Medical Oversight and Scope of Practice of Medical Spas (Med-Spas).

BACKGROUND: The regulation of medical spas (med-spas) in the United States varies considerably from state to state with important ramifications for patient safety. OBJECTIVE: To describe the current state of med-spas in the United States and degree of medical oversight in these facilities. MATERIALS AND METHODS: Descriptive study based on web search and standardized phone interviews of med-spas in the most heavily populated cities in each state of the United States. Information obtained included the following: whether medical directors were listed; if so, whether they were advertised as being on site; medical directors' training and board certification; and services offered. RESULTS: Of 247 medical spas reviewed, 72% advertised a medical director on their website, and 6.5% claimed that the director was on site. Of listed medical directors, 41% were trained in dermatology and/or plastic surgery. In phone interviews, 79% of med-spas endorsed the medical director to be board certified, and 52% stated that the medical director was on site less than 50% of the time. CONCLUSION: There is significant variation in medical directorship and oversight among medical spas in the United States. Appropriate regulation of medical directors' training and the degree of oversight provided are warranted to optimize patient safety.

The medical-legal responsibilities of a dialysis unit medical director.

The specialty of Nephrology, by virtue of its relationship with the dialysis procedure, is highly vulnerable to litigation. As is the case with all nephrologists, a dialysis unit medical director is not immune to medical malpractice suits, and can be held liable for any act of perceived or potential harm to any dialysis patient, regardless of the director's level of involvement. The medical director, per the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation, accepts the responsibilities, accountability, and consequent legal liabilities of the quality of the medical care provided to every dialysis patient in the unit. This review is a synopsis of lawsuits filed against medical directors of dialysis units in the past forty years. Six categories of legal actions were noted; medical malpractice, fraudulent claims, self-referral and Stark Law, discrimination, negligence, and violation of patient autonomy and dignity.

What is expected of a medical director in the Centers for Medicare and Medicaid Services Conditions of Coverage?

The Medicare Conditions for Coverage for dialysis facilities, effective since 2008, make the medical director responsible for all levels of quality patient care in the facility. This includes issues such as water quality, infection control, staff education, policy/procedure development and implementation, dialyzer reuse, involuntary discharges, and patient safety. Most importantly, the medical director is the leader of the team responsible for quality assessment and performance improvement, which is central to the process of continuous quality improvement in the dialysis facility and the basis for much of Medicare's evaluation of facility performance. Through the measures assessment tool, the Conditions for Coverage specify the required domains for quality improvement activities in the dialysis facility, including dialysis adequacy, nutrition, bone disease, anemia management, vascular access, medical errors, patient satisfaction, and infection control. Under the leadership of the medical director, the quality assessment and performance improvement team identifies opportunities for improvement, tests and implements interventions, collects data, interprets results, and links system change with improved outcomes. These activities are rigorously documented and provide evidence to Medicare that the facility is acting responsibly to provide the best possible services for which it is being paid. The medical director is fairly compensated for his/her services by the facility, but must always act in the patients' best interest when evaluating policy changes directed at cost containment. The success of a medical director in shepherding positive change in a dialysis facility can be immensely satisfying as it impacts on patients other than his/her own.

[Personnel reduction in clinics and legal responsibility]. / Personalabbau in der Klinik und rechtliche Verantwortung : Personnel reduction in clinics and legal responsibility.

Executive clinical physicians are increasingly being made jointly responsible for the economic success of clinics and it is to be expected that this joint responsibility will result in measures to reduce personnel. In this article it will be explained to which limits a reduction in medical personnel can be justified with respect to liability and from what level a reduction in staff can result in forensic risks. Furthermore, it will be discussed which liability or even penal responsibility in this connection affects the physicians, the hospital and especially the senior medical personnel.

Serving two masters? Recent legal developments regarding the professional obligations of medical administrators in Australia.

Medical administration is a recognised medical specialty in Australia. Historically, medical administrators have rarely been subjected to litigation or disciplinary hearings relating specifically to their administrative functions. However, the legal landscape for medical administrators in Australia appears to be shifting. In 2009, the Queensland Health Practitioners Tribunal heard two separate cases involving the professional conduct of medical administrators who were implicated in the scandal surrounding Dr. Jayant Patel at Bundaberg Hospital. In September 2010, judgment in one of those cases was delivered. This article reviews the tribunal's decision through the lens of relevant United Kingdom authorities and recent legislative changes in Australia regulating the health professions.

