[Required Framework for the Collection of Real-life Data: An Example from University Eye Hospital Munich]. / Rahmenbedingungen zur Sammlung von "Real-Life"-Daten am Beispiel der Augenklinik der Universität München.

Background The importance of evaluating real-life data is constantly increasing. Currently available computer systems better allow for analyses of data, as more and more data is available in a digital form. Before a project for real-life data analyses is started, technical considerations and staff, legal, and data protection procedures need to be addressed. In this manuscript, experiences made at the University Eye Hospital in Munich will be shared. Materials and Methods Legal requirements, as found in laws and guidelines governing documentation and data privacy, are highlighted. Technical requirements for information technology infrastructure and software are defined. A survey conducted by the German Ophthalmological Society, among German eye hospitals investigating the current state of digitalization, was conducted. Also, staff requirements are outlined. Results A database comprising results of 330,801 patients was set up. It includes all diagnoses, procedures, clinical findings and results from diagnostic devices. This database was approved by the local data protection officer. In less than half of German eye hospitals (n = 21) that participated in the survey (n = 54), a complete electronic documentation is done. Fourteen institutions are completely paper-based, and the remainder of the hospitals used a mixed system. Conclusion In this work, we examined the framework that is required to develop a comprehensive database containing real-life data from clinics. In future, these databases will become increasingly important as more and more innovation are made in decision support systems. The base for this is comprehensive and well-curated databases.

Moral Legitimacy: The Struggle Of Homeopathy in the NHS.

This article deploys a well-established theoretical model from the accountability literature to the domain of bioethics. Specifically, homeopathy is identified as a controversial industry and the strategic action of advocates to secure moral legitimacy and attract public funding is explored. The Glasgow Homeopathic Hospital (GHH) is used as the location to examine legitimizing strategies, from gaining legitimacy as a National Health Service (NHS) hospital in 1948, followed by maintaining and repairing legitimacy in response to government enquires in 2000 and 2010. An analysis of legitimizing strategies leads to the conclusion that advocates have been unsuccessful in maintaining and repairing moral legitimacy for homeopathy, thus threatening continued public funding for this unscientific medical modality. This is an encouraging development towards open and transparent NHS accountability for targeting limited public resources in pursuit of maximizing society's health and well-being. Policy implications and areas for future research are suggested.

[Actors in liver transplantation advocate greater transparency and systematic evaluations of transplant centres]. / Akteure der Lebertransplantation befürworten größere Transparenz und systematische Evaluationen der Transplantationszentren.

BACKGROUND: Following the introduction of the MELD score, the survival rates have worsened after liver transplantation (LTX) in Germany. Existing organ shortages, shorter survival rates after LTX, and failures in the liver allocation process provide true challenges. Facilitated by a structured questionnaire, the appropriate German liver transplantation actors were approached with regard to these challenges for the first time. The aim was to provide a balanced experts' view in an anonymous fashion thereby identifying areas for potential improvement. METHOD: Data collection was performed by a structured, standardised, anonymous survey of all LTX centres in Germany. RESULTS: We received 75 % replies of the questionnaires, 35 of 36 participants responded to more than 75 % of all questions. The following key points were highlighted. A minimum amount of LTX per centre was deemed important and monetary incentives must not exist. The ultimate goal of LTX is a prolongation of life and social as well as occupational reintegration. Quality management and transparent LTX registers are prerequisites for both adequate organ allocation and distribution of resources in order to achieve the best possible transplant outcomes. CONCLUSION: The German liver transplant experts consider transparency of organ allocation and systematic evaluation of the quality of transplant centres and the transplantation process itself to be mandatory, however, executed in a participatory way. A scoring system to facilitate the decision making process in order to predict the likelihood of satisfactory LTX outcome thereby circumventing some of the ethical and constitutional doubts would be highly appreciated.

Reporting of quality measures in gynecologic oncology programs at Prospective Payment System (PPS)-Exempt Cancer Hospitals: an early glimpse into a challenging initiative.

