Category: Other

New Jersey Supreme Court Plows the Field for Implementation of the Medical Aid in Dying for the Terminally Ill Act

This post is intended to update our prior article printed in the summer edition of Garden State Focus, where we wrote about the newly enacted Medical Aid in Dying for the Terminally Ill Act (the “Act”).

The Act “permits qualified terminally ill patient[s] to self-administer medication to end [their] live[s] in [a] humane and dignified manner.”  Under the Act, “terminally ill” is defined as a patient who “is in the terminal stage of an irreversibly fatal illness, disease, or condition with a prognosis, based upon reasonable medical certainty,” with a life expectancy of six months or less.   Qualified patients choosing to exercise their rights under the Act will be required to submit their request in writing stating, among other things, that they have been fully informed of any available alternatives.  Two individuals, one who must not be a relative, entitled to any portion of the patient’s estate, or the patient’s doctor, must witness and attest to the voluntariness of the patient’s request.  With the passage of the Act, New Jersey became the eighth state in the country to allow competent, terminally-ill adults to exercise their “right to die.”

The Act was set to go into effect on August 1, 2019 when Yosef Glassman, a medical doctor, filed an order to show cause and verified complaint seeking to enjoin the implementation of the Act. Dr. Glassman’s eleven-count verified complaint alleged that the Act violated: (1) “the fundamental right to defend life”; (2) the equal protection clauses of the state and federal constitutions and the Fifth Amendment’s right to due process; (3) religious physicians’ and religious pharmacists’ First Amendment rights under the United States Constitution; (4) the “canon of common law” which prohibits killing oneself and aiding and abetting another’s death; (5) state and federal law prohibiting the felonious possession of narcotics; (6) a physician’s right to practice medicine and a pharmacist’s right to practice pharmacy by involving unwilling participants “to be involved in the machinery of death”; (7) the duty to warn; (8) the Administrative Procedure Act by failing to promulgate rulemaking, “thereby rendering its entire process of death wholly and dangerously unregulated, leaving ambiguities and contradiction in statutory language”; (9) Article Ten of the United States Constitution forbidding the institution of state action that impairs existing contracts between physicians and their patients; and (10) a physician’s obligation not to falsify records. Finally, Dr. Glassman sought declaratory relief deeming the Act unconstitutional and invalid.

 On August 14, 2019, the Chancery Court entered an order preliminarily enjoining the enforcement of the Act, concluding that the failure to promulgate regulations would cause Dr. Glassman “immediate and irreparable injury” based on the significant change in the law when “dealing with individuals who are terminally ill.” That preliminary injunction held in abeyance the effective date of the Act.

At the behest of the State Attorney General to dissolve the preliminary injunction, the Appellate Division ordered expedited briefing, to be completed by August 23, 2019, but declined to dissolve the injunction. On August 20, 2019, the New Jersey Supreme Court entered an order denying the Attorney General’s request to dissolve the preliminary injunction and declined to take any further action concerning “an issue of this magnitude” until the Appellate Division addressed the issue with “thoughtful consideration.” The Supreme Court also requested the Appellate Division to “resolve the matter expeditiously.”

Dr. Glassman raised a number of hard-hitting arguments attacking the lack of standards in the Act and potential disparate impacts on terminally ill patients. He argued that the Act:

  • Sets forth no age or literacy qualifications for witnesses of a request for medication;
  • Permits witnesses to make viatical agreements or will provisions immediately after witnessing a terminally ill patient’s request;
  • Sets forth no due diligence requirements for attending physicians to verify witness signatures;
  • Does not disqualify physicians who determine a terminally ill patient’s capacity by virtue of being a blood relative or beneficiary in a will;
  • Permits an employee or director of a facility in which a patient resides to witness a request;
  • Does not require that a check be made of the Prescription Monitoring Program before writing a prescription for a lethal drug;
  • Permits life or medical insurance agents, or insurance beneficiaries to be a witness to the terminally ill patient’s request;
  • Does not recognize the lack of uniformity in lethal medications which may involve varying degrees of pain and suffering;
  • Does not recognize that non-specialist health care professionals might apply different standards for decision-making capacity;
  • Does not recognize the potential disparate treatment of patients based on economic status and ability to pay for costly lethal pharmaceuticals;
  • Does not recognize that some medications are faster-acting than others; and
  • Does not recognize that terminally ill patients may be of sound mind when they make the request for medication, but may later become incompetent at the time of administration.