[Breach of secrecy by handing out psychiatric certificates]. / Schweigepflichtsverletzung durch Weitergabe psychiatrischer Atteste. Zu den Grenzen arztlichen Handelns und zur Rolle der Ehefrau im psychiatrischen Kontext.

The article reports about a medical malpractice case against the director of a psychiatric University Hospital, who was convicted for breach of secrecy by the Oberlandesgericht in Munich. The court found him guilty of issuing and giving to the plaintiff's wife an unauthorised psychiatric certificate, stating that the plaintiff, a carpet dealer for oriental rugs, who was caught in a war of roses with his wife at this time and was never a patient of the psychiatrist, let alone properly examined by him or his staff, suffered from an acute and severe psychosis with immediate need for compulsory admission. This all happened behind his back and enabled the wife to spread rumors of the alleged mental illness of her husband. Banks and trading partners therefore shunned him, which nearly caused his bankruptcy. This is why this unusual case led to the decision that the psychiatrist had to reimburse Euro 15000 for pain and suffering and additionally cover all material damages resulting from the tort.

Contested roles of Canada's Chief Medical Officers of Health.

The roles and responsibilities of Canada's Chief Medical Officers of Health (CMOHs) are contested. On the one hand, they are senior public servants who confidentially advise government on public health matters and manage the implementation of government priorities. On the other hand, CMOHs are perceived as independent communicators and advocates for public health. This article analyzes public health legislation across Canada that governs the CMOH role. Our legal analysis reveals that the presence and degree of advisory, communication, and management roles for the CMOH vary considerably across the country. In many jurisdictions, the power and authority of the CMOH is not clearly defined in legislation. This creates great potential for confusion and conflict, particularly with respect to CMOHs' authority to act as public health advocates. We call on governments to clarify their preferences when it comes to the CMOH role and either amend the relevant statute or otherwise find ways to clarify the mandate of their CMOHs.

The role of the medical laboratory director.

The American Medical Association notes in its Principles of Medical Ethics that a physician "shall be dedicated to provide competent medical service with compassion and respect for human dignity." As physicians whose profession involves the medical direction of pathology and clinical laboratory services, pathologists strive to provide high-quality, cost-effective services to support the needs of patient care. These services must be provided under the aegis of extensive legal and regulatory mandates of various governmental and nongovernmental entities. To accomplish his/her task, the pathologist can use tools of evidence-based medicine and clinical practice guidelines together with his/her medical and scientific training and experience. At the same time, the Medical Director must be able to measure and demonstrate the value of his/her contribution in today's competitive environment.

How to avoid deferred-compensation troubles.

Executive compensation packages have long included stock options and deferred compensation plans in order to compete for talent. Last year, Congress passed a law in response to the Enron debacle, in which executives were perceived to be protecting their deferred compensation at the expense of employees, creditors, and investors. The new law is designed to protect companies and their shareholders from being raided by the very executives that guided the company to financial ruin. Physicians who are part owners of medical practices need to know about the changes in the law regarding deferred compensation and how to avoid costly tax penalties. This article discusses how the changes affect medical practices as well as steps physician-owned clinics can take to avoid the risk of penalty, such as freezing deferred compensation and creating a new deferred compensation plan.

Legal Issues for the Medical Director.

The nephrologist serving as medical director of a dialysis clinic must understand that the role of director is not simply an extension of being a good nephrologist. The two roles-nephrology practice and the leadership of a dialysis clinic-may be filled by a single person. However, each role contains unique tasks, requiring specific skill sets, and each role comes with inherent, associated legal risks. The medical director assumes a new level of responsibility and accountability defined by contractual obligations to the dialysis provider and by state and federal regulations. Hence, a medical director is accountable not only for providing standard-of-care treatment to his or her private practice patients dialyzed at the clinic but also for maintaining the safety of the dialysis clinic patient population and staff. Accordingly, a nephrologist serving in the role of medical director faces distinct legal risks beyond typical professional liability concerns. The medical director must also be mindful of regulatory compliance, unique avenues to licensure board complaints, and implications of careless communication habits. A thoughtful and prepared medical director can mitigate these risk exposures by understanding the sources of these challenges: contractual obligations, pertinent regulatory responsibilities, and the modern electronic communications environment.