OBJECTIVE: The Affordable Care Act mandates the Prospective Payment System (PPS)-Exempt Cancer Hospitals Quality Reporting program. These 11 hospitals (which are paid fee-for-service rather than on a DRG system) began reporting measures (2 general safety, 2 breast, 1 colon) in 2013. Given this reporting mandate, we set out to determine whether the PPS-exempt gynecologic oncology programs could identify quality measures specific to the care of our patients. METHODS: A list of 12 quality measures specific to gynecologic oncology was created (from sources including the National Quality Forum and the SGO). Measures already in use were not included. The list was ranked by the gynecologic oncology program directors at the PPS-exempt hospitals. Descriptive statistics (including mean and SD for rankings) were utilized. RESULTS: Despite mandatory reporting of quality measures for PPS-exempt cancer hospitals, little consensus exists regarding specific gynecologic cancer measures. Documentation of debulking status, cancer survival, and offering minimally invasive surgery (for endometrial cancer) and intraperitoneal chemotherapy (for ovarian cancer) are important, but with widely variable responses (when ranked 1-12, standard deviations are 2-3). General issues regarding adherence to guidelines for the use of GCSF, documentation of functional status, and tracking of patient satisfaction scores were ranked the lowest. Three of the directors reported that their compensation is partially linked to quality outcomes. CONCLUSIONS: There is wide variability in ranking of quality measures, and may relate to provider or institutional factors. Despite the mandatory reporting in PPS-exempt cancer hospitals, work remains to define gynecologic cancer quality measures.

[Amendment of the structural quality for inpatient rheumatology. A forward-looking concept]. / Neufassung der Strukturqualität der akut-stationären Rheumatologie. Ein zukunftsweisendes Projekt.

In 2010 a total of 9 guidelines on structural quality were endorsed by the Association of Rheumatology Clinics in Germany (VRA). These 9 structural criteria replace the regulations published in 2002 and were elaborated with the support of the German Rheumatology League. With guideline number 9 even the structural requirements for university hospitals are defined for the first time.Along with taking part in the quality project "Kobra" (continuous outcome benchmarking in rheumatology inpatient treatment) compliance with the new structural criteria constitutes a prerequisite for acquiring a quality certificate, which is awarded by an external institution.By this means the VRA sets the stage for its members to be prepared for future challenges and quality competition among hospitals. Furthermore, the provision of a high quality treatment for chronically diseased patients in rheumatology clinics will be effectively supported.

Aligning physician and hospital incentives: the approach at hospital for special surgery.

Healthcare administrators and physicians alike are navigating an increasingly complex and highly regulated healthcare environment. Unlike in the past, institutions now require strong collaboration among physician and administrative leaders. As providers and managers are trained and work differently, new methods are needed to provide the infrastructure and resources necessary to create, nurture, and sustain alignment between them. We describe four initiatives by administrators and physicians at Hospital for Special Surgery to work together in mutually beneficial relationships that help us achieve the highest level of patient care, satisfaction and safety. These initiatives include improving management efficiency through an orthopaedic service line structure, helping individual physicians grow their practices through the demand-office-operating room initiative of the Physicians Service Department, controlling costs through the supply effectiveness policy, and promoting teamwork in innovation through the technology transfer program.

[Legal aspects of compulsory hospitalization of incompliant patients with tuberculosis].

The main task of an antituberculosis service is to treat patients with tuberculosis and to follow up needy persons in order to prevent the spread of tuberculosis among the population. However, phthisiatricians are unable to solve some problems without assistance from the government as they are associated with social and behavioral causes--no or partial patient's motivation for treatment. Early therapy discontinuation in patients with tuberculosis, latent or obvious interruption of chemotherapy, patients' use of a partial dose of drugs give the vast majority of Russian phthisiatricians concern. These lower the efficiency of treatment, increase the likelihood of drug resistance in Mycobacterium tuberculosis, and contribute to the chronic pattern of the tuberculosis process, continuously replenishing the pool of untreatable patients with tuberculosis and bacterial discharge. An incompliant tuberculosis patient discharging bacteria may be compulsorily taken to a tuberculosis hospital by the court decision. This is in line with Article 10, the 18 June, 2001 Federal Law No. 77--"On Prevention of Tuberculosis Spread in the Russian Federation". This investigation was undertaken to enhance the effectiveness of involvement of incompliant bacteria-discharging patients with tuberculosis to compulsory examination and treatment. The mechanism of realization of Article 10 of the abovementioned Law was analyzed from the experience of an antituberculosis service of the Ryazan Region (178 writs). At present, it is impossible to fulfill this Article 10 in corpore due to there is an improper legal base that is in no subordinate legislation and actuate sentences for non-implementation of court decisions. Subordinate legislation regulating a compulsory hospitalization procedure by officers of justice should be elaborated. It is necessary to introduce amendments into the base to make patients with infectious tuberculosis who have not carried a court decision on compulsory hospitalization. Tuberculosis facilities should be used to set up social centers for the complex work and treatment of socially dysadapted patients with tuberculosis (including those who have been released from confinement institutions). For this, tuberculosis institutions should be staffed by social workers, psychologists, psychiatrists, lawyers, and narcology experts with the appropriate funds being allocated.