Finding that the Chancery Court “abused its discretion in awarding preliminary injunctive relief,” on August 23, 2019, the Appellate Division dissolved the restraints imposed in the Chancery Court’s August 14, 2019 order. In doing so, the Appellate Division applied the well-settled standards for injunctive relief set forth in Crowe v. DeGioia, 90 N.J. 126 (1982). First, the Court found that Dr. Glassman failed to establish that injunctive relief was necessary to prevent irreparable harm. The only harm identified, said the Court, was the Executive Branch’s failure to adopt enabling regulations, but there was no showing that the absence of such regulations harmed Dr. Glassman. At that point, no party had sought medical advice or assistance from Dr. Glassman to implement any provision in the Act. Other than a blanket assertion that there was a “material change in the law” regarding terminally ill patients, neither Dr. Glassman nor the Chancery Court identified a single provision of the Act that lacked clarity necessary for a patient or any affected individual or entity to effectuate the Act’s purpose. Moreover, the Act makes participation by physicians like Dr. Glassman entirely voluntary. “The only requirement the Act imposes on health care providers who, based upon religious or other moral bases, voluntarily decide not to treat a fully-informed, terminally-ill patient interested in ending their lives, is to transfer any medical records to the new provider selected by the patient.” Characterizing the transfer of medical records from one physician to another as a purely “administrative function,” the Appellate Division found that function to have no constitutional import, nor did it run contrary to a physician’s professional obligations.

Second, Dr. Glassman failed to demonstrate that he had a likelihood of succeeding on the merits of the claims he asserted in his complaint. The Appellate Division disagreed with the Chancery Judge’s conclusion that an injunction was necessary because the Executive Branch failed to implement enabling regulations prior to the Act’s effective date, finding that ruling to be contrary to the clear, plain and unambiguous language of the Act. Pointing out that the Act permitted but did not require the relevant administrative agencies with a vested interest in the Act’s implementation to adopt regulations, the Appellate Division stated, “[h]ad the Legislature intended the Act to remain in a period of perpetual quiescence, thereby keeping all interested parties in limbo until a half-dozen administrative bodies decided to engage in their rule-making functions, it could have clearly said so.” In fact, the “absence of agency action here,” said the Court, “may imply . . . that regulations were not necessary to implement the Act.” Further, the Court found that Dr. Glassman did not have standing to assert claims on behalf of other physicians, patients or interested family members. In addition, his claims ignore the voluntary nature of his participation under the Act and his “already existing obligation under relevant regulations to provide a patient with his or her medical records.”

Finally, the Appellate Division weighed the relative hardships that granting injunctive relief would have on the parties and concluded that the Chancery Court failed to adequately consider “the interests of qualified terminally-ill patients, who the Legislature determined have clearly prescribed rights to end their lives consistent with the Act.” Consequently, the Appellate Division dissolved the preliminary injunction.

By order entered on August 27, 2019, the New Jersey Supreme Court likewise found that Dr. Glassman failed to satisfy the Crowe v. DeGioia standards for emergent injunctive relief and determined that the Act could be implemented without further delay. By doing so, the New Jersey Supreme Court has averted a head-on collision between the Medical Aid in Dying for the Terminally Ill Act and the State and Federal Constitutions – at least for the moment…

Physician Impairment and Burnout: An Alternative Perspective

Thinking about physician impairment and burnout rarely leads to happy thoughts.  Another side of the topic’s coin, however, can be found.  Nonetheless, the difficulties presented by such matters are appropriate starting points for a blog such as this one. 

Pursuant to the Health Care Professional Responsibility and Reporting Enhancement Act (the “Act”), both health care entities and health care professionals in New Jersey have reporting obligations in the event a practitioner demonstrates impairment that would present danger to a patient or to the public.  Reporting to the New Jersey Board of Medical Examiners of such impairment or unprofessional conduct is codified in N.J.S.A. 45:1-37 and for health care entities in N.J.S.A.  26:2H-12.2b et seq.  Common overlapping regulations are found at N.J.A.C. 13:45E-1 et seq.  Such reporting can lead to an appearance before the Medical Practitioner Review Panel and action by the Board of Medical Examiners.

While the Act does not define “impairment,” the regulations set forth the following: “‘Impairment’ means an inability to function at an acceptable level of competency, or lacking the capacity to continue to practice with the requisite skill, safety and judgment, as a result of alcohol or chemical use, psychiatric or emotional disorder, senility or a disabling physical disorder.”  N.J.A.C. 13:45E-2.1.  Physician impairment can spill over and lead to disruptive behavior, which is itself potentially reportable when it is such that “a prudent health care professional reasonably would believe is likely to adversely affect the ability of another health care professional to safely render patient care for which he or she is responsible.”  Id.  There are judicial decisions in New Jersey upholding hospital privileging action based on disruptive behavior.  Nanavati v. Burdette Tomlin Hospital, 107 N.J 240, 254 (1987); Courtney v. Shore Memorial Hospital, 245 N.J. Super. 138, 140-41 (App. Div. 1990).  The test is not “actual harm to patients” but rather that specific conduct “will probably have an adverse impact on patient care.”

At least since its 2008 Sentinel Event Alert, the potential for “disruptive behavior” adversely affecting patient safety has been the subject of commentary in connection with The Joint Commission’s standards.  But it has also been recognized that disruptive behavior may arise from psychiatric or emotional conditions.  While substance abuse has long been known to lead to disruptive behavior, impaired patterns of professional conduct can also result from stress, burnout, and depression.  See generally Brown, Goske & Johnson, “Beyond Substance Abuse: Stress, Burnout and Depression as Causes of Physician Impairment and Disruptive Behavior,” 6 J. Am. Coll. Radiol. 479 (2009).  The concept that “physician burnout” contributes to physician errors has its critics and challengers.  See, e.g., Lawson, “Burnout is Not Associated with Increased Medical Errors,” 93 Mayo Clinic Proceed. 1683 (2018).

