Bill Requiring Licensure of One-Room Ambulatory Surgery Centers In New Jersey Dies in Gov. Christie’s Pocket

Governor Christie has pocket vetoed a bill that would have required one-room ambulatory surgery centers (ASCs) in New Jersey to be licensed by the State Department of Health and Senior Services (DHSS), as ASCs with more than one operating room already are.

More than One Room

Under current law (e.g., N.J.S.A. 26:2H-1 et seq.; N.J.A.C. 8:43A), ASCs with more than one operating room are subject to a variety of statutes and regulations, including that they must obtain a license that specifies the health care services they are authorized to perform (N.J.S.A. 26:2H-12(a)) and report certain information to DHSS on a quarterly basis (N.J.S.A. 26:25-5.1e).  ASCs providing surgical and related services must “obtain ambulatory care accreditation from an accredited body recognized by [CMS]” as a condition of licensure (N.J.S.A. 26:2H-12(h)).  They also must establish and maintain a uniform system of cost accounting, reports and audits; prepare and annually review a long range plan; and establish and maintain a centralized, coordinated system of discharge planning (N.J.S.A. 26:2H-12(a)).  The statute also assesses various fees, which it caps at $4,000 for applications for licensure or renewal and $2,000 for biennial inspections (N.J.S.A. 26:2H-12(b)).    Since 2004, licensed ASCs with gross receipts greater than $300,000 also must pay an annual assessment based on its gross receipts and the assessment, capped at $200,000 (N.J.S.A. 26:2H-18.57(b); N.J.A.C. 8:31A)), is deposited in the Health Care Subsidy Fund (N.J.S.A. 26:2H-18.58).

DHHS’s implementing regulations cover a broad array of topics, including the qualifications of  persons working at these facilities, housekeeping protocols, emergency equipment, disaster plans, physical plant requirements, and laundry policies and procedures (NJAC 8:43a-1 et seq.).   The regulations impose a biennial inspection fee (N.J.A.C. 8:43A-2.2(m), although DHSS’s web site says that it inspects licensed ASCs every three years.

One Room

ASCs with only one operating room presently escape this licensure requirement (and its corresponding regulatory demands) because they are defined as physician’s surgical practices, which are excluded from the definition of surgical facilities that must be licensed.   (N.J.S.A. 26:2H-12(g)(5); N.J.A.C. 8:43A-1.3)  While surgical practices do not yet need to obtain a license,  they must register with DHSS, which registration, in turn, carries a variety of conditions.  For one, they must “obtain certification by the Centers for Medicare and Medicaid Services [(CMS)] as [] ambulatory surgery center provider[s] or obtain ambulatory care accreditation from an accrediting body recognized by [CMS]” - similar to larger ASCs.  They also must annually report to DHSS data regarding patients serviced by payment source and staffing levels.   The Commissioner of DHSS has the ability to revoke, suspend, or deny an application for a registration if the surgical practice is not in compliance.   The statute also prohibits ownership, management, or operation of a surgical practice “by any person convicted of a crime relating adversely to the person’s capability of owning, managing, or operating the practice.”  (N.J.S.A. 26:2H-12(j)) One-room ASCs also are regulated by the State Board of Medical Examiners as private physician practices.  The BME has enacted regulations establishing policies, procedures, staffing, and equipment requirements when practitioners perform surgery (other than minor surgery), special procedures, and anesthesia services in an office setting (N.J.A.C. 13:25-4A).  The BME has the authority to investigate and bring a licensing action against any physician who fails to comply with these regulations (N.J.S.A. 45:1-18, 45:1-21).  One-room ASCs serving Medicare or Medicaid patients also must satisfy federal standards and be certified by CMS.   If a one-room ASC is certified by CMS, DHSS conducts inspections on behalf of CMS every four years.  DHSS and the BME (N.J.S.A. 45:1-18(c)) also may conduct inspections to investigate complaints filed about a one-room ASC.  But there is no present state requirement that one-room ASCs be inspected by the BME or DHHS.