The attack on ancillary service providers at the federal and state level.

The health care delivery system in the United States has witnessed more dramatic changes during the last decade than it had since the passage of Medicare. The managed care revolution and changes in reimbursement for Medicare services have forced providers to look for more efficient ways to provide services as well as for additional sources of revenue- and margin-producing business. The move toward specialized inpatient and outpatient facilities, often owned by physicians, is a natural reaction to these significant changes. These developments have resulted a "turf war" between physicians and hospitals over who should control these revenues.

Back in business. Heartland Spine & Specialty Hospital showed that a small, physician-owned hospital can beat the big guys in court.

It's too soon to tell if a precedent has been set, officials say, but the Heartland Spine settlement could serve as a "guidepost" for other physician-owned hospitals feeling squeezed out of their markets. But Jeff Micklos, left, the Federation of American Hospitals' general counsel, said: "I don't think this settlement or any settlement changes the underlying influence of conflict of interest of physician-owners who self-refer.

The implications of reimbursement changes for specialty hospitals.

Although proposed Medicare reimbursement changes may reduce financial incentives to develop specialty hospitals, other anticipated reimbursement changes, such as pay for performance, could perpetuate current growth trends. Hospital executives will need to develop new tools for coping with the continued development of specialty hospitals.

Limited service maximum fuss. Specialty hospital issue has caught the attention of senators as a physician-owned Oregon facility fights for its Medicare status.

The battle over specialty hospitals got more bruising last week, with two powerful senators seeking more oversight data, and a hospital that's become a symbol of the controversy fighting for its life. The AMA's William Plested, left, says the problem isn't specialty hospitals, but how hospitals are paid. "The way all payments are figured makes winners and losers," he says, noting for-profits contribute to communities through taxes.

Specialty versus community hospitals: what role for the law?

U.S. health care has long featured a struggle between regulation and markets as vehicles of reform, and the community hospital is at the center of this struggle. The key to its financial viability is cross-subsidization, whereby revenues from insured patients subsidize the care of the uninsured and underinsured, and profits from well-compensated services support those operating at a loss. Cross-subsidization has been challenged by efforts to move highly compensated services and well-insured patients to ambulatory surgical centers and specialty hospitals. We review the ongoing battle between through a legal lens and offer conjectures about the outcome. Refined certificate-of-need regulation may be the preferable policy choice.

Understanding the physician-owned specialty hospital phenomenon: the confluence of DRG payment methodology and physician self-referral laws.

Physician-owned specialty hospitals have flourished in today's healthcare arena, but also have been the subject of a great deal of controversy. The author argues that the rise of specialty hospitals has been the result of a confluence of two healthcare policies: (1) skewed DRG payment methodologies and (2) the misapplication of exemptions to the Stark Law's ban on physician self-referral. This Article examines the aspects of these healthcare policies that have allowed for the explosion of specialty hospitals, as well as the arguments for and against the creation and need for specialty hospitals. The Article also analyzes the reform proposals to correct the Stark and DRG methodologies and how those proposals will affect both specialty and general hospitals.

Orthopedic-driven ambulatory surgery centers and specialty hospitals--a physician and hospital perspective.

This article provides an overview of several issues facing the orthopedic-driven ambulatory surgery center and specialty hospital development industry. The article specifically then reviews certain key business drivers to industry growth, examines key risks related to ASC and specialty hospital projects, and provides a brief review of certain legal issues related to the same.