But unquestionably, there is extensive literature concerning physician burnout and possible interventions. See, e.g., West, Dyrbye & Shanafelt, “Physician burnout: contributors, consequences and solutions,” 283 J. Internal Med. 516 (2018); Tawik, Profit, Morgenthaler et al., “Physician Burnout, Well-being, and Work Unit Safety Grades in Relationship to Reported Medical Errors,” 93 Mayo Clinic Proceed. 1571 (2018). This includes greater attention to well-being.  Indeed, reviews of this topic with an emphasis on physician wellness and work-life integration are the focus of a recent issue of MDAdvisor which has a series of six articles dealing with different aspects.  

A definitely more uplifting approach to the issue of physician burnout and impairment with a different vantage point is provided in the March 14, 2019 issue of the New England Journal of Medicine:  Schor, “When Sparks Fly – Or How Birding Beat My Burnout,” 380 N.E.J.M. 997 (2019).  The author is a geriatrics specialist who wrote that the part of him that had “long reveled in making a ‘great diagnosis’” was burning out and depriving him of professional satisfaction because of the felt need to balance professionalism and compassion.  The intellectual high in making an esoteric but lethal diagnosis so to give the physician a great day was repressed in view of what was possibly the worst day for the patient. 

He describes the fortuitous circumstance of discovering birding while having stopped during a bike ride in Sandy Hook, New Jersey.  The generosity of an experienced birder having loaned him the use of his binoculars provided a new vista and set him on a path to diagnose different species of birds and to once again feel the joy of a differential diagnosis that worked out well.  Dr. Schor provides an elegant illustration of this phenomenon:

The least sandpiper and the semipalmated sandpiper are almost identical “peeps,” but for the slightly richer, chocolatey brown back on the former and the darker legs on the latter. Similarly, distinguishing two closely related vasculitides, such as Behçet’s and Buerger’s diseases, depends on the caliber of the blood vessel that’s inflamed. Making such fine distinctions is what birders and diagnosticians have in common.

            Hopefully his suggestions take wing and soar.

Hospital-With-Hospital Joint Ventures

In an era of uncertain reimbursement, increasing value-based care and consolidations, some hospitals have looked to joint venture with other hospitals on specific service lines or specific projects. Most common are independent community hospitals working with other community hospitals or community hospitals working with smaller health systems. Joint venturing allows hospitals to draw on the expertise of other hospitals, pool capital resources, achieve efficiencies and aim for better outcomes. Another reason may be to avoid merging with, or being purchased by, a larger system.

Examples of areas where hospitals have pursued joint ventures are oncology service lines, outpatient facilities, home health, rehabilitation facilities, imaging and skilled nursing facilities. Some systems have formed “across-the-board” joint ventures to partner on a number of projects over time with each hospital having the ability to “opt in” or “opt out” of individual ventures.

As with nearly everything in health care, legal and regulatory pitfalls abound, and it is important that hospitals consider the risks before sealing the deal. Some of those issues are as follows:

• Certificate of Need and Licensing: will the venture require a certificate of need to proceed? Is a license required? How much lead time is required for the applications and inspections? Which hospital will take the lead on pursuing the applications and licenses? Will the venture involve using space in one of the hospitals? That may trigger a transfer of a license.

• Contributions: Is one or more of the partners contributing assets, but others are not? Who will take the lead in obtaining valuations for the assets? Is intellectual property one of the assets being contributed? How will that be valued? Do the non-contributing partners have cash to make corresponding capital contributions? Or will the non-contributing partners allow redirecting of initial profits, if any and if permitted by applicable laws, until their contributions are paid off?

• Non-profit Considerations: Are there a mix of for-profit and non-profit partners? Has the non-profit partner ensured that there are the appropriate charitable considerations built into the venture’s governing documents? How will decision-making for the venture be affected? Does the venture fit into each non-profit partner’s charitable mission?

• Governing Document Considerations: What are the exit rights for the venture? What is the composition of the governing board? How are decisions made? Are there competitive restrictions?

• Anti-Kickback Considerations: Besides the regularly applicable federal Anti-Kickback Statute, do not forget state anti-kickback laws and regulations as well, although some folks sometimes think certain laws and regulations apply when they do not. It can be frustrating to automatically assume that a law applies and devise an overly complicated structure when it may not be necessary. Generally, any type of venture requires fair market value considerations and careful examination of how profits and losses will be shared to avoid running afoul of anti-kickback laws and regulations. If physicians will be involved in the venture, then the Stark Law as well as state self-referral laws may apply, but again, do not make that assumption. Remember that the Stark Law only applies to designated health services, and even within those eleven categories, only certain types (i.e. not every imaging service is a designated health service). The same can be true of certain state self-referral laws.