One Rooms Cited for ‘Immediate Jeopardy’

A report issued by the New Jersey Health Care Quality Institute (NJHCQI) in April 2011 shined the spotlight on the lack of oversight of one-room ASCs.  NJHCQI reviewed reports of inspections in 2009 and 2010 of 91 ASCs in New Jersey that reportedly were funded by a one-time federal grant.  40 of the 91 inspected facilities were unlicensed one-room ASCs, 17 of which (43%) were cited for “immediate jeopardy,” which is “defined as noncompliance with established rules that has caused, or is likely to cause, serious injury, harm, impairment or death to a patient.”  (In comparison, 8 of the 51 licensed facilities (15%) that were inspected were found in “immediate jeopardy.”)   The cited violations included, among others, a variety of improper sterilization and infection control procedures; inadequate tracking of medications, including controlled substances and expired medications; improper anesthesia administration; and failing to have necessary emergency medications or an agreement to transfer patients requiring emergency care to a hospital.  The report concluded that, “[b]ased on this snapshot,  . . there is evidence that consumers may be at greater risk in unlicensed Surgical Practices than in licensed ASCs” (emphasis in original).  Thus, the NJHCQI urged the State to require regular inspections of one-room ASCs and warned patients, in the mean time, not to use these unlicensed facilities.

What Could have Been

S.2780 looked to close the regulatory gap between one-room and larger ASCs - for the most part.  The version that passed New Jersey’s Assembly and Senate on January 9, 2012 would have amended N.J.S.A. 26:2H-12 to require ASCs with one operating room to be licensed by DHSS within one year of enactment as an “ambulatory care facility licensed to provide surgical and related services.”  This licensure requirement would have replaced the current registration requirements.  DHHS, then, would have had to inspect one room ASCs, just as it inspects larger ASCs.

But S.2780 also included provisions that treated one-room ASCs differently than larger ASCs.  All one-room ASCs would have been exempt from paying the ambulatory care facility assessment required by N.J.S.A. 26:2H-18.57.  Those that are certified by CMS (whether in operation on the day of enactment or not) or accredited by the American Association for Accreditation of Ambulatory Surgery Facilities or other CMS-recognized accrediting body (and in operation on the day of enactment) would not have had to meet the physical plant and structural requirements detailed in N.J.A.C. 8:43A-19.1 et seq.  The rest of the one-room ASCs that fail these exemptions would still have been able to seek a waiver (N.J.A.C. 8:43A-2.9) of the physical plant and structural requirements, which the Commissioner could have granted if it would not have “endanger[ed] the life, safety, or health of patients of the public.”  These concessions seemed to respond to reported warnings from some one-room ASC owners that “a new fee and a potential requirement to remodel their offices might drive [them] out of business.”  The bill also would not have subjected one-room ASCs to the current restrictions on DHSS’s ability to issue new licenses to ASCs with more than one operating room (N.J.S.A. 26:2H-12(i)).

Jeffrey Shanton, chair of Advocacy & Legislative Affairs Committee for the New Jersey Association of Ambulatory Surgery Centers, is quoted as describing S2780 as “one of the most important pieces of legislation concerning the ASC industry in New Jersey in years.”  Reportedly, the New Jersey Hospital Association and the Medical Society of New Jersey joined NJAASC in supporting its passage (in addition to consumer groups, like NJHCQI).

But now, S.2780 is dead.  Governor Christie did not veto it - directly.  Instead, by not taking action on this bill, which was passed on the last day of the legislative session, he has killed it via a “pocket veto.”

Going Forward

Legislators can’t override a pocket veto, but they may re-introduce the bill and try again.  If they do, it seems eminently reasonable to require inspections of one-room ASCs, whether by DHHS or BME, as long as there is adequate funding and staffing to complete these inspections without draining resources from other critical public health programs.    It would be critical to ensure that the $2,000 inspection fee is sufficient to cover DHSS’s costs and that the Department would not be prohibited from hiring necessary staff to fulfill this legislative requirement.

The Legislature also should be sure public safety requires the one-size fits all regulation model that this bill proposed.  If the costs of complying are too high, small offices may not seek licensure as an ASC and cease performing procedures that patients may have appreciated.  Perhaps that’s an acceptable outcome, but the Legislature should study the public safety benefits against the potential costs on physicians and patient access to services.  The standard of care and quality should not vary in different settings, but perhaps there is a way for the level of formality and overhead to be in proportion to the size of the facility without compromising public safety.

