have already raised the possibility of a constitutional amendment.  Other legislators, such as State Rep. Dave Heaton, aren’t exactly warmed up to the idea of same-sex marriage, but recognize the need for rights– such as the Court’s concern for health care decisions– for same-sex couples.  To read those reactions and more, click here.

States’ Attorneys General Get Busy With Health Reform

Across our nation, states’ attorneys general are stepping up in the fight for health reform.  Not too long ago, Modern Healthcare (subscription required) ran a piece called “When Attorneys General Attack,” featuring health reform-oriented attorneys general.  Among them was Michigan’s Mike Cox (who is aggressively working to preserve state oversight of Blue Cross and Blue Shield of Michigan), Minnesota’s Lori Swanson (who filed a suit against a major hospital and clinic network alleging illegal interest rates), and Texas’ Greg Abbott (who alleged, and forced a settlement, that Memorial Herman orchestrated an agreement among health insurance providers not to do business with facilities owned by Memorial’s competitors).

Cuomo’s interest in health reform doesn’t stop there.  As reported in my last post (States Respond to College and University Health Care Practices), Cuomo heads one of the nation’s leading state efforts investigating college and university health care practices.  The head of Cuomo’s Health Bureau, Timothy Clune, recently spoke to a seniors home in Middletown, New York and highlighted Cuomo’s commitment to helping New Yorkers with their medical and health insurance problems.  The Times Herald-Record reports Clune as stating that the Attorney General’s office “handle[s] health-care issues from the $60 denial to ensuring that people get the life-saving care they’re entitled to.”

Read more

Florida Senators Move to Pass Bill to Prevent Medicaid Fraud

Kaiser Family Foundation reports that Florida Senators will likely pass legislation aimed to prevent Medicaid fraud.

KFF states:

Florida Senate Health Regulation Committee Chair Don Gaetz (R) and state Senate Health and Human Services Appropriations Committee Chair Durell Peaden (R) at a news conference on Wednesday “expressed confidence” that lawmakers will pass legislation (SB 1986) aiming to prevent and detect Medicaid fraud, the Tallahassee Democrat reports. Medicaid fraud has become a considerable issue in Southeast Florida, where home health care clinics open quickly and operate with little to no regulation or accountability, according to Gaetz and Peaden. Miami alone has twice as many home health providers than all of California, they noted.

Florida is susceptible to heightened Medicaid abuse given its relatively large Medicaid enrollment and the concomitant funds devoted to Medicaid.  In 2005, Medicaid enrollment in Florida was almost 3 million people.  In Florida, Medicaid home health participants have increased by approximately 50% between 1999 and 2005 (from 14,793 in 1999 to 21,192 in 2005). In 2006, Florida spent approximately $12.7 Billion on Medicaid.  Approximately $1.5 billion of the $12.7 billion was spent on home health and personal care.  In 2007, Florida Medicaid expenditures increased to over $14 Billion.

In addition to other fraud prevention and detection measures, the bill would also create greater incentives for whistleblowers.  KFF states:

The bill also would increase to 25% the share of recovered money that whistleblowers would be eligible to receive. Peaden said money recovered from fraud would be redirected by his panel “into health care for the truly needy.”

Further, KFF reports:

The bill also would target companies’ recruiting of patients and the practices of filing claims for non-existent patients and ordering unneeded devices and treatments. Gaetz said Florida would work with federal and local agencies to create a database that would prevent operators of fraudulent companies from re-incorporating new clinics or home services and allow regulators to prevent fraudulent companies from renewing their operating licenses. Peaden said a companion bill is being worked out in the state House (Cotterell, Tallahassee Democrat, 3/26).

As we noted recently, a Florida case (Federal Court) which would fall rather squarely within the intended aim of the proposed legislation took 10 years to discover and prosecute.  The Florida legislation is similar in purpose to the Federal Civil False Claims Act, which members of  the U.S Senate have proposed to amend to strengthen a whistleblower’s action as well.

States Respond to College and University Health Care Practices

A little while back, NPR Morning Edition reported that states are taking a closer look at how health insurance and care is provided at colleges and universities. You can listen to the broadcast or read its transcript here.   While many colleges and universities simply require proof of insurance for admission (and offer a school-sponsored plan to uninsured admitted students), some schools charge an additional health fee or even require participation in the school’s particular plan.  Students with their own insurance who opt-out of the school plan, if there even is such an option, often find that on-campus health facilities will not accept their private insurance and that they must pay for treatment with cash.  Even worse, a recent survey showed that less than one quarter of such out-of-pocket expenses are in turn reimbursed by students’ private insurance companies.  This dilemma has caused many parents to purchase the school sponsored insurance, despite the fact that their child is already insured– effectively causing them to pay double. Nonetheless, Chad Henderson, director of health services for the University of Rhode Island and president of the American College Health Association, told NPR that school-acceptance of private health insurance can be “an administrative nightmare” because of “multiple carriers with multiple different policies, multiple different beneficiary bundles.”