The above are merely some examples of the legal and regulatory issues for hospital-with-hospital joint ventures. A full description is beyond the scope of this blog post. However, given the popularity of these ventures, many projects that hospitals are now considering have likely already been done before, and there are folks out there who bring the experience to the table to help with construction. While this may be new to your hospital, it is likely not new to the world.

Patient-to-Nurse Ballot Measure Could Have a Big Impact on Massachusetts Providers

As election season comes to a head, Massachusetts Health Care Providers should be learning all they can about ballot measure Question 1, the “Initiative Petition for A Law Relative to Patient Safety and Hospital Transparency” (the “Initiative”).  The Initiative sets maximum patient-to-nurse assignment limits, creates new patient assessment requirements, and conveys enforcement authority for regulating the great majority of hospitals and acute care facilities in the Commonwealth. The measure applies to hospitals licensed under M.G.L. c. 111 § 51, “the teaching hospitals of the University of Massachusetts medical school, any licensed private or state owned and state-operated general acute care hospital, acute psychiatric hospitals, and any acute care unit within a state operated health care facility.” Rehabilitation and long-term care facilities fall outside the scope of the measure.

PROPOSED REQUIREMENTS

If adopted, the Initiative would set the following patient-to-nurse assignment limits:

  • Step-Down Intermediate Care—Patients requiring intermediate level of care between the intensive care unit and general medical surgical unit—three (3) patients per nurse.
  • Post Anesthesia Care (PACU) — One (1) patient under anesthesia per nurse; Two (2) patients post-anesthesia per nurse.
  • Operating Room (OR) Units—One (1) patient under anesthesia per nurse; Two (2) patients post-anesthesia per nurse.
  • Emergency Services Departments:
    • One (1) critical or intensive care patient per nurse. (RNs may accept a second patient if initial patient is assessed as “stable”.)
    • Three (3) urgent stable patients per nurse.
    • Five (5) non-urgent stable patients per nurse.
  • Maternal Child Care Patients:
    • One (1) patient in active labor, with intermittent auscultation, or obstetrical complication per nurse.
    • During Birth and Two Hours Post Partum: One (1) Mother per nurse whose sole responsibility is the mother AND (1) baby per nurse whose sole responsibility is the baby.
    • After mother and child are stable and critical elements are met, one nurse may be assigned to mother and baby.
    • Uncomplicated Postpartum Mother/Baby: Six (6) total individual patients / three (3) couplets.
    • Intermediate or Continuing Care Babies: Two (2) babies per nurse.
    • Well-baby patients: Six (6) per nurse.
  • Pediatric Patients—Four (4) pediatric patients per nurse.
  • Psychiatric Patients—Five (5) psychiatric patients per nurse.
  • Medical, Surgical, Telemetry Patients—Four (4) patients per nurse.
  • Observational/Outpatient Treatments—Four (4) patients per nurse.
  • Rehabilitation Patients—Five (5) patients per nurse.
  • Other Unspecified Units—Four (4) patients per nurse.

In addition to staffing requirements, the Initiative requires facilities to develop a compliant “Patient Acuity Tool” designed to improve care quality in conjunction with a RN’s assessment and clinical judgment. This tool must be developed by a committee with a majority membership of staff nurses.  The tool will be utilized by nurses to determine whether a lower nurse-to-patient ratio should be applied to a particular patient. The Patient Acuity Tool must be certified by the Massachusetts Health Policy Commission (“HPC”) based on a proscribed criteria and providers should expect the HPC to promulgate regulations governing the tool’s content and implementation. The Initiative also compels the HPC to develop a notice regarding these requirements that must be placed on display in each unit, patient room, or waiting area.

The Initiative empowers the HPC to enforce the foregoing through facility inspections and the imposition of fines up to $25,000 for each initial violation and up to $25,000 per day following notification. Failure to properly post notice may result in a civil penalty between $250 and $2,500.

Proponents of the Initiative argue that patient-to-nurse limits improve nursing outcomes by preventing burnout and increasing job satisfaction. This is believed to translate to systemic improvements in patient outcomes and safety.  However, the Initiative specifically states that the new staffing requirements must be implemented without reducing other health care workforce staffing levels. That means that providers will either need to limit services to preserve profitability or grow their workforce to maintain current levels of operation, and those strategic decisions come at a cost.

PROJECTED FISCAL IMPACT

According to a detailed presentation before the Market Oversight and Transparency Committee on October 3, 2018, the HPC estimates that the Initiative will require an infusion of between 2,286 and 3,101 additional RNs into the workforce, which will drive up demand for qualified nurses resulting in increased RN earnings over time. The HPC’s research also indicates that once these standards are fully implemented, maintaining staffing ratios and the new compliance infrastructure may result in annual increased costs between $676 and $949 million. The HPC cautions that its projections are “conservative” because they do not take certain known costs into account such as implementation into emergency departments, observation units, outpatient departments, or one-time costs. For example, the HPC estimates that acute care hospitals will incur a collective one-time cost as high as $57.9 million just to develop the Patient Acuity Tool. The HPC advises that the measure could result in reductions in hospital margins or assets, reduced capital investments, closure of unprofitable service lines, and reductions in non-health care staffing. The Massachusetts Nurses Association has vehemently challenged the HPC’s cost projections as inflated and misleading.