It also is notable that S.2780 did nothing to resolve the existing tangle of issues caused when in-network providers refer their patients to out-of-network ambulatory surgery centers that then charge an out-of-network facility fee.    (Senator Vitale’s earlier amendment to S.2780 conditioning waiver of the ambulatory care facility assessment on the one-room ASCs’ agreement “not to charge patients or third party payors a facility fee, room charge, or other similar fee or charge” did not survive legislative negotiations.)  S.2780 also would have amended N.J.S.A. 45:9-22.5 to extend the exception to the Codey Act’s self-referral prohibitions for larger ASCs to one-room ASCs.  As Kate Greenwood has discussed, there are reasons to question the wisdom of this exception (much less to extend it).

While legislators tackle these issues, one-room ASCs still do not have to be licensed in New Jersey.  But the State may investigate complaints, so be sure to speak up, if you have concerns.  There are links here to check if a facility is licensed, get copies of inspection reports, file a complaint, and search for information about providers.

Photo (Pocket) by ArnoldRheinhold
Photo (Jeopardy!) by Justin_Levy via Flickr

Reason to Hope in NJ as State to Propose Stipend for Families Caring for the Developmentally Disabled

The Star Ledger reports that in the midst of group home waiting lists populated with thousands of developmentally disabled adults, New Jersey is on the verge of proposing help–in the form of at least $10,000 per year, perhaps $15,000, for families to “take care of their disabled children on their own.”

The waiting list for group home admission is said to top 8,000 each year with waits as long as 10 years for entrance.

The Star Ledger reports that in New Jersey

There are 8,840 people with developmental disabilities in 2,200 state-licensed homes, according to the state. About 8,000 more are on a waiting list to get into group homes or receive services designed to meet their needs. Because of budget cuts, in some years 100 people on the list have moved into homes.

According to the state, a group home costs approximately $120,000 per year to operate. With 8,840 in 2,200 homes, that comes out to roughly $30,000 per person.

The proposal will require federal approval, as Medicaid supplies funding for the need of the developmentally disabled. In this case, the federal government would be expected to provide approximately $45 million in matching funds.

The Star Ledger writes

Christie administration officials say the state would still try to build group housing for the developmentally disabled, but the payment would help families acquire services such as part-time aides, pay for summer camp or buy vehicles with wheelchair access. Families could also pool their funds to set up housing arrangements on their own rather than wait for a state-sponsored group home to open.

When only half of those in need are provided with what they need, and waits exceed 10 years to fill that need– the word “crisis” is not hyperbole. Anyone raising children can relate to demands– even, or perhaps more so, after those children have reached the age of majority. But families caring for the developmentally disabled are called upon to meet needs that often border (if not surpass) the heroic. And although money doesn’t solve everything, anyone who has been without knows it can help. Putting the access to services that money can buy into the hands of those struggling to provide for their children is a good step in the right direction.

New Jersey’s Commissioner of Health and Senior Services Discusses Medical Marijuana and Two Other Regulatory “Case Studies” at Seton Hall Law

On Tuesday, March 1, 2011, New Jersey’s Commissioner of Health and Senior Services Dr. Poonam Alaigh gave a lively and illuminating talk to an audience from within and outside the Seton Hall Law School community.  Reflecting her medical training, Dr. Alaigh organized her talk around three “case studies”: (1) the implementation of the New Jersey Compassionate Use Medical Marijuana Act; (2) the rulemaking procedure to amend the hospital licensing standards relating to nurse anesthetists; and (3) the decision by the Department of Health and Senior Services to defer implementation of New Jersey’s menu-labeling law.  Two central themes of Dr. Alaigh’s presentation were the remarkable complexity of the legislative and rulemaking processes and the importance of a patient-centered approach to healthcare regulation.