Student medical debt, despite student medical insurance coverage, has increasingly become a concern.  The Boston Globe recently highlighted efforts of Massachusetts state regulators that would require colleges and universities to tally and report the amount of student medical care liability which surpasses school provided insurance coverage.  The proposal is in part a product of the diligent efforts of student organizers at Massachusetts’ Tufts University, who formed the Student Health Organizing Coalition.  Tufts Daily, the student newspaper of Tufts University, reported on the state effort in Massachusetts, as well as the efforts of Attorney General Andrew Cuomo in New York State.  Cuomo recently launched an investigation of New York colleges and universities that will most likely lead to disclosure requirements similar to those proposed in Massachusetts.

Other states are seemingly less skeptical of schools’ involvement with health insurance.  Read more

Washington State Provokes National Dialogue on Assisted Suicide

This Thursday, Washington will join Oregon as one of only two states to allow assisted suicide, reports the Seattle Times.  Initiative 1000, the Washington law’s genesis, was approved by voters this past November with a surprising level of support, which included that of popular former-Governor Booth Gardner.

The law will allow patients with less than six months to live to ask their doctors for a life-ending prescription.  There are a number of requirements to be satisfied by patients, but HealthNews.com contends that the law lacks appropriate ethical safeguards.  As a result, several Washington hospitals have already opted out and will disallow doctors to write such prescriptions on hospital property.  HealthNews.com also reports that opponents take issue with the uncertainty of six-month diagnoses of fatality– that is to say a terminally-ill patient who could have lived two years may turn to the new law prematurely after an overly cautious and dire diagnosis by her physician.  Nonetheless, there are others like Dr. Robert Thompson of Seattle’s Swedish Medical Center, who tells HealthNews.com that he believes in the law for “the sake of compassion, and for a person’s own individual rights.”

The dialogue in Washington is spreading across the nation and into other state legislatures.  Last week, New Hampshire legislator  Charles Weed introduced a bill that would make his state the first to legalize assisted suicide by an act of the legislature rather than voter initiative.  According to the Associated Press, Weed and his colleagues in New Hampshire are not atypical.  The legislatures of Massachusetts, Montana, New Mexico, and Vermont will be calling votes on similar bills before their current sessions close.  Hawaii’s legislature failed to pass a similar bill last month.

State law enforcement has also entered the fray.  Last week’s Chicago Tribune Sunday edition tells the story of a Georgia sting operation resulting in the arrest of four members of the Final Exit Network, one of the nation’s leading pro-assisted suicide groups.  Before the arrest, undercover agents sought and were about to receive assisted suicide from the members.

What’s more, media outlets are responding to the growing focus on assisted suicide.  This week, Time Magazine featured a brief history of assisted suicide.  Visit it here.  Additionally, for a state-by-state break down of assisted suicide laws, visit last Thursday’s Atlanta Journal-Constitution.

Las Vegas Health Care Practices Prompt State and Federal Concerns

This week MSNBC covered special hearings held by the health committees of both the Nevada Senate and Assembly.  The hearings aimed to reform certain state laws as a response to last year’s hepatitis C outbreak in Las Vegas, NV.  The outbreak required over 60,000 Las Vegas surgical center patients to be notified of possible infection– the largest patient-related notification effort in U.S. history– after improper injection of anesthesia resulted in several cases of hepatitis C.

According to MSNBC, proposed reforms in state law would offer stronger whistle blower protection for nurses, more frequent inspections of health facilities, and a streamlining of the reporting and investigation of future major patient problems.

In addition, Las Vegas is among a handful of regions at the center of federal concern over Medicare spending.   Yesterday, the Las Vegas Sun reported that a new study by the Dartmouth Atlas Project finds Las Vegas hospitals to be among the top ten percent most expensive in the country for Medicare spending costs.  Dr. David Goodman, co-principal investigator of the report, tells the Las Vegas Sun that these costs do not necessarily reflect a high level of care, but may actually be a product of “greedy” Las Vegas doctors billing for services beyond what they provide.  In the same interview, Goodman expressed fear that such practices may lead to the bankruptcy of Medicare– a program that some argue will be deficient by over 660 billion by 2023.

Such practices have not gone unnoticed in Washington.  House Representative Henry Waxman (D-Ca), Chair of the Energy and Commerce Committee, sees the recent Stimulus as an opportunity to establish needed oversight, according to CQPolitics.  In addition to monitoring state spending of Stimulus funds designated for health care, Waxman’s committee has crafted an oversight plan that looks out for “Medicare waste and fraud” in general.

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