The Initiative will come to a vote on November 6, 2018. In the intervening period, the HPC will hold Health Care Cost Trends Hearings on October 16 and October 17. Providers with questions about the details of the Initiative and/or plans for future compliance should reach out to a qualified legal professional.

New Jersey Supreme Court Explicitly Adopts Federal Daubert Standard for Expert Testimony

In the unanimous opinion of In re Accutane Litigation (Docket No. A-25-17) released on August 1, 2018, the New Jersey Supreme Court embraced the federal standards for admissibility of expert opinion testimony developed in the decision of Daubert v. Merrill Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993) and its progeny. Daubert principles set aside the traditional requirement of “general acceptance” for the admissibility of expert opinion and moved to a multi-factorial approach evaluating an expert’s methodology in arriving at that opinion.   A key element in the Daubert approach was an emphasis on the “gate-keeping” function of the trial judge and frequent use of hearings pursuant to Rule 104 concerning admissibility of scientific and technical evidence.

There has been a long-standing view that the New Jersey standards for expert testimony are different and somewhat more relaxed. In May 2013, the Supreme Court had held a public hearing on the Report of the Committee on the Rules of Evidence requesting whether or not it should pursue a re-evaluation of the New Jersey jurisprudence that it had begun in 2002 and previously concluded “works well and should not be altered.”  No action was taken at that time.

In the extensive 85-page opinion authored by Justice Jaynee LaVecchia, the Court undertook a comprehensive review of Daubert generally and the New Jersey approach that had begun with Rubanick v. Witco Chemical Co., 125 N.J. 421 (1991) and Landrigan v. Celotex Corp., 127 N.J. 404 (1992).  Justice LaVecchia wrote:

We perceive little distinction between Daubert’s principles regarding expert testimony and our own, and believe that its factors for assessing the reliability of expert testimony will aid our trial courts in their role as the gatekeeper of scientific expert testimony in civil cases. Accordingly, we now reconcile our standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases.

Nevertheless, the Court commented that in adopting the use of Daubert factors, “we stop short of declaring ourselves a ‘Daubert jurisdiction.’”  In doing so, it preserved its claim to being a vanguard jurisdiction in the area of expert opinion evidence.  This also assured that both federal and other state decisions under Daubert would be persuasive authority at best and not binding on New Jersey judges.

The opinion summarized the pertinent but non-exhaustive list of factors for a court to consider as follows:

  1. Whether the scientific theory can be, or at any time has been, tested;
  2. Whether the scientific theory has been subjected to peer review and publication, noting that publication is one form of peer review, but is not a “sine qua non”;
  3. Whether there is any known or potential rate of error and whether there exists any standards for maintaining or controlling the technique’s operation; and
  4. Whether there does exist a general acceptance in the scientific community about the scientific theory.

It repeatedly emphasized the need for determining the reliability of the methodology used by the expert to reach the opinion and not the opinion’s conclusion.

This ruling was made in the context of toxic tort litigation where the primary issue was whether or not the drug Accutane caused the development of Crohn’s disease in patients using the drug to treat acne with significant use of epidemiological studies. The trial court had excluded plaintiff’s experts after conducting a two-week Rule 104 hearing and entered an order dismissing 2,076 claims with prejudice.  That determination was reversed by the Appellate Division in a published opinion.  451 N.J. Super. 153 (App. Div. 2017).  The Supreme Court in turn reversed the judgment that had reversed the exclusion of the experts’ testimony.

That product liability context may have implications for the future applicability of the decision and the use of Daubert factors. Moreover, the Court specifically noted that it was not incorporating this standard for admissibility of expert opinion into the criminal context.  “[T]o date, we retain the general acceptance test for reliability in criminal matters.”  In addition, the Daubert factors and virtually all of the New Jersey cases reviewed in the Accutane opinion involved issues of “medical cause-effect expert testimony.”

The applicability of Daubert to expert testimony concerning standard of care opinions has been variable in other jurisdictions in the relatively few decisions considering the issue.  In Berk v. St. Vincent’s Hosp. & Med. Ctr., 380 F. Supp. 2d 334, 352 (S.D.N.Y. 2005), the court concluded that the plaintiff’s expert report together with the expert’s testimony that the defendant surgeon had “departed from the applicable standard of care fail the Daubert reliability test” since it had “too great a gap between the data and the opinion.”   But on the other hand, in Reese v. Stroh, 907 P.2d 282, 286 (Wash. 1995), the Washington Supreme Court held that Daubert would not be applied to standard of care testimony that was based on the expert’s “experience and knowledge, not a novel scientific theory.”  Similarly, in Palandjian v. Foster, 108 842 N.E. 2d 916, 923 (Mass. 2006), Massachusetts’ highest court held that there was no need for a Daubert evaluation of standard of care testimony “based on the expert’s knowledge of the care provided by other qualified physicians, not on scientific theory or research: ‘How physicians practice medicine is a fact, not an opinion derived from data or other scientific inquiry by employing a recognized methodology.’”  (Quoting Cramm, Ascertaining Customary Care in Malpractice Cases: Asking Those Who Know, 37 Wake Forest L.Rev. 699, 725 (2002)). However, testimony as to increased risk similarly to diagnosis and causation might require such an evaluation since it requires the application of science to patient care.