The bulk of Dr. Alaigh’s presentation addressed the unusually extensive back-and-forth between the Department and the Legislature that has characterized the implementation of New Jersey’s medical marijuana law.  After the New Jersey Senate invalidated the Department’s initial set of draft regulations, on the grounds that they “would not comply with the intent of the law and would make it much too difficult for eligible patients to access relief through marijuana,” the Department promulgated a revised set of draft regulations reflecting the terms of a bi-partisan compromise.  Dr. Alaigh described the massive effort she and her staff — at times, she said, her entire staff — have made to educate themselves about both the science supporting the use of marijuana for medical purposes and the experience of other states with medical marijuana laws.  Dr. Alaigh believes the result of the Department’s hard work is a regulatory regime that serves patients in need while avoiding the fraud and criminal diversion problems experienced in California and Colorado.  She described New Jersey’s medical marijuana program as the “gold standard” and said that the Department has fielded calls from officials in other states interested in adopting something similar.  Among the unique elements of New Jersey’s program is a registry of de-identified patient treatment and outcomes data that will allow researchers to learn more about marijuana’s safety and efficacy.

Dr. Alaigh also spoke about the Department’s rulemaking amending the hospital licensing standards relating to nurse anesthetists.  On the one hand, Dr. Alaigh explained, nurse anesthetists are advanced practice nurses who by statute do not require the supervision of a doctor.  On the other hand, Dr. Alaigh knows from practice how quickly a patient’s condition can turn critical while under anesthesia.  The final regulation provides that nurse anesthetists can administer anesthesia in a hospital setting in accordance with a joint protocol that ensures that an anesthesiologist (1) is available at all times for consultation and (2) is physically present “during induction, emergence and critical change in status.”  Dr. Alaigh noted that this result was not likely to have made either anesthesiologists or nurse anesthetists happy.  A sign of success for a regulator, perhaps?

The third and final case study that Dr. Alaigh discussed was the Department’s decision not to promulgate draft regulations implementing New Jersey’s menu-labeling law and instead to wait for the federal Food & Drug Administration to implement the menu-labeling provisions of the Patient Protection and Affordable Care Act.  As Dr. Alaigh explained in a post on her blog, “[p]ausing to see what the FDA proposes in nine weeks is reasonable.  It avoids unnecessary duplication and costs for restaurant owners who would have to invest in new menus and then redo them when the federal rules supersede the state law.”  That’s right, Dr. Alaigh has a blog, NJ Health Beat.  You can keep up with her here.

President Obama Offers State Opt Out to Health Reform Law Provisions, What to Expect in Return

Interesting editorial/analysis over at the LA Times on President Obama’s support of an opt out for states from  provisions of the Health Reform law:

President Obama has thrown his support behind a bill to let states opt out of key features of the healthcare reform law before they take effect, including the controversial requirement that virtually all adult Americans buy insurance. The caveat, though, is that states must offer alternatives that provide comparable coverage to at least as many of the uninsured as the new law would, at no greater cost to federal taxpayers. It’s a small but welcome move that invites opponents of the law to shift from repealing it to improving it. Unfortunately, they probably won’t accept that invitation. Read more.

The editorial raises the spectre that the backlash witnessed to this proposal, from Republicans and other foes of the Health Care law, may be attributable to a fundamental difference in objectives.:

But there’s a fundamental disconnect between what the administration is offering and what opponents of the healthcare law are seeking. Obama wants to focus the debate on how best to achieve the law’s interrelated goals of increasing insurance coverage, improving the quality of care and slowing the increase in cost. Republican critics, however, don’t share those goals. To them, the reform should be primarily about controlling the cost of care.

It’s an interesting perspective, and  one which deserves  consideration and credit– especially by the light of the governors’ collective fiscal plight. But let’s not forget political gain as a motivation– President Obama is wildly unpopular among many. And the lack of approval for the President varies from state to state. A recent Gallup poll broke out the approval numbers by state, and the results are worth considering: Approval in Hawaii is (not surprisingly) 65.9%, Maryland is 57.6%, New York is 56.6. Half of the 10 most approving states are in the Northeast. But then there’s the West: Wyoming, 27.6%, Idaho, 31.6%, Utah, 33.8%. Half of the most disapproving states are in the West.The President didn’t fare all that well in West Virginia either, 33.4%.