The preliminary impact of Maryland's medical director and attending physician regulations.

OBJECTIVES: To identify the impact of the regulations implemented in Maryland in 2001, related to nursing home attending physicians and medical directors, and nursing home quality assurance requirements, on Maryland nursing homes, administrators, and physicians. DESIGN: Two surveys were mailed to all nursing home administrators in Maryland, one for their completion and one to give to their medical directors to complete. These surveys were to be returned by mail to the authors. SETTING: All nursing homes in all jurisdictions in Maryland. PARTICIPANTS: Two-fifths of administrators and medical directors in Maryland nursing homes completed and returned the survey. MEASUREMENTS: Results were tabulated for each question of each survey, and were calculated as percentages of the total responses. Additionally, individual comments were reviewed. RESULTS: A relatively large sample of administrators and medical directors in Maryland responded. Most respondents were positive or at least neutral about the impact of these regulations on them and their organizations. Many administrators agreed that there had been improvements in medical director participation and performance. There were significant advances in medical director compensation. There were relatively few negative comments about the impact. CONCLUSION: Requirements for physician and medical director accountability appear to have had a positive impact on medical director performance and relationships with nursing home administrators. Additional study is warranted to measure the impact of that performance on patient care outcomes and facility performance.

Doctors in the executive suite: should the U.S. and U.K. be putting M.D. licensure at risk for shortfalls in institutional quality of care?

As our healthcare system becomes further managed, delivery organizations are reincreasingly relying upon physician executives to administer the delivery of care by other individual providers. In both the United States and the United Kingdom, this has led to instances in which physician disciplinary procedures have been invoked with respect to physicians who are perceived to be responsible for institutional defiiciencies. The author examines and analyzes the contrasting approaches taken in the two countries, and recommends an activist approach for disciplinary agencies faced with these circumstances.

The liability of medical directors for utilization review decisions.

Managed Care Organizations (MCOs) have turned to numerous cost-containment measures to combat rising healthcare costs. One of the most common is the use of utilization review to ascertain whether a recommended mode of treatment is "medically necessary." When the medical director of an MCO determines that care recommended by a patient's treating physician is not medically necessary and not eligible for coverage (and, as a result, potentially unattainable due to cost), the stage is set for litigation. In such situations, medical directors may become potentially liable for disciplinary action by their state medical licensing board as well as lawsuits for malpractice or negligence. However, plaintiffs wishing to recover damages for improper determinations of this nature or state boards trying to discipline these physicians, face the hurdles of the preemptive force of ERISA, and state doctrines to the effect that corporations (and, derivatively, their medical directors) cannot practice medicine and therefore cannot be liable for malpractice. Conflicting decisions and opinions make it impossible at the present time to have a settled expectation regarding the potential liability of medical directors in this context, although the law appears to be moving toward the treatment of utilization review as medical decisionmaking; therefore, it appears likely that the activities of medical directors increasingly will face state oversight--including the imposition of common law liability in appropriate situations.

Medicare and Medicaid programs; revisions to conditions of participation for hospitals--HCFA. Final rule.

This final rule establishes as a condition of participation (which facilities must meet in order to participate in the Medicare and Medicaid programs) the requirement that hospitals have a discharge planning process for patients who require such services and specifies the elements of that process. It also changes the required qualifications of a hospital's medical director. These provisions implement sections 9305(c) of the Omnibus Budget Reconciliation Act of 1986 (OBRA '86) and 6025 of the Omnibus Budget Reconciliation Act of 1989. Also, we are not adopting several minor proposed revisions to the conditions for coverage of suppliers of end-stage renal disease (ESRD) services. We are now developing comprehensive revisions to the ESRD regulations and believe that it would be appropriate to reconsider the proposed changes as part of that rulemaking process.