These are issues that have yet to be dealt with in any reported New Jersey opinion. The Accutane decision may indeed be broadly applicable.  Certainly, aspects of the opinion should be readily transferrable.  These include the Court’s emphatic instruction that a trial court’s determination, after a full Rule 104 hearing, to exclude expert testimony on unreliability grounds was subject on appeal to an abuse of discretion standard and that the Appellate Division had “veer[ed] off” that standard and erred when it determined that a trial court’s determination regarding expert testimony was entitled to “somewhat less deference.” This should encourage the development of a record at the trial level with the kind of “robust analysis” of the expert opinions that had received the strong endorsement by the Court in Accutane. It provides a model to follow.

New Jersey Health Care Services Firms Now Required to Obtain Accreditation

Last month, the New Jersey Department of Human Services (“DHS”) adopted a rule that requires all health care service firms to become accredited by an accrediting body recognized by DHS as an accrediting body for homemaker agencies participating in the Medicaid program.

Health care service firms essentially have a twelve month period to come into compliance with the new rule. Existing registered health care service firms must provide evidence of accreditation to DHS with their first registration renewal on or after May 21, 2019.  A health care service firm that obtained its initial registration less than twelve months prior to renewal of registration will not be required to submit evidence of accreditation when renewing its registration for the first time.

If a health care service firm loses its accreditation, it is required to notify DHS in writing within ten days of the loss.

The rule also provides for a new audit requirement.  Every three years, beginning with May 21, 2021, every health care service firm must submit an audit to DHS when renewing its registration.  The audit must:

  1. Be conducted by a certified public accountant licensed in New Jersey and shall include an examination of the health care service firm’s financial records, financial statements, the general management of its operations and its internal control systems;
  2. Include an audit report with an unqualified opinion and shall be accompanied by any management letters prepared by the auditor in connection with the audit commenting on the internal controls or management practices of the health care service firm; and
  3. Be divided into two components of which:
  • One is a compliance component that evaluates the health care service firm’s compliance with laws and rules governing health care service firms; and
  • One is a financial component that includes an audit of the financial statements and accompanying notes, as specified in the Statements on Auditing Standards issued by the American Institute of Certified Public Accountants.

Many critics had complained for years that health care service firms had lax regulatory oversight as compared to other health care entities. While these new requirements are not as strict as the regulatory scheme that applies to many other types of health care entities, they are big changes for health care service firms, particularly ones that are small businesses.  This rule may be just the beginning in a new effort to closely supervise health care service firms.

Teamwork Makes the Dream Work: New Jersey Innovation Institute Joins Forces With New Jersey Department of Health To Improve Patient Health Data Exchange

The New Jersey Innovation Institute (NJII) is teaming up with the New Jersey Department of Health to develop and improve patient health data exchange through the New Jersey Health Information Network (HIN).

Health information is important for various reasons:

  • Improve Health Care: Improve health care and patient results by reducing medication and medical inaccuracies.
  • Efficiency:  Diminish redundant tests and services and improve efficiency of care by making sure that everyone has the same information.
  • Streamline: Reduce administrative costs.
  • Engage Patients: Increase patient participation in their own care and decrease completing paperwork.

NJII will develop the federal grant-funded HIN to improve interoperability and allow for better-informed decision-making. “There has long been a need to share information and get them out of silos in hospitals, physicians’ offices or long-term care facilities,” NJ HIN Executive Director Jim Cavanagh told ROI New Jersey. “Interoperability is a big issue right now with government in health care reform. It drives the ability to do population health management, as well as reducing health care costs and making it more efficient, too.”

Cavanagh, who already was successful in Michigan, has stated that the NJ HIN will be modeled after Michigan and tailored toward what is necessary for New Jersey. Concerning costs, NJII and the state health department intend to keep the program cost-efficient by leveraging data exchange capabilities and resources already available through existing HIEs in certain regions of New Jersey.

While that goal may sound arcane, New Jersey must figure out where the State’s needs are concerning health care treatment and how best to meet those need in an efficient manner. Unfortunately, the landscape of data exchange efficiency continues to be uneven, with some healthcare organizations communicating more proficiently than others. In speaking with Modern Medicine, Laura Young, interim executive director of the Alaska eHealth Network, stated “Health plans are often sharing claims data that can be 30 days or older and medication history is one of the most important records that needs to be complete and easy to share with providers.”