There is political capital to be had in opposing President Obama– and at this juncture, the Health Reform law is still his signature piece of legislation. This simple truth has not escaped Republican strategists. Whether or not the olive branch opt out overture is ultimately accepted, the rhetoric will surely not reflect acceptance– at least in certain states.

Navigating Vaccine Policy in New Jersey

[Ed Note: This article was originally published in print and online by The Record, New Jersey's most awarded newspaper.]

NEW JERSEY’S immunization law attempts to strike a balance between protecting public health and the accommodation of religious observance. Children must be vaccinated as a condition of school attendance, but the requirement is waived if the vaccination “interferes with the free exercise of the pupil’s religious rights.”

Last summer, the Department of Health and Senior Services amended its regulations to simplify the process for obtaining this exemption. Several legislators, pointing to New Jersey’s drop in childhood immunization rates, have filed a resolution to force the withdrawal or amendment of this relaxed standard.

Emotions on this topic run high. New Jersey can, however, craft a policy that protects the public health while accommodating those who feel most passionately about avoiding childhood vaccinations.

Under such a policy, permissible exemptions could fall into three categories: medical exemptions for children with conditions, such as immune disorders, that render vaccinations inappropriate (the department estimates that about 0.2 percent of children fit this category last year); exemptions for those with genuine religious reasons to refuse vaccinations (the department estimates that about 0.8 percent of children fit this category last year), and exemptions for those who categorically oppose vaccines on non-religious principles. The first two categories combined amount to only 1 percent of children.

Fueling fears

It is, then, growth in the size of the final category that fuels fears that childhood immunizations could drop to levels threatening population health. The adoption of two practical steps can allay those fears.

First, some factual background. New Jersey’s immunization rates have been dropping. The department’s figures show that the rate of children under 3 with complete age-appropriate vaccinations has dropped from about 80.5 percent in 2007 to about 67.2 percent in 2009. The drop is significant, and may pose a threat to our “herd immunity” - the level of population vaccination necessary to block outbreaks of infectious diseases.

Public health officials recommend vaccine levels at least in the mid-80 percent to low-90 percent level to protect “herd immunity.” This is important stuff: children who are not immunized because they’re too young or medically compromised are at risk if overall rates drop to unsafe level.

Routine vaccinations are safe

Almost all medical and public health experts believe that routine vaccinations are safe and appropriate for almost all children. Even so, we can reach safe levels of childhood immunizations while respecting the strongly felt contrary views of vaccine deniers. Two steps are necessary.

1) Primary care focus. The American Academy of Family Physicians has encouraged primary care providers to remind parents of immunization schedules, provide accurate vaccine education and open their scheduling to encourage primary care visits.

Here in New Jersey, Summit Medical Group has reported that such programs raised its patients’ childhood immunization rates from 84 percent to 97 percent from 2008 to 2010. If primary care providers focus on the reminders, education and open scheduling that achieve such dramatic level of improvement, we’re mostly there.

Restricting exemptions

2) Tightened process for non-medical exemptions. This step is more controversial. Let’s be candid and admit that religious exemptions are sometimes employed by those with strong non-religious objections to vaccinations.

Further, let’s admit that it is uncomfortable for the state to pass judgment on the sincerity of claims of sincere religious belief. A 2001 study published in the American Journal of Public Health provides a way out of this conflict.

It found that non-medical vaccine exemptions can be minimized when states take minor steps as requiring parents to file annually, and at that time to receive accurate information on risks and benefits of immunizations. Such processes can tip the balance toward immunization for two groups of parents.

First, parents without strong objections but for whom doctors’ appointments for vaccinations were inconvenient may find that it is now easier on balance to comply with the law. Second, those confused by the controversy may have their fears addressed by public health information provided.

The article found that these simple steps can increase the level of immunization, while respecting the views of those parents with implacable objections to vaccinations. Objecting parents can simply accept the information, and file the annual reports.

These two steps could raise immunizations to safe levels without the need to force the hands of parents with strong religious or other principled objections. If, as the studies suggest, vehement objectors are relatively few, population health and personal beliefs can be accommodated.

Medicaid Targeted as States Cut Budgets

On January 21, Arizona passed legislation allowing the state to submit a Medicaid-waiver request to cut 280,000 people from the program next year.  When filed, it became the first official request to suspend PPACA’s “maintenance-of-effort” provision.  The mandate requires states to maintain early 2010 Medicaid eligibility levels until the 2014 nationwide expansion of eligibility.  Arizona could lose its entire federal Medicaid contribution, approximately $3 billion, if it fails to meet the maintenance-of-effort provision.

The Associated Press reports that most Arizonans who lose coverage are “non-pregnant, non-disabled, childless adults and also parents with incomes above 50 percent of the federal poverty level.”  According to the Arizona Republic, however:

Though the cuts have been billed as affecting only childless adults, about 30,000 of those who would lose coverage are parents and another 11,000 are children.

Read more

Jonathan Blum, CMS Deputy Adminstrator, Speaks on ACOs

We’re waiting for the Department of Health and Human Services to release proposed regulations on Accountable Care Organizations.  This site has previously discussed the potential good and bad of ACOS (see here, here, and here).   I attended a conference last week at which an innovative model of “Medicaid ACO” was discussed.  The Medicaid ACO would be authorized in New Jersey under a bill pending before the NJ Legislature.  It is an exciting idea that will attempt to reach the poor and vulnerable who often lose out in health reform programs.  The godfather of the Medicaid ACO project is Jeff Brenner, about whom Atu Gawande recently wrote in the New Yorker.   (subscription required)    I’ll be blogging about the New Jersey bill in a future post.  The conference was funded by the Nicholson Foundation and presented  by the Health Care Quality Institute.

Speaking at the conference was Jonathan Blum, Deputy Administrator and Director of the Center for Medicare at CMS.  In discussing “Accountable Care Organizations and the Affordable Care Act,” Blum was in the difficult position of speaking about a topic of great interest, while not being able to discuss the contents of draft regulations that are no doubt nearing completion. Nevertheless, he made some interesting points that I’ll pass along.

Blum’s talk focused on policy positions that are driving HHS as it drafts the regulations.  The overriding policy positions he described included:

• The ACO regulations will not be “one size fits all.” He emphasized that CMS will be looking for innovative models, with different payment systems, and with different “on ramps” to formation and approval. He emphasized that CMS is interested in models that serve “safety net populations,” as CMS wants to ensure that the poor and underserved get the same opportunities as “suburban” folks. The primacy (at least in order of presentation) was welcomed by the NJ folks, whose model is directed to Medicaid recipients.
• The orientation, consistent with much of the ACO literature, is “patient first.” He distinguished this orientation from one that would see ACOs as a means for powerful interests to gain market share. That tension is, of course, evident in the ACA’s ACO provisions, as has been pointed out most eloquently by Tim Greaney. Blum described CMS as being focused on care systems’ sensitivity to patient and family concerns, and with payment programs oriented to health care “journeys” and not episodes.
• Clinical quality is key. CMS will focus on outcomes measurements “much more” than in the past. It will be interested in particular in quality measurements and patient experience.
• He spent a fair amount of time emphasizing that CMS does not regard the ACO program as static. CMS will constantly review payment and quality issues, with an eye toward updating oversight and program requirements. It will use payment incentives to drive quality improvements. He indicated that there is some tension between CMS’s interest in having quality be data-driven in ACOs with its insistence on protecting patient confidentiality and privacy issues. CMS is interested in encouraging patient advocacy efforts to support continued emphasis on patient privacy and confidentiality.
• In response to a question, Blum recognized the substantial tension between the ACO model’s emphasis on improving quality and reducing cost through organization of care on one hand, and the ACA’s continued embrace of patient choice of provider on the other. He indicated that this tension might best be addressed by ACOs and their constituent providers creating a sufficiently attractive delivery model that patients will want to be involved — exclusively. (Reaching this goal would clearly require unprecedented patient education efforts.)

The Q & A following Blum’s presentation was predictably frustrating on both sides, as could be anticipated in connection with a talk about not-yet-finalized regulations.  He recognized several outstanding issues that he was not at liberty to discuss, but which had been occupying those drafting the regulations, including:

• Will physicians be able to join more than one ACO? CMS is apparently considering different rules for primary care physicians and specialists, although Blum acknowledged that such overlapping provider networks will make the computation of “gain” difficult when gainsharing is implemented.
• Blum, although asked, would not bite on the question of “who will lead” (physicians or hospitals). He anticipates a variety of models, but stressed that no ACO would flourish without physician buy-in.
• The question of geographic exclusivity for ACOs engendered a similarly noncommittal response. Blum acknowledged the conceptual difficulties presented by such overlap, but also pointed to the negative implications of exclusivity on the robustness of competition.