Time will tell how New Jersey and the country develop networks that help both sides of the medical treatment. In order to improve nationwide HIEs will need to modify their contractual relationships with participating organizations.

Can Corporate America Save the Health Care System?

After months of unsuccessful attempts by Congress to pass a bill overhauling America’s healthcare system, several private parties are stepping forward in an attempt to solve the issue on their own.

In late January, Amazon.com Inc., Berkshire Hathaway Inc. and JP Morgan Chase & Co. announced plans to join forces by forming a new company to change how healthcare is provided in the United States. While the parties provided little detail about their plan, the announcement nevertheless provided some insight.

In the announcement, the three corporate powerhouses indicated that the new independent company would be one “that is free from profit making incentives and constraints.” They further indicated that the company would initially focus on the healthcare provided to the individual companies’ combined nearly one million employees and would focus on moving healthcare forward through technology.

This newly announced partnership will not be the only set of corporate players attempting to overhaul the healthcare system. Following the announcement by Amazon, Berkshire Hathaway and JP Morgan, CVS Health Chief Executive Officer, Larry Merlo, indicated that he believed the proposed new venture is more aspirational than what CVS will be able to accomplish after the completion of its merger with Aetna.  Merlo indicated that the combined CVS Aetna entity will have the infrastructure, assets and healthcare expertise to execute on the goals and objectives sought by the Amazon, Berkshire Hathaway, JP Morgan venture.

Mr. Merlo further indicated that he was willing to partner with others in attempting to find ways to improve the healthcare system, indicating that he wants the new CVS Aetna combination to be an “open source model”, and that he is looking forward to partnering with all groups, including the new Amazon, Berkshire and JP Morgan venture, to help reinvent the healthcare system.

While no specific plans have been announced on how these parties intend to reach their goals, the ingenuity that has been displayed by these corporate giants in their individual industries, suggests they will take a truly innovative and aggressive approach to address what they believe are problems with the current healthcare system. These attempts will surely be closely watched by not only the healthcare industry, but America as a whole.

Fulfilling Your Purpose: Recent Developments Impacting on Non-Profit Hospital’s Liability Cap and Tax-Exempt Status

Recently there has been an increase in the number of challenges to non-profit hospitals related to their limitation of liability pursuant to the Charitable Immunity Act (“CIA”) and to their tax-exempt status for purposes of local property taxation.  A Federal District Court in New Jersey has recently denied one of these challenges by affirming the protection of the liability cap afforded by the CIA applicable to a hospital in a medical malpractice action. In Sexton v. Rizzetta, D.O. et al, Civ. No. 15-3181, plaintiff alleged malpractice during an admission in 2013 to defendant Cape Regional Medical Center (CPRM). The hospital moved to cap damages at $250,000 pursuant to N.J.S.A. 2A:53A-8. Plaintiff opposed arguing that the statute was unconstitutional and not applicable arguing the hospital must show that it was “actually a non-profit” and not one “solely in name” and based an argument on an unpublished opinion dealing with a claim of charitable immunity in a nursing home context. [(Klein v. Bristol Glen, Inc., 2010 WL 3075582 (App. Div. 2010)] The Federal Court granted the application and rejected plaintiff’s arguments. Judge Kugler quickly dispatched the constitutional argument, relying upon caselaw that has settled the constitutionality of the CIA years ago. Citing to Johnson v. Mountainside Hospital, 239 N.J. Super. 312 (App. Div. 1990).

In rejecting the substantive argument the court applied the N.J. Supreme Court case of Kuchera v. Jersey Shore Medical Center, 221 N.J. 299 (2015).  In Kuchera, the N.J. Supreme Court held that the defendant hospital was entitled to limited immunity under 2A:53A-8 (rather than the absolute immunity of 2A:53A-7). The Court noted that whether a nonprofit organization is entitled to the limitation on damages afforded to those institutions organized exclusively for hospital purposes “turns on the purpose of the institution, not the use to which the facility is put on any given day”. Id. at 242.  In doing so the Court focused on the purposes set forth in the organizing documents of the entity:

By the plain language of N.J.S.A. 2A:53-7 and 8, a hospital is subject to limited liability under section 8 if it is formed as a non-profit corporation, society, or association, is organized exclusively for hospital purposes, was promoting those objectives and purposes at the time plaintiff was injured, and the plaintiff was a beneficiary of the activities of the hospital. Id. at 249.

In looking to the “purposes” of the entity, the Court discussed the role of the hospital in today’s modern society. Id. at 250. The Court noted that the modern hospital is now a place where members of the community not only seek emergency services but preventative services, therapy, educational programs and counseling. Id. at 251.The Court also noted that the modern hospital “also provides medical care to those who can pay for the care and those who cannot. In fact, every acute care hospital in this State is required to provide care to anyone who seeks care without regard to ability to pay”. Id. at 254.  The provision of charity care is therefore a “core function of a hospital”. Id.  Applying these principals, the Court concluded that the Defendants are governed by the “specific expressions of legislative intent regarding hospitals articulated in N.J.S.A. 2A: 53A-8”. Id.  Additionally the Sexton Court deemed that the hospital’s 501 (c)(3) status was recognized evidence of its non-profit status. (citing Parker v. St. Stephen’s Urban Dev. Corp., 243 N.J. Super. 317, 324 (App. Div. 1990)).