So, it was an interesting discussion of general principles, whetting our appetites to see how HHS will “square the circle” — or circles — in the upcoming regulations.

The Center for Health & Pharmaceutical Law & Policy Presents Dr. Poonam Alaigh, New Jersey Commissioner of Health & Senior Services

Tuesday, March 1, 2011

Donate a Kidney and Get Out of Jail

I can’t read another paean to Mississippi Gov. Haley Barbour for granting a release from imprisonment to Gladys Scott on condition that she “donate” a kidney to her sister.

The Scott sisters were sentenced to life 16 years ago for an armed robbery that yielded them $11. The women will be eligible for parole in 2014.

Civil rights advocates have sought the two women’s release for some years, arguing that their sentences were excessive.

Barbour’s decision has been hailed by the NAACP President and CEO as “a shining example of the way a governor should use the power of clemency.” A primary reason cited by Barbour for his decision is that sister Jamie’s dialysis is costing the state a lot of money. According to Gladys Scott’s attorney, the idea that she donate a kidney to her sister was her own, which is why he included it in the petition for release.

While available reports do not provide sufficient facts for robust legal-moral analysis, this story raises issues that should give us pause.

First and foremost, I am concerned on Gladys Scott’s behalf that a kidney donation is in neither her short- or long-term best interests - I can only wonder whether her own health makes her an ideal donor after serving a 16-year prison sentence.

We don’t know what led to Jamie’s end-stage renal disease, but it is crucial that Gladys know what her own risk for the disease is before she gives up a healthy kidney. Will her physicians feel comfortable recommending against the surgery if her long-term prognosis is poor - would such a decision result in the revocation of the prison release, or is the release contingent upon a medical “OK” for the procedure?

Compromise

To what extent will the transplant physicians be required to compromise their own ethical duties to the health of these women to accommodate their desire for freedom?

Hopefully, Barbour’s release decision depends upon Gladys’ willingness to be considered as an organ donor, as opposed to her having to actually go through with it.

While I believe it possible that Gladys wishes to donate her kidney to save her sister’s life, the conditions under which she has made this decision are hardly ideal to voluntariness, which our law normally dictates is a necessary condition precedent to organ donation.

These women have been incarcerated their entire adult lives, and have likely made very few decisions on their own behalf, much less life-and-death ones.

Other doubts haunt this scenario. If indeed the Scott sisters merited a suspension of their sentences because they are excessive, then the governor should have made his decision for that reason, thereby enabling the women to resolve how to proceed in addressing Jamie’s kidney failure in the context of their private lives, without state compulsion and outside the glare of the media.

I hope they have significant and stable support upon their release - in addition to undergoing a significant medical procedure, they may not be well-prepared for successful reentry even in the best of circumstances.

Barbour cites the opportunity to save the state health costs by releasing the sisters to pursue the transplant. If the transplant is both a cost-effective and humane alternative to dialysis (which I believe it is) why wasn’t it allowed during the sisters’ incarceration?

While the state may be expecting to save money for the sisters’ health care, it is presumably Medicare that will be covering the cost of the transplant and the extremely expensive post-surgical anti-rejection drugs that Jamie will require (although Jamie’s eligibility for Medicare will likely be fraught with hurdles).

Thus, a large part of the state’s motivation here seems to be the chance to shift Scott from the state’s Medicaid roll to the federal government’s Medicare program.

A fragmented system

While this might work out in the end for the Scott sisters, it represents yet another perversity of our fragmented health care system.

The Scott sisters must be wonderfully excited about their imminent release, and the possibility of saving Jamie’s life, and I am pleased for them.

I am less excited, however, about Barbour’s decision becoming a precedent for other governors.

This article originally appeared in The Record, New Jersey’s most awarded newspaper.

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.

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