Shortly after the Kuchera decision was rendered, a tax court denied a hospital full tax exempt status related to local property taxes based on an interpretation of the so-called “profit test’. See AHS Hospital Corp. v. Town of Morristown, 28 N.J. Tax 456 (2015).  This test is based on the elements of the Paper Mill Playhouse decision which overlap to some degree with the Kuchera elements: (1) the owner of the property must be organized exclusively for the exempt purpose; (2) its property must be actually and exclusively used for the tax-exempt purpose; and (3) its operation and use of its property must not be conducted for profit”. See Paper Mill Playhouse v. Millburn Township, 95 N.J. 503, 506 (1984). The AHS tax court found that many of the facilities involved were not exempt as a result of not meeting the third element of the test as the Hospital “entangled its activities and operations with those of other for-profit entities, thus allowing its property to be used for profit”. AHS Hospital Corp., supra. Recently, the IRS denied tax-exempt status of a hospital as result of a lease agreement it entered into with a for-profit entity. See Herschman, “Hospital Involved in Joint Venture with For-Profit Entity Loses Tax-Exempt Status” National Law Review (December 6, 2017).

These recent developments highlight the importance for non-profit hospitals to follow the guidance the N.J. Supreme Court issued relating to maintaining non-profit status and continuing to demonstrate the fulfillment of “hospital purposes” as the term is applied in the modern context.  Under the Kuchera analysis the focus is not on whether the hospital is exclusively organized for charitable purposes or exclusively acting as a charity (as plaintiffs have attempted to argue especially as it relates to some of the larger non-profit entities with relatively high overall revenues). The challenges highlight the importance of applicable statutory and regulatory compliance as it relates to both the organization of the not-for profit and the ongoing activities to avoid the entanglement with for-profit entities or purposes. Those facing challenges to tax-exempt status may look to the N.J. Supreme Court’s emphasis on the role of the modern hospital in society in order to highlight the aspects of multitude of the charitable and related societal benefits and programs which the hospitals routinely engage which are not driven by monetary profit motive.

Does a “Do Not Resuscitate” Tattoo Accurately Reflect A Patient’s Wish?

The word “tattoo” comes from the Tahitian word “tatu” which means “to mark something” and historians believe the practice began roughly between 3370 and 3100 BC. However, in 2017 medical physicians faced an ethical dilemma that few have experienced when an unconscious man arrived in the emergency room with a tattoo that read “Do Not Resuscitate” illustrated on this chest.

Doctors at Jackson Memorial Hospital in Florida had discussed this quandary but had never been faced with it. The 70-year-old man’s blood pressure was dropping and he had a history of chronic obstructive pulmonary disease and diabetes. Medical ethicist Dr. Arthur Caplan, Ph.D., who was not involved in the patient’s case, reported to CBS News “there’s no law that says you have to respect or recognize a tattoo”. In the United States people have the right to ask not to be resuscitated in the event of a medical emergency and can express their wishes known ahead of time in the event they one day find themselves alone or incapacitated.

Naturally, not all inscriptions are to be taken literally. Nonetheless, medical tattoos have been on the rise for the past few years. As reported in USA Today, medical tattoos first appeared in 2014 to alert doctors to conditions such as diabetes. While a tattoo certainly has a penetrating power, legibility and decipherability may be an issue, especially during a medical emergency.

Normally when faced with ethical conundrums, doctors do not want to choose an irreversible path. As such, doctors attempted to wake the unconscious patient, but he was in a delirious state and unable to respond. The patient also arrived at the hospital without ID or family and next of kin could not be reached. The ethical team eventually ruled that the tattoo expressed his wishes and told doctors to follow his orders. The patient’s status deteriorated throughout the night and he eventually died without intervention. Eventually, the patient’s written DNR request was later found at his home.

Dr. Gregory Holt, an assistant professor of medicine at the University of Miami helped write a case study that was published in The New England Journal of Medicine. The case study conveyed that the tattoo “produced more confusion than clarity, given concerns about its legality and likely unfounded beliefs that tattoos might represent permanent reminders of regretted decisions made while the person was intoxicated.” In the event medical tattoos become more popular it will be interesting to see if legislation is passed on how to properly treat a patient who has medical instructive ink.

For patients, while a tattoo might seem like the most convenient way to convey one’s wishes, it is still important to have a formal Do Not Resuscitate order and to consider a living will or advance directive to make your wishes clear and alleviate potential confusion. For providers, this case study highlights the evolving cultural trends and individuals involved in critical and emergency care must be prepared to address such a situation should it arise since many times there is limited time to research and debate whether such a tattoo will be honored.